MEDIWOUND LTD.
|
|||
Date: November 14, 2019
|
By:
|
/s/ Sharon Malka | |
Name: Sharon Malka | |||
Title: Chief Executive Officer | |||
Exhibit |
Description
|
• |
Total revenues for the third quarter of 2019 were $5.1, driven primarily by revenues from development services;
|
• |
As of September 30, 2019, the Company had $32.9 million in cash and short-term investments, compared to $23.6 million as of December 31, 2018;
|
• |
Initiated the NexoBrid Expanded Access Treatment (NEXT) protocol to treat burn patients with deep partial and full-thickness burns in the U.S. during the ongoing preparation and review of the NexoBrid Biologics License Application
(BLA);
|
• |
The safety data of cosmesis and function collected in the U.S Phase 3 (DETECT) twelve-months patients follow-up period, was comparable between the NexoBrid and the Standard of Care arm and no new safety signals were observed;
|
• |
Highlighted NexoBrid cost effectiveness data and use experience by leaders in the field of burn care in 39 scientific presentations at the 18th European Burns Association (EBA) Congress in Helsinki;
|
• |
Launched the next stage of the U.S. clinical development program for EscharEx, the Company’s topical biological drug candidate for the debridement of chronic and hard-to-heal wounds, with plans to initiate patient treatment in an
adaptive design Phase 2 study in Venus Leg Ulcer in the fourth quarter of 2019.
|
Contacts:
|
|
Boaz Gur-Lavie
|
Jeremy Feffer
|
Chief Financial Officer
|
Managing Director, LifeSci Advisors
|
MediWound Ltd.
|
212-915-2568
|
ir@mediwound.com
|
jeremy@lifesciadvisors.com
|
|
September 30,
|
December 31,
|
||||||||||
|
2019
|
2018
|
2018
|
|||||||||
|
Un-audited
|
Audited
|
||||||||||
Cash, cash equivalents and short term deposits
|
32,856
|
25,738
|
23,633
|
|||||||||
Accounts and other receivable
|
5,156
|
4,704
|
7,400
|
|||||||||
Inventories
|
1,419
|
1,742
|
1,680
|
|||||||||
Total current assets
|
39,431
|
32,184
|
32,713
|
|||||||||
Long term deposits
|
14
|
57
|
48
|
|||||||||
Property, plant and equipment, net
|
2,169
|
2,004
|
2,020
|
|||||||||
Right of use assets
|
2,254
|
-
|
-
|
|||||||||
Intangible assets, net
|
446
|
512
|
495
|
|||||||||
Total long term assets
|
4,883
|
2,573
|
2,563
|
|||||||||
|
||||||||||||
Total assets
|
44,314
|
34,757
|
35,276
|
|||||||||
Current maturities of long-term liabilities
|
810
|
533
|
146
|
|||||||||
Trade payables and accrued expenses
|
2,863
|
3,563
|
2,715
|
|||||||||
Liability in respect of discontinued operation
|
2,240
|
-
|
-
|
|||||||||
Other payables
|
4,898
|
1,792
|
2,036
|
|||||||||
Total current liabilities
|
10,811
|
5,888
|
4,897
|
|||||||||
Deferred revenues
|
1,134
|
1,169
|
1,158
|
|||||||||
Liabilities in respect of Israeli Innovation Authority grants net of current maturities
|
7,099
|
7,850
|
7,568
|
|||||||||
Contingent consideration for the purchase of shares net of current maturities
|
4,621
|
15,292
|
6,330
|
|||||||||
Liability in respect of discontinued operation
|
-
|
6,003
|
6,003
|
|||||||||
Lease liabilities net of current maturities
|
2,015
|
-
|
-
|
|||||||||
Severance pay liability, net
|
316
|
333
|
348
|
|||||||||
Total long term liabilities
|
15,185
|
30,647
|
21,407
|
|||||||||
|
||||||||||||
Shareholders' equity (deficit)
|
18,318
|
(1,778
|
)
|
8,972
|
||||||||
Total liabilities & shareholder equity
|
44,314
|
34,757
|
35,276
|
|
Nine months ended
|
Three months ended
|
||||||||||||||
|
September 30,
|
September 30,
|
||||||||||||||
|
2019
|
2018
|
2019
|
2018
|
||||||||||||
Revenues
|
26,347
|
2,409
|
5,140
|
858
|
||||||||||||
Cost of revenues
|
8,202
|
1,396
|
4,414
|
386
|
||||||||||||
Gross profit
|
18,145
|
1,013
|
726
|
472
|
||||||||||||
Operating expenses:
|
||||||||||||||||
Research and development, gross
|
7,799
|
14,517
|
1,296
|
5,128
|
||||||||||||
Participation by BARDA & IIA
|
(4,568
|
)
|
(10,180
|
)
|
56
|
(3,882
|
)
|
|||||||||
Research and development, net
|
3,231
|
4,337
|
1,352
|
1,246
|
||||||||||||
Selling, general & administrative
|
6,236
|
5,254
|
1,956
|
1,466
|
||||||||||||
Other expenses, net
|
1,041
|
662
|
140
|
-
|
||||||||||||
Operating Profit (loss)
|
7,637
|
(9,240
|
)
|
(2,722
|
)
|
(2,240
|
)
|
|||||||||
Financial expenses, net
|
(2,045
|
)
|
(2,420
|
)
|
(242
|
)
|
(704
|
)
|
||||||||
Profit (loss) from continuing operation
|
5,592
|
(11,660
|
)
|
(2,964
|
)
|
(2,944
|
)
|
|||||||||
Profit from discontinued operation
|
2,806
|
-
|
2,756
|
-
|
||||||||||||
Net Profit (loss) for the period
|
8,398
|
(11,660
|
)
|
(208
|
)
|
(2,944
|
)
|
|||||||||
|
||||||||||||||||
Foreign currency translation adjustments
|
17
|
9
|
15
|
1
|
||||||||||||
Total comprehensive profit (loss)
|
8,415
|
(11,651
|
)
|
(193
|
)
|
(2,943
|
)
|
|||||||||
|
||||||||||||||||
Basic and diluted loss per share:
|
||||||||||||||||
Profit (loss) from continuing operations
|
0.21
|
(0.43
|
)
|
(0.11
|
)
|
(0.11
|
)
|
|||||||||
Profit from discontinued operation
|
0.10
|
-
|
0.10
|
-
|
||||||||||||
Net Profit (loss) per share
|
0.31
|
(0.43
|
)
|
(0.01
|
)
|
(0.11
|
)
|
|||||||||
|
||||||||||||||||
Weighted average number of ordinary shares used in the computation of basic and diluted profit /loss per share:
|
27,179
|
27,092
|
27,179
|
27,179
|
Nine months ended
|
Three months ended
|
|||||||||||||||
|
September 30,
|
September 30,
|
||||||||||||||
|
2019
|
2018
|
2019
|
2018
|
||||||||||||
Profit (Loss) for the period
|
8,398
|
(11,660
|
)
|
(208
|
)
|
(2,944
|
)
|
|||||||||
Adjustments:
|
||||||||||||||||
Financial expenses, net
|
(2,045
|
)
|
(2,420
|
)
|
(242
|
)
|
(704
|
)
|
||||||||
Profit from discontinued operation
|
2,806
|
-
|
2,756
|
-
|
||||||||||||
Other expenses
|
(1,041
|
)
|
(662
|
)
|
(140
|
)
|
-
|
|||||||||
Depreciation and amortization
|
(848
|
)
|
(447
|
)
|
(296
|
)
|
(142
|
)
|
||||||||
Share-based compensation expenses
|
(931
|
)
|
(502
|
)
|
(332
|
)
|
(135
|
)
|
||||||||
Total adjustments
|
(2,059
|
)
|
(4,031
|
)
|
1,746
|
(981
|
)
|
|||||||||
Adjusted EBITDA
|
10,457
|
(7,629
|
)
|
(1,954
|
)
|
(1,963
|
)
|
|
Nine months ended
|
Three months ended
|
||||||||||||||
|
September 30,
|
September 30,
|
||||||||||||||
|
2019
|
2018
|
2019
|
2018
|
||||||||||||
Cash Flows from Operating Activities:
|
||||||||||||||||
Net profit (loss)
|
8,398
|
(11,660
|
)
|
(208
|
)
|
(2,944
|
)
|
|||||||||
Adjustments to reconcile net profit (loss) to net cash used in continuing operating activities:
|
||||||||||||||||
Adjustments to profit and loss items:
|
||||||||||||||||
Profit from discontinued operation
|
(2,806
|
)
|
-
|
(2,756
|
)
|
-
|
||||||||||
Depreciation and amortization
|
848
|
447
|
296
|
142
|
||||||||||||
Share-based compensation
|
931
|
502
|
332
|
135
|
||||||||||||
Revaluation of liabilities in respect of IIA grants
|
(99
|
)
|
624
|
293
|
220
|
|||||||||||
Revaluation of contingent consideration for the purchase of shares
|
1,519
|
1,694
|
197
|
582
|
||||||||||||
Revaluation of lease liabilities
|
(291
|
)
|
-
|
(485
|
)
|
-
|
||||||||||
Increase (decrease) in severance liability, net
|
(32
|
)
|
3
|
(22
|
)
|
(3
|
)
|
|||||||||
Financing income
|
(295
|
)
|
(255
|
)
|
(146
|
)
|
(73
|
)
|
||||||||
Unrealized foreign currency (gain) loss
|
(52
|
)
|
67
|
18
|
(59
|
)
|
||||||||||
|
(277
|
)
|
3,082
|
(2,273
|
)
|
944
|
||||||||||
Changes in asset and liability items:
|
||||||||||||||||
Decrease (increase) in trade receivables
|
(3,955
|
)
|
(314
|
)
|
(3,946
|
)
|
107
|
|||||||||
Decrease in inventories
|
260
|
144
|
114
|
129
|
||||||||||||
Decrease (increase) in other receivables
|
5,198
|
(1,321
|
)
|
2,454
|
251
|
|||||||||||
Increase (decrease) in trade payables
|
150
|
311
|
(1,207
|
)
|
237
|
|||||||||||
Increase (decrease) in other payables & deferred revenues
|
810
|
(389
|
)
|
281
|
(53
|
)
|
||||||||||
|
2,463
|
(1,569
|
)
|
(2,304
|
)
|
671
|
||||||||||
Net cash provided by (used in) operating activities
|
10,584
|
(10,147
|
)
|
(4,785
|
)
|
(1,329
|
)
|
|
Nine months ended
|
Three months ended
|
||||||||||||||
|
September 30,
|
September 30,
|
||||||||||||||
|
2019
|
2018
|
2019
|
2018
|
||||||||||||
Cash Flows from Investment Activities:
|
||||||||||||||||
Purchase of property and equipment
|
(463
|
)
|
(391
|
)
|
(30
|
)
|
(78
|
)
|
||||||||
Purchase of intangible assets
|
-
|
(13
|
)
|
-
|
-
|
|||||||||||
Interest received
|
104
|
44
|
60
|
42
|
||||||||||||
Proceeds from (investment in) short term bank deposits, net of investments
|
(8,005
|
)
|
(20,616
|
)
|
(10,982
|
)
|
549
|
|||||||||
Net cash provided by (used in) continuing investing activities
|
(8,364
|
)
|
(20,976
|
)
|
(10,952
|
)
|
513
|
|||||||||
Net cash used in discontinued investing activities
|
(957
|
)
|
-
|
(1,007
|
)
|
-
|
||||||||||
Net cash provided by (used in) investing activities
|
(9,321
|
)
|
(20,976
|
)
|
(11,959
|
)
|
513
|
|||||||||
Cash Flows from Financing Activities:
|
||||||||||||||||
Repayment of lease liabilities
|
99
|
-
|
411
|
-
|
||||||||||||
Repayment of IIA grants, net of proceeds from IIA grants
|
(376
|
)
|
46
|
(569
|
)
|
16
|
||||||||||
Net cash (used in) provided by financing activities
|
(277
|
)
|
46
|
(158
|
)
|
16
|
||||||||||
|
||||||||||||||||
Exchange rate differences on cash and cash equivalent balances
|
41
|
(125
|
)
|
(22
|
)
|
8
|
||||||||||
Increase (decrease) in cash and cash equivalents from continuing activities
|
1,984
|
(31,202
|
)
|
(15,917
|
)
|
(792
|
)
|
|||||||||
Decrease in cash and cash equivalents from discontinued activities
|
(957
|
)
|
-
|
(1,007
|
)
|
-
|
||||||||||
Balance of cash and cash equivalents at the beginning of the period
|
6,716
|
36,069
|
24,667
|
5,659
|
||||||||||||
Balance of cash and cash equivalents at the end of the period
|
7,743
|
4,867
|
7,743
|
4,867
|
Page
|
|
2
|
|
3
|
|
4 - 6
|
|
7 - 8
|
|
9 – 14
|
September 30,
|
December 31,
|
|||||||||||
2019
|
2018
|
2018
|
||||||||||
Unaudited
|
Audited
|
|||||||||||
CURRENT ASSETS:
|
||||||||||||
Cash and cash equivalents
|
7,743
|
4,867
|
6,716
|
|||||||||
Restricted deposits
|
178
|
616
|
89
|
|||||||||
Short-term bank deposits
|
24,935
|
20,255
|
16,828
|
|||||||||
Trade receivables
|
4,493
|
671
|
560
|
|||||||||
Inventories
|
1,419
|
1,742
|
1,680
|
|||||||||
Other receivables
|
663
|
4,033
|
6,840
|
|||||||||
39,431
|
32,184
|
32,713
|
||||||||||
LONG‑TERM ASSETS:
|
||||||||||||
Long term deposits and prepaid expenses
|
14
|
57
|
48
|
|||||||||
Property, plant and equipment, net
|
2,169
|
2,004
|
2,020
|
|||||||||
Right of-use assets
|
2,254
|
-
|
-
|
|||||||||
Intangible assets, net
|
446
|
512
|
495
|
|||||||||
4,883
|
2,573
|
2,563
|
||||||||||
44,314
|
34,757
|
35,276
|
||||||||||
CURRENT LIABILITIES:
|
||||||||||||
Current maturities of long-term liabilities
|
810
|
533
|
146
|
|||||||||
Trade payables and accrued expenses
|
2,863
|
3,563
|
2,715
|
|||||||||
Liability in respect of discontinued operation
|
2,240
|
-
|
-
|
|||||||||
Other payables
|
4,898
|
1,792
|
2,036
|
|||||||||
10,811
|
5,888
|
4,897
|
||||||||||
LONG‑TERM LIABILITIES:
|
||||||||||||
Deferred revenues
|
1,134
|
1,169
|
1,158
|
|||||||||
Liabilities in respect of IIA grants
|
7,099
|
7,850
|
7,568
|
|||||||||
Contingent consideration for purchase of shares
|
4,621
|
15,292
|
6,330
|
|||||||||
Liability in respect of discontinued operation
|
-
|
6,003
|
6,003
|
|||||||||
Lease liabilities
|
2,015
|
-
|
-
|
|||||||||
Severance pay liability, net
|
316
|
333
|
348
|
|||||||||
15,185
|
30,647
|
21,407
|
||||||||||
SHAREHOLDERS' EQUITY (DEFICIENCY):
|
||||||||||||
Ordinary shares of NIS 0.01 par value:
|
||||||||||||
Authorized: 50,000,000 shares as of September 30, 2019 and 37,244,508 shares as of December 31, 2018 and September 30, 2018; Issued and Outstanding:27,178,839 as of
September 30, 2019, December 31, 2018 and September 30, 2018
|
75
|
75
|
75
|
|||||||||
Share premium
|
140,568
|
139,494
|
139,637
|
|||||||||
Foreign currency translation adjustments
|
(8
|
)
|
(29
|
)
|
(25
|
)
|
||||||
Accumulated deficit
|
(122,317
|
)
|
(141,318
|
)
|
(130,715
|
)
|
||||||
18,318
|
(1,778
|
)
|
8,972
|
|||||||||
44,314
|
34,757
|
35,276
|
Nine months ended
September 30,
|
Three months ended
September 30,
|
Year ended December 31,
|
||||||||||||||||||
2019
|
2018
|
2019
|
2018
|
2018
|
||||||||||||||||
Unaudited
|
Audited
|
|||||||||||||||||||
Revenues from sale of products
|
2,355
|
2,279
|
1,046
|
813
|
3,225
|
|||||||||||||||
Revenues from development services
|
6,346
|
-
|
4,045
|
-
|
-
|
|||||||||||||||
Revenues from license agreements
|
17,646
|
130
|
49
|
45
|
176
|
|||||||||||||||
Total revenues
|
26,347
|
2,409
|
5,140
|
858
|
3,401
|
|||||||||||||||
Cost of revenues from sale of products
|
1,595
|
1,396
|
656
|
386
|
2,088
|
|||||||||||||||
Cost of revenues from development services
|
5,927
|
-
|
3,758
|
-
|
-
|
|||||||||||||||
Cost of revenues from license agreements
|
680
|
-
|
-
|
-
|
-
|
|||||||||||||||
Total cost of revenues
|
8,202
|
1,396
|
4,414
|
386
|
2,088
|
|||||||||||||||
Gross profit
|
18,145
|
1,013
|
726
|
472
|
1,313
|
|||||||||||||||
Research and development, gross
|
7,799
|
14,517
|
1,296
|
5,128
|
18,663
|
|||||||||||||||
Participations by BARDA and IIA
|
(4,568
|
)
|
(10,180
|
)
|
56
|
(3,882
|
)
|
(13,843
|
)
|
|||||||||||
Research and development, net
of participations
|
3,231
|
4,337
|
1,352
|
1,246
|
4,820
|
|||||||||||||||
Selling and marketing
|
3,078
|
3,156
|
944
|
837
|
4,188
|
|||||||||||||||
General and administrative
|
3,158
|
2,098
|
1,012
|
629
|
3,051
|
|||||||||||||||
Other income from settlement agreement
|
-
|
-
|
-
|
- |
(7,537
|
)
|
||||||||||||||
Other expenses
|
1,041
|
662
|
140
|
-
|
751
|
|||||||||||||||
Total operation expenses
|
10,508
|
10,253
|
3,448
|
2,712
|
5,273
|
|||||||||||||||
Operating profit (loss)
|
7,637
|
(9,240
|
)
|
(2,722
|
)
|
(2,240
|
)
|
(3,960
|
)
|
|||||||||||
Financial income
|
300
|
299
|
147
|
117
|
412
|
|||||||||||||||
Financial expense
|
(2,345
|
)
|
(2,719
|
)
|
(389
|
)
|
(821
|
)
|
(2,117
|
)
|
||||||||||
Profit (loss) from continuing operation
|
5,592
|
(11,660
|
)
|
(2,964
|
)
|
(2,944
|
)
|
(5,665
|
)
|
|||||||||||
Profit from discontinued operation
|
2,806
|
-
|
2,756
|
-
|
4,608
|
|||||||||||||||
Net Profit (loss)
|
8,398
|
(11,660
|
)
|
(208
|
)
|
(2,944
|
)
|
(1,057
|
)
|
|||||||||||
Other comprehensive income (loss):
|
||||||||||||||||||||
Foreign currency translation adjustments
|
17
|
9
|
15
|
1
|
13
|
|||||||||||||||
Total comprehensive income (loss)
|
8,415
|
(11,651
|
)
|
(193
|
)
|
(2,943
|
)
|
(1,044
|
)
|
|||||||||||
Basic and diluted net profit (loss) per share from continuing operations
|
0.21
|
(0.43
|
)
|
(0.11
|
)
|
(0.11
|
)
|
(0.21
|
)
|
|||||||||||
Basic and diluted net profit per share from discontinued operation
|
0.10
|
-
|
0.10
|
-
|
0.17
|
|||||||||||||||
Total Basic and diluted net profit (loss) per share
|
0.31
|
(0.43
|
)
|
(0.01
|
)
|
(0.11
|
)
|
(0.04
|
)
|
|||||||||||
Weighted average number of Ordinary shares used in the computation of basic and diluted loss per share (in thousands)
|
27,179
|
27,092
|
27,179
|
27,179
|
27,114
|
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
|
-
|
-
|
-
|
8,398
|
8,398
|
|||||||||||||||
Other comprehensive income
|
-
|
-
|
17
|
-
|
17
|
|||||||||||||||
Total comprehensive income
|
-
|
-
|
17
|
8,398
|
8,415
|
|||||||||||||||
Share-based compensation
|
-
|
931
|
-
|
-
|
931
|
|||||||||||||||
Balance as of September 30, 2019 (unaudited)
|
75
|
140,568
|
(8
|
)
|
(122,317
|
)
|
18,318
|
Share
capital
|
Share
premium
|
Foreign
currency
translation
reserve
|
Accumulated
deficit
|
Total
(Deficiency)
|
||||||||||||||||
Balance as of December 31, 2017
|
75
|
138,992
|
(38
|
)
|
(129,409
|
)
|
9,620
|
|||||||||||||
(audited)
|
||||||||||||||||||||
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
|
-
|
-
|
-
|
(11,660
|
)
|
(11,660
|
)
|
|||||||||||||
Other comprehensive income
|
-
|
-
|
9
|
-
|
9
|
|||||||||||||||
Total comprehensive (loss) income
|
-
|
-
|
9
|
(11,660
|
)
|
(11,651
|
)
|
|||||||||||||
Exercise of options
|
(*
|
)
|
(*
|
)
|
-
|
-
|
-
|
|||||||||||||
Share-based compensation
|
-
|
502
|
-
|
-
|
502
|
|||||||||||||||
Balance as of September 30, 2018 (unaudited)
|
75
|
139,494
|
(29
|
)
|
(141,318
|
)
|
(1,778
|
)
|
(*) |
Represent less than $1.
|
Share
capital
|
Share
premium
|
Foreign
currency
translation
reserve
|
Accumulated
deficit
|
Total
Equity
|
||||||||||||||||
Unaudited
|
||||||||||||||||||||
Balance as of July 1, 2019
|
75
|
140,236
|
(23
|
)
|
(122,109
|
)
|
18,179
|
|||||||||||||
Loss for the period
|
-
|
-
|
-
|
(208
|
)
|
(208
|
)
|
|||||||||||||
Other comprehensive income
|
-
|
-
|
15
|
-
|
15
|
|||||||||||||||
Total comprehensive (loss) income
|
-
|
-
|
15
|
(208
|
)
|
(193
|
)
|
|||||||||||||
Share-based compensation
|
-
|
332
|
-
|
-
|
332
|
|||||||||||||||
Balance as of September 30, 2019 (unaudited)
|
75
|
140,568
|
(8
|
)
|
(122,317
|
)
|
18,318
|
Share
capital
|
Share
premium
|
Foreign
currency
translation
reserve
|
Accumulated
deficit
|
Total
(Deficiency)
|
||||||||||||||||
Unaudited
|
||||||||||||||||||||
Balance as of July 1, 2018
|
75
|
139,359
|
(30
|
)
|
(138,374
|
)
|
1,030
|
|||||||||||||
Loss for the period
|
-
|
-
|
-
|
(2,944
|
)
|
(2,944
|
)
|
|||||||||||||
Other comprehensive income
|
-
|
-
|
1
|
-
|
1
|
|||||||||||||||
Total comprehensive (loss) income
|
-
|
-
|
1
|
(2,944
|
)
|
(2,943
|
)
|
|||||||||||||
Share-based compensation
|
-
|
135
|
-
|
-
|
135
|
|||||||||||||||
Balance as of September 30, 2018 (unaudited)
|
75
|
139,494
|
(29
|
)
|
(141,318
|
)
|
(1,778
|
)
|
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
|
|||||||||||||
Accumulated effect of adopting IFRS 15
|
-
|
-
|
-
|
(249
|
)
|
(249
|
)
|
|||||||||||||
Balance as of January 1, 2018
|
75
|
138,992
|
(38
|
)
|
(129,658
|
)
|
9,371
|
|||||||||||||
Loss for the period
|
-
|
-
|
-
|
(1,057
|
)
|
(1,057
|
)
|
|||||||||||||
Other comprehensive income
|
-
|
-
|
13
|
-
|
13
|
|||||||||||||||
Total comprehensive (loss) income
|
-
|
-
|
13
|
(1,057
|
)
|
(1,044
|
)
|
|||||||||||||
Exercise of options
|
(*
|
)
|
(*
|
)
|
-
|
-
|
(*
|
)
|
||||||||||||
Share-based compensation
|
-
|
645
|
-
|
-
|
645
|
|||||||||||||||
Balance as of December 31, 2018
|
75
|
139,637
|
(25
|
)
|
(130,715
|
)
|
8,972
|
(*)
|
Represents less than $ 1.
|
Nine months ended
September 30,
|
Three months ended
September 30,
|
Year ended December 31,
|
||||||||||||||||||
2019
|
2018
|
2019
|
2018
|
2018
|
||||||||||||||||
Unaudited
|
Audited
|
|||||||||||||||||||
Cash flows from operating activities:
|
||||||||||||||||||||
Net Profit (loss)
|
8,398
|
(11,660
|
)
|
(208
|
)
|
(2,944
|
)
|
(1,057
|
)
|
|||||||||||
Adjustments to reconcile net loss to net cash provided by (used in) continuing operating activities:
|
||||||||||||||||||||
Adjustments to profit and loss items:
|
||||||||||||||||||||
Profit from discontinued operation
|
(2,806
|
)
|
-
|
(2,756
|
)
|
-
|
(4,608
|
)
|
||||||||||||
Depreciation and amortization
|
848
|
447
|
296
|
142
|
577
|
|||||||||||||||
Share-based compensation
|
931
|
502
|
332
|
135
|
645
|
|||||||||||||||
Revaluation of liabilities in respect of IIA grants
|
(99
|
)
|
624
|
293
|
220
|
287
|
||||||||||||||
Revaluation of contingent consideration for purchase of shares
|
1,519
|
1,694
|
197
|
582
|
758
|
|||||||||||||||
Other income from settlement agreement
|
-
|
-
|
-
|
-
|
(7,537
|
)
|
||||||||||||||
Revaluation of lease liabilities
|
(291
|
)
|
-
|
(485
|
)
|
-
|
-
|
|||||||||||||
Increase (decrease) in severance pay liability, net
|
(32
|
)
|
3
|
(22
|
)
|
(3
|
)
|
19
|
||||||||||||
Net financing income
|
(295
|
)
|
(255
|
)
|
(146
|
)
|
(73
|
)
|
(412
|
)
|
||||||||||
Un-realized foreign currency (gain) loss
|
(52
|
)
|
67
|
18
|
(59
|
)
|
182
|
|||||||||||||
(277
|
)
|
3,082
|
(2,273
|
)
|
944
|
(10,089
|
)
|
|||||||||||||
Changes in asset and liability items:
|
||||||||||||||||||||
Decrease (increase) in trade receivables
|
(3,955
|
)
|
(314
|
)
|
(3,946
|
)
|
107
|
(211
|
)
|
|||||||||||
Decrease in inventories
|
260
|
144
|
114
|
129
|
206
|
|||||||||||||||
Decrease (increase) in other receivables
|
5,198
|
(1,321
|
)
|
2,454
|
251
|
(306
|
)
|
|||||||||||||
Increase (decrease) in trade payables and accrued expenses
|
150
|
311
|
(1,207
|
)
|
237
|
(536
|
)
|
|||||||||||||
Increase (decrease) in other payables and deferred revenues
|
810
|
(389
|
)
|
281
|
(53
|
)
|
(161
|
)
|
||||||||||||
2,463
|
(1,569
|
)
|
(2,304
|
)
|
671
|
(1,008
|
)
|
|||||||||||||
Net cash provided by (used in) operating activities
|
10,584
|
(10,147
|
)
|
(4,785
|
)
|
(1,329
|
)
|
(12,154
|
)
|
Nine months ended
September 30,
|
Three months ended
September 30,
|
Year ended December 31,
|
||||||||||||||||||
2019
|
2018
|
2019
|
2018
|
2018
|
||||||||||||||||
Unaudited
|
Audited
|
|||||||||||||||||||
Cash flows from investing activities:
|
||||||||||||||||||||
Purchase of property and equipment
|
(463
|
)
|
(391
|
)
|
(30
|
)
|
(78
|
)
|
(522
|
)
|
||||||||||
Purchase of intangible assets
|
-
|
(13
|
)
|
-
|
-
|
(12
|
)
|
|||||||||||||
Interest received
|
104
|
44
|
60
|
42
|
106
|
|||||||||||||||
Proceeds from (investment in) short term bank deposits, net
|
(8,005
|
)
|
(20,616
|
)
|
(10,982
|
)
|
549
|
(16,612
|
)
|
|||||||||||
Net cash provided by (used in) continued investing activities
|
(8,364
|
)
|
(20,976
|
)
|
(10,952
|
)
|
513
|
(17,040
|
)
|
|||||||||||
Net cash used in discontinued investing activities
|
(957
|
)
|
-
|
(1,007
|
)
|
-
|
-
|
|||||||||||||
Net cash provided by (used in) investing activities
|
(9,321
|
)
|
(20,976
|
)
|
(11,959
|
)
|
513
|
(17,040
|
)
|
|||||||||||
Cash flows from financing activities:
|
||||||||||||||||||||
Repayment of leases liabilities
|
99
|
-
|
411
|
-
|
-
|
|||||||||||||||
Proceeds from exercise of options
|
-
|
-
|
-
|
-
|
(*
|
)
|
||||||||||||||
Repayment of IIA grants, net of proceeds from IIA grants
|
(376
|
)
|
46
|
(569
|
)
|
16
|
46
|
|||||||||||||
Net cash (used in) provided by financing activities
|
(277
|
)
|
46
|
(158
|
)
|
16
|
46
|
|||||||||||||
Exchange rate differences on cash and cash equivalent balances
|
41
|
(125
|
)
|
(22
|
)
|
8
|
(205
|
)
|
||||||||||||
Increase (decrease) in cash and cash equivalents from continuing activities
|
1,984
|
(31,202
|
)
|
(15,917
|
)
|
(792
|
)
|
(29,353
|
)
|
|||||||||||
Decrease in cash and cash equivalents from discontinued activities
|
(957
|
)
|
-
|
(1,007
|
)
|
-
|
-
|
|||||||||||||
Balance of cash and cash equivalents at the beginning of the period
|
6,716
|
36,069
|
24,667
|
5,659
|
36,069
|
|||||||||||||||
Balance of cash and cash equivalents at the end of the period
|
7,743
|
4,867
|
7,743
|
4,867
|
6,716
|
(*)
|
Represents less than $ 1.
|
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 10% of PolyHeal Ltd., a private life sciences company ("PolyHeal").
|
c. |
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 (see also Note 3c).
|
NOTE 2: |
SIGNIFICANT ACCOUNTING POLICIES
|
a. |
Basis of presentation of financial statements:
|
b. |
Basis of preparation of the interim consolidated financial statements:
|
NOTE 2: |
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
|
c. |
Changes in significant accounting policies:
|
d. | Reclassification: |
a. |
On September 15, 2014, a Statement of Claim was filed against the Company by some shareholders of Polyheal (the "Plaintiffs"). The Plaintiffs allege that the Company is obligated to pay them a total amount of $1,475 in exchange for
their respective portion of PolyHeal's shares, following the commencement of a feasibility study for the next generation of the PolyHeal Product in November 15, 2012, which constituted a milestone under a buyout option agreement between
the Company, PolyHeal and its shareholders.
|
b. |
Beginning in 2007, the Company entered into a number of agreements with Teva Pharmaceutical Industries Limited (“Teva”) related to collaboration in the development, manufacturing and commercialization of solutions for the burn and
chronic wound care markets. In consideration for these agreements, Teva made investments in the Company's ordinary shares and agreed to fund certain research and development expenses and manufacturing costs and perform all marketing
activities for both NexoBrid, under the 2007 Teva Agreement, and the PolyHeal Product, under the 2010 PolyHeal Agreements. As of December 31, 2012, all of these agreements were terminated.
|
c. |
On September 30, 2015 BARDA has awarded MediWound a contract, 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. In May 2019, BARDA upsized the contract, providing additional funding of $21,000 to support additional activities towards Biologics License Application (BLA) approval, including the new
NexoBrid expended access treatment protocol (NEXT). The modified contract includes $77,000 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 $16,475 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.
|
d. |
On May 6, 2019, the Company entered into exclusive license and supply agreements with Vericel to commercialize NexoBrid in North America (the “Collaboration Agreements”).
|