MEDIWOUND LTD.
|
|||
Date: November 16, 2017
|
By:
|
/s/ Sharon Malka
|
|
Name:
|
Sharon Malka
|
||
Title:
|
Chief Financial Officer
|
Exhibit
|
Description
|
· |
Total revenues for the third quarter of 2017 were $0.74 million, a 43% increase from $0.52 million in the third quarter of 2016, underscoring the continued growth of NexoBrid® sales.
|
· |
Raised total gross proceeds of $25.2 million through a public offering of 5.04 million shares, which included the exercise of the underwriters' option to purchase additional shares.
|
· |
BARDA upsized contract with MediWound, committing an additional $32 million to support R&D activities, bringing total non-dilutive funding to up to $132 million.
|
· |
Successfully completed the second cohort of the Phase 2 study evaluating EscharEx, MediWound’s topical biologic drug for the debridement of dead or damaged tissue in diabetic foot ulcers and venous leg ulcers. The study achieved its primary objective of demonstrating EscharEx’s safety over extended periods of application with no material safety concerns identified.
|
· |
Awarded Best Poster Presentation in the 17th Annual European Burns Association (EBA) Congress. Overall 43 presentations of burn experts from across Europe on NexoBrid at the EBA conference.
|
· |
New distribution agreement in Taiwan with Holy Stone Healthcare further expands NexoBrid’s® global reach.
|
· |
Appointed Stephen T. Wills as Chairman of the Company’s Board of Directors and Assaf Segal as a new Board member.
|
· |
Tel Aviv district court ordered MediWound to purchase approximately $1.5 million of PolyHeal shares; MediWound weighing an appeal.
|
· |
Positive decision of European Commission on a five-year renewal of NexoBrid's Marketing Authorization.
|
Contacts:
|
Bob Yedid
|
Sharon Malka
|
Managing Director
|
Chief Financial and Operations Officer
|
LifeSci Advisors
|
MediWound
|
646-597-6989
|
ir@mediwound.co.il
|
bob@lifesciadvisors.com
|
September 30,
|
December 31,
|
|||||||||||
2017
|
2016
|
2016
|
||||||||||
Unaudited
|
||||||||||||
Cash, cash equivalents and short term deposits
|
40,593
|
33,956
|
30,029
|
|||||||||
Accounts and other receivable
|
4,238
|
2,606
|
2,739
|
|||||||||
Inventories
|
1,637
|
1,063
|
844
|
|||||||||
Total current assets
|
46,468
|
37,625
|
33,612
|
|||||||||
Long term deposits
|
60
|
103
|
103
|
|||||||||
Property, plant and equipment, net
|
1,834
|
1,362
|
1,276
|
|||||||||
Intangible assets, net
|
649
|
831
|
773
|
|||||||||
Total long term assets
|
2,543
|
2,296
|
2,152
|
|||||||||
Total assets
|
49,011
|
39,921
|
35,764
|
|||||||||
Trade payables and accrued expenses
|
3,289
|
2,505
|
3,320
|
|||||||||
Other payables
|
2,190
|
2,476
|
2,060
|
|||||||||
Other payables from discontinued operation
|
7,500
|
-
|
-
|
|||||||||
Total current liabilities
|
12,979
|
4,981
|
5,380
|
|||||||||
Deferred revenues
|
937
|
1,067
|
1,023
|
|||||||||
Liabilities in respect of Israeli Innovation Authority grants net of current maturities
|
7,395
|
7,637
|
6,839
|
|||||||||
Contingent consideration for the purchase of shares net of current maturities
|
15,673
|
17,265
|
14,533
|
|||||||||
Severance pay liability, net
|
242
|
99
|
219
|
|||||||||
Total long term liabilities
|
24,247
|
26,068
|
22,614
|
|||||||||
Shareholders' equity
|
11,785
|
8,872
|
7,770
|
|||||||||
Total liabilities & shareholder equity
|
49,011
|
39,921
|
35,764
|
Nine months ended
|
Three months ended
|
|||||||||||||||
September 30,
|
September 30,
|
|||||||||||||||
2017
|
2016
|
2017
|
2016
|
|||||||||||||
Revenues
|
1,966
|
1,128
|
739
|
518
|
||||||||||||
Cost of revenues
|
1,162
|
1,303
|
338
|
474
|
||||||||||||
Gross profit (loss)
|
804
|
(175
|
)
|
401
|
44
|
|||||||||||
Operating expenses:
|
||||||||||||||||
Research and development, gross
|
10,068
|
11,420
|
3,446
|
3,947
|
||||||||||||
Participation by IIA & BARDA
|
(5,789
|
)
|
(5,135
|
)
|
(2,602
|
)
|
(1,592
|
)
|
||||||||
Research and development, net
|
4,279
|
6,285
|
844
|
2,355
|
||||||||||||
Selling, general & administrative
|
6,688
|
9,188
|
2,354
|
2,633
|
||||||||||||
Total operating expenses
|
10,967
|
15,473
|
3,198
|
4,988
|
||||||||||||
Operating loss
|
(10,163
|
)
|
(15,648
|
)
|
(2,797
|
)
|
(4,944
|
)
|
||||||||
Financial income (expenses), net
|
(2,117
|
)
|
(1,348
|
)
|
(707
|
)
|
(767
|
)
|
||||||||
Loss from continuing operations
|
(12,280
|
)
|
(16,996
|
)
|
(3,504
|
)
|
(5,711
|
)
|
||||||||
Loss from discontinued operation
|
(7,500
|
)
|
-
|
(7,500
|
)
|
-
|
||||||||||
Loss for the period
|
(19,780
|
)
|
(16,996
|
)
|
(11,004
|
)
|
(5,711
|
)
|
||||||||
Foreign currency translation adjustments
|
(19
|
)
|
(4
|
)
|
(2
|
)
|
(1
|
)
|
||||||||
Total comprehensive loss
|
(19,799
|
)
|
(17,000
|
)
|
(11,006
|
)
|
(5,712
|
)
|
||||||||
Basic and diluted loss per share:
|
||||||||||||||||
Loss from continuing operations
|
(0.56
|
)
|
(0.78
|
)
|
(0.16
|
)
|
(0.26
|
)
|
||||||||
Loss from discontinued operation
|
(0.34
|
)
|
0.00
|
(0.33
|
)
|
0.00
|
||||||||||
Net loss per share
|
(0.90
|
)
|
(0.78
|
)
|
(0.49
|
)
|
(0.26
|
)
|
||||||||
Weighted average number of ordinary shares used in the computation of basic and diluted loss per share:
|
22,105
|
21,853
|
22,438
|
21,857
|
Nine months ended
|
Three months ended
|
|||||||||||||||
September 30,
|
September 30,
|
|||||||||||||||
2017
|
2016
|
2017
|
2016
|
|||||||||||||
Cash Flows from Operating Activities:
|
||||||||||||||||
Net loss
|
(19,780
|
)
|
(16,996
|
)
|
(11,004
|
)
|
(5,711
|
)
|
||||||||
Adjustments to reconcile net loss to net cash used in continuing operating activities:
|
||||||||||||||||
Adjustments to profit and loss items:
|
||||||||||||||||
Loss from discontinued operation
|
7,500
|
-
|
7,500
|
-
|
||||||||||||
Depreciation and amortization
|
430
|
386
|
128
|
133
|
||||||||||||
Share-based compensation
|
1,013
|
2,400
|
348
|
613
|
||||||||||||
Revaluation of liabilities in respect of IIA grants
|
351
|
(190
|
)
|
(51
|
) |
(167
|
) | |||||||||
Revaluation of contingent consideration for the purchase of shares
|
1,672
|
1,180
|
552
|
641
|
||||||||||||
Increase in severance liability, net
|
23
|
-
|
3
|
-
|
||||||||||||
Net financing expenses (income)
|
(319
|
)
|
(367
|
)
|
(54
|
)
|
(107
|
)
|
||||||||
10,670
|
3,409
|
8,426
|
1,113
|
|||||||||||||
Changes in asset and liability items:
|
||||||||||||||||
Decrease (increase) in trade receivables
|
(225
|
)
|
(245
|
)
|
16
|
(90
|
)
|
|||||||||
Decrease (increase) in inventories
|
(793
|
)
|
642
|
(514
|
)
|
96
|
||||||||||
Decrease (increase) in other receivables
|
(1,548
|
)
|
425
|
(1,271
|
)
|
754
|
||||||||||
Increase (decrease) in trade payables
|
(46
|
)
|
1,377
|
1,164
|
935
|
|||||||||||
Increase (decrease) in other payables & deferred revenues
|
(328
|
)
|
(827
|
)
|
131
|
(1,467
|
)
|
|||||||||
(2,940
|
)
|
1,372
|
(474
|
)
|
228
|
|||||||||||
Net cash flows used in operating activities
|
(12,050
|
)
|
(12,215
|
)
|
(3,052
|
)
|
(4,370
|
)
|
||||||||
Cash Flows from Investment Activities:
|
||||||||||||||||
Purchase of property and equipment
|
(864
|
)
|
(642
|
)
|
(499
|
)
|
(202
|
)
|
||||||||
Interest received
|
52
|
45
|
25
|
4
|
||||||||||||
Proceeds from (investment in) short term bank deposits, net of investments
|
(13,837
|
)
|
(25,239
|
)
|
3,000
|
(1,505
|
)
|
|||||||||
Net cash provided by (used in) investing activities
|
(14,649
|
)
|
(25,836
|
)
|
2,526
|
(1,703
|
)
|
|||||||||
Cash Flows from Financing Activities:
|
||||||||||||||||
Proceeds from exercise of options
|
7
|
-
|
5
|
-
|
||||||||||||
Proceeds from issuance of shares, net
|
22,794
|
2
|
22,794
|
2
|
||||||||||||
Proceeds from IIA grants, net of repayments
|
328
|
658
|
365
|
658
|
||||||||||||
Net cash provided by financing activities
|
23,129
|
660
|
23,164
|
660
|
||||||||||||
Exchange rate differences on cash and cash equivalent balances
|
106
|
71
|
(11
|
)
|
1
|
|||||||||||
Increase (decrease) in cash and cash equivalents
|
(3,464
|
)
|
(37,320
|
)
|
22,627
|
(5,412
|
)
|
|||||||||
Balance of cash and cash equivalents at the beginning of the period
|
28,866
|
42,502
|
2,775
|
10,594
|
||||||||||||
Balance of cash and cash equivalents at the end of the period
|
25,402
|
5,182
|
25,402
|
5,182
|
Nine months ended
|
Three months ended
|
|||||||||||||||
September 30,
|
September 30,
|
|||||||||||||||
2017
|
2016
|
2017
|
2016
|
|||||||||||||
Loss for the period
|
(12,280
|
)
|
(16,996
|
)
|
(3,504
|
)
|
(5,711
|
)
|
||||||||
Adjustments:
|
||||||||||||||||
Financial (expenses) income, net
|
(2,117
|
)
|
(1,348
|
)
|
(707
|
)
|
(767
|
)
|
||||||||
Loss from discontinued operation
|
(7,500
|
)
|
-
|
(7,500
|
)
|
-
|
||||||||||
Depreciation and amortization
|
(430
|
)
|
(386
|
)
|
(128
|
)
|
(133
|
)
|
||||||||
Share-based compensation expenses
|
(1,012
|
)
|
(2,401
|
)
|
(347
|
)
|
(614
|
)
|
||||||||
Total adjustments
|
(11,059
|
)
|
(4,135
|
)
|
(8,682
|
)
|
(1,514
|
)
|
||||||||
Adjusted EBITDA
|
(8,721
|
)
|
(12,861
|
)
|
(2,322
|
)
|
(4,197
|
)
|
Page
|
|
F-2
|
|
F-3
|
|
F-4 - F-6
|
|
F-7 - F-8
|
|
F-9 - F-11
|
September 30,
|
December 31,
|
|||||||||||
2017
|
2016
|
2016
|
||||||||||
Unaudited
|
Audited
|
|||||||||||
CURRENT ASSETS:
|
||||||||||||
Cash and cash equivalents
|
25,402
|
5,182
|
28,866
|
|||||||||
Short-term bank deposits
|
15,191
|
28,774
|
1,163
|
|||||||||
Trade receivables
|
616
|
491
|
332
|
|||||||||
Inventories
|
1,637
|
1,063
|
844
|
|||||||||
Other receivables
|
3,622
|
2,115
|
2,407
|
|||||||||
46,468
|
37,625
|
33,612
|
||||||||||
LONG‑TERM ASSETS:
|
||||||||||||
Long term deposits
|
60
|
103
|
103
|
|||||||||
Property, plant and equipment, net
|
1,834
|
1,362
|
1,276
|
|||||||||
Intangible assets, net
|
649
|
831
|
773
|
|||||||||
2,543
|
2,296
|
2,152
|
||||||||||
49,011
|
39,921
|
35,764
|
||||||||||
CURRENT LIABILITIES:
|
||||||||||||
Trade payables and accrued expenses
|
3,289
|
2,505
|
3,320
|
|||||||||
Other payables
|
2,190
|
2,476
|
2,060
|
|||||||||
Other payables from discontinued operation
|
7,500
|
-
|
-
|
|||||||||
12,979
|
4,981
|
5,380
|
||||||||||
LONG‑TERM LIABILITIES:
|
||||||||||||
Deferred revenues
|
937
|
1,067
|
1,023
|
|||||||||
Liabilities in respect of IIA grants
|
7,395
|
7,637
|
6,839
|
|||||||||
Contingent consideration for the purchase of shares
|
15,673
|
17,265
|
14,533
|
|||||||||
Severance pay liability, net
|
242
|
99
|
219
|
|||||||||
24,247
|
26,068
|
22,614
|
||||||||||
SHAREHOLDERS' EQUITY:
|
||||||||||||
Ordinary shares of NIS 0.01 par value:
|
||||||||||||
Authorized: 32,244,508 shares; Issued and Outstanding: 27,047,737 as of September 30, 2017, 21,930,449 as of December 31, 2016 and 21,871,055 as of September 30, 2016
|
75
|
60
|
60
|
|||||||||
Share premium
|
138,778
|
114,203
|
114,979
|
|||||||||
Foreign currency translation adjustments
|
(28
|
)
|
(20
|
)
|
(9
|
)
|
||||||
Accumulated deficit
|
(127,040
|
)
|
(105,371
|
)
|
(107,260
|
)
|
||||||
11,785
|
8,872
|
7,770
|
||||||||||
49,011
|
39,921
|
35,764
|
Nine months ended
September 30,
|
Three months ended
September 30,
|
Year ended
December 31,
|
||||||||||||||||||
2017
|
2016
|
2017
|
2016
|
2016
|
||||||||||||||||
Unaudited
|
Audited
|
|||||||||||||||||||
Revenues
|
1,966
|
1,128
|
739
|
518
|
1,558
|
|||||||||||||||
Cost of revenues
|
1,162
|
1,303
|
338
|
474
|
2,158
|
|||||||||||||||
Gross profit (loss)
|
804
|
(175
|
)
|
401
|
44
|
(600
|
)
|
|||||||||||||
Operating expenses:
|
||||||||||||||||||||
Research and development, net of participations
|
4,279
|
6,285
|
844
|
2,355
|
7,068
|
|||||||||||||||
Selling and marketing
|
4,107
|
6,214
|
1,414
|
1,686
|
8,403
|
|||||||||||||||
General and administrative
|
2,581
|
2,974
|
940
|
947
|
4,084
|
|||||||||||||||
Operating loss
|
(10,163
|
)
|
(15,648
|
)
|
(2,797
|
)
|
(4,944
|
)
|
(20,155
|
)
|
||||||||||
Financial income
|
243
|
492
|
69
|
95
|
2,166
|
|||||||||||||||
Financial expense
|
(2,360
|
)
|
(1,840
|
)
|
(776
|
)
|
(862
|
)
|
(896
|
)
|
||||||||||
Loss from continuing operation
|
(12,280
|
)
|
(16,996
|
)
|
(3,504
|
)
|
(5,711
|
)
|
(18,885
|
)
|
||||||||||
Loss from discontinued operation
|
(7,500
|
)
|
-
|
(7,500
|
)
|
-
|
-
|
|||||||||||||
Net loss
|
(19,780
|
)
|
(16,996
|
)
|
(11,004
|
)
|
(5,711
|
)
|
(18,885
|
)
|
||||||||||
Other comprehensive income (loss):
|
||||||||||||||||||||
Items to be reclassified to profit or loss in subsequent periods:
|
||||||||||||||||||||
Foreign currency translation adjustments
|
(19
|
)
|
(4
|
)
|
(2
|
)
|
(1
|
)
|
7
|
|||||||||||
Total comprehensive loss
|
(19,799
|
)
|
(17,000
|
)
|
(11,006
|
)
|
(5,712
|
)
|
(18,878
|
)
|
||||||||||
Basic and diluted loss per share:
|
||||||||||||||||||||
Loss from continuing operations
|
(0.56
|
)
|
(0.78
|
)
|
(0.16
|
)
|
(0.26
|
)
|
(0.86
|
)
|
||||||||||
Loss from discontinued operation
|
(0.34
|
)
|
-
|
(0.33
|
)
|
-
|
-
|
|||||||||||||
Net loss per share
|
(0.90
|
)
|
(0.78
|
)
|
(0.49
|
)
|
(0.26
|
)
|
(0.86
|
)
|
||||||||||
Weighted average number of Ordinary shares used in the computation of basic and diluted loss per share
|
22,105
|
21,853
|
22,438
|
21,857
|
21,862
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
equity
|
||||||||||||||||
Balance as of January 1, 2017 (audited)
|
60
|
114,979
|
(9
|
)
|
(107,260
|
)
|
7,770
|
|||||||||||||
Loss for the period
|
-
|
-
|
-
|
(19,780
|
)
|
(19,780
|
)
|
|||||||||||||
Other comprehensive loss
|
-
|
-
|
(19
|
)
|
-
|
(19
|
)
|
|||||||||||||
Total comprehensive loss
|
-
|
-
|
(19
|
)
|
(19,780
|
)
|
(19,799
|
)
|
||||||||||||
Exercise of options
|
(*
|
)
|
7
|
-
|
-
|
7
|
||||||||||||||
Share-based compensation
|
-
|
1,013
|
-
|
-
|
1,013
|
|||||||||||||||
Issuance of ordinary shares of NIS 0.01 par value net of issuance expenses
|
15
|
22,779
|
-
|
-
|
22,794
|
|||||||||||||||
Balance as of September 30, 2017 (unaudited)
|
75
|
138,778
|
(28
|
)
|
(127,040
|
)
|
11,785
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
equity
|
||||||||||||||||
Balance as of January 1, 2016 (audited)
|
60
|
111,801
|
(16
|
)
|
(88,375
|
)
|
23,470
|
|||||||||||||
Loss for the period
|
-
|
-
|
-
|
(16,996
|
)
|
(16,996
|
)
|
|||||||||||||
Other comprehensive loss
|
-
|
-
|
(4
|
)
|
-
|
(4
|
)
|
|||||||||||||
Total comprehensive loss
|
-
|
-
|
(4
|
)
|
(16,996
|
)
|
(17,000
|
)
|
||||||||||||
Exercise of options
|
(*
|
)
|
2
|
-
|
-
|
2
|
||||||||||||||
Share-based compensation
|
-
|
2,400
|
-
|
-
|
2,400
|
|||||||||||||||
Balance as of September 30, 2016 (unaudited)
|
60
|
114,203
|
(20
|
)
|
(105,371
|
)
|
8,872
|
(*) |
Represent less than $1.
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
equity
|
||||||||||||||||
Unaudited | ||||||||||||||||||||
Balance as of July 1, 2017
|
60
|
115,646
|
(26
|
)
|
(116,036
|
)
|
(356
|
)
|
||||||||||||
Loss for the period
|
-
|
-
|
-
|
(11,004
|
)
|
(11,004
|
)
|
|||||||||||||
Other comprehensive income
|
-
|
-
|
(2
|
)
|
-
|
(2
|
)
|
|||||||||||||
Total comprehensive loss
|
-
|
-
|
(2
|
)
|
(11,004
|
)
|
(11,006
|
)
|
||||||||||||
Exercise of options
|
(*
|
)
|
5
|
-
|
-
|
5
|
||||||||||||||
Share-based compensation
|
-
|
348
|
-
|
-
|
348
|
|||||||||||||||
Issuance of ordinary shares of NIS 0.01 par value net of issuance expenses
|
15
|
22,779
|
-
|
-
|
22,794
|
|||||||||||||||
Balance as of September 30, 2017
|
75
|
138,778
|
(28
|
)
|
(127,040
|
)
|
11,785
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
equity
|
||||||||||||||||
Unaudited
|
||||||||||||||||||||
Balance as of July 1, 2016
|
60
|
113,588
|
(19
|
)
|
(99,660
|
)
|
13,969
|
|||||||||||||
Loss for the period
|
-
|
-
|
-
|
(5,711
|
)
|
(5,711
|
)
|
|||||||||||||
Other comprehensive income (loss)
|
-
|
-
|
(1
|
)
|
-
|
(1
|
)
|
|||||||||||||
Total comprehensive loss
|
-
|
-
|
(1
|
)
|
(5,711
|
)
|
(5,712
|
)
|
||||||||||||
Exercise of options
|
(*
|
)
|
2
|
-
|
-
|
2
|
||||||||||||||
Share-based compensation
|
-
|
613
|
-
|
-
|
613
|
|||||||||||||||
Balance as of September 30, 2016
|
60
|
114,203
|
(20
|
)
|
(105,371
|
)
|
8,872
|
(*) |
Represent less than $1.
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
Equity
|
||||||||||||||||
Balance as of January 1, 2016
|
60
|
111,801
|
(16
|
)
|
(88,375
|
)
|
23,470
|
|||||||||||||
Loss for the period
|
-
|
-
|
-
|
(18,885
|
)
|
(18,885
|
)
|
|||||||||||||
Other comprehensive income
|
-
|
-
|
7
|
-
|
7
|
|||||||||||||||
Total comprehensive income (loss)
|
-
|
-
|
7
|
(18,885
|
)
|
(18,878
|
)
|
|||||||||||||
Exercise of options
|
(*
|
)
|
7
|
-
|
-
|
7
|
||||||||||||||
Share-based compensation
|
-
|
3,171
|
-
|
-
|
3,171
|
|||||||||||||||
Balance as of December 31, 2016
|
60
|
114,979
|
(9
|
)
|
(107,260
|
)
|
7,770
|
(*) |
Represent less than $1.
|
Nine months ended
September 30,
|
Three months ended
September 30,
|
Year ended December 31,
|
||||||||||||||||||
2017
|
2016
|
2017
|
2016
|
2016
|
||||||||||||||||
Unaudited
|
Audited
|
|||||||||||||||||||
Cash flows from operating activities:
|
||||||||||||||||||||
Net loss
|
(19,780
|
)
|
(16,996
|
)
|
(11,004
|
)
|
(5,711
|
)
|
(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
|
7,500
|
-
|
7,500
|
-
|
-
|
|||||||||||||||
Depreciation and amortization
|
430
|
386
|
128
|
133
|
589
|
|||||||||||||||
Share-based compensation
|
1,013
|
2,400
|
348
|
613
|
3,171
|
|||||||||||||||
Revaluation of liabilities in respect of IIA grants
|
351
|
(190
|
)
|
(51
|
)
|
(167
|
)
|
(1,298
|
)
|
|||||||||||
Revaluation of contingent consideration for the purchase of shares
|
1,672
|
1,180
|
552
|
641
|
(1,621
|
)
|
||||||||||||||
Increase in severance liability
|
23
|
-
|
3
|
-
|
125
|
|||||||||||||||
Net financing income
|
(319
|
)
|
(367
|
)
|
(54
|
)
|
(107
|
)
|
(508
|
)
|
||||||||||
10,670
|
3,409
|
8,426
|
1,113
|
458
|
||||||||||||||||
Changes in asset and liability items:
|
||||||||||||||||||||
Decrease (increase) in trade receivables
|
(225
|
)
|
(245
|
)
|
16
|
(90
|
)
|
(107
|
)
|
|||||||||||
Decrease (increase) in inventories
|
(793
|
)
|
642
|
(514
|
)
|
96
|
873
|
|||||||||||||
Decrease (increase) in other receivables
|
(1,548
|
)
|
425
|
(1,271
|
)
|
754
|
33
|
|||||||||||||
Increase (decrease) in trade payables
|
(46
|
)
|
1,377
|
1,164
|
850
|
2,195
|
||||||||||||||
Increase (decrease) in other payables and deferred revenues
|
(328
|
)
|
(827
|
)
|
131
|
(1,382
|
)
|
(1,012
|
)
|
|||||||||||
(2,940
|
)
|
1,372
|
(474
|
)
|
228
|
1,982
|
||||||||||||||
Net cash flows used in operating activities
|
(12,050
|
)
|
(12,215
|
)
|
(3,052
|
)
|
(4,370
|
)
|
(16,445
|
)
|
Nine months ended
September 30,
|
Three months ended
September 30,
|
Year ended December 31,
|
||||||||||||||||||
2017
|
2016
|
2017
|
2016
|
2016
|
||||||||||||||||
Unaudited
|
Audited
|
|||||||||||||||||||
Cash flows from investing activities:
|
||||||||||||||||||||
Purchase of property and equipment
|
(864
|
)
|
(642
|
)
|
(499
|
)
|
(202
|
)
|
(671
|
)
|
||||||||||
Purchase of intangible assets
|
-
|
-
|
-
|
-
|
(30
|
)
|
||||||||||||||
Interest received
|
52
|
45
|
25
|
4
|
407
|
|||||||||||||||
Proceeds from (investment in) short term bank deposits, net
|
(13,837
|
)
|
(25,239
|
)
|
3,000
|
(1,505
|
)
|
2,110
|
||||||||||||
Net cash (used in) provided by investing activities
|
(14,649
|
)
|
(25,836
|
)
|
2,526
|
(1,703
|
)
|
1,816
|
||||||||||||
Cash flows from financing activities:
|
||||||||||||||||||||
Proceeds from exercise of options
|
7
|
2
|
5
|
2
|
7
|
|||||||||||||||
Proceeds from issuance of ordinary shares of NIS 0.01 par value
net of expenses
|
22,794
|
-
|
22,794
|
-
|
-
|
|||||||||||||||
Proceeds from IIA grants, net of repayments
|
328
|
658
|
365
|
658
|
900
|
|||||||||||||||
Net cash provided by financing activities
|
23,129
|
660
|
23,164
|
660
|
907
|
|||||||||||||||
Exchange rate differences on cash and cash equivalent balances
|
106
|
71
|
(11
|
)
|
1
|
86
|
||||||||||||||
Increase (decrease) in cash and cash equivalents
|
(3,464
|
)
|
(37,320
|
)
|
22,627
|
(5,412
|
)
|
(13,636
|
)
|
|||||||||||
Balance of cash and cash equivalents at the beginning of the period
|
28,866
|
42,502
|
2,775
|
10,594
|
42,502
|
|||||||||||||||
Balance of cash and cash equivalents at the end of the period
|
25,402
|
5,182
|
25,402
|
5,182
|
28,866
|
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 EU marketing authorization holder and EU sales and marketing arm and MediWound UK Limited, an inactive company. In addition, the Company owns approximately 6.5% of PolyHeal Ltd., a private life sciences company ("PolyHeal").
|
c. |
The Company's securities are listed for trading on NASDAQ since March 2014.
|
d. |
On September 29, 2015, the Company was awarded a U.S. Biomedical Advanced Research and Development Authority ("BARDA") contract for development and procurement of NexoBrid for the U.S. The contract is 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 July 19, 2017 BARDA had upsized the contract and exercised an option to fund further research and development activities relating to NexoBrid. The modified contract includes $56 million 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 million 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 million for expanding NexoBrid’s indications and of up to $50 million 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:
|
NOTE 3: |
CONTINGENT LIABILITIES
|
NOTE 4: |
EQUITY
|
NOTE 5: |
SUBSEQUENT EVENTS
|