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Published: 2020-11-10 07:06:09 ET
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EX-99.1 3 exhibit_99-2.htm EXHIBIT 99.2
Exhibit 99.2


MEDIWOUND LTD. AND ITS SUBSIDIARIES

INTERIM CONDENSED FINANCIAL STATEMENTS

AS OF SEPTEMBER 30, 2020

U.S. DOLLARS IN THOUSANDS

UNAUDITED

INDEX

 
Page
   
   
F- 2
   
F-3
   
F- 4 – F- 6
   
F- 7 – F- 8
   
F- 9 – F- 10



MEDIWOUND LTD. AND ITS SUBSIDIARIES

CONDENSED INTERIM CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands

   
September 30,
    
December 31,
  
   
2020
    
2019
    
2019
  
   
Unaudited
    
Audited
  
CURRENT ASSETS:
                  
Cash and cash equivalents
    
10,741
      
7,743
      
7,242
  
Restricted deposits
    
181
      
178
      
180
  
Short-term bank deposits
    
14,101
      
24,935
      
22,036
  
Trade receivables
    
2,650
      
4,493
      
4,107
  
Inventories
    
1,805
      
1,419
      
1,613
  
Other receivables
    
845
      
677
      
450
  
                         
     
30,323
      
39,445
      
35,628
  
LONG‑TERM ASSETS:
                        
Property, plant and equipment, net
    
2,448
      
2,169
      
2,304
  
Right of-use assets
    
2,170
      
2,254
      
2,229
  
Intangible assets, net
    
380
      
446
      
429
  
                         
     
4,998
      
4,869
      
4,962
  
     
35,321
      
44,314
      
40,590
  
CURRENT LIABILITIES:
                        
Current maturities of long-term liabilities
    
1,081
      
810
      
569
  
Trade payables and accrued expenses
    
3,155
      
2,863
      
4,067
  
Liability in respect of discontinued operation
    
-
      
2,240
      
-
  
Other payables
    
7,394
      
4,898
      
5,737
  
                         
     
11,630
      
10,811
      
10,373
  
LONG‑TERM LIABILITIES:
                        
Deferred  revenues
    
1,283
      
1,134
      
1,135
  
Liabilities in respect of IIA grants
    
7,157
      
7,099
      
6,811
  
Contingent consideration for purchase of shares
    
4,408
      
4,621
      
4,853
  
Lease liabilities
    
1,942
      
2,015
      
2,006
  
Severance pay liabilities, net
    
284
      
316
      
243
  
                         
     
15,074
      
15,185
      
15,048
  
SHAREHOLDERS' EQUITY:
                        
Ordinary shares of NIS 0.01 par value:
                        
Authorized: 50,000,000 shares as of September 30, 2020, December 31, 2019 and September 30, 2019; Issued and Outstanding: 27,212,794 as of September 30, 2020, 27,202,795 as of December 31, 2019 and  27,178,839 as of September 30, 2019
    
75
      
75
      
75
  
Share premium
    
141,794
      
140,568
      
140,871
  
Foreign currency translation adjustments
    
(28
)
    
(8
)
    
(17
)
Accumulated deficit
    
(133,224
)
    
(122,317
)
    
(125,760
)
                         
     
8,617
      
18,318
      
15,169
  
     
35,321
      
44,314
      
40,590
  

The accompanying notes are an integral part of the interim consolidated financial statements.

F - 2

MEDIWOUND LTD. AND ITS SUBSIDIARIES

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
U.S. dollars in thousands (except share data and per share data)

   
Nine months ended
September 30,
    
Three months ended
September 30,
    
Year ended December 31,
  
   
2020
    
2019
    
2020
    
2019
    
2019
  
   
Unaudited
    
Audited
  
Revenues from sale of products
    
4,744
      
2,355
      
3,082
      
1,046
      
3,393
  
Revenues from development services
    
10,095
      
6,346
      
3,464
      
4,045
      
10,678
  
Revenues from license agreements
    
251
      
17,646
      
79
      
49
      
17,718
  
Total revenues
    
15,090
      
26,347
      
6,625
      
5,140
      
31,789
  
                                         
Cost of revenues
    
9,873
      
7,489
      
3,855
      
3,969
      
11,849
  
                                         
Gross profit
    
5,217
      
18,858
      
2,770
      
1,171
      
19,940
  
                                         
Research and development, gross
    
5,473
      
7,861
      
2,142
      
1,574
      
10,070
  
Participations by BARDA and IIA
    
-
      
(4,568
)
    
-
      
-
      
(5,101
)
Research and development, net of participations
    
5,473
      
3,293
      
2,142
      
1,574
      
4,969
  
Selling and marketing
    
2,392
      
3,078
      
709
      
944
      
4,064
  
General and administrative
    
3,806
      
3,809
      
1,461
      
1,235
      
5,242
  
Other expenses
    
-
      
1,041
      
-
      
140
      
1,172
  
Total operation expenses
    
11,671
      
11,221
      
4,312
      
3,893
      
15,447
  
                                         
Operating profit (loss)
    
(6,454
)
    
7,637
      
(1,542
)
    
(2,722
)
    
4,493
  
                                         
Financial income
    
416
      
300
      
93
      
147
      
556
  
Financial expense
    
(1,509
)
    
(2,345
)
    
(541
)
    
(389
)
    
(2,983
)
                                         
Profit (loss) from continuing operation
    
(7,547
)
    
5,592
      
(1,990
)
    
(2,964
)
    
2,066
  
Profit from discontinued operation
    
83
      
2,806
      
83
      
2,756
      
2,889
  
Net Profit (loss)
    
(7,464
)
    
8,398
      
(1,907
)
    
(208
)
    
4,955
  
                                         
Other comprehensive income (loss):
                                        
Foreign currency translation adjustments
    
(11
)
    
17
      
(12
)
    
15
      
8
  
                                         
Total comprehensive income (loss)
    
(7,475
)
    
8,415
      
(1,919
)
    
(193
)
    
4,963
  
                                         
   Basic and diluted net profit (loss) per share from continuing operations
    
(0.28
)
    
0.21
      
(0.07
)
    
(0.11
)
    
0.08
  
   Basic and diluted net profit per share from discontinued operation
    
(*
)
    
0.10
      
(*
)
    
0.10
      
0.10
  
Total Basic and diluted net profit (loss) per share
    
(0.28
)
    
0.31
      
(0.07
)
    
(0.01
)
    
0.18
  

  (*)          Represents less than $ 1.

The accompanying notes are an integral part of the interim consolidated financial statements.

F - 3
MEDIWOUND LTD. AND ITS SUBSIDIARIES

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
U.S. dollars in thousands

   
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
    
-
      
-
      
-
      
(7,464
)
    
(7,464
)
Other comprehensive loss
    
-
      
-
      
(11
)
    
-
      
(11
)
Total comprehensive loss
    
-
      
-
      
(11
)
    
(7,464
)
    
(7,475
)
Share-based compensation
    
-
      
923
      
-
      
-
      
923
  
Balance as of  September 30, 2020 (unaudited)
    
75
      
141,794
      
(28
)
    
(133,224
)
    
8,617
  

   
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
  

(*)
Represent less than $1.

The accompanying notes are an integral part of the interim consolidated financial statements.

F - 4
MEDIWOUND LTD. AND ITS SUBSIDIARIES

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
U.S. dollars in thousands

   
Share capital
    
Share premium
    
Foreign currency translation reserve
    
Accumulated
deficit
    
Total
Equity
  
                               
Balance as of July 1, 2020
    
75
      
141,390
      
(16
)
    
(131,317
)
    
10,132
  
                                         
Loss for the period
    
-
      
-
      
-
      
(1,907
)
    
(1,907
)
Other comprehensive loss
    
-
      
-
      
(12
)
    
-
      
(12
)
                                         
Total comprehensive loss
    
-
      
-
      
(12
)
    
(1,907
)
    
(1,919
)
                                         
Share-based compensation
    
-
      
404
      
-
      
-
      
404
  
                                         
Balance as of September 30, 2020 (unaudited)
    
75
      
141,794
      
(28
)
    
(133,224
)
    
8,617
  

   
Share capital
    
Share premium
    
Foreign currency translation reserve
    
Accumulated
deficit
    
Total
Equity
  
                               
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
  

The accompanying notes are an integral part of the interim consolidated financial statements.

F - 5
MEDIWOUND LTD. AND ITS SUBSIDIARIES

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
U.S. dollars in thousands

   
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
  

(*)          Represents less than $ 1.

The accompanying notes are an integral part of the interim consolidated financial statements.

F - 6

MEDIWOUND LTD. AND ITS SUBSIDIARIES

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands

   
Nine months ended
September 30,
    
Three months ended
September 30,
    
Year ended December 31,
  
   
2020
    
2019
    
2020
    
2019
    
2019
  
   
Unaudited
    
Audited
  
                               
Cash flows from operating activities:
                              
                               
Net Profit (loss)
    
(7,464
)
    
8,398
      
(1,907
)
    
(208
)
    
4,955
  
                                         
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
    
(83
)
    
(2,806
)
    
(83
)
    
(2,756
)
    
(2,889
)
Depreciation and amortization
    
866
      
848
      
327
      
296
      
1,149
  
Share-based compensation
    
923
      
931
      
404
      
332
      
1,234
  
Revaluation of liabilities in respect of IIA grants
    
692
      
(99
)
    
268
      
293
      
(392
)
Revaluation of contingent consideration for purchase of shares
    
558
      
1,519
      
210
      
197
      
1,690
  
Revaluation of lease liabilities
    
127
      
(291
)
    
63
      
(485
)
    
340
  
Increase (decrease) in severance pay liability, net
    
35
      
(32
)
    
(5
)
    
(22
)
    
(105
)
Net financing income
    
(244
)
    
(295
)
    
(53
)
    
(146
)
    
(434
)
Un-realized foreign currency (gain) loss
    
(8
)
    
(52
)
    
(36
)
    
18
      
(152
)
                                         
     
2,866
      
(277
)
    
1,095
      
(2,273
)
    
441
  
Changes in asset and liability items:
                                        
Decrease (increase) in trade receivables
    
1,477
      
(3,955
)
    
136
      
(3,946
)
    
(3,553
)
Decrease (increase) in inventories
    
(231
)
    
260
      
95
      
114
      
67
  
Decrease (increase) in other receivables
    
(397
)
    
5,198
      
(113
)
    
2,454
      
6,376
  
Increase (decrease) in trade payables and accrued expenses
    
(925
)
    
150
      
724
      
(1,207
)
    
1,355
  
Increase in other payables and deferred revenues
    
1,288
      
810
      
1,202
      
281
      
247
  
                                         
     
1,212
      
2,463
      
2,044
      
(2,304
)
    
4,492
  
Net cash provided by (used in) Continuing operating activities
    
(3,386
)
    
10,584
      
1,232
      
(4,785
)
    
9,888
  
Net cash used in discontinued operating activities
    
(192
)
    
-
      
(192
)
    
-
      
(1,599
)
Net cash provided by (used in) operating activities
    
(3,578
)
    
10,584
      
1,040
      
(4,785
)
    
8,289
  

The accompanying notes are an integral part of the interim consolidated financial statements.

F - 7
MEDIWOUND LTD. AND ITS SUBSIDIARIES

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands

   
Nine months ended
September 30,
    
Three months ended
September 30,
    
Year ended December 31,
  
   
2020
    
2019
    
2020
    
2019
    
2019
  
   
Unaudited
    
Audited
  
                               
Cash flows from investing activities:
                              
                               
Purchase of property and equipment
    
(480
)
    
(463
)
    
(236
)
    
(30
)
    
(792
)
Interest received
    
43
      
104
      
1
      
60
      
184
  
Proceeds from (investment in) short term bank deposits, net
    
8,136
      
(8,005
)
    
(2,459
)
    
(10,982
)
    
(5,050
)
                                         
Net cash provided by (used in) continued investing activities
    
7,699
      
(8,364
)
    
(2,694
)
    
(10,952
)
    
(5,658
)
Net cash used in discontinued investing activities
    
-
      
(957
)
    
-
      
(1,007
)
    
(1,239
)
                                         
Net cash provided by (used in) investing activities
    
7,699
      
(9,321
)
    
(2,694
)
    
(11,959
)
    
(6,897
)
Cash flows from financing activities:
                                        
                                         
Repayment of leases liabilities
    
(533
)
    
99
      
(220
)
    
411
      
(630
)
Proceeds from exercise of options
    
-
      
-
      
-
      
-
      
(*
)
Proceeds from IIA grants, net of repayments
    
(121
)
    
(376
)
    
(55
)
    
(569
)
    
(376
)
                                         
Net cash used in financing activities
    
(654
)
    
(277
)
    
(275
)
    
(158
)
    
(1,006
)
                                         
Exchange rate differences on cash and cash equivalent balances
    
32
      
41
      
58
      
(22
)
    
140
  
                                         
Increase (decrease) in cash and cash equivalents from continuing activities
    
3,691
      
1,984
      
(1,679
)
    
(15,917
)
    
3,364
  
Decrease in cash and cash equivalents from discontinued activities
    
(192
)
    
(957
)
    
(192
)
    
(1,007
)
    
(2,838
)
                                         
Balance of cash and cash equivalents at the beginning of the period
    
7,242
      
6,716
      
12,612
      
24,667
      
6,716
  
                                         
Balance of cash and cash equivalents at the end of the period
    
10,741
      
7,743
      
10,741
      
7,743
      
7,242
  

(*)          Represents less than $ 1.

The accompanying notes are an integral part of the interim consolidated financial statements.
          
F - 8
MEDIWOUND LTD. AND ITS SUBSIDIARIES

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands

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.

On June 29, 2020, the Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drugs Administration (FDA) seeking the approval of NexoBrid in USA.

On 16 September, 2020, FDA provided the Company with notification of acceptance of the  BLA for review.

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

The following accounting policies have been applied consistently in the financial statements for all periods presented unless otherwise stated.


 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").

F - 9
MEDIWOUND LTD. AND ITS SUBSIDIARIES

NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands

NOTE 2:
SIGNIFICANT ACCOUNTING POLICIES-Cont.

b.        Basis of preparation of the interim consolidated financial statements:

The interim condensed consolidated financial statements for the nine months ended September 30, 2020 have been prepared in accordance with IAS 34 "Interim Financial Reporting".

The interim condensed consolidated financial statements do not include all the information and disclosures required in the annual financial statements, and should be read in conjunction with the Company's annual financial statements as of December 31, 2019 that were included in the Annual Report on Form 20-F filed on February 25, 2020.

The accounting policies adopted in the preparation of the interim condensed consolidated financial statements are consistent with those followed in the preparation of the Company’s annual consolidated financial statements for the year ended December 31, 2019 that were included in the Annual Report on Form 20-F filed on February 25, 2020, except than the change discussed below.

c.         Reclassification:

Certain amounts previously reported in the consolidated financial statements have been reclassified to conform to current year presentation. Such reclassifications did not affect net loss, shareholders’ equity or cash flows.

F - 10