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Published: 2021-05-05 07:05:10 ET
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EX-99.2 3 exhibit_99-2.htm EXHIBIT 99.2
Exhibit 99.2

MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

AS OF MARCH 31, 2021

IN U.S. DOLLARS IN THOUSANDS

UNAUDITED

INDEX

 
Page
   
F-2
   
F-3
   
F-4 – F-5
   
F-6 – F-7
   
F-8 – F-9

- - - - - - - - - - - - -


MEDIWOUND LTD. AND ITS SUBSIDIARIES

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

   
March 31,
    
December 31,
  
   
2021
    
2020
    
2020
  
     Unaudited    
Audited
  
CURRENT ASSETS:
                  
Cash and cash equivalents
    
17,684
      
7,981
      
17,376
  
Restricted deposits
    
178
      
174
      
184
  
Short-term bank deposits
    
-
      
19,156
      
4,024
  
Trade receivables
    
5,153
      
3,195
      
2,767
  
Inventories
    
1,470
      
2,004
      
1,380
  
Other receivables
    
421
      
345
      
462
  
                         
     
24,906
      
32,855
      
26,193
  
LONG-TERM ASSETS:
                        
Property, plant and equipment, net
    
2,694
      
2,339
      
2,630
  
Right of-use assets, net
    
1,747
      
2,191
      
1,884
  
Intangible assets, net
    
347
      
413
      
363
  
                         
     
4,788
      
4,943
      
4,877
  
                         
     
29,694
      
37,798
      
31,070
  
CURRENT LIABILITIES:
                        
Current maturities of long-term liabilities and leases
    
1,884
      
1,417
      
1,750
  
Trade payables and accrued expenses
    
3,258
      
3,423
      
2,992
  
Other payables
    
5,172
      
5,843
      
3,524
  
                         
     
10,314
      
10,683
      
8,266
  
LONG‑TERM LIABILITIES:
                        
Deferred revenues
    
693
      
1,018
      
1,234
  
Liabilities in respect of IIA grants
    
7,275
      
6,942
      
7,267
  
Liabilities in respect of purchase of shares
    
4,733
      
4,097
      
4,998
  
Lease liabilities
    
1,590
      
1,905
      
1,741
  
Severance pay liability, net
    
273
      
264
      
292
  
                         
     
14,564
      
14,226
      
15,532
  
SHAREHOLDERS' EQUITY:
                        
Ordinary shares of NIS 0.01 par value:
                        
Authorized: 50,000,000 shares as of March 31, 2021 ,December 31, 2020 and  March 31, 2020; Issued and Outstanding: 27,245,271 as of March 31, 2021, 27,236,752 as of  December  31, 2020 and 27,211,128 as of March 31, 2020
    
75
      
75
      
75
  
Share premium
    
142,577
      
141,044
      
142,193
  
Foreign currency translation adjustments
    
(29
)
    
(9
)
    
(40
)
Accumulated deficit
    
(137,807
)
    
(128,221
)
    
(134,956
)
                         
     
4,816
      
12,889
      
7,272
  
                         
     
29,694
      
37,798
      
31,070
  

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

F - 2
MEDIWOUND LTD. AND ITS SUBSIDIARIES

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

   
Three months ended
March 31,
    
Year ended
December 31,
  
   
2021
    
2020
    
2020
  
   
Unaudited
    
Audited
  
                   
Revenues from sale of products
    
2,518
      
647
      
7,445
  
Revenues from development services
    
2,940
      
3,709
      
13,935
  
Revenues from license agreements
    
389
      
82
      
383
  
Total revenues
    
5,847
      
4,438
      
21,763
  
                         
Cost of revenues
    
3,431
      
3,208
      
14,218
  
                         
Gross profit
    
2,416
      
1,230
      
7,545
  
                         
Research and development
    
2,242
      
1,719
      
7,698
  
Selling and marketing
    
822
      
824
      
3,228
  
General and administrative
    
1,273
      
893
      
5,459
  
Total operating expenses
    
4,337
      
3,436
      
16,385
  
                         
Operating loss
    
(1,921
)
    
(2,206
)
    
(8,840
)
                         
Financial income
    
11
      
239
      
843
  
Financial expense
    
(941
)
    
(494
)
    
(1,279
)
                         
Loss from continuing operation
    
(2,851
)
    
(2,461
)
    
(9,276
)
Profit from discontinued operation
    
-
      
-
      
80
  
                         
Net loss
    
(2,851
)
    
(2,461
)
    
(9,196
)
                         
Other comprehensive income (loss):
                        
Foreign currency translation adjustments
    
11
      
8
      
(23
)
Total comprehensive loss
    
(2,840
)
    
(2,453
)
    
(9,219
)
                         
Basic and diluted loss per share:
                        
Basic and diluted net loss per share from continuing operations
    
(0.10
)
    
(0.09
)
    
(0.34
)
Basic and diluted net profit per share from discontinued operations
    
-
      
-
      
(*
)
Total Basic and diluted net loss per share
    
(0.10
)
    
(0.09
)
    
(0.34
)

(*) Represents an amount lower than $1.

The accompanying notes are an integral part of the interim 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, 2020
    
75
      
142,193
      
(40
)
    
(134,956
)
    
7,272
  
                                         
Loss for the period
    
-
      
-
      
-
      
(2,851
)
    
(2,851
)
Other comprehensive income
    
-
      
-
      
11
      
-
      
11
  
Total comprehensive income (loss)
    
-
      
-
      
11
      
(2,851
)
    
(2,840
)
Exercise of options and RSU’s
    
(*
)
    
-
      
-
      
-
      
(*
)
Share-based compensation
    
-
      
384
      
-
      
-
      
384
  
                                         
Balance as of March 31, 2021
    
75
      
142,577
      
(29
)
    
(137,807
)
    
4,816
  

   
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
    
-
      
-
      
-
      
(2,461
)
    
(2,461
)
Other comprehensive income
    
-
      
-
      
8
      
-
      
8
  
Total comprehensive income (loss)
    
-
      
-
      
8
      
(2,461
)
    
(2,453
)
Exercise of options and RSU’s
    
(*
)
    
-
      
-
      
-
      
(*
)
Share-based compensation
    
-
      
173
      
-
      
-
      
173
  
                                         
Balance as of March 31, 2020
    
75
      
141,044
      
(9
)
    
(128,221
)
    
12,889
  

(*) Represents an amount lower than $1.

The accompanying notes are an integral part of the interim 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 December 31, 2019
    
75
      
140,871
      
(17
)
    
(125,760
)
    
15,169
  
                                         
Net loss
    
-
      
-
      
-
      
(9,196
)
    
(9,196
)
Other comprehensive loss
    
-
      
-
      
(23
)
    
-
      
(23
)
Total comprehensive loss
    
-
      
-
      
(23
)
    
(9,196
)
    
(9,219
)
Exercise of options and RSU’s
    
(*
)
    
-

   
 -
      
-
      
(*
)
Share-based compensation
    
-
      
1,322
      
-
      
-
      
1,322
  
                                         
Balance as of December 31, 2020
    
75
      
142,193
      
(40
)
    
(134,956
)
    
7,272
  

(*) Represents an amount lower than $1.

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

F - 5
MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands

   
Three months ended
March 31,
    
Year ended
December 31,
  
   
2021
    
2020
    
2020
  
   
Unaudited
    
Audited
  
Cash Flows from Operating Activities:
                  
Net loss
    
(2,851
)
    
(2,461
)
    
(9,196
)
                         
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
                        
                         
Adjustments to profit and loss items:
                        
Profit from discontinued operation
    
-
      
-
      
(80
)
Depreciation and amortization
    
273
      
268
      
1,090
  
Share-based compensation
    
384
      
173
      
1,322
  
Revaluation of liabilities in respect of IIA grants
    
275
      
198
      
828
  
Revaluation of liabilities in respect of purchase of shares
    
152
      
152
      
(433
)
Revaluation of lease liabilities
    
(44
)
    
(36
)
    
305
  
Increase (decrease) in severance pay liability, net
    
(10
)
    
21
      
33
  
Net financing income
    
(11
)
    
(110
)
    
(297
)
Un-realized foreign currency (gain) loss
    
256
      
79
      
(211
)
                         
     
1,275
      
745
      
2,557
  
Changes in asset and liability items:
                        
Decrease (increase)  in trade receivables
    
(2,407
)
    
897
      
1,386
  
Decrease (increase) in inventories
    
(45
)
    
(391
)
    
141
  
Decrease (increase) in other receivables
    
37
      
99
      
(13
)
Increase (decrease) in trade payables and accrued expenses
    
272
      
(645
)
    
(1,096
)
Increase (decrease) in other payables and deferred revenues
    
806
      
(47
)
    
(479
)
                         
     
(1,337
)
    
(87
)
    
(61
)
                         
Net cash used in continuing operating activities
    
(2,913
)
    
(1,803
)
    
(6,700
)
                         
Net cash used in discontinued operating activities
    
-
      
-
      
(195
)
                         
Net cash used in operating activities
    
(2,913
)
    
(1,803
)
    
(6,895
)

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

F - 6
MEDIWOUND LTD. AND ITS SUBSIDIARIES

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

   
Three months ended
March 31,
    
Year ended
December 31,
  
   
2021
    
2020
    
2020
  
   
Unaudited
    
Audited
  
Cash Flows from Investing Activities:
                  
                   
Purchase of property and equipment
    
(218
)
    
(144
)
    
(923
)
Interest received
    
35
      
3
      
274
  
Proceeds from short term bank deposits, net
    
4,006
      
2,992
      
18,034
  
                         
Net cash provided by continuing investing activities
    
3,823
      
2,851
      
17,385
  
                         
Cash Flows from Financing Activities:
                        
                         
Repayment of leases liabilities
    
(131
)
    
(160
)
    
(508
)
Proceeds from issuance of shares, net
    
-
      
(*
)
    
-
  
Repayment of IIA grants, net
    
(180
)
    
(66
)
    
(121
)
                         
Net cash used in continuing financing activities
    
(311
)
    
(226
)
    
(629
)
                         
Exchange rate differences on cash and cash equivalent balances
    
(291
)
    
(83
)
    
273
  
                         
Increase in cash and cash equivalents from continuing activities
    
308
      
739
      
10,329
  
                         
Decrease  in cash and cash equivalents from discontinued activities
    
-
      
-
      
(195
)
                         
Balance of cash and cash equivalents at the beginning of the period
    
17,376
      
7,242
      
7,242
  
                         
Balance of cash and cash equivalents at the end of the period
    
17,684
      
7,981
      
17,376
  
                         
Supplement disclosure of Non-cash transactions:
                        
ROU asset, net recognized with corresponding lease liability
    
-
      
68
      
261
  
Exercise of RSU’s
    
43
      
43
      
147
  

(*) Represents an amount lower than $1.

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

F - 7
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. which incorporated in Yavne, Israel (the "Company" or "MediWound"), is biopharmaceutical company develops, manufactures and commercializes novel, cost effective, bio- therapeutic solutions for tissue repair and regeneration. The Company’s strategy is centered around its validated proteolytic enzyme platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair.

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 while establishing additional local distribution channels to extend its outreach in the European Union. In other territories the company sells NexoBrid through local distribution channels. 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.

The third innovative product candidate, MWPC005, is a topically applied biological drug candidate for the treatment of non-melanoma skin cancers,


 b.
The Company's securities are listed for trading on NASDAQ since March 2014.


c.
The Company has three wholly owned subsidiaries: MediWound Germany GmbH, acting as Europe (“EU”) marketing authorization holder and EU sales and marketing arm, MediWound UK Limited and MediWound US, Inc. currently an inactive companies.

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, manufacturing and emergency readiness for NexoBrid deployment as well as the procurement of NexoBrid as a medical countermeasure as part of BARDA preparedness for mass casualty events.


e.
The Company addressed the challenges associated with the COVID-19 pandemic during the year ended 2020 and three months ended March 31, 2021, while prioritizing the health and safety of its workforce and maintaining operational efficiency and flexibility. With respect to Note 1(a) to our 2020 annual financial statements, the FDA review processes have been affected by COVID-19 travel restriction and by evolving FDA priorities. As a result, the Company cannot predict how long the FDA may take to complete the review of the BLA of NexoBrid. Accordingly, the Company expect the timing of the potential approval of NexoBrid to be impacted.

F - 8
MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands

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").

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

The interim condensed consolidated financial statements for the three months ended March 31, 2021 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, 2020 that were included in the Annual Report on Form 20-F filed on February 25, 2021.

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, 2020 that were included in the Annual Report on Form 20-F filed on February 25, 2021, 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.

NOTE 3: 
EQUITY

On March 4, 2021, the Company's Board of Directors approved the grant of 377,790 options to purchase ordinary shares, for an exercise price of $ 5.36 per share as well as 62,947 RSU’s to its employees, officers and members of the board. The fair value of the options and RSU’s, as of the grant date, was estimated at $1.2, $0.6 million consistently. The general meeting which will approved the grants to the CEO and the chairman of the BOD, is yet to be determined.

F - 9