EX-99.2 3 exhibit_99-2.htm EXHIBIT 99.2
Exhibit 99.2

MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS OF MARCH 31, 2022

IN U.S. DOLLARS IN THOUSANDS

UNAUDITED

INDEX

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

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

MEDIWOUND LTD. AND ITS SUBSIDIARIES

Condensed Interim Consolidated Statements of Financial Position
U.S. dollars in thousands

   
March 31,
    
December 31,
  
   
2022
    
2021
    
2021
  
   
Unaudited
    
Audited
  
                   
Cash and cash equivalents
    
16,651
      
17,684
      
11,046
  
Restricted deposits
    
185
      
178
      
-
  
Trade receivables
    
2,348
      
5,153
      
1,779
  
Inventories
    
1,920
      
1,470
      
1,200
  
Other receivables
    
852
      
421
      
927
  
Total current assets
    
21,956
      
24,906
      
14,952
  
                         
Other receivables
    
230
      
-
      
469
  
Property, plant and equipment, net
    
2,471
      
2,694
      
2,478
  
Right of-use assets, net
    
1,429
      
1,747
      
1,548
  
Intangible assets, net
    
281
      
347
      
297
  
Total non-current assets
    
4,411
      
4,788
      
4,792
  
                         
Total assets
    
26,367
      
29,694
      
19,744
  
                         
Current maturities of long-term liabilities
    
2,572
      
1,884
      
2,408
  
Trade payables and accrued expenses
    
5,623
      
3,258
      
4,693
  
Other payables
    
3,055
      
5,172
      
3,620
  
Total current liabilities
    
11,250
      
10,314
      
10,721
  
                         
Deferred revenues
    
91
      
693
      
119
  
Liabilities in respect of IIA grants
    
7,897
      
7,275
      
7,885
  
Liabilities in respect of purchase of shares
    
3,642
      
4,733
      
3,922
  
Lease liabilities
    
1,239
      
1,590
      
1,391
  
Severance pay liability, net
    
303
      
273
      
288
  
Total non-current liabilities
    
13,172
      
14,564
      
13,605
  
                         
Total liabilities
    
24,422
      
24,878
      
24,326
  
                         
Shareholders' equity:
                        
Ordinary shares of NIS 0.01 par value:
                        
Authorized: 50,000,000 shares as of March 31, 2022, December 31, 2021 and  March 31, 2021; Issued and Outstanding: 33,140,633 as of March 31, 2022, 27,272,818 as of  December  31, 2021 and : 27,245,271 as of March 31, 2021
    
93
      
75
      
75
  
Share premium
    
153,962
      
142,577
      
143,869
  
Foreign currency translation reserve
    
(14
)
    
(29
)
    
(19
)
Accumulated deficit
    
(152,096
)
    
(137,807
)
    
(148,507
)
Total equity (deficit)
    
1,945
      
4,816
      
(4,582
)
                         
Total liabilities and equity
    
26,367
      
29,694
      
19,744
  

The accompanying notes are an integral part of the interim financial statements.
F - 2
MEDIWOUND LTD. AND ITS SUBSIDIARIES

Condensed Interim Consolidated Statements of Profit or Loss and Other Comprehensive Income or Loss
U.S. dollars in thousands (except share and per share data)

   
Three months ended
March 31,
    
Year ended
December 31,
  
   
2022
    
2021
    
2021
  
   
Unaudited
    
Audited
  
                   
Revenues from sale of products
    
1,102
      
2,518
      
9,613
  
Revenues from development services
    
3,089
      
2,940
      
12,372
  
Revenues from license agreements
    
216
      
389
      
1,778
  
Total revenues
    
4,407
      
5,847
      
23,763
  
                         
Cost of revenues from sale of products
    
391
      
1,140
      
4,983
  
Cost of revenues from development services
    
2,541
      
2,273
      
9,907
  
Cost of revenues from license agreements
    
15
      
18
      
102
  
Total cost of revenues
    
2,947
      
3,431
      
14,992
  
                         
Gross profit
    
1,460
      
2,416
      
8,771
  
                         
Research and development
    
2,408
      
2,242
      
10,256
  
Selling and marketing
    
919
      
822
      
3,388
  
General and administrative
    
1,417
      
1,273
      
6,348
  
Total operating expenses
    
4,744
      
4,337
      
19,992
  
                         
Operating loss
    
(3,284
)
    
(1,921
)
    
(11,221
)
                         
Financial income
    
139
      
11
      
11
  
Financial expense
    
(440
)
    
(941
)
    
(2,314
)
Financing expenses, net
    
(301
)
    
(930
)
    
(2,303
)
                         
Loss before taxes on income
    
(3,585
)
    
(2,851
)
    
(13,524
)
                         
Taxes on income
    
(4
)
    
-
      
(27
)
                         
Net loss
    
(3,589
)
    
(2,851
)
    
(13,551
)
                         
Other comprehensive income :
                        
Foreign currency translation adjustments
    
5
      
11
      
21
  
Total comprehensive loss
    
(3,584
)
    
(2,840
)
    
(13,530
)
                         
Loss per share data
                        
Basic and diluted net loss per share - USD
    
(0.12
)
    
(0.10
)
    
(0.50
)
Number of shares used in calculating basic and diluted net loss per share
    
28,733,130
      
27,236,876
      
27,244,475
  

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 (Deficit)
U.S. dollars in thousands

   
Share capital
    
Share premium
    
Foreign currency translation reserve
    
Accumulated
deficit
    
Total
equity (deficit)
  
                               
Balance as of December 31, 2021
    
75
      
143,869
      
(19
)
    
(148,507
)
    
(4,582
)
                                         
Loss for the period
    
-
      
-
      
-
      
(3,589
)
    
(3,589
)
Other comprehensive income
    
-
      
-
      
5
      
-
      
5
  
Total comprehensive income (loss)
    
-
      
-
      
5
      
(3,589
 )    
(3,584
)
Issue of ordinary shares
    
18
      
9,748
      
-
      
-
      
9,766
  
Exercise of options
    
(*
)
    
(*
)
    
-
      
-
      
(*
)
Share-based compensation
    
-
      
345
      
-
      
-
      
345
  
                                         
Balance as of March 31, 2022
    
93
      
153,962
      
(14
)
    
(152,096
)
    
1,945
  
                                         
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
  
                                         
Balance as of December 31, 2020
    
75
      
142,193
      
(40
)
    
(134,956
)
    
7,272
  
                                         
Loss for the period
    
-
      
-
      
-
      
(13,551
)
    
(13,551
)
Other comprehensive income
    
-
      
-
      
21
      
-
      
21
  
Total comprehensive income (loss)
     -
      -
      21
      (13,551
 )    
(13,530
 )
Exercise of options
    
(*
)
    
3
      
-
      
-
      
3
  
Share-based compensation
    
-
      
1,673
      
-
      
-
      
1,673
  
                                         
Balance as of December 31, 2021
    
75
      
143,869
      
(19
)
    
(148,507
)
    
(4,582
)

(*) 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 Cash Flows
U.S. dollars in thousands

   
Three months ended
March 31,
    
Year ended
December 31,
  
   
2022
    
2021
    
2021
  
   
Unaudited
    
Audited
  
Cash Flows from Operating Activities:
                  
Net loss
    
(3,589
)
    
(2,851
)
    
(13,551
)
                         
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
                        
                         
Adjustments to profit and loss items:
                        
Depreciation and amortization
    
321
      
273
      
1,238
  
Share-based compensation
    
345
      
384
      
1,673
  
Revaluation of liabilities in respect of IIA grants
    
234
      
275
      
919
  
Revaluation of liabilities in respect of purchase of shares
    
137
      
152
      
590
  
Revaluation of lease liabilities
    
(14
)
    
(44
)
    
188
  
Increase (decrease) in severance pay liability, net
    
20
      
(10
)
    
13
  
Net financing income
    
-
      
(11
)
    
(11
)
Un-realized foreign currency (gain) loss
    
245
      
256
      
(137
)
                         
     
1,288
      
1,275
      
4,473
  
Changes in asset and liability items:
                        
Decrease (increase) in trade receivables
    
(579
)
    
(2,407
)
    
929
  
Decrease (increase) in inventories
    
(710
)
    
(45
)
    
257
  
Decrease (increase) in other receivables
    
125
      
37
      
(763
)
Increase in trade payables and accrued expenses
    
283
      
272
      
1,723
  
Increase (decrease) in other payables and deferred revenues
    
(883
)
    
806
      
(1,984
)
                         
     
(1,764
)
    
(1,337
)
    
162
  
                         
Net cash used in operating activities
    
(4,065
)
    
(2,913
)
    
(8,916
)

The accompanying notes are an integral part of the 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,
  
   
2022
    
2021
    
2021
  
   
Unaudited
    
Audited
  
Cash Flows from Investing Activities:
                  
                   
Purchase of property and equipment
    
(160
)
    
(218
)
    
(489
)
Interest received
    
-
      
35
      
35
  
Proceeds from short term bank deposits, net
    
-
      
4,006
      
4,002
  
                         
Net cash  (used in) provided by investing activities
    
(160
)
    
3,823
      
3,548
  
                         
Cash Flows from Financing Activities:
                        
                         
Repayment of leases liabilities
    
(178
)
    
(131
)
    
(693
)
Proceeds from issuance of shares, net
    
10,417
      
-
      
3
  
Repayment of IIA grants, net
    
(162
)
    
(180
)
    
(360
)
                         
Net cash provided by (used in) financing activities
    
10,077
      
(311
)
    
(1,050
)
                         
Exchange rate differences on cash and cash equivalent balances
    
(247
)
    
(291
)
    
88
  
                         
Increase (decrease) in cash and cash equivalents
    
5,605
      
308
      
(6,330
)
                         
Balance of cash and cash equivalents at the beginning of the period
    
11,046
      
17,376
      
17,376
  
                         
Balance of cash and cash equivalents at the end of the period
    
16,651
      
17,684
      
11,046
  
                         
Supplement disclosure of Non-cash transactions:
                        
ROU asset, net recognized with corresponding lease liability
    
-
      
-
      
155
  
Exercise of RSU’s
    
177
      
43
      
147
  

The accompanying notes are an integral part of the financial statements.
F - 6

MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
Notes to Condensed Interim Consolidated Financial Statements
U.S. dollars in thousands

Note 1:
GENERAL


a.
Description of the Company and its operations:

MediWound Ltd. was incorporated in Israel. The Company which is located in Yavne, Israel (The "Company" or "MediWound"), is biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. The Company’s strategy leverages its breakthrough enzymatic technology platform into diversified portfolio of biotherapeutics across multiple indications to pioneer solutions for unmet medical needs.  The Company’s current portfolio is focused on next-generation bio-active therapies for burn and wound care and tissue repair.

The Company's first innovative biopharmaceutical product, NexoBrid, has received marketing authorization from the European Medicines Agency ("EMA") as well as the Israeli, Argentinean, South-Korean, Russian, Taiwanese, Ukrainian, United Arab Emirates, Chilean, Peruvian and Switzerland 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 the European Union, United Kingdom, Norway, Switzerland and Israel through its commercial organizations while establishing additional local distribution channels to extend its outreach in the European Union. In other international markets the Company sells NexoBrid through local distributors which are also responsible for obtaining the local marketing authorization within the relevant territory. In the United States, the Company entered into exclusive license and supply agreements with Vericel Corporation (“Vericel”) to commercialize NexoBrid in North America upon FDA's approval.

The Company’s second investigational innovative product, EscharEx, a topical biological drug being developed for debridement of chronic and other hard-to-heal wounds, is currently under a U.S. phase 2 study and in January 2022, a positive topline results were announced from this study. Patient follow-up is ongoing and additional data, including secondary and exploratory endpoints as well as additional safety measurements, will allow further evaluation of clinical benefits, in the second quarter of 2022.

The third clinical-stage innovative product candidate, MW005, is a topical biological drug candidate for the treatment of non-melanoma skin cancers. A U.S. phase 1/2 study of MW005 for the treatment of low-risk basal cell carcinoma (BCC) was initiated in July 2021, and an investigator-initiated phase II trial of MW005 in non-melanoma skin cancer is being conducted in parallel in Israel.


 b.
The Company's securities are listed for trading on NASDAQ since March 2014. In March, 2022, the Company completed a public offering. A total of 5,208,333 new ordinary shares were issued at a public offering price of $1.92 per share. The gross proceeds before deducting underwriting discounts and commissions and offering expenses, were approximately $10 million. (see also Note 3).


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. are currently inactive companies.

F - 7
MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
Notes to Condensed Interim Consolidated Financial Statements
U.S. dollars in thousands

Note 1:
GENERAL (Cont.)
 

 d.
The Company awarded two contracts with the U.S. Biomedical Advanced Research and Development Authority ("BARDA") valued at up to $168,000 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. In February 2022 BARDA has expanded its awarded contract providing supplemental funding of approximately $9,000 to support the NexoBrid BLA resubmission to the FDA and the continuous expanded access program.
 

 e.
On February 17, 2022 the Company engaged with the U.S. Department of Defense (DoD), through the Medical Technology Enterprise Consortium (MTEC), for a $1.7 million contract for the development of NexoBrid as a non-surgical solution for field-care burn treatment for the U.S. Army.


f.
On June 29, 2021, the Company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) seeking approval of NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.

The FDA communicated that it had completed its review of the BLA, as amended, and has determined that the application cannot be approved in its present form. The FDA identified issues related to the Chemistry, Manufacturing and Controls (“CMC”) section of the BLA and requested additional CMC information. The FDA acknowledged receipt of several CMC amendments, submitted by the Company in response to the CMC information requests, which were not reviewed yet by the FDA.

The FDA also stated that an inspection of NexoBrid's manufacturing facilities in Israel and Taiwan, are required before the FDA can approve the BLA, but it was unable to conduct the required inspections during the current review cycle due to COVID-19 related travel restrictions. The FDA stated that it will continue to monitor the public health situation as well as travel restrictions and is actively working to define an approach for scheduling outstanding inspections. In addition, the CRL cited certain observations identified during good clinical practice (GCP) inspections related to the U.S. Phase 3 study (DETECT), and requested the Company to provide its perspective on the potential impact, if any, of these observations on the efficacy findings in the study. The FDA also requested to provide a safety update as part of its BLA resubmission, although there were no safety issues raised in the CRL.

Following a productive Type A meeting with the FDA, the Company gained clarity on a path forward for resubmission of its NexoBrid BLA, which is anticipated in mid-2022. In addition, the FDA’s facility inspection schedule which has been affected by COVID-19-related travel restrictions, is required before the FDA can approve the NexoBrid BLA.
Consequently, the Company expects the timing of the potential approval of NexoBrid to be impacted.


 g.
The Company addresses the challenges associated with the ongoing COVID-19 pandemic, while prioritizing the health and safety of its workforce and maintaining operational efficiency and flexibility.

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, 2022 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, 2021 that were included in the Annual Report on Form 20-F filed on March 17, 2022.

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, 2021 that were included in the Annual Report on Form 20-F filed on March 17, 2022.

NOTE 2:
  EQUITY

On March 7, 2022, the Company completed a public offering. A total of 5,208,333 new ordinary shares were issued in consideration to offering price of $1.92 per share. The net proceeds were $8,641, after deducting commissions and other offering expenses. In addition, on March 22, 2022 the underwriters exercised their options to purchase an additional 623,082 ordinary shares at the public offering price, less underwriting discounts and commissions at an additional net proceeds of $1,125.

As part of the above- mentioned public offering, certain entities affiliated with CBI purchased 1,458,333 of ordinary shares at the public offering price.

F - 9