SECURITIES AND EXCHANGE COMMISSION
 
Washington, D.C.  20549
______________________
 
FORM 6-K
 
REPORT OF FOREIGN PRIVATE ISSUER
 
Pursuant to Rule 13a-16 or 15d-16 of the
Securities Exchange Act of 1934
 
For the month of May 2021
 
Commission File Number: 001-36349
 
                  MediWound Ltd.                   
(Translation of registrant’s name into English)
 
42 Hayarkon Street
Yavne, 8122745 Israel
 (Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
 
Form 20-F ☒        Form 40-F ☐
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):   __
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):   __
 
 

EXPLANATORY NOTE
 
On May 5, 2021, MediWound Ltd. (the “Company”) issued a press release entitled “MediWound Reports First Quarter 2021 Financial Results”. A copy of this press release is attached to this Form 6-K as Exhibit 99.1.

In addition, pursuant to the Information Rights Agreement between the Company and Clal Biotechnology Industries Ltd. ("CBI"), dated March 3, 2014 (which was attached to the Company's registration statement as exhibit 4.3), the Company is required to provide CBI with certain information necessary for CBI to meet its obligations  under Israeli Securities Law. This Form 6-K includes an Un-Audited Condensed Consolidated Interim Financial Statements as of March 31, 2021, attached as Exhibit 99.2, which was provided by the Company to CBI on May 4, 2021 pursuant to such contractual obligation.

The content of this report on Form 6-K (including the information contained in Exhibit 99.1, but excluding quotes of senior management of the Company, and Exhibit 99.2) is hereby incorporated by reference into the Company’s Registration Statements on Form S-8 filed with the SEC on April 28, 2014, March 24, 2016, March 19, 2018, March 25, 2019 and February 25, 2020 (Registration Nos. No. 333-195517, 333-210375, 333-223767, 333-195517, 333-210375, 333-230487 and 333-236635, respectively) and on Form F-3 filed with the SEC on March 25, 2019 (Registration No. 333-230490).

2

 
SIGNATURE
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
 
MEDIWOUND LTD.

 
Date: May 5, 2021
By:
/s/ Boaz Gur-Lavie
 
 
Name:
Boaz Gur-Lavie
 
 
Title:
Chief Financial Officer
 

3


EXHIBIT INDEX

The following exhibit is filed as part of this Form 6-K:

Exhibit
Description

99.1

99.2


4

Exhibit 99.1
MediWound Reports First Quarter 2021 Financial Results

First Quarter Revenues of $5.8 Million, an Increase of 32% Year-over-Year
 
Conference call begins today at 8:30 am ET
 
YAVNE, Israel, May 5, 2021 -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced financial results for the first quarter ended March 31, 2021.

First Quarter and recent weeks Financial and Business Highlights:


Total revenues for the first quarter of 2021 were $5.8 million, an increase of 32% compared with the first quarter of 2020, primarily driven by the procurement of NexoBrid® by the Biomedical Advanced Research and Development Authority (BARDA)


Cash and short-term investments of $17.9 million as of March 31, 2021, compared with $21.6 million as of December 31, 2020


Hosted an Analyst Day on March 30 highlighting EscharEx® as an enzymatic debridement agent for chronic wounds featuring presentations by key opinion leaders.


Enrolled the first patient in phase 2 pharmacology study of EscharEx, with data expected in the second half of 2021


Submitted a protocol to the U.S. Food and Drug Administration (FDA) for a phase I/II clinical study of MWPC005 for the treatment of basal cell carcinoma; study initiation is planned for the second quarter of 2021


Received marketing approval for NexoBrid in Chile and the Republic of China (Taiwan) and continue global expansion strategy with new distribution agreements in Europe and Asia

“This quarter was one of continued progress across the board, highlighted by the continued revenue growth and NexoBrid global expansion, the enrollment of the first patient in our phase 2 pharmacology study of EscharEx, and the initiation of a new clinical program in non-melanoma skin cancer,” said Sharon Malka, Chief Executive Officer of MediWound. “We were proud to host an analyst day webinar in March on EscharEx, featuring four prominent key opinion leaders who discussed the current U.S. wound debridement practices and how EscharEx, upon approval, has the potential to change current standard of practice and care of chronic wounds. We continue to advance our U.S. phase 2 adaptive design study of EscharEx for the treatment of venous leg ulcers and look forward to an interim assessment later this year. Finally, we remain focused on continuing to drive revenue growth and further strengthen our company."

First Quarter Financial Results

Revenues for the first quarter of 2021 were $5.8 million, compared with $4.4 million for the first quarter of 2020, an increase of 32%. Revenues from products and licenses in the first quarter of 2021 were $2.9 million, an increase of 300% compared to the first quarter of 2020, primarily driven by the procurement of NexoBrid by BARDA for emergency response preparedness and sales increase outside the U.S.

Gross profit for the first quarter of 2021 was $2.4 million, or 41% of net revenues, compared to a gross profit of $1.2 million, or 28% of net revenues for the first quarter of 2020.


Research and development expenses for the first quarter of 2021, were $2.2 million, compared with $1.7 million for the first quarter of 2020. The increase was a result of EscharEx clinical development program.

Selling, general and administrative expenses for the first quarter of 2021 were $2.1 million, compared with $1.7 million in the first quarter of 2020 as a result of directors and officer’s insurance cost increase. As a percentage of revenues, selling, general and administrative expenses for the first quarter decreased from 39% in the first quarter of 2020 to 36% for the first quarter of 2021.

Operating loss for the first quarter of 2021 was $1.9 million, reflecting a 13% decrease in operating loss compared to the $2.2 million in the first quarter of 2020.

The Company posted a net loss of $2.9 million, or $0.10 per share, for the first quarter of 2021 compared with a net loss of $2.5 million, or $0.09 per share, for the first quarter of 2020.

Adjusted EBITDA, as defined below, for the first quarter of 2021 was a loss of $1.3 million, compared with a loss of $1.8 million for the first quarter of 2020, reflecting a decrease in adjusted EBIDTA loss of 28%.

Balance Sheet Highlights

As of March 31, 2021, MediWound had $17.9 million in cash and short-term investments, compared with $21.6 million as of December 31, 2020, and no debt. MediWound remained on budget, utilizing $3.7 million in the first quarter of 2021 for its operational activities. The Company expects cash use for 2021 to be in the range of $5.0 to $7.0 million.

Conference Call

MediWound management will host a conference call for investors today, Thursday, May 5, 2021 beginning at 8:30 a.m. Eastern Time to discuss these results and answer questions.  Shareholders and other interested parties may participate in the conference call by dialing 877-602-7189 (in the U.S.)  1 809 315 362 (Israel), or 678-894-3057 (outside the U.S. & Israel) and entering passcode 3496059. The call also will be webcast live on the Company’s website at http://ir.mediwound.com/events-and-presentations.

A replay of the call will be available on the Company website for 90 days at www.mediwound.com.

Non-IFRS Financial Measures

To supplement consolidated financial statements prepared and presented in accordance with IFRS, the Company has provided a supplementary non-IFRS measure to consider in evaluating the Company's performance. Management uses Adjusted EBITDA, which it defines as earnings before interest, taxes, depreciation and amortization, impairment, one-time expenses, restructuring and share-based compensation expenses.

Although Adjusted EBITDA is not a measure of performance or liquidity calculated in accordance with IFRS, we believe the non-IFRS financial measures we present provide meaningful supplemental information regarding our operating results primarily because they exclude certain non-cash charges or items that we do not believe are reflective of our ongoing operating results when budgeting, planning and forecasting and determining compensation, and when assessing the performance of our business with our  senior management.

However, investors should not consider these measures in isolation or as substitutes for operating income, cash flows from operating activities or any other measure for determining the Company's operating performance or liquidity that is calculated in accordance with IFRS. In addition, because Adjusted EBITDA is not calculated in accordance with IFRS, it may not necessarily be comparable to similarly titled measures employed by other companies. The non-IFRS measures included in this press release have been reconciled to the IFRS results in the tables below.



About MediWound Ltd.
 
MediWound is a biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy is centered around our validated enzymatic platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair.

NexoBrid, our first commercialized biological product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently marketed in the European Union and other International markets. On June 29, 2020, a biologics license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. NexoBrid is supported by U.S. Biomedical Advanced Research and Development Authority (BARDA).

EscharEx, our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. MediWound’s third innovative product candidate, MWPC005, is a topical drug under development for the treatment of non-melanoma skin cancer. Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

About BARDA
 
Funding and technical support for development of NexoBrid including the expanded access treatment protocol (NEXT), the pivotal Phase 3 pediatric clinical study (CIDS) and the marketing approval registration process for NexoBrid in the U.S. is provided by the Biomedical Advanced Research and Development Authority (BARDA), under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in adults population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States and readiness for emergencies. For more information, refer to www.phe.gov/about/BARDA.

Cautionary Note Regarding Forward-Looking Statements
MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control.  Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.

Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, objectives anticipated timelines, expectations and commercial potential of our products and product candidates. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic.  For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to “shelter at home” or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.

These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2020, filed with the Securities and Exchange Commission (“SEC”) on February 25, 2021, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time.  These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law

Contacts:
Jeremy Feffer
Boaz Gur-Lavie
Managing Director
Chief Financial Officer
LifeSci Advisors
MediWound Ltd.
212-915-2568
ir@mediwound.com
jeremy@lifesciadvisors.com


MediWound, Ltd.
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands

   
March 31,
   
December 31,
 
   
2021
   
2020
   
2020
 
   
Unaudited
   
Audited
 
Cash, cash equivalents and short term deposits
   
17,862
     
27,311
     
21,584
 
Accounts and other receivable
   
5,574
     
3,540
     
3,229
 
Inventories
   
1,470
     
2,004
     
1,380
 
Total current assets
   
24,906
     
32,855
     
26,193
 
                         
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
 
Total long term assets
   
4,788
     
4,943
     
4,877
 
                         
Total assets
   
29,694
     
37,798
     
31,070
 
                         
Current maturities of long-term liabilities
   
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
 
Total current liabilities
   
10,314
     
10,683
     
8,266
 
                         
Deferred revenues
   
693
     
1,018
     
1,234
 
Liabilities in respect of Israeli Innovation Authority grants net of current maturities
   
7,275
     
6,942
     
7,267
 
Liabilities in respect of purchase of shares net of current maturities
   
4,733
     
4,097
     
4,998
 
Lease liabilities, net of current maturities
   
1,590
     
1,905
     
1,741
 
Severance pay liability, net
   
273
     
264
     
292
 
Total long term liabilities
   
14,564
     
14,226
     
15,532
 
                         
Shareholders' equity
   
4,816
     
12,889
     
7,272
 
Total liabilities & shareholder equity
   
29,694
     
37,798
     
31,070
 



MediWound, Ltd.
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS (UNAUDITED)
U.S. dollars in thousands

 
Three months ended
 
   
March 31,
 
   
2021
   
2020
 
             
Revenues
   
5,847
     
4,438
 
Cost of revenues
   
3,431
     
3,208
 
Gross profit
   
2,416
     
1,230
 
Operating expenses:
               
Research and development
   
2,242
     
1,719
 
Selling, general and administrative
   
2,095
     
1,717
 
Operating loss
   
(1,921
)
   
(2,206
)
Financial income
   
11
     
239
 
Financial expense
   
(941
)
   
(494
)
Loss for the period
   
(2,851
)
   
(2,461
)
                 
Foreign currency translation adjustments
   
11
     
8
 
Total comprehensive loss
   
(2,840
)
   
(2,453
)
                 
Basic and diluted loss per share:
               
Net loss per share
   
(0.10
)
   
(0.09
)
Weighted average number of ordinary shares used in the computation of basic and diluted loss per share:
   
27,237
     
27,211
 


ADJUSTED EBITDA
U.S. dollars in thousands

   
Three months ended
 
   
March 31,
 
   
2021
   
2020
 
Loss for the period
   
(2,851
)
   
(2,461
)
Adjustments:
               
Financial expenses, net
   
(930
)
   
(255
)
Depreciation and amortization
   
(273
)
   
(268
)
Share-based compensation expenses
   
(384
)
   
(173
)
Total adjustments
   
(1,587
)
   
(696
)
Adjusted EBITDA
   
(1,264
)
   
(1,765
)


MediWound, Ltd.
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW (UNAUDITED)
U.S. dollars in thousands

 
Three months ended
 
   
March 31,
 
   
2021
   
2020
 
Cash Flows from Operating Activities:
           
Net loss
   
(2,851
)
   
(2,461
)
                 
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
               
Adjustments to profit and loss items:
               
Depreciation and amortization
   
273
     
268
 
Share-based compensation
   
384
     
173
 
Revaluation of liabilities in respect of IIA grants
   
275
     
198
 
Revaluation of liabilities in respect of purchase of shares
   
152
     
152
 
Revaluation of lease liabilities
   
(44
)
   
(36
)
Increase (decrease) in severance liability, net
   
(10
)
   
21
 
Financing income
   
(11
)
   
(110
)
Unrealized foreign currency (gain) loss
   
256
     
79
 
     
1,275
     
745
 
Changes in asset and liability items:
               
Decrease (increase) in trade receivables
   
(2,407
)
   
897
 
Increase in inventories
   
(45
)
   
(391
)
Decrease in other receivables
   
37
     
99
 
Increase (decrease) in trade payables & accrued expenses
   
272
     
(645
)
Increase (decrease) in other payables & deferred revenues
   
806
     
(47
)
     
(1,337
)
   
(87
)
Net cash used in operating activities
   
(2,913
)
   
(1,803
)
                 
Cash Flows from Investment Activities:
               
Purchase of property and equipment
   
(218
)
   
(144
)
Interest received
   
35
     
3
 
Proceeds from short term bank deposits, net of investments
   
4,006
     
2,992
 
Net cash provided by investing activities
   
3,823
     
2,851
 
                 
Cash Flows from Financing Activities:
               
Repayment of lease liabilities
   
(131
)
   
(160
)
Repayment of IIA grants
   
(180
)
   
(66
)
Net cash used in financing activities
   
(311
)
   
(226
)
                 
Exchange rate differences on cash and cash equivalent balances
   
(291
)
   
(83
)
Increase in cash and cash equivalents
   
308
     
739
 
Balance of cash and cash equivalents at the beginning of the period
   
17,376
     
7,242
 
Balance of cash and cash equivalents at the end of the period
   
17,684
     
7,981
 



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