MediWound Ltd. - 1593984 - 2021
0001593984Q22021false--12-312021-06-30

 

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 August 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 August 10, 2021, MediWound Ltd. (the “Company”) issued a press release entitled “MediWound Reports Second 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 June 30, 2021, attached as Exhibit 99.2, which was provided by the Company to CBI on August 9, 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) 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, February 25, 2020 and May 15, 2021 (Registration Nos. No. 333-195517, 333-210375, 333-223767, 333-195517, 333-210375, 333-230487, 333-236635 and 333-255784, 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.

 

Date: August 10, 2021   
MEDIWOUND LTD.
 
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 Second Quarter Financial Results

Second Quarter Revenues of $6.1 Million - Increase of 50% Year-over-Year
 
Positive Interim Assessment Outcome for EscharEx U.S. Phase II Clinical Study

No Changes to Study Sample Size – No Safety Concerns Identified
 
Conference call begins today at 8:30 am ET
 
YAVNE, Israel, August 10, 2021 -- MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced financial results for the second quarter ended June 30, 2021.

Second Quarter and Recent Weeks Corporate and Financial Highlights:


Total revenues for the second quarter of 2021 were $6.1 million, an increase of 50% compared with the second quarter of 2020


The Company had $17.2 million in cash and short-term investments as of June 30, 2021


Positive outcome of interim assessment for EscharEx U.S. phase II adaptive design study with no changes to study sample size of 120 patients and no safety concerns identified; full study enrollment expected by year-end 2021 and data readout expected in the first half of 2022

Received a Complete Response Letter (CRL) from U.S. FDA for NexoBrid biologics license application (BLA); working together with our partners, Vericel and BARDA, towards BLA resubmission

Positive top line results from phase III pediatric study (CIDS) for eschar removal of severe thermal burns; met all primary endpoints with a high degree of statistical significance, as well as certain secondary endpoints; the study showed NexoBrid to be safe and well tolerated


Initiated a U.S. phase I/II study of MW005 for the treatment of low-risk basal cell carcinoma (BCC); phase II investigator-initiated trial in non-melanoma skin cancers running in parallel with data from both expected by year-end of 2021

“The second quarter of 2021 and the subsequent weeks, have been eventful with positive interim assessment for EscharEx phase II clinical study, FDA feedback on our NexoBrid BLA and positive top line results from NexoBrid phase III pediatric study,” said Sharon Malka, Chief Executive Officer of MediWound. “Moving forward with the best possible outcome of the interim assessment for our U.S. phase II adaptive design study of EscharEx, we have made significant progress in advancing our EscharEx development program, and we look forward to additional significant clinical milestones in the months ahead as we complete enrollment in our phase II study and generate data from our phase II pharmacology study later this year. Chronic wounds impact millions of people worldwide and these important catalysts could advance us one step closer to bringing EscharEx to market as an improvement upon the current standard of care in chronic wound management. We are also excited to commence the clinical development program for MW005 in basal cell carcinoma with two phase II trials underway and look forward to providing further updates on their progress later this year.”

Mr. Malka commented further “Though we were disappointed with the receipt of the NexoBrid CRL, we believe the FDA's comments can be addressed, and remain optimistic about the prospects of NexoBrid in the U.S. We are working closely with our partners Vericel and BARDA, to meet with the FDA as soon as possible and provide the FDA with a detailed response to the CRL. Regarding our CIDS pediatric phase III study, we were pleased with the robust clinical data generated, o which met all of its primary endpoints with highly statistically significant results, reinforcing the strong clinical safety and efficacy profile of NexoBrid. We believe that this data will further support our global expansion of NexoBrid as we continue to gain commercial traction in multiple geographies around the world."


Second Quarter Financial Results

Revenues for the second quarter of 2021 were $6.1 million, compared with $4.0 million for the second quarter of 2020, an increase of 50%. Product revenues in the second quarter of 2021 were $3.0 million, an increase of 175% compared to $1.1 million for the second 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 second quarter of 2021 was $2.4 million or 39% of net revenues compared to a gross profit of $1.2 million or   30% of net revenues for the second quarter of 2020.

Research and development expenses for the second quarter of 2021 were $2.7 million, compared with $1.6 million for the second quarter of 2020. The increase was primarily due to EscharEx clinical development program.

Selling, general and administrative expenses for the second quarter of 2021 were $2.6 million, compared with $2.3 million in the second quarter of 2020. As a percentage of revenues, selling, general and administrative expenses for the second quarter decreased from 57% in the second quarter of 2020 to 43% in the second quarter of 2021

Operating loss for the second quarter of 2021 was $2.9 million, compared with an operating loss of $2.7 million in the second quarter of 2020.

The Company posted a net loss of $3.2 million, or $0.12 per share, for the second quarter of 2021 compared with a net loss of $3.1 million, or $0.11 per share, for the second quarter of 2020.

Adjusted EBITDA, as defined below, for the second quarter of 2021 was a loss of $2.0 million, compared with a loss of $2.1 million for the second quarter of 2020.

Year-to-Date 2021 Financial Results

Revenues for the first half of 2021 were $11.9 million compared with $8.5 million in the first half of 2020, an increase of 41%. Product revenues in the first half of 2021 were $5.9 million, an increase of 224% compared to $1.8 million for the first half 2020.

Operating loss for the first half of 2021 was $4.8 million, compared with an operating loss of $4.9 million in the first half of 2020.

The Company’s net loss for the first half of 2021 was $6.0 million or $0.22 per share compared with net loss of $5.6 million or $0.20 per share for the first half of 2020.

Adjusted EBITDA, for the first half of 2021, was a loss of $3.3 million, compared with a loss of $3.9 million for the first half of 2020.

Balance Sheet Highlights

As of June 30, 2021, MediWound had $17.2 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 $4.4 million in the first half of 2021 for its operational activities. Throughout the remainder of 2021, the company will continue to invest primarily in research and development efforts for EscharEx, while the planned NexoBrid BLA resubmission and its related ongoing development programs will be funded by BARDA. We now expect cash use for 2021 to be in the range of $9.0 to $11.0 million.


Conference Call

MediWound management will host a conference call for investors today, Thursday, August 10, 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 3782335. 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 leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn care, wound care and tissue repair.

NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep-partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the 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.


MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.

Cautionary Note Regarding Forward-Looking Statements

MediWound cautions 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; timing or likelihood of approval by the U.S. Food & Drug Administration (FDA) of a Biologics License Application (BLA) for NexoBrid for treatment of severe burns in the United States following the receipt of a complete response for NexoBrid on June 28, 2021, 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, including availability of funding from 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 on our business or the economy generally. 



For example, we are unable to predict how the COVID-19 pandemic will affect the overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and may impact the response times of governmental agencies, including the FDA, to future regulatory submissions  and/or conduct necessary reviews or inspections of our manufacturing facilities, any or all of which may result in timelines being materially delayed, which could affect the development and ultimate commercialization of our products, including NexoBrid. Other disruptions or potential disruptions of the COVID-19 pandemic include restrictions on the ability of Company personnel to travel and access customers for training, promotion and case support, delays in product development efforts, and additional government-imposed quarantines and requirements to “shelter at home” or other incremental mitigation efforts or initiatives that 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.

 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

   
June 30,
   
December 31,
 
   
2021
   
2020
   
2020
 
   
Un-audited
   
Audited
 
Cash, cash equivalents and short term deposits
   
17,175
     
24,382
     
21,584
 
Accounts and other receivable
   
2,948
     
3,492
     
3,229
 
Inventories
   
1,397
     
1,934
     
1,380
 
Total current assets
   
21,520
     
29,808
     
26,193
 
                         
Property, plant and equipment, net
   
2,565
     
2,326
     
2,630
 
Right of use assets, net
   
1,789
     
2,086
     
1,884
 
Intangible assets, net
   
330
     
396
     
363
 
Total long-term assets
   
4,684
     
4,808
     
4,877
 
                         
Total assets
   
26,204
     
34,616
     
31,070
 
                         
Current maturities of long-term liabilities
   
1,681
     
1,321
     
1,750
 
Trade payables and accrued expenses
   
4,060
     
2,423
     
2,992
 
Other payables
   
3,920
     
6,040
     
3,524
 
Total current liabilities
   
9,661
     
9,784
     
8,266
 
                         
Deferred revenues
   
405
     
1,174
     
1,234
 
Liability in respect of Israeli Innovation Authority grants net of current maturity
   
7,671
     
7,130
     
7,267
 
Liabilities in respect of purchase of shares net of current maturity
   
4,465
     
4,249
     
4,998
 
Lease liability, net of current maturity
   
1,604
     
1,866
     
1,741
 
Severance pay liability, net
   
280
     
281
     
292
 
Total long-term liabilities
   
14,425
     
14,700
     
15,532
 
                         
Shareholders' equity
   
2,118
     
10,132
     
7,272
 
Total liabilities & shareholder equity
   
26,204
     
34,616
     
31,070
 


MediWound, Ltd.

CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE PROFIT (LOSS)
(ANAUDITED)
U.S. dollars in thousands

 
Six months ended
   
Three months ended
 
   
June 30,
   
June 30,
 
   
2021
   
2020
   
2021
   
2020
 
                         
Revenues
   
11,904
     
8,465
     
6,057
     
4,027
 
Cost of revenues
   
7,127
     
6,018
     
3,696
     
2,810
 
Gross profit
   
4,777
     
2,447
     
2,361
     
1,217
 
                                 
Operating expenses:
                               
Research and development
   
4,898
     
3,331
     
2,656
     
1,612
 
Selling, general & administrative
   
4,695
     
4,028
     
2,600
     
2,311
 
Operating loss
   
(4,816
)
   
(4,912
)
   
(2,895
)
   
(2,706
)
                                 
Financial expenses, net
   
(1,211
)
   
(645
)
   
(281
)
   
(390
)
Loss before tax on income
   
(6,027
)
   
(5,557
)
   
(3,176
)
   
(3,096
)
                                 
Tax on income
   
(19
)
   
-
     
(19
)
   
-
 
Loss for the period
   
(6,046
)
   
(5,557
)
   
(3,195
)
   
(3,096
)
Foreign currency translation adjustments
   
8
     
1
     
(3
)
   
(7
)
Total comprehensive loss
   
(6,038
)
   
(5,556
)
   
(3,198
)
   
(3,103
)
                                 
Net loss per share
   
(0.22
)
   
(0.20
)
   
(0.12
)
   
(0.11
)
Weighted average number of ordinary shares used in the computation of basic and diluted loss per share:
   
27,241
     
27,207
     
27,211
     
27,052
 



MediWound, Ltd.

ADJUSTED EBITDA
U.S. dollars in thousands

   
Six months ended
   
Three months ended
 
   
June 30,
   
June 30,
 
   
2021
   
2020
   
2021
   
2020
 
Loss for the period
   
(6,046
)
   
(5,557
)
   
(3,195
)
   
(3,096
)
                                 
Adjustments:
                               
Financial expenses, net
   
(1,211
)
   
(645
)
   
(281
)
   
(390
)
Tax on income
   
(19
)
   
-
     
(19
)
   
-
 
Depreciation and amortization
   
(627
)
   
(539
)
   
(354
)
   
(271
)
Share-based compensation expenses
   
(884
)
   
(519
)
   
(500
)
   
(346
)
Total adjustments
   
(2,741
)
   
(1,703
)
   
(1,154
)
   
(1,007
)
Adjusted EBITDA
   
(3,305
)
   
(3,854
)
   
(2,041
)
   
(2,089
)



MediWound, Ltd.

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

 
 
Six months ended
   
Three months ended
 
 
 
June 30,
   
June 30,
 
 
 
2021
   
2020
   
2021
   
2020
 
Cash Flows from Operating Activities:
                       
Net loss
   
(6,046
)
   
(5,557
)
   
(3,195
)
   
(3,096
)
Adjustments to reconcile net loss to net cash used in operating activities:
                               
Adjustments to profit and loss items:
                               
Depreciation and amortization
   
627
     
539
     
319
     
271
 
Share-based compensation
   
884
     
519
     
500
     
346
 
Revaluation of liabilities in respect of IIA      grants
   
497
     
424
     
222
     
226
 
         Revaluation of liabilities in respect of purchase of shares
   
299
     
348
     
147
     
196
 
Revaluation of lease liabilities
   
35
     
64
     
79
     
100
 
Increase (decrease) in severance liability, net
   
(5
)
   
40
     
5
     
19
 
Financing income, net
   
(11
)
   
(191
)
   
-
     
(81
)
Unrealized foreign currency (gain) loss
   
(226
)
   
28
     
(482
)
   
(51
)
 
   
2,100
     
1,771
     
790
     
1,026
 
Changes in asset and liability items:
                               
Increase in trade receivables
   
680
     
1,341
     
3,087
     
444
 
Decrease (increase) in inventories
   
17
     
(326
)
   
62
     
65
 
Increase in other receivables
   
(432
)
   
(284
)
   
(469
)
   
(383
)
Increase (decrease) in trade payables and prepaid expenses
   
1,075
     
(1,649
)
   
803
     
(1,004
)
Increase  in other payables & deferred revenues
   
(1,257
)
   
86
     
(2,063
)
   
133
 
 
   
83
     
(832
)
   
1,420
     
(745
)
Net cash used in operating activities
   
(3,863
)
   
(4,618
)
   
(985
)
   
(2,815
)
 
                               
Cash Flows from Investment Activities:
                               
Purchase of property and equipment
   
(244
)
   
(244
)
   
(26
)
   
(100
)
Interest received
   
35
     
42
     
-
     
39
 
Proceeds from short term bank deposits, net of investments
   
4,002
     
10,595
     
(4
)
   
7,603
 
Net cash provided by (used in) investing activities
   
3,793
     
10,393
     
(30
)
   
7,542
 
 
                               
Cash Flows from Financing Activities:
                               
Repayment of lease liabilities
   
(337
)
   
(313
)
   
(171
)
   
(153
)
Proceeds from IIA grants, net of repayments
   
(180
)
   
(66
)
   
-
     
-
 
Net cash used in financing activities
   
(517
)
   
(379
)
   
(171
)
   
(153
)
 
                               
Exchange rate differences on cash and cash equivalent balances
   
204
     
(26
)
   
495
     
57
 
Increase (decrease) in cash and cash equivalents from activities
   
(383
)
   
5,370
     
(691
)
   
4,631
 
Balance of cash and cash equivalents at the beginning of the period
   
17,376
     
7,242
     
17,684
     
7,981
 
Balance of cash and cash equivalents at the end of the period
   
16,993
     
12,612
     
16,993
     
12,612
 



MediWound Ltd. - 1593984 - 2021
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Exhibit 99.2
 
MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
INTERIM CONDENSED FINANCIAL STATEMENTS
 
AS OF JUNE 30, 2021
 
IN U.S. DOLLARS IN THOUSANDS
 
UNAUDITED
 
INDEX
 
 
Page
  

F-2

  
F-3
  
F-4 – F-6
  
F-7 – F-8
  
F-9 – F-11
 
 

 

MEDIWOUND LTD. AND ITS SUBSIDIARIES

CONDENSED INTERIM CONSOLIDATED BALANCE SHEETS

U.S. dollars in thousands

 

   
June 30,
   
December 31,
 
   
2021
   
2020
   
2020
 
   
Unaudited
   
Audited
 
CURRENT ASSETS:
                 
Cash and cash equivalents
   
16,993
     
12,612
     
17,376
 
Restricted deposits
   
182
     
179
     
184
 
Short‑term bank deposits
   
     
11,591
     
4,024
 
Trade receivables
   
2,065
     
2,764
     
2,767
 
Inventories
   
1,397
     
1,934
     
1,380
 
Other receivables
   
883
     
728
     
462
 
                         
     
21,520
     
29,808
     
26,193
 
LONG‑TERM ASSETS:
                       
Property, plant and equipment, net
   
2,565
     
2,326
     
2,630
 
Right of-use assets, net
   
1,789
     
2,086
     
1,884
 
Intangible assets, net
   
330
     
396
     
363
 
                         
     
4,684
     
4,808
     
4,877
 
                         
     
26,204
     
34,616
     
31,070
 
CURRENT LIABILITIES:
                       
Current maturities of long-term liabilities
   
1,681
     
1,321
     
1,750
 
Trade payables and accrued expenses
   
4,060
     
2,423
     
2,992
 
Other payables
   
3,920
     
6,040
     
3,524
 
                         
     
9,661
     
9,784
     
8,266
 
LONG‑TERM LIABILITIES:
                       
Deferred revenues
   
405
     
1,174
     
1,234
 
 Liability in respect of IIA grants
   
7,671
     
7,130
     
7,267
 

 Liabilities in respect of purchase of shares

   
4,465
     
4,249
     
4,998
 
Lease liabilities
   
1,604
     
1,866
     
1,741
 
Severance pay liabilities, net
   
280
     
281
     
292
 
                         
     
14,425
     
14,700
     
15,532
 
SHAREHOLDERS' EQUITY:
                       
Ordinary shares of NIS 0.01 par value:
                       
Authorized: 50,000,000 shares as of June 30, 2021 , December 31, 2020 and June 30, 2020; Issued and Outstanding: 27,245,429 as of June 30, 2021, 27,236,752 as of December 31, 2020 and 27,211,128 as of June 30, 2020
   
75
     
75
     
75
 
Share premium
   
143,077
     
141,390
     
142,193
 
Foreign currency translation adjustments
   
(32
)
   
(16
)
   
(40
)
Accumulated deficit
   
(141,002
)
   
(131,317
)
   
(134,956
)
                         
     
2,118
     
10,132
     
7,272
 
                         
     
26,204
     
34,616
     
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 data and per share data)
 
     
Six months ended
June 30,
   
Three months ended
June 30,
   
Year ended December 31,
 
     
2021
   
2020
   
2021
   
2020
   
2020
 
     
Unaudited
   
Audited
 
Revenues from sale of products
     
5,045
     
1,662
     
2,527
     
1,015
     
7,445
 
Revenues from development services
     
5,963
     
6,631
     
3,023
     
2,922
     
13,935
 
Revenues from license agreements
     
896
     
172
     
507
     
90
     
383
 
Total revenues
     
11,904
     
8,465
     
6,057
     
4,027
     
21,763
 
                                           
Cost of revenues
     
7,127
     
6,018
     
3,696
     
2,810
     
14,218
 
                                           
Gross profit
     
4,777
     
2,447
     
2,361
     
1,217
     
7,545
 
                                           
Research and development
     
4,898
     
3,331
     
2,656
     
1,612
     
7,698
 
Selling and marketing
     
1,676
     
1,683
     
854
     
859
     
3,228
 
General and administrative
     
3,019
     
2,345
     
1,746
     
1,452
     
5,459
 
Total operating expenses
     
9,593
     
7,359
     
5,256
     
3,923
     
16,385
 
                                           
Operating loss
     
(4,816
)
   
(4,912
)
   
(2,895
)
   
(2,706
)
   
(8,840
)
                                           
Financial income
     
11
     
323
     
118
     
101
     
843
 
Financial expenses
     
(1,222
)
   
(968
)
   
(399
)
   
(491
)
   
(1,279
)
                                           
Loss before taxes on income
     
(6,027
)
   
(5,557
)
   
(3,176
)
   
(3,096
)
   
(9,276
)
Taxes on income
     
(19
)
   
     
(19
)
   
     
 
                                           
Loss from continuing operation
     
(6,046
)
   
(5,557
)
   
(3,195
)
   
(3,096
)
   
(9,276
)
 Profit from discontinued operation
     
     
     
     
     
80
 
 Net loss
     
(6,046
)
   
(5,557
)
   
(3,195
)
   
(3,096
)
   
(9,196
)
Other comprehensive income (loss):
                                         
Foreign currency translation adjustments
     
8
     
1
     
(3
)    
(7
)
   
(23
)
                                           
Total comprehensive loss
     
(6,038
)
   
(5,556
)
   
(3,198
)
   
(3,103
)
   
(9,219
)
 Total Basic and diluted net loss per share
     
(0.22
)
   
(0.20
)
   
(0.12
)
   
(0.11
)
   
(0.34
)
 

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, 2020
   
75
     
142,193
     
(40
)
   
(134,956
)
   
7,272
 
                                         
Loss for the period
   
     
     
     
(6,046
)
   
(6,046
)
Other comprehensive income
   
     
     
8
     
     
8
 
Total comprehensive income (loss)
   
     
     
8
     
(6,046
)
   
(6,038
)
Exercise of options
   
(*
)
   
     
     
     
(*
)
                                         
Share-based compensation
   
     
884
     
     
     
884
 
                                         
Balance as of  June 30, 2021 (unaudited)
   
75
     
143,077
     
(32
)
   
(141,002
)
   
2,118
 
 
   
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
   
     
     
     
(5,557
)
   
(5,557
)
Other comprehensive income
   
     
     
1
     
     
1
 
Total comprehensive income (loss)
   
     
     
1
     
(5,557
)
   
(5,556
)
Exercise of options
   
(*
)
   
     
     
     
(*
)
                                         
Share-based compensation
   
     
519
     
     
     
519
 
                                         
Balance as of  June 30, 2020 (unaudited)
   
75
     
141,390
     
(16
)
   
(131,317
)
   
10,132
 
 
(*)          Represents 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 April 1, 2021
   
75
     
142,577
     
(29
)
   
(137,807
)
   
4,816
 
                                         
Loss for the period
   
     
     
     
(3,195
)
   
(3,195
)
Other comprehensive loss
   
     
     
(3
)
   
     
(3
)
Total comprehensive loss
   
     
     
(3
)
   
(3,195
)
   
(3,198
)
Exercise of options
   
(*
)
   
     
     
     
(*
)
                                         
Share-based compensation
   
     
500
     
     
     
500
 
                                         
Balance as of  June 30, 2021 (unaudited)
   
75
     
143,077
     
(32
)
   
(141,002
)
   
2,118
 
 
   
Share capital
   
Share premium
   
Foreign currency translation reserve
   
Accumulated
deficit
   
Total
Equity
 
                               
Balance as of April 1, 2020
   
75
     
141,044
     
(9
)
   
(128,221
)
   
12,889
 
                                         
Loss for the period
   
     
     
     
(3,096
)
   
(3,096
)
Other comprehensive loss
   
     
     
(7
)
   
     
(7
)
Total comprehensive loss
   
     
     
(7
)
   
(3,096
)
   
(3,103
)
                                         
Share-based compensation
   
     
346
     
     
     
346
 
                                         
Balance as of  June 30, 2020 (unaudited)
   
75
     
141,390
     
(16
)
   
(131,317
)
   
10,132
 
 
(*)          Represents less than $ 1.
 
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, 2019
   
75
     
140,871
     
(17
)
   
(125,760
)
   
15,169
 
                                         
Loss for the period
   
-
     
-
     
-
     
(9,196
)
   
(9,196
)
Other comprehensive loss
   
-
     
-
     
(23
)
   
-
     
(23
)
Total comprehensive loss
   
-
     
-
     
(23
)
   
(9,196
)
   
(9,219
)
Exercise of options
   
(*
)            
(*
)
   
-
     
(*
)
Share-based compensation
   
-
     
1,322
     
-
     
-
     
1,322
 
                                         
Balance as of December 31, 2020
   
75
     
142,193
     
(40
)
   
(134,956
)
   
7,272
 
 
(*)          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

 
   
Six months ended
June 30,
   
Three months ended
June 30,
   
Year ended December 31,
 
   
2021
   
2020
   
2021
   
2020
   
2020
 
   
Unaudited
   
Audited
 
Cash flows from operating activities:
                             
Net loss
   
(6,046
)
   
(5,557
)
   
(3,195
)
   
(3,096
)    
(9,196
)
                                         
Adjustments to reconcile net loss to net cash used in continuing operating activities:
                                       
                                         
Adjustments to profit and loss items:
                                       
Profit from discontinued operation
   
     
     
     
     
(80
)
Depreciation and amortization
   
627
     
539
     
319
     
271
     
1,090
 
Share-based compensation
   
884
     
519
     
500
     
346
     
1,322
 
Revaluation of liability in respect of IIA grants
   
497
     
424
     
222
     
226
     
828
 

    Revaluation of liabilities in respect of the purchase of shares

   
299
     
348
     
147
     
196
     
(433
)
Revaluation of lease liabilities
   
35
     
64
     
79
     
100
     
305
 
Increase (decrease) in severance pay liabilities, net
   
(5
)
   
40
     
5
     
19
     
33
 
Net financing income
   
(11
)
   
(191
)
   
     
(81
)
   
(297
)
Un-realized foreign currency (gain) loss
   
(226
)
   
28
     
(482
)
   
(51
)
   
(211
)
                                         
     
2,100
     
1,771
     
790
     
1,026
     
2,557
 
Changes in asset and liability items:
                                       
Decrease in trade receivables
   
680
     
1,341
     
3,087
     
444
     
1,386
 
Decrease (increase) in inventories
   
17
     
(326
)
   
62
     
65
     
141
 
 Increase in other receivables
   
(432
)
   
(284
)
   
(469
)
   
(383
)
   
(13
)
Increase (decrease) in trade payables and accrued expenses
   
1,075
     
(1,649
)
   
803
     
(1,004
)
   
(1,096
)
Increase (decrease) in other payables and deferred revenues
   
(1,257
)
   
86
     
(2,063
)
   
133
     
(479
)
                                         
     
83
     
(832
)
   
1,420
     
(745
)
   
(61
)
                                         
Net cash used in continuing operating activities
   
(3,863
)
   
(4,618
)
   
(985
)
   
(2,815
)
   
(6,700
)
Net cash used in discontinued operating activities
   
     
     
     
     
(195
)
Net cash used in operating activities
   
(3,863
)
   
(4,618
)
   
(985
)
   
(2,815
)
   
(6,895
)

 

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

 

   
Six months ended
June 30,
   
Three months ended
June 30,
   
Year ended December 31,
 
   
2021
   
2020
   
2021
   
2020
   
2020
 
   
Unaudited
   
Audited
 
                               
Cash Flows from Investing Activities:
                             
                               
Purchase of property and equipment
   
(244
)
   
(244
)
   
(26
)
   
(100
)
   
(923
)
Interest received
   
35
     
42
     
     
39
     
274
 
Proceeds from short term bank deposits, net
   
4,002
     
10,595
     
(4
)
   
7,603
     
18,034
 
                                         
Net cash provided by (used in) continuing investing activities
   
3,793
     
10,393
     
(30
)
   
7,542
     
17,385
 
                                         
Cash Flows from Financing Activities:
                                       
                                         
Repayment of leases liabilities
   
(337
)