0001178913-21-002628 | 6-K | XBRL Viewer

Document and Entity Information	6 Months Ended
Document and Entity Information	Jun. 30, 2021
Document And Entity Information [Abstract]
Entity Registrant Name	MediWound Ltd.
Entity Central Index Key	0001593984
Document Type	6-K
Document Period End Date	Jun. 30, 2021
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Document Fiscal Period Focus	Q2
Document Fiscal Year Focus	2021
Entity Address, Address Line One	42 Hayarkon Street
Entity Address, City or Town	Yavne
Entity Address, Postal Zip Code	8122745
Entity Address, Country	IL

CONDENSED INTERIM CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands	Jun. 30, 2021	Dec. 31, 2020	Jun. 30, 2020
CURRENT ASSETS:
Cash and cash equivalents	$ 16,993	$ 17,376	$ 12,612
Restricted deposits	182	184	179
Short-term bank deposits	0	4,024	11,591
Trade receivables	2,065	2,767	2,764
Inventories	1,397	1,380	1,934
Other receivables	883	462	728
CURRENT ASSETS, TOTAL	21,520	26,193	29,808
LONG-TERM ASSETS:
Property, plant and equipment, net	2,565	2,630	2,326
Right of-use assets, net	1,789	1,884	2,086
Intangible assets, net	330	363	396
LONG-TERM ASSETS, TOTAL	4,684	4,877	4,808
ASSETS, TOTAL	26,204	31,070	34,616
CURRENT LIABILITIES:
Current maturities of long-term liabilities	1,681	1,750	1,321
Trade payables and accrued expenses	4,060	2,992	2,423
Other payables	3,920	3,524	6,040
CURRENT LIABILITIES, TOTAL	9,661	8,266	9,784
LONG-TERM LIABILITIES:
Deferred revenues	405	1,234	1,174
Liability in respect of IIA grants	7,671	7,267	7,130
Liabilities in respect of purchase of shares	4,465	4,998	4,249
Lease liabilities	1,604	1,741	1,866
Severance pay liabilities, net	280	292	281
LONG TERM LIABILITIES, TOTAL	14,425	15,532	14,700
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	142,193	141,390
Foreign currency translation adjustments	(32)	(40)	(16)
Accumulated deficit	(141,002)	(134,956)	(131,317)
SHAREHOLDERS' EQUITY, TOTAL	2,118	7,272	10,132
LIABILITIES AND SHAREHOLDERS' EQUITY, TOTAL	$ 26,204	$ 31,070	$ 34,616

CONDENSED INTERIM CONSOLIDATED BALANCE SHEETS (Parenthetical) - ₪ / shares	Jun. 30, 2021	Dec. 31, 2020	Jun. 30, 2020
Statement of financial position [abstract]
Ordinary shares, par value (per share)	₪ 0.01	₪ 0.01	₪ 0.01
Ordinary shares, Authorized	50,000,000	50,000,000	50,000,000
Ordinary shares, Issued	27,245,429	27,236,752	27,211,128
Ordinary shares, Outstanding	27,245,429	27,236,752	27,211,128

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) $ in Thousands	3 Months Ended		6 Months Ended		12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020	Dec. 31, 2020
Profit or loss [abstract]
Revenues from sale of products	$ 2,527	$ 1,015	$ 5,045	$ 1,662	$ 7,445
Revenues from development services	3,023	2,922	5,963	6,631	13,935
Revenues from license agreements	507	90	896	172	383
Total revenues	6,057	4,027	11,904	8,465	21,763
Cost of revenues	3,696	2,810	7,127	6,018	14,218
Gross profit	2,361	1,217	4,777	2,447	7,545
Research and development	2,656	1,612	4,898	3,331	7,698
Selling and marketing	854	859	1,676	1,683	3,228
General and administrative	1,746	1,452	3,019	2,345	5,459
Total operating expenses	5,256	3,923	9,593	7,359	16,385
Operating loss	(2,895)	(2,706)	(4,816)	(4,912)	(8,840)
Financial income	118	101	11	323	843
Financial expense	(399)	(491)	(1,222)	(968)	(1,279)
Loss before taxes on income	(3,176)	(3,096)	(6,027)	(5,557)	(9,276)
Taxes on income	(19)	0	(19)	0	0
Loss from continuing operation	(3,195)	(3,096)	(6,046)	(5,557)	(9,276)
Profit from discontinued operation	0	0	0	0	80
Net loss	(3,195)	(3,096)	(6,046)	(5,557)	(9,196)
Other comprehensive income (loss):
Foreign currency translation adjustments	(3)	(7)	8	1	(23)
Total comprehensive loss	$ (3,198)	$ (3,103)	$ (6,038)	$ (5,556)	$ (9,219)
Total Basic and diluted net loss per share	$ (0.12)	$ (0.11)	$ (0.22)	$ (0.20)	$ 0.34

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY - USD ($)
$ in Thousands

Share capital [Member]

Share premium [Member]

Foreign currency translation reserve [Member]

Accumulated deficit [Member]

Total

Balance at Dec. 31, 2019

$ 75

$ 140,871

$ (17)

$ (125,760)

$ 15,169

Loss for the period

(5,557)

Other comprehensive loss

Total comprehensive loss

(5,557)

(5,556)

Exercise of options

^[1]

Share-based compensation

519

Balance at Jun. 30, 2020

141,390

(16)

(131,317)

10,132

Balance at Dec. 31, 2019

140,871

(17)

(125,760)

15,169

Loss for the period

(9,196)

Other comprehensive loss

(23)

Total comprehensive loss

(23)

(9,196)

(9,219)

Exercise of options

^[1]

Share-based compensation

1,322

Balance at Dec. 31, 2020

142,193

(40)

(134,956)

7,272

Balance at Mar. 31, 2020

141,044

(9)

(128,221)

12,889

Loss for the period

(3,096)

Other comprehensive loss

(7)

Total comprehensive loss

(7)

(3,096)

(3,103)

Share-based compensation

346

Balance at Jun. 30, 2020

141,390

(16)

(131,317)

10,132

Balance at Dec. 31, 2020

142,193

(40)

(134,956)

7,272

Loss for the period

(6,046)

Other comprehensive loss

Total comprehensive loss

(6,046)

(6,038)

Exercise of options

^[1]

Share-based compensation

884

Balance at Jun. 30, 2021

143,077

(32)

(141,002)

2,118

Balance at Mar. 31, 2021

142,577

(29)

(137,807)

4,816

Loss for the period

(3,195)

Other comprehensive loss

(3)

Total comprehensive loss

(3)

(3,195)

(3,198)

Exercise of options

^[1]

Share-based compensation

500

Balance at Jun. 30, 2021

$ 75

$ 143,077

$ (32)

$ (141,002)

$ 2,118

[1]	Represents less than $ 1

- Definition

The amount of change in equity resulting from transactions and other events, other than those changes resulting from transactions with owners in their capacity as owners.

+ References + Details

- Definition

The amount of residual interest in the assets of the entity after deducting all its liabilities.

+ References + Details

- Definition

The total of income less expenses from continuing and discontinued operations, excluding the components of other comprehensive income. [Refer: Other comprehensive income]

+ References

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+ Details

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands	3 Months Ended		6 Months Ended		12 Months Ended
	Jun. 30, 2021	Jun. 30, 2020	Jun. 30, 2021	Jun. 30, 2020	Dec. 31, 2020
Cash Flows from Operating Activities:
Net loss	$ (3,195)	$ (3,096)	$ (6,046)	$ (5,557)	$ (9,196)
Adjustments to profit and loss items:
Profit from discontinued operation	0	0	0	0	(80)
Depreciation and amortization	319	271	627	539	1,090
Share-based compensation	500	346	884	519	1,322
Revaluation of liability in respect of IIA grants	222	226	497	424	828
Revaluation of liabilities in respect of the purchase of shares	147	196	299	348	(433)
Revaluation of lease liabilities	79	100	35	64	305
Increase (decrease) in severance pay liabilities, net	5	19	(5)	40	33
Net financing income	0	(81)	(11)	(191)	(297)
Un-realized foreign currency (gain) loss	(482)	(51)	(226)	28	(211)
Adjustments to profit and loss items, total	790	1,026	2,100	1,771	2,557
Changes in asset and liability items:
Decrease in trade receivables	3,087	444	680	1,341	1,386
Decrease (increase) in inventories	62	65	17	(326)	141
Increase in other receivables	(469)	(383)	(432)	(284)	(13)
Increase (decrease) in trade payables and accrued expenses	803	(1,004)	1,075	(1,649)	(1,096)
Increase (decrease) in other payables and deferred revenues	(2,063)	133	(1,257)	86	(479)
Changes in asset and liability items, total	(1,420)	(745)	(83)	(832)	(61)
Net cash used in continuing operating activities	(985)	(2,815)	(3,863)	(4,618)	(6,700)
Net cash used in discontinued operating activities	0	0	0	0	(195)
Net cash used in operating activities	(985)	(2,815)	(3,863)	(4,618)	(6,895)
Cash Flows from Investing Activities:
Purchase of property and equipment	(26)	(100)	(244)	(244)	(923)
Interest received	(0)	39	35	42	274
Proceeds from short term bank deposits, net	(4)	7,603	4,002	10,595	18,034
Net cash provided by (used in) continuing investing activities	(30)	7,542	3,793	10,393	17,385
Cash Flows from Financing Activities:
Repayment of leases liabilities	(171)	(153)	(337)	(313)	(508)
Repayments of IIA grant	0	0	(180)	(66)	(121)
Net cash used in financing activities	(171)	(153)	(517)	(379)	(629)
Exchange rate differences on cash and cash equivalent balances	495	57	204	(26)	273
Cash and cash equivalents:
Increase (decrease) in cash and cash equivalents from continuing activities	(691)	4,631	(383)	5,370	10,329
Decrease in cash and cash equivalents from discontinued activities	0	0	0	0	(195)
Balance of cash and cash equivalents at the beginning of the period	17,684	7,981	17,376	7,242	7,242
Balance of cash and cash equivalents at the end of the period	16,993	12,612	16,993	12,612	17,376
Supplement disclosure of Non-cash transactions:
ROU asset, net recognized with corresponding lease liability	155	0	155	105	261
Exercise of RSU’s	$ 0	$ 0	$ 43	$ 43	$ 147

GENERAL

6 Months Ended

Jun. 30, 2021

Disclosure Of General Information [Abstract]

GENERAL

NOTE 1:

GENERAL

General description of the Company and its operations:

MediWound Ltd. which incorporated 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 is centered around its validated enzymatic technology platform, focused on next-generation bioactive therapies for burn care, wound care and 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, Chilean 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. NexoBrid is an investigational product at registration-stage in the U.S.

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

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

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 inactive companies.

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.

The Company addressed the challenges associated with the COVID-19 pandemic during the year ended 2020 and six months ended June 30, 2021, while prioritizing the health and safety of its workforce and maintaining operational efficiency and flexibility.

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 (see Note 1(a) to 2020 Annual Financial Statements).

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 in response the CMC information requests, which were not reviewed for this action.

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-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.

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 expects the timing of the potential approval of NexoBrid to be impacted.

SIGNIFICANT ACCOUNTING POLICIES

6 Months Ended

Jun. 30, 2021

Disclosure of significant accounting policies [Abstract]

SIGNIFICANT ACCOUNTING POLICIES

NOTE 2:

SIGNIFICANT ACCOUNTING POLICIES

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

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").

Basis of preparation of the interim consolidated financial statements:

The interim condensed consolidated financial statements for the six and three months ended June 30, 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 (hereinafter - Annual Consolidated Financial Statements).

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

EQUITY	6 Months Ended
EQUITY	Jun. 30, 2021
SHAREHOLDERS' EQUITY:
EQUITY	NOTE 3: EQUITY On March 4, 2021, the Company's Board of Directors approved the grant of 230,848 options to purchase ordinary shares, for an exercise price of $ 5.36 per share as well as 38,457 restricted share units (“RSU’s”) to its employees and officers. The fair value of the options and RSU’s, as of the grant date, was estimated at $0.71, $0.20 million respectively. In addition, the approval included a grant total of 146,942 options to purchase ordinary shares and 24,490 RSU’s to its directors and the CEO of the Company. On June 15, 2021, this grant was approved at the Company's shareholders meeting. The fair value of the options and RSU’s, as of the grant date, was estimated at approximately $0.38, $0.11 million, respectively.

SIGNIFICANT ACCOUNTING POLICIES (Policies)

6 Months Ended

Jun. 30, 2021

Disclosure of significant accounting policies [Abstract]

Basis of presentation of financial statements

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").

Basis of preparation of the interim consolidated financial statements

Basis of preparation of the interim consolidated financial statements:

The interim condensed consolidated financial statements for the six and three months ended June 30, 2021 have been prepared in accordance with IAS 34 "Interim Financial Reporting".

EQUITY (Details) $ in Thousands		1 Months Ended
EQUITY (Details) $ in Thousands	Mar. 04, 2021 USD ($) ₪ / shares shares	Jun. 15, 2021 USD ($) ₪ / shares shares
CEO [Member]
Statements [Line Items]
Options granted to purchase ordinary shares		146,942
Number of restricted share units \| shares		24,490
Fair value of the options RSU price \| ₪ / shares		₪ 0.38
Fair value of options		₪ 110
Employees, Officers and Members [Member]
Statements [Line Items]
Options granted to purchase ordinary shares	230,848
Options granted, exercise price \| ₪ / shares	₪ 5.36
Number of restricted share units \| shares	38,457
Fair value of the options RSU price \| ₪ / shares	₪ 0.71
Fair value of options	₪ 200