0001178913-22-003004 | 6-K | XBRL Viewer

Document and Entity Information	6 Months Ended
Document and Entity Information	Jun. 30, 2022
Cover [Abstract]
Entity Registrant Name	MediWound Ltd.
Entity Central Index Key	0001593984
Document Type	6-K
Document Period End Date	Jun. 30, 2022
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Document Fiscal Period Focus	Q2
Document Fiscal Year Focus	2022
Entity File Number	001-36349
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 Statements of Financial Position - USD ($) $ in Thousands	Jun. 30, 2022	Dec. 31, 2021	Jun. 30, 2021
CURRENT ASSETS:
Cash and cash equivalents	$ 7,729	$ 11,046	$ 16,993
Restricted deposits	168	0	182
Short-term bank deposits	2,509	0	0
Trade receivables	3,759	1,779	2,065
Inventories	1,991	1,200	1,397
Other receivables	653	927	883
Total current assets	16,809	14,952	21,520
LONG-TERM ASSETS:
Other receivables	230	469	0
Property, plant and equipment, net	2,439	2,478	2,565
Right of-use assets, net	1,364	1,548	1,789
Intangible assets, net	264	297	330
Total non-current assets	4,297	4,792	4,684
Total assets	21,106	19,744	26,204
CURRENT LIABILITIES:
Current maturities of non-current liabilities	2,479	2,408	1,681
Trade payables and accrued expenses	4,877	4,693	4,060
Other payables	3,060	3,620	3,920
Total current liabilities	10,416	10,721	9,661
LONG-TERM LIABILITIES:
Deferred revenues	61	119	405
Liability in respect of IIA grants	8,131	7,885	7,671
Liabilities in respect of purchase of shares	3,361	3,922	4,465
Lease liabilities	1,053	1,391	1,604
Severance pay liability, net	319	288	280
Total non-current liabilities	12,925	13,605	14,425
Total liabilities	23,341	24,326	24,086
SHAREHOLDERS' EQUITY:
Ordinary shares of NIS 0.01 par value: Authorized: 50,000,000 shares as of June 30, 2022 , December 31, 2020 and June 30, 2021; Issued and Outstanding: 33,143,414 as of June 30, 2022, 27,272,818 as of December 31, 2021 and 27,245,429 as of June 30, 2021	93	75	75
Share premium	154,119	143,869	143,077
Foreign currency translation adjustments	3	(19)	(32)
Accumulated deficit	(156,450)	(148,507)	(141,002)
Total equity (deficit)	(2,235)	(4,582)	2,118
Total liabilities and equity	$ 21,106	$ 19,744	$ 26,204

Condensed Interim Consolidated Statements of Profit or Loss and Other Comprehensive Income or Loss - USD ($) $ in Thousands	3 Months Ended		6 Months Ended		12 Months Ended
	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021	Dec. 31, 2021
Profit or loss [abstract]
Revenues from sale of products	$ 1,669	$ 2,527	$ 2,771	$ 5,045	$ 9,613
Revenues from development services	2,777	3,023	5,866	5,963	12,372
Revenues from license agreements	222	507	438	896	1,778
Total revenues	4,668	6,057	9,075	11,904	23,763
Cost of revenues from sale of products	1,148	1,311	1,539	2,451	4,983
Cost of revenues from development services	2,391	2,365	4,932	4,638	9,907
Cost of revenues from license agreements	16	20	31	38	102
Total cost of revenues	3,555	3,696	6,502	7,127	14,992
Gross profit	1,113	2,361	2,573	4,777	8,771
Research and development	2,191	2,656	4,599	4,898	10,256
Selling and marketing	935	854	1,854	1,676	3,388
General and administrative	1,352	1,746	2,769	3,019	6,348
Other expenses	309	0	309	0	0
Total operating expenses	4,787	5,256	9,531	9,593	19,992
Operating loss	(3,674)	(2,895)	(6,958)	(4,816)	(11,221)
Financial income	11	118	11	11	11
Financial expenses	(687)	(399)	(988)	(1,222)	(2,314)
Financing expenses, net	(676)	(281)	(977)	(1,211)	(2,303)
Loss before taxes on income	(4,350)	(3,176)	(7,935)	(6,027)	(13,524)
Taxes on income	(4)	(19)	(8)	(19)	(27)
Net loss	(4,354)	(3,195)	(7,943)	(6,046)	(13,551)
Other comprehensive income (loss):
Foreign currency translation adjustments	17	(3)	22	8	21
Total comprehensive loss	$ (4,337)	$ (3,198)	$ (7,921)	$ (6,038)	$ (13,530)
Basic and diluted net loss per share - USD	$ (0.13)	$ (0.12)	$ (0.26)	$ (0.22)	$ (0.5)
Number of shares used in calculating basic and diluted net loss per share	33,140	27,241	31,079	27,241	27,244

Condensed Interim Consolidated Statements of Changes in Shareholders' Equity (Deficit) - USD ($)
$ in Thousands

Share capital [Member]

Share premium [Member]

Foreign currency translation reserve [Member]

Accumulated deficit [Member]

Total

Balance at Dec. 31, 2020

$ 75

$ 142,193

$ (40)

$ (134,956)

$ 7,272

Loss for the period

(6,046)

Other comprehensive income (loss)

Total comprehensive income (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 Dec. 31, 2020

142,193

(40)

(134,956)

7,272

Loss for the period

(13,551)

Other comprehensive income (loss)

Total comprehensive income (loss)

(13,551)

(13,530)

Exercise of options

Share-based compensation

1,673

Balance at Dec. 31, 2021

143,869

(19)

(148,507)

(4,582)

Balance at Mar. 31, 2021

142,577

(29)

(137,807)

4,816

Loss for the period

(3,195)

Other comprehensive income (loss)

(3)

Total comprehensive income (loss)

(3)

(3,195)

(3,198)

Exercise of options

^[1]

Share-based compensation

500

Balance at Jun. 30, 2021

143,077

(32)

(141,002)

2,118

Balance at Dec. 31, 2021

143,869

(19)

(148,507)

(4,582)

Loss for the period

(7,943)

Other comprehensive income (loss)

Total comprehensive income (loss)

(7,943)

(7,921)

Issue of ordinary shares

9,653

9,671

Exercise of options

^[1]

Share-based compensation

597

Balance at Jun. 30, 2022

154,119

(156,450)

(2,235)

Balance at Mar. 31, 2022

153,962

(14)

(152,096)

1,945

Loss for the period

(4,354)

Other comprehensive income (loss)

Total comprehensive income (loss)

(4,354)

(4,337)

Issuance expenses

(95)

Exercise of options

^[1]

Share-based compensation

252

Balance at Jun. 30, 2022

$ 93

$ 154,119

$ 3

$ (156,450)

$ (2,235)

[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, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021	Dec. 31, 2021
Cash Flows from Operating Activities:
Net loss	$ (4,354)	$ (3,195)	$ (7,943)	$ (6,046)	$ (13,551)
Adjustments to profit and loss items:
Depreciation and amortization	329	319	650	627	1,238
Share-based compensation	252	500	597	884	1,673
Revaluation of liabilities in respect of IIA grants	248	222	482	497	919
Revaluation of liabilities in respect of the purchase of shares	135	147	272	299	590
Revaluation of lease liabilities	(138)	79	(152)	35	188
Increase (decrease) in severance pay liability, net	35	5	55	(5)	13
Net financing income	(11)	0	(11)	(11)	(11)
Un-realized foreign currency (gain) loss	283	(482)	528	(226)	(137)
Adjustments to profit and loss items, total	1,133	790	2,421	2,100	4,473
Changes in asset and liability items:
(Increase) decrease in trade receivables	(1,445)	3,087	(2,024)	680	929
(Increase) decrease in inventories	(37)	62	(747)	17	257
Decrease (increase) in other receivables	205	(469)	330	(432)	(763)
Increase (decrease) in trade payables and accrued expenses	(272)	803	11	1,075	1,723
Decrease in other payables and deferred revenues	(484)	(2,063)	(1,367)	(1,257)	(1,984)
Changes in asset and liability items, total	(2,033)	1,420	(3,797)	83	162
Net cash used in operating activities	(5,254)	(985)	(9,319)	(3,863)	(8,916)
Cash Flows from Investing Activities:
Purchase of property and equipment	(138)	(26)	(298)	(244)	(489)
Interest received	0	0	0	35	35
(Increase) decrease in short term bank deposits, net	(2,499)	(4)	(2,499)	4,002	4,002
Net cash provided by (used in) investing activities	(2,637)	(30)	(2,797)	3,793	3,548
Cash Flows from Financing Activities:
Repayment of leases liabilities	(172)	(171)	(350)	(337)	(693)
Proceeds from issuance of shares, net	(556)	0	9,861	0	3
Repayment of IIA grant	0	0	(162)	(180)	(360)
Net cash provided by (used in) financing activities	(728)	(171)	9,349	(517)	(1,050)
Exchange rate differences on cash and cash equivalent balances	(303)	495	(550)	204	88
Decrease in cash and cash equivalents	(8,922)	(691)	(3,317)	(383)	(6,330)
Balance of cash and cash equivalents at the beginning of the period	16,651	17,684	11,046	17,376	17,376
Balance of cash and cash equivalents at the end of the period	7,729	16,993	7,729	16,993	11,046
Supplement disclosure of Non-cash transactions:
ROU asset, net recognized with corresponding lease liability	43	155	43	155	155
Issuance of shares due to RSUs exercised	$ 14	$ 0	$ 191	$ 43	$ 147

GENERAL

6 Months Ended

Jun. 30, 2022

Disclosure Of General Information [Abstract]

GENERAL

NOTE 1:

GENERAL

Description of the Company and its operations:

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

The Company's first innovative biopharmaceutical product, NexoBrid, has received marketing authorization from the European Medicines Agency ("EMA") as well as the Israeli, Argentinean, South-Korean, Russian, Taiwanese, Ukrainian, United Arab Emirates, Chilean, Peruvian and Switzerland Ministries of Health, for removal of dead or damaged tissue, known as eschar, in adults with deep partial and full thickness thermal burns.

The Company sells NexoBrid in the European Union, United Kingdom, Norway, Switzerland and Israel through its commercial organizations while establishing additional local distribution channels to extend its outreach in the European Union. In other international markets the Company sells NexoBrid through local distributors which are also responsible for obtaining the local marketing authorization within the relevant territory. In the United States, the Company entered into exclusive license and supply agreements with Vericel Corporation (“Vericel”) to commercialize NexoBrid in North America upon FDA's approval.

The Company’s second investigational innovative product, EscharEx, is a topical biological drug being developed for debridement of chronic and other hard-to-heal wounds. In May 2022, the company announced positive results from its U.S. phase 2 study. The study met its primary endpoint, its key secondary endpoints with high degree of statistical significance, as well as its wound closure safety measurements. The Company anticipates meeting with the U.S. Food and Drug Administration (the “FDA”) in the second half of 2022, for an End-of-Phase 2 meeting to discuss study results and a potential Phase 3 pivotal plan for EscharEx.

The third clinical-stage innovative product candidate, MW005, is a topical biological drug candidate for the treatment of non-melanoma skin cancers. A U.S. phase 1/2 study of MW005 for the treatment of low-risk basal cell carcinoma (BCC) was initiated in July 2021, and in July 2022, a positive initial data was announced. The Company anticipates announcing the final data in the second half of 2022.

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

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

The Company awarded two contracts with the U.S. Biomedical Advanced Research and Development Authority ("BARDA") valued at up to $168,000 for the advancement of the development, manufacturing and emergency readiness for NexoBrid deployment as well as the procurement of NexoBrid as a medical countermeasure as part of BARDA preparedness for mass casualty events. In February 2022 BARDA has expanded its awarded contract providing supplemental funding of approximately $9,000 to support the NexoBrid BLA resubmission to the FDA and the continuous expanded access program.

On February 17, 2022 the Company engaged with the U.S. Department of Defense (“DoD”), through the Medical Technology Enterprise Consortium (MTEC), for a $1,800 contract for the development of NexoBrid as a non-surgical solution for field-care burn treatment for the U.S. Army.

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

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

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

Following a productive Type A meeting with the FDA, the Company gained clarity on a path forward for resubmission of its NexoBrid BLA. In addition, the FDA’s facility inspection schedule which has been affected by COVID-19-related travel restrictions, is required before the FDA can approve the NexoBrid BLA.

		On July 1, 2022, the Company has re-submitted the Biologics License Application (BLA) to the U.S. Food and Drugs Administration (FDA) and received an acknowledgement letter from the FDA assigning PDUFA target date to January 1, 2023.

	g.	Since incorporation through June 30, 2022, the Company has incurred losses mainly attributed to its development efforts and has total accumulated deficit of $156,450 thousand, the Company’s total shareholders’ equity amounted to deficit of $2,235. During the six-month period ended June 30, 2022, the Company incurred losses of $7,943 and its cash used in operating activities was $9,319. The Company expects to continue to incur significant research and development and other costs related to its ongoing operations, and in order to continue its future operations, the Company will need to obtain additional funding until becoming profitable. Management’s plans include evaluating alternative financing arrangements and/or reducing expenditures as necessary to meet the Company’s future cash requirements. However, there is no assurance that, if required, the Company will be able to raise additional capital or reduce expenditures to provide the required liquidity. Management expects that the Company's cash and cash equivalents as of June 30, 2022 will allow the Company to fund its operating plan through at least the next 12 months from the financial statement issuance date.

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

GENERAL (Narrative) (Details) - USD ($) $ / shares in Units, $ in Thousands		1 Months Ended				3 Months Ended		6 Months Ended		12 Months Ended
	Mar. 07, 2022	Mar. 31, 2022	Mar. 22, 2022	Feb. 28, 2022	Feb. 17, 2022	Jun. 30, 2022	Jun. 30, 2021	Jun. 30, 2022	Jun. 30, 2021	Dec. 31, 2021	Mar. 31, 2021	Dec. 31, 2020
Disclosure of associates [line items]
Proceeds from issuing shares	$ 8,641	$ 10,000
Number of ordinary shares issuable		5,208,333	623,082
Shares issued price in initial public offering		$ 1.92
Accumulated deficit						$ (156,450)	$ (141,002)	$ (156,450)	$ (141,002)	$ (148,507)
Shareholders' equity		$ 1,945				(2,235)	2,118	(2,235)	2,118	(4,582)	$ 4,816	$ 7,272
Net loss						(4,354)	(3,195)	(7,943)	(6,046)	(13,551)
Cash used in operating activities						$ (5,254)	$ (985)	(9,319)	$ (3,863)	$ (8,916)
BARDA
Disclosure of associates [line items]
Proceeds from funding				$ 9,000
Contract amount for development and manufacturing								$ 168,000
MTEC
Disclosure of associates [line items]
Contract amount for development and manufacturing					$ 1,800

EQUITY (Narrative) (Details) $ / shares in Units, $ in Thousands		1 Months Ended		3 Months Ended
	Mar. 07, 2022 USD ($) $ / shares shares	Mar. 31, 2022 USD ($) shares	Mar. 22, 2022 USD ($) shares	Jun. 30, 2022 USD ($) Share $ / shares
Statements [Line Items]
Number of common shares issued \| shares	5,208,333
Price per common shares issued \| $ / shares	$ 1.92
Proceeds from issuance of shares, net	$ 8,641	$ 10,000
Number of ordinary shares issuable \| shares		5,208,333	623,082
Net proceeds from the issue of additional shares			$ 1,030
Number of options granted \| Share				2,052,922
Weighted average exercise price of options granted \| $ / shares				$ 2.06
Number of restricted share units granted \| Share				275,000
Fair value of options as of the grant date				$ 2,400
Fair value of restricted share units as of the grant date				$ 500
Certain entities affiliated with CBI [Member]
Statements [Line Items]
Number of common shares issued \| shares	1,458,333
Directors and CEO [Member]
Statements [Line Items]
Number of options granted \| Share				1,062,500
Number of restricted share units granted \| Share				275,000
Fair value of options as of the grant date				$ 1,200
Fair value of restricted share units as of the grant date				$ 500

OTHER EXPENSES	6 Months Ended
OTHER EXPENSES	Jun. 30, 2022
Expenses by nature [abstract]
OTHER EXPENSES	NOTE 4: OTHER EXPENSES The other one-time expenses amounted $309 are attributed to the termination expenses of the previous CEO which were approved by the Shareholders General meeting.

SUBSEQUENT EVENTS	6 Months Ended
SUBSEQUENT EVENTS	Jun. 30, 2022
Disclosure of non-adjusting events after reporting period [abstract]
SUBSEQUENT EVENTS	NOTE 5: SUBSEQUENT EVENTS On July 19, 2022, the Company’s Shareholders General meeting approved the abovementioned grants to the directors and the CEO, the compensation terms of Mr. Ofer Gonen as the Company’s new Chief Executive Officer, which terms will be effective as of July 1, 2022 and the termination terms for the previous CEO.

OTHER EXPENSES (Detail Textuals) $ in Thousands	6 Months Ended
OTHER EXPENSES (Detail Textuals) $ in Thousands	Jun. 30, 2022 USD ($)
Expenses by nature [abstract]
Termination expenses	$ 309

Condensed Interim Consolidated Statements of Financial Position (Parenthetical) - ₪ / shares	Jun. 30, 2022	Dec. 31, 2021	Jun. 30, 2021
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	33,143,414	27,272,818	27,245,429
Ordinary shares, Outstanding	33,143,414	27,272,818	27,245,429