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 November 2022
 
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 November 15, 2022, MediWound Ltd. (the “Company”) issued a press release entitled “MediWound Reports Third Quarter 2022 Financial Results and Provides Company Update”. 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 September 30, 2022, attached as Exhibit 99.2, which was provided by the Company to CBI on November 14, 2022 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 May 15, 2021 and August 9, 2022  (Registration Nos. No. 333-195517, 333-210375, 333-223767, 333-195517, 333-210375, 333-230487, 333-236635, 333-255784, and 333-266697 respectively) and on Form F-3 filed with the SEC on May 25, 2022 (Registration No. 333-265203).

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: November 15, 2022
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
   
   


4

Exhibit 99.1
MediWound Reports Third Quarter 2022 Financial Results and Provides Company Update

$30.5 million in gross proceeds raised; operating cash runway through 2025
 
NexoBrid PDUFA date of January 1, 2023; Upon approval, NexoBrid expected to generate meaningful revenues
 
Company focused on the billion-dollar market opportunity with EscharEx Phase 3 clinical study to begin in first-half 2023
 
Conference call begins today at 8:30 a.m. Eastern Time
 
YAVNE, Israel, November 15, 2022 -- MediWound Ltd. (NASDAQ: MDWD), a fully integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced financial results for the third quarter ended September 30, 2022 and provided a corporate update.

“We are approaching several significant inflection points for the Company,” said Ofer Gonen, Chief Executive Officer of MediWound. “We believe, once approved, NexoBrid® is poised to generate meaningful revenues in 2023 and exponential growth going forward. Following the launch of NexoBrid, we will focus on the billion-dollar market opportunity presented to us with EscharEx®, where we plan to initiate a Phase III study next year. We have all the essential elements aligned for success: a mature pipeline, favorable data, large addressable markets, an experienced operational team, tier-1 partners, and a strong balance sheet. We are strategically positioned to unlock additional opportunities that will improve patient lives and add value to our shareholders.”

Third Quarter Highlights and Recent Developments:
 

Raised $30.5 million in gross proceeds in a concurrent Registered Direct and Private Placement offering with participation from current and new shareholders including Israel Biotech Fund, New Era Capital Partners, Discount Capital and Deep Insight, as well as members of the management team and board of directors. The Company intends to use the net proceeds primarily for the development of EscharEx®, scale up of the manufacturing facility, and general corporate purposes.
 

EscharEx’s promising results from the completed Phase 2 trials featured in oral and poster presentations at the Symposium on Advanced Wound Care (SAWC) Fall 2022, in Las Vegas, Nevada. Pivotal Phase 3 clinical study of EscharEx for the debridement of venous leg ulcers (VLUs) is currently expected to start in the first-half of 2023.
 

FDA’s review of NexoBrid BLA is progressing; inspections of manufacturing facilities in Taiwan and Israel are underway.
 

The European Medicines Agency (EMA) validated for review the Company’s Type II Variation to expand NexoBrid’s currently approved indication for the pediatric population. The company anticipates a decision from the EMA during the first quarter of calendar year 2023.
 


NexoBrid was highlighted in 45 posters and presentations at the 19th European Burns Association Congress in Turin, Italy. Leading European burn specialists and thought leaders from around the world shared their positive experiences and patient outcomes using NexoBrid in a wide range of settings.
 

Positive initial data from the Company’s U.S. Phase I/II study of MW005 for the treatment of low-risk basal cell carcinoma (BCC) was announced. The initial data showed MW005 to be safe and well-tolerated, and target lesions clearance data provided clinical efficacy proof-of-concept. Additional study data expected later this year.


Strategic Advisory Board (SAB) of esteemed industry leaders was established to add significant expertise and insight to MediWound’s strategic and operational activities.


Total revenues for the third quarter of 2022 were $5.8 million compared to $6.4 million in the third quarter of 2021, and $4.7 million in the second quarter of 2022.


Cash and short-term investments of $17.6 million as of September 30, 2022. An additional $17.2 million in gross proceeds ($16.6 million net proceeds) was received from the Private Placement Offering closed on October 6, 2022. The Company has sufficient cash to fund its expected operations through 2025.

Third Quarter Financial Highlights
 
Total revenues for the third quarter of 2022 were $5.8 million, compared to $6.4 million for the third quarter of 2021. Revenues from products in the third quarter of 2022 were $1.4 million compared to $2.6 million in the third quarter of 2021. This was primarily due to decrease in emergency stockpile procurement by BARDA.

Gross profit for the third quarter of 2022 was $2.4 million, or 42% of net revenues, compared to a gross profit of $2.5 million, or 39% of net revenues, for the third quarter of 2021.
 
Research and development expenses for the third quarter of 2022 were $2.9 million same as in the third quarter of 2021.

Selling, general and administrative expenses for the third quarter of 2022 were $3.1 million, compared to $2.4 million in the third quarter of 2021. The increase was primarily a result of approximately $0.2 million of share-based compensation costs and $0.3 million of one-time marketing expenses.

Operating loss for the third quarter of 2022 was $3.5 million compared to $2.9 million in the third quarter of 2021.

The Company posted a net loss for the third quarter of 2022 of $4.2 million, or $0.13 per share, compared to a net loss of $3.3 million, or $0.12 per share, for the third quarter of 2021.

Adjusted EBITDA, as defined below, for the third quarter of 2022 was a loss of $2.4 million, compared to a loss of $2.2 million for the third quarter of 2021.



Year-to-Date 2022 Financial Results

Total revenues for the first nine months of 2022 were $14.9 million, compared to $18.3 million in the first nine months of 2021. Revenues from products in the first nine months of 2022 were $4.2 million compared to $7.7 million for the first nine months of 2021. This was primarily the result of a decrease in emergency stockpile procurement by BARDA.

Operating loss for the first nine months of 2022 was $10.5 million, compared to an operating loss of $7.7 million in the first nine months of 2021.

Net loss for the first nine months of 2022 was $12.1 million, or $0.38 per share compared to a net loss of $9.4 million or $0.34 per share for the first nine months of 2021.

Adjusted EBITDA, as defined below, for the first nine months of 2022, was a loss of $7.8 million, compared to a loss of $5.5 million for the first nine months of 2021.

Balance Sheet Highlights

As of September 30, 2022, MediWound had $17.6 million in cash and short-term investments, compared with $11.0 million as of December 31, 2021, and no debt. MediWound utilized $4.6 million in the third quarter of 2022 for its operational activities. The Company reiterates its cash use for 2022 to be in the range of $13 to $15 million. In addition, $17.2 million in gross proceeds ($16.6 million in net proceeds were received in October from the $30.5 equity offering), to support the Company’s expected operations through 2025.

Conference Call

MediWound management will host a conference call for investors today, Tuesday, November 15, 2022, 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 833-630-1956 (in the U.S.), 80-921-2373 (Israel), or 412-317-1837 (outside the U.S. & Israel) and entering passcode 4399134. The call will be webcast live on the Events & Presentations page of Company’s website at: https://ir.mediwound.com/events-and-presentations

A replay of the call will be available on the Company’s website 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
 
MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy is to leverage our enzymatic technology platform, focusing 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 the registration-stage with the United States Food and Drug Administration (FDA) with a PDUFA date set as of January 1, 2023. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).
 
EscharEx is our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. EscharEx is 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 in several Phase 2 trials. A meeting with the FDA to discuss the Phase 3 pivotal study design is targeted for the fourth quarter of calendar year 2022.
 
MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development. The initial data from a Phase I/II study showed MW005 to be safe and well-tolerated, with a majority of the patients who completed the study with MW005 achieving complete histological clearance of their target lesions. The Company anticipates announcing the final data in the fourth quarter of calendar year 2022.
 
Committed to innovation, we are dedicated to improving standard of care and enhancing 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, expected data timing, 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 market potential of our products and product candidates, our expectations regarding future growth and revenues, 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; the approval of regulatory submission by the European Medicines Agency, FDA or by any other regulatory authority, our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets. For Example the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; 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, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 17, 2022, 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:
         
Monique Kosse
 
Boaz Gur-Lavie
         
Managing Director
 
Chief Financial Officer
         
LifeSci Advisors
 
MediWound Ltd.
         
212-915-3820
 
ir@mediwound.com
         
monique@lifesciadvisors.com
 


MediWound, Ltd.

CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands

   
September 30,
   
December 31,
 
   
2022
   
2021
   
2021
 
   
Un-audited
   
Audited
 
Cash, cash equivalents and short-term deposits
   
17,592
     
13,866
     
11,046
 
Accounts and other receivable
   
4,976
     
3,553
     
2,706
 
Inventories
   
1,880
     
1,252
     
1,200
 
Total current assets
   
24,448
     
18,671
     
14,952
 
                         
Trade and Other receivables
   
230
     
-
     
469
 
Property, plant and equipment, net
   
2,354
     
2,531
     
2,478
 
Right of use assets, net
   
1,305
     
1,650
     
1,548
 
Intangible assets, net
   
248
     
314
     
297
 
Total long-term assets
   
4,137
     
4,495
     
4,792
 
                         
Total assets
   
28,585
     
23,166
     
19,744
 
                         
Current maturities of long-term liabilities
   
2,461
     
1,867
     
2,408
 
Trade payables and accrued expenses
   
3,565
     
3,710
     
4,693
 
Other payables
   
2,986
     
4,384
     
3,620
 
Total current liabilities
   
9,012
     
9,961
     
10,721
 
                         
Deferred revenues
   
31
     
352
     
119
 
Liability in respect of Israeli Innovation Authority grants net of current maturity
   
8,451
     
7,715
     
7,885
 
Contingent consideration for the purchase of shares net of current maturity
   
3,076
     
4,195
     
3,922
 
Lease liability, net of current maturity
   
952
     
1,483
     
1,391
 
Warrants
   
5,092
     
-
     
-
 
Severance pay liability, net
   
315
     
281
     
288
 
Total long-term liabilities
   
17,917
     
14,026
     
13,605
 
                         
Shareholders' equity (deficit)
   
1,656
     
(821
)
   
(4,582
)
Total liabilities & shareholder equity
   
28,585
     
23,166
     
19,744
 


MediWound, Ltd.

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

 
Nine months ended
   
Three months ended
 
   
September 30,
   
September 30,
 
   
2022
   
2021
   
2022
   
2021
 
                         
Revenues
   
14,878
     
18,276
     
5,803
     
6,372
 
Cost of revenues
   
9,871
     
11,044
     
3,369
     
3,917
 
Gross profit
   
5,007
     
7,232
     
2,434
     
2,455
 
                                 
Operating expenses:
                               
Research and development, net
   
7,482
     
7,795
     
2,883
     
2,897
 
Selling, general & administrative
   
7,684
     
7,137
     
3,061
     
2,442
 
Other expenses
   
309
     
-
     
-
     
-
 
Operating loss
   
(10,468
)
   
(7,700
)
   
(3,510
)
   
(2,884
)
Financial expenses, net
   
(1,661
)
   
(1,668
)
   
(684
)
   
(457
)
Loss before Taxes on Income
   
(12,129
)
   
(9,368
)
   
(4,194
)
   
(3,341
)
Taxes on Income
   
(13
)
   
(23
)
   
(5
)
   
(4
)
Net Loss
   
(12,142
)
   
(9,391
)
   
(4,199
)
   
(3,345
)
Foreign currency translation adjustments
   
34
     
15
     
12
     
7
 
Total comprehensive loss
   
(12,108
)
   
(9,376
)
   
(4,187
)
   
(3,338
)
                                 
Net loss per share
   
(0.38
)
   
(0.34
)
   
(0.13
)
   
(0.12
)
Weighted average number of ordinary shares used in the computation of basic and diluted loss per share:
   
31,818
     
27,243
     
33,482
     
27,245
 



MediWound, Ltd.

ADJUSTED EBITDA
U.S. dollars in thousands

   
Nine months ended
   
Three months ended
 
   
September 30,
   
September 30,
 
   
2022
   
2021
   
2022
   
2021
 
Loss for the period
   
(12,142
)
   
(9,391
)
   
(4,199
)
   
(3,345
)
                                 
Adjustments:
                               
Financial expenses, net
   
(1,661
)
   
(1,668
)
   
(684
)
   
(457
)
Other expenses
   
(309
)
   
-
     
-
     
-
 
Tax Expenses
   
(13
)
   
(23
)
   
(5
)
   
(4
)
Depreciation and amortization
   
(988
)
   
(962
)
   
(338
)
   
(335
)
Share-based compensation expenses
   
(1,304
)
   
(1,283
)
   
(707
)
   
(399
)
Total adjustments
   
(4,275
)
   
(3,936
)
   
(1,734
)
   
(1,195
)
Adjusted EBITDA
   
(7,867
)
   
(5,455
)
   
(2,465
)
   
(2,150
)

ADJUSTED EBITDA – PROFIT (LOSS) (UNAUDITED)
U.S. dollars in thousands

   
Nine months ended
   
Three months ended
 
   
September 30,
   
September 30,
 
   
2022
   
2021
   
2022
   
2021
 
Revenues
   
14,878
     
18,276
     
5,803
     
6,372
 
Cost of Revenues
   
9,213
     
10,474
     
3,129
     
3,721
 
Gross Profit
   
5,665
     
7,802
     
2,674
     
2,651
 
Research and development
   
6,934
     
7,262
     
2,676
     
2,723
 
Selling, general & administrative
   
6,598
     
5,995
     
2,463
     
2,078
 
Operating Loss
   
(7,867
)
   
(5,455
)
   
(2,465
)
   
(2,150
)


MediWound, Ltd.

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

 
 
Nine months ended
   
Three months ended
 
 
 
September 30,
   
September 30,
 
 
 
2022
   
2021
   
2022
   
2021
 
Cash Flows from Operating Activities:
                       
Net loss
   
(12,142
)
   
(9,391
)
   
(4,199
)
   
(3,345
)
Adjustments to reconcile net loss to net cash used in operating activities:
                               
Adjustments to profit and loss items:
                               
Depreciation and amortization
   
988
     
962
     
338
     
335
 
Share-based compensation
   
1,304
     
1,283
     
707
     
399
 
Revaluation of liabilities in respect of IIA      grants
   
812
     
808
     
330
     
311
 
Revaluation of liabilities in respect of purchase of shares
   
404
     
446
     
132
     
147
 
Revaluation of lease liabilities
   
(146
)
   
84
     
6
     
49
 
Increase in severance liability, net
   
64
     
3
     
9
     
8
 
Net financing expenses (income)
   
334
     
(11
)
   
345
     
-
 
Unrealized foreign currency (gain) loss
   
465
     
(238
)
   
(63
)
   
(12
)
 
   
4,225
     
3,337
     
1,804
     
1,237
 
Changes in asset and liability items:
                               
Decrease (increase) in trade receivables
   
(2,445
)
   
697
     
(421
)
   
17
 
Decrease (increase) in inventories
   
(608
)
   
188
     
139
     
171
 
Decrease (Increase) in other receivables
   
143
     
(1,078
)
   
(187
)
   
(646
)
Increase (decrease) in trade payables and prepaid expenses
   
(1,232
)
   
733
     
(1,243
)
   
(342
)
Increase (decrease) in other payables & deferred revenues
   
(1,826
)
   
(1,167
)
   
(459
)
   
90
 
 
   
(5,968
)
   
(627
)
   
(2,171
)
   
(710
)
Net cash used in operating activities
   
(13,885
)
   
(6,681
)
   
(4,566
)
   
(2,818
)



   
Nine months ended
September 30,
   
Three months ended
September 30,
 
   
2022
   
2021
   
2022
   
2021
 
Cash Flows from Investment Activities:
                       
Purchase of property and equipment
   
(381
)
   
(373
)
   
(83
)
   
(129
)
Interest received
   
3
     
35
     
3
     
-
 
Decrease (Increase) in short term bank deposits, net
   
(2,499
)
   
4,002
     
-
     
-
 
Net cash (used in) provided by (used in) investing activities
   
(2,877
)
   
3,664
     
(80
)
   
(129
)
 
                               
Cash Flows from Financing Activities:
                               
Repayment of lease liabilities
   
(531
)
   
(513
)
   
(181
)
   
(176
)
Proceeds from issuance of shares and warrants, net
   
21,915
     
-
     
12,054
     
-
 
Proceeds from IIA grants, net of repayments
   
(258
)
   
(360
)
   
(96
)
   
(180
)
Net cash provided by (used in) financing activities
   
21,126
     
(873
)
   
11,777
     
(356
)
 
                               
Exchange rate differences on cash and cash equivalent balances
   
(505
)
   
197
     
45
     
(7
)
Increase (decrease) in cash and cash equivalents from continuing activities
   
3,859
     
(3,693
)
   
7,176
     
(3,310
)
Balance of cash and cash equivalents at the beginning of the period
   
11,046
     
17,376
     
7,729
     
16,993
 
Balance of cash and cash equivalents at the end of the period
   
14,905
     
13,683
     
14,905
     
13,683
 




Exhibit 99.2

MEDIWOUND LTD. AND ITS SUBSIDIARIES

CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

AS OF SEPTEMBER 30, 2022

IN U.S. DOLLARS IN THOUSANDS

UNAUDITED

INDEX

 
Page
   
F-2
   
F-3
   
F-4 – F-5
   
F-6 – F-7
   
F-8 – F-12



MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
Unaudited Condensed Interim Consolidated Statements of Financial Position
U.S. dollars in thousands

   
September 30,
   
December 31,
 
   
2022
   
2021
   
2021
 
                   
Cash and cash equivalents
   
14,905
     
13,683
     
11,046
 
Restricted deposits
   
166
     
183
     
-
 
Short-term bank deposits
   
2,521
     
-
     
-
 
Trade receivables
   
4,146
     
2,026
     
1,779
 
Inventories
   
1,880
     
1,252
     
1,200
 
Other receivables
   
830
     
1,527
     
927
 
Total current assets
   
24,448
     
18,671
     
14,952
 
                         
Other receivables
   
230
     
-
     
469
 
Property, plant and equipment, net
   
2,354
     
2,531
     
2,478
 
Right of-use assets, net
   
1,305
     
1,650
     
1,548
 
Intangible assets, net
   
248
     
314
     
297
 
Total non-current assets
   
4,137
     
4,495
     
4,792
 
                         
Total assets
   
28,585
     
23,166
     
19,744
 
                         
Current maturities of non-current liabilities
   
2,461
     
1,867
     
2,408
 
Trade payables and accrued expenses
   
3,565
     
3,710
     
4,693
 
Other payables
   
2,986
     
4,384
     
3,620
 
Total current liabilities
   
9,012
     
9,961
     
10,721
 
                         
Deferred revenues
   
31
     
352
     
119
 
Warrants
   
5,092
     
-
     
-
 
 Liabilities in respect of IIA grants
   
8,451
     
7,715
     
7,885
 
Liabilities in respect of purchase of shares
   
3,076
     
4,195
     
3,922
 
Lease liabilities
   
952
     
1,483
     
1,391
 
Severance pay liability, net
   
315
     
281
     
288
 
Total non-current liabilities
   
17,917
     
14,026
     
13,605
 
                         
Total liabilities
   
26,929
     
23,987
     
24,326
 
                         
Shareholders' equity:
                       
Ordinary shares of NIS 0.01 par value:
                       
Authorized: 50,000,000 shares as of September 30, 2022, December 31, 2021, and September 30, 2021; Issued and Outstanding: 40,735,197 as of September 30, 2022, 27,272,818 as of December 31, 2021 and 27,247,096 as of September 30, 2021
   
115
     
75
     
75
 
Share premium
   
162,175
     
143,476
     
143,869
 
Foreign currency translation adjustments
   
15
     
(25
)
   
(19
)
Accumulated deficit
   
(160,649
)
   
(144,347
)
   
(148,507
)
Total equity (deficit)
   
1,656
     
(821
)
   
(4,582
)
                         
Total liabilities and equity
   
28,585
     
23,166
     
19,744
 

The accompanying notes are an integral part of the interim financial statements.

F - 2

MEDIWOUND LTD. AND ITS SUBSIDIARIES

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

   
Nine months ended
September 30,
   
Three months ended
September 30,
   
Year ended December 31,
 
   
2022
   
2021
   
2022
   
2021
   
2021
 
Revenues from sale of products
   
4,178
     
7,689
     
1,407
     
2,644
     
9,613
 
Revenues from development services
   
10,180
     
9,260
     
4,314
     
3,297
     
12,372
 
Revenues from license agreements
   
520
     
1,327
     
82
     
431
     
1,778
 
Total revenues
   
14,878
     
18,276
     
5,803
     
6,372
     
23,763
 
                                         
Cost of revenues from sale of products
   
2,326
     
3,672
     
787
     
1,221
     
4,983
 
Cost of revenues from development services
   
7,511
     
7,321
     
2,579
     
2,683
     
9,907
 
Cost of revenues from license agreements
   
34
     
51
     
3
     
13
     
102
 
Total cost of revenues
   
9,871
     
11,044
     
3,369
     
3,917
     
14,992
 
                                         
Gross profit
   
5,007
     
7,232
     
2,434
     
2,455
     
8,771
 
                                         
Research and development
   
7,482
     
7,795
     
2,883
     
2,897
     
10,256
 
Selling and marketing
   
3,033
     
2,548
     
1,179
     
872
     
3,388
 
General and administrative
   
4,651
     
4,589
     
1,882
     
1,570
     
6,348
 
Other expenses
   
309
     
-
     
-
     
-
     
-
 
Total operating expenses
   
15,475
     
14,932
     
5,944
     
5,339
     
19,992
 
                                         
Operating loss
   
(10,468
)
   
(7,700
)
   
(3,510
)
   
(2,884
)
   
(11,221
)
                                         
Financial income
   
23
     
11
     
97
     
-
     
11
 
Financial expenses
   
(1,684
)
   
(1,679
)
   
(781
)
   
(457
)
   
(2,314
)
Financing expenses, net
   
(1,661
)
   
(1,668
)
   
(684
)
   
(457
)
   
(2,303
)
                                         
Loss before taxes on income
   
(12,129
)
   
(9,368
)
   
(4,194
)
   
(3,341
)
   
(13,524
)
                                         
Taxes on income
   
(13
)
   
(23
)
   
(5
)
   
(4
)
   
(27
)
 Net loss
   
(12,142
)
   
(9,391
)
   
(4,199
)
   
(3,345
)
   
(13,551
)
                                         
Other comprehensive income:
                                       
Foreign currency translation adjustments
   
34
     
15
     
12
     
7
     
21
 
                                         
Total comprehensive loss
   
(12,108
)
   
(9,376
)
   
(4,187
)
   
(3,338
)
   
(13,530
)
                                         
Loss per share data:
                                       
Basic and diluted net loss per share - USD
   
(0.38
)
   
(0.34
)
   
(0.13
)
   
(0.12
)
   
(0.50
)
Number of shares used in calculating basic and diluted net loss per share
   
31,818
     
27,243
     
33,482
     
27,245
     
27,244
 

The accompanying notes are an integral part of the interim consolidated financial statements.

F - 3

MEDIWOUND LTD. AND ITS SUBSIDIARIES

Unaudited Condensed Interim Consolidated Statements of Changes in Shareholders’ Equity (Deficit)
U.S. dollars in thousands

   
Share capital
   
Share premium
   
Foreign currency translation reserve
   
Accumulated
deficit
   
Total
equity )deficit)
 
                               
Balance as of July 1, 2022
   
93
     
154,119
     
3
     
(156,450
)
   
(2,235
)
                                         
Loss for the period
   
-
     
-
     
-
     
(4,199
)
   
(4,199
)
Other comprehensive income
   
-
     
-
     
12
     
-
     
12
 
Total comprehensive income (loss)
   
-
     
-
     
12
     
(4,199
)
   
(4,187
)
Issuance of ordinary shares and warrants, net of issuance expenses (see note 3)
   
22
     
7,349
     
-
             
7,371
 
Exercise of options
   
(*
)
   
-
     
-
     
-
     
(*
)
                                         
Share-based compensation
   
-
     
707
     
-
     
-
     
707
 
                                         
Balance as of September 30, 2022
   
115
     
162,175
     
15
     
(160,649
)
   
1,656
 

Balance as of July 1, 2021
   
75
     
143,077
     
(32
)
   
(141,002
)
   
2,118
 
                                         
Loss for the period
   
-
     
-
     
-
     
(3,345
)
   
(3,345
)
Other comprehensive income
   
-
     
-
     
7
     
-
     
7
 
Total comprehensive Income (loss)
   
-
     
-
     
7
     
(3,345
)
   
(3,338
)
Exercise of options
   
(*
)
   
-
     
-
     
-
     
(*
)
                                         
Share-based compensation
   
-
     
399
     
-
     
-
     
399
 
                                         
Balance as of September 30, 2021
   
75
     
143,476
     
(25
)
   
(144,347
)
   
(821
)

(*)          Represents less than $ 1.

The accompanying notes are an integral part of the interim consolidated financial statements.

F - 4

MEDIWOUND LTD. AND ITS SUBSIDIARIES

Unaudited Condensed Interim Consolidated Statements of Changes in Shareholders’ Equity (Deficit)
U.S. dollars in thousands

   
Share capital
   
Share premium
   
Foreign currency translation reserve
   
Accumulated
deficit
   
Total
equity (deficit)
 
Balance as of December 31, 2021 (audited)
   
75
     
143,869
     
(19
)
   
(148,507
)
   
(4,582
)
Loss for the period
   
-
     
-
     
-
     
(12,142
)
   
(12,142
)
Other comprehensive income
   
-
     
-
     
34
     
-
     
34
 
Total comprehensive income (loss)
   
-
     
-
     
34
     
(12,142
)
   
(12,108
)
Issuance of ordinary shares and warrants, net of issuance expenses (see note 3)
   
40
     
17,002
     
-
     
-
     
17,042
 
Exercise of options
   
(*
)
   
-
     
-
     
-
     
(*
)
Share-based compensation
   
-
     
1,304
     
-
     
-
     
1,304
 
                                         
Balance as of September 30, 2022
   
115
     
162,175
     
15
     
(160,649
)
   
1,656
 
                                         
Balance as of December 31, 2020 (audited)
   
75
     
142,193
     
(40
)
   
(134,956
)
   
7,272
 
                                         
Loss for the period
   
-
     
-
     
-
     
(9,391
)
   
(9,391
)
Other comprehensive income
   
-
     
-
     
15
     
-
     
15
 
Total comprehensive income (loss)
   
-
     
-
     
15
     
(9,391
)
   
(9,376
)
Exercise of options
   
(*
)
   
-
     
-
     
-
     
(*
)
                                         
Share-based compensation
   
-
     
1,283
     
-
     
-
     
1,283
 
                                         
Balance as of  September 30, 2021
   
75
     
143,476
     
(25
)
   
(144,347
)
   
(821
)
                                         
Balance as of December 31, 2020 (audited)
   
75
     
142,193
     
(40
)
   
(134,956
)
   
7,272
 
Loss for the period
   
-
     
-
     
-
     
(13,551
)
   
(13,551
)
Other comprehensive income
   
-
     
-
     
21
     
-
     
21
 
Total comprehensive income (loss)
   
-
     
-
     
21
     
(13,551
)
   
(13,530
)
Exercise of options
   
(*
)
   
3
     
-
     
-
     
3
 
Share-based compensation
   
-
     
1,673
     
-
     
-
     
1,673
 
                                         
Balance as of December 31, 2021 (audited)
   
75
     
143,869
     
(19
)
   
(148,507
)
   
(4,582
)

(*)          Represents less than $ 1.

The accompanying notes are an integral part of the interim consolidated financial statements.

F - 5

MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
Unaudited Condensed Interim Consolidated Statements of Cash Flows
U.S. dollars in thousands

   
Nine months ended
September 30,
   
Three months ended
September 30,
   
Year ended
December 31,
 
   
2022
   
2021
   
2022
   
2021
   
2021
 
Cash flows from operating activities:
                             
Net loss
   
(12,142
)
   
(9,391
)
   
(4,199
)
   
(3,345
)
   
(13,551
)
                                         
Adjustments to reconcile net loss to net cash used in continuing operating activities:
                                       
                                         
Adjustments to profit and loss items:
                                       
Depreciation and amortization
   
988
     
962
     
338
     
335
     
1,238
 
Share-based compensation
   
1,304
     
1,283
     
707
     
399
     
1,673
 
Revaluation of liabilities in respect of IIA grants
   
812
     
808
     
330
     
311
     
919
 
Revaluation of liabilities in respect of the purchase of shares
   
404
     
446
     
132
     
147
     
590
 
Revaluation of lease liabilities
   
(146
)
   
84
     
6
     
49
     
188
 
Increase in severance pay liability, net
   
64
     
3
     
9
     
8
     
13
 
Net financing expenses (income)
   
334
     
(11
)
   
345
     
-
     
(11
)
Un-realized foreign currency (gain) loss
   
465
     
(238
)
   
(63
)
   
(12
)
   
(137
)
     
4,225
     
3,337
     
1,804
     
1,237
     
4,473
 
Changes in asset and liability items:
                                       
   Decrease (increase) in trade receivables
   
(2,445
)
   
697
     
(421
)
   
17
     
929
 
Decrease (increase) in inventories
   
(608
)
   
188
     
139
     
171
     
257
 
Decrease (increase) in other receivables
   
143
     
(1,078
)
   
(187
)
   
(646
)
   
(763
)
Increase (decrease) in trade payables and accrued expenses
   
(1,232
)
   
733
     
(1,243
)
   
(342
)
   
1,723
 
Increase (decrease) in other payables and deferred revenues
   
(1,826
)
   
(1,167
)
   
(459
)
   
90
     
(1,984
)
     
(5,968
)
   
(627
)
   
(2,171
)
   
(710
)
   
162
 
                                         
Net cash used in operating activities
   
(13,885
)
   
(6,681
)
   
(4,566
)
   
(2,818
)
   
(8,916
)

The accompanying notes are an integral part of the interim consolidated financial statements.

F - 6

MEDIWOUND LTD. AND ITS SUBSIDIARIES

Unaudited Condensed Interim Consolidated Statements of Cash Flows
U.S. dollars in thousands

   
Nine months ended
September 30,
   
Three months ended
September 30,
   
Year ended
December 31,
 
   
2022
   
2021
   
2022
   
2021
   
2021
 
                               
Cash Flows from Investing Activities:
                             
                               
Purchase of property and equipment
   
(381
)
   
(373
)
   
(83
)
   
(129
)
   
(489
)
Interest received
   
3
     
35
     
3
     
-
     
35
 
Decrease (Increase) in short term bank deposits, net
   
(2,499
)
   
4,002
     
-
     
-
     
4,002
 
                                         
Net cash (used in) provided by investing activities
   
(2,877
)
   
3,664
     
(80
)
   
(129
)
   
3,548
 
                                         
Cash Flows from Financing Activities:
                                       
                                         
Repayment of leases liabilities
   
(531
)
   
(513
)
   
(181
)
   
(176
)
   
(693
)
Proceeds from issuance of shares and warrants, net
   
21,915
     
-
     
12,054
     
-
     
3
 
Repayment of IIA grant
   
(258
)
   
(360
)
   
(96
)
   
(180
)
   
(360
)
                                         
Net cash provided by (used in) financing activities
   
21,126
     
(873
)
   
11,777
     
(356
)
   
(1,050
)
                                         
Exchange rate differences on cash and cash equivalent balances
   
(505
)
   
197
     
45
     
(7
)
   
88
 
                                         
Increase (decrease) in cash and cash equivalents
   
3,859
     
(3,693
)
   
7,176
     
(3,310
)
   
(6,330
)
                                         
Balance of cash and cash equivalents at the beginning of the period
   
11,046
     
17,376
     
7,729
     
16,993
     
17,376
 
                                         
Balance of cash and cash equivalents at the end of the period
   
14,905
     
13,683
     
14,905
     
13,683
     
11,046