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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 March 2024
 
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 March 21, 2024, MediWound Ltd. (the “Company”) issued a press release entitled “MediWound Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Company Update”. A copy of this press release is attached to this Form 6-K as Exhibit 99.1.

The content of this report on Form 6-K (including the information contained in Exhibit 99.1, but excluding quotes of senior management of the Company and Exhibit 99.2), is hereby incorporated by reference into the Company’s Registration Statements on Form S-8 filed with the SEC on April 28, 2014, March 24, 2016, March 19, 2018, March 25, 2019, February 25, 2020, May 15, 2021 August 9, 2022 and August 15, 2023 (Registration Nos. No. 333-195517, 333-210375, 333-223767, 333-230487, 333-236635, 333-255784, 333-266697 and 333-273997, respectively) and on Form F-3 filed with the SEC on May 25, 2022 and March 31, 2023 (Registration Nos. 333-265203 and 333-268297, respectively).

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: March 21, 2024
By:  
Name: 
Title:  
/s/ Hani Luxenburg
Hani Luxenburg
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 Fourth Quarter and Full Year 2023 Financial Results and Provides Company
Update

$19 million revenue in 2023; $24 million projected revenue in 2024
NexoBrid® commercially launched in U.S., Japan, India
Potential blockbuster EscharEx® to begin Phase III in the second half of 2024
$42 million cash runway through profitability

Conference call today, March 21 at 8:30am Eastern Time

YAVNE, Israel, March 21, 2024 -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate update.

“2023 was an exceptional year for NexoBrid driven by new market launches, expanded indications, substantial new governmental grants, and increased global demand. Additionally, this lifesaving treatment was successfully battle-tested in real-life burn mass casualty incidents (BMCI) during the war in Israel. Furthermore, the full capacity of our new manufacturing facility in 2025 will enable us to meet the soaring demand of NexoBrid,” said Ofer Gonen, CEO of MediWound. “Recent clinical data further validates our pipeline product, EscharEx, demonstrating that it significantly outperformed SANTYL® in a head-to-head comparative analysis.  The product has attracted research collaborations with industry leaders 3M, Mölnlycke and MIMEDX and the Phase III study is set to begin in the second half of 2024. We strongly believe in the exciting future ahead for MediWound.”

2023 Highlights and Recent Developments:
 
NexoBrid®
 

Expanded commercial availability to U.S., Japan, and India, leading to $19 million revenue in 2023, and a surge of orders for 2024, with $24 million projected revenue.
 

Construction of a new GMP-compliant state-of-the-art manufacturing facility is on track for mid-2024 completion. It is projected to achieve a 6-fold manufacturing capacity increase in 2025.
 

Commercial Activities:
 

o
Launched in the U.S. by Vericel Corp, with more than 50 burn centers submitting packages to Pharmacy and Therapeutics (P&T) committees and more than 25 already approved. Furthermore, the Centers for Medicare & Medicaid Services (CMS) awarded NexoBrid a permanent J code and granted it transitional pass-through payment status, enhancing its accessibility and reimbursement potential.
 

o
Launched in Japan through Kaken Pharmaceuticals, and in India through Bharat Serums and Vaccines (BSV).
 

o
Expanded European market presence by establishing a collaboration with PolyMedics Innovations (PMI) for the promotion of NexoBrid in Germany, Austria, Belgium, the Netherlands, and Luxembourg.
 

o
Successfully fulfilled emergency demand in Israel to treat mass burn casualties resulting from the war, consuming all available non-U.S. inventory.
 



Government Funding:
 

o
Awarded $13.0 million R&D funding by U.S. Department of Defense (DoD) to develop and produce a new NexoBrid temperature stable formulation for use as a non-surgical solution for field-care burn treatment for the U.S. Army.
 

o
Awarded $10.1 million in additional funding from the Biomedical Advanced Research and Development Authority (BARDA) for emergency preparedness product replenishment and R&D activities.
 

Pediatric label expansion:
 

o
Gained European Commission approval for the removal of eschar in deep partial- and full-thickness thermal burns for all ages.
 

o
Supplemental BLA for pediatric indication accepted for review by the U.S. Food and Drug Administration (FDA). Decision expected in the second half of 2024.
 
EscharEx®
 

Aligned the Phase III study protocol with the European Medicine Agency (EMA) and the FDA, and expected to submit a final protocol in the first half of 2024. 216 patients will be treated globally across 40 sites with either EscharEx or a gel vehicle placebo, with an interim assessment to be performed once 67% of participants complete the study. Study initiation is expected in the second half of 2024.
 

Established research collaborations with 3M, Mölnlycke and MIMEDX to support the EscharEx Phase III clinical study.
 

Conducted head-to-head comparative analysis of EscharEx vs SANTYL®.  Data from a Phase II randomized controlled study demonstrated significant superiority of EscharEx over SANTYL in multiple clinical outcome measures:  incidence of complete debridement; median time to achieve complete debridement; incidence of achieving wound bed preparation (WBP); median time to achieve WBP; and time to wound closure. The data is scheduled for oral presentation in May 2024 at three leading annual congresses dedicated to advanced wound care: The Wound Healing Society (WHS), the Symposium on Advanced Wound Care (SAWC), and the European Wound Management Association (EWMA).
 
MW005
 

Reported positive results of the Phase I/II study to evaluate the safety and efficacy of MW005 in the treatment of low-risk Basal Cell Carcinoma (BCC). The data showed MW005 to be safe and well-tolerated, with patients achieving complete clinical and histological clearance of their target lesions.
 

 
Fourth Quarter 2023 Financial Highlights
 

Revenue: Revenue for the fourth quarter 2023 was $5.3 million, compared to $11.6 million in the fourth quarter of 2022. The decrease is primarily attributed to the BLA approval milestone payment from Vericel.
 

Gross Profit: Gross profit in the fourth quarter 2023 was $0.7 million, representing 13.5% of the total revenue in the fourth quarter of 2023, compared to $8.2 million, representing 70.2% of total revenue in the fourth quarter of 2022. The decrease is primarily attributed to the BLA approval milestone payment from Vericel in the fourth quarter of 2022.
 

Expenditures:
 

o
Research and development expenses in the fourth quarter 2023 were $1.8 million compared to $2.7 million in the fourth quarter of 2022. This change is primarily attributed to the completion of EscharEx phase II study in 2022.

o
Selling, general, and administrative expenses in the fourth quarter 2023 were $2.8 million, compared to $3.0 million in the fourth quarter of 2022.
 

Operating Results: Operating loss in the fourth quarter of 2023 was $3.9 million, compared to an operating profit of $2.1 million in the fourth quarter of 2022.
 

Net Loss: Net loss in the fourth quarter of 2023 was $1.7 million or $0.19 per share, compared to the net loss of $7.5 million, or $1.18 per share in the fourth quarter of 2022. The decrease is primarily attributed to a favorable adjustment from the revaluation of warrants.

Non-GAAP Adjusted EBITDA: Adjusted EBITDA in the fourth quarter of 2023 was a loss of $3.2 million, compared to a profit of $3.4 million in the fourth quarter of 2022.
 
Full Year 2023 Financial Highlights
 

Revenue: Revenue for the year ended December 31, 2023, was $18.7 million, compared to $26.5 million for the year ended December 31, 2022. The decrease is primarily attributed to the BLA approval milestone payment from Vericel.
 

Gross Profit: Gross profit for the year ended December 31, 2023, was $3.6 million with a gross margin of 19.1%, compared to $13.2 million with a gross margin of 49.7% in the prior year period. The decrease is primarily attributed to the BLA approval milestone payment from Vericel.
 

Expenditures:
 

o
Research and development expenses for the year ended December 31, 2023, were $7.5 million compared to $10.2 million in the prior year.
 

o
Selling, general, and administrative expenses for the year ended December 31, 2023, were $11.6 million, compared to $10.6 million in the prior year.
 

Operating Results: Operating loss for the year ended December 31, 2023, was $15.3 million, compared to an $8.3 million loss in the year ended December 31, 2022.
 

Net Loss: Net loss in the year ended December 31, 2023 was $6.7 million or $0.75 per share, compared to the net loss of $19.6 million, or $3.93 per share for the year ended December 31, 2022.
 

Non-GAAP Adjusted EBITDA: Adjusted EBITDA for the year ended December 31, 2023 was a loss of $12.3 million, compared to a loss of $4.4 million for the year ended December 31, 2022.
 


Balance Sheet Highlights
 
As of December 31, 2023, the Company’s cash, restricted cash, and investments were $42.1 million, compared to $34.1 million reported on December 31, 2022. In the first quarter of 2023, the Company raised a gross amount of $27.5 million through a registered direct offering. The company used $17.1 million to fund its activities. The existing cash and restricted cash, and investments will provide sufficient funds through profitability.

Conference Call
 
MediWound management will host a conference call for investors on Thursday, March 21, 2024, 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 1-833-630-1956 (in the U.S.), 1-80-921-2373 (Israel), or 1-412-317-1837 (outside the U.S. & Israel). The call will be available via webcast by clicking HERE or on the Events & Presentations page of Company’s website.

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 Ltd. (Nasdaq: MDWD) is the global leader in next-generation enzymatic therapeutics focused on non-surgical tissue repair. The Company specializes in the development, production and commercialization of solutions that seek to improve existing standards of care. MediWound is committed to providing rapid and effective biologics that improve patient experiences and outcomes, while reducing costs and unnecessary surgeries.

MediWound’s first drug, NexoBrid®, is an FDA-approved orphan biologic for eschar removal in severe burns that can replace surgical interventions and minimize associated costs and complications. Utilizing the same core biotherapeutic enzymatic platform technology, MediWound has developed a strong R&D pipeline including the Company’s lead drug under development, EscharEx®. EscharEx is a Phase III-ready biologic for debridement of chronic wounds with significant potential advantages over the $360 million dominant product and an opportunity to expand the market. MediWound’s pipeline also includes MW005, a topical therapeutic for the treatment of basal cell carcinoma that has demonstrated positive results in a Phase I/II study.

For more information visit www.mediwound.com and follow the Company on LinkedIn and X.



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, including EscharEx® and NexoBrid®. 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; the approval of regulatory submission by the FDA, the European Medicines Agency 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; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the current global macroeconomic climate on 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, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 21, 2024 and 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:
       
Hani Luxenburg
Chief Financial Officer
MediWound Ltd.
ir@mediwound.com
     
Daniel Ferry
Managing Director, LifeSci Advisors
617-430-7576
daniel@lifesciadvisors.com

Media Contact: 
Ellie Hanson
FINN Partners for MediWound
ellie.hanson@finnpartners.com
929-588-2008



MediWound, Ltd.

Audited Condensed Consolidated Statements of Financial Position
U.S. dollars in thousands

 
 
Dec 31,
 
 
 
2023
   
2022
 
CURRENT ASSTS:
           
Cash and cash equivalents and short-term deposits
   
41,708
     
33,895
 
Trade and other receivable
   
5,141
     
9,982
 
Inventories
   
2,846
     
1,963
 
Total current assets
   
49,695
     
45,840
 
                 
Non-current assets
               
Other receivables
   
673
     
364
 
Property, plant and equipment, net
   
9,228
     
2,366
 
Right of use assets, net
   
6,698
     
1,215
 
Intangible assets, net
   
165
     
231
 
Total non-current assets
   
16,764
     
4,176
 
 
               
Total assets
   
66,459
     
50,016
 
 
               
CURRENT LIABILITIES:
               
Current maturities of long-term liabilities
   
1,410
     
2,242
 
Trade payables and accrued expenses
   
5,528
     
5,656
 
Other payables
   
3,891
     
4,159
 
Total current liabilities
   
10,829
     
12,057
 
Warrants, net
   
7,296
     
15,606
 
Liabilities in respect of IIA grants
   
7,677
     
7,445
 
Liability in respect of TEVA
   
2,256
     
2,788
 
Lease liabilities
   
6,350
     
846
 
Severance pay liability, net
   
456
     
360
 
Total non-current liabilities
   
24,035
     
27,045
 
 
               
Shareholders' equity
   
31,595
     
10,914
 
Total liabilities & equity
   
66,459
     
50,016
 



MediWound, Ltd.

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

 
 
Twelve months ended
   
Three months ended
 
 
 
Dec 31,
   
Dec 31,
 
 
 
2023
   
2022
   
2023
   
2022
 
Total Revenues
   
18,686
     
26,496
     
5,338
     
11,618
 
Cost of revenues
   
15,108
     
13,331
     
4,619
     
3,460
 
Gross profit
   
3,578
     
13,165
     
719
     
8,158
 
                                 
Research and development
   
7,467
     
10,181
     
1,808
     
2,699
 
Selling and Marketing
   
4,844
     
3,725
     
1,209
     
692
 
General and administrative
   
6,768
     
6,920
     
1,583
     
2,269
 
Other (Income) expenses
   
(211
)
   
684
     
13
     
375
 
Operating loss
   
(15,290
)
   
(8,345
)
   
(3,894
)
   
2,123
 
 
                               
Financial income (expenses), net
   
8,759
     
(11,176
)
   
2,271
     
(9,515
)
Taxes on income
   
(185
)
   
(78
)
   
(120
)
   
(65
)
Net loss
   
(6,716
)
   
(19,599
)
   
(1,743
)
   
(7,457
)
Foreign currency translation adjustments
   
(13
)
   
14
     
(11
)
   
(20
)
Total comprehensive loss
   
(6,729
)
   
(19,585
)
   
(1,754
)
   
(7,477
)
 
                               
Basic and diluted loss per share:
                               
Net loss per share
   
(0.75
)
   
(3.93
)
   
(0.19
)
   
(1.18
)
 
                               
Weighted average number of ordinary shares
   
9,013,144
     
4,987,069
     
9,219,923
     
6,332,981
 



MediWound, Ltd.

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

   
Twelve months ended
   
Three months ended
 
   
Dec 31,
   
Dec 31,
 
   
2023
   
2022
   
2023
   
2022
 
   
Audited
   
Unaudited
 
Cash Flows from Operating Activities:
                       
Net Loss
   
(6,716
)
   
(19,599
)
   
(1,743
)
   
(7,457
)
Adjustments to reconcile net loss to net cash used in operating activities:
                               
                                 
Adjustments to profit and loss items:
                               
Depreciation and amortization
   
1,303
     
1,272
     
346
     
284
 
Share-based compensation
   
1,940
     
1,946
     
298
     
642
 
Revaluation of warrants accounted at fair value
   
(8,310
)
   
8,977
     
(1,603
)
   
8,977
 
Issuance expenses of warrants through profit and loss
   
-
     
1,911
     
-
     
1,523
 
Revaluation of liabilities in respect of IIA grants
   
427
     
(132
)
   
(282
)
   
(944
)
Revaluation of liabilities in respect of TEVA
   
468
     
533
     
111
     
129
 
Financing income and exchange differences of lease liability
   
257
     
(109
)
   
463
     
37
 
Increase in severance liability, net
   
83
     
109
     
3
     
45
 
Other income
   
(211
)
   
-
     
13
     
-
 
Financial income, net
   
(2,231
)
   
(74
)
   
(836
)
   
(408
)
Un-realized foreign currency loss (gain)
   
189
     
525
     
(347
)
   
60
 
     
(6,085
)
   
14,958
     
(1,834
)
   
10,345
 
Changes in asset and liability items:
                               
Decrease (increase) in trade receivables
   
5,658
     
(7,582
)
   
(528
)
   
(5,137
)
Decrease (increase) in inventories
   
(906
)
   
(721
)
   
782
     
(113
)
Decrease (increase) in other receivables
   
(894
)
   
364
     
(696
)
   
221
 
Increase (decrease) in trade payables and accrued expenses
   
(594
)
   
414
     
1,093
     
784
 
Increase (decrease) in other payables
   
(928
)
   
281
     
311
     
2,107
 
     
2,336
     
(7,244
)
   
962
     
(2,138
)
Net cash used in operating activities
   
(10,465
)
   
(11,885
)
   
(2,615
)
   
750
 



MediWound, Ltd.

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

Cash Flows from Investing Activities:
                       
Purchase of property and equipment
   
(6,464
)
   
(555
)
   
(2,209
)
   
(174
)
Interest received
   
1,947
     
74
     
722
     
71
 
Proceeds from (Investment in) short term bank deposits, net
   
(29,804
)
   
-
     
6,515
     
2,499
 
Net cash used in investing activities
   
(34,321
)
   
(481
)
   
5,028
     
2,396
 
                                 
Cash Flows from Financing Activities:
                               
Repayment of lease liabilities
   
(778
)
   
(701
)
   
(204
)
   
(170
)
Proceeds from issuance of shares and warrants, net
   
24,909
     
38,390
     
-
     
16,475
 
Repayments of IIA grants, net
   
(380
)
   
(258
)
   
-
     
-
 
Repayment of liabilities in respect of TEVA
   
(834
)
   
(1,667
)
   
-
     
(417
)
Net cash provided by (used in) financing activities
   
22,917
     
35,764
     
(204
)
   
15,588
 
                                 
Exchange rate differences on cash and cash equivalent balances
   
(160
)
   
(549
)
   
378
     
(44
)
Increase (decrease) in cash and cash equivalents
   
(22,029
)
   
22,849
     
2,587
     
18,990
 
Balance of cash and cash equivalents at the beginning of the period
   
33,895
     
11,046
     
9,279
     
14,905
 
Balance of cash and cash equivalents at the end of the period
   
11,866
     
33,895
     
11,866
     
33,895
 



MediWound, Ltd.

Adjusted EBITDA
U.S. dollars in thousands

 
Twelve months ended
   
Three months ended
 
 
 
Dec 31,
   
Dec 31,
 
 
 
2023
   
2022
   
2023
   
2022
 
Net loss
   
(6,716
)
   
(19,599
)
   
(1,743
)
   
(7,457
)
Adjustments:
                               
Financial income (expenses), net
   
8,759
     
(11,176
)
   
2,271
     
(9,515
)
Other (Income) expenses, net
   
211
     
(684
)
   
(13
)
   
(375
)
Taxes on income
   
(185
)
   
(78
)
   
(120
)
   
(65
)
Depreciation and amortization
   
(1,303
)
   
(1,272
)
   
(346
)
   
(284
)
Share-based compensation expenses
   
(1,940
)
   
(1,946
)
   
(298
)
   
(642
)
Total adjustments
   
5,542
     
(15,156
)
   
1,494
     
(10,881
)
Adjusted EBITDA
   
(12,258
)
   
(4,443
)
   
(3,237
)
   
3,424