Website Notice Block


 
SECURITIES AND EXCHANGE COMMISSION
 
Washington, D.C.  20549
______________________
 
FORM 6-K
 
REPORT OF FOREIGN PRIVATE ISSUER
 
Pursuant to Rule 13a-16 or 15d-16 of the
Securities Exchange Act of 1934
 
For the month of August 2018
 
Commission File Number: 001-36349
 
                  MediWound Ltd.                   
(Translation of registrant’s name into English)
 
42 Hayarkon Street
Yavne, 8122745 Israel
(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
 
Form 20-F ☒          Form 40-F ☐
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):   __
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):   __
 

 
EXPLANATORY NOTE
 
On August 7, 2018, MediWound Ltd. (the “Company”) issued a press release entitled “MediWound Reports Second Quarter 2018 Financial Results”. A copy of this press release is attached to this Form 6-K as Exhibit 99.1.
 
In addition, pursuant to the Information Rights Agreement between the Company and Clal Biotechnology Industries Ltd. ("CBI"), dated March 3, 2014 (which was attached to the Company's registration statement as exhibit 4.3), the Company is required to provide CBI with certain information necessary for CBI to meet its obligations  under Israeli Securities Law. This Form 6-K includes an Un-Audited Condensed Consolidated Interim Financial Statements as of June 30, 2018, attached as Exhibit 99.2, which was provided by the Company to CBI on August 6, 2018 pursuant to such contractual obligation.

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: August 7, 2018
By:
/s/ Sharon Malka  
    Name: Sharon Malka  
    Title: Chief Financial Officer  
       

3


EXHIBIT INDEX

The following exhibit is filed as part of this Form 6-K:
 
Exhibit
Description
 
99.1

99.2

4

 

 
Exhibit 99.1


 
News Release

 
MediWound Reports Second Quarter 2018 Financial Results

Completion of enrollment of Phase 3 DETECT Study of NexoBrid®
Strategic discussions advancing with multiple parties

Conference call begins today at 8:30 a.m. Eastern Time

YAVNE, Israel (August 07, 2018) – MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced financial results for the three and six months ended June 30, 2018.
 
Second Quarter Highlights
·
Revenues for the second quarter of 2018 were $1.0 million, a 50% increase from $0.7 million in the second quarter of 2017, underscoring the continued growth of NexoBrid® sales
·
Completed enrollment of Phase 3 DETECT Study of NexoBrid®Top-line data anticipated around year-end 2018
·
Expanded NexoBrid Phase 3 Children Innovation Debridement Study (CIDS) to the United States following approval of the study protocol by the U.S. Food and Drug Administration (FDA) and BARDA funding of the study
·
NexoBrid® received marketing authorization from South Korea’s Ministry of Health.  BL&H Co., Ltd., the Company’s exclusive distribution partner in South Korea, intends to launch NexoBrid in the second half of 2018
·
FDA cleared the development pathway for NexoBrid® in Sulfur Mustard injuries in accordance with FDA Animal Efficacy Rule (also known as the Animal Rule).
 
“We are pleased with the progress we have made this quarter in our development programs.  Importantly, we have completed enrollment in our Phase 3 DETECT study of NexoBrid and now look forward to sharing the top line results around year-end 2018,” said Gal Cohen, MediWound’s President and Chief Executive Officer. “Additionally, we expanded our NexoBrid Phase 3 CIDS study in children to the U.S. after obtaining both FDA concurrence on the protocol and BARDA funding for the study. We continue to be committed and enthusiastic about the significant medical need and commercial opportunity for EscharEx and are on track to submit the protocol to the FDA in the second half of 2018 for the EscharEx clinical development program. Furthermore, we agreed with FDA on the development pathway of NexoBrid in Sulfur Mustard injuries in accordance with FDA Animal Rule as it is neither ethical nor feasible to conduct human trials with chemical warfare agents."

"The marketing authorization in South Korea is built upon NexoBrid’s marketing authorization from the European Medicines Agency (EMA) for the same indication and validates MediWound’s strategy of using the EMA approved registration file for seeking approval in international markets through collaboration with local companies that possess the expertise in the local regulatory, market access and marketing efforts, and assume the financial commitment and diligence.


Last but not least, we were pleased to be able to assist the medical delegation that treated victims suffering burns in the massive volcano eruption in Guatemala. We have seen again that NexoBrid has a key role in the routine treatment of burn victims, and even more so in mass casualty events, where surgical capacity is limited and the need for injury diagnosis and rapid medical intervention are critical. We will continue to seek cooperation with other countries and international agencies as part of their preparations for future mass casualty events" added Mr. Cohen.”

Stephen T. Wills, MediWound's Chairman, said, "As a reminder, MediWound was approached earlier this year by a third-party to consider a potential strategic transaction. At this point, we are engaged in advancing discussions and diligence with several parties. We are in the process of analyzing specific business transaction scenarios and proposals related to these parties. The Board continues to be advised by Moelis & Company regarding evaluation and assessment of these potential strategic transactions. Importantly, there can be no assurances that a definitive agreement between the parties or any other agreement will be reached.
 
Second Quarter Financial Results
Revenues for the second quarter of 2018 were $1.0 million, an increase of 50% compared to $0.7 million of revenues for the second quarter of 2017.

Gross profit for the second quarter of 2018 was $0.4 million, compared to a gross profit of $0.2 million for the second quarter of 2017.

Research and development expenses for the second quarter of 2018, net of participations, were $1.5 million, down 8% compared with $1.7 million for the second quarter of 2017. The decrease was as a result of an increase of $1.9 million in BARDA's participation and an increase of $1.7 million in the gross research and development expenses.

Selling, general and administrative expenses for the second quarter of 2018 were $2.1 million, compared with $2.2 million for the second quarter of 2017.

Operating loss for the second quarter of 2018 was $3.3 million, an improvement of 11% from $3.7 million in the second quarter of 2017, as a result of the improvement in gross profit and the decrease in operating expenses.

The Company posted a net loss of $4.2 million, or ($0.15) per share, for the second quarter of 2018 compared with a net loss of $4.5 million, or ($0.20) per share, for the second quarter of 2017.
Adjusted EBITDA, as defined below, for the second quarter of 2018 was a loss of $2.9 million, compared with a loss of $3.2 million for the second quarter of 2017.

First Half 2018 Financial Results
Revenues for the first half of 2018 were $1.6 million compared with $1.2 million for the first half of 2017, an increase of 26%.

Gross profit for the first half of 2018 was $0.5 million, compared with a gross profit of $0.4 million in the prior year period, reflecting a gross margin of 35%.


Research and development expenses, net of participations, were $2.7 million for the first half of 2018, compared with $3.4 million for the first half of 2017. The decrease in research and development, net, was as a result of an increase of $2.4 million primarily in NexoBrid clinical trials expenses which was offset by an increase of $3.1 million in participation by BARDA in the Company’s R&D expenses.

Selling, general and administrative expenses in the first half of 2018 were $4.2 million compared with $4.3 million in the prior year period.

Operating loss for the first half of 2018 was $7.0 million, down 5% from $7.4 in the first half of 2017. Operating expenses in the first half of 2018 included other one-time expenses of $0.7 million associated with review and analysis of potential strategic transactions. The decrease in operating loss was primarily due to the improvement in gross profits and the decrease in operating expenses in the first half of 2018 compared to the prior year period, which was offset by one-time other expenses as mentioned above.

For the six months ended June 30, 2018, the Company posted a net loss of $8.7 million, or ($0.32) per share, compared with a net loss of $8.8 million, or ($0.40) per share, for the same period in 2017.

Adjusted EBITDA, as defined below, for the first half of 2018 was a loss of $5.7 million, compared with a loss of $6.4 million for the first half of 2017.
 
Balance Sheet Highlights
As of June 30, 2018, the Company had cash, cash equivalents and short-term bank deposits of $27.0 million, compared with $36.1 million at December 31, 2017.

Throughout 2018, the Company will continue to invest primarily in research and development efforts for EscharEx®, while NexoBrid® research and development programs will be funded by BARDA. As a result, cash use for operating activities in 2018 is expected to be in the range of $14.0 million to $16.0 million.
 
Conference Call
MediWound management will host a conference call for investors today, Thursday, August 7, 2018 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 800-289-0438 (in the U.S.)  1809 212 883 (Israel), or 323-794-2423 (outside the U.S. & Israel) and entering passcode 370010. The call also will be broadcast live on the Internet on the Company’s website at http://ir.mediwound.com/events-and-presentations.

A replay of the call will be accessible two hours after its completion through August 24, 2018 by dialing 844-512-2921 (in the U.S.) or 412-317-6671 (outside the U.S.) and entering passcode 370010. The call will also be archived on the Company website for 90 days at www.mediwound.com.
 

Non-IFRS Financial Measures
To supplement consolidated financial statements prepared and presented in accordance with IFRS, the Company has provided a supplementary non-IFRS measure to consider in evaluating the Company's performance. Management uses Adjusted EBITDA, which it defines as earnings before interest, taxes, depreciation and amortization, impairment, one-time expenses, restructuring and share-based compensation expenses.

Although Adjusted EBITDA is not a measure of performance or liquidity calculated in accordance with IFRS, we believe the non-IFRS financial measures we present provide meaningful supplemental information regarding our operating results primarily because they exclude certain non-cash charges or items that we do not believe are reflective of our ongoing operating results when budgeting, planning and forecasting and determining compensation, and when assessing the performance of our business with our  senior management.

However, investors should not consider these measures in isolation or as substitutes for operating income, cash flows from operating activities or any other measure for determining the Company's operating performance or liquidity that is calculated in accordance with IFRS. In addition, because Adjusted EBITDA is not calculated in accordance with IFRS, it may not necessarily be comparable to similarly titled measures employed by other companies. The non-IFRS measures included in this press release have been reconciled to the IFRS results in the tables below.

About MediWound Ltd.
MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound’s first innovative biopharmaceutical product, NexoBrid®, received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian and South Korean Ministries of Health, for removal of dead or damaged tissue, known as eschar, in adults with deep partial and full-thickness thermal burns. NexoBrid® represents a new paradigm in burn care management, and clinical trials have demonstrated, with statistical significance, its ability to non-surgically and rapidly remove the eschar earlier and, without harming viable tissues.

MediWound's second innovative product, EscharEx® is a topical biological drug being developed for debridement of chronic and other hard-to-heal wounds and is complementary to the large number of existing wound healing products, which require a clean wound bed in order to heal the wound. EscharEx® contains the same proteolytic enzyme technology as NexoBrid®, and benefits from the wealth of existing development data on NexoBrid®.  In two Phase 2 studies, EscharEx® has demonstrated safety and efficacy in the debridement of chronic and other hard-to-heal wounds, within a few daily applications.

For more information, please visit www.mediwound.com.


Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the US Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions and results related to the regulatory authorizations and launch dates. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on MediWound’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors. In particular, you should consider the risks discussed under the heading “Risk Factors” in our annual report on Form 20-F for the year ended December 31, 2017 and information contained in other documents filed with or furnished to the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. The forward-looking statements made herein speak only as of the date of this announcement and MediWound undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.
 
Contacts:
Sharon Malka          
Chief Financial and Operations Officer          
MediWound Ltd.          
ir@mediwound.com      
 
Jeremy Feffer
Managing Director, LifeSci Advisors
212-915-2568
jeremy@lifesciadvisors.com
 

MediWound, Ltd.
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
 
   
June 30,
   
December 31,
 
   
2018
   
2017
   
2017
 
   
Unaudited
   
Audited
 
Cash, cash equivalents and short term deposits
   
27,004
     
20,922
     
36,069
 
Accounts and other receivable
   
5,224
     
3,089
     
3,565
 
Inventories
   
1,871
     
1,124
     
1,886
 
Total current assets
   
34,099
     
25,135
     
41,520
 
Long term deposits
   
65
     
75
     
56
 
Property, plant and equipment, net
   
2,051
     
1,425
     
1,924
 
Intangible assets, net
   
528
     
685
     
635
 
Total long term assets
   
2,644
     
2,185
     
2,615
 
Total assets
   
36,743
     
27,320
     
44,135
 
                         
Trade payables and accrued expenses
   
3,327
     
2,121
     
3,251
 
Other payables
   
2,339
     
2,115
     
2,182
 
Total current liabilities
   
5,666
     
4,236
     
5,433
 
Deferred revenues
   
1,178
     
966
     
988
 
Liabilities in respect of Israeli Innovation Authority grants net of current maturities
   
7,793
     
7,153
     
7,380
 
Contingent consideration for the purchase of shares net of current maturities
   
14,737
     
15,082
     
14,381
 
Liability in respect of discontinued operation
   
6,003
     
-
     
6,003
 
Severance pay liability, net
   
336
     
239
     
330
 
Total long term liabilities
   
30,047
     
23,440
     
29,082
 
                         
Shareholders' equity (deficiency)
   
1,030
     
(356
)
   
9,620
 
Total liabilities & shareholder equity
   
36,743
     
27,320
     
44,135
 
 



MediWound, Ltd.
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS (UNAUDITED)
U.S. dollars in thousands

 
Six months ended
   
Three months ended
 
   
June 30,
   
June 30,
 
   
2018
   
2017
   
2018
   
2017
 
                                 
Revenues
   
1,551
     
1,227
     
1,031
     
687
 
Cost of revenues
   
1,010
     
824
     
629
     
484
 
Gross profit
   
541
     
403
     
402
     
203
 
Operating expenses:
                               
Research and development, gross
   
9,027
     
6,622
     
4,987
     
3,181
 
Participation by BARDA & IIA
   
(6,298
)
   
(3,187
)
   
(3,451
)
   
(1,517
)
Research and development, net
   
2,729
     
3,435
     
1,536
     
1,664
 
Selling, general & administrative
   
4,150
     
4,334
     
2,090
     
2,242
 
Other expenses
   
662
     
-
     
62
     
-
 
Total operating expenses
   
7,541
     
7,769
     
3,688
     
3,906
 
Operating loss
   
(7,000
)
   
(7,366
)
   
(3,286
)
   
(3,703
)
Financial income (expenses), net
   
(1,716
)
   
(1,410
)
   
(879
)
   
(759
)
Loss for the period
   
(8,716
)
   
(8,776
)
   
(4,165
)
   
(4,462
)
                                 
Foreign currency translation adjustments
   
8
     
(17
)
   
18
     
(14
)
Total comprehensive loss
   
(8,708
)
   
(8,793
)
   
(4,147
)
   
(4,476
)
                                 
Net loss per share
   
(0.32
)
   
(0.40
)
   
(0.15
)
   
(0.20
)
                                 
Weighted average number of ordinary shares used in the computation of basic and diluted loss per share (in thousands):
   
27,050
     
21,938
     
27,052
     
21,946
 


ADJUSTED EBITDA
U.S. dollars in thousands

   
Six months ended
   
Three months ended
 
   
June 30,
   
June 30,
 
   
2018
   
2017
   
2018
   
2017
 
Loss for the period
   
(8,716
)
   
(8,776
)
   
(4,165
)
   
(4,462
)
Adjustments:
                               
Financial (expenses) income, net
   
(1,716
)
   
(1,410
)
   
(879
)
   
(759
)
Other expenses
   
(662
)
   
-
     
(62
)
   
-
 
Depreciation and amortization
   
(305
)
   
(302
)
   
(170
)
   
(146
)
Share-based compensation expenses
   
(367
)
   
(665
)
   
(149
)
   
(337
)
Total adjustments
   
(3,050
)
   
(2,377
)
   
(1,260
)
   
(1,242
)
Adjusted EBITDA
   
(5,666
)
   
(6,399
)
   
(2,905
)
   
(3,220
)


MediWound, Ltd.
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW (UNAUDITED)
U.S. dollars in thousands
 
 
Six months ended
   
Three months ended
 
   
June 30,
   
June 30,
 
   
2018
   
2017
   
2018
   
2017
 
Cash Flows from Operating Activities:
                       
Net loss
   
(8,716
)
   
(8,776
)
   
(4,165
)
   
(4,462
)
                                 
Adjustments to reconcile net loss to net cash used in continuing operating activities:
                               
Adjustments to profit and loss items:
                               
Depreciation and amortization
   
305
     
302
     
170
     
146
 
Share-based compensation
   
367
     
665
     
149
     
337
 
Revaluation of liabilities in respect of IIA grants
   
404
     
402
     
218
     
221
 
Revaluation of contingent consideration for the purchase of shares
   
1,112
     
1,120
     
569
     
570
 
Increase (decrease) in severance liability, net
   
6
     
20
     
(5
)
   
12
 
Financing income
   
(182
)
   
(174
)
   
(115
)
   
(88
)
Unrealized foreign currency (gain) loss
   
126
     
(91
)
   
85
     
(39
)
     
2,138
     
2,244
     
1,071
     
1,159
 
Changes in asset and liability items:
                               
Increase in trade receivables
   
(421
)
   
(241
)
   
(494
)
   
(201
)
Decrease (increase) in inventories
   
15
     
(279
)
   
149
     
(132
)
Decrease (increase) in other receivables
   
(1,572
)
   
(277
)
   
(1,690
)
   
278
 
Increase (decrease) in trade payables & accrued expenses
   
74
     
(1,210
)
   
(51
)
   
(2,487
)
Increase (decrease) in other payables & deferred revenues
   
(336
)
   
(459
)
   
(507
)
   
1,606
 
     
(2,240
)
   
(2,466
)
   
(2,593
)
   
(936
)
Net cash used in  operating activities
   
(8,818
)
   
(8,998
)
   
(5,687
)
   
(4,239
)
                                 
Cash Flows from Investment Activities:
                               
Purchase of property and equipment
   
(313
)
   
(365
)
   
(197
)
   
(169
)
Purchase of intangible assets
   
(13
)
   
0
     
(13
)
   
0
 
Interest received
   
2
     
27
     
2
     
12
 
Proceeds from (investment in) short term bank deposits, net of investments
   
(21,165
)
   
(16,837
)
   
1,680
     
3,007
 
Net cash provided by (used in)  investing activities
   
(21,489
)
   
(17,175
)
   
1,472
     
2,850
 
                                 
Cash Flows from Financing Activities:
                               
Proceeds from issuance of shares and warrants, net
   
-
     
2
     
-
     
2
 
Proceeds from IIA grants, net of repayments
   
30
     
(37
)
   
-
     
(65
)
Net cash provided by (used in)  financing activities
   
30
     
(35
)
   
0
     
(63
)
Exchange rate differences on cash and cash equivalent balances
   
(133
)
   
117
     
(117
)
   
76
 
Decrease in cash and cash equivalents from continuing activities
   
(30,410
)
   
(26,091
)
   
(4,332
)
   
(1,376
)
Balance of cash and cash equivalents at the beginning of the period
   
36,069
     
28,866
     
9,991
     
4,151
 
Balance of cash and cash equivalents at the end of the period
   
5,659
     
2,775
     
5,659
     
2,775
 


 

 
Exhibit 99.2
 
MEDIWOUND LTD. AND ITS SUBSIDIARIES

INTERIM CONDENSED FINANCIAL STATEMENTS

AS OF JUNE 30, 2018

IN U.S. DOLLARS IN THOUSANDS

UNAUDITED

INDEX

 
Page
   
2
   
3
   
4 - 6
   
7 - 8
   
9 - 12


MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
CONDENSED INTERIM CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
 
   
June 30,
   
December 31,
 
   
2018
   
2017
   
2017
 
   
Unaudited
   
Audited
 
CURRENT ASSETS:
                 
Cash and cash equivalents
   
5,659
     
2,775
     
36,069
 
Short‑term bank deposits
   
21,345
     
18,147
     
-
 
Trade receivables
   
779
     
612
     
369
 
Inventories
   
1,871
     
1,124
     
1,886
 
Other receivables
   
4,445
     
2,477
     
3,196
 
                         
     
34,099
     
25,135
     
41,520
 
LONG‑TERM ASSETS:
                       
Long term deposits
   
65
     
75
     
56
 
Property, plant and equipment, net
   
2,051
     
1,425
     
1,924
 
Intangible assets, net
   
528
     
685
     
635
 
                         
     
2,644
     
2,185
     
2,615
 
                         
     
36,743
     
27,320
     
44,135
 
CURRENT LIABILITIES:
                       
Trade payables and accrued expenses
   
3,327
     
2,121
     
3,251
 
Other payables
   
2,339
     
2,115
     
2,182
 
                         
     
5,666
     
4,236
     
5,433
 
LONG‑TERM LIABILITIES:
                       
Deferred  revenues
   
1,178
     
966
     
988
 
 Liabilities in respect of IIA grants
   
7,793
     
7,153
     
7,380
 
Contingent consideration for purchase of shares
   
14,737
     
15,082
     
14,381
 
Liability in respect of discontinued operation
   
6,003
     
-
     
6,003
 
Severance pay liability, net
   
336
     
239
     
330
 
                         
     
30,047
     
23,440
     
29,082
 
SHAREHOLDERS' EQUITY (DEFICIENCY):
                       
Ordinary shares of NIS 0.01 par value:
                       
Authorized: 37,244,508 shares as of June 30, 2018, and 32,244,508 shares as of December 31, 2017 and June 30, 2017; Issued and Outstanding: 27,178,839 as of June 30, 2018 and  27,047,737 as of December  31, 2017 and 21,954,078 as of June 30, 2017
   
75
     
60
     
75
 
Share premium
   
139,359
     
115,646
     
138,992
 
Foreign currency translation adjustments
   
(30
)
   
(26
)
   
(38
)
Accumulated deficit
   
(138,374
)
   
(116,036
)
   
(129,409
)
                         
     
1,030
     
(356
)
   
9,620
 
                         
     
36,743
     
27,320
     
44,135
 

The accompanying notes are an integral part of the interim consolidated financial statements.
 
2

MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
U.S. dollars in thousands (except share data and per share data)

   
Six months ended
June 30,
   
Three months ended
June 30,
   
Year ended
December 31,
 
   
2018
   
2017
   
2018
   
2017
   
2017
 
   
Unaudited
   
Audited
 
Revenues
   
1,551
     
1,227
     
1,031
     
687
     
2,496
 
Cost of revenues
   
1,010
     
824
     
629
     
484
     
1,578
 
                                         
Gross profit
   
541
     
403
     
402
     
203
     
918
 
                                         
Research and development, net of participations
   
2,729
     
3,435
     
1,536
     
1,664
     
5,462
 
Selling and marketing
   
2,319
     
2,693
     
1,248
     
1,306
     
5,362
 
General and administrative
   
1,831
     
1,641
     
842
     
936
     
3,781
 
Other expenses
   
662
     
-
     
62
     
-
     
-
 
Total operating expenses
   
7,541
     
7,769
     
3,688
     
3,906
     
14,605
 
                                         
Operating loss
   
(7,000
)
   
(7,366
)
   
(3,286
)
   
(3,703
)
   
(13,687
)
                                         
Financial income
   
182
     
174
     
115
     
87
     
406
 
Financial expense
   
(1,898
)
   
(1,584
)
   
(994
)
   
(846
)
   
(1,252
)
                                         
Loss from continuing operation
   
(8,716
)
   
(8,776
)
   
(4,165
)
   
(4,462
)
   
(14,533
)
Loss from discontinued operation
   
-
     
-
     
-
     
-
     
(7,616
)
Net loss
   
(8,716
)
   
(8,776
)
   
(4,165
)
   
(4,462
)
   
(22,149
)
Other comprehensive income (loss):
                                       
                                         
Foreign currency translation adjustments
   
8
     
(17
)
   
18
     
(14
)
   
(29
)
                                         
Total comprehensive loss
   
(8,708
)
   
(8,793
)
   
(4,147
)
   
(4,476
)
   
(22,178
)
                                         
Basic and diluted net loss per share from continuing operations
   
(0.32
)
   
(0.40
)
   
(0.15
)
   
(0.20
)
   
(0.62
)
Basic and diluted net loss per share from discontinued operations
   
-
     
-
     
-
     
-
     
(0.33
)
Total Basic and diluted net loss per share
   
(0.32
)
   
(0.40
)
   
(0.15
)
   
(0.20
)
   
(0.95
)
                                         
Weighted average number of ordinary shares used in the computation of basic and diluted loss per share (in thousands)
   
27,050
     
21,938
     
27,052
     
21,946
     
23,341
 
 
The accompanying notes are an integral part of the interim consolidated financial statements.
 
3

MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (DEFICIENCY)
U.S. dollars in thousands
 
   
Share capital
   
Share premium
   
Foreign currency translation reserve
   
Accumulated
deficit
   
Total
Equity
 
                               
Balance as of December 31, 2017
   
75
     
138,992
     
(38
)
   
(129,409
)
   
9,620
 
Cumulative effect adjustment on accumulated deficit as a result of adopting IFRS 15
   
-
     
-
     
-
     
(249
)
   
(249
)
                                         
Balance as of January 1, 2018
   
75
     
138,992
     
(38
)
   
(129,658
)
   
9,371
 
                                         
Loss for the period
   
-
     
-
     
-
     
(8,716
)
   
(8,716
)
Other comprehensive loss
   
-
     
-
     
8
     
-
     
8
 
                                         
Total comprehensive loss
   
-
     
-
     
8
     
(8,716
)
   
(8,708
)
                                         
Exercise of options
   
(*
)    
(*
)    
-
     
-
     
-
 
                                         
Share-based compensation
   
-
     
367
     
-
     
-
     
367
 
                                         
Balance as of  June 30, 2018 (unaudited)
   
75
     
139,359
     
(30
)
   
(138,374
)
   
1,030
 
 
   
Share capital
   
Share premium
   
Foreign currency translation reserve
   
Accumulated
deficit
   
Total
Equity (Deficiency)
 
                               
Balance as of January 1, 2017
   
60
     
114,979
     
(9
)
   
(107,260
)
   
7,770
 
                                         
Loss for the period
   
-
     
-
     
-
     
(8,776
)
   
(8,776
)
Other comprehensive loss
   
-
     
-
     
(17
)
   
-
     
(17
)
                                         
Total comprehensive loss
   
-
     
-
     
(17
)
   
(8,776
)
   
(8,793
)
                                         
Exercise of options
   
-
     
2
     
-
     
-
     
2
 
                                         
Share-based compensation
   
-
     
665
     
-
     
-
     
665
 
                                         
Balance as of  June 30, 2017 (unaudited)
   
60
     
115,646
     
(26
)
   
(116,036
)
   
(356
)
 
(*)   Represents less than $1.
 
The accompanying notes are an integral part of the interim consolidated financial statements.
 
4

MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (DEFICIENCY)
U.S. dollars in thousands

   
Share capital
   
Share premium
   
Foreign currency translation reserve
   
Accumulated
deficit
   
Total
Equity
 
                               
Balance as of April 1, 2018
   
75
     
139,210
     
(48
)
   
(134,209
)
   
5,028
 
                                         
Loss for the period
   
-
     
-
     
-
     
(4,165
)
   
(4,165
)
Other comprehensive loss
   
-
     
-
     
18
     
-
     
18
 
                                         
Total comprehensive loss
   
-
     
-
     
18
     
(4,165
)
   
(4,147
)
                                         
Exercise of options
(*
)    
(*
)    
-
     
-
     
-
 
                                         
Share-based compensation
   
-
     
149
     
-
     
-
     
149
 
                                         
Balance as of  June 30, 2018 (unaudited)
   
75
     
139,359
     
(30
)
   
(138,374
)
   
1,030
 
 
 
Share capital
   
Share premium
   
Foreign currency translation reserve
   
Accumulated
deficit
   
Total
Equity (Deficiency)
 
                             
Balance as of April 1, 2017
   
60
     
115,307
     
(12
)
   
(111,574
)
   
3,781
 
                                       
Loss for the period
   
-
     
-
     
-
     
(4,462
)
   
(4,462
)
Other comprehensive loss
   
-
     
-
     
(14
)
   
-
     
(14
)
                                         
Total comprehensive loss
   
-
     
-
     
(14
)
   
(4,462
)
   
(4,476
)
                                         
Exercise of options
   
-
     
2
     
-
     
-
     
2
 
                                         
Share-based compensation
   
-
     
337
     
-
     
-
     
337
 
                                         
Balance as of  June 30, 2017 (unaudited)
   
60
     
115,646
     
(26
)
   
(116,036
)
   
(356
)
 
(*)   Represents less than $1.
 
The accompanying notes are an integral part of the interim consolidated financial statements.
 
5

MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (DEFICIENCY)
U.S. dollars in thousands

   
Share capital
   
Share premium
   
Foreign currency translation reserve
   
Accumulated
deficit
   
Total
equity
 
                               
Balance as of December 31, 2016
   
60
     
114,979
     
(9
)
   
(107,260
)
   
7,770
 
                                         
Loss for the period
   
-
     
-
     
-
     
(22,149
)
   
(22,149
)
Other comprehensive loss
   
-
     
-
     
(29
)
   
-
     
(29
)
                                         
Total comprehensive loss
   
-
     
-
     
(29
)
   
(22,149
)
   
(22,178
)
                                         
Exercise of options
   
(*
)
   
7
     
-
     
-
     
7
 
Issuance of ordinary shares of NIS 0.01 par value net of issuance expenses
   
15
     
22,643
     
-
     
-
     
22,658
 
Share-based compensation
   
-
     
1,363
     
-
     
-
     
1,363
 
                                         
Balance as of December 31, 2017
   
75
     
138,992
     
(38
)
   
(129,409
)
   
9,620
 
 
(*)    Represents less than $1.

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

6

MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands

   
Six months ended
June 30,
   
Three months ended
June 30,
   
Year ended
December 31,
 
   
2018
   
2017
   
2018
   
2017
   
2017
 
   
Unaudited
   
Audited
 
Cash flows from operating activities:
                             
Net loss
   
(8,716
)
   
(8,776
)
   
(4,165
)
   
(4,462
)
   
(18,885
)
                                         
Adjustments to reconcile net loss to net cash used in continuing operating activities:
                                       
                                         
Adjustments to profit and loss items:
                                       
Loss from discontinued operation
   
-
     
-
     
-
     
-
     
7,616
 
Depreciation and amortization
   
305
     
302
     
170
     
146
     
567
 
Share-based compensation
   
367
     
665
     
149
     
337
     
1,363
 
Revaluation of liabilities in respect of IIA grants
   
404
     
402
     
218
     
221
     
229
 
Revaluation of contingent consideration for the purchase of shares
   
1,112
     
1,120
     
569
     
570
     
351
 
Increase (decrease) in severance liability
   
6
     
20
     
(5
)
   
12
     
111
 
Net financing income
   
(182
)
   
(174
)
   
(115
)
   
(88
)
   
(349
)
Un-realized foreign currency (gain) loss
   
126
     
(91
)
   
85
     
(39
)
   
(185
)
                                         
     
2,138
     
2,244
     
1,071
     
1,159
     
9,703
 
Changes in asset and liability items:
                                       
    Decrease (increase) in trade receivables
   
(421
)
   
(241
)
   
(494
)
   
(201
)
   
28
 
Decrease (increase) in inventories
   
15
     
(279
)
   
149
     
(132
)
   
(1,042
)
Decrease (increase) in other receivables
   
(1,572
)
   
(277
)
   
(1,690
)
   
278
     
(1,227
)
Increase (decrease) in trade payables
   
74
     
(1,210
)
   
(51
)
   
(2,487
)
   
(135
)
Increase (decrease) in other payables and deferred revenues
   
(336
)
   
(459
)
   
(507
)
   
1,606
     
(70
)
                                         
     
(2,240
)
   
(2,466
)
   
(2,593
)
   
(936
)
   
(2,446
)
                                         
Net cash flows used in operating activities
   
(8,818
)
   
(8,998
)
   
(5,687
)
   
(4,239
)
   
(14,892
)
Net cash used in discontinued operating activities
   
-
     
-
     
-
     
-
     
(1,563
)
     
(8,818
)
   
(8,998
)
   
(5,687
)
   
(4,239
)
   
(16,455
)
 
The accompanying notes are an integral part of the interim consolidated financial statements.

7

MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
 
   
Six months ended
June 30,
   
Three months ended
June 30,
   
Year ended
December 31,
 
   
2018
   
2017
   
2018
   
2017
   
2017
 
   
Unaudited
   
Audited
 
                               
Cash Flows from Investing Activities:
                             
                               
Purchase of property and equipment
   
(313
)
   
(365
)
   
(197
)
   
(169
)
   
(1,045
)
Purchase of intangible assets
   
(13
)
   
-
     
(13
)
   
-
     
(30
)
Interest received
   
2
     
27
     
2
     
12
     
349
 
Proceeds from (investment in) short term bank deposits, net
   
(21,165
)
   
(16,837
)
   
1,680
     
3,007
     
1,163
 
                                         
Net cash provided by (used in) investing activities
   
(21,489
)
   
(17,175
)
   
1,472
     
2,850
     
437
 
                                         
Cash Flows from Financing Activities:
                                       
                                         
Proceeds from exercise of options
   
(*
   
2
     
(*
)    
2
     
7
 
Proceeds from issuance of shares, net
   
-
     
-
     
-
     
-
     
22,658
 
Proceeds from IIA grants, net of repayments
   
30
     
(37
)
   
-
     
(65
)
   
330
 
                                         
Net cash provided by (used in) financing activities
   
30
     
(35
)
   
-
     
(63
)
   
22,995
 
                                         
Exchange rate differences on cash and cash equivalent balances
   
(133
)
   
117
     
(117
)
   
76
     
226
 
                                         
Increase (decrease) in cash and cash equivalents from continuing activities
   
(30,410
)
   
(26,091
)
   
(4,332
)
   
(1,376
)
   
8,766
 
                                         
Decrease in cash and cash equivalents from discontinued activities
   
-
     
-
     
-
     
-
     
(1,563
)
                                         
Balance of cash and cash equivalents at the beginning of the period
   
36,069
     
28,866
     
9,991
     
4,151
     
28,866
 
                                         
Balance of cash and cash equivalents at the end of the period
   
5,659
     
2,775
     
5,659
     
2,775
     
36,069
 
 
(*)     Represents less than $1.
 
The accompanying notes are an integral part of the interim consolidated financial statements.

8

 
MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands

NOTE 1:
GENERAL

a.
General description of the company and its operations:

MediWound Ltd. (the "Company" or "MediWound"), is a fully integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel products to address unmet needs in the fields of severe burns, as well as chronic and other hard to heal wounds, connective tissue disorders and other indications.

The Company's innovative biopharmaceutical product, NexoBrid, received marketing authorization from the European Medicines Agency ("EMA") and the Israeli, Argentinean and South Korean 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 organization and in other territories through local distributers.

b.
The Company has two wholly owned subsidiaries: MediWound Germany GmbH, acting as Europe (“EU”) marketing authorization holder and EU sales and marketing arm and MediWound UK Limited, an inactive company. In addition, the Company owns approximately 8% of PolyHeal Ltd., a private life sciences company ("PolyHeal").

c.
The Company's securities are listed for trading on NASDAQ since March 2014. In September 2017, the Company completed a follow-on public offering. A total of 5,037,664 new ordinary shares were issued in consideration to net proceeds of $22,658, after deducting underwriter’s discounts, commissions and other offering expenses.

d.
The Company has a contract with the U.S. Biomedical Advanced Research and Development Authority ("BARDA"), which was modified in July 2017, for the advancement of the development and manufacturing, as well as the procurement of NexoBrid, as a medical countermeasure as part of BARDA preparedness for mass casualty events. The modified contract includes $56,000 of funding to support development activities to complete the U.S. Food and Drug Administration (FDA) approval process for NexoBrid for use in thermal burn injuries, as well as $16,000 for procurement of NexoBrid, which is contingent upon FDA Emergency Use Authorization (EUA) and/or FDA marketing authorization for NexoBrid. In addition, the contract includes options for further funding of up to $10,000 for expanding NexoBrid’s indications and of up to $50,000 for additional procurement of NexoBrid.

As of June 30, 2018 the Company recorded $ 21,200 in funding from BARDA under the contract.

9

MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
 
NOTE 2:
SIGNIFICANT ACCOUNTING POLICIES
 
The following accounting policies have been applied consistently in the financial statements for all periods presented unless otherwise stated.

a.
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").
 
b.
Basis of preparation of the interim consolidated financial statements:

The interim condensed consolidated financial statements for the six months ended June 30, 2018 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, 2017 that were included in the Annual Report on Form 20-F filed on March 19, 2018.

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 for the year ended December 31, 2017 that were included in the Annual Report on Form 20-F filed on March 19, 2018, except than the change discussed below.

c.
Changes in significant accounting policies

IFRS 15, "Revenue from Contracts with Customers":

IFRS 15 establishes a comprehensive framework for determining whether, how much and when revenue is recognized. It replaced IAS 18 Revenue, IAS 11 Construction Contracts and related interpretations and it applies to all revenue arising from contracts with customers, unless those contracts are in the scope of other standards.

The new standard establishes a five-step model to account for revenue arising from contracts with customers. Under IFRS 15, revenue is recognized at an amount that reflects the consideration to which an entity expects to be entitled in exchange for transferring goods or services to a customer.
The standard requires entities to exercise judgment, taking into consideration all of the relevant facts and circumstances when applying each step of the model to contracts with their customers.
The Company generates revenues from direct and indirect sales of its products and from license agreements with its distributors.

10

MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands

NOTE 2:
SIGNIFICANT ACCOUNTING POLICIES (Cont.)

1.
Revenue from the Sale of products:

The Company contracts with customers for the sale of products which generally include one performance obligation. The Company has concluded that revenue from sale of products should be recognized at the point in time when control of the asset is transferred to the customer, generally on delivery of the products. Therefore, the adoption of IFRS 15 did not have an impact on the timing of revenue recognition.

2.
Revenue from distribution agreements with Multiple- element:

According to the new Standard, entities need to determine whether the licenses for intellectual property is distinct from other goods and services included in the contract. An analysis of the Company's contracts with its distributors indicates that in the majority of contracts, the Company grants its distributors a right to access its intellectual property as it exists throughout the license period. Accordingly, the Company recognizes revenue from the granting of licenses over the license period which is identical to the legacy accounting treatment.

In addition, in accordance with terms of some license agreements, the Company is entitled for up-front payments which are accounted for as deferred revenues and recognized in profit and loss over the license period.  According to the new Standard, when long-term advances (exceeding one year) are received for a future service, the Company is required to accrue interest and recognize finance expense on the advances over the period of the contract. Under the legacy revenue recognition guidance the Company did not recognize finance expenses in respect of deferred revenue.
 
On January 1, 2018, the Company adopted the new standard for all its distribution agreements at the date of initial application, and applied the standard using the modified retrospective approach, with the cumulative effect of applying the new guidance recognized as an adjustment to the opening retained earnings balance. Results for reporting periods beginning after January 1, 2018 are presented under the new guidance, while prior period amounts are not adjusted and continue to be reported under the accounting standards in effect for the prior period. The Company recorded a net increase to opening accumulated deficit of $249 as of January 1, 2018 due to the cumulative impact of adopting the new guidance and an increase of deferred revenues by $249.

11

MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
 
NOTE 2:
SIGNIFICANT ACCOUNTING POLICIES (Cont.)
 
The following table summarizes the impacts of adopting IFRS 15 on the Company’s interim statement of financial position as of June 30, 2018 and its interim consolidated statements of comprehensive loss for the three and six months period ended June 30, 2018 for each of the line items affected.
 
Impact on the condensed interim consolidated statement of financial position:
 
   
As reported
   
Adjustments
   
Amounts without adoption of
IFRS 15
 
                   
Deferred revenues*
   
1,365
     
(311
)
   
1,054
 
                         
Accumulated deficit
   
(138,374
)
   
311
     
(138,063
)
 
* Comprised of short term deferred revenues classified in other payable and long term deferred revenues.
 
Impact on the condensed interim consolidated statements of comprehensive loss for the six months period ended June 30, 2018:
 
   
As reported
   
Adjustments
   
Amounts without adoption of
IFRS 15
 
                   
Revenues
   
1,551
     
(20
)
   
1,531
 
Financial expense
   
(1,898
)
   
82
     
(1,816
)
Net loss
   
(8,716
)
   
62
     
(8,654
)
                         
Total Basic and diluted net loss per share
   
(0.32
)
   
(0.0
)
   
(0.32
)
 
Impact on the condensed interim consolidated statements of comprehensive loss for the three months period ended June 30, 2018:
 
   
As reported
   
Adjustments
   
Amounts without adoption of IFRS 15
 
                   
Revenues
   
1,031
     
(11
)
   
1,020
 
Financial expense
   
(994
)
   
41
     
(953
)
Net loss
   
(4,165
)
   
30
     
(4,135
)
 
Total Basic and diluted net loss per share
   
(0.15
)
   
(0.0
)
   
(0.15
)
 
 
12