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 2019
 
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 13, 2019, MediWound Ltd. (the “Company”) issued a press release entitled “MediWound Reports Second Quarter 2019 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, 2019, attached as Exhibit 99.2, which was provided by the Company to CBI on August 12, 2019 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 13, 2019
By:
/s/ Sharon Malka  
    Name: Sharon Malka  
    Title:   Chief Executive 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 2019 Financial Results

Total revenues of $20.7 million, driven primarily by the upfront payment from Vericel for NexoBrid® license agreement

BARDA committed additional $21 million to fund NexoBrid® expanded access treatment protocol

Confirmed BLA submission plans in a pre-BLA meeting with FDA

Company to initiate an adaptive design adequately-controlled study in 4Q 2019
comparing EscharEx to U.S. SOC and placebo control

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

YAVNE, Israel (August 13, 2019) – MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound care management, today announced financial results for the quarter ended June 30, 2019.

Business and Financial Highlights for the Second Quarter 2019 and Recent Weeks include:


Total revenues for the second quarter of 2019 were $20.7 million, driven primarily by $17.5 million upfront payment from Vericel for the NexoBrid license;


As of June 30 2019, the Company had $38.7 million in cash and short-term investments, compared to $23.6 million as of December 31, 2018;


Entered into an exclusive commercial license and supply agreements with Vericel Corporation for NexoBrid in North America for an upfront payment of $17.5 million, an additional $7.5 million upon U.S. BLA approval, tiered sales royalties, and up to $125 million in potential sales-related milestones;


The U.S. Biomedical Advanced Research and Development Authority (BARDA) upsized contract provides additional $21 million to fund primarily the NexoBrid expanded access treatment (NEXT) protocol planned to be initiated in the third quarter of 2019.  Total non-dilutive funds for NexoBrid now valued at up to $196 million;


Launched the EscharEx U.S. clinical development program and announced plans to initiate an adaptive designed adequately controlled Phase 2 clinical study in the fourth quarter of 2019.  Hosted an Analyst Day in New York to unveil the clinical development program;


Confirmed plans in a pre-BLA meeting with the U.S Food and Drug Administration (FDA), for submission of a Biologics License Application (BLA) for NexoBrid in the second Quarter of 2020;

“We are very pleased with the continued progress we have made this quarter following our terrific start to 2019 highlighted by the robust top-line results from our Phase 3 DETECT study of NexoBrid, in which we met primary and all secondary endpoints,” said Sharon Malka, MediWound’s Chief Executive Officer. “We continued being active in the second quarter and thereafter, with several significant milestones including signing commercial license and supply agreements with Vericel for NexoBrid in North America and confirming with the FDA in a pre-BLA meeting our BLA submission plans, which puts us on track to file a BLA for NexoBrid in the second Quarter of 2020 and a clear path to the U.S. commercial market.”



“The continued BARDA support provides us with additional $21 million to fund the NexoBrid expanded access treatment (NEXT) protocol, which we plan to initiate in the third quarter of 2019,” continued Mr. Malka. “The NEXT protocol allows U.S. burn centers to treat burn patients with NexoBrid prior to BLA approval and to use NexoBrid in non-declared emergency events. The NEXT protocol will result in an increased number of burn centers trained with the use of NexoBrid across the U.S. and thereby furthering the national preparedness for burn mass casualty incidences. In addition, this quarter NexoBrid received marketing authorization from Peru’s Ministry of Health, in line with our global commercial strategy of expanding the use of NexoBrid in international markets through collaborations with local distributors.”

“Following the North American commercial collaboration for NexoBrid, our primary focus turns to EscharEx. We plan to initiate an adequately-controlled, adaptive designed Phase 2 clinical study in the fourth quarter of 2019, with an interim assessment planned by year-end 2020. This study will compare EscharEx to a placebo control arm as well as head-to-head with the current non-surgical standard of care in the U.S, and if successfully completed, we believe it may serve as one of the two pivotal studies required for BLA submission. With adequate financial resources and a solid balance sheet, we are well positioned to support our development plans through our numerous upcoming milestones, and we look forward to making further progress during the second half of the year,” concluded Mr. Malka.

Second Quarter Financial Results
Revenues for the second quarter of 2019 were $20.7 million, including $17.5 million upfront payment and $2.3 million revenues from development services derived by Vericel licensing agreement for NexoBrid, compared with the $1.0 million in the second quarter of 2018.
 
Cost of revenues for the second quarter of 2019 were $3.5 million, compared to $0.6 million in the second quarter of 2018. The increase was primarily driven by $2.2 million cost of development services and $0.7 million royalties attributed to the upfront license payment.

Gross profit for the second quarter of 2019 was $17.3 million, compared to a gross profit of $0.4 million for the second quarter of 2018.

Research and development expenses, net of participations, were $0.2 million for the second quarter of 2019 compared with $1.5 million of the second quarter of 2018.The decrease in research and development, net, was a result of a decrease in clinical trials cost of $3.1 million and a decrease of $1.7 million in participation by BARDA and the Israeli innovation authority grant.

Selling, general and administrative expenses for the second quarter of 2019 were $2.3 million, compared with $2.1 million for the second quarter of 2018.

Operating profit for the second quarter of 2019, which includes the $17.5 million upfront license payment, net of royalty payment of $0.7 million and $0.8 million of other expenses, was $13.9 million. Excluding the upfront license payment, net of deal related expenses, operating loss for the second quarter of 2019 was $2.1 million, an improvement of 37% from the $3.3 million in the second quarter of 2018, primarily due to the decrease in research and development costs, net of participation.

The Company net profit for the second quarter of 2019, which includes the $17.5 million upfront license payment, net of royalty payment of $0.7 million and $0.8 million of other expenses, was $12.7 million, or $0.47 per share.  Excluding the net upfront license payment, net loss for the second quarter of 2019 was $3.3 million, or $(0.12) per share, compared with a net loss of $4.2 million, or $(0.15) per share, in the second quarter of 2018.



Adjusted EBITDA, as defined below, for the second quarter of 2019, was a profit of $15.4 million, compared with a loss of $2.9 million for the second quarter of 2018.

Year-to-Date 2019 Financial Results
Revenues for the first half of 2019 were $21.2 million, including $17.5 million upfront payment and $2.3 million revenues from development services derived by Vericel licensing agreement for NexoBrid, compared with the $1.6 million in the first half of 2018.

Cost of revenues for the first half of 2019 were $3.8 million compared to $1.0 million in the first half of 2018. The increase was primarily driven by $2.2 million cost of development services and $0.7 million royalties attributed to the upfront license payment.

Gross profit for the first half of 2019 was $17.4 million, compared to a gross profit of $0.5 million in the first half of 2018.

Research and development expenses, net of participations, were $1.5 million for the first half of 2019 compared with $2.7 million in first half of 2018. The decrease in research and development, net, was primarily driven by decrease in clinical trials costs of $3.0 million and a decrease of $1.7 million in participation by BARDA and the Israeli innovation authority.

Selling, general and administrative expenses for the first half of 2019 were $4.7 million, compared with $4.2 million for the first half of 2018. The increase was primarily as a result of one-time management transition costs.

Operating profit for the first half of 2019, which includes the $17.5 million upfront license payment, net of royalty payment of $0.7 million and $0.9 million of other expenses, was $10.4 million. Excluding the upfront license payment, net of deal related expenses, operating loss for the first half of 2019 was $5.5 million, an improvement of 21% from the $7.0 million in the first half of 2018, primarily due to the decrease in research and development net of participation.

The Company net profit for the first half of 2019, which includes the $17.5 million upfront license payment, net of royalty payment of $0.7 million and $0.9 million of other expenses, was $8.6 million, or a profit of $0.32 per share. Excluding the upfront license payment net of deal related costs, net loss was $7.3 million, or $(0.27) per share, compared with a net loss of $8.7 million, or $(0.32) per share, in the first half of 2018.

Adjusted EBITDA, for the first half of 2019, was a profit of $12.4 million, compared with a loss of $5.7 million for the first half of 2018.

Balance Sheet Highlights
As of June 30, 2019, the Company had cash, cash equivalents and short-term bank deposits of $38.7 million, compared with $23.6 million at December 31, 2018. The company remained on budget, utilizing $6.4 million in the first half of 2019.

Throughout 2019, 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, the Company expects cash use in the second half of 2019 to be in the range of $6.0 million to $8.0 million, including NexoBrid license related payments and repayment of contingent liabilities.



Conference Call
MediWound management will host a conference call for investors today, Tuesday, August 13, 2019 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 877-602-7189 (in the U.S.)  1809 315 362 (Israel), or 678-894-3057 (outside the U.S. & Israel) and entering passcode 2158065. The call also will be broadcast live on the Internet on the Company’s website at https://edge.media-server.com/mmc/p/yyne5t8t

An archived version of the webcast will be available 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® has demonstrated in clinical trials, with statistical significance the ability to non-surgically and rapidly remove the eschar earlier and without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health. MediWound's second innovative product, EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various 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 content of the BLA filing package, the timeline for the BLA filing; FDA acceptance of the BLA,; the ability to fund the development of NexoBrid until BLA submission; the ability to successfully complete the development  and commercialize NexoBrid, expected funding from BARDA; our ability to meet the timeline for the initiation of the NEXT treatment protocol, results of the NEXT treatment protocol and Vericel’s ability to commercialize NexoBrid, the design of the Phase 2 study, the timeline for the Phase 2 study and the interim assessment; the ability of the Phase 2 study to serve as one of the two adequately controlled studied required for BLA submission our development plan for EscharEx; expected revenues from Vericel and the ability to fund the development of EscharEx until BLA submission; the ability to fit EscharEx into treatment workflow and reimbursement programs; our expectations regarding the wound care market; and the ability to successfully develop and commercialize. 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 important factors. In particular, you should consider that the FDA may not accept part or all of our BLA; FDA may require additional information, which we may or may not able to provide; FDA may not provide marketing approval for NexoBrid in the United States; we may not submit the BLA to FDA in the timeframe expected; risks related to our collaboration with Vericel; our ability to obtain marketing approval of NexoBrid or EscharEx in the U.S.; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of NexoBrid and EscharEx; our commercialization, marketing and manufacturing capabilities and strategy; risks related to our contract with the U.S. Biomedical Advanced Research and Development Authority; the impact of government laws and regulations; and the additional risks discussed under the heading “Risk Factors” in our annual report on Form 20-F for the year ended December 31, 2018 as well as 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                                      Jeremy Feffer
Chief Executive Officer                     Managing Director, LifeSci Advisors
MediWound Ltd.                                212-915-2568
ir@mediwound.com                           jeremy@lifesciadvisors.com



MediWound, Ltd.
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands

   
June 30,
   
December 31,
 
   
2019
   
2018
   
2018
 
   
Un-audited
   
Audited
 
Cash, cash equivalents and short term deposits
   
38,712
     
27,004
     
23,633
 
Accounts and other receivable
   
4,649
     
5,224
     
7,400
 
Inventories
   
1,535
     
1,871
     
1,680
 
Total current assets
   
44,896
     
34,099
     
32,713
 
Long term deposits and prepaid expenses
   
19
     
65
     
48
 
Property, plant and equipment, net
   
2,183
     
2,051
     
2,020
 
Right of use assets
   
2,315
     
-
     
-
 
Intangible assets, net
   
462
     
528
     
495
 
Total long term assets
   
4,979
     
2,644
     
2,563
 
Total assets
   
49,875
     
36,743
     
35,276
 
Current maturities of long-term liabilities
   
896
     
514
     
146
 
Trade payables and accrued expenses
   
4,073
     
3,327
     
2,715
 
Other payables
   
5,889
     
1,825
     
2,036
 
Total current liabilities
   
10,858
     
5,666
     
4,897
 
Deferred revenues
   
1,144
     
1,178
     
1,158
 
Liabilities in respect of Israeli Innovation Authority grants net of current maturities
   
6,919
     
7,793
     
7,568
 
Contingent consideration for the purchase of shares net of current maturities
   
4,412
     
14,737
     
6,330
 
Liability in respect of discontinued operation
   
6,003
     
6,003
     
6,003
 
Lease liability, net of current maturities
   
2,022
     
-
     
-
 
Severance pay liability, net
   
338
     
336
     
348
 
Total long term liabilities
   
20,838
     
30,047
     
21,407
 
Shareholders' equity
   
18,179
     
1,030
     
8,972
 
Total liabilities & shareholder equity
   
49,875
     
36,743
     
35,276
 





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

 
Six months ended
   
Three months ended
 
   
June 30,
   
June 30,
 
   
2019
   
2018
   
2019
   
2018
 
                         
Revenues
   
18,906
     
1,551
     
18,445
     
1,031
 
Cost of revenues
   
1,619
     
1,010
     
1,312
     
629
 
Gross profit
   
17,287
     
541
     
17,133
     
402
 
Operating expenses:
                               
Research and development, gross
   
8,244
     
9,027
     
4,062
     
4,987
 
Participation by BARDA & IIA
   
(6,925
)
   
(6,298
)
   
(4,022
)
   
(3,451
)
Research and development, net
   
1,319
     
2,729
     
40
     
1,536
 
Selling, general & administrative
   
4,708
     
4,150
     
2,343
     
2,090
 
Other expenses
   
901
     
662
     
812
     
62
 
Operating profit (loss)
   
10,359
     
(7,000
)
   
13,938
     
(3,286
)
Financial expenses, net
   
(1,803
)
   
(1,716
)
   
(1,222
)
   
(879
)
Profit (loss) from continuing operations
   
8,556
     
(8,716
)
   
12,716
     
(4,165
)
Profit from discontinued operation
   
50
     
0
     
0
     
0
 
Profit (loss) for the period
   
8,606
     
(8,716
)
   
12,716
     
(4,165
)
Foreign currency translation adjustments
   
2
     
8
     
(2
)
   
18
 
Total comprehensive profit (loss)
   
8,608
     
(8,708
)
   
12,714
     
(4,147
)
                                 
Net Profit (loss) per share
   
0.32
     
(0.32
)
   
0.47
     
(0.15
)
Weighted average number of ordinary shares used in the computation of basic and diluted profit (loss) per share:
   
27,179
     
27,050
     
27,179
     
27,052
 




ADJUSTED EBITDA
U.S. dollars in thousands

   
Six months ended
   
Three months ended
 
   
June 30,
   
June 30,
 
   
2019
   
2018
   
2019
   
2018
 
Profit (loss) for the period
   
8,606
     
(8,716
)
   
12,716
     
(4,165
)
Adjustments:
                               
Financial expenses, net
   
(1,803
)
   
(1,716
)
   
(1,222
)
   
(879
)
Profit from discontinued operation
   
50
     
-
     
-
     
-
 
Other expenses
   
(901
)
   
(662
)
   
(812
)
   
(62
)
Depreciation and amortization
   
(552
)
   
(305
)
   
(278
)
   
(170
)
Share-based compensation expenses
   
(599
)
   
(367
)
   
(324
)
   
(149
)
Total adjustments
   
(3,805
)
   
(3,050
)
   
(2,636
)
   
(1,260
)
Adjusted EBITDA
   
12,411
     
(5,666
)
   
15,352
     
(2,905
)





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

 
 
Six months ended
   
Three months ended
 
 
 
2019
   
2018
   
2019
   
2018
 
 
 
Unaudited
   
Unaudited
 
Cash Flows from Operating Activities:
                       
Net profit (loss)
   
8,606
     
(8,716
)
   
12,716
     
(4,165
)
 
                               
Adjustments to reconcile net profit (loss) to net cash used in continuing operating activities:
                               
Adjustments to profit and loss items:
                               
Profit from discontinued operation
   
(50
)
   
-
     
-
     
-
 
Depreciation and amortization
   
552
     
305
     
278
     
170
 
Share-based compensation
   
599
     
367
     
324
     
149
 
Revaluation of liabilities in respect of IIA grants
   
(392
)
   
404
     
(466
)
   
218
 
Revaluation of contingent consideration for the purchase of shares
   
1,322
     
1,112
     
1,081
     
569
 
Other income
                               
Revaluation of lease liabilities
   
194
     
-
     
91
     
-
 
Increase (decrease) in severance liability, net
   
(10
)
   
6
     
13
     
(5
)
Financing income
   
(149
)
   
(182
)
   
(87
)
   
(115
)
Unrealized foreign currency (gain) loss
   
(70
)
   
126
     
60
     
85
 
 
   
1,996
     
2,138
     
1,294
     
1,071
 
Changes in asset and liability items:
                               
Increase  in trade receivables
   
(9
)
   
(421
)
   
(318
)
   
(494
)
Decrease (increase) in inventories
   
146
     
15
     
(62
)
   
149
 
Decrease (increase) in other receivables
   
2,744
     
(1,572
)
   
2,482
     
(1,690
)
Increase (decrease) in trade payables and prepaid expenses
   
1,357
     
74
     
1,076
     
(51
)
Increase (decrease) in other payables & deferred revenues
   
529
     
(336
)
   
77
     
(507
)
 
   
4,767
     
(2,240
)
   
3,255
     
(2,593
)
Net cash provided by (used in) continuing operating activities
   
15,369
     
(8,818
)
   
17,265
     
(5,687
)
Net cash provided by discontinued operating activities
   
50
     
-
     
-
     
-
 
Net cash provided by (used in)  operating activities
   
15,419
     
(8,818
)
   
17,265
     
(5,687
)



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

 
 
Six months ended
   
Three months ended
 
 
 
2019
   
2018
   
2019
   
2018
 
 
 
Unaudited
   
Unaudited
 
 
                       
Cash Flows from Investment Activities:
                       
Purchase of property and equipment
   
(433
)
   
(313
)
   
(194
)
   
(197
)
Purchase of intangible assets
   
-
     
(13
)
   
-
     
(13
)
Interest received
   
44
     
2
     
14
     
2
 
Proceeds from (investment in) short term bank deposits, net of investments
   
2,977
     
(21,165
)
   
412
     
1,680
 
Net cash provided by (used in)  investing activities
   
2,588
     
(21,489
)
   
232
     
1,472
 
Cash Flows from Financing Activities:
                               
Proceeds from exercise of options
   
-
     
*
     
-
     
*
 
Repayment of lease liabilities
   
(312
)
   
-
     
(157
)
   
-
 
Proceeds from IIA grants, net of repayments
   
193
     
30
     
248
     
-
 
Net cash (used in) provided by financing activities
   
(119
)
   
30
     
91
     
0
 
 
                               
Exchange rate differences on cash and cash equivalent balances
   
63
     
(133
)
   
(55
)
   
(117
)
 
                               
Increase (decrease) in cash and cash equivalents from continuing activities
   
17,901
     
(30,410
)
   
17,533
     
(4,332
)
Increase in cash and cash equivalents from discontinued activities
   
50
     
-
     
-
     
-
 
Balance of cash and cash equivalents at the beginning of the period
   
6,716
     
36,069
     
7,134
     
9,991
 
Balance of cash and cash equivalents at the end of the period
   
24,667
     
5,659
     
24,667
     
5,659
 




Exhibit 99.2

MEDIWOUND LTD. AND ITS SUBSIDIARIES

INTERIM CONDENSED FINANCIAL STATEMENTS

AS OF JUNE 30, 2019

IN U.S. DOLLARS IN THOUSANDS

UNAUDITED

INDEX

 
Page
   
   
   
F - 2
   
F - 3
   
F - 4 - F - 6
   
F - 7 - F - 8
   
F - 9 - F - 14


MEDIWOUND LTD. AND ITS SUBSIDIARIES
 
CONDENSED INTERIM CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands

   
June 30,
   
December 31,
 
   
2019
   
2018
   
2018
 
   
Unaudited
   
Audited
 
CURRENT ASSETS:
                 
Cash and cash equivalents
   
24,667
     
5,659
     
6,716
 
Restricted deposits
   
175
     
91
     
89
 
Short‑term bank deposits
   
13,870
     
21,254
     
16,828
 
Trade receivables
   
570
     
779
     
560
 
Inventories
   
1,535
     
1,871
     
1,680
 
Other receivables
   
4,079
     
4,445
     
6,840
 
                         
     
44,896
     
34,099
     
32,713
 
LONG‑TERM ASSETS:
                       
Long term deposits and prepaid expenses
   
19
     
65
     
48
 
Property, plant and equipment, net
   
2,183
     
2,051
     
2,020
 
Right of-use assets
   
2,315
     
-
     
-
 
Intangible assets, net
   
462
     
528
     
495
 
                         
     
4,979
     
2,644
     
2,563
 
                         
     
49,875
     
36,743
     
35,276
 
CURRENT LIABILITIES:
                       
Current maturities of long-term liabilities
   
896
     
514
     
146
 
Trade payables and accrued expenses
   
4,073
     
3,327
     
2,715
 
Other payables
   
5,889
     
1,825
     
2,036
 
                         
     
10,858
     
5,666
     
4,897
 
LONG‑TERM LIABILITIES:
                       
Deferred  revenues
   
1,144
     
1,178
     
1,158
 
 Liabilities in respect of IIA grants
   
6,919
     
7,793
     
7,568
 
Contingent consideration for purchase of shares
   
4,412
     
14,737
     
6,330
 
Liability in respect of discontinued operation
   
6,003
     
6,003
     
6,003
 
Lease liabilities
   
2,022
     
-
     
-
 
Severance pay liability, net
   
338
     
336
     
348
 
                         
     
20,838
     
30,047
     
21,407
 
SHAREHOLDERS' EQUITY:
                       
Ordinary shares of NIS 0.01 par value:
                       
Authorized: 37,244,508 shares as of June 30, 2019, December 31, 2018 and June 30, 2018; Issued and Outstanding: 27,178,839 as of June 30, 2019, December  31, 2018 and June 30, 2018
   
75
     
75
     
75
 
Share premium
   
140,236
     
139,359
     
139,637
 
Foreign currency translation adjustments
   
(23
)
   
(30
)
   
(25
)
Accumulated deficit
   
(122,109
)
   
(138,374
)
   
(130,715
)
                         
     
18,179
     
1,030
     
8,972
 
                         
     
49,875
     
36,743
     
35,276
 

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

F - 2

MEDIWOUND LTD. AND ITS SUBSIDIARIES

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF COMPREHENSIVE PROFIT (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,
 
   
2019
   
2018
   
2019
   
2018
   
2018
 
   
Unaudited
   
Audited
 
Revenues from sale of products
   
1,309
     
1,466
     
895
     
988
     
3,225
 
Revenues from development services
   
2,301
     
-
     
2,301
     
-
     
-
 
Revenues from license agreements
   
17,597
     
85
     
17,550
     
43
     
176
 
Total revenues
   
21,207
     
1,551
     
20,746
     
1,031
     
3,401
 
                                         
Cost of revenues from sale of products
   
917
     
988
     
617
     
614
     
2,017
 
Cost of revenues from development services
   
2,169
     
-
     
2,169
     
-
     
-
 
Cost of revenues from license agreements
   
702
     
22
     
695
     
15
     
71
 
Total cost of revenues
   
3,788
     
1,010
     
3,481
     
629
     
2,088
 
                                         
Gross profit
   
17,419
     
541
     
17,265
     
402
     
1,313
 
                                         
Research and development, gross
   
6,075
     
9,027
     
1,893
     
4,987
     
17,915
 
Participations by BARDA and IIA
   
(4,624
)
   
(6,298
)
   
(1,721
)
   
(3,451
)
   
(13,843
)
Research and development, net of participations
   
1,451
     
2,729
     
172
     
1,536
     
4,072
 
Selling and marketing
   
2,134
     
2,319
     
1,101
     
1,248
     
4,188
 
General and administrative
   
2,574
     
1,831
     
1,242
     
842
     
3,799
 
Other income from settlement agreement
   
-
     
-
     
-
     
-
     
(7,537
)
Other expenses
   
901
     
662
     
812
     
62
     
751
 
Total operating expenses
   
7,060
     
7,541
     
3,327
     
3,688
     
5,273
 
                                         
Operating profit (loss)
   
10,359
     
(7,000
)
   
13,938
     
(3,286
)
   
(3,960
)
                                         
Financial income
   
153
     
182
     
92
     
115
     
412
 
Financial expense
   
(1,956
)
   
(1,898
)
   
(1,314
)
   
(994
)
   
(2,117
)
                                         
Profit (loss) from continuing operation
   
8,556
     
(8,716
)
   
12,716
     
(4,165
)
   
(5,665
)
Profit from discontinued operation
   
50
     
-
     
-
     
-
     
4,608
 
Net Profit (loss)
   
8,606
     
(8,716
)
   
12,716
     
(4,165
)
   
(1,057
)
Other comprehensive income (loss):
                                       
                                         
Foreign currency translation adjustments
   
2
     
8
     
(2
)
   
18
     
13
 
                                         
Total comprehensive income (loss)
   
8,608
     
(8,708
)
   
12,714
     
(4,147
)
   
(1,044
)
Basic and diluted net profit (loss) per share from continuing operations
   
0.32
     
(0.32
)
   
0.47
     
(0.15
)
   
(0.21
)
Basic and diluted net loss per share from discontinued operations
   
(*
)
   
-
     
-
     
-
     
0.17
 
Total Basic and diluted net profit (loss) per share
   
0.32
     
(0.32
)
   
0.47
     
(0.15
)
   
(0.04
)
Weighted average number of ordinary shares used in the computation of basic and diluted loss per share (in thousands)
   
27,179
     
27,050
     
27,179
     
27,052
     
27,114
 

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

(*)Represents an amount lower than $0.01.

F - 3

MEDIWOUND LTD. AND ITS SUBSIDIARIES

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY

U.S. dollars in thousands

   
Share capital
   
Share premium
   
Foreign currency translation reserve
   
Accumulated
deficit
   
Total
Equity
 
                               
Balance as of December 31, 2018
   
75
     
139,637
     
(25
)
   
(130,715
)
   
8,972
 
                                         
Profit for the period
   
-
     
-
     
-
     
8,606
     
8,606
 
Other comprehensive income
   
-
     
-
     
2
     
-
     
2
 
Total comprehensive income
   
-
     
-
     
2
     
8,606
     
8,608
 
                                         
Share-based compensation
   
-
     
599
     
-
     
-
     
599
 
                                         
Balance as of  June 30, 2019 (unaudited)
   
75
     
140,236
     
(23
)
   
(122,109
)
   
18,179
 

   
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
 
Accumulated effect 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 income
   
-
     
-
     
8
     
-
     
8
 
Total comprehensive (loss) income
   
-
     
-
     
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
 

(*)          Represents less than $ 1.

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

F - 4

MEDIWOUND LTD. AND ITS SUBSIDIARIES

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY

U.S. dollars in thousands

   
Share capital
   
Share premium
   
Foreign currency translation reserve
   
Accumulated
deficit
   
Total
Equity
 
                               
Balance as of April 1, 2019
   
75
     
139,912
     
(21
)
   
(134,825
)
   
5,141
 
                                         
Profit for the period
   
-
     
-
     
-
     
12,716
     
12,716
 
Other comprehensive loss
   
-
     
-
     
(2
)
   
-
     
(2
)
Total comprehensive (loss) income
   
-
     
-
     
(2
)
   
12,716
     
12,714
 
                                         
Share-based compensation
   
-
     
324
     
-
     
-
     
324
 
                                         
Balance as of  June 30, 2019 (unaudited)
   
75
     
140,236
     
(23
)
   
(122,109
)
   
18,179
 

   
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 income
   
-
     
-
     
18
     
-
     
18
 
Total comprehensive (loss) income
   
-
     
-
     
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
 

(*)          Represents less than $ 1.

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

F - 5

MEDIWOUND LTD. AND ITS SUBSIDIARIES

CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY

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
 
Accumulated effect of adopting IFRS 15
   
-
     
-
     
-
     
(249
)
   
(249
)
                                         
Balance as of January 1, 2018
   
75
     
138,992
     
(38
)
   
(129,658
)
   
9,371
 
                                         
Loss for the period
   
-
     
-
     
-
     
(1,057
)
   
(1,057
)
Other comprehensive income
   
-
     
-
     
13
     
-
     
13
 
Total comprehensive (loss) income
   
-
     
-
     
13
     
(1,057
)
   
(1,044
)
                                         
Exercise of options
   
(*
)
   
(*
)
   
-
     
-
     
(*
)
Share-based compensation
   
-
     
645
     
-
     
-
     
645
 
                                         
Balance as of December 31, 2018
   
75
     
139,637
     
(25
)
   
(130,715
)
   
8,972
 

(*)          Represents less than $ 1.

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

F - 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,
 
   
2019
   
2018
   
2019
   
2018
   
2018
 
   
Unaudited
   
Audited
 
Cash flows from operating activities:
                             
Net Profit (loss)
   
8,606
     
(8,716
)
   
12,716
     
(4,165
)
   
(1,057
)
                                         
Adjustments to reconcile net profit (loss) to net cash provided by (used in) continuing operating activities:
                                       
                                         
Adjustments to profit and loss items:
                                       
Profit from discontinued operation
   
(50
)
   
-
     
-
     
-
     
(4,608
)
Depreciation and amortization
   
552
     
305
     
278
     
170
     
577
 
Share-based compensation
   
599
     
367
     
324
     
149
     
645
 
Revaluation of liabilities in respect of IIA grants
   
(392
)
   
404
     
(466
)
   
218
     
287
 
Revaluation of contingent consideration for the purchase of shares
   
1,322
     
1,112
     
1,081
     
569
     
758
 
Other income from settlement agreement
   
-
     
-
     
-
     
-
     
(7,537
)
Revaluation of lease liabilities
   
194
     
-
     
91
     
-
     
-
 
Increase (decrease) in severance pay liability, net
   
(10
)
   
6
     
13
     
(5
)
   
19
 
Net financing income
   
(149
)
   
(182
)
   
(87
)
   
(115
)
   
(412
)
Un-realized foreign currency (gain) loss
   
(70
)
   
126
     
60
     
85
     
182
 
                                         
     
1,996
     
2,138
     
1,294
     
1,071
     
(10,089
)
Changes in asset and liability items:
                                       
    Increase in trade receivables
   
(9
)
   
(421
)
   
(318
)
   
(494
)
   
(211
)
Decrease (increase) in inventories
   
146
     
15
     
(62
)
   
149
     
206
 
Decrease (increase) in other receivables
   
2,744
     
(1,572
)
   
2,482
     
(1,690
)
   
(306
)
Increase (decrease) in trade payables and accrued expenses
   
1,357
     
74
     
1,076
     
(51
)
   
(536
)
Increase (decrease) in other payables and deferred revenues
   
529
     
(336
)
   
77
     
(507
)
   
(161
)
                                         
     
4,767
     
(2,240
)
   
3,255
     
(2,593
)
   
(1,008
)
                                         
Net cash flows provided by (used) in operating activities
   
15,369
     
(8,818
)
   
17,265
     
(5,687
)
   
(12,154
)
Net cash provided by discontinued operating activities
   
50
     
-
     
-
     
-
     
-
 
Net cash provided by (used) in operating activities
   
15,419
     
(8,818
)
   
17,265
     
(5,687
)
   
(12,154
)

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

F - 7

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,
 
   
2019
   
2018
   
2019
   
2018
   
2018
 
   
Unaudited
   
Audited
 
                               
Cash Flows from Investing Activities:
                             
                               
Purchase of property and equipment
   
(433
)
   
(313
)
   
(194
)
   
(197
)
   
(522
)
Purchase of intangible assets
   
-
     
(13
)
   
-
     
(13
)
   
(12
)
Interest received
   
44
     
2
     
14
     
2
     
106
 
Proceeds from (investment in) short term bank deposits, net
   
2,977
     
(21,165
)
   
412
     
1,680
     
(16,612
)
                                         
Net cash provided by (used in) investing activities
   
2,588
     
(21,489
)
   
232
     
1,472
     
(17,040
)
                                         
Cash Flows from Financing Activities:
                                       
                                         
Repayment of leases liabilities
   
(312
)
   
-
     
(157
)
   
-
     
-
 
Proceeds from exercise of options
   
-
     
(*
)
   
-
     
(*
)
   
(*
)
Proceeds of IIA grant, net of repayments
   
193
     
30
     
248
     
-
     
46
 
                                         
Net cash (used in) provided by financing activities
   
(119
)
   
30
     
91
     
(*
)
   
46
 
                                         
Exchange rate differences on cash and cash equivalent balances
   
63
     
(133
)
   
(55
)
   
(117
)
   
(205
)