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
Securities Exchange Act of 1934
For the month of August 2020
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 6, 2020, MediWound Ltd. (the “Company”) issued a press release entitled “MediWound Reports Second Quarter 2020 Financial Results and Provides Corporate Update”. A copy of
this press release is attached to this Form 6-K as Exhibit 99.1.
In addition, pursuant to the Information Rights Agreement between the Company and Clal Biotechnology Industries Ltd. ("CBI"), dated March 3, 2014 (which was attached to the Company's registration
statement as exhibit 4.3), the Company is required to provide CBI with certain information necessary for CBI to meet its obligations under Israeli Securities Law. This Form 6-K includes an Un-Audited Condensed Consolidated Interim Financial
Statements as of June 30, 2020, attached as Exhibit 99.2, which was provided by the Company to CBI on August 5, 2020 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.
|
Date: August 6, 2020
|
MEDIWOUND LTD.
By: /s/ Boaz Gur-Lavie
Name: Boaz Gur-Lavie
Title: Chief Financial Office
|
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
MediWound Reports Second Quarter 2020 Financial Results and
Provides Corporate Update
Submitted Biological License Application to the FDA for NexoBrid
EscharEx U.S. Phase 2 Study Resumed Patient Screening
YAVNE, Israel, August 6, 2020 -- MediWound Ltd. (Nasdaq: MDWD) (the “Company”), a fully-integrated biopharmaceutical company bringing innovative therapies to
address unmet needs in severe burn and wound management, today announced financial results for the second quarter ended June 30, 2020 and provided business and financial updates related to the COVID-19 pandemic.
Second Quarter Business and Financial Highlights:
|
•
|
Revenues for the second quarter of 2020 were $4.0 million, compared with $20.7 million for the second quarter of 2019, which included the upfront payment of $17.5 million from the Vericel
licensing agreement
|
|
•
|
The Company had $24.4 million in cash and short-term investments as of June 30, 2020, compared with $29.5 million as of December 31, 2019
|
|
•
|
Resumed patient screening and randomization in U.S. EscharEx® phase 2 adaptive design study for the treatment of venous leg ulcers (“VLU’s”); Interim assessment is anticipated in
the first half of 2021
|
|
•
|
Submitted Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for NexoBrid® for the treatment of severe thermal burns in adults
|
|
•
|
Instituted a series of measures to address challenges associated with the COVID-19 pandemic, while maintaining workforce and operational capacity and flexibility
|
“We are pleased to have submitted the BLA for NexoBrid on schedule despite the disruptions of the COVID-19 pandemic. This submission is a major milestone in our long-term partnership with BARDA,
and we are actively preparing for the commercial launch with our partner, Vericel, upon approval,” said Sharon Malka, Chief Executive Officer of MediWound. “In addition, we are actively recruiting and enrolling patients in our U.S. EscharEx phase 2
study, and we are encouraged to see progress in moving this trial forward.”
Mr. Malka concluded, “In recent months, humanity is facing tremendous challenges with a great deal of uncertainty. We are privileged to be among those tasked with improving patients’ quality of
care and impacting their lives. Our solid balance sheet continues to support our growth as we execute on our strategic plans, and we are optimistic that we will continue to successfully strengthen our Company.”
Corporate Update
MediWound has implemented several measures to safeguard the health and well-being of its employees, their families, and healthcare providers. The Company has reduced expenses to minimize impact to
operations while ensuring full compliance with all necessary regulations. Management continues to assess the impact of the pandemic, the potential implications to business continuity, and necessary remedies and will adjust accordingly to the
challenges created by any directives from regulatory authorities.
The Company continues to manufacture and supply NexoBrid to patients with severe burn injuries, including manufacturing NexoBrid and building an emergency stockpile for the U.S. Biomedical Advanced
Research and Development Authority (BARDA), while the first delivery to BARDA is planned in the third quarter of 2020. The Company maintains a significant safety stock of all key raw materials and NexoBrid inventory to meet expected demand over the
next several quarters. At this time, the Company does not expect any disruptions to its manufacturing operations and global supply chain.
The Company submitted a BLA to the U.S. FDA seeking the approval of NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and full-thickness thermal burns. The BLA
submission is based on multiple preclinical and clinical studies including the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with severe thermal burns. Vericel Corporation (NASDAQ: VCEL) holds an exclusive license for
North American commercial rights of NexoBrid. MediWound is eligible to receive a $7.5 million milestone payment from Vericel upon BLA approval.
On the clinical front, the Company has resumed new patients’ screening and randomization in its U.S. EscharEx phase 2 adaptive design study for the treatment of VLU’s and expects to achieve the
pre-defined interim assessment in the first half of 2021. In addition, enrollment in the NexoBrid expanded access (NEXT) program continues with enhanced safety measures, such as remote visits and virtual tools.
The Company had $24.4 million in cash and short-term investments as of June 30, 2020, compared with $29.5 million as of December 31, 2019, with no debt. The Company reiterates its expectations of
cash use for operating activities in 2020 to be in the range of $8 to $10 million. At this time, the Company cannot predict the extent or duration of the impact of the COVID-19 outbreak on its ongoing financial and operational results.
Second Quarter Financial Results
Revenues for the second quarter of 2020 were $4.0 million, compared with $20.7 million for the second quarter of 2019, which included the upfront payment of $17.5 million from the Vericel licensing
agreement. Revenues from product in the second quarter of 2020 were $1.1 million, reflecting an increase of 17% in comparison to the second quarter of 2019, excluding the one-time upfront payment.
Gross profit for the second quarter of 2020 was $1.2 million, compared to a gross profit of $17.5 million for the second quarter of 2019, which included $16.8 million from the Vericel licensing
agreement.
Research and development expenses for the second quarter of 2020, net of participations, were $1.6 million, compared with $0.4 million for the second quarter of 2019. The increase was primarily due
to decrease of participation by BARDA and Israeli Innovation Authority (IIA).
Selling, general and administrative expenses for the second quarter of 2020 were $2.3 million, in line with the second quarter of 2019.
Operating loss for the second quarter of 2020 was $2.7 million, compared with an operating profit of $13.9 million in the second quarter of 2019, which included the upfront payment of $17.5 million
from the Vericel licensing agreement, net of royalty payment of $0.7 million and $0.8 million of other expenses.
The Company posted a net loss of $3.1 million, or $0.11 per share, for the second quarter of 2020 compared with a net profit of $12.7 million, or $0.47 per share, for the second quarter of 2019,
which included the $17.5 million upfront license payment, net of royalty payment of $0.7 million and $0.8 million of other expenses. Excluding the upfront license payment net of deal related costs, net loss for the second quarter of 2019 was $3.3
million, or $0.12 per share.
Adjusted EBITDA, as defined below, for the second quarter of 2020 was a loss of $2.1 million, compared with a profit of $15.4 million for the second quarter of 2019, which included the upfront
payment of $17.5 million from the Vericel licensing agreement, net of royalty payment of $0.7 million.
Year-to-Date 2020 Financial Results
Revenues for the first half of 2020 were $8.5 million compared with $21.2 million in the first half of 2019, which included the $17.5 million upfront payment from the Vericel licensing agreement
for NexoBrid.
The Company’s net loss for the first half of 2020 was $5.6 million or $0.20 per share compared with net profit of $8.6 million or $0.32 per share for the first half of 2019, which included the
$17.5 million upfront license payment, net of royalty payment of $0.7 million and $0.9 million of other expenses. Excluding the upfront license payment net of deal related costs, net loss for the first half of 2019 was $7.3 million, or $0.27 per
share.
Adjusted EBITDA, for the first half of 2020, was a loss of $3.9 million, compared with a profit of $12.4 million for the first half of 2019, which included the upfront payment of $17.5 million from
the Vericel licensing agreement, net of royalty payment of $0.7 million.
Conference Call
MediWound management will host a conference call for investors today, Thursday, August 6, 2020 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 3176168. The call also will be webcast live 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 27, 2020 by dialing 855-859-2056 (in the U.S.) or 404-537-3406 (outside the U.S.) and entering passcode
3176168. The call will also be archived on the Company website for 90 days at www.mediwound.com.
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, non-surgically and rapidly removes burn eschar 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.
About BARDA
The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human
Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies. For more information, refer to www.phe.gov/about/BARDA.
Funding and technical support for development of NexoBrid to obtain marketing approval in the U.S. including the expanded access treatment protocol (NEXT), the pivotal U.S. Phase 3 clinical study (DETECT) and the marketing approval registration
process for NexoBrid in the U.S. is provided by BARDA, under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional
projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in pediatric population, establishment of a pre-emergency use data package and development of the health economic
model to evaluate the cost savings impact to enable market adoption in the United States.
Cautionary Note Regarding Forward-Looking Statements
MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we
expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about
future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by
the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,”
“outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.
Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations, and commercial potential of
NexoBrid and EscharEx. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of clinical trial and product development activities; the
timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; the availability of funding from BARDA under its
agreement with MediWound for use in connection with NexoBrid development activities; the timing of the NexoBrid delivery to BARDA, expected payments under the license agreement with Vericel; competitive developments; whether FDA will accept all or
part of the BLA and provide marketing approval for NexoBrid in the United States; the risks related to the timing and conduct of NEXT Study; the ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing
of the interim assessment, the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will
affect the overall healthcare infrastructure, including the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to “shelter at home” or
other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of NexoBrid in the future.
These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and
Exchange Commission (“SEC”) on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes,
and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.
|
Contacts:
Boaz Gur-Lavie
Chief Financial Officer
MediWound Ltd.
ir@mediwound.com
|
Jeremy Feffer
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,
|
|||||||||||
|
2020
|
2019
|
2019
|
||||||||||
|
Un-audited
|
Audited
|
|||||||||||
|
Cash, cash equivalents and short term deposits
|
24,382
|
38,712
|
29,458
|
|||||||||
|
Accounts and other receivable
|
3,492
|
4,668
|
4,557
|
|||||||||
|
Inventories
|
1,934
|
1,535
|
1,613
|
|||||||||
|
Total current assets
|
29,808
|
44,915
|
35,628
|
|||||||||
|
Property, plant and equipment, net
|
2,326
|
2,183
|
2,304
|
|||||||||
|
Right of use assets, net
|
2,086
|
2,315
|
2,229
|
|||||||||
|
Intangible assets, net
|
396
|
462
|
429
|
|||||||||
|
Total long-term assets
|
4,808
|
4,960
|
4,962
|
|||||||||
|
Total assets
|
34,616
|
49,875
|
40,590
|
|||||||||
|
Current maturities of long-term liabilities
|
1,321
|
896
|
569
|
|||||||||
|
Trade payables and accrued expenses
|
2,423
|
4,073
|
4,067
|
|||||||||
|
Other payables
|
6,040
|
5,889
|
5,737
|
|||||||||
|
Total current liabilities
|
9,784
|
10,858
|
10,373
|
|||||||||
|
Deferred revenues
|
1,174
|
1,144
|
1,135
|
|||||||||
|
Liability in respect of Israeli Innovation Authority grants net of current maturity
|
7,130
|
6,919
|
6,811
|
|||||||||
|
Contingent consideration for the purchase of shares net of current maturity
|
4,249
|
4,412
|
4,853
|
|||||||||
|
Liability in respect of discontinued operation
|
-
|
6,003
|
-
|
|||||||||
|
Lease liabilities, net of current maturity
|
1,866
|
2,022
|
2,006
|
|||||||||
|
Severance pay liabilities, net
|
281
|
338
|
243
|
|||||||||
|
Total long-term liabilities
|
14,700
|
20,838
|
15,048
|
|||||||||
|
Shareholders' equity
|
10,132
|
18,179
|
15,169
|
|||||||||
|
Total liabilities & shareholder equity
|
34,616
|
49,875
|
40,590
|
|||||||||
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,
|
|||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
|||||||||||||
|
Revenues
|
8,465
|
21,207
|
4,027
|
20,746
|
||||||||||||
|
Cost of revenues
|
6,018
|
3,788
|
2,809
|
3,481
|
||||||||||||
|
Gross profit
|
2,447
|
17,419
|
1,217
|
17,265
|
||||||||||||
|
Operating expenses:
|
||||||||||||||||
|
Research and development, gross
|
3,312
|
6,075
|
1,593
|
1,893
|
||||||||||||
|
Participation by BARDA & IIA
|
19
|
(4,624
|
)
|
19
|
(1,721
|
)
|
||||||||||
|
Research and development, net
|
3,331
|
1,451
|
1,612
|
172
|
||||||||||||
|
Selling, general & administrative
|
4,028
|
4,708
|
2,311
|
2,343
|
||||||||||||
|
Other expenses
|
-
|
901
|
-
|
812
|
||||||||||||
|
Operating profit (loss)
|
(4,912
|
)
|
10,359
|
(2,706
|
)
|
13,938
|
||||||||||
|
Financial expenses, net
|
(645
|
)
|
(1,803
|
)
|
(390
|
)
|
(1,222
|
)
|
||||||||
|
Profit (loss) from continuing operations
|
(5,557
|
)
|
8,556
|
(3,096
|
)
|
12,716
|
||||||||||
|
Profit from discontinued operation
|
-
|
50
|
0
|
0
|
||||||||||||
|
Profit (loss) for the period
|
(5,557
|
)
|
8,606
|
(3,096
|
)
|
12,716
|
||||||||||
|
Foreign currency translation adjustments
|
1
|
2
|
0
|
(2
|
)
|
|||||||||||
|
Total comprehensive profit (loss)
|
(5,556
|
)
|
8,608
|
(3,096
|
)
|
12,714
|
||||||||||
|
Net Profit (loss) per share
|
(0.20
|
)
|
0.32
|
(0.11
|
)
|
0.47
|
||||||||||
|
Weighted average number of ordinary shares used in the computation of basic and diluted profit (loss) per share:
|
27,207
|
27,179
|
27,211
|
27,179
|
||||||||||||
MediWound, Ltd.
ADJUSTED EBITDA
U.S. dollars in thousands
|
Six months ended
|
Three months ended
|
|||||||||||||||
|
June 30,
|
June 30,
|
|||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
|||||||||||||
|
Profit (loss) for the period
|
(5,557
|
)
|
8,606
|
(3,096
|
)
|
12,716
|
||||||||||
|
Adjustments:
|
||||||||||||||||
|
Financial expenses, net
|
(645
|
)
|
(1,803
|
)
|
(390
|
)
|
(1,222
|
)
|
||||||||
|
Profit from discontinued operation
|
-
|
50
|
-
|
-
|
||||||||||||
|
Other expenses
|
-
|
(901
|
)
|
-
|
(812
|
)
|
||||||||||
|
Depreciation and amortization
|
(539
|
)
|
(552
|
)
|
(271
|
)
|
(278
|
)
|
||||||||
|
Share-based compensation expenses
|
(519
|
)
|
(599
|
)
|
(346
|
)
|
(324
|
)
|
||||||||
|
Total adjustments
|
(1,703
|
)
|
(3,805
|
)
|
(1,007
|
)
|
(2,636
|
)
|
||||||||
|
Adjusted EBITDA
|
(3,854
|
)
|
12,411
|
(2,089
|
)
|
15,352
|
||||||||||
MediWound, Ltd.
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW
(UNAUDITED)
U.S. dollars in thousands
|
|
Six months ended
June 30,
|
Three months ended
June 30,
|
||||||||||||||
|
|
2020
|
2019
|
2020
|
2019
|
||||||||||||
|
Cash Flows from Operating Activities:
|
||||||||||||||||
|
Net profit (loss)
|
(5,557
|
)
|
8,606
|
(3,096
|
)
|
12,716
|
||||||||||
|
|
||||||||||||||||
|
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
|
539
|
552
|
271
|
278
|
||||||||||||
|
Share-based compensation
|
519
|
599
|
346
|
324
|
||||||||||||
|
Revaluation of liabilities in respect of IIA grants
|
424
|
(392
|
)
|
226
|
(466
|
)
|
||||||||||
|
Revaluation of contingent consideration for the purchase of shares
|
348
|
1,322
|
196
|
1,081
|
||||||||||||
|
Revaluation of lease liabilities
|
64
|
194
|
100
|
91
|
||||||||||||
|
Increase (decrease) in severance liability, net
|
40
|
(10
|
)
|
19
|
13
|
|||||||||||
|
Financing income
|
(191
|
)
|
(149
|
)
|
(81
|
)
|
(87
|
)
|
||||||||
|
Unrealized foreign currency (gain) loss
|
28
|
(70
|
)
|
(51
|
)
|
60
|
||||||||||
|
|
1,771
|
1,996
|
1,026
|
1,294
|
||||||||||||
|
Changes in asset and liability items:
|
||||||||||||||||
|
Decrease (increase) in trade receivables
|
1,341
|
(9
|
)
|
444
|
(318
|
)
|
||||||||||
|
Decrease (increase) in inventories
|
(326
|
)
|
146
|
65
|
(62
|
)
|
||||||||||
|
Decrease (increase) in other receivables
|
(284
|
)
|
2,744
|
(383
|
)
|
2,482
|
||||||||||
|
Increase (decrease) in trade payables
|
(1,649
|
)
|
1,357
|
(1,004
|
)
|
1,076
|
||||||||||
|
Increase in other payables & deferred revenues
|
86
|
529
|
133
|
77
|
||||||||||||
|
|
(832
|
)
|
4,767
|
(745
|
)
|
3,255
|
||||||||||
|
Net cash provided by (used in) continuing operating activities
|
(4,618
|
)
|
15,369
|
(2,815
|
)
|
17,265
|
||||||||||
|
Net cash provided by discontinued operating activities
|
-
|
50
|
-
|
|||||||||||||
|
Net cash provided by (used in) operating activities
|
(4,618
|
)
|
15,419
|
(2,815
|
)
|
17,265
|
||||||||||
MediWound, Ltd.
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW
(UNAUDITED)-Cont.
U.S. dollars in thousands
|
|
Six months ended
June 30,
|
Three months ended
June 30,
|
||||||||||||||
|
|
2020
|
2019
|
2020
|
2019
|
||||||||||||
|
|
||||||||||||||||
|
Cash Flows from Investment Activities:
|
||||||||||||||||
|
Purchase of property and equipment
|
(244
|
)
|
(433
|
)
|
(100
|
)
|
(194
|
)
|
||||||||
|
Interest received
|
42
|
44
|
39
|
14
|
||||||||||||
|
Proceeds from short term bank deposits, net of investments
|
10,595
|
2,977
|
7,603
|
412
|
||||||||||||
|
Net cash provided by investing activities
|
10,393
|
2,588
|
7,542
|
232
|
||||||||||||
|
Cash Flows from Financing Activities:
|
||||||||||||||||
|
Repayment of lease liabilities
|
(313
|
)
|
(312
|
)
|
(153
|
)
|
(157
|
)
|
||||||||
|
Proceeds from IIA grants, net of repayments
|
(66
|
)
|
193
|
-
|
248
|
|||||||||||
|
Net cash (used in) provided by financing activities
|
(379
|
)
|
(119
|
)
|
(153
|
)
|
91
|
|||||||||
|
|
||||||||||||||||
|
Exchange rate differences on cash and cash equivalent balances
|
(26
|
)
|
63
|
57
|
(55
|
)
|
||||||||||
|
|
||||||||||||||||
|
Increase in cash and cash equivalents from continuing activities
|
5,370
|
17,901
|
4,631
|
17,533
|
||||||||||||
|
Increase in cash and cash equivalents from discontinued activities
|
-
|
50
|
-
|
-
|
||||||||||||
|
Balance of cash and cash equivalents at the beginning of the period
|
7,242
|
6,716
|
7,981
|
7,134
|
||||||||||||
|
Balance of cash and cash equivalents at the end of the period
|
12,612
|
24,667
|
12,612
|
24,667
|
||||||||||||
Exhibit 99.2
MEDIWOUND LTD. AND ITS SUBSIDIARIES
INTERIM CONDENSED FINANCIAL STATEMENTS
AS OF JUNE 30, 2020
IN U.S. DOLLARS IN THOUSANDS
UNAUDITED
INDEX
|
Page
|
|
|
F-2
|
|
|
F-3
|
|
|
F-4 – F-6
|
|
|
F-7 – F-8
|
|
|
F-9 – F-10
|
- - - - - - - - - - - - -
MEDIWOUND LTD. AND ITS SUBSIDIARIES
U.S. dollars in thousands
|
June 30,
|
December 31,
|
|||||||||||
|
2020
|
2019
|
2019
|
||||||||||
|
Unaudited
|
Audited
|
|||||||||||
|
CURRENT ASSETS:
|
||||||||||||
|
Cash and cash equivalents
|
12,612
|
24,667
|
7,242
|
|||||||||
|
Restricted deposits
|
179
|
175
|
180
|
|||||||||
|
Short‑term bank deposits
|
11,591
|
13,870
|
22,036
|
|||||||||
|
Trade receivables
|
2,764
|
570
|
4,107
|
|||||||||
|
Inventories
|
1,934
|
1,535
|
1,613
|
|||||||||
|
Other receivables
|
728
|
4,098
|
450
|
|||||||||
|
29,808
|
44,915
|
35,628
|
||||||||||
|
LONG‑TERM ASSETS:
|
||||||||||||
|
Property, plant and equipment, net
|
2,326
|
2,183
|
2,304
|
|||||||||
|
Right of-use assets, net
|
2,086
|
2,315
|
2,229
|
|||||||||
|
Intangible assets, net
|
396
|
462
|
429
|
|||||||||
|
4,808
|
4,960
|
4,962
|
||||||||||
|
34,616
|
49,875
|
40,590
|
||||||||||
|
CURRENT LIABILITIES:
|
||||||||||||
|
Current maturities of long-term liabilities
|
1,321
|
896
|
569
|
|||||||||
|
Trade payables and accrued expenses
|
2,423
|
3,993
|
4,067
|
|||||||||
|
Other payables
|
6,040
|
5,969
|
5,737
|
|||||||||
|
9,784
|
10,858
|
10,373
|
||||||||||
|
LONG‑TERM LIABILITIES:
|
||||||||||||
|
Deferred revenues
|
1,174
|
1,144
|
1,135
|
|||||||||
|
Liability in respect of IIA grants
|
7,130
|
6,919
|
6,811
|
|||||||||
|
Contingent consideration for purchase of shares
|
4,249
|
4,412
|
4,853
|
|||||||||
|
Liability in respect of discontinued operation
|
-
|
6,003
|
-
|
|||||||||
|
Lease liabilities
|
1,866
|
2,022
|
2,006
|
|||||||||
|
Severance pay liabilities, net
|
281
|
338
|
243
|
|||||||||
|
14,700
|
20,838
|
15,048
|
||||||||||
|
SHAREHOLDERS' EQUITY:
|
||||||||||||
|
Ordinary shares of NIS 0.01 par value:
|
||||||||||||
|
Authorized: 50,000,000 shares as of June 30, 2020, December 31, 2019 and 37,244,508 shares as of June 30, 2019; Issued and Outstanding: 27,211,128 as of June 30,
2020, 27,202,795 as of December 31, 2019 and 27,178,839 as of June 30, 2019
|
75
|
75
|
75
|
|||||||||
|
Share premium
|
141,390
|
140,236
|
140,871
|
|||||||||
|
Foreign currency translation adjustments
|
(16
|
)
|
(23
|
)
|
(17
|
)
|
||||||
|
Accumulated deficit
|
(131,317
|
)
|
(122,109
|
)
|
(125,760
|
)
|
||||||
|
10,132
|
18,179
|
15,169
|
||||||||||
|
34,616
|
49,875
|
40,590
|
||||||||||
The accompanying notes are an integral part of the interim financial statements.
F - 2
MEDIWOUND LTD. AND ITS SUBSIDIARIES
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,
|
||||||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
2019
|
||||||||||||||||
|
Unaudited
|
Audited
|
|||||||||||||||||||
|
Revenues from sale of products
|
1,662
|
1,309
|
1,015
|
895
|
3,393
|
|||||||||||||||
|
Revenues from development services
|
6,631
|
2,301
|
2,922
|
2,301
|
10,678
|
|||||||||||||||
|
Revenues from license agreements
|
172
|
17,597
|
90
|
17,550
|
17,718
|
|||||||||||||||
|
Total revenues
|
8,465
|
21,207
|
4,027
|
20,746
|
31,789
|
|||||||||||||||
|
Cost of revenues
|
6,018
|
3,520
|
2,810
|
3,481
|
11,849
|
|||||||||||||||
|
Gross profit
|
2,447
|
17,687
|
1,217
|
17,265
|
19,940
|
|||||||||||||||
|
Research and development, gross
|
3,312
|
6,343
|
1,593
|
1,893
|
10,070
|
|||||||||||||||
|
Participations by BARDA and IIA
|
19
|
(4,624
|
)
|
19
|
(1,721
|
)
|
(5,101
|
)
|
||||||||||||
|
Research and development, net of participations
|
3,331
|
1,719
|
1,612
|
172
|
4,969
|
|||||||||||||||
|
Selling and marketing
|
1,683
|
2,134
|
859
|
1,101
|
4,064
|
|||||||||||||||
|
General and administrative
|
2,345
|
2,574
|
1,452
|
1,242
|
5,242
|
|||||||||||||||
|
Other expenses
|
-
|
901
|
-
|
812
|
1,172
|
|||||||||||||||
|
Total operating expenses
|
7,359
|
7,328
|
3,923
|
3,327
|
15,447
|
|||||||||||||||
|
Operating profit (loss)
|
(4,912
|
)
|
10,359
|
(2,706
|
)
|
13,938
|
4,493
|
|||||||||||||
|
Financial income
|
323
|
153
|
101
|
92
|
556
|
|||||||||||||||
|
Financial expense
|
(968
|
)
|
(1,956
|
)
|
(491
|
)
|
(1,314
|
)
|
(2,983
|
)
|
||||||||||
|
Profit (loss) from continuing operation
|
(5,557
|
)
|
8,556
|
(3,096
|
)
|
12,716
|
2,066
|
|||||||||||||
|
Profit from discontinued operation
|
-
|
50
|
-
|
-
|
2,889
|
|||||||||||||||
|
Net Profit (loss)
|
(5,557
|
)
|
8,606
|
(3,096
|
)
|
12,716
|
4,955
|
|||||||||||||
|
Other comprehensive income (loss):
|
||||||||||||||||||||
|
Foreign currency translation adjustments
|
1
|
2
|
(7
|
)
|
(2
|
)
|
8
|
|||||||||||||
|
Total comprehensive income (loss)
|
(5,556
|
)
|
8,608
|
(3,103
|
)
|
12,714
|
4,963
|
|||||||||||||
|
Basic and diluted net profit (loss) per share from continuing operations
|
(0.20
|
)
|
0.32
|
(0.11
|
)
|
0.47
|
0.08
|
|||||||||||||
|
Basic and diluted net profit (loss) per share from discontinued operations
|
-
|
(*
|
)
|
-
|
-
|
0.10
|
||||||||||||||
|
Total Basic and diluted net profit (loss) per share
|
(0.20
|
)
|
0.32
|
(0.11
|
)
|
0.47
|
0.18
|
|||||||||||||
(*) Represents less than $ 1.
The accompanying notes are an integral part of the interim consolidated financial statements.
F - 3
MEDIWOUND LTD. AND ITS SUBSIDIARIES
U.S. dollars in thousands
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
Equity
|
||||||||||||||||
|
Balance as of December 31, 2019
|
75
|
140,871
|
(17
|
)
|
(125,760
|
)
|
15,169
|
|||||||||||||
|
Loss for the period
|
-
|
-
|
-
|
(5,557
|
)
|
(5,557
|
)
|
|||||||||||||
|
Other comprehensive income
|
-
|
-
|
1
|
-
|
1
|
|||||||||||||||
|
Total comprehensive loss
|
-
|
-
|
1
|
(5,557
|
)
|
(5,556
|
)
|
|||||||||||||
|
Share-based compensation
|
-
|
519
|
-
|
-
|
519
|
|||||||||||||||
|
Balance as of June 30, 2020 (unaudited)
|
75
|
141,390
|
(16
|
)
|
(131,317
|
)
|
10,132
|
|||||||||||||
|
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
|
|||||||||||||
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, 2020
|
75
|
141,044
|
(9
|
)
|
(128,221
|
)
|
12,889
|
|||||||||||||
|
Loss for the period
|
-
|
-
|
-
|
(3,096
|
)
|
(3,096
|
)
|
|||||||||||||
|
Other comprehensive loss
|
-
|
-
|
(7
|
)
|
-
|
(7
|
)
|
|||||||||||||
|
Total comprehensive loss
|
-
|
-
|
(7
|
)
|
(3,096
|
)
|
(3,103
|
)
|
||||||||||||
|
Share-based compensation
|
-
|
346
|
-
|
-
|
346
|
|||||||||||||||
|
Balance as of June 30, 2020 (unaudited)
|
75
|
141,390
|
(16
|
)
|
(131,317
|
)
|
10,132
|
|||||||||||||
|
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 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
|
|||||||||||||
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, 2018
|
75
|
139,637
|
(25
|
)
|
(130,715
|
)
|
8,972
|
|||||||||||||
|
Profit for the period
|
-
|
-
|
-
|
4,955
|
4,955
|
|||||||||||||||
|
Other comprehensive income
|
-
|
-
|
8
|
-
|
8
|
|||||||||||||||
|
Total comprehensive income
|
-
|
-
|
8
|
4,955
|
4,963
|
|||||||||||||||
|
Exercise of options
|
(*
|
)
|
-
|
-
|
-
|
(*
|
)
|
|||||||||||||
|
Share-based compensation
|
-
|
1,234
|
-
|
-
|
1,234
|
|||||||||||||||
|
Balance as of December 31, 2019
|
75
|
140,871
|
(17
|
)
|
(125,760
|
)
|
15,169
|
|||||||||||||
(*) Represents less than $ 1.
The accompanying notes are an integral part of the interim consolidated financial statements.
F - 6
MEDIWOUND LTD. AND ITS SUBSIDIARIES
U.S. dollars in thousands
|
Six months ended
June 30,
|
Three months ended
June 30,
|
Year ended December 31,
|
||||||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
2019
|
||||||||||||||||
|
Unaudited
|
Audited
|
|||||||||||||||||||
|
Cash flows from operating activities:
|
||||||||||||||||||||
|
Net Profit (loss)
|
(5,557
|
)
|
8,606
|
(3,096
|
) |
12,716
|
4,955
|
|||||||||||||
|
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
|
)
|
-
|
-
|
(2,889
|
)
|
|||||||||||||
|
Depreciation and amortization
|
539
|
552
|
271
|
278
|
1,149
|
|||||||||||||||
|
Share-based compensation
|
519
|
599
|
346
|
324
|
1,234
|
|||||||||||||||
|
Revaluation of liability in respect of IIA grants
|
424
|
(392
|
)
|
226
|
(466
|
)
|
(392
|
)
|
||||||||||||
|
Revaluation of contingent consideration for the purchase of shares
|
348
|
1,322
|
196
|
1,081
|
1,690
|
|||||||||||||||
|
Revaluation of lease liabilities
|
64
|
194
|
100
|
91
|
340
|
|||||||||||||||
|
Increase (decrease) in severance pay liabilities, net
|
40
|
(10
|
)
|
19
|
13
|
(105
|
)
|
|||||||||||||
|
Net financing income
|
(191
|
)
|
(149
|
)
|
(81
|
)
|
(87
|
)
|
(434
|
)
|
||||||||||
|
Un-realized foreign currency (gain) loss
|
28
|
(70
|
)
|
(51
|
)
|
60
|
(152
|
)
|
||||||||||||
|
1,771
|
1,996
|
1,026
|
1,294
|
441
|
||||||||||||||||
|
Changes in asset and liability items:
|
||||||||||||||||||||
|
Decrease (increase) in trade receivables
|
1,341
|
(9
|
)
|
444
|
(318
|
)
|
(3,553
|
)
|
||||||||||||
|
Decrease (increase) in inventories
|
(326
|
)
|
146
|
65
|
(62
|
)
|
67
|
|||||||||||||
|
Decrease (increase) in other receivables
|
(284
|
)
|
2,744
|
(383
|
)
|
2,482
|
6,376
|
|||||||||||||
|
Increase (decrease) in trade payables and accrued expenses
|
(1,649
|
)
|
1,277
|
(1,004
|
)
|
1,058
|
1,355
|
|||||||||||||
|
Increase in other payables and deferred revenues
|
86
|
609
|
133
|
95
|
247
|
|||||||||||||||
|
(832
|
)
|
4,767
|
(745
|
)
|
3,255
|
4,492
|
||||||||||||||
|
Net cash provided by (used in) continuing operating activities
|
(4,618
|
)
|
15,369
|
(2,815
|
)
|
17,265
|
9,888
|
|||||||||||||
|
Net cash provided by (used in) discontinued operating activities
|
-
|
50
|
-
|
-
|
(1,599
|
)
|
||||||||||||||
|
Net cash provided by (used in) operating activities
|
(4,618
|
)
|
15,419
|
(2,815
|
)
|
17,265
|
8,289
|
|||||||||||||
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,
|
||||||||||||||||||
| 2020 |
2019
|
2020 |
2019
|
2019
|
||||||||||||||||
|
Unaudited
|
Audited
|
|||||||||||||||||||
|
Cash Flows from Investing Activities:
|
||||||||||||||||||||
|
Purchase of property and equipment
|
(244
|
)
|
(433
|
)
|
(100
|
)
|
(194
|
)
|
(792
|
)
|
||||||||||
|
Interest received
|
42
|
44
|
39
|
14
|
184
|
|||||||||||||||
|
Proceeds from (investment in) short term bank deposits, net
|
10,595
|
2,977
|
7,603
|
412
|
(5,050
|
)
|
||||||||||||||
|
Net cash provided by (used in) continuing investing activities
|
10,393
|
2,588
|
7,542
|
232
|
(5,658
|
)
|
||||||||||||||
|
Net cash used in discontinued investing activities
|
-
|
-
|
-
|
-
|
(1,239
|
)
|
||||||||||||||
|
Net cash provided by (used in) investing activities
|
10,393
|
2,588
|
7,542
|
232
|
(6,897
|
)
|
||||||||||||||
|
Cash Flows from Financing Activities:
|
||||||||||||||||||||
|
Repayment of leases liabilities
|
(313
|
)
|
(312
|
)
|
(153
|
)
|
(157
|
)
|
(630
|
)
|
||||||||||
|
Proceeds from exercise of options
|
-
|
-
|
-
|
-
|
(*
|
)
|
||||||||||||||
|
Proceeds of IIA grant, net of repayments
|
(66
|
)
|
193
|
-
|
248
|
(376
|
)
|
|||||||||||||
|
Net cash (used in) provided by financing activities
|
(379
|
)
|
(119
|
)
|
(153
|
)
|
91
|
(1,006
|
)
|
|||||||||||
|
Exchange rate differences on cash and cash equivalent balances
|
(26
|
)
|
63
|
57
|
(55
|
)
|
140
|
|||||||||||||
|
Cash and cash equivalents:
|
||||||||||||||||||||
|
Increase in cash and cash equivalents from continuing activities
|
5,370
|
17,901
|
4,631
|
17,533
|
3,364
|
|||||||||||||||
|
Increase (decrease) in cash and cash equivalents from discontinued activities
|
-
|
50
|
-
|
-
|
(2,838
|
)
|
||||||||||||||
|
Balance of cash and cash equivalents at the beginning of the period
|
7,242
|
6,716
|
7,981
|
7,134
|
6,716
|
|||||||||||||||
|
Balance of cash and cash equivalents at the end of the period
|
12,612
|
24,667
|
12,612
|
24,667
|
7,242
|
|||||||||||||||
(*) Represents less than $ 1.
The accompanying notes are an integral part of the interim consolidated financial statements.
F - 8
MEDIWOUND LTD. AND ITS SUBSIDIARIES
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 bringing innovative therapies to address unmet medical needs in severe burn and wound management, The Company's
first innovative biopharmaceutical product, NexoBrid, received marketing authorization from the European Medicines Agency ("EMA") as well as the Israeli, Argentinean, South-Korean, Russian and Peruvian 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 organizations and in other territories through local
distributers. In 2019, the Company entered into exclusive license and supply agreements with Vericel Corporation (“Vericel”) to commercialize NexoBrid in North America.
The Company second investigational innovative product, EscharEx, is a topical biological drug being developed for debridement of chronic and other hard-to-heal wounds.
|
| b. |
The Company's securities are listed for trading on NASDAQ since March 2014.
|
| c. |
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 10% of PolyHeal Ltd., a private life sciences company ("PolyHeal").
|
| d. |
The Company awarded two contracts with the U.S. Biomedical Advanced Research and Development Authority ("BARDA"), 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.
On March 3, 2020 BARDA has expanded its awarded contract with MediWound providing supplemental funding of $5.5 million to support emergency readiness for NexoBrid deployment.
|
| 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").
|
F - 9
MEDIWOUND LTD. AND ITS SUBSIDIARIES
NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
| NOTE 2: |
SIGNIFICANT ACCOUNTING POLICIES-Cont.
|
| b. |
Basis of preparation of the interim consolidated financial statements:
|
The interim condensed consolidated financial statements for the three months ended June 30, 2020 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, 2019 that were included in the Annual Report on Form 20-F filed on February 25, 2020.
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, 2019 that were included in the Annual Report on Form 20-F filed on February 25, 2020, except than the change discussed below.
| c. |
Reclassification:
|
Certain amounts previously reported in the consolidated financial statements have been reclassified to conform to current year presentation. Such reclassifications did not
affect net loss, shareholders’ equity or cash flows.
NOTE 3: EQUITY
On April 23, 2020, the Company's Board of Directors approved the grant of 1,274,379 options to purchase ordinary shares, for an exercise price of $ 1.75 per share, to
its employees, officers and members of the board. The fair value of the options, as of the grant date, was estimated at $1.8 million.
On June 29, 2020, the general meeting of the Company approved the abovementioned grants related the CEO and members of the board which were estimated at approximately
$1.4 million.
******
F - 10