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 May 2020
Commission File Number: 001-36349
MediWound Ltd.
(Translation of registrant’s name into English)
(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 May 20, 2020, MediWound Ltd. (the “Company”) issued a press release entitled “MediWound Reports First 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 March 31, 2020, attached as Exhibit 99.2, which was provided by the Company to CBI on May 19, 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.
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MEDIWOUND LTD.
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|||
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Date: May 20, 2020
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By:
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/s/ Boaz Gur-Lavie | |
| Name: | Boaz Gur-Lavie | ||
| Title: | Chief Financial Officer | ||
3
EXHIBIT INDEX
The following exhibit is filed as part of this Form 6-K:
| Exhibit |
Description |
4
Exhibit 99.1
MediWound Reports First Quarter 2020 Financial Results and
Provides Corporate Update
EscharEx U.S. Phase 2 Study Resumed Patient Screening
YAVNE, Israel, May 20, 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 first quarter ended March 31, 2020 and provided business and financial updates related to the COVID-19 pandemic.
First Quarter Business and Financial Highlights:
| • |
Total revenues for the first quarter of 2020 were $4.4 million
|
| • |
Operating loss for the first quarter of 2020 was $2.2 million, representing a 38% decrease compared to prior-year period
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| • |
Operating cash flow was $2.1 million, and as of March 31, 2020, the company had $27.3 million in cash and short-term investments
|
| • |
Subsequent to the end of the quarter, the Company resumed patient screening and randomization in U.S. EscharEx phase 2 adaptive design study for the treatment of venous leg ulcers (“VLUs”) where clinical trial restrictions being
lifted; interim assessment anticipated in first half of 2021
|
| • |
Following the initiation of the procurement of NexoBrid for emergency response, valued at $16.5 million, the U.S. Biomedical Advanced Research and Development Authority (BARDA) upsized its contract by an additional $5.5 million for
emergency readiness for NexoBrid deployment
|
| • |
Instituted a series of precautionary measures in response to COVID-19 pandemic and implemented expense reduction measures, while maintaining workforce and operational readiness to rapidly return to normal operations when conditions
allow
|
| • |
Continued global expansion of NexoBrid through new distribution agreements
|
| • |
Enhanced Board of Directors with experienced executives with significant expertise in the U.S. pharmaceutical industry
|
“Our thoughts are with those affected by the coronavirus, and we are especially thankful to all healthcare workers for their critical efforts to support patients during this challenging time. Our
first priority remains the health and safety of patients, healthcare providers, and our employees globally,” said Sharon Malka, Chief Executive Officer of MediWound. “We are pleased to resume patient enrollment in our U.S. EscharEx phase 2 study
in regions where restrictions are being lifted. NexoBrid has been less directly impacted by the pandemic given the critical nature of severe burn injuries.”
Mr. Malka concluded, “The tremendous dedication and flexibility our employees have demonstrated during this crisis have enabled us to carry on critical business functions. We will continue to
monitor our operations and assess the impact of the COVID-19, and we will determine whether further actions are appropriate while taking prudent measures to ensure a rapid return to normal operations as conditions allow. Given our financial
position and the underlying fundamentals of our business, we believe that the Company is well-positioned to weather this storm.”
Corporate Update
Over the past several weeks, MediWound has implemented several measures to safeguard the health and well-being of its employees, their families and healthcare providers, including implementing
appropriate expense reduction measures, while continuing to manufacture and supply NexoBrid to patients with severe burn injuries.
The Company continues to manufacture NexoBrid and 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.
Following the initiation of the procurement of NexoBrid for emergency response, MediWound began manufacturing NexoBrid and building an emergency stockpile. As a result of shifting priorities
related to the COVID-19 pandemic, BARDA requested an adjustment to the delivery plan of NexoBrid emergency stock. The first delivery of NexoBrid is currently expected in the third quarter of 2020.
On the clinical front, the Company has resumed new patient screening and randomization in its U.S. EscharEx phase 2 adaptive design study for the treatment of VLUs in regions where COVID-19
clinical trial restrictions are being lifted, and in compliance with applicable governmental orders and clinical sites policies and procedures. Consequently, the pre-defined interim assessment is anticipated 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 also continues to plan for a
mid-2020 submission of the NexoBrid Biologics License Application to the FDA.
The Company expects cash use for ongoing operating activities in 2020 to be in the range of $8 million 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 operating results.
First Quarter Financial Results
Revenues for the first quarter of 2020 were $4.4 million, compared with $0.5 million in the first quarter of 2019, driven primarily by revenues from development services.
Gross profit for the first quarter of 2020 was $1.2 million, compared to a gross profit of $0.2 million for the prior-year period.
Research and development expenses for the first quarter of 2020, net of participations, were $1.7 million, compared with $1.3 million for the first quarter of 2019. The increase was primarily as
a result of EscharEx clinical development.
Selling, general and administrative expenses for the first quarter of 2020 were $1.7 million, compared with $2.4 million for the first quarter of 2019. The decrease was a result of cost reduction
measures and one-time management transition costs in the first quarter of 2019.
Operating loss for the first quarter of 2020 was $2.2 million, compared with $3.6 million in the first quarter of 2019.
The Company posted a net loss of $2.5 million, or $0.09 per share, for the first quarter of 2020 compared with a net loss
of $4.1 million, or $0.15 per share, for the first quarter of 2019.
Adjusted EBITDA, as defined below, for the first quarter of 2020 was a loss of $1.8 million, compared with a loss of $2.9 million for the first quarter of 2019.
Operating cash flow in the first quarter of 2020 was $2.1 million and as of March 31, 2020, the Company had $27.3 million in cash and short-term bank deposits and carries no debt.
Conference Call
MediWound management will host a conference call for investors today, Wednesday, May 20, 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 9851859. 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 May 28, 2020 by dialing 855-859-2056 (in the U.S.) or 404-537-3406 (outside the U.S.) and entering passcode 9851859.
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 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 the Biomedical Advanced Research and Development Authority (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
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 U.S. 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 the impact of the COVID-19 pandemic on the
Company’s operations, including its ongoing clinical studies, enrollment of patients for the Company’s clinical studies, the timing of the Company’s clinical studies, the timing of the pre-defined Phase 2 interim assessment, the operation of the
manufacturing facility, including the level of inventory, the timing of the delivery of NexoBrid emergency stock to BARDA, as well as the filing of the BLA and the Company’s expected financial results, including its cash use guidance. 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 ongoing risks to our business and operations related to the COVID-19 outbreak, that
we may not submit the BLA to FDA in the timeframe expected, or at all; risks related to BARDA contracts the ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, 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 and the risks discussed under the heading “Risk Factors” in our annual report on Form 20-F for the year ended December 31, 2019 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.
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Contacts:
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Jeremy Feffer
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Boaz Gur-Lavie
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Jeremy Feffer
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Chief Financial Officer
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Managing Director, LifeSci Advisors
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MediWound Ltd.
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212-915-2568
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ir@mediwound.com
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jeremy@lifesciadvisors.com
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MediWound, Ltd.
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
|
March 31,
|
December 31,
|
|||||||||||
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2020
|
2019
|
2019
|
||||||||||
|
Un-audited
|
Audited
|
|||||||||||
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Cash, cash equivalents and short term deposits
|
27,311
|
21,517
|
29,458
|
|||||||||
|
Accounts and other receivable
|
3,540
|
6,755
|
4,557
|
|||||||||
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Inventories
|
2,004
|
1,472
|
1,613
|
|||||||||
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Total current assets
|
32,855
|
29,744
|
35,628
|
|||||||||
|
Property, plant and equipment, net
|
2,339
|
2,151
|
2,304
|
|||||||||
|
Right of use assets
|
2,191
|
2,418
|
2,229
|
|||||||||
|
Intangible assets, net
|
413
|
479
|
429
|
|||||||||
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Total long term assets
|
4,943
|
5,048
|
4,962
|
|||||||||
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Total assets
|
37,798
|
34,792
|
40,590
|
|||||||||
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Current maturities of long-term liabilities
|
1,417
|
2,018
|
569
|
|||||||||
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Trade payables and accrued expenses
|
3,423
|
2,996
|
4,067
|
|||||||||
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Other payables
|
5,843
|
2,438
|
5,737
|
|||||||||
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Total current liabilities
|
10,683
|
7,452
|
10,373
|
|||||||||
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Deferred revenues
|
1,018
|
1,145
|
1,135
|
|||||||||
|
Liabilities in respect of Israeli Innovation Authority grants net of current maturities
|
6,942
|
7,497
|
6,811
|
|||||||||
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Contingent consideration for the purchase of shares net of current maturities
|
4,097
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5,186
|
4,853
|
|||||||||
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Liability in respect of discontinued operation
|
-
|
6,003
|
-
|
|||||||||
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Lease liability, net of current maturities
|
1,905
|
2,043
|
2,006
|
|||||||||
|
Severance pay liability, net
|
264
|
325
|
243
|
|||||||||
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Total long term liabilities
|
14,226
|
22,199
|
15,048
|
|||||||||
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Shareholders' equity
|
12,889
|
5,141
|
15,169
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|||||||||
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Total liabilities & shareholder equity
|
37,798
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34,792
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40,590
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|||||||||
MediWound, Ltd.
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS (ANAUDITED)
U.S. dollars in thousands
|
Three months ended
|
||||||||
|
March 31,
|
||||||||
|
2020
|
2019
|
|||||||
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Revenues
|
4,438
|
461
|
||||||
|
Cost of revenues
|
3,208
|
307
|
||||||
|
Gross profit
|
1,230
|
154
|
||||||
|
Operating expenses:
|
||||||||
|
Research and development, gross
|
1,719
|
4,182
|
||||||
|
Participation by BARDA & IIA
|
-
|
(2,903
|
)
|
|||||
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Research and development, net
|
1,719
|
1,279
|
||||||
|
Selling, general and administrative
|
1,717
|
2,365
|
||||||
|
Other expenses
|
-
|
89
|
||||||
|
Operating loss
|
(2,206
|
)
|
(3,579
|
)
|
||||
|
Financial income
|
239
|
61
|
||||||
|
Financial expense
|
(494
|
)
|
(642
|
)
|
||||
|
Loss from continuing operations
|
(2,461
|
)
|
(4,160
|
)
|
||||
|
Profit from discontinued operation
|
-
|
50
|
||||||
|
Loss for the period
|
(2,461
|
)
|
(4,110
|
)
|
||||
|
Foreign currency translation adjustments
|
8
|
4
|
||||||
|
Total comprehensive loss
|
(2,453
|
)
|
(4,106
|
)
|
||||
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Basic and diluted loss per share:
|
||||||||
|
Loss from continuing operations
|
(0.09
|
)
|
(0.15
|
)
|
||||
|
Profit from discontinued operation
|
0.00
|
0.00
|
||||||
|
Net loss per share
|
(0.09
|
)
|
(0.15
|
)
|
||||
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Weighted average number of ordinary shares used in the computation of basic and diluted loss per share:
|
27,211
|
27,179
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||||||
ADJUSTED EBITDA
U.S. dollars in thousands
|
Three months ended
|
||||||||
|
March 31,
|
||||||||
|
2020
|
2019
|
|||||||
|
Loss for the period
|
(2,461
|
)
|
(4,110
|
)
|
||||
|
Adjustments:
|
||||||||
|
Financial (expenses) income, net
|
(255
|
)
|
(581
|
)
|
||||
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Profit from discontinued operation
|
-
|
50
|
||||||
|
Other expenses
|
-
|
(89
|
)
|
|||||
|
Depreciation and amortization
|
(268
|
)
|
(274
|
)
|
||||
|
Share-based compensation expenses
|
(173
|
)
|
(275
|
)
|
||||
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Total adjustments
|
(696
|
)
|
(1,169
|
)
|
||||
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Adjusted EBITDA
|
(1,765
|
)
|
(2,941
|
)
|
||||
MediWound, Ltd.
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW (UNAUDITED)
U.S. dollars in thousands
|
Three months ended
|
||||||||
|
March 31,
|
||||||||
|
2020
|
2019
|
|||||||
|
Cash Flows from Operating Activities:
|
||||||||
|
Net loss
|
(2,461
|
)
|
(4,110
|
)
|
||||
|
Adjustments to reconcile net loss to net cash used in continuing operating activities:
|
||||||||
|
Adjustments to profit and loss items:
|
||||||||
|
Profit from discontinued operation
|
-
|
(50
|
)
|
|||||
|
Depreciation and amortization
|
268
|
274
|
||||||
|
Share-based compensation
|
173
|
275
|
||||||
|
Revaluation of liabilities in respect of IIA grants
|
198
|
74
|
||||||
|
Revaluation of contingent consideration for the purchase of shares
|
152
|
241
|
||||||
|
Revaluation of lease liabilities
|
(36
|
)
|
103
|
|||||
|
Increase (decrease) in severance liability, net
|
21
|
(23
|
)
|
|||||
|
Financing income
|
(110
|
)
|
(62
|
)
|
||||
|
Unrealized foreign currency (gain) loss
|
79
|
(130
|
)
|
|||||
|
745
|
702
|
|||||||
|
Changes in asset and liability items:
|
||||||||
|
Decrease in trade receivables
|
897
|
309
|
||||||
|
Decrease (increase) in inventories
|
(391
|
)
|
208
|
|||||
|
Decrease in other receivables
|
99
|
262
|
||||||
|
Increase (decrease) in trade payables & accrued expenses
|
(645
|
)
|
281
|
|||||
|
Increase (decrease) in other payables & deferred revenues
|
(47
|
)
|
452
|
|||||
|
(87
|
)
|
1,512
|
||||||
|
Net cash used in continuing operating activities
|
(1,803
|
)
|
(1,896
|
)
|
||||
|
Net cash provided by discontinued operating activities
|
-
|
50
|
||||||
|
Net cash used in operating activities
|
(1,803
|
)
|
(1,846
|
)
|
||||
|
Cash Flows from Investment Activities:
|
||||||||
|
Purchase of property and equipment
|
(144
|
)
|
(239
|
)
|
||||
|
Interest received
|
3
|
30
|
||||||
|
Proceeds from short term bank deposits, net of investments
|
2,992
|
2,565
|
||||||
|
Net cash provided by investing activities
|
2,851
|
2,356
|
||||||
|
Cash Flows from Financing Activities:
|
||||||||
|
Repayment of lease liabilities
|
(160
|
)
|
(155
|
)
|
||||
|
Repayment of IIA grants
|
(66
|
)
|
(55
|
)
|
||||
|
Net cash used in financing activities
|
(226
|
)
|
(210
|
)
|
||||
|
Exchange rate differences on cash and cash equivalent balances
|
(83
|
)
|
118
|
|||||
|
Increase in cash and cash equivalents from continuing activities
|
739
|
368
|
||||||
|
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
|
||||||
|
Balance of cash and cash equivalents at the end of the period
|
7,981
|
7,134
|
||||||
Exhibit 99.2
MEDIWOUND LTD. AND ITS SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF MARCH 31, 2020
IN U.S. DOLLARS IN THOUSANDS
UNAUDITED
INDEX
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Page
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F-2
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F-3
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F-4
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F-5 – F-6
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F-7 – F-8
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F-9 – F-10
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 |
Kost Forer Gabbay & Kasierer
144 Menachem Begin Rd.
Tel-Aviv 6492102, Israel
|
Tel: +972-3-6232525
Fax: +972-3-5622555
ey.com
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Introduction
We have reviewed the accompanying financial information of Mediwound Ltd. and its subsidiaries ("the Company") which comprises the condensed consolidated balance sheet as of March 31, 2020 and the
related condensed consolidated statements of comprehensive loss, changes in equity and cash flows for the three months then ended. The Company's board of directors and management are responsible for the preparation and presentation of interim
financial information for this period in accordance with IAS 34, "Interim Financial Reporting". Our responsibility is to express a conclusion on this interim financial information based on our review.
Scope of review
We conducted our review in accordance with Review Standard 1 of the Institute of Certified Public Accountants in Israel, "Review of Interim Financial Information Performed by the Independent Auditor
of the Entity". A review of interim financial information consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in
scope than an audit conducted in accordance with generally accepted auditing standards in Israel and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit.
Accordingly, we do not express an audit opinion.
Conclusion
Based on our review, nothing has come to our attention that causes us to believe that the accompanying interim financial information is not prepared, in all material respects, in accordance with IAS
34.
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Tel-Aviv, Israel
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KOST FORER GABBAY & KASIERER
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May 20, 2020
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A Member of Ernst & Young Global
|
F - 2
MEDIWOUND LTD. AND ITS SUBSIDIARIES
U.S. dollars in thousands
|
March 31,
|
December 31,
|
|||||||||||
|
2020
|
2019
|
2019
|
||||||||||
|
Unaudited
|
Audited
|
|||||||||||
|
CURRENT ASSETS:
|
||||||||||||
|
Cash and cash equivalents
|
7,981
|
7,134
|
7,242
|
|||||||||
|
Restricted deposits
|
174
|
172
|
180
|
|||||||||
|
Short-term bank deposits
|
19,156
|
14,211
|
22,036
|
|||||||||
|
Trade receivables
|
3,195
|
244
|
4,107
|
|||||||||
|
Inventories
|
2,004
|
1,472
|
1,613
|
|||||||||
|
Other receivables
|
345
|
6,511
|
450
|
|||||||||
|
32,855
|
29,744
|
35,628
|
||||||||||
|
LONG-TERM ASSETS:
|
||||||||||||
|
Property, plant and equipment, net
|
2,339
|
2,151
|
2,304
|
|||||||||
|
Right of-use assets, net
|
2,191
|
2,418
|
2,229
|
|||||||||
|
Intangible assets, net
|
413
|
479
|
429
|
|||||||||
|
4,943
|
5,048
|
4,962
|
||||||||||
|
37,798
|
34,792
|
40,590
|
||||||||||
|
CURRENT LIABILITIES:
|
||||||||||||
|
Current maturities of long-term liabilities and leases
|
1,417
|
2,018
|
569
|
|||||||||
|
Trade payables and accrued expenses
|
3,423
|
2,996
|
4,067
|
|||||||||
|
Other payables
|
5,843
|
2,438
|
5,737
|
|||||||||
|
10,683
|
7,452
|
10,373
|
||||||||||
|
LONG‑TERM LIABILITIES:
|
||||||||||||
|
Deferred revenues
|
1,018
|
1,145
|
1,135
|
|||||||||
|
Liabilities in respect of IIA grants
|
6,942
|
7,497
|
6,811
|
|||||||||
|
Contingent consideration for the purchase of shares
|
4,097
|
5,186
|
4,853
|
|||||||||
|
Liability in respect of discontinued operation
|
-
|
6,003
|
-
|
|||||||||
|
Lease liabilities
|
1,905
|
2,043
|
2,006
|
|||||||||
|
Severance pay liability, net
|
264
|
325
|
243
|
|||||||||
|
14,226
|
22,199
|
15,048
|
||||||||||
|
SHAREHOLDERS' EQUITY:
|
||||||||||||
|
Ordinary shares of NIS 0.01 par value:
|
||||||||||||
|
Authorized: 50,000,000 shares as of March 31, 2020 ,December 31, 2019 and 37,244,508 shares as of March 31, 2019; Issued and Outstanding: 27,211,128 as of March 31,
2020, 27,202,795 as of December 31, 2019 and 27,178,839 as of March 31, 2019
|
75
|
75
|
75
|
|||||||||
|
Share premium
|
141,044
|
139,912
|
140,871
|
|||||||||
|
Foreign currency translation adjustments
|
(9
|
)
|
(21
|
)
|
(17
|
)
|
||||||
|
Accumulated deficit
|
(128,221
|
)
|
(134,825
|
)
|
(125,760
|
)
|
||||||
|
12,889
|
5,141
|
15,169
|
||||||||||
|
37,798
|
34,792
|
40,590
|
||||||||||
The accompanying notes are an integral part of the interim financial statements.
F - 3
MEDIWOUND LTD. AND ITS SUBSIDIARIES
U.S. dollars in thousands (except share and per share data)
|
Three months ended
March 31,
|
Year ended
December 31,
|
|||||||||||
|
2020
|
2019
|
2019
|
||||||||||
|
Unaudited
|
Audited
|
|||||||||||
|
Revenues from sale of products
|
647
|
414
|
3,393
|
|||||||||
|
Revenues from development services (1)
|
3,709
|
-
|
10,678
|
|||||||||
|
Revenues from license agreements
|
82
|
47
|
17,718
|
|||||||||
|
Total revenues
|
4,438
|
461
|
31,789
|
|||||||||
|
Cost of revenues
|
(3,208
|
)
|
(307
|
)
|
(11,849
|
)
|
||||||
|
Gross profit
|
1,230
|
154
|
19,940
|
|||||||||
|
Operating expenses:
|
||||||||||||
|
Research and development, gross
|
1,719
|
4,182
|
10,070
|
|||||||||
|
Participations by BARDA and IIA (1)
|
-
|
(2,903
|
)
|
(5,101
|
)
|
|||||||
|
Research and development, net of participations
|
1,719
|
1,279
|
4,969
|
|||||||||
|
Selling and marketing
|
824
|
1,033
|
4,064
|
|||||||||
|
General and administrative
|
893
|
1,332
|
5,242
|
|||||||||
|
Other expenses
|
-
|
89
|
1,172
|
|||||||||
|
Total operating expenses
|
3,436
|
3,733
|
15,447
|
|||||||||
|
Operating profit (loss)
|
(2,206
|
)
|
(3,579
|
)
|
4,493
|
|||||||
|
Financial income
|
239
|
61
|
556
|
|||||||||
|
Financial expense
|
(494
|
)
|
(642
|
)
|
(2,983
|
)
|
||||||
|
Profit (loss) from continuing operation
|
(2,461
|
)
|
(4,160
|
)
|
2,066
|
|||||||
|
Profit from discontinued operation
|
-
|
50
|
2,889
|
|||||||||
|
Net profit (loss)
|
(2,461
|
)
|
(4,110
|
)
|
4,955
|
|||||||
|
Other comprehensive income (loss):
|
||||||||||||
|
Foreign currency translation adjustments
|
8
|
4
|
8
|
|||||||||
|
Total comprehensive income (loss)
|
(2,453
|
)
|
(4,106
|
)
|
4,963
|
|||||||
|
Basic and diluted loss per share:
|
||||||||||||
|
Basic and diluted net loss per share from continuing operations
|
(0.09
|
)
|
(0.15
|
)
|
0.08
|
|||||||
|
Basic and diluted net profit per share from discontinued operations
|
-
|
*
|
)
|
0.10
|
||||||||
|
Total Basic and diluted net loss per share
|
(0.09
|
)
|
(0.15
|
)
|
0.18
|
|||||||
The accompanying notes are an integral part of the interim financial statements.
(1) Starting May 2019, following entrance into the Vericel license and supply agreements, participation by BARDA in the amount of $10.7 million was classified as revenues from
development services. Prior to the Vericel deal, this participation by BARDA was classified as reimbursement of research and development expenses.
*) Represents an amount lower than $1.
F - 4
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
|
-
|
-
|
-
|
(2,461
|
)
|
(2,461
|
)
|
|||||||||||||
|
Other comprehensive income
|
-
|
-
|
8
|
-
|
8
|
|||||||||||||||
|
Total comprehensive income (loss)
|
-
|
-
|
8
|
(2,461
|
)
|
(2,453
|
)
|
|||||||||||||
|
Exercise of options
|
(*
|
|
-
|
-
|
-
|
(*
|
|
|||||||||||||
|
Share-based compensation
|
-
|
173
|
-
|
-
|
173
|
|||||||||||||||
|
Balance as of March 31, 2020
|
75
|
141,044
|
(9
|
)
|
(128,221
|
)
|
12,889
|
|||||||||||||
|
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
|
|||||||||||||
|
Loss for the period
|
-
|
-
|
-
|
(4,110
|
)
|
(4,110
|
)
|
|||||||||||||
|
Other comprehensive income
|
-
|
-
|
4
|
-
|
4
|
|||||||||||||||
|
Total comprehensive income
|
-
|
-
|
4
|
(4,110
|
)
|
(4,106
|
)
|
|||||||||||||
|
Share-based compensation
|
-
|
275
|
-
|
-
|
275
|
|||||||||||||||
|
Balance as of March 31, 2019
|
75
|
139,912
|
(21
|
)
|
(134,825
|
)
|
5,141
|
|||||||||||||
*) Represents an amount lower than $1.
The accompanying notes are an integral part of the interim 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 an amount lower than $1.
The accompanying notes are an integral part of the interim financial statements.
F - 6
MEDIWOUND LTD. AND ITS SUBSIDIARIES
U.S. dollars in thousands
|
Three months ended
March 31,
|
Year ended
December 31,
|
|||||||||||
|
2020
|
2019
|
2019
|
||||||||||
|
Unaudited
|
Audited
|
|||||||||||
|
Cash Flows from Operating Activities:
|
||||||||||||
|
Net Profit (loss)
|
(2,461
|
)
|
(4,110
|
)
|
4,955
|
|||||||
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
|
||||||||||||
|
Adjustments to profit and loss items:
|
||||||||||||
|
Profit from discontinued operation
|
-
|
(50
|
)
|
(2,889
|
)
|
|||||||
|
Depreciation and amortization
|
268
|
274
|
1,149
|
|||||||||
|
Share-based compensation
|
173
|
275
|
1,234
|
|||||||||
|
Revaluation of liabilities in respect of IIA grants
|
198
|
74
|
(392
|
)
|
||||||||
|
Revaluation of contingent consideration for the purchase of shares
|
152
|
241
|
1,690
|
|||||||||
|
Revaluation of lease liabilities
|
(36
|
)
|
103
|
340
|
||||||||
|
Increase (decrease) in severance pay liability, net
|
21
|
(23
|
)
|
(105
|
)
|
|||||||
|
Net financing income
|
(110
|
)
|
(62
|
)
|
(434
|
)
|
||||||
|
Un-realized foreign currency (gain) loss
|
79
|
(130
|
)
|
(152
|
)
|
|||||||
|
745
|
702
|
441
|
||||||||||
|
Changes in asset and liability items:
|
||||||||||||
|
Decrease (increase) in trade receivables
|
897
|
309
|
(3,553
|
)
|
||||||||
|
Decrease (increase) in inventories
|
(391
|
)
|
208
|
67
|
||||||||
|
Decrease in other receivables
|
99
|
262
|
6,376
|
|||||||||
|
Increase (decrease) in trade payables and accrued expenses
|
(645
|
)
|
281
|
1,355
|
||||||||
|
Increase (decrease) in other payables and deferred revenues
|
(47
|
)
|
452
|
247
|
||||||||
|
(87
|
)
|
1,512
|
4,492
|
|||||||||
|
Net cash provided by (used in) continuing operating activities
|
(1,803
|
)
|
(1,896
|
)
|
9,888
|
|||||||
|
Net cash provided by (used in) discontinued operating activities
|
-
|
50
|
(1,559
|
)
|
||||||||
|
Net cash provided by (used in) operating activities
|
(1,803
|
)
|
(1,846
|
)
|
8,289
|
|||||||
The accompanying notes are an integral part of the financial statements.
F - 7
MEDIWOUND LTD. AND ITS SUBSIDIARIES
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
|
Three months ended
March 31,
|
Year ended
December 31,
|
|||||||||||
|
2020
|
2019
|
2019
|
||||||||||
|
Unaudited
|
Audited
|
|||||||||||
|
Cash Flows from Investing Activities:
|
||||||||||||
|
Purchase of property and equipment
|
(144
|
)
|
(239
|
)
|
(792
|
)
|
||||||
|
Interest received
|
3
|
30
|
184
|
|||||||||
|
Proceeds from (investment in) short term bank deposits, net
|
2,992
|
2,565
|
(5,050
|
)
|
||||||||
|
Net cash provided by (used in) continuing investing activities
|
2,851
|
2,356
|
(5,658
|
)
|
||||||||
|
Net cash used in discontinued investing activities
|
-
|
-
|
(1,239
|
)
|
||||||||
|
Net cash provided by (used in) investing activities
|
2,851
|
2,356
|
(6,897
|
)
|
||||||||
|
Cash Flows from Financing Activities:
|
||||||||||||
|
Repayment of leases liabilities
|
(160
|
)
|
(155
|
)
|
(630
|
)
|
||||||
|
Proceeds from issuance of shares, net
|
(*
|
|
-
|
(*
|
|
|||||||
|
Net repayment of IIA grants
|
(66
|
)
|
(55
|
)
|
(376
|
)
|
||||||
|
Net cash used in financing activities
|
(226
|
)
|
(210
|
)
|
(1,006
|
)
|
||||||
|
Exchange rate differences on cash and cash equivalent balances
|
(83
|
)
|
118
|
140
|
||||||||
|
Cash and cash equivalents:
|
||||||||||||
|
Increase in cash and cash equivalents from continuing activities
|
739
|
368
|
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
|
6,716
|
|||||||||
|
Balance of cash and cash equivalents at the end of the period
|
7,981
|
7,134
|
7,242
|
|||||||||
* Represents an amount lower than $1.
The accompanying notes are an integral part of the 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 focused on developing, manufacturing and commercializing novel products to address unmet medical needs in the
fields of severe burns, chronic and other hard to heal wounds, connective tissue disorders and other indications.
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
|
| b. |
Basis of preparation of the interim consolidated financial statements:
|
The interim condensed consolidated financial statements for the three months ended March 31, 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: SUBSEQUENT EVENTS
On April 23, 2020, the Company's Board of Directors approved the grant of 1,277,456 options to purchase ordinary shares, for an exercise price of $ 1.9 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 approximately $1.3 million.
******
F - 10