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 2021
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 5, 2021, MediWound Ltd. (the “Company”) issued a press release entitled “MediWound Reports First Quarter
2021 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 March 31, 2021, attached as Exhibit 99.2, which was provided by the Company to CBI on May 4, 2021 pursuant to such contractual obligation.
The content of this report on Form 6-K (including the information contained in Exhibit 99.1, but excluding quotes of senior management
of the Company, and Exhibit 99.2) is hereby incorporated by reference into the Company’s Registration Statements on Form S-8 filed with the SEC on April 28, 2014, March 24, 2016, March 19, 2018, March 25, 2019 and February 25, 2020 (Registration
Nos. No. 333-195517, 333-210375, 333-223767, 333-195517, 333-210375, 333-230487 and 333-236635, respectively) and on Form F-3 filed with the SEC on March 25, 2019 (Registration No. 333-230490).
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 5, 2021
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By:
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/s/ Boaz Gur-Lavie
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Name:
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Boaz Gur-Lavie
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Title:
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Chief Financial Officer
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3
EXHIBIT INDEX
The following exhibit is filed as part of this Form 6-K:
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Exhibit
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Description
|
| 99.1 |
| 99.2 |
4
Exhibit 99.1
MediWound Reports First Quarter 2021 Financial Results
First Quarter Revenues of $5.8 Million, an Increase of 32% Year-over-Year
Conference call begins today at 8:30 am ET
YAVNE, Israel, May 5, 2021 -- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics
solutions for tissue repair and regeneration, today announced financial results for the first quarter ended March 31, 2021.
First Quarter and recent weeks Financial and Business Highlights:
| • |
Total revenues for the first quarter of 2021 were $5.8 million, an increase of 32% compared with the first quarter of 2020, primarily driven by the procurement of NexoBrid® by the Biomedical Advanced Research and
Development Authority (BARDA)
|
| • |
Cash and short-term investments of $17.9 million as of March 31, 2021, compared with $21.6 million as of December 31, 2020
|
| • |
Hosted an Analyst Day on March 30 highlighting EscharEx® as an enzymatic debridement agent for chronic wounds featuring presentations by key opinion leaders.
|
| • |
Enrolled the first patient in phase 2 pharmacology study of EscharEx, with data expected in the second half of 2021
|
| • |
Submitted a protocol to the U.S. Food and Drug Administration (FDA) for a phase I/II clinical study of MWPC005 for the treatment of basal cell carcinoma; study initiation is planned for the second quarter of 2021
|
| • |
Received marketing approval for NexoBrid in Chile and the Republic of China (Taiwan) and continue global expansion strategy with new distribution agreements in Europe and Asia
|
“This quarter was one of continued progress across the board, highlighted by the continued revenue growth and NexoBrid global expansion, the enrollment of the first patient in our phase 2
pharmacology study of EscharEx, and the initiation of a new clinical program in non-melanoma skin cancer,” said Sharon Malka, Chief Executive Officer of MediWound. “We were proud to host an analyst day webinar in March on EscharEx, featuring four
prominent key opinion leaders who discussed the current U.S. wound debridement practices and how EscharEx, upon approval, has the potential to change current standard of practice and care of chronic wounds. We continue to advance our U.S. phase 2
adaptive design study of EscharEx for the treatment of venous leg ulcers and look forward to an interim assessment later this year. Finally, we remain focused on continuing to drive revenue growth and further strengthen our company."
First Quarter Financial Results
Revenues for the first quarter of 2021 were $5.8 million, compared with $4.4 million for the first quarter of 2020, an increase of 32%. Revenues from products and licenses in the first quarter of
2021 were $2.9 million, an increase of 300% compared to the first quarter of 2020, primarily driven by the procurement of NexoBrid by BARDA for emergency response preparedness and sales increase outside the U.S.
Gross profit for the first quarter of 2021 was $2.4 million, or 41% of net revenues, compared to a gross profit of $1.2 million, or 28% of net revenues for the first quarter of 2020.
Research and development expenses for the first quarter of 2021, were $2.2 million, compared with $1.7 million for the first quarter of 2020. The increase was a result of EscharEx clinical
development program.
Selling, general and administrative expenses for the first quarter of 2021 were $2.1 million, compared with $1.7 million in the first quarter of 2020 as a result of directors and officer’s
insurance cost increase. As a percentage of revenues, selling, general and administrative expenses for the first quarter decreased from 39% in the first quarter of 2020 to 36% for the first quarter of 2021.
Operating loss for the first quarter of 2021 was $1.9 million, reflecting a 13% decrease in operating loss compared to the $2.2 million in the first quarter of 2020.
The Company posted a net loss of $2.9 million, or $0.10 per share, for the first quarter of 2021 compared with a net loss of $2.5 million, or $0.09 per share, for the first quarter of 2020.
Adjusted EBITDA, as defined below, for the first quarter of 2021 was a loss of $1.3 million, compared with a loss of $1.8 million for the first quarter of 2020, reflecting a decrease in adjusted
EBIDTA loss of 28%.
Balance Sheet Highlights
As of March 31, 2021, MediWound had $17.9 million in cash and short-term investments, compared with $21.6 million as of December 31, 2020, and no debt. MediWound remained on budget, utilizing
$3.7 million in the first quarter of 2021 for its operational activities. The Company expects cash use for 2021 to be in the range of $5.0 to $7.0 million.
Conference Call
MediWound management will host a conference call for investors today, Thursday, May 5, 2021 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.) 1 809 315 362 (Israel), or 678-894-3057 (outside the U.S. & Israel) and entering passcode 3496059. 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 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 biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy is
centered around our validated enzymatic platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair.
NexoBrid, our first commercialized biological product for non-surgical and rapid eschar removal of deep, partial and full-thickness thermal burns without harming viable tissue, is currently
marketed in the European Union and other International markets. On June 29, 2020, a biologics license application (BLA) was submitted to the U.S. FDA and was assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021.
NexoBrid is supported by U.S. Biomedical Advanced Research and Development Authority (BARDA).
EscharEx, our next-generation bioactive topical therapeutic under development in the U.S. for debridement of chronic and hard to heal wounds. In two Phase 2 studies, EscharEx was well-tolerated
and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. MediWound’s third innovative product candidate, MWPC005, is a topical drug under development for the
treatment of non-melanoma skin cancer. Committed to innovation, we are dedicated to improving quality of care and patient lives. For more information, please visit www.mediwound.com.
About BARDA
Funding and technical support for development of NexoBrid including the expanded access treatment protocol (NEXT), the pivotal Phase 3 pediatric clinical study (CIDS) 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 adults 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 and readiness for emergencies. For more information, refer to
www.phe.gov/about/BARDA.
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, study design, objectives anticipated timelines,
expectations and commercial potential of our products and product candidates. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and
expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development
programs; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and
products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of
our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and the impact of the COVID-19 pandemic. For example, we are unable to predict how the pandemic will affect the
overall healthcare infrastructure, including the ability to recruit patients, the ability to conduct the studies in medical sites and 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 our products and product candidates in the future.
These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2020, filed with the Securities
and Exchange Commission (“SEC”) on February 25, 2021, 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:
|
Jeremy Feffer
|
|
Boaz Gur-Lavie
|
Managing Director
|
|
Chief Financial Officer
|
LifeSci Advisors
|
|
MediWound Ltd.
|
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,
|
|||||||||||
|
2021
|
2020
|
2020
|
||||||||||
|
Unaudited
|
Audited
|
|||||||||||
|
Cash, cash equivalents and short term deposits
|
17,862
|
27,311
|
21,584
|
|||||||||
|
Accounts and other receivable
|
5,574
|
3,540
|
3,229
|
|||||||||
|
Inventories
|
1,470
|
2,004
|
1,380
|
|||||||||
|
Total current assets
|
24,906
|
32,855
|
26,193
|
|||||||||
|
Property, plant and equipment, net
|
2,694
|
2,339
|
2,630
|
|||||||||
|
Right of use assets, net
|
1,747
|
2,191
|
1,884
|
|||||||||
|
Intangible assets, net
|
347
|
413
|
363
|
|||||||||
|
Total long term assets
|
4,788
|
4,943
|
4,877
|
|||||||||
|
Total assets
|
29,694
|
37,798
|
31,070
|
|||||||||
|
Current maturities of long-term liabilities
|
1,884
|
1,417
|
1,750
|
|||||||||
|
Trade payables and accrued expenses
|
3,258
|
3,423
|
2,992
|
|||||||||
|
Other payables
|
5,172
|
5,843
|
3,524
|
|||||||||
|
Total current liabilities
|
10,314
|
10,683
|
8,266
|
|||||||||
|
Deferred revenues
|
693
|
1,018
|
1,234
|
|||||||||
|
Liabilities in respect of Israeli Innovation Authority grants net of current maturities
|
7,275
|
6,942
|
7,267
|
|||||||||
|
Liabilities in respect of purchase of shares net of current maturities
|
4,733
|
4,097
|
4,998
|
|||||||||
|
Lease liabilities, net of current maturities
|
1,590
|
1,905
|
1,741
|
|||||||||
|
Severance pay liability, net
|
273
|
264
|
292
|
|||||||||
|
Total long term liabilities
|
14,564
|
14,226
|
15,532
|
|||||||||
|
Shareholders' equity
|
4,816
|
12,889
|
7,272
|
|||||||||
|
Total liabilities & shareholder equity
|
29,694
|
37,798
|
31,070
|
|||||||||
MediWound, Ltd.
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS (UNAUDITED)
U.S. dollars in thousands
|
Three months ended
|
||||||||
|
March 31,
|
||||||||
|
2021
|
2020
|
|||||||
|
Revenues
|
5,847
|
4,438
|
||||||
|
Cost of revenues
|
3,431
|
3,208
|
||||||
|
Gross profit
|
2,416
|
1,230
|
||||||
|
Operating expenses:
|
||||||||
|
Research and development
|
2,242
|
1,719
|
||||||
|
Selling, general and administrative
|
2,095
|
1,717
|
||||||
|
Operating loss
|
(1,921
|
)
|
(2,206
|
)
|
||||
|
Financial income
|
11
|
239
|
||||||
|
Financial expense
|
(941
|
)
|
(494
|
)
|
||||
|
Loss for the period
|
(2,851
|
)
|
(2,461
|
)
|
||||
|
Foreign currency translation adjustments
|
11
|
8
|
||||||
|
Total comprehensive loss
|
(2,840
|
)
|
(2,453
|
)
|
||||
|
Basic and diluted loss per share:
|
||||||||
|
Net loss per share
|
(0.10
|
)
|
(0.09
|
)
|
||||
|
Weighted average number of ordinary shares used in the computation of basic and diluted loss per share:
|
27,237
|
27,211
|
||||||
ADJUSTED EBITDA
U.S. dollars in thousands
|
Three months ended
|
||||||||
|
March 31,
|
||||||||
|
2021
|
2020
|
|||||||
|
Loss for the period
|
(2,851
|
)
|
(2,461
|
)
|
||||
|
Adjustments:
|
||||||||
|
Financial expenses, net
|
(930
|
)
|
(255
|
)
|
||||
|
Depreciation and amortization
|
(273
|
)
|
(268
|
)
|
||||
|
Share-based compensation expenses
|
(384
|
)
|
(173
|
)
|
||||
|
Total adjustments
|
(1,587
|
)
|
(696
|
)
|
||||
|
Adjusted EBITDA
|
(1,264
|
)
|
(1,765
|
)
|
||||
MediWound, Ltd.
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW (UNAUDITED)
U.S. dollars in thousands
|
Three months ended
|
||||||||
|
March 31,
|
||||||||
|
2021
|
2020
|
|||||||
|
Cash Flows from Operating Activities:
|
||||||||
|
Net loss
|
(2,851
|
)
|
(2,461
|
)
|
||||
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
|
||||||||
|
Adjustments to profit and loss items:
|
||||||||
|
Depreciation and amortization
|
273
|
268
|
||||||
|
Share-based compensation
|
384
|
173
|
||||||
|
Revaluation of liabilities in respect of IIA grants
|
275
|
198
|
||||||
|
Revaluation of liabilities in respect of purchase of shares
|
152
|
152
|
||||||
|
Revaluation of lease liabilities
|
(44
|
)
|
(36
|
)
|
||||
|
Increase (decrease) in severance liability, net
|
(10
|
)
|
21
|
|||||
|
Financing income
|
(11
|
)
|
(110
|
)
|
||||
|
Unrealized foreign currency (gain) loss
|
256
|
79
|
||||||
|
1,275
|
745
|
|||||||
|
Changes in asset and liability items:
|
||||||||
|
Decrease (increase) in trade receivables
|
(2,407
|
)
|
897
|
|||||
|
Increase in inventories
|
(45
|
)
|
(391
|
)
|
||||
|
Decrease in other receivables
|
37
|
99
|
||||||
|
Increase (decrease) in trade payables & accrued expenses
|
272
|
(645
|
)
|
|||||
|
Increase (decrease) in other payables & deferred revenues
|
806
|
(47
|
)
|
|||||
|
(1,337
|
)
|
(87
|
)
|
|||||
|
Net cash used in operating activities
|
(2,913
|
)
|
(1,803
|
)
|
||||
|
Cash Flows from Investment Activities:
|
||||||||
|
Purchase of property and equipment
|
(218
|
)
|
(144
|
)
|
||||
|
Interest received
|
35
|
3
|
||||||
|
Proceeds from short term bank deposits, net of investments
|
4,006
|
2,992
|
||||||
|
Net cash provided by investing activities
|
3,823
|
2,851
|
||||||
|
Cash Flows from Financing Activities:
|
||||||||
|
Repayment of lease liabilities
|
(131
|
)
|
(160
|
)
|
||||
|
Repayment of IIA grants
|
(180
|
)
|
(66
|
)
|
||||
|
Net cash used in financing activities
|
(311
|
)
|
(226
|
)
|
||||
|
Exchange rate differences on cash and cash equivalent balances
|
(291
|
)
|
(83
|
)
|
||||
|
Increase in cash and cash equivalents
|
308
|
739
|
||||||
|
Balance of cash and cash equivalents at the beginning of the period
|
17,376
|
7,242
|
||||||
|
Balance of cash and cash equivalents at the end of the period
|
17,684
|
7,981
|
||||||
Exhibit 99.2
MEDIWOUND LTD. AND ITS SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF MARCH 31, 2021
IN U.S. DOLLARS IN THOUSANDS
UNAUDITED
INDEX
|
Page
|
|
|
F-2
|
|
|
F-3
|
|
|
F-4 – F-5
|
|
|
F-6 – F-7
|
|
|
F-8 – F-9
|
- - - - - - - - - - - - -
MEDIWOUND LTD. AND ITS SUBSIDIARIES
U.S. dollars in thousands
|
March 31,
|
December 31,
|
|||||||||||
|
2021
|
2020
|
2020
|
||||||||||
| Unaudited |
Audited
|
|||||||||||
|
CURRENT ASSETS:
|
||||||||||||
|
Cash and cash equivalents
|
17,684
|
7,981
|
17,376
|
|||||||||
|
Restricted deposits
|
178
|
174
|
184
|
|||||||||
|
Short-term bank deposits
|
-
|
19,156
|
4,024
|
|||||||||
|
Trade receivables
|
5,153
|
3,195
|
2,767
|
|||||||||
|
Inventories
|
1,470
|
2,004
|
1,380
|
|||||||||
|
Other receivables
|
421
|
345
|
462
|
|||||||||
|
24,906
|
32,855
|
26,193
|
||||||||||
|
LONG-TERM ASSETS:
|
||||||||||||
|
Property, plant and equipment, net
|
2,694
|
2,339
|
2,630
|
|||||||||
|
Right of-use assets, net
|
1,747
|
2,191
|
1,884
|
|||||||||
|
Intangible assets, net
|
347
|
413
|
363
|
|||||||||
|
4,788
|
4,943
|
4,877
|
||||||||||
|
29,694
|
37,798
|
31,070
|
||||||||||
|
CURRENT LIABILITIES:
|
||||||||||||
|
Current maturities of long-term liabilities and leases
|
1,884
|
1,417
|
1,750
|
|||||||||
|
Trade payables and accrued expenses
|
3,258
|
3,423
|
2,992
|
|||||||||
|
Other payables
|
5,172
|
5,843
|
3,524
|
|||||||||
|
10,314
|
10,683
|
8,266
|
||||||||||
|
LONG‑TERM LIABILITIES:
|
||||||||||||
|
Deferred revenues
|
693
|
1,018
|
1,234
|
|||||||||
|
Liabilities in respect of IIA grants
|
7,275
|
6,942
|
7,267
|
|||||||||
|
Liabilities in respect of purchase of shares
|
4,733
|
4,097
|
4,998
|
|||||||||
|
Lease liabilities
|
1,590
|
1,905
|
1,741
|
|||||||||
|
Severance pay liability, net
|
273
|
264
|
292
|
|||||||||
|
14,564
|
14,226
|
15,532
|
||||||||||
|
SHAREHOLDERS' EQUITY:
|
||||||||||||
|
Ordinary shares of NIS 0.01 par value:
|
||||||||||||
|
Authorized: 50,000,000 shares as of March 31, 2021 ,December 31, 2020 and March 31, 2020; Issued and Outstanding: 27,245,271 as of March 31, 2021, 27,236,752 as of December 31, 2020 and 27,211,128 as of March 31, 2020
|
75
|
75
|
75
|
|||||||||
|
Share premium
|
142,577
|
141,044
|
142,193
|
|||||||||
|
Foreign currency translation adjustments
|
(29
|
)
|
(9
|
)
|
(40
|
)
|
||||||
|
Accumulated deficit
|
(137,807
|
)
|
(128,221
|
)
|
(134,956
|
)
|
||||||
|
4,816
|
12,889
|
7,272
|
||||||||||
|
29,694
|
37,798
|
31,070
|
||||||||||
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 and per share data)
|
Three months ended
March 31,
|
Year ended
December 31,
|
|||||||||||
|
2021
|
2020
|
2020
|
||||||||||
|
Unaudited
|
Audited
|
|||||||||||
|
Revenues from sale of products
|
2,518
|
647
|
7,445
|
|||||||||
|
Revenues from development services
|
2,940
|
3,709
|
13,935
|
|||||||||
|
Revenues from license agreements
|
389
|
82
|
383
|
|||||||||
|
Total revenues
|
5,847
|
4,438
|
21,763
|
|||||||||
|
Cost of revenues
|
3,431
|
3,208
|
14,218
|
|||||||||
|
Gross profit
|
2,416
|
1,230
|
7,545
|
|||||||||
|
Research and development
|
2,242
|
1,719
|
7,698
|
|||||||||
|
Selling and marketing
|
822
|
824
|
3,228
|
|||||||||
|
General and administrative
|
1,273
|
893
|
5,459
|
|||||||||
|
Total operating expenses
|
4,337
|
3,436
|
16,385
|
|||||||||
|
Operating loss
|
(1,921
|
)
|
(2,206
|
)
|
(8,840
|
)
|
||||||
|
Financial income
|
11
|
239
|
843
|
|||||||||
|
Financial expense
|
(941
|
)
|
(494
|
)
|
(1,279
|
)
|
||||||
|
Loss from continuing operation
|
(2,851
|
)
|
(2,461
|
)
|
(9,276
|
)
|
||||||
|
Profit from discontinued operation
|
-
|
-
|
80
|
|||||||||
|
Net loss
|
(2,851
|
)
|
(2,461
|
)
|
(9,196
|
)
|
||||||
|
Other comprehensive income (loss):
|
||||||||||||
|
Foreign currency translation adjustments
|
11
|
8
|
(23
|
)
|
||||||||
|
Total comprehensive loss
|
(2,840
|
)
|
(2,453
|
)
|
(9,219
|
)
|
||||||
|
Basic and diluted loss per share:
|
||||||||||||
|
Basic and diluted net loss per share from continuing operations
|
(0.10
|
)
|
(0.09
|
)
|
(0.34
|
)
|
||||||
|
Basic and diluted net profit per share from discontinued operations
|
-
|
-
|
(*
|
)
|
||||||||
|
Total Basic and diluted net loss per share
|
(0.10
|
)
|
(0.09
|
)
|
(0.34
|
)
|
||||||
(*) Represents an amount lower than $1.
The accompanying notes are an integral part of the interim 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, 2020
|
75
|
142,193
|
(40
|
)
|
(134,956
|
)
|
7,272
|
|||||||||||||
|
Loss for the period
|
-
|
-
|
-
|
(2,851
|
)
|
(2,851
|
)
|
|||||||||||||
|
Other comprehensive income
|
-
|
-
|
11
|
-
|
11
|
|||||||||||||||
|
Total comprehensive income (loss)
|
-
|
-
|
11
|
(2,851
|
)
|
(2,840
|
)
|
|||||||||||||
|
Exercise of options and RSU’s
|
(*
|
)
|
-
|
-
|
-
|
(*
|
)
|
|||||||||||||
|
Share-based compensation
|
-
|
384
|
-
|
-
|
384
|
|||||||||||||||
|
Balance as of March 31, 2021
|
75
|
142,577
|
(29
|
)
|
(137,807
|
)
|
4,816
|
|||||||||||||
|
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 and RSU’s
|
(*
|
)
|
-
|
-
|
-
|
(*
|
)
|
|||||||||||||
|
Share-based compensation
|
-
|
173
|
-
|
-
|
173
|
|||||||||||||||
|
Balance as of March 31, 2020
|
75
|
141,044
|
(9
|
)
|
(128,221
|
)
|
12,889
|
|||||||||||||
(*) Represents an amount lower than $1.
The accompanying notes are an integral part of the interim 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 December 31, 2019
|
75
|
140,871
|
(17
|
)
|
(125,760
|
)
|
15,169
|
|||||||||||||
|
Net loss
|
-
|
-
|
-
|
(9,196
|
)
|
(9,196
|
)
|
|||||||||||||
|
Other comprehensive loss
|
-
|
-
|
(23
|
)
|
-
|
(23
|
)
|
|||||||||||||
|
Total comprehensive loss
|
-
|
-
|
(23
|
)
|
(9,196
|
)
|
(9,219
|
)
|
||||||||||||
|
Exercise of options and RSU’s
|
(*
|
)
|
-
|
|
-
|
-
|
(*
|
)
|
||||||||||||
|
Share-based compensation
|
-
|
1,322
|
-
|
-
|
1,322
|
|||||||||||||||
|
Balance as of December 31, 2020
|
75
|
142,193
|
(40
|
)
|
(134,956
|
)
|
7,272
|
|||||||||||||
(*) 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
U.S. dollars in thousands
|
Three months ended
March 31,
|
Year ended
December 31,
|
|||||||||||
|
2021
|
2020
|
2020
|
||||||||||
|
Unaudited
|
Audited
|
|||||||||||
|
Cash Flows from Operating Activities:
|
||||||||||||
|
Net loss
|
(2,851
|
)
|
(2,461
|
)
|
(9,196
|
)
|
||||||
|
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
|
||||||||||||
|
Adjustments to profit and loss items:
|
||||||||||||
|
Profit from discontinued operation
|
-
|
-
|
(80
|
)
|
||||||||
|
Depreciation and amortization
|
273
|
268
|
1,090
|
|||||||||
|
Share-based compensation
|
384
|
173
|
1,322
|
|||||||||
|
Revaluation of liabilities in respect of IIA grants
|
275
|
198
|
828
|
|||||||||
|
Revaluation of liabilities in respect of purchase of shares
|
152
|
152
|
(433
|
)
|
||||||||
|
Revaluation of lease liabilities
|
(44
|
)
|
(36
|
)
|
305
|
|||||||
|
Increase (decrease) in severance pay liability, net
|
(10
|
)
|
21
|
33
|
||||||||
|
Net financing income
|
(11
|
)
|
(110
|
)
|
(297
|
)
|
||||||
|
Un-realized foreign currency (gain) loss
|
256
|
79
|
(211
|
)
|
||||||||
|
1,275
|
745
|
2,557
|
||||||||||
|
Changes in asset and liability items:
|
||||||||||||
|
Decrease (increase) in trade receivables
|
(2,407
|
)
|
897
|
1,386
|
||||||||
|
Decrease (increase) in inventories
|
(45
|
)
|
(391
|
)
|
141
|
|||||||
|
Decrease (increase) in other receivables
|
37
|
99
|
(13
|
)
|
||||||||
|
Increase (decrease) in trade payables and accrued expenses
|
272
|
(645
|
)
|
(1,096
|
)
|
|||||||
|
Increase (decrease) in other payables and deferred revenues
|
806
|
(47
|
)
|
(479
|
)
|
|||||||
|
(1,337
|
)
|
(87
|
)
|
(61
|
)
|
|||||||
|
Net cash used in continuing operating activities
|
(2,913
|
)
|
(1,803
|
)
|
(6,700
|
)
|
||||||
|
Net cash used in discontinued operating activities
|
-
|
-
|
(195
|
)
|
||||||||
|
Net cash used in operating activities
|
(2,913
|
)
|
(1,803
|
)
|
(6,895
|
)
|
||||||
The accompanying notes are an integral part of the financial statements.
F - 6
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,
|
|||||||||||
|
2021
|
2020
|
2020
|
||||||||||
|
Unaudited
|
Audited
|
|||||||||||
|
Cash Flows from Investing Activities:
|
||||||||||||
|
Purchase of property and equipment
|
(218
|
)
|
(144
|
)
|
(923
|
)
|
||||||
|
Interest received
|
35
|
3
|
274
|
|||||||||
|
Proceeds from short term bank deposits, net
|
4,006
|
2,992
|
18,034
|
|||||||||
|
Net cash provided by continuing investing activities
|
3,823
|
2,851
|
17,385
|
|||||||||
|
Cash Flows from Financing Activities:
|
||||||||||||
|
Repayment of leases liabilities
|
(131
|
)
|
(160
|
)
|
(508
|
)
|
||||||
|
Proceeds from issuance of shares, net
|
-
|
(*
|
)
|
-
|
||||||||
|
Repayment of IIA grants, net
|
(180
|
)
|
(66
|
)
|
(121
|
)
|
||||||
|
Net cash used in continuing financing activities
|
(311
|
)
|
(226
|
)
|
(629
|
)
|
||||||
|
Exchange rate differences on cash and cash equivalent balances
|
(291
|
)
|
(83
|
)
|
273
|
|||||||
|
Increase in cash and cash equivalents from continuing activities
|
308
|
739
|
10,329
|
|||||||||
|
Decrease in cash and cash equivalents from discontinued activities
|
-
|
-
|
(195
|
)
|
||||||||
|
Balance of cash and cash equivalents at the beginning of the period
|
17,376
|
7,242
|
7,242
|
|||||||||
|
Balance of cash and cash equivalents at the end of the period
|
17,684
|
7,981
|
17,376
|
|||||||||
|
Supplement disclosure of Non-cash transactions:
|
||||||||||||
|
ROU asset, net recognized with corresponding lease liability
|
-
|
68
|
261
|
|||||||||
|
Exercise of RSU’s
|
43
|
43
|
147
|
|||||||||
(*) Represents an amount lower than $1.
The accompanying notes are an integral part of the financial statements.
F - 7
MEDIWOUND LTD. AND ITS SUBSIDIARIES
U.S. dollars in thousands
| NOTE 1: |
GENERAL
|
| a. |
General description of the Company and its operations:
|
MediWound Ltd. which incorporated in Yavne, Israel (the "Company" or "MediWound"), is biopharmaceutical company develops, manufactures and
commercializes novel, cost effective, bio- therapeutic solutions for tissue repair and regeneration. The Company’s strategy is centered around its validated proteolytic enzyme platform technology, focused on next-generation bio-active therapies for
burn and wound care and biological medicinal products for tissue repair.
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 while establishing additional local distribution channels to extend its outreach in the
European Union. In other territories the company sells NexoBrid through local distribution channels. 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.
The third innovative product candidate, MWPC005, is a topically applied biological drug candidate for the treatment of non-melanoma skin cancers,
| b. |
The Company's securities are listed for trading on NASDAQ since March 2014.
|
| c. |
The Company has three wholly owned subsidiaries: MediWound Germany GmbH, acting as Europe (“EU”) marketing authorization holder and EU sales and marketing arm, MediWound UK Limited and MediWound US, Inc. currently an inactive companies.
|
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, manufacturing and emergency readiness for NexoBrid deployment as well as the
procurement of NexoBrid as a medical countermeasure as part of BARDA preparedness for mass casualty events.
|
| e. |
The Company addressed the challenges associated with the COVID-19 pandemic during the year ended 2020 and three months ended March 31, 2021, while prioritizing the health and safety of its workforce and maintaining operational efficiency
and flexibility. With respect to Note 1(a) to our 2020 annual financial statements, the FDA review processes have been affected by COVID-19 travel restriction and by evolving FDA priorities. As a result, the Company cannot predict how long
the FDA may take to complete the review of the BLA of NexoBrid. Accordingly, the Company expect the timing of the potential approval of NexoBrid to be impacted.
|
F - 8
MEDIWOUND LTD. AND ITS SUBSIDIARIES
NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
| NOTE 2: |
SIGNIFICANT ACCOUNTING POLICIES
|
The following accounting policies have been applied consistently in the financial statements for all periods presented unless otherwise stated.
| a. |
Basis of presentation of financial statements:
|
These financial statements have been prepared in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board
("IASB").
|
b.
|
Basis of preparation of the interim consolidated financial statements:
|
The interim condensed consolidated financial statements for the three months ended March 31, 2021 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, 2020 that were included in the Annual Report on Form 20-F filed on February 25, 2021.
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, 2020 that were included in the Annual Report on Form 20-F filed on February 25, 2021, 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 March 4, 2021, the Company's Board of Directors approved the grant of 377,790 options to purchase ordinary shares, for an exercise price of $ 5.36 per share as well as
62,947 RSU’s to its employees, officers and members of the board. The fair value of the options and RSU’s, as of the grant date, was estimated at $1.2, $0.6 million consistently. The general meeting which will approved the grants to the CEO and the
chairman of the BOD, is yet to be determined.
F - 9