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 November 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 November 10, 2020, MediWound Ltd. (the “Company”) issued a press release entitled “MediWound Reports Third Quarter
2020 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 September 30, 2020, attached as Exhibit 99.2, which was provided by the Company to CBI on November 9, 2020 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.
|
MEDIWOUND LTD.
|
|||
|
Date: November 10, 2020
|
By:
|
/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
|
| 99.2 |
4
Exhibit 99.1
MediWound Reports Third Quarter 2020 Financial Results
Total Third Quarter Revenues of $6.6 Million Increased 29% Year-over-Year
Assigned PDUFA Goal Date of June 29, 2021 for NexoBrid BLA
YAVNE, Israel, November 10, 2020
-- MediWound Ltd. (Nasdaq: MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced financial results for the third quarter ended September 30,
2020.
Third Quarter Business and Financial
Highlights:
| • |
Revenues for the third quarter of 2020 were $6.6 million, an increase of 29% compared with the third quarter of 2019, primarily driven by the procurement of NexoBrid®
by the Biomedical Advanced Research and Development Authority (BARDA)
|
| • |
Cash and short term investments of $25.0 million as of September 30, 2020, compared with $29.5 million as of December 31, 2019
|
| • |
Announced the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) for NexoBrid and assigned a Prescription Drug User Fee
Act (PDUFA) goal date of June 29, 2021
|
| • |
Delivered the first shipment of NexoBrid to BARDA for emergency response preparedness
|
| • |
Completed enrollment stage of the NexoBrid Phase 3 Children Innovation Debridement Study (CIDS). Top-line data anticipated in the second half of 2021
|
| • |
Completed U.S Phase 3 (DETECT) including patient long-term safety follow-up; The twenty-four-month safety data of cosmesis and function was comparable across all study
arms with no new safety signals observed
|
| • |
Continue to address challenges associated with the COVID-19 pandemic, while prioritizing the health and safety of our workforce and maintaining operational efficiency
and flexibility
|
“We generated strong revenue growth in the third quarter, driven by the first delivery of NexoBrid emergency stock to BARDA,” said
Sharon Malka, Chief Executive Officer of MediWound. “The quarter was highlighted by several important milestones that bring us closer to our goal of providing a new standard of care for eschar removal in patients with severe burns. Our NexoBrid BLA
was accepted for review, we successfully completed the long-term safety patient follow-up stage of our U.S Phase 3 DETECT study, which showed comparable results across all arms, we completed the enrollment stage of our NexoBrid pediatric Phase 3
study and we continue to enroll patients under the NEXT protocol. In addition, we are actively recruiting patients in our U.S. EscharEx® Phase 2 study. While the COVID-19 pandemic continues to cause considerable uncertainty, we expect to
maintain growth and are optimistic that we remain on track to strengthen our company further.”
Third Quarter Financial Results
Revenues for the quarter ended September 30, 2020 were $6.6 million, compared with $5.1million for the third quarter of 2019, an
increase of 29%. Revenues from products for the quarter ended September 30, 2020, were $3.2 million, an increase of 189% in comparison to the third quarter of 2019, primarily driven by the procurement of NexoBrid by BARDA for emergency response
preparedness.
Gross profit for the quarter ended September 30, 2020 was $2.8 million, compared with $1.2 million for the third quarter of 2019.
Gross margin increased from 23% of revenues in the third quarter of 2019 to 42% in the third quarter of 2020.
Research and development expenses for the quarter ended September 30, 2020, were $2.1 million, compared with $1.6 million for the
third quarter of 2019. The increase was a result of EscharEx clinical development.
Selling, general and administrative expenses for the quarter ended September 30, 2020 were $2.2 million, in line with the third
quarter of 2019.
Operating loss for the quarter ended September 30, 2020 was $1.5 million, compared with a loss of $2.7 million in the third quarter of
2019.
MediWound’s loss for the quarter ended September 30, 2020 was $1.9 million, or $0.07 per share, compared with a loss of $0.2 million,
or $0.01 per share, for the third quarter of 2019, which included one-time profit from discontinued operations of $2.8 million.
Adjusted EBITDA, as defined below, for the quarter ended September 30, 2020, was a loss of $0.8 million, compared with a loss of $2.0
million for the third quarter of 2019.
Year-to-Date 2020 Financial Results
Revenues for the nine months ended September 2020 were $15.1 million, compared with $26.3 million in the first nine months of 2019,
which included a $17.5 million upfront payment from the Vericel licensing agreement for NexoBrid.
Operating loss for the nine months ended September 2020 was $6.5 million, compared with a profit of $7.6 million in the comparable
period, which includes a $17.5 million upfront license payment and $1.7 million of NexoBrid licensing related expenses. Excluding the upfront license payment, net of deal related costs, operating loss for the first nine months of 2019 was $8.2
million.
MediWound’s loss for the nine months ended September 2020 was $7.5 million, or $0.28 per share, compared with net profit of $8.4
million, or $0.31 per share, for the first nine months of 2019, which included the $17.5 million upfront license payment, $1.7 million licensing deal related expenses and discontinued operating profit of $2.8 million. Excluding the upfront license
payment, net of deal related costs, and discontinued profit, net loss for the first nine months of 2019 was $10.2 million, or $0.37 per share.
Adjusted EBITDA, for the nine months ended September 2020, was a loss of $4.7 million, compared with a profit of $10.5 million for the
first nine months of 2019, which included the upfront payment of $17.5 million from the Vericel licensing agreement, net of royalty payment of $0.7 million.
Balance Sheet Highlights
As of September 30, 2020, MediWound had $25.0 million in cash and short-term investments, compared with $29.5 million as of December
31, 2019, and no debt. MediWound remained on budget, utilizing $4.5 million in the first nine months of 2020 for its operational activities. MediWound reiterates its expectations of cash use for operating activities in 2020 to be in the range of $8
to $10 million.
Conference Call
MediWound management will host a conference call for investors today, Tuesday, November 10, 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 6997223. The call also will be webcast live on the MediWound’s website at http://ir.mediwound.com/events-and-presentations.
A replay of the call will be accessible two hours after its completion through November 24, 2020 by dialing 855-859-2056 (in the U.S.)
or 404-537-3406 (outside the U.S.) and entering passcode 6997223. The call will also be archived on MediWound's 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 for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. On June 29, 2020, a biological 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. 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; timeline of the 12- and 24-month top-line data in the CIDS; 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 Corporation; 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, its ability to monitor our clinical trials, and/or conduct necessary reviews or inspections any or all of which may result in timelines being materially delayed, which could affect the
development and ultimate commercialization of NexoBrid and EscharEx. 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:
|
Jeremy Feffer
|
|
|
Boaz Gur-Lavie
|
Jeremy Feffer
|
|
|
Chief Financial Officer
|
Managing Director, LifeSci Advisors
|
|
|
MediWound Ltd.
|
212-915-2568
|
|
|
ir@mediwound.com
|
jeremy@lifesciadvisors.com
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MediWound, Ltd.
CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands
|
Sep 30,
|
Dec 31,
|
|||||||||||
|
2020
|
2019
|
2019
|
||||||||||
|
Un-audited
|
Audited
|
|||||||||||
|
Cash, cash equivalents and short term deposits
|
25,023
|
32,856
|
29,458
|
|||||||||
|
Accounts and other receivable
|
3,495
|
5,170
|
4,557
|
|||||||||
|
Inventories
|
1,805
|
1,419
|
1,613
|
|||||||||
|
Total current assets
|
30,323
|
39,445
|
35,628
|
|||||||||
|
LONG‑TERM ASSETS:
|
||||||||||||
|
Property, plant and equipment, net
|
2,448
|
2,169
|
2,304
|
|||||||||
|
Right of use assets, net
|
2,170
|
2,254
|
2,229
|
|||||||||
|
Intangible assets, net
|
380
|
446
|
429
|
|||||||||
|
Total long term assets
|
4,998
|
4,869
|
4,962
|
|||||||||
|
Total assets
|
35,321
|
44,314
|
40,590
|
|||||||||
|
CURRENT LIABILITIES:
|
||||||||||||
|
Current maturities of long-term liabilities
|
1,081
|
810
|
569
|
|||||||||
|
Trade payables and accrued expenses
|
3,155
|
2,863
|
4,067
|
|||||||||
|
Liability in respect of discontinued Operations
|
-
|
2,240
|
-
|
|||||||||
|
Other payables
|
7,394
|
4,898
|
5,737
|
|||||||||
|
Total current liabilities
|
11,630
|
10,811
|
10,373
|
|||||||||
|
|
||||||||||||
|
Deferred revenues
|
1,283
|
1,134
|
1,135
|
|||||||||
|
Liabilities in respect of Israeli Innovation Authority grants net of current maturities
|
7,157
|
7,099
|
6,811
|
|||||||||
|
Contingent consideration for the purchase of shares net of current maturities
|
4,408
|
4,621
|
4,853
|
|||||||||
|
Lease liabilities net of current maturities
|
1,942
|
2,015
|
2,006
|
|||||||||
|
Severance pay liability, net
|
284
|
316
|
243
|
|||||||||
|
Total long term liabilities
|
15,074
|
15,185
|
15,048
|
|||||||||
|
|
||||||||||||
|
Shareholders' equity
|
8,617
|
18,318
|
15,169
|
|||||||||
|
Total liabilities & shareholder equity
|
35,321
|
44,314
|
40,590
|
|||||||||
MediWound, Ltd.
CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME (LOSS) (UNAUDITED)
U.S. dollars in thousands
|
Nine months ended
|
Three months ended
|
|||||||||||||||
|
Sep 30,
|
Sep 30,
|
|||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
|||||||||||||
|
Revenues
|
15,090
|
26,347
|
6,625
|
5,140
|
||||||||||||
|
Cost of revenues
|
9,873
|
7,489
|
3,855
|
3,969
|
||||||||||||
|
Gross profit
|
5,217
|
18,858
|
2,770
|
1,171
|
||||||||||||
|
Operating expenses:
|
||||||||||||||||
|
Research and development, gross
|
5,473
|
7,861
|
2,142
|
1,574
|
||||||||||||
|
Participation by BARDA & IIA
|
-
|
(4,568
|
)
|
-
|
-
|
|||||||||||
|
Research and development, net
|
5,473
|
3,293
|
2,142
|
1,574
|
||||||||||||
|
Selling, general & administrative
|
6,198
|
6,887
|
2,170
|
2,179
|
||||||||||||
|
Other expenses, net
|
-
|
1,041
|
-
|
140
|
||||||||||||
|
Total operating expenses
|
11,671
|
11,221
|
4,312
|
3,893
|
||||||||||||
|
Operating profit (loss)
|
(6,454
|
)
|
7,637
|
(1,542
|
)
|
(2,722
|
)
|
|||||||||
|
|
||||||||||||||||
|
Financial expenses, net
|
(1,093
|
)
|
(2,045
|
)
|
(448
|
)
|
(242
|
)
|
||||||||
|
Profit (loss) from continuing operations
|
(7,547
|
)
|
5,592
|
(1,990
|
)
|
(2,964
|
)
|
|||||||||
|
Profit from discontinued operation
|
83
|
2,806
|
83
|
2,756
|
||||||||||||
|
Profit (loss) for the period
|
(7,464
|
)
|
8,398
|
(1,907
|
)
|
(208
|
)
|
|||||||||
|
Foreign currency translation adjustments
|
(11
|
)
|
17
|
(12
|
)
|
15
|
||||||||||
|
Total comprehensive income (loss)
|
(7,475
|
)
|
8,415
|
(1,919
|
)
|
(193
|
)
|
|||||||||
|
Basic and diluted loss per share:
|
||||||||||||||||
|
Profit (loss) from continuing operations
|
(0.28
|
)
|
0.21
|
(0.07
|
)
|
(0.11
|
)
|
|||||||||
|
Profit from discontinued operation
|
(*
|
)
|
0.10
|
(*
|
)
|
0.10
|
||||||||||
|
Net profit (loss) per share
|
(0.28
|
)
|
0.31
|
(0.07
|
)
|
(0.01
|
)
|
|||||||||
|
Weighted average number of ordinary shares used in the computation of basic and diluted profit /loss per share:
|
27,206
|
27,179
|
27,179
|
27,179
|
||||||||||||
(*) Represents less than $ 1
MediWound, Ltd.
ADJUSTED EBITDA
U.S. dollars in thousands
|
Nine months ended
|
Three months ended
|
|||||||||||||||
|
Sep 30,
|
Sep 30,
|
|||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
|||||||||||||
|
Un-audited
|
Un-audited
|
|||||||||||||||
|
Profit (loss) for the period
|
(7,464
|
)
|
8,398
|
(1,907
|
)
|
(208
|
)
|
|||||||||
|
Adjustments:
|
||||||||||||||||
|
Financial expenses, net
|
(1,093
|
)
|
(2,045
|
)
|
(448
|
)
|
(242
|
)
|
||||||||
|
Profit from discontinued operation
|
83
|
2,806
|
83
|
2,756
|
||||||||||||
|
Other expenses
|
-
|
(1,041
|
)
|
-
|
(140
|
)
|
||||||||||
|
Depreciation and amortization
|
(866
|
)
|
(848
|
)
|
(327
|
)
|
(296
|
)
|
||||||||
|
Share-based compensation expenses
|
(923
|
)
|
(931
|
)
|
(404
|
)
|
(332
|
)
|
||||||||
|
Total adjustments
|
(2,799
|
)
|
(2,059
|
)
|
(1,096
|
)
|
1,746
|
|||||||||
|
Adjusted EBITDA
|
(4,665
|
)
|
10,457
|
(811
|
)
|
(1,954
|
)
|
|||||||||
MediWound, Ltd.
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW
(UNAUDITED)
U.S. dollars in thousands
|
Nine months ended
|
Three months ended
|
|||||||||||||||
|
Sep 30,
|
Sep 30,
|
|||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
|||||||||||||
|
Net profit (loss)
|
(7,464
|
)
|
8,398
|
(1,907
|
)
|
(208
|
)
|
|||||||||
|
Adjustments to reconcile net profit (loss) to net cash used in continuing operating activities:
|
||||||||||||||||
|
Adjustments to profit and loss items:
|
||||||||||||||||
|
Profit from discontinued operation
|
(83
|
)
|
(2,806
|
)
|
(83
|
)
|
(2,756
|
)
|
||||||||
|
Depreciation and amortization
|
866
|
848
|
327
|
296
|
||||||||||||
|
Share-based compensation
|
923
|
931
|
404
|
332
|
||||||||||||
|
Revaluation of liabilities in respect of IIA grants
|
692
|
(99
|
)
|
268
|
293
|
|||||||||||
|
Revaluation of contingent consideration for the purchase of shares
|
558
|
1,519
|
210
|
197
|
||||||||||||
|
Revaluation of lease liabilities
|
127
|
(291
|
)
|
63
|
(485
|
)
|
||||||||||
|
Increase (decrease) in severance liability, net
|
35
|
(32
|
)
|
(5
|
)
|
(22
|
)
|
|||||||||
|
Financing income, net
|
(244
|
)
|
(295
|
)
|
(53
|
)
|
(146
|
)
|
||||||||
|
Unrealized foreign currency (gain) loss
|
(8
|
)
|
(52
|
)
|
(36
|
)
|
18
|
|||||||||
|
|
2,866
|
(277
|
)
|
1,095
|
(2,273
|
)
|
||||||||||
|
Changes in asset and liability items:
|
||||||||||||||||
|
Decrease (Increase) in trade receivables
|
1,477
|
(3,955
|
)
|
136
|
(3,946
|
)
|
||||||||||
|
Decrease (increase) in inventories
|
(231
|
)
|
260
|
95
|
114
|
|||||||||||
|
Decrease (increase) in other receivables
|
(397
|
)
|
5,198
|
(113
|
)
|
2,454
|
||||||||||
|
Increase (decrease) in trade payables and prepaid expenses
|
(925
|
)
|
150
|
724
|
(1,207
|
)
|
||||||||||
|
Increase in other payables & deferred revenues
|
1,288
|
810
|
1,202
|
281
|
||||||||||||
|
Net cash provided by (used in)
|
1,212
|
2,463
|
2,044
|
(2,304
|
)
|
|||||||||||
|
continuing operating activities
|
(3,386
|
)
|
10,584
|
1,232
|
(4,785
|
)
|
||||||||||
|
Net cash provided by discontinued operating activities
|
(192
|
)
|
-
|
(192
|
)
|
-
|
||||||||||
|
Net cash provided by (used in) operating activities
|
(3,578
|
)
|
10,584
|
1,040
|
(4,785
|
)
|
||||||||||
MediWound, Ltd.
CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW
(UNAUDITED)-Cont.
U.S. dollars in thousands
|
|
Nine months ended
|
Three months ended
|
||||||||||||||
|
|
Sep 30,
|
Sep 30,
|
||||||||||||||
|
|
2020
|
2019
|
2020
|
2019
|
||||||||||||
|
Cash Flows from Investment Activities:
|
||||||||||||||||
|
Purchase of property and equipment
|
(480
|
)
|
(463
|
)
|
(236
|
)
|
(30
|
)
|
||||||||
|
Interest received
|
43
|
104
|
1
|
60
|
||||||||||||
|
Proceeds from short term bank deposits, net of investments
|
8,136
|
(8,005
|
)
|
(2,459
|
)
|
(10,982
|
)
|
|||||||||
|
Net cash provided by (used in) continuing investing activities
|
7,699
|
(8,364
|
)
|
(2,694
|
)
|
(10,952
|
)
|
|||||||||
|
Net cash used in discontinued investing activities
|
-
|
(957
|
)
|
-
|
(1,007
|
)
|
||||||||||
|
Net cash provided by investing activities
|
7,699
|
(9,321
|
)
|
(2,694
|
)
|
(10,952
|
)
|
|||||||||
|
|
||||||||||||||||
|
Cash Flows from Financing Activities:
|
||||||||||||||||
|
Repayment of lease liabilities
|
(533
|
)
|
99
|
(220
|
)
|
411
|
||||||||||
|
Proceeds from IIA grants, net of repayments
|
(121
|
)
|
(376
|
)
|
(55
|
)
|
(569
|
)
|
||||||||
|
Net cash used in financing activities
|
(654
|
)
|
(277
|
)
|
(275
|
)
|
(158
|
)
|
||||||||
|
|
||||||||||||||||
|
Exchange rate differences on cash and cash equivalent balances
|
32
|
41
|
58
|
(22
|
)
|
|||||||||||
|
Increase (decrease) in cash and cash equivalents from continuing activities
|
3,691
|
1,984
|
(1,679
|
)
|
(15,917
|
)
|
||||||||||
|
Decrease in cash and cash equivalents from discontinued activities
|
(192
|
)
|
(957
|
)
|
(192
|
)
|
(1,007
|
)
|
||||||||
|
Balance of cash and cash equivalents at the beginning of the period
|
7,242
|
6,716
|
12,612
|
24,667
|
||||||||||||
|
Balance of cash and cash equivalents at the end of the period
|
10,741
|
7,743
|
10,741
|
7,743
|
||||||||||||
Exhibit 99.2
MEDIWOUND LTD. AND ITS SUBSIDIARIES
INTERIM CONDENSED FINANCIAL STATEMENTS
AS OF SEPTEMBER 30, 2020
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
|
September 30,
|
December 31,
|
|||||||||||
|
2020
|
2019
|
2019
|
||||||||||
|
Unaudited
|
Audited
|
|||||||||||
|
CURRENT ASSETS:
|
||||||||||||
|
Cash and cash equivalents
|
10,741
|
7,743
|
7,242
|
|||||||||
|
Restricted deposits
|
181
|
178
|
180
|
|||||||||
|
Short-term bank deposits
|
14,101
|
24,935
|
22,036
|
|||||||||
|
Trade receivables
|
2,650
|
4,493
|
4,107
|
|||||||||
|
Inventories
|
1,805
|
1,419
|
1,613
|
|||||||||
|
Other receivables
|
845
|
677
|
450
|
|||||||||
|
30,323
|
39,445
|
35,628
|
||||||||||
|
LONG‑TERM ASSETS:
|
||||||||||||
|
Property, plant and equipment, net
|
2,448
|
2,169
|
2,304
|
|||||||||
|
Right of-use assets
|
2,170
|
2,254
|
2,229
|
|||||||||
|
Intangible assets, net
|
380
|
446
|
429
|
|||||||||
|
4,998
|
4,869
|
4,962
|
||||||||||
|
35,321
|
44,314
|
40,590
|
||||||||||
|
CURRENT LIABILITIES:
|
||||||||||||
|
Current maturities of long-term liabilities
|
1,081
|
810
|
569
|
|||||||||
|
Trade payables and accrued expenses
|
3,155
|
2,863
|
4,067
|
|||||||||
|
Liability in respect of discontinued operation
|
-
|
2,240
|
-
|
|||||||||
|
Other payables
|
7,394
|
4,898
|
5,737
|
|||||||||
|
11,630
|
10,811
|
10,373
|
||||||||||
|
LONG‑TERM LIABILITIES:
|
||||||||||||
|
Deferred revenues
|
1,283
|
1,134
|
1,135
|
|||||||||
|
Liabilities in respect of IIA grants
|
7,157
|
7,099
|
6,811
|
|||||||||
|
Contingent consideration for purchase of shares
|
4,408
|
4,621
|
4,853
|
|||||||||
|
Lease liabilities
|
1,942
|
2,015
|
2,006
|
|||||||||
|
Severance pay liabilities, net
|
284
|
316
|
243
|
|||||||||
|
15,074
|
15,185
|
15,048
|
||||||||||
|
SHAREHOLDERS' EQUITY:
|
||||||||||||
|
Ordinary shares of NIS 0.01 par value:
|
||||||||||||
|
Authorized: 50,000,000 shares as of September 30, 2020, December 31, 2019 and September 30, 2019; Issued and Outstanding: 27,212,794 as of September 30, 2020, 27,202,795
as of December 31, 2019 and 27,178,839 as of September 30, 2019
|
75
|
75
|
75
|
|||||||||
|
Share premium
|
141,794
|
140,568
|
140,871
|
|||||||||
|
Foreign currency translation adjustments
|
(28
|
)
|
(8
|
)
|
(17
|
)
|
||||||
|
Accumulated deficit
|
(133,224
|
)
|
(122,317
|
)
|
(125,760
|
)
|
||||||
|
8,617
|
18,318
|
15,169
|
||||||||||
|
35,321
|
44,314
|
40,590
|
||||||||||
The accompanying notes are an integral part of the interim consolidated financial statements.
F - 2
MEDIWOUND LTD. AND ITS SUBSIDIARIES
U.S. dollars in thousands (except share data and per share data)
|
Nine months ended
September 30,
|
Three months ended
September 30,
|
Year ended December 31,
|
||||||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
2019
|
||||||||||||||||
|
Unaudited
|
Audited
|
|||||||||||||||||||
|
Revenues from sale of products
|
4,744
|
2,355
|
3,082
|
1,046
|
3,393
|
|||||||||||||||
|
Revenues from development services
|
10,095
|
6,346
|
3,464
|
4,045
|
10,678
|
|||||||||||||||
|
Revenues from license agreements
|
251
|
17,646
|
79
|
49
|
17,718
|
|||||||||||||||
|
Total revenues
|
15,090
|
26,347
|
6,625
|
5,140
|
31,789
|
|||||||||||||||
|
Cost of revenues
|
9,873
|
7,489
|
3,855
|
3,969
|
11,849
|
|||||||||||||||
|
Gross profit
|
5,217
|
18,858
|
2,770
|
1,171
|
19,940
|
|||||||||||||||
|
Research and development, gross
|
5,473
|
7,861
|
2,142
|
1,574
|
10,070
|
|||||||||||||||
|
Participations by BARDA and IIA
|
-
|
(4,568
|
)
|
-
|
-
|
(5,101
|
)
|
|||||||||||||
|
Research and development, net of participations
|
5,473
|
3,293
|
2,142
|
1,574
|
4,969
|
|||||||||||||||
|
Selling and marketing
|
2,392
|
3,078
|
709
|
944
|
4,064
|
|||||||||||||||
|
General and administrative
|
3,806
|
3,809
|
1,461
|
1,235
|
5,242
|
|||||||||||||||
|
Other expenses
|
-
|
1,041
|
-
|
140
|
1,172
|
|||||||||||||||
|
Total operation expenses
|
11,671
|
11,221
|
4,312
|
3,893
|
15,447
|
|||||||||||||||
|
Operating profit (loss)
|
(6,454
|
)
|
7,637
|
(1,542
|
)
|
(2,722
|
)
|
4,493
|
||||||||||||
|
Financial income
|
416
|
300
|
93
|
147
|
556
|
|||||||||||||||
|
Financial expense
|
(1,509
|
)
|
(2,345
|
)
|
(541
|
)
|
(389
|
)
|
(2,983
|
)
|
||||||||||
|
Profit (loss) from continuing operation
|
(7,547
|
)
|
5,592
|
(1,990
|
)
|
(2,964
|
)
|
2,066
|
||||||||||||
|
Profit from discontinued operation
|
83
|
2,806
|
83
|
2,756
|
2,889
|
|||||||||||||||
|
Net Profit (loss)
|
(7,464
|
)
|
8,398
|
(1,907
|
)
|
(208
|
)
|
4,955
|
||||||||||||
|
Other comprehensive income (loss):
|
||||||||||||||||||||
|
Foreign currency translation adjustments
|
(11
|
)
|
17
|
(12
|
)
|
15
|
8
|
|||||||||||||
|
Total comprehensive income (loss)
|
(7,475
|
)
|
8,415
|
(1,919
|
)
|
(193
|
)
|
4,963
|
||||||||||||
|
Basic and diluted net profit (loss) per share from continuing operations
|
(0.28
|
)
|
0.21
|
(0.07
|
)
|
(0.11
|
)
|
0.08
|
||||||||||||
|
Basic and diluted net profit per share from discontinued operation
|
(*
|
)
|
0.10
|
(*
|
)
|
0.10
|
0.10
|
|||||||||||||
|
Total Basic and diluted net profit (loss) per share
|
(0.28
|
)
|
0.31
|
(0.07
|
)
|
(0.01
|
)
|
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
|
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
|
-
|
-
|
-
|
(7,464
|
)
|
(7,464
|
)
|
|||||||||||||
|
Other comprehensive loss
|
-
|
-
|
(11
|
)
|
-
|
(11
|
)
|
|||||||||||||
|
Total comprehensive loss
|
-
|
-
|
(11
|
)
|
(7,464
|
)
|
(7,475
|
)
|
||||||||||||
|
Share-based compensation
|
-
|
923
|
-
|
-
|
923
|
|||||||||||||||
|
Balance as of September 30, 2020 (unaudited)
|
75
|
141,794
|
(28
|
)
|
(133,224
|
)
|
8,617
|
|||||||||||||
|
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
|
-
|
-
|
-
|
8,398
|
8,398
|
|||||||||||||||
|
Other comprehensive income
|
-
|
-
|
17
|
-
|
17
|
|||||||||||||||
|
Total comprehensive income
|
-
|
-
|
17
|
8,398
|
8,415
|
|||||||||||||||
|
Share-based compensation
|
-
|
931
|
-
|
-
|
931
|
|||||||||||||||
|
Balance as of September 30, 2019 (unaudited)
|
75
|
140,568
|
(8
|
)
|
(122,317
|
)
|
18,318
|
|||||||||||||
| (*) |
Represent less than $1.
|
The accompanying notes are an integral part of the interim consolidated financial statements.
F - 4
MEDIWOUND LTD. AND ITS SUBSIDIARIES
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
U.S. dollars in thousands
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
Equity
|
||||||||||||||||
|
Balance as of July 1, 2020
|
75
|
141,390
|
(16
|
)
|
(131,317
|
)
|
10,132
|
|||||||||||||
|
Loss for the period
|
-
|
-
|
-
|
(1,907
|
)
|
(1,907
|
)
|
|||||||||||||
|
Other comprehensive loss
|
-
|
-
|
(12
|
)
|
-
|
(12
|
)
|
|||||||||||||
|
Total comprehensive loss
|
-
|
-
|
(12
|
)
|
(1,907
|
)
|
(1,919
|
)
|
||||||||||||
|
Share-based compensation
|
-
|
404
|
-
|
-
|
404
|
|||||||||||||||
|
Balance as of September 30, 2020 (unaudited)
|
75
|
141,794
|
(28
|
)
|
(133,224
|
)
|
8,617
|
|||||||||||||
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
Equity
|
||||||||||||||||
|
Balance as of July 1, 2019
|
75
|
140,236
|
(23
|
)
|
(122,109
|
)
|
18,179
|
|||||||||||||
|
Loss for the period
|
-
|
-
|
-
|
(208
|
)
|
(208
|
)
|
|||||||||||||
|
Other comprehensive income
|
-
|
-
|
15
|
-
|
15
|
|||||||||||||||
|
Total comprehensive (loss) income
|
-
|
-
|
15
|
(208
|
)
|
(193
|
)
|
|||||||||||||
|
Share-based compensation
|
-
|
332
|
-
|
-
|
332
|
|||||||||||||||
|
Balance as of September 30, 2019 (unaudited)
|
75
|
140,568
|
(8
|
)
|
(122,317
|
)
|
18,318
|
|||||||||||||
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
|
Nine months ended
September 30,
|
Three months ended
September 30,
|
Year ended December 31,
|
||||||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
2019
|
||||||||||||||||
|
Unaudited
|
Audited
|
|||||||||||||||||||
|
Cash flows from operating activities:
|
||||||||||||||||||||
|
Net Profit (loss)
|
(7,464
|
)
|
8,398
|
(1,907
|
)
|
(208
|
)
|
4,955
|
||||||||||||
|
Adjustments to reconcile net loss to net cash provided by (used in) continuing operating activities:
|
||||||||||||||||||||
|
Adjustments to profit and loss items:
|
||||||||||||||||||||
|
Profit from discontinued operation
|
(83
|
)
|
(2,806
|
)
|
(83
|
)
|
(2,756
|
)
|
(2,889
|
)
|
||||||||||
|
Depreciation and amortization
|
866
|
848
|
327
|
296
|
1,149
|
|||||||||||||||
|
Share-based compensation
|
923
|
931
|
404
|
332
|
1,234
|
|||||||||||||||
|
Revaluation of liabilities in respect of IIA grants
|
692
|
(99
|
)
|
268
|
293
|
(392
|
)
|
|||||||||||||
|
Revaluation of contingent consideration for purchase of shares
|
558
|
1,519
|
210
|
197
|
1,690
|
|||||||||||||||
|
Revaluation of lease liabilities
|
127
|
(291
|
)
|
63
|
(485
|
)
|
340
|
|||||||||||||
|
Increase (decrease) in severance pay liability, net
|
35
|
(32
|
)
|
(5
|
)
|
(22
|
)
|
(105
|
)
|
|||||||||||
|
Net financing income
|
(244
|
)
|
(295
|
)
|
(53
|
)
|
(146
|
)
|
(434
|
)
|
||||||||||
|
Un-realized foreign currency (gain) loss
|
(8
|
)
|
(52
|
)
|
(36
|
)
|
18
|
(152
|
)
|
|||||||||||
|
2,866
|
(277
|
)
|
1,095
|
(2,273
|
)
|
441
|
||||||||||||||
|
Changes in asset and liability items:
|
||||||||||||||||||||
|
Decrease (increase) in trade receivables
|
1,477
|
(3,955
|
)
|
136
|
(3,946
|
)
|
(3,553
|
)
|
||||||||||||
|
Decrease (increase) in inventories
|
(231
|
)
|
260
|
95
|
114
|
67
|
||||||||||||||
|
Decrease (increase) in other receivables
|
(397
|
)
|
5,198
|
(113
|
)
|
2,454
|
6,376
|
|||||||||||||
|
Increase (decrease) in trade payables and accrued expenses
|
(925
|
)
|
150
|
724
|
(1,207
|
)
|
1,355
|
|||||||||||||
|
Increase in other payables and deferred revenues
|
1,288
|
810
|
1,202
|
281
|
247
|
|||||||||||||||
|
1,212
|
2,463
|
2,044
|
(2,304
|
)
|
4,492
|
|||||||||||||||
|
Net cash provided by (used in) Continuing operating activities
|
(3,386
|
)
|
10,584
|
1,232
|
(4,785
|
)
|
9,888
|
|||||||||||||
|
Net cash used in discontinued operating activities
|
(192
|
)
|
-
|
(192
|
)
|
-
|
(1,599
|
)
|
||||||||||||
|
Net cash provided by (used in) operating activities
|
(3,578
|
)
|
10,584
|
1,040
|
(4,785
|
)
|
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
|
Nine months ended
September 30,
|
Three months ended
September 30,
|
Year ended December 31,
|
||||||||||||||||||
|
2020
|
2019
|
2020
|
2019
|
2019
|
||||||||||||||||
|
Unaudited
|
Audited
|
|||||||||||||||||||
|
Cash flows from investing activities:
|
||||||||||||||||||||
|
Purchase of property and equipment
|
(480
|
)
|
(463
|
)
|
(236
|
)
|
(30
|
)
|
(792
|
)
|
||||||||||
|
Interest received
|
43
|
104
|
1
|
60
|
184
|
|||||||||||||||
|
Proceeds from (investment in) short term bank deposits, net
|
8,136
|
(8,005
|
)
|
(2,459
|
)
|
(10,982
|
)
|
(5,050
|
)
|
|||||||||||
|
Net cash provided by (used in) continued investing activities
|
7,699
|
(8,364
|
)
|
(2,694
|
)
|
(10,952
|
)
|
(5,658
|
)
|
|||||||||||
|
Net cash used in discontinued investing activities
|
-
|
(957
|
)
|
-
|
(1,007
|
)
|
(1,239
|
)
|
||||||||||||
|
Net cash provided by (used in) investing activities
|
7,699
|
(9,321
|
)
|
(2,694
|
)
|
(11,959
|
)
|
(6,897
|
)
|
|||||||||||
|
Cash flows from financing activities:
|
||||||||||||||||||||
|
Repayment of leases liabilities
|
(533
|
)
|
99
|
(220
|
)
|
411
|
(630
|
)
|
||||||||||||
|
Proceeds from exercise of options
|
-
|
-
|
-
|
-
|
(*
|
)
|
||||||||||||||
|
Proceeds from IIA grants, net of repayments
|
(121
|
)
|
(376
|
)
|
(55
|
)
|
(569
|
)
|
(376
|
)
|
||||||||||
|
Net cash used in financing activities
|
(654
|
)
|
(277
|
)
|
(275
|
)
|
(158
|
)
|
(1,006
|
)
|
||||||||||
|
Exchange rate differences on cash and cash equivalent balances
|
32
|
41
|
58
|
(22
|
)
|
140
|
||||||||||||||
|
Increase (decrease) in cash and cash equivalents from continuing activities
|
3,691
|
1,984
|
(1,679
|
)
|
(15,917
|
)
|
3,364
|
|||||||||||||
|
Decrease in cash and cash equivalents from discontinued activities
|
(192
|
)
|
(957
|
)
|
(192
|
)
|
(1,007
|
)
|
(2,838
|
)
|
||||||||||
|
Balance of cash and cash equivalents at the beginning of the period
|
7,242
|
6,716
|
12,612
|
24,667
|
6,716
|
|||||||||||||||
|
Balance of cash and cash equivalents at the end of the period
|
10,741
|
7,743
|
10,741
|
7,743
|
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
| 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.
On June 29, 2020, the Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drugs Administration (FDA) seeking the approval of NexoBrid in USA.
On 16 September, 2020, FDA provided the Company with notification of acceptance of the BLA for review.
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 nine months ended September 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.
F - 10