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F-3 | |
F-4 – F-5 | |
F-6 – F-7 | |
F-8 – F-11 |
MEDIWOUND LTD. AND ITS SUBSIDIARIES
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June 30,
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December 31,
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2022
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2021
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2021
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||||||||||
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Unaudited
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Audited
|
|||||||||||
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Cash and cash equivalents
|
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Restricted deposits
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Short-term bank deposits
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Trade receivables
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Inventories
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Other receivables
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Total current assets
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Other receivables
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Property, plant and equipment, net
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Right of-use assets, net
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Intangible assets, net
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Total non-current assets
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Total assets
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Current maturities of non-current liabilities
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Trade payables and accrued expenses
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Other payables
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Total current liabilities
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Deferred revenues
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Liabilities in respect of IIA grants
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Liabilities in respect of purchase of shares
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Lease liabilities
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Severance pay liability, net
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Total non-current liabilities
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Total liabilities
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Shareholders' equity:
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Ordinary shares of NIS
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Authorized:
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Share premium
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Foreign currency translation adjustments
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(
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)
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(
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)
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Accumulated deficit
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(
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)
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(
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)
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(
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)
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Total equity (deficit)
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(
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)
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(
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)
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Total liabilities and equity
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MEDIWOUND LTD. AND ITS SUBSIDIARIES
|
Six months ended
June 30,
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Three months ended
June 30,
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Year ended
December 31,
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|
2022
|
2021
|
2022
|
2021
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2021
|
||||||||||||||||
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Unaudited
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Audited
|
|||||||||||||||||||
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Revenues from sale of products
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Revenues from development services
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Revenues from license agreements
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Total revenues
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Cost of revenues from sale of products
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Cost of revenues from development services
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Cost of revenues from license agreements
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Total cost of revenues
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Gross profit
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Research and development
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Selling and marketing
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|||||||||||||||
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General and administrative
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Other expenses
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|||||||||||||||
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Total operating expenses
|
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|||||||||||||||
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Operating loss
|
(
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)
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(
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)
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(
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)
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(
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)
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(
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)
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||||||||||
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Financial income
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|||||||||||||||
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Financial expenses
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(
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)
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(
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)
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(
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)
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(
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)
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(
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)
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||||||||||
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Financing expenses, net
|
(
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)
|
(
|
)
|
(
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)
|
(
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)
|
(
|
)
|
||||||||||
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Loss before taxes on income
|
(
|
)
|
(
|
)
|
(
|
)
|
(
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)
|
(
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)
|
||||||||||
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Taxes on income
|
(
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)
|
(
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)
|
(
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)
|
(
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)
|
(
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)
|
||||||||||
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Net loss
|
(
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)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
Other comprehensive income (loss):
|
||||||||||||||||||||
|
Foreign currency translation adjustments
|
|
|
|
(
|
) |
|
||||||||||||||
|
Total comprehensive loss
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
Loss per share data:
|
||||||||||||||||||||
|
Basic and diluted net loss per share - USD
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
Number of shares used in calculating basic and diluted net loss per share
|
|
|
|
|
|
|||||||||||||||
MEDIWOUND LTD. AND ITS SUBSIDIARIES
|
Share capital
|
Share premium
|
Foreign currency
translation
reserve
|
Accumulated
deficit
|
Total
equity (deficit)
|
||||||||||||||||
|
Balance as of April 1, 2022
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||
|
Loss for the period
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
|
Other comprehensive income
|
|
|
|
|
|
|||||||||||||||
|
Total comprehensive income (loss)
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
|
Issuance expenses, see Note 3
|
|
(
|
)
|
|
|
(
|
)
|
|||||||||||||
|
Exercise of options
|
(
|
)
|
|
|
|
(
|
)
|
|||||||||||||
|
Share-based compensation
|
|
|
|
|
|
|||||||||||||||
|
Balance as of June 30, 2022 (unaudited)
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
|
Balance as of April 1, 2021
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||
|
Loss for the period
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
|
Other comprehensive loss
|
|
|
(
|
)
|
|
(
|
)
|
|||||||||||||
|
Total comprehensive loss
|
|
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||||
|
Exercise of options
|
(
|
)
|
|
|
|
(
|
)
|
|||||||||||||
|
Share-based compensation
|
|
|
|
|
|
|||||||||||||||
|
Balance as of June 30, 2021 (unaudited)
|
|
|
(
|
)
|
(
|
)
|
|
MEDIWOUND LTD. AND ITS SUBSIDIARIES
|
Share capital
|
Share premium
|
Foreign currency
translation
reserve
|
Accumulated
deficit
|
Total
equity (deficit)
|
||||||||||||||||
|
Balance as of December 31, 2021
|
|
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||||
|
Loss for the period
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
|
Other comprehensive income
|
|
|
|
|
|
|||||||||||||||
|
Total comprehensive income (loss)
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
|
Issuance of ordinary shares, net of issuance expenses(see note 3)
|
|
|
|
|
|
|||||||||||||||
|
Exercise of options
|
(
|
)
|
|
|
|
(
|
)
|
|||||||||||||
|
Share-based compensation
|
|
|
|
|
|
|||||||||||||||
|
Balance as of June 30, 2022 (unaudited)
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
|
Balance as of December 31, 2020
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||
|
Loss for the period
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
|
Other comprehensive income
|
|
|
|
|
|
|||||||||||||||
|
Total comprehensive income (loss)
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
|
Exercise of options
|
(
|
)
|
|
|
|
(
|
)
|
|||||||||||||
|
Share-based compensation
|
|
|
|
|
|
|||||||||||||||
|
Balance as of June 30, 2021 (unaudited)
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||
|
Balance as of December 31, 2020
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||
|
Loss for the period
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
|
Other comprehensive income
|
|
|
|
|
|
|||||||||||||||
|
Total comprehensive income (loss)
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
|
Exercise of options
|
(*
|
)
|
|
|
|
|
||||||||||||||
|
Share-based compensation
|
|
|
|
|
|
|||||||||||||||
|
Balance as of December 31, 2021
|
|
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||||
MEDIWOUND LTD. AND ITS SUBSIDIARIES
|
Six months ended
June 30,
|
Three months ended
June 30,
|
Year ended
December 31,
|
||||||||||||||||||
|
2022
|
2021
|
2022
|
2021
|
2021
|
||||||||||||||||
|
Unaudited
|
Audited
|
|||||||||||||||||||
|
Cash flows from operating activities:
|
||||||||||||||||||||
|
Net loss
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
Adjustments to reconcile net loss to net cash used in continuing operating activities:
|
||||||||||||||||||||
|
Adjustments to profit and loss items:
|
||||||||||||||||||||
|
Depreciation and amortization
|
|
|
|
|
|
|||||||||||||||
|
Share-based compensation
|
|
|
|
|
|
|||||||||||||||
|
Revaluation of liabilities in respect of IIA grants
|
|
|
|
|
|
|||||||||||||||
|
Revaluation of liabilities in respect of the purchase of shares
|
|
|
|
|
|
|||||||||||||||
|
Revaluation of lease liabilities
|
(
|
)
|
|
(
|
)
|
|
|
|||||||||||||
|
Increase (decrease) in severance pay liability, net
|
|
(
|
)
|
|
|
|
||||||||||||||
|
Net financing income
|
(
|
)
|
(
|
)
|
(
|
)
|
|
(
|
)
|
|||||||||||
|
Un-realized foreign currency (gain) loss
|
|
(
|
)
|
|
(
|
)
|
(
|
)
|
||||||||||||
|
|
|
|
|
|
||||||||||||||||
|
Changes in asset and liability items:
|
||||||||||||||||||||
|
(Increase) decrease in trade receivables
|
(
|
)
|
|
(
|
)
|
|
|
|||||||||||||
|
(Increase) decrease in inventories
|
(
|
)
|
|
(
|
)
|
|
|
|||||||||||||
|
Decrease (increase) in other receivables
|
|
(
|
)
|
|
(
|
)
|
(
|
)
|
||||||||||||
|
Increase (decrease) in trade payables and accrued expenses
|
|
|
(
|
)
|
|
|
||||||||||||||
|
Decrease in other payables and deferred revenues
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
(
|
)
|
|
(
|
)
|
|
|
||||||||||||||
|
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
MEDIWOUND LTD. AND ITS SUBSIDIARIES
|
Six months ended
June 30,
|
Three months ended
June 30,
|
Year ended
December 31,
|
||||||||||||||||||
|
2022
|
2021
|
2022
|
2021
|
2021
|
||||||||||||||||
|
Unaudited
|
Audited
|
|||||||||||||||||||
|
Cash Flows from Investing Activities:
|
||||||||||||||||||||
|
Purchase of property and equipment
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
Interest received
|
|
|
|
|
|
|||||||||||||||
|
(Increase) decrease in short term bank deposits, net
|
(
|
)
|
|
(
|
)
|
(
|
)
|
|
||||||||||||
|
Net cash provided by (used in) investing activities
|
(
|
)
|
|
(
|
)
|
(
|
)
|
|
||||||||||||
|
Cash Flows from Financing Activities:
|
||||||||||||||||||||
|
Repayment of leases liabilities
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
Proceeds from issuance of shares, net
|
|
|
(
|
)
|
|
|
||||||||||||||
|
Repayment of IIA grant
|
(
|
)
|
(
|
)
|
|
|
(
|
)
|
||||||||||||
|
Net cash provided by (used in) financing activities
|
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
|||||||||||
|
Exchange rate differences on cash and cash equivalent balances
|
(
|
)
|
|
(
|
)
|
|
|
|||||||||||||
|
Decrease in cash and cash equivalents
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
Balance of cash and cash equivalents at the beginning of the period
|
|
|
|
|
|
|||||||||||||||
|
Balance of cash and cash equivalents at the end of the period
|
|
|
|
|
|
|||||||||||||||
|
Supplement disclosure of Non-cash transactions:
|
||||||||||||||||||||
|
ROU asset, net recognized with corresponding lease liability
|
|
|
|
|
|
|||||||||||||||
|
Issuance of shares due to RSUs exercised
|
|
|
|
|
|
|||||||||||||||
The accompanying notes are an integral part of the interim consolidated financial statements.
MEDIWOUND LTD. AND ITS SUBSIDIARIES
| NOTE 1: |
GENERAL
|
| a. |
Description of the Company and its operations:
MediWound Ltd. was incorporated in Israel. The Company which is located in Yavne, Israel (The "Company" or "MediWound"), is biopharmaceutical company that develops, manufactures and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. The Company’s strategy leverages its breakthrough enzymatic technology platform into diversified portfolio of biotherapeutics across multiple indications to pioneer solutions for unmet medical needs. The Company’s current portfolio is focused on next-generation bio-active therapies for burn and wound care and tissue repair.
The Company's first innovative biopharmaceutical product, NexoBrid, has received marketing authorization from the European Medicines Agency ("EMA") as well as the Israeli, Argentinean, South-Korean, Russian, Taiwanese, Ukrainian, United Arab Emirates, Chilean, Peruvian and Switzerland 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 the European Union, United Kingdom, Norway, Switzerland and Israel through its commercial organizations while establishing additional local distribution channels to extend its outreach in the European Union. In other international markets the Company sells NexoBrid through local distributors which are also responsible for obtaining the local marketing authorization within the relevant territory. In the United States, the Company entered into exclusive license and supply agreements with Vericel Corporation (“Vericel”) to commercialize NexoBrid in North America upon FDA's approval.
The Company’s second investigational innovative product, EscharEx, is a topical biological drug being developed for debridement of chronic and other hard-to-heal wounds. In May 2022, the company announced positive results from its U.S. phase 2 study. The study met its primary endpoint, its key secondary endpoints with high degree of statistical significance, as well as its wound closure safety measurements. The Company anticipates meeting with the U.S. Food and Drug Administration (the “FDA”) in the second half of 2022, for an End-of-Phase 2 meeting to discuss study results and a potential Phase 3 pivotal plan for EscharEx.
The third clinical-stage innovative product candidate, MW005, is a topical biological drug candidate for the treatment of non-melanoma skin cancers. A U.S. phase 1/2 study of MW005 for the treatment of low-risk basal cell carcinoma (BCC) was initiated in July 2021, and in July 2022, a positive initial data was announced. The Company anticipates announcing the final data in the second half of 2022.
|
| b. |
The Company's securities are listed for trading on NASDAQ since March 2014. In March, 2022, the Company completed an additional public offering. A total of
|
MEDIWOUND LTD. AND ITS SUBSIDIARIES
Notes to Condensed Interim Consolidated Financial Statements
| NOTE 1: |
GENERAL (Cont.)
|
| c. |
The Company has three wholly owned subsidiaries: MediWound Germany GmbH, acting as Europe (“EU”) marketing authorization holder and EU sales and marketing arm, and MediWound UK Limited and MediWound US, Inc. which are currently inactive companies.
|
| d. |
The Company awarded two contracts with the U.S. Biomedical Advanced Research and Development Authority ("BARDA") valued at up to $
|
| e. |
On February 17, 2022 the Company engaged with the U.S. Department of Defense (“DoD”), through the Medical Technology Enterprise Consortium (MTEC), for a $
|
| f. |
On June 29, 2021, the Company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) seeking approval of NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.
The FDA communicated that it had completed its review of the BLA, as amended, and has determined that the application cannot be approved in its present form. The FDA identified issues related to the Chemistry, Manufacturing and Controls (“CMC”) section of the BLA and requested additional CMC information. The FDA acknowledged receipt of several CMC amendments, submitted by the Company in response to the CMC information requests, which were not reviewed yet by the FDA.
The FDA also stated that an inspection of NexoBrid's manufacturing facilities in Israel and Taiwan, are required before the FDA can approve the BLA, but it was unable to conduct the required inspections during the current review cycle due to COVID-19 related travel restrictions. The FDA stated that it will continue to monitor the public health situation as well as travel restrictions and is actively working to define an approach for scheduling outstanding inspections. In addition, the CRL cited certain observations identified during good clinical practice (GCP) inspections related to the U.S. Phase 3 study (DETECT), and requested the Company to provide its perspective on the potential impact, if any, of these observations on the efficacy findings in the study. The FDA also requested to provide a safety update as part of its BLA resubmission, although there were no safety issues raised in the CRL.
Following a productive Type A meeting with the FDA, the Company gained clarity on a path forward for resubmission of its NexoBrid BLA. In addition, the FDA’s facility inspection schedule which has been affected by COVID-19-related travel restrictions, is required before the FDA can approve the NexoBrid BLA.
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MEDIWOUND LTD. AND ITS SUBSIDIARIES
Notes to Condensed Interim Consolidated Financial Statements
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GENERAL (Cont.)
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On July 1, 2022, the Company has re-submitted the Biologics License Application (BLA) to the U.S. Food and Drugs Administration (FDA) and received an acknowledgement letter from the FDA assigning PDUFA target date to January 1, 2023. |
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| g. |
Since incorporation through June 30, 2022, the Company has incurred losses mainly attributed to its development efforts and has total accumulated deficit of $
Management’s plans include evaluating alternative financing arrangements and/or reducing expenditures as necessary to meet the Company’s future cash requirements. However, there is no assurance that, if required, the Company will be able to raise additional capital or reduce expenditures to provide the required liquidity. Management expects that the Company's cash and cash equivalents as of June 30, 2022 will allow the Company to fund its operating plan through at least the next 12 months from the financial statement issuance date.
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| h. |
The Company addresses the challenges associated with the ongoing COVID-19 pandemic, while prioritizing the health and safety of its workforce and maintaining operational efficiency and flexibility.
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| NOTE 2: |
SIGNIFICANT ACCOUNTING POLICIES
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The following accounting policies have been applied consistently in the financial statements for all periods presented unless otherwise stated. |
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a.
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Basis of presentation of financial statements:
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These financial statements have been prepared in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board ("IASB"). |
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b.
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Basis of preparation of the interim consolidated financial statements:
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The interim condensed consolidated financial statements for the six and three months ended June 30, 2022 have been prepared in accordance with IAS 34 "Interim Financial Reporting". |
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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, 2021 that were included in the Annual Report on Form 20-F filed on March 17, 2022. |
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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, 2021 that were included in the Annual Report on Form 20-F filed on March 17, 2022. |
MEDIWOUND LTD. AND ITS SUBSIDIARIES
Notes to Condensed Interim Consolidated Financial Statements
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NOTE 3: |
EQUITY |
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| a. |
On March 7, 2022, the Company completed an additional public offering. A total of
As part of the above- mentioned public offering, certain entities affiliated with CBI purchased
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| b. |
Over the second quarter of 2022, the Company’s Board of Directors approved the grant of
The above-mentioned grant includes the grant of |
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