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F-2 | |
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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2023
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2022
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2022
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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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Warrants
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Liabilities in respect of IIA grants
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Liabilities in respect of TEVA
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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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Accumulated deficit
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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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Total liabilities and equity
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MEDIWOUND LTD. AND ITS SUBSIDIARIES
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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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2023
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2022
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2023
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2022
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2022
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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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General and administrative
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Other expenses
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Total operating expenses
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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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Financial income
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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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Financing income (expenses), net
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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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Profit (loss) before 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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)
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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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)
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(
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(
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)
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Net profit (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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Other comprehensive income:
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||||||||||||||||||||
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Foreign currency translation adjustments
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(
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)
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Total comprehensive profit (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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Loss per share data:
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Basic and diluted net profit (loss) per share - USD
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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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Number of shares used in calculating basic and diluted net loss per share
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*
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*
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MEDIWOUND LTD. AND ITS SUBSIDIARIES
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Share capital
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Share premium
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Foreign currency translation reserve
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Accumulated
deficit
|
Total
equity (deficit)
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||||||||||||||||
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Balance as of April 1, 2023
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(
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)
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(
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)
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Profit for the period
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Other comprehensive income
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Total comprehensive income
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Issuance expenses, see Note 3
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Exercise of options
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Share-based compensation
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Balance as of June 30, 2023 (unaudited)
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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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Balance as of April 1, 2022
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(
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)
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(
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)
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|||||||||||||
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Loss for the period
|
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(
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)
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(
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)
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|||||||||||||
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Other comprehensive income
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Total comprehensive Income (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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Issuance expenses, see Note 3
|
|
(
|
)
|
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(
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)
|
|||||||||||||
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Exercise of options
|
(
|
)
|
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|
(
|
)
|
|||||||||||||
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Share-based compensation
|
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|
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|||||||||||||||
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Balance as of June 30, 2022 (unaudited)
|
|
|
|
(
|
)
|
(
|
)
|
MEDIWOUND LTD. AND ITS SUBSIDIARIES
Unaudited Condensed Interim Consolidated Statements of Changes in Shareholders’ Equity (Deficit)
|
Share capital
|
Share premium
|
Foreign currency translation reserve
|
Accumulated
deficit
|
Total
equity (deficit)
|
||||||||||||||||
|
Balance as of December 31, 2022 (audited)
|
|
|
(
|
)
|
(
|
)
|
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|||||||||||||
|
Loss for the period
|
|
|
|
(
|
)
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(
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)
|
|||||||||||||
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Other comprehensive (loss)
|
|
|
(
|
)
|
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(
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)
|
|||||||||||||
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Total comprehensive (loss)
|
|
|
(
|
)
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(
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)
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(
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)
|
||||||||||||
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Issuance of ordinary shares, net of issuance expenses (see Note 3)
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Exercise of options
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|||||||||||||||
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Share-based compensation
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|||||||||||||||
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Balance as of June 30, 2023 (unaudited)
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||
|
Balance as of December 31, 2021 (audited)
|
|
|
(
|
)
|
(
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)
|
(
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)
|
||||||||||||
|
Loss for the period
|
|
|
|
(
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)
|
(
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)
|
|||||||||||||
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Other comprehensive income
|
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|
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Total comprehensive income (loss)
|
|
|
(
|
)
|
(
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)
|
||||||||||||||
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Issuance of ordinary shares, net of issuance expenses (see Note 3)
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|
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Exercise of options
|
(
|
)
|
|
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|
(
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)
|
|||||||||||||
|
Share-based compensation
|
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|
|||||||||||||||
|
Balance as of June 30, 2022 (unaudited)
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
|
Balance as of December 31, 2021 (audited)
|
|
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||||
|
Loss for the period
|
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
|
Other comprehensive income
|
|
|
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|||||||||||||||
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Total comprehensive loss
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||
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Exercise of options
|
(
|
)
|
(
|
)
|
|
|
(
|
)
|
||||||||||||
|
Issuance of ordinary shares, net of issuance expenses
|
|
|
|
|
|
|||||||||||||||
|
Exercise of pre-funded warrants
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|
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|
|||||||||||||||
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Share-based compensation
|
|
|
|
|
|
|||||||||||||||
|
Balance as of December 31, 2022 (audited)
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||
MEDIWOUND LTD. AND ITS SUBSIDIARIES
|
Six months ended
June 30,
|
Three months ended
June 30,
|
Year ended December 31,
|
||||||||||||||||||
|
2023
|
2022
|
2023
|
2022
|
2022
|
||||||||||||||||
|
Cash flows from operating activities:
|
||||||||||||||||||||
|
Net income (loss)
|
(
|
)
|
(
|
)
|
|
(
|
)
|
(
|
)
|
|||||||||||
|
Adjustments to reconcile net income (loss) to net cash used in operating activities:
|
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Adjustments to profit and loss items:
|
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Depreciation and amortization
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Share-based compensation
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|
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Revaluation of warrants accounted at fair value
|
(
|
)
|
|
(
|
)
|
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|
|||||||||||||
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Issuance expenses of warrants through profit and loss
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|
|||||||||||||||
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Revaluation of liabilities in respect of IIA grants
|
|
|
|
|
(
|
)
|
||||||||||||||
|
Revaluation of liabilities in respect of TEVA
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|
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|
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|
|||||||||||||||
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Revaluation of lease liabilities
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
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Increase (decrease) in severance pay liability, net
|
|
|
(
|
)
|
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|
||||||||||||||
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Net financing income
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
Un-realized foreign currency loss
|
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|
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|
|||||||||||||||
|
(
|
)
|
|
(
|
)
|
|
|
||||||||||||||
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Changes in asset and liability items:
|
||||||||||||||||||||
|
Decrease (increase) in trade receivables
|
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
|||||||||||
|
Increase in inventories
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
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Decrease in other receivables
|
|
|
|
|
|
|||||||||||||||
|
Increase (decrease) in trade payables and accrued expenses
|
(
|
)
|
|
|
(
|
)
|
|
|||||||||||||
|
Increase (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,
|
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|
2023
|
2022
|
2023
|
2022
|
2022
|
||||||||||||||||
|
Cash Flows from Investing Activities:
|
||||||||||||||||||||
|
Purchase of property and equipment
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
Interest received
|
|
|
|
|
|
|||||||||||||||
|
Investment in short term bank deposits, net
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
|
|||||||||||
|
Net cash used in investing activities
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
Cash Flows from Financing Activities:
|
||||||||||||||||||||
|
Repayment of leases liabilities
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
Proceeds from exercise of options
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
Proceeds from exercise of pre-funded warrants
|
|
|
|
|
|
|||||||||||||||
|
Proceeds from (Repayment of) issuance of shares and warrants, net
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||
|
Repayment of IIA grants, net
|
(
|
)
|
(
|
)
|
|
|
(
|
)
|
||||||||||||
|
Repayment of liabilities in respect of TEVA
|
(
|
)
|
|
|
|
(
|
)
|
|||||||||||||
|
Net cash provided by (used in) financing activities
|
|
|
(
|
)
|
(
|
)
|
|
|||||||||||||
|
Exchange rate differences on cash and cash equivalent balances
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
(
|
)
|
||||||||||
|
Increase (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
|
|
|
|
|
|
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F - 7
MEDIWOUND LTD. AND ITS SUBSIDIARIES
Notes to Unaudited Condensed Interim Consolidated Financial Statements
| 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, non-surgical 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 protein-based therapies for burn care, wound care and tissue repair.
The Company's first innovative biopharmaceutical product, NexoBrid, has received in December 2022, an approval from the U.S. Food and Drug Administration (“FDA”) and marketing approval in each of India, Switzerland and Japan. In addition it has a marketing authorization from the European Medicines Agency (“EMA”) and regulatory agencies in other international markets for removal of dead or damaged tissue, known as eschar, in adults with deep partial and full thickness thermal burns.
The Company commercialize NexoBrid globally through multiple sales channels.
|
| • |
The Company sell NexoBrid to burn centers in the European Union, United Kingdom and Israel, primarily through its commercial organizations.
|
| • |
The Company have established local distribution channels in multiple international markets, focusing on Asia Pacific, EMEA, CEE and LATAM, which local distributors are also responsible for obtaining local marketing authorization within the relevant territories.
|
| • |
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 approval.
|
|
The Company’s second investigational next-generation enzymatic therapy product, EscharEx, a topical biological drug being developed for debridement of chronic and other hard-to-heal wounds, is currently under discussions with the FDA regarding the pivotal Phase 3 study design.
The third clinical-stage innovative product candidate, MW005, is a topical applied 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 an investigator-initiated phase II trial of MW005 in non-melanoma skin cancer is being conducted in parallel in Israel. In December 2022, the Company announced final positive results from the study. Based on the positive results, The Company plan to continue enrolling patients in its Phase 1/2 study.
|
MEDIWOUND LTD. AND ITS SUBSIDIARIES
Notes to Unaudited Condensed Interim Consolidated Financial Statements
| Note 1: |
General (Cont.)
|
| 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, 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. |
Our Partner, Vericel Corporation Inc. (“Vericel”) has received the first lot of NexoBrid® finished product from the company for the U.S. commercial market in June 2023, which currently is warehoused at Vericel’s third-party logistics distributor. Although this NexoBrid finished product batch has met all required release criteria for distribution in the U.S., Vericel is unable to release this product into the commercial channel at this time due to a deviation associated with a third-party testing lab used during the manufacturing process. A detailed risk assessment prepared by the Company and Vericel has concluded that the deviation presents no incremental risk to the finished product’s quality and safety, and the company actively engaged with Vericel and the U.S. Food and Drug Administration (FDA) to address this matter. Future manufacturing of NexoBrid drug product for the U.S. market will not be impacted because the at-issue test will be conducted directly by the Company. As the FDA has not yet authorized the commercial release of the finished product affected by the deviation, the company is currently preparing for a production campaign scheduled to begin in September 2023.
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| f. |
In 2022 the Company engaged with the U.S. Department of Defense (DoD), through the Medical Technology Enterprise Consortium (MTEC), for a $
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MEDIWOUND LTD. AND ITS SUBSIDIARIES
Notes to Unaudited Condensed Interim Consolidated Financial Statements
| 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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|
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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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|
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The interim condensed consolidated financial statements for the six and three months ended June 30, 2023 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, 2022 that were included in the Annual Report on Form 20-F filed on March 16, 2023. |
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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, 2022 that were included in the Annual Report on Form 20-F filed on March 16, 2023. |
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Note 3:
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Equity
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| 1. |
On February 7, 2023, the Company completed a public offering of
|
| 2. |
On February 15, 2023, the Company granted to its employees and officers
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| 3. |
On April 3, 2023, the Company granted to its board members and officers
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| 4. |
On May 31, 2023 the Shareholders of the Company approved an amendment to Article 6 of the Company’s Amended and Restated Articles of Association, which increased the Company’s authorized share capital from
|
MEDIWOUND LTD. AND ITS SUBSIDIARIES
Notes to Unaudited Condensed Interim Consolidated Financial Statements
|
Note 3:
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Equity (Cont.)
|
| 5. |
On May 31, 2023 the Shareholders of the Company approved the increase by
|
| 6. |
On May 31, 2023 the Shareholders of the Company approved the extension to the exercise period of options which were granted to the company’s directors on April 23, 2020 for an additional
|
|
Note 4: |
Subsequent events |
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|
1. |
On July 17, 2023 the company signed a turnkey scale-up agreement with Biopharmax Group Ltd. This strategic agreement is designed to bolster the company’s manufacturing infrastructure to support our long-term growth trajectory. The objective of this agreement is to establish, commission, and validate a cutting-edge, sterile, and GMP-compliant manufacturing facility. The venture aims to increase our production capacity significantly, projected to expand to six times the current capacity, aligning with our strategic plan to meet the escalating global demand for NexoBrid. |
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| The new facility, equipped with fully operational clean rooms, will be exclusively designed for NexoBrid production. It will comply with stringent regulations from the GMP, FDA, EMA, Israeli Ministry of Health, and relevant Israeli regulatory bodies. An estimated $
The Scale-up Agreement encompasses various standard provisions, including those related to reporting, compliance, guarantees, representations, liability, insurance, confidentiality, and ownership. |
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| 2. |
Alongside entering the Scale-up Agreement, the company has also secured a new lease agreement with the current property owner. This agreement allows the company to continue the utilization of our existing facilities and the planned manufacturing site. This property, located in Yavne, Israel, serves as the base for the company’s administrative headquarters, research and development laboratories, and manufacturing plant. The duration of the lease extends until 2035, with an option for a further three-year extension until 2038. In parallel the existing sub lease agreement with Clal Life Science L.P. and the company was terminated.
The property, measuring approximately |
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F - 11
