Exhibit 99.2
MEDIWOUND LTD. AND ITS SUBSIDIARIES
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF MARCH 31, 2021
IN U.S. DOLLARS IN THOUSANDS
UNAUDITED
INDEX
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MEDIWOUND LTD. AND ITS SUBSIDIARIES
U.S. dollars in thousands
March 31, | December 31, | |||||||||||
2021 | 2020 | 2020 | ||||||||||
Unaudited | Audited | |||||||||||
CURRENT ASSETS: | ||||||||||||
Cash and cash equivalents | 17,684 | 7,981 | 17,376 | |||||||||
Restricted deposits | 178 | 174 | 184 | |||||||||
Short-term bank deposits | - | 19,156 | 4,024 | |||||||||
Trade receivables | 5,153 | 3,195 | 2,767 | |||||||||
Inventories | 1,470 | 2,004 | 1,380 | |||||||||
Other receivables | 421 | 345 | 462 | |||||||||
24,906 | 32,855 | 26,193 | ||||||||||
LONG-TERM ASSETS: | ||||||||||||
Property, plant and equipment, net | 2,694 | 2,339 | 2,630 | |||||||||
Right of-use assets, net | 1,747 | 2,191 | 1,884 | |||||||||
Intangible assets, net | 347 | 413 | 363 | |||||||||
4,788 | 4,943 | 4,877 | ||||||||||
29,694 | 37,798 | 31,070 | ||||||||||
CURRENT LIABILITIES: | ||||||||||||
Current maturities of long-term liabilities and leases | 1,884 | 1,417 | 1,750 | |||||||||
Trade payables and accrued expenses | 3,258 | 3,423 | 2,992 | |||||||||
Other payables | 5,172 | 5,843 | 3,524 | |||||||||
10,314 | 10,683 | 8,266 | ||||||||||
LONG‑TERM LIABILITIES: | ||||||||||||
Deferred revenues | 693 | 1,018 | 1,234 | |||||||||
Liabilities in respect of IIA grants | 7,275 | 6,942 | 7,267 | |||||||||
Liabilities in respect of purchase of shares | 4,733 | 4,097 | 4,998 | |||||||||
Lease liabilities | 1,590 | 1,905 | 1,741 | |||||||||
Severance pay liability, net | 273 | 264 | 292 | |||||||||
14,564 | 14,226 | 15,532 | ||||||||||
SHAREHOLDERS' EQUITY: | ||||||||||||
Ordinary shares of NIS 0.01 par value: | ||||||||||||
Authorized: 50,000,000 shares as of March 31, 2021 ,December 31, 2020 and March 31, 2020; Issued and Outstanding: 27,245,271 as of March 31, 2021, 27,236,752 as of December 31, 2020 and 27,211,128 as of March 31, 2020 | 75 | 75 | 75 | |||||||||
Share premium | 142,577 | 141,044 | 142,193 | |||||||||
Foreign currency translation adjustments | (29 | ) | (9 | ) | (40 | ) | ||||||
Accumulated deficit | (137,807 | ) | (128,221 | ) | (134,956 | ) | ||||||
4,816 | 12,889 | 7,272 | ||||||||||
29,694 | 37,798 | 31,070 |
The accompanying notes are an integral part of the interim financial statements.
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MEDIWOUND LTD. AND ITS SUBSIDIARIES
U.S. dollars in thousands (except share and per share data)
Three months ended March 31, | Year ended December 31, | |||||||||||
2021 | 2020 | 2020 | ||||||||||
Unaudited | Audited | |||||||||||
Revenues from sale of products | 2,518 | 647 | 7,445 | |||||||||
Revenues from development services | 2,940 | 3,709 | 13,935 | |||||||||
Revenues from license agreements | 389 | 82 | 383 | |||||||||
Total revenues | 5,847 | 4,438 | 21,763 | |||||||||
Cost of revenues | 3,431 | 3,208 | 14,218 | |||||||||
Gross profit | 2,416 | 1,230 | 7,545 | |||||||||
Research and development | 2,242 | 1,719 | 7,698 | |||||||||
Selling and marketing | 822 | 824 | 3,228 | |||||||||
General and administrative | 1,273 | 893 | 5,459 | |||||||||
Total operating expenses | 4,337 | 3,436 | 16,385 | |||||||||
Operating loss | (1,921 | ) | (2,206 | ) | (8,840 | ) | ||||||
Financial income | 11 | 239 | 843 | |||||||||
Financial expense | (941 | ) | (494 | ) | (1,279 | ) | ||||||
Loss from continuing operation | (2,851 | ) | (2,461 | ) | (9,276 | ) | ||||||
Profit from discontinued operation | - | - | 80 | |||||||||
Net loss | (2,851 | ) | (2,461 | ) | (9,196 | ) | ||||||
Other comprehensive income (loss): | ||||||||||||
Foreign currency translation adjustments | 11 | 8 | (23 | ) | ||||||||
Total comprehensive loss | (2,840 | ) | (2,453 | ) | (9,219 | ) | ||||||
Basic and diluted loss per share: | ||||||||||||
Basic and diluted net loss per share from continuing operations | (0.10 | ) | (0.09 | ) | (0.34 | ) | ||||||
Basic and diluted net profit per share from discontinued operations | - | - | (* | ) | ||||||||
Total Basic and diluted net loss per share | (0.10 | ) | (0.09 | ) | (0.34 | ) |
(*) Represents an amount lower than $1.
The accompanying notes are an integral part of the interim financial statements.
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MEDIWOUND LTD. AND ITS SUBSIDIARIES
U.S. dollars in thousands
Share capital | Share premium | Foreign currency translation reserve | Accumulated deficit | Total Equity | ||||||||||||||||
Balance as of December 31, 2020 | 75 | 142,193 | (40 | ) | (134,956 | ) | 7,272 | |||||||||||||
Loss for the period | - | - | - | (2,851 | ) | (2,851 | ) | |||||||||||||
Other comprehensive income | - | - | 11 | - | 11 | |||||||||||||||
Total comprehensive income (loss) | - | - | 11 | (2,851 | ) | (2,840 | ) | |||||||||||||
Exercise of options and RSU’s | (* | ) | - | - | - | (* | ) | |||||||||||||
Share-based compensation | - | 384 | - | - | 384 | |||||||||||||||
Balance as of March 31, 2021 | 75 | 142,577 | (29 | ) | (137,807 | ) | 4,816 |
Share capital | Share premium | Foreign currency translation reserve | Accumulated deficit | Total Equity | ||||||||||||||||
Balance as of December 31, 2019 | 75 | 140,871 | (17 | ) | (125,760 | ) | 15,169 | |||||||||||||
Loss for the period | - | - | - | (2,461 | ) | (2,461 | ) | |||||||||||||
Other comprehensive income | - | - | 8 | - | 8 | |||||||||||||||
Total comprehensive income (loss) | - | - | 8 | (2,461 | ) | (2,453 | ) | |||||||||||||
Exercise of options and RSU’s | (* | ) | - | - | - | (* | ) | |||||||||||||
Share-based compensation | - | 173 | - | - | 173 | |||||||||||||||
Balance as of March 31, 2020 | 75 | 141,044 | (9 | ) | (128,221 | ) | 12,889 |
(*) Represents an amount lower than $1.
The accompanying notes are an integral part of the interim financial statements.
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MEDIWOUND LTD. AND ITS SUBSIDIARIES
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
U.S. dollars in thousands
Share capital | Share premium | Foreign currency translation reserve | Accumulated deficit | Total Equity | ||||||||||||||||
Balance as of December 31, 2019 | 75 | 140,871 | (17 | ) | (125,760 | ) | 15,169 | |||||||||||||
Net loss | - | - | - | (9,196 | ) | (9,196 | ) | |||||||||||||
Other comprehensive loss | - | - | (23 | ) | - | (23 | ) | |||||||||||||
Total comprehensive loss | - | - | (23 | ) | (9,196 | ) | (9,219 | ) | ||||||||||||
Exercise of options and RSU’s | (* | ) | - | - | - | (* | ) | |||||||||||||
Share-based compensation | - | 1,322 | - | - | 1,322 | |||||||||||||||
Balance as of December 31, 2020 | 75 | 142,193 | (40 | ) | (134,956 | ) | 7,272 |
(*) Represents an amount lower than $1.
The accompanying notes are an integral part of the interim financial statements.
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MEDIWOUND LTD. AND ITS SUBSIDIARIES
U.S. dollars in thousands
Three months ended March 31, | Year ended December 31, | |||||||||||
2021 | 2020 | 2020 | ||||||||||
Unaudited | Audited | |||||||||||
Cash Flows from Operating Activities: | ||||||||||||
Net loss | (2,851 | ) | (2,461 | ) | (9,196 | ) | ||||||
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||||||||||||
Adjustments to profit and loss items: | ||||||||||||
Profit from discontinued operation | - | - | (80 | ) | ||||||||
Depreciation and amortization | 273 | 268 | 1,090 | |||||||||
Share-based compensation | 384 | 173 | 1,322 | |||||||||
Revaluation of liabilities in respect of IIA grants | 275 | 198 | 828 | |||||||||
Revaluation of liabilities in respect of purchase of shares | 152 | 152 | (433 | ) | ||||||||
Revaluation of lease liabilities | (44 | ) | (36 | ) | 305 | |||||||
Increase (decrease) in severance pay liability, net | (10 | ) | 21 | 33 | ||||||||
Net financing income | (11 | ) | (110 | ) | (297 | ) | ||||||
Un-realized foreign currency (gain) loss | 256 | 79 | (211 | ) | ||||||||
1,275 | 745 | 2,557 | ||||||||||
Changes in asset and liability items: | ||||||||||||
Decrease (increase) in trade receivables | (2,407 | ) | 897 | 1,386 | ||||||||
Decrease (increase) in inventories | (45 | ) | (391 | ) | 141 | |||||||
Decrease (increase) in other receivables | 37 | 99 | (13 | ) | ||||||||
Increase (decrease) in trade payables and accrued expenses | 272 | (645 | ) | (1,096 | ) | |||||||
Increase (decrease) in other payables and deferred revenues | 806 | (47 | ) | (479 | ) | |||||||
(1,337 | ) | (87 | ) | (61 | ) | |||||||
Net cash used in continuing operating activities | (2,913 | ) | (1,803 | ) | (6,700 | ) | ||||||
Net cash used in discontinued operating activities | - | - | (195 | ) | ||||||||
Net cash used in operating activities | (2,913 | ) | (1,803 | ) | (6,895 | ) |
The accompanying notes are an integral part of the financial statements.
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MEDIWOUND LTD. AND ITS SUBSIDIARIES
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
Three months ended March 31, | Year ended December 31, | |||||||||||
2021 | 2020 | 2020 | ||||||||||
Unaudited | Audited | |||||||||||
Cash Flows from Investing Activities: | ||||||||||||
Purchase of property and equipment | (218 | ) | (144 | ) | (923 | ) | ||||||
Interest received | 35 | 3 | 274 | |||||||||
Proceeds from short term bank deposits, net | 4,006 | 2,992 | 18,034 | |||||||||
Net cash provided by continuing investing activities | 3,823 | 2,851 | 17,385 | |||||||||
Cash Flows from Financing Activities: | ||||||||||||
Repayment of leases liabilities | (131 | ) | (160 | ) | (508 | ) | ||||||
Proceeds from issuance of shares, net | - | (* | ) | - | ||||||||
Repayment of IIA grants, net | (180 | ) | (66 | ) | (121 | ) | ||||||
Net cash used in continuing financing activities | (311 | ) | (226 | ) | (629 | ) | ||||||
Exchange rate differences on cash and cash equivalent balances | (291 | ) | (83 | ) | 273 | |||||||
Increase in cash and cash equivalents from continuing activities | 308 | 739 | 10,329 | |||||||||
Decrease in cash and cash equivalents from discontinued activities | - | - | (195 | ) | ||||||||
Balance of cash and cash equivalents at the beginning of the period | 17,376 | 7,242 | 7,242 | |||||||||
Balance of cash and cash equivalents at the end of the period | 17,684 | 7,981 | 17,376 | |||||||||
Supplement disclosure of Non-cash transactions: | ||||||||||||
ROU asset, net recognized with corresponding lease liability | - | 68 | 261 | |||||||||
Exercise of RSU’s | 43 | 43 | 147 |
(*) Represents an amount lower than $1.
The accompanying notes are an integral part of the financial statements.
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MEDIWOUND LTD. AND ITS SUBSIDIARIES
U.S. dollars in thousands
NOTE 1: | GENERAL |
a. | General description of the Company and its operations: |
MediWound Ltd. which incorporated in Yavne, Israel (the "Company" or "MediWound"), is biopharmaceutical company develops, manufactures and commercializes novel, cost effective, bio- therapeutic solutions for tissue repair and regeneration. The Company’s strategy is centered around its validated proteolytic enzyme platform technology, focused on next-generation bio-active therapies for burn and wound care and biological medicinal products for tissue repair.
The Company's first innovative biopharmaceutical product, NexoBrid, received marketing authorization from the European Medicines Agency ("EMA") as well as the Israeli, Argentinean, South-Korean, Russian and Peruvian Ministries of Health, for removal of dead or damaged tissue, known as eschar, in adults with deep partial and full thickness thermal burns.
The Company sells NexoBrid in Europe and in Israel through its commercial organizations while establishing additional local distribution channels to extend its outreach in the European Union. In other territories the company sells NexoBrid through local distribution channels. In 2019, the Company entered into exclusive license and supply agreements with Vericel Corporation (“Vericel”) to commercialize NexoBrid in North America.
The Company second investigational innovative product, EscharEx, is a topical biological drug being developed for debridement of chronic and other hard-to-heal wounds.
The third innovative product candidate, MWPC005, is a topically applied biological drug candidate for the treatment of non-melanoma skin cancers,
b. | The Company's securities are listed for trading on NASDAQ since March 2014. |
c. | The Company has three wholly owned subsidiaries: MediWound Germany GmbH, acting as Europe (“EU”) marketing authorization holder and EU sales and marketing arm, MediWound UK Limited and MediWound US, Inc. currently an inactive companies. |
In addition, the Company owns approximately 10% of PolyHeal Ltd., a private life sciences company ("PolyHeal").
d. | The Company awarded two contracts with the U.S. Biomedical Advanced Research and Development Authority ("BARDA"), for the advancement of the development, manufacturing and emergency readiness for NexoBrid deployment as well as the procurement of NexoBrid as a medical countermeasure as part of BARDA preparedness for mass casualty events. |
e. | The Company addressed the challenges associated with the COVID-19 pandemic during the year ended 2020 and three months ended March 31, 2021, while prioritizing the health and safety of its workforce and maintaining operational efficiency and flexibility. With respect to Note 1(a) to our 2020 annual financial statements, the FDA review processes have been affected by COVID-19 travel restriction and by evolving FDA priorities. As a result, the Company cannot predict how long the FDA may take to complete the review of the BLA of NexoBrid. Accordingly, the Company expect the timing of the potential approval of NexoBrid to be impacted. |
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MEDIWOUND LTD. AND ITS SUBSIDIARIES
NOTES TO CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands
NOTE 2: | SIGNIFICANT ACCOUNTING POLICIES |
The following accounting policies have been applied consistently in the financial statements for all periods presented unless otherwise stated.
a. | Basis of presentation of financial statements: |
These financial statements have been prepared in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board ("IASB").
b. | Basis of preparation of the interim consolidated financial statements: |
The interim condensed consolidated financial statements for the three months ended March 31, 2021 have been prepared in accordance with IAS 34 "Interim Financial Reporting".
The interim condensed consolidated financial statements do not include all the information and disclosures required in the annual financial statements, and should be read in conjunction with the Company's annual financial statements as of December 31, 2020 that were included in the Annual Report on Form 20-F filed on February 25, 2021.
The accounting policies adopted in the preparation of the interim condensed consolidated financial statements are consistent with those followed in the preparation of the Company’s annual consolidated financial statements for the year ended December 31, 2020 that were included in the Annual Report on Form 20-F filed on February 25, 2021, except than the change discussed below.
c. | Reclassification: |
Certain amounts previously reported in the consolidated financial statements have been reclassified to conform to current year presentation. Such reclassifications did not affect net loss, shareholders’ equity or cash flows.
NOTE 3: | EQUITY |
On March 4, 2021, the Company's Board of Directors approved the grant of 377,790 options to purchase ordinary shares, for an exercise price of $ 5.36 per share as well as 62,947 RSU’s to its employees, officers and members of the board. The fair value of the options and RSU’s, as of the grant date, was estimated at $1.2, $0.6 million consistently. The general meeting which will approved the grants to the CEO and the chairman of the BOD, is yet to be determined.
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