Document and Entity Information
Document and Entity Information | 6 Months Ended |
Jun. 30, 2020 | |
Document And Entity Information | |
Entity Registrant Name | MediWound Ltd. |
Entity Central Index Key | 0001593984 |
Document Type | 6-K |
Document Period End Date | Jun. 30, 2020 |
Amendment Flag | false |
Current Fiscal Year End Date | --12-31 |
Document Fiscal Period Focus | Q2 |
Document Fiscal Year Focus | 2020 |
CONDENSED INTERIM CONSOLIDATED
CONDENSED INTERIM CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 | Jun. 30, 2019 |
CURRENT ASSETS: | |||
Cash and cash equivalents | $ 12,612 | $ 7,242 | $ 24,667 |
Restricted deposits | 179 | 180 | 175 |
Short-term bank deposits | 11,591 | 22,036 | 13,870 |
Trade receivables | 2,764 | 4,107 | 570 |
Inventories | 1,934 | 1,613 | 1,535 |
Other receivables | 728 | 450 | 4,098 |
CURRENT ASSETS, TOTAL | 29,808 | 35,628 | 44,915 |
LONG-TERM ASSETS: | |||
Property, plant and equipment, net | 2,326 | 2,304 | 2,183 |
Right of-use assets, net | 2,086 | 2,229 | 2,315 |
Intangible assets, net | 396 | 429 | 462 |
LONG-TERM ASSETS, TOTAL | 4,808 | 4,962 | 4,960 |
ASSETS, TOTAL | 34,616 | 40,590 | 49,875 |
CURRENT LIABILITIES: | |||
Current maturities of long-term liabilities | 1,321 | 569 | 896 |
Trade payables and accrued expenses | 2,423 | 4,067 | 3,993 |
Other payables | 6,040 | 5,737 | 5,969 |
CURRENT LIABILITIES, TOTAL | 9,784 | 10,373 | 10,858 |
LONG-TERM LIABILITIES: | |||
Deferred revenues | 1,174 | 1,135 | 1,144 |
Liability in respect of IIA grants | 7,130 | 6,811 | 6,919 |
Contingent consideration for purchase of shares | 4,249 | 4,853 | 4,412 |
Liability in respect of discontinued operation | 6,003 | ||
Lease liabilities | 1,866 | 2,006 | 2,022 |
Severance pay liabilities, net | 281 | 243 | 338 |
LONG TERM LIABILITIES, TOTAL | 14,700 | 15,048 | 20,838 |
SHAREHOLDERS' EQUITY: | |||
Ordinary shares of NIS 0.01 par value: Authorized: 50,000,000 shares as of June 30, 2020, December 31, 2019 and 37,244,508 shares as of June 30, 2019; Issued and Outstanding: 27,211,128 as of June 30, 2020, 27,202,795 as of December 31, 2019 and 27,178,839 as of June 30, 2019 | 75 | 75 | 75 |
Share premium | 141,390 | 140,871 | 140,236 |
Foreign currency translation adjustments | (16) | (17) | (23) |
Accumulated deficit | (131,317) | (125,760) | (122,109) |
SHAREHOLDERS' EQUITY, TOTAL | 10,132 | 15,169 | 18,179 |
LIABILITIES AND SHAREHOLDERS' EQUITY, TOTAL | $ 34,616 | $ 40,590 | $ 49,875 |
CONDENSED INTERIM CONSOLIDATE_2
CONDENSED INTERIM CONSOLIDATED BALANCE SHEETS (Parenthetical) | Jun. 30, 2020$ / sharesshares | Dec. 31, 2019$ / sharesshares | Jun. 30, 2019₪ / sharesshares |
Statement of financial position [abstract] | |||
Ordinary shares, par value | (per share) | $ 0.01 | $ 0.01 | ₪ 0.01 |
Ordinary shares, Authorized | 50,000,000 | 50,000,000 | 37,244,508 |
Ordinary shares, Issued | 27,211,128 | 27,202,795 | 27,178,839 |
Ordinary shares, Outstanding | 27,211,128 | 27,202,795 | 27,178,839 |
CONDENSED INTERIM CONSOLIDATE_3
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | ||
Profit or loss [abstract] | ||||||
Revenues from sale of products | $ 1,015 | $ 895 | $ 1,662 | $ 1,309 | $ 3,393 | |
Revenues from development services | 2,922 | 2,301 | 6,631 | 2,301 | 10,678 | |
Revenues from license agreements | 90 | 17,550 | 172 | 17,597 | 17,718 | |
Total revenues | 4,027 | 20,746 | 8,465 | 21,207 | 31,789 | |
Cost of revenues | 2,810 | 3,481 | 6,018 | 3,520 | 11,849 | |
Gross profit | 1,217 | 17,265 | 2,447 | 17,687 | 19,940 | |
Research and development, gross | 1,593 | 1,893 | 3,312 | 6,343 | 10,070 | |
Participations by BARDA and IIA | 19 | (1,721) | 19 | (4,624) | (5,101) | |
Research and development, net of participations | 1,612 | 172 | 3,331 | 1,719 | 4,969 | |
Selling and marketing | 859 | 1,101 | 1,683 | 2,134 | 4,064 | |
General and administrative | 1,452 | 1,242 | 2,345 | 2,574 | 5,242 | |
Other expenses | 812 | 901 | 1,172 | |||
Total operating expenses | 3,923 | 3,327 | 7,359 | 7,328 | 15,447 | |
Operating profit (loss) | (2,706) | 13,938 | (4,912) | 10,359 | 4,493 | |
Financial income | 101 | 92 | 323 | 153 | 556 | |
Financial expense | (491) | (1,314) | (968) | (1,956) | (2,983) | |
Profit (loss) from continuing operation | (3,096) | 12,716 | (5,557) | 8,556 | 2,066 | |
Profit from discontinued operation | 50 | 2,889 | ||||
Net Profit (loss) | (3,096) | 12,716 | (5,557) | 8,606 | 4,955 | |
Other comprehensive income (loss): | ||||||
Foreign currency translation adjustments | (7) | (2) | 1 | 2 | 8 | |
Total comprehensive income (loss) | $ (3,103) | $ 12,714 | $ (5,556) | $ 8,608 | $ 4,963 | |
Basic and diluted net profit (loss) per share from continuing operations | $ (0.11) | $ 0.47 | $ (0.20) | $ 0.32 | $ 0.08 | |
Basic and diluted net profit (loss) per share from discontinued operations | [1] | 0.10 | ||||
Total Basic and diluted net profit (loss) per share | $ (0.11) | $ 0.47 | $ (0.20) | $ 0.32 | $ 0.18 | |
[1] | Represents less than $ 1. |
CONDENSED INTERIM CONSOLIDATE_4
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY - USD ($) $ in Thousands | Share capital [Member] | Share premium [Member] | Foreign currency translation reserve [Member] | Accumulated deficit [Member] | Total | ||
Balance at Dec. 31, 2018 | $ 75 | $ 139,637 | $ (25) | $ (130,715) | $ 8,972 | ||
Loss for the period | 8,606 | 8,606 | |||||
Other comprehensive loss | 2 | 2 | |||||
Total comprehensive income (loss) | 2 | 8,606 | 8,608 | ||||
Share-based compensation | 599 | 599 | |||||
Balance at Jun. 30, 2019 | 75 | 140,236 | (23) | (122,109) | 18,179 | ||
Balance at Dec. 31, 2018 | 75 | 139,637 | (25) | (130,715) | 8,972 | ||
Loss for the period | 4,955 | 4,955 | |||||
Other comprehensive loss | 8 | 8 | |||||
Total comprehensive income (loss) | 8 | 4,955 | 4,963 | ||||
Exercise of options | [1] | [1] | |||||
Share-based compensation | 1,234 | 1,234 | |||||
Balance at Dec. 31, 2019 | 75 | 140,871 | (17) | (125,760) | 15,169 | ||
Balance at Mar. 31, 2019 | 75 | 139,912 | (21) | (134,825) | 5,141 | ||
Loss for the period | 12,716 | 12,716 | |||||
Other comprehensive loss | (2) | (2) | |||||
Total comprehensive income (loss) | (2) | 12,716 | 12,714 | ||||
Share-based compensation | 324 | 324 | |||||
Balance at Jun. 30, 2019 | 75 | 140,236 | (23) | (122,109) | 18,179 | ||
Balance at Dec. 31, 2019 | 75 | 140,871 | (17) | (125,760) | 15,169 | ||
Loss for the period | (5,557) | (5,557) | |||||
Other comprehensive loss | 1 | 1 | |||||
Total comprehensive income (loss) | 1 | (5,557) | (5,556) | ||||
Share-based compensation | 519 | 519 | |||||
Balance at Jun. 30, 2020 | 75 | 141,390 | (16) | (131,317) | 10,132 | ||
Balance at Mar. 31, 2020 | 75 | 141,044 | (9) | (128,221) | 12,889 | ||
Loss for the period | (3,096) | (3,096) | |||||
Other comprehensive loss | (7) | (7) | |||||
Total comprehensive income (loss) | (7) | (3,096) | (3,103) | ||||
Share-based compensation | 346 | 346 | |||||
Balance at Jun. 30, 2020 | $ 75 | $ 141,390 | $ (16) | $ (131,317) | $ 10,132 | ||
[1] | Represents less than $ 1. |
CONDENSED INTERIM CONSOLIDATE_5
CONDENSED INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Dec. 31, 2019 | ||
Cash Flows from Operating Activities: | ||||||
Net Profit (loss) | $ (3,096) | $ 12,716 | $ (5,557) | $ 8,606 | $ 4,955 | |
Adjustments to profit and loss items: | ||||||
Profit from discontinued operation | (50) | (2,889) | ||||
Depreciation and amortization | 271 | 278 | 539 | 552 | 1,149 | |
Share-based compensation | 346 | 324 | 519 | 599 | 1,234 | |
Revaluation of liability in respect of IIA grants | 226 | (466) | 424 | (392) | (392) | |
Revaluation of contingent consideration for the purchase of shares | 196 | 1,081 | 348 | 1,322 | 1,690 | |
Revaluation of lease liabilities | 100 | 91 | 64 | 194 | 340 | |
Increase (decrease) in severance pay liabilities, net | 19 | 13 | 40 | (10) | (105) | |
Net financing income | (81) | (87) | (191) | (149) | (434) | |
Un-realized foreign currency (gain) loss | (51) | 60 | 28 | (70) | (152) | |
Adjustments to profit and loss items, total | 1,026 | 1,294 | 1,771 | 1,996 | 441 | |
Changes in asset and liability items: | ||||||
Decrease (increase) in trade receivables | 444 | (318) | 1,341 | (9) | (3,553) | |
Decrease (increase) in inventories | 65 | (62) | (326) | 146 | 67 | |
Decrease (increase) in other receivables | (383) | 2,482 | (284) | 2,744 | 6,376 | |
Increase (decrease) in trade payables and accrued expenses | (1,004) | 1,058 | (1,649) | 1,277 | 1,355 | |
Increase in other payables and deferred revenues | 133 | 95 | 86 | 609 | 247 | |
Changes in asset and liability items, total | (745) | 3,255 | (832) | 4,767 | 4,492 | |
Net cash provided by (used in) continuing operating activities | (2,815) | 17,265 | (4,618) | 15,369 | 9,888 | |
Net cash provided by (used in) discontinued operating activities | 50 | (1,599) | ||||
Net cash provided by (used in) operating activities | (2,815) | 17,265 | (4,618) | 15,419 | 8,289 | |
Cash Flows from Investing Activities: | ||||||
Purchase of property and equipment | (100) | (194) | (244) | (433) | (792) | |
Interest received | 39 | 14 | 42 | 44 | 184 | |
Proceeds from (investment in) short term bank deposits, net | 7,603 | 412 | 10,595 | 2,977 | (5,050) | |
Net cash provided by (used in) continuing investing activities | 7,542 | 232 | 10,393 | 2,588 | (5,658) | |
Net cash used in discontinued investing activities | (1,239) | |||||
Net cash provided by (used in) investing activities | 7,542 | 232 | 10,393 | 2,588 | (6,897) | |
Cash Flows from Financing Activities: | ||||||
Repayment of leases liabilities | (153) | (157) | (313) | (312) | (630) | |
Proceeds from exercise of options | [1] | |||||
Proceeds of IIA grant, net of repayments | 248 | (66) | 193 | (376) | ||
Net cash (used in) provided by financing activities | (153) | 91 | (379) | (119) | (1,006) | |
Exchange rate differences on cash and cash equivalent balances | 57 | (55) | (26) | 63 | 140 | |
Cash and cash equivalents: | ||||||
Increase in cash and cash equivalents from continuing activities | 4,631 | 17,533 | 5,370 | 17,901 | 3,364 | |
Increase (decrease) in cash and cash equivalents from discontinued activities | 50 | (2,838) | ||||
Balance of cash and cash equivalents at the beginning of the period | 7,981 | 7,134 | 7,242 | 6,716 | 6,716 | |
Balance of cash and cash equivalents at the end of the period | $ 12,612 | $ 24,667 | $ 12,612 | $ 24,667 | $ 7,242 | |
[1] | Represents less than $ 1. |
GENERAL
GENERAL | 6 Months Ended |
Jun. 30, 2020 | |
Disclosure of general [Abstract] | |
GENERAL | 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. 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. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended |
Jun. 30, 2020 | |
Disclosure of significant accounting policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | 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 June 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. |
EQUITY
EQUITY | 6 Months Ended |
Jun. 30, 2020 | |
SHAREHOLDERS' EQUITY: | |
EQUITY | NOTE : EQUITY On April 23, 2020, the Company's Board of Directors approved the grant of 1,274,379 options to purchase ordinary shares, for an exercise price of $ 1.75 per share, to its employees, officers and members of the board. The fair value of the options, as of the grant date, was estimated at $1.8 million. On June 29, 2020, the general meeting of the Company approved the abovementioned grants related the CEO and members of the board which were estimated at approximately $1.4 million. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Disclosure of significant accounting policies [Abstract] | |
Basis of presentation of financial statements | a. Basis of presentation of financial statements: These financial statements have been prepared in accordance with International Financial Reporting Standards ("IFRS") as issued by the International Accounting Standards Board ("IASB"). |
Basis of preparation of the interim consolidated financial statements | b. Basis of preparation of the interim consolidated financial statements: The interim condensed consolidated financial statements for the three months ended June 30, 2020 have been prepared in accordance with IAS 34 "Interim Financial Reporting". The interim condensed consolidated financial statements do not include all the information and disclosures required in the annual financial statements, and should be read in conjunction with the Company's annual financial statements as of December 31, 2019 that were included in the Annual Report on Form 20-F filed on February 25, 2020. The accounting policies adopted in the preparation of the interim condensed consolidated financial statements are consistent with those followed in the preparation of the Company’s annual consolidated financial statements for the year ended December 31, 2019 that were included in the Annual Report on Form 20-F filed on February 25, 2020, except than the change discussed below. |
Reclassification | c. Reclassification: Certain amounts previously reported in the consolidated financial statements have been reclassified to conform to current year presentation. Such reclassifications did not affect net loss, shareholders’ equity or cash flows. |
GENERAL (Details)
GENERAL (Details) - USD ($) $ in Millions | Mar. 03, 2020 | Jun. 30, 2020 |
BARDA [Member] | ||
Disclosure of associates [line items] | ||
Supplemental Funding | $ 5.5 | |
PolyHeal Ltd. [Member] | ||
Disclosure of associates [line items] | ||
Ownership percentage | 10.00% |
EQUITY (Details)
EQUITY (Details) - Employees, Officers and Members [Member] $ / shares in Units, $ in Millions | 1 Months Ended | |
Jun. 29, 2020USD ($) | Apr. 23, 2020USD ($)shares$ / shares | |
Statement Line Items [Line Items] | ||
Options granted to purchase ordinary shares | shares | 1,274,379 | |
Options granted, exercise price | $ / shares | $ 1.75 | |
Fair value of options | $ 1.8 | |
CEO [Member] | ||
Statement Line Items [Line Items] | ||
Fair value of options | $ 1.4 |