☐ | REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR |
☒ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Ordinary shares, par value NIS 0.01 per share | MDWD | Nasdaq Global Market |
Large accelerated filer ☐ | Accelerated filer | Emerging Growth Company |
U.S. GAAP ☐ | International Financial Reporting Standards as issued by the International Accounting Standards Board ☒ | Other ☐ |
FORM ANNUAL REPORT FOR THE FISCAL YEAR ENDED DECEMBER 31, |
i | |
i | |
PART I | |
1 | |
1 | |
1 | |
PART II | |
PART III | |
Item 1. | IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS |
Item 2. | OFFER STATISTICS AND EXPECTED TIMETABLE |
Item 3. | KEY INFORMATION |
A. | [Reserved] |
Year Ended December 31, | ||||||||||||||||||||
2013 | 2014 | 2015 | 2016 | 2017 | ||||||||||||||||
(in thousands, except per share data) | ||||||||||||||||||||
Consolidated statements of operations data: | ||||||||||||||||||||
Revenues | $ | — | $ | 259 | $ | 601 | $ | 1,558 | $ | 2,496 | ||||||||||
Cost of revenues(1) | — | 2,785 | 2,519 | 2,158 | 1,578 | |||||||||||||||
Gross (loss) profit | — | (2,526 | ) | (1,918 | ) | (600 | ) | 918 | ||||||||||||
Operating expenses: | ||||||||||||||||||||
Research and development, gross | 4,513 | 6,054 | 8,139 | 14,779 | 14,625 | |||||||||||||||
Participation by BARDA and the Israeli Innovation Authority | (878 | ) | (705 | ) | (2,118 | ) | (7,711 | ) | (9,163 | ) | ||||||||||
Research and development, net of participations(1)(2) | 3,635 | 5,349 | 6,021 | 7,068 | 5,462 | |||||||||||||||
Selling and marketing(1) | 2,259 | 8,829 | 9,284 | 8,403 | 5,362 | |||||||||||||||
General and administrative(1) | 1,687 | 4,723 | 4,004 | 4,084 | 3,781 | |||||||||||||||
Operating loss | (7,581 | ) | (21,427 | ) | (21,227 | ) | (20,155 | ) | (13,687 | ) | ||||||||||
Financial income (expense), net | (920 | ) | 2,552 | (444 | ) | 1,270 | (846 | ) | ||||||||||||
Loss from continuing operations | (8,501 | ) | (18,875 | ) | (21,671 | ) | (18,885 | ) | (14,533 | ) | ||||||||||
Loss from discontinued operation(1)(3) | (6,850 | ) | — | (417 | ) | — | (7,616 | ) | ||||||||||||
Net loss | $ | (15,351 | ) | $ | (18,875 | ) | $ | (22,088 | ) | $ | (18,885 | ) | $ | (22,149 | ) | |||||
Foreign currency translation adjustments | (32 | ) | 14 | 2 | 7 | (29 | ) | |||||||||||||
Total comprehensive loss | $ | (15,383 | ) | $ | (18,861 | ) | $ | (22,086 | ) | $ | (18,878 | ) | $ | (22,178 | ) | |||||
Basic loss per share(4) | $ | (0.98 | ) | $ | (0.95 | ) | $ | (1.02 | ) | $ | (0.86 | ) | $ | (0.95 | ) | |||||
Diluted loss per share(4) | $ | (0.98 | ) | $ | (0.95 | ) | $ | (1.02 | ) | $ | (0.86 | ) | $ | (0.95 | ) | |||||
Weighted average number of ordinary shares used in computing loss per ordinary share (in thousands): | ||||||||||||||||||||
Basic: | 15,671 | 19,940 | 21,718 | 21,862 | 23,341 | |||||||||||||||
Diluted: | 15,671 | 19,940 | 21,718 | 21,862 | 23,341 |
As of December 31, | ||||||||||||||||||||
2013 | 2014 | 2015 | 2016 | 2017 | ||||||||||||||||
(in thousands) | ||||||||||||||||||||
Consolidated balance sheet data: | ||||||||||||||||||||
Cash and cash equivalents and short‑term bank deposits | $ | 9,553 | $ | 64,853 | $ | 45,768 | $ | 30,029 | $ | 36,069 | ||||||||||
Working capital, net(5) | 10,042 | 64,600 | 45,189 | 28,232 | 36,087 | |||||||||||||||
Total assets | 14,826 | 71,121 | 52,523 | 35,764 | 44,135 | |||||||||||||||
Total non‑current liabilities | 32,607 | 24,353 | 23,847 | 22,614 | 29,082 | |||||||||||||||
Total shareholders’ equity (deficit) | (19,804 | ) | 42,871 | 23,470 | 7,770 | 9,620 |
Capitalization and Indebtedness |
Year Ended December 31, | ||||||||||||||||||||
2013 | 2014 | 2015 | 2016 | 2017 | ||||||||||||||||
(in thousands) | ||||||||||||||||||||
Cost of revenues | $ | — | $ | 763 | $ | 372 | $ | 504 | $ | 188 | ||||||||||
Research and development | 315 | 657 | 511 | 752 | 488 | |||||||||||||||
Selling and marketing | 24 | 1,430 | 669 | 765 | 204 | |||||||||||||||
General and administrative | 192 | 1,977 | 1,107 | 1,150 | 483 | |||||||||||||||
Share‑based compensation expenses from continuing operations | 531 | 4,827 | 2,659 | 3,171 | 1,363 | |||||||||||||||
Discontinued operation(3) | 76 | — | — | — | — | |||||||||||||||
Total share‑based compensation expenses | $ | 607 | $ | 4,827 | $ | 2,659 | $ | 3,171 | $ | 1,363 |
C. | Reasons for the Offer and Use of Proceeds |
D. | Risk Factors |
our preclinical tests or clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional trials or to abandon strategic projects; |
actual or anticipated variations in our and our competitors’ results of operations and financial condition; |
A. | History and Development of the Company |
B. | Business Overview |
The extent of the surface that the burn occupies is usually referred to as percent of total body surface area (“TBSA”). A burn on an adult’s entire palm would generally amount to 1% TBSA, and the average hospitalized patient has a burn covering approximately 9% TBSA. Burns covering more than 15-20% TBSA usually require hospitalization and may result in dehydration, shock and increased risk of mortality. |
Superficial or first degree burns. Such burns do not penetrate the basal membrane and usually heal naturally. |
Dermal/partial thickness or second degree burns. Such burns are characterized by varying amounts of damaged dermis and can be further subdivided into superficial and deep |
Full thickness or third degree burns. Such burns are characterized by death of the entire dermal tissue down to the subcutaneous fat and must be debrided and treated by autografting, which is the process of harvesting skin from healthy donor sites on a patient’s body and transplanting it on the |
Fourth degree burns. Such burns, which are rare, extend beyond the subcutaneous fat tissue into the underlying structures, such as muscle or bone, and also require debridement and further substantial treatment. |
Surgical debridement predominantly includes tangential excision, a procedure in which a surgeon amputates the entire dead tissue mass, layer after layer, down to healthy, viable tissue. The excision is extended into healthy intact tissue to make sure that no trace of the eschar remains, resulting in up to an estimated |
The benefits of surgical eschar removal are that it is usually fast and effective. Disadvantages include the significant trauma of the procedure, associated blood loss, risk of surgery in delicate areas of the body such as hands, added costs, and, most importantly, the loss of viable tissue that necessitates additional surgical procedures for harvesting skin from healthy donor sites and autografting. |
Due to the disadvantages of surgery in extensive burns some surgeons limit their debriding surgery to only a part of the affected area in a single session |
The benefits of this approach are that it is |
Trial 1 | Trial 2 | Trial 3 | Trial 4 | Trial 5 | Trial 6 | Trial 7 | Trial 8 | Trial 9 | |
Study Type | Retrospective Phase 2 Investigator initiated | Dose range Phase 2 | Prospective Phase 2 IND/FDA | Phase 2 IND/FDA | Phase 3 EMA | Phase 3b EMA | Phase 2 EMA | Post approval safety study EMA | Phase 3 IND/FDA |
Design | Data collected from files of patients treated with NexoBrid | Parallel, controlled, observer- blind, randomized, single-center | Parallel, controlled, observer- blind, three-arm, randomized, multi-center | Parallel, controlled, open label, three-arm, randomized, single-center | Parallel, controlled, open label, two-arm, randomized, multi-center | Parallel, controlled, blinded, two-arm, multi-center | Open label, single-arm, multi-center | Observational retrospective data collection | Parallel, controlled, open label, three-arm, randomized, multi-center |
Main Objectives | Safety and efficacy | Comparison of efficacy and safety | Safety and efficacy | Safety | Safety Efficacy | Long-term scar assessment Quality of life | Safety and pharmacokinetics Efficacy | Effectiveness of the risk minimization activities | Safety Efficacy |
Wound Types | Deep partial/full thickness thermal burns | Deep partial /full thickness thermal burns | Deep partial /full thickness thermal burns | Deep partial /full thickness thermal burns | Deep partial/ full thickness thermal burns | Scar formation | Deep partial/full thickness thermal burns | Burns which were treated with NexoBrid in the market | Deep partial/ full thickness thermal burns |
Number of Patients | 154 | 20 | 140 | 30 | 182 | 89 | 36 | 160 | 175 |
Study Length | 1985-2000 | 2002-2005 | 2003-2004 | 2006-2007 | 2006-2009 | 2011 | 2009-2015 | 2017-2019 | 2015-2020 |
Location | Israel | Israel | International | United States | International | International | International | Europe | International |
Venous leg ulcers. VLUs develop as a result of vascular insufficiency, or the inability for the vasculature of the leg to return blood back toward the heart properly. Based on our comprehensive market research study on EscharEx that involved more than 200 healthcare professionals in the U.S. and Europe, which was updated in 2019, the VLU overall prevalence is approximately 3.3 million (1% of total U.S. population). Furthermore, the annual incidence of VLUs in the U.S. alone, is approximately 960,000 (accounting for 45% recurrence), of which approximately 690,000 undergo debridement in a given year. These ulcers usually form on the sides of the lower leg, above the ankle and below the calf, and are slow to heal and often recur if preventative steps are not taken. The risk of VLUs can increase as a result of a blood clot forming in the deep veins of the legs, obesity, smoking, lack of physical activity or work that requires many hours of standing. |
Phase 1 (Most typical kind of study: Human Pharmacology); |
medicines that have been authorized for marketing in the European Union with the results of PIP studies included in the product information are eligible for an extension of their patent protection by six months. This is the case even when the studies’ results are negative; |
Mutual recognition procedure. If an authorization has been granted by one-member state, or the Reference Member State, an application may be made for mutual recognition in one or more other member states, or the Concerned Member State(s). |
Decentralized procedure. The decentralized procedure may be used to obtain a marketing authorization in several European member states when the applicant does not yet have a marketing authorization in any country. |
National procedure. Applicants following the national procedure will be granted a marketing authorization that is valid only in a single member state. Furthermore, this marketing authorization is not based on recognition of another marketing authorization for the same product awarded by an assessment authority of another member state. If marketing authorization in only |
approval by an independent institutional review board (“IRB”) at each clinical site before each trial may be initiated; |
Phase 1: | The |
Phase 2: | The |
Phase 3: | The |
the federal False Claims Act imposes civil penalties, and provides for civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government; |
A. | Operating Results |
Years Ended December 31, | ||||||||||||
2015 | 2016 | 2017 | ||||||||||
(in thousands) | ||||||||||||
Consolidated statements of operations data: | ||||||||||||
Revenues | $ | 601 | $ | 1,558 | $ | 2,496 | ||||||
Cost of revenues | 2,519 | 2,158 | 1,578 | |||||||||
Gross (loss) profit | (1,918 | ) | (600 | ) | 918 | |||||||
Operating expenses: | ||||||||||||
Research and development, gross | 8,139 | 14,779 | 14,625 | |||||||||
Participation by BARDA and IIA | (2,118 | ) | (7,711 | ) | (9,163 | ) | ||||||
Research and development, net of participations | 6,021 | 7,068 | 5,462 | |||||||||
Selling and marketing | 9,284 | 8,403 | 5,362 | |||||||||
General and administrative | 4,004 | 4,084 | 3,781 | |||||||||
Operating loss | (21,227 | ) | (20,155 | ) | (13,687 | ) | ||||||
Financial income | 1,052 | 2,166 | 406 | |||||||||
Financial expense | (1,496 | ) | (896 | ) | (1,252 | ) | ||||||
Loss from continuing operations | (21,671 | ) | (18,885 | ) | (14,533 | ) | ||||||
Loss from discontinued operation | (417 | ) | — | (7,616 | ) | |||||||
Net loss | $ | (22,088 | ) | $ | (18,885 | ) | $ | (22,149 | ) |
Years Ended December 31, | ||||||||
2019 | 2020 | |||||||
Consolidated statements of operations data: | ||||||||
Revenue from sales of products | $ | 3,611 | $ | 7,828 | ||||
Revenue from development services | $ | 10,678 | $ | 13,935 | ||||
Revenue from license agreements | $ | 17,500 | $ | - | ||||
Total Revenues | $ | 31,789 | $ | 21,763 | ||||
Cost of revenues | 11,849 | 14,218 | ||||||
Gross profit | 19,940 | 7,545 | ||||||
Operating expenses: | ||||||||
Research and development, net of participation | 4,969 | 7,698 | ||||||
Selling and marketing | 4,064 | 3,228 | ||||||
General and administrative | 5,242 | 5,459 | ||||||
Other expenses | 1,172 | - | ||||||
Operating profit (loss) | 4,493 | (8,840 | ) | |||||
Financial income | 556 | 843 | ||||||
Financial expense | (2,983 | ) | (1,279 | ) | ||||
Profit (loss) from continuing operations | 2,066 | (9,276 | ) | |||||
Profit from discontinued operation | 2,889 | 80 | ||||||
Net profit (loss) | $ | 4,955 | $ | (9,196 | ) |
Years Ended December 31, | ||||||||
2019 | 2020 | |||||||
International (excluding U.S.) | $ | 3,285 | $ | 3,733 | ||||
U.S. | $ | 28,504 | $ | 18,030 | ||||
$ | 31,789 | $ | 21,763 |
Issuance of Ordinary Shares and Warrants | Government Grants and BARDA Funding, net | Total | ||||||||||
(in thousands) | ||||||||||||
Year ended December 31, 2017 | $ | 22,665 | $ | 8,895 | $ | 31,560 | ||||||
Year ended December 31, 2016 | $ | 7 | $ | 6,466 | $ | 6,473 | ||||||
Year ended December 31, 2015 | $ | 26 | $ | 1,552 | $ | 1,578 |
Issuance of Ordinary Shares | BARDA Funding | Total | ||||||||||
(in thousands) | ||||||||||||
Year ended December 31, 2020 | $ | - | $ | 20,241 | $ | 20,241 | ||||||
Year ended December 31, 2019 | $ | - | $ | 14,773 | $ | 14,773 |
Year Ended December 31, | Year Ended December 31, | |||||||||||||||||||
2015 | 2016 | 2017 | 2019 | 2020 | ||||||||||||||||
(in thousands) | ||||||||||||||||||||
Net cash provided by (used in): | ||||||||||||||||||||
Continuing operating activities | $ | (19,601 | ) | $ | (16,445 | ) | $ | (14,892 | ) | $ | 9,888 | $ | (6,700 | ) | ||||||
Continuing investing activities | 36,046 | 1,816 | 437 | (5,658 | ) | 17,385 | ||||||||||||||
Continuing financing activities | 778 | 907 | 22,995 | (1,006 | ) | (629 | ) | |||||||||||||
Discontinued operating activities | — | — | (1,563 | ) | (1,599 | ) | (195 | ) | ||||||||||||
Discontinued investing activities | (1,239 | ) | - |
Fair value of our ordinary shares. After March 20, 2014, the date our ordinary shares began trading on Nasdaq, the grant date fair value for equity‑based awards is based on the closing price of our ordinary shares on Nasdaq on the date of grant and fair value for all other purposes related to share‑based awards is the closing price of our ordinary shares on Nasdaq on the relevant date. |
Volatility. The expected share price volatility was based on the historical equity volatility of the ordinary shares of comparable companies that are publicly traded. |
Early exercise factor. Since adequate historical experience is not available to provide a reasonable estimate, the early exercise factor is determined based on peer group imperial studies. |
Risk‑free rate. The risk‑free interest rate is based on the yield from U.S. Treasury zero‑coupon bonds with a term equivalent to the contractual life of the options. |
Expected dividend yield. We have never declared or paid any cash dividends and do not presently plan to pay cash dividends in the foreseeable future. Consequently, we use an expected dividend yield of zero. |
Payments Due by Period | ||||||||||||||||
Total | 2018 | 2019 | 2020 and thereafter | |||||||||||||
(in thousands) | ||||||||||||||||
Operating lease obligations(1) | $ | 1,719 | $ | 522 | $ | 450 | $ | 747 |
Name | Age | Position | ||
Executive Officers | ||||
Sharon Malka | 49 | Chief Executive Officer | ||
Boaz Gur-Lavie | 47 | Chief Financial | ||
Lior Rosenberg, M.D. | Chief Medical Technology Officer | |||
Ety Klinger Ph.D. | Chief Research and Development Officer | |||
Yaron Meyer | Executive Vice President, General Counsel and Corporate Secretary | |||
Directors | ||||
Executive Chairman of the Board of Directors | ||||
Ofer Gonen | 48 | Director | ||
49 | Director | |||
Vickie R. Driver, M.D(3) | 67 | Director | ||
Nissim Mashiach(1)(2)(3)(4) | 60 | Director | ||
Sharon Kochan(1)(2)(3)(4) | 52 | Director | ||
Samuel Moed (2)(3)(4) | 58 | Director | ||
David Fox(1)(3)(4) | 63 | Director |
(1) | Member of our audit committee. |
(2) | Member of our compensation committee. |
(3) | Independent director under the listing rules of the Nasdaq Stock Market. |
(4) | External director under the Companies Law. |
Name and Position | Salary & Social Benefits(1) | Bonus | Share‑Based Payment(2) | Other Compensation(3) | Total | |||||||||||||||
(U.S. dollars)(4) | ||||||||||||||||||||
Gal Cohen, President and Chief Executive Officer | 391,116 | 129,972 | 175,284 | (22,175 | ) | 674,197 | ||||||||||||||
Sharon Malka, Chief Financial and Operations Officer | 260,450 | 98,599 | 161,581 | 34,822 | 555,453 | |||||||||||||||
Lior Rosenberg, M.D., Chief Medical Technology Officer | 291,990 | 96,078 | 91,265 | 36,630 | 515,964 | |||||||||||||||
Carsten Henke, Chief Commercial Officer EU & Managing Director of MediWound Germany GmbH | 270,734 | 98,223 | 104,044 | 50,874 | 523,875 | |||||||||||||||
Ety Klinger, Chief Research & Development Officer | 220,303 | 77,311 | 104,424 | 11,625 | 413,662 |
Name and Position | Salary & Social Benefits(1) | Bonus | Share‑Based Payment(2) | Other Compensation(3) | Total | |||||||||||||||
( thousand U.S. dollars)(4) | ||||||||||||||||||||
Sharon Malka, Chief Executive Officer | 398 | 119 | 250 | 3 | 770 | |||||||||||||||
Lior Rosenberg, M.D., Chief Medical Technology Officer | 313 | 104 | 45 | 23 | 485 | |||||||||||||||
Ety Klinger, Chief Research & Development Officer | 273 | 86 | 60 | 16 | 435 | |||||||||||||||
Boaz Gur-Lavie, Chief Financial Officer | 241 | 76 | 63 | 24 | 404 | |||||||||||||||
Yaron Meyer, Executive Vice president, General Counsel & Corporate Secretary | 238 | 72 | 49 | 5 | 364 |
(1) | Represents the officer’s gross salary plus payment of mandatory social benefits made by the company on behalf of such officer. Such benefits may include, to the extent applicable to the executive, payments, contributions and/or allocations for savings funds (e.g., Managers’ Life Insurance Policy), education funds (referred to in Hebrew as “keren hishtalmut”), pension, severance, risk insurances (e.g., life or work disability insurance) and payments for social security. |
(2) | Represents the equity‑based compensation expenses recorded in the company’s consolidated financial statements for the year ended December 31, |
(3) | Represents the other benefits to such officer, which includes either or both of (i) car expenses, including lease costs, gas and maintenance, provided to the officers, and (ii) vacation benefits. |
(4) | Converted (i) from NIS into U.S. dollars at the rate of 2020. |
Name | Number of Options | Grant Date | Exercise Price | Vested Options as of March 15, 2018 | Expiration Date | |||||||||
Gal Cohen, President and Chief Executive Officer | 208,332 | 11/14/2006 | $ | 2.63 | 208,332 | 11/13/2020 | ||||||||
45,600 | 1/15/2011 | $ | 9.82 | 45,600 | 1/14/2021 | |||||||||
152,000 | 12/24/2013 | $ | 12.89 | 152,000 | 12/23/2023 | |||||||||
70,000 | 1/28/2016 | $ | 9.58 | 35,000 | 12/22/2025 | |||||||||
Lior Rosenberg, Chief Medical Technology Officer | 76,000 | 12/24/2013 | $ | 12.89 | 76,000 | 12/23/2023 | ||||||||
25,000 | 12/23/2015 | $ | 9.58 | 12,500 | 12/22/2025 |
Name | Number of Options | Number of RSUs | Grant Date | Exercise Price | Vested Options/RSU's as of February 15, 2021 | Expiration Date | ||||||||||||
Sharon Malka, Chief Executive Officer | 121,600 | 12/24/2013 | $ | 12.89 | 121,600 | 12/23/2023 | ||||||||||||
50,000 | 12/23/2015 | $ | 9.58 | 50,000 | 12/22/2025 | |||||||||||||
135,000 | 12/31/2018 | $ | 5.15 | 67,500 | 12/30/2028 | |||||||||||||
45,000 | 12/31/2018 | 22,500 | ||||||||||||||||
40,000 | 5/2/2019 | $ | 4.92 | 10,000 | 5/1/2029 | |||||||||||||
20,000 | 5/2/2019 | 5,000 | ||||||||||||||||
81,170 | 6/29/2020 | $ | 1.75 | - | 6/28/2030 | |||||||||||||
Lior Rosenberg, Chief Medical Technology Officers | 76,000 | 12/24/2013 | $ | 12.89 | 76,000 | 12/23/2023 | ||||||||||||
25,000 | 12/23/2015 | $ | 9.58 | 25,000 | 12/22/2025 | |||||||||||||
20,000 | 12/31/2018 | $ | 5.15 | 5,000 | 12/30/2028 | |||||||||||||
6,667 | 12/31/2018 | 3,334 | ||||||||||||||||
43,600 | 4/23/2020 | $ | 1.75 | - | 4/22/2030 |
(i) | his or her service for each such additional term is recommended by one or more shareholders holding at least 1% of the company’s voting rights and is approved at a shareholders meeting by a disinterested majority, where the total number of shares held by non‑controlling, disinterested shareholders voting for such reelection exceeds 2% of the aggregate voting rights in the company, subject to additional restrictions set forth in the Israeli Companies Law with respect to affiliations of external director nominee; or |
(ii) | his or her service for each such additional term is recommended by the board of directors and is approved at a meeting of shareholders by the same majority required for the initial election of an external director (as described above). |
a transaction other than in the ordinary course of business; |
D. | Employees |
As of December 31, | ||||||||||||
2015 | 2016 | 2017 | ||||||||||
Department | ||||||||||||
Administrative | 6 | 7 | 8 | |||||||||
Research and development | 16 | 22 | 26 | |||||||||
Manufacturing | 20 | 23 | 26 | |||||||||
Sales and marketing | 25 | 20 | 16 | |||||||||
Total | 67 | 72 | 76 |
E. | Share Ownership |
A. | Major Shareholders |
Name of Beneficial Owner | Number of Shares Beneficially Held | Percentage of Class | ||||||
Directors and Executive Officers | ||||||||
Stefan T. Wills | * | * | ||||||
Ofer Gonen | * | * | ||||||
Assaf Segal | * | * | ||||||
Vickie R. Driver | * | * | ||||||
Nissim Mashiach | * | * | ||||||
Sharon Kochan | * | * | ||||||
Gal Cohen(1) | 440,932 | 1.6 | % | |||||
Sharon Malka | * | * | ||||||
Lior Rosenberg(2) | 1,939,072 | 7.1 | % | |||||
Carsten Henke | * | * | ||||||
Ety Klinger | * | * | ||||||
Yaron Meyer | * | * | ||||||
All executive officers and directors as a group (12 persons)(3) | 2,877,316 | 10.6 | % | |||||
Principal Shareholders | ||||||||
Clal Biotechnology Industries Ltd.(4) | 9,429,555 | 34.9 | % | |||||
Wellington Management Group LLP(5) | 3,642,979 | 13.5 | % | |||||
Migdal Insurance & Financial Holdings Ltd.(6) | 2,209,368 | 8.2 | % | |||||
Yelin Lapidot(7) | 1,432,381 | 5.3 | % |
Name of Beneficial Owner | Number of Shares Beneficially Held | Percentage of Class | ||||||
Directors and Executive Officers | ||||||||
Stephen T. Wills | * | * | ||||||
Ofer Gonen | * | * | ||||||
Assaf Segal | * | * | ||||||
Vickie R. Driver | * | * | ||||||
Nissim Mashiach | * | * | ||||||
Sharon Kochan | * | * | ||||||
David Fox | * | * | ||||||
Samuel Moed | * | * | ||||||
Sharon Malka | 378,772 | 1.4 | % | |||||
Boaz Gur-Lavie | * | * | ||||||
Lior Rosenberg(1) | 1,964,905 | 7.2 | % | |||||
Ety Klinger | * | * | ||||||
Yaron Meyer | * | * | ||||||
All executive officers and directors as a group (13 persons)( 2) | 2,679,800 | 9.3 | % | |||||
Principal Shareholders (who are not Directors or Executive Officers) | ||||||||
Clal Biotechnology Industries Ltd.(3) | 9,429,555 | 34.6 | % | |||||
Migdal Insurance & Financial Holdings Ltd.(4) | 2,126,058 | 7.8 | % |
* | Less than 1%. |
(1) |
As reported on a Schedule 13G/A filed on February |
Shares beneficially owned consist of |
As reported on a Schedule 13G/A filed on February 12, 2019, shares beneficially owned consist of: (i) |
As reported on a Schedule |
B. | Related Party Transactions |
C. | Interests of Experts and Counsel |
Item 8. | FINANCIAL INFORMATION |
A. | Consolidated Statements and Other Financial Information |
B. | Significant Changes |
Item 9. | THE OFFER AND LISTING |
A. | Listing Details |
Low | High | |||||||
Annual: | ||||||||
2017 | $ | 4.15 | $ | 8.25 | ||||
2016 | $ | 4.25 | $ | 9.29 | ||||
2015 | $ | 5.00 | $ | 10.47 | ||||
2014 (beginning March 20, 2014) | $ | 4.60 | $ | 19.31 | ||||
Quarterly: | ||||||||
First Quarter 2018 (through March 15, 2018) | $ | 3.95 | $ | 4.45 | ||||
Fourth Quarter 2017 | $ | 4.15 | $ | 5.37 | ||||
Third Quarter 2017 | $ | 4.75 | $ | 7.50 | ||||
Second Quarter 2017 | $ | 5.70 | $ | 8.25 | ||||
First Quarter 2017 | $ | 4.55 | $ | 6.80 | ||||
Fourth Quarter 2016 | $ | 4.25 | $ | 7.91 | ||||
Third Quarter 2016 | $ | 6.32 | $ | 8.58 | ||||
Second Quarter 2016 | $ | 7.34 | $ | 8.90 | ||||
First Quarter 2016 | $ | 5.66 | $ | 9.29 | ||||
Most Recent Six Months: | ||||||||
February 2017 | $ | 4.55 | $ | 3.56 | ||||
January 2017 | $ | 4.83 | $ | 4.30 | ||||
December 2017 | $ | 4.40 | $ | 4.95 | ||||
November 2017 | $ | 4.15 | $ | 5.10 | ||||
October 2017 | $ | 4.80 | $ | 5.37 | ||||
September 2017 | $ | 4.75 | $ | 6.70 |
B. | Plan of Distribution |
C. | Markets |
D. | Selling Shareholders |
E. | Dilution |
F. | Expenses of the Issue |
Item 10. | ADDITIONAL INFORMATION |
A. | Share Capital |
B. | Articles of Association |
D. | Exchange Controls |
E. | Taxation |
such gain is effectively connected with your conduct of a trade or business in the United States (or, if required by an applicable income tax treaty, the gain is attributable to a permanent establishment or fixed base that such holder maintains in the United States); or |
Change in | Exchange Rate | |||||||
Period | Shekel against the U.S. dollar (%) | Euro against the U.S. dollar (%) | ||||||
2013 | 7.0 | 4.5 | ||||||
2014 | (12.0 | ) | (11.8 | ) | ||||
2015 | (0.3 | ) | (10.4 | ) | ||||
2016 | 1.5 | (3.4 | ) | |||||
2017 | 9.8 | 13.9 |
Appreciation (Devaluation) of | ||||||||
Period | Shekel against the U.S. dollar (%) | Euro against the U.S. dollar (%) | ||||||
2018 | (8.1 | ) | (4.4 | ) | ||||
2019 | 7.8 | (2.0 | ) | |||||
2020 | 7.0 | 8.0 |
2016 | 2017 | 2019 | 2020 | ||||||||||||
Audit Fees | $ | 140,000 | $ | 290,000 | $ | 240,000 | $ | 170,000 | |||||||
Audit‑Related Fees | — | — | 35,000 | 33,500 | |||||||||||
Tax Fees | — | — | — | — | |||||||||||
Total | $ | 140,000 | $ | 290,000 | $ | 275,000 | $ | 203,500 |
Quorum. As permitted under the Israeli Companies Law pursuant to our articles of association, the quorum required for an ordinary meeting of shareholders will consist of at least two shareholders present in person, by proxy or by other voting instrument in accordance with the Israeli Companies Law, who hold at least 25% of the voting power of our shares (and in an adjourned meeting, with some exceptions, at least two shareholders), instead of 33 1/3% of the issued share capital required under the Nasdaq Stock Market listing rules. |
Nomination of directors. With the exception of external directors and directors elected by our board of directors due to vacancy, our directors are elected by an annual meeting of our shareholders to hold office until the next annual meeting following one year from his or her election. The nominations for directors, which are presented to our shareholders by our board of directors, are generally made by the entire board of directors itself, in accordance with the provisions of our articles of association and the Israeli Companies Law. Nominations need not be made by a nominating committee of our board of directors consisting solely of independent directors or otherwise, as required under the Nasdaq Stock Market listing rules. |
Majority of independent directors. Under the Israeli Companies Law, we are only required to appoint at least two external directors, within the meaning of the Israeli Companies Law, to our board of directors. Currently, four of our directors (of whom two are external directors, within the meaning of the Israeli Companies Law) qualify as independent directors under the rules of the U.S. federal securities laws and the Nasdaq Stock Market listing rules. If at any time we no longer have a controlling shareholder, we will no longer be required to have external directors, Shareholder approval. We do not intend to follow Nasdaq Stock Market rules which require shareholder approval in order to enter into any transaction, other than a public offering, involving the sale, issuance or potential issuance by the Company of ordinary shares (or securities convertible into or exercisable for ordinary shares) equal to 20% or more of the outstanding share capital of the Company or 20% or more of the voting power outstanding before the issuance for less than the greater of book or market value of the ordinary shares. We will follow Israeli law with respect to any requirement to obtain shareholder approval in connection with any private placements of equity securities. |
Exhibit No. | Description | |
100 | The following financial information from the Registrant’s Annual Report on Form 20‑F for the year ended December 31, | |
† | Portions of this exhibit have been omitted pursuant to Instruction 4(a) to Exhibits to Form 20-F because they are both (i) not material and |
(1) | Previously filed with the SEC on February 25, 2020 pursuant to the Registrant’s annual report on Form 20-F for the year ended December 31, 2019 (File No. 001-36349) and incorporated by reference herein. |
(2) | Previously filed with the SEC on March |
Previously filed with the SEC on |
(4) | Previously |
Previously filed with the SEC on January 25, 2016 |
Previously filed with the SEC on February 21, 2017 |
(7) | Previously filed with the SEC on March 19, 2018 as Exhibit 4.16 to the Registrant’s annual report on Form 20‑F for the year ended December 31, 2017 (File No. 001‑36349) and incorporated by reference herein. |
(8) | Previously filed with the SEC on March 25, 2019 as Exhibit 4.17 to the Registrant’s annual report on Form 20‑F for the year ended December 31, 2018 (File No. 001‑36349) and incorporated by reference herein. |
(9) | Previously filed with the SEC on March 19, 2018 as Exhibit 4.17 to the Registrant’s annual report on Form 20‑F for the year ended December 31, 2017 (File No. 001‑36349) and incorporated by reference herein |
(10) | Previously filed with the SEC on March 25, 2019 as Exhibit 4.20 to the Registrant’s annual report on Form 20‑F for the year ended December 31, 2018 (File No. 001‑36349) and incorporated by reference herein. |
(11) | Previously filed with the SEC on March 25, 2019 as Exhibit 4.21 to the Registrant’s annual report on Form 20‑F for the year ended December 31, 2018 (File No. 001‑36349) and incorporated by reference herein |
(12) | Previously filed with the SEC by Vericel Corporation on August 6, 2019 as Exhibit 10.9 to its quarterly report on Form 10-Q for the quarter ended June 30, 2019 (File No. 001‑35280) and incorporated by reference herein. |
(13) | Previously filed with the SEC by Vericel Corporation on August 6, 2019 as Exhibit 10.10 to its quarterly report on Form 10-Q for the quarter ended June 30, 2019 (File No. 001‑35280) and incorporated by reference herein |
MediWound Ltd. | ||
Date: February 25, 2021 | ||
Boaz Gur-Lavie | ||
Chief Financial |
Page | |
F -5 | |
Kost Forer Gabbay & Kasierer 144 Menachem Begin Rd. Tel-Aviv 6492102, Israel | Tel: +972-3-6232525 Fax: +972-3-5622555 ey.com |
Kost Forer Gabbay & Kasierer 144 Menachem Begin Rd. Tel-Aviv 6492102, Israel | Tel: +972-3-6232525 Fax: +972-3-5622555 ey.com |
Description of the matter | As described in Notes 3 and 16b to the consolidated financial statements, the Company’s research and development efforts have been financed in part through grants from the Israeli Innovation Authority (“IIA”). Grants received from the IIA are recognized as a liability if future economic benefits are expected from the research and development activity that will result in royalty‑bearing sales. The Company undertook to pay royalties of 3% on the revenues derived from sales of products or services developed in whole or in part using IIA grants, up to the amount of total grants received, plus LIBOR interest. The liability to the IIA is measured at amortized cost using the effective interest method and amounted as of December 31, 2020 to $7,529 thousands. Auditing the Company's IIA liability involved a high degree of subjectivity as it is based on assumptions about future revenue forecasts, such as long-term demand for the Company’s products and licenses and revenue growth rates. These significant assumptions are forward-looking and could be affected by future economic and market conditions. |
How we addressed the matter in our audit | Our substantive audit procedures included, among others, evaluating the significant assumptions and operating data used by management. For example, we compared the significant assumptions and operating data used by management to historical trends, we performed look-back analyses by comparing the Company's historical financial forecasted revenues with the actual results and we agreed future revenues to approved budgets. In addition, we considered the phases of development of the Company's products and the Company’s ability of obtaining regulatory approvals. We also tested the completeness and accuracy of the relevant data used in management's calculation, tested the mathematical accuracy of management’s calculations and performed sensitivity analyses over significant assumptions used by management related to revenue growth rates. |
Tel-Aviv, Israel February 25, 2021 | KOST FORER GABBAY & KASIERER A Member of Ernst & Young Global |
December 31, | December 31, | ||||||||||||||||||||
Note | 2016 | 2017 | Note | 2019 | 2020 | ||||||||||||||||
CURRENT ASSETS: | |||||||||||||||||||||
Cash and cash equivalents | 5 | 28,866 | 36,069 | 4 | 7,242 | 17,376 | |||||||||||||||
Restricted deposits | 5 | 180 | 184 | ||||||||||||||||||
Short-term bank deposits | 6 | 1,163 | - | 5 | 22,036 | 4,024 | |||||||||||||||
Trade receivables | 332 | 369 | 6 | 4,107 | 2,767 | ||||||||||||||||
Inventories | 7 | 844 | 1,886 | 7 | 1,613 | 1,380 | |||||||||||||||
Other receivables | 8, 22 | 2,407 | 3,196 | 8, 24 | 450 | 462 | |||||||||||||||
33,612 | 41,520 | 35,628 | 26,193 | ||||||||||||||||||
LONG-TERM ASSETS: | |||||||||||||||||||||
Long term deposits | 103 | 56 | |||||||||||||||||||
Property, plant and equipment, net | 9 | 1,276 | 1,924 | 9 | 2,304 | 2,630 | |||||||||||||||
Right of-use assets, net | 10 | 2,229 | 1,884 | ||||||||||||||||||
Intangible assets, net | 10 | 773 | 635 | 11 | 429 | 363 | |||||||||||||||
2,152 | 2,615 | 4,962 | 4,877 | ||||||||||||||||||
35,764 | 44,135 | 40,590 | 31,070 | ||||||||||||||||||
CURRENT LIABILITIES: | |||||||||||||||||||||
Current maturities of long-term liabilities | 569 | 1,750 | |||||||||||||||||||
Trade payables and accrued expenses | 3,320 | 3,251 | 4,067 | 2,992 | |||||||||||||||||
Other payables | 11, 22 | 2,060 | 2,182 | 12, 24 | 5,737 | 3,524 | |||||||||||||||
5,380 | 5,433 | 10,373 | 8,266 | ||||||||||||||||||
LONG‑TERM LIABILITIES: | |||||||||||||||||||||
Deferred revenues | 1,023 | 988 | 1,135 | 1,234 | |||||||||||||||||
Liabilities in respect of IIA grants | 12,13 | 6,839 | 7,380 | 13, 16b | 6,811 | 7,267 | |||||||||||||||
Contingent consideration for purchase of shares | 13,16 | 14,533 | 14,381 | ||||||||||||||||||
Liability in respect of discontinued operation | 19 | - | 6,003 | ||||||||||||||||||
Liabilities in respect of purchase of shares | 16c | 4,853 | 4,998 | ||||||||||||||||||
Lease liabilities | 10 | 2,006 | 1,741 | ||||||||||||||||||
Severance pay liability, net | 14 | 219 | 330 | 15 | 243 | 292 | |||||||||||||||
22,614 | 29,082 | 15,048 | 15,532 | ||||||||||||||||||
SHAREHOLDERS' EQUITY: | 16 | 18 | |||||||||||||||||||
Ordinary shares of NIS 0.01 par value: | |||||||||||||||||||||
Authorized: 32,244,508 shares as of December 31, 2016 and 2017; Issued and Outstanding 21,930,449 and 27,047,737 shares respectively. | 60 | 75 | |||||||||||||||||||
Authorized: 50,000,000 shares as of December 31, 2020 and December 31, 2019; Issued and Outstanding 27,236,752 shares as of December 31, 2020 and 27,202,795 shares as of December 31, 2019 | 75 | 75 | |||||||||||||||||||
Share premium | 114,979 | 138,992 | 140,871 | 142,193 | |||||||||||||||||
Foreign currency translation adjustments | (9 | ) | (38 | ) | (17 | ) | (40 | ) | |||||||||||||
Accumulated deficit | (107,260 | ) | (129,409 | ) | (125,760 | ) | (134,956 | ) | |||||||||||||
7,770 | 9,620 | 15,169 | 7,272 | ||||||||||||||||||
35,764 | 44,135 | 40,590 | 31,070 |
Year ended December 31, | |||||||||||||
Note | 2015 | 2016 | 2017 | ||||||||||
Revenues | 601 | 1,558 | 2,496 | ||||||||||
Cost of revenues | 20a | 2,519 | 2,158 | 1,578 | |||||||||
Gross profit (loss) | (1,918 | ) | (600 | ) | 918 | ||||||||
Operating expenses: | |||||||||||||
Research and development, net of participations | 20b | 6,021 | 7,068 | 5,462 | |||||||||
Selling and marketing | 20c | 9,284 | 8,403 | 5,362 | |||||||||
General and administrative | 20d | 4,004 | 4,084 | 3,781 | |||||||||
Total operating expenses | 19,309 | 19,555 | 14,605 | ||||||||||
Operating loss | (21,227 | ) | (20,155 | ) | (13,687 | ) | |||||||
Financial income | 20e | 1,052 | 2,166 | 406 | |||||||||
Financial expense | 20e | (1,496 | ) | (896 | ) | (1,252 | ) | ||||||
Loss from continuing operations | (21,671 | ) | (18,885 | ) | (14,533 | ) | |||||||
Loss from discontinued operation | 19 | (417 | ) | - | (7,616 | ) | |||||||
Net loss | (22,088 | ) | (18,885 | ) | (22,149 | ) | |||||||
Other comprehensive income (loss): | |||||||||||||
Items to be reclassified to profit or loss in subsequent periods: | |||||||||||||
Foreign currency translation adjustments | 2 | 7 | (29 | ) | |||||||||
Total comprehensive loss | (22,086 | ) | (18,878 | ) | (22,178 | ) | |||||||
Basic and diluted net loss per share: | 21 | ||||||||||||
Basic and diluted net loss per share from continuing operations | (1.00 | ) | (0.86 | ) | (0.62 | ) | |||||||
Basic and diluted net loss per share from discontinued operations | (0.02 | ) | - | (0.33 | ) | ||||||||
Total Basic and diluted net loss per share | (1.02 | ) | (0.86 | ) | (0.95 | ) |
Year ended December 31, | ||||||||||||||||
Note | 2018 | 2019 | 2020 | |||||||||||||
Revenues from sale of products | 3,401 | 3,611 | 7,828 | |||||||||||||
Revenues from development services | - | 10,678 | 13,935 | |||||||||||||
Revenues from license agreements | - | 17,500 | - | |||||||||||||
Total revenues | 22a | 3,401 | 31,789 | 21,763 | ||||||||||||
Cost of revenues | 22b | 2,088 | 11,849 | 14,218 | ||||||||||||
Gross profit | 1,313 | 19 ,940 | 7,545 | |||||||||||||
Research and development, net of Participations | 22c | 4,072 | 4,969 | 7,698 | ||||||||||||
Selling and marketing | 22d | 4,188 | 4,064 | 3,228 | ||||||||||||
General and administrative | 22e | 3,799 | 5,242 | 5,459 | ||||||||||||
Other income from settlement agreement | 16c | (7,537 | ) | - | - | |||||||||||
Other expenses | 22f | 751 | 1,172 | - | ||||||||||||
Total operating expenses | 5,273 | 15,447 | 16,385 | |||||||||||||
Operating profit (loss) | (3,960 | ) | 4,493 | (8,840 | ) | |||||||||||
Financial income | 22g | 412 | 556 | 843 | ||||||||||||
Financial expense | 22g | (2,117 | ) | (2,983 | ) | (1,279 | ) | |||||||||
Profit (loss) from continuing operations | (5,665 | ) | 2,066 | (9,276 | ) | |||||||||||
Profit from discontinued operation | 16c,21 | 4,608 | 2,889 | 80 | ||||||||||||
Net profit (loss) | (1,057 | ) | 4,955 | (9,196 | ) | |||||||||||
Other comprehensive income (loss): | ||||||||||||||||
Foreign currency translation adjustments | 13 | 8 | (23 | ) | ||||||||||||
Total comprehensive income (loss) | (1,044 | ) | 4,963 | (9,219 | ) | |||||||||||
23 | ||||||||||||||||
Basic and diluted net profit (loss) per share from continuing operations | (0.21 | ) | 0.08 | (0.34 | ) | |||||||||||
Basic and diluted net profit per share from discontinued operations | 0.17 | 0.10 | - | |||||||||||||
Total Basic and diluted net profit (loss) per share | (0.04 | ) | 0.18 | (0.34 | ) |
Share capital | Share premium | Foreign currency translation reserve | Accumulated deficit | Total Equity | ||||||||||||||||
Balance as of January 1, 2018 | 75 | 138,992 | (38 | ) | (129,658 | ) | 9,371 | |||||||||||||
Net loss | - | - | - | (1,057 | ) | (1,057 | ) | |||||||||||||
Other comprehensive income | - | - | 13 | - | 13 | |||||||||||||||
Total comprehensive (loss) income | - | - | 13 | (1,057 | ) | (1,044 | ) | |||||||||||||
Exercise of options | (* | ) | (* | ) | - | - | (* | ) | ||||||||||||
Share-based compensation | - | 645 | - | - | 645 | |||||||||||||||
Balance as of December 31, 2018 | 75 | 139,637 | (25 | ) | (130,715 | ) | 8,972 | |||||||||||||
Net profit | - | - | - | 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 | |||||||||||||
Net loss | - | - | - | (9,196 | ) | (9,196 | ) | |||||||||||||
Other comprehensive loss | - | - | (23 | ) | - | (23 | ) | |||||||||||||
Total comprehensive loss | - | - | (23 | ) | (9,196 | ) | (9,219 | ) | ||||||||||||
Exercise of options | (* | ) | - | (* | ) | - | - | |||||||||||||
Share-based compensation | - | 1,322 | - | - | 1,322 | |||||||||||||||
Balance as of December 31, 2020 | 75 | 142,193 | (40 | ) | (134,956 | ) | 7,272 |
Share capital | Share premium | Foreign currency translation Adjustments | Accumulated deficit | Total Equity | ||||||||||||||||
Balance as of January 1, 2015 | 59 | 109,117 | (18 | ) | (66,287 | ) | 42,871 | |||||||||||||
Loss for the period | - | - | - | (22,088 | ) | (22,088 | ) | |||||||||||||
Other comprehensive income | - | - | 2 | - | 2 | |||||||||||||||
Total comprehensive (loss) income | - | - | 2 | (22,088 | ) | (22,086 | ) | |||||||||||||
Exercise of options | 1 | 25 | - | - | 26 | |||||||||||||||
Share-based compensation | - | 2,659 | - | - | 2,659 | |||||||||||||||
Balance as of December 31, 2015 | 60 | 111,801 | (16 | ) | (88,375 | ) | 23,470 | |||||||||||||
Loss for the period | - | - | - | (18,885 | ) | (18,885 | ) | |||||||||||||
Other comprehensive income | - | - | 7 | - | 7 | |||||||||||||||
Total comprehensive (loss) income | - | - | 7 | (18,885 | ) | (18,878 | ) | |||||||||||||
Exercise of options | * | 7 | - | - | 7 | |||||||||||||||
Share-based compensation | - | 3,171 | - | - | 3,171 | |||||||||||||||
Balance as of December 31, 2016 | 60 | 114,979 | (9 | ) | (107,260 | ) | 7,770 | |||||||||||||
Loss for the period | - | - | - | (22,149 | ) | (22,149 | ) | |||||||||||||
Other comprehensive loss | - | - | (29 | ) | - | (29 | ) | |||||||||||||
Total comprehensive loss | - | - | (29 | ) | (22,149 | ) | (22,178 | ) | ||||||||||||
Exercise of options | * | 7 | - | - | 7 | |||||||||||||||
Issuance of ordinary shares of NIS 0.01 par value net of issuance expenses | 15 | 22,643 | - | - | 22,658 | |||||||||||||||
Share-based compensation | - | 1,363 | - | - | 1,363 | |||||||||||||||
Balance as of December 31, 2017 | 75 | 138,992 | (38 | ) | (129,409 | ) | 9,620 |
Year ended December 31, | ||||||||||||
2018 | 2019 | 2020 | ||||||||||
Cash Flows from operating activities: | ||||||||||||
Net Profit (loss) | (1,057 | ) | 4,955 | (9,196 | ) | |||||||
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 | (4,608 | ) | (2,889 | ) | (80 | ) | ||||||
Depreciation and amortization | 577 | 1,149 | 1,090 | |||||||||
Share-based compensation | 645 | 1,234 | 1,322 | |||||||||
Revaluation of liabilities in respect of IIA grants | 287 | (392 | ) | 828 | ||||||||
Revaluation of liabilities in respect of purchase of shares | 758 | 1,690 | (433 | ) | ||||||||
Other income from settlement agreement | (7,537 | ) | - | - | ||||||||
Revaluation of lease liabilities | - | 340 | 305 | |||||||||
Increase (decrease) in severance pay liability, net | 19 | (105 | ) | 33 | ||||||||
Net financing income | (412 | ) | (434 | ) | (297 | ) | ||||||
Un-realized foreign currency (gain) loss | 182 | (152 | ) | (211 | ) | |||||||
(10,089 | ) | 441 | 2,557 | |||||||||
Changes in asset and liability items: | ||||||||||||
Decrease (increase) in trade receivables | (211 | ) | (3,553 | ) | 1,386 | |||||||
Decrease in inventories | 206 | 67 | 141 | |||||||||
Decrease (increase) in other receivables | (306 | ) | 6,376 | (13 | ) | |||||||
Increase (decrease) in trade payables and accrued expenses | (536 | ) | 1,355 | (1,096 | ) | |||||||
Increase (decrease) in other payables and deferred revenues | (161 | ) | 247 | (479 | ) | |||||||
(1,008 | ) | 4,492 | (61 | ) | ||||||||
Net cash provided by (used in) continuing operating activities | (12,154 | ) | 9,888 | (6,700 | ) | |||||||
Net cash used in discontinued operating activities | - | (1,599 | ) | (195 | ) | |||||||
Net cash provided by (used in) operating activities | (12,154 | ) | 8,289 | (6,895 | ) |
Year ended December 31, | ||||||||||||
2015 | 2016 | 2017 | ||||||||||
Cash Flows from Operating Activities: | ||||||||||||
Net loss | (22,088 | ) | (18,885 | ) | (22,149 | ) | ||||||
Adjustments to reconcile net loss to net cash used in continuing operating activities: | ||||||||||||
Adjustments to profit and loss items: | ||||||||||||
Loss from discontinued operation | 417 | - | 7,616 | |||||||||
Depreciation and amortization | 503 | 589 | 567 | |||||||||
Share-based compensation | 2,659 | 3,171 | 1,363 | |||||||||
Revaluation of liabilities in respect of IIA grants | (474 | ) | (1,298 | ) | 229 | |||||||
Revaluation of contingent consideration for purchase of shares | (764 | ) | (1,621 | ) | 351 | |||||||
Increase in severance pay liability, net | 90 | 125 | 111 | |||||||||
Net financing income | (288 | ) | (414 | ) | (349 | ) | ||||||
Un-realized foreign currency (gain) loss | 69 | (94 | ) | (185 | ) | |||||||
2,212 | 458 | 9,703 | ||||||||||
Changes in asset and liability items: | ||||||||||||
Decrease (increase) in trade receivables | (181 | ) | (107 | ) | 28 | |||||||
Decrease (increase) in inventories | (273 | ) | 873 | (1,042 | ) | |||||||
Decrease (increase) in other receivables and long term deposits | (556 | ) | 33 | (1,227 | ) | |||||||
Increase (decrease) in trade payables and accrued expenses | 33 | 2,195 | (135 | ) | ||||||||
Increase (decrease) in other payables and deferred revenues | 1,252 | (1,012 | ) | (70 | ) | |||||||
275 | 1,982 | (2,446 | ) | |||||||||
Net cash used in continuing operating activities | (19,601 | ) | (16,445 | ) | (14,892 | ) | ||||||
Net cash used in discontinued operating activities | - | - | (1,563 | ) | ||||||||
Net cash used in operating activities | (19,601 | ) | (16,445 | ) | (16,455 | ) |
Year ended December 31, | ||||||||||||
2018 | 2019 | 2020 | ||||||||||
Cash Flows from Investing Activities: | ||||||||||||
Purchase of property and equipment | (522 | ) | (792 | ) | (923 | ) | ||||||
Purchase of intangible assets | (12 | ) | - | - | ||||||||
Interest received | 106 | 184 | 274 | |||||||||
Proceeds from (investments in) short term bank deposits, net | (16,612 | ) | (5,050 | ) | 18,034 | |||||||
Net cash provided by (used in) continuing investing activities | (17,040 | ) | (5,658 | ) | 17,385 | |||||||
Net cash used in discontinued investing activities | - | (1,239 | ) | - | ||||||||
Net cash provided by (used in) investing activities | (17,040 | ) | (6,897 | ) | 17,385 | |||||||
Cash Flows from Financing Activities: | ||||||||||||
Repayment of leases liabilities | - | (630 | ) | (508 | ) | |||||||
Proceeds from exercise of options | (* | ) | - | - | ||||||||
Proceeds from (repayment of) IIA grants, net | 46 | (376 | ) | (121 | ) | |||||||
Net cash provided by (used in) continuing financing activities | 46 | (1,006 | ) | (629 | ) | |||||||
Exchange rate differences on cash and cash equivalent balances | (205 | ) | 140 | 273 | ||||||||
Increase (decrease) in cash and cash equivalents from continuing activities | (29,353 | ) | 3,364 | 10,329 | ||||||||
Decrease in cash and cash equivalents from discontinued activities | - | (2,838 | ) | (195 | ) | |||||||
Balance of cash and cash equivalents at the beginning of the year | 36,069 | 6,716 | 7,242 | |||||||||
Balance of cash and cash equivalents at the end of the year | 6,716 | 7,242 | 17,376 | |||||||||
Supplement disclosure of Non-cash transactions: | ||||||||||||
ROU asset, net recognized with corresponding lease liability | - | 209 | 261 | |||||||||
Exercise of RSU’s | - | 97 | 147 |
Year ended December 31, | ||||||||||||
2015 | 2016 | 2017 | ||||||||||
Cash Flows from Investing Activities: | ||||||||||||
Purchase of property and equipment | (376 | ) | (671 | ) | (1,045 | ) | ||||||
Purchase of intangible assets | (30 | ) | (30 | ) | (30 | ) | ||||||
Interest received | 287 | 407 | 349 | |||||||||
Proceeds from short term bank deposits, net | 36,165 | 2,110 | 1,163 | |||||||||
Net cash provided by investing activities | 36,046 | 1,816 | 437 | |||||||||
Cash Flows from Financing Activities: | ||||||||||||
Proceeds from exercise of options | 26 | 7 | 7 | |||||||||
Proceeds from issuance of shares, net | - | - | 22,658 | |||||||||
Proceeds from the IIA grants, net of re-payment | 752 | 900 | 330 | |||||||||
Net cash provided by financing activities | 778 | 907 | 22,995 | |||||||||
Exchange rate differences on cash and cash equivalent balances | (143 | ) | 86 | 226 | ||||||||
Increase (decrease) in cash and cash equivalents from continuing activities | 17,080 | (13,636 | ) | 8,766 | ||||||||
Decrease in cash and cash equivalents from discontinued activities | - | - | (1,563 | ) | ||||||||
Balance of cash and cash equivalents at the beginning of the year | 25,422 | 42,502 | 28,866 | |||||||||
Balance of cash and cash equivalents at the end of the year | 42,502 | 28,866 | 36,069 |
NOTE 1: | GENERAL |
a. | General description of the Company and its operations: |
b. | The Company's securities are listed for trading on NASDAQ since March 2014. |
The Company has In addition, the Company owns approximately |
The |
NOTE 1: | GENERAL (Cont.) |
e. | The COVID-19 pandemic has developed rapidly in 2020, with a significant number of cases. Measures taken by various governments to contain the virus have affected economic activity.The Company addressed the challenges associated with the COVID-19 pandemic during the year ended 2020, while prioritizing the health and safety of its workforce and maintaining operational efficiency and flexibility.The Company continued its operations and had no impact on its revenues while achieving cost reduction in its Sales and marketing As well as general and administration expenditures. |
NOTE 2:- | SIGNIFICANT ACCOUNTING POLICIES |
a. | Basis of presentation of financial statements: |
b. |
Consolidated financial statements include the financial statements of companies that the Company controls (subsidiaries). Control is achieved when the Company is exposed, or has rights, to variable returns from its investment with the investee and has the ability to affect those returns through its power over the investee. |
Functional currency, reporting currency and foreign currency: |
1. | Functional currency and reporting currency: |
NOTE 2:- | SIGNIFICANT ACCOUNTING POLICIES (Cont.) |
2. | Transactions, assets and liabilities in foreign currency: |
Cash equivalents: |
Short-term bank deposits: |
Inventories: |
Raw materials | - | At cost of purchase using the first-in, first-out method. |
Finished goods | - | On the basis of average standard costs (which approximates actual cost on a weighted average basis) including materials, labor and other direct and indirect manufacturing costs based on practical capacity. |
NOTE 2:- | SIGNIFICANT ACCOUNTING POLICIES (Cont.) |
Liability in respect of Israeli Innovation Authority ("IIA"): |
h. | Leases: |
NOTE 2:- | SIGNIFICANT ACCOUNTING POLICIES (Cont.) |
Years | ||||
Motor vehicles | 3 | |||
Buildings and equipment | 5-8 |
NOTE 2:- |
i. | Property, plant and equipment, net: |
% | ||||
Office furniture | 6-15 | |||
15-33 | ||||
Computers | 33 | |||
Leasehold improvements | See below |
Intangible assets, net: |
NOTE 2:- | SIGNIFICANT ACCOUNTING POLICIES (Cont.) |
Revenues recognition: |
NOTE 2:- | SIGNIFICANT ACCOUNTING POLICIES (Cont.) |
The contracts are negotiated as a package with a single commercial objective. |
- | The amount of consideration to be paid in one contract depends on the consideration or performance of another contract. |
- | The goods or services that the Company will provide according to the contracts represent a single performance obligation for the Company. |
NOTE 2:- | SIGNIFICANT ACCOUNTING POLICIES (Cont.) |
l. | Research and development expenses: |
m. | Funding by BARDA: |
n. | Impairment of non-financial assets: |
NOTE 2:- | SIGNIFICANT ACCOUNTING POLICIES (Cont.) |
o. | Financial instruments: |
1. | Financial assets: |
- | The Company's business model for managing financial assets; and |
- | The contractual cash flow terms of the financial asset. |
NOTE 2:- | SIGNIFICANT ACCOUNTING POLICIES (Cont.) |
2. | Financial liabilities: |
Financial |
b) | Financial liabilities measured at fair value through profit or loss: |
3. | Fair value: |
NOTE 2:- | SIGNIFICANT ACCOUNTING POLICIES (Cont.) |
All assets and liabilities for which fair value is measured or disclosed in the financial statements are categorized within the fair value hierarchy, described as follows, based on the lowest level input that is significant to the fair value measurement as a whole: |
Level 1 | - | quoted prices (unadjusted) in active markets for identical assets or liabilities. |
Level 2 | - | inputs other than quoted prices included within level 1 that are observable either directly or indirectly. |
Level 3 | - | inputs that are not based on observable market data (valuation techniques which use inputs that are not based on observable market data). |
5. | Offsetting financial instruments: |
6. | De-recognition of financial instruments: |
a) | Financial assets: A financial asset is derecognized when the contractual rights to the cash flows from the financial asset expire or the Company has transferred its contractual rights to receive cash flows from the financial asset or assumes an obligation to pay the cash flows in full without material delay to a third party and has transferred substantially all the risks and rewards of the asset, or has neither transferred nor retained substantially all the risks and rewards of the asset, but has transferred control of the asset. |
b) | Financial liabilities: A financial liability is derecognized when it is extinguished, that is when the obligation is discharged or cancelled or expires. A financial liability is extinguished when the debtor (the Company) discharges the liability by paying in cash, other financial assets, goods or services; or is legally released from the liability. |
7. | Contingent consideration for purchase of shares: The contingent consideration liability for purchase of shares is measured at fair value (Level 3 of the fair value hierarchy) and initially recorded against equity. Subsequent changes in the fair value are recognized in profit or loss. |
NOTE 2:- | SIGNIFICANT ACCOUNTING POLICIES (Cont.) |
p. | Provisions: |
q. | Short-term employee benefits and severance pay liability, net: |
1. | Short-term employee benefits: |
2. | Post-employment benefits: |
r. | Share-based compensation: Certain Company employees and directors are entitled to remuneration in the form of equity-settled share-based compensation. |
NOTE 2:- | SIGNIFICANT ACCOUNTING POLICIES (Cont.) |
s. | Discontinued operation: |
t. | Profit / Loss per share: |
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, Changes in Stockholders' Equity or cash flows. |
NOTE 3:- | SIGNIFICANT ACCOUNTING JUDGMENTS, ESTIMATES AND ASSUMPTIONS USED IN THE PREPARATION OF THE FINANCIAL STATEMENTS |
December 31, | ||||||||
2016 | 2017 | |||||||
USD cash for immediate withdrawal | 25,863 | 26,700 | ||||||
Non-USD cash for immediate withdrawal | 3,003 | 9,369 | ||||||
28,866 | 36,069 |
December 31, | ||||||||
2016 | 2017 | |||||||
USD bank deposits | 1,163 | - | ||||||
1,163 | - |
Year ended December 31, | ||||||||
2016 | 2017 | |||||||
Raw materials | 296 | 339 | ||||||
Finished goods | 548 | 1,547 | ||||||
844 | 1,886 |
Year ended December 31, | ||||||||
2016 | 2017 | |||||||
Government authorities | 61 | 226 | ||||||
BARDA funds | 953 | 2,175 | ||||||
Prepaid expenses and other | 224 | 129 | ||||||
Former shareholder, net (see Note 15d) | 1,169 | 666 | ||||||
2,407 | 3,196 |
Office furniture | Electronic machinery and laboratory equipment | Computers | Leasehold improvements | Total | ||||||||||||||||
Cost | ||||||||||||||||||||
Balance as of January 1, 2017 | 227 | 2,551 | 185 | 2,120 | 5,083 | |||||||||||||||
Disposals | - | - | (74 | ) | - | (74 | ) | |||||||||||||
Additions | 9 | 1,010 | 26 | - | 1,045 | |||||||||||||||
Foreign currency translation | 12 | - | 2 | - | 14 | |||||||||||||||
Balance as of December 31, 2017 | 248 | 3,561 | 139 | 2,120 | 6,068 | |||||||||||||||
Accumulated Depreciation | ||||||||||||||||||||
Balance as of January 1, 2017 | 126 | 1,508 | 118 | 2,057 | 3,809 | |||||||||||||||
Disposals | - | - | (74 | ) | - | (74 | ) | |||||||||||||
Additions | 20 | 294 | 47 | 38 | 399 | |||||||||||||||
Foreign currency translation | 8 | - | 2 | - | 10 | |||||||||||||||
Balance as of December 31, 2017 | 154 | 1,802 | 93 | 2,095 | 4,144 | |||||||||||||||
Depreciated cost as of December 31, 2017 | 94 | 1,759 | 46 | 25 | 1,924 |
Office furniture | Electronic machinery and laboratory equipment | Computers | Leasehold improvements | Total | ||||||||||||||||
Cost | ||||||||||||||||||||
Balance as of January 1, 2016 | 221 | 1,955 | 174 | 2,095 | 4,445 | |||||||||||||||
Disposals | - | - | (27 | ) | - | (27 | ) | |||||||||||||
Additions | 12 | 596 | 38 | 25 | 671 | |||||||||||||||
Foreign currency translation | (6 | ) | - | - | - | (6 | ) | |||||||||||||
Balance as of December 31, 2016 | 227 | 2,551 | 185 | 2,120 | 5,083 | |||||||||||||||
Accumulated Depreciation | ||||||||||||||||||||
Balance as of January 1, 2016 | 102 | 1,205 | 86 | 2,012 | 3,405 | |||||||||||||||
Disposals | - | - | (27 | ) | - | (27 | ) | |||||||||||||
Additions | 27 | 303 | 59 | 47 | 436 | |||||||||||||||
Foreign currency translation | (7 | ) | - | - | - | (7 | ) | |||||||||||||
Balance as of December 31, 2016 | 122 | 1,508 | 118 | 2,059 | 3,807 | |||||||||||||||
Depreciated cost as of December 31, 2016 | 105 | 1,043 | 67 | 61 | 1,276 |
NOTE |
Year ended December 31, | ||||||||
2019 | 2020 | |||||||
USD cash for immediate withdrawal | 5,766 | 13,067 | ||||||
Non-USD cash for immediate withdrawal | 1,476 | 4,309 | ||||||
7,242 | 17,376 |
NOTE 5:- | SHORT-TERM BANK DEPOSITS |
Year ended December 31, | ||||||||
2019 | 2020 | |||||||
USD bank deposits (1) | 22,036 | 4,024 | ||||||
Restricted bank deposits (2) | 180 | 184 | ||||||
22,216 | 4,208 | |||||||
Year ended December 31, | ||||||||
2016 | 2017 | |||||||
Employees and payroll accruals | 1,566 | 1,621 | ||||||
Current maturities of IIA grants | 49 | 57 | ||||||
Related parties | 295 | 324 | ||||||
Deferred revenues | 122 | 131 | ||||||
Other | 28 | 49 | ||||||
2,060 | 2,182 |
(1) | The USD deposits bear annual interest of 1.12% for the period of 282 days for 2020 and 2.48%-3.10% for the period of 357-368 days for 2019. |
(2) | Restricted bank deposits which are primarily used as security for the Company’s office leases. |
NOTE |
Year ended December 31, | ||||||||
2016 | 2017 | |||||||
Balance as of January 1 | 7,303 | 6,888 | ||||||
Grants received | 929 | 401 | ||||||
Royalties | (46 | ) | (81 | ) | ||||
Amounts carried to Profit or Loss | (1,298 | ) | 229 | |||||
Balance as of Decmber 31 | 6,888 | 7,437 | ||||||
Current maturities | (49 | ) | (57 | ) | ||||
Long term liabilities in respect of IIA grants | 6,839 | 7,380 |
Year ended December 31, | ||||||||
2019 | 2020 | |||||||
BARDA (see also Note 17a) | 3,267 | 2,189 | ||||||
Others receivables | 840 | 578 | ||||||
4,107 | 2,767 |
NOTE 7:- | INVENTORIES |
Year ended December 31, | ||||||||
2019 | 2020 | |||||||
Raw materials | 709 | 631 | ||||||
Finished goods | 904 | 749 | ||||||
1,613 | 1,380 |
NOTE 8:- | OTHER RECEIVABLES |
Year ended December 31, | ||||||||
2019 | 2020 | |||||||
Government authorities | 228 | 73 | ||||||
Prepaid expenses and other | 222 | 389 | ||||||
450 | 462 |
NOTE 9:- | PROPERTY, PLANT AND EQUIPMENT, NET |
Office furniture | Manufacturing machinery and lab equipment | Computers | Leasehold improvements | Total | ||||||||||||||||
Cost | ||||||||||||||||||||
Balance as of January 1, 2020 | 301 | 4,534 | 124 | 2,315 | 7,274 | |||||||||||||||
Disposals | - | - | (29 | ) | - | (29 | ) | |||||||||||||
Additions | 20 | 241 | 73 | 445 | 779 | |||||||||||||||
Re-classified from RSU assets | - | - | - | 144 | 144 | |||||||||||||||
Foreign currency translation | 11 | - | 1 | - | 12 | |||||||||||||||
Balance as of December 31, 2020 | 332 | 4,775 | 169 | 2,904 | 8,180 | |||||||||||||||
Accumulated Depreciation | ||||||||||||||||||||
Balance as of January 1, 2020 | 175 | 2,606 | 60 | 2,129 | 4,970 | |||||||||||||||
Disposals | - | - | (29 | ) | - | (29 | ) | |||||||||||||
Additions | 18 | 486 | 44 | 49 | 597 | |||||||||||||||
Foreign currency translation | 11 | - | 1 | - | 12 | |||||||||||||||
Balance as of December 31, 2020 | 204 | 3,092 | 76 | 2,178 | 5,550 | |||||||||||||||
Depreciated cost | ||||||||||||||||||||
December 31, 2020 | 128 | 1,683 | 93 | 726 | 2,630 |
NOTE 9:- | PROPERTY, PLANT AND EQUIPMENT, NET (Cont.) |
Office furniture | Manufacturing machinery and lab equipment | Computers | Leasehold improvements | Total | ||||||||||||||||
Cost | ||||||||||||||||||||
Balance as of January 1, 2019 | 243 | 4,054 | 102 | 2,123 | 6,522 | |||||||||||||||
Disposals | - | - | (38 | ) | - | (38 | ) | |||||||||||||
Additions | 60 | 480 | 60 | 192 | 792 | |||||||||||||||
Foreign currency translation | (2 | ) | - | - | - | (2 | ) | |||||||||||||
Balance as of December 31, 2019 | 301 | 4,534 | 124 | 2,315 | 7,274 | |||||||||||||||
Accumulated Depreciation | ||||||||||||||||||||
Balance as of January 1, 2019 | 161 | 2,153 | 70 | 2,118 | 4,502 | |||||||||||||||
Disposals | - | - | (38 | ) | - | (38 | ) | |||||||||||||
Additions | 17 | 453 | 28 | 11 | 509 | |||||||||||||||
Foreign currency translation | (3 | ) | - | - | - | (3 | ) | |||||||||||||
Balance as of December 31, 2019 | 175 | 2,606 | 60 | 2,129 | 4,970 | |||||||||||||||
Depreciated cost | ||||||||||||||||||||
December 31, 2019 | 126 | 1,928 | 64 | 186 | 2,304 |
NOTE 10:- | LEASES |
a. | Lease Agreements: The Company's offices and its production facility in Israel are located in a building that the Company leases from its Parent Company (see Note 24a), in accordance with a sub-lease agreement. The Company subleases approximately 3,000 square meters of laboratory, office and clean room space at a monthly rent fee of NIS 119 (approximately $37). This sub-lease agreement which was amended on January 1, 2019, expires in October 2022 and provides with 3 years extention period at the sole discretion of the Company which were included in the calculation of the lease liability and ROU asset. In addition the Company and its subsidiary have operating lease agreements for 14 vehicles for a period of three years. |
b. | Lease extension and termination options: The Company has leases that include extension and termination options. These options provide flexibility in managing the leased assets and align with the Company's business needs. The Company exercises significant judgement in deciding whether it is reasonably certain that the extension and termination options will be exercised. |
NOTE 10:- | LEASES (Cont.) In leases of motor vehicles, the Company does not include in the lease term the exercise of extension options since the Company does not ordinarily exercise options that extend the lease period beyond 3 years. |
c. | Information on leases: |
Year ended December 31, | ||||||||
2019 | 2020 | |||||||
Interest expense on lease liabilities | 139 | 144 | ||||||
Expenses relating to short-term leases | 444 | 566 | ||||||
Total cash outflow for leases (1) | 630 | 652 |
(1) | As of the year ended December 31,2020 the cash flow for leases includes $144 which was classified under CAPEX as Leashold improvments. |
c. | Disclosures in respect of RSU assets: |
Buildings | Motor vehicles | Total | ||||||||||
Cost | ||||||||||||
Balance as of January 1, 2020 | 2,362 | 442 | 2,804 | |||||||||
New leases | - | 305 | 305 | |||||||||
Adjustments for indexation | (17 | ) | (18 | ) | (35 | ) | ||||||
Disposals | (76 | ) | (217 | ) | (293 | ) | ||||||
Termination of leases | (44 | ) | - | (44 | ) | |||||||
Balance as of December 31, 2020 | 2,225 | 512 | 2,737 | |||||||||
Accumulated depreciation | ||||||||||||
Balance as of January 1, 2020 | 381 | 194 | 575 | |||||||||
Depreciation and amortization | 249 | 178 | 427 | |||||||||
Re-classified to Leasehold improvements | 144 | - | 144 | |||||||||
Disposals | (76 | ) | (217 | ) | (293 | ) | ||||||
Balance as of December 31, 2020 | 698 | 155 | 853 | |||||||||
Disposals | ||||||||||||
Depreciated cost | ||||||||||||
Balance as of December 31, 2020 | 1,527 | 357 | 1,884 |
NOTE 10:- | LEASES (Cont.) |
Buildings | Motor vehicles | Total | ||||||||||
Cost | ||||||||||||
Balance as of January 1, 2019 | - | 46 | 46 | |||||||||
Cumulative effect adjustment on accumulated ROU assets as a result of adopting IFRS 16 | 2,335 | 187 | 2,522 | |||||||||
New leases | - | 209 | 209 | |||||||||
Adjustments for indexation | 27 | - | 27 | |||||||||
Balance as of December 31, 2019 | 2,362 | 442 | 2,804 | |||||||||
Accumulated depreciation | ||||||||||||
Balance as of January 1, 2019 | - | - | - | |||||||||
Depreciation and amortization | 381 | 194 | 575 | |||||||||
Balance as of December 31, 2019 | 381 | 194 | 575 | |||||||||
Depreciated cost | ||||||||||||
Balance as of December 31, 2019 | 1,981 | 248 | 2,229 |
The Company recognized depreciation expenses in the amount of $571 which comprise of $427 recorded in the profit and loss and $144 which was re-classified to Leasehold improvements as of 31 December 2020. |
d. | Disclosures in respect of lease liabilities: |
Buildings | Motor vehicles | Total | ||||||||||
Balance as of January 1, 2020 | 2,225 | 225 | 2,450 | |||||||||
Repayment of leases liabilities | (479 | ) | (173 | ) | (652 | ) | ||||||
Effect of changes in exchange rates | 134 | 28 | 162 | |||||||||
New finance lease obligation recognized | - | 283 | 283 | |||||||||
Adjustments for indexation | (17 | ) | (18 | ) | (35 | ) | ||||||
Interest | 134 | 10 | 144 | |||||||||
Disposals-Termination of leases | (44 | ) | (1 | ) | (45 | ) | ||||||
Balance as of December 31, 2020 | 1,953 | 354 | 2,307 | |||||||||
Current maturities of long-term leases | (396 | ) | (170 | ) | (566 | ) | ||||||
Lease liability Balance as of December 31, 2020 | 1,557 | 184 | 1,741 |
NOTE 10:- | LEASES (Cont.) |
Buildings | Motor vehicles | Total | ||||||||||
Balance as of January 1, 2019 | - | - | - | |||||||||
Cumulative effect adjustment on accumulated liabilities as a result of adopting IFRS 16 | 2,344 | 178 | 2,522 | |||||||||
Repayment of leases liabilities | (458 | ) | (172 | ) | (630 | ) | ||||||
Effect of changes in exchange rates | 189 | 10 | 199 | |||||||||
New finance lease obligation recognized | - | 193 | 193 | |||||||||
Adjustments for indexation | 11 | 16 | 27 | |||||||||
Interest | 139 | - | 139 | |||||||||
Balance as of December 31, 2019 | 2,225 | 225 | 2,450 | |||||||||
Current maturities of long-term leases | (403 | ) | (41 | ) | (444 | ) | ||||||
Lease liability Balance as of December 31, 2019 | 1,822 | 184 | 2,006 |
At the initial application date, the Company recognized a lease liability in the amount of about $2,522 under Long term debt and current maturity, according to the present value of the future lease payments discounted using the Company's incremental interest rate at that date, and concurrently recognized a ROU asset in the same amount with certain adjustments. The Company's incremental interest rates used for measuring the lease liability are in the range of 0.1% to 6.7%. Depreciation is calculated on a straight-line basis over the remaining contractual lease period. |
NOTE 11:- | INTANGIBLE ASSETS, NET |
License and Knowhow | ||||||||
2019 | 2020 | |||||||
Cost | ||||||||
Balance as of January 1, | 1,538 | 1,538 | ||||||
Additions | - | - | ||||||
Balance as of December 31, | 1,538 | 1,538 | ||||||
Accumulated Amortization | ||||||||
Balance as of January 1, | 1,043 | 1,109 | ||||||
Additions | 66 | 66 | ||||||
Balance as of December 31, | 1,109 | 1,175 | ||||||
Amortized cost | ||||||||
Balance as of December 31, | 429 | 363 |
Intangible assets include exclusive licenses to use patents, know-how and intellectual property for the development, manufacturing and marketing of products related to burn treatments and other products in the field of wound care. These licenses were purchased from third parties and from one of the Company's shareholders. |
NOTE 12:- | OTHER PAYABLES |
Year ended December 31, | ||||||||
2019 | 2020 | |||||||
Employees and payroll accruals | 1,723 | 1,910 | ||||||
Liability in respect of purchase of shares (see Note 16c) | 3,167 | 667 | ||||||
Related parties | 214 | 225 | ||||||
Deferred Revenues | 249 | 462 | ||||||
Other | 384 | 260 | ||||||
5,737 | 3,524 |
NOTE 13:- | LIABILITIES IN RESPECT OF IIA GRANTS |
Year ended December 31, | ||||||||
2019 | 2020 | |||||||
Balance as of January 1, | 7,714 | 6,935 | ||||||
Grants received | 248 | - | ||||||
Royalties | (635 | ) | (235 | ) | ||||
Amounts carried to Profit or Loss | (392 | ) | 828 | |||||
Balance as of Decmber 31, | 6,935 | 7,528 | ||||||
Current maturities | (124 | ) | (261 | ) | ||||
Long term liabilities in respect of IIA grants | 6,811 | 7,267 |
The Company is committed to pay royalties to the IIA up to the total grants received plus the applicable accrued interest. The total amount of grants actually received by the Company from the IIA including accrued LIBOR interest, net of royalties as of December 31, 2020 is approximately $ 15,787, while the amortized cost of this liability as of that date is $ 7,528, using the interest method. |
NOTE 14:- | FINANCIAL INSTRUMENTS |
a. | Financial risk factors: |
NOTE 14:- | FINANCIAL INSTRUMENTS (Cont.) |
Sensitivity tests relating to changes in market factors: |
December 31, | ||||||||||||
2018 | 2019 | 2020 | ||||||||||
Gain (loss) from change: | ||||||||||||
5% increase in exchange rate | $ | 31 | $ | 285 | $ | 76 | ||||||
5% decrease in exchange rate | $ | (31 | ) | $ | (285 | ) | $ | (76 | ) |
b. | Fair value: |
NOTE |
December 31, | ||||||||||||
2015 | 2016 | 2017 | ||||||||||
Sensitivity test to changes in NIS and EURO exchange rates | ||||||||||||
Gain (loss) from change: | ||||||||||||
5% increase in exchange rate | $ | 361 | $ | 11 | $ | 346 | ||||||
5% decrease in exchange rate | $ | (361 | ) | $ | (11 | ) | $ | (346 | ) |
SEVERANCE PAY LIABILTY, NET |
NOTE | CONTINGENT LIABILITIES AND COMMITMENTS |
a. | In 2000, the Company signed an exclusive license agreement (as amended in 2007) with a third party with regard to its patents and intellectual property. Pursuant to the agreement, the Company received an exclusive license to use the third party's patents and intellectual property, for the purpose of developing, manufacturing, marketing, and commercializing products for treatment of burns and other wounds. |
b. | Under the Research and Development Law, (the "R&D Law") the Company undertook to pay royalties of 3% on the |
NOTE | CONTINGENT LIABILITIES AND COMMITMENTS |
c. | Beginning in 2007, the Company entered into a number of agreements with Teva Pharmaceutical Industries Limited (“Teva”) related to collaboration in the development, manufacturing and commercialization of solutions for the burn and chronic wound care markets. In consideration for these agreements, Teva made investments in the Company's ordinary shares and agreed to fund certain research and development expenses and manufacturing costs and perform all marketing activities for both NexoBrid, under the 2007 Teva Agreement, and the PolyHeal Product, under the 2010 PolyHeal Agreements (see also Note 21a). As of December 31, 2012, all of these agreements were terminated. |
2018 | 522 | |||
2019 | 450 | |||
2020 | 296 | |||
2021 | 246 | |||
2022 | 205 | |||
1,719 |
NOTE | MATERIAL AGREEMENTS |
a. | The Company has awarded a contract with BARDA which was modified in July 2017 and May 2019 providing supplemental funds and support. In addition, in March 2020 the company was awarded with $5,500 to support emergency readiness for NexoBrid deployment. The amended contract valued up to $159,000. The modified contract includes $82,000 of funding to support development activities to complete the FDA approval process for NexoBrid for use in thermal burn injuries and emergency readiness for NexoBrid deployment, as well as procurement of NexoBrid. |
As of December 31, 2020, the Company has recorded $63,183 in funding, in the aggregate, from BARDA under the two contracts as well as the procurement of NexoBrid as a medical countermeasure. The participation by BARDA comprises $31,955 which was classified as reimbursement of research and development expenses. Starting May 2019, following entrance into the Vericel license and supply agreements, participation by BARDA in the amount of $24,613 was classified as Revenues from development services, clinical supply in the amount of $596 was recorded as Revenues from sales of products as well as $6,036 of BARDA procurement which were recorded at the net amount of $3,825 following the split of gross profit agreement with Vericel for the initial BARDA procurement . |
b. | On May 6, 2019, the Company entered into exclusive license and supply agreements with Vericel to commercialize NexoBrid in North America (the “Collaboration Agreements”). Pursuant to the Collaboration Agreements, Vericel will obtain the authority over and control of the development, regulatory approval and commercialization of licensed products in the North America territory. MediWound will be responsible for the development of the product through BLA approval, supported and funded by BARDA, as well as the manufacture and supply of NexoBrid. In addition, MediWound retains the commercial rights to NexoBrid in non-North American territory. |
NOTE 17:- | MATERIAL AGREEMENTS (Cont.) |
NOTE 17:- | MATERIAL AGREEMENTS (Cont.) |
NOTE 18:- | EQUITY |
a. | Share |
Year ended December 31, | ||||||||
2019 | 2020 | |||||||
Authorized number of shares | 50,000,000 | 50,000,000 | ||||||
Issued and outstanding number of shares | 27,202,795 | 27,236,752 |
Year ended December 31, | ||||||||
2016 | 2017 | |||||||
Authorized number of shares | 32,244,508 | 32,244,508 | ||||||
Issued and outstanding number of shares | 21,930,449 | 27,047,737 |
b. | Rights attached to shares: |
c. | In March 2014, the Company completed its IPO, and its securities are listed for trading on NASDAQ. |
d. | Movement in |
NOTE | SHARE‑BASED COMPENSATION |
a. | Expense recognized in the financial statements: |
Year ended December 31, | Year ended December 31, | |||||||||||||||||||||||
2015 | 2016 | 2017 | 2018 | 2019 | 2020 | |||||||||||||||||||
Cost of revenues | 372 | 504 | 188 | |||||||||||||||||||||
Cost of Revenues | 71 | 226 | 115 | |||||||||||||||||||||
Research and development | 511 | 752 | 488 | 181 | 375 | 179 | ||||||||||||||||||
Selling and marketing | 669 | 765 | 204 | 63 | 40 | 3 | ||||||||||||||||||
General and administrative | 1,107 | 1,150 | 483 | 330 | 593 | 1,025 | ||||||||||||||||||
Total share-based compensation | 2,659 | 3,171 | 1,363 | 645 | 1,234 | 1,322 |
b. | Share-based payment plan for employees and directors: |
NOTE 19:- | SHARE‑BASED COMPENSATION (Cont.) |
c. | Share options activity: |
2015 | 2016 | 2017 | ||||||||||||||||||||||
Number of options | Weighted Average Exercise price | Number of options | Weighted Average Exercise price | Number of options | Weighted Average Exercise price | |||||||||||||||||||
Outstanding at beginning of year | 1,902,324 | 7.98 | 2,313,224 | 9.35 | 2,181,075 | 9.62 | ||||||||||||||||||
Granted | 739,500 | 9.27 | 47,500 | 8.56 | 40,000 | 6.72 | ||||||||||||||||||
Exercised | (300,000 | ) | 0.09 | (80,149 | ) | 0.09 | (79,624 | ) | 0.09 | |||||||||||||||
Forfeited | (28,600 | ) | 12.69 | (99,500 | ) | 10.80 | (206,716 | ) | 8.93 | |||||||||||||||
Outstanding at end of year | 2,313,224 | 9.35 | 2,181,075 | 9.62 | 1,934,735 | 10.02 | ||||||||||||||||||
Exercisable at end of year | 1,535,055 | 9.39 | 1,401,866 | 9.35 | 1,562,235 | 10.25 |
2018 | 2019 | 2020 | ||||||||||||||||||||||
Number of options | Weighted Average Exercise price | Number of options | Weighted Average Exercise price | Number of options | Weighted Average Exercise price | |||||||||||||||||||
Outstanding Options at beginning of year | 1,934,735 | 10.02 | 2,313,249 | 9.31 | 2,334,432 | 9.18 | ||||||||||||||||||
Option's Granted | 665,000 | 5.12 | 95,000 | 4.45 | 1,274,379 | 1.43 | ||||||||||||||||||
Option's Exercised | (208,332 | ) | 2.63 | - | - | - | - | |||||||||||||||||
Option's Forfeited and/or expired | (78,154 | ) | 9.06 | (73,817 | ) | 5.17 | (11,000 | ) | 7.19 | |||||||||||||||
Outstanding options and at end of year | 2,313,249 | 9.31 | 2,334,432 | 9.18 | 3,597,811 | 6.55 | ||||||||||||||||||
Option's Exercisable at end of year | 1,475,451 | 11.23 | 1,753,803 | 4.76 | 1,952,014 | 9.98 |
Options outstanding as of December 31, 2017 | ||||||||||||
Range of exercise prices ($ ) | Number of options | Weighted Average Remaining contractual life | Weighted average exercise price | |||||||||
2.63 | 208,332 | 0.86 | 2.63 | |||||||||
7.26 ‑ 9.82 | 903,703 | 6.49 | 9.06 | |||||||||
12.89 ‑ 13.76 | 822,700 | 5.92 | 12.94 | |||||||||
Total | 1,934,735 | 5.64 | 10.02 |
Options and outstanding as of December 31, 2020 | ||||||||||||
Range of exercise prices | Number of options | Weighted Average Remaining contractual life | Weighted average exercise price | |||||||||
1.75-5.15 | 1,988,129 | 6.67 | 2.93 | |||||||||
6.72- 9.82 | 790,782 | 3.86 | 9.05 | |||||||||
12.89 ‑ 13.76 | 818,900 | 2.92 | 12.94 | |||||||||
Total | 3,597,811 | 5.20 | 6.55 |
RSU's 2018 | RSU's 2019 | RSU's 2020 | ||||||||||
Outstanding at beginning of year | - | 95,833 | 108,544 | |||||||||
Granted | 95,833 | 36,667 | - | |||||||||
Forfeited | - | - | - | |||||||||
Vested | - | (23,956 | ) | (33,958 | ) | |||||||
Outstanding at the end of the period | 95,833 | 108,544 | 74,587 |
NOTE 19:- | SHARE‑BASED COMPENSATION (Cont.) |
1. | On |
$76. On June |
2. | On December 31, 2018, the Company's Board of Directors approved the grant of 625,000 options to purchase ordinary shares, for an exercise price of $ 5.15 per share, and the grant of 95,833 RSU's to its employees. The fair value of the options and RSU's granted, as of the grant date, was estimated at approximately $1,261 and $389, respectivaly. |
3. | On March 24, 2019, the Company granted to its incoming CEO and chairman of the board 60,000 options (40,000 and 20,000 respectively) to purchase ordinary shares, for an exercise price of $ 4.92 per share, and 30,000 RSU's (20,000 and 10,000 respectively), under the "2014 Share Incentive Plan". The options are exercisable in accordance with the terms of the plan and will vest over three-four years. The fair value of the options and RSU's granted, as of the grant date, was estimated at approximately $164 and $158, respectively. On May 2, 2019, the general meeting of the Company approved the abovementioned grants. |
4. | On June 6, 2019, the Company granted to its incoming CFO 40,000 options to purchase ordinary shares, for an exercise price of $ 3.84 per share, and 6,667 RSU's, under the "2014 Share Incentive Plan". The options are exercisable in accordance with the terms of the plan and will vest over four years. The fair value of the options and RSU's granted, as of the grant date, was estimated at approximately $93 and $26, respectively. |
5. | On April 23, 2020, the Company's Board of Directors approved the grant of 1,274,379 options to purchase ordinary shares under the |
d. | The fair value of the Company's share options granted to employees and directors for the years ended December 31, |
December 31, | ||||||||||||
2018 | 2019 | 2020 | ||||||||||
Dividend yield (%) | 0 | 0 | 0 | |||||||||
Expected volatility of the share prices (%) | 44-54 | 41-53 | 51-71 | |||||||||
Risk‑free interest rate (%) | 1.63-2.69 | 1.85-2.45 | 0.2-0.9 | |||||||||
Early exercise factor (%) | 100-150 | 150 | 100-150 | |||||||||
Weighted average share prices (Dollar) | 4.07 | 4.83 | 2.43 |
December 31, | ||||||||||||
2015 | 2016 | 2017 | ||||||||||
Dividend yield (%) | 0 | 0 | 0 | |||||||||
Expected volatility of the share prices (%) | 71 | 72 | 63 | |||||||||
Risk‑free interest rate (%) | 0.25-2.24 | 0.28-2.0 | 1.22-2.15 | |||||||||
Early exercise factor (%) | 100-150 | 100-150 | 150 | |||||||||
Weighted average share prices (Dollar) | 8.98 | 8.56 | 7.80 |
NOTE | TAXES ON INCOME |
a. | The Company operates in two main tax jurisdictions: Israel and Germany. As such, the Company is subject to the applicable tax rates in the jurisdictions in which it conducts its business. |
b. | Corporate tax rates in Israel: |
c. | The principal tax rates applicable to the subsidiary whose place of incorporation is outside Israel are: The statutory corporate tax rate in |
d. | Final tax assessments: The Company has finalized its tax assessments through the 2014 tax year. |
NOTE 20:- | TAXES ON INCOME (Cont.) |
e. | Net operating carryforward losses for tax purposes and other temporary differences: |
f. | Deferred taxes: |
g. | Current taxes on income: |
h. | Theoretical tax: |
The reconciliation between the |
NOTE | DISCONTINUED OPERATION |
Year ended December 31, | ||||||||||||
2015 | 2016 | 2017 | ||||||||||
Salary and benefits (including share-based compensation) | 1,961 | 2,112 | 2,073 | |||||||||
Subcontractors | 67 | 66 | 121 | |||||||||
Depreciation and amortization | 417 | 475 | 457 | |||||||||
Cost of materials | 486 | 410 | 535 | |||||||||
Other manufacturing expenses | 657 | 892 | 989 | |||||||||
Decrease (increase) in inventory of finished products | (309 | ) | 780 | (999 | ) | |||||||
Allotment of manufacturing costs to R&D | (760 | ) | (2,577 | ) | (1,598 | ) | ||||||
2,519 | 2,158 | 1,578 |
Year ended December 31, | ||||||||||||
2015 | 2016 | 2017 | ||||||||||
Salary and benefits (including share-based compensation) | 2,610 | 3,171 | 3,840 | |||||||||
Subcontractors | 4,464 | 8,517 | 8,780 | |||||||||
Depreciation and amortization | 5 | 28 | 42 | |||||||||
Cost of materials | 81 | 351 | 223 | |||||||||
Allotment of manufacturing costs | 760 | 2,577 | 1,598 | |||||||||
Other research and development expenses | 219 | 135 | 142 | |||||||||
Research and development, gross | 8,139 | 14,779 | 14,625 | |||||||||
Participations: | ||||||||||||
BARDA funds | (800 | ) | (5,566 | ) | (8,565 | ) | ||||||
Revaluation of liabilities in respect of IIA grants | (1,318 | ) | (2,145 | ) | (598 | ) | ||||||
6,021 | 7,068 | 5,462 |
NOTE | SUPPLEMENTARY INFORMATION TO THE STATEMENTS OF COMPREHENSIVE |
Year ended December 31, | ||||||||||||
2015 | 2016 | 2017 | ||||||||||
Salary and benefits (including share based compensation) | 5,631 | 5,438 | 3,062 | |||||||||
Marketing and medical support | 2,835 | 2,444 | 1,628 | |||||||||
Depreciation and amortization | 22 | 18 | 12 | |||||||||
Shipping and delivery | 180 | 111 | 236 | |||||||||
Registration and marketing license fees | 616 | 392 | 424 | |||||||||
9,284 | 8,403 | 5,362 |
Additional information on Revenues: |
Year ended December 31, | ||||||||||||
2015 | 2016 | 2017 | ||||||||||
Salary and benefits (including share‑based compensation) | 2,670 | 2,361 | 2,032 | |||||||||
Professional fees | 1,054 | 1,241 | 1,224 | |||||||||
Depreciation and amortization | 59 | 66 | 56 | |||||||||
Other | 221 | 416 | 469 | |||||||||
4,004 | 4,084 | 3,781 |
BARDA and No other customer contributed 10% or more of our Revenues in 2020 and 2019. |
Year ended December 31, | ||||||||||||
2015 | 2016 | 2017 | ||||||||||
Financial income: | ||||||||||||
Interest income | 288 | 414 | 349 | |||||||||
Revaluation of contingent consideration for the purchase of shares | 764 | 1,621 | - | |||||||||
Exchange differences, net | - | 131 | 57 | |||||||||
1,052 | 2,166 | 406 | ||||||||||
Financial expense: | ||||||||||||
Interest in respect of IIA grants | 844 | 847 | 827 | |||||||||
Revaluation of contingent consideration for the purchase of shares | - | - | 351 | |||||||||
Exchange differences, net | 614 | - | - | |||||||||
Other | 38 | 49 | 74 | |||||||||
1,496 | 896 | 1,252 |
The Revenues reported in the financial statements are based on the location of the customers, as follows: |
Year ended December 31, | ||||||||||||
2018 | 2019 | 2020 | ||||||||||
USA ( see also Note 17a, 17b) | - | 28,504 | 18,030 | |||||||||
EU and other international markets | 3,401 | 3,285 | 3,733 | |||||||||
3,401 | 31,789 | 21,763 |
b. | Cost of Revenues: |
1. | Cost of Revenues from sale of products |
Year ended December 31, | ||||||||||||
2018 | 2019 | 2020 | ||||||||||
Salary and benefits (including share-based compensation) | 2,212 | 1,916 | 2,139 | |||||||||
Subcontractors | 72 | 89 | 153 | |||||||||
Depreciation and amortization | 474 | 512 | 554 | |||||||||
Cost of materials | 468 | 456 | 704 | |||||||||
Other manufacturing expenses | 783 | 657 | 840 | |||||||||
Decrease in inventory of finished products | 299 | 344 | 155 | |||||||||
Allotment of manufacturing costs to R&D | (2,220 | ) | (1,621 | ) | (1,394 | ) | ||||||
2,088 | 2,353 | 3,151 |
2. | Cost of Revenues from development services |
Year ended December 31, | ||||||||||||
2018 | 2019 | 2020 | ||||||||||
Salary and benefits | - | 1,404 | 2,320 | |||||||||
Subcontractors | - | 7,412 | 8,747 | |||||||||
- | 8,816 | 11,067 |
NOTE | SUPPLEMENTARY INFORMATION TO THE STATEMENTS OF COMPREHENSIVE PROFIT OR LOST (Cont.) |
3. | Cost of Revenues from license agreements |
Year ended December 31, | ||||||||||||
2018 | 2019 | 2020 | ||||||||||
Royalties payments | - | 680 | - | |||||||||
- | 680 | - |
c. | Research and development expenses, net of participations: |
Year ended December 31, | ||||||||||||
2018 | 2019 | 2020 | ||||||||||
Salary and benefits (including share-based compensation) | 3,703 | 2,965 | 2,094 | |||||||||
Subcontractors | 11,423 | 4,694 | 3,173 | |||||||||
Depreciation and amortization | 51 | 342 | 346 | |||||||||
Cost of materials | 309 | 311 | 517 | |||||||||
Allotment of manufacturing costs | 2,220 | 1,621 | 1,394 | |||||||||
Other research and development expenses | 209 | 137 | 174 | |||||||||
Research and development, gross | 17,915 | 10,070 | 7,698 | |||||||||
Participations: | ||||||||||||
BARDA funds | (13,238 | ) | (3,785 | ) | - | |||||||
Revaluation of liabilities in respect of IIA grants | (605 | ) | (1,316 | ) | - | |||||||
4,072 | 4,969 | 7,698 |
Year ended December 31, | ||||||||||||
2018 | 2019 | 2020 | ||||||||||
Salary and benefits (including share based compensation) (1) | 2,343 | 2,028 | 1,700 | |||||||||
Marketing and medical support | 1,055 | 1,298 | 740 | |||||||||
Depreciation and amortization | 9 | 49 | 82 | |||||||||
Shipping and delivery | 192 | 200 | 282 | |||||||||
Registration and marketing license fees | 589 | 489 | 424 | |||||||||
4,188 | 4,064 | 3,228 |
(1) | The salary costs for the year ended December 31,2020 Includes one time payment of $243 derived from restructuring astrategy at the EU subsidery. |
NOTE 22:- | SUPPLEMENTARY INFORMATION TO THE STATEMENTS OF COMPREHENSIVE PROFIT OR LOST (Cont.) |
e. | General and administrative expenses: |
Year ended December 31, | ||||||||||||
2018 | 2019 | 2020 | ||||||||||
Salary and benefits (including share‑based compensation) | 2,035 | 2,621 | 2,784 | |||||||||
Professional fees | 1,361 | 1,628 | 2,267 | |||||||||
Depreciation and amortization | 43 | 247 | 108 | |||||||||
Other | 360 | 746 | 300 | |||||||||
3,799 | 5,242 | 5,459 |
f. | Other expenses: The other one-time expenses amounted $751 and $1,172 for the years ended December 31, 2018 and 2019 respectivally, are associated with the review and assessment of the strategic deal. |
g. | Financial income and expense: |
Year ended December 31, | ||||||||||||
2018 | 2019 | 2020 | ||||||||||
Financial income: | ||||||||||||
Interest income | 412 | 434 | 297 | |||||||||
Revaluation of liabilities in respect of the purchase of shares | - | - | 433 | |||||||||
Exchange differences, net | - | 122 | 113 | |||||||||
412 | 556 | 843 | ||||||||||
Financial expense: | ||||||||||||
Interest in respect of IIA grants | 892 | 925 | 832 | |||||||||
Revaluation of liabilities in respect of IFRS16 | - | 140 | 144 | |||||||||
Revaluation of liabilities in respect of the purchase of shares | 758 | 1,690 | - | |||||||||
Exchange differences, net | 219 | - | - | |||||||||
Finance expenses in respect of deferred Revenues | 164 | 161 | 247 | |||||||||
Other | 84 | 67 | 56 | |||||||||
2,117 | 2,983 | 1,279 |
NOTE 23:- | NET PROFIT (LOSS) PER SHARE |
a. | Details of the number of shares and loss used in the computation of loss per share from continuing operations: |
Year ended December 31, | ||||||||||||||||||||||||
2018 | 2019 | 2020 | ||||||||||||||||||||||
Weighted average number of shares | Loss | Weighted average number of shares | Profit | Weighted average number of shares | Loss | |||||||||||||||||||
Basic and diluted profit (loss) | 27,113,617 | (5,665 | ) | 27,178,839 | 2,066 | 27,209,878 | (9,276 | ) |
Year ended December 31, | ||||||||||||||||||||||||
2015 | 2016 | 2017 | ||||||||||||||||||||||
Weighted average number of shares | Loss | Weighted average number of shares | Loss | Weighted average number of shares | Loss | |||||||||||||||||||
Basic and diluted loss | 21,718,401 | (21,671 | ) | 21,862,169 | (18,885 | ) | 23,341,040 | (14,533 | ) |
b. | Details of the number of shares and |
Year ended December 31, | ||||||||||||||||||||||||
2018 | 2019 | 2020 | ||||||||||||||||||||||
Weighted average number of shares | Profit | Weighted average number of shares | Profit | Weighted average number of shares | Profit | |||||||||||||||||||
Basic and diluted profit | 27,113,617 | 4,608 | 27,178,839 | 2,889 | 27,209,878 | 80 |
Year ended December 31, | ||||||||||||||||||||||||
2015 | 2016 | 2017 | ||||||||||||||||||||||
Weighted average number of shares | Loss | Weighted average number of shares | Loss | Weighted average number of shares | Loss | |||||||||||||||||||
Basic and diluted loss | 21,718,401 | (417 | ) | - | - | 23,341,040 | (7,616 | ) |
c. | Net profit (loss) per share from continuing and discontinued operations: |
Year ended December 31, | ||||||||||||
2018 | 2019 | 2020 | ||||||||||
Basic and Diluted loss per share: | ||||||||||||
Profit (loss) from from continuing operations | (0.21 | ) | 0.08 | (0.34 | ) | |||||||
Profit from discontinued operation | 0.17 | 0.10 | - | |||||||||
Profit (loss) per share | (0.04 | ) | 0.18 | (0.34 | ) |
Year ended December 31, | ||||||||||||
2015 | 2016 | 2017 | ||||||||||
Basic and Diluted loss per share: | ||||||||||||
Net loss from continuing operations | (1.00 | ) | (0.86 | ) | (0.62 | ) | ||||||
Loss from discontinued operation | (0.02 | ) | - | (0.33 | ) | |||||||
Net loss per share | (1.02 | ) | (0.86 | ) | (0.95 | ) |
NOTE | BALANCES AND TRANSACTIONS WITH RELATED PARTIES AND KEY OFFICERS |
a. | Related parties consist of: |
NOTE | BALANCES AND TRANSACTIONS WITH RELATED PARTIES AND KEY OFFICERS |
b. | Balances of related parties: |
Other Payables | ||||
Parent Company (1): | ||||
As of December 31, | ||||
As of December 31, | ||||
Other related parties: | ||||
As of December 31, | ||||
As of December 31, | 86 |
c. | Transactions with related parties: |
Professional Fee (1) | Rent expenses | |||||||
Parent company: | ||||||||
2015 | 52 | 730 | ||||||
2016 | 27 | 804 | ||||||
2017 | 35 | 817 | ||||||
Other related parties: | ||||||||
2015 | 127 | - | ||||||
2016 | 159 | - | ||||||
2017 | 225 | - |
Professional Fee (1) | Rent expenses and other | |||||||
Parent company: | ||||||||
2018 | 44 | 292 | ||||||
2019 | 52 | 415 | ||||||
2020 | 54 | 446 | ||||||
Other related parties: | ||||||||
2018 | 162 | (246 | ) | |||||
2019 | 249 | (59 | ) | |||||
2020 | 272 | - |
(1) | Professional fees do not include short-term employee benefits and share-based compensation to one of the Company's shareholders, who is a key officer, in the amounts of |
d. | Compensation of officers of the Company: The following amounts disclosed in the table are recognized as an expense during the reporting period related to officers: |
Year ended December 31, | ||||||||||||
2018 | 2019 | 2020 | ||||||||||
Short-term employee benefits (*) | 2,304 | 2,533 | 1,993 | |||||||||
Share-based compensation | 276 | 565 | 467 | |||||||||
2,580 | 3,098 | 2,460 | ||||||||||
Number of officers | 6 | 7 | 5 |
Year ended December 31, | ||||||||||||
2015 | 2016 | 2017 | ||||||||||
Short-term employee benefits | 2,639 | 2,108 | 2,324 | |||||||||
Share-based compensation | 1,702 | 1,445 | 731 | |||||||||
4,341 | 3,553 | 3,055 | ||||||||||
Number of officers | 7 | 7 | 6 |