O registration statement pursuant to section 12(b) or (g) of the securities exchange act of 1934


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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 20-F

 

o

REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934

 

OR

 

x

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the fiscal year ended December 31, 2015

 

OR

 

o

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

OR

 

o

SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

Commission file number 001-36349

 



 

 MEDIWOUND LTD.

(Exact name of Registrant as specified in its charter)

 

ISRAEL

(Jurisdiction of incorporation or organization)

 

42 Hayarkon Street

Yavne, 8122745 Israel

(Address of principal executive offices)

 

Yaron Meyer, Adv.

General Counsel and Corporate Secretary

Telephone: +972 (77) 971-4100

E-mail: yaronm@mediwound.com

MediWound Ltd.

42 Hayarkon Street

Yavne, 8122745 Israel

(Name, telephone, e-mail and/or facsimile number and address of company contact person)

 

 

 





 

 

Securities registered or to be registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Name of each exchange on which registered

Ordinary shares, par value NIS 0.01 per share

 

NASDAQ Global Market

 

Securities registered or to be registered pursuant to Section 12(g) of the Act: None.

 

Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None.

 

Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report: As of December 31, 2015, the registrant had outstanding 21,850,300 ordinary shares, par value NIS 0.01 per share.

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.  

 

Yes o     No x

 

If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.

 

Yes o     No x

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  

 

Yes x     No o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§229.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  

 

Yes o     No x

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated file, or a non-accelerated filer. See the definitions of “accelerated filer” and “large accelerated filer” in Rule 12b-2 of the Exchange Act (Check one):

 

 Large accelerated filer o

Accelerated filer o

Non-accelerated filer x

 

Indicate by check mark which basis for accounting the registrant has used to prepare the financing statements included in this filing:

 

 U.S. GAAP o

International Financial Reporting Standards as issued

by the International Accounting Standards Board x

Other o

 

If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.

 

o Item 17               o Item 18

 

If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

 

Yes o                       No x

 

 

 

 



 

 

 

 

 

MEDIWOUND LTD.

 

FORM 20-F

ANNUAL REPORT FOR THE FISCAL YEAR ENDED DECEMBER 31, 2015

 

TABLE OF CONTENTS

 

 

 

Introduction

i

Special Note Regarding Forward-Looking Statements

i

 

PART I

Item 1. Identity of Directors, Senior Management and Advisers

1

Item 2. Offer Statistics and Expected Timetable

1

Item 3. Key Information

1

Item 4. Information on the Company

28

Item 4A. Unresolved Staff Comments

54

Item 5. Operating and Financial Review and Prospects

54

Item 6. Directors, Senior Management and Employees

66

Item 7. Major Shareholders and Related Party Transactions

84

Item 8. Financial Information

87

Item 9. The Offer and Listing

88

Item 10. Additional Information

89

Item 11. Quantitative and Qualitative Disclosures About Market Risk

103

Item 12. Description of Securities Other than Equity Securities

104

 

PART II

Item 13. Defaults, Dividend Arrearages and Delinquencies

105

Item 14. Material Modifications to the Rights of Security Holders and Use of Proceeds

105

Item 15. Controls and Procedures

105

Item 16. [Reserved]

106

Item 16A. Audit Committee Financial Expert

106

Item 16B. Code of Ethics

106

Item 16C. Principal Accountant Fees and Services

106

Item 16D. Exemptions from the Listing Standards for Audit Committees

107

Item 16E. Purchases of Equity Securities by the Issuer and Affiliated Purchasers

107

Item 16F. Change in Registrant’s Certifying Accountant

107

Item 16G. Corporate Governance

107

Item 16H. Mine Safety Disclosure

107

 

PART III

Item 17. Financial Statements

108

Item 18. Financial Statements

108

Item 19. Exhibits

108

Signatures

109

Index to Consolidated Financial Statements

F-1

 

 

 

 

 

INTRODUCTION

 

In this annual report, the terms “MediWound,” “we,” “us,” “our” and “the company” refer to MediWound Ltd. and its subsidiaries.

 

This annual report includes other statistical, market and industry data and forecasts which we obtained from publicly available information and independent industry publications and reports that we believe to be reliable sources. These publicly available industry publications and reports generally state that they obtain their information from sources that they believe to be reliable, but they do not guarantee the accuracy or completeness of the information. Although we believe that these sources are reliable, we have not independently verified the information contained in such publications. Certain estimates and forecasts involve uncertainties and risks and are subject to change based on various factors, including those discussed under the headings “Special Note Regarding Forward-Looking Statements” and “ITEM 3.D. Risk Factors” in this annual report.

 

Throughout this annual report, we refer to various trademarks, service marks and trade names that we use in our business. The “MediWound” design logo, “MediWound,” “NexoBrid,” “EscharEx” and other trademarks or service marks of MediWound Ltd. appearing in this annual report are the property of MediWound Ltd. We have several other trademarks, service marks and pending applications relating to our solutions. Other trademarks and service marks appearing in this annual report are the property of their respective holders.

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

In addition to historical facts, this annual report on Form 20-F contains forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended (the “Securities Act”), Section 21E of the U.S. Securities Exchange Act of 1934, as amended (the “Exchange Act”) and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995.We make forward-looking statements in this annual report that are subject to risks and uncertainties. These forward-looking statements include information about possible or assumed future results of our business, financial condition, results of operations, liquidity, plans and objectives. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. The statements we make regarding the following matters are forward-looking by their nature:

 

 

·

the timing and conduct of our trials of NexoBrid and our pipeline product candidates, including statements regarding the timing, progress and results of current and future preclinical studies and clinical trials, and our research and development programs;

 

 

·

the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of NexoBrid and our pipeline products;

 

 

·

our expectations regarding future growth, including our ability to develop new products;

 

 

·

our commercialization, marketing and manufacturing capabilities and strategy and the ability of our marketing team to cover regional burn centers and units;

 

 

·

our ability to maintain adequate protection of our intellectual property;

 

 

·

our plans to develop and commercialize our pipeline products;

 

 

·

our estimates regarding expenses, future revenues, capital requirements and the need for additional financing;

 

 

·

our estimates regarding the market opportunity for NexoBrid and our pipeline products;

 

 

·

our expectation regarding the duration of our inventory of intermediate drug substance and products;

 

 

·

the impact of our research and development expenses as we continue developing product candidates;

 

 



 

 

 

·

our expectations regarding the time during which we will be an emerging growth company under the JOBS Act; and

 

 

·

the impact of government laws and regulations.

 

The preceding list is not intended to be an exhaustive list of all of our forward-looking statements. The forward-looking statements are based on our beliefs, assumptions and expectations of future performance, taking into account the information currently available to us. These statements are only predictions based upon our current expectations and projections about future events. There are important factors that could cause our actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. These statements may be found in the sections of this annual report on Form 20-F entitled “ITEM 3.D. Risk Factors,” “ITEM 4. Information on the Company,” “ITEM 5. Operating and Financial Review and Prospects,” “ITEM 10.E. Taxation—United States Federal Income Taxation—Passive Foreign Investment Company Considerations” and elsewhere in this annual report, including the section entitled “ITEM 4.B. Business Overview” and “ITEM 4.B. Business Overview—Our Focus: Wounds,” which contain information obtained from independent industry sources. Actual results could differ materially from those anticipated in these forward-looking statements due to various factors, including all the risks discussed in “ITEM 3.D. Risk Factors” and information contained in other documents filed with or furnished to the Securities and Exchange Commission.

 

You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. Except as required by law, we undertake no obligation to publicly update any forward-looking statements for any reason after the date of this annual report to conform these statements to actual results or to changes in our expectations.

 

 

ii 

 

 

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