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MediWound Ltd.
Response Received
1 company response(s)
High - file number match
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MediWound Ltd.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-09-05
MediWound Ltd.
Summary
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MediWound Ltd.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-11-16
MediWound Ltd.
Summary
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MediWound Ltd.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-05-31
MediWound Ltd.
Summary
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Company responded
2022-06-01
MediWound Ltd.
Summary
CORRESP · 2022-06-01
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MediWound Ltd.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2019-04-08
MediWound Ltd.
Summary
UPLOAD · 2019-04-08
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Company responded
2019-04-12
MediWound Ltd.
References: April 8, 2019
Summary
CORRESP · 2019-04-12
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Company responded
2019-04-18
MediWound Ltd.
Summary
CORRESP · 2019-04-18
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MediWound Ltd.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2016-02-16
MediWound Ltd.
Summary
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Company responded
2016-02-24
MediWound Ltd.
References: February 12, 2016
Summary
CORRESP · 2016-02-24
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Company responded
2016-02-29
MediWound Ltd.
Summary
CORRESP · 2016-02-29
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Company responded
2016-03-03
MediWound Ltd.
Summary
CORRESP · 2016-03-03
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MediWound Ltd.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2014-03-07
MediWound Ltd.
Summary
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2014-03-17
MediWound Ltd.
Summary
CORRESP · 2014-03-17
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MediWound Ltd.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2014-02-12
MediWound Ltd.
Summary
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Company responded
2014-02-18
MediWound Ltd.
References: February 12, 2014
Summary
CORRESP · 2014-02-18
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MediWound Ltd.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2014-01-16
MediWound Ltd.
Summary
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Company responded
2014-01-31
MediWound Ltd.
References: January 16, 2014
Summary
CORRESP · 2014-01-31
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-25 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2025-03-24 | SEC Comment Letter | MediWound Ltd. | Israel | 333-285908 | Read Filing View |
| 2024-09-05 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2024-09-05 | SEC Comment Letter | MediWound Ltd. | Israel | 333-281843 | Read Filing View |
| 2022-11-22 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2022-11-16 | SEC Comment Letter | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2022-06-01 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2022-05-31 | SEC Comment Letter | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2019-04-18 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2019-04-12 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2019-04-08 | SEC Comment Letter | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2016-03-03 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2016-02-29 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2016-02-24 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2016-02-16 | SEC Comment Letter | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2014-03-17 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2014-03-07 | SEC Comment Letter | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2014-02-18 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2014-02-12 | SEC Comment Letter | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2014-01-31 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2014-01-16 | SEC Comment Letter | MediWound Ltd. | Israel | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-24 | SEC Comment Letter | MediWound Ltd. | Israel | 333-285908 | Read Filing View |
| 2024-09-05 | SEC Comment Letter | MediWound Ltd. | Israel | 333-281843 | Read Filing View |
| 2022-11-16 | SEC Comment Letter | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2022-05-31 | SEC Comment Letter | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2019-04-08 | SEC Comment Letter | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2016-02-16 | SEC Comment Letter | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2014-03-07 | SEC Comment Letter | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2014-02-12 | SEC Comment Letter | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2014-01-16 | SEC Comment Letter | MediWound Ltd. | Israel | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-03-25 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2024-09-05 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2022-11-22 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2022-06-01 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2019-04-18 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2019-04-12 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2016-03-03 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2016-02-29 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2016-02-24 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2014-03-17 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2014-02-18 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
| 2014-01-31 | Company Response | MediWound Ltd. | Israel | N/A | Read Filing View |
2025-03-25 - CORRESP - MediWound Ltd.
CORRESP
1
filename1.htm
MediWound Ltd.
42 Hayarkon Street
Yavne 8122745, Israel
+972 (77) 971-4100
March 25, 2025
Via EDGAR Transmission
Tim Buchmiller
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
MediWound Ltd.
Registration Statement on Form F-3
Filed March 19, 2025
Registration No. 333-285908
Dear Mr. Buchmiller:
In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933,
as amended, we hereby request the acceleration of the effective date of the above-referenced Registration Statement so that it will become effective on March 27, 2025 at 4:00 p.m. Eastern Time or as soon thereafter as practicable, or at such later
time as MediWound Ltd. (the “ Company ”) or its counsel may request via telephone call to the staff. Please contact Michael J. Rosenberg of Latham &
Watkins LLP, counsel to the Company, at (212) 906-1829, to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter.
Sincerely yours,
MediWound Ltd.
By:
/s/ Hani Luxenburg
Name: Hani Luxenburg
Title: Chief Financial Officer
cc: Yaron Meyer, MediWound Ltd.
Joshua Kiernan, Latham & Watkins LLP
Michael J. Rosenberg, Latham & Watkins LLP.
2025-03-24 - UPLOAD - MediWound Ltd. File: 333-285908
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 24, 2025 Ofer Gonen Chief Executive Officer MediWound Ltd. 42 Hayarkon Street Yavne 8122745, Israel Re: MediWound Ltd. Registration Statement on Form F-3 Filed March 19, 2025 File No. 333-285908 Dear Ofer Gonen: This is to advise you that we have not reviewed and will not review your registration statement. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Tim Buchmiller at 202-551-3635 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Michael J. Rosenberg, Esq. </TEXT> </DOCUMENT>
2024-09-05 - CORRESP - MediWound Ltd.
CORRESP
1
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MediWound Ltd.
42 Hayarkon Street
Yavne 8122745, Israel
+972 (77) 971-4100
September 5, 2024
Via EDGAR Transmission
Tim Buchmiller
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
MediWound Ltd.
Registration Statement on Form F-3
Filed August 29, 2024
Registration No. 333-281843
Dear Mr. Buchmiller:
In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as
amended, we hereby request the acceleration of the effective date of the above-referenced Registration Statement so that it will become effective on September 9, 2024 at 4:00 p.m. Eastern Time or as soon thereafter as practicable, or at such later
time as MediWound Ltd. (the “Company”) or its counsel may request via telephone call to the staff. Please contact Michael J. Rosenberg of Latham & Watkins
LLP, counsel to the Company, at (212) 906-1829, to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter.
Sincerely yours,
MediWound Ltd.
By:
/s/ Hani Luxenburg
Name: Hani Luxenburg
Title: Chief Financial Officer
cc:
Yaron Meyer, MediWound Ltd.
Joshua Kiernan, Latham & Watkins LLP
Nathan Ajiashvili, Latham & Watkins LLP
Shachar Hadar, Meitar | Law Offices
Jonathan Nathan, Meitar | Law Offices
2024-09-05 - UPLOAD - MediWound Ltd. File: 333-281843
September 5, 2024
Ofer Gonen
Chief Executive Officer
MediWound Ltd.
42 Hayarkon Street
Yavne 8122745, Israel
Re:MediWound Ltd.
Registration Statement on Form F-3
Filed August 29, 2024
File No. 333-281843
Dear Ofer Gonen:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that
the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tim Buchmiller at 202-551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Michael J. Rosenberg, Esq.
2022-11-22 - CORRESP - MediWound Ltd.
CORRESP
1
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MediWound Ltd.
42 Hayarkon Street
Yavne 8122745, Israel
November 22, 2022
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
Securities and Exchange Commission
Washington, D.C. 20549
Attention: Joshua Gorsky
Re:
MediWound Ltd.
Registration Statement on Form F-1
Filed November 10, 2022
File No. 333-268297 (the “Registration Statement”)
Request for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 460 and 461 of the Rules and Regulations of the Securities and Exchange Commission (the “Commission”) under the Securities Act of 1933, as amended, MediWound Ltd. (the “Company”) hereby respectfully requests acceleration of the effective date of the
Registration Statement, so that it may become effective at 5:00 p.m., Eastern Time, on November 25, 2022, or as soon thereafter as practicable.
Should any member of the staff of the Commission have any questions or comments with respect to this request, please contact our counsel,
Michael J. Rosenberg, Esq. of Latham & Watkins LLP at (212) 906-1829.
Very truly yours,
MEDIWOUND LTD.
By:
/s/ Ofer Gonen
Ofer Gonen
Chief Executive Officer
cc: Michael J. Rosenberg, Esq., Latham & Watkins LLP
2022-11-16 - UPLOAD - MediWound Ltd.
United States securities and exchange commission logo
November 16, 2022
Ofer Gonen
Chief Executive Officer
MediWound Ltd.
42 Hayarkon Street
Yavne 8122745, Israel
Re:MediWound Ltd.
Registration Statement on Form F-1
Filed November 10, 2022
File No. 333-268297
Dear Ofer Gonen:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Joshua Gorsky at 202-551-7836 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Michael J. Rosenberg, Esq.
2022-06-01 - CORRESP - MediWound Ltd.
CORRESP
1
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MediWound Ltd.
42 Hayarkon Street
Yavne 8122745, Israel
+972 (77) 971-4100
June 1, 2022
Via EDGAR Transmission
Michael Davis
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
MediWound Ltd.
Registration Statement on Form F-3
Filed May 25, 2022
Registration No. 333-265203
Dear Mr. Davis:
In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933,
as amended, we hereby request the acceleration of the effective date of the above-referenced Registration Statement so that it will become effective on June 3, 2022 at 4:00 p.m. Eastern Time or as soon thereafter as practicable, or at such later
time as MediWound Ltd. (the “Company”) or its counsel may request via telephone call to the staff. Please contact Michael J. Rosenberg of Latham &
Watkins LLP, counsel to the Company, at (212) 906-1829, to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter.
Sincerely yours,
MediWound Ltd.
By:
/s/Boaz Gur-Lavie
Name: Boaz Gur-Lavie
Title: Chief Financial Officer
cc:
Sharon Malka, MediWound Ltd.
Yaron Meyer, MediWound Ltd.
Joshua Kiernan, Latham & Watkins LLP
Nathan Ajiashvili, Latham & Watkins LLP
David Glatt, Meitar | Law Offices
Jonathan Nathan, Meitar | Law Offices
2022-05-31 - UPLOAD - MediWound Ltd.
United States securities and exchange commission logo
May 31, 2022
Sharon Malka
Chief Executive Officer
MediWound Ltd.
42 Hayarkon Street
Yavne 8122745, Israel
Re:MediWound Ltd.
Registration Statement on Form F-3
Filed May 25, 2022
File No. 333-265203
Dear Ms. Malka:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Michael Davis at 202-551-4385 or Joe McCann at 202-551-6262 with any
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Michael Rosenberg
2019-04-18 - CORRESP - MediWound Ltd.
CORRESP 1 filename1.htm MediWound Ltd. 42 Hayarkon Street Yavne 8122745, Israel April 18, 2019 Via EDGAR Transmission Tonya K. Aldave, Esq. Division of Corporation Finance Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: MediWound Ltd. Registration Statement on Form F-3 Filed March 25, 2019 Registration No. 333-230490 Dear Ms. Aldave: In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request the acceleration of the effective date of the above-referenced Registration Statement so that it will become effective on April 22, 2019 at 4:00 p.m. Eastern Time or as soon thereafter as practicable, or at such later time as MediWound Ltd. (the “Company”) or its counsel may request via telephone call to the staff. Please contact Nathan Ajiashvili of Latham & Watkins LLP, counsel to the Company, at (212) 906-2916, or in his absence, Gilad Zohari at (212) 906-4667, to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter. Sincerely yours, MediWound Ltd. By: /s/ Sharon Malka Name: Sharon Malka Title: Chief Financial and Operations Officer cc: Nathan Ajiashvili, Latham & Watkins LLP
2019-04-12 - CORRESP - MediWound Ltd.
CORRESP 1 filename1.htm 53rd at Third 885 Third Avenue New York, New York 10022-4834 Tel: +1.212.906.1200 Fax: +1.212.751.4864 www.lw.com FIRM / AFFILIATE OFFICES Beijing Moscow Boston Munich Brussels New York Century City Orange County Chicago Paris Dubai Riyadh Düsseldorf San Diego Frankfurt San Francisco Hamburg Seoul Hong Kong Shanghai Houston Silicon Valley London Singapore Los Angeles Tokyo Madrid Washington, D.C. Milan April 12, 2019 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Tonya K. Aldave Justin Dobbie Re: MediWound Ltd. Registration Statement on Form F-3 Filed on March 25, 2019 File No. 333-230490 CIK No. 0001593984 Ladies and Gentlemen: We are in receipt of the Staff’s letter dated April 8, 2019 with respect to the above-referenced Registration Statement on Form F-3 (the “Registration Statement”). We are responding to the Staff’s comment on behalf of MediWound Ltd. (the “Company”) as set forth below. For ease of reference, we have set forth the Staff’s comment and the Company’s response below. Defined terms used but not otherwise defined herein have the meanings ascribed to such terms in the Registration Statement. General 1. Please provide us with support for your conclusion that you are eligible to conduct a primary offering under General Instruction I.B.1 of Form F-3. In this regard, provide us with your calculation of the aggregate market value of the shares held by non-affiliates. Response: The Company respectfully advises the Staff that at the date of the filing of the Registration Statement on March 25, 2019, the Company determined that its unaffiliated market capitalization was $75 million or more consistent with the requirements of General Instruction I.B.1 of Form F-3 and the related instruction thereto. The key parameters for the calculation were as follows: Closing share price on March 20, 2019 (date within 60 days of the filing date) $5.24 Total outstanding shares on March 20, 2019 27,178,839 shares Outstanding shares held by affiliates as of March 20, 2019: Clal Biotechnology Industries Ltd. 9,429,555 shares Gal Cohen 131,102 shares Lior Rosenberg 1,850,572 shares Other directors and officers (each less than 1% holders per Form 20-F) 0 shares Total outstanding shares on March 20, 2019 held by non-affiliates 15,767,610 shares Total unaffiliated market capitalization on March 20, 2019 $82.2 million By way of further explanation, the Company notes that the following shareholders, Wellington Management Group LLP, Migdal Insurance & Financial Holdings Ltd. and Yelin Lapidot, are not its affiliates. The Company confirms that they are not represented on its board and do not otherwise exercise control over, or are under common control with, the Company. * * * We hope the foregoing has been responsive to the Staff’s comment and look forward to resolving any outstanding issues as quickly as possible. Please do not hesitate to contact us at (212) 906-2916 with any questions or further comments you have regarding this filing or if you wish to discuss the above. Thank you in advance for your cooperation in connection with this matter. Very truly yours, /s/ Nathan Ajiashvili Nathan Ajiashvili of LATHAM & WATKINS LLP cc: (via email) Gal Cohen, MediWound Ltd. Yaron Meyer, MediWound Ltd. Josh Kiernan, Latham & Watkins LLP
2019-04-08 - UPLOAD - MediWound Ltd.
April 8, 2019
Gal Cohen
Chief Executive Officer
MediWound Ltd.
42 Hayarkon Street
Yavne 8122745, Israel
Re:MediWound Ltd.
Registration Statement on Form F-3
Filed March 25, 2019
File No. 333-230490
Dear Mr. Cohen:
We have limited our review of your registration statement to those issues we have
addressed in our comments. In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Registration Statement on Form F-3
General
1.Please provide us with support for your conclusion that you are eligible to conduct a
primary offering under General Instruction I.B.1 of Form F-3. In this regard, provide us
with your calculation of the aggregate market value of the shares held by non-affiliates.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
FirstName LastNameGal Cohen
Comapany NameMediWound Ltd.
April 8, 2019 Page 2
FirstName LastName
Gal Cohen
MediWound Ltd.
April 8, 2019
Page 2
Please contact Tonya K. Aldave at (202) 551-3601 or Justin Dobbie, Legal Branch Chief,
at (202) 551-3469 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Nathan Ajiashvili, Esq.
2016-03-03 - CORRESP - MediWound Ltd.
CORRESP
1
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zk1618161.htm
MediWound Ltd.
42 Hayarkon Street
Yavne, 8122745 Israel
March 3, 2016
VIA EDGAR
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attention: Scot Foley, Attorney-Advisor
Re: MediWound Ltd.
Registration Statement on Form F-3 (File No. 333-209106)
Dear Mr. Foley:
Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, MediWound Ltd. hereby requests acceleration of the effectiveness of its Registration Statement on Form F-3 (File No. 333-209106), to 10:00 a.m., Eastern Time, on March 7, 2016, or as soon as practicable thereafter.
Please contact Colin Diamond at (212) 819-8754 or Irina Yevmenenko at (212) 819-8570, both of White & Case LLP, with any questions you may have concerning this request. In addition, please notify Mr. Diamond and Ms. Yevmenenko when this request for acceleration has been granted.
MEDIWOUND LTD.
By:
/s/ Yaron Meyer
Name: Yaron Meyer
Title: General Counsel
2016-02-29 - CORRESP - MediWound Ltd.
CORRESP
1
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zk1618142.htm
MediWound Ltd.
42 Hayarkon Street
Yavne, 8122745 Israel
February 29, 2016
VIA EDGAR
Division of Corporation Finance
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
MediWound Ltd. (the “Company”)
Registration Statement on Form F-3 (File No. 333-209106) filed on January 25, 2016 (the “Registration Statement”)
Ladies and Gentlemen:
The Company hereby acknowledges the following:
·
should the Securities and Exchange Commission (the “Commission”) or the Staff of the Division of Corporation Finance of the Commission (the “Staff”), acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement;
·
the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement; and
·
the Registrant may not assert Staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Should you have any questions regarding this letter, please do not hesitate to contact Colin Diamond at (212) 819-8754 or Irina Yevmenenko at (212) 819-8570, both of White & Case LLP, counsel to the Company.
Sincerely,
MEDIWOUND LTD.
By:
/s/ Yaron Meyer
Name: Yaron Meyer
Title: General Counsel
2
2016-02-24 - CORRESP - MediWound Ltd.
CORRESP
1
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zk1618128.htm
February 24, 2016
VIA EDGAR
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attn:
Scot Foley, Attorney-Advisor
MediWound Ltd.
Registration Statement on Form F-3
Filed on January 25, 2016
File No. 333-209106
Dear Mr. Foley:
On behalf of our client, MediWound Ltd., an Israeli company (the “Company”), we note that the Company has filed the above-referenced registration statement on FormF-3 (the “Registration Statement”) via the EDGAR system of the Securities and Exchange Commission (the “Commission”). In this letter, we set forth the Company’s responses to the comments of the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”) contained in the Staff’s letter dated February 12, 2016 (the “Comment Letter”).
Set forth below are the Company’s responses to the comments in the Comment Letter. For ease of reference, each comment contained in the Comment Letter is printed below and is followed by the Company’s response. All page references in the responses set forth below refer to page numbers in the Registration Statement. Defined terms used but not otherwise defined herein have the meanings ascribed to such terms in the Registration Statement.
Prospectus Cover Page
1.
It appears you may be relying on General Instruction I.B.5 of Form F-3 to register the primary offering of securities covered by the registration statement. As such, please revise to disclose the aggregate market value of your outstanding voting and non-voting common equity, as well as the amount of all securities offered pursuant to General Instruction I.B.5 of Form F-3 during the previous 12 months up to and including the date of your prospectus. We refer you to Instruction 7 to General Instruction I.B.5.
Securities and Exchange Commission
February 24, 2016
Response:
At the date of the filing of the registration statement on January 25, 2016, the Company determined that its unaffiliated market capitalization was $75 million or more consistent with the requirements of General Instruction I.B.1 of Form F-3 and the related instruction thereto. The key parameters for the calculation were as follows:
Closing share price on November 30, 2015 (date within 60 days of the filing date)
$9.44
Total outstanding shares on November 30, 2015
21,850,300 shares
Outstanding shares held by affiliates:
Clal Biotechnology Industries Ltd.
9,789,555 shares
Lior Rosenberg
1,851,272 shares
Other directors and officers (each less than 1% holders per Form 20-F)
0 shares
Total
Total outstanding shares on November 30, 2015 held by non-affiliates
10,209,473 shares
Total unaffiliated market capitalization on November 30, 2015
$96.4 million
By way of further explanation, the Company notes that its two shareholders, Harel Insurance Investments & Financial Services Ltd. and Migdal Insurance & Financial Holdings Ltd., are not its affiliates. The Company confirms that they are not represented on its board and do not otherwise exercise “control” over the Company as such term is defined in Rule 405 under the Securities Act of 1933.
In addition, the Company notes that none of its directors and officers, other than Lior Rosenberg, own any outstanding shares of the Company. All of the beneficial ownership of such other directors and officers is in the form of options to purchase ordinary shares.
Selling Shareholders, page 4
2.
As it appears that you may not be eligible to conduct a primary offering in reliance on General Instruction I.B.1 of Form F-3, you do not appear to be eligible to omit the information regarding selling shareholders in reliance on Rule 430B. Please revise to identify the selling shareholders and the number of shares each one is offering pursuant to this prospectus, or advise.
Response:
The Company respectfully refers the Staff to its response set forth above regarding its eligibility to rely on General Instruction I.B.1 of Form F-3.
2
Securities and Exchange Commission
February 24, 2016
Please do not hesitate to contact Colin Diamond at (212) 819-8754 or Irina Yevmenenko at (212) 819-8570 of White & Case LLP with any questions or comments regarding this letter.
Sincerely,
/s/ White & Case LLP
White & Case LLP
cc:
Yaron Meyer, General Counsel, MediWound Ltd.
3
2016-02-16 - UPLOAD - MediWound Ltd.
Mail Stop 4720 February 12, 2016 Gal Cohen President and Chief Executive Office r MediWound Ltd. 42 Hayarkon Street Yavne 8122745, Israel Re: MediWound Ltd. Registration Statement on Form F-3 Filed January 25, 2016 File No. 333-209106 Dear Mr. Cohen: We have limited our review of your registration statement to those issues we have addressed in our comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe our com ments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, w e may have additional comments. Prospectus Cover Page 1. It appears you may be relying on General Instruction I.B.5 of Form F -3 to register the primary offering of securities covered by the registration statement. As such, please revise to disclose the a ggregate market value of your outstanding voting and non -voting common equity, as well as the amount of all securities offered pursuant to General Instruction I.B.5 of Form F -3 during the previous 12 months up to and including the date of your prospectus. We refer you to Instruction 7 to General Instruction I.B.5. Selling Shareholders, page 4 2. As it appears that you may not be eligible to conduct a primary offering in reliance on General Instruction I.B.1 of Form F -3, you do not appear to be eligible to omit the information regarding selling shareholders in reliance on Rule 430B. Please revise to Gal Cohen MediWound Ltd. February 12, 2016 Page 2 identify the selling shareholders and the number of shares each one is offering pursuant to this prospectus, or advise. We urge all persons who are responsibl e for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of al l facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the event you request acceleration of the effective date of the pending registration state ment , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant t o delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effect iveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceler ation of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. Gal Cohen MediWound Ltd. February 12, 2016 Page 3 You may contact Scot Foley at (202) 551 -3383 or Mary Beth Breslin at (202) 551 -3625 with any questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Joshua G. Kiernan, Esq.
2014-03-17 - CORRESP - MediWound Ltd.
CORRESP 1 filename1.htm March 17, 2014 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, D.C. 20549 Re: REQUEST FOR ACCELERATION OF EFFECTIVENESS MediWound (CIK No. 0001593984) Registration Statement on Form F-1 (File No. 333-193856) Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended, MediWound Ltd. (the “Company”) hereby requests acceleration of the effective date of its Registration Statement on Form F-1 (File No. 333-193856), as amended, to 4:00 p.m., Eastern Time, on Wednesday, March 19, 2014, or as soon thereafter as practicable. The Company hereby acknowledges that: · should the Securities and Exchange Commission (the “Commission”) or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; · the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and · the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Should you have any questions regarding this letter, please do not hesitate to contact Joshua G. Kiernan at +44 20 7532 1408 or Jonathan Miner at (212) 819-8947 of White & Case LLP, counsel to the Company. [Remainder of Page Intentionally Blank] Sincerely, MEDIWOUND LTD. By: /s/ SHARON MALKA Name: Sharon Malka Title: Chief Financial Officer Signature Page to Company Acceleration Request CREDIT SUISSE SECURITIES (USA) LLC JEFFERIES LLC BMO CAPITAL MARKETS CORP. c/o Credit Suisse Securities (USA) LLC Eleven Madison Avenue New York, New York 10010 March 17, 2014 Re: MediWound Ltd. Registration Statement on Form F-1 Registration File No. 333-193856 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Dear Sir/Madam: Pursuant to Rule 460 of the General Rules and Regulations under the Securities Act of 1933 (the “Act”), we, as representatives of the several Underwriters, wish to advise you that (i) the Registration Statement, Form F-1, as filed on February 10, 2014 and as amended through Amendment No. 3 as filed on March 14, 2014, and (ii) the Preliminary Prospectus issued March 3, 2014, were distributed during the period March 3, 2014 through 12 noon, Eastern Standard Time, March 17, 2014, as follows: Registration Statement Preliminary Prospectus 4 to 4 Underwriters 638 to 638 Institutions 1,030 to 1,030 Dealers, Underwriters and Others Total: 4 Total: 1,668 We were advised by the Corporate Financing Department of the Financial Industry Regulatory Authority that it has reviewed the above-captioned proposed offering and that it has determined to raise no objections with respect to the fairness of the terms and arrangements of the offering. We have been informed by the participating underwriters that they will comply with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934. In accordance with Rule 461 of the Act, we hereby join in the request of MediWound Ltd. for acceleration of the effective date of the above-named Registration Statement so that it becomes effective at 4:00 p.m. Eastern Standard Time on Wednesday, March 19, 2014, or as soon thereafter as practicable. Very truly yours, CREDIT SUISSE SECURITIES (USA) LLC JEFFERIES LLC BMO CAPITAL MARKETS CORP. Acting severally on behalf of themselves and the several Underwriters By: Credit Suisse Securities (USA) LLC By: /s/ Mark Page Name: Mark Page Title: Managing Director Signature Page to Underwriter Acceleration Request 2
2014-03-07 - UPLOAD - MediWound Ltd.
March 7, 2014 Via E -mail Gal Cohen Chief Executive Officer MediWound Ltd. 42 Hayarkon Street Yavne 8122745, Israel Re: MediWound Ltd. Amendment No. 2 to Registration Statement on Form F-1 Filed March 3, 2014 File No. 333 -193856 Dear Mr. Cohen: We have reviewed your registration statement and have the following comment . Please respond to this letter by amending your registration statement and providing the requested information. If you do not believe our comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to this comment , we may have additional comments. Capitalization, page 44 1. Please revise the number of pro forma as -adjusted shares outstanding to agree with the amount disclosed on pages 7 and 46 of 20,399,068. We urge all persons who are re sponsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 1933 and all applicable Securities Act rules require. Since the company and its management are in possessi on of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Gal Cohen MediWound Ltd. March 7, 2014 Page 2 Notwithstanding our comment , in the event you request acceleration of the effective date of the pending registr ation statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action w ith respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration. We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date o f the registration statement. You may contact Vanessa Robertson at (202) 551 -3649 or Lisa Vanjoske at (202) 551 - 3614 if you have questions regarding comments on the financial statements and related matters. Please contact Christina De Rosa at (202) 551-3577 or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Bryan J. Pitko for Jeffrey P. Riedler Assistant Director cc: Via E -mail Joshua G. Kiernan, Esq. White & Case LLP 1155 Avenue of the Americas New York, NY 10036
2014-02-18 - CORRESP - MediWound Ltd.
CORRESP 1 filename1.htm February 18, 2014 VIA EDGAR & HAND DELIVERY Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Christina M. De Rosa Re: MediWound Ltd. Registration Statement on Form F-1, Registration No. 333-193856 CIK No. 0001593984 Dear Ms. De Rosa: On behalf of our client, MediWound Ltd., an Israeli company (the “Company”), we file herewith Amendment No. 1 (“Amendment No. 1”) of the Registration Statement on Form F-1 (the “Registration Statement”) via the Securities and Exchange Commission’s (the “Commission”) EDGAR system. The Registration Statement was first publicly filed on February 10, 2014 and had initially been submitted confidentially to the Commission on December 23, 2013, as amended on January 15, 2014, January 27, 2014 and January 31, 2014. In this letter, we respond to the comments of the staff (the “Staff”) of the Division of Corporation Finance of the Commission contained in the Staff’s letter dated February 12, 2014 (the “Comment Letter”). Set forth below are the responses of the Company to the Staff’s comments in the Comment Letter. For ease of reference, each comment contained in the Comment Letter is printed below and is followed by the Company’s response. All page references in the responses set forth below refer to page numbers in Amendment No. 1. Defined terms used but not otherwise defined herein have the meanings ascribed to such terms in Amendment No. 1. Prospectus Summary, page 1 1. We note your response to our prior comment 6. Please also define the following scientific terms at their first use in the Prospectus Summary to provide a reasonable investor with understanding of such terms: · “proteolytic;” · “sepsis;” and · “ex vivo.” Response: The Company acknowledges the Staff’s comment and has revised the prospectus summary in Amendment No. 1 to include definitions of the terms “proteolytic”, “sepsis”, and “ex vivo” at their first use. Use of Proceeds, page 42 2. We note your response to our prior comment 12 and the associated revisions to your registration statement. Please provide your best estimate as to how far the application of the proceeds to be dedicated to clinical trials will allow you to go with regard to both the Phase III trial in the USA and the pediatric trial in the EU. Please address sufficiency for these two specific clinical trials rather than sufficiency for clinical trials in general through 2016. Response: The Company has revised the disclosure related to its use of proceeds on page 42 of Amendment No. 1 to include the Company’s current estimate as to how far the application of the proceeds to be dedicated to clinical trials will allow the Company to go with regard to both the Phase III trial in the United States and the pediatric trial in the European Union. Capitalization, page 44 3. Please refer to your response to our prior comment 13. Please explain how you concluded that it was appropriate to include the future royalty obligation to Teva in the Capitalization table and whether it is expected to be affected by the net proceeds of the offering. Response: The Company acknowledges the Staff’s comment and has revised page 44 of Amendment No. 1. to remove the contigent consideration for the purchase of treasury shares line item from the Capitalization Table as the item is not expected to be affected by the net proceeds of the offering. 2 Dilution, page 45 4. Please remove the ‘pro forma net tangible book value per ordinary share’ line item since you have revised your disclosures throughout the document to only present ‘pro forma as adjusted’ amounts. Response: The Company has removed the “pro forma net tangible book value per ordinary share” line item on page 45 of Amendment No. 1. Notes to Consolidated Financial Statements Note 12: Financial Instruments, page F-21 5. Please refer to your response to our prior comment 30. Please revise your disclosure to clarify that prior to the termination of the collaboration with Teva, the fair value of the derivative instrument related to the Company’s right to repurchase its own shares was zero. Response: The Company has revised the disclosure on page F-25 of Amendment No.1 to clarify that prior to the termination of the collaboration with Teva, the fair value of the derivative instrument related to the Company’s right to repurchase its own shares was zero, and it has provided a cross-reference on page F-21 to the relevant disclosure in Note 15. * * * Please do not hesitate to contact Joshua G. Kiernan at +44 20 7532 1408 or Jonathan Miner at (212) 819-8947 of White & Case LLP with any questions or comments regarding this letter. Sincerely, /s/ White & Case LLP White & Case LLP 3
2014-02-12 - UPLOAD - MediWound Ltd.
February 12 , 2014 Via E -mail Gal Cohen Chief Executive Officer MediWound Ltd. 42 Hayarkon Street Yavne 8122745, Israel Re: MediWound Ltd. Amendment No. 3 to Draft Registration Statement on Form F -1 Submitted January 31, 2013 CIK No. 0001593984 Dear Mr. Cohen : We have reviewed your amended draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. We note that subsequent to the f iling of this amended draft registration statement you publicly filed a registration on Form F -1. Please respond to this letter by amending your registration statement and providing the requested information . If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing any amendment to your registration statement and the information you provide in response to these comments, we may have additional comments. Prospectus Summary, page 1 1. We note your response to our prior comment 6. Please also define the following scientific terms at their first use in the Prospectus Summary to provide a reasonable investor with understanding of such terms: “proteolytic;” “sepsis;” and “ex vivo.” Gal Cohen MediWound Ltd. February 12, 2014 Page 2 Use of Proceeds, page 42 2. We note your response to our prior comment 12 and the associated revisions to your registration statement. Please provide your best estimate as to how far the application of the proceeds to be dedicated to clinical trials will allow you to go with regard to both the Phase III trial in the USA and the pediatric trial in the EU. Please address sufficiency for these two specific clinical trials rather than sufficiency for clinical trials in general through 2016. Capitalization, page 44 3. Please refer to your response to our prior comment 13. Please explain how you concluded that it was appropriate to include the f uture royalty obligation to Teva in the Capitalization table and whether it is expected to be affected by the net proceeds of the offering. Dilution, page 45 4. Please remove the ‘pro forma net tangible book value per ordinary share’ line item since you have revised your disclosures throughout the document to only present ‘pro forma as adjusted’ amounts. Notes to Consolidated Financial Statements Note 12: Financ ial Instruments, page F -21 5. Please refer to your response to our prior comment 30. Please revise your disclosure to clarify that prior to the termination of the collaboration with Teva, the fair value of the derivative instrument related to the Company’s right to repurchase its own shares was zero. We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the event you request acceleration of the effective date of the pending regist ration statement please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; Gal Cohen MediWound Ltd. February 12, 2014 Page 3 the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration . We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of their respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to review any amendment prior to the requested effective date of the registration statement. You may contact Vanessa Robertson at (202) 551 -3649 or Lisa Vanjoske at (202) 551 - 3614 if you have questions re garding comments on the financial statements and related matters. Please contact Christina De Rosa at (202) 551 -3577 or me at (202) 551 -3715 with any other questions. Sincerely, /s/ Jeffrey P. Riedler Jeffrey P. Riedler Assistant Director cc: Via E -mail Joshua G. Kierna n, Esq. White & Case LLP 1155 Avenue of the Americas New York, NY 10036
2014-01-31 - CORRESP - MediWound Ltd.
CORRESP 1 filename1.htm January 31, 2014 VIA EDGAR & HAND DELIVERY Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Christina M. De Rosa Re: MediWound Ltd. Draft Registration Statement on Form F-1 Submitted December 23, 2013 CIK No. 0001593984 Dear Ms. De Rosa: On behalf of our client, MediWound Ltd., an Israeli company (the “Company”), we confidentially submit herewith Amendment No. 3 (“Amendment No. 3”) to the above-referenced draft Registration Statement on Form F-1 (the “Registration Statement”) via the Securities and Exchange Commission’s (the “Commission”) EDGAR system. The Registration Statement was initially submitted confidentially to the Commission on December 23, 2013. In this letter, we respond to the comments of the staff (the “Staff”) of the Division of Corporation Finance of the Commission contained in the Staff’s letter dated January 16, 2014 (the “Comment Letter”). Set forth below are the responses of the Company to the Staff’s comments in the Comment Letter. For ease of reference, each comment contained in the Comment Letter is printed below and is followed by the Company’s response. All page references in the responses set forth below refer to page numbers in Amendment No. 3. Defined terms used but not otherwise defined herein have the meanings ascribed to such terms in Amendment No. 3. General 1. Please submit all exhibits as soon as practicable. We may have further comments upon examination of these exhibits. Response: The Company acknowledges the Staff’s comment and will provide all exhibits as soon as practicable. 2. Please confirm that the images included in your draft registration statement are all of the graphic, visual or photographic information you will be including. If you intend to use any additional images, please provide us proofs of such materials. Please note that we may have comments regarding this material. Response: The Company will provide the Staff with copies of the additional artwork that it proposes to include in the prospectus, including any related support for claims and statistics therein in a subsequent filing or supplementally. 3. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retain copies of the communications. Similarly, please supplementally provide us with any research reports about you that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Business Startups Act by any broker or dealer that is participating or will participate in your offering. Response: The Company has not had any communications or authorized anyone to have communications with potential investors in reliance on Section 5(d) of the Securities Act of 1933 (the “Securities Act”). There has not been any published or distributed research reports about the Company by any broker or dealer participating in this offering in reliance on Section 2(a)(3) of the Securities Act. If the Company or anyone authorized by the Company engages in such communications in reliance on Section 5(d) of the Securities Act, or if any broker or dealer participating in the offering publishes any reports in reliance on Section 2(a)(3) of the Securities Act going forward, the Company will supplementally provide any such communications or research reports to the Staff as requested. 4. We will deliver any comments to your confidential treatment request via separate letter. Please be advised that we will have to grant the confidential treatment 2 request before we can act upon any request for effectiveness of the registration statement you will file. Response: The Company acknowledges the Staff’s comment and will respond to any of the Staff’s comments to the confidential treatment request via separate letter. Prospectus Summary, page 1 5. Since you appear to qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act (“JOBS Act”), please disclose that you are an emerging growth company. Please also clarify the relief a company gets as a Foreign Private Issuer and the additional relief that you will enjoy as an emerging growth company. In addition, revise your prospectus to describe how you will eventually lose this additional JOBS Act relief under the JOBS Act and indicate that you have irrevocably decided not to avail yourselves of the relief from adopting new accounting standards. Please conform your disclosure in the Risk Factors section on pages 33 and 34 to comply with this comment. Response: The Company acknowledges the Staff’s comment and has added disclosure regarding the Company’s qualifications as an “emerging growth company” on page 6 of Amendment No. 3 in addition to stating that the Company is an “emerging growth company” on the cover of the prospectus within Amendment No. 3 and disclosing the relief available to the Company as a Foreign Private Issuer and emerging growth company on pages 35-37 and 66 of Amendment No. 3. The Company has also included disclosure that it will not to avail itself of the relief from adopting new accounting standards, and that such election is irrevocable, on pages 6 and 66 of Amendment No. 3. 6. Please define the following scientific terms to provide a reasonable investor with understanding of such terms: · “proteolytic;” · “sepsis;” and · “ex vivo.” Response: The Company acknowledges the Staff’s comment and has revised the Registation Statement in Amendment No. 3 to include definitions of the terms “proteolytic”, “sepsis”, and “ex vivo” in the “Business” Section on pages 75, 69 and 68, respectively. 3 Risk Factors, page 10 “We depend on key persons on our management team…,” page 20 7. Please disclose the names of your key personnel who are not executive officers and explain why these additional people are considered to be key personnel. Response: The Company has revised the heading of the risk factor and the disclosure on page 22 to clarify that the key personnel the Company depends on are its executive officers. Such disclosure identifies the key personnel by the title of the executive officer. The Company does not deem any of its employees who are not executive officers as key personnel. 8. Please disclose any difficulties you have experienced attracting or retaining senior management or key personnel in the past. Response: The Company has revised the disclsoure on page 22 to clarify that while the Company has not had difficulites in attracting or retaining senior management or key personnel in the past, the Company may experience such difficulties in the future. “We could be subject to product liability lawsuits…,” page 23 9. Please disclose the amount of product liability coverage you have obtained. Response: The Company has revised Amendment No. 3 to include the amount of its product liability coverage on page 25. “Our success depends in part on our ability to obtain and maintain…,” page 24 10. We note your statement that you are party to certain licenses for issued patents related to NexoBrid. Please disclose whether these are encompassed in the Klein License Agreement or other licensing agreements. If you are a party to other material licensing agreements that relate to either NexoBrid or EscharEx, please describe these agreements in the Business section and file them as exhibits to the registration statement. Please also identify the “certain license agreements” you refer to in the last sentence on page 24. Response: The Company acknowledges the Staff’s comment and has revised the disclosure on pages 26-27 of Amendment No. 3 to clarify that the agreements related to NexoBrid and its pipeline products are agreements with Mark Klein and L.R. R&D Ltd., an entity which is 4 wholly-owned by Prof. Lior Rosenberg. The agreement with Prof. Rosenberg was filed as Exhibit 10.4 to the Registration Statement and on January 27, 2013, the Company filed the Klein License Agreement, as amended as Exhibit 10.7 to Amendment No. 2 to the Registration Statement. The Company is seeking confidential treatment for portions of the Klein License Agreement and has submitted such requests concurrently with the January 27 submission of Amendment No. 2. “As a foreign private issuer, we are permitted, and intend, to follow certain…,” page 33 11. This risk factor combines two technically distinct risk factors concerning: (1) being permitted to follow certain home country corporate governance practices instead of certain Nasdaq corporate governance requirements for domestic issuers; and (2) being exempt from certain Exchange Act disclosure requirements (e.g. Section 14’s proxy requirements) and subject to more lenient Exchange Act disclosure requirements in certain respects (e.g. not having to file Form 10-Qs or being permitted to provide executive compensation disclosure on an aggregate basis as long as individual disclosure is not required in the home country.) While both sets of risks hinge on your maintaining your status as a foreign private issuer, combining them in one risk factor results in an unduly long discussion that is cumbersome to read and potentially confusing for investors. Accordingly, please revise this risk factor by creating two distinct risk factors as outlined above. In the second risk factor (regarding being subject to different Exchange Act disclosure requirements), please add to your discussion the different executive compensation disclosure standard for foreign private issuers (see Item 6.B of Form 20-F) and the fact that foreign private issuers are not subject to Regulation FD (see 17 CFR 243.101(b)). Response: The Company acknowledges the Staff’s comment and has separated the risk factor to create two risk factors on pages 35 and 36 of Amendment No. 3. In addition, the Company has added disclosure on page 36 providing that the Company, as a foreign private issuer, is not subject to Regulation FD, and is permitted to provide compensation disclosure on an aggregate rather than an individual basis. Please see the Company’s response to Comment 19 for more information regarding compensation disclosure. Use of Proceeds, page 40 12. We note your disclosure that management will have significant flexibility in applying the net proceeds of this offering. Pursuant to the requirements of Item 3.C.1. of Form 20-F, where you have identified the specific purposes for which you intend to use the offering proceeds, you must disclose the approximate amount of proceeds intended to be used for each such purpose. This includes: · research and development; 5 · expanding your sales and marketing infrastructure; · expanding your manufacturing capabilities; and · general corporate purposes. In addition, to the extent practicable, please estimate the stage of development you expect to reach with respect to each of your major product candidates as a result of the offering proceeds allocated to such programs. Specifically, please elaborate on the research and development amount to separately state the amounts that you expect to spend on each of the three planned or ongoing trials; the Phase III NexoBrid trial in USA, the pediatric Phase II NexoBrid trial in the EU and the Phase II EscharEx trial in Israel. Please also state how far the application of the proceeds to each of these trials will allow you to progress as to each such trial. Response: The Company has revised the disclosure related to its use of proceeds on pages 7 and 42 of Amendment No. 3 to include the approximate amount of proceeds intended to be used for each listed purpose. Additionally, the Company has added disclosure related to the use of proceeds in funding its clinical trials on page 42 and its expectation that the proceeds will allow the Company to conduct its clinical trials through 2016. The Company supplementally informs the Staff that due to the uncertain cost associated with, and duration of, clinical trials, the Company is unable to provide a detailed breakdown of the projected use of proceeds for each trial or predict how far the application of proceeds will allow each trial to progress. Capitalization, page 42 13. Please explain why you did not include liabilities in respect of Chief Scientist government grants in the Capitalization table. Response: The Company acknowledges the Staff’s comment and respectfully submits that the Capitalization table includes only the accounts that are affected by the net proceeds of this offering, which includes the equity accounts on one hand and the cash balances and borrowings/loans, if any, on the other hand. As the repayment of the liability in respect of the Chief Scientist government grants is based on future royalty payments derived from actual sales and is not expected to be affected by the net proceeds of the offering, such liability is not presented as part of the capitalization table. 6 14. Expand your pro forma disclosures in the filing to explain your basis for assuming the warrants will be exercised prior to the closing of the offering. Response: The Company acknowledges the Staff’s comment and has included disclosure on pages 44 and 134 of Amendment No. 3 reflecting the execution of an amendment to the warrants between the Company and its shareholders in December 2013. The amendment provides that warrants expire upon the Company’s initial public offering and the warrant holders may exercise, either in a cash or cashless manner, such warrants immediately prior to our initial public offering. Therefore, the Company assumes that all of the warrants will be exercised prior to the consummation of this offering. Management’s Discussion and Analysis of Financial Condition and Results of Operations, page 47 Financial Operations Overview, page 48 Operating Expenses, page 49 Participation by others, page 50 Participation by the Chief Scientist, page 51 15. Please file the contracts related to the grants from the Office of the Chief Scientist (“OCS”) or explain why you are not required to file them. Please also disclose the performance or other obligations that you must satisfy in order to maintain the grants wherever you describe these grants in the registration statement and the extent to which you do or do not have access to additional grant money from the OCS and the conditions related to additional grants. Response: The amount of funding obtained by the Company from the OCS was $0.9 million, $0.1 million and $0.5 million in 2013, 2012 and 2011, respectively. Accordingly, the dollar amount provided under the agreements (or letter of approval, as they are usually referred to) neither was, nor is, material to the Company’s business. Moreover, the principal requirements and restrictions that apply to the Company in connection with OCS grants are not contained in the agreements themselves, but rather in the Law for the Encouragement of Industrial Research and Development of 1984. The Company has detailed the requirements, restrictions and obligations, including with respect to additional grants, on pages 38 an
2014-01-16 - UPLOAD - MediWound Ltd.
January 16 , 2014 Via E -mail Gal Cohen Chief Executive Officer MediWound Ltd. 42 Hayarkon Street Yavne 8122745, Israel Re: MediWound Ltd. Draft Registration Statement on Form F -1 Submitted December 23, 2013 CIK No. 0001593984 Dear Mr. Cohen : We have reviewed your draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statemen t, we may have additional comments. General 1. Please submit all exhibits as soon as practicable. We may have further comments upon examination of these exhibits. 2. Please confirm that the images included in your draft registration statement are all of the graphic, visual or photographic information you will be including. If you intend to use any additional images, please provide us proofs of such materials. Please note that we may have comments regarding this material. 3. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Securities Act, whether or not they retai n copies of the communications. Similarly, please Gal Cohen MediWound Ltd. January 16, 2014 Page 2 supplementally provide us with any research reports about you that are published or distributed in reliance upon Section 2(a)(3) of the Securities Act of 1933 added by Section 105(a) of the Jumpstart Our Bu siness Startups Act by any broker or dealer that is participating or will participate in your offering. 4. We will deliver any comments to your confidential treatment request via separate letter. Please be advised that we will have to grant the confidential treatment request before we can act upon any request for effectiveness of the registration statement you will file. Prospectus Summary, page 1 5. Since you appear to qualify as an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act (“JOBS Act”) , please disclose that you are an emerging growth company. Please also clarify the relief a company gets as a Foreign Private Issuer and the additional relief th at you will enjoy as an emerging growth company. In addition, revise your p rospectus to describe how you will eventually lose this additional JOBS Act relief under the JOBS Act and indicate that you have irrevocably decided not to avail yourselves of the relief from adopting new accounting standards . Please conform your disclosur e in the Risk Factors section on pages 33 and 34 to comply with this comment. 6. Please define the following scientific terms to provide a reasonable investor with understanding of such terms: “proteolytic;” “sepsis;” and “ex vivo.” Risk Factors, page 10 “We depend on key persons on our management team…,” page 20 7. Please disclose the names of your key personnel who are not executive officers and explain why these additional people are considered to be key personnel . 8. Please disclose any difficulties you ha ve experienced attracting or retaining senior management or key personnel in the past . “We could be subject to product liability lawsuits…,” page 23 9. Please disclose the amount of product liability coverage you have obtained. Gal Cohen MediWound Ltd. January 16, 2014 Page 3 “Our success depends in part on our ability to obtain and maintain…,” page 24 10. We note your statement that you are party to certain license s for issued patents related to NexoBrid. Please disclose whether these are encompassed in the Klein License Agreement or other licensing ag reements . If you are a party to other material licensing agreements that relate to either NexoBrid or EscharEx , please describe these agreements in the Business section and file them as exhibits to the registration statement . Please also identify the “certain license agreements” you refer to in the last sentence on page 24. “As a foreign private issuer, we are permitted, and intend, to follow certain …,” page 33 11. This risk factor combines two technically distinct risk factors concerning: (1) being permitted to follow certain home country corporate governance practices instead of certain Nasdaq corporate governance requirements for domestic issuers; and (2) being exempt from certain Exchange Act disclosure requirements (e.g. Section 14’s proxy requirements) and subject to more lenient Exchange Act disclosure requirements in certain respects (e.g. not having to file Form 10 -Qs or being permitted to provide executive c ompensation disclosure on an aggregate basis as long as individual disclosure is not required in the home country.) While both sets of risks hinge on your maintaining your status as a foreign private issuer, combining them in one risk factor results in an unduly long discussion that is cumbersome to read and potentially confusing for investors. Accordingly, please revise this risk factor by creating two distinct risk factors as outlined above. In the second risk factor (regarding being subject to differe nt Exchange Act disclosure requirements), please add to your discussion the different executive compensation disclosure standard for foreign private issuers ( see Item 6.B of Form 20 -F) and the fact that foreign private issuers are not subject to Regulation FD (see 17 CFR 243.101(b)). Use of Proceeds, page 40 12. We note your disclosure that management will have significant flexibility in applying the net proceeds of this offering. Pursuan t to the requirements of Item 3.C.1 . of Form 20 -F, where you have ident ified the specific purposes for which you intend to use the offering proceeds, you must disclose the approximate amount of proceeds intended to be used for each such purpose. This includes: research and development; expanding your sales and marketing infr astructure; expanding your manufacturing capabilities; and general corporate purposes. In addition, to the extent practicable, please estimate the stage of development you expect to reach with respect to each of your major product candidates as a result o f the offering Gal Cohen MediWound Ltd. January 16, 2014 Page 4 proceeds allocated to such programs . Specifically, please elaborate on the research and development amount to separately state the amounts that you expect to spend on each of the three planned or ongoing trials; the Phase III NexoBrid trial in USA, the pediatric Phase II NexoBrid trial in the EU and the Phase II EscharEx trial in Israel. Please also state how far the application of the proceeds to each of these trials will allow you to progress as to each such trial . Capitalization, page 42 13. Please explain why you did not include liabilities in respect of Chief Scientist government grants in the Capitalization table. 14. Expand your pro forma disclosures in the filing to explain your basis for assuming the warrants will be exercised pri or to the closing of the offering . Management’s Discussion and Analysis of Financial Condition and Results of Operations, page 47 Financial Operations Overview, page 48 Operating Expenses, page 49 Participation by others, page 50 Participation by the Chief Scientist, page 51 15. Please file the contracts related to the grants from the Office of the Chief Scientist (“OCS”) or explain why you are not required to file them. Please also disclose the performance or other obligations th at you must satisfy in o rder to maintain the grants where ver you describe these grants in the registration statement and the extent to which you do or do not have access to additional grant money from the OCS and the conditions related to additional grants . Application of Critic al Accounting Policies and Estimates , page 60 Equity -based compensation, page 60 16. Please c onfirm that no other stock options have been granted that have not already been disclosed and update that confirmation through the date the filing goes effective. 17. We may have additional comments on your accounting for equity -based compensation and related disclosure once you have disclosed an estimated offering price. Please provide quantitative and qualitative disclosures explaining the difference between the estim ated offering price and the fair value of each equity issuance. Gal Cohen MediWound Ltd. January 16, 2014 Page 5 Fair value of financial instruments, page 63 18. Please revise your disclosure in this section and elsewhere in the filing to clarify that the obligation to pay Teva future royalty payments no longer includes amounts from the sale or license of the PolyHeal products since the license to the PolyHeal products has expired. Management, page 98 Compensation of Executive Officers and Directors, page 114 19. Please s upplementally advise us whether you are required to disclose, or otherwise have disclosed, the executive compensation of your named directors and executive officers on an individual basis in Israel. See Item 6.B. of Form 20 -F. 20. Please update your disclosu re of executive compensation to include 2013 executive compensation information. Principal Shareholders, page 117 21. Please indicate whether your major shareholders have different voting rights, or an appropriate negative s tatement, as required by Item 7. A.1.c . of Form 20 -F. Certain Relationships and Related Party Transactions, page 120 22. Please file the Shareholder s’ Right Agreement and the financing agreements with Clal Life Sciences, L.P . or explain why you are not required to file them . Supply A greement with Challenge Bioproducts Corporation Ltd. 23. Please explain how and why the supply agreement with Challenge Bioproducts Corporation Ltd. is apparently an affiliated agreement . Klein License Agreement, page 122 24. Please dis close each party’s termination rights under the Klein License Agreement. Please also disclose the patents that you license from Klein and whether the patents relate to composition of matter or method of use or process. Please also disclose your performan ce or other obligations th at you will have to satisfy in order to maintain the license . Lastly, please file both the 2000 license agreement and the 2007 amendment as exhibits to your registration statement. Gal Cohen MediWound Ltd. January 16, 2014 Page 6 Description of Share Capital, page 123 25. If your shares currently trade in Israel or elsewhere , please provide the offer and listing information set forth in Item 9.A.4. of Form 20 -F. Shares Eligible for Future Sale, page 130 Lock -Up Agreements, page 130 26. When available, please file a form of the l ock-up agreement as an exhibit to your registration statement. Underwriting, page 144 27. Please disclose the manner of determining the initial public offering price of you r shares, as required by Item 9.A.2. of Form 20 -F. Enforceability of Civil Liabilitie s, page 150 28. Please be advised that the consent of counsel to be filed as Exhibit 23.2 should also include consent of counsel to the use of its name on page 150 of the prospectus. Notes to Consolidated Financial Statements , page F -8 Note 11: Chief Scient ist Government Grants, page F -20 29. Please explain the difference between the $9,400 disclosed at the bottom of the note and the $6.4 million disclosed on page 79 and also reflected in the table in the note. In addition, please explain the difference betwee n the $9.6 million disclosed on page 79 and elsewhere in the document as the balance of the commitments to the OCS as of September 30, 2013 and the $6.8 million disclosed on the balance sheet. Note 12: Financial Instruments, page F -21 30. Please provide us with an analysis of how you concluded that the right to repurchase your shares from Teva was a derivative instrument including the authoritative accounting literature that you relied upon. Please include in your analysis how you conclude d that it was appropriate to record financial income in the amount of $15.4 million for the revaluation to fair value of the option to repurchase the shares and why it is appropriate to record an asset at December 31, 2012. Tell us your consideration of the statement “No gain or loss shall be recognized in profit or loss on the purchase, sale, issue or cancellation of an entity’s own equity instruments” in paragraph 33 of IAS 32. Gal Cohen MediWound Ltd. January 16, 2014 Page 7 c. Fair value, page F -21 31. For your liabilities in respect of the Chief Sc ientist government grants and the contingent consideration for the purchase of treasury shares classified as Level 3, please expand your disclosures to include a more detailed discussion of the valuation techniques and inputs used in the fair value measure ment and provide quantitative information about the significant unobservable inputs used as required by IFRS 13. General If you intend to respond to these comments with an amended draft registration statement , please submit it and any associated correspondence in accordance with the guidance we provide in the Division’s October 11, 2012 announcement on the SEC website at http://www.sec.gov/divisions/corpfin/cfannouncements/drsfilingprocedures101512.htm . Please keep in mind that we may publicly post filing review correspondence in accordance with our December 1, 2011 policy (http://www.sec.gov/divisions/corpfin/cfannouncements/edgarcorrespondence.htm ). If you intend to use Rule 83 (17 CFR 200.83) to request confidential treatment of information in the correspondence you submit on EDGAR, please properly mark that information in each of your confidential submissions to us so we do not repeat or refer to that information in our comment letters to you. You may contact Vanessa Robertso n at (202) 551 -3649 or Lisa Vanjoske at (202) 551 - 3614 if you have questions regarding comments on the financial statements and related matters. Please contact Christina De Rosa at (202) 551 -3577 or me at (202) 551 -3715 with any other questions. Sincerel y, /s/ Jeffrey P. Riedler Jeffrey P. Riedler Assistant Director cc: Via E -mail Joshua G. Kiernan, Esq. White & Case LLP 1155 Avenue of the Americas New York, NY 10036