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SEC Company Response from MediWound Ltd. (MDWD) (CIK 0001593984) (MDWD) — Jan 31, 2014

MediWound Ltd. (MDWD) (CIK 0001593984)
Date: Jan. 31, 2014 · CIK: 0001593984 · Accession: 0001104659-14-005710

AI Filing Summary & Sentiment

Referenced dates: January 16, 2014

Date
January 31, 2014
Author
Not clearly detected
Form
CORRESP
Company
MediWound Ltd. (MDWD) (CIK 0001593984)

Letter

VIA EDGAR & HAND DELIVERY Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Draft Registration Statement on Form F-1 Submitted December 23, 2013 CIK No. 0001593984

Re: MediWound Ltd.

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

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.

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

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;

· 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.

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

Show Raw Text
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