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SEC Comment Letter for MediWound Ltd. (MDWD) (CIK 0001593984) (MDWD) — Jan 16, 2014

MediWound Ltd. (MDWD) (CIK 0001593984)
Date: Jan. 16, 2014 · CIK: 0001593984 · Accession: 0000000000-14-002556

AI Filing Summary & Sentiment

Date
December 23, 2013
Author
Not clearly detected
Form
UPLOAD
Company
MediWound Ltd. (MDWD) (CIK 0001593984)

Letter

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

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

Show Raw Text
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