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SEC Comment Letters
Company Responses
Letter Text
Protalix BioTherapeutics, Inc.
Response Received
1 company response(s)
High - file number match
↓
Protalix BioTherapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-06-30
Protalix BioTherapeutics, Inc.
Summary
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Protalix BioTherapeutics, Inc.
Response Received
11 company response(s)
High - file number match
SEC wrote to company
2008-06-26
Protalix BioTherapeutics, Inc.
Summary
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Company responded
2008-07-11
Protalix BioTherapeutics, Inc.
References: June 26, 2008
Summary
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Company responded
2008-10-16
Protalix BioTherapeutics, Inc.
References: October 2, 2008
Summary
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Company responded
2008-12-23
Protalix BioTherapeutics, Inc.
References: October 16, 2008
Summary
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Company responded
2009-02-05
Protalix BioTherapeutics, Inc.
Summary
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Company responded
2009-03-04
Protalix BioTherapeutics, Inc.
Summary
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Company responded
2009-03-16
Protalix BioTherapeutics, Inc.
References: December 23, 2008 | March 4,
2009 | March 4, 2009 | October 16, 2008
Summary
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Company responded
2010-10-12
Protalix BioTherapeutics, Inc.
References: September 22, 2010
Summary
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Company responded
2010-11-24
Protalix BioTherapeutics, Inc.
References: November 16, 2010
Summary
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Company responded
2018-12-27
Protalix BioTherapeutics, Inc.
References: December 4, 2018
Summary
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Company responded
2019-03-11
Protalix BioTherapeutics, Inc.
References: February 13,
2019
Summary
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Company responded
2022-06-29
Protalix BioTherapeutics, Inc.
References: June 23, 2022
Summary
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Protalix BioTherapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2022-06-23
Protalix BioTherapeutics, Inc.
Summary
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Protalix BioTherapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-04-25
Protalix BioTherapeutics, Inc.
Summary
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Company responded
2022-04-27
Protalix BioTherapeutics, Inc.
Summary
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Protalix BioTherapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-04-22
Protalix BioTherapeutics, Inc.
Summary
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Company responded
2020-04-27
Protalix BioTherapeutics, Inc.
Summary
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Protalix BioTherapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-04-08
Protalix BioTherapeutics, Inc.
Summary
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Company responded
2019-04-10
Protalix BioTherapeutics, Inc.
Summary
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Protalix BioTherapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-03-15
Protalix BioTherapeutics, Inc.
Summary
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Protalix BioTherapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-02-14
Protalix BioTherapeutics, Inc.
Summary
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Protalix BioTherapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2018-12-04
Protalix BioTherapeutics, Inc.
Summary
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Protalix BioTherapeutics, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2015-11-19
Protalix BioTherapeutics, Inc.
Summary
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Company responded
2015-11-27
Protalix BioTherapeutics, Inc.
References: November 19, 2015
Summary
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Company responded
2015-12-16
Protalix BioTherapeutics, Inc.
Summary
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Protalix BioTherapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-12-30
Protalix BioTherapeutics, Inc.
Summary
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Protalix BioTherapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-11-16
Protalix BioTherapeutics, Inc.
Summary
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Protalix BioTherapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2010-09-22
Protalix BioTherapeutics, Inc.
Summary
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Protalix BioTherapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2009-03-23
Protalix BioTherapeutics, Inc.
Summary
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Protalix BioTherapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2008-10-02
Protalix BioTherapeutics, Inc.
Summary
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Protalix BioTherapeutics, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2007-08-07
Protalix BioTherapeutics, Inc.
Summary
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Company responded
2007-09-24
Protalix BioTherapeutics, Inc.
References: August 7, 2007
Summary
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Company responded
2007-09-25
Protalix BioTherapeutics, Inc.
Summary
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Protalix BioTherapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2007-02-15
Protalix BioTherapeutics, Inc.
Summary
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Company responded
2007-02-21
Protalix BioTherapeutics, Inc.
References: February 13, 2007
Summary
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Protalix BioTherapeutics, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2007-01-18
Protalix BioTherapeutics, Inc.
Summary
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Company responded
2007-01-22
Protalix BioTherapeutics, Inc.
References: January 17, 2007
Summary
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Protalix BioTherapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2007-01-17
Protalix BioTherapeutics, Inc.
Summary
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Protalix BioTherapeutics, Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2007-01-10
Protalix BioTherapeutics, Inc.
Summary
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Company responded
2007-01-10
Protalix BioTherapeutics, Inc.
References: December 28, 2006
Summary
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Company responded
2007-01-16
Protalix BioTherapeutics, Inc.
References: January 12, 2007
Summary
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Protalix BioTherapeutics, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2005-05-17
Protalix BioTherapeutics, Inc.
Summary
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Company responded
2005-05-20
Protalix BioTherapeutics, Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-20 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-04-30 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | 333-286802 | Read Filing View |
| 2022-06-30 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-06-29 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-06-23 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-04-27 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-04-25 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-04-27 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-04-22 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-04-10 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-04-08 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-03-15 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-03-11 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-02-14 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-12-27 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-12-04 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-12-16 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-11-27 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-11-19 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2010-12-30 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2010-11-24 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2010-11-16 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2010-10-12 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2010-09-22 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2009-03-23 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2009-03-16 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2009-03-04 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2009-02-05 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2008-12-23 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2008-10-16 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2008-10-02 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2008-07-11 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2008-06-26 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-09-25 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-09-24 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-08-07 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-02-21 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-02-15 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-01-22 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-01-18 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-01-17 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-01-16 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-01-10 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-01-10 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2005-05-20 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2005-05-17 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-04-30 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | 333-286802 | Read Filing View |
| 2022-06-30 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-06-23 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-04-25 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-04-22 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-04-08 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-03-15 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-02-14 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-12-04 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-11-19 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2010-12-30 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2010-11-16 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2010-09-22 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2009-03-23 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2008-10-02 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2008-06-26 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-08-07 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-02-15 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-01-18 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-01-17 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-01-10 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2005-05-17 | SEC Comment Letter | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-20 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-06-29 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-04-27 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-04-27 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-04-10 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-03-11 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2018-12-27 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-12-16 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-11-27 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2010-11-24 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2010-10-12 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2009-03-16 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2009-03-04 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2009-02-05 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2008-12-23 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2008-10-16 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2008-07-11 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-09-25 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-09-24 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-02-21 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-01-22 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-01-16 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2007-01-10 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
| 2005-05-20 | Company Response | Protalix BioTherapeutics, Inc. | DE | N/A | Read Filing View |
2025-08-20 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP 1 filename1.htm August 20, 2025 Via EDGAR Securities and Exchange Commission Division of Corporation Finance Office of Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Protalix BioTherapeutics, Inc. Registration Statement on Form S-3 File No. 333-286802 To whom it may concern: Pursuant to Rule 461 under the Securities Act of 1933, as amended, Protalix BioTherapeutics, Inc. (the " Company ") hereby respectfully requests that the effective date of the above-referenced Registration Statement on Form S-3 be accelerated by the Securities and Exchange Commission to 4:00 p.m. Eastern Time on August 22, 2025, or as soon as practicable thereafter. The Company requests that we be notified of such effectiveness by a telephone call to Brian Hirshberg of Mayer Brown LLP at +1 (212) 506-2176. Very truly yours, Protalix BioTherapeutics, Inc. By: /s/ Eyal Rubin Name: Eyal Rubin Title: Sr. Vice President and Chief Financial Officer cc: Dror Bashan Protalix BioTherapeutics, Inc. Brian Hirshberg Mayer Brown LLP
2025-04-30 - UPLOAD - Protalix BioTherapeutics, Inc. File: 333-286802
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 30, 2025 Dror Bashan President and Chief Executive Officer Protalix BioTherapeutics, Inc. 2 University Plaza, Suite 100 Hackensack, NJ 07601 Re: Protalix BioTherapeutics, Inc. Registration Statement on Form S-3 Filed April 28, 2025 File No. 333-286802 Dear Dror Bashan: 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 Chris Edwards at 202-551-6761 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Brian D. Hirshberg </TEXT> </DOCUMENT>
2022-06-30 - UPLOAD - Protalix BioTherapeutics, Inc.
United States securities and exchange commission logo
June 30, 2022
Eyal Rubin
Senior Vice President and Chief Financial Officer
Protalix BioTherapeutics, Inc.
2 University Plaza, Suite 100
Hackensack, NJ 07601
Re:Protalix BioTherapeutics, Inc.
Form 10-K for the Year Ended December 31, 2021
Filed March 31, 2022
File No. 001-33357
Dear Mr. Rubin:
We have completed our review of your filing. 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.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2022-06-29 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP
1
filename1.htm
June 29, 2022
U.S. Securities and Exchange Commission
Division of Corporate Finance
Office of Life Sciences
Mail Stop 4720
100 F Street, N.E.
Washington, D.C. 20549
Re: Protalix BioTherapeutics, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2021
Filed March 31, 2022
File No. 001-33357
Ladies and Gentlemen:
Transmitted herewith is the response of Protalix
BioTherapeutics, Inc. (the “Company”) to the Staff’s comment to the Company’s Annual Report on Form 10-K for the
fiscal year ended December 31, 2021 (the “Form 10-K”), which comment was set forth in the Staff’s letter dated
June 23, 2022 (the “Comment Letter”) to Eyal Rubin, the Company’s Chief Financial Officer. For ease of reference,
the Company has noted the Staff’s comment in bold-faced type and the response in regular type.
Management's Discussion and Analysis of Financial
Condition and Results of Operations
You disclose on page 64 that you currently
do not record and maintain research and development costs per project. You also disclose on page 66 that the decrease in your research
and development expense was primarily due to the completion of the three phase III clinical trials of PRX-102. Please revise your future
filings to provide a quantified breakdown of research and development costs by nature of expense for each period presented. As part of
your breakdown, separately identify the amount of cost reimbursement netted against such expenses. Please provide us with an example of
your proposed disclosure in your response.
Response: The Company
respectfully acknowledges the Staff’s comment and provides an example of the requested breakdown of research and development
expenses below. The Company will provide, in its future filings with the U.S. Securities and Exchange Commission, where applicable,
a quantified breakdown of research and development costs by nature of expense for each period presented consistent with the
narrative disclosure example following this paragraph. The Company notes, however, that the example does not identify any cost
reimbursement that are netted against the research and development expenses as the Company has determined that for the current
period, the amount of such reimbursements do not reach a level of materiality that warrants such disclosure. The Company further
notes that the foregoing example sets forth the requested disclosure had it been included in the Form 10-K.
Research and Development Expenses,
Net
For the year ended December 31,
2021, our total research and development expenses were approximately $29.7 million comprised of approximately $18.3 million in subcontractor-related
expenses, approximately $7.4 million of salary and related expenses, approximately $1.2 million of materials-related expenses and approximately
$2.8 million of other expenses. For the year ended December 31, 2020, our total research and development expenses were approximately
$38.2 million comprised of approximately $21.9 million of subcontractor-related expenses, approximately $10.7 million of salary and
related expenses, approximately $1.7 million of materials-related expenses and approximately $4.0 million of other expenses.
The decrease in research and developments
expenses of $8.5 million, or 22%, from the year ended December 31, 2020 compared to the year ended December 31, 2021 was primarily
due to the completion of our three phase III clinical trials of PRX-102.
We expect research and development
expenses to continue to be our primary expense as we enter into a more advanced stage of preclinical and clinical trials for certain of
our product candidates.
* * *
We thank you in advance for your time and attention to this response
letter. Should you wish to discuss this response letter at any time, please do not hesitate to contact me at +972 (4) 902-8100 or Eyal.Rubin@protalix.com
or the Company’s counsel, Brian Hirshberg of Mayer Brown LLP at +1 (212) 506-2176 or bhirshberg@mayerbrown.com.
Sincerely,
/s/
Eyal Rubin
Eyal
Rubin
Sr.
Vice President and Chief Financial Officer
Protalix
BioTherapeutics, Inc.
cc:
Dror
Bashan
Protalix
BioTherapeutics, Inc.
Anna
Pinedo
Brian
Hirshberg
Mayer
Brown LLP
2
2022-06-23 - UPLOAD - Protalix BioTherapeutics, Inc.
United States securities and exchange commission logo
June 23, 2022
Eyal Rubin
Senior Vice President and Chief Financial Officer
Protalix BioTherapeutics, Inc.
2 University Plaza, Suite 100
Hackensack, NJ 07601
Re:Protalix BioTherapeutics, Inc.
Form 10-K for the Year Ended December 31, 2021
Filed March 31, 2022
File No. 001-33357
Dear Mr. Rubin:
We have limited our review of your filing to the financial statements and related
disclosures 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 these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
Form 10-K for the Year Ended December 31, 2021
Management's Discussion and Analysis of Financial Condition and Results of Operations, page
60
1.You disclose on page 64 that you currently do not record and maintain research and
development costs per project. You also disclose on page 66 that the decrease in your
research and development expense was primarily due to the completion of the three phase
III clinical trials of PRX-102. Please revise your future filings to provide a quantified
breakdown of research and development costs by nature of expense for each period
presented. As part of your breakdown, separately identify the amount of cost
reimbursement netted against such expenses. Please provide us with an example of your
proposed disclosure in your response.
In closing, 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
FirstName LastNameEyal Rubin
Comapany NameProtalix BioTherapeutics, Inc.
June 23, 2022 Page 2
FirstName LastName
Eyal Rubin
Protalix BioTherapeutics, Inc.
June 23, 2022
Page 2
absence of action by the staff.
You may contact Tracie Mariner, Staff Accountant, at (202) 551-3744 or Kevin Vaughn,
Branch Chief, at (202) 551-3494 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2022-04-27 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP
1
filename1.htm
April 27, 2022
VIA EDGAR
Jessica Ansart
Office of Life Sciences
U.S. Securities and Exchange Commission
Division of Corporation Finance
Mail Stop 4720
100 F Street, N.E.
Washington, D.C. 20549
Re: Protalix BioTherapeutics, Inc.
Registration Statement on Form S-3
Filed April 20, 2022
File No. 333-264394
Dear Ms. Ansart:
We refer to the registration statement on Form
S-3 (File No. 333-264394) (the “Registration Statement”) of Protalix BioTherapeutics, Inc., a Delaware corporation (the “Company”).
In accordance with Rule 461 under the Securities Act of 1933, as amended, the Company hereby respectfully requests the acceleration of
the effectiveness of the Registration Statement so that it may become effective at 5:00 p.m. (Eastern time) on April 29, 2022 or
as soon as practicable thereafter, which shall be after we file our Definitive Proxy Statement for our Annual Meeting of Stockholders
scheduled for June 30, 2022.
We thank you in advance for your time and attention
to the Registration Statement. Should you wish to discuss the enclosed materials at any time, please do not hesitate to contact me at
+972 (4) 902-8100 or Eyal.Rubin@protalix.com, or the Company’s counsel, Brian Hirshberg of Mayer Brown LLP at +1 (212) 506-2176
or bhirshberg@mayerbrown.com.
Sincerely,
/s/ Eyal Rubin
Eyal Rubin
Sr. Vice President and Chief Financial Officer
Protalix BioTherapeutics, Inc.
cc: Dror Bashan
Protalix BioTherapeutics, Inc.
Brian
Hirshberg
Mayer Brown LLP
2
Snunit Street, Science Park P.O.B. 455, Carmiel 20100, Israel
Tel:
972-4-988-9488 | Fax: 972-4-988-9489 | Web: www.protalix.com
2022-04-25 - UPLOAD - Protalix BioTherapeutics, Inc.
United States securities and exchange commission logo
April 25, 2022
Joseph Magnas
General Counsel
Protalix BioTherapeutics, Inc.
2 University Plaza, Suite 100
Hackensack, NJ 07601
Re:Protalix BioTherapeutics, Inc.
Registration Statement on Form S-3
Filed April 20, 2022
File No. 333-264394
Dear Mr. Magnas:
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 Jessica Ansart at 202-551-4511 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Brian Hirshberg
2020-04-27 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP 1 filename1.htm April 27, 2020 VIA EDGAR Jeffrey Gabor Office of Life Sciences U.S. Securities and Exchange Commission Division of Corporation Finance Mail Stop 4720 100 F Street, N.E. Washington, D.C. 20549 Re: Protalix BioTherapeutics, Inc. Registration Statement on Form S-3 Filed April 17, 2020 File No. 333-237736 Dear Mr. McCann: We refer to the registration statement on Form S-3 (File No. 333-237736) (the “Registration Statement”) of Protalix BioTherapeutics, Inc., a Delaware corporation (the “Company”). In accordance with Rule 461 under the Securities Act of 1933, as amended, the Company hereby respectfully requests the acceleration of the effectiveness of the Registration Statement so that it may become effective at 4:30 p.m. (Eastern time) on April 29, 2020 or as soon as practicable thereafter. We thank you in advance for your time and attention to the Registration Statement. Should you wish to discuss the enclosed materials at any time, please do not hesitate to contact me at +972 (4) 902-8100 or Eyal.Rubin@protalix.com, or the Company’s counsel, Anna T. Pinedo of Mayer Brown LLP at +1 (212) 506-2275 or apinedo@mayerbrown.com. Sincerely, /s/ Eyal Rubin Eyal Rubin Sr. Vice President and Chief Financial Officer Protalix BioTherapeutics, Inc. cc: Dror Bashan Protalix BioTherapeutics, Inc. Anna T. Pinedo Mayer Brown LLP 2 Snunit Street, Science Park P.O.B. 455, Carmiel 20100, Israel Tel: 972-4-988-9488 | Fax: 972-4-988-9489 | Web: www.protalix.com
2020-04-22 - UPLOAD - Protalix BioTherapeutics, Inc.
April 22, 2020
Dror Bashan
Chief Executive Officer
Protalix BioTherapeutics, Inc.
2 Snunit Street, Science Park
P.O. Box 455
Carmiel 2161401, Israel
Re:Protalix BioTherapeutics, Inc.
Registration Statement on Form S-3
Filed April 17, 2020
File No. 333-237736
Dear Mr. Bashan:
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 Jeffrey Gabor at 202-551-2544 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Brian Hirshberg, Esq.
2019-04-10 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP 1 filename1.htm April 10, 2019 VIA EDGAR Joseph McCann Office of Healthcare and Insurance U.S. Securities and Exchange Commission Division of Corporate Finance Mail Stop 4720 100 F Street, N.E. Washington, D.C. 20549 Re: Protalix BioTherapeutics, Inc. Registration Statement on Form S-3 Filed March 29, 2019 File No. 333-230604 Dear Mr. McCann: We refer to the registration statement on Form S-3 (File No. 333-230604) (the “Registration Statement”) of Protalix BioTherapeutics, Inc., a Delaware corporation (the “Company”). In accordance with Rule 461 under the Securities Act of 1933, as amended, the Company hereby respectfully requests the acceleration of the effectiveness of the Registration Statement so that it may become effective at 4:05 p.m. (Eastern time) on April 12, 2019 or as soon as practicable thereafter. We thank you in advance for your time and attention to the Registration Statement. Should you wish to discuss the enclosed materials at any time, please do not hesitate to contact me at +972 (4) 902-8100 or YossiM@protalix.com, or the Company’s counsel, Anna T. Pinedo of Mayer Brown LLP at +1 (212) 506-2275 or apinedo@mayerbrown.com. Sincerely, /s/ Yossi Maimon Yossi Maimon Vice President and Chief Financial Officer Protalix BioTherapeutics, Inc. cc: Moshe Manor Protalix BioTherapeutics, Inc. Anna T. Pinedo Mayer Brown LLP 2 Snunit Street, Science Park P.O.B. 455, Carmiel 20100, Israel Tel: 972-4-988-9488 | Fax: 972-4-988-9489 | Web: www.protalix.com
2019-04-08 - UPLOAD - Protalix BioTherapeutics, Inc.
April 5, 2019
Moshe Manor
President and Chief Executive Officer
Protalix BioTherapeutics, Inc.
2 Snunit Street
Science Park
P.O. Box 455
Carmiel, Israel 20100
Re:Protalix BioTherapeutics, Inc.
Registration Statement on Form S-3
Filed March 29, 2019
File No. 333-230604
Dear Mr. Manor:
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 Joseph McCann at (202) 551-6262 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-03-15 - UPLOAD - Protalix BioTherapeutics, Inc.
March 14, 2019
Yossi Maimon
Chief Financial Officer
Protalix BioTherapeutics, Inc.
2 Snunit Street
Science Park
POB 455
Carmiel, Israel 20100
Re:Protalix BioTherapeutics, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed March 6, 2018
File No. 001-33357
Dear Mr. Maimon:
We have completed our review of your filings. 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.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-03-11 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP
1
filename1.htm
March 11, 2019
Mary Mast
Angela Connell
U.S. Securities and Exchange Commission
Division of Corporation Finance
Mail Stop 4720
100 F Street, N.E.
Washington, D.C. 20549
Re:
Protalix BioTherapeutics, Inc.
Form 10-K for the Fiscal Year Ended December
31, 2017
Filed March 6, 2018
Form 10-Q for the Quarterly Period Ended September
30, 2018
Filed November 7, 2018
File No. 001-33357
Ladies and Gentlemen:
Transmitted herewith is the response of Protalix
BioTherapeutics, Inc. (the “Company” or “Protalix”) to the Staff’s comments to our Annual Report
on Form 10-K for the year ended December 31, 2017 (the “Form 10-K”) and Quarterly Report on Form 10-Q for the
quarter ended September 30, 2018 (the “Form 10-Q”), which were set forth in the Staff’s letter dated February 13,
2019 (the “Second Comment Letter”) to Yossi Maimon, our Chief Financial Officer. The original comment letter was dated
December 4, 2018, and our initial response was filed on December 27, 2018. For ease of reference, we have noted the Staff’s
comments in bold-faced type and the responses in regular type.
Notes to the Consolidated Financial Statements
d. Revenue Recognition, page 8
1. We
acknowledge your response to comment one. Please address the following as it relates to your determination that the performance
obligations represented a single performance obligation since the license, clinical development and manufacturing and supply obligations
were not distinct:
● how your statement on page 2 of your response that Chiesi was not granted any other rights to,
or benefits from, the intellectual property is consistent with Section 2.1b of the agreements. The agreements appear to give Chiesi
the right to use Protalix Technology as necessary to (i) seek and obtain Regulatory Approval for the Licensed Product in the Field
in the Territory.
2 Snunit Street,
Science Park P.O.B. 455, Carmiel 20100, Israel
Tel: 972-4-988-9488
| Fax: 972-4-988-9489 | Web: www.protalix.com
● why the license and research and development services, either alone or combined, are not capable
of being distinct from the manufacturing services pursuant to ASC 606-10-25-19a. In this respect, the subcontracting and sublicensing
rights in Section 2.4 and step-in rights in Section 3.2 of the agreements appear to indicate there may be available resources outside
of the company that could provide the research and development services and supplies. Refer also to Example 56, Case B in ASC 606-10-55-371
through 55-372. In this regard, we note in Case A that an approved drug is provided in the contract with manufacturing services,
for which no other promised goods or services are included in the contract, which appears to be contrary to the company’s
facts and circumstances.
● why the license and research and development services, either alone or combined, are not separately
identifiable from the supply obligation and thus do not meet the criteria in ASC 606-10-25-19b. In this regard, it appears due
to the subcontracting and sublicensing rights, the license and research and development services are not interrelated with the
manufacturing services pursuant to ASC 606-10-25-21c. Refer also to Example 56, Case B, ASC 606-10-55-372A.
Response:
The Company
reviewed its position in light of the Staff’s comments and will change its accounting analysis of the arrangements with Chiesi
Farmaceutici S.p.A. (“Chiesi”) and related revenue recognition, as detailed below.
After review
of the Staff’s comments, and a subsequent reconsideration of applicable accounting guidance in ASC 606-10-25-14 through 25-21,
the Company has concluded that the license and R&D services are not distinct promises
and should be combined as a single performance obligation. However, the Company’s obligation to manufacture product
upon approval essentially represents an optional future purchase by Chiesi at a standalone selling price. Accordingly, in effect,
the contract contains one performance obligation for the license and R&D services and an option for Chiesi to purchase manufactured
product that does not represent a material right.
With respect
to the license and R&D services, the rationale for a combined performance obligation is as follows: Chiesi cannot benefit from
the license without the R&D services. The R&D services are highly specialized and depend completely on the supply of the
drug that can only be produced by the Company. Chiesi cannot supply the drug for the clinical trials by itself or with the use
of a third party (for example, a contract manufacturing organization) as the plant-based process is so complex and highly specialized
that it requires specific infrastructure and know-how that only the Company and its employees possess. The license and R&D
(including the supply of product for the clinical studies) are significantly affected by each other because Protalix would not
be able to fulfill its promise by transferring each of the goods or services independently. Based on the foregoing and the factors
set forth in ASC-10-25-21, specifically 25-21(c), the Company concluded that the license is not distinct from the R&D services.
2
Chiesi’s
option to purchase commercial product manufactured by Protalix, after receipt of regulatory approval for the drug, is at standalone
selling prices (a market-based, tiered royalty arrangement common in the industry), and, therefore, does not represent a material
right. As such, the manufacture and sale of drug product is not a performance obligation as of December 31, 2018. Upon receipt
of regulatory approval, and at the request of Chiesi for Protalix to provide drug product, Protalix’s commitment to manufacture
and sell drug product would be accounted for, in effect, as a separate contract—a modification that adds distinct goods/services
at standalone selling price—for purposes of revenue recognition under ASC 606. The performance obligation would begin after
completion of the R&D services and receipt of regulatory approval for the drug.
The transaction
price of the Ex-US agreement was $50 million at contract inception, which was comprised of $25 million of fixed consideration and
an estimate of $25 million of variable consideration for reimbursement of R&D services. However, as those reimbursements are
subject to a cap, which is considerably less than the Company’s expected R&D costs, this consideration essentially becomes
fixed consideration. The transaction price of the US agreement was $45 million at contract inception, which was comprised of $25
million of fixed consideration and an estimate of $20 million of variable consideration for R&D reimbursements, which are similarly
capped, and, in effect fixed consideration.
With respect
to the various R&D milestone payments, the Company estimates variable consideration using the most likely amount method. At
contract inception and through December 31, 2018, no milestone payments were included in transaction price.
The method
of measuring progress for the combined performance obligation (the license and the R&D services) is the cost-to-cost method,
which the Company believes best depicts the pattern of transfer to the customer. Under the cost-to-cost method, the extent of progress
towards completion is measured based on the ratio of actual costs incurred to the total estimated costs expected to be incurred
upon satisfying the identified performance obligation. Under this method, revenue will be recorded as a percentage of the estimated
transaction price based on the extent of progress towards completion.
The estimate
of the Company’s measure of progress and estimate of variable consideration to be included in the transaction price will
be updated at each reporting date. For the portion of the performance obligation already satisfied, the change in transaction price
will be reflected as a change in accounting estimate. The amount related to the unsatisfied portion will be recognized as that
portion is satisfied over time.
Upon clarification
of this position with the Staff, subject to the approval of its Audit Committee and Board of Directors, the Company intends to
restate its 2018 quarterly financial statements, disclosing the reason for the restatement and its effect. With respect to the
2017 annual consolidated financial statements, the Company evaluated the materiality of the error from quantitative and qualitative
perspectives, and concluded that the error was immaterial.
2. As
it relates to your determination that revenue from the combined performance obligation should be recognized at a point in time
upon the supply of the drug, please address the following:
3
● Your response states that you intend to recognize revenue at the point in time in which Chiesi
achieves control over batches supplied. However, you also state that you will recognize revenue as product is delivered to Chiesi
based on the quantity supplied compared to the forecasted quantity of the drug to be supplied over the term of the agreements,
which would appear to be an over time measurement. Please clarify this apparent inconsistency. Please also explain how you intend
to estimate the forecasted quantity of the drug to be supplied over the term of the agreements and how this estimate would be deemed
to be a reasonable measure of progress considering the guidance in ASC 606-10-25-36.
● Your response states that Protalix will “start satisfying its performance obligation only
upon supply of the drug after issuance of regulatory marketing approvals.” Explain how you considered the contract duration
guidance in ASC 606-10-25-3 which states that the guidance in this Topic should be applied to the duration of the contract (that
is, the contractual period) in which the parties to the contract have present enforceable rights and obligations. In this regard,
it would appear that the enforceable rights and obligations under these contracts began at their effective dates, which was October
19, 2017 for the Chiesi Ex-U.S. Agreement and July 23, 2018 for the Chiesi U.S. Agreement. Accordingly, it is unclear to us why
an over time measurement of your performance obligation would not be recognized over the entire contractual period.
● Explain how you considered the guidance in ASC 606-10-25-27(c) in determining whether your performance
obligation is being satisfied over time. In this regard, address the following:
o Clarify whether your performance under the contracts
create an asset with alternative future use. In this regard, explain whether you are contractually restricted from developing
pegunigalsidase alfa (PRX-102) for your or any other entity’s benefit as long as the Chiesi agreements are in effect.
o Explain whether you have an enforceable right to payment for performance completed to date under
the contracts. In this regard, it would appear that you would have the full right to the non-refundable upfront payments (at a
minimum) even in the event that the drug does not receive regulatory approval and enter the commercialization phase.
Response:
As noted in the response to Question
number 1, after reconsidering the performance obligations in the contract, the supply of product is an optional purchase. Please
refer to the response to Question number 1.
* * *
4
We thank you in advance for your time and
attention to this response letter. Should you wish to discuss this response letter at any time, please do not hesitate to contact
me at +972 (4) 902-8100 or YossiM@protalix.com or our counsel, Brian Hirshberg of Mayer Brown LLP at +1 (212) 506-2176 or bhirshberg@mayerbrown.com.
Sincerely,
/s/ Yossi Maimon
Yossi Maimon
Vice President and Chief Financial Officer
Protalix BioTherapeutics, Inc.
cc:
Moshe Manor
Protalix BioTherapeutics, Inc.
Brian Hirshberg
Mayer Brown LLP
5
2019-02-14 - UPLOAD - Protalix BioTherapeutics, Inc.
February 13, 2019
Yossi Maimon
Chief Financial Officer
Protalix BioTherapeutics, Inc.
2 Snunit Street
Science Park
POB 455
Carmiel, Israel 20100
Re:Protalix BioTherapeutics, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed March 6, 2018
Form 10-Q for the Quarterly Period Ended September 30, 2018
Filed November 7, 2018
File No. 001-33357
Dear Mr. Maimon:
We have reviewed your December 27, 2018 response to our comment letter 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 these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comments apply to your facts and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional
comments. Unless we note otherwise, our references to prior comments are to comments in our
December 4, 2018 letter.
Form 10-Q for the Quarterly Period Ended September 30, 2018
Notes to the Consolidated Financial Statements
d. Revenue Recognition, page 8
1.We acknowledge your response to comment one. Please address the following as it relates
to your determination that the performance obligations represented a single performance
obligation since the license, clinical development and manufacturing and supply
obligations were not distinct:
FirstName LastNameYossi Maimon
Comapany NameProtalix BioTherapeutics, Inc.
February 13, 2019 Page 2
FirstName LastNameYossi Maimon
Protalix BioTherapeutics, Inc.
February 13, 2019
Page 2
•how your statement on page 2 of your response that Chiesi was not granted any other
rights to, or benefits from, the intellectual property is consistent with Section 2.1b of
the agreements. The agreements appear to give Chiesi the right to use Protalix
Technology as necessary to (i) seek and obtain Regulatory Approval for the Licensed
Product in the Field in the Territory.
•why the license and research and development services, either alone or combined, are
not capable of being distinct from the manufacturing services pursuant to ASC 606-
10-25-19a. In this respect, the subcontracting and sublicensing rights in Section 2.4
and step-in rights in Section 3.2 of the agreements appear to indicate there may be
available resources outside of the company that could provide the research and
development services and supplies. Refer also to Example 56, Case B in ASC 606-10-
55-371 through 55-372. In this regard, we note in Case A that an approved drug is
provided in the contract with manufacturing services, for which no other promised
goods or services are included in the contract, which appears to be contrary to the
company's facts and circumstances.
•why the license and research and development services, either alone or combined, are
not separately identifiable from the supply obligation and thus do not meet the criteria
in ASC 606-10-25-19b. In this regard, it appears due to the subcontracting and
sublicensing rights, the license and research and development services are not inter-
related with the manufacturing services pursuant to ASC 606-10-25-21c. Refer also to
Example 56, Case B, ASC 606-10-55-372A.
2.As it relates to your determination that revenue from the combined performance
obligation should be recognized at a point in time upon the supply of the drug, please
address the following:
•Your response states that you intend to recognize revenue at the point in time in which
Chiesi achieves control over batches supplied. However, you also state that you will
recognize revenue as product is delivered to Chiesi based on the quantity supplied
compared to the forecasted quantity of the drug to be supplied over the term of the
agreements, which would appear to be an over time measurement. Please clarify this
apparent inconsistency. Please also explain how you intend to estimate the forecasted
quantity of the drug to be supplied over the term of the agreements and how this
estimate would be deemed to be a reasonable measure of progress considering the
guidance in ASC 606-10-25-36.
•Your response states that Protalix will "start satisfying its performance obligation only
upon supply of the drug after issuance of regulatory marketing approvals." Explain
how you considered the contract duration guidance in ASC 606-10-25-3 which states
that the guidance in this Topic should be applied to the duration of the contract (that is,
the contractual period) in which the parties to the contract have present enforceable
rights and obligations. In this regard, it would appear that the enforceable rights and
obligations under these contracts began at their effective dates, which was October 19,
FirstName LastNameYossi Maimon
Comapany NameProtalix BioTherapeutics, Inc.
February 13, 2019 Page 3
FirstName LastName
Yossi Maimon
Protalix BioTherapeutics, Inc.
February 13, 2019
Page 3
2017 for the Chiesi Ex-U.S. Agreement and July 23, 2018 for the Chiesi U.S.
Agreement. Accordingly, it is unclear to us why an over time measurement of your
performance obligation would not be recognized over the entire contractual period.
•Explain how you considered the guidance in ASC 606-10-25-27(c) in determining
whether your performance obligation is being satisfied over time. In this regard,
address the following:
oClarify whether your performance under the contracts create an asset with
alternative future use. In this regard, explain whether you are contractually
restricted from developing pegunigalsidase alfa (PX-102) for your or any other
entity's benefit as long as the Chiesi agreements are in effect.
oExplain whether you have an enforceable right to payment for performance
completed to date under the contracts. In this regard, it would appear that you
would have the full right to the non-refundable upfront payments (at a minimum)
even in the event that the drug does not receive regulatory approval and enter the
commercialization phase.
You may contact Mary Mast at (202) 551-3613 or Angela Connell at (202) 551-3426
with any other questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2018-12-27 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP
1
filename1.htm
December 27, 2018
Mary Mast
Angela Connell
U.S. Securities and Exchange Commission
Division of Corporate Finance
Mail Stop 4720
100 F Street, N.E.
Washington, D.C. 20549
Re:
Protalix BioTherapeutics, Inc.
Form 10-K for the Fiscal Year Ended December
31, 2017
Filed March 6, 2018
Form 10-Q for the Quarterly Period Ended September 30, 2018
Filed November 7, 2018
File No. 001-33357
Ladies and Gentlemen:
Transmitted herewith is the response of Protalix
BioTherapeutics, Inc. to the Staff’s comments to our Annual Report on Form 10-K for the fiscal year ended December 31,
2017 (the “Form 10-K”) and Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2018 (the
“Form 10-Q”), which comments were set forth in the Staff’s letter dated December 4, 2018 (the “Comment
Letter”) to Yossi Maimon, our Chief Financial Officer. For ease of reference, we have noted the Staff’s comments in
bold-faced type and the responses in regular type.
Notes to the Consolidated Financial Statements
d. Revenue Recognition, page 8
1. You state that the development and manufacturing services for the Chiesi agreements are viewed as a single performance obligation
and therefore the upfront payments, future research and development reimbursement payments and any potential additional development
milestone payments under each agreement will be deferred until the commencement of commercial manufacturing. Please address the
following:
· Identify for us each of the promised goods or services in these agreements including the transfers
of licenses and explain how you determined that you only had a single performance obligation under the guidance in ASC 606-10-25-14.
Response: Protalix Ltd.,
our wholly-owned subsidiary, develops recombinant therapeutic proteins based on its proprietary ProCellEx® protein
expression system. ProCellEx is a production system based on plant cell culture technology for the development, expression and
manufacture of recombinant proteins. Protalix Ltd.’s research and development activities target the development of drugs
to treat certain diseases using its unique technology in the manufacturing process of the drugs. It is the first company to gain
U.S. Food and Drug Administration approval of a protein produced through plant cell-based expression. The ProCellEx platform is
a proven alternative to mammalian cell-based production technology (the most common form of recombinant protein production), overcoming
many of the disadvantages of mammalian cell-based production while offering significant production, regulatory and cost advantages.
Protalix Ltd. has entered into
two separate agreements with Chiesi Farmaceutici S.p.A. (“Chiesi”) with respect to the license and supply of pegunigalsidase
alfa, our drug candidate for the treatment of Fabry disease that currently is under advanced stages of clinical development (the
“drug” or the “product”): the Exclusive License and Supply Agreement dated as of October 17, 2017 covering
all territories outside of the United States and the Exclusive U.S. License and Supply Agreement dated as of July 23, 2018 covering
the United States (collectively, the “Chiesi Agreements”). Under the terms of the Chiesi Agreements, the parties have
agreed to the following:
i) License
– Chiesi was granted exclusive, non-transferrable, worldwide license rights to commercialize pegunigalsidase alfa. Chiesi
was not granted any other rights to, or benefits from, the intellectual property of Protalix Ltd. (the “IP”).
ii) Clinical
development – Protalix Ltd. is responsible for continuing the actual clinical development of the product in order to obtain
regulatory approvals for the drug. Chiesi did not receive any right to use the clinical data other than for commercialization purposes.
Hence, Chiesi does not have the right to use the results of Protalix Ltd.’s clinical development activities with respect
to the product for its own research and development activities in other areas or for other products.
iii) Manufacturing
and supply – After a regulatory approval for the drug is obtained, Protalix is required to manufacture and supply the drug
to Chiesi based on Chiesi’s purchase orders. Chiesi will have no other way to obtain the product other than purchasing the
product from Protalix Ltd.
ASC 606-10-25-14 states:
“At contract inception, an
entity shall assess the goods or services promised in a contract with a customer and shall identify as a performance obligation
each promise to transfer to the customer either:
a. A good or service (or a bundle of goods or services) that is distinct.
b.
A series of distinct goods or services that are substantially the same and that have the same pattern of transfer to the customer
(see paragraph 606-10-25-15).”
2
ASC 606-10-25-17 states:
“Performance obligations
do not include activities that an entity must undertake to fulfill a contract unless those activities transfer a good or service
to a customer.”
ASC 606-10-25-19 states:
“A good or service that is
promised to a customer is distinct if both of the following criteria are met:
a. The customer can benefit from the good or service either on its own or together with other resources
that are readily available to the customer (that is, the good or service is capable of being distinct).
b. The entity’s promise to transfer the good or service to the customer is separately identifiable
from other promises in the contract (that is, the promise to transfer the good or service is distinct within the context of the
contract).”
ASC 606-10-25-20 states:
“A customer can benefit from
a good or service in accordance with paragraph 606-10-25-19(a) if the good or service could be used, consumed, sold for an amount
that is greater than scrap value, or otherwise held in a way that generates economic benefits...”
The grant of non-transferrable
commercialization rights and Protalix Ltd.’s commitment to complete the clinical development of the drug are not distinct
actions and do not transfer any benefit to Chiesi prior to the commencement of commercial production of the drug, for the following
reasons:
· Chiesi cannot benefit from the license on
its own or together with other available resources. Chiesi does not have sublicensing rights (except for certain small territories)
and has neither the right, the ability nor the know-how to continue the clinical development of the product (subject to certain,
limited exceptions). Therefore, the license is not distinct.
· Completion of the clinical development is
a condition precedent to Chiesi’s ultimate sale of the product. Chiesi cannot benefit in any other manner from the clinical
development activities performed by Protalix Ltd. as Chiesi does not have the right to use any information obtained from Protalix
Ltd.’s clinical development efforts, or from the license granted to Chiesi to use the clinical development information, for
other indications that could be developed from the IP. Protalix Ltd. continues to be the owner of the IP and to be entitled to
use the IP for its research and development activities in other areas and for the development of other drugs. Therefore, the clinical
development activities are not capable of being distinct.
· Chiesi is obligated to acquire the product
from Protalix Ltd. It cannot generate economic benefits from the commercialization license or from the completion of the clinical
development in any way except from the ability to sell the finished product, which must be purchased from Protalix Ltd. Since the
unique manufacturing process is crucial to the drug and only Protalix Ltd. can perform the manufacturing, no one else can produce
the product and/or complete the clinical development.
3
Based on the above, the criterion
in paragraph 606-10-25-19(a) is not met. Consequently, the license, the clinical development and the manufacturing services are
not distinct activities and thus, we have accounted for the Chiesi Agreements as a single performance obligation. See also
Example 56 to ASC 606 —“Identifying a Distinct License – case A”.
In substance, we deem the Chiesi
Agreements to be a transfer of specifically defined commercialization rights and a supply agreement for a drug pending approval
in exchange for Chiesi’s upfront contributions to Protalix Ltd.’s development costs, and additional payments of the
ongoing purchase price of the product as stipulated in the Chiesi Agreements.
· With reference to ASC 606-10-25-23 to 25-26, explain to us why revenue is deferred until commencement
of commercial manufacturing and how you considered that you have already transferred the licenses and begun providing development
services.
Response: As described above,
based on the unique facts and the terms of the Chiesi Agreements, we believe that each of the Chiesi Agreements should be viewed
as a commercialization and distribution agreement as Chiesi will benefit from an agreement only upon the purchase of the drug from
Protalix Ltd. and the subsequent sales of the drug.
Neither the grant of the license
to commercialize the drug nor the continuation of the clinical development transfers any goods or services to Chiesi and, therefore,
neither of these activities qualifies as a distinct performance obligation of Protalix Ltd.
Protalix Ltd. will start satisfying
its performance obligation only upon supply of the drug after issuance of regulatory marketing approvals. All consideration received
and to be received up to the commercialization phase relates to the ultimate supply of product to Chiesi and therefore are deferred
and recognized only upon satisfaction of a single performance obligation, which is the supply of the drug.
· Explain to us whether you intend to recognize revenue over time or at a point in time, and why
with reference to ASC 606-10-25-30 or 25-31, as applicable.
Response: As described above,
we intend to begin recognizing revenue when entering into the commercial manufacturing/supply phase as product is delivered to
Chiesi for commercial purposes. At that date, we intend to estimate the forecasted quantity of the drug to be supplied over the
term of the Chiesi Agreements. Deferred revenue will be recognized based on the quantity supplied out of the total expected quantity.
Hence, we intend to recognize revenue at a point in time at which Chiesi achieves control over batches supplied.
We intend to evaluate the need to expand the related disclosure
in our financial statements included in future filings in order to further clarify the rational for the accounting for the consideration
received under the Chiesi Agreements and the related revenue recognition.
* * *
4
We thank you in advance for your time and attention to this
response letter. Should you wish to discuss this response letter at any time, please do not hesitate to contact me at +972 (4)
902-8100 or YossiM@protalix.com or our counsel, Brian Hirshberg of Mayer Brown LLP at +1 (212) 506-2176 or bhirshberg@mayerbrown.com.
Sincerely,
/s/ Yossi Maimon
Yossi Maimon
Vice President and Chief Financial Officer
Protalix BioTherapeutics, Inc.
cc:
Moshe Manor
Protalix BioTherapeutics, Inc.
Brian Hirshberg
Mayer Brown LLP
5
2018-12-04 - UPLOAD - Protalix BioTherapeutics, Inc.
December 4, 2018
Yossi Maimon
Chief Financial Officer
Protalix BioTherapeutics, Inc.
2 Snunit Street
Science Park
POB 455
Carmiel, Israel 20100
Re:Protalix BioTherapeutics, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2017
Filed March 6, 2018
Form 10-Q for the Quarterly Period Ended September 30, 2018
Filed November 7, 2018
File No. 001-33357
Dear Mr. Maimon:
We have limited our review of your filing to the financial statements and related
disclosures and have the following comment. In our comment, we may ask you to provide us
with information so we may better understand your disclosure.
Please respond to the comment within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe our
comment applies to your facts and circumstances, please tell us why in your response.
After reviewing your response to the comment, we may have additional comments.
Form 10-Q for the Quarterly Period Ended September 30, 2018
Notes to the Consolidated Financial Statements
d. Revenue Recognition, page 8
1.You state that the development and manufacturing services for the Chiesi agreements
are viewed as a single performance obligation and therefore the upfront payments, future
research and development reimbursement payments and any potential additional
development milestone payments under each agreement will be deferred until the
commencement of commercial manufacturing. Please address the following:
•Identify for us each of the promised goods or services in these agreements including
the transfers of licenses and explain how you determined that you only had a single
FirstName LastNameYossi Maimon
Comapany NameProtalix BioTherapeutics, Inc.
December 4, 2018 Page 2
FirstName LastName
Yossi Maimon
Protalix BioTherapeutics, Inc.
December 4, 2018
Page 2
performance obligation under the guidance in ASC 606-10-25-14.
•With reference to ASC 606-10-25-23 to 25-26, explain to us why revenue is deferred
until commencement of commercial manufacturing and how you considered that you
have already transferred the licenses and begun providing development services.
•Explain to us whether you intend to recognize revenue over time or at a point in time,
and why with reference to ASC 606-10-25-30 or 25-31, as applicable.
In closing, 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.
You may contact Mary Mast at (202) 551-3613 or Angela Connell at (202) 551-
3426 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2015-12-16 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP 1 filename1.htm December 16, 2015 VIA EDGAR Suzanne Hayes Assistant Director Office of Healthcare and Insurance Securities and Exchange Commission Division of Corporate Finance Mail Stop 4720 100 F Street, N.E. Washington, D.C. 20549 Re: Protalix BioTherapeutics, Inc., Registration Statement on Form S-3 Filed November 13, 2015 and amended on November 27, 2015 File No. 333-208004 Dear Ms. Hayes: We refer to the registration statement on Form S-3 (File No. 333-208004) (as amended, the “Registration Statement”) of Protalix BioTherapeutics, Inc., a Florida corporation (the “Company”). In accordance with Rule 461 under the Securities Act of 1933, as amended, the Company hereby respectfully requests the acceleration of the effectiveness of the Registration Statement so that it may become effective at 4:05 p.m. (Eastern time) on December 18, 2015 or as soon as practicable thereafter. 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. We thank you in advance for your time and attention to the Registration Statement. Should you wish to discuss the enclosed materials at any time, please do not hesitate to contact me at +972 (4) 902-8100 or YossiM@protalix.com or the Company’s counsel, James R. Tanenbaum of Morrison & Foerster LLP at +1 (212) 468-8163 or jtanenbaum@mofo.com. Sincerely, /s/ Yossi Maimon Yossi Maimon Vice President and Chief Financial Officer Protalix BioTherapeutics, Inc. cc: Moshe Manor Protalix BioTherapeutics, Inc. James R. Tanenbaum Morrison & Foerster LLP 2 Snunit Street, Science Park P.O.B. 455, Carmiel 20100, Israel Tel: 972-4-988-9488 | Fax: 972-4-988-9489 | Web: www.protalix.com
2015-11-27 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP
1
filename1.htm
November 27, 2015
Suzanne Hayes
Assistant Director
Office of Healthcare and Insurance
Securities and Exchange Commission
Division of Corporate Finance
Mail Stop 4720
100 F Street, N.E.
Washington, D.C. 20549
Re: Protalix BioTherapeutics, Inc.
Registration Statement on Form S-3
Filed November 13, 2015
File No. 333-208004
Dear Ms. Hayes:
Reference is made to Amendment No. 1 to the Registration Statement
on Form S-3 (File No. 333-208004) (the “Registration Statement”) filed by Protalix BioTherapeutics, Inc. (the “Company”)
on November 27, 2015. The initial Registration Statement was filed with the Commission on November 13, 2015. The amended
Registration Statement was filed with the Securities and Exchange Commission (“Commission”) in response to the comments
of the staff (the “Staff”) that were contained in your letter dated November 19, 2015 (the “Comment Letter”).
Responses to Comment Letter
The following are the Company’s responses to the issues
and questions raised by the Staff in the Comment Letter. We have noted the Staff’s comments below in bold face type
and the responses in regular type.
General
1. We note you have a confidential treatment request
that is outstanding. The request will need to be granted prior to the effectiveness of this registration statement.
We understand that our outstanding confidential treatment request
must be granted before the Registration Statement can be declared effective. We will not request effectiveness until the Staff
has granted the confidential treatment request.
Exhibit Index, page II-9
2. We note that you intend to file your forms of indenture
by amendment or with current reports on Form 8-K. Please be advised that these documents must be filed as exhibits to your registration
statement prior to effectiveness, as this is when the indentures will be qualified pursuant to the Trust Indenture Act of 1939.
2 Snunit Street,
Science Park P.O.B. 455, Carmiel 20100, Israel
Tel: 972-4-988-9488
| Fax: 972-4-988-9489 | Web: www.protalix.com
Exhibit Index, page II-9
2. We note that you intend to file your forms of indenture
by amendment or with current reports on Form 8-K. Please be advised that these documents must be filed as exhibits to your registration
statement prior to effectiveness, as this is when the indentures will be qualified pursuant to the Trust Indenture Act of 1939.
In response to the Staff’s comment, the Company has filed
forms of indenture in Amendment No. 1 described above.
* * *
The Company hereby acknowledges 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 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.
The Company would be grateful if the Staff would provide any
comments to the amended Registration Statement at its earliest convenience so that the Company may provide any additional responses
required.
We thank you in advance for your time and attention to these
amendments, as well as to our comments. Should you wish to discuss the enclosed materials at any time, please do not hesitate to
contact me at +972 (4) 902-8100 or YossiM@protalix.com or the Company’s counsel, James R. Tanenbaum of Morrison & Foerster
LLP at +1 (212) 468-8163 or jtanenbaum@mofo.com.
Sincerely,
/s/ Yossi Maimon
Yossi Maimon
Vice President and Chief Financial Officer
Protalix BioTherapeutics, Inc.
cc: Moshe Manor
Protalix BioTherapeutics, Inc.
James R. Tanenbaum
Morrison & Foerster LLP
2
2015-11-19 - UPLOAD - Protalix BioTherapeutics, Inc.
Mailstop 4720 November 19, 2015 Via E -mail Moshe Manor 2 Snunit Street Science Park P.O. Box 455 Carmiel, Israel 20100 Re: Protalix BioTherapeutics, Inc. Registration Statement on Form S-3 Filed November 13, 2015 File No. 333-208004 Dear Mr. Manor : 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. General 1. We note that you have a pending request for confidential treatment. Please be advised that we will not be in a position to declare this registration statement effective until we resolve all issues concerning the confidential treatment request. Exhibit Index, page II -9 2. We note that you intend to file your forms of indenture by amendment or with current report s on Form 8 -K. Please be advised that the se document s must be filed as exhibit s to your registration statement prior to effectiveness, as this is when the indenture s will be qualified pursuant to the Trust Indenture Act of 1939. Moshe Manor Protalix BioTherapeutics, Inc. November 19, 2015 Page 2 We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to b e 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 registration statement , please provide a written statement from the company acknowledg ing 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 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. Please contact Christina Thomas at (202) 551 -3577 or me at (202) 551 -3675 with any questions. Sincerely, /s/ Suzanne Hayes Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Via E -mail James R. Tanenbaum, Esq. Moshe Manor Protalix BioTherapeutics, Inc. November 19, 2015 Page 3 Morrison & Foerster LLP 1290 Avenue of the Americas New York, NY 10104
2010-12-30 - UPLOAD - Protalix BioTherapeutics, Inc.
Via Facsimile and U.S. Mail December 30, 2010 David Aviezer, Ph.D. President and Chief Executive Officer Protalix Biotherapeutics , Inc. 2 Snunit St., Science Park POB 455, Carmiel 20100, Israel Re: Protalix Biotherapeutics, Inc. Form 10 -K for the Fiscal Year Ended December 31 , 2009 Filed February 26 , 2010 File No. 001-33357 Dear Dr. Aviezer : We have completed our review of your filings and do not have any further comments at this time. Sincerely, Jeffrey Riedler Assistant Director cc: James R. Tanenbaum , Esq. Joseph Magnas, Esq. Neeraj Kumar, Esq. Morrison & Foerster LLP 1290 Avenue of the Americas New York, NY 10104 -0050
2010-11-24 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP
1
filename1.htm
corresp
Writer’s Direct Contact
212.468.8163
JTanenbaum@mofo.com
November 24, 2010
Mr. Jeffery Riedler
Assistant Director
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549
RE:
Protalix BioTherapeutics, Inc.
Form 10-K for the Fiscal Year ended December 31, 2009
Filed February 26, 2010
File No. 001-33357
Ladies and Gentlemen:
On behalf of our client, Protalix BioTherapeutics, Inc., a Florida corporation (the “Company”),
transmitted herewith are responses to the Staff’s comments to the Company’s Annual Report on Form
10-K for the fiscal year ended December 31, 2009 (the “2009 Form 10-K”), which comments were set
forth in the Staff’s letter dated November 16, 2010 (the “Comment Letter”) to David Aviezer, Ph.D.,
the Company’s Chief Executive Officer. References to the Company in this response letter include
the Company and its wholly-owned subsidiary, Protalix Ltd., unless stated otherwise. The Staff
presented its original comments to the Company in a letter to Dr. Aviezer dated September 22, 2010
(“Original Letter”), and the Company responded to the Original Letter with a response letter from
this firm dated October 12, 2010 (the “Original Response”). For ease of reference, we have noted
the Staff’s comments in bold faced type and the responses in regular type.
Item 1. Business
1.
We note that your responses to comments 1, 3 and 6 state that the annual
maintenance fees were granted confidential treatment. It appears that these requests
were granted without the benefit of staff review. Please disclose the amounts of these
payments or tell us why you believe the amount of these payments is not material
information.
Response: In response to this comment, the Company intends to disclose the amount of the
annual license maintenance fees under its license agreements with both the Yissum Research and
Development Company and the Yeda Research and Development Company Limited in its next Annual Report
on Form 10-K and all other applicable filings under the Securities Act of 1933,
and the Securities
Exchange Act of 1934. The Company respectfully notes that there are no annual maintenance fees
under its license agreement with Icon Genetics AG. In Exhibit A and Exhibit B to
this letter, we have provided, on the Company’s behalf, revised examples of the disclosure that the
Company intends to make in its next annual report in response to this comment. These exhibits will
replace Exhibit A and Exhibit B to the Original Response. In each of Exhibit A and
Exhibit B, the Company has added a sentence regarding the annual fees payable under the
applicable license agreement. The Company has also provided a revised Exhibit D to clarify certain
disclosure regarding the Company’s obligation to pay royalties under the applicable license
agreement.
Item 11. Executive Compensation
Compensation Discussion and Analysis, page 65
2.
We note your response to our prior comment 9. Your response is unclear as you
state that the Compensation Committee has established a bonus plan for “certain
milestones” and that the Compensation Committee determines awards on a “discretionary
basis.” If the Compensation Committee identified and communicated goals to be used to
determine whether a bonus is paid and the amount of the bonus, please disclose all
goals set by the Committee, identify which goals were achieved and explain how the
level of achievement was used to determine the amount of each officer’s bonus. If
there were no predetermined goals and the awards were based solely on the discretion of
the Committee and the Committee based its discretion on the achievements identified,
please clarify that there were no predetermined goals.
Response: In February 2010, the Company’s Board of Directors, acting upon a resolution of
a majority of the independent directors, awarded bonuses payable to the Company’s named executive
officers in two tranches. The first tranche was awarded and payable at the discretion of the Board
of Directors and without the consideration of any predetermined goals. The second tranche of bonus
payments are payable upon the Company’s achievement of certain milestones relating to the progress
towards the anticipated commercialization of taliglucerase alfa, but are not based upon any
predetermined, individual goals communicated to any executive officer. The Company has revised the
language in Exhibit F to clarify the proposed disclosure. Exhibit F will replace
Exhibit F to the Original Response.
The Company notes that in September, 2010, the Company made its first shipment of taliglucerase
alfa, the first milestone in the second tranche of the milestone-based bonus payments. Promptly
after the achievement of that milestone, the Company paid the entire allocated amount to each named
executive officer, respectively. The Company intends to include disclosure regarding the final
bonus payments made in 2010 in its Annual Report on Form 10-K for the year ending December 31,
2010.
* * *
2
Please call the undersigned at the telephone number set forth above or Joseph Magnas at
212-336-4170 with any question or comment you may have regarding the responses set forth herein.
In addition, please send all written correspondence directly to the undersigned and Joseph Magnas
of Morrison & Foerster LLP, 1290 Avenue of the Americas, New York, New York 10104, telecopy
212-468-7900, with copies to David Aviezer, Ph.D., the Company’s President and Chief Executive
Officer, at 2 Snunit Street, Science Park, P.O.B. 455, Carmiel 20100, Israel, telecopy
+972-4-988-9489.
Sincerely,
/s/ James R. Tanenbaum
cc:
David Aviezer, Ph.D.
Yossi Maimon
3
Exhibit A
In August 2007, Protalix Ltd. licensed the rights to certain technology under a research and
license agreement with Yissum Research and Development Company, or Yissum, and the Boyce Thompson
Institute, Inc., or Boyce Thompson. Pursuant to the agreement, we are developing a proprietary
plant cell-based acetylcholinesterase (AChE) and its molecular variants for the use in several
therapeutic and prophylactic indications, as well as in a biodefense program and an
organophosphate-based pesticide treatment program. Under the terms of the agreement, Yissum and
Boyce Thompson granted us an exclusive, worldwide right and license to certain technology,
including patents and certain patent applications relating to AChE for the therapeutic and
prophylactic indications as well as an exclusive license not limited to such indications with
respect to certain of those patents and patent applications. As consideration for the license, we
are obligated to pay Yissum and Boyce Thompson, collectively, an annual, non-refundable initial
maintenance fee of $20,000, commencing on the fourth anniversary of the execution of the agreement,
which is subject to a 12% annual increase. In addition, we are obligated to make royalty payments
equal to varying low, single-digit percentages of net sales of products under the agreement. These
royalty rates are evaluated on a country-by-country basis, and are subject to reduction if a third
party commercializes a competing product or commercializes an authorized generic version of the
applicable product, subject to certain conditions. We also have the right to grant sublicenses
relating to the licensed technology under the agreement, subject to the payment of sublicensing
fees. The fees payable in connection with any sublicense are equal to varying percentages, in the
low-teens through the low-twenties, of the consideration we receive in connection with the
sublicense, depending on the level of clinical development of the product at the time we enter into
the sublicense. Last, we are obligated to pay Yissum and Boyce Thompson, collectively, milestone
payments equal to $700,000, in the aggregate, upon the achievement of certain milestones under the
license agreement.
The license agreement remains in effect until the expiration of all obligations to Yissum and
Boyce Thompson under the agreement, determined on a country-by-country basis. We have the right to
terminate the agreement for any reason upon 60 days’ prior written notice to Yissum and Boyce
Thompson. Subject to certain conditions, Yissum and Boyce Thompson may terminate the agreement
immediately upon written notice to us in connection with certain events relating to bankruptcy,
lapses in our insurance coverage, failures to defend against third party claims or claims we may
make regarding the validity or enforceability of any licensed patent. We or Yissum and Boyce
Thompson may terminate the agreement within 60 days after receiving written notice if the
non-terminating party passes a resolution for a voluntary wind up, if a receiver or liquidator is
appointed for the non-terminating party, or the non-terminating party enters into an insolvency or
bankruptcy proceeding. In addition, either party may terminate the agreement due to a material
breach by the other party if the breaching party is unable to cure the breach within 60 days after
receiving written notice of the breach from the non-breaching party. Any termination of the
agreement will result in a loss of our rights to the licensed technology, which will revert back to
Yissum and Boyce Thompson.
Exhibit B
In March 2006, Protalix Ltd. entered into a research and license agreement with the Yeda
Research and Development Company Limited, or Yeda, the technology transfer arm of the Weizmann
Institute of Science. Under the terms of the agreement, Yeda agreed to use its technology to
design a next generation of glucoceribrosidase (GCD) for the treatment of Gaucher disease that can
be expressed using our ProCellEx protein expression system and that may have certain benefits over
the first generation treatments used today. The technology licensed from Yeda provides a
methodology for the rational design of an improved drug for the treatment of Gaucher disease by
enzyme replacement therapy, based on the three-dimensional crystal structure of glucoceribrosidase
(GCD) that was solved by scientists from the Weizmann Institute of Science. Yeda has granted us an
exclusive worldwide license to use their technology and discoveries for the development, production
and sale of enzymatically active mutations of glucoceribrosidase (GCD) and derivatives thereof for
the treatment of Gaucher disease. Under the terms of the agreement, we are required to take all
necessary steps to develop and commercialize the products subject to the agreement.
As consideration for the license, we agreed to pay Yeda a fixed research budget amount,
subject to certain conditions. We have since completed the research phase of the arrangement with
Yeda. Accordingly, we are no longer making any research-related payments to Yeda under the
agreement. In addition, we are obligated to make an annual non-refundable license fee of $10,000
during the term of the agreement, commencing on the fifth anniversary of the execution of the
agreement until, and including, the 19th anniversary thereof. We are also obligated to
make royalty payments equal to varying low, single-digit percentages of net sales of products under
the agreement. Sublicenses relating to the licensed technology may be granted under the agreement,
subject to the payment of sublicensing fees. The fee for any sublicense is equal to a percentage,
ranging from the low-teens through the low-twenties, of the consideration we receive in connection
with the sublicense, depending on the level of clinical and regulatory development of the products
under the agreement at the time we enter into the sublicense.
The license agreement remains in effect until the earlier of the expiration of the last patent
licensed under the agreement or if there are no commercial sales of any products for a continuous
period of 20 years. Yeda may modify the exclusivity component of the agreement by written notice
to us and without our consent. Yeda may terminate the agreement by written notice to us if we fail
to satisfy any one or more specified milestones, and we fail to cure any such failure within a
certain time period after we receive the notice. Yeda is not entitled to exercise this termination
right if we demonstrate that we are making all necessary efforts to achieve such milestones, that
our inability to satisfy the milestones is due to factors beyond our control, and that the total
delay with respect to any one milestone does not exceed 12 months and the total cumulative delay in
respect of all milestones has not exceeded 30 months. Yeda may also terminate the agreement if we
contest the validity of any of the patents included in the agreement. We or Yeda may terminate the
agreement due to a material breach by the other party if the breach is unable to be cured or, if
curable, the breach is not cured within 21 days after the breaching party’s receipt of written
notice of the breach from the non-breaching party. In addition, either party may terminate the
agreement in connection with certain events relating to a wind up or bankruptcy.
Exhibit D
In April 2005, Protalix Ltd. entered into a license agreement with Icon Genetics AG, or
Icon, pursuant to which we received an exclusive worldwide license to develop, test, use and
commercialize Icon’s technology to express certain proteins in our ProCellEx protein expression
system. Under the terms of the agreement, we are also entitled to a non-exclusive worldwide
license to make and have made other proteins expressed by using Icon’s technology in our
technology. As consideration for the license, we are obligated to make royalty payments equal to
varying low, single-digit percentages of net sales of products by us, our affiliates, or any
sublicensees under the agreement. In addition, we are obligated to make milestone payments
equal to $350,000, in aggregate, upon the achievement of certain milestones.
The license agreement remains in effect until the earlier of the expiration of the last patent
under the agreement or, if all of the patents under the agreement expire, 20 years after the first
commercial sale of any product under the agreement. Icon may terminate the agreement upon written
notice to us that we are in material breach of our obligations under the agreement and we are
unable to remedy such within 30 days after we receive such notice. Further, Icon may terminate the
agreement in connection with certain events relating to a wind up or bankruptcy, if we make a
general assignment for the benefit of our creditors, or if we cease to conduct operations for a
certain period. Icon may also terminate the exclusivity granted to us by written notice if we fail
to reach certain milestones within a designated period of time. Notwithstanding the termination
date of the agreement, our obligation to pay royalties under the agreement to Icon may expire prior
to the termination of this agreement, subject to certain conditions.
Exhibit F
Annual Bonus. The Compensation Committee has the authority to award discretionary annual
bonuses to our executive officers. For 2010, the Compensation Committee has established a formal
bonus plan for certain milestones, as described below. The discretionary annual bonus awards are
intended to compensate officers for achieving financial, clinical, regulatory and operational goals
and for achieving individual annual performance objectives. For any given year, the compensation
objectives vary, but relate generally to strategic factors such as developments in our clinical
path, the execution of a license agreement for the commercialization of product candidates, the
establishment of key strategic collaborations, the build-up of our pipeline and financial factors
such as raising capital. Bonuses are awarded generally based on corporate performance, with
adjustments made within a rang
2010-11-16 - UPLOAD - Protalix BioTherapeutics, Inc.
Via Facsimile and U.S. Mail
November 16, 2010
David Aviezer, Ph.D.
President and Chief Executive Officer
Protalix Biotherapeutics , Inc.
2 Snunit St., Science Park
POB 455, Carmiel 20100, Israel
Re: Protalix Biotherapeutics, Inc.
Form 10 -K for the Fiscal Year Ended December 31 , 2009
Filed February 26 , 2010
File No. 001-33357
Dear Dr. Aviezer :
We have reviewed your response dated October 13, 2010 and have the followin g
additional comments.
Please respond to this letter within ten business days by providing the requested
information . If you do not believe our comments apply to your facts and circumstances ,
please tell us why in your response.
After reviewing the information you provide in response to these comments, we
may have additional comments.
Item 1. Business
1. We note that your responses to comments 1, 3 and 6 state that the annual
maintenance fees were granted confidential treatment. It appears that these
requests were granted without the benefit of staff review. Please disclose the
amounts of these payments or tell us why you believe the amount of these
payments is not material information.
Item 11. Executive Compensation
Compensation Discussion and Analysis, page 65
2. We note your response to our prior comment 9. Your response is unclear as you
state that the Compensation Committee has established a bonus plan for “certain
milestones” and that the Compensation Committee determines awards on a
David Aviezer, Ph.D.
Protalix Biotherapeutics , Inc.
November 16, 2010
Page 2
“discretionary basis.” If the Compensation Committ ee identified and
communicated goals to be used to determine whether a bonus is paid and the
amount of the bonus, please disclose all goals set by the Committee, identify
which goals were achieved and explain how the level of achievement was used to
determ ine the amount of each officer’s bonus. If there were no predetermined
goals and the awards were based solely on the discretion of the Committee and
the Committee based its discretion on the achievements identified, please clarify
that there were no predetermin ed goals.
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
Exchange Act of 1934 and all applicable Exchange 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.
In responding to our comments, please provide a written statement from the
company acknowledging that:
the company is responsible for the adequacy and accuracy of the disclosure in the
filing;
staff comments or change s to disclosure in response to staff comments do not
foreclose the Commission from taking any action with respect to the filing;
and the company may not assert staff comments as a defense in any proceeding
initiated by the Commission or any person under the federal securities laws of the
United States.
Please contact Scot Foley at (202) 551 -3383 , Suzanne Hayes, Branch Chief, at
(202) 551 -3675 or me at (202) 551 -3715 with any questions.
Sincerely,
Jeffrey Riedler
Assistant Director
2010-10-12 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP
1
filename1.htm
corresp
1290 AVENUE OF THE AMERICAS
NEW YORK, NY 10104-0050
TELEPHONE: 212.468.8000
FACSIMILE: 212.468.7900
WWW.MOFO.COM
morrison & foerster llp
new york, san francisco,
los angeles, palo alto,
san diego, washington, d.c.
northern virginia, denver,
sacramento, walnut creek
tokyo, london, brussels,
beijing, shanghai, hong kong
Writer’s Direct Contact
212.468.8163
JTanenbaum@mofo.com
October 12, 2010
Mr. Jeffery Riedler
Assistant Director
Division of Corporation Finance
U.S. Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549
RE:
Protalix BioTherapeutics, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2009
Filed February 26, 2010
File No. 001-33357
Ladies and Gentlemen:
On behalf of our client, Protalix BioTherapeutics, Inc., a Florida corporation (the
“Company”), transmitted herewith are responses to the Staff’s comments to the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2009 (the “2009 Form 10-K”), which
comments were set forth in the Staff’s letter dated September 22, 2010 (the “Comment Letter”) to
David Aviezer, Ph.D., the Company’s Chief Executive Officer. For purposes of reference, the
Company, formerly named “Orthodontix, Inc.,” acquired Protalix Ltd. on December 31, 2006 through a
reverse merger and Protalix Ltd. is currently the Company’s wholly-owned subsidiary. The Company
subsequently changed its name to “Protalix BioTherapeutics, Inc.” Prior to the merger, the Company
had no disclosure obligations with respect to Protalix Ltd. References to the Company in this
response letter include the Company and Protalix Ltd., unless stated otherwise. For ease of
reference, we have noted the Staff’s comments in bold faced type and the responses in regular type.
Item 1. Business
Other Drug Candidates in Our Pipeline, page 14
1.
Please provide us with draft disclosure for an amendment to your annual report that provides
additional information about your agreement with Yissum Research and Development Company and
the Boyce Thompson Institute, Inc., which includes the term of the agreement, its termination
provisions, the aggregate potential milestone payments, the amount of the license maintenance
fee, and an indication of the royalty percentage, e.g., “single-digits,” “teens,” “twenties,”
etc.
Response: In response to this comment, the Company proposes that it provide
disclosure substantially in the form set forth on Exhibit A in future filings, as
applicable. The Company respectfully notes that the amount of the license maintenance fee under
the Research and License Agreement made on August 8, 2007, by and between Yissum Research
Development Company of Jerusalem (“Yissum”), the Boyce Thompson Institute (“Boyce”) and Protalix
Ltd. (the “Yissum Agreement”) is the subject of a confidential treatment request granted by the
Staff on December 3, 2007.
2.
Please explain each party’s obligations with respect to the collaborative research program in
the laboratory of Professor Hermona Soreq.
Response: The Company has no material obligations with respect to the laboratory of
Professor Hermona Soreq. Rather, the Company’s obligations are to Yissum and Boyce under the
Yissum Agreement, as described in the 2009 Form 10-K and as discussed in the Company’s answer to
Comment No. 1. Professor Soreq is currently the researcher under the Yissum Agreement. The
Company does not know what obligations Yissum and Boyce have to Professor Soreq’s laboratory.
Further, the Company is not required to disclose the obligations of Yissum and Boyce in its public
disclosure.
Strategic Collaborations, page 16
3.
With respect to your agreement with Weizmann Institute of Science, please provide us with
draft disclosure for an amendment to your annual report that includes the term and termination
provisions, the aggregate potential milestone payments, the
amount of the research budget amount, and an indication of the range of royalty payments to
be made, e.g., “single-digits,” “teens,” “twenties,” etc.
Response: In response to this comment, the Company proposes that it provide
disclosure substantially in the form set forth on Exhibit B in future filings, as
applicable. The Company respectfully notes that the amount of the research budget under the
agreement is the subject of a confidential treatment request granted by the Staff on January 18,
2008.
Intellectual Property, page 17
4.
Please indicate not only that your patents relate to your ProCellEx protein expression system
but also the individual products they relate to. Additionally, disclose when the patents
expire.
Response: In response to this comment, the Company proposes that it provide
disclosure substantially in the form set forth on Exhibit C in future filings, as
applicable.
2
5.
Please indicate the product or products that are dependent on the jointly held patent and the
licensed patent rights and identify the joint holder and licensees. If the licensing
agreements have not been filed, please provide your analysis supporting your determination
that you are not required to file them as exhibits.
Response: The jointly held patent relates to a new splice variant of human
follicle-stimulating hormone, or FSH. The Company is not proceeding with its FSH project at this
time. Accordingly, the license agreement relating to the joint patent is not material to the
Company. The other licensed patents and patent applications were licensed to the Company from
Yissum, Virginia Tech Intellectual Properties, Inc. (“VTIP”), Yeda and Icon. All of the applicable
agreements have been filed by the Company other than its agreement with VTIP. In response to this
comment, the Company has decided to file the agreement with VTIP as an exhibit to its Quarterly
Report on Form 10-Q for the quarter ended September 30, 2010.
6.
Please provide us with draft disclosure for an amendment to your annual report that provides
additional information about your agreement with Icon Genetics AG, such as the term of the
agreement, its termination provisions, the aggregate potential milestone payments you are
required to make and an indication of the royalty range, e.g., “single-digits,” “teens,”
“twenties,” etc. Additionally, indicate which product candidates are dependent on this
agreement and provide an analysis supporting your determination that you are not required to
file the agreement as an exhibit.
Response: Protalix has entered into two agreements with Icon Genetics AG (“Icon”).
The first is a Collaborative Research Agreement dated April 30, 2004 (the “Research Agreement”) and
the second is the Research and License Agreement between Yeda Research and Development Company
Limited and Protalix Ltd. dated as of March 15, 2006 (the “License Agreement”). The Research
Agreement is no longer in effect and neither the Company nor Icon has any continuing material
obligations under the Research Agreement. The only material obligation to survive the expiration
of the Research Agreement was an option by Protalix Ltd. to license the know-how, data, information
and inventions developed under the Research
Agreement to the extent the foregoing relates to plant cell cultures. Protalix Ltd. exercised
this right by entering into the License Agreement. Upon the execution of the License Agreement,
the Research Agreement ceased to be material to the Company. Consequently, the Company has not
filed the Research Agreement as an exhibit to any of its filings under the Securities Exchange Act
of 1934. In response to this comment, the Company proposes that it provide disclosure
substantially in the form set forth on Exhibit D in future filings with respect to the
License Agreement, as applicable. The Company respectfully notes that the amount of the license
maintenance fee under the License Agreement is the subject of a confidential treatment request
granted by the Staff on January 18, 2008.
Item 10. Directors, Executive Officers and Corporate Governance, page 62
General
7.
Please, provide us with draft disclosure for an amendment to your annual report
that states for each incumbent director and director nominee the particular
3
experience,
qualifications, attributes or skills that led your Board of Directors to conclude that these
individuals should serve as your directors. We refer you to Item 401(e) of Regulation S-K.
Response: The Company provided disclosure regarding the particular experience,
qualifications, attributes or skills of each incumbent director and director nominee that led the
Company’s Board of Directors to conclude that these individuals should serve as the Company’s
directors as required under Item 401(e) of Regulation S-K. The Company intends to include
substantially similar disclosure in its future Annual Reports on Form 10-K and its proxy
statements, to the extent required by such filings.
Item 11. Executive Compensation
Compensation Discussion and Analysis, page 65
8.
We note your statement that the Compensation Committee evaluates individual executive
performance with a goal of setting compensation levels the committee believes are comparable
with executives in other companies of similar size and stage of development operating in your
industry. From this disclosure, it appears that you engage in benchmarking activities.
Please provide draft disclosure identifying the peer companies that you use for benchmarking
purposes.
Response: The Company’s Compensation Committee does not engage in benchmarking
activities as contemplated in Item 402(b) of Regulation S-K. Rather, the Compensation Committee
reviews the executive compensation practices of other companies of similar size and stage of
development operating in its industry for comparative purposes to ensure that its compensation
decisions are not inconsistent with the practices of its peer companies. In response to this
comment, the Company proposes that it provide disclosure substantially in the form set forth on
Exhibit E in future filings, as applicable, in response to this comment.
9.
Please provide us with draft disclosure for an amendment to your annual report that includes
the following:
• The individual and corporate performance objectives applicable to each named
executive officer and used to determine their annual bonuses and how each objective was
weighted, if applicable. To the extent that any of the performance objectives were
quantitative, your disclosure should also be quantitative;
• The threshold, target, and maximum levels of achievement of each performance
measure, if applicable;
• The intended relationship between the level of achievement of corporate and
individual performance objectives and the amount of bonus to be awarded;
• The evaluation by the Committee of the level of achievement by each named executive
officer of the corporate and individual performance objectives applicable to them; and
4
• Any other factors that were considered by the Committee that modified the actual
cash bonuses awarded.
Response: In response to this comment, the Company proposes that it provide
disclosure in the format set forth on Exhibit F in future filings, as applicable.
10.
Your Summary Compensation Table includes a dollar value for option awards you granted to your
named executive officers in fiscal year 2009 but your Grants of Plan-Based Awards table
displays no awards made in the last fiscal year and your narrative disclosure concerning
options on page 66 omits any mention of option grants made last year. Please reconcile this
discrepancy in your disclosure.
Response: The lack of disclosure in the Grants of Plan-Based Awards table for fiscal
year 2009 was the result of an error. The corrected table is included in the Grants of Plan-Based
Awards table set forth in the Company’s proxy statement filed by the Company on October 4, 2010 in
connection with the Company’s annual meeting of shareholders to be held on November 7, 2010.
11.
We note that you have not included any disclosure in response to Item 402(s) of Regulation
S-K. Please advise us of the basis for your conclusion that disclosure is not necessary and
describe the process you undertook to reach that conclusion.
Response: The Company does not believe that its employee compensation policies and
practices are reasonably likely to have a material adverse effect on the Company. The Company’s
employees, and hence the Company’s compensation structure, is not allocated among different
business units. Accordingly, there is no risk that the Company’s compensation structure will
create risks among business units. In addition, although the Company has, from time to time,
granted cash bonuses to certain employees in connection with the Company’s achievement of
designated regulatory or clinical milestones, most of the bonuses paid by the Company are paid
after the year end. Last, the Company’s Compensation Committee decisions are generally made on an
annual basis after a review of financial and other developments by the Company limiting the risk
that a compensation decision would have a material adverse effect on
the Company. For the foregoing reasons, the Company does not believe that it has any risks to
disclose under Item 402(s) of Regulation S-K.
General
12.
You state in your list of exhibits that Exhibits 10.6, 10.7, and 10.8, which are incorporated
by reference to your current report on Form 8-K filed on September 20, 2007, have been granted
confidential treatment under Rule 24b-2 of the Exchange Act. A search of our records does not
reflect an application for confidential treatment with respect to these exhibits being
received from you. Please provide us with a copy of the confidential treatment application
you submitted after these agreements were filed.
Response: On January 8, 2007, the Company submitted a confidential treatment request
for Exhibits 10.6, 10.7 and 10.8 which are incorporated by reference to the 2009 Form 10-K.
5
The
Company submitted an amended confidential treatment request for the same exhibits on August 22,
2007. The SEC granted the Company’s confidential treatment in an order dated January 18, 2008.
The Company has faxed a copy of the order granting confidential
treatment for those exhibits to the SEC separately.
* * *
Please call the undersigned at the telephone number set forth above or Joseph Magnas at
212-336-4170 with any question or comment you may have regarding the responses set forth herein.
In addition, please send all written correspondence directly to the undersigned and Joseph Magnas
of Morrison & Foerster LLP, 1290 Avenue of the Americas, New York, New York 10104, telecopy
212-468-7900, with copies to David Aviezer, Ph.D., the Company’s President and Chief Executive
Officer, at 2 Snunit Street, Science Park, P.O.B. 455, Carmiel 20100, Israel, telecopy
+972-4-988-9489.
Sincerely,
/s/ James R. Tanenbaum
cc: David Aviezer, Ph.D.
Yossi Maimon
6
Exhibit A
In August 2007, Protalix Ltd. licensed the rights to certain technology under a research
and license agreement with Yissum Research and Development Company, or Yissum, and the Boyce
Thompson Institute, Inc., or Boyce Thompson. Pursuant to the agreement, we are developing a
proprietary plant cell-based acetylcholinesterase (AChE) and its molecular variants for the use in
several therapeutic and prophylactic indications, as well as in a biodefense program and an
organophosphate-based pesticide treatment program. Under the terms of the agreement, Yissum and
Boyce Thompson granted us an exclusive, worldwide right and license to certain technology,
including patents and certain patent applications relating to AChE for the therapeutic and
prophylactic indications as well
2010-09-22 - UPLOAD - Protalix BioTherapeutics, Inc.
Via Facsimile and U.S. Mail
September 22 , 2010
David Aviezer , Ph.D.
President and Chief Executive Officer
Protalix Biotherapeutics , Inc.
2 Snunit St., Science Park
POB 455, Carmiel 20100, Israel
Re: Protalix Biotherapeutics, Inc.
Form 10 -K for the Fiscal Year Ended December 31 , 2009
Filed February 26 , 2010
File No. 001-33357
Dear Dr. Aviezer :
We have reviewed your filing and have the following comments. In some of our
comme nts, we may ask you to provide us with information so we may better understand
your disclosure.
Please respond to this letter within ten business days by amending your filing, by
providing the requested information, or by advising us when you will provid e the
requested response. 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 filing and the information you pr ovide in
response to these comments, we may have additional comments.
Item 1. Business
Other Drug Candidates in Our Pipeline, page 14
1. Please provide us with draft disclosure for an amendment to your annual report
that provides additional i nformation about your agreement with Yissum Research
and Development Company and the Boyce Thompson Institute, Inc. , which
includes the term of the agreement, its termination provisions, the aggr egate
potential milestone payments , the amount of the licen se maintenance fee, and an
indication of the royalty percentage , e.g. “single -digits,” “teens,” “twenties,” etc.
David Aviezer , Ph.D.
Protalix Biotherapeutics , Inc.
September 22 , 2010
Page 2
2. Please explain each party’s obligations with respect to the collaborative research
program in the laboratory of Professor Hermona Soreq.
Strategic Collaborations, page 16
3. With respect to your agreement with Weizmann Institute of Science, please
provide us with draft disclosure for an amendment to your annual report that
includes the term and termination provisions, the aggregate potential milestone
payments, the amount of the research budget amount, and an indication of the
range of royalty payments to be made, e.g. “single -digits,” “teens,” “twenties,”
etc.
Intellectual Property, page 17
4. Please indicate not only that your patents relate to your ProCellEx protein
expression system but also the indi vidual products they relate to. Additionally,
disclose when the patents expire.
5. Please indicate the product or products that are dependent on the jointly held
patent and the licensed patent rights and identify the joint holder and licensees. If
the licensing agreement s have not been filed, please provide your analysis
supporting your determination that you are not required to file them as exhibit s.
6. Please provide us with draft disclosure for an amendment to your annual report
that provides additional i nformation about your agreement with Icon Genetics
AG, such as the term of the agreement, its termination provisions, the aggregate
potential milestone payments you are required to make and an indication of the
royalty range , e.g. “single -digits,” “teens,” “twenties,” etc. Additionally, indicate
which produ ct candidates are dependent on this agreement and provide an
analysis supporting your determination that you are not required to file the
agreement as an exhibit.
Item 10. Directors, Executive Officers and Corporate Governance , page 62
General
7. Please provide us with draft disclosure for an amendment to your annual report
that states for each incumbent director and director nominee the particular
experience, qualifications, attributes or skills that led your Board of Directors to
conclude that these individuals should serve as your directors. We refer you to
Item 401(e) of Regulation S -K.
David Aviezer , Ph.D.
Protalix Biotherapeutics , Inc.
September 22 , 2010
Page 3
Item 11. Executive Compensation
Compensation Discussion and Analysis, page 65
8. We note your statement that the Compensation Committee evaluates individual
executive performance with a goal of setting compensation levels the committee
believes are comparable with executives in other compa nies of similar size and
stage of development operating in your industry. From this disclosure, it appears
that you engage in benchmarking activities. Please provide draft disclosure
identifying the peer companies that you use for benchmarking purposes.
9. Please provide us with draft disclosure for an amendment to your annual report
that includes the following:
The individual and corporate performance objectives applicable to each
named executive officer and used to determine their ann ual bonuses and
how each objective was weighted, if applicable. To the extent that any of
the performance objectives were quantitative, your disclos ure should also
be quantitative;
The threshold, target, and maximum levels of achievement of each
performan ce measure, if applicable;
The intended relationship between the level of achievement of corporate
and individual performance objectives and the amount of bonus to be
awarded;
The evaluation by the Committee of the level of achievement by each
named exe cutive officer of the corporate and individual performance
objectives applicable to them; and
Any other factors that were considered by the Committee that modified
the actual cash bonuses awarded.
10. Your Summary Compensation Table includes a dollar value for option awards
you granted to your named executive officers in fiscal year 2009 but your Grants
of Plan -Based Awards table displays no awards made in the last fiscal year and
your narrative disclosure concerning options on page 66 omits any mention of
option grants made last year. Please reconcile this discrepancy in your disclosure.
11. We note that you have not included any disclosure in response to Item 402(s) of
Regulation S -K. Please advise us of the basis for your conclusion that disclosure
is not necessary and describe the process you undertook to reach that conclusion.
David Aviezer , Ph.D.
Protalix Biotherapeutics , Inc.
September 22 , 2010
Page 4
Item 15. Exhibits and Financial Statement Schedules
General
12. You state in your list of exhibits that Exhibits 10.6, 10.7, and 10.8, which are
incorporated by reference to your current report on Form 8 -K filed on September
20, 2007, have been granted confidential treatment under Rule 24b -2 of the
Exchange Act. A sear ch of our records does not reflect an application for
confidential treatment with respect to these exhibits being received from you.
Please provide us with a copy of the confidential treatment application you
submitted after these agreements were filed.
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
Exchange Act of 1934 and all applicable Exchange 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.
In responding to our comments, please provide a written statement from the
company acknowledging that:
the company is responsible for the adequacy and accuracy of the disclosure in the
filing;
staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking any action with respect to the filing;
and the company may not assert staff comments as a defense in any proceeding
initiated by the Commission or any person under the federal secu rities laws of the
United States.
Please contact Scot Foley at (202) 551 -3383 , Suzanne Hayes, Branch Chief, at
(202) 551 -3675 or me at (202) 551 -3715 with any questions.
Sincerely,
Jeffrey Riedler
Assistant Director
2009-03-23 - UPLOAD - Protalix BioTherapeutics, Inc.
Via Facsimile and U.S. Mail Mail Stop 6010 March 19, 2009
Yossi Maimon
Chief Financial Officer and Treasurer
Protalix BioTherapeutics, Inc.
2 Snunit Street
Science Park
POB 455
Carmiel, Israel 20100
Re: Protalix BioTherapeutics
Form 10-K for the Fiscal Year Ended December 31, 2007
Filed March 17, 2008
File Number: 001-33357
Dear Mr. Maimon:
We have completed our review of your Form 10-K and have no further
comments at this time. S i n c e r e l y ,
Joel Parker
A c c o u n t i n g B r a n c h C h i e f
2009-03-16 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP
1
filename1.htm
CORRESP
Writer’s Direct Contact
212.468.8163
JTanenbaum@mofo.com
March 16, 2009
Mr. Todd E. Hardiman
Associate Chief Accountant
Division of Corporation Finance
United States Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549
RE:
Protalix BioTherapeutics, Inc.
Annual Report on Form 10-K, filed March 17, 2008
for the Fiscal Year Ended December 31, 2007
File No. 001-33357
Ladies and Gentlemen:
On behalf of our client, Protalix BioTherapeutics, Inc., a Florida corporation (the
“Company”), transmitted herewith are responses to the Staff’s comments to the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2007 (the “2007 Form 10-K”). The
comments were delivered by the Staff to the Company and its counsel by way of a telephone call on
March 5, 2009.
For ease of reference, we have noted the Staff’s comments in bold faced type and the responses
in regular type.
1. In reference to the Company’s response to Comment 4 of the Company’s letter dated March 4, 2009,
the Staff requested a detailed description of its calculation of the compensation expense recorded
with respect to the options to purchase 387,542 shares of common stock issued to a nonemployee on
December 31, 2006 for the second quarter of 2007. The Staff noted that the description should
include an explanation of the $140,000 effect of the remeasurement of such options disclosed in the
Company’s Current Report on Form 8-K dated February 26, 2009.
RESPONSE: Reference is made to the Company’s response to Comment 4 of its letter dated March 4,
2009. In the response, the Company described its accounting treatment of the options
to purchase 387,542 shares of common stock issued to a nonemployee on December 31, 2006 (the
“Referenced Options”). As discussed in that response, the Company remeasures each individual
tranche of options for which the applicable vesting/service period crosses interim periods (such as
the Referenced Options) at the end of each period until the final vesting date of the tranche. The
Company calculates the proportionate compensation expense for outstanding options issued to
nonemployees by dividing the number of months in the calculation period (generally a quarter) by
the number of months in the vesting period of the tranche and multiplying the result by the portion
of the option that vests during the vesting period of the tranche. For purposes of determining the
fair value of the options using the Black-Scholes option-pricing model, the Company uses the
closing sale price of its common stock on the NYSE Alternext US on the calculation date.
For purposes of the restated financial statements for the first quarter of 2007, the Company
calculated the compensation expense of the Referenced Options by multiplying the fair value of the
options (based on the Black-Scholes option-pricing model) on March 31, 2007, by the number achieved
by (A) dividing three over 14; the number of months in the first quarter of 2007 over the number of
months in the vesting period and (B) multiplying the result by 40%, the portion of the option that
was to vest during the vesting period. The result of this calculation for March 31, 2007 was
approximately $744,000.
For purposes of the restated financial statements for the second quarter of 2007, the Company
calculated the compensation expense of the Referenced Options by multiplying the fair value of the
options (based on the Black-Scholes option-pricing model) on June 30, 2007, by the number achieved
by (A) dividing six over 14; the cumulative number of months in the first two quarters of 2007 over
the number of months in the vesting period and (B) multiplying the result by 40%, the portion of
the option that was to vest during the vesting period. The result of this calculation for June 30,
2007 was approximately $1,362,000. The Company then subtracted the compensation expense recorded
for the Referenced Options in the first quarter yielding a total compensation expense in connection
with the Referenced Options for the second quarter of 2007 equal to approximately $618,000.
As discussed in the Company’s response letter dated March 4, 2009, when preparing the financial
statements for the second quarter of 2007 as originally reported, the Company did not remeasure the
compensation expense in connection with options held by nonemployees. Rather, the Company
calculated the compensation expense by multiplying the fair value of the options (based on the
Black-Scholes option-pricing model) on June 30, 2007, by the quotient of the total number of
Referenced Options divided by 11, which is the total number of fiscal quarters during the full
vesting period of the Referenced Options. The result of this calculation for June 30, 2007 was
approximately $722,000 which was increased to $758,000 to adjust for an error in calculation made
in the originally reported financial statements for the first quarter of 2007. The difference
between the originally reported calculation and the restated calculation, which is approximately
$140,000, was primarily caused by the remeasurement of the first quarter’s compensation expenses as
of the end of the second quarter of 2007.
The Company notes that the remeasurements described in this response are consistent with the
straight-line attribution accounting treatment described in the Company’s response letter dated
December 23, 2008. The measurements and the subsequent remeasurements focus on the
-2-
portion of the options in question that will vest on the next vesting date, not on the entire
unvested portion of such options. In the application of graded attribution, however, the
measurements are based on all of the unvested options. Had the Company applied graded attribution
to the Referenced Options, the difference in compensation expense that would have been recorded is
immaterial.
2. The Staff requested that the Company describe the accounting treatment of the 60% of the options
to purchase 387,542 shares of common stock issued to a nonemployee on December 31, 2006 that vest
after March 1, 2008.
RESPONSE: The remaining 60% of the Referenced Options vest in four tranches of 15% on each of the
following dates: June 30, 2008; December 31, 2008; June 30, 2009; and September 30, 2009. After the
first vesting period of the Referenced Options, for each subsequent quarter, the Company applied a
final measurement to the tranches of options that reached a vesting date during each of the
quarters of 2008 following the first vesting period of March 1, 2008, and with an interim
measurement for the remaining unvested tranches of options in the relevant quarter. For example,
the Company calculated the final measurement of the compensation expense for the Referenced Options
for the quarter ended March 31, 2008 by multiplying the fair value of the options (using the
Black-Scholes option-pricing model) on March 1, 2008, by 40%, the portion of the option that were
vested as of that date. The Company then subtracted the compensation expense recorded for the
Referenced Options during 2007. In addition, the compensation expense recorded as of March 31, 2008
included an interim measurement for the month of March 2008 of the proportionate value of the
second tranche of the Referenced Options. The interim measurement was calculated by (A) dividing 1
over 4; the number of months of the second tranche of the Referenced Options that coincided with
the first quarter of 2008 over the number of months in the vesting period of the second tranche and
(B) multiplying the result by 15%, the portion of the Referenced Options were to vest during the
second vesting period. Interim measurements were remeasured until the Company was able to apply a
final measurement.
3. The Staff requested that the Company describe the forfeiture rate it applied in calculating the
fair value of the options issued to nonemployees.
RESPONSE: The Company did not apply a forfeiture rate adjustment to the Referenced Options in the
calculation of the compensation expense thereof. The Company expects to continue to engage the
consultant for the entire vesting period of the Referenced Options. In addition, in light of the
flexibility afforded to the consultant with respect to the terms of his engagement by the Company,
and based upon the Company’s relationship with the consultant, the Company believes that it is
unlikely that the consultant will cease providing services to the Company prior to the end of the
last vesting period of the Referenced Options. The Company notes that the application of any
commonly accepted forfeiture rate adjustment to the Referenced Options, would not result in a
material change to the compensation expense recorded by the Company for the Referenced Options.
-3-
4. The Staff requested that the Company confirm the accounting treatment of the other 1,753,027
options issued to nonemployees and confirm that the compensation expense recorded for such options
is not subject to remeasurement.
RESPONSE: The Company confirms that the compensation expenses recorded for the 1,753,027 options
described in Exhibit B to the Company’s response letter dated October 16, 2008 involved final
measurements for each of the quarters of 2007 and 2008 as such options vested at the end of each
quarter and were not subject to any remeasurement.
5. The Staff requested that the Company confirm that it will not reference the use of the
simplified method to estimate the contractual term of outstanding options in future filings.
RESPONSE: The Company confirms that that it will not reference the use of the simplified method to
estimate the contractual term of outstanding options in future filings. The Company notes, however,
that it may use the simplified method in the future in connection with the grant of options that
meet the criteria of Footnote 7 of SAB 107A.
* * *
Please call the undersigned at the telephone number set forth above or Joseph Magnas at
212-336-4170 with any question or comment you may have regarding the responses set forth herein. In
addition, please send all written correspondence directly to the undersigned and Joseph Magnas of
Morrison & Foerster LLP, 1290 Avenue of the Americas, New York, New York 10104, telecopy
212-468-7900, with copies to David Aviezer, Ph.D., the Company’s President and Chief Executive
Officer, at 2 Snunit Street, Science Park, P.O.B. 455, Carmiel 20100, Israel, telecopy
+972-4-988-9489.
Sincerely,
/s/ James R. Tanenbaum
cc:
David Aviezer, Ph.D.
Yossi Maimon
-4-
2009-03-04 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP
1
filename1.htm
CORRESP
Writer’s Direct Contact
212.468.8163
JTanenbaum@mofo.com
March 4, 2009
Mr. Todd E. Hardiman
Associate Chief Accountant
Division of Corporation Finance
United States Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549
RE:
Protalix BioTherapeutics, Inc.
Annual Report on Form 10-K, filed March 17, 2008
for the Fiscal Year Ended December 31, 2007
File No. 001-33357
Ladies and Gentlemen:
On behalf of our client, Protalix BioTherapeutics, Inc., a Florida corporation (the
“Company”), transmitted herewith are responses to the Staff’s comments to the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2007 (the “2007 Form 10-K”). The
comments were delivered by the Staff to the Company and its counsel by way of telephone calls on
February 18, 2009 and March 3, 2009.
For ease of reference, we have noted the Staff’s comments in bold faced type and the responses
in regular type.
1. Please refer to your response to Comment 4. It is still not clear what the remaining 2,325,250
options represent. Please confirm whether any of these are employee options and please tell us the
accounting treatment relating to the issuance of those remaining options and subsequent vesting.
You state in Note 5(f) on page F-23 and in Note 5(g) on page F-27 of your 10-K that only 2,201,972
options were granted to employees during 2006.
RESPONSE: All of the remaining 2,325,250 options represent options that were issued to
nonemployees on December 31, 2006. In accordance with Statement of Financial Accounting Standards
No. 123 (revised 2004), “Share-Based Payment,” the Company recorded a portion of the expense for
the first vesting period of the options during the first three quarters of 2007. All
of the options expired in accordance with the terms of the options in the fourth quarter of 2007,
prior to the first vesting date of the options. Accordingly, the compensation expense of such
options were reversed for purposes of the fourth quarter of 2007, with no expense for the fiscal
year of 2007. The 2,201,972 options discussed in Note 5(f) on page F-23 and in Note 5(g) on page
F-27 of the 2007 Form 10-K for the year ended December 31, 2007 are options that were granted to
employees in 2006 and are not related to the 2,325,250 options or the 387,542 options included in
Exhibit B of our response dated October 16, 2008.
2. Please revise your valuation methodology for the first and third quarters of 2007 with respect
to compensation expense of certain option grants to use the trading value of the stock or tell us
why no revision is necessary.
RESPONSE: In response to the Staff’s comments and after consulting with the Audit Committee of the
Company’s Board of Directors, the Company has determined that it should amend and restate its
financial statements for the year ended December 31, 2007, and each of the fiscal quarters of 2007.
The Company intends to use the trading price of the Company’s common stock on each quarter end in
preparing the restated financial statements.
3. In certain draft language reflecting the proposed restatement provided to the Staff by the
Company, the Company stated that it had previously issued 2,605,514 shares of equity instruments to
nonemployees whose terms indicated that performance was not complete until the applicable vesting
requirements were fulfilled. The Company subsequently provided the Staff with revised language
that stated that the number of such equity instruments issued to nonemployees was 2,148,569. The
Staff asked that the Company reconcile the two different numbers.
RESPONSE: The Company hereby clarifies that the correct number of equity instruments issued to
nonemployees during the first three quarters of 2007, whose terms indicated that performance was
not complete until the applicable vesting requirements were fulfilled, was 2,148,569 and that the
2,605,514 number was a typographical error. The Company refers the Staff to Exhibit B of its
October 16, 2008 response. Exhibit B presents, in tabular form, an exhaustive list of all
non-employee issuances/grants by the Company based on a vesting date during 2007 and 2008. There
are three sets of issuances included in Exhibit B: (i) the grant of 1,753,027 options to a related
party; (ii) the grant of 387,542 options to a nonemployee; and (iii) the grant of 8,000 shares of
restricted common stock to a nonemployee. The three grants represent 2,148,569 shares of common
stock, in the aggregate.
4. The Staff requested that the Company explain how it remeasured recorded compensation expenses
with respect to certain options granted to nonemployees for the different quarters of 2007.
RESPONSE: To illustrate the Company’s remeasurement calculations, the Company presents the options
to purchase 387,542 shares of common stock issued to a nonemployee on December 31, 2006 (see
Exhibit B of the Company’s October 16, 2008 response). None of the shares underlying the options
vested during 2007. The first vesting date of the options was March 1, 2008, which was 14 months
after the date of grant. On that date, 40% of the shares underlying the options vested. For
individual tranches of options for which the applicable vesting/service
-2-
period crossed interim periods (such as the options issued to the nonemployee), the Company
remeasures the tranches at the end of each period until the final vesting date of the tranche. The
calculation of the proportionate compensation expense is as follows:
(i) To calculate the compensation expense for the options at the end of the first quarter of
2007, the Company divided three by 14; the number of months in the quarter over the number of
months in the vesting period and multiplied the result by 40%, the portion of the option that was
to vest during the vesting period. For purposes of determining the fair value of the options, the
Company’s management used the closing sale price of the Common Stock on the NYSE Alternext US
(then, the American Stock Exchange) on March 31, 2007.
(ii) To calculate the compensation expense for the options at the end of the second quarter of
2007, the Company divided six by 14; the cumulative number of months in the first two quarters of
2007 over the number of months in the vesting period and multiplied the result by 40%, the portion
of the option that was to vesting during the vesting period. For purposes of the second quarter,
the Company based the valuation on the closing sale price of the Company’s Common Stock on the last
day of the quarter. Since the calculation for the second quarter included an adjustment for the
first quarter vesting, the compensation expense for the option for the first quarter of 2007, as
measured on March 31, 2007, was remeasured using the reported traded price on June 30, 2007.
(iii) To calculate the compensation expense for the options at the end of the third quarter of
2007, the Company divided nine by 14; the cumulative number of months in the three quarters of 2007
over the number of months in the vesting period and multiplied the result by 40%, the portion of
the option that was to vest during the vesting period. The fair value of the options was based on
the closing sale price of the Company’s Common Stock on September 30, 2007. As a result, the
compensation expenses recorded for the first six months of 2007 with respect to the option, as
measured on June 30, 2007, were remeasured using the closing sale price as of September 30, 2007.
(iv) To calculate the compensation expense for the option at the end of 2007, the Company
divided 12 by 14; the cumulative number of months in the four quarters of 2007 over the number of
months in the vesting period and multiplied the result by 40%, the portion of the option that was
to vest during the vesting period. The fair value of the options was based on the closing sale
price of the Company’s Common Stock on December 31, 2007. As a result, the compensation expenses
recorded for the first nine months of 2007 with respect to the options, as measured on September
30, 2007, were remeasured using the closing sale price as of December 31, 2007.
The Company notes that in the Quarterly Reports on Form 10-Q filed for the second and third quarter
of 2007, the Company did not remeasure the compensation expenses in connection with options held by
nonemployees in the manner discussed above. Rather, the Company continued to amortize the expense
for each quarter individually based on the fair value of the Company’s Common Stock at the end of
the second and third quarter. Since the Company is restating its financial statements for such
quarters and although the effect of the remeasurements are immaterial, the Company has elected to
perform such remeasurements in the amended Quarterly Reports on Form 10-Q it intends to file in
connection with the restatement.
-3-
5. The Staff requested that the Company explain management’s decision that effective internal
controls were in place as of the end of the 2007 fiscal year in light of the need to restate the
Company’s financial statements.
Auditing Standard No. 5, Section 69, provides a list of potential indicators of a material weakness
in a company’s internal control over financial reporting. One of the listed criteria is the
restatement of previously issued financial statements to reflect the correction of a material
misstatement. While assessing the effect of the restatement on the Company’s internal control over
financial reporting and in light of Section 69, the Company’s management considered the following
factors:
•
The misstatement was not a result of a miscalculation of financial figures;
•
The misstatement is not a result of a typographical error;
•
Management reviewed and discussed the accounting treatment thoroughly and in-depth with
the Company’s audit committee and Board of Directors;
•
Management’s decision not to use the closing sale price to calculate the fair value of
certain stock-based compensation issued to nonemployees was understood by all
aforementioned parties to be non-standard accounting treatment but all such parties agreed
that an alternative valuation mechanism was appropriate given the limited market for the
Company’s Common Stock at that time; and
•
The Company disclosed its decision not to rely on the reported traded price to calculate
the fair value of certain stock-based compensation issued to nonemployees in each relevant
filing with the Securities and Exchange Commission.
In light of the foregoing, the Company believes that the need to restate the financial statements
is the result of a difference in professional judgment. It was not caused by a failure of
management’s internal control over financial reporting and procedures in connection with the
preparation of its financial statements. In addition, the need to restate the financial statements
was not the result of any design control deficiency or the lack of the operation of any controls
that were designed to operate.
Management believes that it has adequate and effective internal controls relating to the
completeness and accuracy of stock-based compensation in place. These controls are designed to
apply the applicable rules, test for compliance, fraud and other factors.
Management believes that its internal controls that relate to the recording of share-based
compensation for nonemployees were effective. The restatement results from the application of
professional judgment that the Company made regarding the application of the share based
compensation expense. Notwithstanding the need to change certain accounting treatment, the
Company’s internal decision making process regarding accounting guidance was thorough, and included
all relevant controls including discussions with all relevant functionaries within the Company
relating to the financial reporting process. These functionaries include the Company’s management,
consultants, audit committee and the board of directors. The Company elected to
-4-
restate its financial statements and change the accounting treatment of its share-based payments
following the same internal control and accounting process. Since the Company believes that the
restatement was not the result of a failure of any internal control, the Company concluded that it did not need to disclose any changes in its internal
controls or financial reporting and concluded that it did not have a material weakness in its
internal controls as a result of the restatement.
The
Company confirms that its independent registered public accounting
firm has completed its review of the amended Quarterly Reports on
Form 10-Q/A.
* * *
Please call the undersigned at the telephone number set forth above or Joseph Magnas at
212-336-4170 with any question or comment you may have regarding the responses set forth herein.
In addition, please send all written correspondence directly to the undersigned and Joseph Magnas
of Morrison & Foerster LLP, 1290 Avenue of the Americas, New York, New York 10104, telecopy
212-468-7900, with copies to David Aviezer, Ph.D., the Company’s President and Chief Executive
Officer, at 2 Snunit Street, Science Park, P.O.B. 455, Carmiel 20100, Israel, telecopy
+972-4-988-9489.
Sincerely,
/s/ James R. Tanenbaum
cc:
David Aviezer, Ph.D.
Yossi Maimon
-5-
2009-02-05 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP
1
filename1.htm
CORRESP
1290 AVENUE OF THE AMERICAS
morrison & foerster llp
NEW YORK, NY 10104-0050
new york, san francisco,
TELEPHONE: 212.468.8000
los angeles, palo alto,
FACSIMILE: 212.468.7900
san diego, washington, d.c.w
WWW.MOFO.COM
northern virginia, denver,
sacramento, walnut creek
tokyo, london, beijing,
shanghai, hong kong,
singapore, brussels
Writer’s Direct Contact
212.468.8163
JTanenbaum@mofo.com
February 5, 2009
Mr. Todd E. Hardiman
Associate Chief Accountant
Division of Corporation Finance
United States Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549
RE:
Protalix BioTherapeutics, Inc.
Annual Report on Form 10-K, filed March 17, 2008
for the Fiscal Year Ended December 31, 2007
File No. 001-33357
Ladies and Gentlemen:
On behalf of our client, Protalix BioTherapeutics, Inc., a Florida corporation (the
“Company”), transmitted herewith are responses to the Staff’s comments to the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2007 (the “Form 10-K”),
which comments were delivered by the Staff to the Company’s counsel by way of telephone calls
on January 22, 2009.
For ease of reference, we have noted the Staff’s comments in bold faced type and the responses
in regular type.
1. In a verbal comment issued by the Staff to the Company on January 22, 2009, reference was made
to the Company’s treatment of the exchange of certain options and warrants in connection with the
December 31, 2006, merger as a modification. The Staff requested that the Company provide an
analysis of the Company’s application of the modification treatment of the options and warrants
issued with respect to the lock up imposed on such options and warrants upon the closing of the
Merger and upon the termination of related lock-up agreements on June 11, 2008.
RESPONSE: As discussed in the Company’s response of December 23, 2008, on December 31, 2006, the
Company’s wholly-owned subsidiary, Protalix Acquisition Co., Ltd., merged with and into Protalix
Ltd., a privately-held Israeli biotechnology company (the “Merger”). In connection with the
Merger, the Company issued options and warrants in exchange for substantially similar securities
issued by Protalix Ltd. prior to the Merger. For accounting purposes, the Company
treated the exchange as a modification of such securities and determined that the modification did not result
in an increase in the incremental value of the securities. Accordingly, the Company did not record
any incremental compensation costs due to the modification of stock options in connection with the
exchange of the Protalix Ltd. options in connection with the Merger. The underlying business
purpose of the modification was to provide the holders of Protalix Ltd. securities with the same
terms and conditions with respect to the new options and warrants as they had with respect to the
options and warrants surrendered in connection with the Merger.
Notwithstanding the foregoing, the terms of the Merger required that 90% of the shares, options and
warrants of each holder be subject to a lock-up agreement for a two-year period to satisfy certain
conditions imposed on the transaction by the Israeli Tax Authorities. The Company determined that
the lock-up agreements imposed on the holders of such securities by the Israeli Tax Authorities did
not significantly diminish the value of the locked-up options and warrants and, accordingly, the
Company did not adjust the calculated value of the outstanding options and warrants to reflect the
imposition of the related transfer restrictions.
Similarly, the Company determined that the termination of certain lock-up agreements (for
shareholders holding less than 5% of the Company’s shares outstanding at that time) in June 2008
resulting from the completion of negotiations with the Israeli Tax Authorities did not
significantly increase the value the options and warrants. The termination of the lock-up
agreements did not result in any incremental value to the holders of the applicable securities as
the valuation assumptions, including the expected term, did not increase. For reference purposes,
the lock-up agreements had a term of two years and the contractual term of the applicable options
are 10 years. Further, the expected term of the options at the time that the holders entered into
the lock-up agreements and at the time that the lock-up agreements were terminated well exceeded
the lock-up period and therefore applied only to a portion of the expected term of the applicable
securities. Last, the lock-up period did not cause an increase in
the expected term assumption or any other adjustment to the calculated value of the applicable
securities and, accordingly, did not impact the value of the securities.
2. In a verbal comment issued by the Staff to the Company on January 22, 2009, the Staff requested
that the Company provide an example of how it applies straight-line attribution to nonemployee
equity awards.
RESPONSE: An example of the Company’s application of the straight-line method in connection with
the accounting of equity awards issued to nonemployees is set forth in Exhibit C hereto.
3. In reference to a verbal comment that the Staff issued to the Company on August 28, 2008
regarding the Company’s response dated July 11, 2008, the Staff requested that the Company confirm
that it will include a note to the contractual obligations table in future filings that explains
what the purchase obligations represent.
RESPONSE: The Company will include a note to the contractual obligations table in its future
filings that explains what the purchase obligations represent.
2
4. Please tell us how the 2,712,792 options issued immediately after the December 31, 2006 merger
as referred to on Page 3 of your response relates to the 387,542 options issued in Exhibit B of
your October 16, 2007 response. Also, please tell us the accounting treatment relating to the
issuance of those options and subsequent vesting.
RESPONSE: The 2,712,792 options issued by the Company immediately after the Merger as referred to
on Page 3 of the Company’s December 23, 2008 response includes the 387,542 options listed in
Exhibit B of the Company’s October 16, 2008 response. The accounting treatment applied by the
Company in connection with the issuance of the 387,542 options was straight-line attribution in the
manner described in the example described in Comment 2 and Exhibit C to this response.
5. Please confirm that you will revise your policy and disclosure in future filings to use the
contractual term of the options to estimate the expected term rather than the simplified method.
RESPONSE: The Company confirms that it will revise its policy and disclosure in future filings
regarding future grants to use the contractual term of an option to estimate the expected term of
the option rather than the simplified method.
6. Please explain to us why there are two different trading values listed in Exhibit A of your
response dated October 16, 2008 for May 15, 2007. Please confirm which trading value you used to
calculate the compensation expense recorded in 2007 related to the 204,351 options granted to
employees. In addition, please explain to us why the amount of compensation recorded in 2008
related to these options was a negative amount.
RESPONSE: The two different trading prices listed in Exhibit A of the Company’s October 16, 2008
response for May 15, 2007 were the result of a typographical error in the Exhibit. There
was no difference between the “Fair value used” and the “Trading value on the measurement date” of
each of the awards issued in May 15, 2007. The closing price of the Company’s common stock on May
15, 2007 was $31.40, which was also the input price used for by the Company for the purposes of
calculating the common stock in the valuation of the awards. The measurement date of the
restricted stock issued on May 15, 2007 (row 3) should have been listed as June 30, 2007, at which
time both the “Trading value on the measurement date” and the “Fair value used” of such restricted
shares were each $26.99.
The amount of compensation recorded for 2007 and for the six months ended June 30, 2008 for both of
the issuances on May 15, 2007 listed in Exhibit A of the Company’s October 16, 2008 response is
correct. A revised analysis of the two issuances of May 15, 2007 is attached as Exhibit D to this
response. The employment by the Company of the employee that received the 204,351 options on May
15, 2007 was terminated on May 6, 2008, prior to the completion of the entire vesting period of the
option. Accordingly, the Company recorded a reversal of stock compensation expense related to
unvested awards during the termination period, which reversal resulted in a negative number.
3
7. Please reconcile the total expense for 2007 shown in Exhibits A and B of your response dated
October 16, 2008 to the total share-based compensation expense for 2007 of 10,845,000.
RESPONSE: Exhibit A of the Company’s response of October 16, 2008 is an analysis of all equity
issuances in 2007 and 2008 (through the date of the response). Exhibit B of the Company’s response
of October 16, 2008 is an analysis of all issuances and grants to non-employees for which
compensation expenses were recorded by the Company in 2007 and 2008 (through June 30, 2008). The
analysis in Exhibit B of the Company’s response of October 16, 2008 includes compensation expense
recorded for options granted to nonemployees that were remeasured during the applicable time period
in accordance with Statement of Financial Accounting Standards No. 123 (Revised 2004), “Share-Based
Payment” and Emerging Issue Task Force 96-18 “Accounting for Equity Instruments that are Issued to
Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services.” The
analysis does not include any compensation expense recorded for equity awards issued prior to 2007.
Such awards were measured as of their respective grant dates but the expenses are recorded over
their respective vesting periods. This reconciliation is summarized below:
Amount
Description
(in thousands)
Non-employee awards (see Exhibit B of the Company’s
response of October 16, 2008)
$
7,487
Employee awards included in Exhibit A of the Company’s
response of October 16, 2008
$
2,266
Equity awards issued pre-Merger for which compensation
expense was attributed in 2007
$
1,092
Total 2007 share-based compensation
$
10,845
The Company is evaluating the Staff’s comments to the valuation methods used by the Company
for the first and third quarters of 2007 with respect to the compensation expense of certain option
grants. Upon resolution of the matters discussed in this response, the Company intends to make a
final decision regarding its financial statements.
* * *
4
Please call the undersigned at the telephone number set forth above or Joseph Magnas at
212-336-4170 with any question or comment you may have regarding the responses set forth herein.
In addition, please send all written correspondence directly to the undersigned and Joseph Magnas
of Morrison & Foerster LLP, 1290 Avenue of the Americas, New York, New York 10104, telecopy
212-468-7900, with copies to David Aviezer, Ph.D., the Company’s President and Chief Executive
Officer, at 2 Snunit Street, Science Park, P.O.B. 455, Carmiel 20100, Israel, telecopy
+972-4-988-9489.
Sincerely,
/s/ James R. Tanenbaum
cc:
David Aviezer, Ph.D.
Yossi Maimon
5
Exhibit C
Example of the Company’s Application of the Straight-Line Method
in connection with the Accounting of Equity Awards Issued to Nonemployees
Assumptions
An award to purchase 100 shares of the Company’s common stock to a non-employee that vests in four
equal tranches of 25% each at the end of each quarter. The fair value of the award at the end of
each of the four quarters is as follows:
End of the first quarter:
$2.00 per share
End of the second quarter:
$5.00 per share
End of the third quarter:
$4.00 per share
End of the fourth quarter:
$1.00 per share
Expense
The aggregate compensation expense recorded by the Company calculated under the straight-line
attribution method is $300.00. The expense for each quarter is factor of the number of shares that
vested as of the quarter multiplied by the fair value per share for the quarter, as follows:
First quarter:
25 shares multiplied by $2.00 per share = $50.00
Second quarter:
25 shares multiplied by $5.00 per share = $125.00
Third quarter:
25 shares multiplied by $4.00 per share = $100.00
Fourth quarter:
25 shares multiplied by $1.00 per share = $25.00
Rationale
The illustration above reflects the same expense recognition as if a company had agreed to pay cash
for each quarter of service. The Company believes that the EITF 96-18 approach requires the
Company to use the then current value of the award as the final measurement. Each period’s
compensation cost reflects the valuation of the incremental shares earned during that period as the
period is completed. The use of a graded attribution methodology would result in the same
aggregate compensation cost.
Exhibit D
Analysis of all equity issuances in 2007 and 2008—Revisions
Number
Trading
Post-
Amount of
Amount of
of shares
value on
vesting/
compensation
compensation
Type of
of
Date of
Fair
the
Recipient
service
recorded for
recorded for
grant/
common
grant/
value
Measure-
measure-
Exercise
of grant/
period
2007 (in
2008 (in
issuance
stock
issuance
used
ment date
ment date
price
issuance
restrictions
$1,000s)
$1,000s) [6]
Grant of options[3]
204,351
5/15/2007
$
31.40
5/15/2007
$
31.40
$
4.33
Employee
None
2,255.00
-145.00
Issuance of
restricted shares[4]
8,000
5/15/2007
$
26.99
6/30/2007
$
26.99
$
0.001
Non-employee
Contractual lockup[5]
11.00
-5.00
[3]
Employee terminated in May 2008.
[4]
Restricted shares, subject to vesting.
[5]
Only a portion such grants are restricted and the restrictions terminate before the term of the options.
[6]
For the six-month period ended June 30, 2008.
2008-12-23 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP
1
filename1.htm
LETTER TO THE S.E.C.
1290
AVENUE OF THE AMERICAS
NEW YORK, NY 10104-0050
TELEPHONE:
212.468.8000
FACSIMILE: 212.468.7900
WWW.MOFO.COM
MORRISON & FOERSTER LLP
NEW
YORK, SAN FRANCISCO,
LOS ANGELES, PALO ALTO,
SAN DIEGO, WASHINGTON, D.C.
NORTHERN
VIRGINIA, DENVER,
SACRAMENTO, WALNUT CREEK
TOKYO,
LONDON, BEIJING,
SHANGHAI, HONG KONG,
SINGAPORE, BRUSSELS
Writer’s Direct Contact
212.468.8163
JTanenbaum@mofo.com
December 23, 2008
Mr. Todd E. Hardiman
Associate Chief Accountant
Division of Corporation Finance
United States Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549
RE:
Protalix BioTherapeutics, Inc.
Annual Report on Form 10-K, filed March 17, 2008
for the Fiscal Year Ended December 31, 2007
File No. 001-33357
Ladies and Gentlemen:
On behalf of our client, Protalix BioTherapeutics, Inc., a Florida corporation (the
“Company”), transmitted herewith are responses to the Staff’s comments to the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2007 (the “Form 10-K”), which comments
were delivered by the Staff to the Company’s counsel by way of a telephone call on December 4,
2008.
For ease of reference, we have noted the Staff’s comments in bold faced type and the responses
in regular type.
The staff requested a description of the Company’s analysis of the accounting for the options and
restricted stock issued by the Company in the reverse recapitalization of December 31, 2006. The
analysis should cover both the vested and unvested options and restricted stock issued on that
date.
RESPONSE: On December 31, 2006, the Company, which was then named Orthodontix, Inc., completed the
acquisition of Protalix Ltd., a privately-held Israeli biotechnology company. The acquisition was
effected through the merger (the “Merger”) of the Company’s wholly-owned subsidiary, Protalix
Acquisition Co., Ltd., with Protalix Ltd. At the closing of the Merger, the former shareholders of
Protalix Ltd. received shares of the Company’s common stock, par value $.001 per share (the “Common
Stock”), in exchange for all of their ordinary shares of Protalix Ltd. in a proportion equal to
approximately 61 shares of Common Stock for each ordinary share of Protalix Ltd. At and as of the
closing of the Merger, the former shareholders of Protalix Ltd.
received a number of shares of Common Stock equal to more than 99% of the outstanding shares of
Common Stock. As a result, Protalix Ltd. is now the Company’s wholly-owned subsidiary. For
accounting purposes, the Merger was treated as a recapitalization of Protalix Ltd.
The Stock Option Plan of Protalix Ltd. that was in effect prior to the Merger provided that if
Protalix Ltd. merged or consolidated with another corporation, all outstanding options granted by
Protalix Ltd. would automatically become fully vested unless they are assumed or substituted by the
successor entity. With respect to the Merger, the Company agreed to assume all of the outstanding
options issued by Protalix Ltd. to both employees and non-employees prior to the closing of the
Merger. In accordance with the terms and conditions of the Merger Agreement and Plan of
Reorganization made and entered into in connection with the Merger, all of the outstanding options
and warrants of Protalix Ltd. at the closing were exchanged for options and warrants of the
Company. In connection with the exchange, the Company issued options and warrants to purchase
9,004,061 shares of Common Stock.
All of the options issued by the Company in exchange for options of Protalix Ltd. in connection
with the Merger were identical to the options they replaced except that the number of shares of
Common Stock underlying each option, and the per share exercise price of the options, were adjusted
based upon the ratio used in the Merger to determine how many shares of Common Stock were to be
issued for each ordinary share of Protalix Ltd. surrendered. The aggregate exercise price remained
unchanged and there were no changes to the vesting schedule and terms of any option issued by the
Company pursuant to the terms and conditions of the Merger.
For accounting purposes, the Company treated the exchange of the options and warrants as a
modification of the surrendered options and warrants. According to Statement of Financial
Accounting Standards No. 123(R) (“Statement 123R”), modifications to the terms of an award are
treated as an exchange of the original award for a new award, and result in the incurrence of
additional compensation cost for that incremental value. The incremental value is equal to the
difference between (a) the fair value of the modified award and (b) the value of the original award
immediately before its terms are modified. In calculating the incremental value of the
modification, the Company found that there was no change in the fair value of the options as a
result of the Merger. Accordingly, the Company did not record any incremental costs due to the
issuance of stock options in connection with the exchange of the Protalix Ltd. option in connection
with the Merger.
The following table provides the data analyzed by the Company in its determination that there was
no difference in the fair value of the options surrendered in connection with the Merger and the
options issued in replacement of such surrendered options. All figures are in thousands, except
per share data.
Immediately before
Immediately after
the Merger
the Merger (1)
Value of Ordinary Shares of
Protalix Ltd.
$91.59
$1.50
Exercise Price range ($) (1)
0.01-59.40
0.001-0.97
Number of Options (2)
147,412
9,004,061
2
(1)
There were five different exercise prices that applied to the outstanding options.
(2)
The data does not include options to purchase 2,712,792 shares of Common Stock that
were granted immediately after the closing of the Merger with an exercise price equal to
$16.70. None of such options were exercisable as of December 31, 2006.
All other assumptions regarding dividend yield, expected volatility, risk-free interest rate and
expected life remained the same.
The following table provides the data relating to the options issued in connection with the closing
of the Merger.
Vested
Unvested
Employees
1,670,132
2,474,685
Non-Employees
3,377,058
1,482,186
(1)
(1)
The data does not include options to purchase 2,712,792 shares of Common Stock that
were granted immediately after the closing of the Merger with an exercise price equal to
$16.70. None of such options were exercisable as of December 31, 2006.
The fair value of the Company did not change as compared before and after the Merger as the Company
(Orthodontix, Inc., at the time of the Merger) was not an operating entity, did not have any assets
or liabilities, other than approximately $877,000 in net assets, and was quoted on the OTC Bulletin
Board, which is not a major exchange. In addition, neither the Common Stock that was issued in
exchange for ordinary shares of Protalix Ltd., nor the Common Stock underlying the stock options
issued in connection with the Merger were registered with the Securities and Exchange Commission.
Rather, as of December 31, 2006, all such shares of Common Stock were subject to trading
restrictions.
In accordance with Emerging Issues Task Force Issue (“EITF”) Topic No. D-90, the Company did not
record any increase in its equity as a result of exchange transaction. It should be noted that
since the Merger was treated as a recapitalization for accounting purposes, all of the
financial statements of the Company are those of the predecessor company, Protalix Ltd. The sole
exception is the share capital line item in the balance sheets. In addition, the Company’s capital
accounts do not include any amounts assigned to share-based payments not yet recorded as expenses.
Virtually all of the total share-based compensation expense recorded by the Company during fiscal
year 2007 resulted from the following two grants to non-employees recorded in 2007:
•
On January 1, 2006, Protalix Ltd. issued to two entities affiliated with the Chairman of
the Company’s Board of Directors, Eli Hurvitz, options to purchase 1,753,027 shares of
Common Stock. The per share exercise price of the options is 0.01 New Israeli Shekels
(NIS). The options vest as follows: 10% of the options vested at the date of the
3
appointment (January 1, 2006) and an additional 10% of the options vest at the end of each
three-month period thereafter, provided that Mr. Hurvitz continues to serve as the Chairman
of the Board. The Chairman is not an employee of the Company. Accordingly, the accounting
model followed by the Company in connection with this grant is EITF 96-18. The Company
recorded stock compensation expense of $1,085,000; $4,731,000; $877,000; and $596,000 for
the four quarters of 2007, respectively. The per share common stock value used in the
foregoing calculations was $6.19, $26.99, $5.00 and $3.40, respectively.
•
On December 31, 2006, immediately after the closing of the Merger, the Company issued to
a consultant options to purchase 387,542 shares of Common Stock in consideration for
services to be provided to the Company. Unlike the other options, this option was not
issued to replace options issued by Protalix Ltd. prior to the Merger. The options
originally vested in five equal increments commencing upon the date that the Common Stock
being listed by the American Stock Exchange and on the next four six-month anniversaries of
such date. On February 28, 2007, the vesting schedule of the options was modified as
follows: 40% of the options shall vest on March 1, 2008 and an additional 15% of the
options vest in four equal installments on each of the following dates: June 30, 2008,
December 31, 2008, June 30, 2009, and September 30, 2009. The modification had no effect
on the accounting records of the Company. The per share exercise price of the
options is $16.70 per share.
The Company elected to recognize the stock-based compensation expense related to these awards using
the straight-line attribution method. The Company considered the following factors in determining
the attribution method to apply:
1)
EITF 96-18, Issue 3, provides that changes in the fair value of outstanding awards to
nonemployees between interim reporting dates should be attributed in accordance with the
methods illustrated in Financial Interpretation 28. The Company believes that EITF 96-18,
Issue 3, relates to the requirement to remeasure the awards for changes in fair value
between interim reporting dates and does not prescribe the attribution method that must be
used.
2)
Effective as of January 1, 2006, for purposes of the Company’s financial statements,
FIN 28 was superseded by Statement 123R. Paragraph 42 of Statement 123R allows companies
to make a policy election about whether to recognize compensation cost for an employee
award with only service conditions that has a graded vesting schedule on a straight-line
method over the requisite service period for each separately vesting portion of the award
as if the award was, in substance, multiple awards, or on a straight-line basis over the
requisite service period of the last separately vesting portion of the award.
3)
While Statement 123R applies to employee awards, Statement 123R may also be applied to
non-employee awards when such non-employee awards have a service only condition. Staff
Accounting Bulletin (SAB) 107 states as follows:
Statement 123R does not supersede any of the authoritative literature that
specifically addresses accounting for share-based payments with
4
nonemployees. For example, Statement 123R does not specify the measurement
date for share-based payment transactions with nonemployees when the
measurement of the transaction is based on the fair value of the equity
instruments issued. For determining the measurement date of equity
instruments issued in share-based transactions with nonemployees, a company
should refer to Emerging Issues Task Force (“EITF”) Issue No. 96-18,
Accounting for Equity Instruments That Are Issued to Other Than Employees
for Acquiring, or in Conjunction with Selling, Goods or Services.
With respect to questions regarding nonemployee arrangements that are not
specifically addressed in other authoritative literature, the staff believes
that the application of guidance in Statement 123R would generally result in
relevant and reliable financial statement information. As such, the staff
believes it would generally be appropriate for entities to apply the
guidance in Statement 123R by analogy to share-based payment transactions
with nonemployees unless other authoritative accounting literature more
clearly addresses the appropriate accounting, or the application of the
guidance in Statement 123R would be inconsistent with the terms of the
instrument issued to a nonemployee in a share-based payment arrangement.
Since EITF 96-18 does not prescribe the attribution model to apply for a graded vesting
award, the Company elected to use straight-line attribution for the options granted to
nonemployees based upon the guidance set forth in Statement 123R. The Company does not
believe that there is any other authoritative accounting literature that more clearly
addresses the appropriate accounting of the nonemployee options. In addition, the Company
does not believe that the guidance in Statement 123R is inconsistent with the terms of the
options granted by the Company to nonemployees.
The Company applies the straight-line attribution accounting treatment as follows. Upon having
vested in an individual tranche of an option granted to an nonemployee, the Company deems the
nonemployee’s performance for that tranche to be completed. The Company also deems the vesting
date for each tranche of an option to be the final measurement date of that tranche. Therefore,
the Company does not remeasure vested tranches in subsequent periods. For individual tranches for
which the applicable vesting/service period crossed interim periods (such as the options issued to
the consultant), the Company remeasures the tranches until the final vesting date of the tranche.
The Company recognizes that other attribution methods may be acceptable methods for the calculation
of the stock-based compensation expense of awards to nonemployees. However, the Company believes
that the method described above conforms not only with the applicable accounting literature but
also with the substance of the arrangements.
As indicated in the letter dated October 16, 2008, the Company applied the simplified method for
the expected term of the stock options. Had the Company applied the contractual term of the
options rather that the simplified method, the recorded compensation expense would have been
5
approximately $143,000 and $420,000 more for each of fiscal year 2007 and the first three quarters
of 2008, respectively. The Company does not believe that either of these amounts are material for
accounting purposes.
* * *
Please call the undersigned at the telephone number set forth above or Joseph Magnas at
212-336-4170 with any question or comment you may have regarding the responses set forth herein.
In addition, please send all written correspondence directly to the undersigned and Joseph Magnas
of Morrison & Foerster LLP, 1290 Avenue of the Americas, New York, New York 10104, telecopy
212-468-7900, with copies to David Aviezer, Ph.D., the Company’s President and Chief Executive
Officer, at 2 Snunit Street, Science Park, P.O.B. 455, Carmiel 20100, Israel, telecopy
+972-4-988-9489.
Sincerely,
/s/ James R. Tanenbaum
cc:
David Aviezer, Ph.D.
Yossi Maimon
6
2008-10-16 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP
1
filename1.htm
CORRESP
Writer’s Direct Contact
212.468.8163
JTanenbaum@mofo.com
October 16, 2008
Mr. Jim Rosenberg
Senior Chief Accountant
Division of Corporation Finance
United States Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549
RE:
Protalix BioTherapeutics, Inc.
Annual Report on Form 10-K, filed March 17, 2008
for the Fiscal Year Ended December 31, 2007
File No. 001-33357
Ladies and Gentlemen:
On behalf of our client, Protalix BioTherapeutics, Inc., a Florida corporation (the
“Company”), transmitted herewith are responses to the Staff’s comments to the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2007 (the “Form 10-K”), which comments
were set forth in the Staff’s letter to the Company dated October 2, 2008 (the “Comment Letter”) to
Yossi Maimon, the Company’s Chief Financial Officer and Treasurer.
For ease of reference, we have noted the Staff’s comments in bold faced type and the responses
in regular type.
Note 5 — Share Capital, page F-20
1.
On page F-13 you state that the fair value of stock options was determined using the
Black-Scholes options pricing model. Please confirm to us that you used this model and tell
us the assumptions you used for 2007. Please refer to paragraph A240e.(2) of FAS 123R.
RESPONSE: The Company hereby confirms that it used the Black-Scholes options-pricing model
to determine the fair value of options to purchase shares of its common stock, par
value $.001 per share (the “Common Stock”), granted by the Company in 2007. However, the
Company treats the fair value of options granted with an exercise price equal to the par
value of the Common Stock (“Par Options”) as being equal to the fair value of the Common
Stock underlying the options, as discussed below.
Set forth below are the assumptions used by the Company to calculate the fair value of stock
options in 2007.
Employees:
The assumptions used for option grants in 2007 are disclosed in Note 5(f)(1)(b) on page F-24
of the financial statements contained in the Form 10-K, as follows:
2007
Dividend yield
0
%
Expected volatility
53
%
Risk-free interest rate
4.62
%
Expected life — in years
6.0
As discussed in the response to Comment No. 2, there are no restrictions on the transfer
of shares of Common Stock underlying the options granted to employees other than the
restrictions relating to the transfer of options granted to employees. Accordingly, when the
Company determined the value of options under the Black-Scholes options-pricing model, the
Company used the expected term of each option which differs from its contractual term and did
not apply a discount to the pricing model for options granted to employees.
Non-employees:
During 2007, the Company granted Par Options and restricted shares, which are subject to a
vesting schedule (“restricted shares”), to certain non-employees. The Company treats the
grant of Par Options as grants of Common Stock. Accordingly, the Company calculated the fair
value of the restricted shares and the Par Options to be equal to the fair value of the
Common Stock.
2.
We are unable to discern a consistent policy for the measurement date used under 123(R) and
EITF 96-18 as well as the valuation methodology used. In order to help us understand these
matters, please tell us the nature of the restrictions, and whether or not the restrictions
extend beyond the vesting or service period, for the following grants and how the restrictions
are reflected in the valuation method (paragraph 17 of 123(R) for employees). Please tell us
whether the nature of the restrictions is the same as the trading restrictions on the 99% of
outstanding shares of common stock.
•
Options held by non-employees that vested during the period
•
Options granted to employees during the period
•
Restricted common stock held by non-employees that vested during the period
•
Restricted common stock granted to employees during the period
RESPONSE: The options and restricted shares granted by the Company were not subject to the
same trading restrictions that applied to the 99% of outstanding shares of Common
2
Stock. Set forth below is a description of the restrictions imposed on the options and
restricted shares issued by the Company.
Options held by non-employees that vested during 2007 and restricted
common stock held by non-employees that vested during 2007:
Options and shares of Common Stock held by non-employees that vested during 2007 are not
subject to any restrictions. Notwithstanding the foregoing, certain securities held by
non-employees on December 31, 2006, the date of the merger of Protalix Ltd. with the
Company’s then wholly-owned subsidiary, Protalix Acquisition Co. Ltd. (the “Merger”) are
subject to restrictions. In connection with the Merger, substantially all of the former
shareholders of Protalix Ltd. entered into lock-up agreements to satisfy Israeli tax laws and
certain contractual obligations. The lock-up agreements prohibited such former shareholders
of Protalix Ltd. from, directly or indirectly, selling or otherwise transferring the shares
of Common Stock issued to them in connection with the Merger (including any shares of Common
Stock issuable upon the exercise of outstanding options or warrants) during the period
commencing upon the closing of the Merger and ending on January 1, 2009. However, during
such period, each such former shareholder of Protalix Ltd. had the option, under the terms of
the lock-up agreements and the tax ruling described below, to sell an aggregate of 10% of
each such shareholder’s original number of locked-up shares. On June 11, 2008, after
completing discussions with the Israeli tax authorities regarding a tax ruling regarding the
treatment of the Merger under Israeli tax laws, the Company terminated the lock-up agreements
for holders of 5% or less of the Company’s outstanding shares as of the closing of the
Merger.
The Company did not consider these restrictions when it measured the fair value of options
and shares of Common Stock held by non-employees that vested during 2007. The Israeli tax
authorities imposed these restrictions on the options as a precondition to favorable tax
treatment of such considerations. As the holders of the options benefit from the
restrictions, the Company determined that the restrictions should not lead to a discount to the
fair value of the options.
Options granted to employees during the period:
Options granted to employees, prior to exercise, may not be sold, pledged, assigned,
transferred or disposed of in any manner other than by will or by the laws of descent or
distribution. In addition, if an employee’s continuous service is terminated while an option
is unexercised, the employee (or his or her estate or a person who acquired the right to
exercise the award by bequest or inheritance) may exercise the portion of the employee’s
award that was vested as of the date of such termination or such other portion of the
employee’s award as may be determined by the administrator of the Protalix BioTherapeutics,
Inc., 2006 Stock Incentive Plan according to the following post-termination exercise periods
(unless the applicable award agreement provides otherwise):
for any reason other than cause, disability or death:
12 months from date of termination
3
for cause:
14 days from date of termination
for disability:
12 months from date of termination
for death (including the death of the employee during these post-termination exercise periods):
12 months from date of death
Notwithstanding the foregoing, in no event shall an option be exercisable later than the
expiration date of the term of the award as set forth in the applicable award agreement. To
the extent that an employee’s award was unvested at the date of termination, or if the
employee does not exercise the vested portion of the employee’s award within the time
specified in the applicable award agreement, the award shall terminate.
The options are not subject to any additional restrictions other than the vesting conditions.
Restricted common stock granted to employees during the period:
The Company did not issue any restricted shares to employees during the period.
As required by FAS 123R, the Company considered the restrictions discussed herein when
valuing options under the Black-Scholes options-pricing model using
an expected term for the
options that differs from the contractual term of the options.
3.
You stated in your disclosure on page 57 that you are using the expected term based on the
simplified method. Please address the following:
•
Please tell us if any of the features discussed in footnote 7 of SAB 107A
exists, and if not, why you believe using the expected term, which may be shorter
than the contractual term, is appropriate. Refer to SAB 107D(2)(Q6).
•
If there are restrictions on stock that go beyond the vesting or service date,
it does not appear that the simplified method is appropriate.
•
It appears that an option that is “in the money” may have a different expected
term than an option that is “at the money”, which was one of the prerequisites
for using the simplified method for determining the expected term. Please tell us
why you believe use of the simplified method is appropriate based on the guidance
in SAB 107D(2)(Q6).
RESPONSE: The disclosure on page 57 of the Form 10-K refers to the use of the simplified
method to calculate the expected term of options granted by the Company to employees in 2007.
The following is an analysis of the Company’s use of the simplified method in connection
with options granted to employees in 2007.
4
As discussed in the response to Comment No. 2, options, prior to exercise, may not be sold,
pledged, assigned, transferred or disposed of in any manner other than by will or by the laws
of descent or distribution. In addition, as noted in the response to Comment No. 2, the
contractual terms of options are subject to early termination in connection with post-vesting
service termination. Such features are consistent with the features discussed in Footnote 7
of SAB 107A.
Except as discussed in the response to Comment No. 2, there are no other restrictions on the
stock options granted to employees during the period, other than the vesting conditions. In
addition, there are no restrictions on the shares of Common Stock issued in connection with
the exercise of stock options by employees. As required by FAS 123R, the Company considered
the restrictions discussed herein when valuing options under the Black-Scholes
options-pricing model using an expected term for the options that differs from the
contractual term of the options.
While the Company assumed that the average exercise period for options granted “in the money”
would be shorter than the average period between the vesting and the expiration of the
options, due to the lack of information regarding exercise behavior, the Company implemented
the simplified method for the calculation of the expected period. As indicated in Exhibit B,
the Company only made one option grant to an employee during 2007. The grant to an employee
in May 2007 of options to purchase 204,351 shares of Common Stock was “in the money,” based
on the closing price of the Common Stock on the date of grant. Accordingly, management does
not believe that the fair value of the option would be materially different based on a
shorter expected term assumption.
4.
Please provide us an analysis, preferably in tabular format, of all equity issuances in 2007
and 2008, the date of grant/ issuance, fair value used, measurement date, trading value on the
measurement date, the exercise price, if applicable, recipient of the grant/ issuance
(employee/ non-employee and related party/ non-related party), any post-vesting/service period
restrictions, and the amount of compensation recorded for each issuance. Please provide a
separate table for non-employee issuances/grants in which compensation was recorded based on a
vesting date during the period.
RESPONSE:
Please see Exhibit A and Exhibit B attached hereto.
5.
For the first quarter in 2007 you used the quoted market price on the Tel-Aviv Stock Exchange
for Bio-Cell rather than Over-the-Counter Bulletin Board (OTCBB) bid/ask because you stated
there was insufficient volume on OTCBB. Please address the following:
•
Tell us if you used the quoted market price on the measurement date or the quoted
market price at the end of the quarter (i.e. March 31, 2007)
•
We understand your stock was listed on the American Stock Exchange beginning
March 12, 2007. Tell us if you had any measurement dates on or
5
after this date and if so, why you used Tel-Aviv stock exchange for Bio-Cell instead of
the American Stock Exchange for the company.
RESPONSE: During the first quarter of 2007, the Company did not grant any options to
employees or non-employees. The only measurement the Company made for the first quarter of
2007 was the final measurement of 175,303 outstanding options held by non-employees that
vested at the end of the quarter, and an interim measurement for 35,231 remaining options
that were subject to further vesting as of the end of the quarter.
For purposes of the March 30, 2007 measurement date, the Company determined the fair value of
outstanding options held by non-employees that vested at the end of the first quarter of 2007
based on the valuation of the Company’s largest shareholder, Bio-Cell Ltd. (“Bio-Cell”), an
Israeli public company traded on the Tel Aviv Stock Exchange, not on the trading price of the
Common Stock reported by the American Stock Exchange (the “AMEX”). As of March 31, 2007,
Bio-Cell held approximately 20% of the outstanding shares of Common Stock and did not have
any other significant assets other than its interest in the Company.
Fundamentally, while the Company understands that observable transactions in its Common Stock
are generally presumed to be the fair value of the Common Stock, it is the Company’s belief
that the price levels of the Common Stock throughout most of 2007 were not reflective of a
reasonable fair value for the Common Stock if one considers all other available evidence
relating to the value of the Common Stock. As the Company prepared the financial statements
for the first quarter of 2007, it believed that the trading prices reported by the AMEX
should not be the exclusive determinant of the fair value of the Common Stock. Rather, in
situations like the Company’s, in which the trading price of a security is clearly not
indicative of its fair value, the Company should consider all available evidence of the fair
value of the Common Stock in order to accurately reflect the cost of stock compensation
arrangements. The Company believes that the aggregate trading volume of 38,500 shares of
Common Stock on the AMEX during the first quarter of 2007 was not sufficient evidence to
determine a fair value for transactions involving the
2.1 million shares of Common Stock underlying the stock
compensation arrangements. Further, the trading price of the Common Stock on the AMEX was
especially not indicative of the market value of the Company’s outstanding shares of Common
Stock, in the aggregate, if one considers the 65 million shares of Common Stock outstanding
(resulting in an implied value of the Company equal to approximately $2 billion).
In the Company’s judgment, there was sufficient activity in the market for Bio-Cell’s shares
to use as an evidence of the fair value of the Common Stock for the first quarter of 2007.
The average daily trading volume of Bio-Cell’s sh
2008-10-02 - UPLOAD - Protalix BioTherapeutics, Inc.
Via Facsimile and U.S. Mail
Mail Stop 6010
October 2, 2008
Yossi Maimon
Chief Financial Officer and Treasurer
Protalix BioTherapeutics, Inc.
2 Snunit Street
Science Park
POB 455
Carmiel, Israel 20100
Re: Protalix BioTherapeutics
Form 10-K for the Fiscal Year Ended December 31, 2007
Filed March 17, 2008
File Number: 001-33357
Dear Mr. Maimon:
We have the following additional co mments on your response dated July 11,
2008. In our comments we ask you to provide us with information so we may better
understand your disclosure. After reviewing th is information, we may raise additional
comments.
Note 5 – Share Capital, page F-20
1. On page F-13 you state that the fair valu e of stock options was determined using
the Black-Scholes optio ns-pricing model. Please conf irm to us that you used this
model and tell us the assumptions you us ed for 2007. Please refer to paragraph
A240e.(2) of FAS 123R.
2. We are unable to discern a consistent policy for the measurement date used under
123(R) and EITF 96-18 as well as the va luation methodology used. In order to
help us understand these matters , please tell us the nature of the restrictions, and
whether or not the restric tions extend beyond the vesting or service period, for the
following grants and how the restrictions are reflected in the valuation method
(paragraph 17 of 123(R) for employees). Please tell us whether the nature of the restrictions is the same as the tradin g restrictions on th e 99% of outstanding
shares of common stock.
• Options held by non-employees th at vested during the period
• Options granted to employees during the period
Yossi Maimon
Protalix BioTherapeutics, Inc.
October 2, 2008
Page 2
• Restricted common stock held by non- employees that vested during the
period
• Restricted common stock granted to employees during the period
3. You state in your disclosure on page 57 that you are using the expected term
based on the simplified method. Please address the following:
• Please tell us if any of the features discussed in footnote 7 of SAB 107A
exist, and if not, why you believe usi ng the expected term, which may be
shorter than the contract ual term, is appropriate. Refer to SAB
107D(2)(Q6).
• If there are restrictions on the stoc k that go beyond the vesting or service
date, it does not appear that the si mplified method is appropriate.
• It appears that an opti on that is “in the money” may have a different
expected term than an option that is “at the money,” which was one of the
prerequisites for using the simplified method for determining the expected
term. Please tell us why you believe use of the simplified method is appropriate based on the gui dance in SAB 107D(2)(Q6).
4. Please provide us an analysis, preferably in tabular format, of all equity issuances
in 2007 and 2008, the date of grant/issuance, fair value used, measurement date,
trading value on the measurement date, the ex ercise price, if a pplicable, recipient
of the grant/issuance (employee/non-em ployee and related party/non-related
party), any post-vesting/service peri od restrictions, and the amount of
compensation recorded for each issuance. Please provide a separate table for non-
employee issuances/grants in which compensation was recorded based on a vesting date during the period.
5. For the first quarter in 2007 you used th e quoted market price on the Tel-Aviv
Stock Exchange for Bio-Cell rather th an Over-the Counter Bulletin Board
(OTCBB) bid/ask because you state ther e was insufficient volume on OTCBB.
Please address the following:
• Tell us if you used the quoted market price on the measurement date or the
quoted market price at the end of the quarter (i.e. March 31, 2007)
• We understand your stock was listed on the American Stock Exchange
beginning March 12, 2007. Tell us if you had any measurement dates on
or after this date and if so, why you used the Tel-Aviv stock exchange for
Bio-Cell instead of the American Stock Exchange for the company.
6. For the second quarter in 2007 you used th e quoted trading valu e on the American
Stock Exchange. Please address the following:
• What consideration you gave to restricti ons in determining the fair value.
• Whether or not the quoted trading pri ce was used or if that price was
adjusted.
Yossi Maimon
Protalix BioTherapeutics, Inc.
October 2, 2008
Page 3
• Tell us if you used the quoted tradin g price at the measurement date or
some other date like the end of period.
7. For the third quarter in 2007 you used the private placement in the fourth quarter
to determine your fair value. Please address the following:
• What consideration you gave to the fact that the tr ading volume was
higher in the third quarte r than the second quarter.
• What consideration was give n to restrictions in determining the fair value.
8. For the fourth quarter in 2007 you used the quoted trading price on December 31,
2007. Tell us if there were issuances/grants or vested equity issuances other than
on December 31, 2007 and why the measurement date was not used for those.
9. Tell us what methodology you used for stoc k compensation in the first and second
quarter of 2008 addressing the above concerns as applicable.
10. You use the terminology “the appropriate da te” on page 57 and in Note 5 to the
financial statements when referring to th e date in which you used for determining
fair value. Your response letter implies that you may have used the date at the
end of the quarter, which may differ from the measurement date. Please confirm
that you are referring to the measuremen t date as discussed in SFAS 123R and
EITF 96-18 and revise your wording accordingly or tell us why the measurement date has not been used.
* * * *
Please provide us the information request ed within 10 busine ss days or tell us
when you will provide us with a response. Pl ease furnish a cover le tter with your response
that keys your response to our comments. De tailed cover letters gr eatly facilitate our
review. Please furnish your letter on EDGAR under the form type label CORRESP.
You may contact Vanessa R obertson, Staff Accountant, at (202) 551-3649 or
Mary Mast, Senior Staff A ccountant, at (202) 551-3613 if you have any questions
regarding the comment. In th is regard, do not hesitate to contact me, at (202) 551-3679.
S i n c e r e l y ,
J i m B . R o s e n b e r g
Senior Assistant Chief
Accountant
2008-07-11 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP
1
filename1.htm
CORRESP
1290 AVENUE OF THE AMERICAS
NEW YORK, NY 10104-0050
TELEPHONE: 212.468.8000
FACSIMILE: 212.468.7900
WWW.MOFO.COM
morrison & foerster llp
new york, san francisco,
los angeles, palo alto,
san diego, washington, d.c.
northern virginia,
orange county, denver,
sacramento, walnut creek
tokyo, london, beijing,
shanghai, hong kong,
singapore, brussels
July 11, 2008
Writer’s Direct Contact
212.468.8163
JTanenbaum@mofo.com
Ms. Vanessa Robertson
Staff Accountant
Division of Corporation Finance
United States Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549
RE:
Protalix BioTherapeutics, Inc.
Annual Report on Form 10-K, filed March 17, 2008
for the Fiscal Year Ended December 31, 2007
File No. 001-33357
Ladies and Gentlemen:
On behalf of our client, Protalix BioTherapeutics, Inc., a Florida corporation (the
“Company”), transmitted herewith are responses to the Staff’s comments to the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2007 (the “Form 10-K”), which comments
were set forth in the Staff’s letter to the Company dated June 26, 2008 (the “Comment Letter”) to
Yossi Maimon, the Company’s Chief Financial Officer and Treasurer.
For ease of reference, we have noted the Staff’s comments in bold faced type and the responses
in regular type.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Results of Operations, page 58
Research and Development Expenses
1.
We believe that your disclosures about historical research and development expenses and
estimated future expenses related to your major research and development projects could be
enhanced for investors. Please refer to the Division of Corporation Finance “Current
issues and Rulemaking Projects Quarterly Update” under section VIII – Industry Specific
Issues – Accounting and Disclosure by Companies Engaged in Research and Development
Activities.
You can find it at the following website address:
http://www.sec.gov/divisions
/corpfin/cfcrq032001.htm. Please revise your MD&A to disclose the following information
for each of your major research and development projects.
a.
The current status of the project;
b.
The costs incurred during each period presented and to date on
each project;
c.
The nature, timing and estimated costs of the efforts necessary
to complete each project;
d.
The anticipated completion dates of each project;
e.
The risks and uncertainties associated with completing
development on schedule, and the consequences to operations, financial position
and liquidity if each project is not completed timely; and finally
f.
The period in which material net cash inflows from significant
projects are expected to commence for each project.
Regarding b., if you do not maintain any research and development costs by project, disclose
that fact and explain why management does not maintain and evaluate research and development
costs by project. Provide other quantitative or qualitative disclosure that indicates the
amount of the company’s resources being used on the project.
Regarding c. and d., disclose the amount or range of estimated costs and timing to complete
the phase in process and each future phase. To the extent that information is not
estimable, disclose those facts and circumstances indicating the uncertainties that preclude
you from making a reasonable estimate.
Response: The majority of the Company’s research and development expenses are currently
incurred in connection with the phase III clinical trial of the Company’s lead product
candidate, prGCD for the treatment of Gaucher disease. As disclosed in the Form 10-K, the
Company is also engaged in the research and development of three other projects, each of
which is in the research stage. When compared to the expenditures for the research and
development of prGCD, the Company believes that the expenditures for the other research and
development projects are immaterial to the business and prospects of the Company. For such
reasons, the Company does not record and maintain research and development costs on a per
project basis. In addition, due to the inherently unpredictable nature of the preclinical
and clinical development process, the Company is not able to estimate the future costs of
any of its research and development projects with any certainty, nor is the Company able to
predict the timing or receipt of net cash inflows for any project, if any. Based upon the
foregoing, the Company believes that it has disclosed the appropriate information regarding
its research and development expenses in the Management’s Discussion and Analysis of
Financial Condition and Results of Operations (the “MD&A”) section of the 10-K.
Based upon the Staff’s comment, the Company intends to structure the Research and
Development Expense subsection in the MD&A
2
section of future annual reports in a manner similar to model disclosure set forth on
Exhibit A.
Report of Independent Registered Public Accounting Firm, page F-2
2.
Auditor association with the cumulative data is required on an annual basis as long as the
registrant is in the development stage. There is no reference to the cumulative data in the
accountant’s report. In addition, it does not appear as though a waiver for this requirement
was granted by the Office of the Chief Accountant within the Division of Corporation Finance.
Please advise whether a waiver was obtained and provide us a copy or include the appropriate
accountant report. To be granted a waiver it must be impracticable for you to obtain an audit
opinion on the cumulative data. A written submission explaining why it is impracticable must
be provided to the Office of the Chief Accountant within the Division of Corporation Finance
to obtain a waiver.
RESPONSE: The omission of the reference to the cumulative data in the Report of the
Independent Registered Accounting Firm included in the Company’s Financial Statements for
the fiscal year ended December 31, 2007 is due to a typographical error. The Company’s
accountants provided an opinion on the cumulative data in their report for the 2006
financial statements and intended to include the cumulative data in the 2007 integrated
audit opinion. A copy of the corrected Report of the Independent Registered Accounting Firm
included in the Company’s Financial Statements for the fiscal year ended December 31, 2007
is attached hereto as Exhibit B.
Note 4 — Commitments, page F-18
3.
Please revise your disclosure to include all of the milestone payments you will be required
to pay under certain research and license agreements. Please include the events that would
trigger these payments. Also tell us why you did not include these amounts in your
contractual obligation table. Finally, please include the length of and the termination
provisions for all of your material agreements.
RESPONSE: As discussed with the Staff, most of the payments under the Company’s research and
license agreements are in the form of royalties on the net sales of an approved product, if
any. There are few provisions in such agreements which obligate the Company or its
wholly-owned subsidiary, Protalix Ltd., to make milestone payments or other similar payments
other than the royalties. The Company believes that the amounts of these payments,
individually and in the aggregate, are immaterial to the business and prospects of the
Company due to the relatively small amounts of the payments, the contingent nature of the
payments, the fact that certain of the payments are payable in the future and the fact that
certain of the payments are creditable against future royalty payments.
For the foregoing reasons, the Company does not believe that additional disclosure regarding
the milestone payments and other payments is necessary for the protection of
3
investors. Such payments, if all of the contingencies are met, amount to approximately $1.3
million and would be payable, if at all, as the Company’s projects progress over the course
of a number of years. In addition, the Commission has previously granted confidential
treatment for the amount and timing of all such payments. For the same reasons, the Company
did not include any of the payments in the contractual obligation table set forth in the
MD&A section of the Form 10-K.
Based upon the Staff’s comments, the Company intends to include disclosure regarding the
aggregate amount of the milestone and other payments in the financial statements it prepares
in future annual reports. Also, to the extent applicable, the Company intends to include
disclosure regarding the length of and termination provisions of its research and license
agreements in the financial statements it prepares in future annual reports.
4.
Please explain how the $1,724,000 commitment under your sub-contracting agreements relates to
the purchase obligations of $4,086,000 included in your contractual obligations table.
RESPONSE: The purchase obligations of approximately $4,086,000 disclosed in the contractual
obligation table in the MD&A of the Form 10-K includes the Company’s commitments of
approximately $1,724,000, as of December 31, 2007, under certain of the Company’s research
and development agreements as disclosed in Note 4 of the Company’s Financial Statements for
the fiscal year ended December 31, 2007. The remaining approximately $2,362,000 disclosed
in the contractual obligation table represents open purchase orders which the Company had
issued to certain suppliers and other vendors that were outstanding as of December 31, 2007.
Note 5—Share Capital, page F-20
5.
Please provide us a chronology of facts, circumstances and events explaining the change in
fair value of the common stock issued during 2006 of approximately $1.50 per share to the
trading value immediately after the merger of approximately $27 per share.
RESPONSE: As discussed in Note 5(b) of the Company’s Financial Statements for the fiscal
year ended December 31, 2007, the description of share capital in the Company’s historical
financial statements reflects the historical financial statements of Protalix Ltd., and have
been retroactively restated to reflect the implicit conversion ratio related to the exchange
of ordinary shares of Protalix Ltd. for shares of the Company’s common stock, par value
$.001 per share (the “Common Stock”), in connection with the merger of the Company with a
wholly-owned subsidiary of the Company, which was consummated on December 31, 2006 (the
“Merger”). In August 2006, Protalix Ltd. sold 163,774 of its ordinary shares to investors
for aggregate proceeds equal to $15,000,000 or $91.59 per ordinary share. On the same date,
Protalix Ltd. entered into a merger agreement with the Company and a wholly-owned subsidiary
of the Company. After giving retroactive effect to the conversion ratio in the Merger,
which was approximately 1 for 61.08, the offering was conducted at approximately $1.50 per
share (after giving effect to the 10-
4
for-1 reverse stock split which went into effect on December 29, 2006, as discussed below
(the “Reverse Stock Split”)).
On August 21, 2006, the closing price of the Common Stock quoted on the OTC Bulletin
Board® (the “OTCBB”) was $3.90 per share (which is a pre-Reverse Stock Split
number). From August 22, 2006 through December 29, 2006, the closing price of the Common
Stock declined to $1.67 per share (which is a pre-Reverse Stock Split number) with very low
volume. On many days during such period, there was no trading in the Common Stock at all.
In connection with the closing of the Merger, the Company completed a 10-for-1 reverse stock
split on December 29, 2006. Accordingly, on January 3, 2007, the first trading day after
the effective date of the Reverse Stock Split and the closing of the Merger, the opening
price of the Common Stock, as quoted on the OTCBB, was $14.00 per share. The closing price
of the Common Stock on that date was $27 per share. All of the corporate events discussed
in this response have been disclosed by the Company in either the Form 10-K or in other
filings made with the Commission. All of the Company’s officers and directors entered into
lock-up agreements in connection with the Merger and were restricted from selling more than
10% of their holdings in the Company. To the Company’s knowledge, none of the Company’s
officers or directors sold any shares of Common Stock during fiscal year 2007.
6.
You state in Note 5 and on pages 56-57 that you used various methods to determine the fair
value of your common stock. It appears as though your stock was trading prior to the March
12, 2007 date that it was listed on the American Stock Exchange. In addition, it appears you
used the $5 per share offering price in October 2007 to value equity issuances granted before
that including for issuances during the third quarter ended September 30, 2007 even though
there was a trading price of your stock during that period. Please tell us how your use of
valuation methods during the first and third quarters of 2007 rather than the trading price of
your stock to value equity issuances for compensation expense/consulting expense, etc.
complies with FAS 123R.
RESPONSE: Prior to March 12, 2007, the Common Stock was quoted on the OTCBB. On March 12,
2007, the Common Stock was accepted for listing on the American Stock Exchange (the “AMEX”).
During the quarter ended March 31, 2007 (the “First Quarter”), more than 99% of the
outstanding shares of Common Stock were restricted or otherwise subject to contractual
lock-up agreements, and were not available for sale in the public market, the number of
trades in the public market were infrequent and the average daily volume was very low. The
average daily trading volume of the Common Stock during the First Quarter was 983 shares,
with a value of approximately $22,000 (representing approximately 0.001% of the Company’s
market capitalization at the time). There were 22 days during the First Quarter in which
there were no trades of the Common Stock at all. During the First Quarter, the closing
price of the Common Stock ranged from $15.75 to $31.32, reflecting market capitalizations
well in excess of the valuation of Protalix Ltd. prior to the Merger. The Company does not
believe that there was any business or clinical development justifying the increase in its
valuation. In preparing its quarterly financial statements for the First Quarter, the
Company determined
5
that it was not appropriate to use the quoted price of the Common Stock to establish the
fair value of the options granted to the Company’s consultants and non-employees because the
prices quoted did not reflect an active market for the Common Stock. In lieu of the prices
quoted on the OTCBB, and later reported by the AMEX, the fair value was established by the
Company’s management in good faith, based on a retrospective valuation of the fair value of
the Common Stock at the end of the First Quarter and in consultation with a third-party
specialist. The Company decided that too much time had passed since the last financing by
Protalix Ltd. in August 2006 for the Company to use the valuation to calculate fair value.
Rather, the Company based its valuation on the valuation of Bio-Cell Ltd., an Israeli public
company traded on the Tel-Aviv Stock Exchange (“Bio-Cell”). As of March 31, 2007, Bio-Cell
held approximately 20% of the outstanding shares of the Company’s Common Stock and did not
have any other significant assets other than its interest in the Company. The Company’s
management took the position that there was an active market in Bio-Cell’s shares as the
average daily trading volume of Bio-Cell’s shares on the Tel-Aviv Stock Exchange was
2008-06-26 - UPLOAD - Protalix BioTherapeutics, Inc.
Via Facsimile and U.S. Mail
Mail Stop 6010
June 26, 2008
Yossi Maimon
Chief Financial Officer and Treasurer
Protalix BioTherapeutics, Inc.
2 Snunit Street
Science Park
POB 455
Carmiel, Israel 20100
Re: Protalix BioTherapeutics
Form 10-K for the Fiscal Year Ended December 31, 2007
Filed March 17, 2008
File Number: 001-33357
Dear Mr. Maimon:
We have reviewed your filing and have the following comments. We have limited
our review to your financial statements a nd related disclosures and do not intend to
expand our review to other portions of your document. In our comments, we ask you to
provide us with information to better unde rstand your disclosure. Where a comment
requests you to revise disclosure, the info rmation you provide should show us what the
revised disclosure will look like and identify the annual or quarterly filing, as applicable,
in which you intend to first include it. If you do not believe that revised disclosure is
necessary, explain the reason in your response. After reviewing the information
provided, we may raise additional comments and/or request that you amend your filing.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filing. We look forward to working with you in these respects. We
welcome any questions you may have about our comments or on any other aspect of our
review. Feel free to call us at the telephone numbers listed at the end of this letter.
Management’s Discussion and Analysis of Fi nancial Condition and Results of Operations
Results of Operations, page 58
Research and Development Expenses
1. We believe that your disclosures about historical research and development
expenses and estimated future expenses related to your major research and
Yossi Maimon
Protalix BioTherapeutics, Inc. June 26, 2008 Page 2
development projects could be enhanced for investors. Please refer to the
Division of Corporation Finance “Curre nt Issues and Ru lemaking Projects
Quarterly Update” under section VIII – I ndustry Specific Issues – Accounting and
Disclosure by Companies Engaged in Research and Development Activities. You can find it at the following website address: http://www.sec.gov/divisi ons/corpfin/cfcrq032001.htm
. Please revise your
MD&A to disclose the following information for each of your major research and development projects.
a. The current status of the project;
b. The costs incurred during each peri od presented and to date on each
project;
c. The nature, timing and estimated costs of the efforts necessary to complete
each project;
d. The anticipated completion dates of each project;
e. The risks and uncertainties associated with completing development on
schedule, and the consequences to operations, financial position and
liquidity if each project is not completed timely; and finally
f. The period in which material net cash in flows from significant projects are
expected to commence for each project.
Regarding b., if you do not maintain a ny research and development costs by
project, disclose that fact and explai n why management does not maintain and
evaluate research and development costs by project. Provide other quantitative or
qualitative disclosure that indicates th e amount of the company’s resources being
used on the project.
Regarding c. and d., disclose the amount or range of estimated costs and timing to
complete the phase in process and each future phase. To the extent that information is not estimable, disclose t hose facts and circumstances indicating the
uncertainties that preclude you fr om making a reasonable estimate .
Report of Independent Registered Public Accounting Firm, page F-2
2. Auditor association with th e cumulative data is requi red on an annual basis as
long as the registrant is in the development stage. Th ere is no reference to the
cumulative data in the accountant’s report. In addition, it does not appear as
though a waiver for this requirement wa s granted by the Office of the Chief
Accountant within the Division of Corporat ion Finance. Please advise whether a
waiver was obtained and provide us a c opy or include the appropriate accountant
report. To be granted a waiver it must be impracticable for y ou to obtain an audit
opinion on the cumulative data. A written submission explaining why it is impracticable must be provided to the O ffice of the Chief Accountant within the
Division of Corporation Finan ce to obtain a waiver.
Yossi Maimon
Protalix BioTherapeutics, Inc. June 26, 2008 Page 3 Note 4 – Commitments, page F-18
3. Please revise your disclosure to include all of the milestone payments you will be
required to pay under certain research and license agreements. Please include the
events that would trigger these payments . Also tell us why you did not include
these amounts in your contractual obligati on table. Finally, please include the
length of and the termination provisions for all of your material agreements.
4. Please explain how the $1,724,000 commit ment under your sub-contracting
agreements relates to the purchase obligations of $4,086,000 included in your
contractual obligations table.
Note 5 – Share Capital, page F-20
5. Please provide us a chronology of facts, circumstances and events explaining the
change in fair value of the common st ock issued during 2006 of approximately
$1.50 per share to the trading value immediately after the merger of
approximately $27 per share.
6. You state in Note 5 and on pages 56- 57 that you used various methods to
determine the fair value of your common stock. It appears as though your stock
was trading prior to the March 12, 2007 da te that it was liste d on the American
Stock Exchange. In addition, it appears you used the $5 per share offering price
in October 2007 to value equity issuan ces granted before that including for
issuances during the third quarter ended September 30, 2007 even though there
was a trading price of your stock during that period. Pl ease tell us how your use of
valuation methods during th e first and third quarters of 2007 rather than the
trading price of your stock to valu e equity issuances for compensation
expense/consulting expense, et c. complies with FAS 123R.
* * * *
Please provide us the information request ed within 10 busine ss days or tell us
when you will provide us with a response. Pl ease furnish a cover le tter with your response
that keys your response to our comments. De tailed cover letters gr eatly facilitate our
review. Please furnish your letter on EDGAR under the form type label CORRESP.
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 all in formation required under
the Securities Exchange Act of 1934 and th at they have provided all information
investors require for an informed invest ment decision. Since the company and its
management are in possession of all facts re lating to a company’s disclosure, they are
responsible for the accuracy and adequacy of the disclosures they have made.
Yossi Maimon
Protalix BioTherapeutics, Inc. June 26, 2008 Page 4
In connection with responding to our co mments, please provide, in your letter, a
statement from the company acknowledging that:
• the company is responsible for the adequacy and accuracy of the disclosure in
the filing;
• staff comments or changes to disclosure in response to staff comments do not
foreclose the Commission from taking a ny action with respect to the filing;
and
• the company may not assert staff comme nts as a defense in any proceeding
initiated by the Commission or any pers on under the federal s ecurities laws of
the United States.
In addition, please be advi sed that the Division of En forcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing.
You may contact Vanessa R obertson, Staff Accountant, at (202) 551-3649 or
Mary Mast, Senior Staff A ccountant, at (202) 551-3613 if you have any questions
regarding the comments. In th is regard, do not hesitate to contact me, at (202) 551-3679.
S i n c e r e l y ,
J i m B . R o s e n b e r g
Senior Assistant Chief
Accountant
2007-09-25 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP 1 filename1.htm Protalix BioTherapeutics, Inc. 2 Snunit Street Science Park Carmiel 20100 Israel September 25, 2007 VIA COURIER AND EDGAR Mr. Greg Belliston Securities and Exchange Commission Division of Corporate Finance Mail Stop 6010 100 F Street, N.E. Washington, D.C. 20549 Re: Protalix BioTherapeutics, Inc. Registration Statement on Form S-3 (File No. 333-144801) Acceleration Request Ladies and Gentlemen: Protalix BioTherapeutics, Inc. (the “Company”) pursuant to Rule 461 under the Securities Act of 1933, as amended, hereby requests the Securities and Exchange Commission (the “Commission”) to accelerate the effective date of the above-referenced Registration Statement and declare the Registration Statement, as then amended, effective as of 4:30 P.M., eastern standard time, on September 26, 2007, or as soon thereafter as practicable. The Company also requests the Commission to specifically confirm such effective date and time to the Company in writing. The Company acknowledges that (i) should the Commission or the staff of the Commission, acting pursuant to delegated authority, declare the filing effective, such declaration does not foreclose the Commission from taking any action with respect to the filing; (ii) the action of the Commission or the staff of the Commission, 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 (iii) 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 contact Jim Tanenbaum of Morrison & Foerster LLP with any questions or comments at 212-468-8163. Thank you for your assistance with this filing. Sincerely yours, PROTALIX BIOTHERAPEUTICS, INC. By: /s/ David Aviezer Name: David Aviezer Title: President and Chief Executive Officer cc: Morrison & Foerster LLP 2
2007-09-24 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP 1 filename1.htm 1290 AVENUE OF THE AMERICAS NEW YORK, NY 10104-0050 TELEPHONE: 212.468.8000 FACSIMILE: 212.468.7900 WWW.MOFO.COM MORRISON & FOERSTER LLP NEW YORK, SAN FRANCISCO, LOS ANGELES, PALO ALTO, SAN DIEGO, WASHINGTON, D.C. DENVER, NORTHERN VIRGINIA, ORANGE COUNTY, SACRAMENTO, WALNUT CREEK, CENTURY CITY TOKYO, LONDON, BEIJING, SHANGHAI, HONG KONG, SINGAPORE, BRUSSELS Writer's Direct Contact 212.468-8163 JTanenbaum@mofo.com September 24, 2007 Mr. Greg Belliston Securities and Exchange Commission Division of Corporate Finance Mail Stop 6010 100 F Street, N.E. Washington, D.C. 20549 Re: Protalix BioTherapeutics, Inc. Registration Statement on Form S-3 Filed July 24, 2007 File No. 333-144801 Dear Mr. Belliston: On behalf of our client, Protalix BioTherapeutics, Inc., a Florida corporation (the “Company”), enclosed please find for review by the Securities and Exchange Commission (the “Commission”) copies of Amendment No. 1 and Amendment No. 2 to the Company’s Registration Statement on Form S-3 (File No. 333-144801) (the “Registration Statement”). The Registration Statement was initially filed with the Commission on July 24, 2007. On September 24, 2007, the Company filed Amendment No. 1 to the Registration Statement with the Commission in response to the comments of the staff of the Commission (the “Staff”) that were contained in your letter (the “Comment Letter”) dated August 7, 2007. On September 24, 2007, the Company also filed Amendment No. 2 to the Registration Statement solely for the purpose of correcting an error in the date of the auditor’s consent. Responses to Comment Letter The following are the Company’s responses to the issues and questions raised by the Staff in the Comment Letter. We have noted the Staff’s comments below in bold face type and the responses in regular type. Securities and Exchange Commission September 24, 2007 Page 2 General 1. We note you have a confidential treatment request that is outstanding. The request will need to be granted prior to the effectiveness of this registration statement. In response to the Staff’s comment, the Company has amended its confidential treatment request to the Commission. We subsequently we received a telephone call from John Fieldsend of the Staff in which he indicated that the Staff had no further questions or comments to the confidential treatment request and that the request was granted by the Commission. 2. We note the registration statement covers a primary offering and a secondary offering. Please revise throughout the filing, including in the registration fee table, to specify the dollar amount for each offering and the number of shares for the secondary offering. In response to the Staff’s comment, the Company has revised the registration fee table to reflect the fact that the Registration Statement covers both a primary offering and a secondary offering. Selling Securityholders, page 8 3. Please provide the information required by Item 507 of Regulation S-K in a pre-effective amendment. You do not appear to be eligible to provide this information in prospectus supplements or post-effect amendments because it appears you do not satisfy the conditions of Rule 430B(b). In response to the Staff’s comment, the Company has included the information required by Item 507 of Regulation S-K in the Selling Securityholder section of the Registration Statement. * * * The Company would be grateful if the Staff would provide any comments to the revised Registration Statement at its earliest convenience so that the Company may provide any additional responses required. Securities and Exchange Commission September 24, 2007 Page 3 We thank you in advance for your time and attention to these amendments, as well as to our comments. Should you wish to discuss the enclosed materials at any time, please do not hesitate to contact James Tanenbaum at (212) 468-8163 or Joseph Magnas at (212) 336-4170 of Morrison & Foerster LLP. Sincerely, /s/ James R. Tanenbaum James R. Tanenbaum cc: David Aviezer, Ph.D. Protalix BioTherapeutics, Inc. Enclosures
2007-08-07 - UPLOAD - Protalix BioTherapeutics, Inc.
Mail Stop 6010
August 7, 2007
David Aviezer
Chief Executive Officer
Protalix BioTherapeutics, Inc.
2 Snunit Street
Science Park
POB 455
Carmiel, Israel
Re: Protalix BioTherapeutics, Inc.
Registration Statement on Form S-3
Filed July 24, 2007
File No. 333-144801
Dear Dr. Aviezer:
We have limited our review of your filing to those issues we have addressed in
our comments. Where indicated, we think you should revise your document in response
to these comments. If you disagree, we w ill consider your explanation as to why our
comment is inapplicable or a revision is unneces sary. Please be as detailed as necessary
in your explanation. In some of our comme nts, we may ask you to provide us with
information so we may better understand your disclosure. After reviewing this
information, we may raise additional comments.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall
disclosure in your filing. We look forward to working with you in these respects. We
welcome any questions you may have about our comments or any other aspect of our
review. Feel free to call us at the telephone numbers listed at the end of this letter.
General
1. We note you have a confidential treatm ent request that is outstanding. The
request will need to be granted prior to the effectiveness of this registration
statement.
2. We note the registration statement cove rs a primary offering and a secondary
offering. Please revise throughout the f iling, including in the registration fee
David Aviezer
Protalix BioTherapeutics, Inc. August 7, 2007 Page 2
table, to specify the dollar amount for each offering and the number of shares for the secondary offering.
Selling Securityholders, page 8
3. Please provide the information required by Item 507 of Regulation S-K in a pre-
effective amendment. You do not appear to be eligible to provide this
information in prospectus supplements or post-effective am endments because it
appears you do not satisfy the conditions of Rule 430B(b).
* * *
As appropriate, please amend your regist ration statement in response to these
comments. You may wish to provide us with marked copies of the amendment to expedite our review. Please furnish a cove r letter with your amendment that keys your
responses to our comments and provides any requested information. Detailed cover
letters greatly facilitate our review. Please understand that we may have additional comments after reviewing your amendmen t and responses to our comments.
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 all in formation required under
the Securities Act of 1933 and that they have provided all information investors require
for an informed investment decision. 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 ev ent the company requests acceleration of
the effective date of the pending registration statement, it should furnish a letter, at the time of such request, acknowledging that:
• should the Commission or the staff, acting purs uant to delegated authority, declare the
filing effective, it does not foreclose th e 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 a nd 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.
David Aviezer
Protalix BioTherapeutics, Inc. August 7, 2007 Page 3
In addition, please be advi sed that the Division of En forcement has access to all
information you provide to the staff of the Di vision of Corporation Finance in connection
with our review of your filing or in response to our comments on your filing.
We will consider a written request for acceleration of the effective date of the registration statement as conf irmation of the fact that t hose requesting acceleration are
aware of their respective re sponsibilities under the S ecurities Act of 1933 and the
Securities Exchange Act of 1934 as they rela te to the proposed public offering of the
securities specified in the above registration statement. We will act on the request and,
pursuant to delegated authority, grant acce leration of the effective date.
We direct your attention to Rules 460 and 461 regarding requesting acceleration
of a registration statement. Please allow ad equate time after the filing of any amendment
for further review before submitting a request for acceleration. Please provide this request at least two business days in a dvance of the requested effective date.
Please contact Greg Belliston at (202 ) 551-3861 or me at (202) 551-3715 with
any questions.
S i n c e r e l y ,
J e f f r e y P . R i e d l e r
A s s i s t a n t D i r e c t o r
cc: James R. Tanenbaum, Esq.
Morrison & Foerster LLP
1290 Avenue of the Americas
New York, New York 10104
2007-02-21 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP
1
filename1.htm
SEC Response Letter
Morrison & Foerster LLP
1290 Avenue of the Americas
New York, NY 10104
Telephone: 212-468-8000
Facsimile: 212-468-7900
www.mofo.com
February 21, 2007
Writer’s Direct Contact
212.468.8163
JTanenbaum@mofo.com
Mr. Eric C. McPhee
Staff Accountant
Division of Corporation Finance
United States Securities and Exchange Commission
100 F. Street, N.E.
Washington, D.C. 20549
RE:
Orthodontix, Inc.
Current Report on Form 8-K, filed February 7, 2007
File No. 000-27836
Ladies and Gentlemen:
On behalf of our client, Orthodontix, Inc., a Florida corporation (the “Company”),
transmitted herewith are responses to the Staff’s comments to the Current Report on Form 8-K, filed
February 7, 2007 (the “Form 8-K”), which comments were set forth in the Staff’s letter
dated February 13, 2007 (the “Comment Letter”) to David Aviezer, Ph.D. of the Company.
For ease of reference, we have noted the Staff’s comments in bold faced type and the responses
in regular type. The Company plans to file Amendment No. 1 to the Form 20-F (“Amendment No.
1”), which includes changes that principally reflect responses to the Staff’s comments as set
forth in this letter below.
1.
Please revise the Form to comply with Item 403(a)(1)(ii) of Regulation S-K
which requires a statement indicating whether the principal accountant’s report on the
financial statements was qualified as to uncertainty, audit scope, or accounting
principles, and a description of each such qualification.
In response to the Staff’s comments, we will amend the Form 8-K so that the
disclosure regarding the principal accountant’s report on the Company’s financial
statements set forth therein is in compliance with Item 403(a)(1)(ii) of Regulation
S-K. In particular, the amended disclosure will indicate that the financial
statements on which the principal accountants reported were not modified or
qualified as to uncertainty, audit scope, or accounting principles.
Page 2
2.
In addition, Item 204(a)(1)(iv) of Regulation S-K requires a statement whether
during the registrant’s two most recent fiscal years and any subsequent interim period
through the date of resignation, declination or dismissal there were any disagreements
with the former accountant on any matter of accounting principles or practices,
financial statement disclosure, or auditing scope or procedure, which disagreement(s),
if not resolved to the satisfaction of the former accountant, would have caused it to
make reference to the subject matter of the disagreement(s) in connection with its
reports. In the event of disagreement(s) and/or reportable event(s), provide the
specific disclosures required by Item 304(a)(1)(iv) and (v) of Regulation S-K.
The Company’s principal independent accountants, Sherb & Company, LLC
(“Sherb”), were first engaged on September 29, 2005. Accordingly, we will
amend the Form 8-K to reflect the dates of Sherb’s engagement during which Sherb was
responsible for auditing the Company’s financial statements. Furthermore, we will
amend the disclosure in the Form 8-K to comply with the language of Regulation S-K
by stating that there were no disagreements between the Company and Sherb on any
matter of accounting principles or practices, financial statement disclosure, or
auditing scope or procedure, which disagreements, if not resolved to the
satisfaction of Sherb, would have caused Sherb to make reference to the subject
matter of the disagreements in connection with its report and there were no
reportable events within the meaning of Regulation S-K.
3.
To the extent that you make changes to the Form 8-K to comply with our
comments, please obtain and file an updated Exhibit 16 letter from the former
accountant stating whether the accountant agrees with the statements made in your
revised Form 8-K. Refer to Item 304(a) of Regulation S-K.
As required under Item 304(a) of Regulation S-K, we will attach an updated letter
from Sherb stating that Sherb agrees with the statements made in the amended Form
8-K.
Please note that the Company has authorized us to inform you that it acknowledges that the
Company is responsible for the adequacy and accuracy of the disclosure in the filing; that Staff
comments or changes to disclosure in response to Staff comments do not foreclose the Commission
from taking any action with respect to the filing; and that the Company may not assert Staff
comments as a defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.
Page 3
Please call the undersigned at the telephone number set forth above or Joseph Magnas at (212)
336-4170 with any question or comment you may have regarding the responses set forth herein. In
addition, please send all written correspondence directly to the undersigned and Joseph Magnas of
Morrison & Foerster LLP, 1290 Avenue of the Americas, New York, New York 10104, telecopy (212)
468-7900, with copies to David Aviezer, Ph.D., the Company’s Chief Executive Officer, at 2 Snunit
Street, Science Park, P.O.B. 455, Carmiel 20100, Israel, telecopy +972-4-988-9489.
Sincerely,
/s/ James R. Tanenbaum
James R. Tanenbaum
cc:
David Aviezer, Ph.D.
Yossi Maimon
2007-02-15 - UPLOAD - Protalix BioTherapeutics, Inc.
Mail Stop 4561
February 13, 2007
VIA U.S. MAIL AND FAX (305) 579-9724
Mr. David Aviezer, Ph.D.
President and Chief Executive Officer
Orthodontix, Inc.
2 Snunit Street
Science Park
POB 455
Carmiel, Israel 21000
Re: Orthodontix, Inc.
Item 4.01 Form 8-K
Filed February 7, 2007
File No. 000-27836
Dear Mr. Aviezer:
We have reviewed your filing and have the following comments. Where
indicated, we think you should revise your document in response to these comments. If
you disagree, we will consider your explanation as to why our comment is inapplicable or a revision is unnecessary. Please be as detailed as necessary in your explanation. After reviewing this information, we may raise additional comments.
Please understand that the purpose of our review process is to assist you in your
compliance with the applicable disclosure requirements and to enhance the overall disclosure in your filing. We look forward to working with you in these respects. We welcome any questions you may have about our comments or on any other aspect of our review. Feel free to call us at the telephone number listed at the end of this letter.
Form 8-K filed February 7, 2007
1. Please revise the Form to comply with Item 304(a)(1)(ii) of Regulation S-K which requires a statement indicating whether the principal accountant’s report on the financial statements was qualified as to uncertainty, audit scope, or accounting principles, and a description of each such qualification.
2. In addition, Item 304(a)(1)(iv) of Regulation S-K requires a statement whether during the registrant's two most recent fiscal years and any subsequent interim
Mr. David Aviezer
Orthodontix, Inc.
February 7, 2007 Page 2
period through the date of resignation, declination or dismissal there were any
disagreements with the former accountant on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreement(s), if not resolved to the satisfaction of the former accountant, would have caused it to make reference to the subject matter of the disagreement(s) in connection with its reports. In the event of disagreement(s) and/or reportable event(s), provide the specific disclosures required by Item 304(a)(1)(iv) and (v) of Regulation S-K.
3. To the extent that you make changes to the Form 8-K to comply with our comments, please obtain and file an updated Exhibit 16 letter from the former accountant stating whether the accountant agrees with the statements made in your revised Form 8-K. Refer to Item 304(a) of Regulation S-K.
* * * *
As appropriate, please amend your filing and respond to these comments within
five business days or tell us when you will respond. You may wish to provide us with marked copies of the amendment to expedite our review. Please furnish a cover letter with your amendment that keys your responses to our comments and provides any requested information. Detailed cover letters greatly facilitate our review. Please understand that we may have additional comments after reviewing your amendment and responses to our comments.
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 all information required under the Securities Exchange Act of 1934 and that they have provided all information investors require for an informed investment decision. 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.
In connection with responding to our comments, please provide, in writing, a statement from the company acknowledging that:
the company is responsible for the adequacy and accuracy of the disclosure in the filing;
staff comments or changes to disclosure in response to staff comments do not foreclose the Commission from taking any action with respect to the filing; and
the company may not assert staff comments as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States.
Mr. David Aviezer
Orthodontix, Inc.
February 7, 2007 Page 3
In addition, please be advised that the Division of Enforcement has access to all
information you provide to the staff of the Di vision of Corporation Finance in our review
of your filing or in response to our comments on your filing.
Any questions regarding the above should be directed to me at (202) 551-3693.
S i n c e r e l y ,
E r i c M c P h e e
Staff Accountant
2007-01-22 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP
1
filename1.htm
Correspondence
Morrison & Foerster LLP
1290 Avenue of the Americas
New York, NY 10104
Telephone: 212-468-8000
Facsimile: 212-468-7900
www.mofo.com
January 22, 2007
Writer’s Direct Contact
212.468.8163
JTanenbaum@mofo.com
Mr. Adé K. Heyliger
Ms. Elaine Wolfe
Ms. Pam Carmody
Attorney-Advisors
Division of Corporate Finance
United States Securities and Exchange Commission
100 F. Street, N.E., Mail Stop 7010
Washington, D.C. 20549
RE:
Orthodontix, Inc.
Schedule 14F-1 filed on December 18, 2006
File No. 005-50118
Ladies and Gentlemen:
On behalf of our client, Orthodontix, Inc., a Florida corporation (the “Company”),
transmitted herewith are responses to the Staff’s comments to the Information Statement filed on
Schedule 14F-1 by the Company (the “Schedule 14F-1”), which comments were set forth in the
Staff’s letter dated January 17, 2007 (the “Comment Letter”) to Joshua Goldstein of
Morrison & Foerster LLP.
For ease of reference, we have noted the Staff’s comments in bold faced type and the responses
in regular type. Per our discussions with the Staff, no amendments to the Schedule 14F-1 are being
made.
1.
We note your response to prior comment 1. We note that Section 2.5(b) of the
Agreement and Plan of Reorganization (Exhibit 10.10 to the Form 8-K filed January 8,
2007) provides that shares of Protalix held by existing shareholders prior to the
merger “will be converted into the right to receive such number of shares of Parent
Common Stock, which... shall constitute in
Page 2
the aggregate, 85% of the issued and
outstanding share capital of the Parent upon the Merger Effective Time” and that the
Agreement requires the Parent to file an S-3 to register the resale of such shares.
While you have provided your analysis as to why you believe the Parent is not a party
to the merger, despite the fact that the Parent is a party to the merger agreement
and is providing the merger consideration, it is unclear as to why the transaction
would not be governed by the provisions applicable to a share exchange under FBCA
607.1102. Accordingly, please provide us with a reasoned opinion of counsel that
addresses why shareholder approval was not required in these circumstances.
Pursuant to the Staff’s request, we enclose with this letter a legal opinion issued by
Greenberg Traurig P.A., counsel to the Company, that the transaction described in the Merger Agreement and
Plan of Reorganization should not be deemed a share exchange under Section 607.1102 of the Florida
Business Corporation Act and that shareholder approval was not required in connection with the
transaction.
Please call the undersigned at the telephone number set forth above or Joseph Magnas at (212)
336-4170 with any questions or comments you may have regarding the responses set forth herein. In
addition, please send all written correspondence directly to the undersigned and Joseph Magnas of
Morrison & Foerster LLP, 1290 Avenue of the Americas, New York, New York 10104, telecopy (212)
468-7900, with copies to David Aviezer, Ph.D., the Company’s Chief Executive Officer at 2 Snunit
Street, Science Park, P.O.B. 455, Carmiel 20100, Israel, telecopy +972-4-988-9489.
Sincerely,
/s/ James R. Tanenbaum
cc:
David Aviezer, Ph.D.
Yossi Maimon
January 22, 2007
Orthodontix, Inc.
2 Snunit Street
Science Park
POB 455
Carmiel, Israel 21000
Ladies and Gentlemen:
We have acted as counsel to Orthodontix, Inc., a Florida corporation (the “Company”), in
connection with the Merger Agreement, dated as of August 21, 2006, as amended (the “Merger
Agreement”), among the Company, Protalix Acquisition Co., Ltd., an Israeli company and Protalix
Ltd., an Israeli company. All capitalized terms used herein which are defined in the Merger
Agreement shall have the respective meanings assigned to them thereunder unless otherwise specified
herein.
You have requested us to review the transaction as contemplated in the Merger Agreement (the
“Transaction”) and, specifically, whether consummation of the Transaction constituted a Share
Exchange governed by Section 607.1102 of the Florida Business Corporation Act, as in effect as of
the date hereof (the “FBCA”) and, regardless of whether the Transaction is governed by Section
607.1102 of the FBCA, whether the Transaction required approval by holders of a majority of the
shares of outstanding common stock of the Company.
In preparing this letter, we have reviewed the Merger Agreement and all documents referenced
or contemplated therein. We are attorneys admitted to practice law in the State of Florida, and we
do not purport to be experts on, or to express any opinion herein concerning, any law other than
the laws of the State of Florida, the federal laws of the United States of America, and the General
Corporation Law of the State of Delaware.
A. Discussion of Relevant Provisions of Florida Law
Section 607.1102 (captioned “Share Exchange”) of the FBCA provides, in pertinent part, as
follows:
“(1)
A corporation may acquire all of the outstanding shares .... Of
another corporation if the board of directors of each corporation
adopts and its shareholders (if required...) approve a plan of share
exchange.
(2)
The plan of share exchange shall set forth:
Orthodontix, Inc.
January 22, 2007
Page 2
(a)
The name of the corporation the shares of which
will be acquired and the name of the acquiring corporation
(b)
The terms and conditions of the exchange;
(c)
The manner and basis of exchanging the shares
to be acquired for shares, obligations, or other securities of
the acquiring or any other corporation or, in whole or in part,
for cash or other property, and the manner and basis of
exchanging rights to acquire shares of the corporation to be
acquired for rights to acquire shares, obligations or, in whole
or in part, other securities of the acquiring or any other
corporation or, in whole or in part, for cash or other
property.”
Section 607.1101 (captioned “Merger”) of the FBCA provides, in pertinent part,
(1) One or more corporations may merge into another corporation if the board of directors of
each corporation adopts and its shareholders (if required) approval a plan of merger.
(2) The plan of merger shall set forth:
(a) The name of each corporation planning to merge and the name of the surviving corporation
into which each other corporation plans to merge, which is hereinafter designated as the surviving
corporation;
(b) The terms and conditions of the proposed merger; and
(c) The manner and basis of converting the shares of each corporation into shares,
obligations, or other securities of the surviving corporation or any other corporation or, in whole
or in part, into cash or other property and the manner and basis of converting rights to acquire shares of each corporation into rights to acquire shares, obligations, or other securities of the
surviving or any other corporation or, in whole or in part, into cash or other property.”
B. Relevant Case Law
An exhaustive search of Florida case law resulted in our belief that there are no Florida
cases interpreting the definition of a “share exchange”. However, commentary by Stuart R. Cohn, a
leading expert on the FBCA and Professor of Law at the Levin College of Law at the University of
Florida, states as follows:
In a share exchange, one corporation acquires all of the outstanding shares of one or more classes or series of shares of another
corporation, with the acquired corporation retaining its
Orthodontix, Inc.
January 22, 2007
Page 3
separate corporate existence....One distinguishing feature of the
share exchange is that none of the corporate parties to the exchange
disappears. Instead, the acquiring corporation acquires all the
outstanding shares of one or more classes of the “acquired”
corporation....Prior to the adoption of the share exchange form of
transaction, the same result could be achieved by “reverse
triangular merger” in which a “temporary” subsidiary corporation was
formed by the acquiring corporation followed by the “reverse” merger
of the newly-formed subsidiary into the target corporation. The
share exchange transaction can be effectuated without the formation
of the temporary or “transitory” corporation.
Based upon with Dr. Cohn’s reasoning, we distinguish between a reverse triangular merger and a
share exchange. The Transaction was effected through the form of a reverse triangular merger.
An exhaustive search of Florida case law resulted in our belief that there are no Florida
cases interpreting shareholder suffrage issues in the context of a triangular merger. However, the
United States District Court for the Southern District of Florida has ruled on this issue within
the context of facts that are significantly similar to the Transaction. In Equity Group Holdings v.
DMG, Inc. et al. (576 F. Supp. 1197 (S.D. FL 1983)), the court had to rule with respect to a
triangular merger, the facts of which mimic the Transaction. A publicly-traded parent company
merged a subsidiary with and into the target company to be acquired such that after consummation of
the merger, the surviving company consisting of the merged subsidiary and the target was a
wholly-owned subsidiary of the parent. The consideration for this merger was shares of the parent
constituting over a majority of the parent’s issued and outstanding shares of common stock. The
shareholders in that transaction sued claiming Florida law required shareholder approval (the
shareholders sued because the parent was traded on the New York Stock Exchange, the voting
requirement for which was lower than would have been the case under Florida law had the court
determined Florida law required such a vote). The court held that it could not surmise from the
FBCA that Florida intended anything other than to allow triangular mergers to occur without the
necessity of a vote. Accordingly, only the voting requirements of the applicable exchange
controlled.
In ruling as such, the court expressly stated as follows:
Moreover, it cannot be said that corporate suffrage with respect to
the shareholders of a parent corporation in a forward triangular
merger of its subsidiary with another corporation is a value which
the Florida legislature has seen fit to recognize. Florida Statute
Section 607.221 [the precursor statute to the provision quoted
above] guarantees voting rights to the shareholders of the merging
subsidiary and the third company, the target or on-surviving
Orthodontix, Inc.
January 22, 2007
Page 4
corporation; but the section does not contemplate the triangular
situation with which the Court is herein faced. The Florida
statutes permit the use of the parent’s shares as merger
consideration. Coupled with the tax advantages and tax-free status
of the triangular merger under the Internal Revenue Code, and the
convenience of a merger by exchange of stock rather than assets,
this is just the type of transaction which the legislature cannot be
presumed to have overlooked. In fact it might be inferred that the
legislature intentionally did not want to discourage such forms of
merger by awarding voting or appraisal rights to the shareholders of
the parent. It will be noted that commentators familiar with the
drafting of provisions authorizing triangular mergers support
exactly this position. See generally S. Schulman and Alan Schenk,
“Shareholders’ Voting and Appraisal Rights in Corporation
Acquisition Transactions”, The Business Lawyer, vol. 38 at 1529,
1537-42.
Id. at 1206.
The Schulman and Schenk commentary noted above, in turn, provides, within an exhaustive
discussion of the mechanics of triangular mergers, “nothing in the Model Act specifically extends
rights to the parent’s shareholders.” It should be noted that the FBCA was based on the Model
Business Corporation Act to which the commentary refers.
C. Comparable Transactions
In preparing this opinion, we have also conducted a cursory review of several comparable
transactions by Florida publicly traded companies. We noted no evidence of shareholder approval
having been obtained by the respective parent in any of these transactions:
•
Andrx Corporation’s (“Andrx”) acquisition of Mediconsult.com, Inc. (“Mediconsult”) by
merger of Mediconsult with and into a wholly-owned subsidiary of Andrx. (see Form S-4/A
filed by Andrx on February 12, 2001)
•
Brown & Brown, Inc.’s (“B&B”) acquisition of Golden Gate Holdings, Inc. (“Golden Gate”)
by merger of Golden Gate with and into a wholly-owned subsidiary of B&B (see Form S-4/a
filed by B&B on October 2, 2001)
•
OrthAlliance, Inc.’s (“OrthAlliance”) acquisition of Orthodontic Centers of America,
Inc. (“OCA”) by merger of OrthAlliance with and into a wholly-owned subsidiary of OCA (see
Form S-4/A filed by OrthAlliance on October 5, 2001)
•
Xedar Corporation’s (“Xedar”) acquisition of Premier Data Services, Inc. (“Premier”) by
merger of Premier with and into a wholly-owned subsidiary of Xedar. (see Form 8-K filed by
Xedar on January 5, 2007)
Orthodontix, Inc.
January 22, 2007
Page 5
D. Discussion
The transaction fails the threshold question set forth by Prof. Cohn for determining whether
it is a share exchange, which is to ask whether the acquired corporation has retained its separate
corporate existence with none of the corporate parties to the “exchange” disappearing. To the
contrary, the Company’s subsidiary does, in fact, disappear in connection with its merger with the
target, which, in turn, becomes the surviving company. Were the transaction to have been
structured as a share exchange, the end result would be a three-tiered structure with the Company
owning Protalix Acquisition Co. Ltd. and Protalix Acquisition Co. Ltd. owning Protalix Ltd. No
such final structure exists in this transaction. It is further instructive that Prof. Cohn
expressly distinguishes between triangular mergers and share exchanges, thus highlighting the two
are separate and distinct transactions.
In the alternative, even if the Transaction were deemed to be a share exchange, the statute
grants shareholder approval rights only to the parties that are directly parties to the share
exchange, even where securities of a third party corporation are used as consideration for the
exchange. As a point of statutory consistency, Section 607.1102(2)(c) uses the language “exchanging
rights to acquire shares of the
corporation to be acquired for rights to acquire shares,
obligations or, in whole or in part, other securities of the acquiring or any other corporation”
(emphasis added) reflecting the legislature’s intent to allow securities of a third party
corporation to be used. Yet this “any other corporation” language does not appear in Section
607.1102(1), the provision that actually grants shareholders rights. Given the legislature’s proven
ability to reflect its intent to reference third party corporations in Section 607.1102(2)(c), it
does not appear to be an oversight that a similar reference did not appear in Section 607.1102(1)
and, instead, the likely scenario is the legislature simply did not intend such transactions to
require shareholder approval of such third parties.
Once it has been established that the Transaction is more appropriately governed by the merger
provisions of the FBCA, it must be determined whether these provisions themselves require
shareholder approval. With respect to the merger, Section 607.1101 of the FBCA requires approval
only from those shareholders who hold shares in a company that is a party to the merger (as
contrasted against simply being a party to the governing merger agreement). Be
2007-01-18 - UPLOAD - Protalix BioTherapeutics, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549-0303
DIVISION OF
CORPORATION FINANCE
January 17, 2007
Via Facsimile (212.336.4263) and U.S. Mail
Joshua Goldstein, Esq.
Morrison & Foerster LLP
1290 Avenue of the Americas
New York, NY 10104
RE: Orthodontix, Inc.
Schedule 14F-1 filed on December 18, 2006
File No. 005-50118
Dear Mr. Goldstein:
We have reviewed your filing and have th e following comments. Where indicated, we
think you should revise your document in response to these comments. If you disagree, we will
consider your explanation as to why a comment is inapplicable or a revision is unnecessary.
Please be as detailed as necessa ry in your explanation. In some of our comments, we may ask
you to provide us with supplemental informati on so we may better understand your disclosure.
After reviewing this information, we ma y or may not raise additional comments.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requir ements and to enhance the overall disclosure in
your filing. We look forward to working with you in these respects. We welcome any questions
you may have about our comments or any other aspect of our review. Feel fr ee to call us at the
telephone numbers listed at th e end of this letter.
1. We note your response to prior comment 1. We note that Section 2.5(b) of the
Agreement and Plan of Reorganization (Exhi bit 10.10 to the Form 8-K filed January 8,
2007) provides that shares of Protalix held by existing shareholders prior to the merger
“will be converted into the ri ght to receive such number of shares of Parent Common
Stock, which…shall constitute in the aggregate, 85% of the issued and outstanding share
capital of the Parent upon th e Merger Effective Time” and that the Agreement requires
the Parent to file an S-3 to register the re sale of such shares. While you have provided
your analysis as to why you believe the Parent is not a party to the merger, despite the
fact that the Parent is a party to the me rger agreement and is providing the merger
consideration, it is unclear as to why the transaction would not be governed by the
provisions applicable to a share exchange under FBCA 607.1102. Accordingly, please
January 17, 2007
Page 2
provide us with a reasoned opinion of counsel that addresses why shareholder approval
was not required in these circumstances.
Please direct any questions to me at ( 202) 551-3636 or, in may absence, to Pam
Carmody, Special Counsel, at (202) 551-3265. You may also contact me via facsimile at (202)
772-9203. Please send all correspo ndence to us at the following ZIP code: 20549-3628.
Very truly yours,
Adé K. Heyliger
Attorney-Advisor
Office of Mergers and Acquisitions
2007-01-17 - UPLOAD - Protalix BioTherapeutics, Inc.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549-0303
DIVISION OF
CORPORATION FINANCE
January 12, 2007
Via Facsimile (212.336.4263) and U.S. Mail
Joshua Goldstein, Esq.
Morrison & Foerster LLP
1290 Avenue of the Americas
New York, NY 10104
RE: Orthodontix, Inc.
Schedule 14F-1 filed on December 18, 2006
File No. 005-50118
Dear Mr. Goldstein:
We have reviewed your filing and have th e following comments. Where indicated, we
think you should revise your document in response to these comments. If you disagree, we will
consider your explanation as to why a comment is inapplicable or a revision is unnecessary.
Please be as detailed as necessa ry in your explanation. In some of our comments, we may ask
you to provide us with supplemental informati on so we may better understand your disclosure.
After reviewing this information, we ma y or may not raise additional comments.
Please understand that the purpose of our re view process is to assist you in your
compliance with the applicable disclosure requir ements and to enhance the overall disclosure in
your filing. We look forward to working with you in these respects. We welcome any questions
you may have about our comments or any other aspect of our review. Feel fr ee to call us at the
telephone numbers listed at th e end of this letter.
The Merger, page 2
1. We note your response to prior comment 1. Pl ease provide your analysis as to why you
believe Orthodontix should not be considered a party to the merger, particularly in light
of the fact that Orthodontix is a party to the Merger Agreement and Plan of
Reorganization (Exhibit 10.10 to the Form 8-K filed January 8, 2007) and the fact that
Orthodontix is also providing the merger consideration in the form of Orthodontix
common stock.
Please direct any questions to me at ( 202) 551-3636 or, in may absence, to Pam
Carmody, Special Counsel, at (202) 551-3265. You may also contact me via facsimile at (202)
Joshua Goldstein, Esq.
Morrison & Foerster LLP
January 12, 2007 Page 2
772-9203. Please send all correspo ndence to us at the following ZIP code: 20549-3628.
Very truly yours,
Adé K. Heyliger
Attorney-Advisor
Office of Mergers and Acquisitions
2007-01-16 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP
1
filename1.htm
SEC Response Letter
Morrison & Foerster LLP
1290 Avenue of the Americas
New York, NY 10104
Telephone: 212-468-8000
Facsimile: 212-468-7900
www.mofo.com
January 16, 2007
Writer’s Direct Contact
212.468.8163
JTanenbaum@mofo.com
Mr. Adé K. Heyliger
Ms. Elaine Wolfe
Ms. Pam Carmody
Attorney-Advisors
Division of Corporate Finance
United States Securities and Exchange Commission
100 F. Street, N.E., Mail Stop 7010
Washington, D.C. 20549
RE:
Orthodontix, Inc.
Schedule 14F-1 filed on December 18, 2006
File No. 005-50118
Ladies and Gentlemen:
On behalf of our client, Orthodontix, Inc., a Florida corporation (the “Company”),
transmitted herewith are responses to the Staff’s comments to the Information Statement filed on
Schedule 14F-1 by the Company (the “Schedule 14F-1”), which comments were set forth in the
Staff’s letter dated January 12, 2007 (the “Comment Letter”) to Joshua Goldstein of
Morrison & Foerster LLP.
For ease of reference, we have noted the Staff’s comments in bold faced type and the responses
in regular type. Per our discussions with the Staff, no amendments to the Schedule 14F-1 are being
made.
The Merger, Page 2
1.
We note your response to prior comment 1. Please provide your analysis as to
why you believe Orthodontix should not be considered a party to the merger,
particularly in light of the fact that Orthodontix is a party to the Merger Agreement
and Plan of Reorganization (Exhibit 10.10 to the Form 8-
Page 2
K filed January 8, 2007) and the fact that Orthodontix is also providing the merger
consideration in the form of Orthodontix common stock.
The transaction completed pursuant to the Merger Agreement and Plan of
Reorganization (“Agreement”) made and entered as of August 21, 2006, by and
among the Company, Protalix Acquisition Co., Ltd., an Israeli company
(“Acquisition Subsidiary”), which was a wholly-owned subsidiary of the
Company, and Protalix Ltd., an Israeli company (“Protalix”) was completed in
the form of a reverse triangular merger. In the reverse triangular merger, Protalix
and Acquisition Subsidiary were the parties to the merger itself, not the Company.
Protalix merged with and into Acquisition Subsidiary and is the surviving company,
and, accordingly, Protalix became a wholly-owned subsidiary of the Company. By
completing the transaction in the form of a reverse triangular merger, the Company
was not subject to the shareholder consent requirements under the Florida Business
Corporation Act, or FBCA, which would have been required if the transaction was
effected by way of a direct forward merger. As set forth in our previous letter,
Section 607.1101 of the FBCA requires approval only from those
shareholders who hold shares in a company that is subject to the merger.
At the time of the merger, Protalix and Acquisition Subsidiary were both Israeli
companies and, accordingly, the merger was subject to the Israeli Companies Law.
The merger was approved by the shareholders of Protalix and by the sole shareholder
of Acquisition Subsidiary, which in this case was the Company. In addition, the
merger was approved by the board of directors of each of the Company, Acquisition
Subsidiary and Protalix. The merger complied with the Israeli Companies Law.
The fact that the Company was a party to the Agreement does not necessitate that the
Company is a party to the merger itself. Rather, the Company was a party to the
Agreement to help facilitate the transaction. The Company made the representations,
warranties, covenants, and indemnities that are customary in merger agreements and
required by the counterparties to the transaction. In addition, the fact that the
Company provided the consideration to Protalix’s shareholders in connection with the
transaction is a feature of a reverse triangular merger and does not make the
Company a party to the merger.
Please note that the Company has authorized us to inform you that it acknowledges that the
Company is responsible for the adequacy and accuracy of the disclosure in the filing; that Staff
comments or changes to disclosure in response to staff comments do not foreclose the Commission
from taking any action with respect to the filing; and that the Company may not assert staff
comments as a defense in any proceeding initiated by the Commission or any person under the federal
securities laws of the United States.
Please call the undersigned at the telephone number set forth above or Joseph Magnas at (212)
336-4170 with any questions or comments you may have regarding the responses set forth herein. In
addition, please send all written correspondence directly to the undersigned and Joseph
Page 3
Magnas of Morrison & Foerster LLP, 1290 Avenue of the Americas, New York, New York 10104,
telecopy (212) 468-7900, with copies to David Aviezer, Ph.D., the Company’s Chief Executive Officer
at 2 Snunit Street, Science Park, P.O.B. 455, Carmiel 20100, Israel, telecopy +972-4-988-9489.
Sincerely,
/s/ James R. Tanenbaum
cc:
David Aviezer, Ph.D.
Yossi Maimon
2007-01-10 - UPLOAD - Protalix BioTherapeutics, Inc.
December 28, 2006
Via Facsimile (305.579.9724) and U.S. Mail
Glenn L. Halpryn
Orthodontix, Inc.
1428 Brickell Avenue, Suite 105
Miami, FL 33131
RE: Orthodontix, Inc.
Schedule 14F-1 filed on December 18, 2006
File No. 005-50118
Dear Mr. Halpryn:
We have reviewed your filing and have the following comments. Where
indicated, we think you should re vise your document in response to these comments. If
you disagree, we will consider your explanation as to why a comment is inapplicable or a
revision is unnecessary. Please be as detailed as necessary in your explanation. In some
of our comments, we may ask you to provide us with supplemental information so we
may better understand your disclosure. After reviewing this inform ation, we may or may
not raise additional comments.
Please understand that the pur pose of our review process is to assist you in
your compliance with the applicable disclosu re requirements and to enhance the overall
disclosure in your filing. We look forward to working with you in these respects. We
welcome any questions you may have about our comments or any other aspect of our
review. Feel free to call us at the telephone numbers listed at the end of this letter.
The Merger, page 2
1. Please amend your disclosure to describe the corporate action taken to approve
the Merger, reverse stock split and related transactions. For example, was a vote
taken or were written consents or aut horizations collected if no meeting was
held? Please provide us with your analysis of your corporate action taken and the relevant Florida state law and proxy rule s of the Securities Exchange Act of 1934.
Please see Section 14(a) of the Securities Exchange Act of 1934 and Rules 14a-3
and Rule 14c-2 of Regulation 14A. In th is regard, tell us why a Schedule 14C
was not filed in connect ion with the Merger?
Corporate Governance and Inde pendent Directors, page 17
2. We note that you have no standing audit, nominating or compensation committees
of the Board of Directors or committees performing similar functions. Please
identify each director who participates in the consideration of director nominees .
See Item 7(d)(2)(i) of Schedule 14A.
3. Please provide the information regarding the registrant’s director nomination
process required by Item 7( d)(2)(ii). Please note that the information regarding
the registrant’s director nomination process require d by Item 7(d)(2)(ii), is
required not only for nominating committees and committees performing similar
functions, but also for groups of direct ors fulfilling the ro le of a nominating
committee, including the entire board of di rectors. See Instruction to paragraph
(d)(2)(ii) of Item 7 of Schedule 14A.
Closing Comment
We urge all persons who are responsible for the accuracy and adequacy of the
disclosure in the filings reviewed by the staff to be certain that they have provided all information investors require. Since the Co mpany 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.
In connection with responding to our comments, please provide, in writing, a
statement from the company acknowledging that
• The company is responsible for the adequacy and accuracy of the
disclosure in the filings;
• staff comments or changes to disclosure in response to staff comments in the filings reviewed by the staff do not foreclose the Commission from
taking any action with resp ect to the filing; and
• The company may not assert staff comments as a defense in any proceeding initiated by the Commissi on or any person under the federal
securities laws of the United States.
In addition, please be advise d that the Division of Enfo rcement has access to all
information you provide to the staff of the Divi sion of Corporation Fi nance in our review
of your filing or in response to our comments on your filing.
Please direct any questions to me at ( 202) 551-3636 or, in may absence, to Pam
Carmody, Special Counsel, at (202) 551-3265. You may also contact me via facsimile at
(202) 772-9203. Please send all correspondence to us at the following ZIP code: 20549-
3628.
Very truly yours,
Adé K. Heyliger
Attorney-Advisor
Office of Mergers and Acquisitions
2007-01-10 - CORRESP - Protalix BioTherapeutics, Inc.
CORRESP
1
filename1.htm
Letter to SEC
Morrison & Foerster LLP
1290 Avenue of the Americas
New York, NY 10104
Telephone: 212-468-8000
Facsimile: 212-468-7900
www.mofo.com
January 10, 2007
Writer’s Direct Contact
212.468.8163
JTanenbaum@mofo.com
Mr. Adé K. Heyliger
Ms. Elaine Wolfe
Ms. Pam Carmody
Attorney-Advisors
Division of Corporate Finance
United States Securities and Exchange Commission
100 F. Street, N.E., Mail Stop 7010
Washington, D.C. 20549
RE:
Orthodontix, Inc.
Schedule 14C filed on December 15, 2006
Schedule 14F-1 filed on December 18, 2006
File No. 005-50118
Ladies and Gentlemen:
On behalf of our client, Orthodontix, Inc., a Florida corporation (the “Company”),
transmitted herewith are responses to the Staff’s comments to the Information Statement filed on
Schedule 14F-1 by the Company (the “Schedule 14F-1”), which comments were set forth in the
Staff’s letter dated December 28, 2006 (the “Comment Letter”) to Glenn Halpryn, the former
Chief Executive Officer of the Company. In addition, through telephonic discussions with Elaine
Wolfe of the Division of Corporate Finance and other counsel to the Company, we understand the
Staff has similar comments to the Information Statement filed on Schedule 14C by the Company (the
“Schedule 14C” and, together with the Schedule 14F-1, the “Information
Statements”).
For ease of reference, we have noted the Staff’s comments in bold faced type and the responses
in regular type. We have also attached to this Letter as Exhibit A, the statement that the
Commission has requested from the Company. Per our discussions with the Staff, no amendments to
the Schedule 14F-1 are being made.
Page 2
The Company supplementally advises the Staff that, given the timing of when the Schedule 14C
will be mailed as compared to the closing of the merger of Protalix Acquisition Co. Ltd., the
Company’s wholly-owned subsidiary, with Protalix Ltd, some of the disclosures in the Schedule 14C
will be revised to reflect that the merger has already occurred.
The Merger, Page 2
1.
Please amend your disclosure to describe the corporate action taken to approve
the Merger, reverse stock split and related transactions. For example, was a vote
taken or were written consents or authorizations collected it no meeting was held?
Please provide us with your analysis of your corporate action taken and the relevant
Florida state law and proxy rules of the Securities Exchange Act of 1934. Please see
Section 14(a) of the Securities Exchange Act of 1934 and Rules 14a-3 and Rule 14c-2 of
Regulation 14A. In this regard, tell us why a Schedule 14C was not filed in connection
with the Merger?
The Company supplementally advises the Staff that the only corporate action taken by
the Company with respect to (i) the merger of Protalix Acquisition Co. Ltd., a
wholly-owned Israeli subsidiary of the Company, with and into Protalix Ltd., an
Israeli company and (ii) a 1-for-10 reverse stock split of the Company’s common
stock, par value $.0001, was unanimous approval by the Company’s Board of Directors.
As discussed below, applicable Florida law does not require further corporate
action be taken.
In the case of the reverse stock split, Section 607.10025 of the Florida Business
Corporation Act, or FBCA, provides that “unless the articles of incorporation
provide otherwise, a division or combination may be effected solely by the action of
the board of directors.” Subsection (2) of this provision goes further to allow a
board to amend the articles of incorporation to effect this combination without
shareholder approval as well. The FBCA clarifies that a “combination” is intended to
refer to a reverse stock split by defining the term as “combining shares of any
issued and outstanding class or series into a lesser number of shares of the same
class or series”.
With respect to the merger, Section 607.1101 of the FBCA requires approval only from
those shareholders who hold shares in a company that is subject to the merger.
Because the parties to the merger were Protalix Ltd. and Protalix Acquisition Co.
Ltd., the Company’s wholly-owned Israeli subsidiary, shareholder approval by the
Company’s shareholders was not required. Although the Company was not a party to
the merger and, accordingly, was not required to obtain approval from its
shareholders, it provided the consideration paid to the Protalix Ltd. shareholders -
namely, shares of the Company’s common stock. Sections 607.1101 and 607.1106 of the
FBCA permit this. Section 607.1101 provides that the applicable plan of merger
shall set forth the manner and basis of converting the shares of each corporation
[subject to the merger] into shares, obligations, or other securities of the
surviving corporation or any other
Page 3
corporation” (emphasis added), and Section 607.1106 provides that “when a
merger becomes effective...the shares (and the rights to acquire shares,
obligations, or other securities) of each corporation party to the merger that are
to be converted into shares, rights, obligations or other securities of the
surviving or any other corporation ... are converted.” (emphasis added) The
words “or any other corporation” allows the Company to issue shares of its common
stock in the merger to the Protalix Ltd. shareholders even though the Company,
itself, was not subject to the merger.
Furthermore, because the Company is not listed on any stock exchange, the typical
exchange rules requiring shareholder approval for the issuance of shares in excess
of a number equal to 20% of an issuer’s outstanding shares did not apply.
Rules 14a-2 and 14a-3 under the Securities Exchange Act of 1934, as amended, require
the mailing of a proxy statement or information statement when proxies for
shareholder votes are solicited or action has already been taken by shareholders.
As explained above, no such shareholder action was required or solicited in
connection with the aforementioned transactions and, accordingly, without any such
shareholder action these rules are not implicated and no mailing is required.
To the extent a transaction required shareholder approval or a mailing of an
information statement to the Company’s shareholders, the Company believes it has
complied with all such requirements. Accordingly, the Company filed the Schedule 14C
to disclose it had obtained shareholder approval with respect to the Company’s
adoption of its new 2006 Stock Incentive Plan and with respect to its proposed name
change to “Protalix BioTherapeutics, Inc.”. Furthermore, the Company filed the
Schedule 14F-1 because the merger resulted in a change in a majority of the
directors of the Company.
In accordance with Staff’s request, the Company will amend its disclosure in the
Schedule 14C to describe the corporate action taken to approve the Merger, reverse
stock split, and related transactions. Specifically, the Company has included the
below disclosure:
Our Board of Directors unanimously approved the
reverse stock split and the merger. We did not
obtain, and we are not soliciting shareholder
approval of these transactions. Florida law allowed
us to effect these transactions without obtaining or
soliciting this approval. Florida law does, however,
require us to obtain approval from our shareholders
to amend our Articles of Incorporation to change our
name to “Protalix BioTherapeutics, Inc.” In
addition, applicable tax law and SEC rules require us
to obtain shareholder approval of our new 2006 Stock
Incentive Plan. Accordingly, we obtained the
Page 4
written consent of at least a majority of our
shareholders approving these actions and are mailing
this information statement disclosing that we
obtained this consent to our remaining shareholders.
In addition, the merger resulted in a change of a
majority of our directors and, accordingly, we are
also mailing an information statement disclosing this
change to our shareholders.
Corporate Governance and Independent Directors, page 17
2.
We note that you have no standing audit, nominating or
compensation committees of the Board of Directors or committees performing
similar functions. Please identify each director who participates in the
consideration of director nominees. See Item 7(d)(2)(i) of Schedule 14A.
As discussed with the Staff telephonically, information regarding the
Company’s director nomination process has been provided in the Company’s
Current Report on Form 8-K that was filed with the SEC on January 8, 2007.
3.
Please provide the information regarding the registrant’s
director nomination process required by Item 7(d)(2)(ii). Please note that the
information regarding the registrant’s director nomination process required by
Item 7(d)(2)(ii), is required not only for nominating committees and committees
performing similar functions, but also for groups of directors fulfilling the
role of a nominating committee, including the entire board of directors. See
Instruction to paragraph (d)(2)(ii) of Item 7 of Schedule 14A.
As discussed with the Staff telephonically, information regarding the
Company’s director nomination process has been provided in the Company’s
Current Report on Form 8-K that was filed with the SEC on January 8, 2007.
In addition, please note that the Company has authorized us to inform you that it acknowledges
that the Company is responsible for the adequacy and accuracy of the disclosure in the filing; that
Staff comments or changes to disclosure in response to staff comments do not foreclose the
Commission from taking any action with respect to the filing; and that the Company may not assert
staff comments as a defense in any proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
Please call the undersigned at the telephone number set forth above or Joseph Magnas at (212)
336-4170 with any questions or comments you may have regarding the responses set forth herein. In
addition, please send all written correspondence directly to the undersigned and Joseph
Page 5
Magnas of Morrison & Foerster LLP, 1290 Avenue of the Americas, New York, New York 10104,
telecopy (212) 468-7900, with copies to David Aviezer, Ph.D., the Company’s Chief Executive Officer
at 2 Snunit Street, Science Park, P.O.B. 455, Carmiel 20100, Israel, telecopy +972-4-988-9489.
Sincerely,
/s/ James R. Tanenbaum
cc:
David Aviezer, Ph.D.
Yossi Maimon
2005-05-20 - CORRESP - Protalix BioTherapeutics, Inc.
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
<PAGE>
May 18, 2005
Thomas Flinn, Staff Accountant
Division of Corporation Finance
United States Securities and Exchange Commission
450 Fifth Street, N.W.
Washington, D.C. 20549
Re: Orthodontix, Inc. (the "Company")
Form 8-K filed May 13, 2005
File No. 0-27836
Dear Mr. Flinn:
In response to your letter of May 17, 2005, the Company has
today filed an amended Form 8-K to provide additional disclosure.
This letter will confirm that the Company acknowledges its
responsibility for the adequacy and accuracy of the disclosure in
Company filings. The Company also acknowledges that staff
comments or changes to disclosure in response to staff comments
in the filings reviewed by the staff do not foreclose the
Commission from taking any action with respect to the filing.
The Company further acknowledges that the Company may not assert
staff comments as a defense in any proceeding initiated by the
Commission or any person under the federal securities laws of the
United States.
Very truly yours,
Alan Jay Weisberg
Acting Chief Financial Officer
(Principal Financial and
Accounting Officer)
</TEXT>
</DOCUMENT>
2005-05-17 - UPLOAD - Protalix BioTherapeutics, Inc.
<DOCUMENT>
<TYPE>LETTER
<SEQUENCE>1
<FILENAME>filename1.txt
<TEXT>
May 17, 2005
Mail Stop 4561 via U.S. Mail and Fax (305) 371-4112
Mr. Alan Jay Weisberg
Chief Financial Officer
Orthodontix, Inc.
1428 Bricknell Avenue, Suite 105
Miami, Florida 33131
RE: Orthodontix, Inc.
Form 8-K filed May 13, 2005
File No. 0-27836
Dear Mr. Weisberg:
We have reviewed your filing and have the following comments.
Where
indicated, we think you should revise your document in response to
these comments. If you disagree, we will consider your
explanation
as to why our comment is inapplicable or a revision is
unnecessary.
Please be as detailed as necessary in your explanation. In some
of
our comments, we may ask you to provide us with supplemental
information so we may better understand your disclosure. After
reviewing this information, we may or may not raise additional
comments.
Please understand that the purpose of our review process is
to
assist you in your compliance with the applicable disclosure
requirements and to enhance the overall disclosure in your filing.
We look forward to working with you in these respects. We welcome
any questions you may have about our comments or on any other
aspect
of our review. Feel free to call me at the telephone number
listed
at the end of this letter.
1. Amend to provide the disclosures required by Item 304(a)(2)(i)
and
(ii) of Regulation S-K for the Company`s two most recent fiscal
years
and any subsequent interim period prior to engaging Salberg &
Company, P.A.
We urge all persons who are responsible for the accuracy and
adequacy
of the disclosure in the filings reviewed by the staff to be
certain
that they have provided all information investors 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.
In connection with responding to our comments, please provide, in
writing, a statement from the company acknowledging that
* the company is responsible for the adequacy and accuracy of the
disclosure in the filings;
* staff comments or changes to disclosure in response to staff
comments in the filings reviewed by the staff do not foreclose the
Commission from taking any action with respect to the filing; and
* the company may not assert staff comments as a defense in any
proceeding initiated by the Commission or any person under the
federal securities laws of the United States.
In addition, please be advised that the Division of Enforcement
has
access to all information you provide to the staff of the Division
of
Corporation Finance in our review of your filing or in response to
our comments on your filing.
Please provide the supplemental information requested above within
five business days from the date of this letter. The supplemental
information should be filed as correspondence on EDGAR.
Any questions regarding the above should be directed to me at
(202)
551-3469.
Sincerely,
Thomas Flinn
Staff Accountant
Orthodontix, Inc.
May 17, 2005
Page 1
</TEXT>
</DOCUMENT>