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RedHill Biopharma Ltd.
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RedHill Biopharma Ltd.
Response Received
1 company response(s)
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SEC wrote to company
2024-08-15
RedHill Biopharma Ltd.
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2024-08-15
RedHill Biopharma Ltd.
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RedHill Biopharma Ltd.
Response Received
1 company response(s)
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SEC wrote to company
2024-02-14
RedHill Biopharma Ltd.
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2024-02-15
RedHill Biopharma Ltd.
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RedHill Biopharma Ltd.
Orphan - no UPLOAD in window
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Low - unmatched response
Company responded
2023-10-26
RedHill Biopharma Ltd.
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RedHill Biopharma Ltd.
Response Received
1 company response(s)
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SEC wrote to company
2023-08-09
RedHill Biopharma Ltd.
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2023-08-09
RedHill Biopharma Ltd.
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RedHill Biopharma Ltd.
Response Received
1 company response(s)
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SEC wrote to company
2021-08-04
RedHill Biopharma Ltd.
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Company responded
2021-08-05
RedHill Biopharma Ltd.
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RedHill Biopharma Ltd.
Response Received
1 company response(s)
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SEC wrote to company
2021-04-05
RedHill Biopharma Ltd.
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2021-04-06
RedHill Biopharma Ltd.
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RedHill Biopharma Ltd.
Response Received
1 company response(s)
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SEC wrote to company
2019-07-31
RedHill Biopharma Ltd.
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2019-08-06
RedHill Biopharma Ltd.
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RedHill Biopharma Ltd.
Response Received
1 company response(s)
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SEC wrote to company
2018-07-31
RedHill Biopharma Ltd.
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2018-07-31
RedHill Biopharma Ltd.
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RedHill Biopharma Ltd.
Awaiting Response
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High
SEC wrote to company
2016-09-13
RedHill Biopharma Ltd.
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RedHill Biopharma Ltd.
Response Received
1 company response(s)
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SEC wrote to company
2016-08-16
RedHill Biopharma Ltd.
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Company responded
2016-08-31
RedHill Biopharma Ltd.
References: August 16, 2016
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RedHill Biopharma Ltd.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2016-03-08
RedHill Biopharma Ltd.
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Company responded
2016-03-09
RedHill Biopharma Ltd.
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RedHill Biopharma Ltd.
Awaiting Response
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Medium
SEC wrote to company
2012-12-14
RedHill Biopharma Ltd.
Summary
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RedHill Biopharma Ltd.
Awaiting Response
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Medium
SEC wrote to company
2012-11-09
RedHill Biopharma Ltd.
Summary
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RedHill Biopharma Ltd.
Awaiting Response
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Medium
SEC wrote to company
2012-10-10
RedHill Biopharma Ltd.
Summary
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RedHill Biopharma Ltd.
Awaiting Response
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Medium
SEC wrote to company
2012-10-01
RedHill Biopharma Ltd.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-30 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2025-06-30 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | 333-288324 | Read Filing View |
| 2024-08-15 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2024-08-15 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | 333-281417 | Read Filing View |
| 2024-02-15 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2024-02-14 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | 333-276979 | Read Filing View |
| 2023-10-26 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2023-08-09 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2023-08-09 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2021-08-05 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2021-08-04 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2021-04-06 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2021-04-05 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2019-08-06 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2019-07-31 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2018-07-31 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2018-07-31 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2016-09-13 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2016-08-31 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2016-08-16 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2016-03-09 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2016-03-08 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2012-12-14 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2012-11-09 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2012-10-10 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2012-10-01 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-30 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | 333-288324 | Read Filing View |
| 2024-08-15 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | 333-281417 | Read Filing View |
| 2024-02-14 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | 333-276979 | Read Filing View |
| 2023-08-09 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2021-08-04 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2021-04-05 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2019-07-31 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2018-07-31 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2016-09-13 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2016-08-16 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2016-03-08 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2012-12-14 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2012-11-09 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2012-10-10 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2012-10-01 | SEC Comment Letter | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-30 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2024-08-15 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2024-02-15 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2023-10-26 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2023-08-09 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2021-08-05 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2021-04-06 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2019-08-06 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2018-07-31 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2016-08-31 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
| 2016-03-09 | Company Response | RedHill Biopharma Ltd. | Israel | N/A | Read Filing View |
2025-06-30 - CORRESP - RedHill Biopharma Ltd.
CORRESP 1 filename1.htm RedHill Biopharma Ltd. 21 Ha'arba'a Street Tel Aviv, 6473921, Israel June 30, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street N.E. Washington, D.C. 20549 Attention: Lauren Hamill Re: RedHill Biopharma Ltd. Registration Statement on Form F-1 Filed June 25, 2025 File No. 333-288324 (the “ Registration Statement ”) Ladies and Gentlemen: Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, RedHill Biopharma Ltd. (the “ Company ”) hereby respectfully requests that the effective date of the Company’s Registration Statement be accelerated by the Securities and Exchange Commission to 4:00 p.m., Eastern Time on July 2, 2025, or as soon thereafter as practicable. The undersigned respectfully requests that it be notified of the effectiveness of the Registration Statement by telephone call to the Company’s counsel, Haynes and Boone, LLP, by calling Jayun Koo at (212) 835-4823, and that such effectiveness also be confirmed in writing. Very truly yours, REDHILL BIOPHARMA LTD. By: /s/ Dror Ben-Asher Dror Ben-Asher Chief Executive Officer and Chairman of the Board of Directors cc: Rick A. Werner, Esq., Haynes and Boone, LLP Jayun Koo, Esq., Haynes and Boone, LLP
2025-06-30 - UPLOAD - RedHill Biopharma Ltd. File: 333-288324
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> June 30, 2025 Dror Ben-Asher Chief Executive Officer RedHill Biopharma Ltd. 21 Ha'arba'a Street Tel Aviv, 6473921, Israel Re: RedHill Biopharma Ltd. Registration Statement on Form F-1 Filed June 25, 2025 File No. 333-288324 Dear Dror Ben-Asher: 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 Lauren Hamill at 303-844-1008 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Jayun Koo </TEXT> </DOCUMENT>
2024-08-15 - CORRESP - RedHill Biopharma Ltd.
CORRESP
1
filename1.htm
RedHill Biopharma Ltd.
21 Ha'arba'a Street
Tel Aviv, 6473921, Israel
August 15, 2024
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street N.E.
Washington, D.C. 20549
Attention: Chris Edwards
Re:
RedHill Biopharma Ltd.
Registration Statement on Form F-3
Filed August 9, 2024
File No. 333-281417 (the “Registration Statement”)
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules
and Regulations under the Securities Act of 1933, as amended, RedHill Biopharma Ltd. (the “Company”) hereby respectfully requests
that the effective date of the Company’s Registration Statement be accelerated by the Securities and Exchange Commission to 4:30 p.m., Eastern Time on August 19,
2024, or as soon thereafter as practicable.
The undersigned respectfully requests that it be notified of the effectiveness of the Registration Statement by
telephone call to the Company’s counsel, Haynes and Boone, LLP, by calling Alla Digilova at (212) 659-4993, and that such effectiveness also be confirmed in writing.
Very truly yours,
REDHILL BIOPHARMA LTD.
By:
/s/ Dror Ben-Asher
Dror Ben-Asher
Chief Executive Officer and Chairman of the
Board of Directors
cc:
Rick A. Werner, Esq., Haynes and Boone, LLP
Alla Digilova, Esq., Haynes and Boone, LLP
2024-08-15 - UPLOAD - RedHill Biopharma Ltd. File: 333-281417
August 15, 2024
Dror Ben-Asher
Chief Executive Officer
RedHill Biopharma Ltd.
21 Ha'arba'a Street
Tel Aviv 6473921
Israel
Re:RedHill Biopharma Ltd.
Registration Statement on Form F-3
Filed August 9, 2024
File No. 333-281417
Dear Dror Ben-Asher:
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:Alla Digilova, Esq.
2024-02-15 - CORRESP - RedHill Biopharma Ltd.
CORRESP
1
filename1.htm
RedHill Biopharma Ltd.
21 Ha'arba'a Street
Tel Aviv, 6473921, Israel
February 15, 2024
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street N.E.
Washington, D.C. 20549
Attention: Tim Buchmiller
Re:
RedHill Biopharma Ltd.
Registration Statement on Form F-1
Filed February 9, 2024
File No. 333-276979 (the “Registration Statement”)
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, RedHill Biopharma Ltd. (the “Company”) hereby respectfully requests that the effective date of the Company’s Registration Statement be accelerated by the Securities and Exchange Commission to 4:30 p.m., Eastern Time on February 15, 2024, or as soon thereafter
as practicable.
The undersigned respectfully requests that it be notified of the effectiveness of the Registration Statement by telephone call to the Company’s counsel, Haynes and Boone, LLP, by
calling Alla Digilova at (212) 659-4993, and that such effectiveness also be confirmed in writing.
Very truly yours,
REDHILL BIOPHARMA LTD.
By:
/s/ Dror Ben-Asher
Dror Ben-Asher
Chief Executive Officer and Chairman of the Board of Directors
cc:
Rick A. Werner, Esq., Haynes and Boone, LLP
Alla Digilova, Esq., Haynes and Boone, LLP
2024-02-14 - UPLOAD - RedHill Biopharma Ltd. File: 333-276979
United States securities and exchange commission logo
February 14, 2024
Dror Ben-Asher
Chief Executive Officer
RedHill Biopharma Ltd.
21 Ha'arba'a Street
Tel Aviv 6473921
Israel
Re:RedHill Biopharma Ltd.
Registration Statement on Form F-1
Filed February 9, 2024
File No. 333-276979
Dear Dror Ben-Asher:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tim Buchmiller at 202-551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Alla Digilova, Esq.
2023-10-26 - CORRESP - RedHill Biopharma Ltd.
CORRESP
1
filename1.htm
RedHill Biopharma Ltd.
21 Ha'arba'a Street
Tel Aviv, 6473921, Israel
October 26, 2023
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street N.E.
Washington, D.C. 20549
Attention: Tim Buchmiller
Re:
RedHill Biopharma Ltd.
Registration Statement on Form F-3
Filed October 13, 2023
File No. 333-274957 (the “Registration Statement”), as amended
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, RedHill Biopharma Ltd. (the “Company”) hereby respectfully requests that the effective date of the Company’s Registration Statement be accelerated by the Securities and Exchange Commission to 4:30 p.m., Eastern Time on October 26, 2023, or as soon thereafter as
practicable.
The undersigned respectfully requests that it be notified of the effectiveness of the Registration Statement by telephone call to the Company’s counsel, Haynes and Boone, LLP, by
calling Jayun Koo at (212) 835-4823, and that such effectiveness also be confirmed in writing.
Very truly yours,
REDHILL BIOPHARMA LTD.
By:
/s/ Dror Ben-Asher
Dror Ben-Asher
Chief Executive Officer and Chairman of the Board of Directors
cc:
Rick A. Werner, Esq., Haynes and Boone, LLP
Jayun Koo, Esq., Haynes and Boone, LLP
2023-08-09 - CORRESP - RedHill Biopharma Ltd.
CORRESP
1
filename1.htm
RedHill Biopharma Ltd.
21 Ha'arba'a Street
Tel Aviv, 6473921, Israel
August 9, 2023
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
Office of Life Sciences
100 F Street N.E.
Washington, D.C. 20549
Attention: Daniel Crawford
Re:
RedHill Biopharma Ltd.
Registration Statement on Form F-3
Filed August 4, 2023
File No. 333-273709
Ladies and Gentlemen:
Pursuant to Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as
amended, RedHill Biopharma Ltd. (the “Company”) hereby respectfully requests that the effective date of the Company’s Registration Statement on Form F-3 (File No. 333-273709)
(the “Registration Statement”) be accelerated by the Securities and Exchange Commission to 4:30 p.m., Eastern Time on August 11, 2023, or as soon thereafter as practicable.
The undersigned respectfully requests that it be notified of the effectiveness of the Registration Statement by
telephone call to the Company’s counsel, Haynes and Boone, LLP, by calling Jayun Koo at (212) 659-7300, and that such effectiveness also be confirmed in writing.
Very truly yours,
REDHILL BIOPHARMA LTD.
By:
/s/ Dror Ben-Asher
Dror Ben-Asher
Chief Executive Officer and Chairman of the Board of Directors
cc:
Rick A. Werner, Esq., Haynes and Boone, LLP
Jayun Koo, Esq., Haynes and Boone, LLP
2023-08-09 - UPLOAD - RedHill Biopharma Ltd.
United States securities and exchange commission logo
August 9, 2023
Dror Ben-Asher
Chief Executive Officer and Director
RedHill Biopharma Ltd.
8045 Arco Corporate Drive, Suite 200
Raleigh, NC 27617
Re:RedHill Biopharma Ltd.
Registration Statement on Form F-3
Filed August 4, 2023
File No. 333-273709
Dear Dror Ben-Asher:
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 Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jayun Koo, Esq.
2021-08-05 - CORRESP - RedHill Biopharma Ltd.
CORRESP
1
filename1.htm
RedHill Biopharma Ltd.
21 Ha'arba'a St.
Tel Aviv, 6473921, Israel
August 5, 2021
By EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street N.E.
RE:
RedHill Biopharma Ltd.
Registration Statement on Form F-3
Filed July 29, 2021
File No. 333-258259
Ladies and Gentlemen:
Pursuant to Rules 460 and 461 of the Rules and Regulations of the Securities and Exchange Commission (the “Commission”) under the Securities Act of 1933, as amended, RedHill Biopharma Ltd. (the “Company”) hereby requests acceleration of the effective date of the above-mentioned Registration Statement on Form F-3 (the “Registration
Statement”) to 4:00 p.m., Eastern Time on August 9, 2021, or as soon thereafter as practicable.
Should any member of the staff of the U.S. Securities and Exchange Commission have any questions or comments with
respect to this request, please contact our U.S. counsel, Haynes and Boone, LLP, attention: Rick A. Werner, Esq. at (212) 659-4974.
Very truly yours,
RedHill Biopharma Ltd.
By:
/s/ Dror Ben-Asher
Dror Ben-Asher
Chief Executive Officer
2021-08-04 - UPLOAD - RedHill Biopharma Ltd.
United States securities and exchange commission logo
August 4, 2021
Dror Ben-Asher
Chief Executive Officer
RedHill Biopharma Ltd.
21 Ha'arba'a Street
Tel Aviv 6473921
Israel
Re:RedHill Biopharma Ltd.
Registration Statement on Form F-3
Filed July 29, 2021
File No. 333-258259
Dear Mr. Ben-Asher:
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 Jordan Nimitz at 202-551-6001 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Perry Wildes
2021-04-06 - CORRESP - RedHill Biopharma Ltd.
CORRESP
1
filename1.htm
RedHill Biopharma Ltd.
21 Ha'arba'a Street
Tel Aviv, 6473921, Israel
April 6, 2021
VIA EDGAR
U.S. Securities and Exchange Commission
Division of Corporation Finance
100 F Street N.E.
Washington, D.C. 20549
Attention: Deanna Virginio
Re:
RedHill Biopharma Ltd.
Registration Statement on Form F-3
Filed on March 30, 2021
File No. 333-254848 (the “Registration Statement”)
Request for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 461 of the Rules and Regulations of the Securities and Exchange Commission (the “Commission”) under the Securities Act of 1933, as amended, RedHill Biopharma Inc. (the “Company”) hereby respectfully requests acceleration of the effective date of the Registration Statement so that it may become effective at 4:00 p.m.,
Eastern Time, on April 8, 2021, or as soon thereafter as practicable.
Should any member of the staff of the Commission have any questions or comments with respect to this request, please
contact our counsel, Haynes and Boone, LLP, attention: Rick A. Werner, Esq. at (212) 659-4974.
Very truly yours,
REDHILL BIOPHARMA LTD.
By:
/s/ Dror Ben-Asher
Dror Ben-Asher
Chief Executive Officer
and Chairman of the Board of Directors
cc: Rick A. Werner, Esq.,
Haynes and Boone, LLP
2021-04-05 - UPLOAD - RedHill Biopharma Ltd.
United States securities and exchange commission logo
April 5, 2021
Dror Ben-Asher
Chief Executive Officer
RedHill Biopharma Ltd.
21 Ha'arba'a Street
Tel Aviv 6473921
Israel
Re:RedHill Biopharma Ltd.
Registration Statement on Form F-3
Filed March 30, 2021
File No. 333-254848
Dear Mr. Ben-Asher:
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 Deanna Virginio at 202-551-4530 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Rick Werner, Esq.
2019-08-06 - CORRESP - RedHill Biopharma Ltd.
CORRESP
1
filename1.htm
RedHill Biopharma Ltd.
21 Ha'arba'a St.
Tel Aviv, 6473921, Israel
August 6, 2019
By EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street N.E.
Washington, D.C. 20549
RE:
RedHill Biopharma Ltd.
Registration Statement on Form F-3
Filed July 24, 2019
File No. 333-232777
Ladies and Gentlemen:
Pursuant to Rules 460 and 461 of the Rules
and Regulations of the Securities and Exchange Commission (the “Commission”) under the Securities Act of 1933,
as amended, RedHill Biopharma Ltd. (the “Company”) hereby requests acceleration of the effective date of the
above-mentioned Registration Statement on Form F-3 to 4:00 p.m., Eastern Time on August 8, 2019, or as soon thereafter as practicable.
Should any member of the staff of the U.S. Securities
and Exchange Commission have any questions or comments with respect to this request, please contact our counsel, Haynes and Boone,
LLP, attention: Rick A. Werner, Esq. at (212) 659-4974.
Very truly yours,
RedHill Biopharma Ltd.
By:
/s/ Dror Ben- Asher
Dror Ben-Asher
Chief Executive Officer
2019-07-31 - UPLOAD - RedHill Biopharma Ltd.
July 30, 2019
Dror Ben-Asher
Chief Executive Officer
RedHill Biopharma Ltd.
21 Ha'arba'a Street
Tel Aviv 6473921
Israel
Re:RedHill Biopharma Ltd.
Registration Statement on Form F-3
Filed July 24, 2019
File No. 333-232777
Dear Mr. Ben-Asher:
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 Donald Field at 202-551-3680 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2018-07-31 - UPLOAD - RedHill Biopharma Ltd.
July 31, 2018
Dror Ben-Asher
Chief Executive Officer
RedHill Biopharma Ltd.
21 Ha'arba'a Street
Tel Aviv 64739
Israel
Re:RedHill Biopharma Ltd.
Registration Statement on Form F-3
Filed July 23, 2018
File No. 333-226278
Dear Mr. Ben-Asher:
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 Christine Westbrook at 202-551-5019 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Rick Werner, Esq.
2018-07-31 - CORRESP - RedHill Biopharma Ltd.
CORRESP
1
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RedHill Biopharma Ltd.
21 Ha'arba'a St.
Tel Aviv, 64739, Israel
July 31, 2018
By EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street N.E.
Washington, D.C. 20549
RE:
RedHill Biopharma Ltd.
Registration Statement on Form F-3
Filed July 23, 2018
File No. 333-226278
Ladies and Gentlemen:
Pursuant to Rules 460 and 461 of the Rules
and Regulations of the Securities and Exchange Commission (the “Commission”) under the Securities Act of 1933,
as amended, RedHill Biopharma Ltd. (the “Company”) hereby requests acceleration of the effective date of the
above-mentioned Registration Statement on Form F-3 (the “Registration Statement”) to 4:00 p.m., Eastern Time
on July 31, 2018, or as soon thereafter as practicable.
Should any member of the staff of the U.S. Securities
and Exchange Commission have any questions or comments with respect to this request, please contact our counsel, Haynes and Boone,
LLP, attention: Rick A. Werner, Esq. at (212) 659-4974.
Very truly yours,
RedHill Biopharma Ltd.
By:
/s/ Dror Ben- Asher
Dror Ben-Asher
Chief Executive Officer
2016-09-13 - UPLOAD - RedHill Biopharma Ltd.
Mailstop 4546 September 12, 2016 Ori Shilo Deputy Chief Executive Officer Finance and Operations RedHill Biopharma Ltd. 21 Ha’arba’a Street Tel Aviv 64739, Israel Re: RedHill Biopharma Ltd. Form 20-F Filed February 25, 2016 File No. 001-35773 Dear Mr. Shilo : We have completed our review of your filing . We remind you that our comments or changes to disclosure in response to our comments do not foreclose the Commission from taking any action with respect to the company or 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. 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 rules require. Sincerely, /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Rick A. Werner, Esq. Haynes and Boone, LLP
2016-08-31 - CORRESP - RedHill Biopharma Ltd.
CORRESP
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August 31, 2016
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Suzanne Hayes, Assistant Director, Office of
Healthcare and Insurance
Re:
RedHill Biopharma Ltd.
Form 20-F
Filed February 25, 2016
File No. 001-35773
Ladies and Gentlemen:
We are submitting this letter in response to comments
contained in a letter dated August 16, 2016 by the staff (the "Staff") of the U.S. Securities and Exchange Commission
(the "Commission") with respect to the above-referenced Form 20-F. This letter repeats the comment in the Staff's letter,
followed by our response. Unless the context otherwise requires, references to "the Company," "our," "us,"
or "we" mean RedHill Biopharma Ltd.
Item 4. Information on the Company
Acquisition and License Agreements
License Agreement for BEKINDA, page 47
1.
In future filings, please revise the description of your license agreement with Temple University to describe the material provisions of the agreement. Your disclosure should include up-front payments, aggregate amounts paid to date under the agreement, aggregate future potential milestone payments, a range of the royalty rates, the term of the agreement and any material termination provisions. Please also file the agreement as an exhibit to your future Exchange Act filings. In the alternative, tell us why you believe you are not substantially dependent on the license agreement. See Instruction 4(b) to the Exhibits for Form 20-F.
Response: The Company advises the Staff that it
does not believe it is substantially dependent on the license agreement with Temple University. The license agreement grants a
license to patents for controlled drug release used by the Company's product, BEKINDA®, which is just one of the Company's
nine therapeutic candidates, and possibly a number of years away from significant commercial sales.
Moreover, all the patents that are subject to the Agreement
expire in 2018, which may even be before the Company product that uses them is approved for marketing. The Company has several
other more important patent applications that were filed by the Company and could provide the Company with patent protection through
2034 and are much more important to protecting the Company’s product
Furthermore, the Company considers the payment terms under
the license agreement for the foreseeable future to be immaterial, and therefore no disclosure was provided in the Form 20-F. There
were no up-front payments under the license agreement. In addition, the royalty payments, which are not anticipated to be material
and will not be payable following expiration of the patents in 2018, are subject to future regulatory approval, if received, and
are only due if and when sales will commence.
Therefore, the Company does not believe that is substantially
dependent on the license agreement with Temple University.
* * * * * *
The Company hereby acknowledges that:
•
the Company is responsible for the adequacy and accuracy of the disclosure in the filing;
•
Staff comments or changes to the 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 direct any comments or inquiries regarding the
foregoing to me at +972-3541-3131 (telephone) or micha@redhillbio.com (e-mail).
Very truly yours,
/s/ Micha Ben Chorin
Micha Ben Chorin
Chief Financial Officer
cc: Rick A. Werner, Esq.
Haynes and Boone, LLP
2
2016-08-16 - UPLOAD - RedHill Biopharma Ltd.
August 16, 2016 Ori Shilo Deputy Chief Executive Officer Finance and Operations RedHill Biopharma Ltd. 21 Ha’arba’a Street Tel Aviv 64739, Israel Re: RedHill Biopharma Ltd. Form 20-F Filed February 25, 2016 File No. 001-35773 Dear Mr. Shilo : We have reviewed your filing an d 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 busine ss days by providing the requested information or advis e 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 r esponse. After reviewing your response to these comments, we may have additional comments. Item 4. Information on the Company Acquisition and License Agreements License Agreement for BEKINDA, page 47 1. In future filings, please revise the d escription of your license agreement with Temple University to describe the material provisions of the agreement. Your disclosure should include up -front payments, aggregate amounts paid to date under the agreement, aggregate future potential milestone pa yments, a range of the royalty rates, the term of the agreement and any material termination provisions. Please also file the agreement as an exhibit to your future Exchange Act filings. In the alternative, tell us why you believe you are not substantial ly dependent on the license agreement. See Instruction 4(b) to the Exhibits for Form 20 -F. 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 Se curities Exchange Act of 1934 and all applicable Exchange Act rules require. Since the company and its management are Ori Shilo RedHill Biopharma Ltd. August 16, 2016 Page 2 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 re sponse 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 Christina Thomas at (202) 551 -3577 or Erin Jaskot at (202) 551 -3442 with any other questions. Sincerely, /s/ Erin K. Jaskot, for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Rick A. Werner, Esq. Haynes and Boone, LLP
2016-03-09 - CORRESP - RedHill Biopharma Ltd.
CORRESP
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RedHill Biopharma Ltd.
21 Ha'arba'a St.
Tel Aviv, 64739, Israel
March 9, 2016
By EDGAR
Suzanne Hayes
Assistant Director
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street N.E.
Washington, D.C. 20549
RE: RedHill Biopharma Ltd.
Registration Statement on Form F-3
Filed February 25, 2016
File No. 333-209702
Dear Mr. Riedler:
Pursuant to Rules 460
and 461 of the Rules and Regulations of the Securities and Exchange Commission (the “Commission”) under
the Securities Act of 1933, as amended, RedHill Biopharma Ltd. (the “Company”) hereby requests acceleration
of the effective date of the above-mentioned Registration Statement on Form F-3 (the “Registration Statement”)
to 2:00 p.m., Eastern Time on March 11, 2016, or as soon thereafter as practicable.
In
connection with the foregoing, the Company hereby acknowledges the following:
should the Commission or the staff of the Commission,
acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from
taking any action with respect to the filing;
the action of the Commission or the staff of the Commission,
acting pursuant to delegated authority, in declaring the Registration Statement 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.
Very truly yours,
RedHill Biopharma Ltd.
By:
/s/ Dror Ben- Asher
Dror Ben-Asher
Chief
Executive Officer
2016-03-08 - UPLOAD - RedHill Biopharma Ltd.
Mail Stop 4720 March 8, 2016 Dror Ben -Asher Chief Executive Officer RedHill Biopharma Ltd. 21 Ha'arba'a Street Tel Aviv 64739 Israel Re: RedHill Biopharma Ltd. Registration Statement on Form F-3 Filed February 25 , 2016 File No. 333-209702 Dear Mr. Ben-Asher : This is to advise you that we have not reviewed and will not review your registration statement . We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 193 3 and all applicable Securities Act rules require. Since the company and its management are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. In the event you request acceleration of t he effective date of the pending regist ration statement , please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclos e 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 ad equacy 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 Unit ed 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 Dror Ben -Asher RedHill Biopharma Ltd. March 8, 2016 Page 2 of the fact that those requesting acceleration are a ware 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 registered securities . Please contact Michael Gershon at (202) 551 -6598 or Mary Be th Breslin at (202) 551 - 3625 with any questions. Sincerely, /s/ Mary Beth Breslin for Suzanne Hayes Assistant Director Office of Healthcare and Insurance cc: Rick A. Werner, Esq.
2012-12-14 - UPLOAD - RedHill Biopharma Ltd.
December 13, 2012 Via E -mail Mr. Ori Shilo Deputy Chief Executive Officer Finance and Operations RedHill Biopharma Ltd. 21 Ha’arba’a Street Tel Aviv 64739, Israel Re: RedHill Biopharma Ltd Amendment No. 2 to Draft Registration Statement on Form 20 -F Submitted December 3 , 2012 CIK No. 0001553846 Dear Mr. Shilo : We have reviewed your amended draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understan d your disclosure. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to you r facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. Amendment No. 2 to Draft Registration Statement on Form 20 -F Item 18. Financial Statements Note 2 -Summary of Significant Accounting Policies e. Research and Development, page F -16 1. With reference to prior comment five, revise your policy disclosure to state that research and development costs for the performance of clinical trials and manufacturing by subcontractors are recognized as incurred , as that is GAAP, and revise the financial statements if necessary. Mr. Ori Shilo RedHill Biopharma Ltd. December 13, 2012 Page 2 Note 21 -Loss Per Ordinary Share, page F -47 2. Please refer to prior comment seven . Please revise your disclosure in Note 2p to conform to your disclosure in Note 21. General If you intend to respond to these comments with an amended draft registration statement, please submit it and any associated correspondence in accordance with the guidance we provide in the Division’s October 11, 2012 announcement on the SEC website at http://www.sec.gov/divisions/corpfin/cfannouncements/drsfilingprocedures101512.htm . You may contact Frank Wyman at (202) 551 -3660 or Lisa Vanjoske at (202) 551 -3614 if you have questions regarding comments on the financial statements and related matters. Please contact Rose Zukin at (202) 551 -3239 or me at (202) 551 -3710 with any other questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director
2012-11-09 - UPLOAD - RedHill Biopharma Ltd.
November 8 , 2012
Via E -mail
Mr. Ori Shilo
Deputy Chief Executive Officer Finance and Operations
RedHill Biopharma Ltd.
21 Ha’arba’a Street
Tel Aviv 64739, Israel
Re: RedHill Biopharma Ltd
Amendment No. 1 to Draft Registration Statement on Form 20 -F
Submitted October 26, 2012
CIK No. 0001553846
Dear Mr. Shilo :
We have reviewed your amended draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understan d your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or filing your registration statement on EDGAR. If you
do not believe our comments apply to your facts a nd circumstances or do not believe an
amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form 20 -F
Item 4. Information on the Company, page 26
B. Business Overview, page 26
Acquisition and License Agreements, page 38
1. Please refer to prior comment 23. Please revise your disclosure on page 55 to remove the
implication that clinical development for RHB -102 and RHB -103 had been successfully
completed by June 30, 2012. Also, add the expenses for clinical trials and researc h and
development for the six months ended June 30, 2012 to the tables on page 59, consistent
with the information in your response. Also, you indicate the clinical development costs
for RHB -103 were $0.2 million in 2011 and $0.1 million in 2010. However, the table on
page 59 appears to omit the costs for 2010. Please revise accordingly.
Mr. Ori Shilo
RedHill Biopharma Ltd.
November 8, 2012
Page 2
License Agreement for MAP diagnostic test related to RHB -104, page 41
2. Please refer to your response to Comment 22. Please expand your description of the
license agreeme nt governing RHB -104 to indicate that RedHill is entitled to terminate the
agreement at any time. It appears that Article X, Section B of the license agreement
allows Redhill to terminate the agreement with 90 days’ notice.
Item 5. Operating and Financia l Review and Prospects
F. Tabular Disclosure of Contractual Obligations, page 61
3. With regard to prior comment 29 clarify in the disclosure if the milestone payments are
contingent. If the milestone payments are not contingent the amounts due under your
manufacturing agreements should be included in the table of contractual obligations.
Estimates of when contractually due amounts will be paid can be made for purposes of
preparing the table. Also, disaggregate obligations into less than 1 year, 1 -3 years, 3-5
years and more than 5 years as specified in Item 5F of Form 20 -F.
In addition, the table should include the $8 million and $4 million related to the clinical
services agreement for RHB -104 disclosed on page 44.
Item 6. Directors, Senior Management and Employees, page 62
B. Compensation, page 64
4. Please refer to your response to Comment 30 and your discussion of employment
agreements beginning on page 66. The employment agreements for Messrs. Ben -Asher,
Shilo, and Raday, and the consultancy service s agreement with Dr. Fathi do not appear to
fall within the exception from filing of Instruction 4(c)(iv) to the Exhibits of Form 20 -F.
Notably, these agreements are not available by its terms to employees generally, but
contain payment terms specific to each named individual. In addition, these agreements
must be filed pursuant to Instruction 4(c) to the Exhibits of Form 20 -F regardless of
whether the public filing of these agreements is required in your home country. Please
file these agreements accord ingly.
Item 18. Financial Statements
Note 2 -Summary of Significant Accounting Policies , page F -16
5. With regard to prior comments 42 and 43, illustrate for us how recognition upon
completion of development milestones results in recognizing research and development
expense as incurred. Clarify if “milestones” are just an event which triggers a payment
under the contract.
Mr. Ori Shilo
RedHill Biopharma Ltd.
November 8, 2012
Page 3
Note 12 -Mandatory Convertible Loans and Royalty Obligation to Investors, page F -32
6. Please refer to prior comment 44. Please explai n to us your basis for concluding that the
$391,000 value of the royalty obligation approximated its fair value in August 2010.
Also, explain to us how you determined the 27.98% effective interest rate and how this
rate resulted in accretion of $327,000 in 2010 and $168,000 in 2011.
Note 21 -Loss Per Ordinary Share, page F -45
7. Please refer to prior comment 47. Your disclosure appears to indicate that basic and
diluted earnings per share was calculated based on the weighted average of o rdinary
shares issued in the period instead of the weighted average number of ordinary shares
outstanding during the period, as stipulated in IAS 33. Please revise your presentation of
basic and diluted earnings per share for each period presented to be in accordance with
IAS 3 3. Also, your response indicates that your init ial share capital of $3 million was
determined by multiplying 960,000 ordinary shares issued in 2009 by the par value per
share (NIS 0.01) and then dividing the result by the exchange rate of the New Israeli
Shekel to the US dollar at date of issuance. Please provide us the exchange rate used in
this calculation. Also, explain why you used 960,000 ordina ry shares when your
disclosure in on page F -45 indicates that 8.9 million ordinary shares were issued in 2009 .
General
If you intend to respond to these comments with an amended draft registration statement,
please submit it and any associated correspondence in accordance with the guidance we provide
in the Division’s October 11 , 2012 announcement on the SEC website at
http://www.sec.gov/divisions/corpfin/cfannouncements/drsfilingprocedures101512.htm .
You may contact Frank Wyman at (202) 551 -3660 or Lisa Vanjoske at (202) 551 -3614 if
you have questions regarding comments on the financial statements and related matters. Please
contact Rose Zukin at (202) 551 -3239 or me at (202) 551 -3710 with any other questions.
Sincerely,
/s/ Jeffrey P. Riedler
Jeffrey P. Riedler
Assistant Director
Mr. Ori Shilo
RedHill Biopharma Ltd.
November 8, 2012
Page 4
cc: Rick Werner . Esq.
Haynes and Boone, LLP
30 Rockefeller Plaza, 26th Floor
New York, NY 10112
2012-10-10 - UPLOAD - RedHill Biopharma Ltd.
October 10, 2012 Via E -mail Mr. Ori Shilo Deputy Chief Executive Officer Finance and Operations RedHill Biopharma Ltd. 21 Ha’arba’a Street Tel Aviv 64739, Israel Re: RedHill Biopharma Ltd . Draft Registration Statement on Form 20 -F Submitted September 12, 2012 CIK No. 0001553846 Dear Mr. Shilo : We have reviewed your draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in response to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. Draft Registration Statement on Form 20 -F General 1. Please note that our comments on your request for confidential treatment of exhibits to your draft registration statement will be provided under separate cover. 2. Please amend your filing to disclose the exchange rate between the U.S. dollar and NIS as of the latest practicable date, and amend all related discussion to reflect this exchange rate. We note that the relevant disclosure appears on pages 45 -46, 53, 60 -63, and 82 -83. Mr. Ori Shilo RedHill Biopharma Ltd. October 10, 2012 Page 2 Item 3. K ey Information D. Risk Factors, page 3 “Clinical trials may involve and lengthy and expensive process . . .,” page 5 3. To the extent that you have experienced any problems with your clinical trials such as those described in the bullet points on page 6, pl ease revise to describe those problems. “Any collaborative arrangements that we establish may not be successful . . .,” page 6 4. To the extent that you have experienced any problems with your collaborative arrangements such as those described in the bullet points on page 7, please revise to describe those problems. “If third parties do not manufacture our therapeutic candidates . . .,” page 8 5. It appears this risk factor discusses two risks: the risk to your company of relying on third parties for the manu facture of their therapeutic candidates, and the risk to your company of your single supply source for your APIs. Please amend your disclosure to discuss these risks in separate risk factors, each accompanied by a specific, descriptive risk factor header. 6. In the risk factor discussing your single supply source for your APIs, please identify the source. If you have a written agreement with this source, please expand your disclosure in Item 4 to describe the material terms of the agreement, including each party’s obligations, the term of the agreement, and any termination provisions. Please also file the agreement as an exhibit to your registration statement. 7. To the extent that you have experienced any problems with the third -party manufacturers or supply source such as those described in this risk factor, please revise to describe those problems. “We and our third -party manufacturers are, and will be, subject to regulations . . .,” page 8 8. To the extent that you have experienced any problems with the thi rd-party manufacturers relating to cGMP, please revise to describe those problems. “If we cannot meet requirements under our acquisition or in -license . . .,” page 10 9. Please amend the header of this risk factor to also describe the risk to your compan y of not renewing or renegotiating your in -licensing agreements. 10. Please identify in the text of the risk factor the in -license agreements that are subject to renegotiation or renewal. In addition, please disclose when these contracts will come up for ren egotiation or renewal . Mr. Ori Shilo RedHill Biopharma Ltd. October 10, 2012 Page 3 “Our business could suffer if we are unable to attract and retain key . . .,” page 10 11. Please amend this risk factor to identify the key employees on which you rely. 12. To the extent that you have experienced any problems attracting or retaining qualified personnel, please revise to describe those problems. “We could be exposed to significant drug product liability claims . . .,” page 13 13. Please expand this risk factor to quantify the extent of your product liability insurance coverage. “Our business involves risks related to handing regulated substances . . .,” page 14 14. To the extent you have experienced any problems such as those described in this risk factor, please revise to disclose those problems. “We may be a passive foreign investment company . . .,” page 16 15. Disclose in this risk factor, as you have done on page 94 of the registration statement, that “[b]ased on [your] estimated gross income, the average value of [your] gross assets, and the nature of [your] business, [you] believe that [you] may be classified as a PFIC in the current taxable year and in future years.” This statement of belief conveys a great er risk than your statement that “there can be no assurance that we will not be considered a PFIC for 2012 or for any future taxable year.” “As a foreign private issuer, we are permitted to follow certain . . .,” page 18 16. Clarify that you may follow hom e country practice in Israel with regard to composition of the board of directors, which does not require that a majority of a company’s board be independent. “We currently do not anticipate paying cash dividends, . . .,” page 19 17. Please a dd a risk factor that discloses that the deposit agreement governs the rights of ADR holders to receive dividends or other distributions, and discusses whether under the deposit agreement, ADR holders may not have the same rights to, and in some circumstances, may not rec eive dividends or other distributions issued by you to ordinary shareholders. Mr. Ori Shilo RedHill Biopharma Ltd. October 10, 2012 Page 4 “Your rights and responsibilities as a shareholder will be governed . . .,” page 22 18. Please revise the risk factor heading to reference obligations rather than rights, and to indicate that Israeli la w may impose obligations and liabilities on a shareholder of an Israeli corporation that U.S. states do not impose upon shareholders of corporations incorporated in their respective states . Item 4. Information on the Company B. Business Overview, page 22 Our Therapeutic Candidates, page 23 19. If you have submitted an Investigational New Drug application to the FDA other than the one described on page 30, please disclose this fact and state when you filed this application. RHB -104, page 28 20. You state on page 29 that you have entered into an agreement with Quest Diagnostics Ltd. to develop a commercial diagnostic test for detecting the presence of MAP bacteria in the blood. Please expand your disclosure of this agreement to describe all material terms, including each part y’s obligations, any financial provisions, the term, and any termination provisions. In addition, please file this agreement as an exhibit to your registration statement, or provide us with a legal analysis as to w hy this agreement need not be filed pursuant to Instruction 4(a) to Exhibits of Form 20 -F. RHB -106, page 32 21. Please identify the manufacturer of the drug PrepoPik. Acquisition and License Agreements, page 34 22. Please expand your descriptions of the lice nse agreements governing RHB -101, RHB - 102, RHB -103, and RHB -104 that RedHill is entitled to terminate the agreement at any time. 23. You discuss an obligation under your joint development and commercialization agreement with IntelGenx Corp to finance RHB -103 development “in the amount of approximately $849,000 subject to deviations of 10%.” However, on page 50, you indicate that clinical trials for RHB -103 were successfully completed as of June 30, 2012. We a re unable to determine to what extent these development costs have been recognized through this date . Please quantify these development costs for each period, quantify your obligation for this financing obligation at June 30, 2012 and refer us to the technical guidance that served as a basis for your accounting treatment . Mr. Ori Shilo RedHill Biopharma Ltd. October 10, 2012 Page 5 License Agreement for RHB -103, page 35 Acquisition of RHB -104, RHB -105, and RHB -106, page 36 License Agreement for MAP diagnostic test related to RHB -104, page 37 Manufacturing Agreement Related to RHB -105, page 38 Manufacturing Agre ement Related to RHB -106, page 38 Clinical Services Agreement Related to RHB -104, page 38 24. Please expand your description of the material terms of the above agreements to disclose the term and termination provisions. 25. Please revise your description of th e Clinical Services Agreement related to RHB -104 to disclose the aggregate amount of milestones payable under the agreement. Manufacturing Agreements, page 37 26. Please explain the purpose and key terms governing the installment payment obligations under your manufacturing agreements. Intellectual Property, page 39 27. Please expand your description of the “Monopithic tablet for controlled drug release” patent fami ly to identify the jurisdictions in which the three issued patents were granted. D. Property, Plant and Equipment , page 45 28. Please file the lease agreement dated February 23, 2011 as an exhibit to your registration statement, or provide a legal analysis as to why the lease agreement need not be filed pursuant to Instruction 4(b)(iv) to Exhibits of Form 20 -F. Item 5. Operating and Financial Review and Prospects F. Tabular Disclosure of Contractual Obligations, page 56 29. Please disclose the installment pa yment obligations under your manufacturing agreements. Item 6. Directors, Senior Management and Employees B. Compensation, page 60 Employment Agreements, page 60 30. Please file all executed employment agreements with your executive officers, pursuant to Instruction 4(c) to Exhibits of Form 20 -F. Mr. Ori Shilo RedHill Biopharma Ltd. October 10, 2012 Page 6 C. Board Practices, page 64 31. Please add a risk factor addressing the risks to your company from the provisions in Israeli Companies Law regarding indemnification of office holders, as described on page 72. Nasdaq Stock Market Listing Rules and Home Country Practices, page 68 32. Please clarify how the shareholder approval requirements under the Israeli Companies Law are different than the shareholder approval requirements under the Nasdaq Marketplace Rules. E. Share Ownership, page 74 33. You provide information regarding the number of people you employ as of August 31, 2012. Please amend the disclosure in this section to reflect the most recent practicable date. Item 7. Major Shareholders and Related Part y Transactions A. Major Shareholders, page 77 34. The disclosure in this section reflects ownership as of August 31, 2012. Please amend the information to reflect the most recent practicable date. Please refer to Item 7 of Form 20-F for guidance. 35. We note your disclosure that the “All of the information with respect to beneficial ownership of the ordinary shares is given to the best of our knowledge.” Please tell us why you need to qualify your disclosure “to the best of [your] knowledge.” Please explain or delete the qualifying language. 36. Please expand your filing to provide the disclosure required by Item 7.A.2 of Form 20 -F. Item 10. Additional Information C. Material Contracts, page 88 37. On page 90, you refer to the Manufacturing Agreements describe d on pages 37 -39 as “material agreements.” However, not all manufacturing agreements have been filed as exhibits to your registration statement pursuant to Instruction 4(a) as to Exhibits of Form 20-F. Specifically, the manufacturing agreements related t o RHB -102, RHB -105, and RHB -106 with Pharmaceutics International, Inc. and Corealis Pharma Inc. have not been filed. Please file these material agreements as exhibits, or provide us with a legal analysis as to why these agreements need not be filed pursua nt to Instruction 4(a) to Exhibits of Form 20 -F. Mr. Ori Shilo RedHill Biopharma Ltd. October 10, 2012 Page 7 E. Taxation, page 90 Israeli Tax Considerations, page 90 38. This section should address the material tax consequences under Israeli law concerning the purchase, ownership and disposition of your shares by U.S. holders and not just be “a summary of the current tax regime of the State of Israel. . .” Please r evise a ccordingly. 39. Delete your disclaimer that the Israeli tax discussion “is not intended and should not be construed as legal or professional tax advice” since it inappropriately implies that an investor is not entitled to rely on the tax information disclosed in the registration statement. Item 12. Description of Securities Other Than Equity Securities 40. Please disclose that, in connection with this Form 20 -F registration statement, a Form F -6 has been filed to register the ADSs under the Securities Act. Ple ase further inform investors that attached to the Form F -6 is a copy of the deposit agreement to which they may refer. 41. Please expand your discussion under this section to explain: How ADSs are issued; How ADS holders may withdraw the deposited sec urities; How ADS holders may interchange between certificated and uncertificated ADSs; Whether the failure to give timely instructions to the depositary regarding the exercise of voting rights will result in granting a discretionary proxy to the depositary ; Whether the exercise of voting rights is conditioned under certain circumstances on the timely withdrawal of the underlying securities; The fee structure under the deposit agreement; The effect of reclassifications, recapitalizations and mergers on the A DSs; and Whether the deposit agreement permits the pre -release of ADSs and, if so, whether the conditions governing such pre -release include the pre -release’s full collateralization with cash or other collateral that the depositary considers appropriate. Item 18. Financial Statements Note 2 - Summary of Significant Accounting Policies , page F -14 General 42. Please disclose your accounting treatment for the installment payment obligations to your manufacturers, which aggregate $11.7 million. Mr. Ori Shilo RedHill Biopharma Ltd. October 10, 2012 Page 8 43. Disclose your accounting policy for costs incurred for clinical trials but have not yet been billed to you. Note 12 - Mandatory Convertible Loans and Royalty Obligation to Investors, page F -32 44. In August 2010, your initial royalty obligation represented the difference between consideration received and the fair value of the mandatory convertible loans, which in subsequent periods will accrete at a 27.98% effective interest rate. Prior to your February 2011 initial public offering, these loans converted into 19,818,314 o rdinary shares. Please explain to us the method and key assumptions used to estimate the ultimate value of this royalty obligation, the period over which you expect it to be paid and your basis for using the 27.98% accretion rate. Refer us to the technical guidance upon which you based your accounting treatment for this obligation. 45. Please explain the relationship between the 5 -year royalty payment term “since beginning of commercial sales for one of the therapeutic candidates” and the royalty payment timeframe disclosed on page F -26. 46. Please explain the 5% royalty provision of the mandatory convertible loans that states “income of the Company from advances or milestones as part of licensing transaction will be paid over 5 years starting on August 11, 2010. ” Note 21 -Loss Per Ordinary Share, page F -45 47. Ple
2012-10-01 - UPLOAD - RedHill Biopharma Ltd.
October 1, 2012 Via Secure E-mail Mr. Ori Shilo Deputy Chief Executive Officer Finance and Operations RedHill Biopharma Ltd. 21 Ha’arba’a Street Tel Aviv 64739, Israel Re: RedHill Biopharma Ltd Draft Registration Statement on Form 20 -F Originally Submitted September 12, 2012 CIK No. 0001553846 Dear Mr. Shilo : We are sending you this letter because you have a draft registration statement under review by the staff of the Division of Corporation Finance. Beginning in April, we adopted temporary policies allowing the submission of draft registration statement s using either the SEC’s mail room or , in May, a secure email system . On October 1, 2012 you will be able to submit draft registration statements using EDGAR . You will not be required to use EDGAR until the Commission adopts the changes to the EDGAR Filer Manual for Release 12.2. We will announce on the Commission’s website when you will be required to start using EDGAR for your submissions. This letter is to provide guidance to you on how to start using the EDGAR system to submit your draft registration statements. You already have a Central Index Key, or CIK number, assigned to you. You will need your CIK number to make your initial filing on EDGAR and you must take a number of steps to prepare for that filing. Following the procedures set forth in S ection 3.3.1.1 of the EDGAR Filer Manual – Volume I at http://www.sec.gov/info/edgar/edgarfm -vol1-v13.pdf , you must: Submit a request to us to convert yo ur EDGAR status to an electronic fi ler if we generated the CIK number for you . Request access codes and passwords to file your registration statement on the EDGAR system. If you already had a CIK number when you submitted your confidential draft, we used that number and you should confi rm that you have your previously obtained access codes available for filing. If you need new or replacement EDGAR access codes and passwords, we suggest that you complete the process to obtain them as soon as possible so that you can use EDGAR Mr. Ori Shilo RedHill Biopharma Ltd. October 1, 2012 Page 2 when you are ready to submit your next draft filing . Please call the Division’s Filer Support team at 202 -551-8900 (choose option number four) if you have questions about this process. If you do call, please make sure to tell us that we have already assigned a CIK number to your company and have that number readily available. Make any necessary changes to your contact information and business and mailing addresses in EDGAR prior to making your initial filing so we can contact you about your filing. You should make sure that you list your secure email address in your EDGAR information, since that is the address the staff will use to send you comment letters. See Volume 1, section 5 of the EDGAR Filer Manual on how to make Company data modifications . Once you have your EDGAR access codes, login to the EDGAR Filer Website at https://www.edgarfiling.sec.gov . Select “Draft Reg. Statement” on the left hand side of the opening page and proceed to attach your draft su bmission as described in the EDGAR Filer Manual and the d etailed instructions that are posted on the SEC Website at http://www.sec.gov/divisions/corpfin/guidance/drsfilin gprocedures.pdf . When you make your first EDGAR draft submission, you should submit it as a new draft registration statement, even if it is an amendment to a previously submitted version. In addition to the new draft, i n this first EDGAR submission, you should also: Attach each previously submitted draft registration statement , including exhibits, to your initial registration statement as a separate Exhibit 99 document and clearly identify each confidential submission attached as an Exhibit 99 document (e.g., EX-99.1 “Original Draft Registration Statement, dated xx/xx/2012” ). Do not attach submissions marked to show changes from earlier submissions. Submit each item of correspondence you sent to us in connection with your draft submissions, including your responses to our comments, as a separate “COVER” document within the submission. If you intend to use Rule 83 (17 CFR 200.83) to request confidenti al treatment of information in the correspondence you submit on EDGAR, please properly mark that information in each of your confidential submissions to us so we do not repeat or refer to that information in our comment letters to you. Mr. Ori Shilo RedHill Biopharma Ltd. October 1, 2012 Page 3 You may contact Rose Zukin at (202) 551 -3239 or me at (202) 551 -3710 with any questions. Sincerely, /s/ Daniel Greenspan for Jeffrey P. Riedler Assistant Director cc: Rick Werner Haynes and Boone, LLP 30 Rockefeller Plaza, 26th Floor New York, NY 10112