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Probe Score (365d)
45
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25
SEC Comment Letters
20
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25
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SEC Comment Letters
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Letter Text
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2025-04-17  ·  Last active: 2025-04-17
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2025-04-17
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2007-05-15  ·  Last active: 2025-04-03
Response Received 19 company response(s) High - file number match
UL SEC wrote to company 2007-05-15
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
CR Company responded 2007-05-22
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
References: May 10, 2007
Summary
Generating summary...
CR Company responded 2007-05-29
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
CR Company responded 2009-07-27
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
CR Company responded 2009-08-19
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
CR Company responded 2013-07-26
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
References: July 12, 2013
Summary
Generating summary...
CR Company responded 2014-04-30
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
References: April 17, 2014
Summary
Generating summary...
CR Company responded 2014-06-12
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
References: April 30, 2014
Summary
Generating summary...
CR Company responded 2014-06-24
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
References: April 17, 2014 | April 30, 2014
Summary
Generating summary...
CR Company responded 2015-03-27
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
References: March 23, 2015
Summary
Generating summary...
CR Company responded 2016-05-04
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
References: May 2, 2016
Summary
Generating summary...
CR Company responded 2016-05-23
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
References: May 2, 2016
Summary
Generating summary...
CR Company responded 2016-07-07
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
References: June 23, 2016 | May 23, 2016
Summary
Generating summary...
CR Company responded 2016-08-04
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
References: July 29, 2016
Summary
Generating summary...
CR Company responded 2016-08-19
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
References: July 29, 2016 | July 7, 2016 | May 23, 2016
Summary
Generating summary...
CR Company responded 2016-10-12
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
References: August 19, 2016 | May 23, 2016 | September 28, 2016
Summary
Generating summary...
CR Company responded 2022-10-07
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
References: September 21, 2022
Summary
Generating summary...
CR Company responded 2024-05-20
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
References: May 8, 2024
Summary
Generating summary...
CR Company responded 2024-08-01
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
References: July 22, 2024 | May 20, 2024
Summary
Generating summary...
CR Company responded 2025-04-03
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
References: March 21, 2025
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2025-03-21  ·  Last active: 2025-03-21
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2025-03-21
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2024-09-11  ·  Last active: 2024-09-11
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2024-09-11
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2024-07-22  ·  Last active: 2024-07-22
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2024-07-22
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2024-05-09  ·  Last active: 2024-05-09
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2024-05-09
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2022-11-07  ·  Last active: 2022-11-07
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2022-11-07
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2022-09-21  ·  Last active: 2022-09-21
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2022-09-21
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): N/A  ·  Started: 2021-01-04  ·  Last active: 2021-01-04
Awaiting Response 0 company response(s) Medium
UL SEC wrote to company 2021-01-04
REGENERON PHARMACEUTICALS, INC.
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): N/A  ·  Started: 2020-11-20  ·  Last active: 2020-12-07
Response Received 1 company response(s) Medium - date proximity
UL SEC wrote to company 2020-11-20
REGENERON PHARMACEUTICALS, INC.
Summary
Generating summary...
CR Company responded 2020-12-07
REGENERON PHARMACEUTICALS, INC.
References: November 20, 2020
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2016-10-18  ·  Last active: 2016-10-18
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2016-10-18
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2016-09-28  ·  Last active: 2016-09-28
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2016-09-28
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2016-07-29  ·  Last active: 2016-07-29
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2016-07-29
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2016-06-23  ·  Last active: 2016-06-23
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2016-06-23
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2016-05-03  ·  Last active: 2016-05-03
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2016-05-03
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): N/A  ·  Started: 2015-03-31  ·  Last active: 2015-03-31
Awaiting Response 0 company response(s) Medium
UL SEC wrote to company 2015-03-31
REGENERON PHARMACEUTICALS, INC.
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): N/A  ·  Started: 2015-03-23  ·  Last active: 2015-03-23
Awaiting Response 0 company response(s) Medium
UL SEC wrote to company 2015-03-23
REGENERON PHARMACEUTICALS, INC.
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2014-07-21  ·  Last active: 2014-07-21
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2014-07-21
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2014-04-17  ·  Last active: 2014-04-17
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2014-04-17
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2013-08-26  ·  Last active: 2013-08-26
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2013-08-26
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2013-07-12  ·  Last active: 2013-07-12
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2013-07-12
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2009-08-25  ·  Last active: 2009-08-25
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2009-08-25
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2009-08-10  ·  Last active: 2009-08-10
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2009-08-10
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2009-07-15  ·  Last active: 2009-07-15
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2009-07-15
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
REGENERON PHARMACEUTICALS, INC.
CIK: 0000872589  ·  File(s): 000-19034  ·  Started: 2007-07-23  ·  Last active: 2007-07-23
Awaiting Response 0 company response(s) High
UL SEC wrote to company 2007-07-23
REGENERON PHARMACEUTICALS, INC.
File Nos in letter: 000-19034
Summary
Generating summary...
DateTypeCompanyLocationFile NoLink
2025-04-17 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY 000-19034 Read Filing View
2025-04-03 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2025-03-21 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY 000-19034 Read Filing View
2024-09-11 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY 000-19034 Read Filing View
2024-08-01 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2024-07-22 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY 000-19034 Read Filing View
2024-05-20 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2024-05-09 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY 000-19034 Read Filing View
2022-11-07 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2022-10-07 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2022-09-21 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2021-01-04 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2020-12-07 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2020-11-20 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-10-18 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-10-12 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-09-28 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-08-19 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-08-04 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-07-29 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-07-07 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-06-23 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-05-23 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-05-04 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-05-03 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2015-03-31 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2015-03-27 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2015-03-23 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2014-07-21 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2014-06-24 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2014-06-12 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2014-04-30 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2014-04-17 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2013-08-26 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2013-07-26 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2013-07-12 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2009-08-25 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2009-08-19 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2009-08-10 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2009-07-27 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2009-07-15 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2007-07-23 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2007-05-29 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2007-05-22 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2007-05-15 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
DateTypeCompanyLocationFile NoLink
2025-04-17 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY 000-19034 Read Filing View
2025-03-21 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY 000-19034 Read Filing View
2024-09-11 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY 000-19034 Read Filing View
2024-07-22 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY 000-19034 Read Filing View
2024-05-09 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY 000-19034 Read Filing View
2022-11-07 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2022-09-21 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2021-01-04 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2020-11-20 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-10-18 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-09-28 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-07-29 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-06-23 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-05-03 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2015-03-31 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2015-03-23 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2014-07-21 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2014-04-17 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2013-08-26 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2013-07-12 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2009-08-25 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2009-08-10 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2009-07-15 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2007-07-23 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2007-05-15 SEC Comment Letter REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
DateTypeCompanyLocationFile NoLink
2025-04-03 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2024-08-01 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2024-05-20 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2022-10-07 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2020-12-07 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-10-12 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-08-19 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-08-04 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-07-07 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-05-23 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2016-05-04 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2015-03-27 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2014-06-24 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2014-06-12 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2014-04-30 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2013-07-26 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2009-08-19 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2009-07-27 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2007-05-29 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2007-05-22 Company Response REGENERON PHARMACEUTICALS, INC. NY N/A Read Filing View
2025-04-17 - UPLOAD - REGENERON PHARMACEUTICALS, INC. File: 000-19034
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 April 17, 2025

Christopher Fenimore
Executive Vice President, Finance and Chief Financial Officer
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY 10591-6707

 Re: Regeneron Pharmaceuticals, Inc.
 Form 10-K for the Fiscal Year Ended December 31, 2024
 Filed February 5, 2025
 File No. 000-19034
Dear Christopher Fenimore:

 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
cc: Richard Gluckselig
</TEXT>
</DOCUMENT>
2025-04-03 - CORRESP - REGENERON PHARMACEUTICALS, INC.
Read Filing Source Filing Referenced dates: March 21, 2025
CORRESP
 1
 filename1.htm

 Document Regeneron Pharmaceuticals, Inc. 777 Old Saw Mill River Road Tarrytown, NY 10591-6707 Phone 914 847 7000 www.regeneron.com April 3, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attn: Bonnie Baynes and Angela Connell Re: Regeneron Pharmaceuticals, Inc. Form 10-K for the Fiscal Year Ended December 31, 2024 Filed February 5, 2025 File No. 000-19034 Dear Ms. Baynes and Ms. Connell: This letter sets forth the response of Regeneron Pharmaceuticals, Inc. (the "Company," "Regeneron," "we," "us," and "our") to the comment of the staff (the "Staff") of the U.S. Securities and Exchange Commission set forth in the Staff's letter dated March 21, 2025, with respect to the above-referenced Annual Report on Form 10-K filed on February 5, 2025. Set forth below in bold are the heading and text of the Staff's comment followed by the Company's response. Form 10-K for the Fiscal Year Ended December 31, 2024 Part II Item 7. Management's Discussion and Analysis of Financial Condition and Results and Results of Operations Results of Operations, page 74 1. We note your disclosures on (i) page 36 regarding the impact of biosimilar competition on net product sales of EYLEA and/or EYLEA HD and (ii) pages 19 and 41 regarding competition from Vabysmo. With reference to Item 303(b)(2)(ii) of Regulation S-K, please revise your Results of Operations disclosures in future filings to discuss trends or uncertainties resulting from competitor products and/or biosimilars that have had or could have a material impact on net product sales of EYLEA and/or EYLEA HD. 1 Response: We acknowledge the Staff's comment and confirm that we will give further consideration to Item 303(b)(2)(ii) of Regulation S-K when preparing Results of Operations disclosures in Regeneron's future filings, in particular to enhance disclosures of trends or uncertainties resulting from competitor products (including, as applicable, Vabysmo ® and/or biosimilars) that have had or could have a material impact on net product sales of EYLEA ® (aflibercept) Injection and/or EYLEA HD ® (aflibercept) Injection 8 mg. *** If you have any questions regarding the foregoing, please contact me at (914) 847-7880. Sincerely,                          REGENERON PHARMACEUTICALS, INC. /s/ Christopher Fenimore Christopher Fenimore Executive Vice President, Finance and Chief Financial Officer 2
2025-03-21 - UPLOAD - REGENERON PHARMACEUTICALS, INC. File: 000-19034
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 March 21, 2025

Christopher Fenimore
Executive Vice President, Finance and Chief Financial Officer
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY 10591-6707

 Re: Regeneron Pharmaceuticals, Inc.
 Form 10-K for the Fiscal Year Ended December 31, 2024
 Filed February 5, 2025
 File No. 000-19034
Dear Christopher Fenimore:

 We have reviewed your filing and have the following comment.

 Please respond to this letter 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 a
comment applies to your facts and circumstances, please tell us why in your
response.

 After reviewing your response to this letter, we may have additional
comments.

Form 10-K for the Fiscal Year Ended December 31, 2024
Part II
Item 7. Management's Discussion and Analysis of Financial Condition and Results
and
Results of Operations
Results of Operations, page 74

1. We note your disclosures on (i) page 36 regarding the impact of
biosimilar
 competition on net product sales of EYLEA and/or EYLEA HD and (ii) pages
19 and
 41 regarding competition from Vabysmo. With reference to Item
303(b)(2)(ii) of
 Regulation S-K, please revise your Results of Operations disclosures in
future filings
 to discuss trends or uncertainties resulting from competitor products
and/or
 biosimilars that have had or could have a material impact on net product
sales of
 EYLEA and/or EYLEA HD.
 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.
 March 21, 2025
Page 2

 Please contact Bonnie Baynes at 202-551-4924 or Angela Connell at
202-551-3426 if
you have questions regarding comments on the financial statements and related
matters. Please contact Daniel Crawford at 202-551-7767 or Alan Campbell at
202-551-4224
with any other questions.

 Sincerely,

 Division of Corporation
Finance
 Office of Life Sciences
cc: Richard Gluckselig
</TEXT>
</DOCUMENT>
2024-09-11 - UPLOAD - REGENERON PHARMACEUTICALS, INC. File: 000-19034
September 11, 2024
Christopher Fenimore
Chief Financial Officer
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591-6707
Re:Regeneron Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2023
Filed February 5, 2024
File No. 000-19034
Dear Christopher Fenimore:
            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
2024-08-01 - CORRESP - REGENERON PHARMACEUTICALS, INC.
Read Filing Source Filing Referenced dates: July 22, 2024, May 20, 2024
CORRESP
1
filename1.htm

Document

  Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY  10591-6707  Phone   914 847 7000
www.regeneron.com

August 1, 2024

VIA EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, NE

Washington, D.C. 20549

Attn: Frank Wyman and Angela Connell

Re: Regeneron Pharmaceuticals, Inc.

 Form 10-K for the Fiscal Year Ended December 31, 2023

 Filed February 5, 2024

 File No. 000-19034

Dear Mr. Wyman and Ms. Connell:

This letter sets forth the responses of Regeneron Pharmaceuticals, Inc. (the "Company," "Regeneron," "we," "us," and "our") to the comments of the staff (the "Staff") of the U.S. Securities and Exchange Commission (the "Commission") set forth in the Staff's letter dated July 22, 2024, with respect to the above-referenced Annual Report on Form 10-K filed on February 5, 2024 (the "2023 Form 10-K"). Capitalized terms not otherwise defined in this letter have the respective meanings given to such terms in the Company's letter to the Staff dated May 20, 2024 (the "Prior Response").

Set forth below in bold are the headings and text of the Staff's comments followed by the Company's response.

Form 10-K for the Fiscal Year Ended December 31, 2023

Item 1. Business

Products, page 3

1. We note your response to prior comment one and your intended disclosure revisions. As your disclosure of net product sales of Regeneron-discovered products appears to constitute a metric, the disclosure requirements set forth in Staff Release No. 33-10751 are applicable. Accordingly, please revise your future filings to include the information provided in your response that describes how management uses these operating metrics in managing or monitoring the performance of your business, and why these metrics provide useful information to investors.

1

Response:

In addition to the disclosure referenced in the Prior Response, we will include the following disclosure starting with the Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2024:

"The table below includes net product sales of Regeneron-discovered products. Such net product sales are recorded by us or others, as further described in the footnotes to the table. We believe the information in the table is useful to investors as it demonstrates our pipeline productivity and our ability to innovate, discover, and develop new products, and bring those products to market either alone or based on contractual arrangements with other parties, which has a direct impact on our results of operations and financial condition. The table also shows the degree to which we, a collaborator, and/or a licensee is currently commercializing the products discovered by Regeneron. In addition, this information allows management and investors to assess the commercial trends and developments impacting Regeneron-discovered products. In arrangements where our collaborator or licensee is currently commercializing such products and is recording net product sales as a result, the net product sales shown in the table also are an important metric for management's review and assessment of (i) the revenues we record for our share of profits and/or royalties from such sales and (ii) the impact of our obligation to supply commercial product to certain of these collaborators or licensees."

Notes to the Consolidated Financial Statements

3. Collaboration, License and Other Agreements

a. Sanofi, page F-17

2. We note your response to prior comment two. In order to illustrate the mechanics of your contingent reimbursement obligation and the amounts reported in your Statement of Operations, please provide us with the following:

•Provide us with the calculation of your contingent reimbursement obligation as of December 31, 2023 based on the cumulative development costs incurred prior to July 1, 2022 and the contractually specified reimbursement percentages, as well as a rollforward of your obligation for each period presented;

Response:

The calculation and rollforward of our contingent reimbursement obligation is as follows:

2

(In millions)  Contingent Reimbursement Obligation - Liability Recognized

  Contingent Reimbursement Obligation - Liability Not Recognized

Contingent reimbursement obligation as of December 31, 2021  $ —    $ 3,152

Development costs incurred by the parties added to the contingent reimbursement obligation

  —    98

Development compensation payment (contractually defined as 10% of Regeneron's share of Antibody collaboration profits)

  —    (110)

Contingent reimbursement obligation as of July 1, 2022

  $ —    $ 3,140

One-time reduction to the contingent reimbursement obligation per terms of the amended Antibody License and Collaboration Agreement

  —    (30)

Development costs incurred by the parties added to the contingent reimbursement obligation(1)(3)

  95    —

Development compensation payment(2)(4)

  (95)   (246)

Contingent reimbursement obligation as of December 31, 2022  $ —    $ 2,864

Development costs incurred by the parties added to the contingent reimbursement obligation(1)(3)

  187    —

Development compensation payment(2)(4)

  (187)   (535)

Contingent reimbursement obligation as of December 31, 2023  $ —    $ 2,329

(1) As described in the Prior Response, as a result of the modification of the Sanofi Antibody collaboration (July 1, 2022), we concluded that any future Antibody collaboration research and development costs funded by Sanofi (i.e., funded after July 1, 2022) would not represent a substantive and genuine transfer of risk (i.e., it was probable that research and development costs funded by Sanofi would be repaid by the Company); and, as a result, we determined it was appropriate to recognize a liability each quarter thereafter equal to the amount of funding the Company is obligated to repay in respect of such quarter (i.e., the quarterly increase to the development balance).

(2) Under the terms of the July 1, 2022 amendment to the Antibody License and Collaboration agreement, the development compensation payment in a given quarter is applied first towards development costs added to the contingent reimbursement obligation after the effective date of the amendment (i.e., the amounts included in (1) above) and any remaining amount of the development compensation payment in such quarter is then applied towards cumulative development costs added to the contingent reimbursement obligation prior to the effective date of the amendment. Subsequent to July 1, 2022, the development compensation payment (in the aggregate) is contractually defined as 20% of Regeneron's share of Antibody collaboration profits.

(3) See subsequent table - amount included in R&D expense.

(4) A portion of the development compensation payment for which a liability was not recognized was deemed to be contingent consideration attributable to the acquisition of the Libtayo rights and is recorded as an increase to the Libtayo intangible asset. Refer to the below response related to the Libtayo intangible asset for further details.

•Provide us with the calculation of "Regeneron's obligation for its share of Sanofi R&D expenses, net of reimbursement of R&D expenses" for each period presented;

3

Response:

The calculation of "Regeneron's obligation for its share of Sanofi R&D expenses, net of reimbursements of R&D expenses" for each period presented is as follows:

  Statement of Operations Classification  Year Ended December 31,

(In millions)   2023  2022  2021

Sanofi Antibody collaboration:

Development costs incurred by the parties added to the contingent reimbursement obligation(1)

  (R&D expense)  $ (187)   $ (95)   $ —

Regeneron's obligation for its share of Sanofi R&D expenses(2)

  (R&D expense)  (38)   (42)   (47)

Sanofi's reimbursement of Regeneron's R&D expenses(2)

  Reduction of R&D expense  142    180    176

Regeneron's obligation for its share of Sanofi R&D expenses, net of reimbursements of R&D expenses

  Reduction of R&D expense/(R&D expense)

  $ (83)   $ 43    $ 129

(1) See preceding table - amount added to the contingent reimbursement obligation in accordance with the contractually specified formula. As described in the Previous Response, such amount represents the research and development costs funded by Sanofi subsequent to July 1, 2022 (i.e., the increase to the contingent reimbursement obligation) that we are obligated to repay from our share of profits and for which we determined it was appropriate to recognize a liability.

(2) Under the terms of the Antibody License and Collaboration Agreement, Sanofi is generally responsible for funding 80% to 100% of agreed-upon development costs. We record the reimbursable amounts from Sanofi as a reduction to R&D expense in the period in which such costs are incurred. When Sanofi performs research and development work, we also recognize, as research and development expense in the period when Sanofi incurs such expense, the portion of Sanofi's expenses that we are obligated to reimburse in accordance with the contractually specified formula, and which do not get added to the contingent reimbursement obligation per the terms of the contract.

•Quantify for us the estimated net present value differential of the 10% repayment rate versus the 20% repayment rate which was deemed to be contingent consideration attributable to your acquisition of the Libtayo rights and the amount recorded as an increase to the Libtayo intangible asset for each period presented.

4

Response:

As described in the Prior Response, we concluded the modification to the Antibody LCA represented additional consideration transferred by the Company to Sanofi to acquire the exclusive worldwide rights to Libtayo. As of July 1, 2022, the estimated net present value differential of the 10% repayment rate versus the 20% repayment rate, which was deemed to be contingent consideration in an asset acquisition attributable to our acquisition of the Libtayo rights, was $364 million.

Accordingly, a portion of the development compensation payment each quarter under the Antibody LCA is attributable to the acquisition of the Libtayo intangible asset, and as a result, such portion is recognized as an addition to the Libtayo intangible asset over time (i.e., each quarter). During the period from July 1, 2022 to December 31, 2022, $25 million was recorded as an increase to the Libtayo intangible asset related to the differential of the 10% repayment rate versus the 20% repayment rate, and during the year ended December 31, 2023, $73 million was recorded as an increase to the Libtayo intangible asset.

***

If you have any questions regarding the foregoing, please contact me at (914) 847-7880.

Sincerely,

REGENERON PHARMACEUTICALS, INC.

/s/ Christopher Fenimore

Christopher Fenimore

Senior Vice President, Finance and

Chief Financial Officer

5
2024-07-22 - UPLOAD - REGENERON PHARMACEUTICALS, INC. File: 000-19034
July 22, 2024
Christopher Fenimore
Chief Financial Officer
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591-6707
Re:Regeneron Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2023
Filed February 5, 2024
File No. 000-19034
Dear Christopher Fenimore:
            We have reviewed your May 20, 2024 response to our comment letter and have the
following comments.
            Please respond to this letter 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 a
comment applies to your facts and circumstances, please tell us why in your response.
            After reviewing your response to this letter, we may have additional comments. Unless we
note otherwise, any references to prior comments are to comments in our May 8, 2024 letter.
Form 10-K for the fiscal year ended December 31, 2023
Item 1. Business
Products, page 3
1.We note your response to prior comment one and your intended disclosure revisions. As
your disclosure of net product sales of Regeneron-discovered products appears to
constitute a metric, the disclosure requirements set forth in Staff Release No. 33-10751
are applicable. Accordingly, please revise your future filings to include the information
provided in your response that describes how management uses these operating metrics in
managing or monitoring the performance of your business, and why these metrics provide
useful information to investors.

July 22, 2024
Page 2
Notes to the Consolidated Financial Statements
3. Collaborations, License and Other Agreements
Sanofi, page F-17
2.We note your response to prior comment two. In order to illustrate the mechanics of your
contingent reimbursement obligation and the amounts reported in your Statement of
Operations, please provide us with the following:
•Provide us with the calculation of your contingent reimbursement obligation as of
December 31, 2023 based on the cumulative development costs incurred prior to July
1, 2022 and the contractually specified reimbursement percentages, as well as a
rollforward of your obligation for each period presented;
•Provide us with the calculation of "Regeneron's obligation for its share of Sanofi
R&D expenses, net of reimbursement of R&D expenses" for each period presented;
and
•Quantify for us the estimated net present value differential of the 10% repayment rate
versus the 20% repayment rate which was deemed to be contingent consideration
attributable to your acquisition of the Libtayo rights and the amount recorded as an
increase to the Libtayo intangible asset for each period presented.
            Please contact Frank Wyman at 202-551-3660 or Angela Connell at 202-551-3426 if you
have questions regarding comments on the financial statements and related matters.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2024-05-20 - CORRESP - REGENERON PHARMACEUTICALS, INC.
Read Filing Source Filing Referenced dates: May 8, 2024
CORRESP
1
filename1.htm

Document

  Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY  10591-6707  Phone   914 847 7000
www.regeneron.com

May 20, 2024

VIA EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, NE

Washington, D.C. 20549

Attn: Franklin Wyman and Angela Connell

Re: Regeneron Pharmaceuticals, Inc.

 Form 10-K for the Fiscal Year Ended December 31, 2023

 Filed February 5, 2024

 File No. 000-19034

Dear Mr. Wyman and Ms. Connell:

This letter sets forth the responses of Regeneron Pharmaceuticals, Inc. (the "Company," "Regeneron," "we," "us," and "our") to the comments of the staff (the "Staff") of the U.S. Securities and Exchange Commission (the "Commission") set forth in the Staff's letter dated May 8, 2024, with respect to the above-referenced Annual Report on Form 10-K filed on February 5, 2024 (the "2023 Form 10-K").

Set forth below in bold are the headings and text of the Staff's comments followed by the Company's response.

Form 10-K for the Fiscal Year Ended December 31, 2023

Item 1. Business

Products, page 3

1. Please address the following as it relates to your presentation of net product sales of Regeneron-discovered products on page 5:

•Explain the purpose of this disclosure and its usefulness to investors.

1

Response:

Regeneron is a fully integrated biotechnology company whose primary business is developing intellectual property ("IP") and monetizing Company-developed IP through its own commercialization, commercialization by collaborators, and licensure to third parties. The table of net product sales of Regeneron-discovered products demonstrates the Company's ability to innovate, discover and develop new products, and bring those products to market either alone or based on contractual arrangements with other parties. The table also shows the degree to which the Company, a collaborator, and/or a licensee is currently commercializing the products discovered by Regeneron. In arrangements where the Company's collaborator or licensee is currently commercializing such products and is recording net product sales as a result, the Company records its share of profits and/or royalties on such sales in Collaboration revenue or Other revenue, as applicable.

In addition, as noted in Part I. Item 1A. "Risk Factors" and Part II. Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations" of the 2023 Form 10-K, the Company is substantially dependent on the success of EYLEA® (aflibercept) Injection, EYLEA® HD (aflibercept) Injection 8 mg, and Dupixent® (dupilumab) (both in jurisdictions in which Regeneron records net product sales and jurisdictions in which a collaborator records net product sales of such products); therefore, we believe disclosing total net product sales of these products (as well as the other products listed in the table), regardless of the party recording such net product sales, provides useful context for investors.

•Disclose more prominently that not all of the net product sales presented on page 5 are recognized as revenue in your Statements of Operations.

Response:

We direct the Staff to the top of page 5 of the 2023 Form 10-K, which contains the following disclosure:

"Note: Refer to table below (net product sales of Regeneron-discovered products) for information regarding whether net product sales for a particular product are recorded by us or others . . . "

In future filings, we will also include similar disclosure in the lead-in to the table presenting net product sales of Regeneron-discovered products as follows:

"The table below includes net product sales of Regeneron-discovered products. Such net product sales are recorded by us or others, as further described in the footnotes to the table."

•For those net product sales recorded by a collaboration partner and for which you record your share of profits in connection with the collaboration, quantify the amounts recorded and specify where such amounts are recorded on your Statements of Operations (i.e., collaboration revenue).

•Provide cross-references to your revenue disclosure for each collaboration in MD&A.

2

Response:

To the extent that net product sales presented in the table of net product sales of Regeneron-discovered products are recorded by a collaborator or licensee, we will specify in future filings where our share of profits or royalties on such sales are recorded within our Statements of Operations (i.e., within Collaboration revenue or Other revenue). In addition, to the extent that our share of profits or royalties are separately disclosed in the MD&A because they are deemed to be material, we will include a cross-reference to the relevant disclosure. Accordingly, in future filings, we will amend relevant footnotes to the table presenting net product sales of Regeneron-discovered products to read as follows (changes are noted in italics):

(a) Regeneron records net product sales of EYLEA HD and EYLEA in the United States, and Bayer records net product sales outside the United States. The Company records its share of profits in connection with sales outside the United States within Collaboration revenue. Refer to Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations - Revenues - Bayer Collaboration Revenue" for such amounts.

(b) Sanofi records global net product sales of Dupixent and Kevzara. The Company records its share of profits in connection with global sales of Dupixent and Kevzara within Collaboration revenue. Refer to Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations - Revenues - Sanofi Collaboration Revenue" for such amounts.

(d) Regeneron records net product sales of Praluent in the United States. Sanofi records net product sales of Praluent outside the United States, and pays the Company a royalty on such sales, which is recorded within Other revenue.

(e) Roche records net product sales of Ronapreve outside the United States, and the parties share gross profits from sales, which are recorded within Collaboration revenue. Refer to Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations - Revenues - Roche Collaboration Revenue" for such amounts.

Notes to the Consolidated Financial Statements

3. Collaboration, License and Other Agreements

a. Sanofi, page F-17

2. We note your disclosure on page 89 that under your collaboration agreements with Bayer and Sanofi, you have contingent contractual obligations to reimburse Bayer and Sanofi for a defined percentage of agreed-upon development expenses funded by Bayer and Sanofi (i.e., "development balance") if the applicable collaboration is profitable. You also disclose that these reimbursements are deducted each quarter, in accordance with a formula, from your share of the collaboration profits otherwise payable to you. Please address the following specifically as it relates to your contingent reimbursement obligation under the Sanofi Antibody License and Collaboration Agreement ("LCA"):

•Describe and quantify the contractual terms governing your contingent reimbursement obligation under the LCA and the methods and key assumptions used to determine the associated $2.33 billion contingent obligation as of December 31, 2023.

3

Response:

We believe the existing disclosure contained in Part I, Item 1. "Business - Collaboration, License, and Other Agreements - Sanofi - Antibody" of the 2023 Form 10-K (which is also included in Note 3 on page F-17) describes the key terms governing our contingent reimbursement obligations (see excerpt below). In future filings, the Company will clarify that the July 1, 2022 amendment to the Antibody License and Collaboration Agreement (the "Antibody LCA") was entered into in connection with the Company's acquisition of exclusive worldwide rights to Libtayo described further below in this letter (changes to future filings are noted in italics).

"Under the terms of the Antibody License and Collaboration Agreement (the "LCA"), Sanofi is generally responsible for funding 80% to 100% of agreed-upon development costs. We are obligated to reimburse Sanofi for 30% to 50% of worldwide development expenses that were funded by Sanofi based on our share of collaboration profits from commercialization of collaboration products. Under the terms of the LCA, we were required to apply 10% of our share of the profits from the Antibody Collaboration in any calendar quarter to reimburse Sanofi for these development costs. On July 1, 2022, an amendment to the LCA, which had been entered into in connection with our acquisition of exclusive worldwide rights to Libtayo, became effective. Pursuant to this amendment, the percentage of Regeneron’s share of profits used to reimburse Sanofi for such development costs has increased from 10% to 20%."

The development balance as of the end of a quarter is contractually defined in the Antibody LCA (previously filed as an exhibit and listed as Exhibit 10.10 to the 2023 Form 10-K) as "(a) fifty percent (50%) of the aggregate amount of Development Costs incurred by both Parties under the Global Development Plan for all Licensed Products from the Effective Date through the close of such Quarter, excluding any Shared Phase 3 Trial Costs, plus (b) thirty percent (30%) of the aggregate amount of Shared Phase 3 Trial Costs incurred by both Parties under the Global Development Plans for all Licensed Products from the Effective Date through the close of such Quarter, less (c) the aggregate amount of Development Compensation Payments included in the calculation of the Quarterly True-Up in all prior Quarters."

As it relates to the $2.33 billion contingent obligation as of December 31, 2023, we note that the method of calculation is also contractually specified. In addition, the inputs necessary to calculate the development costs incurred and the development balance (i.e., the funding percentages described in the preceding paragraph and the percentage used to calculate the Company's quarterly repayment of the development balance (currently defined as 20% of Regeneron's share of profits)) come directly from the accounting records of the Company and Sanofi each quarter or are similarly contractually specified. Consequently, given the nature of these inputs and the contractually specified formula, no assumptions were used to determine the associated $2.33 billion contingent obligation as of December 31, 2023. In addition, Regeneron and Sanofi reconcile the contingent obligation balance with each other on a quarterly basis.

•Clarify why the $2.33 billion contingent repayment obligation does not appear to be recorded as a liability on your balance sheet. In particular, explain your basis for deeming the obligation to be contingent given the likelihood of continued profits under the Antibody LCA.

4

Response:

We account for arrangements deemed to be collaborations, including the collaboration governed by the Antibody LCA, in accordance with ASC 808, Collaborative Arrangements. In accordance with ASC 808, parts of a collaborative arrangement that are within the scope of other authoritative literature shall be accounted for using the relevant provisions of that literature. Accordingly, the Company utilized the guidance in ASC 730, Research and development expense, to determine the appropriate recognition of amounts received from parties who fund our research and development costs which are subject to potential repayment. We note the following guidance pursuant to ASC 730-20 related to research and development arrangements:

25-2 An entity shall determine the nature of the obligation it incurs when it enters into an arrangement with other parties who fund its research and development . . .

25-3 If the entity is obligated to repay any of the funds provided by the other parties regardless of the outcome of the research and development, the entity shall estimate and recognize that liability. This requirement applies whether the entity may settle the liability by paying cash, by issuing securities, or by some other means.

25-4 To conclude that a liability does not exist, the transfer of the financial risk involved with research and development from the entity to the other parties must be substantive and genuine. To the extent that the entity is committed to repay any of the funds provided by the other parties regardless of the outcome of the research and development, all or part of the risk has not been transferred. The following are some examples in which the entity is committed to repay:

a.The entity guarantees, or has a contractual commitment that assures, repayment of the funds provided by the other parties regardless of the outcome of the research and development.

b.The other parties can require the entity to purchase their interest in the research and development regardless of the outcome.

c.The other parties automatically will receive debt or equity securities of the entity upon termination or completion of the research and development regardless of the outcome.

25-5 Even though the written agreements or contracts under the arrangement do not require the entity to repay any of the funds provided by the other parties, surrounding conditions might indicate that the entity is likely to bear the risk of failure of the research and development. If those conditions suggest it is probable that the entity will repay any of the funds regardless of the outcome of the research and development, there is a presumption that the entity has an obligation to repay the other parties. That presumption can be overcome only by substantial evidence to the contrary. In this context, probable means that repayment is likely.

25-6 Examples of conditions leading to the presumption that the entity will repay the other parties include any of the following:

a.The entity has indicated an intent to repay all or a portion of the funds provided regardless of the outcome of the research and development.

b.The entity would suffer a severe economic penalty if it failed to repay any of the funds provided to it regardless of the outcome of the research and development. An economic penalty is considered severe if in the normal course of business an entity would probably

5

choose to pay the other parties rather than incur the penalty. For example, an entity might purchase the partnership's interest in the research and development if the entity had provided the partnership with proprietary basic technology necessary for the entity's ongoing operations without retaining a way to recover that technology, or prevent it from being transferred to another party, except by purchasing the partnership's interest.

c.A significant related party relationship between the entity and the parties funding the research and development exists at the time the entity enters into the arrangement.

d.The entity has essentially completed the project before entering into the arrangement.

Upon entering into the original Antibody LCA in 2007 (which, in accordance with ASC 730-20-25-2, was the time as of which we were to determine the nature of the obligation to repay Sanofi a portion of the research and development costs funded by Sanofi), the products under the collaboration were in preclinical or early-stage clinical development. At such time, we concluded that there was a substantive and genuine transfer of risk (i.e., it was not probable that research and development costs funded by Sanofi would be repaid by the Company given the risk and uncertainty as to whether any products subject to the Antibody LCA would be approved; and, if approved, whether any such products would generate profits). Therefore, we did not record a liability related to the contingent repayment obligation (i.e.,
2024-05-09 - UPLOAD - REGENERON PHARMACEUTICALS, INC. File: 000-19034
United States securities and exchange commission logo
May 8, 2024
Christopher Fenimore
Chief Financial Officer
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591-6707
Re:Regeneron Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2023
Filed February 5, 2024
File No. 000-19034
Dear Christopher Fenimore:
            We have limited our review of your filing to the financial statements and related
disclosures and have the following comments.
            Please respond to this letter 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 a
comment applies to your facts and circumstances, please tell us why in your response.
            After reviewing your response to this letter, we may have additional comments.
Form 10-K for the Fiscal Year Ended December 31, 2023
Item 1. Business
Products, page 3
1.Please address the following as it relates to your presentation of net product sales of
Regeneron-discovered products on page 5:

•Explain the purpose of this disclosure and its usefulness to investors.
•Disclose more prominently that not all of the net product sales presented on page 5
are recognized as revenue in your Statements of Operations.
•For those net product sales recorded by a collaboration partner and for which you
record your share of profits in connection with the collaboration, quantify the
amounts recorded and specify where such amounts are recorded on your Statements
of Operations (i.e., collaboration revenue).
•Provide cross-references to your revenue disclosure for each collaboration in MD&A.

 FirstName LastNameChristopher  Fenimore
 Comapany NameRegeneron Pharmaceuticals, Inc.
 May 8, 2024 Page 2
 FirstName LastNameChristopher  Fenimore
Regeneron Pharmaceuticals, Inc.
May 8, 2024
Page 2
Notes to the Consolidated Financial Statements
3. Collaboration, License and Other Agreements
a. Sanofi, page F-17
2.We note your disclosure on page 89 that under your collaboration agreements with Bayer
and Sanofi, you have contingent contractual obligations to reimburse Bayer and Sanofi for
a defined percentage of agreed-upon development expenses funded by Bayer and Sanofi
(i.e., "development balance") if the applicable collaboration is profitable. You also
disclose that these reimbursements are deducted each quarter, in accordance with a
formula, from your share of the collaboration profits otherwise payable to you. Please
address the following specifically as it relates to your contingent reimbursement
obligation under the Sanofi Antibody License and Collaboration Agreement ("LCA"):

•Describe and quantify the contractual terms governing your contingent
reimbursement obligation under the LCA and the methods and key assumptions used
to determine the associated $2.33 billion contingent obligation as of December 31,
2023.
•Clarify why the $2.33 billion contingent repayment obligation does not appear to be
recorded as a liability on your balance sheet. In particular, explain your basis for
deeming the obligation to be contingent given the likelihood of continued profits
under the Antibody LCA.
•Clarify your basis for reporting certain reimbursements of Sanofi development
expenses as R&D expense, while reporting other such reimbursements as a reduction
of collaboration profits. For example, if true, confirm that the $83.7 million in R&D
expenses classified as "Regeneron's obligation for its share of Sanofi R&D expenses,
net of reimbursement of R&D expenses" on page F-17 represents your share of
current period R&D expenses incurred by Sanofi based on the original expense
sharing percentage in the LCA, while the $459.8 million reported on page 80 as
"Reimbursement of development expenses incurred by Sanofi in accordance with
Regeneron's payment obligation" represents reimbursements of amounts due under
your contingent repayment obligation which relates to cumulative development costs.
•Clarify your disclosure on page F-17 that a portion of the value associated with the
increase in reimbursement percentage (from 10% to 20%) was deemed to be
contingent consideration attributable to your acquisition of the Libtayo (cemiplimab)
rights under the IO LCA, which will be recorded as an increase to the Libtayo
intangible asset over time as you repay such development costs to Sanofi. Cite the
relevant accounting guidance supporting this accounting treatment.
•Revise your disclosure accordingly.
            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.

 FirstName LastNameChristopher  Fenimore
 Comapany NameRegeneron Pharmaceuticals, Inc.
 May 8, 2024 Page 3
 FirstName LastName
Christopher  Fenimore
Regeneron Pharmaceuticals, Inc.
May 8, 2024
Page 3
            Please contact Franklin Wyman at 202-551-3660 or Angela Connell at 202-551-3426
with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2022-11-07 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
United States securities and exchange commission logo
November 7, 2022
Leonard S. Schleifer
Chief Executive Officer
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591
Re:Regeneron Pharmaceuticals, Inc.
Definitive Proxy Statement on Schedule 14A
Filed April 21, 2022
File No. 000-19034
Dear Leonard S. Schleifer:
            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
Disclosure Review Program
2022-10-07 - CORRESP - REGENERON PHARMACEUTICALS, INC.
Read Filing Source Filing Referenced dates: September 21, 2022
CORRESP
1
filename1.htm

  Regeneron Pharmaceuticals, Inc.

  777 Old Saw Mill River Road

  Tarrytown, NY 10591-6707
  Phone 914 847 7000

  www.regeneron.com

October 7, 2022

VIA EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, NE

Washington, D.C. 20549

  Re:
  Regeneron Pharmaceuticals, Inc.

  Definitive Proxy Statement on Schedule 14A

  Filed April 21, 2022

  File No. 000-19034

Dear Ms. Ravitz:

This letter sets forth the responses of Regeneron
Pharmaceuticals, Inc. (the “Company,” “we,” “us,” and “our”) to the comments of the staff
(the “Staff”) of the U.S. Securities and Exchange Commission set forth in the Staff’s letter dated September 21, 2022,
with respect to the above-referenced Definitive Proxy Statement on Schedule 14A filed on April 21, 2022 (the “Proxy Statement”).

Set forth below in bold are the headings and text
of the Staff’s comments followed by the Company’s response.

Definitive Proxy Statement on Schedule 14A filed April 21,
2022

General

 1. Please discuss the circumstances under which you would consider
                                            having the Chair and CEO roles filled by a single individual, when shareholders would be
                                            notified of any such change, and whether you will seek prior input from shareholders. In
                                            addition, please discuss how the experience of your Presiding Director is brought to bear
                                            in connection with your board’s role in risk oversight.

Response:

As a preliminary matter, it is our belief that
the Company’s disclosures in the Proxy Statement comply with all applicable rules and regulations, including Item 407(h) of Regulation
S-K. In particular, we note the requirement in Item 407(h) of Regulation S-K is to “[b]riefly describe” the leadership structure
of the registrant’s board. In this regard, the Proxy Statement includes a comprehensive discussion of the leadership structure
of our Board of Directors (the “Board”). As discussed in the Proxy Statement, the Board has determined that the roles of
Chair and CEO should be held by separate individuals to realize the benefit of the business and industry experience of the Chair and
to enhance the Board’s oversight of management. Additionally, as also disclosed in the Proxy Statement, the Board has a Presiding
Director, who is an independent director under the listing standards of the Nasdaq Stock Market LLC and chairs all executive sessions
of independent directors (which generally follow each regularly scheduled Board meeting); and the Board believes that this governance
arrangement bolsters the Board’s leadership structure and independent oversight of management. Pursuant to the Company’s
Corporate Governance Guidelines (which are posted on the Company’s website and are available to investors), the Board periodically
evaluates and determines an appropriate leadership structure for the Board so as to provide effective oversight of management.

Accordingly, the Company believes its current
Proxy Statement disclosure is appropriate and complete under the relevant disclosure requirement. In light of the Staff’s comment,
we will continue to evaluate, and consider whether to expand, our disclosure pursuant to Item 407(h) in future proxy statements (including,
if applicable, in light of any material developments to the Company’s risk oversight structure).

 2. Please expand upon the role that your Presiding Director plays
                                            in the leadership of the board. For example, please enhance your disclosure to address whether
                                            or not your Presiding Director may:

 · represent the board
                                            in communications with shareholders and other stakeholders;

 · require board consideration
                                            of, and/or override your CEO on, any risk matters; or

 · provide input on
                                            design of the board itself.

Response:

As described in the response to comment 1 above,
the Company believes its disclosures in the Proxy Statement comply with all applicable rules and regulations. Notably, the Proxy Statement
currently includes a section titled “Board Leadership Structure–Separate Chair and CEO with Presiding Director” that
describes the role of our Presiding Director. Additionally, the Proxy Statement, in the section titled “Shareholder Engagement
Philosophy and Board Responsiveness,” provides that the Company encourages director participation in its shareholder engagement
program and that the Presiding Director (who is also the Chair of the Corporate Governance and Compliance Committee of the Board) has
led many shareholder discussions. We believe the disclosure in these sections (along with the other applicable disclosures made in the
Proxy Statement) satisfies the required disclosure under Item 407(h).

We seek to comply with the requirement of Item
407(h) to provide a brief description of our leadership structure while balancing our desire to provide information that investors will
find useful. While the Company believes its current Proxy Statement disclosure is fully compliant with the applicable disclosure requirements,
we will consider carefully the Staff’s comments as we evaluate our disclosures about the role of our Presiding Director in future
proxy statements.

    2

 3. Please expand upon how your board administers its risk oversight
                                            function. For example, please disclose:

 · the timeframe over
                                            which you evaluate risks (e.g., short-term, intermediate-term, or long-term) and how you
                                            apply different oversight standards based upon the immediacy of the risk assessed;

 · whether you consult
                                            with outside advisors and experts to anticipate future threats and trends, and how often
                                            you re-assess your risk environment;

 · how the board interacts
                                            with management to address existing risks and identify significant emerging risks;

 · whether you have
                                            a Chief Compliance Officer and to whom this position reports; and

 · how your risk oversight
                                            process aligns with your disclosure controls and procedures.

Response:

As described in the responses to comments 1 and
2 above, the Company believes its disclosures in the Proxy Statement comply with all applicable rules and regulations. Specifically,
Item 407(h) requires disclosure of “the extent of the board’s role in the risk oversight of the registrant, such as how the
board administers its oversight function, and the effect that this has on the board’s leadership structure.” The Proxy Statement
currently includes a section titled “Board Oversight of Risk and Key Pricing Decisions,” which provides a detailed description
of the Board’s role in our risk oversight, how the Board and its committees administer risk oversight, and the relationship between
the Board and management in risk oversight. In particular, the Proxy Statement highlights the oversight role of the Audit Committee of
the Board with respect to the Company’s risk management program and the fact that the Company’s Chief Audit Executive reports
independently to the Audit Committee and facilitates the risk management program. The Proxy Statement further describes the duties of
the Compensation, Corporate Governance and Compliance, and Technology Committees, which are primarily responsible for oversight of the
Company’s risk framework relating to their respective focus areas. The Proxy Statement provides additional information on how the
Board administers its risk oversight function, as follows:

The Board is kept abreast of its committees’ risk oversight
and other activities via reports of the committee chairs to the full Board at regular Board meetings…. In addition, the Board
receives detailed regular reports from members of our senior management that include discussions of the risks and exposures involved
in their respective areas of responsibility. Further, the Board is routinely informed by the appropriate members of senior management
of developments internal and external to the Company that could affect our risk profile.

(Capitalization conformed to the convention used in this letter.)

The Company has established the role of Chief
Compliance Officer, which is currently filled and reports to the Company’s General Counsel. The Chief Compliance Officer provides
regular updates to the Corporate Governance and Compliance Committee of the Board, and relevant information is shared with the full Board
as part of the Committee’s report to the Board.

We believe our disclosure about the Company’s
risk oversight process is both comprehensive and informative. While the Company believes its current Proxy Statement disclosure is fully
compliant, we will consider carefully the Staff’s comments as we evaluate our required disclosures pursuant to Item 407(h) in future
proxy statements (including, if applicable, in light of any material developments to the Company’s risk oversight structure).

*         *
        *

    3

If you have any questions regarding the foregoing,
please contact Richard Gluckselig, Vice President, Associate General Counsel and Assistant Secretary, at 914-847-5290 or via email at
richard.gluckselig@regeneron.com. If you would like to speak with me directly, I can be reached at 914-847-7498 or via email at
joseph.larosa@regeneron.com.

  Very truly yours,

  REGENERON PHARMACEUTICALS, INC.

  /s/ Joseph J. LaRosa

  Joseph J. LaRosa

  Executive Vice President, General Counsel and Secretary

    4
2022-09-21 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
United States securities and exchange commission logo
September 21, 2022
Leonard S. Schleifer
Chief Executive Officer
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591
Re:Regeneron Pharmaceuticals, Inc.
Definitive Proxy Statement on Schedule 14A
Filed April 21, 2022
File No. 000-19034
Dear Dr. Schleifer:
            We have limited our review of your most recent definitive proxy statement to those issues
we have addressed in our comments.
            Please respond to these comments by confirming that you will enhance your future proxy
disclosures in accordance with the topics discussed below as well as any material developments
to your risk oversight structure. For guidance, refer to Item 407(h) of Regulation S-K.
Definitive Proxy Statement on Schedule 14A filed April 21, 2022
General
1.Please discuss the circumstances under which you would consider having the Chair and
CEO roles filled by a single individual, when shareholders would be notified of any such
change, and whether you will seek prior input from shareholders. In addition, please
discuss how the experience of your Presiding Director is brought to bear in connection
with your board’s role in risk oversight.
2.Please expand upon the role that your Presiding Director plays in the leadership of the
board. For example, please enhance your disclosure to address whether or not your
Presiding Director may:
•represent the board in communications with shareholders and other stakeholders;
•require board consideration of, and/or override your CEO on, any risk matters; or
•provide input on design of the board itself.
3.Please expand upon how your board administers its risk oversight function. For example,
please disclose:
•the timeframe over which you evaluate risks (e.g., short-term, intermediate-term, or

 FirstName LastNameLeonard S. Schleifer
 Comapany NameRegeneron Pharmaceuticals, Inc.
 September 21, 2022 Page 2
 FirstName LastName
Leonard S. Schleifer
Regeneron Pharmaceuticals, Inc.
September 21, 2022
Page 2
long-term) and how you apply different oversight standards based upon the
immediacy of the risk assessed;
•whether you consult with outside advisors and experts to anticipate future threats and
trends, and how often you re-assess your risk environment;
•how the board interacts with management to address existing risks and identify
significant emerging risks;
•whether you have a Chief Compliance Officer and to whom this position reports; and
•how your risk oversight process aligns with your disclosure controls and procedures.
            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 Amanda Ravitz at 202-551-3412 or Barbara Jacobs at 202-551-3735 with
any questions.
Sincerely,
Division of Corporation Finance
Disclosure Review Program
2021-01-04 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
United States securities and exchange commission logo
January 4, 2021
Robert E. Landry
Chief Financial Officer
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591-6707
Re:Regeneron Pharmaceuticals, Inc.
Form 10-K for the fiscal year ended December 31, 2019
Filed on February 7, 2020
File No. 0-19034
Dear Mr. Landry:
            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
2020-12-07 - CORRESP - REGENERON PHARMACEUTICALS, INC.
Read Filing Source Filing Referenced dates: November 20, 2020
CORRESP
1
filename1.htm

Document

  Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY  10591-6707  Phone   914 847 7000
www.regeneron.com

December 7, 2020

VIA EDGAR

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, NE

Washington, D.C. 20549

Re: Regeneron Pharmaceuticals, Inc.

 Form 10-K for the fiscal year ended December 31, 2019

 Filed on February 7, 2020

 Form 10-Q for the quarterly period ended September 30, 2020

 Filed on November 5, 2020

 File No. 0-19034

Dear Ms. Connell:

This letter sets forth the responses of Regeneron Pharmaceuticals, Inc. (the "Company," "Regeneron," "we," "us," and "our") to the comments of the staff (the "Staff") of the Securities and Exchange Commission (the "Commission") set forth in the Staff's letter dated November 20, 2020, with respect to the above-referenced Form 10-K and Form 10-Q.

Set forth below in bold are the headings and text of the Staff's comments followed by the Company's response.

Form 10-K, Filed February 7, 2020

Item 10. Directors, Executive Officers and Corporate Governance, page 76

1. We note the following statement on page 26 of the proxy statement that has been

incorporated by reference "[t]he board has determined that this leadership structure is

appropriate for the Company at this time." In future filings, please provide detail

concerning why you have determined that this leadership structure is appropriate given

your specific characteristics or circumstances as required by Item 407(h) of Regulation S-K.

Response:

We believe that the disclosure set forth in the first paragraph under the heading "Board Leadership and Role in Risk Oversight" on page 26 of the proxy statement describing the qualifications of the Chairman of Regeneron's Board of Directors and his role vis-à-vis the Board of Directors and the Chief Executive

1

Officer is responsive to Item 407(h) of Regulation S-K. However, in future filings, we will revise our disclosure to clarify further why we have determined that our leadership structure is appropriate given our specific characteristics or circumstances.

Item 11. Executive Compensation, page 76

2. We note your reference to a share repurchase program in the Compensation Discussion

and Analysis section of the definitive proxy statement that is incorporated by reference, and the disclosure in your Form 10-K of the repurchases that occurred in 2019. Please tell us why you do not discuss in your CD&A the impact of share repurchases on your compensation levels in 2019.

Response:

We did not discuss in our most recent CD&A the impact of our share repurchases on our executive compensation levels in 2019 because we do not believe our repurchases had a material impact on our executive compensation levels in 2019. Therefore, we do not believe that a discussion of those repurchases would have provided material information necessary to an understanding of the compensation program applicable to our named executive officers in 2019. In particular, we note that the 2019 executive compensation program did not utilize earnings-per-share metrics or other similar metrics directly impacted by the number of outstanding shares of Regeneron common stock reduced as a result of stock repurchases that occurred in 2019.

Form 10-Q for the Quarterly Period Ended September 30, 2020

Notes to Condensed Consolidated Financial Statements (Unaudited)

1. Interim Financial Statements

Basis of Presentation, page 7

3. We note your disclosure that effective January 1, 2020 you changed the presentation of

cost reimbursements from collaborators who are not deemed to be your customers from

collaboration revenue to a reduction of the corresponding operating expense. We note

that you also changed the presentation of amounts recognized in connection with up-front

and development milestone payments from collaboration revenue to other operating

income. Please provide us with your full analysis supporting this change and its impact

on each element of your collaboration agreements. In particular, please explain why you

changed your conclusion regarding whether your collaborators were deemed to be

customers and how this impacted your application of applicable revenue recognition

guidance.

Response:

Background

The Company is a party to collaboration agreements to develop and commercialize, as applicable, certain products and product candidates. Effective January 1, 2020, the Company implemented changes in the presentation of its financial statements related to certain reimbursements and other payments for products developed and commercialized with collaborators. We note by way of background:

•The Company has entered into various collaborative arrangements. At the inception of each of these arrangements, the Company and its collaborator were each deemed to be active participants in the collaborations' joint operating activities and were exposed to significant risks and rewards

2

dependent on the commercial success of the activity (e.g., profit sharing, sales milestones, etc.). Accordingly, the arrangements were deemed to be collaborations in accordance with ASC 808, Collaborative Arrangements.

•Historically, the Company made a determination that its collaborative arrangements, including those with Sanofi, Bayer, Teva, and Mitsubishi Tanabe Pharma Corporation ("MTPC"), fell within the scope of ASC 808. Given the lack of prescriptive guidance in ASC 808 and the fact that performance of research and development ("R&D") activities was part of Regeneron's ongoing major or central operations, the Company previously presented reimbursements and other payments from its collaborators by analogy to revenue guidance (initially ASC 605, Revenue Recognition, and subsequently ASC 606, Revenue from Contracts with Customers) pursuant to ASC 808-10-45-3 and 45-4 (as originally codified).

•The Company's ongoing major or central operations have evolved from being responsible for providing R&D activities in exchange for consideration to being a "fully integrated biotechnology company" with significant commercial operations (as described in the Company's Form 10-K for the year ended December 31, 2019). The evolution is evidenced by the fact that Regeneron has entered into arrangements whereby its collaborators are responsible for conducting R&D activities in exchange for funding provided by Regeneron. In addition, the Company has been conducting commercialization activities for products that have received regulatory approval. By way of example, through 2016, the Company was performing commercialization activities solely for ARCALYST® (rilonacept) and EYLEA® (aflibercept); from 2017 to 2019, four additional products received marketing approval for which the Company conducts various commercialization activities. We believe that the Company's historical primary activities were consistent with the roles and responsibilities assumed by "Biotech", and that our current primary activities are consistent with the roles and responsibilities assumed by "Pharma", in the illustrative examples included in ASC 808-10-55. Consequently, we believe that it was appropriate to change our accounting presentation for certain reimbursements and other payments from our collaborators to be presented in accordance with ASC 808.

•In addition to the evolution of the Company's ongoing or central operations, there have been changes to the Company's roles and responsibilities within our existing collaborative arrangements. Most notably, in December 2019, we and Sanofi announced our intent to restructure the collaboration for Praluent® and enter into a royalty-based arrangement. The restructuring, which was effective April 1, 2020, resulted in fundamental changes to parties' respective rights and obligations under the collaboration.

Based on the above considerations as well as the analysis below, we believe it is appropriate and preferable to present certain reimbursements and other payments from collaborators outside of revenue. The Company made these changes in presentation effective January 1, 2020 to better reflect the nature of the Company’s costs incurred and revenues earned pursuant to arrangements with collaborators and to enhance the comparability of Regeneron's financial statements with industry peers.

Historical Facts and Circumstances

Historically, a significant portion of the Company's business was related to performing R&D activities in connection with collaborative arrangements, as evidenced by the arrangements summarized below (detailed information related to each of the Company's significant collaborative arrangements can be found in the Company's Form 10-K for the year ended December 31, 2019):

•Bayer – EYLEA. Since 2006, we and Bayer have been parties to a global license and collaboration agreement for the development and commercialization outside the United States of EYLEA. EYLEA was in Phase 2 clinical studies at the time of entering into the arrangement, and it ultimately received U.S. Food and Drug Administration ("FDA") and other marketing approvals outside the United States commencing in 2011. At the inception of the collaboration agreement,

3

Regeneron was responsible for leading the worldwide development activities. Bayer is responsible for commercialization activities for EYLEA outside the United States and the Company is responsible for commercialization of EYLEA in the United States.

•Sanofi – Antibodies. Since 2007, we and Sanofi have been parties to a global, strategic collaboration to research, develop, and commercialize fully human monoclonal antibodies. The collaboration was governed by a Discovery and Preclinical Development Agreement ("Antibody Discovery Agreement") and a License and Collaboration Agreement (each as amended), collectively referred to as the "Antibody Collaboration". Pursuant to the Antibody Discovery Agreement, as amended, Sanofi was responsible for funding up to a specified amount of our antibody discovery activities each year to identify and validate potential drug discovery targets and develop fully human monoclonal antibodies against these targets. We led the design and conduct of research activities under the Antibody Discovery Agreement, including target identification and validation, research and preclinical activities, and manufacturing of preclinical and clinical supplies. The Company's Antibody Discovery Agreement with Sanofi ended on December 31, 2017 (see "Current Facts and Circumstances" section below).

For each drug candidate identified through discovery research under the Antibody Discovery Agreement, Sanofi had the option to license rights to the candidate under the License and Collaboration Agreement. If it elected to do so, Sanofi would co-develop the drug candidate with us through product approval. Sanofi leads commercialization activities for products developed under the License and Collaboration Agreement, subject to the Company's right to co-commercialize such products.

•Sanofi – Immuno-Oncology. In 2015, we and Sanofi entered into a global strategic collaboration to discover, develop, and commercialize antibody-based cancer treatments in the field of immuno-oncology (the "IO Collaboration"). The IO Collaboration is governed by an Immuno-oncology Discovery and Development Agreement ("IO Discovery Agreement"), and an Immuno-oncology License and Collaboration Agreement ("IO License and Collaboration Agreement") (each as amended). In connection with the IO Discovery Agreement, Sanofi made an up-front payment to us. Pursuant to the original IO Discovery Agreement, we agreed to spend up to a certain amount to identify and validate potential targets and develop antibodies against such targets through clinical proof-of-concept. Sanofi agreed to reimburse us for up to a certain portion of these costs. Pursuant to the IO Discovery Agreement, we were primarily responsible for the design and conduct of all research activities, including target identification and validation, preclinical activities, manufacture of preclinical and clinical supplies, and clinical development. With regard to product candidates for which proof-of-concept is established, Sanofi had the option to license rights to the product candidate pursuant to the IO License and Collaboration Agreement.

Under the terms of the IO License and Collaboration Agreement, Sanofi made an up-front payment to the Company, and the parties were (and are currently) co-developing and co-commercializing Libtayo® (cemiplimab). The parties share equally, on an ongoing basis, agreed-upon development and commercialization expenses for Libtayo. The Company has principal control over the development of Libtayo and leads commercialization activities in the United States, while Sanofi leads commercialization activities outside of the United States.

•Fasinumab. In 2015, we entered into a collaboration agreement with MTPC providing them with development and commercial rights to fasinumab in certain Asian countries. In connection with the agreement, MTPC made an up-front payment to the Company, and the Company is obligated to manufacture and supply MTPC with clinical and commercial supplies of fasinumab.

4

In 2016, the Company and Teva entered into a collaboration agreement to develop and commercialize fasinumab globally, excluding certain Asian countries that are subject to the Company's collaboration agreement with MTPC. In connection with the Teva Collaboration Agreement, Teva made an up-front payment to the Company. We lead global development activities, and the parties share equally, on an ongoing basis, development costs under a global development plan.

At the inception of each of these arrangements, the Company and its collaborator were each deemed to be active participants in the collaborations' joint operating activities and were exposed to significant risks and rewards dependent on the commercial success of the activity (e.g., profit sharing, sales milestones, etc.). Accordingly, the arrangements were deemed to be collaborations in accordance with ASC 808. In addition, the collaborators were deemed to be the Company's "customer" (by analogy to ASC 605 and subsequently ASC 606) for certain elements of the arrangement, as the collaborator was providing consideration in exchange for the Company providing goods/services (e.g., license to intellectual property ("IP") and R&D services, including manufacturing) utilizing its proprietary technology. Such elements were accounted by applying ASC 606 by analogy because the performance of R&D services was considered to be part of Regeneron’s ongoing major or central operations at the inception of these arrangements. The treatment of bifurcating elements within a collaboration arrangement accounted for under ASC 808 is implicitly permitted in ASC 808 (pre-issuance of ASU 2018-18, Collaborative Arrangements) and occurs in practice. This treatment was later explicitly permitted through the issuance of ASU 2018-18 which the Company adopted on January 1, 2020. In addition, the treatment of consideration received in exchange for the performance of R&D services as revenue is illustrated in Example 1 and 2 of ASC 808-10-55-3 through 55-10.

In determining the historical presentation of reimbursements from its collaborators, we considered the below guidance from ASC 808-10 (as originally codified):

45-3      Payments between participants pursuant to a collaborative arrangement that are within the scope of other authoritative accounting literature on income statement classification shall be accounted for using the relevant provisions of that literature. If the payments are not within the scope of other authoritative accounting literature, the income statement classification for the payments shall be based on an analogy to authoritative accounting literature or if there is no appropriate analogy, a reasonable, rational, and consistently
2020-11-20 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
United States securities and exchange commission logo
November 20, 2020
Robert E. Landry
Chief Financial Officer
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591-6707
Re:Regeneron Pharmaceuticals, Inc.
Form 10-K for the fiscal year ended December 31, 2019
Filed on February 7, 2020
Form 10-Q for the quarterly period ended September 30, 2020
Filed on November 5, 2020
File No. 0-19034
Dear Mr. Landry:
            We have reviewed your filing 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, Filed February 7, 2020
Item 10. Directors, Executive Officers and Corporate Governance, page 76
1.We note the following statement on page 26 of the proxy statement that has been
incorporated by reference “[t]he board has determined that this leadership structure is
appropriate for the Company at this time.” In future filings, please provide detail
concerning why you have determined that this leadership structure is appropriate given
your specific characteristics or circumstances as required by Item 407(h) of Regulation S-
K.
Item 11. Executive Compensation, page 76
2.We note your reference to a share repurchase program in the Compensation Discussion
and Analysis section of the definitive proxy statement that is incorporated by reference,

 FirstName LastNameRobert E. Landry
 Comapany NameRegeneron Pharmaceuticals, Inc.
 November 20, 2020 Page 2
 FirstName LastName
Robert E. Landry
Regeneron Pharmaceuticals, Inc.
November 20, 2020
Page 2
and the disclosure in your Form 10-K of repurchases that occurred in 2019. Please tell us
why you do not discuss in your CD&A the impact of share repurchases on your
compensation levels in 2019.
Form 10-Q for the Quarterly Period Ended September 30, 2020
Notes to Condensed Consolidated Financial Statements (Unaudited)
1. Interim Financial Statements
Basis of Presentation, page 7
3.We note your disclosure that effective January 1, 2020 you changed the presentation of
cost reimbursements from collaborators who are not deemed to be your customers from
collaboration revenue to a reduction of the corresponding operating expense.  We note
that you also changed the presentation of amounts recognized in connection with up-front
and development milestone payments from collaboration revenue to other operating
income.  Please provide us with your full analysis supporting this change and its impact
on each element of your collaboration agreements.  In particular, please explain why you
changed your conclusion regarding whether your collaborators were deemed to be
customers and how this impacted your application of applicable revenue recognition
guidance.
            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 Angela Connell at 202-551-3426 if you have questions regarding
comments on the financial statements and related matters.  Please contact Margaret Schwartz at
202-551-7153 or Mary Beth Breslin at 202-551-3625 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2016-10-18 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
Mail Stop 4546

Octo ber 18, 2016

VIA E -mail
Dr. Leonard S. Schleifer, M.D., Ph.D.
President and Chief Executive Officer
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road ,
Tarrytown, New York  10591

Re: Regeneron Pharmaceuticals, Inc.
 Form 10 -K for Fis cal Year Ended December 31, 2015
Filed February 11, 2016
File No. 000-19034

Dear Dr. Schleifer :

We have comple ted our review of your filing .  We remind you that the company and its
management are responsible for the accuracy and adequacy of the ir disclosure s, notwithstanding
any review, comments, action or absence  of action  by the staff .

Sincerely,

 /s/ Angela M. Connell

Angela M. Connell
Accounting Branch Chief
Office of Healthcare and Insurance
2016-10-12 - CORRESP - REGENERON PHARMACEUTICALS, INC.
Read Filing Source Filing Referenced dates: August 19, 2016, May 23, 2016, September 28, 2016
CORRESP
1
filename1.htm

		Document

 Regeneron Pharmaceuticals, Inc.

777 Old Saw Mill River Road

Tarrytown, NY  10591-6707

 Phone   914 847 7000

www.regeneron.com

October 12, 2016

VIA EDGAR

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Office of HealthCare and Insurance

U.S. Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, D.C. 20549

Re:

 Regeneron Pharmaceuticals, Inc.

 Form 10-K for the Fiscal Year Ended December 31, 2015

 Filed February 11, 2016

 File No. 000-19034

Dear Mr. Rosenberg:

This letter sets forth the responses of Regeneron Pharmaceuticals, Inc. (the "Company" or "Regeneron") to the comments of the staff (the "Staff") of the Securities and Exchange Commission (the "Commission") set forth in the Staff's letter dated September 28, 2016, with respect to the above-referenced Form 10-K.  Capitalized terms not otherwise defined in this letter have the respective meanings given to such terms in the Company's letters to the Staff dated May 23, 2016, July 7, 2016, and August 19, 2016 (collectively, the "Prior Responses").  Set forth below in bold are the headings and text of the Staff's comments followed by the Company's response.

Notes to Consolidated Financial Statements

3. Collaboration Agreements

a. Sanofi

Immuno-Oncology, page F-16

1. Please refer to our prior comment one. As discussed in conference calls with you and other members of the company and its independent accounting firm on September 16th and 27th, we continue to have the following concerns:

•

 As to whether the Antibody and IO collaborations are in substance one arrangement, please tell us your consideration of the following as of the date of the IO in concluding that the collaborations are not in substance one arrangement:

▪

 Was the $75 million reduction in funding in connection with the amended Antibody collaboration, which was based on the proportionate number of IO targets in the Antibody Collaboration to the total number of targets, representative of its economic

1

substance considering the terms of the amended Antibody Collaboration? Why or why not?

Response:

•

 The Company believes that the $75 million reduction in available funding in connection with the amended Antibody Collaboration was representative of its economic substance.  The Company is being reimbursed for performing research and development services for actual expenses incurred and time incurred on a FTE basis, which is at market rates.  The Company is not obligated to perform services beyond the available funding.  This did not change for the targets/product candidates researched under the Antibody Collaboration when they were transferred to the IO Collaboration and, as a result, there was no change in economic substance.  While there are additional funds available under the IO Discovery Agreement, the funds are fungible and the Company has no obligation to perform services beyond the total funding available.  Additionally, the remaining available funding under the Antibody Collaboration is to reimburse the Company for actual costs and time incurred with no obligation to perform services beyond the remaining available funding.  As described in the Company's letter to the Staff on August 19, 2016, the $75 million reduction in available reimbursable research and development funding was proportionate with the number of total IO targets being pursued under the Antibody Discovery Agreement over the past several years relative to the total number of targets being researched under the Antibody Discovery Agreement over the same period (i.e., the reduction in funding was structured to be commensurate with the reduction in the Company's discovery activities to identify and validate potential drug discovery targets in the field of immuno-oncology and to develop fully human monoclonal antibodies against these targets as such activities are now performed as part of the IO Collaboration).  Note that it is the Company's expectation that the cost to research a pre-clinical target/antibody product candidate should generally be the same and should not be impacted by whether the target/product candidate is an IO target/product candidate or not.  In addition, the FTE rates that the Company charges Sanofi for research and development services performed are approximately the same under both the Antibody and IO Collaborations.

The methodology to quantify the amount of the reduction in funding was agreed to by both parties, as it was not practical to identify specific costs incurred associated with researching individual targets at such an early-stage of pre-clinical development.

The $75 million was not related to any intangible assets (i.e., rights or intellectual property) as Sanofi already had such rights to the targets under the Antibody Collaboration, but rather related to the estimated research costs associated with the IO targets/product candidates.

▪

 How would you assess the fair value of the IO targets transferred to the IO collaboration in relation to the Antibody agreement and your basis for the assessment?

Response:

•

 As described above, the $75 million was related to reimbursement of anticipated research and development services, and not to any existing rights to intellectual property associated with the IO targets/product candidates transferred.  The $75 million represents fair value as

2

it is the estimated amount for what Sanofi pays the Company to perform research and development services based on actual third-party expenditures incurred and, for internal costs, incurred hours multiplied by an FTE rate (which, as described in the Prior Responses, is consistent with and within the range of prices the Company charges other collaborators for similar research and development services).

Additionally, given the early, pre-clinical stage of development (and the related future research, development, regulatory, and commercial risks), the Company estimates the fair value of the IO targets, or the early stage product candidates against such IO targets, that were transferred to the IO collaboration would be insignificant, both individually and in the aggregate, relative to the overall Antibody Collaboration (and therefore did not factor into the economic decisions of the parties outside of the $75 million).  In addition, it should be noted that Sanofi did not obtain any additional rights to the intellectual property relative to the IO targets/product candidates transferred from the Antibody Collaboration that would have increased the fair value of such targets/product candidates upon transfer, as Sanofi had already obtained rights under the Antibody Collaboration.

▪

 In the negotiation of the IO and the amended Antibody collaborations, tell us about relevant discussions with Sanofi in connection with the transferred IO antibodies regarding their terms including the $640 million upfront payment. How would you assess the transferred IO antibodies with respect to the $640 million upfront payment and your basis for the assessment?

Response:

•

 For the reasons described above, there were no discussions or negotiations with Sanofi in connection with the transferred IO targets/product candidates relative to the IO upfront payments of $640 million (i.e., the $640 million was negotiated irrespective of the transfer of IO targets/product candidates).  The parties determined that $75 million (as described above) was appropriate compensation for the reimbursable research and development services to be performed by the Company under the IO Collaboration in connection with the transferred IO targets/product candidates.

•

 How would you assess the potential for overlap/sharing of management, staff, facilities and/or information between the Antibody and IO collaborations to each of the collaborations and your basis for the assessment?

Response:

•

 As with any of the Company's ongoing research projects (whether conducted under a Sanofi collaboration agreement, a collaboration agreement with a different third party, or developed independently by the Company), there is some level of overlap and sharing of management, staff, facilities, and other information.  This, in and of itself, is not a presumptive, much less determinative, factor for concluding that two collaboration arrangements are interdependent of one another.  Rather, this type of overlap and sharing is a function of the nature of the research and drug-development process and represents a matter of functional and administrative efficiency.  Fundamentally, the research and development activities under the Antibody and IO Collaborations are not interdependent in terms of design, technology, or function.  Each collaboration could stand on its own and

3

exist and function independently of the other collaboration.  Notwithstanding that the Company has some level of personnel and facilities used to research and develop product candidates under both collaborations, it is not necessary for the success of either/both collaborations that such personnel/facilities be used for both. Furthermore, each of these collaborations could be terminated or expire without impacting the terms or activities conducted under the remaining collaboration; for example, the two collaboration agreements have different contractually stated expiration dates.

•

 With respect to the alternative accounting treatment, as provided in your response, and whether it complies with ASC 605-25, it is not clear why besides the mice, there is only one other unit of accounting. As discussed, it would appear that there would be at least two units of accounting besides the mice. Please provide us:

▪

 an analysis of your determination of the units of accounting under ASC 605-25-25;

Response:

•

 As noted in the Prior Responses, the Company concluded (and continues to believe) that the amendments to the Antibody Collaboration were not a material modification of the existing Antibody Discovery Agreement or Antibody License and Collaboration Agreement with Sanofi and that the IO Collaboration and the Antibody Collaboration should not be accounted for together as a single arrangement.  However, the Company did consider what the accounting treatment would have been had the Company reached a conclusion that the IO Collaboration and the Antibody Collaboration should be accounted for together as a single new arrangement.

In the Company's letter to the Staff dated August 19, 2016, the Company noted that there would potentially be two units of accounting under the "alternative accounting treatment": (a) the deliverable associated with the mouse purchase agreement (the "mice"), and (b) the licenses to certain rights and intellectual property and research and development services under both the Antibody and IO Collaborations.  The reason for that determination was that, in assessing what the "alternative accounting treatment" would be, the Company wanted to illustrate (a) the scenario that would yield the largest difference relative to the Company's current accounting treatment, and (b) an interrelationship of the collaborations and underlying deliverables that do not have standalone value and therefore would not be considered separate units of accounting.

An alternative answer (albeit one that was previously considered and rejected by the Company) could be that there were three units of accounting: (a) the mice ("mouse unit of accounting"), (b) the license to certain rights and intellectual property and research and development services under the Antibody Collaboration ("Antibody unit of accounting"), and (c) the license to certain rights and intellectual property and research and development services under the IO Collaboration ("IO unit of accounting").  The Company would recognize the reimbursements of capital improvements (for which Sanofi does not have separate utility) initially over the Antibody Collaboration performance period and then over the IO performance period from the date of the commencement of the IO Collaboration, as the IO unit of accounting will be amortized over a longer period than the Antibody unit of accounting.

4

The licensed intellectual property does not have standalone value separate from the research and development services (including manufacture of clinical supplies) under the respective collaboration primarily due to the fact that such rights were not sold separately by the Company, nor could Sanofi gain economic benefit from each license without fulfillment of other ongoing obligations by the Company, including the clinical supply arrangements.  This conclusion is consistent with the accounting applied by the Company with respect to both the Antibody and IO Collaborations in its financial statements (please refer to the more detailed and related analysis of this point in the Company's letter to the Staff dated May 23, 2016).

▪

 the amount of the total arrangement consideration and how it would be determined under ASC 605-25-30-1 including how any remaining deferred income under the Antibody collaboration before it was amended in connection with the IO collaboration would be considered;

Response:

•

 Under the Company's current accounting treatment, the following arrangement consideration was recorded as deferred revenue upon receipt and was being amortized over the related performance period: (i) an $85 million up-front payment received in 2007 in connection with the execution of the Antibody Discovery Agreement ($32 million of which was remaining as deferred revenue as of July 2015), (ii) $22 million of payments received from Sanofi in exchange for providing genetically modified mice ($9 million of which was remaining as deferred revenue as of July 2015), (iii) $30 million of reimbursements of capital expenditures received in connection with the Antibody Collaboration ($16 million of which was remaining as deferred revenue as of July 2015), and (iv) the $640 million of up-front payments received in connection with the execution of the IO Collaboration in July 2015.  The arrangement consideration described in the preceding sentence was considered to be fixed and determinable as such amounts were contractually stated and non-refundable; the $85 million, $22 million, and $30 million were fully paid to Regeneron prior to the July 2015 amendment of the Antibody Collaboration; and the $640 million was fully paid to Regeneron shortly after execution of the IO Collaboration.  As it relates to other arrangement consideration that the Company is entitled to under the Antibody and IO Collaborations, which was contingent upon entering the arrangements and which comprises reimbursement for ongoing research and development services and manufacture of clinical supplies, the Company records those reimbursable amounts as collaboration revenue proportionately as the Company incurs and recognizes the related expenses.

▪

 how the total arrangement consideration would be allocated to the units of accounting including the selling prices that would be used and the basis used to determine selling prices under ASC 605-25-30-2,

Response:

•

 Mouse unit of accounting - As it relates to the deliverable associated with the mouse purchase agreement, the Company would conclude that the mice (i.e., the deliverable) have value to Sanofi on a standalone basis.  As noted in the Company's letter to the Staff dated August 19, 2016, there was objective evidence that the contractual value of $22 million was the fair value of the mice at the time of execution of the original agreement since

5

Regeneron had entered into agreements with other pharmaceutical companies with similar economic terms to the Sanofi agreement.

Antibody unit of accounting - The Company believes that the contractually stated Antibody up-front payment was representative of the best estimate of the standalone selling price of the license.  In determining the amount of the up-front payment,
2016-09-28 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
Mail Stop 4546

September  28, 2016

VIA E -mail
Dr. Leonard S. Schleifer, M.D., Ph.D.
Presid ent and Chief Executive  Officer
Regeneron  Pharmaceuticals, Inc.
777 Old Saw Mill River Road ,
Tarrytown, New York  10591

Re: Regeneron  Pharmaceuticals, Inc.
 Form 10-K for Fis cal Year Ended December 31, 2015
Filed February 11, 2016
File No. 000-19034

Dear Dr. Schleifer :

We have reviewed  your August 19 , 2016 response to our comment letter and have the
following comment .  In our comment, we ask you to provide us with information so we may
better understand your disclosure.

Please respond to the comment  within ten busine ss days by providing the requested
information or advis e us as soon as p ossible when you will r espond.  If you do not believe th e
comment applies to your facts and circumstances, please tell us why in your response.

After reviewing your response to the comme nt, we may have additional comments.
Unless we note otherwise, our  reference  to our prior comment  is to a comment  in our July 29 ,
2016 letter .

Notes to Consolidated Financial Statements
3. Collaboration Agreements
a. Sanofi
Immuno -Oncology, page F -16

1. Please refer to our prior comment one. As discussed in conference calls with you and other
members of the company and its independent accounting firm on September 16th and 27th,
we continue to have the following concerns:
 As to whether the Antibody and IO collaborations are in substance one arrangement,
please tell us yo ur consideration of the following as of the date of the IO in concluding
that the collaborations are not in substance one arrangement:
o Was the $75 million reduction in funding in connection with the amended Antibody
collaboration, which was based on the proportionate number of IO targets in the

Dr. Leonard S. Schleifer
Regeneron  Pharmaceuticals, Inc.
September 28, 2016
Page 2

 Antibody Collaboration to the total number of targets, representative of its economic
substance  considering the terms of the amended Antibody Collaboration? Why or
why not?
o How would you assess the fair value of the IO targets transferred to the IO
collaboration in relation to the Antibody agreement and your basis for the
assessment?
o In the negotiat ion of the IO and the amended Antibody collaborations, tell us about
relevant discussions with Sanofi in connection with the transferred IO antibodies
regarding their terms including the $640 million upfront payment. How would you
assess the transferred IO  antibodies with respect to the $640 million upfront payment
and your basis for the assessment?
o How would you assess the potential for overlap/sharing of management, staff,
facilities and/or information between the Antibody and IO collaborations to each of
the collaborations and your basis for the assessment?
 With respect to the alternative accounting treatment, as provided in your response, and
whether it complies with ASC 605 -25, it is not clear why besides the mice, there is only
one other unit of ac counting. As discussed, it would appear that there would be at least
two units of accounting besides the mice.  Please provide us:
o an analysis of your determination of the units of accounting under ASC 605 -25-25;
o the amount of the total arrangement consid eration and how it would be determined
under ASC 605 -25-30-1 including how any remaining deferred income under the
Antibody collaboration before it was amended in connection with the IO
collaboration would be considered;
o how the total arrangement consider ation would be allocated to the units of accounting
including the selling prices that would be used and the basis used to determine selling
prices under ASC 605 -25-30-2,
o how revenue for each deliverable would be recognized
o the amount of revenue that would have been recognized in 2015 and the six months
ended June 30, 2016 and 2015.
o Your analysis demonstrating that the alternative accounting would not be materially
different than the accounting applied in your financial statements for 2015, the six
months e nded June 30, 2016 and future periods.

You may contact Bonnie Baynes, Staff Accountant, at (202) 551 -4924 if you have
questions regarding the  comments . In this regard, do not hesitate to contact me at (202) 551 -
3679.

Sincerely,

 /s/ Jim B. Rosenberg

Jim B. Rosenbe rg
Senior Assistant Chief  Accountant
Office of Healthcare and Insurance
2016-08-19 - CORRESP - REGENERON PHARMACEUTICALS, INC.
Read Filing Source Filing Referenced dates: July 29, 2016, July 7, 2016, May 23, 2016
CORRESP
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		Document

 Regeneron Pharmaceuticals, Inc.

777 Old Saw Mill River Road

Tarrytown, NY  10591-6707

 Phone   914 847 7000

www.regeneron.com

August 19, 2016

VIA EDGAR

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Office of HealthCare and Insurance

U.S. Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, D.C. 20549

Re:

 Regeneron Pharmaceuticals, Inc.

 Form 10-K for the Fiscal Year Ended December 31, 2015

 Filed February 11, 2016

 File No. 000-19034

Dear Mr. Rosenberg:

This letter sets forth the responses of Regeneron Pharmaceuticals, Inc. (the "Company" or "Regeneron") to the comments of the staff (the "Staff") of the Securities and Exchange Commission (the "Commission") set forth in the Staff's letter dated July 29, 2016, with respect to the above-referenced Form 10-K.  Capitalized terms not otherwise defined in this letter have the respective meanings given to such terms in the Company's letters to the Staff dated May 23, 2016 and July 7, 2016 (collectively, the "Prior Responses").  Set forth below in bold are the headings and text of the Staff's comments followed by the Company's response.

Notes to Consolidated Financial Statements

3. Collaboration Agreements

a. Sanofi

Immuno-Oncology, page F-16

1. We acknowledge your response to prior comment 1 and request some additional information to support your conclusion that the IO Collaboration and the amended Antibody Collaboration are not in substance one new arrangement.

•

 Please tell us the nature and type of evidence you have supporting that, had you not entered into the IO Collaboration with Sanofi, the change in scope under the Antibody Collaboration would have resulted in the $75 million reduction in the funding obligation spread over three years.

•

 In your response on page 3 in support of your conclusion that there were no discounts provided to Sanofi, you refer to discussions with other third parties prior to agreeing on economic terms for the IO Collaboration with Sanofi.  Tell us the nature of and the number

1

of these third parties and the business purpose of each discussion.  Also tell us how these discussions support a conclusion that no discount was provided in the IO Collaboration with Sanofi.  In this regard, explain how you considered the fair value of the research transferred from the Antibody Collaboration to the IO Collaboration, as further discussed in the next bullet, in determining the terms of the IO Collaboration.  Further, tell us whether the IO Collaboration could have been consummated with these third parties without breaching the Antibody Collaboration with Sanofi.

Response:

Under the terms of the Sanofi Antibody Discovery Agreement, Sanofi is responsible for paying 100% of all "Discovery Program Costs" (as defined by the agreement) incurred by the Company through the term of the agreement, provided that such payments by Sanofi shall not exceed certain annual thresholds.  For any research and development costs incurred by the Company in excess of the annual threshold, such amounts are fully funded by Regeneron.  As noted in the Company's letter to the Staff dated July 7, 2016, any IO product candidates previously being researched under the terms of the Antibody Collaboration (all of which were in pre-clinical development) were transferred to the IO Collaboration upon execution of the IO Agreement.  Given this reduction in the scope of research activities under the Antibody Collaboration, the Antibody Discovery Agreement was amended to reduce the aggregate funding by a total of $75 million through the remaining term of the agreement (i.e., July 2015 through December 2017).  The $75 million reduction in funding was proportionate with the number of total IO targets being pursued under the Antibody Discovery Agreement over the past several years relative to the total number of targets being researched under the Antibody Discovery Agreement over the same period (i.e., the reduction in funding was structured to be commensurate with the reduction in the Company's discovery activities to identify and validate potential drug discovery targets in the field of immuno-oncology and develop fully human monoclonal antibodies against these targets as such activities are now to be performed as part of the IO Collaboration).  Note that consistent with the Antibody Discovery Agreement, Sanofi also reimburses the Company for its research and development costs, subject to certain annual limits, under the IO Discovery Agreement.  There is no obligation by the Company under either the Antibody Discovery Agreement or the IO Discovery Agreement to incur costs or perform services beyond the annual Sanofi funding limits.  As it relates to research and development services performed by the Company and reimbursed by Sanofi, under both the Antibody Collaboration and the IO Collaboration (a) the nature of reimbursable costs is consistent and (b) the FTE rates utilized are consistent.

The Company and Sanofi likely would not have agreed to reduce Sanofi's funding obligation under the Antibody Discovery Agreement had they not entered into the IO Collaboration, as the Company would have continued to research IO product candidates under the provisions of the Antibody Discovery Agreement.  The Company and Sanofi did not discuss removing IO antibody programs from the Antibody Collaboration other than in the course of negotiating the new Sanofi IO Collaboration.

The Company could have entered into a license and collaboration agreement focused on immuno-oncology with third parties other than Sanofi without breaching the Antibody Collaboration to the extent that such an agreement related to targets and/or IO product candidates that were not subject to the Antibody Collaboration.  Regeneron is free to develop and commercialize, either directly with third party collaborators or licensees, antibody product candidates that are directed to targets that have been excluded from the Antibody Collaboration or antibody product candidates that were developed pre-clinically by the Company under the Antibody Discovery Agreement but which Sanofi did not opt-in to or elected to not continue to co-develop and co-commercialize under the Antibody License and Collaboration Agreement. Prior to entering into the IO Collaboration with Sanofi, the Company held preliminary, high-level

2

discussions with various third parties.  These preliminary discussions were the basis for subsequent, more detailed discussions with three large, multi-national pharmaceutical companies (not including Sanofi) regarding various potential immuno-oncology collaborations.  The primary focus of these discussions was a collaboration in the immuno-oncology space, including a license to the Company's antibody product candidate targeting the receptor known as programmed cell death protein, or PD-1 ("REGN2810").  Sanofi had not previously opted into REGN2810 under the Antibody Discovery Agreement and thus Regeneron retained sole global rights.  In addition to the PD-1 antibody, which was in Phase 1 clinical development in the first quarter of 2015, these discussions also included potentially licensing and collaborating on additional antibodies that were not subject to the Sanofi Antibody Collaboration.  Therefore, if such an arrangement had been consummated with another third party, the arrangement would not have breached the Company's Antibody Collaboration with Sanofi.  The Company's discussions with third parties included financial terms such as an up-front payment and the parties' proposed sharing (on an equal basis) of research and development costs for product candidates, as well as any profits or losses on commercialization of products, which was no more favorable to the Company than what was agreed to in the IO Collaboration with Sanofi.  The Company received one term sheet from a third party, which proposed an up-front payment to the Company that was less than what the Company ultimately received from Sanofi under the IO Collaboration.  In addition to the factors described in the Company's Prior Responses, these were some of the data points utilized by the Company to conclude that there was no discount provided to Sanofi with respect to the IO Collaboration.

•

 You indicate in the bullet "Separation of targets and product candidates" on page 4 of your response that "Any IO product candidates previously being researched under the terms of the Antibody Collaboration (all of which were in pre-clinical development) were transferred to the IO Collaboration upon execution of the IO Agreement."  You also indicate in your response that there are separate and distinct governance structures for the Antibody Collaboration and IO Collaboration and that one or more elements of the Antibody Collaboration are not essential to the functionality of any elements in the IO Collaboration and vice versa.  Notwithstanding, it would seem that information from and results of the Antibody Collaboration could potentially be useful to and shared with the IO Collaboration and vice versa due to the nature of the collaborations.  Please tell us why the transfer of product candidates to the IO Collaboration and the potential for sharing of information/results between the collaborations does not provide significant linkage among the collaborations that would indicate that the collaborations are closely related.

Response:

As noted in the Company's letter to the Staff dated July 7, 2016, the significant differences between the IO Collaboration and the Antibody Collaboration include novel and distinct scientific approaches and technologies that will be utilized by the Company to identify IO targets and to develop IO antibody product candidates.  In addition, in the IO Collaboration, Regeneron will utilize a broader range of proprietary technologies that it has developed (including technologies that it has developed in recent years outside of the Antibody Collaboration) in the discovery of IO targets and the research and development of IO antibody product candidates.  Therefore, from the perspective of discovery activities performed under the new IO Collaboration, the Company does not consider such activities to be dependent upon activities performed under the original Antibody Collaboration and vice versa.

In addition, as with any of the Company's ongoing research projects (whether conducted under a collaboration arrangement or developed independently by the Company), and generally in the life sciences space, results and information generated in conducting activities under one program may prove to be

3

useful and applicable to conducting research activities under any other of the Company's programs (whether collaborated or not); however, given the specific technologies and scientific approach used in the IO Collaboration, the utility of such results/information would not be deemed to provide a significant linkage between the Antibody Collaboration and the IO Collaboration.

Finally, it should be noted that the Company strategically pursued executing new IO Collaboration agreements with Sanofi (as opposed to merely amending the existing Antibody Collaboration agreements), principally due to the fact that the Company desired to have significantly different terms regarding governance structure and opt-in timing for IO products relative to the terms of the legacy Antibody Collaboration agreements.

Alternative Accounting Treatment Considered

As noted in the Prior Responses, the Company concluded that the amendments to the Antibody Collaboration were not a material modification of the existing Antibody Discovery Agreement or Antibody License and Collaboration Agreement with Sanofi and that the IO Collaboration and the Antibody Collaboration should not be accounted for together as a single arrangement.  However, the Company did consider what the accounting treatment would have been had the Company reached a conclusion that the IO Collaboration and the Antibody Collaboration should be accounted for together as a single new arrangement.  In doing so, the Company reassessed the deliverables related to the Antibody Collaboration as if it were accounted for under ASU 2009-13, since the Company would have accounted for the contract modification as if it were part of the original contract.  The Company ultimately concluded that if it had accounted for the Antibody and IO Collaborations as a single arrangement, such alternative accounting treatment would not have resulted in any material differences from the Company's financial results reported for the quarterly periods ended September 30, 2015, December 31, 2015, March 31, 2016, June 30, 2016 nor the annual period ended December 31, 2015.  The Company's support for this conclusion is below.

a. Summary of deliverables under the Antibody Collaboration

Under the Antibody Collaboration, significant deliverables consist of the following:

(i)  Rights and intellectual property.  The Company out-licensed certain rights and intellectual property.

(ii) Research and development services.  Sanofi reimburses the Company for certain costs in connection with researching and developing product candidates.

(iii) Manufacturing services.  The Company has an obligation to provide clinical supply manufacturing services.  The price charged to Sanofi for manufacturing clinical supplies is at the fully burdened manufacturing cost, as defined in the applicable agreement.

(iv) Other

•

 Sanofi’s option to license rights to product candidates ("opt-in" right), which the Company considers to be a contingent deliverable (and therefore excluded from the allocation of consideration).

•

 The Company's participation in a joint steering committee ("JSC"), which the Company did not account for as a deliverable separately as (a) it does not have standalone value from the research and development services being provided and (b) any services deemed to be provided under this

4

deliverable would not be considered material given that the JSC meets quarterly and only requires participation of three Company representatives.

In addition to the deliverables noted above, there were two other deliverables related to the Antibody Collaboration as follows:

•

 In August 2008, the Company entered into a mouse purchase agreement with Sanofi to use the Company's VelociGene platform technology to supply Sanofi with genetically modified mammalian models of gene function and disease (genetically modified mice).  Under the terms of the agreement, Sanofi agreed to pay the Company a total of approximately $22 million for knock-out and transgenic models of gene function for target genes identified by Sanofi.  Sanofi also became able to use these models for its internal research programs that are outside of the scope of the Antibody Collaboration.  The principal terms of this agreement had been negotiated in connection with the companies' Antibody Discovery Agreement.

•

 In November 2009, in connection with the Antibody Collaboration, Sanofi agreed to reimburse the Company for up to $30 million of agreed-upon costs incurred by the Company for capital expenditures to expand the Company's manufacturing capacity at its Rensselaer, New York facility to support collaboration development activities.

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b. Summary of current accounting for the Antibody Collaboration deliverables

The Company considered the deliverables to be provided under the initial Antibody Collaboration (license to rights and intellectual property, research and development services, and manufacture of clinical supplies) as a single unit of accounting.  The Company initially recorded the receipt of (i) an $85 million up-front payment received in 2007 in connection with the execution of the Antibody Discovery Agreement, (ii) the $22 million of payments received from Sanofi in exchange for providing genetically modified mice, and (iii) the $30 million of re
2016-08-04 - CORRESP - REGENERON PHARMACEUTICALS, INC.
Read Filing Source Filing Referenced dates: July 29, 2016
CORRESP
1
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		Document

 Regeneron Pharmaceuticals, Inc.

777 Old Saw Mill River Road

Tarrytown, NY  10591-6707

 Phone   914 847 7000

www.regeneron.com

Via EDGAR

August 4, 2016

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Office of Healthcare and Insurance

U.S. Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, D.C. 20549

Re:

 Regeneron Pharmaceuticals, Inc.

Form 10-K for the Fiscal Year Ended December 31, 2015

Filed February 11, 2016

 File No. 000-19034

Dear Mr. Rosenberg:

Regeneron Pharmaceuticals, Inc. (the "Company") acknowledges receipt of the letter dated July 29, 2016 provided by the staff of the Securities and Exchange Commission (the "Staff") with respect to the above-referenced Form 10-K.  The Company subsequently corresponded with Bonnie Baynes of the Staff on August 3, 2016, who kindly granted the Company’s request for a five business day extension.  Accordingly, the Company plans to provide its response to the letter on or before August 19, 2016.

If you have any questions regarding the foregoing, please contact me at (914) 847-7270.

Very truly yours,

REGENERON PHARMACEUTICALS, INC.

/s/ Robert E. Landry

Robert E. Landry

Senior Vice President, Finance and Chief Financial Officer

cc:     Bonnie Baynes, Staff Accountant
2016-07-29 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
Mail Stop 4546

July 29, 2016

VIA E -mail
Dr. Leonard S. Schleifer, M.D., Ph.D.
Presid ent and Chief Executive  Officer
Regeneron  Pharmaceuticals, Inc.
777 Old Saw Mill River Road ,
Tarrytown, New York  10591

Re: Regeneron  Pharmaceuticals, Inc.
 Form 10-K for Fis cal Year Ended December 31, 2015
Filed February 11, 2016
File No. 000-19034

Dear Dr. Schleifer :

We have reviewed  your July 7 , 2016 response to our comment letter and have  the
following comment .  In our comment, we ask you to provide us with information so we may
better understand your disclosure.

Please respond to the comment  within ten busine ss days by providing the requested
information or advis e us as soon as possible when you will r espond.  If you do not believe th e
comment applies to your facts and circumstances, please tell us why in your response.

After reviewing your response to the comme nt, we may have additional comments.
Unless we note otherwise, our referen ce to our prior comment  is to a comment  in our June 23 ,
2016 letter .

Notes to Consolidated Financial Statements
3. Collaboration Agreements
a. Sanofi
Immuno -Oncology, page F -16

1. We acknowledge your response to prior comment 1 and request some additional
information to support your conclusion that the IO Collaboration and the amended
Antibody Collaboration are not in substance one new arrangement.
 Please tell us the nature and ty pe of evidence you have supporting that, had you not
entered into the IO Collaboration with Sanofi, the change in scope under the
Antibody Collaboration would have resulted in the $75 million reduction in the
funding obligation spread over three years.

Dr. Leonard S. Schleifer
Regeneron  Pharmaceuticals, Inc.
July 29, 2016
Page 2

  In your response on page 3 in support of your conclusion that there were no discounts
provided to Sanofi, you refer to discussions with other third parties prior to agreeing
on economic terms for the IO Collaboration with Sanofi. Tell us the nature of and t he
number of these third parties and the business purpose of each discussion.  Also tell
us how these discussions support a conclusion that no discount was provided in the
IO Collaboration with Sanofi.  In this regard, explain how you considered the fair
value of the research transferred from the Antibody Collaboration  to the IO
Collaboration, as further discussed in the next bullet,  in determining the terms of the
IO Collaboration. Further, tell us whether the IO Collaboration could have been
consummated w ith these third parties without breaching the Antibody Collaboration
with Sanofi.
 You indicate in the bullet “Separation of targets and product candidates” on page 4 of
your response that “Any IO product candidates previously being researched under the
terms of the Antibody Collaboration (all of which were in pre -clinical development)
were transferred to the IO Collaboration upon execution of the IO Agreement.” You
also indicate in your response that there are separate and distinct governance
structures  for the Antibody Collaboration and IO Collaboration and that one or more
elements of the Antibody Collaboration are not essential to the functionality of any
elements in the IO Collaboration and vice versa.  Notwithstanding, it would seem that
information  from  and results of  the Antibody Collaboration could potentially be
useful to and shared with the IO Collaboration and vice versa due to the nature of the
collaborations. Please tell us why the transfer of product candidates to the IO
Collaboration and th e potential for sharing of information /results  between the
collaborations does not provide significant linkage among the collaborations that
would indicate that the collaborations are closely related.

You may contact Bonnie Baynes, Staff Accountant, at (202) 551 -4924 if you have
questions regarding the  comments . In this regard, do not hesitate to contact me at (202) 551 -
3679.

Sincerely,

 /s/ Jim B. Rosenberg

Jim B. Rosenberg
Senior Assistant Chief  Accountant
Office of Healthcare and Insuran ce
2016-07-07 - CORRESP - REGENERON PHARMACEUTICALS, INC.
Read Filing Source Filing Referenced dates: June 23, 2016, May 23, 2016
CORRESP
1
filename1.htm

		Document

 Regeneron Pharmaceuticals, Inc.

777 Old Saw Mill River Road

Tarrytown, NY  10591-6707

 Phone   914 847 7000

www.regeneron.com

July 7, 2016

VIA EDGAR

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Office of HealthCare and Insurance

U.S. Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, D.C. 20549

Re:

 Regeneron Pharmaceuticals, Inc.

 Form 10-K for the Fiscal Year Ended December 31, 2015

 Filed February 11, 2016

 Form 8-K dated February 9, 2016

 Filed February 9, 2016

 File No. 000-19034

Dear Mr. Rosenberg:

This letter sets forth the responses of Regeneron Pharmaceuticals, Inc. (the "Company" or "Regeneron") to the comments of the staff (the "Staff") of the Securities and Exchange Commission (the "Commission") set forth in the Staff’s letter dated June 23, 2016, with respect to the above-referenced Form 10-K and Form 8-K (collectively, the "Filings").  Capitalized terms not otherwise defined in this letter have the respective meanings given to such terms in the Company's letter to the Staff dated May 23, 2016 (the "Prior Response").  Set forth below in bold are the headings and text of the Staff's comments followed by the Company's response.

Form 10-K for the Year Ended December 31, 2015

Notes to Consolidated Financial Statements

3. Collaboration Agreements

a. Sanofi

Immuno-Oncology, page F-16

1. Please refer to your response to our prior comment 3.  Address each of the following in order to further support a conclusion that the IO Collaboration and the amended Antibody Collaboration are not in substance one new arrangement:

•

 You indicate that:

◦

 the reductions in funding pursuant to the amended Antibody Discovery Agreement from $160 million in each of 2015, 2016, and 2017 to $145 million, $130 million, and $130 million, respectively, were not considered to be a significant modification relative to Sanofi's overall funding obligations under the Antibody Discovery Agreement;

1

◦

 the $75 million of aggregate funding from the Antibody Collaboration used to reimburse the Company for a portion of its IO Discovery program costs is not material to the total anticipated funding under the IO Collaboration; and

◦

 although IO product candidates and products will no longer be within the scope of the Antibody Collaboration, the broad deliverables under the agreements governing the Antibody Collaboration have not changed - i.e., the Company will still be identifying and developing targets, providing research and development and manufacturing services, etc., as originally required.

Explain to us why each of the above bullets is a factor in concluding that the IO Collaboration and the amended Antibody Collaboration should not be accounted for together.

Response:

As noted in the Prior Response, the Company concluded that the amendments to the Antibody Collaboration were not a material modification of the existing Antibody Discovery Agreement or Antibody License and Collaboration Agreement with Sanofi, and that the IO Collaboration and the Antibody Collaboration should not be accounted for together as a single new arrangement.  The considerations noted above support the Company's conclusion for the following reasons:

•

 Pursuant to the Antibody Discovery Agreement, Sanofi had committed to fund up to a total of approximately $1.4 billion for research and preclinical development activities conducted under this agreement.  Given the reduction in the scope of research activities under the Antibody Collaboration (as further described below), the Antibody Discovery Agreement was amended to reduce the $1.4 billion of aggregate funding by a total of $75 million (spread over a three-year period).  This reduction represents approximately 5% of Sanofi's overall funding obligation under the Antibody Discovery Agreement.  In addition to the $1.4 billion, Sanofi has an obligation to reimburse the Company for development costs incurred under the Antibody License and Collaboration Agreement, which is also significant - for example, in 2015, Sanofi's reimbursement of the Company's antibody research and development expenses under such agreement was approximately $590 million.  This reimbursement obligation provides additional support for the view that the $75 million aggregate reduction in Sanofi's funding obligation was immaterial to the arrangement and did not constitute a significant modification of the Antibody Collaboration arrangement.  Further, in light of the $1.09 billion in aggregate funding available under the IO Discovery and Development Agreement to reimburse the Company for research and development costs under the IO Discovery program, the Company did not consider $75 million to be material to the total anticipated funding by Sanofi under the IO Discovery and Development Agreement either.  Sanofi also has an obligation to reimburse the Company for development costs incurred under the IO License and Collaboration Agreement and such amounts are anticipated to be substantial; this further supports the view that the $75 million aggregate reduction was immaterial to the IO Collaboration.

•

 The amendments to the Antibody Discovery Agreement and the Antibody License and Collaboration Agreement did not change the activities conducted or the deliverables under the Antibody Collaboration.  Although certain potential research molecules will no longer be within the scope of the Antibody Collaboration, the Company will continue to: identify and validate conventional antibody targets (typically cell surface receptors and ligands that interact with cell surface receptors); discover and conduct preclinical development of antibodies that bind to these targets through the filing of an Investigational New Drug application (IND); and present such antibody product candidates to Sanofi for "opt in" prior to initiation of clinical trials.  For each product candidate for which Sanofi "opts in", the Company and Sanofi will

2

continue to conduct clinical development and manufacturing, and potentially commercialization, of such product candidates pursuant to the Antibody License and Collaboration Agreement.  These activities and deliverables were not altered in any way by the amendments to the Antibody Discovery Agreement and the Antibody License and Collaboration Agreement.  While the Company and Sanofi will continue to conduct the same discovery and development activities under the existing Antibody Collaboration, the new IO Collaboration will have a different scientific and technological focus and, therefore, was structured differently, as described below.

•

 You also indicate as a factor for not concluding that the IO Collaboration and the amended Antibody Collaboration should not be accounted for together that there were no discounts provided to Sanofi in the new IO Collaboration agreements.  Since the IO Collaboration was negotiated when you already had a significant contract with Sanofi (i.e. the Antibody Collaboration) and at the same time as the amended Antibody Collaboration, provide us support for your assertion that no discounts were provided.

Response:

The Company considered the following factors in reaching such conclusion:

•

 The prices at which the Company charges Sanofi (i.e., the FTE rate) for research and development activities pursuant to the IO Collaboration are consistent with those the Company utilizes in its other collaborative arrangements, including the Antibody Collaboration.  Specifically, under the terms of the IO Collaboration, Sanofi reimburses the Company for out-of-pocket costs, FTE costs, and manufacturing costs (as defined in the agreements).

•

 While Sanofi has made a significant commitment to fund the discovery and early development of IO antibody product candidates and, for candidates for which it exercises its option, to fund half of the cost of clinical development, the Company retains significant control and final say in many instances over collaboration activities, including development and commercialization strategy and execution for certain collaboration product candidates and products.

•

 The Company's internal analyses and assessments prepared during the course of the negotiation of the IO Collaboration, as well as the Company's discussions with other third parties prior to agreeing on economic terms for the Sanofi IO Collaboration (and the Company's analysis of such terms as compared to the potential Sanofi agreement).

•

 Demonstrate to us that the different elements within the IO Collaboration are not closely interrelated or interdependent in terms of design, technology, or function to elements in the amended Antibody Collaboration, and vice versa.  Address as part of your response to this bullet that IO product candidates have been moved from the Antibody Collaboration to the IO Collaboration.

3

Response:

The Company's conclusion is supported by the following factors:

•

 New and distinct scientific approaches and technologies for IO Collaboration.  The significant differences between the IO Collaboration and the Antibody Collaboration include novel and distinct scientific approaches and technologies that will be utilized by the Company to identify IO targets and to develop IO antibody product candidates.  Under the existing Antibody Collaboration, the Company identifies and validates conventional antibody targets (typically cell surface receptors and ligands that interact with cell surface receptors) and discovers and develops product candidates to these targets.  Under the IO Collaboration, the Company will discover, develop and, potentially, commercialize therapies that attempt to treat cancer by stimulating a patient’s immune system to mount an immune response and eradicate the cancer cells.  This might be accomplished by modulating cells (or cellular pathways) that act to inhibit the patient's immune system from sensing and reacting to the presence of cancer cells or by actively inducing and stimulating an immune response in patients to eradicate the cancer cells.  In addition, in the IO Collaboration, Regeneron will utilize a broader range of proprietary technologies that it has developed (including technologies that it has developed in recent years outside of the Antibody Collaboration) in the discovery of immuno-oncology targets and the research and development of IO antibody product candidates.  For example, in the IO Discovery and Development Agreement, the Company will employ its proprietary bi-specific antibody technology to discover and develop antibody therapeutics that bind simultaneously to both cancer cells and cytotoxic T-cells, thereby harnessing the properties of T-cells to "kill" cancer cells with high specificity.  Furthermore, the use of certain of these technologies in the Antibody Collaboration would require additional payments by Sanofi if utilized (and no such payments have been received to date).

•

 Different focus of IO Collaboration.  Another significant difference between the existing Antibody Collaboration and the new IO Collaboration the Company considered is the broad therapeutic focus of the Antibody Collaboration and the comparatively narrow focus of the IO Collaboration.  Under the Antibody Collaboration, the parties are conducting activities in a broad range of therapeutic areas.  The IO Collaboration is narrowly focused on the discovery, development and, if regulatory approval is received, commercialization of IO antibodies, which are antibodies intended to treat only cancer diseases through a specific mechanistic approach.  Specifically, an IO antibody is an antibody that has a primary mode of action of modifying a human immune response for the purpose of treating cancer.  As such, targets to be identified, researched, and discovered under the IO Collaboration are much more specific to a sole indication area than those under the Antibody Collaboration.

•

 Separation of targets and product candidates.  Any IO product candidates previously being researched under the terms of the Antibody Collaboration (all of which were in pre-clinical development) were transferred to the IO Collaboration upon execution of the IO Agreement.  Subsequent to the execution of the IO Collaboration, the Company's discovery activities to identify and validate potential drug discovery targets in the field of immuno-oncology and develop fully human monoclonal antibodies against these targets will now be performed as part of the IO Collaboration.

•

 Different approaches regarding development timing, opt-in structure, and development control.  The IO Discovery Agreement and IO License and Collaboration Agreement were designed specifically in anticipation of the clinical development of IO antibodies.  In structuring the IO Collaboration, the parties anticipated that the timelines for the clinical development of IO antibodies and relevant regulatory requirements might facilitate the determination of clinical proof-of-concept more quickly than for other antibodies being developed under the Antibody

4

Collaboration.  Therefore, the Company will conduct clinical development and will progress product candidates through a proof-of-concept clinical study (which is typically Phase 2), at which stage Sanofi may "opt-in".  This is a significant difference from the Antibody Collaboration in which Sanofi’s "opt-in" decision is prior to the initiation of clinical studies.  The Company therefore has significantly more control over the clinical development of product candidates and significantly more responsibility under the IO Collaboration than the Antibody Collaboration.  In addition, the Company will be conducting a range of activities under the IO Discovery Program that are not included in the Antibody Discovery Program, including clinical translational studies, Phase 1 and Phase 2 clinical trials, and the development of companion diagnostics for use with IO Discovery Program Antibodies.

•

 Separate and distinct governance structures.  The collaborations are governed by separate joint committees that hold separate meetings to discuss each collaboration's activities and progress.  In addition, the responsibilities of the joint research committee under the Antibody Discovery Agreement are significantly different from the responsibilities of the corresponding committee under the IO Discovery and Development Agreement.  Under the Antibody Discovery Agreement, the joint research committee provides guidance and makes decisions about which antibody targets to validate and research.  In contrast, under the IO Discovery and Development Agreement, the Company reports to Sanofi periodically on its progress in conducting the IO Discovery Program; however, Regeneron has final decision-making authority regarding which potential IO targets to validate and research, and in which types of cancer, and subsequently how to develop therapeutic antibodies that recruit the immune system to target and attack such types of cancer (including how to design clinical trials) through clinical proof-of-concept.

•

 Demonstrate to us that one or more elements in the amended Antibody Collaboration are not essential to the functionality of any elements in the IO Collaboration, and vice versa.

Response:

The functional separation between the Antibody Collaboration and the IO Collaboration is supported by the lack of interdependencies between the Antibody Collaboration and the IO Collaboration.  Specifically, each of these collaborations could stand on its own, exist, and function independently of the other collaboration.  Furthermore, each of these collaborations could be terminated or expire without impacting the terms or activities conducted under the remaining collaboration.  These two collaborations also have different expiration dates: the Antibody Discovery Agreement expires in 2017 (subject to Sanofi's option to extend certain antibody development and p
2016-06-23 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
Mail Stop 4720

June 23, 2016

VIA E -mail
Dr. Leonard S. Schleifer, M.D., Ph.D.
Presid ent and Chief Executive  Officer
Regeneron  Pharmaceuticals, Inc.
777 Old Saw Mill River Road ,
Tarrytown, New York  10591

Re: Regeneron  Pharmaceuticals, Inc.
 Form 10-K for Fis cal Year Ended December 31, 2015
Filed February 11, 2016
Form 8 -K dated February 9, 2016
Filed February 9, 2016
File No. 000-19034

Dear Dr. Schleifer :

We have reviewed  your May 23, 2016 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 busine ss da ys by providing the requested
information or advis e us as soon as possible when you will respond.  If you do not believe a
comment applies to your facts and circumstances, please tell us why in your response.

After reviewing your response to these  comme nts, we may have additional comments.
Unless we note otherwise, our references to prior comments are to comments in our May 2, 2016
letter .

Form 10 -K for the Year Ended December 31, 2015
Notes to Consolidated Financial Statements
3. Collaboration Agreeme nts
a. Sanofi
Immuno -Oncology, page F -16

1. Please refer to your response to our prior comment 3. Address each of the following in
order to further support a conclusion that the IO Collaboration and the amended Antibody
Collaboration are not in substance one  new arrangement :
 You indicate that:

Dr. Leonard S. Schleifer
Regeneron  Pharmaceuticals, Inc.
June 23, 2016
Page 2

 o the reductions in funding pursuant to the amended Antibody Discovery
Agreement from $160 million in each of 2015, 2016, and 2017 to $145 million,
$130 million, and $130 million, respectively, were not considered to be a
significant modification relative to Sanofi's overall funding obligations under the
Antibody Discovery Agreement ;
o the $75 million of aggregate funding from the Antibody Collaboration used to
reimburse the Company for a portion of its IO Discovery program  costs is not
material to the total anticipated funding under the IO Collaboration ; and
o although  IO product candidates and products will no longer be within the scope of
the Antibody Collaboration, the broad deliverables under the agreements
governing the Antibody Collaboration have not changed - i.e., the Company will
still be identifying and developing targets, providing research and development
and manufacturing services, etc., as originally required.
Explain to us why each of the above bullets is a fact or in concluding that the IO
Collaboration and the amended Antibody Collaboration should not be accounted for
together.
 You also indicate as a factor for not concluding that the IO Collaboration and the
amended Antibody Collaboration should not be account ed for together that there were
no discounts provided to Sanofi in the new IO Collaboration agreements. Since the IO
Collaboration was negotiated when you already had a significant contract with Sanofi
(i.e. the Antibody Collaboration) and at the same time  as the amended Antibody
Collaboration, provide us support for your assertion that no discounts were provided.
 Demonstrate to us that the different elements within the IO Collaboration are not
closely interrelated or interdependent in terms of design, tec hnology, or function to
elements in the amended Antibody Collaboration, and vice versa. Address as part of
your response to this bullet that IO product candidates have been moved from the
Antibody Collaboration to the IO Collaboration.
 Demonstrate to us  that one or more elements in the amended Antibody Collaboration
are not essential to the functionality of any element s in the IO Collaboration, and vice
versa.

Form 8 -K filed February 9, 2016
Exhibit 99.1
Table 3

2. Please refer to your response to our pr ior comment 5. Since you assert that your non -
GAAP net income and non -GAAP net income per share are measures of operating
performance, we do not believe it is appropriate to adjust GAAP taxes to show taxes paid
in cash and is inconsistent with question 102 .11 of the updated Compliance and
Disclosure Interpretations issued on May 17, 2016.  Please review this guidance when
preparing your next earnings release.

Dr. Leonard S. Schleifer
Regeneron  Pharmaceuticals, Inc.
June 23, 2016
Page 3

 You may contact Bonnie Baynes, Staff Accountant, at (202) 551 -4924 if you have
questions regarding the  comments . In this regard, do not hesitate to contact me at (202) 551 -
3679.

Sincerely,

 /s/ Jim B. Rosenberg

Jim B. Rosenberg
Senior Assistant Chief  Accountant
Office of Healthcare and Insurance
2016-05-23 - CORRESP - REGENERON PHARMACEUTICALS, INC.
Read Filing Source Filing Referenced dates: May 2, 2016
CORRESP
1
filename1.htm

		SEC Document

 Regeneron Pharmaceuticals, Inc.

777 Old Saw Mill River Road

Tarrytown, NY  10591-6707

 Phone   914 847 7000

www.regeneron.com

May 23, 2016

VIA EDGAR

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Office of HealthCare and Insurance

U.S. Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, D.C. 20549

Re:

 Regeneron Pharmaceuticals, Inc.

 Form 10-K for the Fiscal Year Ended December 31, 2015

 Filed February 11, 2016

 Form 8-K dated February 9, 2016

 Filed February 9, 2016

 File No. 000-19034

Dear Mr. Rosenberg:

This letter sets forth the responses of Regeneron Pharmaceuticals, Inc. (the "Company" or "Regeneron") to the comments of the staff (the "Staff") of the Securities and Exchange Commission (the "Commission") set forth in the Staff’s letter dated May 2, 2016, with respect to the above-referenced Form 10-K and Form 8-K (collectively, the "Filings").  Set forth below are the headings and text of the Staff's comments followed by the Company's response.

Form 10-K for the Year Ended December 31, 2015

Patents, Trademarks, and Trade Secrets, page 22

1. We refer to the third paragraph under the heading which discloses that the patents for your three commercially marketed products and ZALTRAP "generally" expire between 2020 and 2029 and "may be subject" to extension.  Please confirm that you will revise future filings to discuss separately the patent coverage for each product that is material to your business, including the patent expiration dates for any material patents and the current status of efforts to extend those expiration dates.  Also, discuss coverage by jurisdiction where material.  With reference to your disclosures in the fourth paragraph under the heading, please also confirm that in future filings you will revise your discussion of material licenses to discuss the term of those licenses.  To the extent that the term of a material license is tied to patent expiration, please confirm that you will identify the applicable expiration date in the future filing.

1

Response:

In its future Form 10-K filings, the Company will include disclosure relating to patent coverage for each product that the Company considers material to its business at the time of filing, including (i) patent expiration dates for patents viewed as material by the Company, (ii) the current status of relevant efforts to extend those expiration dates, if applicable, and (iii) patent coverage by jurisdiction, to the extent considered material by the Company.

In its future Form 10-K filings, the Company also will include the term of any licenses it considers material to its business at the time of filing and, to the extent any such license is tied to patent expiration, the applicable expiration date.  By way of background, the Company did previously disclose in the "Liquidity and Capital Resources - License and Settlement Agreements with Genentech" section of its Form 10-K for the fiscal year ended December 31, 2015 that the royalty payments to Genentech based on sales of EYLEA® (aflibercept) Injection (which the Company was obligated to pay pursuant to the agreements discussed in the fourth paragraph under "Patents, Trademarks, and Trade Secrets" referenced in this comment) ended on May 7, 2016, as expressly set forth in the agreements.

Notes to Consolidated Financial Statements

1. Business Overview and Summary of Significant Accounting Policies

Accounts Receivable - Trade, page F-10

2. Please tell us why your days sales outstanding for the quarter ended March 31, 2014 of 199 days is substantially higher than for the quarter ended March 31, 2015 of 168 days.  Further tell us why the days sales outstanding for each of these quarters is substantially higher than for the quarters for the rest of the respective fiscal year.  In this regard, we computed days sales by dividing accounts receivable - trade, net as end of a quarter by net product sales for the respective quarter and multiplying the result by the number of days in the quarter.

Response:

As disclosed in the "Liquidity and Capital Resources - Sources and Uses of Cash" section of the Company's Form 10-Q for the quarter ended March 31, 2014, the Company originally offered extended payment terms to its EYLEA customers in connection with the U.S. product launch of EYLEA in the fourth quarter of 2011 and subsequently shortened, effective January 2014, the payments terms to certain of its EYLEA customers.  The Company had initially offered extended payment terms in recognition of anticipated delays in reimbursement to physicians by government and commercial payers during the launch of EYLEA.

2

The Company commenced sales of EYLEA in the United States for the treatment of diabetic macular edema ("DME") in the third quarter of 2014 and macular edema following branch retinal vein occlusion ("BRVO") in the fourth quarter of 2014.  In recognition of anticipated delays in reimbursement to physicians by government and commercial payers during the initial launch of EYLEA for these new indications, the Company lengthened its payment terms to its distributors for approximately 5 months effective August 2014 (with the understanding that such payment terms would revert back to the January 2014 payment terms in February 2015).  As disclosed in the "Liquidity and Capital Resources - Sources and Uses of Cash" section of the Company's Form 10-Q for the quarter ended March 31, 2015, "As of March 31, 2015, Sanofi, Bayer HealthCare, and trade accounts receivable increased by $321.1 million, compared to December 31, 2014, primarily due to higher trade accounts receivable resulting from lengthened payment terms to certain of our U.S. EYLEA customers effective mid-2014."  Note that EYLEA sales in the United States to these U.S. EYLEA customers (i.e., the Company's distributors) account for a significant portion of the Company's net product sales.

A change in payment terms offered to distributors does not have an impact on the Company’s days sales outstanding ("DSO") in the period in which the change in payment terms was made effective, but rather in subsequent periods when accounts receivable amounts in respect of sales made under the revised payment terms are due to be collected.  As an example, the shortening of payment terms effective in January 2014 resulted in a lower DSO beginning in the second quarter of 2014, in contrast to the first quarter of 2014 and periods prior.  Additionally, the lengthening of payment terms effective in August 2014 resulted in an increase in the Company's DSO commencing in the first quarter of 2015, in contrast to the second, third, and fourth quarters of 2014.

The Company monitors product supply levels in the distribution channel, as well as sales by its customers of EYLEA to healthcare providers.  As noted in the Company's quarterly earnings releases for the periods ended March 31, 2014 through March 31, 2015 furnished as exhibits to the Company's Current Reports on Form 8-K, overall EYLEA distributor inventory levels were consistently within the Company's one- to two- week targeted range from the first quarter of 2014 through the first quarter of 2015.  In addition, during 2015, 2014, and 2013, the Company did not recognize any charges for write-offs of accounts receivable related to its marketed products, as disclosed in Item 7A. "Quantitative and Qualitative Disclosures About Market Risk - Credit Quality Risk" of the Company's Form 10-K for the fiscal year ended December 31, 2015.

3. Collaboration Agreements

a. Sanofi

Immuno-Oncology, page F-16

3. Please provide us a full accounting analysis of the July 2015 IO Collaboration with Sanofi and, as amended in connection with the IO Collaboration, the Antibody Discovery Agreement and its License and Collaboration Agreement with Sanofi.  Include in your analysis:

•

 How you viewed the IO Collaboration and the amended agreements (i.e. separately or together) and the basis for your conclusion;

•

 Evaluation of the deliverables;

•

 Arrangement consideration, its determination and allocation;

•

 Revenue and expense recognition; and

•

 Authoritative literature supporting your analysis.

3

Response:

Background

In November 2007, the Company entered into a global, strategic collaboration with Sanofi to discover, develop, and commercialize fully human monoclonal antibodies (the "Antibody Collaboration").  The Antibody Collaboration is governed by the companies' Discovery and Preclinical Development Agreement (the "Antibody Discovery Agreement") and a License and Collaboration Agreement (each as amended).  In July 2015, the Company and Sanofi entered into a global strategic collaboration to discover, develop, and commercialize antibody-based cancer treatments in the field of immuno-oncology (the "IO Collaboration").  The Company's discovery activities to identify and validate potential drug discovery targets in the field of immuno-oncology and develop fully human monoclonal antibodies against these targets will be funded by Sanofi under the terms of the IO collaboration, as further described below.

The IO Collaboration is governed by an Immuno-oncology Discovery and Development Agreement (the "IO Discovery Agreement"), and an Immuno-oncology License and Collaboration Agreement (the "IO License and Collaboration Agreement").  In connection with entering into the IO Discovery Agreement, Sanofi made a $265.0 million non-refundable up-front payment to the Company.  Pursuant to the IO Discovery Agreement, the Company will incur costs to identify and validate potential immuno-oncology targets and develop therapeutic antibodies against such targets through clinical proof-of-concept.  Sanofi will reimburse the Company for up to $825.0 million (the "IO Discovery Funding") of these costs, subject to certain annual limits, which consists of (i) $750 million in new funding and (ii) $75 million of funding that would have otherwise been available to Regeneron under the existing Antibody Discovery Agreement with Sanofi.  The Company will reimburse Sanofi for half of the development costs they funded that are attributable to clinical development of antibody product candidates under the IO Discovery Agreement from Regeneron's share of future profits, if any, to the extent they are sufficient for this purpose.  However, the Company is not required to apply more than 10% of its share of the profits from IO Collaboration products in any calendar quarter towards reimbursing Sanofi for these development costs.  With regard to product candidates for which proof-of-concept is established, Sanofi will have the option to license rights to the candidate pursuant to the IO License and Collaboration Agreement (as further described below).  If Sanofi does not exercise its option to license rights to a product candidate, the Company will retain the exclusive right to develop and commercialize such product candidate and Sanofi will be entitled to receive a royalty on sales.

     In connection with entering into the IO License and Collaboration Agreement, Sanofi made a $375.0 million non-refundable up-front payment to the Company.  If Sanofi exercises its option to license rights to a product candidate thereunder, it will co-develop the drug candidate with the Company through product approval.  Principal control of development of each product candidate that enters development under the IO License and Collaboration Agreement will alternate between the Company and Sanofi on a candidate-by-candidate basis.  Sanofi will fund drug candidate development costs up front (i.e., Sanofi will "pay as they go") for the candidates for which it is the principal controlling party and the Company will reimburse half of the total development costs for all such candidates from its share of future profits, if any, to the extent they are sufficient for this purpose, subject to the same 10% reimbursement limitation described above.  In addition, Sanofi and the Company will share equally, on an ongoing basis, the development costs for the drug candidates for which the Company is the principal controlling party.  The party having principal control over the development of a product candidate will also lead the commercialization activities for such product candidate in the United States.  For all products commercialized under the IO License and Collaboration Agreement, Sanofi will lead commercialization

4

activities outside of the United States.  Each party will have the right to co-promote licensed products in countries where it is not the lead commercialization party.  The parties will share equally in any profits from worldwide sales of collaboration products.  Regeneron is obligated to use commercially reasonable efforts to supply clinical requirements of each drug candidate under the IO License and Collaboration Agreement until commercial supplies of that IO drug candidate are being manufactured.  Prior to commencement of manufacturing commercial supplies, both parties will determine who will be responsible for manufacturing and finishing commercial supplies for each IO licensed product.

     Under the terms of the IO License and Collaboration Agreement, the parties will also co-develop the Company's antibody product candidate targeting the receptor known as programmed cell death protein 1, or PD-1 ("REGN2810").  The parties will share equally, on an ongoing basis, development expenses for REGN2810 up to a total of $650.0 million (for clarity, Regeneron would have to solely fund any development expenses in excess of such amount).  The Company will have principal control over the development of REGN2810 and will lead commercialization activities in the United States, subject to Sanofi’s right to co-promote, while Sanofi will lead commercialization activities outside of the United States and the parties will equally share profits from worldwide sales.  The Company will be entitled to a milestone payment of $375.0 million in the event that sales of all licensed products targeting PD-1 (including REGN2810), together with sales of any other products licensed under the IO License and Collaboration Agreement and sold for use in combination with a licensed product targeting PD-1, equal or exceed $2.0 billion in any consecutive twelve-month period.  At the time of execution of the IO License and Collaboration Agreement, REGN2810 was in Phase 1 clinical development by Regeneron.  There were no other product candidates subject to the IO License and Collaboration Agreement at the time of execution of such contract.

Analysis of the IO Collaboration and amendments to the Antibody Collaboration

The Company first determined whether (a) the Antibody Discovery Agreement and Antibody License and Collaboration Agreement had been "materially modified" and (b) the IO Collaboration and the Antibody Collaboration should be accounted for together.   The Company does not deem the amendments to the Antibody Collaboration to be a material modification of the existing Antibody Discovery Agreement or Antibody License and Collaboration Agreement with Sanofi, and concluded that the IO Collaboration and the Antibody Collaboration should not be accounted for together, primarily in light of the following factors:

•

 Sanofi previously agreed to fund up to $75 million for 2008, $100 million for 2009, and $160 million per year from 2010 - 2017 (or a total of approximately $1.4 billion) in connection with the Antibody Discovery Agreement.  The reductions in funding pursuant to the amended Antibody Discovery Agreement from $160 million in each of 2015, 2016, and 2017 to $145 million, $130 million, and $130 million, respectively, were not considered to be a significant modification relative to Sanofi's overall funding obligations under the Antibody Discovery Agreement.

•

 The $75 million of aggregate funding from the Antibody Collaboration, as described above
2016-05-04 - CORRESP - REGENERON PHARMACEUTICALS, INC.
Read Filing Source Filing Referenced dates: May 2, 2016
CORRESP
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		CORRESP

 Regeneron Pharmaceuticals, Inc.

777 Old Saw Mill River Road

Tarrytown, NY  10591-6707

 Phone   914 847 7000

www.regeneron.com

Via EDGAR

May 4, 2016

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Office of Healthcare and Insurance

U.S. Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, D.C. 20549

Re:

 Regeneron Pharmaceuticals, Inc.

Form 10-K for the Fiscal Year Ended December 31, 2015

Filed February 11, 2016

 Form 8-K dated February 9, 2016

 Filed February 9, 2016

 File No. 000-19034

Dear Mr. Rosenberg:

Regeneron Pharmaceuticals, Inc. (the "Company") acknowledges receipt of the letter dated May 2, 2016 provided by the staff of the Securities and Exchange Commission (the "Staff") with respect to the above-referenced Form 10-K and Form 8-K.  The Company subsequently corresponded with Bonnie Baynes of the Staff on May 3, 2016, who kindly granted the Company’s request for a five business day extension.  Accordingly, the Company plans to provide its response to the letter on or before May 23, 2016.

If you have any questions regarding the foregoing, please contact me at (914) 847-7270.

Very truly yours,

REGENERON PHARMACEUTICALS, INC.

/s/ Robert E. Landry

Robert E. Landry

Senior Vice President, Finance and Chief Financial Officer

cc:     Bonnie Baynes, Staff Accountant
2016-05-03 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
Mail Stop 4720

May 2, 2016

VIA E -mail
Dr. Leonard S. Schleifer, M.D., Ph.D.
Presid ent and Chief Executive  Officer
Regeneron  Pharmaceuticals, Inc.
777 Old Saw Mill River Road ,
Tarrytown, New York  10591

Re: Regeneron  Pharmaceuticals, Inc.
 Form 10-K for Fis cal Year Ended December 31, 2015
Filed February 11, 2016
Form 8 -K dated February 9, 2016
Filed February 9, 2016
File No. 000-19034

Dear Dr. Schleifer :

We have reviewed your filing and have the following comments .  In some of our
comment s, we may ask you to provide us with information so we may better understand your
disclosure.

Please respond to these  comment s within ten  business days by providing the requ ested
information or advise  us as soon as possible  when you will respond .  If you do not believe  a
comment  applies to your facts and circumstances, please tell us why in your response.

After reviewing  your response to these  comment s, we may have additional co mments .

Form 10 -K for the Year Ended December 31, 2015

Patents, Trademarks, and Trade Secrets, page 22

1. We refer to the third paragraph under the heading which discloses that the patents for
your three commercially marketed products and ZALTRAP “generally” expire
between 2020 and 2029 and “may be subject” to extension.   Please confirm that you
will revise fu ture filings to discuss separately the patent coverage for each product
that is material to your business, including the patent expiration dates for any material
patents and the current status of efforts to extend those expiration dates.   Also, discuss
coverage by jurisdiction where material.   With reference to your disclosures in the
fourth paragraph under the heading, please also confirm that in future filings you will

Dr. Leonard S. Schleifer
Regeneron  Pharmaceuticals, Inc.
May 2 , 2016
Page 2

 revise your discussion of material licenses to discuss the term of those licenses.   To
the extent that the term of a material license is tied to patent expiration, please
confirm that you will identify the applicable expiration date in the future filing.

Notes to Consolidated Financial Statements

1. Business Overview and Summary of Significant Accounting Policies
Accounts Receivable – Trade, page F -10

2. Please tell us why your days  sales outstanding for the quarter ended March 31, 2014
of 199 days is substantially higher than for the quarter ended March 31, 2015 of 168
days. Further tell us why the days sales outstanding for each of these quarters is
substantially higher than for th e quarters for the rest of the respective fiscal year.  In
this regard, we computed days sales by dividing accounts receivable – trade, net as
end of a quarter by net product sales for the respective quarter and multiplying the
result by the number of days  in the quarter.

3. Collaboration Agreements
a. Sanofi
Immuno -Oncology, page F -16

3. Please provide us a full accounting analysis of the July 2015 IO Collaboration with
Sanofi and, as amended in connection with the IO Collaboration, the Antibody
Discover y Agreement and its License and Collaboration Agreement with Sanofi.
Include in your analysis:
 How you viewed the IO Collaboration and the amended agreements  (i.e.
separately or together) and the basis for your conclusion;
 Evaluation of the deliverables;
 Arrangement consideration, its determination and allocation;
 Revenue and expense recognition; and
 Authoritative literature supporting your analys is.

11. Debt
a. Convertible Debt
Warrant Transactions, page F -32

4. Please tell us why the amendment entere d into in November 2015 was not accounted
for similar to the amendment entered into in November 2014 whereby you accounted
for warrants as a liability effective with the amendment and subsequently measured
them at fair value with changes in fair value reco gnized in earnings.

Dr. Leonard S. Schleifer
Regeneron  Pharmaceuticals, Inc.
May 2 , 2016
Page 3

 Form 8 -K filed February 9, 2016
Exhibit 99.1
Table 3

5. Please refer to your non -GAAP net income and related per share amounts. Explain to
us precisely what the non -cash income tax adjustment represents and the components
included therein. Also explain to us what non -GAAP income taxes represent after the
non-cash income tax adjustment is deducted from GAAP income tax expense. In this
regard, it appears that not only do you exclude certain elements of income tax
expense in arriving a t non -GAAP net income, but it also appear that you fail to
recognize additional tax for the increase in pre -tax non -GAAP income. As such, it
does not appear that your non -GAAP net income reflects the full income tax
consequences of your pre -tax non -GAAP income. If that is the case, tell us what your
non-GAAP net income would have been for each of the last three fiscal years had you
included the  full income tax consequences of your pre -tax non -GAAP income.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing s to be certain that the filing s include 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 respond ing to our comment s, 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 s;
 staff comment s or changes to disclosure in response to staff comment s do not foreclose
the Commission from taking any action with respect to the filing s; and
 the company may not assert staff comment s as a defense in any proceeding initiated by
the Commission or any person under the federal securities laws of the United States.

You may contact Bonnie Baynes, Staff Accountant, at (202) 551 -4924 if you have
questions regarding the processing of your response as well as any questions regarding
comments on the financial  statements and related matters .  Please  contact Dorman Yale, S taff
Attorney, at (202) 551 -8776 or Joseph McCann, Attorney Advisor, at (202) 551 -6262 with
question s on any of the  other  comments.   In this regard, do not hesitate to contact me at (202)
551-3679.
Sincerely,

  /s/ Jim B. Rosenberg

Jim B. Rosenberg
Senior Assistant Chief  Accountant
Office of Healthcare and Insurance
2015-03-31 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
March 30 , 2015

Via E -mail
Robert E. Landry
Senior Vice President of  Finance - Chief Financial Officer
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591

Re: Regeneron Pharmaceuticals, Inc.
  Preliminary Proxy Statement on Schedule 14A
  Filed March 16, 2015
  File No. 000 -19034

Dear Mr. Landry:

We have completed our review of your filing.  We remind you that our comment s or
changes to disclo sure in  response to our comment s 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
feder al 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 ru les require.

Sincerely,

 /s/ Bryan J. Pitko for

Jeffrey P. Riedler
Assistant Director
2015-03-27 - CORRESP - REGENERON PHARMACEUTICALS, INC.
Read Filing Source Filing Referenced dates: March 23, 2015
CORRESP
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		SEC Comment Letter Response

 Regeneron Pharmaceuticals, Inc.

777 Old Saw Mill River Road

Tarrytown, NY  10591

 Phone     914 847 7000

www.regeneron.com

March 27, 2015

VIA EDGAR

Mr. Jeffrey P. Riedler

Assistant Director

U.S. Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, D.C. 20549

Re:

 Regeneron Pharmaceuticals, Inc.

 Preliminary Proxy Statement on Schedule 14A

 Filed March 16, 2015

 File No. 000-19034

Dear Mr. Riedler:

This letter provides the response of Regeneron Pharmaceuticals, Inc. (the “Company”) to the comment of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) set forth in the Staff’s letter dated March 23, 2015 with respect to the above-referenced Preliminary Proxy Statement on Schedule 14A (the “Proxy Statement”).  Set forth below are the heading and the text of the comment followed by the Company’s response.  References to page numbers are to the page numbers of the Proxy Statement.

Proposal 4, page 73

1.

 We note that you have proposed to amend your certificate of incorporation to increase the number of authorized shares of capital stock and common stock. Please amend your proxy statement to disclose whether you have any current plans, arrangements, or understandings to issue any of the shares that would be newly available for issuance following the proposed increase to your authorized shares. If such plans exist, please disclose all material information. If no such plans exist, please revise your disclosure accordingly.

RESPONSE:

The Company confirms that it currently has no specific plans, arrangements, or understandings to issue any of the shares that would be newly available for issuance following the proposed increase.

In response to the comment, the Company will amend the disclosure in the Proxy Statement, which will be reflected in the Company’s Definitive Proxy Statement on Schedule 14A to be filed with the Commission on or about April 20, 2015, by revising the penultimate sentence of the fourth paragraph on page 73 as follows (revisions shown bolded and underlined):

The newly authorized shares of common stock would be issuable for any proper corporate purpose, including future acquisitions, investment opportunities, capital raising transactions of equity or convertible debt securities, stock splits, stock dividends, issuance under current or future equity compensation plans, employee stock plans and savings plans, or for other corporate purposes; however, the Company currently has no specific plans, arrangements, or understandings to issue any of the newly authorized shares.

***

As requested by the Staff, the Company acknowledges that:

•

 The Company is responsible for the adequacy and accuracy of the disclosure in its filings with the Commission under the Securities Exchange Act of 1934, as amended (“Exchange Act Filings”);

•

 Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the Company’s Exchange Act Filings; and

•

 It is the Staff's view 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.

If you have any questions regarding the foregoing, please contact me at (914) 847-7270 or Richard Gluckselig, Director, Corporate Counsel at (914) 847-5290.

Very truly yours,

REGENERON PHARMACEUTICALS, INC.

/s/ Robert E. Landry

Robert E. Landry

Senior Vice President, Finance and

Chief Financial Officer

cc:     Securities and Exchange Commission

Preston Brewer

Bryan J. Pitko
2015-03-23 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
March 23 , 2015

Via E -mail
Robert E. Landry
Senior Vice President of  Finance - Chief Financial Officer
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591

Re: Regeneron Pharmaceuticals, Inc.
  Preliminary Proxy Statement on Schedule 14A
  Filed March 16, 2015
  File No. 000 -19034

Dear Mr. Landry :

We have limited our review of your proxy statement to the issue we have addressed in
our comment.  Please respond to this letter by amending your proxy statement and providing the
requested information .  Where  you do not believe our comment applies  to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.

After reviewing any amendment to your proxy statement  or your response to our
comment , we may have  additional comments.

Proposal 4, page 73

1. We note that you have proposed to amend your c ertifica te of incorporation to i ncrease the
number of  authorized shares of capital stock and common stock .  Please amend your
proxy statement to disclose whether  you have any current plans, arrangements, or
understandings  to issue any of the shares that would be newly available  for issuance
following the proposed increase to your authorized shares .  If such plans exist, please
disclose all material information.   If no such plans exist, please revise your discl osure
accordingly .

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 disclos ures they have made.

In responding to our comments, please provide a written statement from the company
acknowledging that:

Robert E. Landry
Regeneron Pharmaceuticals , Inc.
March 23 , 2015
Page 2

 the company is responsible for the adequacy and accuracy of the disclosure in its filing;

 staff comments or changes to disclos ures 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 Preston Brewer  at (202) 551 -4325  or me at (202) 551 -3715  with any other
questions.

Sincerely,

 /s/ Bryan J. Pitko for

 Jeffrey P. Riedler
Assistant Director
2014-07-21 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
July 21, 2014

Via E -mail
Robert E. Landry
Senior Vice President, Finance and Chief Financial Officer
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591

Re: Regeneron Pharmaceuticals, Inc.
   Form 10-K for the Fiscal Year Ended December 31, 201 3
   Filed February 13, 2014
   File No. 000-19034

Dear M r. Landry :

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 a ny 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 1 934 and all applicable rules require.

Sincerely,

 /s/ Joel Parker

Joel Parker
Accounting Branch Chief
2014-06-24 - CORRESP - REGENERON PHARMACEUTICALS, INC.
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CORRESP
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		Comment Letter - June 2014 response

 Regeneron Pharmaceuticals, Inc.

777 Old Saw Mill River Road

Tarrytown, NY  10591-6707

 Phone   914 847 7000

www.regeneron.com

June 24, 2014

Via EDGAR

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

U.S. Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, D.C. 20549

Re:

 Regeneron Pharmaceuticals, Inc.

 Form 10-K for the Fiscal Year Ended December 31, 2013

 Filed February 13, 2014

 File No. 000-19034

Dear Mr. Rosenberg:

This letter sets forth the responses of Regeneron Pharmaceuticals, Inc. (the “Company”) to the comments of the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) set forth in the Staff’s letter dated April 17, 2014, with respect to the above-referenced Form 10-K.  Set forth below is the heading and text of the comment followed by the Company's response.  Based on a telephonic discussion with the Staff on June 3, 2014, the Company is providing additional analyses to supplement its initial responses in its letter dated April 30, 2014.

Notes to the Consolidated Financial Statements

Note 13. Commitments and Contingencies

b. Research Collaboration and Licensing Agreements, page F-29

Regarding your Genentech agreement, please tell us how you concluded that recognizing royalty expense using a blended mid-single digit royalty rate that reflects both the $60 million payment and the royalties payable on cumulative sales is appropriate, as opposed to expensing the $60 million upon cumulative U.S. sales of EYLEA reaching $400 million in 2012 and expensing the royalties for sales over $400 million at the contractual rate when incurred.  Please cite the authoritative literature used to support your conclusion.

Response:

In December 2011, the Company and Genentech, a member of the Roche Group, entered into a Non-Exclusive License and Partial Settlement Agreement (the “Agreement”).  Pursuant to the Agreement, the Company received a) a non-exclusive license to certain patents from Genentech, and b) an agreement by Genentech not to sue the Company for any activity prior to the effective date of the Agreement relating to the licensed patents, which had previously been the subject of litigation between the Company and Genentech.  Additionally, pursuant to the Agreement, the Company became obligated to make a $60 million payment upon cumulative U.S. sales of EYLEA® (aflibercept) Injection (“EYLEA”) reaching $400 million, and is obligated to pay royalties of 4.75% on cumulative U.S. sales of EYLEA between $400 million and $3 billion and 5.5% on any cumulative U.S. sales of EYLEA over $3 billion.  The royalty term ends upon expiration of the Davis-Smyth patents (May 7, 2016).  The Company did not pay cash or any other consideration to Genentech upon execution of the Agreement.

In performing its accounting analysis, the Company determined the elements exchanged in the arrangement, which are summarized above.  The Company then investigated how to allocate the consideration amongst those elements and whether to treat any consideration as payment for settlement of a litigation and/or damages caused to Genentech.  The Company did not believe it was appropriate to immediately recognize a charge in its financial statements for any amounts attributed to Genentech’s agreement to not sue for damages due to the following factors:

•

 Payments for damages would have been to compensate Genentech for events that occurred in the past.  EYLEA product sales in the United States commenced during November 2011, and the royalty terms in the Agreement commenced with the first commercial sale of EYLEA in the United States.  Therefore, the Company concluded that Genentech could not have suffered any damages prior to November 2011, and all sales following approval of EYLEA by the U.S. Food and Drug Administration (“FDA”) were and would continue to be captured as part of the consideration to be paid based on U.S. sales of EYLEA.

•

 The Company concluded that the blended royalty rate it had estimated, which would be paid over the life of the royalty term, is within the range of fair value for similar licensing transactions, and therefore it is paying a fair market value rate for the licensed patents.  The Company determined that the total blended royalty rate is within a reasonable range of royalty rates primarily based on the following factors:

◦

 The Company engaged third-party valuation experts to assess whether the blended royalty rate (i.e., total amount expected to be paid in exchange for the non-exclusive license) was within a reasonable range of royalty rates for similar licensing transactions, and the analysis provided by such valuation experts confirmed such.

◦

 The blended royalty rate is within the range of royalties the Company pays in connection with licensing arrangements the Company has entered into in the past.

◦

 The Company and Genentech were not related parties, nor did they historically have a “customer/vendor” relationship, and the total consideration in the Agreement was negotiated by the two parties in an arm's-length transaction.

Thus, the Company concluded that since it is not paying in excess of a fair value royalty rate for the licensed patents and since it had no basis for concluding that Genentech had incurred damages in the past, there were no potential payments under the Agreement that should be attributed to any other elements of the arrangement.

In assessing the appropriate accounting treatment for the $60 million payment and royalties payable, the Company considered the guidance in ASC 815, Derivatives and Hedging.  Per ASC 815-10-15-59, “Contracts that are not exchange-traded are not subject to the requirements of this Subtopic if the underlying on which the settlement is based is any one of the following:

a. A climatic or geological variable or other physical variable.  Climatic, geological, and other physical variables include things like the number of inches of rainfall or snow in a particular area and the severity of an earthquake as measured by the Richter scale.

b. The price or value of a nonfinancial asset of one of the parties to the contract provided that the asset is not readily convertible to cash. This scope exception applies only if both of the following are true:

1.

 The nonfinancial assets are unique.

2.   The nonfinancial asset related to the underlying is owned by the party that would not benefit under the contract from an increase in the fair value of the nonfinancial asset. (If the contract is a call option, the scope exception applies only if that nonfinancial asset is owned by the party that would not benefit under the contract from an increase in the fair value of the nonfinancial asset above the option’s strike price.)

c. The fair value of a nonfinancial liability of one of the parties to the contract provided that the liability does not require delivery of an asset that is readily convertible to cash.

d. Specified volumes of sales or service revenues of one of the parties to the contract. (This scope exception applies to contracts with settlements based on the volume of items sold or services rendered, for example, royalty agreements. This scope exception does not apply to contracts based on changes in sales or revenues due to changes in market prices.)”

Based on the guidance in ASC 815-10-15-59(d) referenced above, the Company concluded that the payments to be made to Genentech are not within the scope of the derivatives and hedging accounting literature.  Therefore, the Company considered the guidance, by analogy, in ASC 840-10-25-35 which states, “A lessee should recognize contingent rental expense (in annual as well as in interim periods) before the achievement of the specified target that triggers the contingent rental expense, provided that the achievement of that target is considered probable.”  The Company also considered the guidance in FASB Concepts Statement 6 (and specifically paragraph 149) and Concepts Statement 5 (paragraph 86) which provide that some assets yield their benefits to an entity over several periods, and expenses resulting from their use are normally allocated to the periods over which they are expected to provide benefits by a “systematic and rational” allocation procedure.

Given that the Company determined, based on its forecasts of U.S. EYLEA sales over the royalty period, that it was probable that it would meet the step triggers (i.e., it would reach U.S. EYLEA sales in excess of $400 million) over the life of the Agreement, the Company determined that it would be appropriate to record royalty expense at the anticipated blended rate, rather than based on the contractual rate.  An “obligating event” has occurred upon execution of the contract, and the Company determined that recognizing expense based on a blended royalty rate as sales occur was also a “systematic and rational” allocation of the expense over the estimated period for which the licensed patents are expected to provide benefits to the Company.  The benefit the Company receives by having the license to the patents is the same throughout the term of the arrangement.  Based on the analysis performed as described above, the Company concluded that the total estimated consideration to be paid to Genentech over the life of the licensed patents is a royalty in exchange for the non-exclusive license, regardless of the cash payment provisions set forth in the Agreement.

The Company would observe that recognizing royalty expense on a level basis (in relation to U.S. EYLEA sales) is analogous to the requirement in the Leases standard (ASC 840-20-25-2) to straight line rent expense in certain circumstances.  In addition, while specific to interim reporting requirements, the underlying concepts in ASC 270-10-45-9 and 45-10 also support using a blended approach.  ASC 270-10-45-9(a) states, “If a cost that is expensed for annual reporting purposes clearly benefits two or more interim periods, each interim period should be charged for an appropriate portion of the annual cost by the use of accruals or deferrals.”  ASC 270-10-45-10 states, “The amounts of certain costs and expenses are frequently subjected to year-end adjustments even though they can be reasonably approximated at interim dates.  To the extent possible such adjustments should be estimated and the estimated costs and expenses assigned to interim periods so that the interim periods bear a reasonable portion of the anticipated annual amount.  Examples of such items include inventory shrinkage, allowance for uncollectible accounts, allowance for quantity discounts, and discretionary year-end bonuses.”

In addition to the guidance referred to above, it should be noted there are several other analogous topics covered specifically in the Accounting Standards Codification in which amounts are payable only if a certain performance level or target is achieved are nonetheless recognized as expense over the period that services are performed or benefit is received:

•

 ASC 718-10-25-20 specifies that compensation cost for a share-based payment award subject to a performance condition are based on the probable outcome of the condition, with probable having the same meaning as in ASC 450.  The Company notes that sales target would be treated as a performance condition were it part of a share-based payment arrangement, and it does not believe that form of payment should affect the timing of recognition.

•

 ASC 420-10-25-6, 25-9, 30-6, and 55-4 through 55-8 illustrate the accounting for one-time termination benefits that require an employee to render service through a specified date in order to be entitled to the benefit.  In that situation, the guidance stipulates that the related expense for those expected to earn the benefit is recognized over time as the employee renders the required service even though no payment will be made if the employee terminates prior to the stated date.

•

 ASC 605-50-25-7 specifies the accounting for contingent sales incentives, which are payable only if the customer reaches a specified cumulative level of revenue transactions, and requires that the contingent obligation be recognized based upon a systematic and rational allocation of the cost of honoring the arrangement to each of the underlying transactions based upon the estimated number of customers that will ultimately earn the rebate.

The Company believes that each of the three citations noted immediately above, as well as the lease guidance noted earlier, have characteristics very similar to the Company’s royalty arrangement with Genentech.  In each case, a contractual arrangement requires a payment to be made if a certain cumulative level of performance is reached, with no payment required if that level is not ultimately achieved.  And in each case, the FASB determined that recognition of expense is required over the period in which benefit is received if the entity estimates that the cumulative performance level will be achieved and the contingent payment will therefore be made.

The Company’s calculation of the blended royalty rate is based on its projections of total estimated U.S. EYLEA cumulative sales over the royalty term.  EYLEA sales forecasts are periodically updated and reviewed by management, and the blended royalty rate is adjusted accordingly, as necessary (note, however, that the blended royalty rate has not changed significantly since the Agreement was executed).

The Company did not believe it would be appropriate to defer recognition of any expense until the $60 million payment was made as (i) that would not appropriately reflect the economic reality of the Agreement, and (ii) the Company deemed that it was probable that the $60 million payment would be triggered in the future.  Furthermore, the Company did not deem it appropriate to expense the $60 million over the first $400 million of cumulative sales as that would have resulted in a 15% effective royalty rate, which would not have accurately reflected the underlying economics of the arrangement.

Based on the factors and analyses described above, the Company concluded that it is appropriate to recognize royalty expense in connection with the Genentech Agreement as it recognizes U.S. EYLEA sales, using a blended royalty rate that reflects both the $60 million payment and the estimated royalties expected to be paid on future U.S. EYLEA sales.

***

As requested by the Staff, the Company acknowledges that:

•

 The Company is responsible for the adequacy and accuracy of the disclosure in its filings with the Commission under the Securities Exchange Act of 1934, as amended (“Exchange Act Filings”);

•

 Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the Company's Exchange Act Filings; and

•

 It is the Staff's view 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.

If you have any questions regarding the foregoing, please contact me at (914) 847-7270.

Very truly yours,

REGENERON PHARMACEUTICALS, INC.

/s/ Robert E. Landry

Robert E. Landry

Senior Vice President, Finance and

Chief Financial Officer

cc:    Securities and Exchange Commission

Scott Wuenschell

Joel Parker
2014-06-12 - CORRESP - REGENERON PHARMACEUTICALS, INC.
Read Filing Source Filing Referenced dates: April 30, 2014
CORRESP
1
filename1.htm

		Comment Letter - June 2014 Request for Response Extension

 Regeneron Pharmaceuticals, Inc.

777 Old Saw Mill River Road

Tarrytown, NY  10591-6707

 Phone   914 847 7000

www.regeneron.com

June 12, 2014

Via EDGAR

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

U.S. Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, D.C. 20549

Re:

 Regeneron Pharmaceuticals, Inc.

Form 10-K for the Fiscal Year Ended December 31, 2013

Filed February 13, 2014

 File No. 000-19034

Dear Mr. Rosenberg:

Regeneron Pharmaceuticals, Inc. (the “Company”) acknowledges receipt of oral comments provided by the staff of the Securities and Exchange Commission on June 3, 2014, with respect to the above-referenced Form 10-K.  The Company subsequently corresponded with Scott Wuenschell on June 9, 2014, who kindly granted the Company’s request for a five business day extension.  Accordingly, the Company plans to expand its explanations to supplement its initial responses in its letter dated April 30, 2014, on or before June 24, 2014.

If you have any questions regarding the foregoing, please contact me at (914) 847-7270.

Very truly yours,

REGENERON PHARMACEUTICALS, INC.

/s/ Robert E. Landry

Robert E. Landry

Senior Vice President, Finance and

Chief Financial Officer

cc:     Securities and Exchange Commission

Scott Wuenschell

Joel Parker
2014-04-30 - CORRESP - REGENERON PHARMACEUTICALS, INC.
Read Filing Source Filing Referenced dates: April 17, 2014
CORRESP
1
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		SEC Comment Letter Response - April 2014

 Regeneron Pharmaceuticals Inc.

777 Old Saw Mill River Road

Tarrytown, NY  10591

 Phone     914 345 7400

Fax         914 347 2847

www.regeneron.com

April 30, 2014

Via EDGAR

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

U.S. Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, D.C. 20549

Re:

 Regeneron Pharmaceuticals, Inc.

 Form 10-K for the Fiscal Year Ended December 31, 2013

 Filed February 13, 2014

 File No. 000-19034

Dear Mr. Rosenberg:

This letter sets forth the responses of Regeneron Pharmaceuticals, Inc. (the “Company”) to the comments of the staff (the "Staff") of the Securities and Exchange Commission (the "Commission") set forth in the Staff’s letter dated April 17, 2014, with respect to the above-referenced Form 10-K.  Set forth below is the heading and text of the comment followed by the Company's response.

Notes to the Consolidated Financial Statements

Note 13. Commitments and Contingencies

b. Research Collaboration and Licensing Agreements, page F-29

Regarding your Genentech agreement, please tell us how you concluded that recognizing royalty expense using a blended mid-single digit royalty rate that reflects both the $60 million payment and the royalties payable on cumulative sales is appropriate, as opposed to expensing the $60 million upon cumulative U.S. sales of EYLEA reaching $400 million in 2012 and expensing the royalties for sales over $400 million at the contractual rate when incurred. Please cite the authoritative literature used to support your conclusion.

Response:

In December 2011, the Company and Genentech, a member of the Roche Group, entered into a Non-Exclusive License and Partial Settlement Agreement (the “Agreement”). Pursuant to the Agreement, the Company received a non-exclusive license to certain patents from Genentech.  In exchange for these patent rights, the Company became obligated to make a $60 million payment upon cumulative U.S. sales of EYLEA reaching $400 million, and is obligated to pay royalties of 4.75% on cumulative U.S. sales of EYLEA between $400 million and $3 billion and 5.5% on any cumulative U.S. sales of

EYLEA over $3 billion.   The royalty term ends upon expiration of the Davis-Smyth patents (May 7, 2016).

In assessing the appropriate accounting treatment for the $60 million payment and royalties payable, the Company considered the guidance in FASB Concepts Statement 5 (paragraphs 144 through 149) and Concepts Statement 6 (paragraph 86).  The Company also considered the guidance in ASC 270-10-45-9 through 45-10 to support its accounting conclusion.  ASC 270-10-45-9a states, "If a cost that is expensed for annual reporting purposes clearly benefits two or more interim periods, each interim period should be charged for an appropriate portion of the annual cost by the use of accruals or deferrals."  ASC 270-10-45-10 states, "The amounts of certain costs and expenses are frequently subjected to year-end adjustments even though they can be reasonably approximated at interim dates.  To the extent possible such adjustments should be estimated and the estimated costs and expenses assigned to interim periods so that the interim periods bear a reasonable portion of the anticipated annual amount…"  Additionally, the Company considered the guidance, by analogy, in ASC 840-10-25-35 which states, "A lessee should recognize contingent rental expense (in annual as well as in interim periods) before the achievement of the specified target that triggers the contingent rental expense, provided that the achievement of that target is considered probable."

The Company’s calculation of the blended royalty rate is based on its projections of total estimated U.S. EYLEA cumulative sales over the royalty term.  EYLEA sales forecasts are periodically updated and reviewed by management, and the blended royalty rate is adjusted accordingly, as necessary; note that the blended royalty rate has not changed significantly since the Agreement was executed.  In calculating the blended royalty rate, the Company determined, based on its forecasts of U.S. EYLEA sales over the royalty period, that it is probable that it will meet the step triggers (i.e., $400 million and $3 billion) provided for in the Agreement.  Additionally, the Company determined that the total blended royalty rate is within a reasonable range of royalty rates primarily based on the following factors:

•

 The blended royalty rate is within the range of royalties the Company pays in connection with licensing arrangements the Company has entered into in the past.

•

 The Company and Genentech were not related parties, nor did they historically have a “customer/vendor” relationship, and the total consideration in the Agreement was negotiated by the two parties in an arm's-length transaction.

•

 The Company engaged third-party valuation experts to assess whether the blended royalty rate (i.e., total amount expected to be paid in exchange for the non-exclusive license) was within a reasonable range of royalty rates for similar licensing transactions, and the analysis provided by such valuation experts confirmed such.

The benefit the Company receives by having the license is the same throughout the term of the arrangement.  Based on the analysis performed as described above, the Company concluded that the total estimated consideration to be paid to Genentech over the life of the patents is a royalty in exchange for the non-exclusive license, regardless of the cash payment provisions set forth in the Agreement.  The Company did not believe it would be appropriate to defer recognition of any expense until the $60 million payment was made as (i) that would not appropriately reflect the economic reality of the Agreement, and (ii) the Company deemed that it was probable that the $60 million payment would be triggered in the future.  Furthermore, the Company did not deem it appropriate to expense the $60 million over the first $400 million of cumulative sales as that would have resulted in a 15% effective royalty rate, which would not have accurately reflected the underlying economics of the arrangement.  Therefore, the Company concluded that it is appropriate to recognize royalty expense in connection with the Genentech Agreement

as it recognizes U.S. EYLEA sales, using a blended royalty rate that reflects both the $60 million payment and the royalties payable on estimated cumulative sales.

***

As requested by the Staff, the Company acknowledges that:

•

 The Company is responsible for the adequacy and accuracy of the disclosure in its filings with the Commission under the Securities Exchange Act of 1934, as amended ("Exchange Act Filings");

•

 Staff comments or changes to disclosure in response to Staff comments do not foreclose the Commission from taking any action with respect to the Company's Exchange Act Filings; and

•

 It is the Staff's view 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.

If you have any questions regarding the foregoing, please contact me at (914) 847-7270.

Very truly yours,

REGENERON PHARMACEUTICALS, INC.

/s/ Robert E. Landry

Robert E. Landry

Senior Vice President, Finance and

Chief Financial Officer

cc:     Securities and Exchange Commission

Scott Wuenschell

Joel Parker
2014-04-17 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
April 17 , 2014

Via E -mail
Robert E. Landry
Senior Vice President, Finance and Chief Financial Officer
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591

Re: Regeneron Pharmaceuticals, Inc.
   Form 10-K for the Fi scal Year Ended December 31, 2013
   Filed February 13, 2014
   File No. 000-19034

Dear M r. Landry :

We have reviewed your filing and have the following comment s.  In our comment s, we
ask you to provide us with information so we may better understand your disclosure.

Please respond to this letter within 10 business days by  providing us the requested
information or  by advising us when you will provide the requested response.   If you  do not
believe a comment  applies to your facts and circumstances, please tell us why in your response.
Please furnish us a letter on EDGAR under the form type label CORRESP that key s your
response to our comment s.

After reviewing the information provide d, we may raise additional comments  and/or
request that you amend your filing .

Part III, page 83

1. We have not yet reviewed the Part III information that is included in your Form 10 -K.
We may have further comments after reviewing that information and we wi ll not be able
to clear our review of your filing until we have the opportunity to resolve any resulting
comments.

Notes to Consolidated Financial Statements
13. Commitments and Contingencies
b. Research Collaboration and Licensing Agreements, page F -29

2. Regarding your Genentech agreement, please tell us how you concluded that recognizing
royalty  expense using a blended mid -single digit royalty rate that reflects both the $60
million payment and the royalties payable on cumulative sales is appropriate, as opposed
to expensing the $60 million  upon cumulative U.S. sales of EYLEA reaching $400

Robert E. Landry
Regeneron Pharmaceuticals, Inc.
April 17 , 2014
Page 2

 million in 2012 and expensing  the royalties  for sales over $400 million at the contractual
rate when incurred . Please cite the authoritative literature used to support y our
conclusion.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be  certain that the filing include s 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 comment s, please provide  a written state ment 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 initia ted by
the Commission or any person under the federal securities laws of the United States.

You may contact Scott Wuenschell, Staff Accountant,  at (202) 551 -3467 or Joel Parker,
Accounting Branch Chief, at (202) 551 -3651 if you have questions regarding the processing of
your response as well as any questions regarding comments on the financial statements and
related matters. You may contact Austi n Stephenson, Staff Attorney, at (202) 551 -3192 or Bryan
Pitko , Attorney Advisor at (202) 551 -3203  with questions on any of the other comments.  In this
regard, do not hesitate to contact me at (202) 551 -3679.

Sincerely,

 /s/ Jim B. Rosenberg

Jim B. Rosenberg
Senior Assistant Chief Accountant
2013-08-26 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
August 26 , 2013

Via E-mail
Mr. Murray A. Goldberg
Chief Financial Officer
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY  10591 -6707

Re: Regeneron  Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31 , 2012
Filed February  15, 2013
File No . 000-19034

Dear M r. Goldberg :

We have completed our review of your filing.  We remind you that our comment s or
changes to disclo sure in response  to our comment  do not foreclose the Commission from taking
any action with respect to the company or the filing and the company may not assert the staff
comment  as a defense in any proceeding initiated by the Commission or any person under the
federal sec urities laws of the United States.  We urge all persons who are responsible for the
accuracy and adequacy of the disclosure in the filing s to be certain that the filing s include the
information the Securities Exchange Act of 1934 and all applicable rules r equire.

Sincerely,

 /s/ Joel Parker

Joel Parker
Accounting Branch Chief
2013-07-26 - CORRESP - REGENERON PHARMACEUTICALS, INC.
Read Filing Source Filing Referenced dates: July 12, 2013
CORRESP
1
filename1.htm

		SEC Comment Letter Response

`

 Regeneron Pharmaceuticals Inc.

777 Old Saw Mill River Road

Tarrytown, NY  10591

 Phone     914 345 7400

Fax         914 347 2847

www.regeneron.com

July 26, 2013

Via EDGAR

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

U.S. Securities and Exchange Commission

Division of Corporation Finance

100 F Street, NE

Washington, D.C. 20549

Re:

 Regeneron Pharmaceuticals, Inc.

 Form 10-K for the Fiscal Year Ended December 31, 2012

 Filed February 15, 2013

 File No. 000-19034

Dear Mr. Rosenberg:

This letter sets forth the responses of Regeneron Pharmaceuticals, Inc. (the “Company”) to the comments of the staff of the Securities and Exchange Commission (the “Staff”) set forth in the Staff’s letter dated July 12, 2013, with respect to the above-referenced Form 10-K.  Set forth below is the heading and text of each of the comments followed by our response.

Notes to the Consolidated Financial Statements

Note 12. Convertible Debt, page F-26

1.

 You state that the conversion price is adjustable under certain circumstances.  Please provide us your analysis of why you do not believe the conversion option is a derivative pursuant to ASC 815.  If you do not believe the conversion option is required to be recorded as a derivative, please tell us what consideration was given to ASC 470-20 in recording a beneficial conversion feature.

Response:

The Company evaluated whether the conversion option in the Company’s 1.875% Convertible Senior Notes due 2016 (the “Notes”) (a copy of the indenture governing which was filed as Exhibit 4.1 to the Company’s Current Report on Form 8-K filed October 24, 2011) is an embedded derivative that should be bifurcated from the hybrid instrument (the convertible debt) pursuant to ASC 815.    The Company concluded that all the conditions in ASC 815-15-25-1 were met.  However, ASC 815-10-15-74(a) specifies that if an embedded conversion option (or other embedded derivative feature) is (i) indexed to the reporting entity’s own stock, and (ii) would be classified in shareholders’ equity if it were a freestanding derivative, then the conversion option (or other embedded feature)

would be excluded from the scope of ASC 815.  The Company concluded that the embedded conversion option is excluded from the scope of ASC 815, and thus would not be considered a derivative for purposes of applying ASC 815.  The Company’s analysis of the relevant accounting guidance is detailed below.

(i)

 Conversion option indexed to the Company’s own stock

ASC 815-40-15-7 requires that companies apply a two-step approach in evaluating whether an equity-linked financial instrument or embedded feature is indexed to its own stock.  The first step requires an evaluation of the instrument's contingent exercise provisions, if any.  As described in footnote #12 of the Company’s 2012 Form 10-K, the Notes do contain contingent exercise provisions that allow the holders the ability to exercise the instrument prior to maturity only under the following circumstances:

•

 During any calendar quarter commencing after the calendar quarter ending on December 31, 2011 (and only during such calendar quarter), if the last reported sale price of the Company's common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than or equal to 130% of the conversion price on each applicable trading day;

•

 During the five business day period after any ten consecutive trading day period (the “measurement period”) in which the Trading Price (as defined in the indenture governing the Notes), of the Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of the Company's common stock and the conversion rate on each such trading day;

•

 If the Company elects to issue to all or substantially all holders of its common stock any rights, options or warrants (other than pursuant to a rights plan) entitling them for a period of not more than 60 calendar days after the record date for such issuance, to subscribe for or purchase shares of the Company's common stock, at a price per share less than the average of the last reported sales prices of the Company's common stock for the ten consecutive day period ending on, and including, the trading day immediately preceding the declaration date for such issuance;

•

 Upon distribution to all or substantially all holders of the Company’s common stock its assets, debt securities or rights to purchase its securities (other than pursuant to a rights plan), which distribution has a per share value, as reasonably determined by the Company’s board of directors or a committee thereof, exceeding 10% of the last reported sale price of the Company’s common stock on the trading day preceding the declaration date for such distribution; or

•

 Upon the occurrence of the following specified corporate transactions: (i) a “person” or “group” within the meaning of Section 13(d) of the Exchange Act other than the Company or its subsidiaries, files a Schedule TO or any schedule, form or report under the Exchange Act disclosing that such person or group has become the direct or indirect ultimate “beneficial owner,” as defined in Rule 13d-3 under the Exchange Act, of the Company’s common equity representing more than 50% of the voting power of our common equity; (ii) consummation of any binding share exchange, exchange offer, tender offer, consolidation or merger of the Company pursuant to which all or substantially all of the Company’s common stock will be converted into cash, securities or other property or any sale, lease or other transfer in one transaction or a series of related transactions of all or substantially all of the consolidated assets of the Company, taken as a whole, to any person other than one or more of its

subsidiaries; provided, however, that any such event where the holders of more than 50% of the Company’s shares of common stock immediately prior to such event, own, directly or indirectly, more than 50% of all classes of common equity of the continuing or surviving person or transferee or the parent thereof immediately after such event shall not be a fundamental change; (iii) the Company’s  shareholders approve any plan or proposal for our liquidation or dissolution; or (iv) the Company’s common stock (or other common stock into which the notes are then convertible) ceases to be listed on at least one U.S. national securities exchange; excluding, in each case, a transaction or event in which at least 90% of the consideration, excluding cash payments for fractional shares, in the transaction or event consists of shares of common stock that are traded on a U.S. national securities exchange or that will be so traded when issued or exchanged in connection with the relevant transaction or event (“publicly traded securities”) and, as a result of the transaction or event, the Notes become convertible into such publicly traded securities, excluding cash payments for fractional shares.

The holder’s ability to exercise the conversion option early is not based on either (1) an observable market other than the market for the Company’s stock, or (2) an observable index other than an index calculated or measured solely by reference to the Company’s operations.  Thus, the conversion option satisfied the first step of the “indexed to the Company’s stock” analysis.

The second step in ASC 815-40-15-7 requires an analysis of the instrument’s (or embedded feature’s) settlement provisions to determine if the instrument’s settlement amount is based solely on the entity’s stock.  Per ASC 815-40-15-7C, if the settlement amount equals the difference between the fair value of a fixed number of the entity's equity shares and a fixed monetary amount or a fixed amount of a debt instrument issued by that entity, the instrument/feature would be considered indexed to an entity's own stock.  Additionally, per ASC 815-40-15-7D, if the instrument's strike price or the number of shares used to calculate the settlement amount are not fixed, the instrument (or embedded feature) would still be considered indexed to an entity's own stock if the only variables that could affect the settlement amount would also be inputs that are typically used to determine the fair value of a "fixed-for-fixed" forward or option on equity shares. "Anti-dilution" provisions that are designed to prevent a holder's position from being diluted should not prevent an instrument (or embedded derivative feature) from being considered indexed to an entity's own stock.  There is an implicit assumption in standard pricing models for equity-linked financial instruments that events such as the occurrence of a stock split, rights offering, dividend, or a spin-off will not occur or that the strike price of the instrument will be adjusted to offset the dilution caused by such events.  Accordingly, these anti-dilution provisions typically would be adjustments to the inputs to the fair value of a "fixed-for-fixed" forward or option on equity shares.  Refer to ASC 815-40-15-7G and 815-40-55-42 to 55-43 for guidance on this issue.  As disclosed in footnote #12 of the Company’s 2012 Form 10-K, the Company’s Notes contain certain make-whole and customary anti-dilution provisions.

Conversion rate adjustments will be made in the following circumstances: (i) if the Company issues solely shares of its common stock as a dividend or distribution on all or substantially all of its shares of common stock, or if the Company effects a share split or share combination of our common stock, (ii) if the Company distributes to all or substantially all holders of its common stock any rights, options or warrants entitling them for a period of not more than 45

days from the record date for such distribution to subscribe for or purchase shares of the Company’s common stock, at a price per share less than the average of the last reported sale prices of the Company’s common stock for the 10 consecutive trading-day period ending on, and including, the trading day immediately preceding the declaration date for such distribution, (iii) if the Company distributes shares of its capital stock, evidences of the Company’s indebtedness or other assets or property of the Company’s to all or substantially all holders of the Company’s common stock, excluding: dividends or distributions referred to in (i) and (ii) above, dividends or distributions paid exclusively in cash, and spin-offs, (iv) if the Company makes or pays any cash dividend or distribution to all, or substantially all, holders of its outstanding common stock, and (v) if (a) the Company makes a payment in respect of a tender offer or exchange offer for its common stock and (b) the cash and value of any other consideration included in the payment per share of common stock exceeds the average of the last reported sale prices of our common stock over the 10 consecutive trading-day period commencing on, and including, the trading day next succeeding the last date on which tenders or exchanges may be made pursuant to such tender or exchange offer.  The Company has concluded, based on its review of the guidance in ASC 815-40-55 (and related examples), that the conversion rate adjustments are considered to be indexed to the Company’s common stock.

In the event of a conversion upon a make-whole fundamental change (i.e., (i) a “person” or “group” within the meaning of Section 13(d) of the Exchange Act other than the Company or its subsidiaries, files a Schedule TO or any schedule, form or report under the Exchange Act disclosing that such person or group has become the direct or indirect ultimate “beneficial owner,” as defined in Rule 13d-3 under the Exchange Act, of the Company’s common equity representing more than 50% of the voting power of our common equity, or (ii) consummation of any binding share exchange, exchange offer, tender offer, consolidation or merger of the Company, in each case other than an event where holders of more than 50% of the Company’s common stock prior to such event own, directly or indirectly, more than 50% of all classes of common equity of the continuing or surviving person or transferee or the parent thereof immediately after such event, in the case of each of (i) and (ii) above other than a transaction where 90% of the consideration, excluding cash payments for fractional shares, in the transaction or event consists of publicly traded securities and, as a result of the transaction or event, the Notes become convertible into such publicly traded securities, excluding cash payments for fractional shares), the Company would settle conversions and issue additional shares (or, at its option, cash in lieu thereof), determined by reference to a table set forth in the agreement, the axes of which are stock price in the relevant transaction or event and the date of the relevant transaction or event, which is a commercially reasonable adjustment to the inputs used in the valuation of a fixed-for-fixed option.  The table was designed such that the aggregate fair value of the shares deliverable would be expected to approximate the fair value of the convertible debt instrument at the settlement date (i.e., to compensate the holder for the lost time value of the option in the event of a fundamental change).  As such, per ASC 815-40-55-46, this feature is considered indexed to the Company’s stock.  The anti-dilution provisions allow for the conversion rate to be adjusted based on formulas set forth in the agreement.  Further, the anti-dilution provisions in the contract generally give the note holders a level of protection that is the same as to what would be afforded by typical holders of outstanding shares.  Therefore, the Company has concluded that the conversion option is indexed to the Company’s stock.

(ii)

 Classified as shareholders’ equity if freestanding

Since the Company has the ability, at its election, to satisfy the conversion option in shares or cash or any combination of the two, the Company considered the guidance in ASC 815-40-25 and ASC 815-40-55 in assessing whether or not the conversion option would be classified as equity or a liability if it were freestanding.  The Company considered the following conditions/factors when performing its analysis:

•

 The Notes do not contain provisions that could require cash settlement upon conversion, other than where other holders of common stock receive cash (see subsequent bullet for further information).

•

 The “Fundamental Change” provisions of the contract would only require the principal (together with accrued and unpaid interest thereon) associated with the debt host to be repaid in cash.  If the Company undergoes a fundamental change, holders may require the Company to purchase all or a portion of their notes for cash at a price equal to 100% of the principal amount of the notes to be purchased plus any accrued and unpaid interest.  Furthermore, upon the occurrence of (i) any reclassification of the common stock, (ii) any consolidation, merger, combination or binding share exchange involving the Company, or (iii) any sale or conveyance to another person of all or substantially all of the property and assets of the Company, in each case as a result of which holders of common stock are entitled to receive cash, securities or other property or assets with respect to or in exchange for such common stock, the right to convert the notes into cash, shares of common stock or a combination of cash and shares is changed into a right to convert into cash, the kind and amount of shares of stock, securities or other property or assets (including cash or any combination thereof).  Accordingly, only in the event where holders of the common stock receive cash (cash merger) would the Co
2013-07-12 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
July 12, 2013

Via E-mail
Mr. Murray A. Goldberg
Chief Financial Officer
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY  10591 -6707

Re: Regeneron  Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31 , 2012
Filed February  15, 2013
File No . 000-19034

Dear M r. Goldberg :

We have limited our review  to only your financial statements and related disclosures and
do not intend to expand our review to other portions of your documents.  In our comments , we
ask you to provide us with information so we may better understand your disclosure.

Please respond to this letter within 10 business days by providing the requested
information  or by advising us when you will provide the requested response.   If you do not
believe a comment appl ies to your facts and circumstances, please tell us why in your response.
Please furnish us a letter on EDGAR under the form type label CORRESP that key s your
responses to our comments.

After reviewing the information provided, we may have additional comments and/or
request that you amend your filing.

Notes to the Consolidat ed Financial Statements

Note 12. Convertible Debt, page F -26

1. You state that the conversion price is adjustable under certain circumstances.  Please provide
us your analysis of why you do not believe the conversion option is a derivative pursuant to
ASC 81 5.  If you do not believe the conversion option is required to be recorded as a
derivative, p lease tell us what consideration was given to ASC  470-20 in recording  a
beneficial conversion feature.

2. You state that the warrants have an initial strike price of  $103.41 per share.  If the strike price
may fluctuate, please tell us under what conditions the strike price may change and why you
believe the warrants are not required to be accounted for as a derivative.  Also, please
provide us your analysis relating to the accounting treatment for the convertible note hedge
and why you do not believe it is required to be recorded as a derivative.  Tell us the terms of
the hedge, including the customary anti -dilution adjustments.   Provide us the  literature you

Mr. Murray A. Goldberg
Regeneron Pharmaceuticals, Inc.
July 1 2, 2013
Page 2

 are usin g to support recording the hedge as a reduction to additional paid -in capital.  For both
the warrant and the convertible note hedge, provide us your analysis as to why you believe
they are indexed to the company’s common stock under ASC 815 -40.  Also, refe r to ASC
815-10-15-83 in your analysis.

We urge all persons who are responsible for the accuracy and adequacy of the disclosure
in the filing to be certain that the filing  include s the information the Securities Exchange Act of
1934 and all applicable Exc hange 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 comment s, 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 Com mission 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.

You may contact Christine Allen, Staff Accountant , at (202) 551 -3652  or Mary Mast ,
Senior Staff Accountant , at (202) 551 -3613 if you have questions regarding the comment s.  In
this regard, do not hesitate to contact me at (202) 551 -3679.

Sincerely,

/s/ Jim B. Rosenberg

Jim B. Rosenberg
Senior Assistant Chief Accountant
2009-08-25 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
Via Facsimile and U.S. Mail Mail Stop 4720                                                                                                   August 25, 2009  Leonard S. Schleifer, M.D., Ph.D.    Chief Executive Officer    Regeneron Pharmaceuticals, Inc. 777 Old Saw Mill River Road Tarrytown, New York 10591-6707
Re: Regeneron Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2008 Filed February 26, 2009 File Number 000-19034

Dear Dr. Schleifer:

We have completed our review of your Fo rm 10-K and related filings and have no
further comments at this time.

Sincerely,

  Jeffrey Riedler,  Assistant Director
2009-08-19 - CORRESP - REGENERON PHARMACEUTICALS, INC.
CORRESP
1
filename1.htm

[REGENERON LETTERHEAD]

      August 19, 2009

BY EDGAR

Mr. Jeffrey Riedler
Assistant Director

Securities and Exchange
Commission
Division of Corporation Finance
100 F Street, NE

Washington, D.C. 20549

                  RE:

      Regeneron Pharmaceuticals, Inc.

Form 10-K for the fiscal year ended
      December 31, 2008
Filed February 26, 2009
Definitive Proxy Statement
      on Schedule 14A
Filed April 24, 2009
File No. 000-19034

Dear Mr. Riedler:

     This letter
sets forth the response of Regeneron Pharmaceuticals, Inc., a New York
corporation (the “Company”), to the additional comments of the staff of the
Securities and Exchange Commission (the “Staff”) set forth in the Staff’s letter
of August 10, 2009 (the “Comment Letter”) to Leonard S. Schleifer, M.D., Ph.D.,
President and Chief Executive Officer of the Company, regarding the
above-referenced definitive proxy statement on Schedule 14A (the “2009 Annual
Meeting Proxy Statement”). For the convenience of the Staff, this letter
restates in bold the comment in the Comment Letter, and immediately thereafter
sets forth the Company's response.

Mr. Jeffrey Riedler
Assistant Director

Securities and Exchange Commission
August
19, 2009
Page 2

Performance Based Vesting Stock
Options, page 25

    1.

      We note your response to comment
      5. Please provide proposed disclosure that you intend to provide in your
      proxy statement for the year 2009 which expands upon your description of
      the “point scale system” for the vesting of your performance based vesting
      stock options. Please include the following in your proposed disclosure:

  Discussion of the specific number of
  points or range of points awarded based on achievement of each of the
  development milestones you identify;

  Discussion of how the number of
  points earned corresponds to the amount of stock options that vest;

  Discussion of the minimum number of
  points that must be earned during the Performance Period for any of the
  performance based vesting options to vest; and,

  To the extent applicable, discussion
  of whether the Compensation Committee can exercise its discretion with regard
  to any of the bullets identified above.

     Please see
Exhibit A attached hereto. In compliance with the Staff’s comment, Exhibit A
sets forth proposed disclosure expanding upon the Company’s description in the
2009 Annual Meeting Proxy Statement of the “point scale system” for the vesting
of the Company’s performance based vesting stock options. Subject to appropriate
factual updating, the Company intends to include in its 2010 Annual Meeting
Proxy Statement disclosure in substantially the form set forth on Exhibit A. For
the convenience of the Staff, the text of Exhibit A has been marked to show
changes to the analogous paragraphs under the caption “Performance Based Vesting
Stock Options” in the 2009 Annual Meeting Proxy Statement. The proposed
disclosure set forth on Exhibit A includes the information requested in each of
the bullet points in the Staff’s comment. In this regard, the Company notes that
the last bullet point is addressed in and subsumed by the first sentence of the
last paragraph of the text of Exhibit A.

* * *

     As requested by the Staff, the
Company acknowledges that:

           (i) The Company is responsible for the adequacy and accuracy of the
      disclosure in the filings;

           (ii) Staff comments or changes to disclosure in response to Staff
      comments do not foreclose the Commission from taking any action with
      respect to the filings; and

           (iii) 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. Jeffrey Riedler
Assistant Director

Securities and Exchange Commission
August
19, 2009
Page 3

     If you have
any questions regarding the foregoing, please contact me at (914) 345-7498.

      Very truly yours,
REGENERON PHARMACEUTICALS, INC.

      /s/ Stuart A. Kolinski

      Stuart A. Kolinski
Senior Vice President, General Counsel
and Secretary

    cc:

      Securities and Exchange
      Commission
Bryan Pitko

      Skadden, Arps, Slate, Meagher & Flom LLP
Kent A. Coit, Esq.
Timothy F. Nelson,
    Esq.

Mr. Jeffrey Riedler
Assistant Director

Securities and Exchange Commission
August
19, 2009
Page 4

EXHIBIT A

Performance Based Vesting Stock
Options: These non-qualified stock options
will be eligible to vest on December 31 three years following the date of grant, 2011.
The number of stock options that will vest on that date will be determined based
on a point scale system, where points are earned upon the achievement of product
candidate development milestones between grant date and the vesting dateDecember 31, 2011 (the
Performance Measurement Period). The development milestones and the points
earned for achieving the development milestones are described below:

  filing of the first Investigational New
  Drug Application for a new product candidate (2 points each);

  data from a successful proof of concept
  study testing one of our product candidates (2 or 4 points each);

  filing of a Biologics License
  Application for one of our product candidates (5 or 7 points each); and

  approval of a Biologics License
  Application for one of our product candidates (20 or 28 points each).

     Later stage
development milestones earn incrementally more points than the earlier stage
development milestones. For the last three milestones described above, the
greater number of points more points areis earned for novel drug candidates and diseases and
the lesser number of points is earned than for follow-on product candidates with
potential competitive advantages over existing drugs that are approved for the
treatment of a disease.

     The number
of stock options from the award that will vest on the applicable December 31
vesting date will be calculated by multiplying the total number of stock options
subject to the award by a fraction, the numerator of which is the total number
of points earned during the Performance Measurement Period and the denominator
of which is 38, provided that no more than one hundred percent of the stock
option award can vest. If at least twelve a certain minimum number of points are not earned during the
Performance Measurement Period, or the applicable Named Officer ceases to be
employed by the company before the end of the Performance Measurement Period
(other than for reasons related to a change of control as discussed under the
heading Post-Employment Compensation on page 34), then none of the performance
based vesting stock options granted under the award will vest. Moreover, if we
do not file a Biologics License Application for at least one product candidate
during the Performance Measurement Period, then the maximum number of
performance based vesting stock options that can vest on the vesting dateDecember 31, 2011 is
capped at two-thirds of the total award, unless otherwise determined by the
Compensation Committee.

Mr. Jeffrey Riedler
Assistant Director

Securities and Exchange Commission
August
19, 2009
Page 5

     The
Compensation Committee retains the discretionright to accelerate the vesting of the
performance based stock options, either in whole or in part. Vesting of these
stock options may accelerate following a change of control as described under
the heading Post-Employment Compensation on page 34. As with the time based
vesting stock options, the performance based vesting stock options have a
ten-year term.
2009-08-10 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
Via Facsimile and U.S. Mail Mail Stop 4720                                                                                                   August 10, 2009  Leonard S. Schleifer, M.D., Ph.D.    Chief Executive Officer    Regeneron Pharmaceuticals, Inc. 777 Old Saw Mill River Road Tarrytown, New York 10591-6707
Re: Regeneron Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2008 Filed February 26, 2009 File Number 000-19034

Dear Dr. Schleifer:
  We have reviewed your response to our comments and have the following additional comments.   In our comments, we ask you to provide us with information to
better understand your disclosure. Where it requests you to revise disclosure, the
information you provide should show us what the revised disclosure will look like and
identify the annual or quarterly filing, as a pplicable, in which you in tend to first include
it. If you do not believe that revised disclosu re is necessary, expl ain the reason in your
response.  After reviewing the informati on 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.

Definitive Proxy Statement

 Performance Based Vesti ng Stock Options, page 25

1. We note your response to comment 5.  Pl ease provide proposed disclosure that
you intend to provide in your  proxy statement for the year 2009 which expands
upon your description of the “point scale system” for the vesting of your performance based vesting stock options .  Please include the following in your
proposed disclosure:

Leonard S. Schleifer, M.D., Ph.D.
Regeneron Pharmaceuticals, Inc. August 10, 2009 Page 2

• Discussion of the specific number of poi nts or range of points awarded based
on achievement of each of the development milestones you identify;
• Discussion of how the number of points  earned corresponds to the amount of
stock options that vest;
• Discussion of the minimum number of poi nts that must be earned during the
Performance Period for any of the perfo rmance based vesting options to vest;
and,
• To the extent applicable, discussion of whether the Compensation Committee
can exercise its discretion w ith regard to any of the bullets identified above.

*    *    *    *
 Please respond to these comments within  10 business days or tell us when you
will provide us with a response.  Please furnish a cover letter that keys your responses to
our comments and provide any requested inform ation.  Detailed letter s greatly facilitate
our review.  Please file y our 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.
  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 any 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 person under the federal secu rities laws of the
United States.

Leonard S. Schleifer, M.D., Ph.D.
Regeneron Pharmaceuticals, Inc. August 10, 2009 Page 3
 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 comment on your filing.
Please contact Bryan Pitko at  (202) 551-3203 with any quest ions.  In this regard,
please feel free to cont act me at (202) 551-3715.

Sincerely,

  Jeffrey Riedler,  Assistant Director
2009-07-27 - CORRESP - REGENERON PHARMACEUTICALS, INC.
CORRESP
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    Stuart Kolinski, Esq.
    Phone
    914 345 7498

    Senior Vice President & General
      Counsel
    Fax
    914 345 7721

    Regeneron Pharmaceuticals, Inc.
    www.regeneron.com

    777 Old Saw Mill River Road

    Tarrytown, NY 10591-6707

      July 27, 2009

BY EDGAR

Mr. Jeffrey Riedler
Assistant Director

Securities and Exchange Commission

Division of Corporation Finance
100 F Street, NE
Washington, D.C. 20549

    RE:

    Regeneron
      Pharmaceuticals, Inc.

    Form 10-K for
      the fiscal year ended December 31, 2008

    Filed February
      26, 2009

    Definitive Proxy
      Statement on Schedule 14A

    Filed April 24,
      2009

    File No.
      000-19034

Dear Mr. Riedler:

This letter sets forth the responses of
Regeneron Pharmaceuticals, Inc., a New York corporation (the “Company”), to the
comments of the staff of the Securities and Exchange Commission (the “Staff”)
set forth in the Staff’s letter of July 15, 2009 (the “Comment Letter”) to
Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of the
Company, regarding the above-referenced annual report on Form 10-K (the “Form
10-K”) and the above-referenced definitive proxy statement on Schedule 14A (the
“Proxy Statement”). For the convenience of the Staff, this letter restates in
bold each of the comments in the Comment Letter, and immediately thereafter sets
forth the Company's response. Capitalized terms used and not defined regarding
the Form 10-K or Proxy Statement have the meanings to such terms given in the
Form 10-K or Proxy Statement, as applicable. References to page numbers and
captions correspond to the page numbers and captions in the Form 10-K or the
Proxy Statement as indicated.

Form 10-K for the year ended
December 31, 2008

Item 1.
Business
Patents. Trademarks, and Trade Secrets, page
11

1.
Please expand your intellectual property
disclosure to identify your material patents and patent applications, discuss
the technology and product candidates dependent on these patents and disclose
their respective expiration dates. Where you have licensed a material patent
from another party, please identify the licensor, describe the terms of your
agreement, and ensure that the license agreement has been filed as an exhibit to
your filing. It may be helpful to provide your revised disclosure in chart form.

In our future Form 10-K filings, we will
expand our discussion of intellectual property in compliance with the Staff's
comment. Specifically, subject to updating to reflect changes in our
intellectual property rights after the date hereof, we propose that the
disclosure under the caption Patents, Trademarks and Trade Secrets will be
substantially as follows:

“Our success depends, in part, on our
ability to obtain patents, maintain trade secret protection, and operate without
infringing on the proprietary rights of third parties (see “Risk Factors –
We may be restricted in our development and/or
commercialization activities by, and could be subject to damage awards if we are
found to have infringed, third party patents or other proprietary
rights.”). Our policy is to file patent
applications to protect technology, inventions, and improvements that we
consider important to our business and operations. As of December 31, 2008, we
held an ownership interest in a total of approximately 150 issued patents in the
United States and over 670 issued patents in foreign countries with respect to
our products and technologies. In addition, we held an ownership interest in
hundreds of patent applications in the United States and foreign
countries.

Our patent portfolio includes granted
patents and pending patent applications covering our VelociSuite™ technologies,
including our VelocImmune® mouse platform which produces fully human monoclonal
antibodies. Our issued patents covering these technologies generally expire
between 2020 and 2030. However, we continue to file patent applications directed
to improvements to these technology platforms.

Our patent portfolio also includes issued
patents and pending applications relating to our marketed product, ARCALYST®,
and our product candidates in clinical development. These patents cover the
proteins and DNA encoding the proteins, manufacturing patents, method of use
patents, pharmaceutical compositions, as well as various methods of using the
products. For each of ARCALYST and our late-stage clinical candidates,
aflibercept (VEGF Trap) and the VEGF Trap-Eye, these patents generally expire
between 2020 and 2026. However, the projected patent terms may be subject to
extension based on potential patent term extensions in countries where such
extensions are available.

We also are the nonexclusive licensee of a
number of additional patents and patent applications. In July 2008 we entered
into an Amended and Restated Non-Exclusive License Agreement with Cellectis S.A.
pursuant to which we licensed certain patents and patent applications relating
to a process for the specific replacement of a copy of a gene in the receiver
genome by homologous recombination. Pursuant to this agreement, we agreed to pay
Cellectis a low, single-digit royalty based on any future revenue received by us
from any future licenses or sales of our VelociGene® or VelocImmune products or
services. No royalties are payable on any revenue from commercial sales of
antibodies from our VelocImmune technology. We also have non-exclusive license
agreements with Amgen and other organizations for patent rights related to
ARCALYST. In exchange for these licenses, we pay a mid-single digit royalty on
net sales of ARCALYST.

Patent law relating to the patentability
and scope of claims in the biotechnology field is evolving and our patent rights
are subject to this additional uncertainty. The degree of patent protection that
will be afforded to our products in the United States and other important
commercial markets is uncertain and is dependent upon the scope of protection
decided upon by the patent offices, courts and governments in these countries.
There is no certainty that our existing patents or others, if obtained, will
provide us protection from competition or provide commercial benefit.

Others may independently develop similar
products or processes to those developed by us, duplicate any of our products or
processes or, if patents are issued to us, design around any products and
processes covered by our patents. We expect to continue, when appropriate, to
file product and process applications with respect to our inventions. However,
we may not file any such applications or, if filed, the patents may not be
issued. Patents issued to or licensed by us may be infringed by the products or
processes of others.

Defense and enforcement of our
intellectual property rights is expensive and time consuming, even if the
outcome is favorable to us. It is possible that patents issued or licensed to us
will be successfully challenged, that a court may find that we are infringing
validly issued patents of third parties, or that we may have to alter or
discontinue the development of our products or pay licensing fees to take into
account patent rights of third parties.”

Item 15. Exhibits and Financial
Statement Schedules, page 58

2.
Please file your August 2008 agreement
with sanofi-aventis, in relation to their use of your VelociGene platform, as an
exhibit to your filing or identify the filing in which this agreement will be
filed as an exhibit. Please note that we will not be in a position to clear our
comment until this agreement has been filed.

The Company did not include its August
2008 agreement with sanofi-aventis as an exhibit to the Form 10-K because it
considers that agreement to be both made in the ordinary course
and not
material to the Company, and therefore not a required exhibit under Item 601(10)
of Regulation S-K. The ordinary course nature of this agreement is evidenced by
the fact that the Company has entered into similar agreements with a number of
other parties (e.g., Serono, the Karolinska Institute, the Gates Foundation, the
Spinal Muscle Atrophy (SMA) Foundation, etc.) whereby, as with the mouse
purchase agreement with sanofi-aventis, such parties pay specified amounts to
the Company for the Company to supply them with genetically modified mammalian
models of gene function and disease. Moreover, like these other agreements, the
VelociGene® agreement with sanofi-aventis is not material to the Company from a
financial or any other perspective. The Company is entitled to receive
approximately $4 million annually under the agreement, and the existence or
non-existence of this agreement does not affect the Company's rights or
obligations under its larger, worldwide antibody collaboration with
sanofi-aventis. In light of the foregoing, the Company believes that the
VelociGene® agreement with sanofi-aventis is not a required exhibit to the Form
10-K, and respectfully requests that the Staff reconsider this comment.

Definitive Proxy
Statement

Executive Compensation, page
21
Compensation Discussion and Analysis

3.
Please identify the “nationally recognized
surveys” that your Compensation Committee uses to benchmark compensation for
your NEOs.

The nationally recognized compensation
survey used by the Compensation Committee to benchmark 2008 compensation for the
Company's Named Officers is the Radford Global Life Sciences Survey. If the
Compensation Committee continues to use one or more nationally recognized
compensation surveys to benchmark compensation for the Company's Named Officers,
in future annual meeting proxy statements such compensation survey(s) will be
identified. Specifically, by reference to the Proxy Statement, the second
sentence of the last paragraph under the caption "Peer Group" (on page 22) would
be revised to read as follows:

"In addition, management and the
Compensation Committee reviewed compensation data for biotechnology companies
from the Radford Global Life Sciences Survey to benchmark total compensation
paid to our Named Officers."

Cash Bonus, page
23

4.
We note that your disclosure in relation
to the cash bonus for NEOs does not describe how the listed corporate
performance goals and individual contributions are assessed to determine the
“personal performance multiplier” and “company performance multiplier.” Please
provide us with draft disclosure for your 2009 proxy statement which provides
the following:

Disclosure of specific corporate
performance objectives and personal performance objectives used to calculate the
applicable multiplier(s) for each NEO; Identification of specific target figures
for each objective to the extent that multipliers are calculated based on the
achievement of quantified performance targets;
Discussion of how the level of achievement in relation to the
objectives is assessed to determine the respective “personal performance
multiplier” and “company performance multiplier;” and,
Confirmation that you
will discuss the level of achievement with respect to these objectives in your
2009 proxy statement.

The payment of annual cash bonuses to the
Company’s Named Officers with respect to the 2008 fiscal year was based entirely
upon the discretion of the Company’s Compensation Committee. As stated on page
23 of the Proxy Statement “Although each Named Officer is eligible to receive an
annual bonus, we historically have had no formal bonus plan and the granting of
any bonus to a Named Officer is entirely at the discretion of the Compensation
Committee.” Specifically, the company performance multiplier was determined
based on the Compensation Committee’s subjective assessment of the Company’s
performance with respect to the general corporate goals described on pages 23
and 24 of the Proxy Statement. Similarly, the determination of the personal
performance multiplier was based upon a subjective assessment by the
Compensation Committee of the particular Named Officer’s performance. There
were, however, no specific target achievement levels, and no specific formulas
or metrics by which to measure performance, established with respect to these
company and personal goals. Thus, the determination of the company and personal
performance multipliers were made by the Compensation Committee in its
discretion and not by the application of any pre-established formulas to
specific performance targets. The Compensation Committee is continuing in its
2009 fiscal year the practice of determining annual bonus payments to its Named
Officers on a discretionary basis. Although the disclosure in the Proxy
Statement does describe the discretionary nature of these annual bonuses, the
Company will, in its 2009 proxy statement, provide additional disclosure to
reinforce this fact. Specifically, the Company expects to include in its 2009
proxy statement a sentence substantially as follows:

“Both the personal performance multiplier
and the company performance multiplier were determined by the Compensation
Committee in its discretion based on the Committee’s subjective assessment of
the Company’s performance of the general corporate goals described on pages 23
and 24 and the Named Officers’ performance during the year.”

Performance Based Vesting Stock
Options, page 25

5.
We note that the vesting of your
performance based vesting stock options is determined based on points earned for
the achievement of “product candidate development milestones.” Please provide
additional disclosure about how these stock options vest under your “point scale
system.” In particular, please provide us with draft disclosure for your 2009
proxy statement which provides the following:

A discussion of how many points were
earned by NEOs based upon the achievement of development milestones in 2008;

A discussion of the specific points attributed to each respective
achievement; and,
The number of options that vested as a result of the points
earned.

The performance based vesting stock
options described in the Proxy Statement were granted very late in the 2008
fiscal year. As stated on page 24 of the Proxy Statement, “stock option awards
were granted to our Named Officers and other eligible employees on December 17,
2008.” As described below, none of the performance based vesting stock options
vested in 2008.

As disclosed in the Proxy Statement,
points may be earned with respect to the vesting of the stock options upon the
achievement of product candidate development milestones "between the grant date
and December 31, 2011 . . ." However, the Company wishes to emphasize that (as
is also disclosed in the Proxy Statement), the performance based vesting stock
options described in the Proxy Statement are generally not eligible to vest
until December 31, 2011, and only if the recipient remains continuously employed
through that date, irrespective of the number of points earned through that
date. Accordingly, the Company believes that the disclosure requested by the
Staff with respect to the performance based vesting stock options would be
material and appropriate in the proxy statement covering the year in which such
options actually vest, if such vesting were to occur. In the case of the
performance based vesting stock options described in the Proxy Statement, this
disclosure would be included in the 2012 annual meeting proxy statement, as the
options will generally only be eligible to vest on December 31, 2011 (assuming
no accelerated vesting in the interim due to a change in control or exercise of
Compensation Committee discretion). Only on the vesting eligibility date for any
grant of performance based vesting options will it be possible to know the
extent to which such option grant has vested.

In this regard, the Company also notes
that it expects that similar grants of performance based vesting stock options
will be made in the future on an annual basis. As a result, the Company expects
that in the future there will be multiple performance based v
2009-07-15 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
Via Facsimile and U.S. Mail Mail Stop 4720                                                                                                   July 15, 2009 Leonard S. Schleifer, M.D., Ph.D.    Chief Executive Officer    Regeneron Pharmaceuticals, Inc. 777 Old Saw Mill River Road Tarrytown, New York 10591-6707
Re: Regeneron Pharmaceuticals, Inc.
Form 10-K for the Fiscal Year Ended December 31, 2008 Filed February 26, 2009 File Number 000-19034

Dear Dr. Schleifer:
  We have reviewed your filing and have the following comments.   In our comments, we ask you to provide us with  information to better understand your
disclosure. Where it requests you to revise disclosure, the information you provide should
show us what the revised di sclosure will look like and iden tify 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 r eason in your response.  After reviewing the
information provided, we may raise additiona l 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.

Form 10-K for the Fiscal Year Ended December 31, 2008

Item 1. Business
Patents, Trademarks, and Trade Secrets, page 11

1. Please expand your intellectual property di sclosure to identify your material
patents and patent applications, disc uss the technology and product candidates
dependent on these patents and disclose th eir respective expirati on dates.   Where
you have licensed a material patent fr om another party, please identify the
licensor, describe the terms of your ag reement, and ensure that the license

Leonard S. Schleifer, M.D., Ph.D.
Regeneron Pharmaceuticals, Inc. July 15, 2009 Page 2
 agreement has been filed as an exhibit to your filing.  It may be helpful to provide
your revised disclosure in chart form.

Item 15. Exhibits and Financia l Statement Schedules, page 58

2. Please file your August 2008 agreement with  sanofi-aventis, in relation to their
use of your VelociGene platform, as an e xhibit to your filing or identify the filing
in which this agreement will be filed as an exhibit.  Please note that we will not be in a position to clear our comment until this agreement has been filed.

Definitive Proxy Statement

 Executive Compensation, page 21

Compensation Discussion and Analysis

3. Please identify the “nationally recogni zed surveys” that your Compensation
Committee uses to benchmark compensation for your NEOs.
 Cash Bonus, page 23

4. We note that your disclosure in relatio n to the cash bonus for NEOs does not
describe how the listed cor porate performance goals and individual contributions
are assessed to determine the “personal performance multiplier” and “company performance multiplier.”  Please provide us with draft disclosure for your 2009
proxy statement which pr ovides the following:
• Disclosure of specific corporate performance objectives and personal
performance objectives used to calculat e the applicable multiplier(s) for each
NEO;
• Identification of specific target figures for each objective to the extent that
multipliers are calculated based on the achievement of quantified performance targets;
• Discussion of how the level of achieveme nt in relation to the objectives is
assessed to determine the respective “personal performance multiplier” and “company performance multiplier;” and,
• Confirmation that you will discuss the le vel of achievement with respect to
these objectives in your 2009 proxy statement.

Performance Based Vesti ng Stock Options, page 25

5. We note that the vesting of your perfor mance based vesting stock options is
determined based on points earned for the achievement of “product candidate development milestones.”   Please provide  additional disclosure about how these
stock options vest under your “ point scale system.”  In particular, please provide
us with draft disclosure for your 2009 proxy statement which provides the
following:

Leonard S. Schleifer, M.D., Ph.D.
Regeneron Pharmaceuticals, Inc. July 15, 2009 Page 3
 • A discussion of how many points were  earned by NEOs based upon the
achievement of development milestones in 2008;
• A discussion of the specific points attr ibuted to each respective achievement;
and,
• The number of options that vested as a result of the points earned.

 Grants of Plan-Based Awards Table on page 29.

6. We note your statement that no non-equity incentive plan awards were granted in
2008.  However, we also note that your annual cash bonus was paid to NEOs in
the form of non-equity compensation ba sed upon the achievement of performance
objectives over a specified period of time.  As such, this compensation appears to
have been paid pursuant to a non-equity  incentive plan as defined in Item
402(a)(6)(iii) of Regulation S-K.  See also Question 119.02 of the Regulation S-K
Compliance and Disclosure Interpreta tions at the following web address:
http://www.sec.gov/divisions/corpfin/cfguida nce.shtml.  Please provide us with
your analysis for why the annual cash bonus is not non-equity incentive plan
compensation that must be reflecte d under Column (g) to your Summary
Compensation Table and in the Grants of Plan-Based Awards Table.

*    *    *    *

Please respond to these comments within  10 business days or tell us when you
will provide us with a response.  Please furnish a cover letter that keys your responses to
our comments and provide any requested inform ation.  Detailed letter s greatly facilitate
our review.  Please file y our 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.
  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 any 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 person under the federal secu rities laws of the
United States.

Leonard S. Schleifer, M.D., Ph.D.
Regeneron Pharmaceuticals, Inc. July 15, 2009 Page 4
 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 comment on your filing.
Please contact Bryan Pitko at  (202) 551-3203 with any quest ions.  In this regard,
please feel free to cont act me at (202) 551-3715.

Sincerely,

  Jeffrey Riedler,  Assistant Director
2007-07-23 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
Mail Stop 6010
Via Facsimile and U.S. Mail

                                                                                                July 18, 2007

Dr. Leonard S. Schleifer, M.D., Ph.D
President and Chief Executive Officer
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591-6707

Re:      Regeneron Pharmaceuticals, Inc.
Form 10-K for fiscal year ended December 31, 2006
            File No. 000-19034

Dear Dr. Schleifer:

We have completed our review of your Form 10-K and have no further comments
at this time.

Sincerely,

Jim B. Rosenberg
Senior Assistant Chief Accountant
2007-05-29 - CORRESP - REGENERON PHARMACEUTICALS, INC.
CORRESP
1
filename1.htm

May 29, 2007

BY EDGAR

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Securities and Exchange Commission

Division of Corporation Finance

Mail Stop 6010

100 F Street, NE

Washington, D.C. 20549

RE:

Regeneron Pharmaceuticals, Inc.

Form 10-K for the fiscal year ended December 31, 2006

File No. 000-19034

Dear Mr. Rosenberg:

This letter sets forth the responses of Regeneron Pharmaceuticals, Inc., a New York corporation (the “Company”), to the comments of the staff of the Securities and Exchange Commission (the “Staff”) set forth in the Staff’s letter of May 10, 2007 (the “Comment Letter”) to Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of the Company, regarding the above-referenced annual report on Form 10-K (the “Annual Report”). For the convenience of the Staff, we have restated in this letter each of the comments in the Comment Letter and numbered each of the responses to correspond with the numbers of the comments in the Comment Letter. Capitalized terms used and not defined regarding the Annual Report have the meanings given in the Annual Report. All references to page numbers and captions correspond to the page numbers and captions in the Annual
Report.

Form 10-K for the year ended December 31, 2006

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Research and Development Expenses, page 36

1.

We believe your disclosure related to research and development expenses could be improved by separately quantifying costs incurred for your product candidates, principally VEGF Trap-Oncology, VEGF Trap-Eye and IL-1 Trap and provide information that would allow investors to determine the reasonably likely timing for commercialization of your lead drug candidates and related revenue generation. Please provide in disclosure-type format the

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Securities and Exchange Commission

Page 2

following information for each of your major research and development projects. 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.hmt#secviii

a.

The costs incurred during each period presented and to date on the project;

b.

The nature, timing and estimated costs of the efforts necessary to complete the project;

c.

The anticipated completion date for the project;

d.

The risks and uncertainties associated with completing development on schedule, and the consequences to operations, financial position and liquidity if the project is not completed timely; and,

e.

The period in which material net cash inflows from the project are expected to commence.

Regarding “a,” if you do not maintain any research and development costs by project, 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 “b” and “c,” provide the amount or range of estimated costs and timing to complete the phase in the process and each future phase. To the extent that information is not estimable, describe those facts and circumstances indicating the uncertainties that prelude you from making a reasonable estimate.

The Company acknowledges the Staff’s comment. We disclosed on pages 36 and 37 of the Annual Report the major categories of our research and development expenses and primary causes of year to year fluctuations in the principal cost components of research and development expenses for the periods presented. This discussion included references to the clinical programs for our lead product candidates. In future filings, we will expand our discussion of research and development expenses to address the issues in “a” through “e” above to the extent appropriate. We have provided estimates of research and development costs for clinical development programs for 2006 and 2005. Cumulative costs for projects from inception are not available, as we do not compile full project costs for projects in discovery or preclinical stages. Our disclosure would be supplemented substantially as
follows:

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Securities and Exchange Commission

Page 3

Drug development and approval in the United States is a multi-step process regulated by the FDA. The process begins with discovery and preclinical evaluation, leading up to the submission of an IND to the FDA which, if successful, allows the opportunity for study in humans, or clinical study, of the potential new drug. Clinical development typically involves three phases of study: Phase 1, 2 and 3. The most significant costs in clinical development are in Phase 3 clinical trials, as they tend to be the longest and largest studies in the drug development process. Following successful completion of Phase 3 clinical trials for a biological product, a biologics license application (or BLA) must be submitted to, and accepted by, the FDA, and the FDA must approve the BLA prior to commercialization of the drug. It is not uncommon for the FDA to request additional data following its
review of a BLA, which can significantly increase the drug development timeline and expenses. We may elect either on our own, or at the request of the FDA, to conduct further studies that are referred to as Phase 3B and 4 studies. Phase 3B studies are initiated and either completed or substantially completed while the BLA is under FDA review. These studies are conducted under an IND. Phase 4 studies, also referred to as post-marketing studies, are studies that are initiated and conducted after the FDA has approved a product for marketing. In addition, as discovery research, preclinical development, and clinical programs progress, opportunities to expand development of drug candidates into new disease indications can emerge. We may elect to add such new disease indications to our development efforts (with the approval of our collaborator for joint development programs), thereby extending the period during which we will be developing a product. For example, we, and our collaborators, where applicable,
continue to explore further development of the IL-1 Trap, VEGF Trap, and VEGF Trap-Eye in different disease indications.

There are numerous uncertainties associated with drug development, including uncertainties related to safety and efficacy data from each phase of drug development, uncertainties related to the enrollment and performance of clinical trials, changes in regulatory requirements, changes in the competitive landscape affecting a product candidate, and other risks and uncertainties described under “Risk Factors -- Risks Related to Development of our Product Candidates,” “--Regulatory and Litigation Risks”, and “--Risks Related to Commercialization of Products.” The lengthy process of seeking FDA approvals, and subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources. Any failure by us to obtain, or delay in obtaining, regulatory approvals could materially adversely affect our business. We cannot assure you
that we will obtain any approval required by the FDA on a timely basis, if at all.

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Securities and Exchange Commission

Page 4

We budget our research and development costs by expense category, rather than by project. We also prepare estimates of research and development costs for projects in clinical development, which include direct costs and allocations of certain costs such as indirect labor, non-cash stock-based employee compensation expense related to stock option awards, and manufacturing and other costs related to activities that benefit multiple projects. Our estimates of research and development costs for clinical development programs are shown below:

(In millions)

Year ended December 31,

Project Costs

2006

2005

Increase

(Decrease)

VEGF Trap – Oncology

$30.7

$27.8

$2.9

VEGF Trap- Eye

21.9

9.3

12.6

IL-1 Trap

29.6

57.2

(27.6)

Other research programs & unallocated costs

54.9

61.3

(6.4)

Total research and development expenses

$137.1

$155.6

($18.5)

For the reasons described above and due to the variability in the costs necessary to develop a product, the uncertainties related to future indications to be studied, the estimated cost and scope of the projects, and uncertainty as to our ultimate ability to obtain governmental approval for commercialization, accurate and meaningful estimates of the total cost to bring our product candidates to market are not available. Similarly, we are currently unable to reasonably estimate if our product candidates will generate product revenues and material net cash inflows. We plan to submit a BLA for our IL-1 Trap for the treatment of CAPS, a spectrum of rare genetic disorders, in the second quarter of 2007. We cannot predict whether or when the commercialization of the IL-1 Trap in CAPS will result in a material net cash inflow to the company.

Funding Requirements, page 44

2.

Please explain in disclosure-type format your basis for omitting estimated payments from the table of contractual obligations that appear reasonably likely to arise from your research and development agreements with sanofi-aventis and Bayer Healthcare LLC. Discuss how profitability will be measured, your expected timing for achieving profitability and payment of development expense reimbursements if the collaborations are profitable.

The Company advises the Staff that under our research and development agreement with sanofi-aventis, the Company will be obligated to reimburse sanofi-aventis for 50% of the development expenses incurred by both companies out of our share of any future profits generated by the collaboration. We will repay sanofi-aventis for these development expenses in accordance with a formula based on the amount of development expenses incurred under the research and

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Securities and Exchange Commission

Page 5

development agreement and our share of profits generated in a calendar quarter. We disclosed this obligation in the Annual Report on page 42 (see “Liquidity and Capital Resources -- Collaboration with the sanofi-aventis Group”) and on page 30 (see “Collaborations -- The sanofi-aventis Group”).

We are unable to estimate development costs over the term of the sanofi-aventis arrangement which would be subject to reimbursement. These reimbursements are contingent contractual obligations which are predicated on the collaboration becoming profitable. In addition, the Company will not be required to make payments to sanofi-aventis to satisfy this reimbursement obligation. Rather, the reimbursement will be deducted from payments the Company would have otherwise been entitled to receive from sanofi-aventis out of our share of the collaboration’s profits, assuming that profitability is achieved. If profitability is never achieved, we will have no obligation to reimburse sanofi-aventis.

The Company also advises the Staff that under our research and development agreement with Bayer HealthCare, agreed upon VEGF Trap-Eye development expenses incurred by both companies, beginning in 2007, under a global development plan will be shared, as described in the Annual Report (see page reference below). If the collaboration becomes profitable, the Company will be obligated to reimburse Bayer HealthCare for 50% of Bayer HealthCare’s share of the VEGF Trap-Eye development expenses out of our share of the collaboration profits. We disclosed this obligation in the Annual Report on page 43 (see “Liquidity and Capital Resources -- Collaboration with Bayer Healthcare”) and on page 31 (see “Collaborations -- Bayer Healthcare LLC”).

We are unable to estimate development costs over the term of the Bayer HealthCare arrangement which would be subject to reimbursement. These reimbursements are contingent contractual obligations which are predicated on the collaboration becoming profitable. In addition, the Company will not be required to make payments to Bayer HealthCare to satisfy this reimbursement obligation. Rather, the reimbursement will be deducted from payments the Company would have otherwise been entitled to receive from Bayer HealthCare out of our share of the collaboration’s profits, assuming that profitability is ever achieved. If profitability is never achieved, we will have no obligation to reimburse Bayer HealthCare.

The Company acknowledges the Staff’s comment. In future filings, we will expand our discussion under “Funding Requirements” to explain why the contingent contractual obligations for reimbursement of development expenses incurred by sanofi-aventis and Bayer HealthCare have been omitted from the table of contractual obligations. Our disclosure would be supplemented substantially as follows:

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Securities and Exchange Commission

Page 6

As described above under “Collaboration with Bayer Healthcare”, over the next several years we and Bayer Healthcare are sharing agreed-upon VEGF Trap-Eye development expenses.

In addition, as described above under “Collaboration with the sanofi-aventis Group” and “Collaboration with Bayer Healthcare”, if the applicable collaboration becomes profitable, we have contingent contractual obligations to reimburse sanofi-aventis and Bayer Healthcare for 50% of agreed-upon development expenses incurred by sanofi-aventis and Bayer Healthcare, respectively. Profitability under each collaboration will be measured by calculating net sales less agreed-upon expenses. These reimbursements will be deducted from our share of the collaboration profits and, for sanofi-aventis, royalties otherwise payable to us based on product sales in Japan, unless we agree to reimburse these expenses at a faster rate at our option. Given the uncertainties related to drug
development (including the development of the VEGF Trap-Oncology in collaboration with sanofi-aventis and the VEGF Trap-Eye in collaboration with Bayer Healthcare) such as the variability in the length of time necessary to develop a product candidate and the ultimate ability to obtain governmental approval for commercialization, we are currently unable to reliably estimate if our collaborations with sanofi-aventis and Bayer Healthcare will become profitable.

Critical Accounting Policies and Significant Judgments and Estimates

Revenue Recognition, page 46

3.

You do not appear to have discussed the variability implicit in critical accounting estimates associated with your revenue recognition of contract research and development and research progress payments. Your disclosure should provide investors with a fuller understanding of the uncertainties in applying critical accounting estimates and the likelihood that materially different amounts would be reported under different conditions or using different assumptions. It should include quantification of the related variability in operating results that you expect to be reasonably likely to occur. Please describe in disclosure-type format the expected uncertainties and variability implicit in critical accounting estimates associated with your revenue recognition of these payments, the effect that changes in such estimates have had on your financial statements for each period presented, and the
effect that reasonably likely changes in the key assumptions underlying these estimates may have on your financial statements in the future. Also, explain your basis for concluding that research and development activities other than clinical trial expenses do not involv
2007-05-22 - CORRESP - REGENERON PHARMACEUTICALS, INC.
Read Filing Source Filing Referenced dates: May 10, 2007
CORRESP
1
filename1.htm

[Regeneron Pharmaceuticals, Inc. Letterhead]

May 22, 2007

BY EDGAR AND FACSIMILE

Mr. Jim B. Rosenberg

Senior Assistant Chief Accountant

Securities and Exchange Commission

Division of Corporation Finance

Mail Stop 6010

100 F Street, NE

Washington, D.C. 20549

            RE:

            Regeneron Pharmaceuticals, Inc.

            Form 10-K for the fiscal year ended December 31, 2006

            File No. 000-19034

Dear Mr. Rosenberg:

We are in receipt of your letter dated May 10, 2007 to Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron Pharmaceuticals, Inc. regarding the above-referenced annual report on Form 10-K. We are in the process of finalizing a letter responding to your comments and will send it to you on or before May 31, 2007.

            Sincerely,

            /s/ Stuart Kolinski

            Stuart Kolinski

            Senior Vice President & General Counsel
2007-05-15 - UPLOAD - REGENERON PHARMACEUTICALS, INC.
Mail Stop 6010
Via Facsimile and U.S. Mail

                                                                                                May 10, 2007

Dr. Leonard S. Schleifer, M.D., Ph.D
President and Chief Executive Officer
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591-6707

Re:      Regeneron Pharmaceuticals, Inc.
Form 10-K for fiscal year ended December 31, 2006
            File No. 000-19034

Dear Dr. Schleifer:

We have reviewed your filing and have the following comments. We have limited
our review to only your financia l statements and related disclosures and do not intend to
expand our review to other portions of your documents. In our comments, we 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.

Form 10-K for fiscal year  ended December 31, 2006

Managements Discussion and Analysis of Fi nancial Condition and Re sults of Operations

Research and Development Expenses, page 36
1. We believe your disclosure related to re search and development expenses could
be improved by separately quantifying co sts incurred for your product candidates,
principally VGEF Trap-Oncology, VEGF Tr ap-Eye and IL-1 Trap and provide
information that would allow investors to determine the reasonably likely timing for commercialization of your lead drug candidates and related revenue
generation. Please provide in disclosure-t ype format the following information for
each of your major research and developm ent projects. Refer to the Division of

Dr. Leonard S. Schleifer, M.D., Ph.D
Regeneron Pharmaceuticals, Inc.
May 10, 2007 Page 2
Corporation Finance “Current Issues a nd Rulemaking Projects Quarterly Update”
under section VIII – Industry Specific Issues – Accounting and Disclosure by
Companies Engaged in Research and Deve lopment Activities.  You can find it at
the following website address:
http://www.sec.gov/divisions/c orpfin/cfcrq032001.htm#secviii .

a. The costs incurred during each period presented and to date on the project;
b. The nature, timing and estimated costs of the efforts necessary to complete the project;
c. The anticipated completion date for the project;
d. The risks and uncertainties associated with completing development on schedule, and the consequences to oper ations, financial position and liquidity
if the project is not completed timely; and,
e. The period in which material net cash in flows from the project are expected
to commence.

Regarding “a,” if you do not maintain any research and development costs by project, explain why management does not maintain and evaluate research and development costs by project.  Provide othe r quantitative or qualitative disclosure
that indicates the amount of the compa ny’s resources being used on the project.

Regarding “b” and “c,” provide 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, describe t hose facts and circumstances indicating the
uncertainties that preclude you fr om making a reasonable estimate.

Funding Requirements, page 44
2. Please explain in disclosure-type format your basis for omitting estimated payments from the table of contractual oblig ations that appear reasonably likely to
arise from your research and development agreements with sanofi-aventis and Bayer Healthcare LLC. Discuss how profitabi lity will be measured, your expected
timing for achieving profitability and payment of development expense reimbursements if the collabo rations are profitable.

Critical Accounting Policies and Si gnificant Judgments and Estimates

Revenue Recognition, page 46

3. You do not appear to have discussed the va riability implicit in critical accounting
estimates associated with your revenue recognition of contra ct research and
development and research progress payments. Your disclosure should provide investors with a fuller unde rstanding of the uncertain ties in applying critical
accounting estimates and the likelihood th at materially different amounts would

Dr. Leonard S. Schleifer, M.D., Ph.D
Regeneron Pharmaceuticals, Inc.
May 10, 2007 Page 3
be reported under different conditions or using different assu mptions. It should
include quantification of the related variab ility in operating results that you expect
to be reasonably likely to occur. Please  describe in disclosure-type format the
expected uncertainties and variability im plicit in critical accounting estimates
associated with your revenue recogniti on of these payments, the effect that
changes in such estimates have had on your financial statements for each period presented, and the effect that reasonabl y likely changes in the key assumptions
underlying these estimates may have on your financial statements in the future. Also, explain your basis for concluding th at research and development activities
other than clinical trial expenses do not  involve critical ac counting estimates.

4. You record substantive performance m ilestones in accordance with various
criteria, including whether a “reasonab le amount of time has passed between
receipt of an upfront payment and achie vement of the milestone and the amount
of the milestone is reasonable in relation to the effort, value and risk associated
with achieving the milestone.” Please explain in disclosure-type format the factors that you consider in evaluating these tw o revenue recognition criteria, including
the quantifications associated with the term, “reasonable.”

Clinical Trial Accrual Estimates, page 46

5. You expense certain clinical trial costs “b ased on the total number of patients in
the trial, the rate at which patients enter the trial and the period over which clinical investigators or c ontract research organizations  are expected to provide
services.”  Please provide in disclosure -type format the signi ficant terms of your
arrangements with clinical investigators and contract rese arch organizations,
including payment schedules.  Include in  your discussion an explanation of the
methods and key assumptions used for accruing and recognizi ng clinical trial
costs.
*    *    *    *

Please respond to these comments within  10 business days or tell us when you
will provide us with a respons e.  Your letter should key your responses to our comments.
Detailed cover letters greatly 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.

Dr. Leonard S. Schleifer, M.D., Ph.D
Regeneron Pharmaceuticals, Inc.
May 10, 2007 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
filings;
• 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 comme nts as a defense in any proceeding
initiated by the Commission or any person under the federal secu rities 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 Frank Wyman, St aff Accountant, at 202-551-3660  or Don
Abbott, Senior Staff Accountant, at 202- 551-3608, if you have questions regarding the
comments.  In this regard, do not hes itate 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