<SEC-DOCUMENT>0000914475-21-000060.txt : 20211214
<SEC-HEADER>0000914475-21-000060.hdr.sgml : 20211214
<ACCEPTANCE-DATETIME>20211103160834
<PRIVATE-TO-PUBLIC>
ACCESSION NUMBER:		0000914475-21-000060
CONFORMED SUBMISSION TYPE:	CORRESP
PUBLIC DOCUMENT COUNT:		1
FILED AS OF DATE:		20211103

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			NEUROCRINE BIOSCIENCES INC
		CENTRAL INDEX KEY:			0000914475
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				330525145
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		CORRESP

	BUSINESS ADDRESS:	
		STREET 1:		12780 EL CAMINO REAL
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92130
		BUSINESS PHONE:		(858) 617-7600

	MAIL ADDRESS:	
		STREET 1:		12780 EL CAMINO REAL
		CITY:			SAN DIEGO
		STATE:			CA
		ZIP:			92130
</SEC-HEADER>
<DOCUMENT>
<TYPE>CORRESP
<SEQUENCE>1
<FILENAME>filename1.htm
<TEXT>
<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN" "http://www.w3.org/TR/html4/loose.dtd"><html><head>
<!-- Document created using Wdesk -->
<!-- Copyright 2021 Workiva -->
<title>Document</title></head><body><div id="ifac4a0c4670a4cb3a8fb8c17463fa241_1"></div><div style="min-height:72pt;width:100%"><div><font><br></font></div></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">November 3, 2021</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Via EDGAR and FedEx</font></div><div style="text-align:justify"><font><br></font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Ms. Jeanne Baker</font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Mr. Terence O'Brien</font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">United States Securities and Exchange Commission</font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Division of Corporation Finance</font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Office of Life Sciences</font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">100 F Street, NE Washington, DC 20549</font></div><div><font><br></font></div><div style="padding-left:36pt;text-indent:-36pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:700;line-height:120%">Re&#58;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">       </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:700;line-height:120%">Neurocrine Biosciences, Inc.</font></div><div style="padding-left:36pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:700;line-height:120%">Form 10-K filed February 5, 2021</font></div><div style="padding-left:36pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:700;line-height:120%">Form 8-K filed August 3, 2021</font></div><div style="padding-left:36pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:700;line-height:120%">Form 8-K filed February 4, 2021</font></div><div style="padding-left:36pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:700;line-height:120%">File No. 000-22705</font></div><div><font><br></font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Ladies and Gentlemen&#58;</font></div><div><font><br></font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">This letter is being transmitted by Neurocrine Biosciences, Inc. (the &#8220;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Company</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">&#8221;) in response to comments received from the staff (the &#8220;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Staff</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">&#8221;) of the Securities and Exchange Commission (the &#8220;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">SEC</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">&#8221;), by supplemental letter dated October 27, 2021 (the &#8220;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Supplemental Letter</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">&#8221;), with respect to the Company&#8217;s (i) Current Report on Form 8-K filed on August 3, 2021 and (ii) Current Report on Form 8-K filed on February 4, 2021. The Supplemental Letter from the Staff was received in response to the Company&#8217;s letter dated October 5, 2021 responding to comments from the Staff by letter dated September 22, 2021.  The text of the Staff&#8217;s comments has been included in this letter in italics for your convenience, and we have numbered the paragraphs below to correspond to the numbering of the Supplemental Letter.</font></div><div style="text-align:justify"><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%;text-decoration:underline">Form 8-K filed August 3, 2021</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%;text-decoration:underline">Exhibit 99.1, page 1</font></div><div><font><br></font></div><div style="padding-left:36pt;text-indent:-36pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">1.</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%;padding-left:27.67pt">We have reviewed your response to prior comment 2. We believe the adjustments to exclude milestone payments received from licenses and collaborations, milestones paid related to licenses and collaborations, non-cash collaboration revenue and acquired in-process research and development R&#38;D expense are inconsistent with the guidance in Question 100.01 of the Non-GAAP Financial Measures Compliance and Disclosure Interpretations. Please confirm to us that you will no longer include these adjustments in any non-GAAP financial measure presented in accordance with Item 10(e) of Regulation S-K or Regulation G.</font></div><div style="text-indent:-18pt"><font><br></font></div><div style="padding-left:36pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:700;line-height:120%">Response&#58; </font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company acknowledges the Staff&#8217;s comment and advises the Staff that beginning with the Company&#8217;s Current Report on Form 8-K filed on November 1, 2021 and commits that, to the extent applicable, in the Company&#8217;s future Form 8-K filings, earnings releases and other presentations that include Non-GAAP Financial Measures, for all periods presented, the Company will no longer exclude from such Non-GAAP Financial Measures amounts for (i) milestone payments received from licenses and collaborations, (ii) milestones paid related to licenses and collaborations, (iii) non-cash collaboration revenue, or (iv) acquired in-process research and development R&#38;D expense. The Company will update prior period information for comparability to current year presentation.</font></div><div style="height:72pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div><font><br></font></div></div></div><hr style="page-break-after:always"><div style="min-height:72pt;width:100%"><div><font><br></font></div></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">United States Securities and Exchange Commission</font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">November 3, 2021</font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Page Two</font></div><div><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%;text-decoration:underline">Form 8-K filed February 4, 2021</font></div><div style="text-align:justify"><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%;text-decoration:underline">Exhibit 99.1</font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%;text-decoration:underline">Full Year 2021 Expense Guidance, page 3</font></div><div><font><br></font></div><div style="padding-left:36pt;text-indent:-36pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">2.</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:120%;padding-left:27.67pt">We note your response to prior comment 3. Notwithstanding the reasons for excluding any potential milestones or in-process research and development costs, we note that these amounts should not be excluded from GAAP measures. With reference to Item 10(e)(1)(B) of Regulation S-K, in lieu of presenting Combined GAAP R&#38;D and SG&#38;A expenses, you may need to indicate that a reconciliation to your most comparable GAAP measure is not available without unreasonable efforts. Please advise</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">.</font></div><div style="text-align:justify;text-indent:-18pt"><font><br></font></div><div style="padding-left:36pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:700;line-height:120%">Response&#58;</font><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%"> The Company acknowledges the Staff&#8217;s comment and advises the Staff that the Company&#8217;s practice is to include the following expenses in Combined GAAP R&#38;D and SG&#38;A expense guidance&#58; (i) amounts for milestones that are probable of achievement or have been achieved and (ii) amounts for in-process research and development once significant collaboration and licensing arrangements have been completed.  In acknowledgement of conversations with the Staff, the Company advises the Staff that beginning with the Company&#8217;s Current Report on Form 8-K filed on November 1, 2021 and commits that in future Form 8-K filings, earnings releases and other presentations that include Combined GAAP R&#38;D and SG&#38;A expense guidance, the Company will continue to include such amounts in Combined GAAP R&#38;D and SG&#38;A expense guidance to the extent applicable.</font></div><div style="padding-left:36pt;text-align:justify"><font><br></font></div><div style="text-align:center"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">***</font></div><div style="text-align:center"><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company further acknowledges that it is responsible for the accuracy and adequacy of its disclosures, notwithstanding any review, comments, action or absence of action by the Staff.</font></div><div style="text-align:justify"><font><br></font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Please contact me at (858) 617-7642 with any questions or further comments regarding the Company&#8217;s responses to the Staff&#8217;s comments.</font></div><div style="text-align:justify"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Sincerely, </font></div><div><font><br></font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">&#47;s&#47; Matthew Abernethy</font></div><div><font><br></font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Matthew Abernethy</font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Chief Financial Officer</font></div><div><font><br></font></div><div><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">cc&#58; Darin Lippoldt, Chief Legal Officer </font></div><div style="padding-left:14.4pt"><font style="color:#000000;font-family:'Arial',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Jason L. Kent, Cooley LLP</font></div><div><font><br></font></div><div style="text-align:justify"><font><br></font></div><div style="height:72pt;position:relative;width:100%"><div style="bottom:0;position:absolute;width:100%"><div><font><br></font></div></div></div></body></html>
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
