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<P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1px solid #000000">&nbsp;</P> <P STYLE="margin-top:4pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>UNITED STATES </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>SECURITIES AND EXCHANGE COMMISSION </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Washington, D.C. 20549 </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:18pt; font-family:Times New Roman" ALIGN="center"><B>FORM <FONT
STYLE="white-space:nowrap">8-K</FONT> </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>CURRENT
REPORT </B></P> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Pursuant to Section&nbsp;13 or 15(d) of the </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Securities Exchange Act of 1934 </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>Date of Report (Date of earliest event reported): January&nbsp;28, 2019 </B></P>
<P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center> <P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>NEUROCRINE BIOSCIENCES, INC. </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>(Exact name of registrant as specified in its charter) </B></P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><center>
<P STYLE="line-height:6.0pt;margin-top:0pt;margin-bottom:2pt;border-bottom:1.00pt solid #000000;width:21%">&nbsp;</P></center> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD VALIGN="top" ALIGN="center"><B>Delaware</B></TD>
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<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">0-22705</FONT></B></TD>
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<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">33-0525145</FONT></B></TD></TR>
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<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(State or other jurisdiction of</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>incorporation)</B></P></TD>
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<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Commission</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>File Number)</B></P></TD>
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<TD VALIGN="top" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(IRS Employer</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Identification No.)</B></P></TD></TR>
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<TD VALIGN="top" ALIGN="center"><B>12780 El Camino Real, San Diego, California</B></TD>
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<TD VALIGN="top" ALIGN="center"><B>92130</B></TD></TR>
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<TD VALIGN="top" ALIGN="center"><B>(Address of principal executive offices)</B></TD>
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<TD VALIGN="top" ALIGN="center"><B>(Zip Code)</B></TD></TR>
</TABLE> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Registrant&#146;s telephone number, including area code: (858)
<FONT STYLE="white-space:nowrap">617-7600</FONT> </B></P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>N/A </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>(Former name or former address, if changed since last report.) </B></P>
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<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Check the appropriate box below if the Form <FONT STYLE="white-space:nowrap">8-K</FONT> filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions: </P> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) </P></TD></TR></TABLE>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left">Soliciting material pursuant to Rule <FONT STYLE="white-space:nowrap">14a-12</FONT> under the Exchange Act (17
CFR <FONT STYLE="white-space:nowrap">240.14a-12)</FONT> </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to Rule <FONT
STYLE="white-space:nowrap">14d-2(b)</FONT> under the Exchange Act (17 CFR <FONT STYLE="white-space:nowrap">240.14d-2</FONT> (b)) </P></TD></TR></TABLE> <P STYLE="font-size:6pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><FONT STYLE="white-space:nowrap">Pre-commencement</FONT> communications pursuant to Rule <FONT
STYLE="white-space:nowrap">13e-4(c)</FONT> under the Exchange Act (17 CFR <FONT STYLE="white-space:nowrap">240.13e-4</FONT> (c)) </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933
(&#167;230.405 of this chapter) or Rule <FONT STYLE="white-space:nowrap">12b-2</FONT> of the Securities Exchange Act of 1934 <FONT STYLE="white-space:nowrap">(&#167;240.12b-2</FONT> of this chapter). </P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Emerging growth company&nbsp;&nbsp;&#9744; </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section&nbsp;13(a) of the Exchange
Act.&nbsp;&nbsp;&#9744; </P> <P STYLE="font-size:10pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P> <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Item&nbsp;1.01 Entry into a Material Definitive Agreement. </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Collaboration and License Agreement </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On January&nbsp;28,
2019 (the &#147;<B><I>Agreement Date</I></B>&#148;), Neurocrine Biosciences, Inc. (the &#147;<B><I>Company</I></B>&#148;) entered into a Collaboration and License Agreement (the &#147;<B><I>Collaboration Agreement</I></B>&#148;) with Voyager
Therapeutics, Inc. (&#147;<B><I>Voyager</I></B>&#148;) for the research, development and commercialization of adeno-associated virus (&#147;<B><I>AAV</I></B>&#148;)-based gene therapy products. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>Collaboration and Licenses</I>. Under the Collaboration Agreement, upon the expiration or termination of applicable waiting periods and the receipt of any
required approvals or clearances under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (such date, the &#147;<B><I>Effective Date</I></B>&#148; and such clearance, &#147;<B><I>Antitrust Clearance</I></B>&#148;), the Company and
Voyager have agreed to collaborate on the conduct of four collaboration programs (the &#147;<B><I>Programs</I></B>&#148;): Voyager&#146;s <FONT STYLE="white-space:nowrap">VY-AADC</FONT> program, intended to advance Voyager&#146;s <FONT
STYLE="white-space:nowrap">VY-AADC</FONT> product candidate for the treatment of Parkinson&#146;s disease, which is currently in an ongoing Phase 2 trial (the &#147;<B><I>AADC Program</I></B>&#148;); Voyager&#146;s program intended to generate gene
therapy product candidates for the treatment of Friedreich&#146;s ataxia, including Voyager&#146;s <FONT STYLE="white-space:nowrap">VY-FXN01</FONT> product candidate (the &#147;<B><I>FA Program</I></B>&#148; and, collectively with the AADC Program,
the &#147;<B><I>Existing Programs</I></B>&#148;); and two programs to be determined by the Company and Voyager at a later date, as described below (each a &#147;<B><I>Discovery Program</I></B>&#148; and, collectively, the &#147;<B><I>Discovery
Programs</I></B>&#148;). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Under the terms of the Collaboration Agreement, subject to the rights retained by Voyager thereunder, Voyager has agreed to
collaborate with the Company on, and to grant, as of the Effective Date, exclusive, royalty-bearing, <FONT STYLE="white-space:nowrap">non-transferable,</FONT> sublicensable licenses to certain of Voyager&#146;s intellectual property rights, for all
human and veterinary diagnostic, prophylactic, and therapeutic uses, for the research, development, and commercialization of gene therapy products (the &#147;<B><I>Collaboration Products</I></B>&#148;) under (i)&nbsp;the AADC Program, on a worldwide
basis; (ii)&nbsp;the FA program, for the United States and, upon expiration of Sanofi Genzyme&#146;s option to the FA Program pursuant to its ongoing collaboration with Voyager (the &#147;<B><I>Sanofi Genzyme Collaboration</I></B>&#148;) without
exercise of such option, all countries in the world in which the Collaboration Agreement remained in effect with respect to the FA Program; and (iii)&nbsp;each Discovery Program, on a worldwide basis. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Pursuant to development plans agreed to by the Company and Voyager, and as overseen by a joint steering committee (&#147;<B><I>JSC</I></B>&#148;), Voyager has
operational responsibility, subject to certain exceptions, for the conduct of each Program (prior to the Transition Event (as defined below) for each Program) and is required to use commercially reasonable efforts to develop the Collaboration
Products. The Company has agreed to be responsible for all costs incurred by Voyager in conducting these activities for each Program, in accordance with an agreed budget. If Voyager breaches its development responsibilities or in certain
circumstances upon a change in control of Voyager, the Company has the right but not the obligation to assume the activities under such Program. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Upon the
occurrence of a specified event for each Program (a &#147;<B><I>Transition Event</I></B>&#148;), the Company agrees to assume responsibility for development, manufacturing and commercialization activities for such Program from Voyager and to pay
milestones and royalties on future net sales as described further below. For each Existing Program, Voyager has the option (a &#147;<B><I><FONT STYLE="white-space:nowrap">Co-Co</FONT> Option</I></B>&#148;) to
<FONT STYLE="white-space:nowrap">co-develop</FONT> and <FONT STYLE="white-space:nowrap">co-commercialize</FONT> such Program upon the occurrence of a specified event (a &#147;<B><I><FONT STYLE="white-space:nowrap">Co-Co</FONT> Trigger
Event</I></B>&#148;). Should Voyager elect to exercise its <FONT STYLE="white-space:nowrap">Co-Co</FONT> Option, the Company and Voyager agree to enter into a cost- and profit-sharing arrangement (a
&#147;<B><I><FONT STYLE="white-space:nowrap">Co-Co</FONT> Agreement</I></B>&#148;) whereby the Company and Voyager agree to jointly develop and commercialize Collaboration Products for such Program
(&#147;<B><I><FONT STYLE="white-space:nowrap">Co-Co</FONT> Products</I></B>&#148;) and share in its costs, profits and losses, and Voyager agrees to forfeit certain milestones and royalties on net sales in the United States during the effective
period of the applicable <FONT STYLE="white-space:nowrap">Co-Co</FONT> Agreement. The Transition Events are (i)&nbsp;with respect to the AADC Program, Voyager&#146;s receipt of topline data for the ongoing Phase 2 clinical trial for <FONT
STYLE="white-space:nowrap">VY-AADC;</FONT> (ii)&nbsp;with respect to the FA Program, Voyager&#146;s receipt of topline data for the initial Phase 1 clinical trial for an FA Program product candidate; and (iii)&nbsp;with respect to each Discovery
Program, the preparation by Voyager and the approval by the Company of an investigational new drug application to be filed with the U.S. Food and Drug Administration (&#147;<B><I>FDA</I></B>&#148;) by the Company for the first development candidate
in such Discovery Program. The <FONT STYLE="white-space:nowrap">Co-Co</FONT> Trigger Events are (i)&nbsp;with respect to the AADC Program, Voyager&#146;s receipt of topline data for the ongoing Phase 2 clinical trial for <FONT
STYLE="white-space:nowrap">VY-AADC</FONT> and (ii)&nbsp;with respect to the FA Program, the achievement of milestones or metrics specified in the applicable development plan, as determined by the JSC. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Subject to exceptions specified in the Collaboration Agreement, profits and losses under Voyager&#146;s <FONT STYLE="white-space:nowrap">Co-Co</FONT> Option
are agreed to be allocated (i)&nbsp;50% to the Company and 50% to Voyager for a Collaboration Product from the AADC Program and (ii)&nbsp;60% to the Company and 40% to Voyager for a Collaboration Product from the FA Program; provided, however, that
the Company may elect, within a specified period following the acceptance for filing of a biologics license application from the FDA, to pay a $35&nbsp;million rate-shifting fee to Voyager to change the allocation for the AADC Program to 55% to the
Company and 45% to Voyager. The parties have agreed that each <FONT STYLE="white-space:nowrap">Co-Co</FONT> Agreement will provide Voyager the right to terminate for any reason upon prior written notice to the Company, and the Company the right to
terminate in certain circumstances upon a change of control of Voyager. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>Candidate Selection</I>. The Company and Voyager have committed, following the Effective Date, to agree
on a list of up to eight target genes (&#147;<B><I>Targets</I></B>&#148;), from which the Company has the right to nominate Targets for the two Discovery Programs. Each Target for the Discovery Programs must be approved by a consensus of the JSC or
the executive officers of the parties. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>Financial Terms</I>. Under the terms of the Collaboration Agreement, the Company has agreed to pay Voyager an
upfront payment of $115&nbsp;million (the &#147;<B><I>Upfront Payment</I></B>&#148;) within five business days after the Effective Date. The Collaboration Agreement provides for aggregate development milestone payments from the Company to Voyager
for Collaboration Products under (i)&nbsp;the AADC Program of up to $170&nbsp;million; (ii)&nbsp;the FA Program of up to $195&nbsp;million, and (iii)&nbsp;each of the two Discovery Programs of up to $130&nbsp;million per Discovery Program. Voyager
may be entitled to receive aggregate commercial milestone payments for each Collaboration Product of up to $275&nbsp;million, subject to an aggregate cap on commercial milestones across all Programs of $1.1&nbsp;billion. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Company has also agreed to pay Voyager royalties, based on future net sales of the Collaboration Products. Such royalty percentages, for net sales in and
outside the United States, range from (i)&nbsp;for the AADC Program, the <FONT STYLE="white-space:nowrap">mid-teens</FONT> to thirty and the <FONT STYLE="white-space:nowrap">low-teens</FONT> to twenty, respectively; (ii)&nbsp;for the FA Program, <FONT
STYLE="white-space:nowrap">low-teens</FONT> to high-teens and high-single digits to <FONT STYLE="white-space:nowrap">mid-teens,</FONT> respectively; and (iii)&nbsp;for each Discovery Program, high-single digits to
<FONT STYLE="white-space:nowrap">mid-teens</FONT> and <FONT STYLE="white-space:nowrap">mid-single</FONT> digits to <FONT STYLE="white-space:nowrap">low-teens,</FONT> respectively. On a
<FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">country-by-country</FONT></FONT> and <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">Program-by-Program</FONT></FONT> basis, royalty payments would commence on the
first commercial sale of a Collaboration Product and terminate on the later of (a)&nbsp;the expiration of the last patent covering the Collaboration Product or its method of use in such country, (b) 10 years from the first commercial sale of the
Collaboration Product in such country and (c)&nbsp;the expiration of regulatory exclusivity in such country (the &#147;<B><I>Royalty Term</I></B>&#148;). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><I>Termination</I>.&nbsp;Unless earlier terminated, the Collaboration Agreement expires on the later of (i)&nbsp;the expiration of the last to expire Royalty
Term with respect to a Collaboration Product in all countries in the relevant territory or (ii)&nbsp;the expiration or termination of all <FONT STYLE="white-space:nowrap">Co-Co</FONT> Agreements. The Company may terminate the Collaboration Agreement
in its entirety or on a <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">Program-by-Program</FONT></FONT> or <FONT STYLE="white-space:nowrap"><FONT STYLE="white-space:nowrap">country-by-country</FONT></FONT> basis by providing at
least (x) <FONT STYLE="white-space:nowrap">180-day</FONT> advance notice if such notice is provided prior to the first commercial sale of the Collaboration Product to which the termination applies or
<FONT STYLE="white-space:nowrap">(y)&nbsp;one-year</FONT> advance notice if such notice is provided after the first commercial sale of the Collaboration Product to which the termination applies. Voyager may terminate the Collaboration Agreement,
subject to specified conditions, if (i)&nbsp;the Company fails to make the equity purchase described in greater detail below or (ii)&nbsp;the Company challenges the validity or enforceability of certain Voyager intellectual property rights. Subject
to a cure period, either party may terminate the Collaboration Agreement in the event of a material breach in whole or in part, subject to specified conditions.&nbsp;Either party may also terminate the Collaboration Agreement if specified regulatory
agencies seek to enjoin the transaction or if the parties are unable to obtain Antitrust Clearance within 180 days of the Agreement Date. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The foregoing
description of the terms of the Collaboration Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Collaboration Agreement, a copy of which will be filed with the Securities and Exchange
Commission as an exhibit to the Company&#146;s Annual Report on Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the year ended December&nbsp;31, 2018. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Stock Purchase Agreement </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In connection with the
execution of the Collaboration Agreement, the Company and Voyager also entered into a stock purchase agreement on the Agreement Date (the &#147;<B><I>Stock Purchase Agreement</I></B>&#148;) for the sale and issuance of 4,179,728 shares of common
stock (the &#147;<B><I>Shares</I></B>&#148;) to the Company at a price of $11.9625 per share, for an aggregate purchase price of approximately $50.0&nbsp;million. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The consummation of the transactions contemplated by the Stock Purchase Agreement is subject to the parties&#146; obtaining Antitrust Clearance, the
Collaboration Agreement and Investor Agreement (as defined below) remaining in full force and effect, and the satisfaction or waiver of other customary closing conditions. The parties have agreed to hold the closing of the purchase and sale of the
Shares (the &#147;<B><I>Closing</I></B>&#148;) on the second business day after the satisfaction or waiver of such closing conditions. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The Stock Purchase
Agreement may be terminated upon the mutual consent of the parties. Either party may terminate the Stock Purchase Agreement upon written notice to the other party if certain closing conditions are unable to be met within 180 days of applicable
antitrust filings. Subject to specified exceptions, either party also may terminate the Stock Purchase Agreement prior to the Closing upon material breach of certain covenants or agreements by the other party or upon certain representations and
warranties of such other party becoming untrue. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The foregoing description of the terms of the Stock Purchase Agreement does not purport to be complete
and is qualified in its entirety by reference to the full text of the Stock Purchase Agreement, a copy of which will be filed with the Securities and Exchange Commission as an exhibit to the Company&#146;s Annual Report on Form <FONT
STYLE="white-space:nowrap">10-K</FONT> for the year ended December&nbsp;31, 2018. </P>
</DIV></Center>


<p Style='page-break-before:always'>
<HR  SIZE="3" style="COLOR:#999999" WIDTH="100%" ALIGN="CENTER">


<Center><DIV STYLE="width:8.5in" align="left">
 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Investor Agreement </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In connection with the execution of the Collaboration Agreement, the Company and Voyager also entered into an investor agreement on the Agreement Date (the
&#147;<B><I>Investor Agreement</I></B>&#148;) providing for standstill and <FONT STYLE="white-space:nowrap">lock-up</FONT> restrictions and a voting agreement with respect to the Shares. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Pursuant to the terms of the Investor Agreement, the Company has agreed not to, without the prior written approval of Voyager and subject to specified
conditions, directly or indirectly acquire shares of Voyager&#146;s outstanding common stock, seek or propose a tender or exchange offer or merger between the parties, solicit proxies or consents with respect to any matter, or undertake other
specified actions related to the potential acquisition of additional equity interests in Voyager (the &#147;<B><I>Standstill Restrictions</I></B>&#148;). Further, the Company has also agreed not to, and to cause its affiliates not to, sell or
transfer the Shares without the prior written approval of Voyager, subject to specified conditions (the &#147;<B><I><FONT STYLE="white-space:nowrap">Lock-Up</FONT> Restrictions</I></B>&#148;). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In addition, pursuant to the terms of the Investor Agreement, the Company has agreed that the Shares are subject to a voting agreement such that, subject to
specified conditions and excluding specified extraordinary matters, the Company has agreed to, and has agreed to cause its permitted transferees to, vote in accordance with the recommendation of Voyager&#146;s Board of Directors and has granted
Voyager an irrevocable proxy with respect to the foregoing (the &#147;<B><I>Voting Agreement</I></B>&#148;). </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Each of the Standstill Restrictions, the <FONT
STYLE="white-space:nowrap">Lock-Up</FONT> Restrictions, and the Voting Agreement terminate upon the earliest to occur of (i)&nbsp;a liquidation or dissolution of Voyager, and (ii)&nbsp;the later of the third anniversary of the date of the Closing
and the initial announcement or release of topline results from Voyager&#146;s anticipated second pivotal clinical trial. The Standstill Restrictions and Voting Agreement also terminate upon the expiration or termination of the Collaboration
Agreement, if earlier. The Standstill Restrictions and <FONT STYLE="white-space:nowrap">Lock-Up</FONT> Restrictions also terminate upon the deregistration of Voyager&#146;s common stock, if earlier. The
<FONT STYLE="white-space:nowrap">Lock-Up</FONT> Restrictions and Voting Agreement also terminate on a change in control of Voyager or the date on which the Company and its affiliates beneficially own less than three percent of the common stock of
Voyager on an outstanding basis. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The foregoing description of the terms of the Investor Agreement does not purport to be complete and is qualified in its
entirety by reference to the full text of the Investor Agreement, a copy of which will be filed with the Securities and Exchange Commission as an exhibit to the Company&#146;s Annual Report on Form <FONT STYLE="white-space:nowrap">10-K</FONT> for
the year ended December&nbsp;31, 2018. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Forward-Looking Statements </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">This Current Report on Form <FONT STYLE="white-space:nowrap">8-K</FONT> contains &#147;forward-looking statements&#148; within the meaning of Section&nbsp;27A
of the Securities Act of 1933, as amended, and Section&nbsp;21E of the Securities Exchange Act of 1934, as amended. These statements relate to future events and involve known and unknown risks, uncertainties and other factors which may cause the
Company&#146;s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking
statements by terms such as &#147;may&#148;, &#147;will&#148;, &#147;should&#148;, &#147;could&#148;, &#147;would&#148;, &#147;expects&#148;, &#147;plans&#148;, &#147;anticipates&#148;, &#147;believes&#148;, &#147;estimates&#148;,
&#147;projects&#148;, &#147;predicts&#148;, &#147;potential&#148; and similar expressions intended to identify forward-looking statements. These statements reflect the Company&#146;s current views with respect to future events and are based on
assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, these forward-looking statements represent the Company&#146;s estimates and assumptions
only as of the date of this Current Report on Form <FONT STYLE="white-space:nowrap">8-K.</FONT> </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Item&nbsp;9.01 Financial Statements and Exhibits
</B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">(d) Exhibits </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
<TABLE STYLE="BORDER-COLLAPSE:COLLAPSE; font-family:Times New Roman; font-size:10pt" BORDER="0" CELLPADDING="0" CELLSPACING="0" WIDTH="100%">
<TR style = "page-break-inside:avoid">
<TD WIDTH="4%" VALIGN="top" ALIGN="left">99.1</TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><A HREF="d665990dex991.htm">Joint Press Release of Neurocrine Biosciences, Inc. and Voyager Therapeutics, Inc. dated
 January&nbsp;29, 2019. </A> </P></TD></TR></TABLE>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>SIGNATURES </B></P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TR STYLE="page-break-inside:avoid ; font-family:Times New Roman; font-size:10pt">
<TD VALIGN="top">Dated: January&nbsp;29, 2019</TD>
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<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">NEUROCRINE BIOSCIENCES, INC.</TD></TR>
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<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="bottom" STYLE=" BORDER-BOTTOM:1px solid #000000">&nbsp;</TD>
<TD VALIGN="top" STYLE="BORDER-BOTTOM:1px solid #000000">/s/ Darin M. Lippoldt</TD></TR>
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<TD VALIGN="bottom">&nbsp;</TD>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top">Darin M. Lippoldt</TD></TR>
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<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="top"></TD>
<TD VALIGN="bottom">&nbsp;</TD>
<TD VALIGN="bottom">Chief Legal Officer</TD></TR>
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</BODY></HTML>
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8-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 28, 2019
NEUROCRINE BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
Delaware
0-22705
33-0525145
(State or other jurisdiction of
incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
12780 El Camino Real, San Diego, California
92130
(Address of principal executive offices)
(Zip Code)
Registrant's telephone number, including area code: (858)
617-7600
N/A
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form
8-K
filing is intended to simultaneously satisfy the filing obligation of
the registrant under any of the following provisions:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule
14a-12
under the Exchange Act (17
CFR
240.14a-12)
☐
Pre-commencement
communications pursuant to Rule
14d-2(b)
under the Exchange Act (17 CFR
240.14d-2
(b))
☐
Pre-commencement
communications pursuant to Rule
13e-4(c)
under the Exchange Act (17 CFR
240.13e-4
(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule
12b-2
of the Securities Exchange Act of 1934
(§240.12b-2
of this chapter).
Emerging growth company  ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange
Act.  ☐
Item 1.01 Entry into a Material Definitive Agreement.
Collaboration and License Agreement
On January 28,
2019 (the "
Agreement Date
"), Neurocrine Biosciences, Inc. (the "
Company
") entered into a Collaboration and License Agreement (the "
Collaboration Agreement
") with Voyager
Therapeutics, Inc. ("
Voyager
") for the research, development and commercialization of adeno-associated virus ("
AAV
")-based gene therapy products.
Collaboration and Licenses
. Under the Collaboration Agreement, upon the expiration or termination of applicable waiting periods and the receipt of any
required approvals or clearances under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended (such date, the "
Effective Date
" and such clearance, "
Antitrust Clearance
"), the Company and
Voyager have agreed to collaborate on the conduct of four collaboration programs (the "
Programs
"): Voyager's
VY-AADC
program, intended to advance Voyager's
VY-AADC
product candidate for the treatment of Parkinson's disease, which is currently in an ongoing Phase 2 trial (the "
AADC Program
"); Voyager's program intended to generate gene
therapy product candidates for the treatment of Friedreich's ataxia, including Voyager's
VY-FXN01
product candidate (the "
FA Program
" and, collectively with the AADC Program,
the "
Existing Programs
"); and two programs to be determined by the Company and Voyager at a later date, as described below (each a "
Discovery Program
" and, collectively, the "
Discovery
Programs
").
Under the terms of the Collaboration Agreement, subject to the rights retained by Voyager thereunder, Voyager has agreed to
collaborate with the Company on, and to grant, as of the Effective Date, exclusive, royalty-bearing,
non-transferable,
sublicensable licenses to certain of Voyager's intellectual property rights, for all
human and veterinary diagnostic, prophylactic, and therapeutic uses, for the research, development, and commercialization of gene therapy products (the "
Collaboration Products
") under (i) the AADC Program, on a worldwide
basis; (ii) the FA program, for the United States and, upon expiration of Sanofi Genzyme's option to the FA Program pursuant to its ongoing collaboration with Voyager (the "
Sanofi Genzyme Collaboration
") without
exercise of such option, all countries in the world in which the Collaboration Agreement remained in effect with respect to the FA Program; and (iii) each Discovery Program, on a worldwide basis.
Pursuant to development plans agreed to by the Company and Voyager, and as overseen by a joint steering committee ("
JSC
"), Voyager has
operational responsibility, subject to certain exceptions, for the conduct of each Program (prior to the Transition Event (as defined below) for each Program) and is required to use commercially reasonable efforts to develop the Collaboration
Products. The Company has agreed to be responsible for all costs incurred by Voyager in conducting these activities for each Program, in accordance with an agreed budget. If Voyager breaches its development responsibilities or in certain
circumstances upon a change in control of Voyager, the Company has the right but not the obligation to assume the activities under such Program.
Upon the
occurrence of a specified event for each Program (a "
Transition Event
"), the Company agrees to assume responsibility for development, manufacturing and commercialization activities for such Program from Voyager and to pay
milestones and royalties on future net sales as described further below. For each Existing Program, Voyager has the option (a "
Co-Co
Option
") to
co-develop
and
co-commercialize
such Program upon the occurrence of a specified event (a "
Co-Co
Trigger
Event
"). Should Voyager elect to exercise its
Co-Co
Option, the Company and Voyager agree to enter into a cost- and profit-sharing arrangement (a
"
Co-Co
Agreement
") whereby the Company and Voyager agree to jointly develop and commercialize Collaboration Products for such Program
("
Co-Co
Products
") and share in its costs, profits and losses, and Voyager agrees to forfeit certain milestones and royalties on net sales in the United States during the effective
period of the applicable
Co-Co
Agreement. The Transition Events are (i) with respect to the AADC Program, Voyager's receipt of topline data for the ongoing Phase 2 clinical trial for
VY-AADC;
(ii) with respect to the FA Program, Voyager's receipt of topline data for the initial Phase 1 clinical trial for an FA Program product candidate; and (iii) with respect to each Discovery
Program, the preparation by Voyager and the approval by the Company of an investigational new drug application to be filed with the U.S. Food and Drug Administration ("
FDA
") by the Company for the first development candidate
in such Discovery Program. The
Co-Co
Trigger Events are (i) with respect to the AADC Program, Voyager's receipt of topline data for the ongoing Phase 2 clinical trial for
VY-AADC
and (ii) with respect to the FA Program, the achievement of milestones or metrics specified in the applicable development plan, as determined by the JSC.
Subject to exceptions specified in the Collaboration Agreement, profits and losses under Voyager's
Co-Co
Option
are agreed to be allocated (i) 50% to the Company and 50% to Voyager for a Collaboration Product from the AADC Program and (ii) 60% to the Company and 40% to Voyager for a Collaboration Product from the FA Program; provided, however, that
the Company may elect, within a specified period following the acceptance for filing of a biologics license application from the FDA, to pay a $35 million rate-shifting fee to Voyager to change the allocation for the AADC Program to 55% to the
Company and 45% to Voyager. The parties have agreed that each
Co-Co
Agreement will provide Voyager the right to terminate for any reason upon prior written notice to the Company, and the Company the right to
terminate in certain circumstances upon a change of control of Voyager.
Candidate Selection
. The Company and Voyager have committed, following the Effective Date, to agree
on a list of up to eight target genes ("
Targets
"), from which the Company has the right to nominate Targets for the two Discovery Programs. Each Target for the Discovery Programs must be approved by a consensus of the JSC or
the executive officers of the parties.
Financial Terms
. Under the terms of the Collaboration Agreement, the Company has agreed to pay Voyager an
upfront payment of $115 million (the "
Upfront Payment
") within five business days after the Effective Date. The Collaboration Agreement provides for aggregate development milestone payments from the Company to Voyager
for Collaboration Products under (i) the AADC Program of up to $170 million; (ii) the FA Program of up to $195 million, and (iii) each of the two Discovery Programs of up to $130 million per Discovery Program. Voyager
may be entitled to receive aggregate commercial milestone payments for each Collaboration Product of up to $275 million, subject to an aggregate cap on commercial milestones across all Programs of $1.1 billion.
The Company has also agreed to pay Voyager royalties, based on future net sales of the Collaboration Products. Such royalty percentages, for net sales in and
outside the United States, range from (i) for the AADC Program, the
mid-teens
to thirty and the
low-teens
to twenty, respectively; (ii) for the FA Program,
low-teens
to high-teens and high-single digits to
mid-teens,
respectively; and (iii) for each Discovery Program, high-single digits to
mid-teens
and
mid-single
digits to
low-teens,
respectively. On a
country-by-country
and
Program-by-Program
basis, royalty payments would commence on the
first commercial sale of a Collaboration Product and terminate on the later of (a) the expiration of the last patent covering the Collaboration Product or its method of use in such country, (b) 10 years from the first commercial sale of the
Collaboration Product in such country and (c) the expiration of regulatory exclusivity in such country (the "
Royalty Term
").
Termination
. Unless earlier terminated, the Collaboration Agreement expires on the later of (i) the expiration of the last to expire Royalty
Term with respect to a Collaboration Product in all countries in the relevant territory or (ii) the expiration or termination of all
Co-Co
Agreements. The Company may terminate the Collaboration Agreement
in its entirety or on a
Program-by-Program
or
country-by-country
basis by providing at
least (x)
180-day
advance notice if such notice is provided prior to the first commercial sale of the Collaboration Product to which the termination applies or
(y) one-year
advance notice if such notice is provided after the first commercial sale of the Collaboration Product to which the termination applies. Voyager may terminate the Collaboration Agreement,
subject to specified conditions, if (i) the Company fails to make the equity purchase described in greater detail below or (ii) the Company challenges the validity or enforceability of certain Voyager intellectual property rights. Subject
to a cure period, either party may terminate the Collaboration Agreement in the event of a material breach in whole or in part, subject to specified conditions. Either party may also terminate the Collaboration Agreement if specified regulatory
agencies seek to enjoin the transaction or if the parties are unable to obtain Antitrust Clearance within 180 days of the Agreement Date.
The foregoing
description of the terms of the Collaboration Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Collaboration Agreement, a copy of which will be filed with the Securities and Exchange
Commission as an exhibit to the Company's Annual Report on Form
10-K
for the year ended December 31, 2018.
Stock Purchase Agreement
In connection with the
execution of the Collaboration Agreement, the Company and Voyager also entered into a stock purchase agreement on the Agreement Date (the "
Stock Purchase Agreement
") for the sale and issuance of 4,179,728 shares of common
stock (the "
Shares
") to the Company at a price of $11.9625 per share, for an aggregate purchase price of approximately $50.0 million.
The consummation of the transactions contemplated by the Stock Purchase Agreement is subject to the parties' obtaining Antitrust Clearance, the
Collaboration Agreement and Investor Agreement (as defined below) remaining in full force and effect, and the satisfaction or waiver of other customary closing conditions. The parties have agreed to hold the closing of the purchase and sale of the
Shares (the "
Closing
") on the second business day after the satisfaction or waiver of such closing conditions.
The Stock Purchase
Agreement may be terminated upon the mutual consent of the parties. Either party may terminate the Stock Purchase Agreement upon written notice to the other party if certain closing conditions are unable to be met within 180 days of applicable
antitrust filings. Subject to specified exceptions, either party also may terminate the Stock Purchase Agreement prior to the Closing upon material breach of certain covenants or agreements by the other party or upon certain representations and
warranties of such other party becoming untrue.
The foregoing description of the terms of the Stock Purchase Agreement does not purport to be complete
and is qualified in its entirety by reference to the full text of the Stock Purchase Agreement, a copy of which will be filed with the Securities and Exchange Commission as an exhibit to the Company's Annual Report on Form
10-K
for the year ended December 31, 2018.
Investor Agreement
In connection with the execution of the Collaboration Agreement, the Company and Voyager also entered into an investor agreement on the Agreement Date (the
"
Investor Agreement
") providing for standstill and
lock-up
restrictions and a voting agreement with respect to the Shares.
Pursuant to the terms of the Investor Agreement, the Company has agreed not to, without the prior written approval of Voyager and subject to specified
conditions, directly or indirectly acquire shares of Voyager's outstanding common stock, seek or propose a tender or exchange offer or merger between the parties, solicit proxies or consents with respect to any matter, or undertake other
specified actions related to the potential acquisition of additional equity interests in Voyager (the "
Standstill Restrictions
"). Further, the Company has also agreed not to, and to cause its affiliates not to, sell or
transfer the Shares without the prior written approval of Voyager, subject to specified conditions (the "
Lock-Up
Restrictions
").
In addition, pursuant to the terms of the Investor Agreement, the Company has agreed that the Shares are subject to a voting agreement such that, subject to
specified conditions and excluding specified extraordinary matters, the Company has agreed to, and has agreed to cause its permitted transferees to, vote in accordance with the recommendation of Voyager's Board of Directors and has granted
Voyager an irrevocable proxy with respect to the foregoing (the "
Voting Agreement
").
Each of the Standstill Restrictions, the
Lock-Up
Restrictions, and the Voting Agreement terminate upon the earliest to occur of (i) a liquidation or dissolution of Voyager, and (ii) the later of the third anniversary of the date of the Closing
and the initial announcement or release of topline results from Voyager's anticipated second pivotal clinical trial. The Standstill Restrictions and Voting Agreement also terminate upon the expiration or termination of the Collaboration
Agreement, if earlier. The Standstill Restrictions and
Lock-Up
Restrictions also terminate upon the deregistration of Voyager's common stock, if earlier. The
Lock-Up
Restrictions and Voting Agreement also terminate on a change in control of Voyager or the date on which the Company and its affiliates beneficially own less than three percent of the common stock of
Voyager on an outstanding basis.
The foregoing description of the terms of the Investor Agreement does not purport to be complete and is qualified in its
entirety by reference to the full text of the Investor Agreement, a copy of which will be filed with the Securities and Exchange Commission as an exhibit to the Company's Annual Report on Form
10-K
for
the year ended December 31, 2018.
Forward-Looking Statements
This Current Report on Form
8-K
contains "forward-looking statements" within the meaning of Section 27A
of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements relate to future events and involve known and unknown risks, uncertainties and other factors which may cause the
Company's actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking
statements by terms such as "may", "will", "should", "could", "would", "expects", "plans", "anticipates", "believes", "estimates",
"projects", "predicts", "potential" and similar expressions intended to identify forward-looking statements. These statements reflect the Company's current views with respect to future events and are based on
assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, these forward-looking statements represent the Company's estimates and assumptions
only as of the date of this Current Report on Form
8-K.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
99.1
Joint Press Release of Neurocrine Biosciences, Inc. and Voyager Therapeutics, Inc. dated
 January 29, 2019.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
Dated: January 29, 2019
NEUROCRINE BIOSCIENCES, INC.
/s/ Darin M. Lippoldt
Darin M. Lippoldt
Chief Legal Officer