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 <P STYLE="line-height:1.0pt;margin-top:0pt;margin-bottom:0pt;border-bottom:1px solid #000000">&nbsp;</P>
<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>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) </B></P>
<P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:12pt; font-family:Times New Roman" ALIGN="center"><B>of the 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>
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<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:24pt; font-family:Times New Roman" ALIGN="center"><B>SCPHARMACEUTICALS 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>
<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">001-38293</FONT></B></TD>
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<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">46-5184075</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</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>of incorporation or organization)</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>(I.R.S. 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" COLSPAN="3" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>2400 District Avenue, Suite 310</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Burlington, Massachusetts</B></P></TD>
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<TD VALIGN="bottom" ALIGN="center"><B>01803</B></TD></TR>
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<TD VALIGN="top" COLSPAN="3" 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: (617)
<FONT STYLE="white-space:nowrap">517-0730</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: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 (<I>see </I>General Instruction A.2. below): </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(b))</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">13e-4(c)</FONT> under the Exchange Act (17 CFR <FONT STYLE="white-space:nowrap">240.13e-4(c))</FONT> </P></TD></TR></TABLE>
<P STYLE="margin-top:12pt; margin-bottom:0pt; 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 or Rule <FONT
STYLE="white-space:nowrap">12b-2</FONT> of the Securities Exchange Act of 1934. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Emerging growth company&nbsp;&nbsp;&#9746; </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; 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;&#9746; </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> <P STYLE="line-height:3.0pt;margin-top:0pt;margin-bottom:2pt;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; text-indent:4%; font-size:10pt; font-family:Times New Roman">On January&nbsp;28, 2019, scPharmaceuticals Inc. (the &#147;Company&#148;) entered into a Development Agreement (the &#147;Development
Agreement&#148;) with West Pharmaceutical Services, Inc. (&#147;West&#148;), pursuant to which the Company will incorporate the SmartDose<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP> on-body drug delivery system developed by West with
the Company&#146;s lead product candidate, FUROSCIX<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP>. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">Under the terms of the
Development Agreement, the Company paid to West a <FONT STYLE="white-space:nowrap">one-time</FONT> upfront payment of approximately $1.7&nbsp;million upon signing of the agreement. In addition, West shall be eligible to receive up to an aggregate of
$4.5&nbsp;million upon the occurrence of certain device development and validation milestones, as well as an additional $5&nbsp;million in fixed exclusivity fees, payable through 2020, and up to an aggregate of $2&nbsp;million in additional
contingent exclusivity fees in the event that the Company exercises its option to obtain worldwide exclusivity rights under the Development Agreement. In addition to development and validation of the SmartDose<SUP
STYLE="font-size:85%; vertical-align:top">&reg;</SUP> drug delivery device, the Development Agreement provides for <FONT STYLE="white-space:nowrap">non-binding</FONT> terms and conditions under which the Company and West may enter into a definitive
commercial supply agreement for the supply of SmartDose<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP> drug delivery devices in quantities sufficient for the Company to commercialize FUROSCIX, if approved. The Development Agreement
provides that West will exclusively develop SmartDose<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP> drug delivery devices for the use of treating edema with loop diuretics in the United States and the Company has the further right to
extend this exclusivity worldwide. The Company may terminate the Development Agreement for convenience upon written notice to West, and either party may terminate the Development Agreement as a result of a material breach by the other party that
remains uncured for a specified period of time. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The foregoing description of the Development Agreement does not purport to be complete
and is qualified in its entirety by reference to the full text of the Development Agreement, which the Company expects to file as an exhibit to a report filed under the Securities Exchange Act of 1934 (the &#147;Exchange Act&#148;), and intends to
seek confidential treatment for certain terms and provisions of the Development Agreement. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Item&nbsp;1.02. Termination of a Material Definitive
Agreement. </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On January&nbsp;29, 2019, the Company issued to Sensile Medical AG (&#147;Sensile&#148;) a notice of termination for
business reasons under the License Agreement, dated as of June&nbsp;29, 2015, as subsequently amended, by and between the Company and Sensile (the &#147;License Agreement&#148;). The termination of the License Agreement will become effective as of
March&nbsp;30, 2019. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Item&nbsp;5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory
Arrangements of Certain Officers. </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On January&nbsp;28, 2019, the Company and Troy Ignelzi, the Company&#146;s Chief Financial Officer
(and principal financial and accounting officer) agreed to end Mr.&nbsp;Ignelzi&#146;s employment with the Company and its subsidiaries effective February&nbsp;28, 2019 (the &#147;Effective Date&#148;). Mr.&nbsp;Ignelzi&#146;s resignation was not
related to any disagreements with the Company on any matter relating to its operations, policies, practices or any issues regarding financial disclosures, accounting or legal matters. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">In connection with his departure, on January&nbsp;28, 2019, Mr.&nbsp;Ignelzi entered into a Separation Agreement (the &#147;Separation
Agreement&#148;) with the Company, providing for the terms of Mr.&nbsp;Ignelzi&#146;s separation from the Company and pursuant to which Mr.&nbsp;Ignelzi provides the Company with a customary release of claims. Under the terms of the Separation
Agreement, Mr.&nbsp;Ignelzi will continue to receive his base salary and benefits now in effect for six months following the Effective Date, provided that if he has </P>
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not entered into a Service Relationship (as defined in the Separation Agreement) at the end of such <FONT STYLE="white-space:nowrap">six-month</FONT> period, he will continue to receive his base
salary and benefits now in effect for either an additional three months thereafter or until his earlier entry into a Service Relationship. The Separation Agreement further provides that the exercise period for Mr.&nbsp;Ignelzi&#146;s vested options
will be extended until 24 months following his separation from the Company. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The above description of the Separation Agreement does not
purport to be complete and is qualified in its entirety by reference to the full text of the Separation Agreement, which is filed with this Current Report on Form <FONT STYLE="white-space:nowrap">8-K</FONT> as Exhibit 10.1 and is incorporated herein
by reference. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On January&nbsp;28, 2019, the Board appointed Rachael Nokes to succeed Mr.&nbsp;Ignelzi as the Company&#146;s principal
accounting officer and John Tucker to succeed Mr.&nbsp;Ignelzi as the Company&#146;s principal financial officer, in each case effective as of the Effective Date. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Item&nbsp;7.01 Regulation FD Disclosure. </B></P>
<P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">On January&nbsp;29, 2019, the Company issued a press release announcing its entry into the West Development Agreement. A copy of this press
release is furnished as Exhibit 99.1 to this Report on <FONT STYLE="white-space:nowrap">Form&nbsp;8-K.</FONT> </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">The information in this
Item&nbsp;7.01 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed &#147;filed&#148; for purposes of Section&nbsp;18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed
incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing. </P>
<P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B>Item&nbsp;8.01 Other Events. </B></P> <P STYLE="margin-top:6pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">As
previously disclosed, on June&nbsp;11, 2018, the Company received a complete response letter (&#147;CRL&#148;) from the U.S. Food and Drug Administration regarding its New Drug Application (the &#147;NDA&#148;) under section 505(b)(2) of the Federal
Food, Drug, and Cosmetic Act for FUROSCIX Infusor (furosemide), 80 mg/10 mL, drug-device combination product.&nbsp;On January&nbsp;28, 2019, management implemented a restructuring plan to reduce operating costs and better align the Company&#146;s
workforce with the needs of its business following the Company&#146;s focus on its next generation of FUROSCIX using the West SmartDose delivery technology. Under this restructuring plan, the Company reduced its workforce by approximately 43%, to 13
employees. The Company currently estimates that it will record a charge in the first quarter of 2019 of approximately $1.4 million, consisting of severance, benefits and outplacement services. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">By filing this information, the Company makes no admission as to the materiality of any information in this report.&nbsp;The information
contained in this report is intended to be considered in the context of the Company&#146;s filings with the U.S. Securities and Exchange Commission (the &#147;Commission&#148;) and other public announcements that the Company makes, by press release
or otherwise, from time to time.&nbsp;The Company undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate.&nbsp;Any
such updating may be made through the filing of other reports or documents with the Commission, through press releases or through other public disclosure. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; text-indent:4%; font-size:10pt; font-family:Times New Roman">This report contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to statements regarding the effects of the Company&#146;s restructuring plan,
reduction in force charges, and the potential cost saving resulting from these Company&#146;s restructuring and reduction in force, are forward-looking statements which involve risks and uncertainties that could cause actual results to differ
materially from those discussed in such forward-looking statements. Such risks and uncertainties include, without limitation, risks associated with whether the Company will realize cost savings from its restructuring plan, whether the Company will
receive regulatory approval for its next generation of FUROSCIX, as well as other risks set forth under the caption &#147;Risk Factors&#148; in the Company&#146;s Annual Report on Form <FONT STYLE="white-space:nowrap">10-K</FONT> for the year ended
December&nbsp;31, 2017 and its subsequent public filings with the Commission. The Company cautions investors not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Except as required by law, the
Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that
actual results will differ from those set forth in the forward-looking statements. </P> <P STYLE="margin-top:12pt; 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>
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<TD VALIGN="bottom" NOWRAP ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:8pt; font-family:Times New Roman" ALIGN="center"><B>Exhibit</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; " ALIGN="center"><B>Number</B></P></TD>
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<TD VALIGN="bottom" NOWRAP> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; border-bottom:1.00pt solid #000000; display:table-cell; font-size:8pt; font-family:Times New Roman; "><B>Description</B></P></TD></TR>


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<TD VALIGN="top" NOWRAP>10.1</TD>
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<TD VALIGN="top"><A HREF="d700664dex101.htm">Separation Agreement, by and between the registrant and Troy Ignelzi, dated January&nbsp;28, 2019 </A></TD></TR>
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<TD VALIGN="top" NOWRAP>99.1</TD>
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<TD VALIGN="top"><A HREF="d700664dex991.htm">Press release issued by the registrant on January&nbsp;29, 2019 </A></TD></TR>
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<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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<TD VALIGN="top" COLSPAN="3"><B>SCPHARMACEUTICALS&nbsp;INC.</B></TD></TR>
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<TD VALIGN="top">Date: January&nbsp;29, 2019</TD>
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<TD VALIGN="top">By:</TD>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ John H. Tucker</P></TD></TR>
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<TD VALIGN="top">Name:</TD>
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<TD VALIGN="top">John H. Tucker</TD></TR>
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<TD VALIGN="top"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">President, Chief Executive Officer and</P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman">Principal Executive Officer</P></TD></TR>
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8-K
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
SCPHARMACEUTICALS INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware
001-38293
46-5184075
(State or other jurisdiction
of incorporation or organization)
(Commission
File Number)
(I.R.S. Employer
Identification No.)
2400 District Avenue, Suite 310
Burlington, Massachusetts
01803
(Address of principal executive offices)
(Zip Code)
Registrant's telephone number, including area code: (617)
517-0730
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 (
see
General Instruction A.2. below):
☐
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 or Rule
12b-2
of the Securities Exchange Act of 1934.
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.
On January 28, 2019, scPharmaceuticals Inc. (the "Company") entered into a Development Agreement (the "Development
Agreement") with West Pharmaceutical Services, Inc. ("West"), pursuant to which the Company will incorporate the SmartDose
®
on-body drug delivery system developed by West with
the Company's lead product candidate, FUROSCIX
®
.
Under the terms of the
Development Agreement, the Company paid to West a
one-time
upfront payment of approximately $1.7 million upon signing of the agreement. In addition, West shall be eligible to receive up to an aggregate of
$4.5 million upon the occurrence of certain device development and validation milestones, as well as an additional $5 million in fixed exclusivity fees, payable through 2020, and up to an aggregate of $2 million in additional
contingent exclusivity fees in the event that the Company exercises its option to obtain worldwide exclusivity rights under the Development Agreement. In addition to development and validation of the SmartDose
®
drug delivery device, the Development Agreement provides for
non-binding
terms and conditions under which the Company and West may enter into a definitive
commercial supply agreement for the supply of SmartDose
®
drug delivery devices in quantities sufficient for the Company to commercialize FUROSCIX, if approved. The Development Agreement
provides that West will exclusively develop SmartDose
®
drug delivery devices for the use of treating edema with loop diuretics in the United States and the Company has the further right to
extend this exclusivity worldwide. The Company may terminate the Development Agreement for convenience upon written notice to West, and either party may terminate the Development Agreement as a result of a material breach by the other party that
remains uncured for a specified period of time.
The foregoing description of the Development Agreement does not purport to be complete
and is qualified in its entirety by reference to the full text of the Development Agreement, which the Company expects to file as an exhibit to a report filed under the Securities Exchange Act of 1934 (the "Exchange Act"), and intends to
seek confidential treatment for certain terms and provisions of the Development Agreement.
Item 1.02. Termination of a Material Definitive
Agreement.
On January 29, 2019, the Company issued to Sensile Medical AG ("Sensile") a notice of termination for
business reasons under the License Agreement, dated as of June 29, 2015, as subsequently amended, by and between the Company and Sensile (the "License Agreement"). The termination of the License Agreement will become effective as of
March 30, 2019.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory
Arrangements of Certain Officers.
On January 28, 2019, the Company and Troy Ignelzi, the Company's Chief Financial Officer
(and principal financial and accounting officer) agreed to end Mr. Ignelzi's employment with the Company and its subsidiaries effective February 28, 2019 (the "Effective Date"). Mr. Ignelzi's resignation was not
related to any disagreements with the Company on any matter relating to its operations, policies, practices or any issues regarding financial disclosures, accounting or legal matters.
In connection with his departure, on January 28, 2019, Mr. Ignelzi entered into a Separation Agreement (the "Separation
Agreement") with the Company, providing for the terms of Mr. Ignelzi's separation from the Company and pursuant to which Mr. Ignelzi provides the Company with a customary release of claims. Under the terms of the Separation
Agreement, Mr. Ignelzi will continue to receive his base salary and benefits now in effect for six months following the Effective Date, provided that if he has
not entered into a Service Relationship (as defined in the Separation Agreement) at the end of such
six-month
period, he will continue to receive his base
salary and benefits now in effect for either an additional three months thereafter or until his earlier entry into a Service Relationship. The Separation Agreement further provides that the exercise period for Mr. Ignelzi's vested options
will be extended until 24 months following his separation from the Company.
The above description of the Separation Agreement does not
purport to be complete and is qualified in its entirety by reference to the full text of the Separation Agreement, which is filed with this Current Report on Form
8-K
as Exhibit 10.1 and is incorporated herein
by reference.
On January 28, 2019, the Board appointed Rachael Nokes to succeed Mr. Ignelzi as the Company's principal
accounting officer and John Tucker to succeed Mr. Ignelzi as the Company's principal financial officer, in each case effective as of the Effective Date.
Item 7.01 Regulation FD Disclosure.
On January 29, 2019, the Company issued a press release announcing its entry into the West Development Agreement. A copy of this press
release is furnished as Exhibit 99.1 to this Report on
Form 8-K.
The information in this
Item 7.01 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed "filed" for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed
incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
As
previously disclosed, on June 11, 2018, the Company received a complete response letter ("CRL") from the U.S. Food and Drug Administration regarding its New Drug Application (the "NDA") under section 505(b)(2) of the Federal
Food, Drug, and Cosmetic Act for FUROSCIX Infusor (furosemide), 80 mg/10 mL, drug-device combination product. On January 28, 2019, management implemented a restructuring plan to reduce operating costs and better align the Company's
workforce with the needs of its business following the Company's focus on its next generation of FUROSCIX using the West SmartDose delivery technology. Under this restructuring plan, the Company reduced its workforce by approximately 43%, to 13
employees. The Company currently estimates that it will record a charge in the first quarter of 2019 of approximately $1.4 million, consisting of severance, benefits and outplacement services.
By filing this information, the Company makes no admission as to the materiality of any information in this report. The information
contained in this report is intended to be considered in the context of the Company's filings with the U.S. Securities and Exchange Commission (the "Commission") and other public announcements that the Company makes, by press release
or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any
such updating may be made through the filing of other reports or documents with the Commission, through press releases or through other public disclosure.
This report contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to statements regarding the effects of the Company's restructuring plan,
reduction in force charges, and the potential cost saving resulting from these Company's restructuring and reduction in force, are forward-looking statements which involve risks and uncertainties that could cause actual results to differ
materially from those discussed in such forward-looking statements. Such risks and uncertainties include, without limitation, risks associated with whether the Company will realize cost savings from its restructuring plan, whether the Company will
receive regulatory approval for its next generation of FUROSCIX, as well as other risks set forth under the caption "Risk Factors" in the Company's Annual Report on Form
10-K
for the year ended
December 31, 2017 and its subsequent public filings with the Commission. The Company cautions investors not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Except as required by law, the
Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that
actual results will differ from those set forth in the forward-looking statements.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
Number
Description
10.1
Separation Agreement, by and between the registrant and Troy Ignelzi, dated January 28, 2019
99.1
Press release issued by the registrant on 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.
SCPHARMACEUTICALS INC.
Date: January 29, 2019
By:
/s/ John H. Tucker
Name:
John H. Tucker
Title:
President, Chief Executive Officer and
Principal Executive Officer