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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>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) </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 7, 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>AKEBIA THERAPEUTICS, 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">001-36352</FONT></B></TD>
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<TD VALIGN="top" ALIGN="center"><B><FONT STYLE="white-space:nowrap">20-8756903</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)</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" COLSPAN="3" ALIGN="center"> <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>245 First Street</B></P>
<P STYLE="margin-top:0pt; margin-bottom:1pt; font-size:10pt; font-family:Times New Roman" ALIGN="center"><B>Cambridge, Massachusetts</B></P></TD>
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<TD VALIGN="bottom" ALIGN="center"><B>02142</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">871-2098</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: </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 (&#167;&nbsp;230.405 of this
chapter) or Rule <FONT STYLE="white-space:nowrap">12b-2</FONT> of the Securities Exchange Act of 1934 (&#167; <FONT STYLE="white-space:nowrap">240.12b-2</FONT> of this chapter). </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman" ALIGN="right">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>
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<TD WIDTH="10%" VALIGN="top" ALIGN="left"><B>Item&nbsp;7.01</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Regulation FD Disclosure. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Spokespersons of Akebia Therapeutics, Inc. (the &#147;Company&#148;) plan to present the information in the J.P. Morgan Healthcare Conference Presentation
attached hereto as Exhibit 99.1 (the &#147;Presentation&#148;) at the 37th Annual J.P. Morgan Healthcare Conference on January&nbsp;9, 2019 at 9:30 a.m. Pacific Time and at various meetings beginning on January&nbsp;7, 2019, including investor and
analyst meetings. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">In December 2018, the Independent Data Monitoring Committee held another meeting and recommended that the Company&#146;s global Phase 3
PRO<SUB STYLE="font-size:85%; vertical-align:bottom">2</SUB>TECT and INNO<SUB STYLE="font-size:85%; vertical-align:bottom">2</SUB>VATE programs for its product candidate, vadadustat, continue and did not recommend any modifications to the programs.
</P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">The information in this Item 7.01 of this Current Report on Form <FONT STYLE="white-space:nowrap">8-K</FONT> and Exhibit 99.1 hereto shall not be deemed
&#147;filed&#148; for purposes of Section&nbsp;18 of the Securities Exchange Act of 1934, as amended (the &#147;Exchange Act&#148;), or otherwise subject to the liabilities under that Section. The information contained in this Item 7.01 and Exhibit
99.1 hereto shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission (the &#147;SEC&#148;) made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or
after the date hereof, regardless of any general incorporation language in such filing. </P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="10%" VALIGN="top" ALIGN="left"><B>Item&nbsp;8.01</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Other Events. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">As previously disclosed, on December&nbsp;12, 2018, the Company completed a merger, whereby Keryx Biopharmaceuticals, Inc. (&#147;Keryx&#148;) became a wholly
owned subsidiary of the Company (the &#147;Merger&#148;). At the consummation of the Merger, each issued and outstanding share of common stock of Keryx, $0.001 par value per share, was converted into 0.37433 of a share of common stock of the
Company, $0.00001 par value per share (&#147;Common Stock&#148;), and cash in lieu of fractional shares. At December&nbsp;31, 2018, the Company had 116,887,518 shares of Common Stock outstanding. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">As previously disclosed, on October&nbsp;31, 2018 and November&nbsp;6, 2018, Keryx received Paragraph IV certification notice letters regarding Abbreviated
New Drug Applications (&#147;ANDAs&#148;) submitted to the U.S. Food and Drug Administration (&#147;FDA&#148;) by Lupin Atlantis Holdings SA (&#147;Lupin&#148;) and Teva Pharmaceuticals USA, Inc. (&#147;Teva&#148;), respectively, requesting approval
for generic versions of Auryxia<SUP STYLE="font-size:85%; vertical-align:top">&reg;</SUP> (ferric citrate) tablets (210 mg iron per tablet). On December&nbsp;13, 2018, Keryx and its licensors, Panion&nbsp;&amp; BF Biotech, Inc. (&#147;Panion&#148;)
and Chen Hsing Hsu, M.D., filed a complaint for patent infringement against Lupin and Lupin Ltd. (the &#147;Lupin Defendants&#148;) in the United States District Court for the District of Delaware (the &#147;Delaware Court&#148;) arising from
Lupin&#146;s ANDA filing with the FDA, and on December&nbsp;19, 2018, Keryx and Panion filed a complaint for patent infringement against Teva and Teva Pharmaceutical Industries Limited (the &#147;Teva Defendants&#148;) in the Delaware Court arising
from Teva&#146;s ANDA filing with the FDA. As a result of the timely filing of these lawsuits in accordance with statute, a <FONT STYLE="white-space:nowrap">30-month</FONT> stay of approval will be imposed by the FDA on Lupin&#146;s and Teva&#146;s
ANDAs, which stays are expected to remain in effect until April 2021 and May 2021, respectively, absent an earlier judgment by the Delaware Court in each of these lawsuits finding the patents at issue invalid, unenforceable or not infringed. The
plaintiffs in each of these lawsuits seek, among other relief, an order that the effective date of FDA approval of the ANDA be a date no earlier than the expiration of each of the patents at issue, equitable relief enjoining the Lupin Defendants and
Teva Defendants from infringing these patents, and monetary relief as a result of any such infringement. </P> <P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">On December&nbsp;24, 2018, Keryx received a
Paragraph IV certification notice letter regarding an ANDA submitted to the FDA by Chemo Research S.L. (&#147;Chemo&#148;) requesting approval to market, sell and use a generic version of the Auryxia tablets (210 mg iron per tablet). In its notice
letter, Chemo alleges that Keryx&#146;s U.S. Patents Nos. 9,387,191; 5,753,706; 7,767,851; 8,093,423; 8,299,298; 8,338,642; 8,609,896; 8,754,257; 8,754,258; 8,846,976; 8,901,349; 9,050,316; 9,328,133; and 9,757,416 (the &#147;Patents&#148;), which
cover the approved drug substance, drug product and/or methods of using Auryxia, are invalid, unenforceable and/or will not be infringed by Chemo&#146;s manufacture, use or sale of the product described in its ANDA.&nbsp;Keryx is currently reviewing
the notice letter and intends to vigorously enforce its intellectual property rights relating to Auryxia. By statute, Keryx has 45 days from receipt of the notice letter to initiate a patent infringement lawsuit against Chemo. Such a lawsuit would
automatically preclude the FDA from approving Chemo&#146;s ANDA until the earlier of 30 months from December&nbsp;24, 2018 or entry of a district court decision finding the Patents invalid, unenforceable or not infringed. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">Going forward, the Company plans to provide updates on any additional Paragraph IV certification notices that Keryx may receive and about patent litigation
against ANDA filers through the Company&#146;s Quarterly Reports on Form <FONT STYLE="white-space:nowrap">10-Q</FONT> and Annual Reports on Form <FONT STYLE="white-space:nowrap">10-K</FONT> filed with the SEC. </P>
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 <P STYLE="margin-top:0pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">By providing the information in Items 7.01 and 8.01 of this Current Report on Form <FONT
STYLE="white-space:nowrap">8-K,</FONT> including Exhibit 99.1 hereto, the Company is not making an admission as to the materiality of any information herein. The information contained in this Current Report on Form
<FONT STYLE="white-space:nowrap">8-K</FONT> is intended to be considered in the context of more complete information included in the Company&#146;s filings with the SEC, the SEC filings of the Company&#146;s wholly owned subsidiary, Keryx, and other
public announcements that the Company or Keryx has made and may make from time to time by press release or otherwise. The Company undertakes no duty or obligation to update or revise the information contained in this Current Report on Form <FONT
STYLE="white-space:nowrap">8-K,</FONT> 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 SEC, through press releases or through
other public disclosures. </P> <P STYLE="margin-top:18pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman"><B><I>Cautionary Note on Forward-Looking Statements </I></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> including Exhibit 99.1 hereto, includes forward-looking statements. These statements
are not historical facts, but instead represent only the Company&#146;s beliefs regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company&#146;s control. </P>
<P STYLE="margin-top:12pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">For a discussion of risks related to the forward-looking statements in this Current Report on Form <FONT STYLE="white-space:nowrap">8-K,</FONT> including the
risks related to the ANDA filings discussed in this Current Report on Form <FONT STYLE="white-space:nowrap">8-K,</FONT> see the &#147;Risk Factors&#148; section of the Company&#146;s Quarterly Report on Form
<FONT STYLE="white-space:nowrap">10-Q</FONT> for the quarter ended September&nbsp;30, 2018, filed by the Company on November&nbsp;8, 2018, including the risk factor under the heading &#147;If generic products that compete with Keryx&#146;s marketed
product, Auryxia, or any future product of the combined company are approved and launched, the combined company&#146;s business, financial position or results of operations would be adversely affected,&#148; and the &#147;Risk Factors&#148; section
of Keryx&#146;s Quarterly Report on Form <FONT STYLE="white-space:nowrap">10-Q</FONT> for the quarter ended September&nbsp;30, 2018, filed by the Keryx on November&nbsp;8, 2018, including the risk factor under the heading &#147;If our competitors
develop and market products that are less expensive, have a reduced pill burden, are or are promoted as more effective or safer than our drug product, or our drug product does not achieve market acceptance <FONT STYLE="white-space:nowrap"><FONT
STYLE="white-space:nowrap">vis-&agrave;-vis</FONT></FONT> existing treatments, our commercial opportunities may be reduced or eliminated.&#148; For additional important information about forward-looking statements, see also the slide titled
&#147;Cautionary Note on Forward-Looking Statements&#148; in Exhibit 99.1 hereto. </P> <P STYLE="font-size:18pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P>
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<TD WIDTH="10%" VALIGN="top" ALIGN="left"><B>Item&nbsp;9.01</B></TD>
<TD ALIGN="left" VALIGN="top"> <P STYLE=" margin-top:0pt ; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman; " ALIGN="left"><B>Financial Statements and Exhibits. </B></P></TD></TR></TABLE>
<P STYLE="margin-top:6pt; margin-bottom:0pt; font-size:10pt; font-family:Times New Roman">(d) <U>Exhibits</U>. </P> <P STYLE="font-size:12pt;margin-top:0pt;margin-bottom:0pt">&nbsp;</P><DIV ALIGN="right">
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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>Exhibit Description</B></P></TD></TR>


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<TD VALIGN="top" NOWRAP>99.1</TD>
<TD VALIGN="bottom">&nbsp;&nbsp;</TD>
<TD VALIGN="top"><A HREF="d675400dex991.htm">J.P. Morgan Healthcare Conference Presentation </A></TD></TR>
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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; text-indent:4%; 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="bottom">AKEBIA THERAPEUTICS, INC.</TD></TR>
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<TD VALIGN="top">Date: January&nbsp;7, 2019</TD>
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<TD VALIGN="bottom">By:</TD>
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<TD VALIGN="bottom"> <P STYLE="margin-top:0pt; margin-bottom:1pt; border-bottom:1px solid #000000; font-size:10pt; font-family:Times New Roman">/s/ John P. Butler</P></TD></TR>
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<TD VALIGN="bottom">Name:</TD>
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<TD VALIGN="bottom">Title:</TD>
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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 7, 2019
AKEBIA THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Delaware
001-36352
20-8756903
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
245 First Street
Cambridge, Massachusetts
02142
(Address of principal executive offices)
(Zip Code)
Registrant's telephone number, including area code: (617)
871-2098
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 7.01
Regulation FD Disclosure.
Spokespersons of Akebia Therapeutics, Inc. (the "Company") plan to present the information in the J.P. Morgan Healthcare Conference Presentation
attached hereto as Exhibit 99.1 (the "Presentation") at the 37th Annual J.P. Morgan Healthcare Conference on January 9, 2019 at 9:30 a.m. Pacific Time and at various meetings beginning on January 7, 2019, including investor and
analyst meetings.
In December 2018, the Independent Data Monitoring Committee held another meeting and recommended that the Company's global Phase 3
PRO
2
TECT and INNO
2
VATE programs for its product candidate, vadadustat, continue and did not recommend any modifications to the programs.
The information in this Item 7.01 of this Current Report on Form
8-K
and Exhibit 99.1 hereto shall not be deemed
"filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities under that Section. The information contained in this Item 7.01 and Exhibit
99.1 hereto shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission (the "SEC") made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or
after the date hereof, regardless of any general incorporation language in such filing.
Item 8.01
Other Events.
As previously disclosed, on December 12, 2018, the Company completed a merger, whereby Keryx Biopharmaceuticals, Inc. ("Keryx") became a wholly
owned subsidiary of the Company (the "Merger"). At the consummation of the Merger, each issued and outstanding share of common stock of Keryx, $0.001 par value per share, was converted into 0.37433 of a share of common stock of the
Company, $0.00001 par value per share ("Common Stock"), and cash in lieu of fractional shares. At December 31, 2018, the Company had 116,887,518 shares of Common Stock outstanding.
As previously disclosed, on October 31, 2018 and November 6, 2018, Keryx received Paragraph IV certification notice letters regarding Abbreviated
New Drug Applications ("ANDAs") submitted to the U.S. Food and Drug Administration ("FDA") by Lupin Atlantis Holdings SA ("Lupin") and Teva Pharmaceuticals USA, Inc. ("Teva"), respectively, requesting approval
for generic versions of Auryxia
®
(ferric citrate) tablets (210 mg iron per tablet). On December 13, 2018, Keryx and its licensors, Panion & BF Biotech, Inc. ("Panion")
and Chen Hsing Hsu, M.D., filed a complaint for patent infringement against Lupin and Lupin Ltd. (the "Lupin Defendants") in the United States District Court for the District of Delaware (the "Delaware Court") arising from
Lupin's ANDA filing with the FDA, and on December 19, 2018, Keryx and Panion filed a complaint for patent infringement against Teva and Teva Pharmaceutical Industries Limited (the "Teva Defendants") in the Delaware Court arising
from Teva's ANDA filing with the FDA. As a result of the timely filing of these lawsuits in accordance with statute, a
30-month
stay of approval will be imposed by the FDA on Lupin's and Teva's
ANDAs, which stays are expected to remain in effect until April 2021 and May 2021, respectively, absent an earlier judgment by the Delaware Court in each of these lawsuits finding the patents at issue invalid, unenforceable or not infringed. The
plaintiffs in each of these lawsuits seek, among other relief, an order that the effective date of FDA approval of the ANDA be a date no earlier than the expiration of each of the patents at issue, equitable relief enjoining the Lupin Defendants and
Teva Defendants from infringing these patents, and monetary relief as a result of any such infringement.
On December 24, 2018, Keryx received a
Paragraph IV certification notice letter regarding an ANDA submitted to the FDA by Chemo Research S.L. ("Chemo") requesting approval to market, sell and use a generic version of the Auryxia tablets (210 mg iron per tablet). In its notice
letter, Chemo alleges that Keryx's U.S. Patents Nos. 9,387,191; 5,753,706; 7,767,851; 8,093,423; 8,299,298; 8,338,642; 8,609,896; 8,754,257; 8,754,258; 8,846,976; 8,901,349; 9,050,316; 9,328,133; and 9,757,416 (the "Patents"), which
cover the approved drug substance, drug product and/or methods of using Auryxia, are invalid, unenforceable and/or will not be infringed by Chemo's manufacture, use or sale of the product described in its ANDA. Keryx is currently reviewing
the notice letter and intends to vigorously enforce its intellectual property rights relating to Auryxia. By statute, Keryx has 45 days from receipt of the notice letter to initiate a patent infringement lawsuit against Chemo. Such a lawsuit would
automatically preclude the FDA from approving Chemo's ANDA until the earlier of 30 months from December 24, 2018 or entry of a district court decision finding the Patents invalid, unenforceable or not infringed.
Going forward, the Company plans to provide updates on any additional Paragraph IV certification notices that Keryx may receive and about patent litigation
against ANDA filers through the Company's Quarterly Reports on Form
10-Q
and Annual Reports on Form
10-K
filed with the SEC.
By providing the information in Items 7.01 and 8.01 of this Current Report on Form
8-K,
including Exhibit 99.1 hereto, the Company is not making an admission as to the materiality of any information herein. The information contained in this Current Report on Form
8-K
is intended to be considered in the context of more complete information included in the Company's filings with the SEC, the SEC filings of the Company's wholly owned subsidiary, Keryx, and other
public announcements that the Company or Keryx has made and may make from time to time by press release or otherwise. The Company undertakes no duty or obligation to update or revise the information contained in this Current Report on Form
8-K,
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 SEC, through press releases or through
other public disclosures.
Cautionary Note on Forward-Looking Statements
This Current Report on Form
8-K,
including Exhibit 99.1 hereto, includes forward-looking statements. These statements
are not historical facts, but instead represent only the Company's beliefs regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company's control.
For a discussion of risks related to the forward-looking statements in this Current Report on Form
8-K,
including the
risks related to the ANDA filings discussed in this Current Report on Form
8-K,
see the "Risk Factors" section of the Company's Quarterly Report on Form
10-Q
for the quarter ended September 30, 2018, filed by the Company on November 8, 2018, including the risk factor under the heading "If generic products that compete with Keryx's marketed
product, Auryxia, or any future product of the combined company are approved and launched, the combined company's business, financial position or results of operations would be adversely affected," and the "Risk Factors" section
of Keryx's Quarterly Report on Form
10-Q
for the quarter ended September 30, 2018, filed by the Keryx on November 8, 2018, including the risk factor under the heading "If our competitors
develop and market products that are less expensive, have a reduced pill burden, are or are promoted as more effective or safer than our drug product, or our drug product does not achieve market acceptance
vis-à-vis
existing treatments, our commercial opportunities may be reduced or eliminated." For additional important information about forward-looking statements, see also the slide titled
"Cautionary Note on Forward-Looking Statements" in Exhibit 99.1 hereto.
Item 9.01
Financial Statements and Exhibits.
(d)
Exhibits
.
Exhibit
No.
Exhibit Description
99.1
J.P. Morgan Healthcare Conference Presentation
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.
AKEBIA THERAPEUTICS, INC.
Date: January 7, 2019
By:
/s/ John P. Butler
Name:
John P. Butler
Title:
President and Chief Executive Officer