<SEC-DOCUMENT>0001178913-19-002907.txt : 20191209
<SEC-HEADER>0001178913-19-002907.hdr.sgml : 20191209
<ACCEPTANCE-DATETIME>20191209070017
ACCESSION NUMBER:		0001178913-19-002907
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20191209
FILED AS OF DATE:		20191209
DATE AS OF CHANGE:		20191209

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			KAMADA LTD
		CENTRAL INDEX KEY:			0001567529
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			L3
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-35948
		FILM NUMBER:		191274304

	BUSINESS ADDRESS:	
		STREET 1:		2 HOLTZMAN ST., SCIENCE PARK
		CITY:			REHOVOT
		STATE:			L3
		ZIP:			7670402
		BUSINESS PHONE:		97289406472

	MAIL ADDRESS:	
		STREET 1:		2 HOLTZMAN ST., SCIENCE PARK
		CITY:			REHOVOT
		STATE:			L3
		ZIP:			7670402
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>zk1923731.htm
<DESCRIPTION>6-K
<TEXT>
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      <div style="text-align: center; line-height: 1.25; font-weight: bold;">UNITED STATES</div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold;">SECURITIES AND EXCHANGE COMMISSION</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Washington, D.C. 20549</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 14pt; font-weight: bold;">FORM 6-K</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Report of Foreign Private Issuer</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">Pursuant to Rule 13a-16 or 15d-16</div>
      <div style="text-align: center; line-height: 1.25; font-weight: bold;">of the Securities Exchange Act of 1934</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: center; line-height: 1.25;">For the Month of December 2019</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: center; line-height: 1.25;">Commission File Number 001-35948</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold;">Kamada Ltd.</div>
      <div style="text-align: center; line-height: 1.25;">(Translation of registrant&#8217;s name into English)</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
      <div style="text-align: center; line-height: 1.25;"><font style="font-weight: bold;">2 Holzman Street</font><br>
        <font style="font-weight: bold;">Science Park, P.O. Box 4081</font><br>
        <font style="font-weight: bold;">Rehovot 7670402</font><br>
        <font style="font-weight: bold;">Israel</font><br>
        <font style="font-family: 'Times New Roman',Times,serif;">&#160;(Address of principal executive offices)</font></div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
      <div style="line-height: 1.25;">Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: center; line-height: 1.25;">Form 20-F &#9746;&#160; &#160; &#160; &#160; Form 40-F &#9744;</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the
        information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: center; line-height: 1.25;">Yes &#9744;&#160; &#160; &#160; &#160; No &#9746;</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">If &#8220;Yes&#8221; is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82&#8209;____</div>
      <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25; font-weight: bold;">This Form 6-K is being incorporated by reference into the Registrant's Form S-8 Registration Statements, File Nos.
        333-192720, 333-207933, 333-215983, 333-222891 and 333-233267,&#160;and the Registrant's Form F-3 Registration Statement, as amended, File No. 333-214816.</div>
      <div style="background-color: #FFFFFF; line-height: 1.25;">
        <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
        <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">
          <hr noshade="noshade" align="center" style="height: 2px; color: #000000; background-color: #000000; text-align: center; margin-left: auto; margin-right: auto; border: none;"> </div>
        <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
        <div style="line-height: 1.25;">The following exhibit is attached:</div>
        <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160; <br>
        </div>
        <div style="line-height: 1.25;">99.1 Press Release: Kamada Enters into a Binding Term Sheet for Contract Manufacturing of an FDA Approved, Commercialized Hyper-Immune
          Globulin Product</div>
        <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160; <br>
        </div>
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      <div style="background-color: #FFFFFF; line-height: 1.25;">
        <div style="text-align: center; line-height: 1.25; font-weight: bold;">SIGNATURE</div>
        <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160; <br>
        </div>
      </div>
      <div style="background-color: #FFFFFF; line-height: 1.25;">
        <div style="line-height: 1.25;">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.</div>
        <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160; <br>
        </div>
        <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">
          <table cellspacing="0" cellpadding="0" border="0" style="width: 100%; border-collapse: separate; font-family: 'Times New Roman', Times, serif; font-size: 10pt;">

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                  <div style="text-align: left; line-height: 1.25;">Date:&#160; December 9, 2019</div>
                </td>
                <td valign="top" style="width: 38%;" colspan="2">
                  <div style="text-align: left; line-height: 1.25; font-weight: bold;">KAMADA LTD.</div>
                </td>
                <td valign="top" style="width: 12%;">&#160;</td>
              </tr>
              <tr>
                <td valign="top" style="width: 50%;">&#160;</td>
                <td valign="top" style="width: 3%;">&#160;</td>
                <td valign="top" style="width: 35%;">&#160;</td>
                <td valign="top" style="width: 12%;">&#160;</td>
              </tr>
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                </td>
                <td valign="top" style="width: 3%; padding-bottom: 2px;">
                  <div align="left" style="margin-left: 0pt; text-indent: 0pt; margin-right: 0pt;">By: </div>
                </td>
                <td valign="top" align="left" style="width: 35%; border-bottom: #000000 2px solid;">/s/ Orna Naveh __</td>
                <td valign="top" style="width: 12%; padding-bottom: 2px;">&#160;</td>
              </tr>
              <tr>
                <td valign="top" style="width: 50%;">&#160;</td>
                <td valign="top" style="width: 3%;">&#160;</td>
                <td valign="bottom" align="left" style="width: 35%;">
                  <div style="text-align: left; line-height: 1.25;">Orna Naveh</div>
                </td>
                <td valign="top" style="width: 12%;">&#160;</td>
              </tr>
              <tr>
                <td valign="top" style="width: 50%;">&#160;</td>
                <td valign="top" style="width: 3%;">&#160;</td>
                <td valign="top" style="width: 35%;">
                  <div style="text-align: left; line-height: 1.25;">General Counsel and Corporate Secretary</div>
                </td>
                <td valign="top" style="width: 12%;">&#160;</td>
              </tr>

          </table>
        </div>
        <div style="background-color: #FFFFFF; line-height: 1.25;"> <br>
        </div>
        <div style="background-color: #FFFFFF; line-height: 1.25;">
          <hr noshade="noshade" align="center" style="height: 2px; color: #000000; background-color: #000000; text-align: center; margin-left: auto; margin-right: auto; border: none;">&#160;
          <div style="text-align: center; line-height: 1.25;"><u>EXHIBIT INDEX</u></div>
          <div style="line-height: 1.25; font-family: 'Times New Roman',Times,serif;">&#160;</div>
        </div>
      </div>
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              <div style="text-align: center; line-height: 1.25;"><u>EXHIBIT NO.</u></div>
            </td>
            <td style="width: 91%; vertical-align: top; background-color: rgb(255, 255, 255); font-family: 'Times New Roman',Times,serif;">
              <div style="line-height: 1.25;"><u>DESCRIPTION</u></div>
            </td>
          </tr>
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            <td style="width: 9%; vertical-align: top; background-color: rgb(255, 255, 255);">
              <div>
                <div>
                  <div style="text-align: center; line-height: 1.25;"><a href="exhibit_99-1.htm"> <br>
                    </a></div>
                  <div style="text-align: center; line-height: 1.25;"><a href="exhibit_99-1.htm">99.1</a></div>
                </div>
              </div>
            </td>
            <td style="width: 91%; vertical-align: top; background-color: rgb(255, 255, 255);">
              <div>
                <div>
                  <div style="background-color: #FFFFFF; line-height: 1.25;">
                    <div style="line-height: 1.25;"> <a href="exhibit_99-1.htm"><br>
                      </a></div>
                    <div style="line-height: 1.25;"><a href="exhibit_99-1.htm">Press
                        Release: Kamada Enters into a Binding Term Sheet for Contract Manufacturing of an FDA Approved, Commercialized Hyper-Immune Globulin Product</a></div>
                  </div>
                </div>
              </div>
            </td>
          </tr>

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<DOCUMENT>
<TYPE>EX-99.1
<SEQUENCE>2
<FILENAME>exhibit_99-1.htm
<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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    <div style="text-align: right;"><u><font style="font-weight: bold;">Exhibit 99.1</font></u><br>
    </div>
    <div> <br>
    </div>
    <div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold;">Kamada Enters into a Binding Term Sheet for Contract Manufacturing of an FDA Approved, </div>
      <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 12pt; font-weight: bold;">Commercialized Hyper-Immune Globulin Product</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="line-height: 1.25;">
        <div>
          <table cellspacing="0" cellpadding="0" id="z2deb8f6b3de54518a3acdb4f97f99d6d" class="DSPFListTable" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

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                <td style="width: 36pt;"><br>
                </td>
                <td style="width: 18pt; vertical-align: top; align: right;">&#8226;</td>
                <td style="width: auto; vertical-align: top;">
                  <div style="font-style: italic;">Commercial supply of the 12-year contract manufacturing agreement, following the completion of the required tech-transfer project, is expected
                    to commence in early 2023</div>
                </td>
              </tr>

          </table>
        </div>
      </div>
      <div style="line-height: 1.25;">
        <div>
          <table cellspacing="0" cellpadding="0" id="z1049b988f9f04c42998516e4a90b6813" class="DSPFListTable" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

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                </td>
                <td style="width: 18pt; vertical-align: top; align: right;">&#8226;</td>
                <td style="width: auto; vertical-align: top;">
                  <div style="font-style: italic;">Based on current market sales volume, the new product is estimated to add approximately $8 million to $10 million in annual revenues to Kamada</div>
                </td>
              </tr>

          </table>
        </div>
      </div>
      <div style="line-height: 1.25;">
        <div>
          <table cellspacing="0" cellpadding="0" id="ze231e53b310549719f12cbac10ebd47a" class="DSPFListTable" style="font-family: 'Times New Roman', Times, serif; font-size: 10pt; width: 100%; text-align: left; color: #000000;">

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                </td>
                <td style="width: 18pt; vertical-align: top; align: right;">&#8226;</td>
                <td style="width: auto; vertical-align: top;">
                  <div style="font-style: italic;">Gross margin level of the new product is anticipated to be similar to average gross margins of the Company&#8217;s proprietary products segment</div>
                </td>
              </tr>

          </table>
        </div>
      </div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;"><font style="font-weight: bold;">REHOVOT, Israel &#8211; December 9, 2019</font>
        -- Kamada Ltd. (Nasdaq: KMDA; TASE: KMDA.TA), a plasma-derived protein therapeutics company, today announced that it has entered into a binding term sheet for a 12-year contract manufacturing agreement with an undisclosed partner to manufacture a
        U.S. Food and Drug Administration (FDA) approved and commercialized specialty hyper-immune globulin product.&#160; Following the execution of the required technology transfer from the current manufacturer, and pending obtaining all required FDA
        approvals, Kamada is expected to commence commercial manufacturing of the product in early 2023.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">&#8220;This binding term sheet supports our strategy to leverage our experience and available manufacturing capacity at our FDA-approved
        manufacturing facility to initiate the production of additional plasma-derived products following the transition of GLASSIA&#174; manufacturing to Takeda during 2021,&#8221; said Amir London, CEO of Kamada. &#8220;Based on the current market sales volume of this
        specialty hyper-immune globulin product, we estimate that its manufacturing will add approximately $8 million to $10 million to our annual revenues, with estimated gross margin level similar to the average gross margins of our proprietary products
        segment. In addition to this new product, we will continue to manufacture and sell KEDRAB&#174;, our anti-rabies immunoglobulin, which is experiencing growing demand in the U.S. market, as well as our other proprietary products, which are sold in
        international markets. Moreover, we continue to proactively explore additional new product opportunities for our manufacturing plant.&#8221;</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25; font-weight: bold;">About Kamada</div>
      <div style="text-align: justify; line-height: 1.25;">Kamada Ltd. is focused on plasma-derived protein therapeutics for orphan indications, and has a commercial product portfolio and a
        late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as
        other plasma-derived Immune globulins.&#160; AAT is a protein derived from human plasma with known and newly-discovered therapeutic roles given its immunomodulatory, anti-inflammatory, tissue-protective and antimicrobial properties. The Company&#8217;s
        flagship product is GLASSIA, the first liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. Food and Drug Administration. Kamada markets GLASSIA in the U.S. through a strategic partnership with Takeda Pharmaceuticals
        Company Limited and in other counties through local distributors.&#160; Kamada&#8217;s second leading product is KamRAB, a rabies immune globulin (Human) for Post-Exposure Prophylaxis against rabies infection. KamRAB is FDA approved and is being marketed in
        the U.S. under the brand name KEDRAB and through a strategic partnership with Kedrion S.p.A. In addition to GLASSIA and KEDRAB, Kamada has a product line of four other plasma-derived pharmaceutical products administered by injection or infusion,
        that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. Kamada has late-stage products in development, including an inhaled formulation of AAT for the
        treatment of AAT deficiency, and in addition, its intravenous AAT is in development for other indications, such as GvHD, prevention of lung transplant rejection and type-1 diabetes. Kamada also leverages its expertise and presence in the
        plasma-derived protein therapeutics market by distributing more than 20 complementary products in Israel that are manufactured by third parties.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="clear: both; margin-top: 10pt; margin-bottom: 10pt;" id="DSPFPageBreakArea">
        <div style="page-break-after: always;" id="DSPFPageBreak">
          <hr noshade="noshade" style="border-width: 0px; clear: both; margin: 4px 0px; width: 100%; height: 2px; color: #000000; background-color: #000000;"></div>
      </div>
      <div style="text-align: justify; line-height: 1.25; font-weight: bold;">Cautionary Note Regarding Forward-Looking Statements</div>
      <div style="text-align: justify; line-height: 1.25;">This release includes forward-looking statements within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as
        amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, including statements regarding (i) the expected addition of $8 million to
        $10 million in annual revenues to be derived from the commercial manufacturing of the new hyper-immune globulin product; (ii) the expectation for obtaining all required FDA approvals and initiation of the new hyper-immune globulin product
        manufacturing during early 2023; (iii) our forecast that the gross margins from the manufacturing and sale of the new hyper-immune globulin product will be at similar margins to those of our current average proprietary product segment margins; (iv)
        the continued manufacturing and growing demand for KEDRAB in the U.S. market; (v) the continued manufacturing and distribution of our other proprietary products; and (vi) our continued proactive efforts to explore additional new products
        opportunities for our manufacturing plant. Forward-looking statements are based on Kamada&#8217;s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual
        results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, failure to receive or delays in receiving FDA approval for the
        transfer in manufacturing for the new hyper-immune globulin product, unexpected delays in the technology transfer relating to the same product, unanticipated increase in manufacturing costs or otherwise changes in the demand for the new
        hyper-immune globulin product, additional competition in the markets that Kamada competes, including with respect to KEDRAB and other proprietary products, corporate events associated with our partners, including the new undisclosed partner and
        Kedrion, and the impact of general economic, industry or political conditions in the U.S., Israel or otherwise. The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to update
        publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25; font-weight: bold;">CONTACTS:</div>
      <div style="text-align: justify; line-height: 1.25;">Chaime Orlev</div>
      <div style="text-align: justify; line-height: 1.25;">Chief Financial Officer</div>
      <div style="text-align: justify; line-height: 1.25;">IR@kamada.com</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">Bob Yedid</div>
      <div style="text-align: justify; line-height: 1.25;">LifeSci Advisors, LLC</div>
      <div style="text-align: justify; line-height: 1.25;">646-597-6989</div>
      <div style="text-align: justify; line-height: 1.25;"><u>Bob@LifeSciAdvisors.com</u></div>
      <div style="text-align: justify; line-height: 1.25;"><u> <br>
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