<SEC-DOCUMENT>0001178913-22-003638.txt : 20221014
<SEC-HEADER>0001178913-22-003638.hdr.sgml : 20221014
<ACCEPTANCE-DATETIME>20221014163023
ACCESSION NUMBER:		0001178913-22-003638
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20221014
FILED AS OF DATE:		20221014
DATE AS OF CHANGE:		20221014

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			RedHill Biopharma Ltd.
		CENTRAL INDEX KEY:			0001553846
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			L3

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-35773
		FILM NUMBER:		221311628

	BUSINESS ADDRESS:	
		STREET 1:		21 HA'ARBA'A STREET
		CITY:			TEL AVIV
		STATE:			L3
		ZIP:			64739
		BUSINESS PHONE:		972-3-541-3131

	MAIL ADDRESS:	
		STREET 1:		21 HA'ARBA'A STREET
		CITY:			TEL AVIV
		STATE:			L3
		ZIP:			64739
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>zk2228563.htm
<DESCRIPTION>6-K
<TEXT>
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    <div style="text-align: center; line-height: 1.25;"><font style="font-weight: bold;">&#160;UNITED STATES&#160;</font>&#160;&#160;</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.&#160;20549</div>
    <div style="text-align: center; line-height: 1.25;">&#160;</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="text-align: center; line-height: 1.25;">&#160;&#160;</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&#160;the Securities Exchange Act of 1934</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">&#160;</div>
    <div style="text-align: center; line-height: 1.25;">For the month of October 2022<br>
      Commission File No.:001-35773</div>
    <div style="text-align: center; line-height: 1.25;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif; font-size: 16pt; font-weight: bold;">REDHILL BIOPHARMA LTD.</div>
    <div style="text-align: center; line-height: 1.25;">(Translation of registrant&#8217;s name into English)</div>
    <div style="text-align: center; line-height: 1.25;">&#160;</div>
    <div style="text-align: center; line-height: 1.25; font-weight: bold;">21 Ha'arba'a Street, Tel Aviv, 6473921, Israel</div>
    <div style="text-align: center; line-height: 1.25;">(Address of principal executive offices)</div>
    <div style="line-height: 1.25;">&#160;</div>
    <div style="text-align: justify; text-indent: 28.35pt; 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.&#160;&#160;</div>
    <div style="line-height: 1.25;"><br style="line-height: 1.25;">
    </div>
    <div style="text-align: center; line-height: 1.25; font-family: 'Times New Roman',Times,serif;">Form 20-F&#160;<font style="font-family: 'Segoe UI Symbol',sans-serif;">&#9746;</font> &#160; &#160; &#160; &#160;&#160; Form 40-F&#160;<font style="font-family: 'Segoe UI Symbol',sans-serif;">&#9744;</font></div>
    <div style="text-indent: 14.2pt; line-height: 1.25;">&#160;</div>
    <div style="text-align: justify; text-indent: 28.35pt; line-height: 1.25;">Indicate by check mark if the Registrant is&#160;submitting&#160;the Form 6-K in paper as permitted by Regulation S-T Rule
      101(b)(1): ____&#160;</div>
    <div style="text-indent: 28.35pt; line-height: 1.25;">&#160;</div>
    <div style="text-align: justify; text-indent: 28.35pt; line-height: 1.25;">Indicate by check mark if the Registrant is&#160;submitting&#160;the Form 6-K in paper as permitted by Regulation S-T Rule
      101(b)(7): ____</div>
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    <div style="line-height: 1.25;">&#160;&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">RedHill Biopharma Ltd. (the &#8220;Company&#8221;) is continuing to work with its advisors and independent registered public accounting firm to
      finalize the condensed consolidated interim financial statements for the fiscal quarter ended June 30, 2022. The delay from the previously expected publication date is primarily due to an analysis of the application of certain adjustments between
      gross and net revenue being conducted by the audit committee with the assistance of independent advisors retained by the committee. Although the review is not complete, in connection with this review, the Company intends to restate its previously
      issued financial statements for the three months ended March 31, 2022.</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">The Company and its advisors are continuing to engage in constructive discussions with HCR Collateral Management, LLC (&#8220;HCR&#8221;) to
      evaluate strategic alternatives to satisfy its outstanding obligations under the credit agreement, dated as of February 23, 2020, by and among the Company, its wholly-owned subsidiary RedHill Biopharma Inc. and HCR.</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="line-height: 1.25;">
      <div style="text-align: justify; line-height: 1.25;">To that end, the previously announced potential transaction with respect to Movantik&#174; is progressing, and the Company is currently
        negotiating with a potential acquirer of Movantik&#174;. There can be no assurance that such negotiations will result in a transaction.</div>
      <div style="line-height: 1.25;"><br style="line-height: 1.25;">
      </div>
      <div style="text-align: justify; line-height: 1.25;">The Company expects that it will finalize its interim financial statements for the quarter ended June 30, 2022 and restate its interim
        financial statements for the three months ended March 31, 2022 as soon as practicable following completion of the audit committee&#8217;s review. As a result of the restatement, investors should no longer rely upon the Company&#8217;s previously issued interim
        financial statements for the three months ended March 31, 2022. The Company has determined that a material weakness exists within its internal control over financial reporting as it relates to recognition of certain allowances for deductions. While
        the review is still in process, management, with the oversight of the audit committee, is implementing additional processes and controls with respect to recognition of certain allowances for deduction to address this issue.</div>
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      </div>
    </div>
    <div style="text-align: justify; line-height: 1.25;">This Form 6-K is hereby incorporated by reference into the Company's Registration Statements on Form S-8 filed with the Securities and
      Exchange Commission on May 2, 2013 (Registration No. 333-188286), on October 29, 2015 (Registration No. 333-207654), on July 25, 2017 (Registration No. 333-219441), on May 23, 2018 (Registration No. 333-225122), on July 24, 2019 (File No.
      333-232776), on March 25, 2021 (File No. 333-254692), on May 3, 2021 (File No. 333-255710), on January 11, 2022 (File No. 333-262099) and on June 27, 2022 (File No. 333-265845), and its Registration Statements on Form F-3 filed with the Securities
      and Exchange Commission on March 30, 2021 (File No. 333-254848) and on July 29, 2021 (File No. 333-258259).</div>
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    <div style="text-align: justify; line-height: 1.25;"> <br>
    </div>
    <div style="line-height: 1.25; font-weight: bold;"><u>Forward-Looking Statements</u></div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;"><font style="font-style: italic;">This report contains &#8220;forward-looking
        statements&#8221; within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words &#8220;intends,&#8221; &#8220;may,&#8221; &#8220;will,&#8221; &#8220;plans,&#8221; &#8220;expects,&#8221; &#8220;anticipates,&#8221; &#8220;projects,&#8221; &#8220;predicts,&#8221; &#8220;estimates,&#8221; &#8220;aims,&#8221;
        &#8220;believes,&#8221; &#8220;hopes,&#8221; &#8220;potential&#8221; or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company&#8217;s control and cannot be
        predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the risk that</font>&#160;<font style="font-style: italic;">the Company may not be successful in closing a strategic or other transaction with respect to Movantik&#174;,
        risks relating to the restatement of the Company&#8217;s financial statements for the three months ended March 31, 2022, risks relating to the determination that a material weakness exists within the Company&#8217;s internal control over financial reporting,
        as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company&#8217;s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing
        of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company&#8217;s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or
        clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company&#8217;s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings,
        approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company&#8217;s therapeutic candidates and Talicia</font><sup style="font-style: italic; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-style: italic;">; (v) the Company&#8217;s ability to successfully commercialize and promote Movantik</font><sup style="font-style: italic; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-style: italic;">, Talicia</font><sup style="font-style: italic; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-style: italic;">&#160;and Aemcolo</font><sup style="font-style: italic; vertical-align: text-top; line-height: 1; font-size: smaller;">&#174;</sup><font style="font-style: italic;">; (vi) the Company&#8217;s ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in
        the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company&#8217;s therapeutic candidates and the results obtained
        with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company&#8217;s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is
        able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from
        whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company&#8217;s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients
        suffering adverse events using investigative drugs under the Company's Expanded Access Program; and (xiv) competition from other companies and technologies within the Company&#8217;s industry. More detailed information about the Company and the risk
        factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on March 17, 2022.
        All forward-looking statements included in this report are made only as of the date of this report. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or
        otherwise unless required by law.</font></div>
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    <div style="text-align: center; line-height: 1.25; font-weight: bold;">SIGNATURES</div>
    <div style="line-height: 1.25">&#160;</div>
    <div style="text-align: justify; line-height: 1.25;">Pursuant to the requirements of&#160;the&#160;Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its
      behalf by the undersigned, thereunto duly authorized.&#160;</div>
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        <tr>
          <td style="width: 50%; vertical-align: middle;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="vertical-align: middle;" colspan="2">
            <div style="line-height: 1.25;">REDHILL BIOPHARMA LTD.</div>
          </td>
          <td style="width: 16.1%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
        </tr>
        <tr>
          <td style="width: 50%; vertical-align: middle;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="vertical-align: middle;" colspan="2">
            <div style="line-height: 1.25;">(the "Registrant")</div>
          </td>
          <td style="width: 16.1%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
        </tr>
        <tr>
          <td style="width: 50%; vertical-align: middle;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 3%; vertical-align: middle;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 30.77%; vertical-align: middle;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="width: 16.1%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
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        <tr>
          <td style="width: 50%; vertical-align: middle;">
            <div style="line-height: 1.25;">Date: October 14, 2022</div>
          </td>
          <td style="width: 3%; vertical-align: middle;">
            <div style="line-height: 1.25;">By:</div>
          </td>
          <td style="width: 30.77%; vertical-align: middle; border-bottom: #000000 2px solid;">
            <div style="line-height: 1.25;">/s/ Dror Ben-Asher&#160;</div>
          </td>
          <td style="width: 16.1%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
        </tr>
        <tr>
          <td style="width: 50%; vertical-align: top;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="vertical-align: middle;" colspan="2">
            <div style="line-height: 1.25;">Dror Ben-Asher&#160;</div>
          </td>
          <td style="width: 16.1%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
        </tr>
        <tr>
          <td style="width: 50%; vertical-align: top;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
          <td style="vertical-align: middle;" colspan="2">
            <div style="line-height: 1.25;">Chief Executive Officer</div>
          </td>
          <td style="width: 16.1%; vertical-align: bottom;">
            <div style="line-height: 1.25;">&#160;</div>
          </td>
        </tr>

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