0001178913-22-003638.txt : 20221014 0001178913-22-003638.hdr.sgml : 20221014 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 6-K 1 zk2228563.htm 6-K

 UNITED STATES   
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 6-K
  
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
 
For the month of October 2022
Commission File No.:001-35773
 
REDHILL BIOPHARMA LTD.
(Translation of registrant’s name into English)
 
21 Ha'arba'a Street, Tel Aviv, 6473921, Israel
(Address of principal executive offices)
 
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.  

Form 20-F ☒          Form 40-F ☐
 
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): ____ 
 
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): ____


  
RedHill Biopharma Ltd. (the “Company”) 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.
 
The Company and its advisors are continuing to engage in constructive discussions with HCR Collateral Management, LLC (“HCR”) 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.
 
To that end, the previously announced potential transaction with respect to Movantik® is progressing, and the Company is currently negotiating with a potential acquirer of Movantik®. There can be no assurance that such negotiations will result in a transaction.

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’s review. As a result of the restatement, investors should no longer rely upon the Company’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.

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).


Forward-Looking Statements
 
This report contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” 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’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 the Company may not be successful in closing a strategic or other transaction with respect to Movantik®, risks relating to the restatement of the Company’s financial statements for the three months ended March 31, 2022, risks relating to the determination that a material weakness exists within the Company’s internal control over financial reporting, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’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’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’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’s therapeutic candidates and Talicia®; (v) the Company’s ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company’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’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’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’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’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.
 
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, thereunto duly authorized. 
 
 
REDHILL BIOPHARMA LTD.
 
 
(the "Registrant")
 
 
 
 
 
Date: October 14, 2022
By:
/s/ Dror Ben-Asher 
 
 
Dror Ben-Asher 
 
 
Chief Executive Officer