6-K
RedHill Biopharma Ltd. (RDHL)
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 December 2025
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 ☐
Attached as Exhibit 99.1 and incorporated by reference herein is unaudited pro forma condensed consolidated financial information relating to the definitive agreements between the RedHill Biopharma Ltd. (the “Company”) and Cumberland Pharmaceuticals Inc., which are described in the Company’s Current Report on Form 6-K filed with the Securities and Exchange Commission on October 20, 2025.
Forward Looking Statements
The unaudited pro forma condensed consolidated financial information contained in Exhibit 99.1 to this Form 6-K contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to substantial risks and uncertainties. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words, and include, among others, statements regarding the potential impact of the strategic transaction with Cumberland Pharmaceuticals Inc. 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, without limitation the risk that the strategic transaction with Cumberland will not bring the currently anticipated benefits to the Company or the global Talicia business and the risk that the assumptions made by the Company in preparing the unaudited pro forma condensed consolidated financial information are incorrect. The Company believes such assumptions are reasonable as of the date of this filing; however, such assumptions are inherently uncertain, are subject to change and may be affected by factors beyond the Company’s control. As a result, actual results may differ materially from the unaudited pro forma condensed consolidated financial information. 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 April 10, 2025. All forward-looking statements included in this Form 6-K are made only as of the date of Form 6-K. 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.
Exhibit Index
| Exhibit No. | Description |
|---|---|
| 99.1 | Unaudited Pro Forma Condensed Consolidated Financial Information |
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), on June 27, 2022 (File No. 333-265845), on June 29, 2023 (File No. 333-273001), on June 20, 2024 (File No. 333-280327) and on March 25, 2025 (File No. 333-286082), and its Registration Statements on Form F-3 filed with the Securities and Exchange Commission on March 30, 2021 (File No. 333-254848), on August 4, 2023 (File No. 333-273709), on October 13, 2023 (File No. 333-274957), as amended, and on August 9, 2024 (File No. 333-281417).
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: December 31, 2025 | By: | /s/ Dror Ben-Asher |
| Name: | Dror Ben-Asher | |
| Title: | Chief Executive Officer |
Exhibit 99.1
UNAUDITED PRO FORMA CONDENSED CONSOLIDATED FINANCIAL INFORMATION
Overview
On October 17, 2025 (the “Closing Date”), RedHill Biopharma Ltd. (“RedHill” or the “Company”) completed a strategic transaction regarding its proprietary drug, Talicia®. The transaction was effected through the sale to Cumberland Pharmaceuticals Inc. (“Cumberland”) of a portion of its holdings in Talicia Holdings Inc. (“THI”), a newly formed entity incorporated in Delaware to hold the global rights to Talicia® and manage its commercialization worldwide.
Pursuant to a Stock Purchase Agreement, Cumberland agreed to invest $4.0 million in two equal tranches ($2.0 million of which was paid at closing and $2.0 million to be paid within 12 months), to acquire a 30% equity interest and joint control in THI (the “Transaction”). Following the Transaction, RedHill retains a 70% ownership interest in THI.
Concurrently with the Transaction, the parties established a new governance structure for THI. Under these provisions, the composition of THI’s Board of Directors and the voting rights attached to the shares result in a structure where effectively all decisions regarding the relevant activities of THI require the unanimous approval of both RedHill and Cumberland.
As a result of these governance rights, the Company determined that it lost control over THI and currently shares joint control (as defined in IFRS 11, Joint Arrangements) over THI together with Cumberland. Consequently, the Company deconsolidated THI as of the Closing Date and recognizes its retained interest as an investment in a Joint Venture.
Basis of Presentation
The following unaudited pro forma condensed consolidated financial information is intended to show how the Transaction might have affected the historical consolidated financial statements of the Company if it had been completed at an earlier time as indicated herein. The unaudited pro forma condensed consolidated financial information has been prepared in accordance with Article 11 of Regulation S-X and is based on the historical consolidated financial statements of RedHill.
The unaudited pro forma condensed consolidated financial information has been prepared to reflect the Transaction as if it had occurred on January 1, 2022 (the beginning of the earliest period presented) for the purposes of the Unaudited Pro Forma Condensed Consolidated Statements of Comprehensive Loss for the years ended December 31, 2024, 2023, and 2022 and for the six months ended June 30, 2025 and 2024.
The unaudited pro forma condensed consolidated financial information and the accompanying notes should be read in conjunction with (i) the Company’s historical audited consolidated financial statements and the accompanying notes included in the Company’s Annual Report on Form 20-F for the year ended December 31, 2024 and (ii) the Company’s historical unaudited condensed consolidated financial statements included in the Company’s Interim Report on Form 6-K/A for the six months ended June 30, 2025.
The Transaction is accounted for as a loss of control of a subsidiary and the recognition of a retained investment in a Joint Venture. Since the Company has rights to THI's net assets, the retained 70% investment is accounted for under the equity method in accordance with IAS 28, Investments in Associates and Joint Ventures.
Additionally, the Company determined that the Talicia® activity constitutes a business as defined in IFRS 3, Business Combinations. Due to the loss of control and subsequent deconsolidation, the historical results of the Talicia® activity are classified as discontinued operations in the pro forma statements of comprehensive loss in accordance with IFRS 5, Non-current Assets Held for Sale and Discontinued Operations.
The unaudited pro forma condensed consolidated financial information is provided for informational purposes only and is presented to illustrate the estimated effects of the Transaction. The unaudited pro forma condensed consolidated financial information does not purport to represent what the Company’s actual consolidated results of operations would have been had the Transaction occurred on the dates indicated, nor does it purport to project or predict the Company’s future consolidated results of operations. The unaudited pro forma condensed consolidated financial information is based on preliminary information and assumptions that the Company believes are reasonable as of the date of this filing; however, such information and assumptions are inherently uncertain, are subject to change and may be affected by factors beyond the Company’s control. As a result, actual results may differ materially from the unaudited pro forma condensed consolidated financial information.
The unaudited pro forma condensed consolidated financial information does not reflect any (i) non-recurring transaction-related costs, expenses or charges (including professional fees and other costs) or (ii) any potential cost savings, synergies, dis-synergies, transition costs, stranded costs, changes in operating strategy, or other operating or financial impacts that may result from the Transaction, unless specifically stated in the unaudited pro forma condensed consolidated financial information and the accompanying notes.
The Company undertakes no obligation to update or revise the unaudited pro forma condensed consolidated financial information to reflect events or circumstances after the date of this filing or to reflect the occurrence of unanticipated events, except as required by applicable law.
The fair value of the retained investment and related pro forma adjustments were determined based on management’s estimates and assumptions as of the date of this filing, including assumptions regarding future cash flows, discount rates and other valuation inputs. These estimates and assumptions are inherently subjective and involve significant judgment. Changes in facts, circumstances or assumptions, including changes in market conditions, regulatory developments, commercialization performance and other factors, could have a material effect on the estimated fair value of the retained investment.
REDHILL BIOPHARMA LTD.
Unaudited Pro Forma Condensed Consolidated Interim Statement of Comprehensive Loss
For the Six Months Ended June 30, 2025
(U.S. dollars in thousands)
| As Reported | Transaction Accounting Adjustments | Notes | Pro Forma | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| NET REVENUES | 4,079 | (3,815 | ) | (a) | 264 | |||||
| COST OF REVENUES | 1,607 | (1,607 | ) | (a) | — | |||||
| GROSS PROFIT | 2,472 | (2,208 | ) | 264 | ||||||
| RESEARCH AND DEVELOPMENT EXPENSES | 964 | — | 964 | |||||||
| SELLING AND MARKETING EXPENSES | 2,035 | (1,617 | ) | (a) | 418 | |||||
| GENERAL AND ADMINISTRATIVE EXPENSES | 3,851 | (1,784 | ) | (a) | 2,067 | |||||
| SHARE IN LOSS OF EQUITY METHOD INVESTEE | 835 | (b) | 835 | |||||||
| OPERATING INCOME (LOSS) | (4,378 | ) | 358 | (4,020 | ) | |||||
| FINANCIAL INCOME | 1,338 | — | 1,338 | |||||||
| FINANCIAL EXPENSES | 1,093 | — | 1,093 | |||||||
| FINANCIAL INCOME, net | 245 | — | 245 | |||||||
| LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD | (4,133 | ) | 358 | (3,775 | ) | |||||
| LOSS PER ORDINARY SHARE, basic and diluted (U.S. dollars) | 0.00 | 0.00 | ||||||||
| WEIGHTED AVERAGE OF ORDINARY SHARE (in thousands) | 18,030,006 | 18,030,006 |
See accompanying notes to the unaudited pro forma condensed consolidated financial information.
REDHILL BIOPHARMA LTD.
Unaudited Pro Forma Consolidated Statement of Comprehensive Loss
For the Year Ended December 31, 2024
(U.S. dollars in thousands)
| As Reported | Transaction Accounting Adjustments | Notes | Pro Forma | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| NET REVENUES | 8,043 | (8,977 | ) | (a) | (934 | ) | ||||
| COST OF REVENUES | 3,192 | (3,449 | ) | (a) | (257 | ) | ||||
| GROSS PROFIT | 4,851 | (5,528 | ) | (677 | ) | |||||
| RESEARCH AND DEVELOPMENT EXPENSES | 1,588 | — | 1,588 | |||||||
| SELLING AND MARKETING EXPENSES | 5,950 | (5,156 | ) | (a) | 794 | |||||
| GENERAL AND ADMINISTRATIVE EXPENSES | 9,567 | (5,510 | ) | (a) | 4,057 | |||||
| OTHER INCOME (EXPENSES) | (2,359 | ) | — | (2,359 | ) | |||||
| SHARE IN LOSS OF EQUITY METHOD INVESTEE | — | 3,596 | (b) | 3,596 | ||||||
| OPERATING INCOME (LOSS) | (14,613 | ) | 1,542 | (13,071 | ) | |||||
| FINANCIAL INCOME | 8,401 | — | 8,401 | |||||||
| FINANCIAL EXPENSES | 2,056 | — | 2,056 | |||||||
| FINANCIAL INCOME, net | 6,345 | — | 6,345 | |||||||
| LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD | (8,268 | ) | 1,542 | (6,726 | ) | |||||
| LOSS PER ORDINARY SHARE, basic and diluted (U.S. dollars) | 0.00 | 0.00 | ||||||||
| WEIGHTED AVERAGE OF ORDINARY SHARE (in thousands) | 12,322,721 | 12,322,721 |
See accompanying notes to the unaudited pro forma condensed consolidated financial information.
REDHILL BIOPHARMA LTD.
Unaudited Pro Forma Condensed Consolidated Interim Statement of Comprehensive Loss
For the Six Months Ended June 30, 2024
(U.S. dollars in thousands)
| As Reported | Transaction Accounting Adjustments | Notes | Pro Forma | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| NET REVENUES | 2,572 | (3,494 | ) | (a) | (922 | ) | ||||
| COST OF REVENUES | 1,404 | (1,712 | ) | (a) | (308 | ) | ||||
| GROSS PROFIT | 1,168 | (1,782 | ) | (614 | ) | |||||
| RESEARCH AND DEVELOPMENT EXPENSES | 659 | — | 659 | |||||||
| SELLING AND MARKETING EXPENSES | 3,487 | (3,134 | ) | (a) | 353 | |||||
| GENERAL AND ADMINISTRATIVE EXPENSES | 5,470 | (3,002 | ) | (a) | 2,468 | |||||
| SHARE IN LOSS OF EQUITY METHOD INVESTEE | — | 3,047 | (b) | 3,047 | ||||||
| OPERATING INCOME (LOSS) | (8,448 | ) | 1,307 | (7,141 | ) | |||||
| FINANCIAL INCOME | 7,157 | — | 7,157 | |||||||
| FINANCIAL EXPENSES | 1,797 | — | 1,797 | |||||||
| FINANCIAL INCOME, net | 5,360 | — | 5,360 | |||||||
| LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD | (3,088 | ) | 1,307 | (1,781 | ) | |||||
| LOSS PER ORDINARY SHARE, basic and diluted (U.S. dollars) | 0.00 | — | 0.00 | |||||||
| WEIGHTED AVERAGE OF ORDINARY SHARE (in thousands) | 11,760,458 | — | 11,760,458 |
See accompanying notes to the unaudited pro forma condensed consolidated financial information.
REDHILL BIOPHARMA LTD.
Unaudited Pro Forma Consolidated Statement of Comprehensive Income
For the Year Ended December 31, 2023
(U.S. dollars in thousands)
| As Reported | Transaction Accounting Adjustments | Notes | Pro Forma | ||||||
|---|---|---|---|---|---|---|---|---|---|
| NET REVENUES | 6,530 | (8,834 | ) | (a) | (2,304 | ) | |||
| COST OF REVENUES | 3,459 | (3,940 | ) | (a) | (481 | ) | |||
| GROSS PROFIT | 3,071 | (4,894 | ) | (1,823 | ) | ||||
| RESEARCH AND DEVELOPMENT EXPENSES | 3,528 | — | 3,528 | ||||||
| SELLING AND MARKETING EXPENSES | 14,756 | (6,751 | ) | (a) | 8,005 | ||||
| GENERAL AND ADMINISTRATIVE EXPENSES | 16,219 | (5,305 | ) | (a) | 10,914 | ||||
| OTHER INCOME (EXPENSES) | 44,064 | — | 44,064 | ||||||
| SHARE IN LOSS OF EQUITY METHOD INVESTEE | — | 5,013 | (b) | 5,013 | |||||
| OPERATING INCOME (LOSS) | 12,632 | 2,149 | 14,781 | ||||||
| FINANCIAL INCOME | 20,889 | — | 20,889 | ||||||
| FINANCIAL EXPENSES | 9,605 | — | 9,605 | ||||||
| FINANCIAL INCOME, net | 11,284 | — | 11,284 | ||||||
| INCOME AND COMPREHENSIVE INCOME FOR THE PERIOD | 23,916 | 2,149 | 26,065 | ||||||
| INCOME PER ORDINARY SHARE, basic and diluted (U.S. dollars) | 0.01 | 0.01 | |||||||
| WEIGHTED AVERAGE OF ORDINARY SHARE (in thousands) | 2,591,222 | 2,591,222 |
See accompanying notes to the unaudited pro forma condensed consolidated financial information.
REDHILL BIOPHARMA LTD.
Unaudited Pro Forma Consolidated Statement of Comprehensive Loss
For the Year Ended December 31, 2022
(U.S. dollars in thousands)
| As Reported | Transaction Accounting Adjustments | Notes | Pro Forma | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| NET REVENUES | 61,800 | (9,693 | ) | (a) | 52,107 | |||||
| COST OF REVENUES | 33,337 | (4,611 | ) | (a) | 28,726 | |||||
| GROSS PROFIT | 28,463 | (5,082 | ) | 23,381 | ||||||
| RESEARCH AND DEVELOPMENT EXPENSES | 7,279 | — | 7,279 | |||||||
| SELLING AND MARKETING EXPENSES | 35,442 | (15,192 | ) | (a) | 20,250 | |||||
| GENERAL AND ADMINISTRATIVE EXPENSES | 28,586 | (8,181 | ) | (a) | 20,405 | |||||
| OTHER INCOME (EXPENSES) | — | 9,478 | (a) | 9,478 | ||||||
| SHARE IN LOSS OF EQUITY METHOD INVESTEE | — | 12,804 | (b) | 12,804 | ||||||
| OPERATING INCOME (LOSS) | (42,844 | ) | 14,965 | (27,879 | ) | |||||
| FINANCIAL INCOME | 13,562 | — | 13,562 | |||||||
| FINANCIAL EXPENSES | 42,387 | — | 42,387 | |||||||
| FINANCIAL INCOME, net | (28,825 | ) | — | (28,825 | ) | |||||
| LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD | (71,669 | ) | 14,965 | (56,704 | ) | |||||
| LOSS PER ORDINARY SHARE, basic and diluted (U.S. dollars) | 0.12 | 0.09 | ||||||||
| WEIGHTED AVERAGE OF ORDINARY SHARE (in thousands) | 616,299 | 616,299 |
See accompanying notes to the unaudited pro forma condensed consolidated financial information.
REDHILL BIOPHARMA LTD.
NOTES TO UNAUDITED PRO FORMA CONDENSED CONSOLIDATED FINANCIAL INFORMATION
- Pro Forma Adjustments to the Statements of Comprehensive Loss
The pro forma adjustments to the Unaudited Condensed Consolidated Interim Statements of Comprehensive Loss for the six months ended June 30, 2025 and 2024 and the Audited Consolidated Statements of Comprehensive Loss for the years ended December 31, 2024, 2023 and 2022, reflect pro forma adjustments giving effect to the Transaction, including the transition of the Talicia® activity from consolidation to a deconsolidated equity method investment:
(a) Discontinued Operations (Talicia® Activity) reflects the elimination of the results of the Talicia® activity from the Company’s continuing operations. The adjustments were determined as follows:
| • | Net Revenues and Cost of Revenues: Represent the elimination of Net Revenues and Cost of Revenues directly attributable to Talicia®. Revenues and costs associated with other commercial products recognized during the respective periods have<br> not been eliminated and remain in the pro forma continuing operations. |
|---|---|
| • | Operating Expenses (Direct and Allocated): Represent the elimination of Operating Expenses attributable to the Talicia® activity. |
| --- | --- |
| o | For the year ended December 31, 2024 and the six months ended June 30, 2025 and 2024, the adjustments reflect the elimination of expenses directly attributable to the Talicia® activity, which essentially constituted the entirety of the<br> Commercial Operations segment’s operating expenses during these periods. |
| --- | --- |
| o | For the years ended December 31, 2023 and 2022, during which the Commercial Operations segment supported multiple products, the adjustments reflect the elimination of direct expenses identifiable to the Talicia® activity, as well as a<br> relative allocation of shared commercial infrastructure costs based on management’s estimates of the resources utilized by the Talicia® activity. |
| --- | --- |
| • | Other Income and Financial Income (Expenses), net: |
| --- | --- |
| o | The “As Reported” amounts have not been eliminated and remain in continuing operations (Pro Forma). These amounts primarily relate to a legacy commercial product (Movantik®) and/or financing activities that were not transferred to the<br> equity method investee. |
| --- | --- |
| o | For the year ended December 31, 2022, the Transaction Accounting Adjustments for the “Other Income (Expenses)” line item reflect the recognition of the estimated gain on deconsolidation of THI, net of estimated transaction costs, to<br> reflect the Transaction as if it had occurred on January 1, 2022. |
| --- | --- |
(b) Share of Loss of Equity Method Investee reflects the recognition of the Company’s 70% share of the net loss of the deconsolidated Talicia® activity for the respective periods, recorded as a single line item, “Share in loss of equity method investee”.