RedHill Biopharma Ltd 6-K, filed Sep 30, 2026
RedHill Biopharma Ltd. (RDHL)
About this 6-K
RedHill Biopharma Ltd filed this 6-K on September 30, 2026.
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 September 2026
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 hereto and incorporated by reference herein are the following:
This Form 6-K (other than the management comments in the second and third paragraphs of Exhibit 99.1) 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), on March 25, 2025 (File No. 333-286082) and on January 22, 2026 (File No. 333-292879), 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), October 13, 2023 (File No. 333-274957), as amended, on August 9, 2024 (File No. 333-281417) and on July 2, 2026 (File No. 333-297223).
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: September 30, 2026 | By: | /s/ Dror Ben-Asher |
| Name: | Dror Ben-Asher |
| Title: | Chief Executive Officer |
Exhibit 99.1
Press Release
RedHill Biopharma Announces Operational Highlights and First Half 2026 Financial Results
Executing a full strategic portfolio reset, RedHill is now a stronger commercial entity with Rebyota® and Clenpiq®, two established FDA-approved gastrointestinal (GI) brands that generated $37.5 million in 2025 net sales under Ferring Pharmaceuticals (“Ferring”), an advanced late-stage pipeline and a fully-controlled commercial infrastructure with capacity for portfolio expansion
TEL AVIV, Israel and RALEIGH, NC, September 30, 2026, RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today reported operational highlights and financial results for the six months ended June 30, 2026.
Commercial portfolio update:
| ● | $12 million upfront payment to Ferring for the acquisition of commercialization rights to Rebyota® and Clenpiq®, fully funded by the $18 million received upfront for the Talicia® divestment |
| ● | Transactions strengthen liquidity, provide potential growth and expansion opportunities and enable addition of complementary revenue-generating products |
| ● | RedHill’s lean commercial infrastructure supports delivery of significant synergies with capacity for further portfolio extension |
Dror Ben-Asher, RedHill’s Chief Executive Officer, said: “We have executed on two major transactions that unlock significant value and fuel our capacity for growth. The acquisition of commercial rights to Rebyota® and Clenpiq®, funded by sale of Talicia, improves our liquidity position and provides us with control to drive increased revenues, identify additional complementary revenue-generating products and support ongoing development of our assets. We are now focused on the rapid and smooth transition of Rebyota® and Clenpiq® into RedHill, utilizing our lean and efficient commercial team, which is already well positioned and deeply embedded in the U.S. GI market.”
Mr. Ben-Asher continued: “Looking forward to the second half of 2026 and beyond, we also aim to progress our R&D development projects, which provide compelling opportunities in areas of significant unmet need, including multiple oncology indications, Crohn’s disease and other GI-associated conditions and Ebola virus disease (EBOV). In oncology, opaganib has been granted the U.S. Food and Drug Administration’s rare pediatric disease designation for neuroblastoma, with potential to receive an accompanying Priority Review Voucher. Furthermore, new preclinical data supportive of opaganib add-on therapy in neuroblastoma and triple negative breast cancer was presented at AACR, while recruitment continues into the Bayer-supported Phase 2 study of opaganib and darolutamide in advanced castrate resistant prostate cancer. Progress has also been made on key aspects of our Phase 2-ready Crohn’s program with RHB-204, potentially the first ever in a wholly MAP-positive population, with in vitro assay data demonstrating RHB-204’s comparable MAP killing to RHB-104. Meanwhile,
RHB-102 continues its late-stage development for oncology support and GI indications including GLP-1/GIP-associated GI intolerance.”
Commercial focus:
Following the divestment of RedHill’s 70% stake in Talicia for $18 million in upfront cash, plus up to $35 million in potential worldwide net sales milestone payments, the Company has acquired for an upfront cash payment of $12 million, plus future milestones and tiered royalties, the exclusive global and U.S. commercialization rights to Rebyota® and Clenpiq®, respectively, two synergistic, revenue-generating, FDA-approved GI drugs that together generated approximately $37.5 million in 2025 net sales under Ferring.
With a growing medical need, the potential for expanded indications and territories, and an experienced and efficient commercial infrastructure that is highly established within the GI market, these two new assets provide RedHill with a stronger commercial engine for revenue growth, in both the U.S. and other new territories, with potential for further added value through acquisition of additional complementary revenue-generating products.
Rebyota:
Rebyota is a proprietary, first and only single-dose FDA-approved Fecal Microbiota Transplant (FMT) for prevention of recurrent Clostridioides difficile (C. diff) infection (rCDI) in individuals 18 years of age and older following antibiotic treatment for rCDI. FDA-approved in 2022, it generated approximately $16.9 million in U.S. net sales in 2025 through its clinical profile, broad coverage and established customer base.
C. diff (CDI) infection is a distressing and life-threatening condition, being the most common cause of healthcare-associated (HA) diarrhea in developed countries1. An estimated 3.6 million cases of CDI occur globally each year, including approximately half a million cases in the U.S. 30,000 Americans die every year due to CDI2, with a global mortality rate of 1-in-10, rising to almost 1-in-3 in high-risk settings1. In the U.S., up to approximately 165,000 CDI cases result in one or more recurrences3, indicating the need for use of prevention strategies.
Rebyota’s one-time administration, which requires no fasting, bowel prep or extended treatment timeframe, has demonstrated more than a 70% success rate at preventing rCDI4. An aging population and accompanying increasing hospital-acquired vulnerabilities will likely increase this need. A streamlined ordering and reimbursement process is already in place for physicians, and broad and improving U.S. payer coverage means that 93% of lives have coverage including 43% with coverage after 1st recurrence5.
Rebyota, which was granted, Breakthrough Therapy and Orphan Drug designations, with exclusivities and other patent protections that could run to 2036, provides multiple growth opportunities, including recent approval in Canada. The existing approvals also provide the potential for additional approvals in other territories.
Clenpiq:
Clenpiq is a ready-to-drink, low-volume bowel preparation on the U.S. market. In 2025, it delivered $20.6 million in net sales, with minimal promotion under Ferring. Colonoscopy is the cornerstone of GI practice, with more than 15 million colonoscopies performed in the U.S. annually6. This number is rising, with follow-up needed after noninvasive screening tests that yield a positive result, an aging population, and guidelines that recommend testing at age 45 instead of age 50, contributing to an increased need for colonoscopy.
Bowel preparation quality drives outcomes and cost, but it is not a pleasant process and is often poorly performed – driving the need for repeated procedures. As such the benefits of a simplified, ready-to-drink, low-volume bowel preparation are evident. Clenpiq has broad commercial and government payer coverage making its benefits readily accessible to patients: More than 108 million lives (63%) with unrestricted (no prior approval) have commercial coverage, including 57 million (33%) with preferred position. 23 million lives (41%) of Medicare Part D lives have unrestricted access to Clenpiq, including 12 million (21%) lives with preferred position5.
Focused and advanced R&D pipeline – first half of 2026 highlights:
| ● | Opaganib granted U.S. Food and Drug Administration (FDA) rare pediatric disease designation for neuroblastoma, the most prevalent cancer in infants, providing potential for an accompanying Priority Review Voucher (PRV) |
| ● | New preclinical data showed positive effects of opaganib as potential add-on therapy in models of neuroblastoma (NB) and triple-negative breast cancer (TNBC). Two sets of data presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting indicate that: |
| o | Opaganib may enhance the therapeutic efficacy of the oxaliplatin + doxorubicin (OXDOX) chemotherapy combination in high-risk NB by directly destabilizing n-Myc, a key oncogenic driver of neuroblastoma and other solid tumors, through increased ceremide production enhancing programmed cell death (apoptosis) in cancer cells7 |
| o | Pre-treatment with opaganib, followed by low-dose diABZI treatment, potentiated the downstream STING-mediated effects and may augment anti-tumor immunity in TNBC, which has the poorest prognosis of the breast cancer subtypes8 |
| o | Opaganib Ebola (Bundibugyo, BDBV) development next steps and potential partnership discussions ongoing with African Medicines Agency, Ugandan Ministry of Health and Mbarara University of Science and Technology (MUST), alongside liaison with the Democratic Republic of Congo (DRC) Scientific Advisory Committee |
| ● | In Crohn’s disease, new RHB-204 in vitro data, from both spot and phage assays, demonstrated comparable MAP killing to RHB-1049. RHB-204 achieved these results with lower doses of key active ingredients enhancing potential for reduced toxicity and side effects, supporting an innovative FDA-aligned Phase 2-ready study design allowing for a smaller sample size, lower study costs and faster time to completion |
Financial results for the six months ended June 30, 2026 (Unaudited)10
Following the transfer of the Talicia commercial operations to Talicia Holding Inc. (“THI”) in October 2025, Talicia’s operations are presented as “discontinued operations” in RedHill’s financial statements. The comparison below is therefore presented on a continuing operations basis, with first half of 2025 comparative figures re-presented on the same basis. RedHill’s ongoing economic participation in the Talicia franchise during the period is reflected separately as its share of loss of the joint venture. RedHill sold its entire 70% interest in THI to Apotex in August 2026.
Net Revenues: No revenues were recognized in the first half of 2026, compared to $0.3 million in the first half of 2025, which was generated from the Hyloris license agreement for RHB-102 (Bekinda®).
Research and Development Expenses for the first half of 2026 were $1.0 million, unchanged from the first half of 2025. During the first half of 2026, the Company continued preclinical work related to RHB-204 and opaganib in Ebola.
General, Administrative and Business Development Expenses for the first half of 2026 were $2.5 million, compared to $2.7 million for the first half of 2025. The decrease was primarily attributable to lower professional services expenses and the allocation of certain costs to THI following the transfer of Talicia commercial operations.
Share of Loss of Joint Venture for the first half of 2026 was $0.7 million, representing RedHill’s share of THI’s net loss for the period. THI recorded net revenues of $1.3 million and a net loss of $1.0 million for the first half of 2026.
Operating Loss for the first half of 2026 was $4.1 million, compared to $3.4 million for the first half of 2025. The increase was mainly attributable to the share of THI’s loss and the absence of license revenues in the first half of 2026, partially offset by lower general, administrative and business development expenses.
Financial Expenses, net for the first half of 2026 were $1.6 million, compared to Financial Income, net of $0.5 million for the first half of 2025. Financial expenses in the first half of 2026 mainly reflected warrant-related issuance costs and fair value adjustments on derivative financial instruments.
Net Loss from Continuing Operations for the first half of 2026 was $5.7 million, compared to $2.9 million for the first half of 2025. The increase was mainly attributable to the share of THI’s loss and higher net financial expenses, partially offset by lower general, administrative and business development expenses.
Net Loss from Discontinued Operations for the first half of 2026 was $0.4 million, compared to $1.2 million for the first half of 2025. The decrease was primarily attributable to the transfer of the Talicia commercial operations to THI.
Net Loss for the first half of 2026 was $6.1 million, compared to $4.1 million for the first half of 2025.
Total Assets as of June 30, 2026, were $26.3 million, compared to $25.3 million as of December 31, 2025. The increase was mainly attributable to higher cash and other receivables, partially offset by a decrease in the investment in THI.
Total Liabilities as of June 30, 2026, were $27.4 million, compared to $21.1 million as of December 31, 2025. The increase primarily reflected derivative liabilities associated with the June 2026 private placement and higher accrued expenses and other liabilities.
Net Cash Used in Operating Activities for the first half of 2026 was $4.6 million, compared to $5.0 million for the first half of 2025.
Net Cash Provided by Financing Activities for the first half of 2026 was $5.4 million, primarily reflecting net proceeds from the June 2026 private placement, compared to $3.3 million for the first half of 2025, primarily generated through the Company’s equity offerings11.
Cash Balance as of June 30, 2026, was $5.3 million12.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a U.S. specialty biopharmaceutical company primarily focused on the development and commercialization of proprietary drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal therapies Rebyota®, for the prevention of recurrent C. diff infection (rCDI), and the bowel preparation treatment, Clenpiq®. RedHill’s key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, metabolic and anticancer activity, targeting multiple indications with a track record of U.S. government and academic collaborations intended for medical countermeasure development including for EVD, radiation exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and an ongoing Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-102 (Bekinda), with a Phase 2-ready proof-of-concept study for GLP-1/GIP receptor agonist-associated GI intolerance, positive results from a first U.S. Phase 3 study for acute gastroenteritis and gastritis, positive results from a U.S. Phase 2 study for IBS-D and potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting. RHB-102 is partnered with Hyloris Pharmaceuticals (EBR: HYL) for worldwide development and commercialization outside North America; (iii) RHB-204, a next-generation optimized formulation of RHB-104, with a Phase 2-ready study for Crohn’s disease (based on RHB-104’s positive U.S. Phase 3 Crohn’s disease study results); and (iv) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, including COVID-19 and influenza and also targeting multiple cancer and inflammatory gastrointestinal diseases.
More information about the Company is available at: www.redhillbio.com and X.com/RedHillBio
Forward Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. 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 expected benefits of the acquisition of commercialization rights to Rebyota and Clenpiq, the anticipated commercial growth and cash contribution from these products, the potential to receive an FDA priority review voucher for opaganib; expectations regarding market share growth, demand, anticipated payer coverage, the Company’s strategic repositioning and path to operational profitability, potential use of milestone and royalty payments, progress in R&D development projects and the Company’s ability to successfully commercialize Rebyota and Clenpiq. 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 acquisition of commercialization rights for Rebyota® and Clenpiq does not result in the planned commercial growth; the risk that opaganib is not accepted into Ebola virus disease control programs, or if accepted, that it does not demonstrate efficacy; the risk that development of RHB-204 for Crohn’s disease may not be completed, or if completed may not be approved or may not achieve commercial success; the risk that opaganib is not effective against the indications for which we develop our products; the risk that RHB-102 (Bekinda) does not effectively reduce GLP-1/GIP-related nausea, vomiting and diarrhea; the risk regarding the Company’s ability to regain and maintain compliance with Nasdaq’s listing requirements, including the minimum bid price requirement; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that the Company will not receive future milestone
payments under its existing agreements or that they will be less than anticipated; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company’s proposed development plans for its programs; the risk that the Company’s development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, pre-clinical 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 pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (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 establish and maintain corporate collaborations; (vi) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (vii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (viii) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (ix) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (x) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xi) the Company’s ability to collect on its judgement against Kukbo; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company’s Expanded Access Program; (xiv) competition from other companies and technologies within the Company’s industry; and (xv) the hiring and employment commencement date of executive managers. 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 27, 2026. All forward-looking statements included in this press release are made only as of the date of this press release. 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.
Company contact:
Adi Frish
Chief Corporate and Business Development Officer
RedHill Biopharma
adi@redhillbio.com
Category: Financials
1 Akorful RAA, Odoom A, Awere-Duodu A, Donkor ES. The Global Burden of Clostridioides difficile Infections, 2016-2024: A Systematic Review and Meta-Analysis. Infect Dis Rep. 2025 Apr 14;17(2):31. doi: 10.3390/idr17020031. PMID: 40277958; PMCID: PMC12026862.
2 Lessa FC, Mu Y, Bamberg WM, Beldavs ZG, Dumyati GK, Dunn JR, Farley MM, Holzbauer SM, Meek JI, Phipps EC, Wilson LE, Winston LG, Cohen JA, Limbago BM, Fridkin SK, Gerding DN, McDonald LC. Burden of Clostridium difficile infection in the United States. N Engl J Med. 2015 Feb 26;372(9):825-34. doi: 10.1056/NEJMoa1408913. PMID: 25714160; PMCID: PMC10966662.
3 Feuerstadt P, Theriault N, Tillotson G. The burden of CDI in the United States: a multifactorial challenge. BMC Infect Dis. 2023 Mar 7;23(1):132. doi: 10.1186/s12879-023-08096-0. PMID: 36882700; PMCID: PMC9990004.
4 Khanna S, Assi M, Lee C, et al. Efficacy and safety of RBX2660 in PUNCH CD3, a phase III, randomized, double-blind, placebo-controlled trial with a Bayesian primary analysis for the prevention of recurrent Clostridioides difficile infection. Drugs. 2022;82(15):1527-1538. doi:10.1007/s40265-022-01797-x.
5 Data on file. Ferring Pharmaceuticals
6 MarketScan Commercial Claims and Encounters and Medicare Supplemental database
7 Abstract 7879: Opaganib in combination with oxaliplatin and doxorubicin as a novel salvage therapy for relapsed/refractory high-risk neuroblastoma. Jeremy Hengst, Mohammad Haque, Muhammad Younis, Thussenthan Walter Angelo, Anna Bourne, Katherine McClain, Meenakshi Shukla, Jonathan Lerch, Tarlan Arjmandi, Eric Cochran, Lynn Maines, Charles D. Smith, Vladimir S. Spiegelman, Jacqueline M. Kraveka, Giselle L. Saulnier Sholler. Cancer Res (2026) 86 (7_Supplement): 7879. https://doi.org/10.1158/1538-7445.AM2026-7879
8 Abstract 4323: The SPHK2 inhibitor opaganib potentiates tumor-intrinsic STING activation in triple-negative breast cancer in vitro. Colette R. Worcester, Amrita Mitra, Harsh B. Pathak, Shane R. Stecklein. Cancer Res (2026) 86 (7_Supplement): 4323. https://doi.org/10.1158/1538-7445.AM2026-4323 Published: 03 April 2026
9 Data on file
10 All financial highlights are approximate and are rounded to the nearest hundreds of thousands.
11 As of September 30, 2026, the Company had 8,887,684 ADSs outstanding (equivalent to 88,876,841,000 ordinary shares of the Company of no par value).
12 Including cash, cash equivalents, short-term bank deposits and restricted cash.
REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
| | Six Months Ended |
| ||
| | June 30, | | ||
| | 2026 | | 2025 | |
| | U.S. dollars in thousands | | ||
REVENUES | | — | | 286 | |
RESEARCH AND DEVELOPMENT EXPENSES | | 965 | | 964 | |
GENERAL, ADMINISTRATIVE, BUSINESS AND DEVELOPMENT EXPENSES | | 2,511 | | 2,715 | |
SHARE OF LOSS OF JOINT VENTURE | | 655 | | — | |
OPERATING LOSS | | (4,131) | | (3,393) | |
FINANCIAL INCOME | | 20 | | 1,307 | |
FINANCIAL EXPENSES | | 1,610 | | 849 | |
FINANCIAL INCOME (EXPENSES), net | | (1,590) | | 458 | |
LOSS FROM CONTINUING OPERATIONS | | (5,721) | | (2,935) | |
LOSS FROM DISCONTINUED OPERATIONS | | (381) | | (1,198) | |
LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD | | (6,102) | | (4,133) | |
LOSS PER ORDINARY SHARE FROM CONTINUING OPERATION, basic and diluted (U.S. dollars) | | (0.00) | | (0.00) | |
LOSS PER ORDINARY SHARE FROM DISCONTINUED OPERATION, basic and diluted (U.S. dollars) | | (0.00) | | (0.00) | |
REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(Unaudited)
| | June 30, | | December 31, |
|
| | 2026 | | 2025 | |
| | U.S. dollars in thousands | | ||
CURRENT ASSETS: | | | | | |
Cash and cash equivalents | | 5,159 | | 3,971 | |
Trade receivables | | — | | 79 | |
Prepaid expenses and other receivables | | 3,415 | | 2,478 | |
| 8,574 | | 6,528 | | |
NON-CURRENT ASSETS: | | | | ||
Restricted cash | | 99 | | 169 | |
Trade receivables | | 210 | | 201 | |
Fixed assets | | 52 | | 49 | |
Right-of-use assets | | 927 | | 1,057 | |
Intangible assets | | 5,291 | | 5,291 | |
Investment in a joint venture | | 11,121 | | 12,050 | |
| 17,700 | | 18,817 | | |
TOTAL ASSETS | | 26,274 | | 25,345 | |
| | | | ||
CURRENT LIABILITIES: | | | | ||
Accounts payable | | 584 | | 731 | |
Lease liabilities | | 216 | | 170 | |
Allowance for deductions from revenue | | 5,622 | | 6,304 | |
Derivative financial instruments | | 6,469 | | — | |
Accrued expenses and other current liabilities | | 12,670 | | 12,016 | |
| 25,561 | | 19,221 | | |
| | | |||
NON-CURRENT LIABILITIES: | | | | ||
Lease liabilities | | 859 | | 900 | |
Other non-current liabilities | | 433 | | 456 | |
Royalty obligation | | 500 | | 500 | |
| 1,792 | | 1,856 | | |
TOTAL LIABILITIES | | 27,353 | | 21,077 | |
| | | |||
EQUITY (CAPITAL DEFICIENCY): | | | | ||
Ordinary shares | | 181,078 | | 147,641 | |
Additional paid-in capital | | 237,007 | | 270,382 | |
Accumulated deficit | | (419,164) | | (413,755) | |
TOTAL EQUITY (CAPITAL DEFICIENCY) | | (1,079) | | 4,268 | |
TOTAL LIABILITIES AND EQUITY (CAPITAL DEFICIENCY) | | 26,274 | | 25,345 | |
REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
(Unaudited)
| | Six Months Ended |
| ||
| | June 30, | | ||
| | 2026 | | 2025 | |
| | U.S. dollars in thousands | | ||
OPERATING ACTIVITIES: | | | | | |
Loss | | (6,102) | | (4,133) | |
Adjustments in respect of income and expenses not involving cash flow: | | | | | |
Share-based compensation to employees and service providers | | 304 | | 297 | |
Depreciation | | 141 | | 152 | |
Amortization of intangible assets | | — | | 16 | |
Share of loss of joint venture | | 655 | | — | |
Fair value (gains) losses on derivative financial instruments and recognition of day 1 loss | | 478 | | (1,269) | |
Issuance costs in respect of warrants and equity line of credit | | 952 | | 518 | |
Exchange differences and revaluation of bank deposits | | 76 | | 26 | |
| 2,606 | | (260) | | |
Changes in assets and liability items: | | | | ||
Decrease (increase) in trade receivables | | 70 | | (2,811) | |
Decrease (increase) in prepaid expenses and other receivables | | (937) | | 94 | |
Decrease in inventories | | — | | 482 | |
Decrease in accounts payable | | (148) | | (333) | |
Increase in accrued expenses and other liabilities | | 631 | | 693 | |
Increase (decrease) in allowance for deductions from revenue | | (682) | | 1,253 | |
| (1,066) | | (622) | | |
Net cash used in operating activities | | (4,562) | | (5,015) | |
Net cash used in operating activities from discontinued operation | | (699) | | (1,725) | |
Net cash used in operating activities from continuing operation | | (3,863) | | (3,290) | |
INVESTING ACTIVITIES: | | | | ||
Purchase of fixed assets | | (14) | | (4) | |
Collection of receivable from joint venture | | 304 | | — | |
Change in investment in non current bank deposits | | 82 | | — | |
Net cash provided by (used in) investing activities | | 372 | | (4) | |
Net cash provided by investing activities from discontinued operation | | — | | — | |
Net cash (used in) provided by investing activities from continuing operation | | 372 | | (4) | |
FINANCING ACTIVITIES: | | | | ||
Proceeds from issuance of ordinary shares and warrants, net of issuance costs | | 5,460 | | 3,448 | |
Payment of principal with respect to lease liabilities | | (81) | | (189) | |
Net cash provided by financing activities | | 5,379 | | 3,259 | |
Net cash provided by financing activities from discontinued operation | | — | | — | |
Net cash provided by financing activities from continuing operation | | 5,379 | | 3,259 | |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | | 1,189 | | (1,760) | |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | | (1) | | 9 | |
BALANCE OF CASH AND CASH EQUIVALENTS AT THE BEGINNING OF PERIOD | | 3,971 | | 4,617 | |
BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF PERIOD | | 5,159 | | 2,866 | |
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH | | 49 | | 89 | |
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH | | 50 | | 10 | |
Exhibit 99.2
REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION
(UNAUDITED)
June 30, 2026
1
REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION
(UNAUDITED)
June 30, 2026
TABLE OF CONTENTS
| |
UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AS OF JUNE 30, 2026, IN U.S. DOLLARS: | Page |
Condensed consolidated interim statements of comprehensive loss | 3 |
| |
Condensed consolidated interim statements of financial position | 4 |
| |
Condensed consolidated interim statements of changes in equity (capital deficiency) | 5 |
| |
6 | |
| |
Notes to the condensed consolidated interim financial statements | 7-14 |
2
REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
| | Six Months Ended | ||
| | June 30, | ||
| | 2026 | | 2025 |
| | U.S. dollars in thousands | ||
REVENUES | | — |
| |
RESEARCH AND DEVELOPMENT EXPENSES | | | | |
GENERAL, ADMINISTRATIVE, BUSINESS AND DEVELOPMENT EXPENSES | | |
| |
SHARE OF LOSS OF JOINT VENTURE | | | | — |
OPERATING LOSS | | ( |
| ( |
FINANCIAL INCOME | | |
| |
FINANCIAL EXPENSES | | |
| |
FINANCIAL INCOME (EXPENSES), net | | ( |
| |
LOSS FROM CONTINUING OPERATIONS | | ( |
| ( |
LOSS FROM DISCONTINUED OPERATIONS | | ( | | ( |
LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD | | ( | | ( |
LOSS PER ORDINARY SHARE FROM CONTINUING OPERATION, basic and diluted (U.S. dollars) | | ( |
| ( |
LOSS PER ORDINARY SHARE FROM DISCONTINUED OPERATION, basic and diluted (U.S. dollars) | | ( | | ( |
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(Unaudited)
| | | | |
| | June 30, | | December 31, |
| | 2026 | | 2025 |
| | U.S. dollars in thousands | ||
CURRENT ASSETS: | | | | |
Cash and cash equivalents | | | ||
Trade receivables | | — | | |
Prepaid expenses and other receivables | | | ||
| | | ||
NON-CURRENT ASSETS: | | | | |
Restricted cash | | | ||
Trade receivables | | | ||
Fixed assets | | | ||
Right-of-use assets | | | ||
Intangible assets | | | ||
Investment in a joint venture | | | ||
| | | ||
TOTAL ASSETS | | | ||
| | | | |
CURRENT LIABILITIES: | | | | |
Accounts payable | | | ||
Lease liabilities | | | ||
Allowance for deductions from revenue | | | ||
Derivative financial instruments | | | — | |
Accrued expenses and other current liabilities | | | ||
| | | ||
| | | | |
NON-CURRENT LIABILITIES: | | | | |
Lease liabilities | | | ||
Other non-current liabilities | | | ||
Royalty obligation | | | ||
| | | ||
TOTAL LIABILITIES | | | ||
| | | | |
EQUITY (CAPITAL DEFICIENCY): | | | | |
Ordinary shares | | | ||
Additional paid-in capital | | | ||
Accumulated deficit | | ( | | ( |
TOTAL EQUITY (CAPITAL DEFICIENCY) | | ( | | |
TOTAL LIABILITIES AND EQUITY (CAPITAL DEFICIENCY) | | | ||
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY (CAPITAL DEFICIENCY)
(Unaudited)
| | Ordinary | | Additional | Accumulated | | Total |
| | shares | | paid-in capital | deficit | | equity (capital deficiency) |
| | U.S. dollars in thousands | |||||
| | | | | | | |
BALANCE AT JANUARY 1, 2026 |
| | | | ( | | |
| | | | | | | |
CHANGES IN THE SIX-MONTH PERIOD ENDED JUNE 30, 2026: | | | | | | | |
Share-based compensation to employees and service providers | | — | | — | | | |
Issuance of ordinary shares (including resulting from warrants exercise), net of issuance costs | | | | ( | — | | |
Issuance of ordinary shares for vested RSUs | | | | ( | — | | — |
Comprehensive loss | | — | | — | ( | | ( |
BALANCE AT JUNE 30, 2026 | | | | | ( | | ( |
| | | | | | | |
BALANCE AT JANUARY 1, 2025 |
| | | | ( | | ( |
CHANGES IN THE SIX-MONTH PERIOD ENDED JUNE 30, 2025: | | | | | | | |
Share-based compensation to employees and service providers | | — |
| — | |
| |
Issuance of ordinary shares (including resulting from warrants exercise), net of issuance costs |
| | | ( | — | | |
Issuance of ordinary shares for vested RSUs | | | | ( | — | | — |
Comprehensive loss |
| — |
| — | ( |
| ( |
BALANCE AT JUNE 30, 2025 |
| |
| | ( |
| ( |
The accompanying notes are an integral part of these condensed consolidated financial statements.
5
REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
(Unaudited)
| | Six Months Ended | | | ||
| | June 30, | | | ||
| | 2026 | | 2025 | | |
| | U.S. dollars in thousands | | | ||
OPERATING ACTIVITIES: | | | | | | |
Loss | | ( |
| ( | | |
Adjustments in respect of income and expenses not involving cash flow: | | | | | | |
Share-based compensation to employees and service providers | | |
| | | |
Depreciation | | |
| | | |
Amortization of intangible assets | | — | | | | |
Share of loss of joint venture | | | | — | | |
Fair value (gains) losses on derivative financial instruments and recognition of day 1 loss | | | | ( | | |
Issuance costs in respect of warrants and equity line of credit | | | | | | |
Exchange differences and revaluation of bank deposits | | | | | | |
| |
| ( | | | |
Changes in assets and liability items: | | | | | | |
Decrease (increase) in trade receivables | | | | ( | | |
Decrease (increase) in prepaid expenses and other receivables | | ( |
| | | |
Decrease in inventories | | — | | | | |
Decrease in accounts payable | | ( | | ( | | |
Increase in accrued expenses and other liabilities | | |
| | | |
Increase (decrease) in allowance for deductions from revenue | | ( | | | | |
| | ( |
| ( | | |
Net cash used in operating activities | | ( |
| ( | | |
Net cash used in operating activities from discontinued operation | | ( | | ( | | |
Net cash used in operating activities from continuing operation | | ( | | ( | | |
INVESTING ACTIVITIES: | | | | | | |
Purchase of fixed assets | | ( |
| ( | | |
Collection of receivable from joint venture | | | | — | | |
Change in investment in non current bank deposits | | |
| — | | |
Net cash provided by (used in) investing activities | | |
| ( | | |
Net cash provided by investing activities from discontinued operation | | — | | — | | |
Net cash (used in) provided by investing activities from continuing operation | | | | ( | | |
FINANCING ACTIVITIES: | | | | | | |
Proceeds from issuance of ordinary shares and warrants, net of issuance costs | | |
| | | |
Payment of principal with respect to lease liabilities | | ( | | ( | | |
Net cash provided by financing activities | | |
| | | |
Net cash provided by financing activities from discontinued operation | | — | | — | | |
Net cash provided by financing activities from continuing operation | | | | | | |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | | |
| ( | | |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | | ( |
| | | |
BALANCE OF CASH AND CASH EQUIVALENTS AT THE BEGINNING OF PERIOD | | |
| | | |
BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF PERIOD | | |
| | | |
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH | | |
| | | |
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH | | |
| | | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
6
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
NOTE 1 - GENERAL:
| 1) | RedHill Biopharma Ltd. (the “Company”), incorporated on August 3, 2009, together with its wholly-owned subsidiary, RedHill Biopharma Inc. (“RedHill Inc.”), incorporated in Delaware, U.S. on January 19, 2017, is a specialty biopharmaceutical company primarily focused on the commercialization, development of proprietary drugs for gastrointestinal (“GI”) diseases and infectious diseasesand oncology. |
The Company’s American Depositary Shares (“ADSs”) were traded on the Nasdaq Capital Market from December 27, 2012, were listed on the Nasdaq Global Market (“Nasdaq”) from July 20, 2018, and have been again listed on the Nasdaq Capital Market since November 15, 2023.
The Company’s registered address is 21 Ha’arba’a St, Tel-Aviv, Israel.
| 2) | Since the Company established its commercial presence in the U.S. in 2017, it has promoted or commercialized various GI-related products that were either developed internally or acquired through in-licensing agreements. In particular, Talicia® which is FDA-approved product, for the treatment of Helicobacter pylori infection in adults, was developed primarily internally by the Company and is its first internally developed product approved by the U.S. Food and Drug Administration (“FDA”). All these commercial activities are presented as discontinued operations, see note 8. |
| 3) | In October 2025, the Company established Talicia Holdings Inc. (“THI”), an entity formed to hold the Talicia® business and related activities, and entered into a strategic transaction with Cumberland Pharmaceuticals Inc. (“Cumberland”). In connection with this transaction, the Company transferred all Talicia®-related activities and operations to THI. For more information, see note 16 in the annual financial statements as of December 31, 2025. (See also note 11(a) regarding the sale of the Company’s |
Prior to the transaction, the Company operated in both research and development and commercial segments, which included the commercialization of internally developed and in-licensed products. Following the transaction, the Company has exited its commercial operations and is primarily focused on research and development activities. See note 11(b) regarding a License and Commercial Supply Agreement signed by a subsidiary of the Company with Ferring Pharmaceuticals for exclusive global commercialization rights to Rebyota® and exclusive U.S. commercialization rights to Clenpiq®.
| 4) | As of June 30, 2026, the Company had an accumulated deficit and negative operating cash flow, and its activities have been funded primarily through public and private offerings of the Company’s securities and senior secured borrowing (now fully extinguished, see note 15(5) in the annual financial statements as of December 31, 2025). There is no assurance that the Company’s business will generate sustainable positive cash flows to fund its business. |
7
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
The Company plans to further fund its future operations through potential distributions and other cash flows arising from out-licensing of its therapeutic candidates, commercialization of in-licensed or acquired products and raising additional capital through equity or debt financing or through other non-dilutive financing. Furthermore, the Company holds from time to time discussions with multiple parties regarding potential strategic transactions, although there is no assurance that these discussions will result in any such transactions. The Company’s current cash resources are not sufficient to complete the research and development of its therapeutic candidates until generation of sustainable positive cash flows. Management expects that the Company will incur additional losses as it continues to focus its resources on advancing the development of its therapeutic candidates, based on a prioritized plan expected to result in negative cash flows from operating activities. Management believes that there is presently insufficient funding available to allow the Company to fund its activities for a period exceeding one year from the date of this filing. In August and September 2026, the upfront payments under the completed transactions described in Note 11 resulted in a net cash inflow of approximately $
The accompanying condensed consolidated interim financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.
| 5) | In October 2023, Israel was attacked by a terrorist organization and entered a state of war. As of the date of these condensed consolidated interim financial statements, sustained conflict in the region is ongoing and has included periods of escalation on multiple fronts, including confrontations involving Iran. During the six months ended June 30, 2026, the impact of these events on the Company's results and financial condition was immaterial, but such impact may increase. |
b. Approval of the condensed consolidated interim financial statements:
These condensed consolidated interim financial statements were approved by the Board of Directors (the "BoD") on September 30, 2026.
NOTE 2 - BASIS OF PREPARATION OF THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AND MATERIAL ACCOUNTING POLICIES:
The Company’s condensed consolidated interim financial statements for the six months ended June 30, 2026 (the "Condensed Consolidated Interim Financial Statements"), have been prepared in accordance with International Accounting Standard IAS 34, “Interim Financial Reporting”. These Condensed Consolidated Interim Financial Statements, that are unaudited, do not include all the information and disclosures that would otherwise be required in a complete set of annual financial statements and should be read in conjunction with the annual financial statements as of December 31, 2025, and their accompanying notes, which have been prepared in accordance with IFRS® Accounting Standards as issued by the International Accounting Standards Board ("IASB"). The results of operations for the six months ended June 30, 2026, are not necessarily indicative of the results that may be expected for the entire fiscal year or for any other interim period.
The accounting policies applied in the preparation of the Condensed Consolidated Interim Financial Statements are consistent with those applied in the preparation of the annual financial statements as of December 31, 2025.
IFRS 18, Presentation and Disclosure in Financial Statements
8
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
This standard replaces IAS 1, “Presentation of Financial Statements.” As part of the new disclosure requirements, companies will be required to present new defined subtotals in the statement of profit or loss, including operating profit and profit before financing and tax. In addition, items in the statement of profit or loss will be classified into defined categories: operating, investing, financing, income taxes and discontinued operations. The standard also includes a requirement to provide separate disclosure regarding the use of management-defined performance measures, as well as principles for the grouping and disaggregation of items in the financial statements and the notes thereto. IFRS 18 is effective for annual reporting periods beginning on or after January 1, 2027, with an option for early adoption. The standard requires retrospective application, including the presentation of comparative information. The Company has not early adopted this standard and is currently evaluating the potential impact of IFRS 18 on its condensed consolidated interim financial statements.
As of the date of approval of these condensed interim financial statements, there are no new standards or amendments to existing standards that are relevant to the Company that were not disclosed in the Company's annual financial statements as of December 31, 2025.
NOTE 3 - SIGNIFICANT EVENTS DURING THE CURRENT REPORTING PERIOD:
| a. | Through June 30, 2026, the Company sold |
| b. | On March 5, 2026, the annual general meeting of shareholders approved the increase of the authorized share capital of the Company to NIS |
| c. | On June 22, 2026, following the execution of a securities purchase agreement on June 18, 2026, the Company completed a private placement with Armistice Capital Master Fund Ltd. |
In connection with the private placement, the Company issued pre-funded warrants exercisable into
The pre-funded warrants have an exercise price of $
The gross proceeds from the private placement were approximately $
The warrants issued to the Investor were classified as financial liabilities due to a net settlement provision. These derivative financial instruments were initially recognized and are subsequently measured at fair value through profit or loss.
The fair value of the warrants was adjusted to reflect an unrecognized day 1 loss. The unrecognized day 1 loss is amortized over the contractual lives of the applicable warrants. Transaction costs attributable to
9
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
the liability-classified warrants were recognized directly in the Condensed Consolidated Statements of Comprehensive Income (Loss).
The Company also issued to the placement agent’s designees warrants exercisable into
| d. | As described in the Company’s annual consolidated financial statements as of December 31, 2025, on December 19, 2025, the Company entered into a Standby Equity Purchase Agreement with Yorkville Advisors Global, LP (“YA”), pursuant to which YA committed to purchase, at the Company’s discretion and subject to certain conditions, up to $ |
During the six months ended June 30, 2026, the Company issued to YA an additional
| e. | As described in Note 15(7) to the Company’s annual consolidated financial statements as of December 31, 2025, the Company obtained final judgments in its favor against Kukbo Co. Ltd. (“Kukbo”). In June 2026, the Company commenced recognition and enforcement proceedings in South Korea, in which Kukbo was served. At that time, the aggregate amount awarded to the Company, including accrued statutory interest, was approximately $ |
NOTE 4 - ALLOWANCE FOR DEDUCTIONS FROM REVENUES:
The following table shows the movement of the allowance for deductions from revenues:
| | Rebates and patient discount programs | | Product returns | | Total |
| | U.S. dollars in thousands | ||||
As of January 1, 2026 |
| |
| | | |
Decreases (utilized) |
| ( | | ( | | ( |
Adjustments | | ( | | ( | | ( |
As of June 30, 2026 |
| |
| | | |
| | Rebates and patient discount programs | | Product returns | | Total |
| | U.S. dollars in thousands | ||||
As of January 1, 2025 |
| |
| | | |
Increases | | | | | | |
Decreases (utilized) |
| ( | | ( | | ( |
Adjustments | | | | | | |
As of June 30,2025 |
| |
| | | |
NOTE 5 - SHARE-BASED PAYMENTS:
On January 23, 2026, the BoD granted
10
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
the Company’s shareholders held on March 5, 2026, following approval by the Company’s BoD in January 2026, approved grant of
NOTE 6 - NET REVENUES:
The Company recognized
NOTE 7 - FINANCIAL INSTRUMENTS:
| a. | The Company’s derivative financial liability, represented by warrants, is measured at fair value and classified as level 3. Fair value adjustments are recognized in profit or loss as financial income or expenses. The following table presents the change in this level 3 derivative liability for the six months ended June 30, 2026, and June 30, 2025: |
| Derivative financial instruments | |||
| Six Months Ended June 30, | |||
| 2026 | | 2025 |
|
| U.S. dollars in thousands | | ||
Balance at beginning of the period | | | | |
Initial recognition of financial liability | | | — | |
Initial recognition of unrecognized day 1 loss | ( | | — | |
Exercise of financial liability | — | | ( | |
Fair value adjustments recognized in profit or loss and recognition of day 1 loss | | | ( | |
Balance at end of the period | | | | |
The fair value of the warrants is computed using the Black-Scholes model. As of June 30, 2026, it is based on the ADS price on that date and the following key parameters: risk-free interest rate of
11
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
NOTE 8 - DISCONTINUED OPERATIONS:
| A. | General |
As described in Note 16 to the Company’s annual consolidated financial statements as of and for the year ended December 31, 2025, on October 17, 2025, the Company completed a strategic transaction with Cumberland Pharmaceuticals Inc. pursuant to which the Talicia® business and related commercial operations were transferred to THI.
Following completion of the transaction, the Company lost unilateral control over THI and accounts for its retained
The Company’s U.S. commercial operations and Talicia® licensing activities represented a separate major line of business and are therefore presented retrospectively as discontinued operations in accordance with IFRS 5. Comparative information for the six months ended June 30, 2025 has been re-presented accordingly.
| B. | Financial performance of the discontinued operation |
The results attributable to the discontinued operation were as follows:
| | Six Months Ended | ||
| | June 30, | ||
| | 2026 | | 2025 |
| | U.S. dollars in thousands | ||
| | | | |
NET REVENUES | | |
| |
COST OF REVENUES | | — | | |
GROSS PROFIT | | | | |
GENERAL AND ADMINISTRATIVE EXPENSES | | |
| |
OPERATING LOSS | | ( |
| ( |
FINANCIAL EXPENSES, net | | ( |
| ( |
LOSS FROM DISCONTINUED OPERATIONS | | ( |
| ( |
| C. | Cash Flow Information of the Discontinued Operation: |
Net cash flows attributable to the discontinued operation were as follows:
| | Six Months Ended | ||
| | | June 30, | |
| | 2026 | | 2025 |
| | U.S. dollars in thousands | ||
OPERATING ACTIVITIES: | | | | |
Net cash used in operating activities | | ( |
| ( |
Net cash provided by financing activities | | — |
| — |
Net cash provided by investing activities | | — | | — |
DECREASE IN CASH AND CASH EQUIVALENTS | | ( |
| ( |
business as a discontinued operation in accordance with IFRS 5.
NOTE 9 - INVESTMENT IN JOINT VENTURE:
| A. | Basis of accounting |
The Company accounts for its interest in THI as an investment in a joint venture using the equity method in accordance with IAS 28.
12
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
| B. | Carrying amount and movements |
The movement in the carrying amount of the investment in THI during the six months ended June 30, 2026 was as follows:
| | U.S. dollars in thousands |
Carrying amount at January 1, 2026 | | |
Share-based compensation | | |
Collection of receivables from THI related to supplier reimbursement obligations | | ( |
Share of loss of THI for the six months ended June 30, 2026 net of the accretion adjustment | | ( |
Carrying amount at June 30, 2026 | | |
| | |
The investment in THI is presented within non-current assets in the condensed consolidated statement of financial position.
| C. | Summarised financial information |
The summarised financial information presented below represents amounts for THI on a
Statement of financial position (
| | June 30, | | December 31, |
| | 2026 | | 2025 |
| | U.S. dollars in thousands | ||
Current Assets* | | | | |
Non-current assets | | | | |
Current Liabilities | | | | |
Non - Current Liabilities | | | | |
Net Assets | | | | |
*includes the reclassification of the stock subscriptions receivable from Cumberland ($ | | | | |
Reconciliation to the carrying amount of the investment | |
| Six Months Ended |
| June 30, 2026 |
| U.S. dollars in thousands |
THI's net assets (on an IFRS basis, see table above), excluding goodwill | |
Goodwill | |
THI's net assets on an IFRS basis, as presented above | |
Company's ownership interest | |
Share of THI's net assets accounted for under the equity method | |
Add: Receivable from THI for inventory transferred * | |
Total investment in joint venture, as presented on the Consolidated Statements of Financial Position | |
| |
* Represents the Company's receivable from THI for inventory transferred in connection with the formation transaction, expected to be settled from THI's operating cash flows over time. | |
13
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
Summarized statement of profit and loss ( | |
| Six Months Ended June 30, 2026 |
| U.S. dollars in thousands |
Net Revenue | |
Gross profit | |
Net loss | ( |
The loss and comprehensive loss above includes the following items required to be separately disclosed under IFRS 12: | |
Depreciation and amortization | |
Interest income | |
Income tax benefit | |
NOTE 10 - LOSS PER ORDINARY SHARE:
The Company had three categories of potentially dilutive ordinary shares: warrants issued to investors, options and RSUs issued to employees and service providers. Pre-funded warrants and vested RSUs were included in the weighted average number of ordinary shares used in the calculation of basic loss per ordinary share. The basic and diluted loss per ordinary share were the same for all periods presented, since the effect of the remaining potentially dilutive ordinary shares was anti-dilutive.
NOTE 11 - EVENTS SUBSEQUENT TO JUNE 30, 2026:
| a. | On August 27, 2026, the Company completed the sale of its |
In connection with the transaction, the Company agreed to a
| b. | On August 28, 2026, the Company, through a subsidiary, entered into a License and Commercial Supply Agreement with Ferring Pharmaceuticals (“Ferring”) for exclusive global commercialization rights to Rebyota® and exclusive U.S. commercialization rights to Clenpiq® (together, the “Products”). The agreement has an initial term of |
The Company made an upfront payment of $
14