RedHill Biopharma Ltd 6-K/A, filed Sep 5, 2025
RedHill Biopharma Ltd. (RDHL)
About this 6-K/A
RedHill Biopharma Ltd filed this 6-K/A on September 5, 2025.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K/A
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 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 hereto and incorporated by reference herein are the following:
Exhibit 99.3: Registrant’s Management Discussion and Analysis of First Half 2025 Financial Results.
This Form 6-K/A 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. |
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| (the “Registrant”) |
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Date: September 5, 2025 | By: | /s/ Dror Ben-Asher |
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| Name: | Dror Ben-Asher | |
| Title: | Chief Executive Officer | |
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Exhibit 99.1
Press Release
RedHill Biopharma Announces First Half 2025 Financial Results and Operational Highlights
Extensive strategic, financial and operational overhaul has reshaped and refocused our business; Strong progress on multiple fronts
Commercial and R&D Highlights:
· | Recruitment initiated in the Bayer-supported Phase 2 combination study of opaganib and darolutamide in advanced prostate cancer |
· | Positive U.S. Food and Drug Administration (FDA) feedback on pathway to approval for RedHill’s next-generation Crohn’s disease program with RHB-204 - planned to be the first ever clinical study in a defined Mycobacterium avium subspecies paratuberculosis infected (MAP-positive) Crohn’s disease (CD) patient population |
· | Increased Talicia net revenues and units sold as compared to first half 2024 - achieved with significantly reduced resources |
· | Talicia U.S. formulary wins securing 8 million additional covered lives, taking the total to more than 204 million lives |
· | UK Marketing Authorization Application (MAA) for Talicia® submission imminent and expected to be in time for potential approval this year |
· | Ex-U.S. Talicia: cash inflows from first sales milestone and from royalties, majority received post–balance sheet date |
· | Up to $60 million global (ex-North America) RHB-102 out-licensing deal signed with Hyloris Pharmaceuticals |
Corporate and financial highlights:
· | Gross profit doubled compared to first half 2024 |
· | 59% increase in net revenues in first half of 2025 to $4.1 million, up from $2.6 million in first half of 2024 |
· | Enhanced financial stability with up to approximately $13.5 million available to the Company through At-the-Market (“ATM”) and Any Market Purchase agreements |
· | Cash balance of $3 million as of June 30, 20251 |
· | Further 19% reduction in cash burn following the previous year’s 74% reduction |
· | Net cash used in operations in first half of 2025 dropped to $5 million from $6.2 million in first half of 2024 |
· | Following RedHill’s approximately $8.25 million including interest New York Supreme Court summary judgment win against Kukbo (appeal to be heard this month), the Court also awarded RedHill approximately $1.82 million including interest in legal costs and expenses. RedHill also won an attachment grant in the Korean courts, preventing Kukbo asset disposal prior to enforcement |
TEL AVIV, Israel and RALEIGH, NC, September 5, 2025, RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today reported its first half of 2025 financial results and operational highlights for the six months ended June 30, 2025.
Dror Ben-Asher, RedHill’s Chief Executive Officer, said: “Last year’s extensive strategic, financial and operational overhaul has reshaped and refocused our business, and our first half of 2025 results show strong progress on multiple fronts. Our predominantly externally funded research and development programs are advancing positively. The Bayer-supported Phase 2 study of opaganib and darolutamide has started recruiting patients. We now have an FDA green light for our planned groundbreaking Crohn’s program with RHB-204 - the first ever in a wholly MAP-positive population, presenting a new potential treatment approach - with an innovative design enabling a smaller sample size, lower study costs and faster time to completion. Commercially, the much-streamlined commercial team has achieved increased Talicia revenues with significantly reduced resources. The commercial team continues to break new ground with new Talicia formulary wins. Equally important is the progress being made with Talicia’s geographic expansion with the potential for a UK Marketing Authorization Application approval this year, first ex-U.S. Talicia sales milestone and royalty payments received and active discussions to secure additional non-dilutive ex-US licensing revenue streams advancing. We have also secured an up to $60 million RHB-102 out-licensing deal to Hyloris Pharma. The significant progress we have made so far this year is largely due to our focused and committed team, and to the quality of programs we are advancing – both R&D and commercial. We have achieved important legal successes and built strong momentum and are working towards the delivery of additional key near-term catalysts to further accelerate our growth trajectory.
Financial results for the six months ended June 30, 2025 (Unaudited)2
Net Revenues for the first half of 2025 were $4.1 million, compared to $2.6 million for the first half of 2024. Talicia net revenues for the first half of 2025 were $3.8 million, up from $3.5 million in the same period of 2024. This included U.S. net revenues of $3.3 million (compared to $3.0 million in the prior-year period, reflecting an increase in units sold) and $0.5 million from our partnership in the United Arab Emirates (“UAE”) in product sales, with an additional $0.1 million recognized from royalties, compared to $0.5 million in product sales in the same period of 2024. In addition, $0.3 million was recorded from the Hyloris license for RHB-102 (Bekinda®), reflecting a $0.1 million upfront payment at signing and $0.2 million related to the present value of minimum annual payments due from 2027 through 2035. In the first half of 2024, Movantik® generated negative net revenues of $0.9 million, primarily due to product returns, compared to an immaterial amount of contra-revenues in the first half of 2025.
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Cost of Revenues for the first half of 2025 was $1.6 million, compared to $1.4 million for the first half of 2024. The 2024 figure included a reduction from Movantik® contra-revenues, while the 2025 revenue increase was only partly reflected in costs, due to royalty and license revenues with no associated COGS.
Gross Profit for the first half of 2025 was $2.5 million, compared to $1.2 million for the first half of 2024 driven by higher revenues, cost-free royalty and license contributions, and the absence of Movantik® adjustments.
Research and Development Expenses for the first half of 2025 were $1 million, as compared to $0.7 million for the first half of 2024. The increase was primarily driven by costs related to various clinical activities as well as regulatory work associated with Talicia.
Selling, Marketing, and General and Administrative Expenses for the first half of 2025 were $5.9 million, as compared to $9 million for the first half of 2024. The decrease was mainly due to U.S. workforce downsizing, continued cost-reduction measures, and an overall lower level of commercial and administrative activity.
Operating Loss for the first half of 2025 was $4.4 million, compared to $8.4 million for the first half of 2024. The decrease is primarily attributable to higher gross profit and reduced operating expenses, as detailed above.
Financial Income, net for the first half of 2025 was $0.2 million, compared to Financial Income, net of $5.4 million for the first half of 2024. In both periods, net financial income was primarily attributable to the revaluation of warrants, partially offset by issuance costs in respect of warrants.
Net Loss for the first half of 2025 was $4.1 million, as compared to $3.1 million for the first half of 2024. The increase in net loss was primarily driven by a significant decrease in financial income related to the revaluation of warrants, partially offset by a reduction in operating loss, as detailed above.
Total Assets as of June 30, 2025, were $18.4 million, as compared to $18.0 million as of December 31, 2024, reflecting higher trade receivables partly offset by lower cash, inventory, and restricted cash.
Total Liabilities as of June 30, 2025, were $22.8 million, as compared to $22.7 million as of December 31, 2024, driven by higher allowances for deductions from revenues and increased accrued expenses, partly offset by lower derivative liabilities following warrant revaluation.
Net Cash Used in Operating Activities for the first half of 2025 was $5 million, compared to $6.2 million for the first half of 2024. The decrease was primarily driven by the continued impact of cost-cutting measures.
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Net Cash Provided by Financing Activities for the first half of 2025 was $3.3 million, driven by use of our ATM program, compared to $7.9 million for the first half of 2024, which were mainly derived from equity offerings.
Cash Balance as of June 30, 2025, was $3 million1.
Enhanced Liquidity:
On June 25, 2025, the Company entered into an Any Market Purchase Agreement (the “Purchase Agreement”) with Alumni Capital LP, whereby the Company has the right, but not the obligation, to sell to Alumni, from time to time, up to $10,000,000 of American Depositary Shares (“ADSs”), subject to the terms and conditions set forth in the Purchase Agreement. Thus far, 1,013,908 ADSs have been sold at an average price of $1.67 per ADS, for an aggregate net proceeds of approximately $1.7 million.
On February 3, 2025, the Company entered into an At-the-Market Offering Agreement with H.C. Wainwright & Co., LLC (“Wainwright”), pursuant to which the Company may offer and sell ADSs, from time to time, through Wainwright acting as the Company’s placement agent. Pursuant to the prospectus supplement dated February 3, 2025, the Company may offer and sell ADSs having an aggregate offering price of up to $3,464,000. Thus far, 890,001 ADSs have been sold at an average price of $3.85 per ADS, for an aggregate net proceeds of approximately $3.3 million.
As of September 3, 2025, the Company had 3,329,857 ADSs outstanding (equivalent to 33,298,571,000 ordinary shares), each ADS representing 10,000 ordinary shares of the Company, par value NIS 0.01 per share.
These activities formed part of our plan submitted to Nasdaq in response to their deficiency letter notifying the Company that it was no longer compliant with Nasdaq Listing Rule 5550(b) (the “Rule”), requiring listed companies to maintain a minimum stockholders’ equity of $2,500,000 for continued listing. On August 8, 2025, Nasdaq granted the Company an extension until October 13, 2025, to regain compliance with the Rule.
Commercial and R&D First Half of 2025 Highlights:
Commercial - streamlined and revenue-generating:
With a streamlined commercial operation, Talicia has increased unit sales compared to the same period in 2024 and has maintained its No.1 position as the most prescribed branded H. pylori therapy by U.S. gastroenterologists.
In the first half of 2025, Talicia generated net revenues of $3.3 million in the U.S. Talicia U.S. formulary wins secured 8 million additional covered lives, taking the total to more than 204
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million lives, following the Medi-Cal renewal and Humana formulary wins. Talicia also generated an additional approximately $0.6 million in net revenues from our UAE partnership.
Following the successful launch of Talicia in the UAE, focus on geographic expansion continues with potential for a UK MAA approval this year. The Company is also in advanced discussions to secure additional non-dilutive ex-US licensing revenue streams.
Talicia has surpassed the 100,000 prescriptions milestone, with minimal refunds claimed via our innovative warranty program, reflecting a positive patient experience.
R&D - focused on new opportunities:
RedHill’s pipeline, which is predominantly externally funded through multiple U.S. Government and non-governmental collaborations, provides new and exciting opportunities in major indications, including prostate cancer, Ebola virus disease (EBOV) and other viral and pandemic preparedness indications, gastrointestinal-acute radiation syndrome (GI-ARS), diabetes and obesity-related disorders and Crohn’s disease.
Opaganib3:
A potentially broad-acting, novel, oral, host-directed small molecule drug, with a robust safety and tolerability database, directed at multiple underserved indications with sizeable multi-billion-dollar market opportunities and potentially advantageous pathways to approval. Opaganib is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications.
Oncology - A new approach in the $12 billion prostate cancer market:
· | Prostate cancer is the second most diagnosed cancer in the world, with around 1.5 million new cases per year, causing almost 400,000 deaths4. People with metastatic castrate-resistant prostate cancer (mCRPC) have few treatment options available to them. |
· | On July 1, 2025, the Company announced the start of recruitment of a Bayer-supported Phase 2 study of opaganib in combination with Bayer’s darolutamide in mCRPC, evaluating the potentially enhancing effect of opaganib in patients with poor prognosis. |
· | Utilizing a precision medicine approach, the unique 60-patient Phase 2 study uses the PCPro™ companion lipid biomarker test to identify patients with poor prognosis most likely to benefit from the combination. The study will utilize PCPro to select mCRPC patients who have a poor prognosis due to standard of care treatment and who may benefit from an opaganib + darolutamide combination treatment approach. The study’s primary endpoint is improved 12-month radiographic progression-free survival (rPFS). Several secondary and exploratory endpoints will also be evaluated. |
Ebola Virus Disease (EBOV):
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· | Opaganib is believed to be the first host-directed molecule to show activity in vivo in EBOV, delivering a statistically significant increase in survival and, separately, demonstrating a robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability. |
GI-ARS:
· | U.S. Government- and non-government funded programs ongoing with the NIH / BARDA-funded nuclear and chemical medical countermeasure programs for GI-ARS, undertaken as part of the U.S. Government’s Radiation and Nuclear Countermeasures Program product pipeline development contract. |
Diabetes and obesity-related disorders:
· | Positive in vivo study results support the potential of opaganib therapy in diabetes and obesity-related disorders - a market projected to be worth approximately $100 billion within the next decade. Positive results from multiple in vivo studies showing the impact of opaganib on weight gain and glucose intolerance in a high fat diet (HFD) model were recently published5 in the journal Diabetes, Metabolic Syndrome and Obesity. |
RHB-2046:
RHB-204, an orally-administered, next-generation optimized formulation of RedHill’s RHB-104 designed to further enhance tolerability, safety and patient adherence, is supported by positive RHB-104 Phase 3 safety and efficacy results7, which delivered a statistically significant 64% improvement in efficacy8. RHB-204 is patent protected through 2041.
Crohn’s Disease (CD) - Paradigm shift in MAP-positive CD treatment approach:
· | On July 21, 2025, the Company announced that it had received positive feedback from the FDA, following a scheduled Type C meeting, in which the FDA provided guidance on the pathway to approval for the Company’s potentially groundbreaking RHB-204 Crohn’s disease development program. |
· | The positive FDA feedback allows for the planned RHB-204 Phase 2 study to be the first ever clinical trial in CD to test a specifically defined population of Mycobacterium avium subspecies paratuberculosis infected (MAP-positive) CD patients. This groundbreaking approach, which tests MAP as a root cause of CD, could potentially make RHB-204, if approved, a paradigm-shifting new therapy treating both the suspected cause of the disease and its symptoms. |
· | As part of the planned Phase 2 study, RedHill has initiated two new collaborations with leading academic centers utilizing cutting-edge rapid and accurate MAP detection |
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diagnostics – the lack of which has previously been a major barrier to advancing the Company’s novel anti-MAP Crohn’s disease program.
· | Innovative study design enables a smaller sample size allowing for lower study costs and faster time to completion. |
RHB-107 (upamostat)9:
On January 30, 2025, we were notified that funding from the U.S. Government Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense for the ongoing 300-patient Phase 2 RHB-107 arm of the ACESO PROTECT platform trial for early COVID-19 outpatient treatment was subject to termination, requiring the study to cease enrollment on February 28, 2025. 92 patients have been enrolled out of a fully enrolled target patient population of 300. Due to the reduced number of patients enrolled in this study, the study result may not lead to conclusions regarding the efficacy of RHB-107 in this trial.
The U.S. Army-funded Ebola development program remains ongoing, with RHB-107 having demonstrated a robust synergistic effect in vitro when combined with remdesivir. Management of potential Ebola virus pandemic outbreaks represents a significant opportunity and is a key concern for global health agencies.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults10. 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, and anticancer activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn’s disease (based on RHB-104’s positive Phase 3 Crohn’s disease study results) and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (iii) RHB-107 (upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (iv) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis and positive results from a U.S. Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America.
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More information about the Company is available at www.redhillbio.com / 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. 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: market and other conditions; the Company’s ability to maintain compliance with the Nasdaq Capital Market’s listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; 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 of market and other conditions and 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 successfully commercialize and promote Talicia®; (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 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, pre-clinical 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
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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 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 10, 2025. 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
+972-54-6543-112
adi@redhillbio.com
Category: Financials
1 Including cash, cash equivalents, short-term bank deposits and restricted cash.
2 All financial highlights are approximate and are rounded to the nearest hundreds of thousands.
3 Opaganib is an investigational new drug, not available for commercial distribution.
4 Bray et al: Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834
5 Maines LW, Keller SN, Smith RA, Smith CD. Opaganib Promotes Weight Loss and Suppresses High-Fat Diet-Induced Obesity and Glucose Intolerance. Diabetes Metab Syndr Obes. 2025;18:969-983 https://doi.org/10.2147/DMSO.S514548
6 RHB-204 is an investigational new drug, not available for commercial distribution.
7 RHB-104 is an investigational new drug, not available for commercial distribution in the United States.
8 Graham DY, et al. Randomized, Double-Blind, Placebo-Controlled Study of Anti-Mycobacterial Therapy (RHB-104) in Active Crohn’s Disease. Antibiotics (Basel). 2024 Jul 25;13(8):694. https://www.mdpi.com/2079-6382/13/8/694. PMID: 39199994; PMCID: PMC11350828.
9 RHB-107 is an investigational new drug, not available for commercial distribution.
10 Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information, see: https://www.talicia.com/.
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REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
| | Six Months Ended |
| ||
| | June 30, | | ||
|
| 2025 |
| 2024 | |
| | U.S. dollars in thousands | | ||
NET REVENUES | | 4,079 | | 2,572 | |
COST OF REVENUES | | 1,607 | | 1,404 | |
GROSS PROFIT | | 2,472 | | 1,168 | |
RESEARCH AND DEVELOPMENT EXPENSES | | 964 | | 659 | |
SELLING AND MARKETING EXPENSES | | 2,035 | | 3,487 | |
GENERAL AND ADMINISTRATIVE EXPENSES | | 3,851 | | 5,470 | |
OPERATING LOSS | | (4,378) | | (8,448) | |
FINANCIAL INCOME | | 1,338 | | 7,157 | |
FINANCIAL EXPENSES | | 1,093 | | 1,797 | |
FINANCIAL INCOME, net | | 245 | | 5,360 | |
LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD | | (4,133) | | (3,088) | |
LOSS PER ORDINARY SHARE, basic and diluted (U.S. dollars) | | 0.00 | | 0.00 | |
WEIGHTED AVERAGE OF ORDINARY SHARE (in thousands) | | 18,030,006 | | 11,760,458 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
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REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(Unaudited)
| | June 30, | | December 31, |
|
|
| 2025 |
| 2024 | |
| | U.S. dollars in thousands | | ||
CURRENT ASSETS: | | | | | |
Cash and cash equivalents | | 2,866 | | 4,617 | |
Restricted cash | | 160 | | — | |
Trade receivables | | 5,350 | | 2,539 | |
Prepaid expenses and other receivables | | 1,010 | | 1,104 | |
Inventory | | 3,169 | | 3,651 | |
| | 12,555 | | 11,911 | |
NON-CURRENT ASSETS: | | | | | |
Restricted cash | | — | | 148 | |
Fixed assets | | 126 | | 135 | |
Right-of-use assets | | 163 | | 302 | |
Intangible assets | | 5,531 | | 5,547 | |
| | 5,820 | | 6,132 | |
TOTAL ASSETS | | 18,375 | | 18,043 | |
| | | | | |
| | | | | |
CURRENT LIABILITIES: | | | | | |
Account payable | | 835 | | 1,168 | |
Lease liabilities | | 214 | | 353 | |
Allowance for deductions from revenue | | 10,541 | | 9,288 | |
Derivative financial instruments | | 11 | | 1,421 | |
Accrued expenses and other current liabilities | | 10,686 | | 9,993 | |
| | 22,287 | | 22,223 | |
| | | | | |
NON-CURRENT LIABILITIES: | | | | | |
Lease liabilities | | — | | 3 | |
Royalty obligation | | 500 | | 500 | |
| | 500 | | 503 | |
TOTAL LIABILITIES | | 22,787 | | 22,726 | |
| | | | | |
CAPITAL DEFICIENCY: | | | | | |
Ordinary shares | | 63,404 | | 35,036 | |
Additional paid-in capital | | 350,303 | | 375,082 | |
Accumulated deficit | | (418,119) | | (414,801) | |
TOTAL CAPITAL DEFICIENCY | | (4,412) | | (4,683) | |
TOTAL LIABILITIES CAPITAL DEFICIENCY | | 18,375 | | 18,043 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
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REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
(Unaudited)
| | Six Months Ended |
| ||
| | June 30, | | ||
|
| 2025 |
| 2024 | |
| | U.S. dollars in thousands | | ||
OPERATING ACTIVITIES: | | | | | |
Loss | | (4,133) | | (3,088) | |
Adjustments in respect of income and expenses not involving cash flow: | | | | | |
Share-based compensation to employees and service providers | | 297 | | 229 | |
Depreciation | | 152 | | 402 | |
Amortization of intangible assets | | 16 | | 16 | |
Gains from early termination of leases, net | | — | | (23) | |
Fair value gains on derivative financial instruments net of recognition of unrecognized day 1 loss | | (1,269) | | (7,108) | |
Issuance costs in respect of warrants | | — | | 1,497 | |
Warrants issued as fees under a Market Purchase Agreement | | 518 | | — | |
Exchange differences and revaluation of bank deposits | | 26 | | (4) | |
| | (260) | | (4,991) | |
Changes in assets and liability items: | | | | | |
Decrease (increase) in trade receivables | | (2,811) | | 1,617 | |
Decrease (increase) in prepaid expenses and other receivables | | 94 | | (108) | |
Decrease in inventories | | 482 | | 585 | |
Decrease in accounts payable | | (333) | | (1,366) | |
Increase (decrease) in accrued expenses and other liabilities | | 693 | | (631) | |
Increase in allowance for deductions from revenue | | 1,253 | | 1,797 | |
| | (622) | | 1,894 | |
Net cash used in operating activities | | (5,015) | | (6,185) | |
INVESTING ACTIVITIES: | | | | | |
Purchase of fixed assets | | (4) | | (1) | |
Net cash used in investing activities | | (4) | | (1) | |
FINANCING ACTIVITIES: | | | | | |
Proceeds from issuance of ordinary shares and warrants, net of issuance costs | | 3,448 | | 8,263 | |
Decrease in restricted cash | | — | | 51 | |
Payment of principal with respect to lease liabilities | | (189) | | (414) | |
Net cash provided by financing activities | | 3,259 | | 7,900 | |
INCREAE (DECREASE) IN CASH AND CASH EQUIVALENTS | | (1,760) | | 1,714 | |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | | 9 | | (6) | |
BALANCE OF CASH AND CASH EQUIVALENTS AT THE BEGINNING OF PERIOD | | 4,617 | | 5,569 | |
BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF PERIOD | | 2,866 | | 7,277 | |
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH | | 89 | | 38 | |
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH | | 10 | | 28 | |
SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING ACTIVITIES: | | | | | |
Acquisition of right-of-use assets by means of lease liabilities | | — | | 5 | |
Decrease in lease liability (with corresponding decrease in right of use asset in amount of $170 in the six months ended June 30, 2024) resulting from early termination of lease | | — | | 193 | |
The accompanying notes are an integral part of these condensed consolidated financial statements.
12
Exhibit 99.2
1
REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM FINANCIAL INFORMATION
(UNAUDITED)
June 30, 2025
TABLE OF CONTENTS
| |
UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS AS OF JUNE 30, 2025, 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 | 7-12 |
2
REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
| | Six Months Ended | ||
| | June 30, | ||
| | 2025 | | 2024 |
| | U.S. dollars in thousands | ||
NET REVENUES | | |
| |
COST OF REVENUES | | | | |
GROSS PROFIT | | | | |
RESEARCH AND DEVELOPMENT EXPENSES, net | | | | |
SELLING AND MARKETING EXPENSES | | | | |
GENERAL AND ADMINISTRATIVE EXPENSES | | | | |
OPERATING LOSS | | ( | | ( |
FINANCIAL INCOME | | | | |
FINANCIAL EXPENSES | | | | |
FINANCIAL INCOME, net | | | | |
LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD | | ( | | ( |
LOSS PER ORDINARY SHARE, basic and diluted (U.S. dollars) | | | | |
WEIGHTED AVERAGE OF ORDINARY SHARE (in thousands) | | |
| |
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, |
|
| 2025 |
| 2024 |
| | U.S. dollars in thousands | ||
CURRENT ASSETS: | | | | |
Cash and cash equivalents | | | ||
Restricted cash | | | — | |
Trade receivables | | | ||
Prepaid expenses and other receivables | | | ||
Inventory | | | ||
| | | ||
NON-CURRENT ASSETS: | | | | |
Restricted cash | | — | | |
Fixed assets | | | ||
Right-of-use assets | | | ||
Intangible assets | | | ||
| | | ||
TOTAL ASSETS | | | ||
| | | | |
| | | | |
CURRENT LIABILITIES: | | | | |
Account payable | | | ||
Lease liabilities | | | ||
Allowance for deductions from revenue | | | ||
Derivative financial instruments | | | ||
Accrued expenses and other current liabilities | | | ||
| | | ||
| | | | |
NON-CURRENT LIABILITIES: | | | | |
Lease liabilities | | — | | |
Royalty obligation | | | ||
| | | ||
TOTAL LIABILITIES | | | ||
| | | | |
CAPITAL DEFICIENCY: | | | | |
Ordinary shares | | | ||
Additional paid-in capital | | | ||
Accumulated deficit | | ( | | ( |
TOTAL CAPITAL DEFICIENCY | | ( | | ( |
TOTAL LIABILITIES 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, 2025 |
| | | | | ( | | ( |
| | | | | | | | |
CHANGES IN THE SIX-MONTHS 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 | | | | | | ( | | ( |
| | | | | | | | |
BALANCE AT JANUARY 1, 2024 |
| | | | | ( | | |
CHANGES IN THE SIX-MONTHS PERIOD ENDED JUNE 30, 2024: | | | | | | | | |
Share-based compensation to employees and service providers | | — |
| — |
| |
| |
Issuance of ordinary shares, net of expenses |
| | | ( | | — | | |
Issuance of ordinary shares for vested RSUs | | | | ( | | — | | — |
Comprehensive loss |
| — |
| — |
| ( |
| ( |
BALANCE AT JUNE 30, 2024 |
| |
| |
| ( |
| |
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, | ||
|
| | 2025 |
| 2024 |
| | | 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 | | | | | |
Gains from early termination of leases, net | | | — | | ( |
Fair value gains on derivative financial instruments net of recognition of unrecognized day 1 loss | | | ( | | ( |
Issuance costs in respect of warrants | | | — | | |
Warrants issued as fees under a Market Purchase Agreement | | | | | — |
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 (decrease) in accrued expenses and other liabilities | | | | | ( |
Increase in allowance for deductions from revenue | | | | | |
| | | ( | | |
Net cash used in operating activities | | | ( | | ( |
INVESTING ACTIVITIES: | | | | | |
Purchase of fixed assets | | | ( | | ( |
Net cash used in investing activities | | | ( | | ( |
FINANCING ACTIVITIES: | | | | | |
Proceeds from issuance of ordinary shares and warrants, net of issuance costs | | | | | |
Decrease in restricted cash | | | — | | |
Payment of principal with respect to lease liabilities | | | ( | | ( |
Net cash provided by financing activities | | | | | |
INCREAE (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 | | | |
| |
SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING ACTIVITIES: | | | | | |
Acquisition of right-of-use assets by means of lease liabilities | | | — | | |
Decrease in lease liability (with corresponding decrease in right of use asset in amount of $ | | | — | | |
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 gastrointestinal (“GI”) diseases and infectious diseases. |
The Company’s ordinary shares were traded on the Tel-Aviv Stock Exchange (“TASE”) from February 2011 to February 2020, after which the Company voluntarily delisted from trading on the TASE, effective February 13, 2020. 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.
On March 23, 2023, the Company changed the ADS ratio from 1 ADS representing
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. As of the date of approval of these condensed consolidated interim financial statements, the Company commercializes in the U.S. Talicia® for the treatment of Helicobacter pylori infection in adults, the first product approved by the U.S. Food and Drug Administration (“FDA”) being developed primarily internally by the Company. Until February 1, 2023, the Company commercialized Movantik® in the U.S, for the treatment of opioid-induced constipation. See also note 15 (6) in the annual financial statements as of December 31, 2024 regarding the transfer of the Company’s rights in Movantik® to HCR Collateral Management, LLC (“HCRM”) in exchange for all the Company’s debt obligations under the Credit Agreement with HCRM, as well as the Global Termination Agreement, which terminated all remaining credit ties related to this transaction. The Company also continues to advance the development part of its late-stage therapeutic candidates. |
| 3) | Through June 30, 2025, the Company had an accumulated deficit and negative working capital, 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(6) in the annual financial statements as of December 31, 2024). There is no assurance that the Company’s business will generate sustainable positive cash flows to fund its business. |
The Company plans to further fund its future operations through commercialization and 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, see also note 10 regarding funds received from the Any Market Purchase Agreement subsequent to June 30, 2025. Furthermore, the Company actively pursuing and holding discussions with multiple parties regarding potential strategic transactions including the possible divestment of certain of the Company’s assets and/or its commercial operations, which the Company expects would provide it with additional capital, although there can be no assurance that these discussions will result in any such transaction. The Company’s current cash resources are not sufficient to complete the research and development of its therapeutic candidates and to fully support its commercial operations 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, as well as supporting
7
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
its commercial operations, 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 addition, as of the reporting date, the Company has a significant amount of obligations related to allowance for deductions from revenues that are past due, including certain obligations that are materially overdue. The Company is actively engaging with various counterparties in an effort to reach structured payment arrangements. While management believes there is a reasonable possibility that such arrangements could be reached and that payments could be rescheduled in line with the Company’s cash flow capabilities, no formal agreements have been finalized to date, and there can be no assurance such arrangements will be achieved.
These conditions and events indicate that a material uncertainty exists that may cast significant doubt (or raise substantial doubt as contemplated by PCAOB standards) about the Company’s ability to continue as a going concern.
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.
| 4) | 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, the war in Israel is ongoing and continues to evolve. In June 2025, a new round of direct hostilities broke out between Israel and Iran, during which Israel attacked a range of targets in Iran. During the six months ended June 30, 2025, 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 4, 2025.
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, 2025 (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, 2024, and their accompanying notes, which have been prepared in accordance with IFRS® Accounting Standarts as issued by the International Accounting Standarts Board ("IASB"). The results of operations for the six months ended June 30, 2025, 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, 2024.
The Company's annual financial statements as of December 31, 2024 included information regarding new international financial reporting standards and amendments to existing standards that are not yet mandatory and have not been early adopted by the Company. 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, 2024.
8
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
NOTE 3 - SIGNIFICANT EVENTS DURING THE CURRENT REPORTING PERIOD:
| a. | On February 24, 2025, the Company entered into an exclusive license agreement with Hyloris Pharmaceuticals SA (“Hyloris”) for the development and commercialization of RHB-102 (Bekinda®) in all territories outside the United States, Canada and Mexico. Under the agreement, the Company received a payment of $ |
| b. | Through June 30, 2025, the Company sold |
| c. | On May 14, 2025, the Company and the investors from the April 2024 offering agreed to the exercise of all |
In connection with the agreement, the Company issued to Alumni as a fee, a commitment warrant to purchase up to
The fair value of the warrant was computed using the Black and Scholes option pricing model. The fair value was based on the price of an ADS on June 20, 2025, and based on the following parameters: risk-free interest rates of
In addition, the Company recognized transactions costs of $
9
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
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, 2025 |
| |
| | | |
Increases | | | | | | |
Decreases (utilized) |
| ( | | ( | | ( |
Adjustments | | | | | | |
As of June 30, 2025 |
| |
| | | |
| | Rebates and patient discount programs | | Product returns | | Total |
| | U.S. dollars in thousands | ||||
As of January 1, 2024 |
| |
| | | |
Increases | | | | | | |
Decreases (utilized) |
| ( | | ( | | ( |
Adjustments | | | | | | |
As of June 30, 2024 |
| |
| | | |
NOTE 5 - SHARE-BASED PAYMENTS:
On March 26, 2025, the BoD granted
NOTE 6 - NET REVENUES:
| | Six Months Ended June 30, | | ||
|
| 2025 |
| 2024 | |
| | U.S dollars in thousands | | ||
Licensing revenues (1) | | | | — | |
Sales of products (2) | | | | | |
|
| |
| |
|
10
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
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, 2025, and June 30, 2024: |
| | | Derivative financial instruments | |||
| | | Six Months Ended June 30, | |||
|
|
| 2025 |
| 2024 |
|
| | | 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, 2025, it is based on the ADS price on that date and the following key parameters: risk-free interest rate of
NOTE 8 - SEGMENT INFORMATION:
The Chief Executive Officer is the Company’s Chief Operating Decision Maker (“CODM”). The CODM allocates resources and assesses the Company’s performance based on the following segmentation: Commercial Operations and Research & Development.
Adjusted EBITDA represents net loss before depreciation, amortization, and financial income (expenses), adjusted to exclude share-based compensation and gains from early termination of leases.
The following table presents segment profitability and a reconciliation to the consolidated net loss and comprehensive loss for the periods indicated:
| | Six Months Ended June 30, | |||
| | 2025 | | 2024 | |
|
| U.S. dollars in thousands | |||
Commercial Operations Segment Adjusted EBITDA | | ( | | ( | |
Research And Development Adjusted EBITDA | | ( | | ( | |
Financial income, net | | | | | |
Share-based compensation to employees and service providers | | ( | | ( | |
Depreciation | | ( | | ( | |
Amortization of intangible assets | | ( | | ( | |
Gain from early termination of lease | | — | | | |
Consolidated Comprehensive loss | | ( | | ( | |
Supplementary information on material income or expense items included in the segment results: | | | | | |
Licensing revenues included in the Research And Development Adjusted EBITDA | | | | — | |
11
REDHILL BIOPHARMA LTD.
NOTES TO THE CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(Unaudited)
NOTE 9 - 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. The basic and diluted loss per ordinary share are the same since the effect of all potentially diluted ordinary shares for all reporting periods is anti-dilutive.
NOTE 10 - EVENT SUBSEQUENT TO JUNE 30, 2025:
Until September 4, 2025, the Company made drawings under its Any Market Purchase Agreement with Alumni Capital LP (see Note 3(d) above). During this period, the Company issued
12
Exhibit 99.3
You should read the following discussion of our financial condition and results of operations in conjunction with the financial statements and the notes thereto included elsewhere in the Form 6-K to which this discussion is an exhibit. Unless the context otherwise requires, all references to “RedHill,” “we,” “us,” “our,” the “Company” and similar designations refer to RedHill Biopharma Ltd. and its wholly owned subsidiary, RedHill Biopharma Inc. The term “NIS” refers to New Israeli Shekels, the lawful currency of the State of Israel, the terms “dollar”, “US$”, “$” or “U.S.” refer to U.S. dollars, the lawful currency of the United States of America. Our functional and presentation currency is the U.S. dollar. Unless otherwise indicated, U.S. dollar amounts herein (other than amounts originally receivable or payable in dollars) have been translated for the convenience of the reader from the original NIS amounts at the representative rate of exchange as of June 30, 2025 ($1 = NIS 3.372). The following discussion contains forward-looking statements that reflect our plans, estimates, and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and those discussed in our Annual Report on Form 20-F for the year ended December 31, 2024.
Forward Looking Statements
This exhibit contains statements that constitute forward-looking statements, including statements concerning our industry, our operations, our anticipated financial performance and financial condition, and our business plans and growth strategy and product development efforts. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms, including “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would,” and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified. In addition, this exhibit contains information obtained from independent industry and other sources that we may not have independently validated. You should not put undue reliance on any forward-looking statements. Unless we are required to do so under U.S. federal securities laws or other applicable laws, we do not intend to update or revise any forward-looking statements.
Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to:
| ● | the going concern reference in our financial statements and our ability to obtain additional financing or successfully conclude a strategic business transaction; |
| ● | our ability to regain and maintain compliance with the listing standards of Nasdaq; |
| ● | our ability to close strategic business transactions; |
| ● | estimates of our expenses, future revenues, capital requirements and our needs for additional financing; |
| ● | our ability to obtain additional financing; |
| ● | the commercialization and market acceptance of Talicia® and any future commercial products; |
| ● | our ability to generate sufficient revenues from Talicia® and any future commercial products, including obtaining commercial insurance and government reimbursement; |
| ● | our ability to advance our therapeutic candidates into clinical trials or to successfully complete our preclinical studies or clinical trials, and to complete the development of such therapeutic candidates and obtain approval for marketing by the FDA or other regulatory authorities; |
| ● | our reliance on third parties to satisfactorily conduct key portions of our commercial operations, including manufacturing and other supply chain functions, market analysis services, safety monitoring, regulatory |
| reporting and sales data analysis and the risk that those third parties may not perform such functions satisfactorily; |
| ● | our ability to maintain an appropriate sales and marketing infrastructure; |
| ● | our ability to establish and maintain corporate collaborations; |
| ● | that Talicia® or commercial products that we may commercialize or promote in the future may be withdrawn from the market by regulatory authorities and our need to comply with continuing laws, regulations and guidelines to maintain clearances and approvals for those products; |
| ● | our exposure to significant drug product liability claims; |
| ● | the initiation and completion of any postmarketing studies or trials; |
| ● | our ability to acquire products approved for marketing in the U.S. that achieve commercial success and to maintain our own marketing and commercialization capabilities; |
| ● | our estimates of the markets, their size, characteristics and their potential for Talicia® and any future commercial products and therapeutic candidates and our ability to serve those markets; |
| ● | the successful commercialization of products we in-license or acquire; |
| ● | our inability to enforce claims relating to a breach of a representation and warranty by a counterparty; |
| ● | the hiring and continued employment of executives, sales personnel, and contractors; |
| ● | our receipt and timing of regulatory clarity and approvals for Talicia® and any future commercial products and therapeutic candidates, and the timing of other regulatory filings and approvals; |
| ● | the initiation, timing, progress, and results of our research, development, manufacturing, preclinical studies, clinical trials, and other commercial efforts and therapeutic candidate development, as well as the extent and number of additional studies that we may be required to conduct; |
| ● | our ability to advance our therapeutic candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; |
| ● | our ability to develop or obtain approval for RHB-104/RHB-204 in Crohn’s may be adversely impacted if a validated lab test for MAP will not become available; |
| ● | our reliance on third parties to conduct key portions of our clinical trials, including data management services and the risk that those third parties may not perform such functions satisfactorily; |
| ● | our reliance on third parties to manufacture and supply our therapeutic candidates and their respective active pharmaceutical ingredients with the requisite quality and manufacturing standards in sufficient quantities and within the required timeframes and at an acceptable cost; |
| ● | the research, manufacturing, clinical development, commercialization, and market acceptance of our therapeutic candidates; |
| ● | the interpretation of the properties and characteristics of Talicia® and any future commercial products or therapeutic candidates and of the results obtained in research, preclinical studies or clinical trials; |
| ● | the implementation of our business model, strategic plans for our business, commercial products, and therapeutic candidates; |
| ● | the impact of other companies and technologies that compete with us within our industry; |
| ● | the scope of protection we are able to establish and maintain for intellectual property rights covering Talicia® and any future commercial products and therapeutic candidates, including from existing or future claims of infringement, and our ability to operate our business without infringing or violating the intellectual property rights of others; |
| ● | parties from whom we license or acquire our intellectual property defaulting in their obligations toward us; |
| ● | the failure by a licensor or a partner of ours to meet their respective obligations under our acquisition, in-license or other development or commercialization agreements or renegotiate the obligations under such agreements, or if other events occur that are not within our control, such as bankruptcy of a licensor or a partner; |
| ● | our reliance on the actions of third parties, including sublicensors and their other sublicensees, to maintain our rights under our in-licenses which are sublicenses; |
| ● | the effect of a potential occurrence of patients suffering serious adverse events using investigative drugs under our Expanded Access Program; |
| ● | our ability to implement network systems and controls that are effective at preventing cyber-attacks, malware intrusions, malicious viruses and ransomware threats; |
| ● | the impact on our business of the political and security situation in Israel, the U.S. and other places in which we operate; and |
| ● | other factors discussed in other factors disclosed in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2024. |
Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make. No forward-looking statement is a guarantee of future performance. You should read this exhibit and the Company’s Annual Report on Form 20-F for the year ended December 31, 2024 completely and with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements in this exhibit represent our views as of the date of this exhibit. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this exhibit.
Company Overview
We are a specialty biopharmaceutical company, primarily focused on GI, infectious diseases and oncology. Our primary goal is to become a leading specialty biopharmaceutical company.
We are currently focused primarily on the advancement of our development pipeline of clinical-stage therapeutic candidates. We also commercialize in the U.S. our GI-related product, Talicia® (omeprazole, amoxicillin, and rifabutin), and continue to explore our strategic plans for other potential products and activities.
Among our therapeutic candidates, we are exploring opaganib as a potential treatment for various conditions, including GI-ARS, viral infections such as COVID-19, Ebola virus disease and additional viruses as part of pandemic preparedness, several cancers and diabetes and obesity-related disorders. Furthermore, we are investigating RHB-107 (upamostat) as a potential treatment for COVID-19 and other viruses as part of pandemic preparedness, including the Ebola virus.
Our current pipeline consists of five therapeutic candidates, part of which are in late stage clinical development. We generate our pipeline of therapeutic candidates by identifying, validating and in-licensing or acquiring products that are consistent with our product and corporate strategy and that have the potential to exhibit a favorable probability of
therapeutic and commercial success. We have one product, Talicia®, that we primarily developed internally which has been approved for marketing and, to date, none of our other therapeutic candidates has generated revenues. We have out-licensed our commercial product, Talicia®, for specific territories outside the U.S., and one of our therapeutic candidates, RHB-102, worldwide (except for the U.S., Canada, and Mexico). Furthermore, we plan to commercialize our therapeutic candidates, upon approval, if any, through licensing and other commercialization arrangements with pharmaceutical companies on a global and territorial basis or independently with a dedicated commercial operation or in potential partnership with other commercial-stage companies. We also evaluate, on a case-by-case basis, co-development, co-promotion, licensing, acquisitions and similar arrangements.
Since inception, we have funded our operations primarily through public and private offerings of our equity securities, loans and revenues from our commercial activity. As of June 30, 2025 and December 31, 2024, we had approximately $3 million and $4.8 million, respectively, of cash, cash equivalents, short-term investments and restricted cash.
Sale of Rights in Movantik® and Extinguishment of our Debt Obligations under the Credit Agreement with HCRM
On February 23, 2020, we, through RedHill U.S., entered into a credit agreement (the “Credit Agreement”) with HCRM, and the lenders from time to time party thereto. Pursuant to the terms of the Credit Agreement, RedHill U.S. received a $30 million loan following the signing of the Credit Agreement. An additional $50 million tranche was used to fund the acquisition of rights to Movantik® from AstraZeneca. On February 2, 2023, we sold our rights in Movantik® to an affiliate of HCRM and in connection therewith our debt obligations under the Credit Agreement were extinguished. In connection with this sale, RedHill U.S. retained substantially all pre-closing liabilities relating to Movantik®, and $16 million of our cash was deposited into the escrow account to pay pre-closing liabilities related to Movantik®.
Following the sale of our rights to Movantik®, we lost our primary revenue source, and our ability to operate as a financially viable commercial business became significantly more difficult. We are working to replace Movantik® with another commercial product, either internal or external, but this may not occur, and we may never achieve levels of revenue we have achieved through Movantik®. We also lost economies of scale in our commercial operations that we were able to benefit from by having Movantik® as a core commercial product.
In addition, in connection with the sale of Movantik®, the obligation to pay indemnification obligations and scheduled pre-closing liabilities of Movantik® were secured by a lien on Talicia®- related assets and our former Aemcolo®-related assets.
On July 15, 2024, we signed a Global Termination Agreement with Movantik Acquisition Co., Valinor Pharma, LLC, and HCR Redhill SPV, LLC, affiliates of HCRM. This agreement terminated all remaining obligations under the Credit Agreement, including the lien previously placed on our Talicia®-related assets, and restored our control over the restricted escrow account established to cover Movantik® pre-closing liabilities and settlement of trade balances resulting from the transition services. As part of the agreement, we received approximately $9.9 million in cash and regained access to an additional $0.7 million previously held in escrow. The cash received was in settlement of liabilities related to Movantik® that were allocatable to HCRM and its affiliates under their agreements with us. As the cash received was less than the total net amount of these liabilities (approximately $12.2 million), we recognized a loss of approximately $2.3 million resulting from the termination agreement, presented under “Other expenses” in our consolidated statements of comprehensive income (loss) in our financial statements included elsewhere in the Form 6-K to which the discussion is an exhibit. The agreement also terminated the transition services arrangement previously in place.
Our financial statements include a going concern reference. We will need to raise significant additional capital to finance our losses and negative cash flows from operations, and if we were to fail to raise sufficient capital or on favorable terms and/or divest assets on favorable terms or at all, we may need to cease operations. Management has substantial doubt about our ability to continue as a going concern.
Description of our Products
The following is a description of our current commercial product and five therapeutic candidates, most of which are in late-stage clinical development:
Commercial Product
Talicia® is our proprietary drug approved by the FDA for marketing in the U.S. for the treatment of H. pylori bacterial infection in adults. Talicia® is a combination of three approved drugs, omeprazole, which is a proton pump inhibitor (it prevents the secretion of hydrogen ions increasing the PH of the stomach), amoxicillin and rifabutin, which are antibiotics. Talicia® is administered to patients orally in the form of a fixed-dose, all-in-one capsule. On November 1, 2019, the FDA approved Talicia® for marketing in the U.S. for the treatment of H. pylori infection in adults and we launched Talicia® in the U.S. in March 2020. Talicia® is expected to receive a total of eight years of U.S. market exclusivity. Talicia® is the first therapeutic candidate we developed to be approved by the FDA.
Therapeutic Candidates
RHB-204 is a proprietary, fixed-dose, orally administered, antibiotic combination therapy targeting Crohn’s disease in Mycobacterium avium subspecies paratuberculosis-positive (MAP+) patients, and is expected to advance to a Phase 2 study. It is a next-generation formulation of RHB-104, which demonstrated positive results in a Phase 3 Crohn’s disease study, meeting both primary and secondary endpoints. RHB-204 combines the same antimicrobial agents as RHB-104 with potent intracellular, anti-mycobacterial, and anti-inflammatory properties, but with an optimized dosing profile designed to support enhanced tolerability, safety and adherence. RHB-204 also has potential for the treatment of pulmonary nontuberculous mycobacterial (NTM) disease caused by Mycobacterium avium complex (MAC). A previously ongoing U.S. Phase 3 study evaluating RHB-204 for the treatment of NTM disease caused by MAC was terminated due to a low patient accrual rate.
Opaganib is an investigational new drug that is a proprietary, first-in-class, orally administered, small molecule sphingosine kinase-2 (SPHK2) selective inhibitor, with anticancer, anti-inflammatory and antiviral activity, targeting multiple inflammatory, viral, oncologic and metabolic diseases. On March 30, 2015, we entered into an exclusive worldwide license agreement with Apogee, pursuant to which Apogee granted us the exclusive worldwide development and commercialization rights to ABC294640 (which we then renamed to ABC294640 (Yeliva®)) and as noted above, received an international non-proprietary name, opaganib, in 2018) and additional intellectual property for all indications. Under the terms of the agreement, as amended, we agreed to pay Apogee initial milestone payments of $3 million, of which the total amount has been paid, as well as up to $2 million in potential development milestone payments, and tiered royalties starting in the low double-digits. For more information regarding this agreement. In March 2022, we entered into an exclusive license agreement (the “Exclusive License Agreement”) with Kukbo for opaganib in South Korea. Under the terms of the Exclusive License Agreement, Kukbo was required to pay an upfront payment of $1.5 million, and we are also eligible milestone payments and royalties on net sales of oral opaganib. On September 2, 2022, we filed a lawsuit against Kukbo in the Supreme Court of the State of New York, County of New York, Commercial Division, as a result of Kukbo’s default in delivering to us $5.0 million under a subscription agreement, dated October 25, 2021 (the “Subscription Agreement”), in exchange for the ADSs we were to issue to Kukbo, and in delivering to us the $1.5 million due under the Exclusive License Agreement. Kukbo thereafter filed counterclaims with various allegations such as breach of contract, misrepresentation, and the breach of the duty of good faith and fair dealing. On November 20, 2023, we entered into a Contingency Fee Agreement with our legal firm, Haynes and Boone, LLP (“H&B”), under which certain legal costs related to the Kukbo litigation will be assumed by H&B. On December 2, 2024, we were awarded a judgment of approximately $8 million, including $6.5 million in principal and approximately $1.5 million in accrued interest, plus costs, in a summary judgment by the Supreme Court of the State of New York, New York County in our legal proceedings against Kukbo. The Court dismissed the entirety of Kukbo’s counterclaims in the case. Kukbo filed a notice of appeal and perfected its appeal on June 4, 2025. We filed our response to Kukbo’s appeal on August 6, 2025. On August 11, 2025, the New York Supreme Court awarded RedHill approximately $1.82 million in legal costs and expenses, including approximately $1.7 million in legal costs and expenses and approximately $120,000 in accrued interest, per the original New York Supreme Court summary judgment ruling. Kukbo has a right to seek an appeal of the award of legal costs and expenses. On August 15, 2025, Kukbo filed its reply brief in its appeal of the summary judgment award, completing briefing on the appeal. The appeal is currently tentatively set for hearing in the Supreme Court of the State of New York, Appellate Division, First Judicial Department’s September 2025 term. We intend to vigorously pursue the recovery of attorneys’ fees and the collection of the judgment. Separately, On May 13, 2025, the Company announced that it had won its attachment petition
to the Incheon District Court in South Korea on Kukbo Co. Ltd’s assets An attachment petition in South Korea refers to a court-ordered seizure (attachment) of a debtor’s assets to secure a claim before or during a lawsuit, designed to prevent the debtor from disposing of assets before the creditor can enforce a judgment.
RHB-107 (upamostat; formerly Mesupron) (INN: upamostat) is a proprietary small molecule, first-in-class, potent serine protease inhibitor administered by oral capsule. RHB-107 is being investigated as a potential treatment for COVID-19 outpatients and other viruses as part of pandemic preparedness, including the Ebola virus. Additional indications in the area of inflammatory digestive diseases and inflammatory lung diseases could be targeted. On June 30, 2014, we acquired from Heidelberg the exclusive development and commercialization rights to RHB-107, excluding China, Hong Kong, Taiwan, and Macao, for all indications. We made an upfront payment to Heidelberg of $1.0 million with potential tiered royalties on net revenues, ranging from mid-teens up to 30%. We are responsible for all development, regulatory and commercialization of RHB-107. See “Item 4. Information on the Company – B. Business Overview – Acquisition, Commercialization and License Agreements – License Agreement for RHB-107.”
RHB-102 (Bekinda®) is an investigational, once-daily, bi-modal release, oral formulation of ondansetron, a leading member of the family of 5-HT3 serotonin receptor inhibitors. RHB-102 is under development for the intended use in oncology support (management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, also referred to as CINV and RINV) (24 mg strength) and in multiple dosage strengths for additional indications which are novel and not yet FDA-approved for ondansetron, including acute gastroenteritis and gastritis (24 mg strength) and irritable bowel syndrome with diarrhea (IBS-D) (lower dose strength, at 12 mg for long-term administration). On February 25, 2025, we entered into an exclusive worldwide development and commercialization licensing agreement, excluding North America, with Hyloris Pharmaceuticals for RHB-102 for gastroenteritis and gastritis, IBS-D and oncology support. Under the terms of the Agreement, Hyloris paid us an upfront payment, in addition to up to $60 million in potential milestone payments, contingent upon achieving specified commercial targets, plus up to mid-20s percent royalties on revenues, subject to certain cost recoupments, with minimum annual payments to us, in return for exclusive rights to RHB-102 across all indications and territories outside the United States, Canada and Mexico. We intend to continue development of RHB-102 for FDA approval in the U.S., if granted. Hyloris will be responsible for all development, regulatory and commercialization activities related to RHB-102 in its territories.
Components of Statements of Comprehensive Loss
Revenues
Revenues are with respect to commercialization and licensing of our commercial products.
Cost of Revenues
Direct costs related to the revenues, such as cost of goods sold and royalties to third parties. Additionally, includes intangible assets amortization and impairment.
Research and Development Expenses
Our research and development expenses consist primarily of costs of clinical trials, professional services, share-based payments and payroll, and related expenses. The clinical trial costs are mainly related to payments to third parties to manufacture our therapeutic candidates, to perform clinical trials with our therapeutic candidates and to provide us with regulatory services. We charge all research and development expenses to operations as they are incurred. The research and development of certain of our product candidates, including RHB-107, have been supported by government-funded programs.
General and Administrative Expenses
General and administrative expenses consist primarily of compensation for employees, directors and consultants and professional services. Other significant general and administrative expenses include medical affairs, office-related expenses, travel, conferences, and others.
Selling, Marketing and Business Development Expenses
Selling, Marketing and Business Development expenses consist primarily of compensation for employees and consultants dedicated to marketing activities with the Company’s commercialized and promoted products and professional services. Other significant selling, marketing and business development expenses include market research, market access, advertising, printed and digital media, product samples, car fleet, travel, conferences, office-related expenses, and others.
Financial Income and Expenses
Financial income and expenses consist of non-cash financing expenses in connection with changes in the fair value of derivative financial instruments, interest earned on our cash, cash equivalents, and short-term bank deposits, bank fees, interest, and finance changes for lease liabilities and other transactional costs and expense or income resulting from fluctuations of the U.S. dollar against other currencies, in which a portion of our assets and liabilities are denominated like NIS, for example.
A. Operating Results
History of Losses
Since inception in 2009, we have generated significant losses in connection with the research and development of our therapeutic candidates and from our commercial operations. We may continue to incur additional losses as we continue our commercial activities and expand our research and development activities over time. As a result, we expect to continue incurring operating losses, which may be substantial over the next several years, and we will need to obtain substantial additional funds. As of June 30, 2025 and December 31, 2024, we had an accumulated deficit of approximately $418.1 million and $414.8 million, respectively.
We expect to continue to fund our operations over the next several years through revenues generated from the commercialization of our commercial products, public or private equity offerings, debt financings, non-dilutive financings, including government grants, commercialization of our therapeutic candidates, if approved, or products we may commercialize or promote in the future. Concurrently, we are actively engaged in discussions to explore strategic business transactions, including potential divestment of certain Company assets.
Going Concern
Our consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. During the six months ended June 30, 2025, our net cash used in operating activities was $5 million leaving a cash balance of $3 million. Because we do not have sufficient resources to fund our operations for the next twelve months from the date of this filing, management has substantial doubt of our ability to continue as a going concern. We have determined that the Company’s available cash on June 30, 2025, together with funds received from the Any Market Purchase Agreement subsequent to June 30, 2025, are not sufficient to fund our operations and satisfy our payment obligations for a period exceeding one year from the date of the Form 6-K to which this discussion is an exhibit. Our operational costs include payment of pre-closing liabilities relating to Movantik®, which our subsidiary, RedHill U.S., retained under our agreement with HCRM for the extinguishment of all our debt obligations under the Credit Agreement in exchange for the transfer of our rights in Movantik® to an affiliate of HCRM. As of June 30, 2025, the estimated pre-closing liabilities relating to Movantik® were approximately $2.4 million. In addition, we assumed obligations under the Global Termination Agreement. As of June 30, 2025, the estimated obligations relating to the Global Termination Agreement were $6.7 million. In addition, as of the reporting date, we have a significant amount of obligations related to allowance for deductions from revenues that are past due, including certain obligations that are materially overdue. We are actively engaging with various counterparties in an effort to reach structured payment arrangements. While management believes there is a reasonable possibility that such arrangements could be reached and that payments could be rescheduled in line with our cash flow capabilities, no formal agreements have been finalized to date, and there can be no assurance such arrangements will be achieved. The consolidated financial statements do not include any adjustments relating to the recoverability and classification of asset amounts or the classification of liabilities that might be necessary should we be unable to continue as a going concern.
We will need to raise significant additional capital to finance our losses and negative cash flows from operations. We are also actively pursuing and in discussions with multiple parties regarding strategic business transactions. If we were to fail
to raise sufficient capital on favorable terms or at all, we may need to cease operations. There are no assurances that we will be able to raise significant additional capital on terms favorable to us or at all, particularly given the current difficult conditions in the capital markets and very low market capitalization which makes it more difficult to raise significant amounts of capital. In addition, if we are unable to maintain our listing on Nasdaq, it may may adversely affect our ability to obtain financing on acceptable terms, if at all, due to, among other things, a substantially decrease trading in the ADSs and potential further decline of the market price of the ADSs. Lastly, following the sale of our rights to Movantik® in 2023, we lost our primary revenue source and our ability to operate as a financially viable commercial business has been significantly more difficult. If we are unsuccessful in achieving sufficient commercial sales of our products, or in raising sufficient capital, we will need to reduce activities and curtail or cease operations.
Comparison of the Six Months Ended June 30, 2025, to the Six Months Ended June 30, 2024
Net Revenues
Net Revenues for the first half of 2025 were $4.1 million, compared to $2.6 million for the first half of 2024. Talicia net revenues for the first half of 2025 were $3.8 million, up from $3.5 million in the same period of 2024. This included U.S. net revenues of $3.3 million (compared to $3.0 million in the prior-year period, reflecting an increase in units sold) and $0.5 million from the UAE partnership in product sales, with an additional $0.1 million recognized from royalties, compared to $0.5 million in product sales in the same period of 2024. In addition, $0.3 million was recorded from the Hyloris license for RHB-102 (Bekinda®), reflecting a $0.1 million upfront payment at signing and $0.2 million related to the present value of minimum annual payments due from 2027 through 2035. In the first half of 2024, Movantik® generated negative net revenues of $0.9 million, primarily due to product returns, compared to an immaterial amount of contra-revenues in the first half of 2025.
Cost of Revenues
Cost of Revenues for the first half of 2025, was $1.6 million, compared to $1.4 million for the first half of 2024. The 2024 figure included a reduction from Movantik® contra-revenues, while the 2025 revenue increase was only partly reflected in costs, due to royalty and license revenues with no associated COGS.
Gross Profit
Gross Profit for the first half of 2025 was $2.5 million, compared to $1.2 million for the first half of 2024 driven by higher revenues, cost-free royalty and license contributions, and the absence of Movantik® adjustments.
Research and Development Expenses
Research and Development Expenses for the first half of 2025 were $1 million, as compared to $0.7 million for the first half of 2024. The increase was primarily driven by costs related to various clinical activities as well as regulatory work associated with Talicia.
Selling, Marketing and General and Administrative Expenses
Selling, Marketing, and General and Administrative Expenses for the first half of 2025 were $5.9 million, as compared to $9 million for the first half of 2024. The decrease was mainly due to U.S. workforce downsizing, continued cost-reduction measures, and an overall lower level of commercial and administrative activity.
Operating Loss
Operating Loss for the first half of 2025 was $4.4 million, compared to $8.4 million for the first half of 2024. The decrease is primarily attributable to higher gross profit and reduced operating expenses, as detailed above.
Financial Income, net
Financial Income, net for the first half of 2025 was $0.2 million, compared to Financial Income, net of $5.4 million for the first half of 2024. In both periods, net financial income was primarily attributable to the revaluation of warrants, partially offset by issuance costs in respect of warrants.
Net Loss
Net Loss for the first half of 2025 was $4.1 million, as compared to $3.1 million for the first half of 2024. The increase in net loss was primarily driven by a significant decrease in financial income related to the revaluation of warrants, partially offset by a reduction in operating loss, as detailed above.
Total Assets
Total Assets as of June 30, 2025, were $18.4 million, as compared to $18.0 million as of December 31, 2024, reflecting higher trade receivables partly offset by lower cash, inventory, and restricted cash.
Total Liabilities
Total Liabilities as of June 30, 2025, were $22.8 million, as compared to $22.7 million as of December 31, 2024 driven by higher allowances for deductions from revenues and increased accrued expenses, partly offset by lower derivative liabilities following warrant revaluation.
B. Liquidity and Capital Resources
Liquidity and Capital Resources
Since inception, we have funded our operations primarily through public and private offerings of our equity securities, loans and revenues from our commercial activity. Other potential sources of liquidity in the future may include government grants or subordinated indebtedness, other non-dilutive financings, or divestment of certain Company assets. As of June 30, 2025, we had approximately $3 million of cash, cash equivalents, short-term investments and restricted cash.
Through our U.S. subsidiary, we currently commercialize Talicia®. However, our ability to generate profits from the commercialization of commercial products still remains uncertain. To date, our commercial operations are still generating operational losses. Other than Talicia®, our therapeutic candidates are in research and development stage, and therefore do not yet generate revenues.
Until our sale to HCRM on February 2, 2023, we also commercialized Movantik® (naloxegol), and until October 8, 2024, we also commercialized Aemcolo®. Following the sale of Movantik®, we lost our primary revenue source which will make it more difficult for us to satisfy our payment obligations. See “- Sale of Rights in Movantik® and Extinguishment of our Debt Obligations under the Credit Agreement with HCRM”. On July 9, 2024, we announced the mutual decision with Cosmo to voluntary terminate the Cosmo License Agreement with respect to Aemcolo®, and it was officially terminated on October 8, 2024.
On August 9, 2024, we filed a registration statement on Form F-3 (File No. 333-281417) with the SEC. As of the filing date of the Form 6-K to which this is an exhibit, we are subject to the limitations of General Instruction I.B.5 of Form F-3, which limits the amount of funds we can raise through primary public offerings of securities in any twelve-calendar month period using a registration statement on Form F-3 to one-third of the aggregate market value of our ordinary shares held by non-affiliates. Therefore, we will be limited in the amount of proceeds we are able to raise by selling our securities using Form F-3, until such time as our public float held by non-affiliates exceeds $75.0 million.
Going Concern
Our consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. During the six months ended June 30, 2025, our net cash used in operating activities was $5 million leaving a cash balance of $3 million. Because we do not have sufficient resources to fund our operations for the next twelve months from the date of this filing, management has substantial doubt of our ability to continue as a going concern. See “– Operating Results – Going Concern”.
Cash Flow
Net Cash Used in Operating Activities
Net Cash Used in Operating Activities for the first half of 2025 was $5 million, compared to $6.2 million for the first half of 2024. The decrease was primarily driven by the continued impact of cost-cutting measures.
Net Cash Provided by Financing Activities
Net Cash Provided by Financing Activities for the first half of 2025 was $3.3 million, driven by use of the ATM program, Compared to $7.9 million for the first half of 2024, mainly from equity offerings.
We did not have any material commitments for capital expenditures, including any anticipated material acquisition of plant and equipment or interests in other companies, as of June 30, 2025.