On September 5, 2025 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported its first half of 2025 financial results and operational highlights for the six months ended June 30, 2025 (Press release, RedHill Biopharma, SEP 5, 2025, View Source [SID1234655787]).
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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.
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.
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 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:
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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.
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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.
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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:
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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:
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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:
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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.
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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.
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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
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):
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.