RedHill Biopharma Announces First Half 2025 Financial Results and Operational Highlights
Rhea-AI Summary
RedHill Biopharma (NASDAQ:RDHL) reported its H1 2025 financial results, showing significant operational improvements. Net revenues increased 59% to $4.1 million compared to H1 2024, with Talicia net revenues reaching $3.8 million. The company achieved a doubled gross profit and reduced operating loss to $4.4 million from $8.4 million year-over-year.
Key developments include the initiation of a Bayer-supported Phase 2 study for opaganib in prostate cancer, positive FDA feedback for RHB-204 in Crohn's disease, and an up to $60 million global licensing deal with Hyloris Pharmaceuticals for RHB-102. The company secured additional Talicia formulary coverage for 8 million more lives, reaching over 204 million covered lives total.
Financial stability was enhanced with $13.5 million available through ATM and Market Purchase agreements, while maintaining a cash balance of $3 million as of June 30, 2025.
Positive
- 59% increase in net revenues to $4.1 million in H1 2025
- Gross profit doubled compared to H1 2024
- Operating loss reduced to $4.4M from $8.4M year-over-year
- Up to $60M global licensing deal secured with Hyloris Pharmaceuticals
- 19% reduction in cash burn following previous year's 74% reduction
- Talicia formulary coverage expanded to over 204 million lives
- Positive FDA feedback received for RHB-204 Crohn's disease program
Negative
- Net loss increased to $4.1M from $3.1M year-over-year
- Low cash balance of $3M as of June 30, 2025
- Nasdaq listing compliance issues requiring extension until October 13, 2025
- Total liabilities of $22.8M exceed total assets of $18.4M
News Market Reaction
On the day this news was published, RDHL gained 16.54%, reflecting a significant positive market reaction. Argus tracked a peak move of +15.5% during that session. Our momentum scanner triggered 20 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $485K to the company's valuation, bringing the market cap to $3M at that time.
Data tracked by StockTitan Argus on the day of publication.
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
global (ex-$60 million 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 in first half of 2024$2.6 million - Enhanced financial stability with up to approximately
available to the Company through At-the-Market ("ATM") and Any Market Purchase agreements$13.5 million - Cash balance of
as of June 30, 20251$3 million - Further
19% reduction in cash burn following the previous year's74% reduction - Net cash used in operations in first half of 2025 dropped to
from$5 million in first half of 2024$6.2 million - Following RedHill's approximately
including interest New York Supreme Court summary judgment win against Kukbo (appeal to be heard this month), the Court also awarded$8.25 million RedHill approximately including interest in legal costs and expenses.$1.82 million RedHill also won an attachment grant in the Korean courts, preventing Kukbo asset disposal prior to enforcement

Dror Ben-Asher,
Financial results for the six months ended June 30, 2025 (Unaudited)2
Net Revenues for the first half of 2025 were
Cost of Revenues for the first half of 2025 was
Gross Profit for the first half of 2025 was
Research and Development Expenses for the first half of 2025 were
Selling, Marketing, and General and Administrative Expenses for the first half of 2025 were
Operating Loss for the first half of 2025 was
Financial Income, net for the first half of 2025 was
Net Loss for the first half of 2025 was
Total Assets as of June 30, 2025, were
Total Liabilities as of June 30, 2025, were
Net Cash Used in Operating Activities for the first half of 2025 was
Net Cash Provided by Financing Activities for the first half of 2025 was
Cash Balance as of June 30, 2025, was
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
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
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
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
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
In the first half of 2025, Talicia generated net revenues of
Following the successful launch of Talicia in the
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:
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
- 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):
- 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 theU.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
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.$100 billion
RHB-2046:
RHB-204, an orally-administered, next-generation optimized formulation of
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 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
The
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
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
Company contact:
Adi Frish
Chief Corporate and Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Category: Financials
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 ( | 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. | ||||
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. | ||||
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 | |||
INCREASE (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 | — | 193 | |||
The accompanying notes are an integral part of these condensed consolidated financial statements. | |||||
[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]
[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
[8] Graham DY, et al. Randomized, Double-Blind, Placebo-Controlled Study of Anti-Mycobacterial Therapy (RHB-104) in Active Crohn's Disease. Antibiotics (
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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SOURCE RedHill Biopharma Ltd.