RedHill Biopharma Announces First Half 2024 Business Highlights
Rhea-AI Summary
RedHill Biopharma (Nasdaq: RDHL) reported its first half 2024 financial results and operational highlights. The company has transformed with a strengthened cash balance, streamlined operations, and a focus on U.S. government collaborations for developing its pipeline. Key highlights include:
- Cash balance of $8.2 million as of June 30, 2024
- Net revenues of $2.6 million for H1 2024
- Talicia maintained leadership position as the top prescribed branded H. pylori therapy in the U.S.
- Advancing opaganib and RHB-107 in U.S. government-supported programs for various indications including Ebola, COVID-19, and radiation protection
- Cost reduction measures resulted in improved operating loss and net loss compared to H1 2023
- Post-balance sheet, RedHill signed a Global Termination Agreement, receiving $9.9 million in cash and reducing net liabilities by approximately $2.3 million
Positive
- Strengthened cash balance with $8.2 million as of June 30, 2024, plus $9.9 million received post-balance sheet
- Talicia maintained leadership position as top prescribed branded H. pylori therapy in U.S.
- Advancing opaganib and RHB-107 in U.S. government-supported programs for various indications
- Cost reduction measures improved operating loss by $9.9 million and net loss by $9.5 million compared to H1 2023
- New patents granted for opaganib and Talicia, extending protection for key assets
Negative
- Net revenues decreased to $2.6 million in H1 2024 from $5.4 million in H1 2023
- Talicia prescriptions in U.S. down by approximately 12% compared to H1 2023
- Movantik recorded negative revenues of $0.9 million due to product returns
- Gross profit declined to $1.2 million in H1 2024 from $3 million in H1 2023
News Market Reaction 1 Alert
On the day this news was published, RDHL gained 3.11%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
A transformed
- Numerous potential catalysts
- Strengthened cash balance and control over our destiny following the Termination Agreement with Movantik Acquisition Co. and others: Executing on our plan to ensure a value-driven focus, operational efficiency and financial streamlining with a low cost-base
U.S. government collaborations: Developing a promising, advancing and largely financially de-risked pipeline viaU.S. government and other collaborations- Addressing substantial and underserved indications: In oncology viral pandemic preparedness, nuclear/radioprotection, and obesity/diabetes
- Building value: In the lab and in the clinic through new studies, generating new intellectual property and publications and forging the right partnerships for our assets
- Streamlined U.S. commercial organization: Cost reduction measures resulted in a much smaller, more efficient and cost-effective organization while still maintaining a leadership position with Talicia®
R&D and Commercial Highlights:
- Opaganib:
-U.S. Army program for Ebola (believed to be the first host-directed molecule to show activity in vivo in Ebola virus disease)
- Orphan drug designation granted by FDA for neuroblastoma
- Discussions ongoing for a potential externally-funded, mid-stage clinical study in an additional underserved oncology indication
-U.S. government-funded programs ongoing with the NIH / BARDA-funded nuclear and chemical medical countermeasure programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure
- Positive in vivo study results support potential of opaganib therapy in diabetes / obesity - RHB-107:
- COVID-19: Enrollment ongoing in theU.S Department of Defense-supported 300-patient Phase 2 ACESO PROTECT platform trial for early COVID-19 outpatient treatment; enrollment estimated to be completed in the first half of 2025
-U.S. Army-funded Ebola development program ongoing; RHB-107 also demonstrated robust synergistic effect in vitro when combined with remdesivir - RHB-104: Newly published positive Phase 3 data demonstrated
64% increased efficacy with RHB-104 in Crohn's disease - Talicia: The leading prescribed branded H. pylori therapy in the
U.S. , maintaining leadership position with a streamlined commercial team:
- Expected upcoming new H. pylori treatment guidelines may further enhance positioning and use
- Potential manufacturing developments aiming to open additional new markets underway
- Commercially launched in theUAE , triggeringRedHill's eligibility for potential milestone and royalty payments; Additional ex-US partnerships under discussions
Financial highlights:
- Cash balance of
as of June 30, 2024[1]; Net revenues for the first half of 2024 totaled$8.2 million . Talicia contributed$2.6 million , down from the first half of 2023 due to a$3.5 million 12% reduction inU.S. prescriptions, driven by employee terminations and other cost-cutting measures. Movantik recorded negative revenues of , primarily due to product returns. Excluding one-time items in the first half of 2023 related to the Movantik® divestiture, the operating loss and net loss improved by$0.9 million and$9.9 million , respectively, as these cost-cutting measures significantly reduced overall expenses$9.5 million - Post-balance sheet date, RedHill signed a Global Termination Agreement with Movantik Acquisition Co. and others (the "Agreement"). The Agreement resulted in
RedHill receiving in cash and gaining full control over$9.9 million in a restricted account, while assuming$0.74 million in liabilities, leading to a net balance sheet reduction of approximately$12.2 million . The Agreement ended all existing credit ties and removed the lien against Talicia$2.3 million

"The first six months of this year have realized significant accomplishments, laying the groundwork for numerous potential upcoming catalysts.
Financial results for the six months ended June 30, 2024 (Unaudited)[2]
Net Revenues for the first half of 2024 were
Movantik had negative net revenues of
Gross Profit for the first half of 2024 was
Research and Development Expenses for the first half of 2024 were
Selling, Marketing, and General and Administrative Expenses for the first half of 2024 were
Other Income – There was no other income for the first half of 2024, as compared to
Operating Loss for the first half of 2024 was
Financial Income, net for the first half of 2024 was
Net Loss was
Total Assets as of June 30, 2024 were
Total Liabilities as of June 30, 2024 were
Net Cash Used in Operating Activities for the six months ended June 30, 2024 was
Net Cash Provided by Financing Activities for the six months ended June 30, 2024 was
Cash Balance as of June 30, 2024 was
R&D and Commercial Highlights:
R&D:
Between them, they are in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and radio/chemical protection (Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure).
Being (i) easy to administer and distribute and (ii) viral mutation-resistant, they are ideally suited for stockpiling strategies in the event of nuclear/chemical incidents and viral pandemic scenarios.
Opaganib:
U.S. Army program for Ebola. Opaganib is believed to be the first host-directed molecule to show activity in vivo in Ebola virus disease, 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- Orphan drug designation granted by FDA for neuroblastoma (opaganib has several such designations in multiple indications, with three in oncology)
- Discussions ongoing for a potential externally-funded, late-stage study in an additional underserved oncology indication
- Positive in vivo study results support potential of opaganib therapy in diabetes / obesity-related disorders – a market projected to be worth approximately
within the next decade$100 billion U.S. government-funded programs ongoing with the NIH / BARDA-funded nuclear and chemical medical countermeasure programs for ARS and Sulfur Mustard exposure- Late-stage COVID-19 program continues to address a multi-hundreds of millions of dollars market
- New opaganib publications:
- The Sphingolipid-Modulating Drug Opaganib Protects against Radiation-Induced Lung Inflammation and Fibrosis: Potential Uses as a Medical Countermeasure and in Cancer Radiotherapy. Publication showed that opaganib significantly improved long-term survival in an in vivo model of lung damage following exposure to ionizing radiation[5]
- Effect of Opaganib on Supplemental Oxygen and Mortality in Patients with Severe SARS-CoV-2 Based Upon FiO2 Requirements. Publication showed that oral opaganib reduced mortality by62% and delivered improved time to room air, and faster time to hospital discharge in a large group of 251 hospitalized, moderately severe COVID-19 patients requiring a Fraction of inspired Oxygen up to and including60% (FiO2≤60% ). The paper also indicates that due to the lack of treatment effect in patients requiring FiO2>60% , this may represent a threshold level for disease irreversibility (likely due to more severe COVID-19 lung disease) and be an important patient selection clinical biomarker, a key finding for future therapeutic strategies and studies[6] - New Chinese patents granted for opaganib:
- In combination with immune checkpoint inhibitors (ICIs) as a method of inducing an anti-cancer immune response. Provides protection for opaganib's potential use in combination with a range of approved and in-development ICIs across a growing range of indications through 2040
- As a therapy for inhibition of single-stranded RNA virus replication (notably Ebola Disease Virus); valid through 2035
RHB-107 (upamostat):
- COVID-19: Enrollment ongoing in the
U.S Department of Defense-supported 300-patient Phase 2 ACESO PROTECT platform trial for early COVID-19 outpatient treatment. Enrollment is estimated to be completed in the first half of 2025 U.S. Army-funded Ebola development program ongoing; RHB-107 also 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
RHB-104[7]: Newly published positive Phase 3 data demonstrated
Commercial:
- Talicia: The leading prescribed branded H. pylori therapy in the
U.S. , maintaining leadership position with a streamlined commercial team: - Expected upcoming new H. pylori treatment guidelines may further enhance positioning and use
- Potential manufacturing developments aiming to open additional new markets underway
- Now commercially launched in the UAE, triggering
RedHill's eligibility for potential milestone and royalty payments - Two new U.S. patent grants covering Talicia as:
- A method for eradicating H. pylori regardless of BMI, valid until May 2042
- Use as an all-in-one treatment of H. pylori infection, valid until 2034
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases.
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 and include, among others, statements regarding the progress of the research and development activities for opaganib and RHB-107, including (i) timing of opaganib's development for Acute Radiation Syndrome, (ii) the potential market opportunity for opaganib and RHB-107, (iii) delays in the research and development activities for opaganib or RHB-107, including the ACESO PROTECT platform trial for early COVID-19 outpatient treatment, (iv) the risk that opaganib or RHB-107 are not found to be well-suited to counter nuclear/chemical exposure and viral pandemic scenarios, and (v) non-dilutive development funding from RHB-107 and its inclusion in a key platform study. 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 regain compliance with the Nasdaq Capital Market's minimum bid price requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk that acceptance onto the RNCP Product Development Pipeline 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 opaganib for any indication; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the FDA pre-study requirements will not be met and/or that the Phase 3 study of RHB-107 in COVID-19 outpatients will not be approved to commence or if approved, will not be completed or, should that be the case, that we will not be successful in obtaining alternative non-dilutive development funding for RHB-107; the risk that RHB-107's late-stage development for non-hospitalized COVID-19 will not benefit from the resources redirected from the terminated RHB-204 Phase 3 study, and that the Phase 2/3 COVID-19 study for RHB-107 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 COVID-19 studies for opaganib and RHB-107 are likely to be required; the risk that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (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 and Aemcolo; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the
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. RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution.
5. Maines LW, Keller SN, Smith RA, Green CL, Smith CD. The Sphingolipid-Modulating Drug Opaganib Protects against Radiation-Induced Lung Inflammation and Fibrosis: Potential Uses as a Medical Countermeasure and in Cancer Radiotherapy. International Journal of Molecular Sciences. 2024; 25(4):2322. https://doi.org/10.3390/ijms25042322
6. Neuenschwander FC, Barnett-Griness O, Piconi S, Maor Y, Sprinz E, Assy N, Khmelnitskiy O, Lomakin NV, Goloshchekin BM, Nahorecka E, et al. Effect of Opaganib on Supplemental Oxygen and Mortality in Patients with Severe SARS-CoV-2 Based upon FIO2 Requirements. Microorganisms. 2024; 12(9):1767. https://doi.org/10.3390/microorganisms12091767
7. RHB-104 is an investigational new drug, not available for commercial distribution.
8. Talicia (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: www.Talicia.com.
9. Aemcolo (rifamycin) is indicated for the treatment of travelers' diarrhea caused by noninvasive strains of Escherichia coli in adults. For full prescribing information see: www.Aemcolo.com.
Logo: https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg
Company contact:
Adi Frish
Chief Corporate and Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Category: Financials
REDHILL BIOPHARMA LTD. | ||||||
Six Months Ended | ||||||
June 30, | ||||||
2024 | 2023 | |||||
U.S. dollars in thousands | ||||||
NET REVENUES | 2,572 | 5,395 | ||||
COST OF REVENUES | 1,404 | 2,418 | ||||
GROSS PROFIT | 1,168 | 2,977 | ||||
RESEARCH AND DEVELOPMENT EXPENSES | 659 | 2,331 | ||||
SELLING AND MARKETING EXPENSES | 3,487 | 9,632 | ||||
GENERAL AND ADMINISTRATIVE EXPENSES | 5,470 | 9,335 | ||||
OTHER INCOME | — | 42,993 | ||||
OPERATING INCOME (LOSS) | (8,448) | 24,672 | ||||
FINANCIAL INCOME | 7,157 | 28,677 | ||||
FINANCIAL EXPENSES | 1,797 | 2,347 | ||||
FINANCIAL INCOME, net | 5,360 | 26,330 | ||||
INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) FOR THE PERIOD | (3,088) | 51,002 | ||||
EARNINGS (LOSS) PER ORDINARY SHARE, basic and diluted ( | (0.00) | 0.04 | ||||
WEIGHTED AVERAGE OF ORDINARY SHARE (in thousands) | 11,760,458 | 1,277,931 | ||||
The accompanying notes are an integral part of these condensed consolidated financial statements. | ||||||
REDHILL BIOPHARMA LTD. | ||||
June 30, | December 31, | |||
2024 | 2023 | |||
U.S. dollars in thousands | ||||
CURRENT ASSETS: | ||||
Cash and cash equivalents | 7,277 | 5,569 | ||
Restricted cash | 739 | 790 | ||
Trade receivables | 974 | 2,591 | ||
Prepaid expenses and other receivables | 2,909 | 2,801 | ||
Inventory | 3,804 | 4,389 | ||
15,703 | 16,140 | |||
NON-CURRENT ASSETS: | ||||
Restricted cash | 143 | 147 | ||
Fixed assets | 147 | 193 | ||
Right-of-use assets | 469 | 989 | ||
Intangible assets | 5,562 | 5,578 | ||
6,321 | 6,907 | |||
TOTAL ASSETS | 22,024 | 23,047 | ||
CURRENT LIABILITIES: | ||||
Account payable | 1,912 | 3,278 | ||
Lease liabilities | 368 | 718 | ||
Allowance for deductions from revenue | 12,451 | 10,654 | ||
Derivative financial instruments | 2,541 | *741 | ||
Accrued expenses and other current liabilities | 3,961 | 4,592 | ||
21,233 | 19,983 | |||
NON-CURRENT LIABILITIES: | ||||
Lease liabilities | 190 | 455 | ||
Royalty obligation | 540 | 540 | ||
730 | 995 | |||
TOTAL LIABILITIES | 21,963 | 20,978 | ||
EQUITY: | ||||
Ordinary shares | 34,785 | 21,441 | ||
Additional paid-in capital | 375,333 | 388,363 | ||
Accumulated deficit | (410,057) | (407,735) | ||
TOTAL EQUITY | 61 | 2,069 | ||
TOTAL LIABILITIES AND EQUITY | 22,024 | 23,047 | ||
*See note 2b | ||||
The accompanying notes are an integral part of these condensed consolidated financial statements. | ||||
REDHILL BIOPHARMA LTD. | |||||
Six Months Ended | |||||
June 30, | |||||
2024 | 2023 | ||||
U.S. dollars in thousands | |||||
OPERATING ACTIVITIES: | |||||
Comprehensive income (loss) | (3,088) | 51,002 | |||
Adjustments in respect of income and expenses not involving cash flow: | |||||
Share-based compensation to employees and service providers | 229 | 849 | |||
Depreciation | 402 | 1,055 | |||
Amortization of intangible assets | 16 | 530 | |||
Gains from the transfer of rights in Movantik® and extinguishment of debt obligations, | — | (56,082) | |||
Gains from early termination of leases, net | (23) | (694) | |||
Fair value gains on derivative financial instruments | (7,108) | (8,071) | |||
Loss from modification of warrants terms as part of a new issuance | — | 1,084 | |||
Issuance costs in respect of warrants | 1,497 | 922 | |||
Exchange differences and revaluation of bank deposits | (4) | (13) | |||
(4,991) | (60,420) | ||||
Changes in assets and liability items: | |||||
Decrease in trade receivables | 1,617 | 31,618 | |||
Decrease (increase) in prepaid expenses and other receivables | (108) | 1,337 | |||
Decrease in inventories | 585 | 1,837 | |||
Decrease in accounts payable | (1,366) | (1,118) | |||
Decrease in accrued expenses and other liabilities | (631) | (10,545) | |||
Increase (decrease) in allowance for deductions from revenue | 1,797 | (31,486) | |||
1,894 | (8,357) | ||||
Net cash used in operating activities | (6,185) | (17,775) | |||
INVESTING ACTIVITIES: | |||||
Purchase of fixed assets | (1) | (7) | |||
Net cash used in investing activities | (1) | (7) | |||
FINANCING ACTIVITIES: | |||||
Proceeds from issuance of ordinary shares and warrants, net of issuance costs | 8,263 | 5,097 | |||
Repayment of payable in respect of intangible asset purchase | — | (6,555) | |||
Decrease in restricted cash | 51 | 6,860 | |||
Payment of principal with respect to lease liabilities | (414) | (589) | |||
Net cash provided by financing activities | 7,900 | 4,813 | |||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 1,714 | (12,969) | |||
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | (6) | (3) | |||
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 5,569 | 19,968 | |||
BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF PERIOD | 7,277 | 6,996 | |||
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH | 38 | 123 | |||
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH | 28 | 315 | |||
SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND | |||||
Acquisition of right-of-use assets by means of lease liabilities | 5 | 224 | |||
Decrease in lease liability (with corresponding decrease in right of use asset in | 193 | 4,811 | |||
Transfer of rights in Movantik® and extinguishment of debt obligations: | |||||
Decrease in Intangible asset | (59,503) | ||||
Decrease in Inventories | (4,233) | ||||
Decrease in Payable in respect of Intangible asset | 4,602 | ||||
Decrease in Borrowing | 115,216 | ||||
Gains from the transfer of the rights in Movantik® and extinguishment of | 56,082 | ||||
The accompanying notes are an integral part of these condensed consolidated financial statements. | |||||
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SOURCE RedHill Biopharma Ltd.