RedHill Biopharma Provides H1/23 Financial Results and Operational Highlights
- H1/23 Talicia net revenues of $5.1 million
- Cash balance of $16.3 million as of June 30, 2023
- None.
RHB-107 included in the
Opaganib awarded a further
Following the divestiture of Movantik and the ongoing commercial and financial streamlining, the Company is debt-free, with a significantly reduced cost-base
H1/23 Talicia net revenues of
Dror Ben-Asher, RedHill's Chief Executive Officer, said: "RedHill has delivered significant achievements in the first half of 2023. We are now debt-free with a significantly reduced cost-base. Our two lead R&D candidates, RHB-107 and opaganib, are progressing their development in outpatient COVID-19 and Acute Radiation Syndrome, respectively, both supported extensively by
Financial results for the six months ended June 30, 2023 (Unaudited)2
Net Revenues for the six months ended June 30, 2023, were
Cost of Revenues for the six months ended June 30, 2023, was
Gross Profit for the six months ended June 30, 2023, was
Research and Development Expenses for the six months ended June 30, 2023, were
Selling, Marketing and General and Administrative Expenses for the six months ended June 30, 2023, were
Other Income for the six months ended June 30, 2023, was
Operating Income for the six months ended June 30, 2023, was
Financial Income, net for the six months ended June 30, 2023, was
Net Income for the six months ended June 30, 2023, was
Total Assets as of June 30, 2023, were
Total Liabilities as of June 30, 2023, were
Net Cash Used in Operating Activities for the six months ended June 30, 2023, was
Net Cash Provided by Financing Activities for the six months ended June 30, 2023, was
Cash Balance as of June 30, 2023, was
Business updates
On July 31, 2023, the Company announced that RHB-107 (upamostat)3 had been accepted for inclusion in the 300-patient
On July 21, 2023, the Company announced that opaganib4 had been awarded a further
On July 25, 2023, the Company closed a
On May 9, 2023, the Company received a written notification from the Nasdaq Stock Market LLC ("Nasdaq"), indicating that the Company is not in compliance with the minimum Market Value of Publicly Held Shares ("MVPHS") set forth in the Nasdaq Rules for continued Nasdaq listing. Nasdaq Listing Rule 5450(b)(3)(C) requires companies to maintain a minimum MVPHS of
On April 3, 2023, the Company closed a
As of August 15, 2023, the Company had 5,854,528 ADSs outstanding.
On February 6, 2023, the Company announced the extinguishment of all RedHill's debt obligations (including all principal, interest, revenue interest, prepayment premiums and exit fees) under the Credit Agreement between RedHill's
RedHill continues its litigation against Kukbo Co. Ltd. ("Kukbo") which was filed on September 2022 as a result of Kukbo's default in delivering to RedHill a total of
RedHill is actively pursuing, and in discussions with multiple parties, regarding strategic business development transactions, including potential divestment of certain RedHill assets.
Commercial Highlights
Talicia® (omeprazole magnesium, amoxicillin and rifabutin)5
- H1/23 saw Talicia recording net revenues of
, maintaining its place as the leading prescribed branded H. pylori therapy by$5.1 million U.S. gastroenterologists6. - On August 1, 2023, the Company announced that its partner, Gaelan Medical LLC ("Gaelan Medical"), a wholly owned subsidiary of the Ghassan Aboud Group (GAG), had received marketing approval from the
United Arab Emirates (UAE ) Ministry of Health for Talicia and that Gaelen had placed an initial Talicia order and were commencing commercialization activities. - On May 9, 2023, the Company announced new Talicia PBPK modeling data, published in AP&T Journal7, showing that generically substituted regimens are non-bioequivalent to Talicia. Separately, new Talicia PBPK modeling data, presented at Digestive Diseases Week (DDW) 2023, supports bioequivalence between TID and Q8H dosing regimens for Helicobacter pylori (H. pylori) eradication therapy; TID dosing is thought to promote patient adherence without impacting efficacy.
- Total Talicia coverage stood at more than 202 million American lives as of June 30, 2023, with 7 out of 10 commercial lives covered8.
Movantik® (naloxegol)9
- Following the sale of Movantik to Movantik Acquisition Co., an affiliate of HCR, and to ensure continuous patient care, RedHill continues to and will provide HCR with transition services for up to 12 months, paid for by HCR.
R&D Highlights
Opaganib (ABC294640) – A novel broad-acting, host-directed oral small molecule capsule targeting radioprotection, COVID-19, other viruses as part of a pandemic preparedness approach, inflammatory and oncology indications.
Nuclear Medical Countermeasures (Acute Radiation Syndrome):
- On July 21, 2023, the Company announced that opaganib had been awarded a further
in$1.7 million U.S. government funding, via a SBIR grant to the Company's development partner, Apogee. This SBIR grant will support research to further the development of opaganib as a medical countermeasure (MCM) for gastrointestinal acute radiation syndrome (GI-ARS). This grant is in addition and complementary to the multimillion dollar-valued RNCP product pipeline development contract awarded to opaganib following its selection by the RNCP for ARS development, announced on February 28, 2023. - On February 28, 2023, the Company announced that the RNCP, of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, has selected opaganib for the nuclear medical countermeasures product development pipeline as a potential treatment for Acute Radiation Syndrome (ARS). As part of this collaboration, contractors directed and supported by the RNCP will undertake studies, designed in collaboration with RedHill, to test opaganib in established ARS models. This announcement followed the February 15, 2023, announcement that the FDA provided guidance on the use of the Animal Rule for opaganib's developmental pathway for Acute Radiation Syndrome (ARS), utilizing pivotal animal model efficacy studies instead of human clinical trials. Sponsors of approved medical countermeasures are eligible for a Priority Review Voucher. These announcements followed publication of data from eight
U.S. government-funded in vivo studies, and additional experiments, indicating that opaganib was associated with10:
- Protection of normal tissue, including gastrointestinal, from radiation damage due to ionizing radiation exposure or cancer radiotherapy.
- Improvement of antitumor activity, response to chemoradiation, and enhancement of tolerability and survival. - Additional collaboration discussions with the
U.S. and other governments are ongoing.
Pandemic preparedness and oncology:
- Preclinical development of opaganib, in collaboration with the
U.S. Army and NIAID, for various antiviral indications is ongoing. - On May 1, 2023, the Company announced that the
U.S. Patent and Trademark Office (USPTO) had granted a new patent for opaganib in respect to combination compositions for treatment of cancer, extending protection to October 2036.
RHB-107 (upamostat) – A novel broad-acting, host-directed oral antiviral targeting COVID-19, other viruses as part of a pandemic preparedness approach, inflammatory and oncology indications.
Outpatient treatment of COVID-19:
- On July 31, 2023, the Company announced that RHB-107 (upamostat) had been accepted for inclusion in the
U.S. Department of Defense-supported Austere environments Consortium for Enhanced Sepsis Outcomes' (ACESO) PROTECT multinational platform trial for early COVID-19 outpatient treatment to be conducted in theU.S. ,Thailand ,Ivory Coast andSouth Africa . The 300-patient Phase 2 study has received FDA clearance to start and is estimated to be completed by the end of 2024. - On January 3, 2023, the Company announced publication of positive data from a Phase 2 study of once-daily oral investigational RHB-107 (upamostat) in non-hospitalized symptomatic COVID-19 patients, in the peer-reviewed International Journal of Infectious Diseases11. The study showed that RHB-107 successfully met the primary endpoint of safety and tolerability and delivered promising efficacy results, despite the small number of patients in each treatment group, including faster recovery from severe COVID-19 symptoms and
100% reduction in hospitalization due to COVID-19. - Discussions are ongoing for external non-dilutive funding for additional late-stage COVID-19 clinical development.
Pandemic preparedness / additional viral indications:
- RHB-107 is also the subject of several cooperative research projects with government and non-government bodies, evaluating RHB-107 against multiple viral targets, including influenza and Ebola (amongst others).
RHB-102 (BEKINDA)12 – Oncology Support
- On May 1, 2023, the Company announced that the European Patent Office granted RHB-102 (BEKINDA), a 24-hr bimodal release, once-daily oral tablet formulation of ondansetron, a patent covering antiemetic extended-release solid dosage forms for the prevention of nausea and vomiting (CINV/RINV). The patent provides the potential for
UK and EU protection of RHB-102 to March 2034. - On February 16, 2023, the Company announced that it held a positive pre-Marketing Authorisation Application meeting with the
UK Medicines & Healthcare products Regulatory Agency (MHRA) with regard to seeking marketing approval for RHB-102 (BEKINDA) for oncology support (management of nausea and vomiting induced by cytotoxic chemotherapy and radiotherapy, also referred to as CINV and RINV).
RHB-20413 - Pulmonary Nontuberculous Mycobacteria (NTM) Disease
- On May 22, 2023, the Company announced the termination of RHB-204's
U.S. Phase 3 study for non-tuberculosis mycobacteria (NTM) disease due to a very low accrual rate.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults, and Aemcolo®, for the treatment of travelers' diarrhea in adults14. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class oral broad-acting, host-directed SPHK2 selective inhibitor with potential for pandemic preparedness, targeting multiple indications with a
More information about the Company is available at: www.redhillbio.com / twitter.com/RedHillBio.
Forward Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements, including, but not limited to, statements regarding the intended use of net proceeds therefrom, may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include statements regarding anticipated the addition of new revenue generating products, out-licensing of the Company's development pipeline assets, timing of opaganib's development for Acute Radiation Syndrome, 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 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 HB-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, 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, as well as risks and uncertainties associated with 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
Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Category: Financials
REDHILL BIOPHARMA LTD. | ||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS) | ||
(Unaudited) | ||
Six Months Ended | ||
June 30, | ||
2023 | 2022 | |
U.S. dollars in thousands | ||
NET REVENUES | 5,395 | 31,450 |
COST OF REVENUES | 2,418 | 15,288 |
GROSS PROFIT | 2,977 | 16,162 |
RESEARCH AND DEVELOPMENT EXPENSES | 2,331 | 4,534 |
SELLING AND MARKETING EXPENSES | 9,632 | 21,833 |
GENERAL AND ADMINISTRATIVE EXPENSES | 9,335 | 15,583 |
OTHER INCOME | (42,993) | — |
OPERATING INCOME (LOSS) | 24,672 | (25,788) |
FINANCIAL INCOME | 28,677 | 1,672 |
FINANCIAL EXPENSES | 2,347 | 8,123 |
FINANCIAL INCOME (EXPENSES), net | 26,330 | (6,451) |
INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) FOR THE PERIOD | 51,002 | (32,239) |
EARNINGS (LOSS) PER ORDINARY SHARE, basic and diluted ( | 0.04 | (0.06) |
WEIGHTED AVERAGE OF ORDINARY SHARE (in thousands) | 1,277,931 | 546,616 |
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, | |
2023 | 2022 | |
U.S. dollars in thousands | ||
CURRENT ASSETS: | ||
Cash and cash equivalents | 6,996 | 19,968 |
Bank deposits | 18 | 15 |
Restricted cash | 9,140 | 16,000 |
Trade receivables | 2,903 | 34,521 |
Prepaid expenses and other receivables | 3,050 | 4,387 |
Inventory | 4,939 | 11,009 |
27,046 | 85,900 | |
NON-CURRENT ASSETS: | ||
Restricted cash | 144 | 150 |
Fixed assets | 244 | 502 |
Right-of-use assets | 2,010 | 6,692 |
Intangible assets | 5,593 | 65,626 |
7,991 | 72,970 | |
TOTAL ASSETS | 35,037 | 158,870 |
CURRENT LIABILITIES: | ||
Account payable | 3,112 | 4,230 |
Lease liabilities | 1,290 | 1,032 |
Allowance for deductions from revenue | 16,384 | 47,870 |
Accrued expenses and other current liabilities | 7,401 | 17,949 |
Borrowing | — | 115,216 |
Payable in respect of intangible assets purchase | — | 11,157 |
28,187 | 197,454 | |
NON-CURRENT LIABILITIES: | ||
Lease liabilities | 994 | 6,443 |
Derivative financial instruments | 1,635 | 2,623 |
Royalty obligation | 750 | 750 |
3,379 | 9,816 | |
TOTAL LIABILITIES | 31,566 | 207,270 |
EQUITY (Capital Deficiency): | ||
Ordinary shares | 4,620 | 2,835 |
Additional paid-in capital | 380,860 | 382,625 |
Accumulated deficit | (382,009) | (433,860) |
TOTAL EQUITY (Capital Deficiency) | 3,471 | (48,400) |
TOTAL LIABILITIES AND EQUITY (Capital Deficiency) | 35,037 | 158,870 |
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, | ||
2023 | 2022 | |
U.S. dollars in thousands | ||
OPERATING ACTIVITIES: | ||
Comprehensive income (loss) | 51,002 | (32,239) |
Adjustments in respect of income and expenses not involving cash flow: | ||
Share-based compensation to employees and service providers | 849 | 2,924 |
Depreciation | 1,055 | 1,154 |
Amortization of intangible assets | 530 | 2,900 |
Gains from the transfer of rights in Movantik® and extinguishment of debt obligations, (see below) | (56,082) | — |
Gains from early termination of leases | (694) | — |
Non-cash expenses related to borrowing and payable in respect of intangible assets purchase | — | 2,813 |
Fair value gains on derivative financial instruments | (8,071) | (1,981) |
Loss from modification of warrants terms as part of a new issuance, see note 3b | 1,084 | — |
Issuance costs in respect of warrants | 922 | 334 |
Exchange differences and revaluation of bank deposits | (13) | (63) |
(60,420) | 8,081 | |
Changes in assets and liability items: | ||
Decrease (increase) in trade receivables | 31,618 | (2,078) |
Decrease in prepaid expenses and other receivable | 1,337 | 1,872 |
Decrease in inventories | 1,837 | 3,091 |
Decrease in accounts payable | (1,118) | (7,291) |
Decrease in accrued expenses and other liabilities | (10,545) | (684) |
Increase (decrease) in allowance for deductions from revenue | (31,486) | 8,512 |
(8,357) | 3,422 | |
Net cash used in operating activities | (17,775) | (20,736) |
INVESTING ACTIVITIES: | ||
Purchase of fixed assets | (7) | (176) |
Change in investment in current bank deposits | — | 8,500 |
Net cash provided (used in) by investing activities | (7) | 8,324 |
FINANCING ACTIVITIES: | ||
Proceeds from issuance of ordinary shares and warrants, net of issuance costs | 5,097 | 16,221 |
Repayment of payable in respect of intangible asset purchase | (6,555) | (5,778) |
Decrease in restricted cash | 6,860 | — |
Payment of principal with respect to lease liabilities | (589) | (470) |
Net cash provided by financing activities | 4,813 | 9,973 |
DECREASE IN CASH AND CASH EQUIVALENTS | (12,969) | (2,439) |
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | (3) | (47) |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 19,968 | 29,474 |
BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF PERIOD | 6,996 | 26,988 |
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH | 123 | 11 |
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH | 315 | 5,283 |
SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Acquisition of right-of-use assets by means of lease liabilities | 224 | 4,767 |
Decrease in lease liability (with corresponding decrease in right of use asset in amount of | 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 debt obligations | 56,082 | |
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 RHB-107 is an investigational new drug, not available for commercial distribution.
4 Opaganib is an investigational new drug, not available for commercial distribution.
5 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.
6 IQVIA XPO Data on file
7 Howden et al. Physiologically based pharmacokinetic modelling to predict intragastric rifabutin concentrations in the treatment of Helicobacter pylori infection. Alimentary Pharmacology and Therapeutics, April 2023. https://doi.org/10.1111/apt.17526
8 Managed Markets Insight & Technology, LLC
9 Movantik® (naloxegol) is indicated for opioid-induced constipation (OIC). Full prescribing information see: www.movantik.com.
10 Maines LW, Schrecengost RS, Zhuang Y, Keller SN, Smith RA, Green CL, Smith CD. Opaganib Protects against Radiation Toxicity: Implications for Homeland Security and Antitumor Radiotherapy. International Journal of Molecular Sciences. 2022; 23(21):13191. https://doi.org/10.3390/ijms232113191
11 Plasse et al. A randomized, placebo-controlled pilot study of upamostat, a host-directed serine protease inhibitor, for outpatient treatment of COVID-19. International Journal of Infectious Diseases, Vol 128, P148-156, March 2023. https://doi.org/10.1016/j.ijid.2022.12.003
12 RHB-102 is an investigational new drug, not available for commercial distribution.
13 RHB-204 is an investigational new drug, not available for commercial distribution.
14 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.
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