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REDHILL BIOPHARMA LTD.
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(the "Registrant")
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Date: April 8, 2024
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By:
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/s/ Dror Ben-Asher
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Name:
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Dror Ben-Asher
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Title:
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Chief Executive Officer
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In November 2022, the Company announced acceleration of opaganib’s nuclear radiation protection development program, with newly published data from eight U.S. government-funded in vivo studies, and additional experiments, indicating that opaganib was associated with:
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Protection of normal tissue, including gastrointestinal, from radiation damage due to ionizing radiation exposure or cancer radiotherapy.
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Improvement of antitumor activity, response to chemoradiation, and enhancement of tolerability and survival.
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Radioprotective capacity in bone marrow, with opaganib showing enhanced survival in mice irradiated with both lethal and half-lethal whole-body radiation.
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Protection of normal tissue, including gastrointestinal, from radiation damage due to ionizing radiation exposure or cancer radiotherapy.
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Improvement of antitumor activity, response to chemoradiation, and enhancement of tolerability and survival.
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Radioprotective capacity in bone marrow, with opaganib showing enhanced survival in mice irradiated with both lethal and half-lethal whole-body radiation.
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In addition, in November 2022, the Company announced additional positive in vivo results from a new pre-clinical study evaluating the effects of opaganib on
radiation-induced hematologic and renal toxicity, which suggests that opaganib exerts a protective impact on key hematological and kidney function parameters following total body irradiation (TBI). Development of opaganib as a homeland
security nuclear medical countermeasure is currently expected to follow the Animal Rule under which human efficacy studies may not be required, and if approved, may be eligible for a Medical Countermeasure Priority Review Voucher.
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In February 2023, the Company announced that the Radiation and Nuclear Countermeasures Program (RNCP), of the National Institute of Allergy and Infectious Diseases,
part of the National Institutes of Health, had selected opaganib for the nuclear medical countermeasures product development pipeline as a potential treatment for ARS. As part of this collaboration, contractors directed and supported by
the RNCP will undertake studies, designed in collaboration with us, to test opaganib in established ARS models.
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In July 2023, the Company announced that Apogee had been awarded a further $1.7 million in U.S. government funding, via a Small Business Innovation Research (SBIR)
grant, which will support research to further the development of opaganib as an MCM for GI-ARS. This grant is in addition and complementary to the multimillion dollar-valued U.S. government RNCP product pipeline development contract
awarded to opaganib following its selection by the RNCP for ARS development.
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In February 2024, the Company announced that the International Journal of Molecular Sciences published data showing that opaganib protects against radiation-induced
lung inflammation and fibrosis in an in vivo mouse model of lung damage following exposure to ionizing radiation.
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In March 2024, the Company announced that opaganib had been selected by the U.S. government’s Chemical Medical Countermeasure Program and chemical countermeasures
research program for evaluation as a potential MCM against inhalation Sulfur Mustard exposure. This selection follows opaganib’s previous acceptance into the RNCP for ARS development, providing the potential to see broad activity across
both radiation and Sulfur Mustard injuries.
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In October 2023, the Company announced that opaganib delivered a statistically significant increase in survival time when given at 150 mg/kg twice a day (BID) with a
30% mice survival benefit compared to control in a United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in vivo
Ebola virus study, making it the first host-directed molecule to show activity in Ebola virus disease.
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In December 2023, the Company announced that opaganib demonstrated a robust synergistic effect when combined with remdesivir (Veklury® by Gilead Sciences, Inc.),
significantly improving viral inhibition while maintaining cell viability, in a new U.S. Army-funded and conducted Ebola virus in vitro
study.
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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 Diseases. 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.
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In July 2023, the Company announced that RHB-107 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. The 300-patient Phase 2 study has received FDA clearance. The study is being conducted in the U.S., Thailand, Ivory Coast,
South Africa and Uganda, and is estimated to be completed by end of 2024. The ACESO PROTECT study is an adaptive, randomized, double blind, multi-site Phase 2 platform trial, being conducted by researchers from ACESO and partner
organizations, and administered by the Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF).
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In December 2023, the Company announced the receipt of non-dilutive external funding, additional to the previously announced U.S. Government funding, which now
covers the entirety of the RHB-107 (upamostat) arm of the ACESO PROTECT adaptive platform trial for early COVID-19 outpatient treatment.
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As part of a collaboration with the Therapeutic Discovery Branch of the USAMRIID (US Army Medical Research Institute of Infectious Diseases) in-vitro studies against different strains of Ebola virus and additional viral infectious diseases were undertaken. Initial data from
high-content imaging assays provided further support for activities of RedHill candidates against these viral diseases.
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In December 2023, the Company announced results from a U.S. Army-funded and conducted Ebola virus in vitro study. RHB-107 demonstrated robust synergistic effect
when combined with remdesivir (Veklury® by Gilead Sciences, Inc.), significantly improving viral inhibition while maintaining cell viability.
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RHB-204: On January 26, 2023, the Company announced that the
U.S. Patent and Trademark Office (USPTO) issued a Notice of Allowance for the granting of a patent covering orphan drug designated RHB-204's oral fixed-dose combination, methods for treating pulmonary Mycobacterium avium Complex (MAC)
disease, and kits comprising a supply of fixed-dose combination products for treating pulmonary MAC disease, expected to protect RHB-2047 through 2041.
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RHB-102: On February 16, 2023, the Company announced that
following a positive pre-MAA meeting it plans to submit a Marketing Authorisation Application (MAA) to the UK Medicines & Healthcare products Regulatory Agency (MHRA) seeking 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) in adults and children over the age of 12.
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RHB-204 and RHB-102 are subject to ongoing commercialization / out-licensing / divestment discussions.
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Talicia continues to be the most prescribed branded agent for H.
pylori eradication by U.S. gastroenterologists9.
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Total Talicia coverage stood at nearly 200 million American lives as of December 31, 202310.
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On August 1, 2023, the Company announced that Gaelan Medical had received marketing approval for Talicia in the UAE and that Gaelan Medical has subsequently placed
the first commercial order for Talicia, which was dispatched from the CMO in December 2023.
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In September 2023, the Company announced that the FDA approved our Supplemental new drug application (sNDA) for Talicia®, allowing a change to a more flexible three
times daily, taken at least 4 hours apart with food, enabling patients to follow a convenient “breakfast, lunch and dinner” dosing routine, which may support increased patient adherence and optimize he potential for successful H. pylori eradication.
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In November 2023, Talicia® was granted another five years’ market exclusivity under the QIDP designation by the FDA under the GAIN Act. This grant is on top of the
three years’ exclusivity granted for the approval of Talicia® under section 505(b)(2). Talicia® is protected by its broad intellectual property suite to 2034.
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In January 2024, the Company announced that the USPTO issued a new patent covering Talicia® as a method for eradicating H. pylori regardless of BMI. The new patent is expected to provide protection for Talicia® until May 2042.
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In March 2024, the Company announced that Talicia had received a new U.S. patent covering its use as an all-in-one treatment of H. pylori infection, providing protection until 2034.
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Year Ended December 31,
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2023
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2022
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2021
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U.S. dollars in thousands
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NET REVENUES
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6,530
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61,800
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85,757
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COST OF REVENUES
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3,459
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33,337
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49,406
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GROSS PROFIT
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3,071
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28,463
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36,351
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RESEARCH AND DEVELOPMENT EXPENSES
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3,528
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7,279
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29,498
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SELLING AND MARKETING EXPENSES
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14,756
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35,442
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55,623
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GENERAL AND ADMINISTRATIVE EXPENSES
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16,219
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28,586
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32,365
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OTHER INCOME
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44,064
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—
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—
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OPERATING INCOME (LOSS)
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12,632
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(42,844
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)
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(81,135
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)
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FINANCIAL INCOME
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20,889
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13,562
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51
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FINANCIAL EXPENSES
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9,605
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42,387
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16,660
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FINANCIAL INCOME (EXPENSES), net
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11,284
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(28,825
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)
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(16,609
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)
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INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) FOR THE PERIOD
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23,916
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(71,669
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(97,744
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)
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EARNINGS (LOSS) PER ORDINARY SHARE, basic and diluted (U.S. dollars)
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0.01
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(0.12
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(0.21
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December 31,
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December 31,
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2023
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2022
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U.S. dollars in thousands
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CURRENT ASSETS:
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Cash and cash equivalents
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5,569
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19,968
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Bank deposits
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—
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15
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Restricted cash
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790
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16,000
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Trade receivables
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2,591
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34,521
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Prepaid expenses and other receivables
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2,801
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4,387
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Inventory
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4,389
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11,009
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16,140
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85,900
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NON-CURRENT ASSETS:
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Restricted cash
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147
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150
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Fixed assets
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193
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502
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Right-of-use assets
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989
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6,692
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Intangible assets
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5,578
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65,626
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6,907
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72,970
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TOTAL ASSETS
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23,047
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158,870
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CURRENT LIABILITIES:
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Account payable
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3,278
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4,230
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Lease liabilities
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718
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1,032
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Allowance for deductions from revenue
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10,654
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47,870
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Accrued expenses and other current liabilities
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4,592
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17,949
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Borrowing
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—
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115,216
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Payable in respect of intangible assets purchase
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—
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11,157
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19,242
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197,454
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NON-CURRENT LIABILITIES:
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Lease liabilities
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455
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6,443
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Derivative financial instruments
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741
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2,623
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Royalty obligation
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540
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750
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1,736
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9,816
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TOTAL LIABILITIES
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20,978
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207,270
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EQUITY (CAPITAL DEFICIENCY):
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Ordinary shares
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21,441
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2,835
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Additional paid-in capital
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388,363
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382,625
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Accumulated deficit
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(407,735
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(433,860
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)
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TOTAL EQUITY (CAPITAL DEFICIENCY)
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2,069
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(48,400
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)
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TOTAL LIABILITIES AND EQUITY (CAPITAL DEFICIENCY)
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23,047
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158,870
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Year Ended December 31,
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2023
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2022
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2021
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U.S. dollars in thousands
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OPERATING ACTIVITIES:
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Comprehensive income (loss)
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23,916
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(71,669
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(97,744
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)
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Adjustments in respect of income and expenses not involving cash flow:
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Share-based compensation to employees and service providers
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1,647
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5,675
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10,212
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Depreciation
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1,445
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2,136
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1,914
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Amortization of intangible assets
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545
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6,018
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16,235
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Gains from the transfer of rights in Movantik® and extinguishment of debt obligations, (see below)
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(56,082
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)
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—
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—
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Gains from early termination of leases and impairment of fixed assets, net
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(543
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)
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—
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—
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Non-cash expenses related to borrowing and payable in respect of intangible assets purchase
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—
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33,151
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5,366
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Fair value (gains) losses on derivative financial instruments and changes in royalty obligation
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5,359
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(13,422
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)
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5
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Loss from modification of warrants terms as part of a new issuance
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1,459
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—
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—
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Issuance costs in respect of warrants
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2,034
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958
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—
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Exchange differences and revaluation of bank deposits
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19
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(40
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)
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118
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(44,117
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)
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34,476
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33,850
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Changes in assets and liability items:
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Decrease (increase) in trade receivables
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31,930
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(2,845
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)
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(3,021
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)
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Decrease in prepaid expenses and other receivables
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1,586
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274
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860
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|||||||||
Decrease (increase) in inventories
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2,387
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3,801
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(8,285
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)
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Increase (decrease) in accounts payable
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(952
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)
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(7,434
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)
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111
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(Decrease) in accrued expenses and other liabilities
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(13,354
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)
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(2,947
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)
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(3,186
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)
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Increase (decrease) in allowance for deductions from revenue
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(37,216
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)
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17,159
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12,368
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(15,619
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)
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8,008
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(1,153
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)
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Net cash used in operating activities
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(35,820
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)
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(29,185
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)
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(65,047
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)
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INVESTING ACTIVITIES:
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Purchase of fixed assets
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(11
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)
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(198
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)
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(115
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)
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Change in investment in current bank deposits
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15
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8,500
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(8,500
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)
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Proceeds from sale of financial assets at fair value through profit or loss
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—
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—
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475
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Net cash provided by (used in) investing activities
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4
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8,302
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(8,140
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)
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FINANCING ACTIVITIES:
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Proceeds from issuance of ordinary shares and warrants, net of issuance costs
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13,959
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23,806
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78,536
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Exercise of options into ordinary shares
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—
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—
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4,006
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|||||||||
Repayment of payable in respect of intangible asset purchase
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(6,555
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)
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(10,878
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)
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(7,397
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)
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Decrease in restricted cash
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15,210
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—
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—
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|||||||||
Payment of principal with respect to lease liabilities
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(1,175
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)
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(1,475
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)
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(1,683
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)
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Net cash provided by financing activities
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21,439
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11,453
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73,462
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INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
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(14,377
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)
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(9,430
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)
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275
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|||||||
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
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(22
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)
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(76
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)
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(96
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)
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BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
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19,968
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29,474
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29,295
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|||||||||
BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF PERIOD
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5,569
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19,968
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29,474
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|||||||||
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH
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138
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84
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47
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|||||||||
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH
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367
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8,182
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11,280
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|||||||||
SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING ACTIVITIES:
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Acquisition of right-of-use assets by means of lease liabilities
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270
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5,590
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303
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Decrease in lease liability (with corresponding decrease in right of use asset in amount of $4,697 in 2023 and $534 in 2022)
resulting from early termination of lease.
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5,413
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587
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—
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Transfer of rights in Movantik® and extinguishment of debt obligations:
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Decrease in Intangible asset
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(59,503
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)
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||||||||||
Decrease in Inventories
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(4,233
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)
|
||||||||||
Decrease in Payable in respect of Intangible asset
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4,602
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|||||||||||
Decrease in Borrowing
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115,216
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|||||||||||
Gains from the transfer of the rights in Movantik® and extinguishment of debt obligations
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56,082
|