RedHill Biopharma Announces Full-Year 2023 Results and Operational Highlights
RedHill continues corporate transformation to focus on U.S. government-funded pipeline development in underserved, sizeable therapeutic areas with a disciplined cost-base
Focused externally funded R&D:
Opaganib for nuclear and chemical medical countermeasure (NIH funding): Selected for evaluation by two U.S. government countermeasures programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure. Nuclear and chemical incident response strategies are characterized by significant government stockpiling of approved agents
Opaganib for Ebola (U.S. Army funding): U.S. Army studies suggest opaganib is the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival; separately, opaganib demonstrated robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability
RHB-107 for COVID-19 (U.S. DoD funding): Selected for inclusion in the 300-patient ACESO PROTECT platform trial for early COVID-19 outpatient treatment; COVID-19 treatment continues to be a multi-hundreds of million-dollar market
RHB-107 for Ebola (U.S. Army funding): RHB-107 also demonstrated 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
With multiple target indications, opaganib and RHB-107 are novel, oral, host-directed small molecule drugs in advanced clinical development, with demonstrated safety & efficacy profiles, well suited to counter nuclear / chemical exposure and viral pandemic scenarios, being viral mutation-resistant and easy to administer and distribute
Discussions ongoing with multiple parties regarding strategic business transactions, including potential divestment of certain of our assets and/or commercial operations
Cash balance of $6.5 million as of December 31, 2023(1); Gross profit of $3.1 million on revenues of $6.5 million and an operating income of $12.6 million during the year ended December 31, 2023, versus operating loss of $42.8 million during the year ended December 31, 2022
TEL AVIV, Israel and RALEIGH, N.C., April 8, 2024 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its full year 2023 financial results and operational highlights and associated filing of its annual report on Form 20-F for the year ended December 31, 2023.
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Dror Ben-Asher, RedHill's Chief Executive Officer, said: "The RedHill of today is transformed - focused on predominantly U.S. government-funded pipeline development in underserved, sizeable therapeutic areas with a disciplined cost-base and unburdened by debt - we have a very clear direction and value proposition. We are actively pursuing and in discussions with multiple parties regarding strategic business transactions, including potential divestment of certain of our assets and/or our commercial operations, while we focus on the progression of our two lead R&D candidates, opaganib and RHB-107. Both are advancing in programs that are externally funded, predominantly through U.S. government support, and directed at multiple underserved indications that provide both an aggregated multi-billion global market opportunities and potentially advantageous pathways to approval under the FDA Animal Rule(2) for certain indications."
Mr. Ben-Asher continued: "We believe that growing geo-political instability and current regional conflicts are causes for concern regarding increased potential for both nuclear and chemical threats. Governments across the world and global health organizations have been stepping up their efforts to find new options in the face of these devastating possibilities - especially those that can be delivered in challenging circumstances. Opaganib has now been selected by separate U.S. government-funded programs for evaluation as a nuclear and chemical medical countermeasure for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure. RHB-107 has been selected for inclusion in the predominantly U.S. Department of Defense (DoD)-funded 300-patient ACESO PROTECT platform trial for early COVID-19 outpatient treatment, for which screening has commenced and first patients are expected to be enrolled imminently. In addition, in U.S. Army studies, both opaganib and RHB-107 have delivered positive results in pre-clinical testing against Ebola - a disease with a more than 50% mortality rate for which innovation in therapy is desperately needed. Opaganib, we believe, became the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival, while both opaganib and RHB-107 showed an in vitro synergistic effect with remdesivir in viral inhibition. Both opaganib and RHB-107 are novel, oral, host-directed small molecule drugs, with demonstrated safety and efficacy profiles, that are well-suited to counter nuclear/chemical exposure and viral pandemic scenarios, being mutation-resistant and easy to administer and distribute."
Financial results for the 12 months ended December 31, 2023(3)
Net Revenues for the year ended December 31, 2023, were $6.5 million, compared to $61.8 million for the year ended December 31, 2022. The decrease was primarily attributable to the divestiture of Movantik. Talicia net revenues for the year ended December 31, 2023, increased to $8.8 million from $7.7 million for the year ended December 31, 2022, driven mainly by a 15% increase in gross revenues, with stable Gross-to-Net. Net revenues for the year ended December 31, 2023, were reduced by ($2.6) million in contra-revenues for Movantik, largely from returns.
Cost of Revenues for the year ended December 31, 2023, was $3.5 million, compared to $33.3 million for the year ended December 31, 2022. This decrease was primarily attributable to the divestiture of Movantik. As a result of this divestiture, both the recognition of revenues and the associated cost of revenues for this product were discontinued starting from February 2, 2023. Additionally, the amortization of the intangible asset related to Movantik was also discontinued as of that date.
Gross Profit for the year ended December 31, 2023, was $3.1 million, compared to $28.5 million for the year ended December 31, 2022, in line with the decrease in Net Revenues and Cost of Revenues as explained above and primarily attributable to the divestiture of Movantik.
Research and Development Expenses for the year ended December 31, 2023, were $3.5 million, as compared to $7.3 million for the year ended December 31, 2022. The difference is attributable to the completion of clinical trials related to COVID-19 and RHB-107, and to ongoing cost-reduction measures.
Selling, Marketing and General and Administrative Expenses for the year ended December 31, 2023, were $31.0 million, as compared to $64.0 million for the year ended December 31, 2022. The difference was primarily attributable to the ongoing cost-reduction measures and to the divesture of Movantik as described above.
Other Income for the year ended December 31, 2023, was $44.1 million, as compared to no other income recognized for the year ended December 31, 2022. The other income was comprised of (i) $35.5 million from the divestiture of Movantik, calculated as the difference between the fair value of the rights and the carrying amount of this asset and (ii) $8.6 million from transitional services fees provided to the buyer of Movantik.
Operating Income for the year ended December 31, 2023, was $12.6 million, compared to operating loss of $42.8 million for the year ended December 31, 2022. The difference is primarily attributable to the changes resulting from the divestiture of Movantik, as detailed above.
Financial Income, net for the year ended December 31, 2023, was $11.3 million, compared to Financial Expenses, net of $28.8 million for the year ended December 31, 2022. The income recognized in the year ended December 31, 2023, was primarily attributable to a $20.6 million gain resulting from the extinguishment of the HCR Collateral Management LLC ("HCR") debt in exchange for the transfer of rights to Movantik, calculated as the difference between the carrying amount of the financial liability and the fair value of the rights transferred, partially offset by financial expenses related to the derivative financial instruments and other financial expenses.
Net Income of $23.9 million for the year ended December 31, 2023, as compared to Net Loss of $71.7 million for the year ended December 31, 2022, primarily attributed to the changes resulting from the sale of Movantik and to the ongoing cost-reduction measures, as detailed above.
Total Assets as of December 31, 2023, were $23 million, as compared to $158.9 million as of December 31, 2022. The decrease was primarily attributable to the sale of Movantik, resulting in the transfer of the rights to Movantik, as well as to a significant decrease in the Trade Receivables balance (attributed to the fact that the receivables as of December 31, 2022, were primarily associated with Movantik).
Total Liabilities as of December 31, 2023, were $21 million, as compared to $207.3 million as of December 31, 2022. This decrease was primarily due to the extinguishment of HCR debt in exchange for the transfer of Movantik rights, assumption of certain liabilities by HCR, and payments made towards pre-closing liabilities related to Movantik. Remaining pre-closing liabilities related to Movantik as of December 2023, are estimated at $4.8 million.
Net Cash Used in Operating Activities for the year ended December 31, 2023, was $35.8 million, compared to $29.2 million for the year ended December 31, 2022. The cash used in operating activities was primarily directed towards settling pre-closing liabilities related to Movantik and other operational activities.
Net Cash Provided by Financing Activities for the year ended December 31, 2023, was $21.4 million, comprised primarily of the net proceeds from offerings and exercise of warrants in the year ended December 31, 2023, and the decrease in restricted cash, partially offset by repayment of payables in respect of intangible asset purchase.
Cash Balance as of December 31, 2023, was $6.5 million(1).
R&D Overview
RedHill's R&D efforts are concentrated on its two lead investigational candidates, opaganib and RHB-107 - with both advancing in programs that are externally funded, predominantly through U.S. government support, and directed at multiple underserved indications that provide both sizeable market opportunities, estimated aggregate to be well in excess of $1 billion globally, and potentially advantageous pathways to approval.
Opaganib's development is focused on a potential role as a nuclear and chemical medical countermeasure in the event of radiation and chemical incidents, while RHB-107 remains focused on the outpatient treatment of COVID-19. Both molecules have also shown promise for potential use in the treatment of the Ebola virus disease, along with other viral pandemic scenarios, and various inflammatory and oncologic conditions.
Both opaganib and RHB-107 are novel, oral, host-directed small molecule drugs with demonstrated safety and efficacy profiles that are ideally suited to nuclear/chemical incidents and viral pandemic scenarios, being viral mutation-resistant and easy to administer and distribute.
Opaganib (ABC294640)(4
)Opaganib is a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with potential for broad activity across radioprotection, cancer, inflammatory and viral conditions. Opaganib's host-directed action is thought to work through the inhibition of multiple pathways, the induction of autophagy and apoptosis, and disruption of viral replication, through simultaneous inhibition of three sphingolipid-metabolizing enzymes in human cells (SPHK2, DES1 and GCS). Current focuses of opaganib's development are:
Nuclear and chemical medical countermeasures: Opaganib has been selected for evaluation by two U.S. government countermeasures programs for Acute Radiation Syndrome (ARS) and Sulfur Mustard exposure, both funded by the NIH.
Ebola virus disease: U.S. Army-funded and conducted studies suggest opaganib is the first host-directed molecule to show activity in vivo in Ebola virus disease, significantly increasing survival time, and separately, opaganib demonstrated robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability.
Nuclear and Chemical Medical Countermeasures updates
-- 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:
-- 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.
-- Radioprotective capacity in bone marrow, with opaganib showing
enhanced survival in mice irradiated with both lethal and
half-lethal whole-body radiation.
-- 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.
-- Radioprotective capacity in bone marrow, with opaganib showing
enhanced survival in mice irradiated with both lethal and
half-lethal whole-body radiation.
-- 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.
-- 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.
-- 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.
-- 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.
-- 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.
Ebola updates
-- 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.
-- 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.
RHB-107 (upamostat)((5))
A novel investigational broad-acting, host-directed once-daily oral antiviral targeting multiple potential indications with a focus on COVID-19 and other viruses as part of a pandemic preparedness approach. RHB-107 targets human serine proteases involved in preparing the spike protein for viral entry into target cells and inhibits several proteases targeting cancer and inflammatory gastrointestinal disease. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein. RHB-107 is well tolerated demonstrating its clinical safety profile in approximately 200 patients((6)). Current focus for RHB-107 development is:
COVID-19 outpatient treatment: Accepted for inclusion in the U.S. DoD-supported 300-patient ACESO PROTECT platform trial for early COVID-19 outpatient treatment, with first patient expected to be enrolled imminently
Ebola virus disease: In U.S. Army-funded and conducted studies RHB-107 also demonstrated robust synergistic effect in vitro when combined with remdesivir
COVID-19 updates:
-- 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.
-- 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).
-- 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.
Ebola Virus Disease updates:
-- 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.
-- 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.
Other R&D updates:
-- 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-204((7)) through 2041.
-- 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.
-- RHB-204 and RHB-102 are subject to ongoing commercialization /
out-licensing / divestment discussions.
Talicia 2023 Updates
Talicia(® )(omeprazole magnesium, amoxicillin and rifabutin)((8))
-- Talicia continues to be the most prescribed branded agent for H. pylori
eradication by U.S. gastroenterologists(9).
-- Total Talicia coverage stood at nearly 200 million American lives as of
December 31, 2023(10).
-- 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.
-- 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.
-- 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.
-- 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.
-- 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.
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((11)), and Aemcolo(®), for the treatment of travelers' diarrhea in adults((12)). 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 U.S. government collaboration for development for Acute Radiation Syndrome (ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program in oncology; (ii) 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, with non-dilutive external funding covering the entirety of the RHB-107 arm of the 300-patient Phase 2 adaptive platform trial, and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; (iii) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; and (v) RHB-204, a Phase 3-stage program for pulmonary nontuberculous mycobacteria (NTM) disease.
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 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 statements regarding the potential divestment of certain of our assets and/or commercial operations, progress of the R&D activities for opaganib and RHB-107, including timing of opaganib's development for Acute Radiation Syndrome and the potential market opportunity for opaganib and RHB-107. 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 Company will not comply with the listing requirements of the Nasdaq Capital Market ("Nasdaq") to remain listed for trading on Nasdaq, the risk that the potential divestment of certain of our assets and/or commercial operations will not occur or will be delayed, the risk of delay in the R&D activities for opaganib or RHB-107, including the ACESO PROTECT platform trial for early COVID-19 outpatient treatment, the risk that opaganib or RHB-107 are not found to be well-suited to counter nuclear/chemical exposure and viral pandemic scenarios, 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; that the RHB-107 Phase 2 ACESO PROTECT platform trial for early COVID-19 outpatient treatment 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 U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.
Company contact:
Adi Frish
Chief Corporate and Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Category: Financials
(1) Including cash, cash equivalents, short-term bank deposits and restricted cash.
(2) The FDA's Animal Rule allows for the use of pivotal animal model efficacy studies to support FDA approval of new drugs when human clinical trials are not ethical or feasible.
(3) All financial highlights are approximate and are rounded to the nearest hundreds of thousands.
(4) Opaganib is an investigational new drug, not available for commercial distribution.
(5) RHB-107 (upamostat) is an investigational new drug, not available for commercial distribution.
(6) https://www.ijidonline.com/article/S1201-9712(22)00638-5/fulltext
(7) RHB-204 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) IQVIA XPO Data on file.
(10) © 1998 - 2024 Managed Markets Insight & Technology, LLC. All rights reserved.
(11) 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.
(12) 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.
REDHILL BIOPHARMA LTD.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
Year Ended December 31,
2023 2022 2021
U.S. dollars in thousands
NET REVENUES 6,530 61,800 85,757
COST OF REVENUES 3,459 33,337 49,406
GROSS PROFIT 3,071 28,463 36,351
RESEARCH AND DEVELOPMENT EXPENSES 3,528 7,279 29,498
SELLING AND MARKETING EXPENSES 14,756 35,442 55,623
GENERAL AND ADMINISTRATIVE EXPENSES 16,219 28,586 32,365
OTHER INCOME 44,064
OPERATING INCOME (LOSS) 12,632 (42,844) (81,135)
FINANCIAL INCOME 20,889 13,562 51
FINANCIAL EXPENSES 9,605 42,387 16,660
FINANCIAL INCOME (EXPENSES), net 11,284 (28,825) (16,609)
INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) FOR THE 23,916 (71,669) (97,744)
PERIOD
EARNINGS (LOSS) PER ORDINARY SHARE, basic and diluted (U.S. dollars) 0.01 (0.12) (0.21)
REDHILL BIOPHARMA LTD
.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
December 31, December 31,
2023 2022
U.S. dollars in thousands
CURRENT ASSETS:
Cash and cash equivalents 5,569 19,968
Bank deposits 15
Restricted cash 790 16,000
Trade receivables 2,591 34,521
Prepaid expenses and other receivables 2,801 4,387
Inventory 4,389 11,009
16,140 85,900
NON-CURRENT ASSETS:
Restricted cash 147 150
Fixed assets 193 502
Right-of-use assets 989 6,692
Intangible assets 5,578 65,626
6,907 72,970
TOTAL ASSETS 23,047 158,870
CURRENT LIABILITIES:
Account payable 3,278 4,230
Lease liabilities 718 1,032
Allowance for deductions from revenue 10,654 47,870
Accrued expenses and other current liabilities 4,592 17,949
Borrowing 115,216
Payable in respect of intangible assets purchase 11,157
19,242 197,454
NON-CURRENT LIABILITIES:
Lease liabilities 455 6,443
Derivative financial instruments 741 2,623
Royalty obligation 540 750
1,736 9,816
TOTAL LIABILITIES 20,978 207,270
EQUITY (CAPITAL DEFICIENCY):
Ordinary shares 21,441 2,835
Additional paid-in capital 388,363 382,625
Accumulated deficit (407,735) (433,860)
TOTAL EQUITY (CAPITAL DEFICIENCY) 2,069 (48,400)
TOTAL LIABILITIES AND EQUITY (CAPITAL DEFICIENCY) 23,047 158,870
REDHILL BIOPHARMA LTD.
CONSOLIDATED STATEMENTS OF CASH FLOWS
Year Ended December 31,
2023 2022 2021
U.S. dollars in thousands
OPERATING ACTIVITIES:
Comprehensive income (loss) 23,916 (71,669) (97,744)
Adjustments in respect of income and expenses not involving cash flow:
Share-based compensation to employees and service providers 1,647 5,675 10,212
Depreciation 1,445 2,136 1,914
Amortization of intangible assets 545 6,018 16,235
Gains from the transfer of rights in Movantik(R) and extinguishment of debt obligations, (see (56,082)
below)
Gains from early termination of leases and impairment of fixed assets, net (543)
Non-cash expenses related to borrowing and payable in respect of intangible assets purchase 33,151 5,366
Fair value (gains) losses on derivative financial instruments and changes in royalty obligation 5,359 (13,422) 5
Loss from modification of warrants terms as part of a new issuance 1,459
Issuance costs in respect of warrants 2,034 958
Exchange differences and revaluation of bank deposits 19 (40) 118
(44,117) 34,476 33,850
Changes in assets and liability items:
Decrease (increase) in trade receivables 31,930 (2,845) (3,021)
Decrease in prepaid expenses and other receivables 1,586 274 860
Decrease (increase) in inventories 2,387 3,801 (8,285)
Increase (decrease) in accounts payable (952) (7,434) 111
(Decrease) in accrued expenses and other liabilities (13,354) (2,947) (3,186)
Increase (decrease) in allowance for deductions from revenue (37,216) 17,159 12,368
(15,619) 8,008 (1,153)
Net cash used in operating activities (35,820) (29,185) (65,047)
INVESTING ACTIVITIES:
Purchase of fixed assets (11) (198) (115)
Change in investment in current bank deposits 15 8,500 (8,500)
Proceeds from sale of financial assets at fair value through profit or loss 475
Net cash provided by (used in) investing activities 4 8,302 (8,140)
FINANCING ACTIVITIES:
Proceeds from issuance of ordinary shares and warrants, net of issuance costs 13,959 23,806 78,536
Exercise of options into ordinary shares 4,006
Repayment of payable in respect of intangible asset purchase (6,555) (10,878) (7,397)
Decrease in restricted cash 15,210
Payment of principal with respect to lease liabilities (1,175) (1,475) (1,683)
Net cash provided by financing activities 21,439 11,453 73,462
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (14,377) (9,430) 275
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS (22) (76) (96)
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 19,968 29,474 29,295
BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF PERIOD 5,569 19,968 29,474
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN CASH 138 84 47
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN CASH 367 8,182 11,280
SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND FINANCING
ACTIVITIES:
Acquisition of right-of-use assets by means of lease liabilities 270 5,590 303
Decrease in lease liability (with corresponding decrease in right of use asset in amount of $4,697 5,413 587
in 2023 and $534 in 2022) resulting from early termination of lease.
Transfer of rights in Movantik(R) 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(R) and extinguishment of debt obligations 56,082
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SOURCE RedHill Biopharma Ltd.
