A transformed RedHill:
- Numerous potential catalysts
- Strengthened cash balance and control over our destiny
following the Termination Agreement with
Movantik Acquisition Co. and others: Executing on our
plan to ensure a value-driven focus, operational efficiency and
financial streamlining with a low cost-base
- U.S. government collaborations: Developing a
promising, advancing and largely financially de-risked pipeline via
U.S. government and other collaborations
- Addressing substantial and underserved
indications: In oncology viral pandemic preparedness,
nuclear/radioprotection, and obesity/diabetes
- Building value: In the lab and in the
clinic through new studies, generating new intellectual property
and publications and forging the right partnerships for our
assets
- Streamlined U.S. commercial
organization: Cost reduction measures resulted in a
much smaller, more efficient and cost-effective organization while
still maintaining a leadership position with
Talicia®
R&D and Commercial Highlights:
- Opaganib:
- U.S. Army program for Ebola (believed
to be the first host-directed molecule to show activity
in vivo in Ebola virus disease)
- Orphan drug designation granted by FDA for
neuroblastoma
- Discussions ongoing for a potential externally-funded,
mid-stage clinical study in an additional underserved oncology
indication
- U.S. government-funded programs
ongoing with the NIH / BARDA-funded nuclear and chemical medical
countermeasure programs for Acute Radiation Syndrome (ARS)
and Sulfur Mustard exposure
- Positive
in vivo study results support potential of opaganib therapy in
diabetes / obesity
- RHB-107:
- COVID-19:
Enrollment ongoing in the U.S Department of Defense-supported
300-patient Phase 2 ACESO PROTECT platform trial for early COVID-19
outpatient treatment; enrollment estimated to be completed in the
first half of 2025
- U.S. Army-funded Ebola
development program ongoing; RHB-107 also demonstrated robust
synergistic effect in vitro when combined with remdesivir
- RHB-104: Newly published positive Phase 3 data
demonstrated 64% increased efficacy with RHB-104 in Crohn's
disease
- Talicia: The leading prescribed branded H.
pylori therapy in the U.S., maintaining leadership position with a
streamlined commercial team:
- Expected upcoming new H.
pylori treatment guidelines may further enhance positioning and
use
- Potential manufacturing developments aiming to open
additional new markets underway
- Commercially launched in the UAE, triggering
RedHill's eligibility for
potential milestone and royalty payments; Additional ex-US
partnerships under discussions
Financial highlights:
- Cash balance of $8.2 million
as of June 30,
2024[1]; Net revenues for the first half
of 2024 totaled $2.6 million. Talicia
contributed $3.5 million, down from
the first half of 2023 due to a 12% reduction in U.S.
prescriptions, driven by employee terminations and other
cost-cutting measures. Movantik recorded negative revenues of
$0.9 million, primarily due to
product returns. Excluding one-time items in the first half of 2023
related to the Movantik® divestiture, the operating loss
and net loss improved by $9.9 million
and $9.5 million, respectively, as
these cost-cutting measures significantly reduced overall
expenses
- Post-balance sheet date, RedHill signed a Global
Termination Agreement with Movantik Acquisition Co. and others (the
"Agreement"). The Agreement resulted in RedHill receiving $9.9
million in cash and gaining full control over $0.74 million in a restricted account, while
assuming $12.2 million in
liabilities, leading to a net balance sheet reduction of
approximately $2.3 million. The
Agreement ended all existing credit ties and removed the lien
against Talicia
TEL
AVIV, Israel and RALEIGH,
N.C., Aug. 29, 2024 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty
biopharmaceutical company, today reported its first half 2024
financial results and operational highlights, for the six months
ended June 30, 2024.
![RedHill Biopharma Logo RedHill Biopharma Logo](https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg)
"The first six months of this year have realized significant
accomplishments, laying the groundwork for numerous potential
upcoming catalysts. RedHill is now
in possession of a promising, advancing and largely financially
de-risked development pipeline designed to address substantial and
underserved indications in oncology, viral pandemic preparedness,
nuclear/radioprotection and diabetes and obesity-related
disorders," said Dror Ben-Asher,
RedHill's Chief Executive
Officer. "There is no doubt that the last four years have been
a challenge, primarily as a result of the pandemic's negative
impact on our commercial launches in the
United States in the first half of 2020. However, we have
been turning the ship around and I am immensely proud of our team
that works tirelessly to create opportunities, deliver on plans and
create value in the lab and in the clinic through new studies,
generating additional patents and publications, identifying
important new indications and forging the right partnerships for
our assets, while maintaining a market leadership position
with Talicia. We are executing on our plans to ensure a clear
value-driven focus, operational efficiency and financial
streamlining with a low cost-base, as well as a strengthened cash
balance and solid control over all elements of our business."
Financial results for the six months ended June 30, 2024
(Unaudited)[2]
Net Revenues for the first half of 2024 were $2.6 million, compared to $5.4 million for the first half of 2023. Talicia
net revenues were $3.5 million for
the six months ended June 30, 2024,
compared to $5.1 million for the six
months ended June 30, 2023, mainly
due to a 26% decrease in gross revenues and a 9% increase in
Gross-to-Net deductions, mainly from increased Medicaid rebates. In
the first half of 2024, $0.5 million
of net revenues came from sales in the UAE. Talicia scripts in the
U.S. in the first half of 2024 were down by approximately 12%,
compared to the same period in 2023, mainly due to reduced
promotion and marketing following employee terminations and other
cost-cutting measures in the United
States. These measures had a significant positive impact on
reducing expenses, as detailed below.
Movantik had negative net revenues of $0.9 million in the first half of 2024, compared
to negative net revenues of $0.1
million in the first half of 2023, mainly due to returns
related to sales in the second and third quarters of 2020.
Gross Profit for the first half of 2024 was $1.2 million, compared to $3 million for the first half of 2023, in line
with the decrease in Net Revenues as explained above and primarily
attributable to the reduction in Talicia prescriptions following
employee terminations and other cost-cutting measures.
Research and Development Expenses for the first half of
2024 were $0.7 million, as compared
to $2.3 million for the first half of
2023. The decrease is mainly attributable to the costs from closing
the RHB-204 clinical trial, which were recognized in the first half
of 2023, and to ongoing cost-reduction measures.
Selling, Marketing, and General and Administrative
Expenses for the first half of 2024 were $9 million, compared to $19 million for the first half of 2023. This
decrease was primarily due to downsizing the U.S. workforce
following the Movantik divestiture, leading to lower payroll and
related expenses, and reduced sales force expenses.
Other Income – There was no other income for the first
half of 2024, as compared to $43
million of other income for the first half of 2023. The
other income recognized in the first half of 2023 was comprised of
(i) $35.5 million from the
divestiture of Movantik and (ii) $7.5
million from transitional services fees provided to the
buyer of Movantik.
Operating Loss for the first half of 2024 was
$8.4 million, compared to operating
income of $24.7 million for the first
half of 2023. The difference is primarily attributable to the
changes resulting from the divestiture of Movantik the previous
year, as detailed above. Excluding the other income from the
Movantik transaction in 2023, the operating loss decreased by
approximately $9.9 million, from an
operating loss of $18.3 million for
the first half of 2023, reflecting the positive operating impact of
the cost-cutting measures.
Financial Income, net for the first half of 2024 was
$5.4 million, compared to
$26.3 million for the first half of
2023. In the first half of 2024, the income recognized was mainly
attributable to warrants' revaluation, offset by offerings'
expenses. In the first half of 2023, the income recognized was
primarily attributable to a $20.6
million gain resulting from the extinguishment of the HCR
Collateral Management LLC debt in exchange for the transfer of
rights to Movantik.
Net Loss was $3.1 million
for the first half of 2024, compared to net income of $51 million for the first half of 2023. This
change was primarily attributable to the effects resulting from the
sale of Movantik and ongoing cost-reduction measures, as detailed
above. Excluding the other income and financial income from the
Movantik transaction in 2023, the net loss decreased by
approximately $9.5 million, from a
net loss of $12.6 million for the
first half of 2023, reflecting the positive net impact of the
cost-cutting measures.
Total Assets as of June 30,
2024 were $22 million, as
compared to $23 million as of
December 31, 2023. The decrease was
primarily attributable to a reduction in the inventory balance due
to sales, as well as a reduction in right-of-use assets, due to
termination of car leases in the six months ended June 30, 2024.
Total Liabilities as of June 30,
2024 were $22 million, as
compared to $21 million as of
December 31, 2023. The increase is
mainly due to higher allowance from deductions from revenues and
increased warrant-related derivative liabilities, partially offset
by lower accounts payable, accrued expenses and lease liabilities
(due to the car leases' termination).
Net Cash Used in Operating Activities for the six
months ended June 30, 2024 was
$6.2 million, compared to
$17.8 million for the same period in
2023. The decrease in cash used was primarily due to settling
pre-closing liabilities associated with Movantik and other
operational activities in the six months ended June 30, 2023. Furthermore, this reduction is
attributable to the cost-cutting measures mentioned above.
Net Cash Provided by Financing Activities for the
six months ended June 30, 2024 was
$7.9 million, comprised primarily of
the net proceeds from securities offerings in the six months ended
June 30, 2024. For the six months
ended June 30, 2023, Net Cash
Provided by Financing Activities was $4.8
million, comprised primarily of the net proceeds from
securities offerings in the six months ended June 30, 2023, and the decrease in restricted
cash, partially offset by the repayment of payables related to the
purchase of intangible assets.
Cash Balance as of June 30,
2024 was $8.2 million1.
R&D and Commercial Highlights:
R&D:
RedHill's pipeline is centered
around opaganib[3] &
RHB-107[4], two promising, potentially broad
utility, novel, oral, host-directed small molecule drugs with
demonstrated safety and efficacy profiles. Both candidates are
advancing in predominantly U.S. government-supported,
externally-funded programs, directed at multiple underserved
indications with sizeable multi-billion-dollar market opportunities
and potentially advantageous pathways to approval.
Between them, they are in development for multiple oncology,
viral, inflammatory and diabetes and obesity-related indications,
including COVID-19, Ebola, acute respiratory distress syndrome
(ARDS) and radio/chemical protection (Acute Radiation Syndrome
(ARS) and Sulfur Mustard exposure).
Being (i) easy to administer and distribute and (ii) viral
mutation-resistant, they are ideally suited for stockpiling
strategies in the event of nuclear/chemical incidents and viral
pandemic scenarios.
Opaganib:
- U.S. Army program for Ebola. Opaganib is believed to be
the first host-directed molecule to show activity in vivo in Ebola
virus disease, delivering a statistically significant increase in
survival and, separately, demonstrating a robust synergistic effect
in vitro when combined with remdesivir (Veklury®; Gilead
Sciences, Inc.), improving viral inhibition while maintaining cell
viability
- Orphan drug designation granted by FDA
for neuroblastoma (opaganib has several such
designations in multiple indications, with three in oncology)
- Discussions ongoing for a potential externally-funded,
late-stage study in an additional underserved oncology
indication
- Positive in vivo study results support potential of
opaganib therapy in diabetes / obesity-related disorders – a
market projected to be worth approximately $100 billion within the next decade
- U.S. government-funded programs ongoing with the NIH /
BARDA-funded nuclear and chemical medical countermeasure programs
for ARS and Sulfur Mustard exposure
- Late-stage COVID-19 program continues to address a
multi-hundreds of millions of dollars market
- New opaganib publications:
- The Sphingolipid-Modulating Drug Opaganib Protects against
Radiation-Induced Lung Inflammation and Fibrosis: Potential Uses as
a Medical Countermeasure and in Cancer
Radiotherapy. Publication showed that opaganib significantly
improved long-term survival in an in vivo model of lung
damage following exposure to ionizing radiation[5]
- Effect of Opaganib on Supplemental Oxygen and Mortality in
Patients with Severe SARS-CoV-2 Based Upon FiO2 Requirements.
Publication showed that oral opaganib reduced mortality by 62% and
delivered improved time to room air, and faster time to hospital
discharge in a large group of 251 hospitalized, moderately severe
COVID-19 patients requiring a Fraction of inspired Oxygen up to and
including 60% (FiO2≤60%). The paper also indicates that due to the
lack of treatment effect in patients requiring FiO2>60%, this
may represent a threshold level for disease irreversibility (likely
due to more severe COVID-19 lung disease) and be an important
patient selection clinical biomarker, a key finding for future
therapeutic strategies and studies[6]
- New Chinese patents granted for opaganib:
- In combination with immune checkpoint inhibitors (ICIs) as a
method of inducing an anti-cancer immune response. Provides
protection for opaganib's potential use in combination with a range
of approved and in-development ICIs across a growing range of
indications through 2040
- As a therapy for inhibition of single-stranded RNA virus
replication (notably Ebola Disease Virus); valid through 2035
RHB-107 (upamostat):
- COVID-19: Enrollment ongoing in the U.S Department
of Defense-supported 300-patient Phase 2 ACESO PROTECT platform
trial for early COVID-19 outpatient treatment. Enrollment is
estimated to be completed in the first half of 2025
- U.S. Army-funded Ebola development program ongoing;
RHB-107 also demonstrated a robust synergistic effect in vitro when
combined with remdesivir. Management of potential Ebola virus
pandemic outbreaks represents a significant opportunity and is a
key concern for global health agencies
RHB-104[7]: Newly published positive
Phase 3 data demonstrated 64% increased efficacy with RHB-104 in
Crohn's disease
Commercial:
- Talicia: The leading prescribed branded H. pylori
therapy in the U.S., maintaining leadership position with a
streamlined commercial team:
- Expected upcoming new H. pylori treatment
guidelines may further enhance positioning and use
- Potential manufacturing developments aiming to open additional
new markets underway
- Now commercially launched in the UAE, triggering
RedHill's eligibility for
potential milestone and royalty payments
- Two new U.S. patent grants covering Talicia as:
- A method for eradicating H. pylori regardless of BMI,
valid until May 2042
- Use as an all-in-one treatment of H. pylori
infection, valid until 2034
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty
biopharmaceutical company primarily focused on gastrointestinal and
infectious diseases. RedHill
promotes the gastrointestinal drugs Talicia, for the
treatment of Helicobacter pylori (H. pylori) infection in
adults[8], and Aemcolo®,
for the treatment of travelers' diarrhea in
adults[9]. 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 / X.com/RedHillBio.
Forward Looking Statements
This press release contains "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995 and may discuss investment opportunities, stock analysis,
financial performance, investor relations, and market trends. Such
statements may be preceded by the words "intends," "may," "will,"
"plans," "expects," "anticipates," "projects," "predicts,"
"estimates," "aims," "believes," "hopes," "potential" or similar
words and include, among others, statements regarding the progress
of the research and development activities for opaganib and
RHB-107, including (i) timing of opaganib's development for Acute
Radiation Syndrome, (ii) the potential market opportunity for
opaganib and RHB-107, (iii) delays in the research and development
activities for opaganib or RHB-107, including the ACESO PROTECT
platform trial for early COVID-19 outpatient treatment, (iv) the
risk that opaganib or RHB-107 are not found to be well-suited to
counter nuclear/chemical exposure and viral pandemic scenarios, and
(v) non-dilutive development funding from RHB-107 and its inclusion
in a key platform study. Forward-looking statements are based on
certain assumptions and are subject to various known and unknown
risks and uncertainties, many of which are beyond the Company's
control and cannot be predicted or quantified, and consequently,
actual results may differ materially from those expressed or
implied by such forward-looking statements. Such risks and
uncertainties include, without limitation: market and other
conditions; the Company's ability to regain compliance with the
Nasdaq Capital Market's minimum bid price requirements; the risk
that the addition of new revenue generating products or
out-licensing transactions will not occur; the risk that acceptance
onto the RNCP Product Development Pipeline will not guarantee
ongoing development or that any such development will not be
completed or successful; the risk that the FDA does not agree with
the Company's proposed development plans for opaganib for any
indication; the risk that observations from preclinical studies are
not indicative or predictive of results in clinical trials; the
risk that the FDA pre-study requirements will not be met and/or
that the Phase 3 study of RHB-107 in COVID-19 outpatients will not
be approved to commence or if approved, will not be completed or,
should that be the case, that we will not be successful in
obtaining alternative non-dilutive development funding for RHB-107;
the risk that RHB-107's late-stage development for non-hospitalized
COVID-19 will not benefit from the resources redirected from the
terminated RHB-204 Phase 3 study, and that the Phase 2/3 COVID-19
study for RHB-107 may not be successful and, even if successful,
such studies and results may not be sufficient for regulatory
applications, including emergency use or marketing applications,
and that additional COVID-19 studies for opaganib and RHB-107 are
likely to be required; the risk that the Company will not
successfully commercialize its products; as well as risks and
uncertainties associated with (i) the initiation, timing, progress
and results of the Company's research, manufacturing, pre-clinical
studies, clinical trials, and other therapeutic candidate
development efforts, and the timing of the commercial launch of its
commercial products and ones it may acquire or develop in the
future; (ii) the Company's ability to advance its therapeutic
candidates into clinical trials or to successfully complete its
pre-clinical studies or clinical trials or the development of a
commercial companion diagnostic for the detection of MAP; (iii) the
extent and number and type of additional studies that the Company
may be required to conduct and the Company's receipt of regulatory
approvals for its therapeutic candidates, and the timing of other
regulatory filings, approvals and feedback; (iv) the manufacturing,
clinical development, commercialization, and market acceptance of
the Company's therapeutic candidates and Talicia; (v) the Company's
ability to successfully commercialize and promote Talicia and
Aemcolo; (vi) the Company's ability to establish and maintain
corporate collaborations; (vii) the Company's ability to acquire
products approved for marketing in the 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.
1. Including cash, cash equivalents, short-term bank
deposits and restricted cash.
2. All financial highlights are approximate and are
rounded to the nearest hundreds of thousands.
3. Opaganib is an investigational new drug, not
available for commercial distribution.
4. RHB-107 (upamostat) is an investigational new drug,
not available for commercial distribution.
5. Maines LW, Keller SN, Smith RA, Green CL, Smith CD.
The Sphingolipid-Modulating Drug Opaganib Protects against
Radiation-Induced Lung Inflammation and Fibrosis: Potential Uses as
a Medical Countermeasure and in Cancer Radiotherapy. International
Journal of Molecular Sciences. 2024; 25(4):2322.
https://doi.org/10.3390/ijms25042322
6. Neuenschwander FC, Barnett-Griness O, Piconi S, Maor
Y, Sprinz E, Assy N, Khmelnitskiy O, Lomakin NV, Goloshchekin BM,
Nahorecka E, et al. Effect of Opaganib on Supplemental Oxygen and
Mortality in Patients with Severe SARS-CoV-2 Based upon FIO2
Requirements. Microorganisms. 2024; 12(9):1767.
https://doi.org/10.3390/microorganisms12091767
7. RHB-104 is an investigational new drug, not available
for commercial distribution.
8. Talicia (omeprazole magnesium, amoxicillin and
rifabutin) is indicated for the treatment of H. pylori
infection in adults. For full prescribing information see:
www.Talicia.com.
9. Aemcolo (rifamycin) is indicated for the treatment of
travelers' diarrhea caused by noninvasive strains of Escherichia
coli in adults. For full prescribing information see:
www.Aemcolo.com.
Logo: https://mma.prnewswire.com/media/1334141/RedHill_Biopharma_Logo.jpg
Company contact:
Adi
Frish
Chief Corporate and Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Category: Financials
REDHILL BIOPHARMA
LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME
(LOSS)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months
Ended
|
|
|
|
June 30,
|
|
|
|
|
2024
|
|
2023
|
|
|
|
|
U.S. dollars in thousands
|
|
NET
REVENUES
|
|
|
2,572
|
|
5,395
|
|
COST OF
REVENUES
|
|
|
1,404
|
|
2,418
|
|
GROSS
PROFIT
|
|
|
1,168
|
|
2,977
|
|
RESEARCH AND
DEVELOPMENT EXPENSES
|
|
|
659
|
|
2,331
|
|
SELLING AND
MARKETING EXPENSES
|
|
|
3,487
|
|
9,632
|
|
GENERAL AND
ADMINISTRATIVE EXPENSES
|
|
|
5,470
|
|
9,335
|
|
OTHER
INCOME
|
|
|
—
|
|
42,993
|
|
OPERATING INCOME
(LOSS)
|
|
|
(8,448)
|
|
24,672
|
|
FINANCIAL
INCOME
|
|
|
7,157
|
|
28,677
|
|
FINANCIAL
EXPENSES
|
|
|
1,797
|
|
2,347
|
|
FINANCIAL
INCOME, net
|
|
|
5,360
|
|
26,330
|
|
INCOME (LOSS) AND
COMPREHENSIVE INCOME (LOSS) FOR THE PERIOD
|
|
|
(3,088)
|
|
51,002
|
|
EARNINGS (LOSS) PER
ORDINARY SHARE, basic and diluted (U.S. dollars)
|
|
|
(0.00)
|
|
0.04
|
|
WEIGHTED AVERAGE OF
ORDINARY SHARE (in thousands)
|
|
|
11,760,458
|
|
1,277,931
|
|
|
|
|
|
|
|
|
The accompanying
notes are an integral part of these condensed consolidated
financial statements.
|
REDHILL BIOPHARMA
LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
|
|
December 31,
|
|
|
2024
|
|
2023
|
|
|
U.S. dollars in thousands
|
CURRENT
ASSETS:
|
|
|
|
|
Cash and cash
equivalents
|
|
7,277
|
|
5,569
|
Restricted
cash
|
|
739
|
|
790
|
Trade
receivables
|
|
974
|
|
2,591
|
Prepaid expenses and
other receivables
|
|
2,909
|
|
2,801
|
Inventory
|
|
3,804
|
|
4,389
|
|
|
15,703
|
|
16,140
|
NON-CURRENT
ASSETS:
|
|
|
|
|
Restricted
cash
|
|
143
|
|
147
|
Fixed assets
|
|
147
|
|
193
|
Right-of-use
assets
|
|
469
|
|
989
|
Intangible
assets
|
|
5,562
|
|
5,578
|
|
|
6,321
|
|
6,907
|
TOTAL
ASSETS
|
|
22,024
|
|
23,047
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
Account
payable
|
|
1,912
|
|
3,278
|
Lease
liabilities
|
|
368
|
|
718
|
Allowance for
deductions from revenue
|
|
12,451
|
|
10,654
|
Derivative financial
instruments
|
|
2,541
|
|
*741
|
Accrued expenses and
other current liabilities
|
|
3,961
|
|
4,592
|
|
|
21,233
|
|
19,983
|
|
|
|
|
|
NON-CURRENT
LIABILITIES:
|
|
|
|
|
Lease
liabilities
|
|
190
|
|
455
|
Royalty
obligation
|
|
540
|
|
540
|
|
|
730
|
|
995
|
TOTAL
LIABILITIES
|
|
21,963
|
|
20,978
|
|
|
|
|
|
EQUITY:
|
|
|
|
|
Ordinary
shares
|
|
34,785
|
|
21,441
|
Additional paid-in
capital
|
|
375,333
|
|
388,363
|
Accumulated
deficit
|
|
(410,057)
|
|
(407,735)
|
TOTAL
EQUITY
|
|
61
|
|
2,069
|
TOTAL LIABILITIES
AND EQUITY
|
|
22,024
|
|
23,047
|
|
*See note
2b
|
The accompanying
notes are an integral part of these condensed consolidated
financial statements.
|
REDHILL BIOPHARMA
LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months
Ended
|
|
|
|
June 30,
|
|
|
|
2024
|
|
2023
|
|
|
|
U.S. dollars in thousands
|
OPERATING
ACTIVITIES:
|
|
|
|
|
|
Comprehensive income
(loss)
|
|
|
(3,088)
|
|
51,002
|
Adjustments in respect
of income and expenses not involving cash flow:
|
|
|
|
|
|
Share-based
compensation to employees and service providers
|
|
|
229
|
|
849
|
Depreciation
|
|
|
402
|
|
1,055
|
Amortization of
intangible assets
|
|
|
16
|
|
530
|
Gains from the
transfer of rights in Movantik® and extinguishment of debt
obligations,
(see below)
|
|
|
—
|
|
(56,082)
|
Gains from early
termination of leases, net
|
|
|
(23)
|
|
(694)
|
Fair value gains on
derivative financial instruments
|
|
|
(7,108)
|
|
(8,071)
|
Loss from modification
of warrants terms as part of a new issuance
|
|
|
—
|
|
1,084
|
Issuance costs in
respect of warrants
|
|
|
1,497
|
|
922
|
Exchange differences
and revaluation of bank deposits
|
|
|
(4)
|
|
(13)
|
|
|
|
(4,991)
|
|
(60,420)
|
Changes in assets and
liability items:
|
|
|
|
|
|
Decrease in trade
receivables
|
|
|
1,617
|
|
31,618
|
Decrease (increase) in
prepaid expenses and other receivables
|
|
|
(108)
|
|
1,337
|
Decrease in
inventories
|
|
|
585
|
|
1,837
|
Decrease in accounts
payable
|
|
|
(1,366)
|
|
(1,118)
|
Decrease in accrued
expenses and other liabilities
|
|
|
(631)
|
|
(10,545)
|
Increase (decrease) in
allowance for deductions from revenue
|
|
|
1,797
|
|
(31,486)
|
|
|
|
1,894
|
|
(8,357)
|
Net cash used in
operating activities
|
|
|
(6,185)
|
|
(17,775)
|
INVESTING
ACTIVITIES:
|
|
|
|
|
|
Purchase of fixed
assets
|
|
|
(1)
|
|
(7)
|
Net cash used in
investing activities
|
|
|
(1)
|
|
(7)
|
FINANCING
ACTIVITIES:
|
|
|
|
|
|
Proceeds from issuance
of ordinary shares and warrants, net of issuance costs
|
|
|
8,263
|
|
5,097
|
Repayment of payable in
respect of intangible asset purchase
|
|
|
—
|
|
(6,555)
|
Decrease in restricted
cash
|
|
|
51
|
|
6,860
|
Payment of principal
with respect to lease liabilities
|
|
|
(414)
|
|
(589)
|
Net cash provided by
financing activities
|
|
|
7,900
|
|
4,813
|
INCREASE (DECREASE)
IN CASH AND CASH EQUIVALENTS
|
|
|
1,714
|
|
(12,969)
|
EXCHANGE DIFFERENCES
ON CASH AND CASH EQUIVALENTS
|
|
|
(6)
|
|
(3)
|
BALANCE OF CASH AND
CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
|
|
5,569
|
|
19,968
|
BALANCE OF CASH AND
CASH EQUIVALENTS AT THE END OF PERIOD
|
|
|
7,277
|
|
6,996
|
SUPPLEMENTARY
INFORMATION ON INTEREST RECEIVED IN CASH
|
|
|
38
|
|
123
|
SUPPLEMENTARY
INFORMATION ON INTEREST PAID IN CASH
|
|
|
28
|
|
315
|
SUPPLEMENTARY
INFORMATION ON NON-CASH INVESTING AND
FINANCING ACTIVITIES:
|
|
|
|
|
|
Acquisition of
right-of-use assets by means of lease liabilities
|
|
|
5
|
|
224
|
Decrease in lease
liability (with corresponding decrease in right of use asset in
amount of $170 in the six months ended June 30, 2024, and $4,117 in
the six months
ended June 30, 2023) resulting from early termination of
lease.
|
|
|
193
|
|
4,811
|
Transfer of rights in
Movantik® and extinguishment of debt obligations:
|
|
|
|
|
|
Decrease in Intangible
asset
|
|
|
|
|
(59,503)
|
Decrease in
Inventories
|
|
|
|
|
(4,233)
|
Decrease in Payable in
respect of Intangible asset
|
|
|
|
|
4,602
|
Decrease in
Borrowing
|
|
|
|
|
115,216
|
Gains from the transfer
of the rights in Movantik® and extinguishment of
debt obligations
|
|
|
|
|
56,082
|
|
|
|
|
|
|
The accompanying
notes are an integral part of these condensed consolidated
financial statements.
|
View original
content:https://www.prnewswire.com/news-releases/redhill-biopharma-announces-first-half-2024-business-highlights-302233927.html
SOURCE RedHill Biopharma Ltd.