RHB-107 included in the U.S. Department of Defense-supported
ACESO PROTECT multinational platform trial for early COVID-19
outpatient treatment; The 300-patient Phase 2 study received FDA
clearance and is estimated to be completed by the end of
2024
Opaganib awarded a further $1.7
million in U.S. government medical countermeasure (MCM)
development funding – additional to the multimillion dollar-valued
National Institutes of Health's Radiation and Nuclear
Countermeasures Program (RNCP) product development contract for
gastrointestinal acute radiation syndrome (GI-ARS)
Following the divestiture of Movantik and the ongoing
commercial and financial streamlining, the Company is debt-free,
with a significantly reduced cost-base
H1/23 Talicia net revenues of $5.1 million; Cash balance of $16.3 million as of June
30, 2023[1]
TEL
AVIV, Israel and RALEIGH,
N.C., Aug. 17, 2023 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, today provided first half,
2023, financial results and operational highlights.
Dror Ben-Asher, RedHill's
Chief Executive Officer, said: "RedHill has delivered
significant achievements in the first half of 2023. We are now
debt-free with a significantly reduced cost-base. Our two lead
R&D candidates, RHB-107 and opaganib, are progressing their
development in outpatient COVID-19 and Acute Radiation Syndrome,
respectively, both supported extensively by U.S. government
funding. Additionally, we are in active discussions with multiple
parties regarding potential divestment of certain RedHill assets,
in order to further strengthen our balance sheet and enhance our
focus."
Financial results for the six months ended June 30, 2023 (Unaudited)2
Net Revenues for the six months ended June 30, 2023, were $5.4
million, as compared to $31.5
million for the six months ended June
30, 2022. The decrease was primarily attributable to the
divestiture of Movantik, resulting in the discontinuation of
revenue recognition from this product starting from February 2, 2023. Talicia net revenues for the
six months ended June 30, 2023, were
$5.1 million, as compared to
$4 million for the six months ended
June 30, 2022, primarily due to an
increase of 10% in units sold.
Cost of Revenues for the six months ended
June 30, 2023, was $2.4 million, as compared to $15.3 million for the six months ended
June 30, 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 six months ended June 30, 2023, was $3
million, as compared to $16.2
million for the six months ended June
30, 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 six
months ended June 30, 2023, were
$2.3 million, as compared to
$4.5 million for the six months ended
June 30, 2022. The decrease is
attributable to completion of clinical trials related to COVID-19
and ongoing cost-reduction measures.
Selling, Marketing and General and Administrative
Expenses for the six months ended June 30, 2023, were $19
million, as compared to $37.4
million for the six months ended June
30, 2022. The difference was primarily attributable to the
ongoing cost-reduction measures.
Other Income for the six months ended
June 30, 2023, was $43 million, as compared to no other income
recognized for the six months ended June 30,
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) $7.5 million from transitional services fees
provided to the buyer of Movantik.
Operating Income for the six months ended
June 30, 2023, was $24.7 million, as compared to an operating loss
of $25.8 million for the six months
ended June 30, 2022, primarily
attributable to the changes resulting from the divestiture of
Movantik, as detailed above.
Financial Income, net for the six months ended
June 30, 2023, was $26.3 million, as compared to Financial Expenses,
net of $6.5 million for the six
months ended June 30, 2022. The
income recognized in the six months ended June 30, 2023, was primarily attributable to 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.
Net Income for the six months ended June 30, 2023, was $51
million, as compared to Net Loss of $32.2 million for the six months ended
June 30, 2022, primarily attributable
to the changes resulting from the sale of Movantik, as detailed
above.
Total Assets as of June 30,
2023, were $35 million, as
compared to $158.9 million as of
December 31, 2022. The decrease was
primarily attributable to the divestiture 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 June 30, 2023, were $31.6
million, as compared to $207.3
million as of December 31,
2022. The decrease was primarily attributable 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 June 30, 2023, are estimated at $14.9 million.
Net Cash Used in Operating Activities for the six
months ended June 30, 2023, was
$17.8 million, as compared to
$20.7 million for the six months
ended June 30, 2022. The difference
was primarily attributable to the ongoing cost reductions. In the
six months ended June 30, 2023, the
cash used in operating activities was primarily directed towards
settling pre-closing liabilities related to Movantik.
Net Cash Provided by Financing Activities for
the six months ended June 30, 2023,
was $4.8 million, comprised primarily from the net proceeds
from the offering completed on April 3,
2023, and the decrease in restricted cash, partially offset
by repayment of payables in respect of intangible asset
purchase.
Cash Balance as of June 30,
2023, was $16.3
million1.
Business updates
On July 31, 2023, the Company
announced that RHB-107 (upamostat)3 had been accepted
for inclusion in the 300-patient U.S. Department of
Defense-supported Austere environments Consortium for Enhanced
Sepsis Outcomes' (ACESO) PROTECT multinational platform trial for
early COVID-19 outpatient treatment to be conducted in the U.S.,
Thailand, Ivory Coast and South Africa.
On July 21, 2023, the Company
announced that opaganib4 had been awarded a further
$1.7 million in U.S. government
funding, via a Small Business Innovation Research (SBIR) grant to
the Company's development partner, Apogee Biotechnology Corporation
("Apogee"). This SBIR grant will support research to further the
development of opaganib as a medical countermeasure (MCM) for
gastrointestinal acute radiation syndrome (GI-ARS). This grant is
in addition and complementary to the multimillion dollar-valued
NIH's Radiation and Nuclear Countermeasures Program (RNCP) product
pipeline development contract awarded to opaganib following its
selection by the RNCP for ARS development, announced on
February 28, 2023.
On July 25, 2023, the Company
closed a $3.8 million registered
direct offering for the purchase and sale of 1,301,923 of the
Company's American Depositary Shares ("ADSs") (or ADS equivalents),
each ADS representing four hundred (400) ordinary shares, at a
purchase price of $1.35 per ADS (or
ADS equivalent). Pursuant to a warrant exercise and reload
agreement, dated July 21, 2023, with
a certain holder holding Series A warrants to purchase up to an
aggregate of 1,500,000 ADSs and Series B warrants to purchase up to
an aggregate of 1,500,000 ADSs previously issued in March 2023, such holder exercised its Series A
warrants in full at a reduced exercised price of $1.35 per ADS, in exchange for new unregistered
warrants to purchase up to an aggregate of 1,500,000 ADSs at an
exercise price of $1.80 per ADS and
an expiration date of April 3, 2028,
and a reduction in the exercise price of the Series B warrants to
$1.80 per ADS. The Company had also
agreed to amend (i) certain existing warrants to purchase up to an
aggregate of 330,106 ADSs at an exercise price of $4.75 per ADS and (ii) certain existing warrants
to purchase up to an aggregate of 971,817 ADSs at an exercise price
of $4.6305 per ADS, so that the
amended warrants have a reduced exercise price of $1.80 per ADS effective upon the closing of the
registered direct offering.
On May 9, 2023, the Company
received a written notification from the Nasdaq Stock Market LLC
("Nasdaq"), indicating that the Company is not in compliance with
the minimum Market Value of Publicly Held Shares ("MVPHS") set
forth in the Nasdaq Rules for continued Nasdaq listing. Nasdaq
Listing Rule 5450(b)(3)(C) requires companies to maintain a minimum
MVPHS of $15 million, and Listing
Rule 5810(c)(3)(D) provides that a failure to meet the MVPHS
requirement exists if the deficiency continues for a period of 30
consecutive business days. Pursuant to Nasdaq Listing Rule
5810(c)(3)(D), the Company has a compliance period of 180 calendar
days (or until November 6, 2023) to regain compliance. If at any
time during this compliance period the Company's MVPHS closes at
US$15 million or more for a minimum of ten consecutive business
days, Nasdaq will notify the Company that it has achieved
compliance with the MVPHS requirement, and the MVPHS matter will be
closed. In the event the Company does not regain compliance with
Rule 5450(b)(3)(C) prior to the expiration of the compliance
period, it will receive written notification that its securities
are subject to delisting. Alternatively, the Company may consider
applying to transfer its securities to the Nasdaq Capital Market.
This notification does not impact the listing and trading of the
Company's securities at this time.
On April 3, 2023, the Company
closed a $6 million registered direct
offering for the purchase and sale of 1,500,000 of the ADSs (or ADS
equivalents), Series A warrants to purchase up to an aggregate of
1,500,000 ADSs and Series B warrants to purchase up to an aggregate
of 1,500,000 ADSs. The Series A warrants had an exercise price of
$4.75 per ADS, which was subsequently
reduced to $1.35 per ADS as discussed
above, were exercisable immediately and had a term of five years
following issuance, and the Series B warrants had an exercise price
of $4.00 per ADS, which was
subsequently reduced to $1.80 per ADS
as discussed above, are exercisable immediately and have a term of
nine months following issuance. 811,000 ADSs underlying pre-funded
warrants purchased at the registered direct offering were exercised
following the closing of the offering. The Company recognized
$1.1 million as a financial expense
in the second quarter of 2023 due to the difference between the
fair value of the warrants arising from the registered direct
offering to the transaction price.
As of August 15, 2023, the Company
had 5,854,528 ADSs outstanding.
On February 6, 2023, the Company
announced the extinguishment of all RedHill's debt obligations
(including all principal, interest, revenue interest, prepayment
premiums and exit fees) under the Credit Agreement between
RedHill's U.S. subsidiary, RedHill Biopharma Inc., and HCR,
announced February 25, 2020, as
amended, in exchange for the transfer of its rights in
Movantik® (naloxegol) to Movantik Acquisition Co., an
affiliate of HCR. HCR assumed substantially all post-closing
liabilities, and RedHill retained substantially all pre-closing
liabilities relating to Movantik. As part of the parties'
arrangement, and to ensure continuous patient care, RedHill
provides HCR with transition services for up to 12 months, paid for
by HCR. HCR will retain security interests in certain RedHill
assets until substantially all pre-closing liabilities relating to
Movantik have been paid or other specific conditions are met.
RedHill continues its litigation against Kukbo Co. Ltd.
("Kukbo") which was filed on September
2022 as a result of Kukbo's default in delivering to RedHill
a total of $6.5 million under the
Subscription Agreement, dated October 25,
2021, and the Exclusive License Agreement, dated
March 14, 2022. Following a recent
decision denying RedHill's motion to reargue while otherwise
correcting the misapprehension that was the basis for the motion,
the parties continue to proceed with discovery and RedHill plans to
continue to rigorously pursue the Kukbo litigation.
RedHill is actively pursuing, and in discussions with multiple
parties, regarding strategic business development transactions,
including potential divestment of certain RedHill assets.
Commercial Highlights
Talicia® (omeprazole magnesium, amoxicillin and
rifabutin)5
- H1/23 saw Talicia recording net revenues of $5.1 million, maintaining its place as the
leading prescribed branded H. pylori therapy by U.S.
gastroenterologists6.
- On August 1, 2023, the Company
announced that its partner, Gaelan Medical LLC ("Gaelan Medical"),
a wholly owned subsidiary of the Ghassan Aboud Group (GAG), had
received marketing approval from the United Arab Emirates (UAE) Ministry of Health
for Talicia and that Gaelen had placed an initial Talicia order and
were commencing commercialization activities.
- On May 9, 2023, the Company
announced new Talicia PBPK modeling data, published in AP&T
Journal7, showing that generically substituted regimens
are non-bioequivalent to Talicia. Separately, new Talicia PBPK
modeling data, presented at Digestive Diseases Week (DDW) 2023,
supports bioequivalence between TID and Q8H dosing regimens for
Helicobacter pylori (H. pylori) eradication therapy;
TID dosing is thought to promote patient adherence without
impacting efficacy.
- Total Talicia coverage stood at more than 202 million American
lives as of June 30, 2023, with 7 out
of 10 commercial lives covered8.
Movantik® (naloxegol)9
- Following the sale of Movantik to Movantik Acquisition Co., an
affiliate of HCR, and to ensure continuous patient care, RedHill
continues to and will provide HCR with transition services for up
to 12 months, paid for by HCR.
R&D Highlights
Opaganib (ABC294640) – A novel broad-acting,
host-directed oral small molecule capsule targeting
radioprotection, COVID-19, other viruses as part of a pandemic
preparedness approach, inflammatory and oncology indications.
Nuclear Medical Countermeasures (Acute Radiation
Syndrome):
- On July 21, 2023, the Company
announced that opaganib had been awarded a further $1.7 million in U.S. government funding, via a
SBIR grant to the Company's development partner, Apogee. This SBIR
grant will support research to further the development of opaganib
as a medical countermeasure (MCM) for gastrointestinal acute
radiation syndrome (GI-ARS). This grant is in addition and
complementary to the multimillion dollar-valued RNCP product
pipeline development contract awarded to opaganib following its
selection by the RNCP for ARS development, announced on
February 28, 2023.
- On February 28, 2023, the Company
announced that the RNCP, of the National Institute of Allergy and
Infectious Diseases, part of the National Institutes of Health, has
selected opaganib for the nuclear medical countermeasures product
development pipeline as a potential treatment for Acute Radiation
Syndrome (ARS). As part of this collaboration, contractors directed
and supported by the RNCP will undertake studies, designed in
collaboration with RedHill, to test opaganib in established ARS
models. This announcement followed the February 15, 2023, announcement that the FDA
provided guidance on the use of the Animal Rule for opaganib's
developmental pathway for Acute Radiation Syndrome (ARS), utilizing
pivotal animal model efficacy studies instead of human clinical
trials. Sponsors of approved medical countermeasures are eligible
for a Priority Review Voucher. These announcements followed
publication of data from eight U.S. government-funded in
vivo studies, and additional experiments, indicating that
opaganib was associated with10:
- Protection of normal tissue, including gastrointestinal, from
radiation damage due to ionizing radiation exposure or cancer
radiotherapy.
- Improvement of antitumor activity, response to
chemoradiation, and enhancement of tolerability and survival.
- Additional collaboration discussions with the U.S. and other
governments are ongoing.
Pandemic preparedness and oncology:
- Preclinical development of opaganib, in collaboration with the
U.S. Army and NIAID, for various antiviral indications is
ongoing.
- On May 1, 2023, the Company
announced that the U.S. Patent and Trademark Office (USPTO) had
granted a new patent for opaganib in respect to combination
compositions for treatment of cancer, extending protection to
October 2036.
RHB-107 (upamostat) – A novel broad-acting, host-directed
oral antiviral targeting COVID-19, other viruses as part of a
pandemic preparedness approach, inflammatory and oncology
indications.
Outpatient treatment of COVID-19:
- On July 31, 2023, the Company
announced that RHB-107 (upamostat) had been accepted for inclusion
in the U.S. Department of Defense-supported Austere environments
Consortium for Enhanced Sepsis Outcomes' (ACESO) PROTECT
multinational platform trial for early COVID-19 outpatient
treatment to be conducted in the U.S., Thailand, Ivory
Coast and South Africa. The
300-patient Phase 2 study has received FDA clearance to start and
is estimated to be completed by the end of 2024.
- On January 3, 2023, the Company
announced publication of positive data from a Phase 2 study of
once-daily oral investigational RHB-107 (upamostat) in
non-hospitalized symptomatic COVID-19 patients, in the
peer-reviewed International Journal of Infectious
Diseases11. The study showed that RHB-107 successfully
met the primary endpoint of safety and tolerability and delivered
promising efficacy results, despite the small number of patients in
each treatment group, including faster recovery from severe
COVID-19 symptoms and 100% reduction in hospitalization due to
COVID-19.
- Discussions are ongoing for external non-dilutive funding for
additional late-stage COVID-19 clinical development.
Pandemic preparedness / additional viral indications:
- RHB-107 is also the subject of several cooperative research
projects with government and non-government bodies, evaluating
RHB-107 against multiple viral targets, including influenza and
Ebola (amongst others).
RHB-102 (BEKINDA)12 – Oncology Support
- On May 1, 2023, the Company
announced that the European Patent Office granted RHB-102
(BEKINDA), a 24-hr bimodal release, once-daily oral tablet
formulation of ondansetron, a patent covering antiemetic
extended-release solid dosage forms for the prevention of nausea
and vomiting (CINV/RINV). The patent provides the potential for UK
and EU protection of RHB-102 to March
2034.
- On February 16, 2023, the Company
announced that it held a positive pre-Marketing Authorisation
Application meeting with the UK Medicines & Healthcare products
Regulatory Agency (MHRA) with regard to seeking marketing approval
for RHB-102 (BEKINDA) for oncology support (management of nausea
and vomiting induced by cytotoxic chemotherapy and radiotherapy,
also referred to as CINV and RINV).
RHB-20413 - Pulmonary Nontuberculous Mycobacteria
(NTM) Disease
- On May 22, 2023, the Company
announced the termination of RHB-204's U.S. Phase 3 study for
non-tuberculosis mycobacteria (NTM) disease due to a very low
accrual rate.
About RedHill Biopharma
RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty
biopharmaceutical company primarily focused on gastrointestinal and
infectious diseases. RedHill promotes the gastrointestinal drugs
Talicia®, for the treatment of Helicobacter
pylori (H. pylori) infection in adults, and
Aemcolo®, for the treatment of travelers'
diarrhea in adults14. RedHill's key clinical late-stage
development programs include: (i) opaganib (ABC294640),
a first-in-class oral broad-acting, host-directed
SPHK2 selective inhibitor with potential for pandemic preparedness,
targeting multiple indications with a 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, 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. Such statements, including, but not limited to, statements
regarding the intended use of net proceeds therefrom, may be
preceded by the words "intends," "may," "will," "plans," "expects,"
"anticipates," "projects," "predicts," "estimates," "aims,"
"believes," "hopes," "potential" or similar words and include
statements regarding anticipated the addition of new revenue
generating products, out-licensing of the Company's development
pipeline assets, timing of opaganib's development for Acute
Radiation Syndrome, non-dilutive development funding from RHB-107
and its inclusion in a key platform study. Forward-looking
statements are based on certain assumptions and are subject to
various known and unknown risks and uncertainties, many of which
are beyond the Company's control and cannot be predicted or
quantified, and consequently, actual results may differ materially
from those expressed or implied by such forward-looking statements.
Such risks and uncertainties include, without limitation, market
and other conditions, the risk that the addition of new revenue
generating products or out-licensing transactions will not occur;
the risk that acceptance onto the RNCP Product Development Pipeline
will not guarantee ongoing development or that any such development
will not be completed or successful; the risk that the FDA does not
agree with the Company's proposed development plans for opaganib
for any indication, the risk that observations from preclinical
studies are not indicative or predictive of results in clinical
trials; the risk that the FDA pre-study requirements will not be
met and/or that the Phase 3 study of RHB-107 in COVID-19
outpatients will not be approved to commence or if approved, will
not be completed or, should that be the case, that we will not be
successful in obtaining alternative non-dilutive development
funding for RHB-107, the risk that HB-107's late-stage
development for non-hospitalized COVID-19 will not benefit from the
resources redirected from the terminated RHB-204 Phase 3 study,
that the Phase 2/3 COVID-19 study for RHB-107 may not be successful
and, even if successful, such studies and results may not be
sufficient for regulatory applications, including emergency use or
marketing applications, and that additional COVID-19 studies for
opaganib and RHB-107 are likely to be required, as well as risks
and uncertainties associated with the risk that the Company will
not successfully commercialize its products; as well as risks and
uncertainties associated with (i) the initiation, timing, progress
and results of the Company's research, manufacturing, pre-clinical
studies, clinical trials, and other therapeutic candidate
development efforts, and the timing of the commercial launch of its
commercial products and ones it may acquire or develop in the
future; (ii) the Company's ability to advance its therapeutic
candidates into clinical trials or to successfully complete its
pre-clinical studies or clinical trials or the development of a
commercial companion diagnostic for the detection of MAP; (iii) the
extent and number and type of additional studies that the Company
may be required to conduct and the Company's receipt of regulatory
approvals for its therapeutic candidates, and the timing of other
regulatory filings, approvals and feedback; (iv) the manufacturing,
clinical development, commercialization, and market acceptance of
the Company's therapeutic candidates and Talicia®; (v) the
Company's ability to successfully commercialize and promote
Talicia® and Aemcolo®; (vi) the Company's ability to establish and
maintain corporate collaborations; (vii) the Company's ability to
acquire products approved for marketing in the 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 28, 2023. 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 & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Category: Financials
REDHILL BIOPHARMA
LTD.
|
CONDENSED CONSOLIDATED
INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
|
(Unaudited)
|
|
|
|
|
Six Months
Ended
|
|
June 30,
|
|
2023
|
2022
|
|
U.S. dollars in thousands
|
NET
REVENUES
|
5,395
|
31,450
|
COST OF
REVENUES
|
2,418
|
15,288
|
GROSS
PROFIT
|
2,977
|
16,162
|
RESEARCH AND
DEVELOPMENT EXPENSES
|
2,331
|
4,534
|
SELLING AND
MARKETING EXPENSES
|
9,632
|
21,833
|
GENERAL AND
ADMINISTRATIVE EXPENSES
|
9,335
|
15,583
|
OTHER
INCOME
|
(42,993)
|
—
|
OPERATING INCOME
(LOSS)
|
24,672
|
(25,788)
|
FINANCIAL
INCOME
|
28,677
|
1,672
|
FINANCIAL
EXPENSES
|
2,347
|
8,123
|
FINANCIAL INCOME
(EXPENSES), net
|
26,330
|
(6,451)
|
INCOME (LOSS) AND
COMPREHENSIVE INCOME (LOSS) FOR THE PERIOD
|
51,002
|
(32,239)
|
EARNINGS (LOSS) PER
ORDINARY SHARE, basic and diluted (U.S. dollars)
|
0.04
|
(0.06)
|
WEIGHTED AVERAGE OF
ORDINARY SHARE (in thousands)
|
1,277,931
|
546,616
|
|
The accompanying
notes are an integral part of these condensed consolidated
financial statements.
|
REDHILL BIOPHARMA
LTD.
|
CONDENSED CONSOLIDATED
INTERIM STATEMENTS OF FINANCIAL POSITION
|
(Unaudited)
|
|
June 30,
|
December 31,
|
|
2023
|
2022
|
|
U.S. dollars in thousands
|
CURRENT
ASSETS:
|
|
|
Cash and cash
equivalents
|
6,996
|
19,968
|
Bank
deposits
|
18
|
15
|
Restricted
cash
|
9,140
|
16,000
|
Trade
receivables
|
2,903
|
34,521
|
Prepaid expenses and
other receivables
|
3,050
|
4,387
|
Inventory
|
4,939
|
11,009
|
|
27,046
|
85,900
|
NON-CURRENT
ASSETS:
|
|
|
Restricted
cash
|
144
|
150
|
Fixed assets
|
244
|
502
|
Right-of-use
assets
|
2,010
|
6,692
|
Intangible
assets
|
5,593
|
65,626
|
|
7,991
|
72,970
|
TOTAL
ASSETS
|
35,037
|
158,870
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
Account
payable
|
3,112
|
4,230
|
Lease
liabilities
|
1,290
|
1,032
|
Allowance for
deductions from revenue
|
16,384
|
47,870
|
Accrued expenses and
other current liabilities
|
7,401
|
17,949
|
Borrowing
|
—
|
115,216
|
Payable in respect of
intangible assets purchase
|
—
|
11,157
|
|
28,187
|
197,454
|
|
|
|
NON-CURRENT
LIABILITIES:
|
|
|
Lease
liabilities
|
994
|
6,443
|
Derivative financial
instruments
|
1,635
|
2,623
|
Royalty
obligation
|
750
|
750
|
|
3,379
|
9,816
|
TOTAL
LIABILITIES
|
31,566
|
207,270
|
|
|
|
EQUITY (Capital
Deficiency):
|
|
|
Ordinary
shares
|
4,620
|
2,835
|
Additional paid-in
capital
|
380,860
|
382,625
|
Accumulated
deficit
|
(382,009)
|
(433,860)
|
TOTAL EQUITY
(Capital Deficiency)
|
3,471
|
(48,400)
|
TOTAL LIABILITIES
AND EQUITY (Capital Deficiency)
|
35,037
|
158,870
|
|
The accompanying
notes are an integral part of these condensed consolidated
financial statements.
|
REDHILL BIOPHARMA
LTD.
|
CONDENSED CONSOLIDATED
INTERIM STATEMENTS OF CASH FLOWS
|
(Unaudited)
|
|
Six Months
Ended
|
|
June 30,
|
|
2023
|
2022
|
|
U.S. dollars in thousands
|
OPERATING
ACTIVITIES:
|
|
|
Comprehensive income
(loss)
|
51,002
|
(32,239)
|
Adjustments in respect
of income and expenses not involving cash flow:
|
|
|
Share-based
compensation to employees and service providers
|
849
|
2,924
|
Depreciation
|
1,055
|
1,154
|
Amortization of
intangible assets
|
530
|
2,900
|
Gains from the
transfer of rights in Movantik® and extinguishment of debt
obligations, (see below)
|
(56,082)
|
—
|
Gains from early
termination of leases
|
(694)
|
—
|
Non-cash expenses
related to borrowing and payable in respect of intangible assets
purchase
|
—
|
2,813
|
Fair value gains on
derivative financial instruments
|
(8,071)
|
(1,981)
|
Loss from modification
of warrants terms as part of a new issuance, see note 3b
|
1,084
|
—
|
Issuance costs in
respect of warrants
|
922
|
334
|
Exchange differences
and revaluation of bank deposits
|
(13)
|
(63)
|
|
(60,420)
|
8,081
|
Changes in assets and
liability items:
|
|
|
Decrease (increase) in
trade receivables
|
31,618
|
(2,078)
|
Decrease in prepaid
expenses and other receivable
|
1,337
|
1,872
|
Decrease in
inventories
|
1,837
|
3,091
|
Decrease in accounts
payable
|
(1,118)
|
(7,291)
|
Decrease in accrued
expenses and other liabilities
|
(10,545)
|
(684)
|
Increase (decrease) in
allowance for deductions from revenue
|
(31,486)
|
8,512
|
|
(8,357)
|
3,422
|
Net cash used in
operating activities
|
(17,775)
|
(20,736)
|
INVESTING
ACTIVITIES:
|
|
|
Purchase of fixed
assets
|
(7)
|
(176)
|
Change in investment in
current bank deposits
|
—
|
8,500
|
Net cash provided
(used in) by investing activities
|
(7)
|
8,324
|
FINANCING
ACTIVITIES:
|
|
|
Proceeds from issuance
of ordinary shares and warrants, net of issuance costs
|
5,097
|
16,221
|
Repayment of payable in
respect of intangible asset purchase
|
(6,555)
|
(5,778)
|
Decrease in restricted
cash
|
6,860
|
—
|
Payment of principal
with respect to lease liabilities
|
(589)
|
(470)
|
Net cash provided by
financing activities
|
4,813
|
9,973
|
DECREASE IN CASH AND
CASH EQUIVALENTS
|
(12,969)
|
(2,439)
|
EXCHANGE DIFFERENCES
ON CASH AND CASH EQUIVALENTS
|
(3)
|
(47)
|
BALANCE OF CASH AND
CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
19,968
|
29,474
|
BALANCE OF CASH AND
CASH EQUIVALENTS AT THE END OF PERIOD
|
6,996
|
26,988
|
|
|
|
SUPPLEMENTARY
INFORMATION ON INTEREST RECEIVED IN CASH
|
123
|
11
|
SUPPLEMENTARY
INFORMATION ON INTEREST PAID IN CASH
|
315
|
5,283
|
SUPPLEMENTARY
INFORMATION ON NON-CASH INVESTING AND FINANCING
ACTIVITIES:
|
|
|
Acquisition of
right-of-use assets by means of lease liabilities
|
224
|
4,767
|
Decrease in lease
liability (with corresponding decrease in right of use asset in
amount of $4,117) resulting from early termination of
lease.
|
4,811
|
—
|
|
|
|
Transfer of rights in
Movantik® and extinguishment of debt obligations:
|
|
|
Decrease in Intangible
asset
|
(59,503)
|
|
Decrease in
Inventories
|
(4,233)
|
|
Decrease in Payable in
respect of Intangible asset
|
4,602
|
|
Decrease in
Borrowing
|
115,216
|
|
Gains from the transfer
of the rights in Movantik® and extinguishment of debt
obligations
|
56,082
|
|
The accompanying
notes are an integral part of these condensed consolidated
financial statements.
|
1 Including cash, cash equivalents, short-term bank
deposits and restricted cash.
2 All financial highlights are approximate and are
rounded to the nearest hundreds of thousands
3 RHB-107 is an investigational new drug, not
available for commercial distribution.
4 Opaganib is an investigational new drug, not
available for commercial distribution.
5 Talicia® (omeprazole magnesium,
amoxicillin and rifabutin) is indicated for the treatment of H.
pylori infection in adults. For full prescribing information
see: www.Talicia.com.
6 IQVIA XPO Data on file
7 Howden et al. Physiologically based pharmacokinetic
modelling to predict intragastric rifabutin concentrations in the
treatment of Helicobacter pylori infection. Alimentary Pharmacology
and Therapeutics, April 2023.
https://doi.org/10.1111/apt.17526
8 Managed Markets Insight & Technology, LLC
9 Movantik® (naloxegol) is indicated for
opioid-induced constipation (OIC). Full prescribing information
see: www.movantik.com.
10 Maines LW, Schrecengost RS, Zhuang Y, Keller SN,
Smith RA, Green CL, Smith CD. Opaganib Protects against Radiation
Toxicity: Implications for Homeland Security and Antitumor
Radiotherapy. International Journal of Molecular Sciences. 2022;
23(21):13191. https://doi.org/10.3390/ijms232113191
11 Plasse et al. A randomized, placebo-controlled
pilot study of upamostat, a host-directed serine protease
inhibitor, for outpatient treatment of COVID-19. International
Journal of Infectious Diseases, Vol 128, P148-156, March 2023.
https://doi.org/10.1016/j.ijid.2022.12.003
12 RHB-102 is an investigational new drug, not
available for commercial distribution.
13 RHB-204 is an investigational new drug, not
available for commercial distribution.
14 Aemcolo® (rifamycin) is indicated
for the treatment of travelers' diarrhea caused by noninvasive
strains of Escherichia coli in adults. For full prescribing
information see: www.aemcolo.com.
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SOURCE RedHill Biopharma Ltd.