Targeting positive cash from operations to start
during H2/22[1]
Focus on earlier achievement of operational profitability
thanks to a recently implemented comprehensive cost reduction plan,
with expected operational cost savings of approximately
$50 million over the next 18
months
Continuous implementation of disciplined cost controls
reduced Q1/22 cash used in operating activities by more than 70% to
approximately $4 million, compared to
approximately $15 million in
Q4/21
Net revenues of $18.2 million
in Q1/22; Cash balance[2] of $45 million as of March
31, 2022
Talicia® TRx up 12.8% over Q4/21 and
Movantik® continues strong Q4/21 prescription
performance
Amendment improves key covenants in the HCR Credit
Agreement
Given encouraging data to date, opaganib and RHB-107 COVID-19
Phase 3-stage programs expected to be funded via external sources;
Global and U.S. regulatory interactions ongoing
Management to host webcast today, at 08:30 a.m. EDT
TEL
AVIV, Israel and RALEIGH,
N.C., June 23, 2022 /PRNewswire/ -- RedHill
Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, today reported its first
quarter 2022 financial results and operational highlights,
targeting positive cash from operations1 to start during
H2/22 and recent implementation of a comprehensive cost reduction
plan, expected to generate operational cost savings of
approximately $50 million over the
next 18 months.
Dror Ben-Asher, RedHill's
Chief Executive Officer, said: "To address the current market
realities and operating landscape, RedHill is being decisive about
controlling its own destiny and is highly focused on achieving
earlier profitability, targeting positive cash from operations to
start during H2/221. Our comprehensive cost reduction
plan is expected to generate operational cost savings of
approximately $50 million over the
next 18 months. The majority of these savings result from an
approximately one-third reduction of the U.S. commercial team
workforce, returning to pre-pandemic levels, streamlined
operational expenditure including selling, general and
administrative (SG&A) expenses and refining the Company's
R&D strategy to rely mostly on external funding sources based
on the promising clinical data generated to date. On behalf of
RedHill and its Board of Directors, I would like to express my
profound and respectful gratitude to the colleagues who are
departing RedHill. We value and are extremely grateful for your
immense contributions and dedication which enabled RedHill to build
a first-class U.S. commercial organization and launch three
innovative products that help patients in need. While difficult,
the changes we have made as part of our cost reduction plan were
necessary given the current realities."
Mr. Ben-Asher continued: "Improved financial stability
resulting from cost savings, a commercial basket including three
FDA-approved proprietary drugs, continued prescription growth and
healthy sales, improved managed care coverage and the amended
credit agreement with HCR, positions RedHill for further growth. To
that end, RedHill is in non-binding discussions to acquire a
synergetic U.S. FDA-approved, patented GI drug currently generating
dozens of millions of dollars, which, if materialized, will help
expedite and increase cash generation."
Micha Ben Chorin, Chief
Financial Officer at RedHill, added: "RedHill's commercial team
has further strengthened Movantik®'s share of the
growing PAMORA class to approximately 74%, and
Talicia®'s approximately 13% quarterly growth further
consolidates its position as the leading U.S. brand for H.
pylori eradication. The Company's disciplined cost control
measures reduced Q1/22 cash used in operating activities by more
than 70% to approximately $4 million,
compared to approximately $15 million
in Q4/21. Despite the challenging market conditions, RedHill is on
its way to achieving company-wide positive cash from
operations1 this year, and this, along with the
envisaged growth drivers from the pipeline and potential
acquisitions, could boost cash generation and further improve cash
flow. We are confident that RedHill is well positioned for
continuing growth."
Mr. Ben-Asher further remarked: "Turning to R&D, in
reliance of promising clinical and other data we generated to date,
we expect external funding for much of our promising R&D
programs, through grants, industry partnerships and participation
in platform studies. COVID-19, included in a broader category of
'pandemic preparedness', remains an area of high interest and need
for novel oral therapeutics such as RedHill's candidates.
Regulatory feedback on opaganib, supportive of a confirmatory study
has provided a pathway to potential opaganib submissions for
approval in COVID-19. Most recently, opaganib further exhibited its
variant-agnostic credentials by demonstrating potent in
vitro efficacy against Omicron, while also showing, in a
separate study, potent in vitro inhibition of influenza A H1N1,
adding to evidence of opaganib's broader antiviral potential and
its promising applicability to 'pandemic preparedness'. Meanwhile,
RedHill's 2nd COVID-19 therapeutic candidate, RHB-107,
successfully met the Part A study primary outcome measure for its
Phase 2/3-stage study in non-hospitalized COVID-19, showing, among
other promising data, a 100% reduction in hospitalization due to
COVID-19. Discussions are ongoing regarding potential external
funding through grants, platform studies and other public, private
and industry partnerships to support the opaganib and RHB-107
programs, as well as our ongoing Phase 3 study with RHB-204 for NTM
disease."
Financial results for the quarter ended March 31, 2022
(Unaudited)[3]
Net Revenues for the first quarter of 2022 were
$18.2 million, as compared to
$22.1 million in the fourth quarter
of 2021, the difference being attributable to typical cyclical
trends in Movantik sales and increased gross to net deductions
related mainly to increased formulary coverage.
Cost of Revenues for the first quarter of 2022
were $8.0 million, as compared
to $19.3 million in the fourth
quarter of 2021. The decrease was attributed to recognition of an
approximately $9 million impairment
related to the intangible asset of Aemcolo® for
travelers' diarrhea in the previous quarter.
Gross Profit for the first quarter of 2022 was
$10.2 million, as compared to
$2.7 million in the fourth quarter of
2021. The increase was attributed to the impairment recognized in
the previous quarter, as detailed above.
Research and Development Expenses for the first
quarter of 2022 were $3.1 million, as
compared to $5.9 million in the
fourth quarter of 2021. The decrease was attributed to the ongoing
optimization of R&D costs and completion of elements of the
opaganib and RHB-107 development programs.
Selling, Marketing and General and
Administrative Expenses for the first quarter of 2022
were $20.4 million, as compared to
$17.6 million in the fourth quarter
of 2021. The increase was mainly attributed to a one-off positive
adjustment in quarter four of 2021 and expenses related to
professional services and other related expenses in the first
quarter of 2022.
Operating Loss for the first quarter of 2022 was
$13.2 million, as compared to
$20.7 million in the fourth quarter
of 2021. The decrease was mainly attributed to the impairment
recognized in the previous quarter, as detailed above.
Net Cash Used in Operating Activities for the
first quarter of 2022 was $4.2
million, as compared to $14.9
million in the fourth quarter of 2021. The decrease was
mainly due to changes in working capital and continued
implementation of cost-reduction measures.
Net Cash Used in Financing Activities for the
first quarter of 2022 was $4.9
million, as compared to Net Cash Provided by Financing
Activities of $17.6 million in the
fourth quarter of 2021, comprised mostly from proceeds of equity
offerings completed in the fourth quarter of 2021. The additional
decrease of $5 million was due to a
reduction of Movantik acquisition liabilities.
Liquidity and Capital Resources
Cash Balance1 as of
March 31, 2022, was $45.0 million, as compared to $54.2 million as of December 31, 2021.
On June 17, 2022, RedHill
Biopharma Inc. signed an amendment to the HCR Credit Agreement
reducing the revenue covenant to $75.0
million for the next two quarters, with a 0.5% increase in
interest.
The license of opaganib[4] for COVID-19 by Kukbo for
South Korea is expected to yield a
$1.5 million upfront payment to
RedHill and, in addition, up to $5.6
million in milestone payments plus royalties on net
sales.
The license of Talicia for H. pylori by Gaelan Medical for the
United Arab Emirates, with
$2.0 million upfront payment
received, is anticipated to yield additional milestones and
royalties on net sales.
Discussions with additional potential partners, for both in- and
out-licensing partnerships, are ongoing including for potential
acquisitions of additional synergetic commercial products with
strong cash generation potential.
Commercial Highlights
Movantik®
(naloxegol)[5]
The Company's focus and determination to drive both Movantik and
the PAMORA class as a whole have delivered important results, with
Movantik's Q1/22 performance matching the record pace set in Q4/21.
This represents an 8.6% increase in new prescriptions compared to
Q1/21, more than doubling the already strong growth of the overall
PAMORA class in the same period and contributing to a further
increase in market share for Movantik, now up to almost 74% of the
PAMORA class.
Nearly 92% of insurance plans provide access for Movantik –
best-in-class coverage – and as of January
1, 2022, Movantik® has been approved for
inclusion as a preferred and unrestricted brand on a major National
Medicare Part D formulary serving more than 10 million Americans.
Movantik's total commercial coverage now extends to 151 million
American patients' lives and has grown to 46 million Medicare
lives, with over 93% coverage of Medicare Part D lives.
With best-in-class payer coverage, focused execution in the pain
segment and continuing the PAMORA class market development,
Movantik is well-positioned for continued growth in 2022 and
beyond.
Talicia® (omeprazole magnesium, amoxicillin and
rifabutin)[6]
Talicia reached new TRx heights in Q1/22, growing a further
12.8% compared to the previous record levels set in Q4/21. This
growth represents an 80% increase in new prescriptions from Q1/21,
further cementing Talicia's position as the most prescribed branded
H. pylori therapy in the U.S. Significant increase in
prescription volume in March of this year, coupled with a growing
prescriber base, improving payor coverage and continuing
promotional focus is expected to result in further growth
acceleration.
Medi-Cal, California's Medicaid
Health Care program, which added Talicia last year to its Contract
Drug List (CDL) for H. pylori treatment, with no prior
authorization required, expanded coverage to 14 million
beneficiaries on January 1, 2022.
Florida Medicaid coverage started in April and another large Part D
plan coverage became effective earlier this quarter. The Company
also expects a major new coverage win to initiate July 1, 2022. As of May
2022, total Talicia coverage stood at nearly 200 million
American lives, equating to seven out of ten lives.
Outside of the U.S., in January
2022, the Company announced that it had entered into an
exclusive license agreement with Gaelan Medical Trade LLC, a wholly
owned subsidiary of the Ghassan Aboud Group (GAG), for Talicia in
the United Arab Emirates (UAE).
Under the terms of the agreement, RedHill received an upfront
payment of $2 million and is eligible
for additional milestone payments as well as tiered royalties up to
mid-teens on net sales of Talicia in the UAE if marketing
authorization is received and Talicia is commercialized. Gaelan
Medical received the exclusive rights to Talicia in the UAE, as
well as a right of first refusal in relation to Talicia in the Gulf
Cooperation Council region (Saudi
Arabia, Kuwait,
Qatar, Bahrain and Oman) for a pre-determined period.
Aemcolo®
(rifamycin)[7]
The Company continues to be ready for post-COVID-19 returning
travel opportunities for Americans.
R&D Highlights
Opaganib (ABC294640)
COVID-19:
COVID-19, included in a broader category of 'pandemic
preparedness', remains an area of high interest and need for novel
oral therapeutics. Data from prespecified analyses of opaganib's
Phase 2/3 study (NCT04467840), announced in January and
February 2022, demonstrated that
opaganib improved viral RNA clearance, achieved faster time to
recovery and reduced mortality in key subpopulations of moderate to
severe hospitalized patients with COVID-19. Additionally, a
post-hoc analysis identified a biomarker, the fraction of inspired
oxygen (FiO2), to select patients that showed superior outcomes
with opaganib vs. placebo. Opaganib also demonstrated potent in
vitro efficacy against the Omicron SARS-CoV-2 variant and is
expected to remain effective against sub-variants BA.2, XE and
other emerging and future variants. Based on regulatory guidance, a
positive confirmatory study constitutes the likely pathway to
potential opaganib submissions for approval in the U.S., EU, and
multiple other territories.
Data from the global Phase 2/3 study has now been published on
MedRxiv and will also be the subject of a "Late-Breaker" oral
presentation at the joint CDC / Task Force for Global
Health-organized International Conference on Emerging Infectious
Diseases, to be held in August.
On June 21, 2022, and adding to
opaganib's expanding patent suite, RedHill was granted an
additional U.S. patent directed to a method for the treatment of
COVID-19 in patients with moderate to severe COVID-19 related
pneumonia using opaganib.
RedHill is pursuing multiple public and private external funding
sources for our programs including grants in the U.S., UK and EU,
government sponsored platform studies and industry partnerships. In
March 2022, the Company announced
that it had entered into an exclusive license agreement with Kukbo
Co. Ltd., a South Korean corporation, for the exclusive rights to
commercialize opaganib for the treatment of COVID-19 in
South Korea. Under the terms of
the agreement, RedHill is entitled to receive an upfront payment of
$1.5 million and is eligible for
$5.6 million in additional milestone
payments, as well as low double-digit royalties on net sales of
opaganib if marketing authorization is received and opaganib is
commercialized.
Other indications under investigation:
Influenza A H1N1: Opaganib demonstrated potent in vitro
inhibition of influenza A H1N1, at low concentrations and with no
evidence of toxicity at these levels. The results were obtained in
Normal Human Bronchial Epithelial Cells (NHBE) assay, the natural
human target of the virus, making it a realistic model. These
results add to previous data demonstrating antiviral activity in
several in vitro and in vivo viral infection models
including SARS-CoV-2, influenza and Ebola, providing further
evidence of opaganib's potential broad-spectrum antiviral effect.
Discussions with NIH are ongoing regarding next steps for
investigating opaganib's broader antiviral potential and its
promising applicability to 'pandemic preparedness'.
Oncology:
The Company continues to advance opaganib's development program
in oncology with the cholangiocarcinoma (CCA) Phase 2 study
analysis expected in Q3/2022
RHB-107 (upamostat)[8]
COVID-19:
In March 2022, the Company
announced positive top-line results from Part A of the two- stage
Phase 2/3 study of novel, once-daily, orally-administered,
antiviral drug candidate, RHB-107. The study, evaluating RHB-107
for the treatment of non-hospitalized patients with symptomatic
COVID-19 in the early course of the disease (NCT04723537), who do
not require supplemental oxygen (the vast majority of COVID-19
patients) was predominantly conducted in the U.S. (60/61 patients)
as well as South Africa.
Results showed that RHB-107 met the primary outcome measure,
demonstrating a favorable safety and tolerability profile and
showed a 100% reduction in hospitalization due to COVID-19, with
zero patients (0/41) on the RHB-107 arms versus 15% (3/20)
hospitalized due to COVID-19 on the placebo-controlled arm (nominal
p-value=0.0317). The study also showed an approximately 88%
reduction in reported new severe COVID-19 symptoms after treatment
initiation, with only one patient in the RHB-107 treated group
2.4%, (1/41) versus 20% (4/20) of patients in the
placebo-controlled arm. Further analysis of study data also showed
a faster recovery from severe COVID-19 symptoms for patients in the
RHB-107 arm, with a median of 3 days to recovery with RHB-107 vs. 8
days with placebo.
RHB 107's unique human host-targeted, suggested antiviral
mechanism is expected to act independently of viral spike protein
mutations and remain effective against Omicron and
sub-variants BA.2, XE and other emerging and future variants.
Next steps for the study are expected following ongoing
discussions with regulators.
RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM)
Disease[9]
A U.S. Phase 3 study is ongoing in the U.S. to evaluate the
efficacy and safety of RHB-204 in adults with pulmonary NTM disease
caused by Mycobacterium avium Complex (MAC)
infection (NCT04616924). The waning of COVID-19 is expected to
accelerate the advancement of the program
The study protocol provides for 6 months co-primary endpoint of
sputum culture conversion (SCC) and clinical outcome
(patient-reported outcomes - PRO) in a randomized
placebo-controlled design, followed by open label active treatment
with RHB-204 for 12 months from conversion.
RHB-204 has been granted Orphan Drug designation and QIDP status
– providing for Fast Track and Priority Review and resulting in
eligibility for 12 years post-approval market exclusivity.
Conference Call and Webcast Information:
The Company will host a conference call and webcast today,
Thursday, June 23, 2022, at
8:30 a.m. EDT, during which it
will present key highlights for the first quarter of 2022.
The webcast including slides will be broadcast live on the
Company's website,
https://ir.redhillbio.com/events, and will be available
for replay for 30 days.
To participate in the conference call, please dial one of the
following numbers up to 30 minutes before the scheduled start
time: United States: +1-855-979-6654; International:
+1-646-664-1960; and Israel:
+972-72-258-7959; the access code for the call is:
647114.
To pre-register for the conference call, click
here.
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,
Movantik® for opioid-induced constipation in
adults7, Talicia® for the treatment of
Helicobacter pylori (H. pylori) infection in adults8, and
Aemcolo® for the treatment of travelers' diarrhea
in adults9. RedHill's key clinical late-stage development programs
include: (i) RHB-204, with an ongoing Phase 3 study for
pulmonary nontuberculous mycobacteria (NTM) disease; (ii)
opaganib (ABC294640), a first-in-class oral
SK2 selective inhibitor targeting multiple indications with a Phase
2/3 program for hospitalized COVID-19 and Phase 2 studies for
prostate cancer and cholangiocarcinoma ongoing; (iii)
RHB-107 (upamostat), an oral serine protease
inhibitor in a Phase 3-stage study as treatment for
non-hospitalized symptomatic COVID-19, and targeting multiple other
cancer and inflammatory gastrointestinal diseases; (iv)
RHB-104, with positive results from a first Phase 3 study
for Crohn's disease; (v) RHB-102 , with positive results
from a Phase 3 study for acute gastroenteritis and gastritis and
positive results from a Phase 2 study for IBS-D; and (vi)
RHB-106, an encapsulated bowel preparation. More
information about the Company is available at www.redhillbio.com/
twitter.com/RedHillBio.
This press release contains "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. 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 anticipated positive cash from operations before interest
expected in 2022, the expected operational cost savings from the
cost reduction plan and discussions regarding the
acquisition of a synergetic U.S. FDA-approved GI drug.
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, the risk that the anticipated positive
cash from operations before interest will not be positive in 2022,
that the expected operational cost savings from the cost reduction
plan will be lower than anticipated, that the acquisition of
a synergetic U.S. FDA-approved GI drug will not materialize, that
the obligations of the term loan are unable to be met, that
we will not be successful in increasing sales of our commercial
products, including due to market conditions, 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® and
Movantik®; (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 March 17, 2022. 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
|
Media
contacts:
U.S. / UK: Amber
Fennell, Consilium
+44 (0) 7739 658 783
fennell@consilium-comms.com
|
REDHILL BIOPHARMA LTD.
|
CONDENSED CONSOLIDATED
INTERIM STATEMENTS OF COMPREHENSIVE LOSS
|
(Unaudited)
|
|
|
|
Three Months
Ended
|
|
|
March 31,
|
|
|
2022
|
|
2021
|
|
|
U.S. dollars in thousands
|
NET
REVENUES
|
|
18,236
|
|
20,575
|
COST OF
REVENUES
|
|
8,034
|
|
10,253
|
GROSS
PROFIT
|
|
10,202
|
|
10,322
|
RESEARCH AND
DEVELOPMENT EXPENSES
|
|
3,062
|
|
7,484
|
SELLING AND
MARKETING EXPENSES
|
|
12,560
|
|
13,895
|
GENERAL AND
ADMINISTRATIVE EXPENSES
|
|
7,818
|
|
7,095
|
OPERATING
LOSS
|
|
13,238
|
|
18,152
|
FINANCIAL
INCOME
|
|
10
|
|
42
|
FINANCIAL
EXPENSES
|
|
3,909
|
|
4,753
|
FINANCIAL
EXPENSES, net
|
|
3,899
|
|
4,711
|
LOSS AND
COMPREHENSIVE LOSS FOR THE PERIOD
|
|
17,137
|
|
22,863
|
|
|
|
|
|
LOSS PER ORDINARY
SHARE, basic and diluted (U.S. dollars):
|
|
0.03
|
|
0.05
|
WEIGHTED AVERAGE OF
ORDINARY SHARE (in thousands)
|
|
525,186
|
|
429,603
|
REDHILL BIOPHARMA LTD.
|
CONDENSED CONSOLIDATED
INTERIM STATEMENTS OF FINANCIAL POSITION
|
(Unaudited)
|
|
|
|
|
|
|
|
March 31,
|
|
December 31,
|
|
|
2022
|
|
2021
|
|
|
U.S. dollars in thousands
|
CURRENT
ASSETS:
|
|
|
|
|
Cash and cash
equivalents
|
|
28,847
|
|
29,474
|
Bank
deposits
|
|
17
|
|
8,530
|
Trade
receivables
|
|
25,934
|
|
31,677
|
Prepaid expenses and
other receivables
|
|
3,507
|
|
4,661
|
Inventory
|
|
14,272
|
|
14,810
|
|
|
72,577
|
|
89,152
|
NON-CURRENT
ASSETS:
|
|
|
|
|
Restricted
cash
|
|
16,165
|
|
16,169
|
Fixed assets
|
|
528
|
|
572
|
Right-of-use
assets
|
|
7,736
|
|
3,651
|
Intangible
assets
|
|
70,043
|
|
71,644
|
|
|
94,472
|
|
92,036
|
TOTAL
ASSETS
|
|
167,049
|
|
181,188
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
Accounts
payable
|
|
5,706
|
|
11,664
|
Lease
liabilities
|
|
1,431
|
|
1,618
|
Allowance for
deductions from revenue
|
|
31,390
|
|
30,711
|
Accrued expenses and
other current liabilities
|
|
24,151
|
|
20,896
|
Payable in respect of
intangible assets purchase
|
|
11,223
|
|
16,581
|
|
|
73,901
|
|
81,470
|
|
|
|
|
|
NON-CURRENT
LIABILITIES:
|
|
|
|
|
Borrowing
|
|
86,397
|
|
83,620
|
Payable in respect of
intangible assets purchase
|
|
4,061
|
|
3,899
|
Lease
liabilities
|
|
7,183
|
|
2,574
|
Royalty
obligation
|
|
750
|
|
750
|
|
|
98,391
|
|
90,843
|
TOTAL
LIABILITIES
|
|
172,292
|
|
172,313
|
|
|
|
|
|
EQUITY:
|
|
|
|
|
Ordinary
shares
|
|
1,506
|
|
1,495
|
Additional paid-in
capital
|
|
375,948
|
|
375,246
|
Accumulated
deficit
|
|
(382,697)
|
|
(367,866)
|
TOTAL
EQUITY
|
|
(5,243)
|
|
8,875
|
TOTAL LIABILITIES
AND EQUITY
|
|
167,049
|
|
181,188
|
REDHILL BIOPHARMA
LTD.
|
CONDENSED CONSOLIDATED
INTERIM STATEMENTS OF CASH FLOWS
|
(Unaudited)
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
|
|
March 31,
|
|
|
|
2022
|
|
2021
|
|
|
|
U.S. dollars in thousands
|
OPERATING ACTIVITIES:
|
|
|
|
|
|
Comprehensive
loss
|
|
(17,137)
|
|
(22,863)
|
|
Adjustments in respect
of income and expenses not involving cash flow:
|
|
|
|
|
|
Share-based
compensation to employees and service providers
|
|
2,306
|
|
872
|
|
Depreciation
|
|
537
|
|
492
|
|
Amortization and
impairment of intangible assets
|
|
1,601
|
|
1,827
|
|
Non-cash interest
expenses related to borrowing and payable in respect of intangible
assets purchase
|
|
3,123
|
|
2,639
|
|
Fair value losses on
financial assets at fair value through profit or loss
|
|
—
|
|
6
|
|
Exchange differences
and revaluation of bank deposits
|
|
4
|
|
46
|
|
|
|
7,571
|
|
5,882
|
|
Changes in assets and
liability items:
|
|
|
|
|
|
Decrease in trade
receivables
|
|
5,743
|
|
5,349
|
|
Decrease in prepaid
expenses and other receivables
|
|
1,154
|
|
1,428
|
|
Decrease (increase) in
inventories
|
|
538
|
|
(2,744)
|
|
Decrease in accounts
payable
|
|
(5,958)
|
|
(5,017)
|
|
Increase in accrued
expenses and other liabilities
|
|
3,255
|
|
1,364
|
|
Increase in allowance
for deductions from revenue
|
|
679
|
|
4,334
|
|
|
|
5,411
|
|
4,714
|
|
Net cash used in operating
activities
|
|
(4,155)
|
|
(12,267)
|
|
INVESTING ACTIVITIES:
|
|
|
|
|
|
Purchase of fixed
assets
|
|
(13)
|
|
(88)
|
|
Change in investment in
current bank deposits
|
|
8,500
|
|
—
|
|
Proceeds from sale of
financial assets at fair value through profit or loss
|
|
—
|
|
475
|
|
Net cash provided by investing
activities
|
|
8,487
|
|
387
|
|
FINANCING ACTIVITIES:
|
|
|
|
|
|
Proceeds from issuance
of ordinary shares, net of issuance costs
|
|
713
|
|
57,941
|
|
Exercise of options
into ordinary shares
|
|
—
|
|
3,227
|
|
Repayment of payable in
respect of intangible asset purchase
|
|
(5,542)
|
|
(2,125)
|
|
Payment of principal
with respect to lease liabilities
|
|
(115)
|
|
(383)
|
|
Net cash (used in) provided by financing
activities
|
|
(4,944)
|
|
58,660
|
|
INCREASE (DECREASE) IN CASH AND CASH
EQUIVALENTS
|
|
(612)
|
|
46,780
|
|
EXCHANGE DIFFERENCES ON CASH AND CASH
EQUIVALENTS
|
|
(15)
|
|
(103)
|
|
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF
PERIOD
|
|
29,474
|
|
29,295
|
|
BALANCE OF CASH AND CASH EQUIVALENTS AT THE END OF
PERIOD
|
|
28,847
|
|
75,972
|
|
|
|
|
|
|
|
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN
CASH
|
|
11
|
|
19
|
|
SUPPLEMENTARY INFORMATION ON INTEREST PAID IN
CASH
|
|
772
|
|
1,990
|
|
SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND
FINANCING ACTIVITIES:
|
|
|
|
|
|
Acquisition of
right-of-use assets by means of lease liabilities
|
|
4,767
|
|
—
|
|
[1] Positive cash from operations before interest payments.
[2] Including cash, cash equivalents, short-term bank deposits
and restricted cash.
[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] Movantik® (naloxegol) is indicated for opioid-induced
constipation (OIC). Full prescribing information see:
www.movantik.com.
[6] 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.
[7] 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.
[8] RHB-107 (upamostat) is an investigational new drug, not
available for commercial distribution.
[9] RHB-204 is an investigational new drug, not available for
commercial distribution.
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content:https://www.prnewswire.com/news-releases/redhill-biopharma-announces-q122-highlights-on-track-for-positive-cash-from-operations-in-h222-301573968.html
SOURCE RedHill Biopharma Ltd.