TEL AVIV, Israel and
RALEIGH, N.C., March 17, 2022 /PRNewswire/ -- RedHill
Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a
specialty biopharmaceutical company, today reported its operational
highlights and financial results for the fourth quarter and full
year ended December 31, 2021.
Dror Ben-Asher, RedHill's
Chief Executive Officer, said: "In 2021, RedHill's team
delivered record revenues against a pandemic backdrop, overall
contribution of commercial operations to the company was positive
for the first time in Q4/21 and positive late-stage clinical data
for two novel oral COVID-19 drugs. A very strong fourth quarter for
both Talicia® and Movantik®, coupled with
disciplined cost-control measures across the business and intensive
out-licensing and in-licensing activities, sets us up for continued
organic and non-organic growth in 2022 and beyond."
Mr. Ben-Asher added: "Our R&D team's drive in
remaining at the forefront of the global search for much needed
novel oral COVID-19 therapies has been outstanding. The challenge
of developing any drug is not to be underestimated and RedHill's
R&D team has delivered exciting efficacy data with both
opaganib and RHB-107, our variant-agnostic investigational drug
candidates for the treatment of hospitalized and non-hospitalized
COVID-19 respectively - a striking achievement."
Micha Ben Chorin, Chief
Financial Officer at RedHill, added: "We have realigned focus
within our 120-person strong customer-facing sales team in the
U.S., providing even greater sales emphasis. In addition, a
substantial decrease in our quarterly operational expenses achieved
through a tight but agile cost-containment plan that allows for
rapid re-adjustments based on compelling business need, are now
starting to be realized following implementation in Q4/21 and we
believe will continue to bear fruit throughout 2022. These
activities are key in our ongoing ability to deliver record
revenues, which amounted to $85.8
million for 2021, while keeping gross margins highly
competitive, with commercial operations profitability expected in
2022. We are committed to continued substantial cost reduction in
2022."
Financial results for the quarter ended December 31, 2021
(Unaudited)[4]
Net Revenues for the fourth quarter of 2021 were
$22.1 million, as compared to
$21.6 million in the third quarter of
2021.
Cost of Revenues for the fourth quarter of 2021
were $19.3 million, as compared to
$9.2 million in the third quarter of
2021. The increase was attributed to recognition of approximately
$9 million impairment related to the
intangible asset of Aemcolo® for travelers'
diarrhea.
Gross Profit for the fourth quarter of 2021 was
$2.7 million, as compared to
$12.4 million in the third quarter of
2021. The decrease was attributed to the impairment recognized, as
detailed above.
Research and Development Expenses for the fourth
quarter of 2021 were $5.9 million,
similar to the $5.8 million in the
third quarter of 2021.
Selling, Marketing and General and
Administrative Expenses for the fourth quarter of 2021
were $17.6 million, as compared to
$24.0 million in the third quarter of
2021. The decrease was a result of the cost-containment plan
implemented.
Operating Loss for the fourth quarter of 2021 were
$20.7 million, as compared to
$17.4 million in the third quarter of
2021. The increase is attributed to the impairment recognized, as
detailed above, partly offset by the decrease in operating
expenses, as detailed above.
Net Cash Used in Operating Activities for the
fourth quarter of 2021 was $14.9
million, as compared to $19.0
million in the third quarter of 2021. The decrease was a
direct result of the decrease in operating expenses, as detailed
above.
Net Cash Provided by Financing Activities for the
fourth quarter of 2021 was $17.6
million, mainly due to proceeds from equity offerings, as
compared to Net Cash Used in Financing Activities of $1.0 million in the third quarter of 2021.
Financial results for the year ended December 31, 2021[4]
Net Revenues were $85.8
million for the year ended December
31, 2021, as compared to $64.4
million for the year ended December
31, 2020, a 33.2% increase in net revenues. The increase was
attributable to the launch of Talicia and Movantik in
March 2020 and April 2020, respectively, as well as growth in
sales in comparable periods of both products.
Cost of Revenues were $49.4
million for the year ended December
31, 2021, as compared to $36.9
million for the year ended December
31, 2020. The increase was mostly attributable to
recognition of approximately $9
million impairment related to the intangible asset of
Aemcolo for travelers' diarrhea and in-line with the increase in
net revenues from our commercial products.
Gross Profit was $36.4
million for the year ended December
31, 2021, as compared to $27.5
million for the year ended December
31, 2020. The increase was primarily due to the increase in
net revenues, and partially offset by the recognized impairment of
Aemcolo intangible asset.
Research and Development
Expenses were $29.5 million for the year ended
December 31, 2021, as compared to
$16.5 million for the year ended
December 31, 2020. The increase was
mainly attributable to the advancement of our COVID-19 programs
with opaganib and RHB-107.
Selling, Marketing and General and Administrative
Expenses were $88.0 million for the year ended
December 31, 2021, as compared to
$74.7 million for the year ended
December 31, 2020. The increase was
mainly attributable to the expansion of commercialization
activities related to Talicia and Movantik and to expenses related
to share-based compensation.
Operating Loss was $81.1 million for the year
ended December 31, 2021, as compared
to $63.7 million for the year ended
December 31, 2020. The increase was
mainly attributable to the intensified activities in both
commercial operations and R&D.
Net Cash Used in Operating Activities was
$65.0 million for the year ended
December 31, 2021, as compared to
$48.6 million for the year ended
December 31, 2020. The increase was
mainly attributable to the increase in operating loss, as described
above.
Net Cash Provided by Financing
Activities was $73.5 million for the year ended
December 31, 2021, comprised
primarily of proceeds from equity offerings. Net Cash Provided by
Financing Activities for the year ended December 31, 2020, was $84.4 million, comprised primarily of debt and
equity-based financing, partially offset by $16 million classified as restricted cash.
Liquidity and Capital Resources
Cash Balance[2] as of
December 31, 2021, was $54.2 million, as compared to $51.5 million as of September 30, 2021, and approximately
$46 million as of December 31, 2020[5].
Strategic investment in RedHill by South Korea's Kukbo Co. ("Kukbo") -
$5 million received and an additional
$5 million investment expected per
the agreement.
Opaganib[6] for COVID-19 licensed by Kukbo for
South Korea for $1.5 million in upfront payment and additional
payment up to $5.6 million in
milestone payments and royalties on net sales.
Talicia for H. pylori licensed by Gaelan Medical for the
United Arab Emirates, with
$2 million upfront to be received
plus milestones and royalties on net sales.
Discussions are ongoing with additional potential partners for
Talicia in other territories.
Commercial Highlights
Movantik®
(naloxegol)[7]
Movantik is the market leader in the PAMORA class holding 73%
market share. The Company's drive and commitment to further growing
Movantik and the PAMORA class, which has increased over the past 12
months, is delivering. In Q4/2021 Movantik had its best performance
since RedHill's launch, growing new prescriptions by 2.4% compared
to the previous quarter.
Nearly 92% of insurance plans provide access for Movantik –
best-in-class coverage – and in December
2021, the Company announced that Movantik® had
been approved for inclusion as preferred and unrestricted brand on
a major National Medicare Part D formulary serving more than 10
million Americans as of January 1,
2022. 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.
In 2021 the Company also successfully brought to a close all
presently pending Movantik patent litigation brought pursuant to
the 'Drug Price Competition and Patent Term Restoration Act' (the
Hatch-Waxman Act). The earliest licensed entry date of any generic
naloxegol in the U.S. is October 1,
2030.
Talicia® (omeprazole magnesium, amoxicillin and
rifabutin)[8]
Talicia is now the most prescribed branded H. pylori
therapy in the U.S. and achieved another record quarter, delivering
a 25.5% increase in prescriptions compared to the previous quarter,
reflecting 78.4% growth of Talicia as compared to Q4/2020.
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 will receive 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. Gaelan Medical
received the exclusive rights to commercialize Talicia in the UAE,
as well as a right of first refusal to commercialize Talicia in the
Gulf Cooperation Council region (Saudi
Arabia, Kuwait,
Qatar, Bahrain and Oman) for a pre-determined period.
In October, Medi-Cal, California's Medicaid Health Care program
covering two million beneficiaries, added Talicia to its Contract
Drug List (CDL) for H. pylori treatment, with no prior
authorization required. This coverage expanded to 14 million
beneficiaries on January 1, 2022. As
of December 2021, total Talicia
coverage stood at greater than 197 million American lives, equating
to 8 out of ten lives.
Also in October 2021, the Company
announced the grant of a new U.S. Patent covering Talicia. This
patent reinforces the protection for Talicia through 2034, and the
Company has listed this patent in the FDA's Approved Drug Products
with Therapeutic Equivalence Evaluations, or Orange Book.
Aemcolo®
(rifamycin)[9]
The Company has maintained promotion of Aemcolo in the fourth
quarter of 2021 in anticipation of renewed post-COVID-19 travel
opportunities for Americans. In December
2021, the exclusive license agreement between the Company
and Cosmo was amended to allow for provision for either party to
terminate the agreement upon 90 days' notice at any time.
R&D Highlights
COVID-19 Program: Opaganib (ABC294640)
The Company previously announced top-line results from the oral
opaganib global 463-patient Phase 2/3 study in hospitalized
patients with severe COVID-19 pneumonia (NCT04467840).
Since the initial results were announced, extensive review of
all the data has shown compelling and consistent efficacy in large
and important sub-group analyses and, earlier this year, the
Company announced results from several recently completed
prespecified analyses from the study showing that opaganib
significantly reduced mortality when given to patients who received
remdesivir and corticosteroids, delivered a significant benefit in
time to recovery and improved the median time to viral RNA
clearance:
- A prespecified mortality analysis, undertaken for all patients
from the Phase 2/3 study who were receiving remdesivir and
corticosteroids at baseline, demonstrated a significant 70.2%
mortality benefit for opaganib-treated patients, with a mortality
rate of 6.98% (n=3/43) for the opaganib arm + SoC versus 23.4%
(n=11/47) for placebo + SoC by Day 42 (p-value=0.034).
- A second prespecified analysis showed that opaganib delivered a
significant 34% benefit in time to recovery, defined as achieving a
score of 1 or less on the WHO Ordinal Scale by Day 14, with 37.4%
of opaganib-treated patients (n=86/230) reaching this event versus
27.9% of patients (n=65/233) treated with placebo + SoC
(p-value=0.013, Hazard Ratio 1.49).
- A third prespecified analysis, of all oral opaganib's Phase 2/3
study patients with positive PCR at screening, demonstrated that
opaganib improved the median time to viral RNA clearance by at
least 4 days. Treatment with opaganib resulted in viral RNA
clearance in a median of 10 days while the median for clearance in
the placebo arm was not reached by the end of 14-days treatment for
placebo (Hazard Ratio 1.34; nominal p-value=0.043, N=437/463)
In December 2021, the Company also
announced that because opaganib's proposed mechanism of action is
not impacted by spike protein mutations, opaganib is expected to be
unaffected by mutations associated with Omicron and other
known variants of concern.
Regulatory discussions are in progress, with opaganib data
submissions in the U.S., Europe,
UK and additional countries. Discussions remain ongoing with
initial guidance requiring confirmatory data on potential path to
approval received from the EU's EMA, the U.S. FDA, UK's MHRA and
others. Data and other regulatory submissions are in process in
multiple other countries. The Company continues its discussions
with U.S. and other government agencies, non-governmental
organizations and potential partners around potential funding to
support the ongoing development of opaganib.
In March 2022, the Company
announced that it has entered into an exclusive license agreement
with Kukbo Co. Ltd., a South Korean corporation, which will receive
the exclusive rights to commercialize opaganib for the treatment of
COVID-19 in South Korea. Under the
terms of the agreement, which adds to the previously announced
strategic investment by Kukbo of up to $10
million, RedHill will in addition 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.
COVID-19 Program: RHB-107
(upamostat)[10]
RedHill continues to advance the Phase 2/3 study of novel,
once-daily, orally-administered, antiviral drug candidate, 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. In March 2022, the Company
announced positive top-line results from the Phase 2 part of the
Phase 2/3 study, predominantly conducted in the U.S. (60/61
patients) as well as South
Africa.
Although not powered for efficacy assessment, the study showed
highly promising efficacy results delivering a 100% reduction in
hospitalization due to COVID-19, with zero patients on the RHB-107
arm hospitalized with COVID-19 (0/41) compared to 15% on the
placebo-controlled arm requiring hospitalization (3/20) (nominal
p-value=0.0317). Furthermore, the study showed an 87.8% reduction
in reported new severe COVID-19 symptoms, with only one patient on
RHB-107 (2.4%, 1/41) compared to 20% (4/20) of patients on the
placebo-controlled arm experiencing new COVID-19 related severe
symptoms (nominal p-value=0.036).
The study met its primary outcome measure, demonstrating a
favorable safety and tolerability profile of RHB-107. Study arms
were well-balanced with respect to baseline disease severity, risk
factors and vaccination status. Patients were also tested for the
specific viral strain (last patient randomized November 12, 2021), with the most common variant
being Delta, found in 62.5% of the patients that had next
generation sequencing (NGS).
The Phase 2 part of the study was designed to evaluate safety
for dose selection and to provide preliminary assessment of
parameters to be used for efficacy evaluation in Part B. A total of
61 patients were enrolled in Part A and randomized on a 1:1:1 basis
to receive one of two dose levels of RHB-107 or a placebo
control.
Discussions with regulators to discuss next steps are expected
during Q2/22.
RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM)
Disease[11]
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). Expansion of sites and the waning of
COVID-19 is expected to increase the pace of enrolment.
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.
Conference Call and Webcast Information:
The Company will host a webcast today, Thursday, March 17, 2022, at 8:30 a.m. EDT, during which it will present
key highlights for the fourth quarter and full year of 2021.
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 15 minutes prior to the start of the call:
United States: +1-877-870-9135;
International: +1-646-741-3167; and Israel: +972-3-530-8845; the access code for
the call is: 2368401.
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
adults[7], 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)
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
2/3 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 non-GAAP commercial operations profitability
expected in 2022 and anticipated operating loss and net cash in
operating activities in 2022. 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
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.: Bryan
Gibbs, Finn Partners
+1 212 529
2236
bryan.gibbs@finnpartners.com
UK: Amber
Fennell, Consilium
+44 (0) 7739 658 783
fennell@consilium-comms.com
|
REDHILL BIOPHARMA
LTD.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
|
|
Year Ended
December 31,
|
|
2021
|
|
2020
|
|
2019
|
|
U.S. dollars in thousands
|
NET
REVENUES
|
85,757
|
|
64,359
|
|
6,291
|
COST OF
REVENUES
|
49,406
|
|
36,892
|
|
2,259
|
GROSS
PROFIT
|
36,351
|
|
27,467
|
|
4,032
|
RESEARCH AND
DEVELOPMENT EXPENSES
|
29,498
|
|
16,491
|
|
17,419
|
SELLING AND
MARKETING EXPENSES
|
55,623
|
|
49,285
|
|
18,333
|
GENERAL AND
ADMINISTRATIVE EXPENSES
|
32,365
|
|
25,375
|
|
11,481
|
OPERATING
LOSS
|
81,135
|
|
63,684
|
|
43,201
|
FINANCIAL
INCOME
|
51
|
|
270
|
|
1,335
|
FINANCIAL
EXPENSES
|
16,660
|
|
12,759
|
|
438
|
FINANCIAL EXPENSES
(INCOME), net
|
16,609
|
|
12,489
|
|
(897)
|
LOSS AND
COMPREHENSIVE LOSS FOR THE YEAR
|
97,744
|
|
76,173
|
|
42,304
|
|
|
|
|
|
|
LOSS PER ORDINARY
SHARE, basic and diluted (U.S. dollars)
|
0.21
|
|
0.21
|
|
0.14
|
REDHILL BIOPHARMA
LTD. CONSOLIDATED STATEMENTS OF FINANCIAL
POSITION
|
|
|
December 31
|
|
|
2021
|
|
2020
|
|
|
U.S. dollars in thousands
|
CURRENT
ASSETS:
|
|
|
|
|
Cash and cash
equivalents
|
|
29,474
|
|
29,295
|
Bank
deposits
|
|
8,530
|
|
17
|
Financial assets at
fair value through profit or loss
|
|
—
|
|
481
|
Trade
receivables
|
|
31,677
|
|
28,655
|
Prepaid expenses and
other receivables
|
|
4,661
|
|
5,521
|
Inventory
|
|
14,810
|
|
6,526
|
|
|
89,152
|
|
70,495
|
NON-CURRENT
ASSETS:
|
|
|
|
|
Restricted
cash
|
|
16,169
|
|
16,164
|
Fixed assets
|
|
572
|
|
511
|
Right-of-use
assets
|
|
3,651
|
|
5,192
|
Intangible
assets
|
|
71,644
|
|
87,879
|
|
|
92,036
|
|
109,746
|
TOTAL
ASSETS
|
|
181,188
|
|
180,241
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
Account
payable
|
|
11,664
|
|
11,553
|
Lease
liabilities
|
|
1,618
|
|
1,710
|
Allowance for
deductions from revenue
|
|
30,711
|
|
18,343
|
Accrued expenses and
other current liabilities
|
|
20,896
|
|
24,082
|
Payable in respect of
intangible assets purchase
|
|
16,581
|
|
17,547
|
|
|
81,470
|
|
73,235
|
|
|
|
|
|
NON-CURRENT
LIABILITIES:
|
|
|
|
|
Borrowing
|
|
83,620
|
|
81,386
|
Payable in respect of
intangible assets purchase
|
|
3,899
|
|
7,199
|
Lease
liabilities
|
|
2,574
|
|
3,807
|
Royalty
obligation
|
|
750
|
|
750
|
|
|
90,843
|
|
93,142
|
TOTAL
LIABILITIES
|
|
172,313
|
|
166,377
|
|
|
|
|
|
EQUITY:
|
|
|
|
|
Ordinary
shares
|
|
1,495
|
|
1,054
|
Additional paid-in
capital
|
|
375,246
|
|
293,144
|
Accumulated
deficit
|
|
(367,866)
|
|
(280,334)
|
TOTAL
EQUITY
|
|
8,875
|
|
13,864
|
TOTAL LIABILITIES
AND EQUITY
|
|
181,188
|
|
180,241
|
REDHILL BIOPHARMA
LTD. CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
Year Ended
December 31,
|
|
2021
|
|
2020
|
|
2019
|
|
U.S. dollars in thousands
|
OPERATING
ACTIVITIES:
|
|
|
|
|
|
Comprehensive
loss
|
(97,744)
|
|
(76,173)
|
|
(42,304)
|
Adjustments in respect
of income and expenses not involving cash flow:
|
|
|
|
|
|
Share-based
compensation to employees and service providers
|
10,212
|
|
4,202
|
|
3,027
|
Depreciation
|
1,914
|
|
1,710
|
|
997
|
Amortization and
impairment of intangible assets
|
16,235
|
|
7,035
|
|
216
|
Non-cash interest
expenses related to borrowing and payable in respect of intangible
assets purchase
|
5,366
|
|
6,032
|
|
—
|
Fair value adjustments
on derivative financial instruments
|
—
|
|
—
|
|
(344)
|
Fair value (gains)
losses on financial assets at fair value through profit or
loss
|
5
|
|
94
|
|
(27)
|
Exchange differences
and revaluation of bank deposits
|
118
|
|
101
|
|
24
|
|
33,850
|
|
19,174
|
|
3,893
|
Changes in assets and
liability items:
|
|
|
|
|
|
Increase in trade
receivables
|
(3,021)
|
|
(27,439)
|
|
(258)
|
Decrease (increase) in
prepaid expenses and other receivables
|
860
|
|
(3,277)
|
|
(368)
|
Increase in
inventories
|
(8,285)
|
|
(4,644)
|
|
(1,113)
|
Increase in accounts
payable
|
111
|
|
7,369
|
|
860
|
Increase (decrease) in
accrued expenses and other liabilities
|
(3,186)
|
|
19,335
|
|
(2,726)
|
Increase in allowance
for deductions from revenue
|
12,368
|
|
17,076
|
|
1,267
|
|
(1,153)
|
|
8,420
|
|
(2,338)
|
Net cash used in
operating activities
|
(65,047)
|
|
(48,579)
|
|
(40,749)
|
INVESTING
ACTIVITIES:
|
|
|
|
|
|
Purchase of fixed
assets
|
(115)
|
|
(406)
|
|
(168)
|
Purchase of intangible
assets
|
—
|
|
(53,368)
|
|
(35)
|
Change in investment in
current bank deposits
|
(8,500)
|
|
10,200
|
|
(2,069)
|
Purchase of financial
assets at fair value through profit or loss
|
—
|
|
—
|
|
(4,325)
|
Proceeds from sale of
financial assets at fair value through profit or loss
|
475
|
|
7,925
|
|
11,761
|
Net cash provided by
(used in) investing activities
|
(8,140)
|
|
(35,649)
|
|
5,164
|
FINANCING
ACTIVITIES:
|
|
|
|
|
|
Proceeds from long-term
borrowings, net of transaction costs
|
—
|
|
78,061
|
|
—
|
Proceeds from issuance
of ordinary shares, net of issuance costs
|
78,536
|
|
23,867
|
|
36,300
|
Exercise of options
into ordinary shares
|
4,006
|
|
52
|
|
5
|
Repayment of payable in
respect of intangible asset purchase
|
(7,397)
|
|
—
|
—
|
—
|
Increase in restricted
cash
|
—
|
|
(20,000)
|
—
|
—
|
Decrease in restricted
cash
|
—
|
|
4,000
|
|
—
|
Payment of principal
with respect to lease liabilities
|
(1,683)
|
|
(1,610)
|
|
(796)
|
Net cash provided by
financing activities
|
73,462
|
|
84,370
|
|
35,509
|
INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
275
|
|
142
|
|
(76)
|
EXCHANGE
DIFFERENCES ON CASH AND CASH EQUIVALENTS
|
(96)
|
|
130
|
|
94
|
BALANCE OF CASH
AND CASH EQUIVALENTS AT BEGINNING OF PERIOD
|
29,295
|
|
29,023
|
|
29,005
|
BALANCE OF CASH
AND CASH EQUIVALENTS AT END OF PERIOD
|
29,474
|
|
29,295
|
|
29,023
|
SUPPLEMENTARY
INFORMATION ON INTEREST RECEIVED IN CASH
|
47
|
|
414
|
|
753
|
SUPPLEMENTARY
INFORMATION ON INTEREST PAID IN CASH
|
11,280
|
|
6,654
|
|
251
|
SUPPLEMENTARY
INFORMATION ON NON-CASH INVESTING AND FINANCING
ACTIVITIES:
|
|
|
|
|
|
Acquisition of
right-of-use assets by means of lease liabilities
|
303
|
|
2,930
|
|
2,805
|
Purchase of
intangible assets posted as payable
|
—
|
|
24,619
|
|
—
|
Purchase of an
intangible asset in consideration for issuance of shares
|
—
|
|
1,914
|
|
11,788
|
[1] Excluding the effect of an approximately
$8.9 million impairment attributed to
the intangible asset of Aemcolo® in 2021, non-GAAP gross
profit would have been $45.3 million
and 2021 non-GAAP gross margin would have been 53%. On a GAAP
basis, 2021 gross profit was $36.4
million and gross margin was 42.0%.
[2] Including cash, cash equivalents, short-term
investments (bank deposits and financial assets at fair value) and
restricted cash.
[3] Subject to market conditions, including COVID-19
pandemic.
[4] All financial highlights are approximate and are
rounded to the nearest hundreds of thousands.
[5] Cash balances for the periods ended December 31, 2020, September 30, 2021, and December 31, 2021, include restricted cash of
$16 million.
[6] Opaganib is an investigational new drug, not
available for commercial distribution.
[7] Movantik® (naloxegol) is indicated for
opioid-induced constipation (OIC). Full prescribing information
see: www.movantik.com.
[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.
[10] RHB-107 (upamostat) is an investigational new drug,
not available for commercial distribution.
[11] RHB-204 is an investigational new drug, not
available for commercial distribution.
View original
content:https://www.prnewswire.com/news-releases/redhill-biopharma-reports-operational-highlights-and-fourth-quarter--full-year-2021-financial-results-301505002.html
SOURCE RedHill Biopharma Ltd.