RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”),
a specialty biopharmaceutical company, today reported its financial
results and operational highlights for the third quarter ended
September 30, 2020.
Dror Ben-Asher,
RedHill’s Chief Executive
Officer, said: “Despite
the challenging pandemic environment, we have shown the strength of
our commercial organization. Our extensive promotional efforts for
Talicia delivered 300% quarter-over-quarter prescription growth, as
well as rapid expansion of the prescriber base alongside national
payor coverage for 167 million Americans. Movantik prescriptions
grew for a second consecutive quarter - reversing the trend of
prescription decline prior to its acquisition by RedHill.”
Mr. Ben-Asher
continued: “Our global Phase 2/3
and U.S. Phase 2 studies with opaganib for COVID-19 are quickly
approaching completion and are supplemented by data demonstrating
opaganib’s complete inhibition of SARS-CoV-2 viral replication. We
have also initiated manufacturing ramp-up in preparation for
potential emergency use applications for opaganib in the first
quarter of 2021. We are initiating the Phase 3 study of RHB-204 as
an oral first-line therapy for pulmonary NTM infections, a disease
with a significant unmet need and no FDA-approved first-line
treatment.”
Micha Ben Chorin, Chief Financial
Officer at RedHill, added: “This has been another positive
quarter for the Company. We have significantly increased gross
profit from 32% in the second quarter to 51% thanks to our new
agreement with Daiichi Sankyo Inc. We expect the trend of
increasing Movantik prescriptions to continue. We are pleased with
the successful transition of Movantik from AstraZeneca and expect
savings in operating expenses, as well as higher distribution
service agreement fees to apply. We continue to effectively manage
our cash position and continue to work toward operational
break-even next year.”
Financial highlights for the
third quarter ended
September
30, 20201
Net Revenues of $20.9 million,
continuing at a similar level to that in the second quarter of
2020. The increase in gross revenues, as well as in the number of
scripts for Talicia and Movantik, were partially offset by the
voluntary discontinuation of our legacy products.
Cost of Revenues of $10.3
million, compared to $14.2 million in the second quarter of 2020.
The decrease was attributable to the reduced royalty rate payable
to Daiichi Sankyo, Inc. for Movantik following the new agreement
between the companies.
Gross Profit of $10.6 million,
compared to $6.7 million in the second quarter of 2020. Gross
profit of 51%, up from 32% in the second quarter, is attributable
to the lower royalties payable.
Research and Development
Expenses were $4.3 million, compared to $3.2 million in
the second quarter of 2020. The increase was primarily attributable
to the progression of the opaganib COVID-19 studies and to
initiation activities for the Phase 3 study with RHB-204 for NTM
infections.
Selling, Marketing and Business
Development Expenses were $13.4 million, compared to $10
million in the second quarter of 2020. The increase was primarily
attributable to the expansion of commercialization activities
related to Talicia and Movantik, as well as to the payment received
in the second quarter under the U.S. Small Business Administration
Payroll Protection Program (PPP) which was recorded as a reduction
in expenses.
General and Administrative
Expenses were $7.3 million, compared to $6 million in the
second quarter of 2020. The increase was primarily attributable to
the payment received in the second quarter under the PPP which was
recorded as a reduction from expenses.
Operating Loss was $14.5
million, compared to $12.5 million in the second quarter of 2020.
The increase was primarily attributable to the expansion of
commercialization activities related to Talicia and Movantik and
investment in the studies with opaganib and RHB-204, partially
offset by the increase in gross profit, as described above.
Net Loss was
$18.6 million, compared to $16 million in the second quarter of
2020. The increase was primarily attributable to the increase in
operating loss, as detailed above, and the increase in financing
expenses due to the financial liability related to the new
agreement with Daiichi Sankyo.
Net Cash Used in Operating
Activities was $9.2 million, compared to $15 million in
the second quarter of 2020. The decrease was primarily attributable
to positive changes in working capital.
Net Cash Provided by Financing
Activities was $12 million, compared to $5.5
million in the second quarter of 2020. The increase was primarily
attributable to the increase in proceeds from the Company’s
“at-the-market” (ATM) facility and a reduction in restricted
cash.
Liquidity and Capital
Resources
Cash Balance2
as of September 30, 2020, was $50.9 million, compared to $53.1
million as of June 30, 2020. The decrease was primarily
attributable to the net cash used in operating activities, as
detailed above, partially offset by proceeds of $9.1 million from
the Company’s ATM in the third quarter of 2020.
Subsequent to September 30, 2020, and through
November 11, 2020, 240,614 American Depositary Shares (ADSs) of the
Company were issued under the Company’s ATM facility, generating
additional net proceeds of approximately $2.3 million.
Commercial
Highlights:
Movantik®
(naloxegol)3The
Company has completed the transition of Movantik from AstraZeneca
and achieved two consecutive full quarters of RedHill-led
prescription. Additionally, the Company has targeted a larger
prescriber base that has driven a 2.1% increase in unique
prescribers of Movantik. This growth reverses a steady decline in
prescriptions prior to RedHill acquiring the rights to Movantik,
representing a shift in the trend and pointing to both a successful
transition by RedHill and the prospects for continuing growth for
Movantik.
RedHill acquired the global rights to Movantik
from AstraZeneca, excluding Europe and Canada, and has, this
quarter, replaced a co-commercialization agreement with Daiichi
Sankyo (assigned under the agreement with AstraZeneca), with a new
royalty-bearing agreement that resulted in RedHill assuming full
control over brand strategy and commercialization activities for
Movantik in the U.S. and increasing gross margin.
Talicia®
(omeprazole magnesium, amoxicillin and
rifabutin)4Since RedHill
launched Talicia in the U.S. in March 2020, the Company has focused
its efforts on the groundwork needed for ongoing and rapid growth,
including expansion of the prescriber base. This has resulted in a
300% quarter-on-quarter increase in Talicia prescriptions. This
growth is supported by major additions of Talicia as a preferred
brand on leading national formularies - achieving coverage for 167
million lives in the commercial and governmental segments. Further
formulary additions are expected in the near future, in addition to
the previously announced listings of Talicia on the national
formularies of Prime Therapeutics, EnvisionRx, and Express
Scripts.
R&D Highlights
COVID-19 (SARS-CoV-2) Program:
Opaganib
(ABC294640,
Yeliva®)5Following
encouraging compassionate use results published6 last quarter, the
late-stage development program for opaganib in patients with severe
COVID-19 pneumonia has progressed rapidly. The Company is currently
enrolling patients in two randomized, double-blind, parallel-arm,
placebo-controlled studies with opaganib in patients with severe
COVID-19 pneumonia requiring hospitalization and treatment with
supplemental oxygen:
- Enrollment in the U.S. Phase 2
study (NCT04414618) is over 90% complete and top-line data is
expected before the end of this year, subject to recruitment
completion. The study has passed two pre-scheduled safety reviews
by an independent Safety Monitoring Committee (SMC) with unanimous
recommendations to continue the study without change.
- A global Phase 2/3 study
(NCT04467840) is advancing rapidly and is approaching 50%
enrollment. Approved in six countries and active across 20 clinical
sites to date, the study is on track to enroll up to 270
patients.
- The studies are intended to support
potential emergency use applications as early as the first quarter
of 2021, subject to positive results.
On September 8, 2020, RedHill announced that
opaganib demonstrated potent inhibition of SARS-CoV-2, achieving
complete blockage of viral replication, as measured after three
days incubation, in an in vitro model of human bronchial tissue,
comparing favorably with remdesivir, the positive control in the
study. Furthermore, treatment of cells infected with SARS-CoV-2
with opaganib did not compromise cell membrane integrity, a measure
of cell viability and drug safety, further demonstrating opaganib’s
promising potential for treating patients with COVID-19.
The Company also entered into collaborations
with European and Canadian suppliers for large-scale ramp-up of
opaganib manufacturing in preparation for potential emergency use
authorizations, further strengthening manufacturing capabilities
and capacity for opaganib. RedHill continues to expand
manufacturing capacity with additional supply agreements expected
to be finalized in the coming weeks.
The Company continues its discussions with U.S.
and other government agencies and non-governmental organizations
around potential funding to support the rapid advancement of
opaganib toward potential emergency use applications and
manufacturing scale-up. In September 2020, opaganib was awarded a
grant from Pennsylvania’s COVID-19 Vaccines, Treatments and
Therapies Program, which supports the rapid advancement of
promising novel COVID-19 therapies.
COVID-19 (SARS-CoV-2) Program:
RHB-107
(upamostat)7In
recently released in vitro results, RedHill’s second COVID-19 drug
candidate, RHB-107, a novel, orally-administered serine protease
inhibitor, strongly inhibited SARS-CoV-2 viral replication. The
Company has submitted an Investigational New Drug (IND) application
to the FDA for a U.S. Phase 2/3 study with RHB-107 in moderate
COVID-19 patients treated in an outpatient setting, a different
population to opaganib which is being evaluated in hospitalized
patients with severe COVID-19 disease. The study is planned to be
initiated early in 2021.
RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM)
InfectionsRedHill announced in July 2020 that the U.S. FDA
had cleared its IND application for a Phase 3 study to evaluate the
efficacy and safety of RHB-204 in adults with pulmonary NTM disease
caused by Mycobacterium avium Complex (MAC) infection.
RedHill is currently initiating the Phase 3 study of RHB-204 in the
U.S. The study aims to enroll 125 patients in up to 40 sites across
the U.S.
The Company recently announced that RHB-204 had
been granted FDA Orphan Drug Designation. This, along with
RHB-204’s previously granted QIDP designation, extends U.S. market
exclusivity for RHB-204 to a potential total of 12 years upon FDA
approval.
Opaganib -
Cholangiocarcinoma and prostate cancer The Phase
2a study evaluating the activity of opaganib in advanced
cholangiocarcinoma (bile duct cancer) is ongoing. Enrollment has
been completed for the first cohort of 39 patients, evaluating the
activity of orally-administered opaganib as a stand-alone
treatment. Preliminary data from this cohort indicated a signal of
activity in a number of subjects with advanced cholangiocarcinoma,
and in light of these data, input from key opinion leaders and
preclinical research that had been conducted at Mayo Clinic,
RedHill initiated enrollment for a second cohort, evaluating
opaganib in combination with hydroxychloroquine, an anti-autophagy
agent.
In light of preclinical findings demonstrating
that treatment with opaganib and RHB-107 (upamostat, WX-671) in
combination resulted in tumor regression, RedHill plans to add an
additional cohort to the ongoing Phase 2a study, evaluating
opaganib in combination with RHB-107, subject to discussions with
the FDA.
RedHill recently announced that it had received
a Notice of Allowance from the United States Patent and Trademark
Office (USPTO) for a new patent application related to the use of
opaganib and RHB-107 for the treatment of solid tumor cancers. The
patent is expected to extend IP protection for the combination
until 2036.
An additional Phase 2 study with opaganib in
prostate cancer is ongoing at the Medical University of South
Carolina (MUSC). The study is supported by a National Cancer
Institute grant awarded to MUSC with additional support from
RedHill.
Exclusive Licensing and Manufacturing
Agreement with Cosmo PharmaceuticalsRedHill announced in
August 2020 that it had entered into a binding term sheet with
Cosmo Pharmaceuticals N.V. (SIX: COPN) (Cosmo) for an exclusive
licensing and manufacturing agreement for multiple products.
COVID-19
Impact Update
RedHill’s primary concern during the COVID-19
pandemic continues to be the safety and protection of its
employees, patients, colleagues, and the communities to which we
belong.
Operationally, the actions the Company took to
mitigate the impact of the COVID-19 pandemic continue to serve us
well, with minimal effect on our ongoing operational and supply
chain activities. Promotional activity has now been largely
re-instated where safe to do so, and in adherence to social
distancing and other public health guidelines. RedHill will
continue to assess the potential impact of COVID-19 on its business
and operations.
Conference Call and Webcast
Information:
The Company will host a conference call and live
webcast today,
Thursday,
November 12,
2020, at 8:30
a.m. EST to present the
third quarter financial results and operational highlights.
The webcast and accompanying slides will be
broadcast live on the Company's website:
http://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: 4549918.
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 adults8, Talicia for the treatment
of Helicobacter pylori (H. pylori) infection in adults9, and
Aemcolo® for the treatment of
travelers’ diarrhea in adults10. RedHill’s key clinical late-stage
development programs include: (i) RHB-204, with a
planned Phase 3 study for pulmonary nontuberculous mycobacteria
(NTM) infections; (ii) opaganib
(Yeliva®),
a first-in-class SK2 selective
inhibitor targeting multiple indications with a Phase 2/3 program
for COVID-19 and Phase 2 studies for prostate cancer and
cholangiocarcinoma ongoing; (iii) RHB-104, with
positive results from a first Phase 3 study for Crohn's disease;
(iv) RHB-102
(Bekinda®), with positive results
from a Phase 3 study for acute gastroenteritis and gastritis and
positive results from a Phase 2 study for IBS-D; (v)
RHB-107, a Phase 2-stage first-in-class, serine
protease inhibitor, targeting cancer and inflammatory
gastrointestinal diseases and is also being evaluated for COVID-19
and (vi) RHB-106, an encapsulated
bowel preparation. More information about the Company is available
at www.redhillbio.com.
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. 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 of a delay in
the closing of the exclusive licensing and manufacturing agreement
with Cosmo, the risk that the transaction with Cosmo will close on
different terms than the terms of the binding term sheet, if it
will close at all; the risk that the U.S. Phase 2 clinical study
evaluating opaganib will not be successful and the risk of delay in
the completion of the enrollment for this study; the risk that the
Company will not expand the Phase 2/3 study to additional
countries; the risk of a delay in the date that the Phase 2 study
and Phase 2/3 study will deliver data for emergency use
applications, if at all; the development risks of early-stage
discovery efforts for a disease that is still little understood,
including difficulty in assessing the efficacy of opaganib for the
treatment of COVID-19, if at all; intense competition from other
companies developing potential treatments and vaccines for
COVID-19; the effect of a potential occurrence of patients
suffering serious adverse events using opaganib under the
compassionate use programs; the risk of a delay in the enrollment
of the Phase 3 study with RHB-204 and that the study will not be
successful; the risk of delay in initiation of the U.S. Phase 2/3
study with RHB-107 in patients with moderate COVID-19 treated in an
outpatient setting; the risk that the Company will not succeed to
show operational break-even next year, 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®, 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, preclinical 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
continued employment 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 4, 2020. 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.
REDHILL BIOPHARMA
LTD.CONDENSED CONSOLIDATED INTERIM STATEMENTS OF
COMPREHENSIVE LOSS(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
September 30, |
|
|
September 30, |
|
|
2020 |
|
2019 |
|
|
|
2020 |
|
2019 |
|
|
|
|
|
|
U.S. dollars in thousands |
NET
REVENUES |
|
20,943 |
|
1,401 |
|
|
|
42,898 |
|
4,701 |
|
COST OF
REVENUES |
|
10,337 |
|
629 |
|
|
|
26,240 |
|
1,471 |
|
GROSS
PROFIT |
|
10,606 |
|
772 |
|
|
|
16,658 |
|
3,230 |
|
RESEARCH AND DEVELOPMENT
EXPENSES, net |
|
4,323 |
|
2,799 |
|
|
|
10,302 |
|
15,143 |
|
SELLING, MARKETING AND
BUSINESS DEVELOPMENT EXPENSES |
|
13,414 |
|
4,892 |
|
|
|
32,384 |
|
12,175 |
|
GENERAL AND
ADMINISTRATIVE EXPENSES |
|
7,329 |
|
2,925 |
|
|
|
17,948 |
|
7,349 |
|
OPERATING
LOSS |
|
14,460 |
|
9,844 |
|
|
|
43,976 |
|
31,437 |
|
FINANCIAL
INCOME |
|
42 |
|
170 |
|
|
|
339 |
|
1,075 |
|
FINANCIAL
EXPENSES |
|
4,220 |
|
161 |
|
|
|
8,205 |
|
251 |
|
FINANCIAL EXPENSES
(INCOME), net |
|
4,178 |
|
(9 |
) |
|
|
7,866 |
|
(824 |
) |
LOSS AND COMPREHENSIVE
LOSS FOR THE PERIOD |
|
18,638 |
|
9,835 |
|
|
|
51,842 |
|
30,613 |
|
|
|
|
|
|
|
|
|
|
|
LOSS PER ORDINARY
SHARE, basic and diluted (U.S.
dollars): |
|
0.05 |
|
0.03 |
|
|
|
0.14 |
|
0.11 |
|
WEIGHTED AVERAGE OF
ORDINARY SHARES (in thousands) |
|
372,893 |
|
283,687 |
|
|
|
359,428 |
|
283,687 |
|
REDHILL BIOPHARMA LTD.CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
Unaudited
Audited |
|
|
|
U.S. dollars in thousands |
CURRENT
ASSETS: |
|
|
|
|
|
Cash and cash equivalents |
|
|
26,198 |
|
|
29,023 |
|
Bank deposits |
|
|
6,187 |
|
|
10,349 |
|
Financial assets at fair value through profit or loss |
|
|
2,407 |
|
|
8,500 |
|
Trade receivables |
|
|
12,424 |
|
|
1,216 |
|
Prepaid expenses and other receivables |
|
|
4,635 |
|
|
2,244 |
|
Inventory |
|
|
5,100 |
|
|
1,882 |
|
|
|
|
56,951 |
|
|
53,214 |
|
NON-CURRENT
ASSETS: |
|
|
|
|
|
Restricted cash |
|
|
16,153 |
|
|
152 |
|
Fixed assets |
|
|
473 |
|
|
228 |
|
Right-of-use assets |
|
|
5,448 |
|
|
3,578 |
|
Intangible assets |
|
|
89,956 |
|
|
16,927 |
|
|
|
|
112,030 |
|
|
20,885 |
|
TOTAL
ASSETS |
|
|
168,981 |
|
|
74,099 |
|
|
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES: |
|
|
|
|
|
Accounts payable |
|
|
6,569 |
|
|
4,184 |
|
Lease liabilities |
|
|
1,546 |
|
|
834 |
|
Accrued expenses and other current liabilities |
|
|
23,536 |
|
|
5,598 |
|
|
|
|
31,651 |
|
|
10,616 |
|
|
|
|
|
|
|
NON-CURRENT
LIABILITIES: |
|
|
|
|
|
Borrowing |
|
|
80,266 |
|
|
— |
|
Payable in respect of intangible assets purchase |
|
|
23,739 |
|
|
— |
|
Lease liabilities |
|
|
4,079 |
|
|
2,981 |
|
Royalty obligation |
|
|
500 |
|
|
500 |
|
|
|
|
108,584 |
|
|
3,481 |
|
TOTAL
LIABILITIES |
|
|
140,235 |
|
|
14,097 |
|
|
|
|
|
|
|
|
|
|
|
|
|
EQUITY: |
|
|
|
|
|
Ordinary shares |
|
|
1,025 |
|
|
962 |
|
Additional paid-in capital |
|
|
284,806 |
|
|
267,403 |
|
Accumulated deficit |
|
|
(257,085 |
) |
|
(208,363 |
) |
TOTAL
EQUITY |
|
|
28,746 |
|
|
60,002 |
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
EQUITY |
|
|
168,981 |
|
|
74,099 |
|
REDHILL BIOPHARMA LTD.CONDENSED
CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Nine Months Ended |
|
|
September 30, |
|
September 30, |
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
U.S. dollars in thousands |
OPERATING
ACTIVITIES: |
|
|
|
|
|
|
|
|
Comprehensive loss |
|
(18,638 |
) |
|
(9,835 |
) |
|
(51,842 |
) |
|
(30,613 |
) |
Adjustments in respect of income and expenses not involving cash
flow: |
|
|
|
|
|
|
|
|
Share-based compensation to employees and service providers |
|
1,695 |
|
|
782 |
|
|
3,120 |
|
|
2,278 |
|
Depreciation |
|
470 |
|
|
288 |
|
|
1,237 |
|
|
744 |
|
Amortization and impairment of intangible assets |
|
2,109 |
|
|
— |
|
|
4,958 |
|
|
— |
|
Unpaid interest expenses related to borrowing and payable in
respect of intangible assets purchase |
|
2,039 |
|
|
— |
|
|
3,656 |
|
|
— |
|
Fair value adjustments on derivative financial instruments |
|
— |
|
|
(5 |
) |
|
— |
|
|
(336 |
) |
Fair value losses (gains) on financial assets at fair value through
profit or loss |
|
31 |
|
|
14 |
|
|
68 |
|
|
(73 |
) |
Exchange differences and revaluation of bank deposits |
|
5 |
|
|
180 |
|
|
(160 |
) |
|
112 |
|
|
|
6,349 |
|
|
1,259 |
|
|
12,879 |
|
|
2,725 |
|
Changes in assets and liability items: |
|
|
|
|
|
|
|
|
Decrease (increase) in trade receivables |
|
6,146 |
|
|
110 |
|
|
(11,208 |
) |
|
105 |
|
Decrease (increase) in prepaid expenses and other receivables |
|
235 |
|
|
(23 |
) |
|
(2,391 |
) |
|
(462 |
) |
Increase in inventories |
|
(350 |
) |
|
(135 |
) |
|
(3,218 |
) |
|
(1,192 |
) |
Increase (decrease) in accounts payable |
|
1,261 |
|
|
51 |
|
|
2,385 |
|
|
1,470 |
|
Increase (decrease) in accrued expenses and other current
liabilities |
|
(4,174 |
) |
|
(321 |
) |
|
17,521 |
|
|
1,087 |
|
|
|
3,118 |
|
|
(318 |
) |
|
3,089 |
|
|
1,008 |
|
Net cash used in operating activities |
|
(9,171 |
) |
|
(8,894 |
) |
|
(35,874 |
) |
|
(26,880 |
) |
INVESTING
ACTIVITIES: |
|
|
|
|
|
|
|
|
Purchase of fixed assets |
|
(166 |
) |
|
(1 |
) |
|
(357 |
) |
|
(135 |
) |
Purchase of intangible assets |
|
(735 |
) |
|
— |
|
|
(53,368 |
) |
|
— |
|
Change in investment in current bank deposits |
|
— |
|
|
6,000 |
|
|
4,200 |
|
|
4,931 |
|
Purchase of financial assets at fair value through profit or
loss |
|
— |
|
|
(9 |
) |
|
— |
|
|
(2,584 |
) |
Proceeds from sale of financial assets at fair value through profit
or loss |
|
2,075 |
|
|
5,748 |
|
|
6,025 |
|
|
7,848 |
|
Net cash provided by (used in) investing
activities |
|
1,174 |
|
|
11,738 |
|
|
(43,500 |
) |
|
10,060 |
|
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from issuance of ordinary shares, net of issuance
costs |
|
9,137 |
|
|
— |
|
|
15,500 |
|
|
— |
|
Exercise of options into ordinary shares |
|
53 |
|
|
— |
|
|
53 |
|
|
— |
|
Proceeds from long-term borrowings, net of transaction costs |
|
(784 |
) |
|
— |
|
|
78,061 |
|
|
— |
|
Increase in restricted cash |
|
— |
|
|
— |
|
|
(20,000 |
) |
|
— |
|
Decrease in restricted cash |
|
4,000 |
|
|
|
|
4,000 |
|
|
|
Payment of principal with respect to lease liabilities |
|
(450 |
) |
|
(206 |
) |
|
(1,186 |
) |
|
(591 |
) |
Net cash provided by (used in) financing
activities |
|
11,956 |
|
|
(206 |
) |
|
76,428 |
|
|
(591 |
) |
INCREASE (DECREASE)
IN CASH AND CASH EQUIVALENTS |
|
3,959 |
|
|
2,638 |
|
|
(2,946 |
) |
|
(17,411 |
) |
EXCHANGE DIFFERENCES ON CASH AND CASH
EQUIVALENTS |
|
(33 |
) |
|
1 |
|
|
121 |
|
|
40 |
|
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF
PERIOD |
|
22,272 |
|
|
8,995 |
|
|
29,023 |
|
|
29,005 |
|
BALANCE OF CASH AND CASH
EQUIVALENTS AT END OF PERIOD |
|
26,198 |
|
|
11,634 |
|
|
26,198 |
|
|
11,634 |
|
SUPPLEMENTARY
INFORMATION ON INTEREST RECEIVED IN CASH |
|
71 |
|
|
284 |
|
|
320 |
|
|
609 |
|
SUPPLEMENTARY
INFORMATION ON INTEREST PAID IN CASH |
|
2,147 |
|
|
48 |
|
|
4,507 |
|
|
71 |
|
SUPPLEMENTARY INFORMATION ON NON-CASH INVESTING AND
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Acquisition of right-of-use
assets by means of lease liabilities |
|
533 |
|
|
— |
|
|
2,738 |
|
|
2,681 |
|
Purchase of intangible assets
posted as payable |
|
12,511 |
|
|
— |
|
|
24,619 |
|
|
— |
|
Purchase of an intangible
asset in consideration for issuance of shares |
|
1,914 |
|
|
— |
|
|
1,914 |
|
|
— |
|
____________________________
1All financial highlights are approximate and
are rounded to the nearest hundreds of thousands.2Including cash,
short-term investments (bank deposits and financial assets at fair
value) and restricted cash.3Movantik® (naloxegol) is indicated for
opioid-induced constipation (OIC). Full prescribing information
see: www.movantik.com.4Talicia® (omeprazole magnesium, amoxicillin
and rifabutin) is indicated for the treatment of H. pylori
infection in adults. For full prescribing information see:
www.Talicia.com.5Opaganib (ABC294640, Yeliva®) is an
investigational new drug, not available for commercial
distribution.6The article was authored by Ramzi Kurd, MD,
Shaare-Zedek Medical Center; Eli Ben-Chetrit, MD, Shaare-Zedek
Medical Center and Hebrew University Faculty of Medicine; Hani
Karameh MD, Shaare-Zedek Medical Center and Maskit Bar-Meir, MD,
Shaare-Zedek Medical Center and Hebrew University Faculty of
Medicine. See full text here:
https://www.medrxiv.org/content/10.1101/2020.06.20.20099010v1?rss=1.7RHB-107
(upamostat) is an investigational new drug, not available for
commercial distribution.8Full prescribing information for Movantik®
(naloxegol) is available at: www.Movantik.com. 9Full
prescribing information for Talicia® (omeprazole magnesium,
amoxicillin and rifabutin) is available at: www.Talicia.com.
10Full prescribing information for Aemcolo®
(rifamycin) is available at: www.Aemcolo.com.
Company contact:
Adi Frish
Chief Corporate and Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
Media contact (U.S.):
Bryan Gibbs
Vice President
Finn Partners
+1 212 529 2236
bryan.gibbs@finnpartners.com
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