- RedHill maintains a strong
and debt-free balance sheet with approximately $66 million in cash
and cash equivalents at the end of 2016, allowing the Company to
continue to execute its development and U.S. commercialization plans
Select 2016
milestones include:
- Successful final results
from the first Phase III study with RHB-105 for the treatment
of H.
pylori infection
- Positive and unanimous
independent DSMB recommendation for the continuation of the Phase
III study with RHB-104 for Crohn's disease (the MAP US
study)
- Encouraging top-line final
results from the Phase IIa proof-of-concept study with RHB-104 for
relapsing-remitting multiple sclerosis
- Exclusive U.S. co-promotion
agreement with Concordia for gastrointestinal drug
Donnatal®
Select
potential milestones expected in 2017:
- Initiation of a
confirmatory Phase III study with RHB-105 for the treatment
of H. pylori infection, expected
in Q2/2017
- Second independent DSMB
meeting for the MAP US Phase III study with RHB-104 for Crohn's
disease, including an interim efficacy analysis and an evaluation
of an option for early stop for success for overwhelming efficacy,
expected in Q2/2017
- Top-line results from the
BEKINDA® Phase
III study for gastroenteritis (the GUARD study), expected in
Q2/2017
- Top-line results from the
BEKINDA® Phase II
study for IBS-D, expected mid-2017
- Initiation of promotional
activities for Donnatal® in selected U.S.
territories
TEL-AVIV, Israel, Feb. 23, 2017 (GLOBE NEWSWIRE)
-- RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or
the "Company"), a specialty biopharmaceutical company primarily
focused on the development and commercialization of late
clinical-stage, proprietary, orally-administered, small molecule
drugs for gastrointestinal and inflammatory diseases and cancer,
today reported its financial results for the fourth quarter and
full-year ended December 31, 2016.
Fourth
Quarter 2016 Results1
Revenues for the fourth quarter of 2016
were $0.1 million, compared to immaterial revenues for the fourth
quarter of 2015.
Research and Development Expenses for
the fourth quarter of 2016 were $7.5 million, up 51% compared to
the fourth quarter of 2015. The increase was mainly due to the
ongoing Phase III and Phase II studies with BEKINDA® for
gastroenteritis and IBS-D, respectively, the ongoing Phase III
study with RHB-104 for Crohn's disease and ongoing studies with
YELIVA® for
multiple indications.
General, Administrative and Business Development
Expenses for the fourth quarter of 2016 were
$1.6 million, down 6.9% compared to the fourth quarter of 2015. The
decrease was mainly due to a decrease in professional services.
Operating Loss for the fourth quarter of
2016 was $9 million, up 33% compared to the fourth quarter of 2015.
The increase was mainly due to an increase in research and
development expenses, as detailed above.
Financial Income, net for the fourth quarter of 2016 was
$0.6 million, up 214%, compared to the fourth quarter of 2015. The
increase was mainly due to a fair value gain on derivative
financial instruments.
Net Cash Used in Operating
Activities for the fourth quarter of 2016 was
$10.1 million, up 69% compared to the fourth quarter of 2015. The
increase was mainly due to the increase in operating loss, as
detailed above.
Net Cash Provided by Investment
Activities for the fourth quarter of 2016 was
$21.3 million, up 206% compared to the fourth quarter of 2015. The
increase was mainly due to maturity of bank deposits.
Net Cash Provided by Financing
Activities for the fourth quarter of 2016 was
$35.9 million compared to an immaterial amount for the fourth
quarter of 2015. The increase was mainly due to the December 2016
public offering.
Full-Year
2016 Results2
Revenues for 2016 were $0.1 million,
compared to immaterial revenues in 2015.
Research and Development Expenses for
2016 were $25.2 million, up 42% compared to 2015. The increase was
mainly due to the ongoing Phase III MAP US study with RHB-104 for
Crohn's disease, the ongoing Phase III and Phase II studies with
BEKINDA® for
gastroenteritis and IBS-D, respectively, and the ongoing studies
with YELIVA® for
multiple indications.
General, Administrative and Business Development
Expenses for 2016 were $5.4 million, up 31%
compared to 2015. The increase was mainly due to an increase in
professional services, compensation and other operating
expenses.
Operating Loss for 2016 was $30.5
million, up 39% compared to 2015. The increase was mainly due to an
increase in research and development expenses, as detailed
above.
Financial Income, net for 2016 was $1.2 million, up 29%
compared to 2015. The increase was mainly due to a fair value gain
on derivative financial instruments.
Net Cash Used in Operating
Activities for 2016 was $28.2 million, up 59%
compared to 2015. The increase was mainly due to an increase in
operating loss, as detailed above.
Net Cash Provided by Investment
Activities for 2016 was $24.5 million, up 215%
compared to 2015. The difference was mainly due to maturity
of bank deposits.
Net Cash Provided by Financing
Activities for 2016 was $36 million, down 34%
compared to 2015. The decrease resulted primarily from the two
public offerings in February and July 2015 of the comparable
period.
Cash Balance3 as of
December 31, 2016 was $66.3 million, an increase of $8.2 million
compared to $58.1 million as of December 31, 2015 and an increase
of $25.8 million compared to $40.5 million as of September 30,
2016.
Micha Ben
Chorin, RedHill's CFO, said: "Our strong cash
position of approximately $66 million at the end of 2016 should
allow us to continue to execute our strategic plans for 2017. We
are looking forward to an important year ahead, including the
planned initiation of a confirmatory Phase III study with RHB-105
for H. pylori infection, a second
independent DSMB meeting for the ongoing MAP US Phase III study
with RHB-104 for Crohn's disease, top-line results from the ongoing
Phase III and Phase II studies with BEKINDA® for
gastroenteritis and IBS-D, respectively, and commencement of our
promotional activities in the U.S. with Donnatal®."
Conference
Call and Webcast Information:
The Company will host a conference
call on Thursday, February 23, 2017, at
9:00 am EST to review the financial results and
business highlights.
To participate in the conference
call, please dial the following numbers 5-10 minutes prior to the
start of the call: United States:
+1-877-280-1254; International: +1-646-254-3366; and Israel:
+972-3-763-0145. The access code for the call is
4402478.
The
conference call will be broadcasted live and available for replay
on the Company's
website, http://ir.redhillbio.com/events.cfm, for 30
days. Please access the Company's website at least 15 minutes ahead
of the conference to register, download, and install any necessary
audio software.
Select 2016
and recent operational highlights:
RHB-105
- H. pylori bacterial infection
(confirmatory Phase III) (QIDP status)
Following the announcement of the successful final results from a
first Phase III clinical study with RHB-105 for the eradication
of H. pylori infection (the
ERADICATE Hp study) in March 2016, RedHill concluded two positive
Type B meetings with the U.S. Food and Drug Administration (FDA)
regarding RHB-105. The first meeting, announced in April 2016,
confirmed the path to marketing approval of RHB-105 and the planned
confirmatory Phase III study. A second Type B meeting, announced in
November 2016, discussed the chemistry, manufacturing and controls
(CMC) aspects of the RHB-105 Phase III development program towards
filing the CMC package as part of the potential U.S. New Drug
Application (NDA) to be submitted for RHB-105, subject to
successful completion of the planned confirmatory Phase III
study.
The two-arm, randomized,
double-blind, active comparator confirmatory Phase III study,
comparing RHB-105 against a dual therapy amoxicillin and omeprazole
regimen at equivalent doses, is planned to be initiated in the
second quarter of 2017, subject to the successful completion of the
ongoing supportive pharmacokinetic (PK) program and submission of
the Clinical Study Report to the FDA. The confirmatory Phase III
study is planned to enroll approximately 440 patients in up to 55
clinical sites in the U.S.
RHB-104 -
Crohn's disease (Phase III), multiple sclerosis (Phase IIa) and
nontuberculous mycobacteria (NTM) infections
In October 2016, RedHill provided
an update on the RHB-104 Phase III Crohn's disease development
program, planned enhancements to the ongoing MAP US Phase III study
and expected milestones, including an increase in the total number
of patients planned to be enrolled in the MAP US study from 270 to
410, and the addition of an open-label extension study offering
patients who complete 26 weeks of study participation and remain
out of remission (Crohn's disease active index (CDAI) >150) the
opportunity to receive treatment with RHB-104 for a 52-week period.
The open-label extension study is expected to be initiated in the
coming weeks.
Following a pre-planned review of
safety data from its ongoing MAP US study by an independent Data
and Safety Monitoring Board (DSMB), RedHill announced in December
2016 that it had received a unanimous recommendation to continue
the MAP US study as planned. A second independent DSMB meeting of
the MAP US study, expected in the second quarter of 2017, will
include an interim efficacy analysis and will evaluate the option
for an early stop for success for overwhelming efficacy, according
to a pre-specified statistical significance threshold.
Taking into account the increase
in the total number of patients planned in the MAP US study, and
assuming the MAP US study is not stopped for success or inefficacy
following the independent DSMB meeting in the second quarter of
2017, completion of recruitment is expected by the end of 2017.
In December 2016, RedHill
announced encouraging top-line final results of a Phase IIa,
proof-of-concept clinical study, evaluating RHB-104 as an add-on
therapy to interferon beta-1a in patients treated for relapsing
remitting multiple sclerosis (the CEASE MS study). The top-line
final results (48 weeks) were consistent with previously announced
interim results, suggesting meaningful positive safety and clinical
signals upon 24 weeks of treatment with RHB-104 as an add-on
therapy, thereby supporting further clinical development.
In January 2017, RedHill announced
that RHB-104 had been granted Qualified Infectious Disease Product
(QIDP) designation by the FDA for the treatment of nontuberculous
mycobacteria (NTM) infections. RedHill plans to consult with the
FDA regarding the RHB-104 development program for NTM
infections.
BEKINDA® (RHB-102)
- acute gastroenteritis and gastritis (Phase III) and IBS-D (Phase
II)
In February 2017, RedHill
announced that the last patient enrolled in the randomized,
double-blind, placebo-controlled Phase III clinical study with
BEKINDA® 24 mg in
the U.S. for acute gastroenteritis and gastritis (the GUARD study)
had completed the treatment course and observation period for the
primary endpoint evaluation. Top-line results are expected in the
second quarter of 2017.
A randomized, double-blind,
placebo-controlled Phase II clinical study with
BEKINDA® 12 mg
for the treatment of diarrhea-predominant irritable bowel syndrome
(IBS-D) is ongoing in the U.S. with top-line results expected in
mid-2017.
YELIVA® (ABC294640)
- Phase I/II studies for multiple oncology and inflammatory
indications
In June 2016, RedHill announced
positive final results from a Phase I study with YELIVA® in
patients with advanced solid tumors. The Phase I study, conducted
at the Medical University of South Carolina Hollings Cancer Center,
successfully met its primary and secondary endpoints, demonstrating
that the drug is well-tolerated and can be safely administered to
cancer patients at doses predicted to have therapeutic
activity.
In September 2016, RedHill
announced a research collaboration with Stanford University School
of Medicine for the evaluation of YELIVA®. The research
collaboration is intended to complement RedHill's planned Phase Ib
clinical study to evaluate YELIVA® as a
radioprotectant for prevention of mucositis in head and neck cancer
patients undergoing therapeutic radiotherapy. The Phase Ib study is
planned to be initiated in mid-2017.
In October 2016, RedHill announced
the initiation of a Phase II clinical study with YELIVA® for
advanced hepatocellular carcinoma at the Medical University of
South Carolina.
In December 2016, RedHill
announced that the first patient was dosed in a Phase Ib/II study
with YELIVA®for refractory
or relapsed multiple myeloma, conducted at Duke University Medical
Center.
A Phase I/II clinical study
evaluating YELIVA® in
patients with refractory/relapsed diffuse large B-cell lymphoma is
ongoing at the Louisiana State University Health Sciences Center
and was recently amended to address overall recruitment prospects
and to include Kaposi sarcoma patients in the study.
A Phase II study to evaluate the
efficacy of YELIVA® in
patients with moderate to severe ulcerative colitis is planned to
be initiated in the second half of
2017.
RIZAPORT® (RHB-103)
- acute migraines (approved for marketing in
Germany)
In 2016, RedHill and its
co-development partner, IntelGenx Corp., entered into exclusive
license agreements for the commercialization of RIZAPORT® oral
thin-film for acute migraines with Grupo JUSTE S.A.Q.F (now Exeltis
Healthcare, S.L.) for Spain and with Pharmatronic Co. for South
Korea.
Re-submission of the
RIZAPORT® NDA to
the FDA is expected in the third quarter of 2017.
MESUPRON
(upamostat) - Gastrointestinal and other solid
tumors
In January 2017, RedHill announced
the signing of a new collaboration agreement with the Department of
Molecular Biology and Genetics of Denmark-based Aarhus University
for the evaluation of RedHill's Phase II-stage oncology drug
candidate, MESUPRON. The new research collaboration follows
previous non-clinical studies conducted with Denmark's Aarhus
University and is designed to identify additional high affinity
molecular targets of MESUPRON. Further evaluation of MESUPRON,
together with Aarhus University, may allow for selection of
appropriate sub-populations of patients toward demonstrating the
activity of MESUPRON in planned clinical trials.
RedHill is currently preparing a
protocol for a Phase I/II study of the safety, efficacy and dose
evaluation of MESUPRON in combination with chemotherapy in patients
receiving adjuvant chemotherapy for resected pancreatic cancer. The
Phase I/II study is expected to be initiated in the second half of
2017 in up to six sites in Germany.
Donnatal® (Phenobarbital,
Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine
Hydrobromide)
As part of RedHill's strategic
initiative to become a revenue-generating,
gastrointestinal-focused, specialty pharmaceutical company with a
commercial presence in the U.S., the Company entered in January
2017 into an exclusive co-promotion agreement with a
subsidiary4 of
Concordia International Corp., granting RedHill certain U.S.
promotional rights for Donnatal®, a
prescription oral drug used with other drugs in the treatment of
irritable bowel syndrome (irritable colon, spastic colon, mucous
colitis) and acute enterocolitis (inflammation of the small
bowel)5. RedHill
expects to initiate promotion of Donnatal® in the
coming months.
Financial
Highlights
In December 2016, RedHill closed
an underwritten public offering and a registered direct offering of
American Depositary Shares (ADSs) and warrants to purchase ADSs for
aggregate net proceeds, after deducting underwriting discounts and
commissions, placement agent fees and other offering expenses, of
$35.9 million. Investors in the public offering included, among
others, Sabby Management, LLC, DAFNA Capital Management, Rosalind
Advisors, Inc., Koramic Holding, Lincoln Park Capital, and Nexthera
Capital LP.
About
Donnatal®:
Donnatal® (Phenobarbital, Hyoscyamine
Sulfate, Atropine Sulfate, Scopolamine Hydrobromide), a
prescription drug, is classified as possibly effective as an
adjunctive therapy in the treatment of irritable bowel syndrome
(irritable colon, spastic colon, mucous colitis) and acute
enterocolitis. Donnatal® slows
the natural movements of the gut by relaxing the muscles in the
stomach and intestines and acts on the brain to produce a calming
effect. Donnatal® comes in
two formulations: immediate release Donnatal® Tablets
and immediate release Donnatal® Elixir,
a fast acting liquid.
Donnatal® is
contraindicated in patients who have glaucoma, obstructive
uropathy, obstructive disease of the gastrointestinal tract,
paralytic ileus, unstable cardiovascular status, severe ulcerative
colitis, myasthenia gravis, hiatal hernia with reflux esophagitis,
or known hypersensitivity to any of the ingredients. Patients who
are pregnant or breast-feeding or who have autonomic neuropathy,
hepatic or renal disease, hyperthyroidism, coronary heart disease,
congestive heart failure, cardiac arrhythmias, tachycardia or
hypertension should notify their doctor before taking
Donnatal®. Side effects
may include: dryness of the mouth, urinary retention, blurred
vision, dilation of pupils, rapid heartbeat, loss of sense of
taste, headache, nervousness, drowsiness, weakness, dizziness,
insomnia, nausea, vomiting and allergic reactions which may be
severe.
Further information, including
prescribing information, can be found on www.donnatal.com.
Please see the following website
for important safety information about Donnatal®: http://www.donnatal.com/professionals/important-safety-information/
About
RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) is a specialty
biopharmaceutical company headquartered in Israel, primarily
focused on the development and commercialization of late
clinical-stage, proprietary, orally-administered, small molecule
drugs for the treatment of gastrointestinal and inflammatory
diseases and cancer. RedHill has a U.S. co-promotion agreement with
Concordia for Donnatal®, a
prescription oral adjunctive drug used in the treatment of IBS and
acute enterocolitis. RedHill's clinical-stage pipeline includes:
(i) RHB-105 - an oral combination therapy for the
treatment of Helicobacter
pylori infection with successful results from a first
Phase III study; (ii) RHB-104 - an oral combination therapy for the
treatment of Crohn's disease with an ongoing first Phase III study,
a completed proof-of-concept Phase IIa study for multiple sclerosis
and QIDP status for nontuberculous mycobacteria (NTM) infections;
(iii) BEKINDA® (RHB-102) - a
once-daily oral pill formulation of ondansetron with an ongoing
Phase III study for acute gastroenteritis and gastritis and an
ongoing Phase II study for IBS-D; (iv) RHB-106 - an encapsulated bowel preparation licensed
to Salix Pharmaceuticals, Ltd.; (v) YELIVA® (ABC294640) - a
Phase II-stage, orally-administered, first-in-class SK2 selective
inhibitor targeting multiple oncology, inflammatory and
gastrointestinal indications; (vi) MESUPRON - a Phase II-stage first-in-class,
orally-administered uPA inhibitor, targeting gastrointestinal and
other solid tumors and (vii) RIZAPORT® (RHB-103)
- an oral thin film formulation of rizatriptan for
acute migraines, with a U.S. NDA currently under discussion with
the FDA and marketing authorization received in Germany in October
2015. 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, risks and uncertainties associated with (i) the
initiation, timing, progress and results of the Company's research,
manufacturing, preclinical studies, clinical trials, and other
therapeutic candidate development efforts; (ii) the Company's
ability to advance its therapeutic candidates into clinical trials
or to successfully complete its preclinical studies or clinical
trials; (iii) the extent and number 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; (v) the
Company's ability to successfully market Donnatal®, (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 of 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; and (xii) estimates of the
Company's expenses, future revenues capital requirements and the
Company's needs for additional financing; (xiii) competitive
companies and technologies within the Company's industry. 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 February 25,
2016. All forward-looking statements included in this Press Release
are made only as of the date of this Press Release. We assume no
obligation to update any written or oral forward-looking statement
unless required by law.
1 All
financial highlights are approximate and are rounded to the nearest
hundreds of thousands.
2 All
financial highlights are approximate and are rounded to the nearest
hundreds of thousands.
3 Including
cash and short-term investments.
4 Concordia
Pharmaceuticals Inc.
5 Donnatal® (Phenobarbital, Hyoscyamine
Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) is a
prescription drug, classified as possibly effective as an
adjunctive therapy in the treatment of irritable bowel syndrome
(irritable colon, spastic colon, mucous colitis) and acute
enterocolitis. For more information, please see the
prescribing
information: http://www.donnatal.com/wp-content/uploads/2015/02/2015-02-18-Risk-Benefit-information-DTC-REV.-SE.pdf.
|
|
REDHILL BIOPHARMA LTD. |
|
STATEMENTS OF FINANCIAL
POSITION |
|
|
|
|
|
|
|
December 31 |
|
|
2016 |
|
2015 |
|
|
U.S. dollars in thousands |
CURRENT
ASSETS: |
|
|
|
|
Cash and cash equivalents |
|
53,786 |
|
|
21,516 |
|
Bank deposits |
|
55 |
|
|
36,622 |
|
Financial assets at fair value
through profit or loss |
|
12,313 |
|
|
- |
|
Prepaid expenses and
receivables |
|
1,661 |
|
|
2,372 |
|
|
|
67,815 |
|
|
60,510 |
|
NON-CURRENT ASSETS: |
|
|
|
|
Bank deposits |
|
137 |
|
|
134 |
|
Fixed assets |
|
165 |
|
|
124 |
|
Intangible assets |
|
6,095 |
|
|
6,060 |
|
|
|
6,397 |
|
|
6,318 |
|
TOTAL
ASSETS |
|
74,212 |
|
|
66,828 |
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES: |
|
|
|
|
Accounts payable and accrued
expenses |
|
3,356 |
|
|
3,514 |
|
Payable in respect of
intangible asset purchase |
|
2,000 |
|
|
2,000 |
|
|
|
5,356 |
|
|
5,514 |
|
|
|
|
|
|
NON-CURRENT LIABILITIES: |
|
|
|
|
Derivative financial
instruments |
|
6,155 |
|
|
1,237 |
|
TOTAL
LIABILITIES |
|
11,511 |
|
|
6,751 |
|
|
|
|
|
|
COMMITMENTS |
|
|
|
|
|
|
|
|
|
EQUITY: |
|
|
|
|
Ordinary shares |
|
441 |
|
|
343 |
|
Additional paid-in
capital |
|
150,838 |
|
|
120,621 |
|
Warrants |
|
1,057 |
|
|
1,057 |
|
Accumulated deficit |
|
(89,635 |
) |
|
(61,944 |
) |
TOTAL
EQUITY |
|
62,701 |
|
|
60,077 |
|
|
|
|
|
|
TOTAL
LIABILITIES AND EQUITY |
|
74,212 |
|
|
66,828 |
|
|
|
|
|
|
|
|
STATEMENTS OF COMPREHENSIVE LOSS
|
|
|
|
Year ended
December 31 |
Three months ended
December 31 |
|
|
|
|
2016
|
|
2015 |
|
2016 |
|
2015 |
|
|
|
|
U.S. dollars in thousands |
REVENUES: |
|
|
|
|
|
|
|
|
|
|
|
Licensing revenue |
|
|
|
100 |
|
- |
|
|
100 |
|
- |
Other revenue |
|
|
|
1 |
|
3 |
|
|
- |
|
- |
TOTAL
REVENUES |
|
|
|
101 |
|
3 |
|
|
100 |
|
- |
COST OF
REVENUE |
|
|
|
- |
|
- |
|
|
- |
|
- |
RESEARCH
AND DEVELOPMENT EXPENSES, net |
|
|
|
25,241 |
|
17,771 |
|
|
7,496 |
|
4,951 |
GENERAL,
ADMINISTRATIVE AND BUSINESS DEVELOPMENT EXPENSES |
|
|
|
5,403 |
|
4,134 |
|
|
1,596 |
|
1,714 |
OTHER
EXPENSES |
|
|
|
- |
|
100 |
|
|
- |
|
100 |
OPERATING LOSS |
|
|
|
30,543 |
|
22,002 |
|
|
8,992 |
|
6,765 |
FINANCIAL INCOME |
|
|
|
1,548 |
|
1,124 |
|
|
1,013 |
|
235 |
FINANCIAL EXPENSES |
|
|
|
375 |
|
212 |
|
|
370 |
|
30 |
FINANCIAL INCOME, net |
|
|
|
1,173 |
|
912 |
|
|
643 |
|
205 |
|
|
|
|
|
|
|
|
|
|
|
|
LOSS AND
COMPREHENSIVE LOSS FOR THE YEAR |
|
|
|
29,370 |
|
21,090 |
|
|
8,349 |
|
6,560 |
LOSS PER
ORDINARY SHARE (U.S. dollars): |
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
|
0.23 |
|
0.19 |
|
|
0.06 |
|
0.05 |
Diluted |
|
|
|
0.24 |
|
0.19 |
|
|
0.07 |
|
0.05 |
|
|
|
|
|
|
|
|
|
|
|
|
STATEMENTS OF CASH FLOWS
|
|
Year ended
December 31
|
|
Three months ended December
31
|
|
|
2016 |
|
2015 |
|
2016
|
|
2015
|
|
|
U.S. dollars in thousands |
OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
(29,370 |
) |
|
(21,090 |
) |
|
(8,349 |
) |
|
(6,560 |
) |
Adjustments in respect of
income and expenses not involving cash flow: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation to
employees and service providers |
|
1,679 |
|
|
1,364 |
|
|
361 |
|
|
409 |
|
Depreciation |
|
44 |
|
|
36 |
|
|
12 |
|
|
10 |
|
Write-off of intangible
assets |
|
- |
|
|
100 |
|
|
- |
|
|
100 |
|
Unrealized gains on derivative
financial instruments |
|
(1,152 |
) |
|
(888 |
) |
|
(1,022 |
) |
|
(166 |
) |
Fair value gains on financial
assets at fair value through profit or loss |
|
(67 |
) |
|
- |
|
|
5 |
|
|
- |
|
Issued cost in respect of
warrants |
|
368 |
|
|
- |
|
|
368 |
|
|
- |
|
Revaluation of bank
deposits |
|
(274 |
) |
|
(69 |
) |
|
(19 |
) |
|
(63 |
) |
Exchange differences in
respect of cash and cash equivalents |
|
(39 |
) |
|
150 |
|
|
38 |
|
|
14 |
|
|
|
559 |
|
|
693 |
|
|
(257 |
) |
|
304 |
|
Changes in assets and
liability items: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease (increase) in prepaid
expenses and receivables |
|
711 |
|
|
702 |
|
|
369 |
|
|
(1,141 |
) |
Increase (decrease) in
accounts payable and accrued expenses |
|
(158 |
) |
|
1,869 |
|
|
(1,932 |
) |
|
1,369 |
|
|
|
553 |
|
|
2,571 |
|
|
(1,563 |
) |
|
228 |
|
Net cash used in operating
activities |
|
(28,258 |
) |
|
(17,826 |
) |
|
(10,170 |
) |
|
(6,028 |
) |
INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of fixed assets |
|
(85 |
) |
|
(14 |
) |
|
(30 |
) |
|
(1 |
) |
Purchase of intangible
assets |
|
(35 |
) |
|
(1,620 |
) |
|
(35 |
) |
|
- |
|
Change in investment in
current bank deposits |
|
36,838 |
|
|
(29,500 |
) |
|
22,170 |
|
|
(20,000 |
) |
Purchase of non-current bank
deposit |
|
- |
|
|
(58 |
) |
|
- |
|
|
(58 |
) |
Purchase of financial
assets at fair value through profit or loss |
|
(12,246 |
) |
|
- |
|
|
(790 |
) |
|
- |
|
Maturity of non-current bank
deposits |
|
- |
|
|
10,000 |
|
|
- |
|
|
- |
|
Net cash provided by (used in)
investing activities |
|
24,472 |
|
|
(21,192 |
) |
|
21,315 |
|
|
(20,059 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of
ordinary shares and warrants, net of expenses |
|
35,754 |
|
|
54,684 |
|
|
35,754 |
|
|
- |
|
Exercise of options into
ordinary shares, net of expenses |
|
263 |
|
|
108 |
|
|
153 |
|
|
34 |
|
Net cash provided by financing
activities |
|
36,017 |
|
|
54,792 |
|
|
35,907 |
|
|
34 |
|
INCREASE
IN CASH AND CASH EQUIVALENTS |
|
32,231 |
|
|
15,774 |
|
|
47,052 |
|
|
(26,053 |
) |
EXCHANGE
DIFFERENCES ON CASH AND CASH EQUIVALENTS |
|
39 |
|
|
(150 |
) |
|
(38 |
) |
|
(14 |
) |
BALANCE
OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD |
|
21,516 |
|
|
5,892 |
|
|
6,772 |
|
|
47,583 |
|
BALANCE
OF CASH AND CASH EQUIVALENTS AT END OF PERIOD |
|
53,786 |
|
|
21,516 |
|
|
53,786 |
|
|
21,516 |
|
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN
CASH |
|
408 |
|
|
236 |
|
|
223 |
|
|
156 |
|
Supplementary information on investing activities not
involving cash flows - Purchase of intangible
assets |
|
- |
|
|
1,925 |
|
|
- |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Company contact:
Adi Frish
Senior VP Business Development &
Licensing
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus@troutgroup.com
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: RedHill Biopharma Ltd. via Globenewswire
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