RedHill Biopharma Reports 2017 Second Quarter Financial Results
(Thomson Reuters ONE) -
RedHill maintains a debt-free balance sheet with $51 million cash(1 )at the end
of the second quarter of 2017
Select recent milestones include:
* Initial net revenues of approximately $0.5 million between June 12-30
following commencement of promotional activities in the U.S. by RedHill's
GI-focused sales force with two GI specialty products, Donnatal(®) and
EnteraGam(®)
* Positive top-line results from the Phase III GUARD study with
BEKINDA(®) (RHB-102) 24 mg for acute gastroenteritis and gastritis
* Initiation of the confirmatory Phase III study with TALICIA((TM)) (RHB-105)
for the treatment of H. pylori infection
* Last patient out in the Phase II study with BEKINDA(®) 12 mg for IBS-
D
* Orphan Drug designation granted to YELIVA(® )(ABC294640) for the treatment
of cholangiocarcinoma
Select potential milestones expected in the second half of 2017:
* Second independent DSMB meeting of the RHB-104 first Phase III study for
Crohn's disease, including an interim efficacy analysis and an evaluation of
an option for early stop for success for overwhelming efficacy; DSMB
recommendation is expected to be announced by early August 2017
* Top-line results from the BEKINDA(®) 12 mg Phase II study for IBS-D,
expected in September 2017
* Type B FDA meeting regarding the successful Phase III GUARD study with
BEKINDA(® )24 mg, expected by October 2017
* Initiation of several Phase Ib and Phase II studies with YELIVA(®) for
cholangiocarcinoma, mucositis in head and neck cancer and ulcerative
colitis, and with MESUPRON for pancreatic cancer
* Re-submission of the RIZAPORT(®) NDA to the FDA, expected in October 2017
TEL-AVIV, Israel and RALEIGH, N.C., July 25, 2017 (GLOBE NEWSWIRE) -- RedHill
Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the
"Company"), a specialty biopharmaceutical company primarily focused on late
clinical-stage development and commercialization of proprietary, orally-
administered, small molecule drugs for gastrointestinal and inflammatory
diseases and cancer, today reported its financial results for the quarter ended
June 30, 2017.
The Company will host a conference call on Tuesday, July 25, 2017 at 9:00 am
EDT to review the financial results and business highlights. Dial-in details are
included below.
Financial highlights for the quarter ended June 30, 2017(2)
Net Revenues for the second quarter of 2017 were approximately $0.5 million,
compared to immaterial Net Revenues in the second quarter of 2016 and in the
first quarter of 2017. The increase was due to the initiation, in mid-June
2017, of the U.S. promotional activities of Donnatal(®) (Phenobarbital,
Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide)(3) and the sale
of EnteraGam(® )(serum-derived bovine immunoglobulin/protein isolate, SBI)(4).
Cost of Revenues for the second quarter of 2017 were $0.3 million, reflecting
costs related to the initiation of the sale of EnteraGam(®) in mid-June 2017.
Research and Development Expenses for the second quarter of 2017 were $8.4
million, an increase of $2.4 million or 40% compared to the second quarter of
2016. The increase was mainly due to the ongoing Phase III and Phase II studies
with BEKINDA(® )(RHB-102) for gastroenteritis and IBS-D, respectively, the
ongoing Phase III study with RHB-104 for Crohn's disease, the ongoing and
planned studies with YELIVA(® )(ABC294640) for multiple indications, and the
initiation of the ongoing confirmatory Phase III study with TALICIA((TM)) (RHB-
105)(5) for H. pylori infection. Research and Development Expenses for the
second quarter of 2017 increased by $0.3 million or 4% compared to the first
quarter of 2017.
General and Administrative Expenses for the second quarter of 2017 were $1.9
million, an increase of $1.2 million compared to the second quarter of 2016.
General and Administrative Expenses for the second quarter of 2017 increased by
$0.6 million or 48% compared to the first quarter of 2017. The increase from the
comparable periods was mainly due to the establishment and advancement of the
Company's U.S. commercial operations in the first quarter of 2017 and enhanced
professional services.
Selling, Marketing and Business Development Expenses for the second quarter of
2017 were $3.4 million, an increase of $3.0 million compared to $0.4 million in
the second quarter of 2016, comprised only of Business Development Expenses. The
increase was mainly due to the establishment and advancement of the Company's
U.S. commercial operations. The Company recognized Selling and Marketing
Expenses in 2017 for the first time.
Operating Loss for the second quarter of 2017 was $13.5 million, an increase of
$6.3 million or 88% compared to the second quarter of 2016. The increase was
mainly due to an increase in Research and Development Expenses and Selling,
Marketing and Business Development Expenses, as detailed above. Operating Loss
for the second quarter of 2017 increased by $3.4 million or 34% compared to the
first quarter of 2017. The increase was mainly due to an increase in Selling,
Marketing and Business Development Expenses, as detailed above.
Financial Income, net for the second quarter of 2017 was $2.5 million, an
increase of $1.9 million compared to the second quarter of 2016. Financial
Income, net for the second quarter of 2017 increased by $1.0 million or 67%
compared to the first quarter of 2017. The increase from the comparable periods
was mainly due to a fair value gain on derivative financial instruments.
Net Cash Used in Operating Activities for the second quarter of 2017 was $9.7
million, an increase of $4 million or 70% compared to the second quarter of
2016. The increase was mainly due to the increase in Operating Loss, as detailed
above. Net Cash Used in Operating Activities for the second quarter of 2017
decreased by $0.6 million or 6% compared to the first quarter of 2017.
Net Cash Used in Investing Activities for the second quarter of 2017 was $4.9
million, an increase of $1.9 million or 67% compared to the second quarter of
2016. Net Cash Used in Investing Activities for the second quarter of 2017
decreased by $13.7 million compared to the first quarter of 2017. The decrease
was mainly due to change in short-term investments.
Cash Balance(6) as of June 30, 2017, was $51 million, a decrease of $15 million,
compared to $66 million as of December 31, 2016, and a decrease of $10 million
compared to March 31, 2017. The decrease was a result of the ongoing operations,
mainly related to research and development activities and the establishment of
the U.S. commercial operations.
Micha Ben Chorin, RedHill's CFO, said: "We are pleased with the important
milestones achieved during the second quarter, including positive top-line
results from the Phase III GUARD study with BEKINDA(®) 24 mg for acute
gastroenteritis, initiation of the confirmatory Phase III study with
TALICIA((TM)) for the treatment of H. pylori infection, and the initiation of
promotional activities in the U.S. by our GI-focused sales force with
Donnatal(®) and EnteraGam(®), which generated encouraging initial net revenues
of approximately $0.5 million in the second half of June alone. Our cash
position of $51 million at the end of the second quarter should allow us to
continue to execute our strategic plans, diligently advance our late-stage
clinical programs and pursue the acquisition of additional commercial GI
products in the U.S."
Conference Call and Webcast Information:
The Company will host a conference call on Tuesday, July 25, 2017 at 9:00 am
EDT to review the financial results and business highlights.
To participate in the conference call, please dial the following numbers 15
minutes prior to the start of the call: United States: +1-877-280-2342;
International: +1-212-444-0412; and Israel: +972-3-763-0146. The access code for
the call is 5090357.
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 call to
register, download and install any necessary audio software.
Recent operational highlights:
1. On April 4, 2017, RedHill announced that the FDA had granted
YELIVA(®) Orphan Drug designation for the treatment of cholangiocarcinoma.
Orphan Drug designation would allow RedHill to benefit from a seven-year
marketing exclusivity period for the indication, if approved, as well as
other development incentives to develop YELIVA(®) for cholangiocarcinoma. A
Phase IIa clinical study with YELIVA(®) in patients with advanced,
unresectable, intrahepatic and extrahepatic cholangiocarcinoma is planned to
be initiated in the third quarter of 2017.
2. On April 5, 2017, RedHill announced the signing of an exclusive license
agreement with Entera Health Inc. ("Entera Health"), granting RedHill the
exclusive U.S. rights to EnteraGam(® )(serum-derived bovine
immunoglobulin/protein isolate, SBI), a commercially-available medical food
intended for the dietary management of chronic diarrhea and loose stools,
which must be administered under medical supervision. Under the terms of the
agreement, RedHill will pay Entera Health royalties based on net sales
generated from the sale of EnteraGam(®) by RedHill.
3. On April 13, 2017, RedHill, together with IntelGenx Corp., announced that
the Ministry of Health of Luxembourg had granted national marketing
authorization for RIZAPORT(® )(5 mg and 10 mg), a thin-film for the
treatment of acute migraines. The national marketing authorization was
granted in Luxembourg on the basis of the European Decentralized Procedure
(DCP), in which Luxembourg served as the Concerned Member State. The
approval in Luxembourg marked the completion of the current marketing
approval process for RIZAPORT(®) under the European DCP. The re-submission
of the RIZAPORT(®) NDA to the FDA is expected in October 2017.
4. On April 24, 2017, RedHill announced the enrollment of the last patient in
the Phase II study with BEKINDA(®) 12 mg for the treatment of diarrhea-
predominant irritable bowel syndrome (IBS-D). On July 17, 2017, RedHill
announced that the last patient had completed the treatment course and the
last follow-up visit. Top-line results are expected in September 2017. The
randomized, double-blind, placebo-controlled Phase II study is evaluating
the efficacy and safety of BEKINDA(®) 12 mg in adults 18 years and older who
suffer from IBS-D. The study enrolled 127 subjects at 16 clinical sites in
the U.S.
5. In May 2017, RedHill adopted an Expanded Access Program (EAP), allowing
patients with life-threatening diseases potential access to RedHill's
investigational new drugs that have not yet received regulatory marketing
approval. Expanded access (sometimes referred to as "compassionate use") is
possible outside RedHill's clinical trials, under certain eligibility
criteria, when a certain investigational new drug is needed to treat life-
threatening condition and there is some clinical evidence suggesting that
the drug might be effective in that condition. Following the adoption of the
program, RedHill continues to receive patient requests to obtain access to
investigational drugs. Therefore, subject to evaluation of eligibility and
all the necessary regulatory and other approvals, RedHill is likely to
provide certain patients with an investigational new drug under the EAP.
Further information about RedHill's EAP can be found on the Company's
website at: http://www.redhillbio.com/expandedaccess.
6. On June 13, 2017, RedHill announced the initiation of the promotion of two
gastrointestinal specialty products, Donnatal(® )and EnteraGam(® )in the
U.S. RedHill's U.S. commercial operations, headquartered in Raleigh, NC,
include a gastrointestinal-focused sales force of more than 30 sales
representatives promoting Donnatal(®) and EnteraGam(®) in select U.S.
territories.
7. On June 14, 2017, RedHill announced positive top-line results from the Phase
III GUARD study with BEKINDA(®) (RHB-102) 24 mg for acute gastroenteritis
and gastritis. The study successfully met its primary endpoint of efficacy
in the treatment of acute gastroenteritis and gastritis. BEKINDA(®)24 mg was
found to be safe and well tolerated in this indication. The randomized,
double-blind, placebo-controlled Phase III GUARD study evaluated the
efficacy and safety of BEKINDA(®) 24 mg in treating acute gastroenteritis
and gastritis. 321 adults and children over the age of 12 were enrolled at
21 clinical sites in the U.S. and randomized in a 60:40 ratio to receive
either BEKINDA(®) 24 mg or placebo, respectively. The primary endpoint of
the study was the proportion of patients without further vomiting, without
rescue medication, and who were not given intravenous hydration from 30
minutes post first dose of the study drug until 24 hours post dose, compared
to placebo. A Type B FDA meeting is expected to take place by October 2017.
Top-line results indicated that the Phase III GUARD study successfully met
its primary endpoint in the Intent to Treat (ITT) population (p = 0.04),
despite high positive outcome rate in the placebo arm. BEKINDA(®) 24 mg
improved the efficacy outcome by 21%; 65.6% of BEKINDA(®)-treated patients
as compared to 54.3% of placebo patients (p = 0.04; n=192 in the
BEKINDA(®) group and n=129 in the placebo group). Correcting for a
randomization error, the difference in effect is greater with 65.8% vs.
53.9% favoring BEKINDA(®) 24 mg vs. placebo in reaching the primary endpoint
of the study (p = 0.03). In per-protocol (PP) analysis of patients who met
all protocol entry criteria and for which the diagnosis of gastroenteritis
was confirmed (n=177 in the BEKINDA(®) group and n=122 in the placebo
group), BEKINDA(®) 24 mg improved the efficacy outcome by 27%; 69.5% of
patients in the BEKINDA(®)group vs. 54.9% in the placebo group (p = 0.01).
8. On June 15, 2017, RedHill announced the initiation of the confirmatory Phase
III study with RHB-105, newly branded as TALICIA((TM)), for the treatment
of H. pylori infection (the ERADICATE Hp2 study). The two-arm, randomized,
double-blind, active comparator, confirmatory Phase III study is planned to
enroll 444 non-investigated dyspepsia patients with confirmed H.
pylori infection in up to 65 clinical sites in the U.S., with a primary
endpoint of eradication of H. pylori infection at 42 through 70 days after
initiation of treatment. Subject to a successful outcome and any additional
regulatory feedback, the confirmatory Phase III study is expected to
complete the package required for a potential U.S. NDA for TALICIA((TM)).
9. On July 12, 2017, RedHill announced that the second independent Data and
Safety Monitoring Board (DSMB) meeting of the first RHB-104 Phase III study
for Crohn's disease (the MAP US study) is expected to convene in late July
2017 and will assess the safety and efficacy of RHB-104 in the first 222
subjects who have completed week 26 assessments. The DSMB meeting will
include an interim efficacy analysis and an evaluation of an option for
early stop for success for overwhelming efficacy. The DSMB's recommendation
is planned to be announced by early August 2017. To date, approximately
300 patients of the planned total of 410 patients have been enrolled in the
ongoing Phase III MAP US study.
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. Donnatal(®) comes in two formulations: immediate release
Donnatal(®) Tablets and immediate release Donnatal(®) Elixir, a fast-acting
liquid.
Important Safety Information about Donnatal(®):
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 complete important safety information about
Donnatal(®):
http://www.donnatal.com/professionals/important-safety-information/
To report suspected adverse reactions, contact Concordia Pharmaceuticals Inc. at
1-877-370-1142 or email: medicalinformation(at)concordiarx.com, or the FDA at
1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.
About EnteraGam(®):
EnteraGam(® )(serum-derived bovine immunoglobulin/protein isolate, SBI) is a
medical food product intended for the dietary management of chronic diarrhea and
loose stools. EnteraGam(®) must be administered under medical supervision.
EnteraGam(®) binds microbial components(7), such as toxic substances released by
bacteria, that upset the intestinal environment. This helps prevent them from
penetrating the lining of the intestine, which may contribute to chronic
diarrhea and loose stools in people who have specific intestinal disorders(8).
Safety Information about EnteraGam(®):
EnteraGam(®) contains beef protein; therefore, patients who have an allergy to
beef or any other component of EnteraGam(®) should not take this product.
EnteraGam(®) has not been studied in pregnant women, in women during labor and
delivery, or in nursing mothers. The choice to administer EnteraGam(®) during
pregnancy, labor and delivery, or to nursing mothers is at the clinical
discretion of the prescribing physician.
EnteraGam(®) does not contain any milk-derived ingredients such as lactose,
casein or whey. EnteraGam(®) is gluten-free, dye-free and soy-free.
Please see full Product Information.
To report suspected adverse reactions, contact Entera Health, Inc. at
1-855-4ENTERA (1-855-436-8372), or the FDA at 1-800-FDA-1088 (1-800-332-1088)
or www.fda.gov/medwatch.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange: 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 promotes two gastrointestinal
products in the U.S. - Donnatal(®), a prescription oral adjunctive drug used in
the treatment of IBS and acute enterocolitis, and EnteraGam(®), a medical food
intended for the dietary management, under medical supervision, of chronic
diarrhea and loose stools. RedHill's clinical-stage pipeline includes:
(i) TALICIA((TM)) (RHB-105) - an oral combination therapy for the treatment
of Helicobacter pylori infection with successful results from a first Phase III
study and an ongoing confirmatory 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 successful top-line results in a 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 protease inhibitor, targeting pancreatic cancer 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 two EU member states under the
European Decentralized Procedure (DCP). 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(® )and EnteraGam(®), (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) the
Company's Expanded Access Program, which allows patients with life-threatening
diseases potential access, subject to regulatory and other approvals, to
RedHill's investigational new drugs that have not yet received regulatory
marketing approval, if a patient suffers an adverse experience using such
investigative drug, potentially adversely affecting the clinical development
program of that investigational product or the Company generally; (xiv)
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 23, 2017. 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 )Including cash and short-term investments.
(2) All financial highlights are approximate and are rounded to the nearest
hundreds of thousands.
(3) 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.
(4) EnteraGam(®) (serum-derived bovine immunoglobulin/protein isolate, SBI) is a
commercially-available medical food, intended for the dietary management of
chronic diarrhea and loose stools due to specific intestinal disorders, which
must be administered under medical supervision.
(5) BEKINDA(®), YELIVA(®) and TALICIA((TM) )are investigational new drugs, not
available for commercial distribution.
(6 )Including cash and short-term investments
(7 )Horgan A, Maas K, Henderson A, Detzel C, Weaver E. Serum-derived bovine
immunoglobulin/protein isolate binds to pathogen-associated molecular patterns.
Poster presented at: Federation of American Societies for Experimental Biology;
April 26-30, 2014; San Diego, CA.
(8) Petschow BW, Burnett B, Shaw AL, Weaver EM, Klein GL. Serum-derived bovine
immunoglobulin/protein isolate: postulated mechanism of action for management of
enteropathy. Clin Exp Gastroenterol. 2014;7:181-190.
Gasbarrini A, Lauritano EC, Garcovich M, Sparano L, Gasbarrini G. New insights
into the pathophysiology of IBS: intestinal microflora, gas production and gut
motility. Eur Rev Med Pharmacol Sci. 2008;12 Suppl 1:111-117.
REDHILL BIOPHARMA LTD.
CONSOLIDATED CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
Three months ended Six months ended
June 30, June 30,
2017 2016 2017 2016
U.S. dollars in thousands U.S. dollars in thousands
NET REVENUES 483 1 483 1
COST OF REVENUE 272 - 272 -
RESEARCH AND
DEVELOPMENT 8,434 6,031 16,571 10,707
EXPENSES, net
SELLING, MARKETING
AND BUSINESS 3,376 * 424 3,981 * 736
DEVELOPMENT EXPENSES
GENERAL AND
ADMINISTRATIVE 1,940 * 740 3,255 * 1,655
EXPENSES
OTHER EXPENSES - - 45 -
OPERATING LOSS 13,539 7,194 23,641 13,097
FINANCIAL INCOME 2,523 666 4,078 1,025
FINANCIAL EXPENSES 7 24 56 4
FINANCIAL 2,516 642 4,022 1,021
INCOME, net
LOSS AND
COMPREHENSIVE LOSS 11,023 6,552 19,619 12,076
FOR THE PERIOD
LOSS PER ORDINARY
SHARE (U.S. dollars)
Basic 0.06 0.05 0.11 0.09
Diluted 0.06 0.06 0.11 0.10
* Reclassified
REDHILL BIOPHARMA LTD.
CONSOLIDATED CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION
(Unaudited)
June 30, December 31,
2017 2016
U.S. dollars in thousands
CURRENT ASSETS:
Cash and cash equivalents 15,319 53,786
Bank deposits 15,407 55
Financial assets at fair value through profit or 20,340 12,313
loss
Trade receivables and contract assets 778 99
Prepaid expenses and other receivables 3,096 1,562
Inventory 610 -
55,550 67,815
NON-CURRENT ASSETS:
Bank deposits 150 137
Fixed assets 235 165
Intangible assets 6,050 6,095
6,435 6,397
TOTAL ASSETS 61,985 74,212
CURRENT LIABILITIES:
Accounts payable 1,145 60
Accrued expenses and other current liabilities 7,415 3,296
Payable in respect of intangible asset purchase 2,000 2,000
10,560 5,356
NON-CURRENT LIABILITIES:
Derivative financial instruments 2,622 6,155
TOTAL LIABILITIES 13,182 11,511
EQUITY:
Ordinary shares 458 441
Additional paid-in capital 156,587 150,838
Warrants - 1,057
Accumulated deficit (108,242 ) (89,635 )
TOTAL EQUITY 48,803 62,701
TOTAL LIABILITIES AND EQUITY 61,985 74,212
REDHILL BIOPHARMA LTD.
CONSOLIDATED CONDENSED INTERIM STATEMENTS OF CASH FLOWS
(Unaudited)
Three months ended Six months ended
June 30, June 30,
2017 2016 2017 2016
U.S. dollars in thousands U.S. dollars in thousands
OPERATING
ACTIVITIES:
Comprehensive loss (11,023 ) (6,552 ) (19,619 ) (12,076 )
Adjustments in
respect of income
and expenses not
involving cash
flow:
Share-based
compensation to 705 495 1,012 869
employees and
service providers
Depreciation 18 11 32 21
Write-off of - - 45 -
intangible assets
Unrealized gains
on derivative (2,251 ) (514 ) (3,513 ) (715 )
financial
instruments
Fair value loses
(gains) on
financial assets 64 (54 ) 79 (62 )
at fair value
through profit or
loss
Revaluation of (87 ) (89 ) (105 ) (147 )
bank deposits
Exchange
differences in
respect of cash (119 ) 41 (361 ) (41 )
and cash
equivalents
(1,670 ) (110 ) (2,811 ) (75 )
Changes in assets
and liability
items:
Increase in trade
receivables and (778 ) - (679 ) -
contract assets
Decrease
(increase) in
prepaid expenses (421 ) (248 ) (1,534 ) 192
and other
receivables
Increase in (610 ) - (610 ) -
Inventory
Increase in 1,124 (224 ) 1,085 323
accrued expenses
Increase in
accounts payable 3,650 1,397 4,119 918
and accrued
expenses
2,965 925 2,381 1,433
Net cash used in
operating (9,728 ) (5,737 ) (20,049 ) (10,718 )
activities
INVESTING
ACTIVITIES:
Purchase of fixed (102 ) (16 ) (102 ) (45 )
assets
Change in
investment in 284 (2,000 ) (15,260 ) -
current bank
deposits
Purchase of
financial assets
at fair value (10,500 ) (908 ) (13,953 ) (7,480 )
through profit or
loss
Proceeds from sale
of financial
assets at fair 5,447 - 5,847 -
value through
profit or loss
Net cash used in
investing (4,871 ) (2,924 ) (23,468 ) (7,525 )
activities
FINANCING
ACTIVITIES:
Proceeds from
issuance of - - 1,282 -
ordinary shares,
net of expenses
Exercise of
warrants and
options into 175 100 3,407 110
ordinary shares,
net of expenses
Net cash provided
by financing 175 100 4,689 110
activities
DECREASE IN CASH
AND CASH (14,424 ) (8,561 ) (38,828 ) (18,133 )
EQUIVALENTS
EXCHANGE
DIFFERENCES ON 119 (41 ) 361 41
CASH AND CASH
EQUIVALENTS
BALANCE OF CASH
AND CASH
EQUIVALENTS AT 29,624 12,026 53,786 21,516
BEGINNING OF
PERIOD
BALANCE OF CASH
AND CASH 15,319 3,424 15,319 3,424
EQUIVALENTS AT END
OF PERIOD
SUPPLEMENTARY
INFORMATION ON 130 4 201 95
INTEREST RECEIVED
IN CASH
Company contact:
Adi Frish
Senior VP Business Development &
Licensing
RedHill Biopharma
+972-54-6543-112
adi(at)redhillbio.com
IR contact (U.S.):
Marcy Nanus
Senior Vice President
The Trout Group
+1-646-378-2927
Mnanus(at)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
Datum: 25.07.2017 - 13:20 Uhr
Sprache: Deutsch
News-ID 553800
Anzahl Zeichen: 39171
contact information:
Town:
Tel-Aviv
Kategorie:
Business News
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Die Pressemitteilung mit dem Titel:
"RedHill Biopharma Reports 2017 Second Quarter Financial Results"
steht unter der journalistisch-redaktionellen Verantwortung von
RedHill Biopharma Ltd. (Nachricht senden)
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