RedHill maintains a
debt-free balance sheet with $51 million
cash1 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, 20172
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
Balance6 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:
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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).
-
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).
-
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@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 components7, 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 disorders8.
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 EXPENSES, net |
|
8,434 |
|
6,031 |
|
16,571 |
|
10,707 |
|
|
SELLING, MARKETING AND BUSINESS DEVELOPMENT
EXPENSES |
|
3,376 |
|
* 424 |
|
3,981 |
|
* 736 |
|
|
GENERAL AND ADMINISTRATIVE EXPENSES |
|
1,940 |
|
* 740 |
|
3,255 |
|
* 1,655 |
|
|
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 INCOME, net |
|
2,516 |
|
642 |
|
4,022 |
|
1,021 |
|
|
LOSS AND COMPREHENSIVE LOSS FOR THE PERIOD |
|
11,023 |
|
6,552 |
|
19,619 |
|
12,076 |
|
|
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 loss |
|
20,340 |
|
|
12,313 |
|
|
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 employees and service providers |
|
705 |
|
|
495 |
|
|
1,012 |
|
|
869 |
|
|
|
|
Depreciation |
|
18 |
|
|
11 |
|
|
32 |
|
|
21 |
|
|
|
|
Write-off of intangible assets |
|
- |
|
|
- |
|
|
45 |
|
|
- |
|
|
|
|
Unrealized gains on derivative financial instruments |
|
(2,251 |
) |
|
(514 |
) |
|
(3,513 |
) |
|
(715 |
) |
|
|
|
Fair
value loses (gains) on financial assets at fair value through
profit or loss |
|
64 |
|
|
(54 |
) |
|
79 |
|
|
(62 |
) |
|
|
|
Revaluation of bank deposits |
|
(87 |
) |
|
(89 |
) |
|
(105 |
) |
|
(147 |
) |
|
|
|
Exchange differences in respect of cash and cash equivalents |
|
(119 |
) |
|
41 |
|
|
(361 |
) |
|
(41 |
) |
|
|
|
|
|
(1,670 |
) |
|
(110 |
) |
|
(2,811 |
) |
|
(75 |
) |
|
|
|
Changes in assets and liability items: |
|
|
|
|
|
|
|
|
|
|
|
Increase in trade receivables and contract assets |
|
(778 |
) |
|
- |
|
|
(679 |
) |
|
- |
|
|
|
|
Decrease (increase) in prepaid expenses and other receivables |
|
(421 |
) |
|
(248 |
) |
|
(1,534 |
) |
|
192 |
|
|
|
|
Increase in Inventory |
|
(610 |
) |
|
- |
|
|
(610 |
) |
|
- |
|
|
|
|
Increase in accrued expenses |
|
1,124 |
|
|
(224 |
) |
|
1,085 |
|
|
323 |
|
|
|
|
Increase in accounts payable and accrued expenses |
|
3,650 |
|
|
1,397 |
|
|
4,119 |
|
|
918 |
|
|
|
|
|
|
2,965 |
|
|
925 |
|
|
2,381 |
|
|
1,433 |
|
|
|
|
Net
cash used in operating activities |
|
(9,728 |
) |
|
(5,737 |
) |
|
(20,049 |
) |
|
(10,718 |
) |
|
|
|
INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
Purchase of fixed assets |
|
(102 |
) |
|
(16 |
) |
|
(102 |
) |
|
(45 |
) |
|
|
|
Change
in investment in current bank deposits |
|
284 |
|
|
(2,000 |
) |
|
(15,260 |
) |
|
- |
|
|
|
|
Purchase of financial assets at fair value through profit or
loss |
|
(10,500 |
) |
|
(908 |
) |
|
(13,953 |
) |
|
(7,480 |
) |
|
|
|
Proceeds from sale of
financial assets at fair value through profit or loss |
|
5,447 |
|
|
- |
|
|
5,847 |
|
|
- |
|
|
|
|
Net
cash used in investing activities |
|
(4,871 |
) |
|
(2,924 |
) |
|
(23,468 |
) |
|
(7,525 |
) |
|
|
|
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance
of ordinary shares, net of expenses |
|
- |
|
|
- |
|
|
1,282 |
|
|
- |
|
|
|
|
Exercise of warrants and options into ordinary shares, net of
expenses |
|
175 |
|
|
100 |
|
|
3,407 |
|
|
110 |
|
|
|
|
Net
cash provided by financing activities |
|
175 |
|
|
100 |
|
|
4,689 |
|
|
110 |
|
|
|
|
DECREASE IN CASH AND CASH EQUIVALENTS |
|
(14,424 |
) |
|
(8,561 |
) |
|
(38,828 |
) |
|
(18,133 |
) |
|
|
|
EXCHANGE DIFFERENCES ON CASH AND CASH
EQUIVALENTS |
|
119 |
|
|
(41 |
) |
|
361 |
|
|
41 |
|
|
|
|
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF
PERIOD |
|
29,624 |
|
|
12,026 |
|
|
53,786 |
|
|
21,516 |
|
|
|
|
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF
PERIOD |
|
15,319 |
|
|
3,424 |
|
|
15,319 |
|
|
3,424 |
|
|
|
|
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN
CASH |
|
130 |
|
|
4 |
|
|
201 |
|
|
95 |
|
|
|
|
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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