RedHill maintains a debt-free balance
sheet with $51 million cash1 at the end of the second quarter
of 2017
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™ (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™ 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™, 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™.
- 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™ (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™ 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
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