YASTEST
- RedHill
maintains a debt-free balance sheet with $39.6 million in
cash1 at the end of the third quarter of 2017
- In addition,
an underwritten public offering of the Company's American
Depositary Shares (ADSs) is scheduled to be closed today, November
13, 2017, subject to customary terms and conditions, for aggregate
net proceeds of approximately $20.6 million, after deducting
underwriting discounts and commissions and other offering
expenses
- Net revenues
of approximately $1.5 million in Q3/2017 from the promotion of
three GI-specialty products in the U.S., Donnatal®, EnteraGam®
(launched in June) and Esomeprazole Strontium Delayed-Release
Capsules 49.3 mg (launched mid-September)
- Decrease
quarterly cash burn rate and continued revenue growth are
expected in 2018
- Increased
focus on partnerships and U.S. co-promotion of select RedHill
development programs
Select
recent and potential milestones:
- Top-line
results from the first Phase III study with RHB-104 for Crohn's
disease (MAP US study) expected in
mid-2018; patient enrollment completed
- Top-line
results from the confirmatory Phase III study with
TALICIA(TM) (RHB-105) (ERADICATE HP2 study) for the treatment
of H. pylori infection, expected
in H2/2018
- Initiation of
pivotal Phase III study with RHB-104 for first line treatment of
Nontuberculous Mycobacteria (NTM) infections expected in
H1/2018
- Successful
top-line results from the Phase II study with
BEKINDA® (RHB-102) 12 mg for the treatment of
diarrhea-predominant irritable bowel syndrome (IBS-D)
TEL-AVIV, Israel and RALEIGH,
N.C., Nov. 13, 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 drugs for gastrointestinal and inflammatory diseases
and cancer, today reported its financial results for the quarter
ended September 30, 2017.
The Company will host a conference
call today, November 13, 2017 at 9:00 am
EST to review the financial results and business
highlights. Dial-in details are included below.
Financial
highlights for the quarter ended September 30,
20172
Net Revenues for the third quarter of
2017 were approximately $1.5 million, compared to $0.5 million in
the second quarter of 2017. The increase was due to the promotional
activities of Donnatal®3 and the sale of EnteraGam®4 and
the initial promotion of Esomeprazole Strontium Delayed-Release
Capsules 49.3 mg5 in mid-September 2017.
Cost of Revenues for the third quarter
of 2017 was $0.9 million, due to the sale of EnteraGam®, compared
to $0.3 million in the second quarter of 2017, also due to the sale
of EnteraGam® and reflecting the cost of goods sold and
royalties.
Gross Profit for the third quarter of
2017 was $0.6 million, compared to $0.2 million in the second
quarter of 2017. The increase was due to higher revenues from the
sale of EnteraGam® and from the promotion of
Donnatal® and due to the initial promotion of Esomeprazole
Strontium Delayed-Release Capsules 49.3 mg in mid-September
2017.
Research and Development
Expenses for the third quarter of 2017 were $8.1
million, an increase of $1.1 million or 15% compared to the third
quarter of 2016. The increase was mainly due to the ongoing
confirmatory Phase III study with TALICIA(TM)(RHB-105)
for H. pylori infection, the Phase
III and Phase II studies with BEKINDA® (RHB-102) for
gastroenteritis and IBS-D, respectively, and the ongoing and
planned studies with YELIVA® (ABC294640)7 for
multiple indications. Research and
Development Expenses for the third quarter of 2017
decreased by $0.3 million or 4% compared to the second quarter of
2017.
General and Administrative
Expenses for the third quarter of 2017 were $2.3
million, an increase of $1.2 million compared to the third quarter
of 2016. General and Administrative
Expenses for the third quarter of 2017 increased
by $0.3 million compared to the second 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.
Selling, Marketing and Business Development
Expenses for the third quarter of 2017 were $4.2
million, an increase of $3.8 million compared to $0.4 million in
the third quarter of 2016, comprised only of Business Development
Expenses. Selling, Marketing and Business
Development Expenses for the third quarter of 2017
increased by $0.8 million or 24% compared to the second 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. The Company recognized Selling
and Marketing Expenses in 2017 for
the first time.
Operating Loss for the third quarter
of 2017 was $14 million, an increase of $5.5 million or 65%
compared to the third quarter of 2016. Operating Loss for the third quarter of 2017
increased by $0.4 million or 3% compared to the second quarter of
2017. The increase from the comparable periods was mainly due to an
increase in Selling, Marketing and Business Development Expenses,
Research and Development Expenses, and General and Administrative
Expenses, as detailed above.
Financial Expenses, net for the third quarter
of 2017 was $1.5 million, an increase of $1.1 million compared to
the third quarter of 2016. Financial Income, net for the second
quarter of 2017 was $2.5 million. The changes from the comparable
periods were mainly due to variations in the fair value of the
derivative financial instruments, which is affected by share price
variations.
Net Cash Used in Operating
Activities for the third quarter of 2017 was $10.6
million, an increase of $3.2 million or 43% compared to the third
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 third quarter of
2017 increased by $0.8 million or 8% compared to the second quarter
of 2017.
Net Cash Provided by Investing
Activities for the third quarter of 2017 was $13.9
million, an increase of $3.2 million or 30% compared to the third
quarter of 2016. Net Cash Used in Investing Activities for the
second quarter of 2017 was $4.9 million. The changes from the
comparable periods were mainly due to changes in bank deposits and
financial assets at fair value through profit or loss.
Cash Balance7 as of September 30, 2017,
was $39.6 million, a decrease of $26.7 million, compared to $66.3
million as of December 31, 2016, and a decrease of $11.6 million
compared to June 30, 2017. The decrease was a result of the ongoing
operations, mainly related to research and development activities
and the establishment and advancement of the U.S. commercial
operations.
"The third quarter of 2017 was the
first full quarter of revenues generation from the promotion of
Donnatal® and EnteraGam®, with $1.5 million in net revenues.
We anticipate net revenues to continue to grow following
initiation of the promotion of Esomeprazole Strontium DR capsules
49.3 mg in mid-September," said Micha Ben Chorin,
RedHill's CFO. "We expect a decrease in quarterly
cash burn rate along with continued revenue growth in
2018. Our cash balance at the end of the third quarter of
approximately $39.6 million, along with expected net proceeds of
approximately $20.6 million from the November 2017 underwritten
public offering of ADSs, should allow us to achieve significant
milestones in 2018, including Phase III top-line results with
RHB-104 for Crohn's disease, expected in mid-2018, and confirmatory
Phase III top-line results with TALICIA(TM)(RHB-105)
for H. pylori infection, expected
in the second half of 2018."
Conference
Call and Webcast Information:
The Company will host a conference
call today, Monday, November 13, 2017 at 9:00 am EST to
review the financial results and business highlights.
To participate in the conference
call, please dial one of the following numbers 15 minutes prior to
the start of the call: United States:
+1-877-280-2296; International: +1-212-444-0896; and
Israel:
+972-3-763-0147. The access code for the call is:
2543708.
The
conference call will be broadcasted live and will be 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 July 31, 2017, RedHill reported,
following a second pre-planned meeting by an independent Data and
Safety Monitoring Board (DSMB) to assess the safety and efficacy
data from its ongoing first Phase III study with RHB-104 for
Crohn's disease (the MAP US study), that it had received a
unanimous recommendation from the DSMB to continue the study as
planned. The DSMB reviewed safety and efficacy data, of which
RedHill remains blinded, from the first 222 subjects who had
completed week 26 assessments in the Phase III MAP US
study.
- On September 13, 2017, RedHill
announced that it had initiated promotion of Esomeprazole Strontium
DR Capsules 49.3 mg in the U.S. Esomeprazole Strontium DR Capsules
49.3 mg is a U.S. Food and Drug Administration (FDA)-approved,
proprietary, prescription proton pump inhibitor (PPI) indicated for
adults for the treatment of gastroesophageal reflux disease (GERD)
and other gastrointestinal (GI) conditions9. On August 17, 2017,
RedHill announced that it had entered into a commercialization
agreement with ParaPRO LLC, an Indiana-based specialty
pharmaceutical company, granting RedHill the exclusive rights to
promote Esomeprazole Strontium DR Capsules 49.3 mg to
gastroenterologists in certain U.S. territories.
- On September 18, 2017, RedHill
announced that it had received a Notice of Allowance from the
United States Patent and Trademark Office (USPTO) for a new patent
covering the use of two of RedHill's Phase II-stage proprietary
investigational compounds, YELIVA® and MESUPRON
(upamostat)10 in combination with a known antibiotic. Upon
issuance, on top of existing intellectual property (IP) protection
covering the individual compounds, the new patent will provide
RedHill with IP protection covering its combination for the
potential treatment of cancer, prevention of cancer recurrence or
progression and inhibition of growth and proliferation of cancer
cells.
- On October 3, 2017, RedHill
announced positive top-line results from the Phase II study with
BEKINDA® 12 mg for the treatment of diarrhea-predominant
irritable bowel syndrome (IBS-D). The study successfully met its
primary endpoint, improving primary efficacy outcome of stool
consistency. RedHill plans one or more pivotal Phase III
studies with BEKINDA®12 mg in IBS-D. RedHill further announced
that, following the positive results from its Phase III GUARD study
with BEKINDA® 24 mg in acute gastroenteritis and gastritis,
the Company met with the FDA to discuss the results and the
clinical and regulatory path towards potential marketing approval
of BEKINDA® 24 mg in the U.S. Following the positive FDA
guidance meeting, the Company is currently working with the FDA to
design the confirmatory Phase III study to support a New Drug
Application (NDA) with BEKINDA® 24 mg for acute
gastroenteritis and gastritis.
- On October 20, 2017, RedHill
announced that the FDA granted MESUPRON (upamostat) Orphan Drug
designation for the adjuvant treatment of pancreatic cancer. The
Orphan Drug designation allows RedHill to benefit from various
incentives to develop MESUPRON for this indication, including a
seven-year marketing exclusivity period for the indication, if
approved. Following the recent identification of a new mechanism of
action for MESUPRON, inhibition of trypsin, RedHill is currently
evaluating potential utilization of MESUPRON in several GI
indications.
- On October 23, 2017, RedHill
announced that it had received a Notice of Allowance from the USPTO
for a new patent covering RHB-104 for relapsing-remitting multiple
sclerosis (MS), which is expected to be valid until 2032, once
granted.
- On November 1, 2017, RedHill
announced, together with IntelGenx Corp. ("IntelGenx"), that they
had resubmitted the 505(b)(2) New Drug Application (NDA) for
RIZAPORT® 10 mg to the FDA. If the RIZAPORT® NDA
resubmission is deemed complete and permits a full review by the
FDA, a Prescription Drug User Fee Act (PDUFA) date is expected to
be set by the FDA for the first half of 2018.
- On November 9, 2017, RedHill
announced that the last patient had been enrolled in the Phase III
study with RHB-104 for Crohn's disease (MAP US study). The study
enrolled 331 subjects across approximately 150 clinical sites in
the U.S., Canada, Europe, Israel, Australia and New Zealand.
Top-line results are expected to be announced in mid-2018. On
October 2, 2017, RedHill announced that it had curtailed the target
sample size in the Phase III study with RHB-104 for Crohn's disease
(MAP US study) from 410 to approximately 325 subjects, while
maintaining statistical power of over 80% with a treatment effect
of 15%.
Financial
Highlights:
On November 9, 2017, RedHill
announced the pricing of its underwritten public offering,
announced on November 8, 2017, for a total number of 4,090,909
American Depositary Shares (ADSs), each representing ten of its
ordinary shares, at a public offering price of $5.50 per ADS. Gross
proceeds from the sale of the ADSs by RedHill before underwriting
discounts and commissions and other offering expenses are expected
to be approximately $22.5 million. The offering is scheduled to be
closed today, subject to customary closing conditions. RedHill has
also granted the underwriters a 30-day option to purchase up to
613,636 additional ADSs at the public offering price. Cantor
Fitzgerald & Co. and Nomura Securities International, Inc. are
acting as joint book-running managers for the offering. SMBC Nikko
Securities America, Inc. is acting as lead manager and H.C.
Wainwright & Co., LLC and Roth Capital Partners, LLC are acting
as co-managers for the offering. The Company intends to use the
proceeds from the offering to fund clinical development programs,
for potential acquisitions, to support commercial operations and
for general corporate purposes.
About
Esomeprazole Strontium Delayed-Release Capsules 49.3
mg12:
Esomeprazole Strontium Delayed-Release Capsules 49.3 mg is
indicated for adults:
- for the short-term treatment (4-8
weeks) of heartburn and other symptoms associated with
gastroesophageal reflux disease (GERD) and/or in healing and
symptomatic resolution of erosive esophagitis (EE).
- to reduce the risk of stomach ulcers
in some people taking non-steroidal anti-inflammatory drugs
(NSAIDs) (controlled studies did not extend beyond 6 months).
- in combination with amoxicillin 1000
mg and clarithromycin 500 mg is indicated for the treatment of
patients with a stomach infection (Helicobacter
pylori) and duodenal ulcer disease.
- is indicated for the long-term
treatment of pathological hypersecretory conditions, including
Zollinger-Ellison Syndrome.
Important
Safety Information about Esomeprazole Strontium Delayed-Release
Capsules 49.3 mg:
- Esomeprazole strontium is
contraindicated in patients with known hypersensitivity to proton
pump inhibitors. For information about contraindications of
antibacterial agents (clarithromycin and amoxicillin) indicated in
combination with esomeprazole strontium, refer to the
contraindications section of their package inserts.
- Symptomatic response to therapy does
not rule out the presence of gastric malignancy. Consider
additional follow-up and diagnostic testing in adult patients who
have a suboptimal response or an early symptomatic relapse after
completing treatment with a proton pump inhibitor (PPI). In older
patients, also consider an endoscopy.
- Acute interstitial nephritis has
been observed in patients taking PPIs. Discontinue esomeprazole
strontium if acute interstitial nephritis develop.
- PPI therapy may be associated with
increased risk of Clostridium difficile-associated diarrhea. This
diagnosis should be considered for diarrhea that does not
improve.
- PPI therapy may be associated with
an increased risk of osteoporosis-related fractures of the hip,
wrist, or spine. The risk of fracture was increased in patients who
received high-dose (multiple daily doses) and long-term (a year or
longer) therapy.
- Cutaneous lupus erythematosus (CLE)
and systemic lupus erythematosus (SLE) have been reported in
patients taking PPIs, including esomeprazole. These events included
both new onset and exacerbations. If signs or symptoms consistent
with CLE or SLE are noted with esomeprazole strontium, discontinue
and refer the patient to a specialist. Most patients improve with
discontinuation of the PPI alone in 4 to 12 weeks.
- Avoid concomitant use of
esomeprazole strontium with clopidogrel, due to a reduction in
plasma concentrations of the active metabolite of clopidogrel. When
using esomeprazole strontium consider alternative anti-platelet
therapy.
- Daily treatment with any
acid-suppressing medications over a long period of time (e.g.,
longer than 3 years) may lead to malabsorption of cyanocobalamin
(vitamin B12). Rare reports of cyanocobalamin deficiency occurring
with acid-suppressing therapy have been reported in the
literature.
- Hypomagnesemia has been reported
rarely with prolonged treatment with PPI therapy and may require
discontinuing PPI therapy.
- Concomitant use of esomeprazole
strontium and St. John's wort or rifampin can substantially
decrease esomeprazole strontium concentrations. Avoid concomitant
use.
- Literature suggests that concomitant
use of PPIs with methotrexate (primarily at high dose; see
methotrexate prescribing information) may elevate and prolong serum
levels of methotrexate and/or its metabolite, possibly leading to
methotrexate toxicities. In high-dose methotrexate administration,
a temporary withdrawal of the PPI may be considered in some
patients.
- Concomitant use of esomeprazole
strontium and atazanavir or nelfinavir is not recommended.
esomeprazole strontium is expected to increase the plasma levels of
saquinavir. Consider dose reduction of saquinavir.
- Patients treated with PPIs and
warfarin concomitantly may need to be monitored for increases in
INR and prothrombin time. Esomeprazole may interfere with the
absorption of drugs for which gastric pH affects bioavailability
(e.g., ketoconazole, iron salts, erlotinib, digoxin and
mycophenolate mofetil).
- Esomeprazole strontium may increase
systemic exposure of cilastozol and one of its active
metabolites. Consider dose reduction of cilastozol.
- In adults, adverse reactions (ARs)
reported at a frequency of 1% or greater with esomeprazole
strontium include headache, diarrhea, nausea, flatulence, abdominal
pain, constipation, and dry mouth.
- Safety and effectiveness of
esomeprazole strontium have not been established in pediatric
patients. Not recommended for use in pediatric patients.
- Safety of esomeprazole strontium has
not been studied in patients with severe renal impairment. Not
recommended for use in patients with severe renal impairment.
Talk to your doctor or healthcare
professional. Please see Prescribing information including
Medication Guide for Esomeprazole Strontium Delayed-Release
Capsules
at https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=53240ab5-98e7-4050-b640-e09c1271899a&type=display
You are encouraged to report
negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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 breastfeeding 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 components13, 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 disorders14.
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, primarily focused on the
development and commercialization of late clinical-stage,
proprietary drugs for the treatment of gastrointestinal and
inflammatory diseases and cancer. RedHill promotes three
gastrointestinal products in the U.S. and its clinical stage
pipeline includes treatments for gastrointestinal indications,
pancreatic cancer and acute migraines: Donnatal® - a prescription oral adjunctive drug used in
the treatment of IBS and acute enterocolitis; Esomeprazole Strontium Delayed-Release Capsules 49.3 mg - a
prescription proton pump inhibitor indicated for adults for the
treatment of gastroesophageal reflux disease (GERD) and other
gastrointestinal conditions; 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 a planned pivotal Phase
III study for nontuberculous mycobacteria (NTM) infections;
(iii) BEKINDA® (RHB-102) - a once-daily oral pill formulation of
ondansetron with successful top-line results from a Phase III study
in acute gastroenteritis and gastritis and successful top-line
results from a Phase II study in 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 inflammatory gastrointestinal
diseases and (vii) RIZAPORT® (RHB-103) - an oral
thin-film formulation of rizatriptan for acute migraines, with a
U.S. NDA resubmitted to the FDA and marketing authorization
received in two EU member states under the European Decentralized
Procedure (DCP).
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 the
results obtained with its therapeutic candidates in research,
preclinical studies or clinical trials; (ix) the implementation of
the Company's business model, strategic plans for its business and
therapeutic candidates; (x) the scope of protection the Company is
able to establish and maintain for intellectual property rights
covering its therapeutic candidates and its ability to operate its
business without infringing the intellectual property rights of
others; (xi) parties from whom the Company licenses its
intellectual property defaulting in their obligations to the
Company; (xii) estimates of the Company's expenses, future revenues
capital requirements and needs for additional financing; (xiii) the
effect of patients suffering adverse experiences using
investigative drugs under the Company's Expanded Access Program;
and (xiv) competition from other 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. The Company assumes no
obligation to update any written or oral forward-looking statement,
whether as a result of new information, future events or otherwise,
unless required by law.
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
|
REDHILL BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE
LOSS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
|
September 30, |
|
September 30, |
|
|
|
2017 |
|
2016 |
|
2017 |
|
|
2016 |
|
|
|
|
U.S. dollars in thousands |
|
NET
REVENUES |
|
1,523 |
|
- |
|
2,006 |
|
|
1 |
|
|
COST OF
REVENUES |
|
935 |
|
- |
|
1,207 |
|
|
- |
|
|
GROSS
PROFIT |
|
588 |
|
- |
|
799 |
|
|
1 |
|
|
RESEARCH
AND DEVELOPMENT EXPENSES, net |
|
8,106 |
|
7,038 |
|
24,677 |
|
|
17,745 |
|
|
SELLING,
MARKETING AND BUSINESS DEVELOPMENT EXPENSES |
|
4,189 |
|
*402 |
|
8,170 |
|
|
1,138 |
|
|
GENERAL
AND ADMINISTRATIVE EXPENSES |
|
2,258 |
|
*1,014 |
|
5,513 |
|
|
2,669 |
|
|
OTHER
EXPENSES |
|
- |
|
- |
|
45 |
|
|
- |
|
|
OPERATING LOSS |
|
13,965 |
|
8,454 |
|
37,606 |
|
|
21,551 |
|
|
FINANCIAL INCOME |
|
150 |
|
109 |
|
2,541 |
|
|
548 |
|
|
FINANCIAL EXPENSES |
|
1,697 |
|
599 |
|
66 |
|
|
17 |
|
|
FINANCIAL EXPENSES (INCOME), net |
|
1,547 |
|
490 |
|
(2,475 |
) |
|
(531 |
) |
|
LOSS AND
COMPREHENSIVE LOSS FOR THE PERIOD |
|
15,512 |
|
8,944 |
|
35,131 |
|
|
21,020 |
|
|
LOSS PER
ORDINARY SHARE, BASIC AND DILUTED (U.S. dollars) |
|
0.09 |
|
0.07 |
|
0.21 |
|
|
0.17 |
|
|
*Reclassified
REDHILL
BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL
POSITION
(Unaudited)
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2017 |
|
|
2016 |
|
|
|
U.S. dollars in thousands |
CURRENT
ASSETS: |
|
|
|
|
Cash and cash equivalents |
|
18,663 |
|
|
53,786 |
|
Bank deposits |
|
8,127 |
|
|
55 |
|
Financial assets at fair value
through profit or loss |
|
12,645 |
|
|
12,313 |
|
Trade receivables and contract
assets |
|
1,399 |
|
|
*99 |
|
Prepaid expenses and other
receivables |
|
2,760 |
|
|
*1,562 |
|
Inventory |
|
221 |
|
|
- |
|
|
|
43,815 |
|
|
67,815 |
|
NON-CURRENT ASSETS: |
|
|
|
|
Bank deposits |
|
149 |
|
|
137 |
|
Fixed assets |
|
250 |
|
|
165 |
|
Intangible assets |
|
6,085 |
|
|
6,095 |
|
|
|
6,484 |
|
|
6,397 |
|
TOTAL
ASSETS |
|
50,299 |
|
|
74,212 |
|
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES: |
|
|
|
|
Accounts payable |
|
1,882 |
|
|
*60 |
|
Accrued expenses and other
current liabilities |
|
9,149 |
|
|
*3,296 |
|
Payable in respect of
intangible asset purchase |
|
1,000 |
|
|
2,000 |
|
|
|
12,031 |
|
|
5,356 |
|
|
|
|
|
|
NON-CURRENT LIABILITIES: |
|
|
|
|
Derivative financial
instruments |
|
4,307 |
|
|
6,155 |
|
TOTAL
LIABILITIES |
|
16,338 |
|
|
11,511 |
|
|
|
|
|
|
EQUITY: |
|
|
|
|
Ordinary shares |
|
459 |
|
|
441 |
|
Additional paid-in
capital |
|
156,616 |
|
|
150,838 |
|
Warrants |
|
- |
|
|
1,057 |
|
Accumulated deficit |
|
(123,114 |
) |
|
(89,635 |
) |
TOTAL
EQUITY |
|
33,961 |
|
|
62,701 |
|
|
|
|
|
|
TOTAL
LIABILITIES AND EQUITY |
|
50,299 |
|
|
74,212 |
|
*Reclassified
REDHILL
BIOPHARMA LTD.
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
Nine months ended |
|
|
September 30, |
|
September 30, |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
U.S. dollars in thousands |
OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Comprehensive loss |
|
(15,512 |
) |
|
(8,944 |
) |
|
(35,131 |
) |
|
(21,020 |
) |
Adjustments in respect of
income and expenses not involving cash flow: |
|
|
|
|
|
|
|
|
Share-based compensation to
employees and service providers |
|
640 |
|
|
449 |
|
|
1,652 |
|
|
1,318 |
|
Depreciation |
|
26 |
|
|
11 |
|
|
58 |
|
|
32 |
|
Write-off of intangible
asset |
|
- |
|
|
- |
|
|
45 |
|
|
- |
|
Unrealized losses (gains) on
derivative financial instruments |
|
1,685 |
|
|
585 |
|
|
(1,828 |
) |
|
(130 |
) |
Fair value losses (gains) on
financial assets at fair value through profit or loss |
|
(12 |
) |
|
(10 |
) |
|
67 |
|
|
(72 |
) |
Revaluation of bank
deposits |
|
(3 |
) |
|
(108 |
) |
|
(108 |
) |
|
(255 |
) |
Exchange differences in
respect of cash and cash equivalents |
|
46 |
|
|
(36 |
) |
|
(315 |
) |
|
(77 |
) |
|
|
2,382 |
|
|
891 |
|
|
(429 |
) |
|
816 |
|
Changes in assets and
liability items: |
|
|
|
|
|
|
|
|
Increase in trade receivables
and contract assets |
|
(621 |
) |
|
- |
|
|
(1,300 |
) |
|
- |
|
Decrease (increase) in prepaid
expenses and other receivables |
|
336 |
|
|
150 |
|
|
(1,198 |
) |
|
342 |
|
Decrease (increase) in
inventory |
|
389 |
|
|
- |
|
|
(221 |
) |
|
- |
|
Increase (decrease) in
accounts payable |
|
737 |
|
|
*(417) |
|
1,822 |
|
|
*(94) |
Increase in accrued
expenses |
|
1,734 |
|
|
*950 |
|
5,853 |
|
|
*1,868 |
|
|
2,575 |
|
|
683 |
|
|
4,956 |
|
|
2,116 |
|
Net cash used in operating
activities |
|
(10,555 |
) |
|
(7,370 |
) |
|
(30,604 |
) |
|
(18,088 |
) |
INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Purchase of fixed assets |
|
(41 |
) |
|
(10 |
) |
|
(143 |
) |
|
(55 |
) |
Purchase of intangible
assets |
|
(1,035 |
) |
|
- |
|
|
(1,035 |
) |
|
- |
|
Change in investment in
current bank deposits |
|
7,284 |
|
|
14,668 |
|
|
(7,976 |
) |
|
14,668 |
|
Purchase of financial assets
at fair value through profit or loss |
|
(978 |
) |
|
(3,976 |
) |
|
(14,931 |
) |
|
(11,456 |
) |
Proceeds from sale of
financial assets at fair value through profit or loss |
|
8,685 |
|
|
- |
|
|
14,532 |
|
|
- |
|
Net cash provided by (used in)
investing activities |
|
13,915 |
|
|
10,682 |
|
|
(9,553 |
) |
|
3,157 |
|
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds from issuance of
ordinary shares, net of expenses |
|
- |
|
|
- |
|
|
1,282 |
|
|
- |
|
Exercise of warrants and
options into ordinary shares, net of expenses |
|
30 |
|
|
- |
|
|
3,437 |
|
|
110 |
|
Net cash provided by financing
activities |
|
30 |
|
|
- |
|
|
4,719 |
|
|
110 |
|
DECREASE
(INCREASE) IN CASH AND CASH EQUIVALENTS |
|
3,390 |
|
|
3,312 |
|
|
(35,438 |
) |
|
(14,821 |
) |
EXCHANGE
DIFFERENCES ON CASH AND CASH EQUIVALENTS |
|
(46 |
) |
|
36 |
|
|
315 |
|
|
77 |
|
BALANCE
OF CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD |
|
15,319 |
|
|
3,424 |
|
|
53,786 |
|
|
21,516 |
|
BALANCE
OF CASH AND CASH EQUIVALENTS AT END OF PERIOD |
|
18,663 |
|
|
6,772 |
|
|
18,663 |
|
|
6,772 |
|
SUPPLEMENTARY INFORMATION ON INTEREST RECEIVED IN
CASH |
|
153 |
|
|
133 |
|
|
354 |
|
|
185 |
|
*Reclassified
1 Including cash, short-term investments and
non-current bank deposits.
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 Esomeprazole Strontium
Delayed-Release (DR) Capsules 49.3 mg is an FDA-approved,
proprietary, prescription proton pump inhibitor, indicated for
adults for the treatment of gastroesophageal reflux disease (GERD)
and other gastrointestinal (GI) conditions. For more information,
please see the prescribing
information: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=53240ab5-98e7-4050-b640-e09c1271899a&type=display.
6 Esomeprazole Strontium
Delayed-Release (DR) Capsules 49.3 mg is an FDA-approved,
proprietary, prescription proton pump inhibitor, indicated for
adults for the treatment of gastroesophageal reflux disease (GERD)
and other gastrointestinal (GI) conditions. For more information,
please see the prescribing
information: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=53240ab5-98e7-4050-b640-e09c1271899a&type=display.
7 TALICIA(TM), BEKINDA® and
YELIVA® are investigational new drugs, not available for
commercial distribution.
8 Including cash and short-term investments
and non-current bank deposits.
9 For more information, please see the
prescribing
information: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=53240ab5-98e7-4050-b640-e09c1271899a&type=display.
10 MESUPRON is an investigational new drug,
not available for commercial distribution.
11 Xifaxan® (rifaximin)
prescribing information:
www.accessdata.fda.gov/drugsatfda_docs/label/2010/022554lbl.pdf;
Viberzi®(eluxadoline) prescribing information:
www.accessdata.fda.gov/drugsatfda_docs/label/2015/206940s000lbl.pdf;
Average absolute difference from reported Phase III studies; The
theoretical comparison between the BEKINDA® Phase II study results
and reported data from studies of IBS-D-approved therapies serves
as a general benchmark for the effect size observed with BEKINDA®
and should not be construed as a direct and/or equal comparison
given that the studies were not identical in design, patient
population and treatment period. For example, in the Xifaxan® Phase
III studies, the referenced efficacy endpoints were evaluated over
a period of 4 weeks after 2 weeks of drug administration, and in
the Viberzi® Phase III studies, the referenced efficacy endpoints
were evaluated after the drug was administered and evaluated for 12
weeks. The studies were not conducted head-to head in the same
patient population.
12 Esomeprazole Strontium Delayed-Release
Capsules is also available in a 24.65 mg dose. RedHill promotes the
Esomeprazole Strontium Delayed-Release Capsules 49.3 mg formulation
only.
13 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.
14 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.
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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