RedHill Biopharma Reports 2017 Third Quarter Financial Results
(Thomson Reuters ONE) -
* 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:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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(at)concordiarx.com, or the FDA at
1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.
About EnteraGam®:
EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI) is a
medical food product intended for the dietary management of chronic diarrhea and
loose stools. EnteraGam® must be administered under medical supervision.
EnteraGam®binds microbial 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: IR contact (U.S.):
Adi Frish Marcy Nanus
Senior VP Business Development & Senior Vice President
Licensing The Trout Group
RedHill Biopharma +1-646-378-2927
+972-54-6543-112 Mnanus(at)troutgroup.com
adi(at)redhillbio.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)
December
September 30, 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=532
40ab5-98e7-4050-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=532
40ab5-98e7-4050-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?set
id=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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