DGAP-News: RedHill Biopharma Ltd. / Key word(s): Final Results
RedHill Biopharma Reports 2015 Fourth Quarter and Full-Year Financial
Results
01.03.2016 / 08:30
The issuer is solely responsible for the content of this announcement.
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Press Release
RedHill Biopharma Reports 2015 Fourth Quarter and Full-Year Financial
Results
Key Highlights Include:
- RedHill maintains a strong and debt-free balance sheet with
approximately $58 million in cash and cash equivalents at the end of
2015, allowing the Company to continue to execute its development plans
- Key milestones in 2015 include positive top-line results from the first
Phase III study with RHB-105 for H. pylori infection and from the Phase
I study with YELIVA(TM) for advanced solid tumors, as well as the first
European marketing approval for the acute migraine drug RIZAPORT(TM) in
Germany
- Selected 2016 potential milestones include interim analysis of the
RHB-104 Phase III study for Crohn's disease, top-line results from the
Phase III study with BEKINDA(TM) for gastroenteritis, interim top-line
results from the Phase IIa proof-of-concept study with RHB-104 for
multiple sclerosis expected in the coming weeks and the initiation of a
confirmatory Phase III study with RHB-105 for H. pylori infection
TEL-AVIV, Israel, March 1, 2016 RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL)
("RedHill" or the "Company"), a biopharmaceutical company primarily focused
on the development and commercialization of late clinical-stage,
proprietary, orally-administered, small molecule drugs for inflammatory and
gastrointestinal diseases, including cancer, today reported its financial
results for the year ended December 31, 2015.
Financial highlights for the year ended December 31, 2015 and for the
fourth quarter of 2015
Revenues for the fourth quarter and for the year ended December 31, 2015
were immaterial, compared to $7 million for the year ended December 31,
2014. The revenues in 2014 were mainly generated from an upfront payment of
$7 million received from Salix Pharmaceuticals, Inc. ("Salix") for the
out-licensing of RedHill's RHB-106 encapsulated bowel preparation and
related rights.
Cost of Revenues for the fourth quarter and for the year ended December 31,
2015 were immaterial compared to $1 million in Cost of Revenues for the
year ended December 31, 2014. The Cost of Revenues for the year ended
December 31, 2014 resulted primarily from a payment made to Giaconda
Limited under a 2010 Asset Purchase Agreement, triggered by the payment
received from Salix as part of the out-licensing transaction described
above.
Research and Development Expenses for the quarter ended December 31, 2015
were approximately $5 million, an increase of approximately 35% compared to
$3.7 million in the comparable quarter of 2014. Research and Development
Expenses for the year ended December 31, 2015 were approximately $17.8
million, an increase of approximately 40%, compared to $12.7 million for
the year ended December 31, 2014. The increase in both periods resulted
primarily from clinical trial costs of approximately $13.6 million, related
mainly to the ongoing Phase III clinical studies with RHB-104 (Crohn's
disease) and BEKINDA(TM) (gastroenteritis).
General and Administrative Expenses for the quarter ended December 31, 2015
were approximately $1.7 million compared to $1.1 million in the comparable
quarter of 2014. The increase was mainly due to an increase in professional
services due to one-time business development expenses. General and
Administrative Expenses for the year ended December 31, 2015 were
approximately $4.1 million compared to $4 million for the year ended
December 31, 2014.
Operating Loss for the quarter ended December 31, 2015 was $6.8 million,
compared to $4.8 million in the comparable quarter of 2014. The increase
was mainly due to an increase in Research and Development Expenses and in
General and Administrative Expenses. Operating Loss for the year ended
December 31, 2015 was approximately $22 million compared to $10.6 million
for the year ended December 31, 2014. The increase was mainly due to an
increase in Research and Development Expenses during 2015 and to revenues
from the Salix licensing transaction in 2014.
Financial Income, net for the quarter ended December 31, 2015 was $0.2
million, compared to $0.5 million in Financial Expenses, net in the
comparable quarter of 2014. The difference was mainly due to a change in
the fair value of derivative financial instruments. Financial Income, net
for the year ended December 31, 2015 were approximately $0.9 million,
compared to Financial Expenses, net of approximately $0.1 million for the
year ended December 31, 2014. The Financial Income, net in 2015 mainly
derived from a fair value gain on derivative financial instruments while
the Financial Expenses, net in 2014 were mainly derived from changes in
exchange rates.
Net Cash Used in Operating Activities for the quarter ended December 31,
2015 was $6 million, compared to $5.9 million in the comparable quarter of
2014. Net Cash Used in Operating Activities for the year ended December
31, 2015 was approximately $17.8 million, an increase of $5.6 million, or
approximately 46%, compared to $12.2 million for the year ended December
31, 2014. The increase resulted from an increase in operating loss, an
increase in advanced payments to suppliers and a decrease in accounts
payable, both mainly related to research and development activities.
Net Cash Used in Investment Activities for the quarter ended December 31,
2015 was $20.1 million, compared to $0.1 million in the comparable quarter
of 2014. The increase was mainly due to investment in bank deposits. Net
Cash Used in Investment Activities for the year ended December 31, 2015 was
approximately $21.2 million, compared to $17.9 million for the year ended
December 31, 2014. The increase was mainly due to investment in bank
deposits, in addition to a payment with respect to the YELIVA(TM) licensing
agreement.
Cash Provided by Financing Activities for the quarter ended December 31,
2015 and the comparable quarter of 2014 were immaterial. Cash Provided by
Financing Activities for the year ended December 31, 2015 was approximately
$54.8 million, compared to $24.4 million for the year ended December 31,
2014. The increase resulted primarily from the two public offerings in
February and July 2015 in the U.S. for a total net amount of $54.7 million.
Cash Balance as of December 31, 2015 was approximately $58.4 million, an
increase of $35.5 million, compared to $22.9 million as of December 31,
2014 and a decrease of $5.8 million, compared to $64.2 million as of
September 30, 2015.
Ori Shilo, Deputy CEO, Finance and Operations said: "We are very pleased
with our financial and operational results for 2015 and are excited for the
many potential milestones in 2016. RedHill maintains a strong cash position
of approximately $58 million at the end of 2015. Our current cash position
allows us to continue to diligently execute our development plans,
including interim analysis in the ongoing Phase III study with RHB-104 for
Crohn's disease, initiation of the confirmatory Phase III study with
RHB-105 for H. pylori infection, top-line results from the ongoing Phase
III study with BEKINDA(TM) for gastroenteritis and interim top-line
results from the Phase IIa proof-of-concept study with RHB-104 for
relapsing-remitting multiple sclerosis, expected in the coming weeks. We
believe that RedHill is well-positioned to execute its strategic plans,
including the establishment of commercial operations activity in the U.S.,
and continue to achieve major milestones in 2016."
Conference Call and Webcast Information:
The Company will host a conference call on Thursday, February 25, 2016, at
9:00 am EST to review the financial results and business highlights.
To participate in the conference call, please dial the following numbers
five to ten minutes prior to the start of the call: United States:
+1-646-254-3388; international: +1-877-280-2342; and Israel:
+972-3-763-0146. The access code for the call is 9515243.
The conference call will be broadcasted simultaneously 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 to register, download, and install any necessary audio
software.
Selected operational highlights for the year ended December 31, 2015:
RHB-105 - H. pylori bacterial infection (Phase III)
In June 2015, the Company received positive top-line results from its first
Phase III study with RHB-105 for the treatment of Helicobacter pylori (H.
pylori) bacterial infection (the ERADICATE Hp study). The study
demonstrated 89.4% efficacy in eradicating H. pylori infection with RHB-105
and successfully met its primary endpoint of superiority over historical
standard-of-care (SoC) efficacy levels of 70%, with high statistical
significance (p< 0.001). No serious adverse events related to the
therapeutic candidate were noted in the study. The Company announced
additional supportive data from the study in September 2015. Results from
the subsequent open-label treatment of patients in the placebo arm with SoC
therapy for persistent H. pylori infection demonstrated a 63% eradication
rate with SoC. These results further support the potential superior
efficacy of RHB-105 over SoC and validate the use of the historical SoC
efficacy threshold of 70% implemented in the Phase III study as the control
for the study's primary endpoint.
RedHill also announced in April 2015 that the United States Patent and
Trademark Office (USPTO) had issued a Notice of Allowance for a new U.S.
patent covering the RHB-105 formulation, which is expected to be valid
until at least 2034.
A meeting with the U.S. Food and Drug Administration (FDA) is scheduled in
early April 2016 to discuss the planned confirmatory Phase III study with
RHB-105 for the treatment of H. pylori infection.
RHB-104 - Crohn's disease (Phase III) and multiple sclerosis (Phase IIa)
The MAP US first Phase III study with RHB-104 for Crohn's disease is
currently ongoing in the U.S. and additional countries, with interim
analysis of the study expected in the second half of 2016, after half of
the 270 patients expected to be enrolled in the study will have completed
26 weeks of treatment.
RedHill further announced, in June 2015, that the UK Medicines and
Healthcare Products Regulatory Agency (MHRA) had accepted RedHill's
Clinical Trial Application (CTA) to initiate a second Phase III study with
RHB-104 for Crohn's disease (the MAP EU study). The MAP EU study is planned
to commence in a select number of European countries, and, once initiated,
will run in parallel with the currently ongoing MAP US first Phase III
study.
In February 2016 the Company announced that it had received a Notice of
Allowance from the USPTO for a fifth U.S. patent covering RHB-104. Two
additional notices of allowance for patents covering RHB-104 were announced
in July 2015. All three patents are expected to be valid through 2029.
In November 2015 the Company announced that it had completed the last
dosing and scheduled follow-up patient visit ahead of interim top-line
interim analysis in the Phase IIa proof-of-concept clinical study
evaluating RHB-104 in patients treated for relapsing-remitting multiple
sclerosis (RRMS). The open label Phase IIa study (the CEASE-MS study) was
designed to assess the efficacy and safety of RHB-104 as an add-on therapy
to interferon beta-1a. Top-line interim results are expected in the coming
weeks.
In January 2015, the Company announced that it had concluded, together with
Quest Diagnostics (Q Squared Solutions LLC), a pre-submission meeting with
the FDA regarding the development path of a commercial companion diagnostic
test for the detection of Mycobacterium avium subspecies paratuberculosis
(MAP) in Crohn's disease patients. RedHill and Quest Diagnostics (Q Squared
Solutions LLC) continue to make progress with the development of the
companion diagnostic MAP test.
BEKINDA(TM) (RHB-102) - Acute gastroenteritis and gastritis (Phase III);
diarrhea-predominant irritable bowel syndrome (IBS-D) (Phase II); oncology
support (PK program)
In October 2015, the Company announced that, following a meeting with the
FDA regarding the development path for BEKINDA(TM) 24 mg, the Company
believes that, subject to achieving highly significant positive results,
the expanded Phase III study for gastroenteritis and gastritis may be
sufficient as a single study to support the filing of a marketing
application for BEKINDA(TM) 24 mg for this indication in both the U.S. and
Europe. Top-line results from the Phase III study are expected in the
second half of 2016.
In February 2016, the Company announced the successful completion of a
first-in-man pharmacokinetic (PK) study with BEKINDA(TM) 12 mg formulation,
intended to be administered in the planned Phase II study for the treatment
of diarrhea-predominant irritable bowel syndrome (IBS-D). RedHill submitted
to the FDA the Investigational New Drug (IND) protocol for the Phase II
clinical study with BEKINDA(TM) 12 mg for IBS-D, planned to be initiated in
the coming weeks, subject to final preparations. The randomized,
double-blind, 2-arm parallel group Phase II clinical study is designed to
evaluate the safety and efficacy of BEKINDA(TM) 12 mg in patients suffering
from IBS-D. The study will be conducted in up to 12 clinical sites in the
U.S. and is expected to enroll 120 patients.
Following a meeting with the FDA, the Company also announced, in October
2015, that additional clinical data is required to support a U.S. New Drug
Application (NDA) with BEKINDA(TM) for oncology support indications under
the 505(b)(2) regulatory path. Further development for oncology support
indications will be decided as data from the ongoing and planned efficacy
studies of BEKINDA(TM) for gastroenteritis and IBS-D becomes available, as
well as additional regulatory feedback from European authorities.
YELIVA(TM) (ABC294640) - Multiple oncology, inflammatory and
gastrointestinal indications (Phase I/II)
In March 2015, the Company and Apogee Biotechnology Corporation ("Apogee"),
a privately-held biotech company located in Hummelstown, Pennsylvania,
U.S., entered into an exclusive worldwide license agreement under which
RedHill acquired the rights to the Phase II therapeutic candidate
YELIVA(TM) (ABC294640) and additional intellectual property rights.
YELIVA(TM) is a proprietary, first-in-class, orally-administered
sphingosine kinase-2 (SK2) inhibitor, with anti-inflammatory and
anti-cancer activities, targeting multiple oncology and inflammatory-GI
diseases. Under the terms of the agreement, RedHill acquired the exclusive
worldwide development and commercialization rights to YELIVA(TM) and
additional intellectual property for all indications.
In June 2015 the Company announced the initiation of a Phase I/II clinical
study in the U.S. to evaluate YELIVA(TM) in patients with
refractory/relapsed diffuse large B-cell lymphoma (DLBCL). The study is
funded primarily by a grant awarded by the National Cancer Institute (NCI)
STTR program awarded to Apogee.
A Phase I/II study with YELIVA(TM) for the treatment of refractory or
relapsed multiple myeloma is planned to be initiated during the second
quarter of 2016. The study will be conducted at Duke University Medical
Center. The study is supported by a $2 million grant from the NCI Small
Business Innovation Research Program (SBIR) awarded to Apogee in
conjunction with Duke University, with additional support from RedHill.
A third Phase II study is planned to evaluate YELIVA(TM) as a
radioprotectant to prevent mucositis in cancer patients undergoing
therapeutic radiotherapy.
In October 2015 the Company announced positive top-line results from the
Phase I study with YELIVA(TM) in patients with advanced solid cancers. The
study successfully met its primary and secondary endpoints, providing key
information about the drug's safety, toxicities, pharmacokinetics (PK) and
pharmacodynamics (PD), supporting the ongoing and planned Phase II studies
with YELIVA(TM).
RP101 - pancreatic and other gastrointestinal cancers
In July 2015 the Company elected to extend its August 2014 exclusive option
agreement with RESprotect GmbH for the acquisition of the Phase II-stage
oncology drug candidate, RP101. In February 2016 the Company announced that
it had entered into a research collaboration with Fraunhofer Institute for
Cell Therapy and Immunology (IZI), for the evaluation of RP101. As part of
the collaboration, Fraunhofer IZI is conducting real-time monitoring of
tumor engraftment, tumoricidal efficacy and response to treatment with
RP101 in combination with SoC chemotherapies. Results from the studies are
expected during the first half of 2016. The preclinical program is intended
to support the existing Phase I and Phase II clinical data for RP101 and to
assess the drug's clinical development path.
RIZAPORT(TM) (RHB-103) - Acute migraines
In November 2015, the Company, together with IntelGenx Corp. ("IntelGenx"),
announced that the Federal Institute for Drugs and Medical Devices of
Germany (BfArM) granted marketing authorization of RIZAPORT(TM) (RHB-103) 5
mg and 10 mg, an oral thin film formulation of rizatriptan benzoate for the
treatment of acute migraines. The national approval of RIZAPORT(TM) in
Germany was granted under the European Decentralized Procedure (DCP), in
which Germany served as the Reference Member State. This authorization is
the first national marketing approval of RIZAPORT(TM). In February 2016 the
United States Patent and Trademark Office (USPTO) issued a Notice of
Allowance for a new patent covering RIZAPORT(TM), which is expected, once
granted, to be valid until 2034. RedHill and IntelGenx continue to work
together to secure commercialization partners for RIZAPORT(TM) to obtain
national phase approvals in other European DCP territories as well as FDA
marketing approval in the U.S.
Financial Highlights
In July 2015, the Company closed an underwritten public offering for a
total of 2,739,143 American Depository Shares ("ADSs"), each representing
10 of its ordinary shares, at an offering price of $16.25 per ADS. Gross
proceeds from the public offering were approximately $44.5 million, before
underwriting discounts and commissions and other offering expenses.
Investors in the offering included Broadfin Capital LLC, Visium Asset
Management, Special Situations Funds, funds managed by Sabby Management
LLC, Longwood Capital Partners LLC, Menora Mivtachim and others. Nomura and
Roth Capital Partners acted as joint book-running managers. MLV & Co. and
H.C. Wainwright & Co. acted as co-managers for the offering.
On February 13, 2015, the Company closed an underwritten public offering
for a total of 1,150,000 ADSs at an offering price of $12.50 per ADS. Gross
proceeds from the public offering were approximately $14.4 million, before
underwriting discounts and commissions and other offering expenses.
Investors in the offering included Broadfin Capital LLC, OrbiMed, Sabby
Capital, LLC, Rosalind Advisors, Inc. and others. Wells Fargo Securities
acted as lead book-running manager and Roth Capital Partners acted as joint
book-running manager. MLV & Co acted as co-manager of the offering.
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) is an emerging 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 inflammatory and gastrointestinal
diseases, including cancer. RedHill's current pipeline of proprietary
products includes: (i) RHB-105 - an oral combination therapy for the
treatment of Helicobacter pylori infection with successful top-line results
from a first Phase III study; (ii) RHB-104 - an oral combination therapy
for the treatment of Crohn's disease with an ongoing first Phase III study;
(iii) BEKINDA(TM) (RHB-102) - a once-daily oral pill formulation of
ondansetron with an ongoing Phase III study in the U.S. for acute
gastroenteritis and gastritis; (iv) RHB-106 - an encapsulated bowel
preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA(TM)
(ABC294640) - an orally-administered first-in-class SK2 selective inhibitor
targeting multiple oncology, inflammatory and gastrointestinal indications
with a Phase I/II study initiated for refractory/relapsed diffuse large
B-cell lymphoma (DLBCL); (vi) MESUPRON(R) - a Phase II-stage first-in-class
uPA inhibitor, administered by oral capsule, targeting gastrointestinal and
other solid tumors; (vii) RP101 - currently subject to an option-to-acquire
by RedHill, RP101 is a Phase II-stage first-in-class Hsp27 inhibitor,
administered by oral tablet, targeting pancreatic and other
gastrointestinal cancers; (viii) RIZAPORT(TM) (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
Germany in October 2015; and (ix) RHB-101 - a once-daily oral pill
formulation of the cardio drug carvedilol.
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 establish
and maintain corporate collaborations; (vi) 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; (vii) the implementation of the
Company's business model, strategic plans for its business and therapeutic
candidates; (viii) 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; (ix) parties from whom the Company
licenses its intellectual property defaulting in their obligations to the
Company; (x) estimates of the Company's expenses, future revenues capital
requirements and the Company's needs for additional financing; (xi)
competitive companies and technologies within the Company's industry; and
(xii) the impact of the political and security situation in Israel on the
Company's business. 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 26, 2015. 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.
<pre>
Company contact: IR contact (U.S.):
Adi Frish Marcy Nanus
Senior VP Business Development & Senior Vice President
The Trout Group
Licensing +1-646-378-2927
RedHill Biopharma Mnanus@troutgroup.com
+972-54-6543-112
adi@redhillbio.com
</pre>
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441361 01.03.2016
DGAP-News: RedHill Biopharma Reports 2015 Fourth Quarter and Full-Year Financial Results
| Source: EQS Group AG