PRESS RELEASE: RedHill Biopharma Reports 2015 Fourth Quarter and Full-Year Financial Results




01.03.16 08:30
Dow Jones Newswires



PRESS RELEASE: RedHill Biopharma Reports 2015 Fourth Quarter and Full-Year Financial Results





DGAP-News: RedHill Biopharma Ltd. / Key word(s): Final Results
RedHill Biopharma Reports 2015 Fourth Quarter and Full-Year Financial Results

2016-03-01 / 08:30
The issuer is solely responsible for the content of this announcement.

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.



(MORE TO FOLLOW) Dow Jones Newswires




March 01, 2016 02:30 ET (07:30 GMT)









 
 
hier klicken zur Chartansicht

Aktuelle Kursinformationen mehr >
Kurs Vortag Veränderung Datum/Zeit
5,4299 $ 5,33 $ 0,0999 $ +1,87% 23.01./20:24
 
ISIN WKN Jahreshoch Jahrestief
US7574681034 A1KBQX 11,25 $ 4,30 $
Handelsplatz Letzter Veränderung  Zeit
Nasdaq 5,4299 $ +1,87%  20:21
Frankfurt 4,20 € +0,48%  17:31
Stuttgart 4,14 € -2,36%  16:30
  = Realtime
Aktien des Tages
  


Mit der Anmeldung für den Newsletter "Aktien des Tages" stimme ich dem gleichzeitigen Erhalt des "GeVestor täglich" unseres Partners GeVestor zu.


Mit der Anmeldung für den Newsletter "Aktien des Tages" stimme ich dem gleichzeitigen Erhalt des "Investors Daily" unseres Partners FID Verlag zu.

Meistgelesene Artikel
Aktuelle Diskussionen
Antw. Thema Zeit
394 RedHill Biopharma (NASDAQ /. 29.12.17
27 relativ unbekannte Biotechperle . 15.12.15
RSS Feeds




Bitte warten...