RedHill Biopharma Reports Financial Results for the First Quarter of 2013

RedHill Biopharma Reports Financial Results for the First Quarter of 2013

 The Company Maintains a Strong Balance Sheet Following Submission to the FDA
        of Its First New Drug Application (NDA) for RHB-103 (Migraine)

   RedHill Plans to Submit a Second NDA, for RHB-102 (Oncology Support Anti
 Emetic), by the First or Second Quarter of 2014 and Continues to Advance the
Planned Phase III and Phase II/III Studies With RHB-104 (Crohn's) and RHB-105
                          (H. pylori), Respectively

TEL-AVIV, Israel, May 2, 2013 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd.
(Nasdaq:RDHL) (TASE:RDHL) (the "Company" or "RedHill"), an emerging Israeli
biopharmaceutical company focused primarily on the development and acquisition
of late clinical-stage, patent-protected, new formulations and combinations of
existing drugs, today reported financial results for the first quarter ended
March 31, 2013.

The Company completed significant milestones in the first quarter of 2013,
including:

(i) Submission of the Company's first New Drug Application (NDA) to the U.S.
Food and Drug Administration (FDA) for the marketing approval of RHB-103, an
oral thin film formulation of rizatriptan for the treatment of acute migraine.

(ii) A positive Type B meeting with the FDA regarding the submission of
RHB-102 (oncology support anti emetic) for a U.S. NDA, planned by the first or
second quarter of 2014; and,

(iii) A successful Scientific Advice Meeting held with the Danish Health and
Medicines Authority (DKMA) regarding the planned submission of RHB-101(cardio)
for a Marketing Authorization Application (MAA) in Europe, with Denmark as the
reference member state for the European Mutual Recognition Procedure (MRP).

(iv) Issuance of a new patent by the United States Patent and Trademark Office
(USPTO) covering RHB-104 (Crohn's). The new patent (No.: 8,343,511), entitled
"Methods and Compositions for Treating Inflammatory Bowel Disease," will
expire no earlier than 2029, and forms a substantial addition to the already
issued and pending patents that support the intellectual property estate of
RHB-104.

Financial highlights for the first quarter ended March 31, 2013:

Research and Development Expenses, net for the quarter ended March 31, 2013
were approximately $1.3 million, a decrease of $1.1 million (approximately
48%) compared to $2.3 million in the first quarter of 2012. This decrease was
mainly attributed to two clinical studies conducted during the first quarter
of 2012, a discount from a Canadian service provider recognized in March 2013
and a reduction in expenses related to options granted to employees and
service providers.

General and Administrative Expenses for the quarter ended March 31, 2013 were
approximately $0.7 million, an increase of $0.1 million (approximately 16%)
compared to $0.6 million in the first quarter of 2012. This increase was
mainly due to an increase in professional services fees in connection with the
Company's NASDAQ listing, partly offset by a decrease in expenses related to
options granted to employees and service providers.

Operating Loss for the quarter ended March 31, 2013 was approximately $2.0
million, a decrease of $0.9 million (approximately 31%) compared to $2.9
million in the first quarter of 2012. This decrease was mainly attributed to a
decrease in research and development expenses, net.

Financing Income, net for the quarter ended March 31, 2013 was approximately
$40,000, a decrease of $0.16 million (approximately 80%) compared to $0.2
million in the first quarter of 2012. This decrease was mainly due to a
decrease in exchange rates and interest income.

Net Cash Used in Operating Activities for the quarter ended March 31, 2013 was
$1.8 million, a decrease of $0.2 million (approximately 10%) compared to $2.0
million in the first quarter of 2012. This decrease was mainly due to a
reduction in research and development expenses, net.

Net Cash Resulting from Investment Activities for the quarter ended March 31,
2013 was $0.55 million, a decrease of $5 million compared to $5.5 million in
the first quarter of 2012. The decrease was mainly due to a change of short
term deposits to cash and cash equivalents.

Cash Balance^1 as of March 31, 2013 was approximately $16.8 million, a
decrease of $1.6 million during the quarter (approximately 9%). This decrease
was mainly due to cash used to fund operating activities.

Key operational highlights for the first quarter ended March 31, 2013:

1.On March 25, 2013 the Company and its co-development partner for RHB-103,
    IntelGenx Corp. submitted an NDA to the FDA seeking marketing approval of
    RHB-103, a proprietary oral thin film formulation of rizatriptan, a
    leading drug for the treatment of acute migraine. The NDA was submitted
    under the 505(b)(2) regulatory path, following a positive pre-NDA meeting
    with the FDA.
    
2.On March 19, 2013 the Company reported that it had concluded a European
    Scientific Advice meeting with the Danish Health and Medicines Authority
    (DKMA) regarding its RHB-101, a controlled release, proprietary,
    once-daily formulation of carvedilol for the treatment of hypertension.
    Based on the positive results of the meeting, the Company intends to
    submit a Marketing Authorization Application (MAA) in Europe, with Denmark
    as the reference member state for the European Mutual Recognition
    Procedure (MRP).
    
3.On February 28, 2013 the Company reported that it had concluded a Type B
    meeting and additional communications with the FDA regarding its RHB-102
    drug, a patent protected, oral, extended release (24 hours) formulation of
    ondansetron for the prevention of radiotherapy induced nausea and vomiting
    (RINV) and chemotherapy induced nausea and vomiting (CINV). Based on these
    communications and subject to additional regulatory and other activities,
    the Company currently estimates that an NDA for RHB-102 will be filed by
    the first or second quarter of 2014.
    
4.On February 19, 2013 the Company reported that the USPTO published a
    Notice of Allowance for U.S. Patent Application Serial Number 12/076,105
    entitled "Controlled Release Carvedilol Compositions" for RedHill's
    RHB-101 drug. This patent family has a priority date of November 8, 2002,
    and the U.S. patent, once granted, is not expected to expire until 2024.
    
5.On January 7, 2013 the Company reported that a multi-site initiation
    process is underway in the U.S., Canada and Israel for a first
    multi-center, randomized, double-blind, placebo-controlled, parallel group
    initial Phase III study (the "MAP US Study") to assess the efficacy and
    safety of fixed-dose combination RHB-104 in subjects with moderately to
    severely active Crohn's disease. Recruitment of patients for the MAP US
    Study is currently planned to commence in the third quarter of 2013. The
    MAP US Study will be conducted under an Investigational New Drug (IND)
    application amended in August, 2012.
    
6.On January 1, 2013 the USPTO issued a new patent covering RHB-104 (No.:
    8,343,511) entitled "Methods and Compositions for Treating Inflammatory
    Bowel Disease," which expires no earlier than 2029. 

Ori Shilo, Deputy CEO Finance and Operations said: "We had a solid first
quarter with substantial progress achieved in our development plans. We
achieved a significant milestone with the submission of our first New Drug
Application (NDA) for RHB-103, an oral thin film formulation of rizatriptan
for the treatment of acute migraine. The Company's cash position remains
strong, with approximately $17 million in cash at the end of the first
quarter, with no financial debt. We continue to advance our operational plans
for 2013, including the planned commencement of the Phase III MAP US Study
with RHB-104 for Crohn's disease, with recruitment of clinical sites in the
U.S., Canada and Israel underway, and the Phase II/III clinical trial with
RHB-105 for H. pylori bacterial infection."

About RedHill Biopharma Ltd.:

RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL) is an emerging Israeli
biopharmaceutical company focused primarily on the development and acquisition
of late clinical-stage, patent-protected, new formulations and combinations of
existing drugs. The Company's current product pipeline includes: (i) RHB-101 -
a once-daily formulation of a leading congestive heart failure and high blood
pressure drug, planned to be submitted for a Marketing Authorization
Application (MAA) in Europe, (ii) RHB-102 - a once-daily formulation of a
leading chemotherapy and radiotherapy-induced nausea and vomiting prevention
drug, planned for U.S. NDA submission by the first or second quarter of 2014,
(iii) RHB-103 - an oral thin film formulation of a leading drug for the
treatment of acute migraine, with a U.S. NDA submitted in March 2013, (iv)
RHB-104 - a combination therapy for the treatment of Crohn's disease, planned
to commence a first Phase III trial in the third quarter of 2013, as well as
Multiple Sclerosis (MS) Phase IIa proof of concept trial, (v) RHB-105 - a
combination therapy for Helicobacter pylori infection, planned to commence a
phase II/III trial in the third quarter of 2013, and (vi) RHB-106 - an
encapsulated formulation for bowel preparation (laxative) ahead of colonoscopy
and other GI procedures. For more information please visit:
www.redhillbio.com.

This press release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995.Such statements may be
preceded by the words "intends," "may," "will," "plans," "expects,"
"anticipates," "projects," "predicts," "estimates," "aims," "believes,"
"hopes," "potential" or similar words. Forward-looking statements are not
guarantees of future performance, are based on certain assumptions and the
Company's current and best understanding of the regulatory status 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 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 and
approvals; (iv) the 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 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 under their respective
licensing agreements; (x) estimates of the Company's expenses, future revenues
capital requirements and the Company's needs for additional financing; (xi)
competitive companies, technologies and the Company's industry; and (xii)
statements as to 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 From 20-F filed with the SEC
on February 19, 2013, and its Reports on Form 6-K. Investors and security
holders are urged to read these documents free of charge on the SEC's web site
at http://www.sec.gov. 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 made by us
or on our behalf as a result of new information, future events or other
factors.

^1 Including cash, bank deposits and short term investments.

REDHILL BIOPHARMA LTD.
STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited)
                                                                   
                                                          Three months ended
                                                           March 31
                                                          2013      2012
                                                          U.S. dollars in
                                                           thousands
                                                                   
                                                                   
REVENUE                                                    4         4
RESEARCH AND DEVELOPMENT EXPENSES, NET                     (1,346)   (2,328)
GENERAL AND ADMINISTRATIVE EXPENSES                        (675)    (609)
OPERATING LOSS                                             (2,017)   (2,933)
FINANCIAL INCOME                                           43        258
FINANCIAL EXPENSES                                         3         59
FINANCIAL INCOME, NET                                      40        199
                                                                   
LOSS AND COMPREHENSIVE LOSS                               (1,977)   (2,734)
                                                                   
LOSS PER ORDINARY SHARE – basic and diluted (U.S. dollars) 0.03      0.05


REDHILL BIOPHARMA LTD.
STATEMENTS OF FINANCIAL POSITION
                                                                
                                                    March 31     December 31
                                                    2013         2012
                                                    (Unaudited)  (Audited)
                                                    U.S. dollars in thousands
CURRENT ASSETS:                                                  
Cash and cash equivalents                            15,729       16,814
Bank deposits                                        14           486
Financial assets at fair value through profit or     1,016        1,065
loss
Prepaid expenses and receivables                     404          198
                                                    17,163       18,563
NON-CURRENT ASSETS:                                              
Restricted bank deposit                              77           75
Fixed assets                                         109          113
Intangible assets                                    1,345        1,345
                                                    1,531        1,533
Total assets                                         18,694       20,096
                                                                
CURRENT LIABILITIES --                                           
Accounts payable and accrued expenses                1,331        1,078
                                                                
COMMITMENTS                                                     
                                                                
EQUITY:                                                          
Ordinary shares                                      167          143
Ordinary shares to be issued                         --           8,02
Additional paid-in capital                           39,598       31,469
Warrants                                             3,255        3,273
Accumulated deficit                                  (25,657)     (23,887)
Total equity                                         17,363       19,018
                                                                
Total liabilities and equity                         18,694       20,096


REDHILL BIOPHARMA LTD.
STATEMENTS OF CASH FLOWS
(Unaudited)
                                                                  
                                                      Three months ended
                                                       March 31
                                                      2013         2012
                                                      US dollars in thousands
                                                                  
CASH FLOWS FROM OPERATING ACTIVITIES:                              
Loss                                                  (1,977)      (2,734)
Adjustments in respect of income and expenses not                  
involving cash flows:
Share-based compensation to employees and service      207          579
providers
Depreciation                                           6            7
Fair value gains on financial assets at fair value     (30)         (55)
through profit or loss
Revaluation of bank deposits                          (3)          (34)
Accretion of royalty obligations to investors          --           56
Exchange differences in respect of cash and cash       (8)          (132)
equivalents
Changes in asset and liability items:                              
Increase in prepaid expenses andreceivables           (206)        (90)
Increase in accounts payable and accrued expenses      253          367
Net cash used in operating activities                  (1,758)      (2,036)
CASH FLOWS FROM INVESTING ACTIVITIES:                              
Purchase of fixed assets                              (2)          (5)
Changes in investment in bank deposits                 473          (5,467)
Proceeds from sale of financial assets at fair value   79           --
through profit or loss
Net cash used in investing activities                  550          (5,472)
CASH FLOWS FROM FINANCING ACTIVITIES:                              
Proceeds from issuance of ordinary shares and warrants 100          --
Exercise of warrants into ordinary shares              15           --
Net cash provided by financing activities              115          --
DECREASE IN CASH AND CASH EQUIVALENTS                  (1,093)      (7,508)
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS      8            132
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF   16,814       14,070
PERIOD
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF PERIOD  15,729       6,694
                                                                  
Supplementary information on interest received in cash 2            33

CONTACT: PR contact (US):
         Lauren Glaser
         Vice President
         The Trout Group
         +1-646-378-2972
         lglaser@troutgroup.com
        
         Company contact:
         Adi Frish
         Senior VP Business Development & Licensing
         RedHill Biopharma
         +972-54-6543-112
         adi@redhillbio.com
 
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