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BioLineRx Reports Year End 2012 Financial Results

  BioLineRx Reports Year End 2012 Financial Results

Business Wire

JERUSALEM -- March 12, 2013

BioLineRx Ltd. (NASDAQ: BLRX)(TASE: BLRX), a biopharmaceutical development
company, today reported its results for the year ended December 31, 2012.

“BioLineRx is rapidly approaching a significant landmark in the evolution of
the Company,” stated Kinneret Savitsky, Ph.D., CEO of BioLineRx. “We are
eagerly anticipating the interim analysis of the on-going CLARITY Phase 2/3
trial for our lead compound, BL-1020 for schizophrenia, which we expect to
receive next week. The analysis will include a recommendation by an
independent Data Monitoring Committee (DMC) regarding the number of additional
patients needed in order to reach statistical significance on the cognitive
effect of BL-1020 compared to Risperidone. Although the data from the ongoing
study is completely confidential, based on promising evidence received in
previous clinical and pre-clinical trials, we hope the information received
will provide a clear indication regarding the strength of the cognition
improvement signal, thereby putting us in a stronger position to out-license
BL-1020 and move towards commercializing the compound.”

“The PRESERVATION I pivotal CE mark registration trial for our other lead
compound, BL-1040 for ventricular remodeling post-AMI, which is being carried
out by Ikaria, Inc., continues to progress on an accelerated basis. Currently,
there are 15 sites recruiting in Australia, Belgium, Canada, Israel and Spain,
and results from the trial are expected in 2014.”

“In addition, our Phase 2 proof-of-concept study for BL-7040, an oral
treatment for Inflammatory Bowel Disease (IBD), is nearing completion. This is
an open-label study to evaluate the efficacy, pharmacodynamics, safety and
tolerability of BL-7040 in up to 30 patients with moderately active ulcerative
colitis, a type of IBD. This trial is being carried out at five sites in
Israel, and we are expecting to announce results in April 2013.”

“During 2012, we in-licensed several high-profile therapeutic compounds that
are already advancing towards clinical testing. This includes BL-8040, a Phase
2-ready drug for the treatment of acute myeloid leukemia (AML) and other
hematological cancers. The interest in this program is high, and we have
recently signed an agreement with one of the premier cancer centers in the
world, MD Anderson Cancer Center in Houston, Texas, to be the lead site in the
trial. We are currently in negotiations with two other U.S.-based, world-class
facilities for their participation in the trial as well,” continued Dr.
Savitsky.

“At the beginning of 2012, we entered the competitive HCV market with the
in-licensing of two orally-available compounds for the treatment of Hepatitis
C from world renowned experts in the field. BL-8020, an orally available,
interferon-free treatment for HCV, is a novel compound with pan-genotypic
efficacy, a unique mechanism of action and a synergistic effect with other HCV
therapies. We have successfully and rapidly completed pre-clinical development
for BL-8020 and expect to launch a Phase 1/2 trial next month. Meanwhile,
BL-8030, our other orally-available HCV program, continues to undergo rigorous
pre-clinical development in preparation for eventual clinical testing. We have
been engaged in advanced discussions with a potential regional co-development
partner, which we believe will substantially expedite the development
process,” continued Dr. Savitsky.

“In addition, during 2012, we significantly strengthened the patent protection
for several key compounds, including BL-1020, which was granted two new
patents in Europe, in addition to a new patent granted in the U.S., which
effectively extended patent protection for the product by nine years, through
2031. We also reported the receipt of a notice of extension from the USPTO for
BL-1040, effectively extending patent protection on this asset for five years,
through 2029. We plan to continue to invest substantial efforts at
strengthening our IP portfolio.”

Dr. Savitsky concluded, “BioLineRx continues to mature and progress on all
fronts, as we anticipate upcoming clinical results and the initiation of new
clinical studies for numerous programs in 2013. We are committed to building
our business as we discover new compounds, meet current portfolio milestones,
and identify partnering opportunities.”

Significant Anticipated 2013 Milestones

  *BL-1020 (Schizophrenia) – results of interim analysis by independent DMC
    of ongoing Phase 2/3 CLARITY trial expected during the week of March 18
  *BL-8040 (Leukemia and other hematological cancers) – Phase 2 clinical
    trial expected to commence in Q2 2013
  *BL-5010 (Skin lesions) – development of a new unique applicator prototype
    for the product should be completed by Q2 2013; pivotal CE Mark
    registration trial expected to commence in Europe during H2 2013
  *BL-7040 (Inflammatory bowel disease or IBD) – results of Phase 2a
    proof-of-concept study expected in April 2013
  *BL-8020 (HCV) – Phase 1/2 clinical study expected to commence in April
    2013

Philip Serlin, BioLineRx's Chief Financial and Operating Officer, added, “In
2012 we witnessed the increased presence of BioLineRx in the U.S. financial
market, with an associated increase in investor awareness. In particular, two
U.S. analysts initiated coverage of the Company, and we held a very successful
Analyst/Investor Day in New York in December 2012. As a result, currently
almost 50% of the Company’s outstanding shares are held by North American
investors, and we have seen a nice increase in the trading volume of our
shares. In addition, we recently raised $8 million through a direct equity
placement, with no underwriting fees or placement commissions, to the OrbiMed
group. This additional capital improved the Company’s balance sheet for
advancing our pipeline, while strengthening our position as we negotiate
potential partnering arrangements. The capital raise will help fund our
programs through 2014."

Financial Results for Year Ended December 31, 2012

During the years ended December 31, 2012 and 2011, no revenues were recorded.

Research and development expenses for the year ended December 31, 2012 were
NIS 64.3 million ($17.2 million), an increase of NIS 21.7 million ($5.8
million), or 51%, compared to NIS 42.6 million ($11.4 million) for the year
ended December 31, 2011. The increase resulted primarily from significantly
higher expenses in 2012 associated with the CLARITY clinical trial in respect
of BL-1020, which commenced at the end of June 2011 and was still in its
initial ramp-up stages during the third and fourth quarters of 2011, as well
as a ramp-up in spending on other clinical-stage projects introduced during
the second half of 2011 and in 2012.

Sales and marketing expenses for the year ended December 31, 2012 were NIS 3.2
million ($0.9 million), a negligible decrease compared to NIS 3.3 million
($0.9 million) for the year ended December 31, 2011. The Company invested
additional resources in its overall business development efforts in 2012,
which were primarily offset by savings from efficiencies realized this year
due to the reorganization of the Company’s business development team, as well
as professional services incurred last year related to the reacquisition of
the rights to BL-1020 from Cypress Bioscience. Sales and marketing expenses
are expected to increase in the foreseeable future, as the Company continues
to increase its business development efforts in respect of BL-1020, as well as
a number of other assets.

General and administrative expenses for the year ended December 31, 2012 were
NIS 14.0 million ($3.8 million), an increase of NIS 1.3 million ($0.4 million)
or 10%, compared to NIS 12.7 million ($3.4 million) for the year ended
December 31, 2011. The increase resulted primarily from professional fees and
other expenses associated with being a listed company on Nasdaq for a full
year in 2012 compared to only five months in 2011, as well as an increase in
excise taxes recorded in 2012 in respect of certain non-deductible expenses.

The Company’s operating loss for the year ended December 31, 2012 amounted to
NIS 81.6 million ($21.8 million), compared with an operating loss of NIS 58.7
million ($15.7 million) for the comparable period in 2011.

Non-operating income, net, for the year ended December 31, 2012 consists of a
NIS 7.3 million ($2.0 million) fair-value adjustment of derivative liabilities
on account of the warrants issued in the private placement carried out in
February 2012, offset by issuance expenses in the amount of NIS 1.2 million
($0.3 million) allocated to the warrants, as well as the initial commitment
and finder’s fees and other one-time expenses in the aggregate amount of NIS
2.1 million ($0.5 million) associated with the Lincoln Park Capital share
purchase agreement.

The Company recognized net financial income of NIS 1.3 million ($0.4 million)
for the year ended December 31, 2012, a decrease of NIS 7.2 million ($1.9
million), compared to net financial income of NIS 8.5 million ($2.3 million)
for the year ended December 31, 2011. Net financial income for both years
results primarily from changes in the average exchange rate of the dollar in
relation to the NIS, which were much more pronounced in 2011 than in 2012, and
had a positive effect on the Company’s net assets denominated in dollars.

Net loss for the year ended December 31, 2012 amounted to NIS 76.3 million
($20.4 million), compared with a net loss of NIS 50.2 million ($13.4 million)
for the comparable period in 2011.

As of December 31, 2012, BioLineRx had NIS 79.8 million ($21.4 million) in
cash, cash equivalents and short-term bank deposits. In February 2013, the
Company raised $8 million through an equity offering to the OrbiMed group. The
Company also utilized its share purchase agreement with Lincoln Park Capital
to raise an additional $2.9 million subsequent to year end. The Company’s
current holdings of cash, cash equivalents and short-term bank deposits amount
to approximately $28 million as of the date of this release.

Net cash used in operating activities was NIS 75.1 million ($20.1 million) for
the year ended December 31, 2012 and NIS 42.7 million ($11.4 million) for the
year ended December 31, 2011. The NIS 32.4 million increase in net cash used
in operating activities during 2012 was primarily the result of increased
research and development spending.

Net cash provided by investing activities for the year ended December 31, 2012
was NIS 51.3 million ($13.8 million), compared to net cash used in investing
activities of NIS 37.6 million ($10.0 million) for the year ended December 31,
2011. The changes in cash flows from investing activities relate primarily to
investments in, and maturities of, short-term bank deposits and other
investments during the respective periods.

Net cash provided by financing activities for the year ended December 31, 2012
was NIS 58.9 million ($15.8 million), compared to insignificant amounts of
cash flows related to financing activities for the year ended December 31,
2011. The net cash provided by financing activities relates primarily to the
private placement completed by the Company in February 2012.

Conference Call and Webcast Information

BioLineRx will hold a conference call to discuss its year-end 2012 results
today, March 12, 2013, at 10:00 a.m. EDT. To access the conference call,
please dial 1-888-407-2553 from the U.S. or +972-3-918-0610 internationally.
The call will also be available via live webcast through BioLineRx’s website.
A replay of the conference call will be available approximately two hours
after completion of the live conference call. To access the replay, please
dial 1-877-456-0009 from the U.S. or +972-3-925-5927 internationally. The
replay will be available through March 15, 2013.

About BioLineRx

BioLineRx is a publicly-traded biopharmaceutical development company.
BioLineRx is dedicated to building a portfolio of products for unmet medical
needs or with advantages over currently available therapies. BioLineRx’s
current portfolio consists of six clinical stage candidates: BL-1020 for
schizophrenia is currently undergoing a Phase II/III study; BL-1040, for
prevention of pathological cardiac remodeling following a myocardial
infarction, which has been out-licensed to Ikaria Inc., is currently
undergoing a pivotal CE-Mark registration trial; BL-5010 for non-surgical
removal of skin lesions has completed a Phase I/II study; BL-1021 for
neuropathic pain is in Phase I development, BL-7040 for treating inflammatory
bowel disease (IBD) is currently undergoing a Phase II trial, and BL-8040 for
treating acute myeloid leukemia (AML) and other hematological cancers has
completed Phase I. In addition, BioLineRx has six products in various
pre-clinical development stages for a variety of indications, including
central nervous system diseases, infectious diseases, cardiovascular and
autoimmune diseases.

BioLineRx’s business model is based on acquiring molecules mainly from
biotechnological incubators and academic institutions. The Company performs
feasibility assessment studies and development through pre-clinical and
clinical stages, with partial funding from the Israeli Government’s Office of
the Chief Scientist (OCS). The final stage includes partnering with medium and
large pharmaceutical companies for advanced clinical development (Phase III)
and commercialization. For more information on BioLineRx, please visit
www.biolinerx.com, the content of which does not form a part of this press
release.

Various statements in this release concerning BioLineRx’s future expectations
constitute “forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements include words such
as “may,” “expects,” “anticipates,” “believes,” and “intends,” and describe
opinions about future events. These forward-looking statements involve known
and unknown risks and uncertainties that may cause the actual results,
performance or achievements of BioLineRx to be materially different from any
future results, performance or achievements expressed or implied by such
forward-looking statements. Some of these risks are: changes in relationships
with collaborators; the impact of competitive products and technological
changes; risks relating to the development of new products; and the ability to
implement technological improvements. These and other factors are more fully
discussed in the “Risk Factors” section of BioLineRx’s most recent annual
report on Form 20-F filed with the Securities and Exchange Commission on March
12, 2013. In addition, any forward-looking statements represent BioLineRx’s
views only as of the date of this release and should not be relied upon as
representing its views as of any subsequent date. BioLineRx does not assume
any obligation to update any forward-looking statements unless required by
law.

 BioLineRx Ltd.
  CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
                                                             
                                                                  
                                                                  Convenience
                                                                  translation
                                                                  into USD
                                          December 31,            December 31,
                                          2011        2012        2012
                                          NIS in thousands        In thousands
  Assets
  CURRENT ASSETS
  Cash and cash equivalents               33,061      68,339      18,307
  Short-term bank deposits                65,782      11,459      3,070
  Prepaid expenses                        687         804         215
  Other receivables                       3,825       2,254       604
  Total current assets                    103,355     82,856      22,196
                                                                  
  NON-CURRENT ASSETS
  Restricted deposits                     2,746       3,513       941
  Long-term prepaid expenses              204         204         54
  Property and equipment, net             4,211       3,172       850
  Intangible assets, net                  1,144       1,063       285
  Total non-current assets                8,305       7,952       2,130
  Total assets                            111,660     90,808      24,326
                                                                  
  Liabilities and equity
  CURRENT LIABILITIES
  Current maturities of long-term         307         137         37
  bank loan
  Accounts payable and accruals:
  Trade                                   11,275      12,283      3,290
  OCS                                     6,233       6,148       1,647
  Other                                   7,894       5,443       1,458
  Total current liabilities               25,709      24,011      6,432
                                                                  
  NON-CURRENT LIABILITIES
  Long-term bank loan, net of current     110         -           -
  maturities
  Retirement benefit obligations          83          143         38
  Warrants                                -           10,725      2,873
  Total non-current liabilities           193         10,868      2,911
  COMMITMENTS AND CONTINGENT                                    
  LIABILITIES
  Total liabilities                       25,902      34,879      9,343
                                                                  
  EQUITY
  Ordinary shares                         1,236       1,837       491
  Share premium                           421,274     464,629     124,468
  Capital reserve                         31,317      33,802      9,055
  Accumulated deficit                     (368,069)   (444,339)   (119,031)
  Total equity                            85,758      55,929      14,983
  Total liabilities and equity            111,660     90,808      24,326
                                                                  

 BioLineRx Ltd.
  CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
                                                            
                                                                             
                                                                Convenience
                            Year ended December 31,             translation
                                                                into USD
                            2010       2011       2012        2012
                            NIS in thousands                    In thousands
                                                                             
  REVENUES                  113,160     -           -           -
  COST OF REVENUES          (25,571 )   -          -          -         
                                                                             
  GROSS PROFIT              87,589      -           -           -
                                                                             
  RESEARCH AND
  DEVELOPMENT EXPENSES,     (54,966 )   (42,623 )   (64,304 )   (17,226   )
  NET
  SALES AND MARKETING
  EXPENSES                  (4,609  )   (3,308  )   (3,227  )   (864      )

  
  GENERAL AND
  ADMINISTRATIVE            (14,875 )   (12,722 )   (14,026 )   (3,757    )
  EXPENSES
                                                                             
  OPERATING INCOME          13,139      (58,653 )   (81,557 )   (21,847   )
  (LOSS)
  NON-OPERATING INCOME,     -           -           3,958       1,060
  NET
  FINANCIAL INCOME          3,056       12,730      8,819       2,362
  FINANCIAL EXPENSES        (8,755  )   (4,263  )   (7,490  )   (2,007    )
                                                                             
  NET INCOME (LOSS) AND
  COMPREHENSIVE INCOME      7,440      (50,186 )   (76,270 )   (20,432   )
  (LOSS)
                                                                             
                            NIS                                 USD
  EARNINGS (LOSS) PER
  ORDINARY SHARE -          0.06       (0.41   )   (0.45   )   (0.12     )
  BASIC
  EARNINGS (LOSS) PER
  ORDINARY                  0.06       (0.41   )   (0.45   )   (0.12     )

  SHARE - DILUTED
                                                                             

 BioLineRx Ltd.
  CONSOLIDATED CASH FLOW STATEMENTS
                                                             
                                                                             
                                                                Convenience
                            Year ended December 31,             translation
                                                                into USD
                            2010       2011       2012        2012
                            NIS in thousands                    In thousands
  CASH FLOWS - OPERATING
  ACTIVITIES
  Net income (loss)         7,440       (50,186 )   (76,270 )   (20,432   )
  Adjustments required to
  reflect net cash
  provided by (used in)     33,231     7,445      1,125      301       
  operating activities
  (see appendix below)
  Net cash provided by
  (used in) operating       40,671     (42,711 )   (75,145 )   (20,131   )
  activities
                                                                             
  CASH FLOWS - INVESTING
  ACTIVITIES
  Investments in            (28,333 )   (63,456 )   (12,025 )   (3,221    )
  short-term deposits
  Maturities of             -           27,308      64,801      17,359
  short-term deposits
  Investments in            (206    )   (1,000  )   (775    )   (208      )
  restricted deposits
  Maturities of             1,353       675         -           -
  restricted deposits
  Purchase of property      (1,853  )   (951    )   (598    )   (160      )
  and equipment
  Purchase of intangible    (492    )   (133    )   (61     )   (16       )
  assets
  Net cash provided by
  (used in) investing       (29,531 )   (37,557 )   51,342     13,754    
  activities
                                                                             
  CASH FLOWS - FINANCING
  ACTIVITIES
  Issuance of share
  capital and warrants,     -           -           59,207      15,861
  net of issuance
  expenses
  Proceeds of bank loan     1,020       -           -           -
  Repayments of bank loan   (281    )   (308    )   (300    )   (80       )
  Proceeds from exercise
  of employee stock         26         1          2          1         
  options
  Net cash provided by
  (used in) financing       765        (307    )   58,909     15,782    
  activities
                                                                             
  INCREASE (DECREASE) IN
  CASH AND CASH             11,905      (80,605 )   35,106      9,405
  EQUIVALENTS
  CASH AND CASH
  EQUIVALENTS - BEGINNING
  OF YEAR                   105,890     111,746     33,061      8,856

  
  EXCHANGE DIFFERENCES ON
  CASH AND CASH             (6,049  )   1,920      172        46        
  EQUIVALENTS
  CASH AND CASH
  EQUIVALENTS - END OF      111,746    33,061     68,339     18,307    
  YEAR
                                                                             
  * Less than 1,000.
                                                                             

 BioLineRx Ltd.
  CONSOLIDATED CASH FLOW STATEMENTS
                                                             
                                                                             
                                                                Convenience
                              Year ended December 31,           translation
                                                                into USD
                              2010       2011      2012       2012
                              NIS in thousands                  In thousands
  APPENDIX
                                                                             
  Adjustments required to
  reflect net cash provided
  by (used in) operating
  activities:
  Income and expenses not
  involving cash flows:
  Depreciation and            1,814       1,563      1,524      409
  amortization
  Impairment of intangible    1,846       88         -          -
  assets
  Retirement benefit          79          53         60         16
  obligations
  Long-term prepaid           954         (8     )   -          -
  expenses
  Exchange differences on     6,049       (1,920 )   (172   )   (46       )
  cash and cash equivalents
  Warrant issuance costs      -           -          1,204      323
  Gain on adjustment of       -           -          (7,265 )   (1,946    )
  warrants to fair value
  Commitment fee paid by      -           -          880        235
  issuance of share capital
  Share-based compensation    6,557       3,983      3,138      841
  Interest and exchange
  differences on short-term   296         (1,597 )   1,547      414
  deposits
  Interest and linkage on     -           (14    )   20         5
  bank loan
  Interest and exchange
  differences on restricted   143        (7     )   8         2         
  deposits
                              17,738     2,141     944       253       
                                                                             
  Changes in operating
  asset and liability
  items:
  Decrease in trade
  accounts receivable and     34,798      1,847      1,454      389
  other receivables
  Increase (decrease) in
  accounts payable and        (19,305 )   3,457     (1,273 )   (341      )
  accruals
                              15,493     5,304     181       48        
                                                                             
                              33,231     7,445     1,125     301       
                                                                             
  
  Supplementary information
  on investing and
  financing activities not
  involving cash flows:
  Credit received in
  connection with purchase    104        265       10        3         
  of property and equipment
  Credit received in
  connection with purchase    100        -         -         -         
  of intangible assets
                                                                             
  Supplementary information
  on interest received in     1,013      1,825     1,720     461       
  cash

Contact:

KCSA Strategic Communications
Garth Russell, 1-212-896-1250
grussell@kcsa.com
or
Todd Fromer, 1-212-896-1215
tfromer@kcsa.com
or
Tsipi Haitovsky, Public Relations
+972-52-598-9892
tsipih@netvision.net.il
 
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