SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 OF
THE SECURITIES EXCHANGE ACT OF 1934
For the month of March 2015
_______________________
BioLineRx Ltd.
(Translation of registrant’s name into English)
_______________________
P.O. Box 45158
19 Hartum Street
Jerusalem 91450, Israel
(Address of Principal Executive Offices)
_______________________
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
Form 20-F x Form 40-F o
Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934:
Yes o No x
On March 23, 2015, the registrant will issue the press release which is filed as Exhibit 1 to this Report on Form 6-K.
This Form 6-K, including all exhibits hereto, is hereby incorporated by reference into all effective registration statements filed by the Company under the Securities Act of 1933.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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BioLineRx Ltd.
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By:
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/s/ Philip Serlin | |
| Philip Serlin | |||
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Chief Financial and Operating Officer
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Dated: March 23, 2015
Exhibit 1
For immediate release
BioLineRx Reports Year End 2014 Financial Results
Jerusalem, Israel - March 23, 2015 - BioLineRx Ltd. (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, today reported its financial results for the year ended December 31, 2014.
Kinneret Savitsky, Ph.D., CEO of BioLineRx, remarked, “2014 marks a year of significant progress for BioLineRx on multiple fronts, both from a product development perspective, as well as from a business perspective. We have continued our focus on the therapeutic areas of oncology and immunology, while increasing the emphasis on our clinical-stage programs.”
“During the past year, we significantly enhanced and expanded the development strategy for our unique BL-8040 cancer therapy platform across a variety of hematological indications. Results to date from our ongoing Phase 2a clinical study of BL-8040 in relapsed and refractory AML patients continue to show substantial mobilization of leukemic cells from the bone marrow and robust induction of cancer cell apoptosis, as well as excellent safety and tolerability. Top-line results from this study are expected in the second half of 2015. BL-8040 is also in the midst of a Phase 1 safety and efficacy study in stem cell mobilization, with top-line results expected by the end of this month. We eagerly await the data from both of these important studies. In addition, we recently expanded our clinical strategy for BL-8040 to include new clinical trials in three additional hematological indications, all of which are expected to commence by the end of the second quarter of this year. We look forward to executing our comprehensive development plan for this promising treatment platform and to reaching several meaningful value inflection points during 2015.”
“With regard to BL-7010, our product for the treatment of celiac disease, we are very pleased with the positive results we reported for the Phase 1/2 safety study completed in the fourth quarter of 2014, including the determination of the optimal safe dose for continued development. We are also very encouraged that the results further support previous preclinical data showing that BL-7010 is not absorbed systemically, which will likely support a medical-device classification and an expedited development pathway for the product in Europe. We are now conducting additional non-clinical studies and formulation development for BL-7010 in preparation for the upcoming efficacy study, which we plan to initiate in the second half of this year.”
“In December 2014, our partner Bellerophon reached a significant milestone in the development of BL-1040 for the prevention of ventricular remodeling following AMI – the completion of enrollment in the large CE Mark registration trial that has been ongoing for the past three years. We look forward to the top-line results from this trial, expected in mid-2015.”
“During the fourth quarter of 2014, we announced two significant business development achievements. First and foremost, we entered into a multi-year strategic collaboration with Novartis for the screening and co-development of therapeutic candidates through clinical proof-of-concept. As part of the collaboration, Novartis made an equity investment in BioLineRx of $10 million. We are very excited about the future potential of this collaboration, and view it as a strong validation of our core competencies by a world leader in our industry. In addition, we also announced the out-licensing to Omega Pharma of BL-5010, our skin lesion product, which we hope will begin to provide a royalty stream to us beginning in 2016.”
“Following the successful completion of our $29 million follow-on public offering earlier this month, we have a strong balance sheet, with enough cash to carry out our operating plan for at least the next three years. We expect to reach multiple significant catalysts during this period of time, both in the short term during 2015, as well as in 2016 and 2017.”
Financial Results for Year Ended December 31, 2014
Research and development expenses for the year ended December 31, 2014 were NIS 42.5 million ($10.9 million), a decrease of NIS 1.6 million ($0.4 million), or 3.7%, compared to NIS 44.1 million ($11.3 million) for the year ended December 31, 2013. The decrease resulted primarily from termination of the BL-1020 CLARITY clinical trial in March 2013 and certain one-time costs associated with several clinical-stage projects in 2013, partially offset by increased spending on BL-8040, BL-7010 and BL-5010 in 2014.
Sales and marketing expenses for the year ended December 31, 2014 were NIS 5.7 million ($1.5 million), an increase of NIS 1.6 million ($0.4 million), or 38.6%, compared to NIS 4.1 million ($1.1 million) for the year ended December 31, 2013. The increase resulted primarily from professional fees related to increased business development activities, including professional services related to the collaboration agreement with Novartis and the out-licensing agreement with Omega regarding BL-5010.
General and administrative expenses for the year ended December 31, 2014 were NIS 13.6 million ($3.5 million), an increase of NIS 0.4 million ($0.1 million) or 2.8%, compared to NIS 13.2 million ($3.4 million) for the year ended December 31, 2013. The small increase resulted primarily from an increase in salary-related payments.
The Company’s operating loss for the year ended December 31, 2014 amounted to NIS 61.7 million ($15.9 million), compared with an operating loss of NIS 61.4 million ($15.8 million) for the year ended December 31, 2013.
The Company recognized net non-operating income of NIS 11.0 million ($2.8 million) for the year ended December 31, 2014, an increase of NIS 6.8 million ($1.7 million), compared to net non-operating income of NIS 4.2 million ($1.1 million) for the year ended December 31, 2013. Non-operating income for both periods primarily relates to fair-value adjustments of liabilities on account of warrants issued in the private and direct placements conducted in February 2012 and 2013. These fair-value adjustments were highly influenced by the Company’s share price at each period end (revaluation date).
Net financial income amounted to NIS 11.2 million ($2.9 million) for the year ended December 31, 2014, a change of NIS 15.5 million ($4.0 million), compared to net financial expenses of NIS 4.3 million ($1.1 million) for the year ended December 31, 2013. Net financial income and expenses result primarily from changes in the average exchange rate of the dollar in relation to the NIS during the respective periods, which have a direct effect on the Company’s net assets denominated in dollars.
The Company’s net loss for the year ended December 31, 2014 amounted to NIS 39.6 million ($10.2 million), compared with a net loss of NIS 61.4 million ($15.8 million) for the year ended December 31, 2013.
The Company held NIS 134.9 million ($34.7 million) in cash, cash equivalents and short-term bank deposits as of December 31, 2014. In March 2015, the Company completed an underwritten public offering of its American Depositary Shares for gross proceeds of $28.8 million.
Net cash used in operating activities was NIS 56.4 million for the year ended December 31, 2014, compared with NIS 70.5 million for the year ended December 31, 2013. The NIS 14.1 million decrease in net cash used in operating activities during 2014 resulted primarily from a large decrease in net trade payables and accruals during the 2013 period.
2
Net cash used in investing activities for the year ended December 31, 2014 was NIS 70.7 million, compared to net cash used for investing activities of NIS 19.8 million for the year ended December 31, 2013. 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, 2014 was NIS 117.8 million, compared to net cash provided by financing activities of NIS 55.2 million for the year ended December 31, 2013. The cash flows from financing activities in 2014 primarily reflect the underwritten public offering in March 2014 and the investment by Novartis in December 2014. The cash flows from financing activities in 2013 reflect the direct placement to OrbiMed completed in February 2013, as well as funding under the previous share purchase agreement with LPC.
Conference Call and Webcast Information
BioLineRx will hold a conference call to discuss its year-end 2014 results today, March 23, 2015, at 10:00 a.m. EDT. To access the conference call, please dial 1-888-407-2553 from the US, 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 US or +972-3-925-5944 internationally. The replay will be available through March 26, 2015.
(Tables follow)
About BioLineRx
BioLineRx is a publicly-traded, clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates. The Company in-licenses novel compounds primarily from academic institutions and biotech companies based in Israel, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.
BioLineRx’s current portfolio consists of a variety of clinical and pre-clinical projects, including: BL-1040 for prevention of pathological cardiac remodeling following a myocardial infarction, which has been out-licensed to Bellerophon BCM (f/k/a Ikaria) and is in the midst of a pivotal CE-Mark registration trial scheduled for completion in mid-2015; BL-8040, a cancer therapy platform, which is in the midst of a Phase 2 study for acute myeloid leukemia (AML) as well as a Phase 1 study for stem cell mobilization; and BL-7010 for celiac disease, which has successfully completed a Phase 1/2 study.
In December 2014, BioLineRx entered into a strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates. The companies intend to co-develop a number of pre-clinical and early clinical therapeutic projects through clinical proof-of-concept for potential future licensing by Novartis.
For more information on BioLineRx, please visit www.biolinerx.com or download the investor relations mobile device app, which allows users access to the Company’s SEC documents, press releases, and events. BioLineRx’s IR app is available on the iTunes App Store as well as the Google Play Store.
3
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 23, 2015. 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.
Contact:
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D.
jdrumm@tiberend.com
+1-212-375-2664
Andrew Mielach
amielach@tiberend.com
+1-212-375-2694
Or
Tsipi Haitovsky
Public Relations
+972-3-6240871
tsipihai5@gmail.com
4
BioLineRx Ltd.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
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Convenience
translation
into USD
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December 31,
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December 31,
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2013
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2014
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2014
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NIS in thousands
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In thousands
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Assets
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CURRENT ASSETS
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Cash and cash equivalents
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30,888 | 22,519 | 5,790 | |||||||||
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Short-term bank deposits
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32,345 | 112,354 | 28,890 | |||||||||
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Prepaid expenses
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896 | 859 | 221 | |||||||||
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Other receivables
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1,249 | 1,000 | 257 | |||||||||
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Total current assets
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65,378 | 136,732 | 35,158 | |||||||||
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NON-CURRENT ASSETS
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Restricted deposits
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573 | 644 | 166 | |||||||||
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Long-term prepaid expenses
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169 | 190 | 49 | |||||||||
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Property and equipment, net
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2,471 | 2,804 | 721 | |||||||||
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Intangible assets, net
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878 | 457 | 117 | |||||||||
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Total non-current assets
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4,091 | 4,095 | 1,053 | |||||||||
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Total assets
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69,469 | 140,827 | 36,211 | |||||||||
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Liabilities and equity
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CURRENT LIABILITIES
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Accounts payable and accruals:
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Trade
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7,945 | 6,431 | 1,654 | |||||||||
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Other
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2,499 | 4,869 | 1,252 | |||||||||
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Total current liabilities
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10,444 | 11,300 | 2,906 | |||||||||
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NON-CURRENT LIABILITIES
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Retirement benefit obligations
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152 | - | - | |||||||||
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Warrants
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18,187 | 5,833 | 1,500 | |||||||||
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Total non-current liabilities
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18,339 | 5,833 | 1,500 | |||||||||
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COMMITMENTS AND CONTINGENT LIABILITIES
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Total liabilities
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28,783 | 17,133 | 4,406 | |||||||||
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EQUITY
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Ordinary shares
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2,414 | 3,911 | 1,006 | |||||||||
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Share premium
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509,857 | 628,710 | 161,664 | |||||||||
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Capital reserve
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34,192 | 36,470 | 9,378 | |||||||||
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Accumulated deficit
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(505,777 | ) | (545,397 | ) | (140,242 | ) | ||||||
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Total equity
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40,686 | 123,694 | 31,806 | |||||||||
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Total liabilities and equity
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69,469 | 140,827 | 36,211 | |||||||||
5
BioLineRx Ltd.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
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Year ended December 31,
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Convenience
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into USD
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2012
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2013
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2014
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2014
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NIS in thousands
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In thousands
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RESEARCH AND DEVELOPMENT EXPENSES, NET
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(64,304 | ) | (44,057 | ) | (42,443 | ) | (10,914 | ) | ||||||||
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SALES AND MARKETING EXPENSES
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(3,227 | ) | (4,101 | ) | (5,685 | ) | (1,462 | ) | ||||||||
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GENERAL AND ADMINISTRATIVE EXPENSES
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(14,026 | ) | (13,225 | ) | (13,591 | ) | (3,495 | ) | ||||||||
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OPERATING LOSS
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(81,557 | ) | (61,383 | ) | (61,719 | ) | (15,871 | ) | ||||||||
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NON-OPERATING INCOME, NET
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3,958 | 4,191 | 10,948 | 2,815 | ||||||||||||
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FINANCIAL INCOME
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8,819 | 2,600 | 12,754 | 3,280 | ||||||||||||
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FINANCIAL EXPENSES
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(7,490 | ) | (6,846 | ) | (1,603 | ) | (412 | ) | ||||||||
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NET LOSS AND COMPREHENSIVE LOSS
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(76,270 | ) | (61,438 | ) | (39,620 | ) | (10,188 | ) | ||||||||
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NIS
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USD
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LOSS PER ORDINARY SHARE – BASIC AND DILUTED
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(0.45 | ) | (0.27 | ) | (0.12 | ) | (0.03 | ) | ||||||||
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WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE
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169,404,730 | 224,885,157 | 324,338,834 | 324,338,834 | ||||||||||||
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BioLineRx Ltd.
CONSOLIDATED CASH FLOW STATEMENTS
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Year ended December 31,
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Convenience
translation
into USD
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2012
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2013
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2014
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2014
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NIS in thousands
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In thousands
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CASH FLOWS - OPERATING ACTIVITIES
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Net loss
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(76,270 | ) | (61,438 | ) | (39,620 | ) | (10,188 | ) | ||||||||
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Adjustments required to reflect net cash used in operating activities (see appendix below)
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1,125 | (9,026 | ) | (16,763 | ) | (4,310 | ) | |||||||||
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Net cash used in operating activities
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(75,145 | ) | (70,464 | ) | (56,383 | ) | (14,498 | ) | ||||||||
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CASH FLOWS - INVESTING ACTIVITIES
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Investments in short-term deposits
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(12,025 | ) | (129,359 | ) | (206,449 | ) | (53,086 | ) | ||||||||
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Maturities of short-term deposits
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64,801 | 107,049 | 136,408 | 35,075 | ||||||||||||
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Investments in restricted deposits
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(775 | ) | - | - | - | |||||||||||
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Maturities of restricted deposits
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- | 2,900 | - | - | ||||||||||||
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Purchase of property and equipment
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(598 | ) | (309 | ) | (674 | ) | (173 | ) | ||||||||
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Purchase of intangible assets
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(61 | ) | (99 | ) | (21 | ) | (5 | ) | ||||||||
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Net cash provided by (used in) investing activities
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51,342 | (19,818 | ) | (70,736 | ) | (18,189 | ) | |||||||||
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CASH FLOWS - FINANCING ACTIVITIES
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Issuance of share capital and warrants, net of issuance expenses
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59,207 | 55,306 | 117,816 | 30,295 | ||||||||||||
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Repayments of bank loan
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(300 | ) | (127 | ) | - | - | ||||||||||
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Proceeds from exercise of employee stock options
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2 | 10 | * | * | ||||||||||||
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Net cash provided by financing activities
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58,909 | 55,189 | 117,816 | 30,295 | ||||||||||||
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INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
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35,106 | (35,093 | ) | (9,303 | ) | (2,392 | ) | |||||||||
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CASH AND CASH EQUIVALENTS - BEGINNING OF YEAR
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33,061 | 68,339 | 30,888 | 7,942 | ||||||||||||
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EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
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172 | (2,358 | ) | 934 | 240 | |||||||||||
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CASH AND CASH EQUIVALENTS - END OF YEAR
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68,339 | 30,888 | 22,519 | 5,790 | ||||||||||||
* Less than 1,000.
7
BioLineRx Ltd.
CONSOLIDATED CASH FLOW STATEMENTS
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Year ended December 31,
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Convenience
translation
into USD
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2012
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2013
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2014
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2014
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NIS in thousands
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In thousands
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APPENDIX
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Adjustments required to reflect net cash used in operating activities:
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Income and expenses not involving cash flows:
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Depreciation and amortization
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1,524 | 1,147 | 960 | 247 | ||||||||||||
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Write-off of intangible assets
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- | 137 | 377 | 97 | ||||||||||||
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Retirement benefit obligations
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60 | 9 | (152 | ) | (39 | ) | ||||||||||
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Long-term prepaid expenses
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- | 35 | (21 | ) | (6 | ) | ||||||||||
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Exchange differences on cash and cash equivalents
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(172 | ) | 2,358 | (934 | ) | (240 | ) | |||||||||
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Warrant issuance costs
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1,204 | 470 | - | - | ||||||||||||
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Gain on adjustment of warrants to fair value
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(7,265 | ) | (5,169 | ) | (12,354 | ) | (3,177 | ) | ||||||||
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Commitment fee paid by issuance of share capital
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880 | - | 1,040 | 267 | ||||||||||||
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Share-based compensation
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3,138 | 3,040 | 3,772 | 970 | ||||||||||||
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Interest and exchange differences on short-term deposits
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1,547 | 1,424 | (9,968 | ) | (2,563 | ) | ||||||||||
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Interest and linkage differences on bank loan
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20 | (10 | ) | - | - | |||||||||||
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Interest and exchange differences on restricted deposits
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8 | 40 | (71 | ) | (18 | ) | ||||||||||
| 944 | 3,481 | (17,351 | ) | (4,462 | ) | |||||||||||
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Changes in operating asset and liability items:
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Decrease in trade accounts receivable and other receivables
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1,454 | 913 | 286 | 74 | ||||||||||||
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Increase (decrease) in accounts payable and accruals
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(1,273 | ) | (13,420 | ) | 302 | 78 | ||||||||||
| 181 | (12,507 | ) | 588 | 152 | ||||||||||||
| 1,125 | (9,026 | ) | (16,763 | ) | (4,310 | ) | ||||||||||
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Supplementary information on investing and financing activities not involving cash flows:
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Credit received in connection with purchase of property and equipment
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10 | - | 554 | 142 | ||||||||||||
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Supplementary information on interest received in cash
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1,720 | 503 | 348 | 90 | ||||||||||||
8