BioLineRx Reports Third Quarter 2015 Financial Results
“Earlier this month we reported positive results from the
dose-escalation part of BL-8040’s Phase 2 clinical trial in relapsed or
refractory AML, including clinical response (remission) data. The
encouraging composite response rate of 38%, which will be presented for
the first time at the upcoming
Dr. Savitsky continued, “After successfully completing a Phase 1/2 study for BL-7010 for the treatment of celiac disease, we are waiting for a response from the EU regulatory authorities regarding classification of BL-7010 as a medical device in Europe. Contingent upon this decision, we are planning to start the next efficacy study in celiac disease in the first half of 2016. In parallel, we are investing considerable efforts in examining alternative development and commercialization pathways for this promising product, including as a food supplement, in order to potentially address the multi-billion dollar market for gluten sensitivity, which also has a significantly shorter time to market, especially in the US.
“Our partner Omega Pharma, now part of Perrigo, is swiftly progressing in the development of BL-5010 as an OTC solution for the non-surgical removal of benign skin lesions. In September, they submitted an application for CE Mark designation for this product. Assuming successful completion of the CE Mark registration process, we expect the first sales in Europe to begin in 2016.”
Dr. Savitsky concluded, “We continue to pursue various collaboration
agreements to maximize the value of our current pipeline assets,
including discussions with additional partners for the purpose of
monetizing some of our non-core programs. In parallel to our internal
pipeline development, we continue to screen potential assets to develop
under our strategic partnership with Novartis, and we look forward to
in-licensing promising therapeutic candidates for development under the
collaboration in the near future. Finally, with over
Financial Results for Quarter and Nine Months Ended
Research and development expenses for the three months ended
Sales and marketing expenses for the three months ended
General and administrative expenses for the three months ended
The Company’s operating loss for the three months ended
Net non-operating income amounted to
Net financial income was immaterial for the three months ended
The Company’s net loss for the three months ended
The Company held
Net cash used in operating activities was
Net cash used in investing activities for the nine months ended
Net cash provided by financing activities for the nine months ended
Conference Call and Webcast Information
BioLineRx will hold a conference call to discuss its third quarter 2015
results today,
(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
BioLineRx’s current portfolio consists of a variety of clinical and pre-clinical projects, including: BL-8040, a cancer therapy platform, which is in the midst of a Phase 2 study for relapsed/refractory acute myeloid leukemia (AML), has recently initiated a Phase 2b study as an AML consolidation treatment, and has successfully completed a Phase 1 study in 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
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.
BioLineRx Ltd. | ||||||||||
CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION |
||||||||||
(UNAUDITED) |
||||||||||
December 31, | September 30, | |||||||||
2014 | 2015 | |||||||||
in USD thousands | ||||||||||
Assets | ||||||||||
CURRENT ASSETS | ||||||||||
Cash and cash equivalents | 5,790 | 5,320 | ||||||||
Short-term bank deposits | 28,890 | 45,387 | ||||||||
Prepaid expenses | 221 | 186 | ||||||||
Other receivables | 257 | 992 | ||||||||
Total current assets | 35,158 | 51,885 | ||||||||
NON-CURRENT ASSETS | ||||||||||
Restricted deposits | 166 | - | ||||||||
Long-term prepaid expenses | 49 | 56 | ||||||||
Property and equipment, net | 721 | 2,962 | ||||||||
Intangible assets, net | 117 | 128 | ||||||||
Total non-current assets | 1,053 | 3,146 | ||||||||
Total assets | 36,211 | 55,031 | ||||||||
Liabilities and equity | ||||||||||
CURRENT LIABILITIES | ||||||||||
Current maturities of long-term bank loan | - | 93 | ||||||||
Accounts payable and accruals: | ||||||||||
Trade | 1,654 | 2,349 | ||||||||
Other | 1,252 | 1,148 | ||||||||
Total current liabilities | 2,906 | 3,590 | ||||||||
NON-CURRENT LIABILITIES | ||||||||||
Long-term bank loan, net of current maturities | - | 366 | ||||||||
Warrants | 1,500 | 404 | ||||||||
Total non-current liabilities | 1,500 | 770 | ||||||||
COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||||
Total liabilities | 4,406 | 4,360 | ||||||||
EQUITY | ||||||||||
Ordinary shares | 1,055 | 1,450 | ||||||||
Share premium | 167,331 | 195,950 | ||||||||
Other reserves | (1,416 | ) | (1,416 | ) | ||||||
Capital reserve | 9,800 | 10,400 | ||||||||
Accumulated deficit | (144,965 | ) | (155,713 | ) | ||||||
Total equity | 31,805 | 50,671 | ||||||||
Total liabilities and equity | 36,211 | 55,031 | ||||||||
BioLineRx Ltd. | ||||||||||||||||
CONDENSED CONSOLIDATED INTERIM STATEMENT OF COMPREHENSIVE LOSS |
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(UNAUDITED) |
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Three months ended |
Nine months ended |
|||||||||||||||
2014 | 2015 | 2014 | 2015 | |||||||||||||
in USD thousands | in USD thousands | |||||||||||||||
RESEARCH AND DEVELOPMENT EXPENSES, NET | (2,975 | ) | (2,576 | ) | (8,486 | ) | (8,678 | ) | ||||||||
SALES AND MARKETING EXPENSES | (305 | ) | (265 | ) | (957 | ) | (824 | ) | ||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | (791 | ) | (762 | ) | (2,615 | ) | (2,594 | ) | ||||||||
OPERATING LOSS | (4,071 | ) | (3,603 | ) | (12,058 | ) | (12,096 | ) | ||||||||
NON-OPERATING INCOME, NET | 1,380 | 1,983 | 3,346 | 1,096 | ||||||||||||
FINANCIAL INCOME | 1,991 | 85 | 2,216 | 363 | ||||||||||||
FINANCIAL EXPENSES | - | (91 | ) | (386 | ) | (111 | ) | |||||||||
NET LOSS | (700 | ) | (1,626 | ) | (6,883 | ) | (10,748 | ) | ||||||||
OTHER COMPREHENSIVE LOSS: | ||||||||||||||||
CURRENCY TRANSLATION DIFFERENCES | (2,027 | ) | - | (1,739 | ) | - | ||||||||||
COMPREHENSIVE LOSS | (2,727 | ) | (1,626 | ) | (8,622 | ) | (10,748 | ) | ||||||||
in USD | in USD | |||||||||||||||
LOSS PER ORDINARY SHARE - BASIC AND DILUTED | (0.02 | ) | (0.03 | ) | (0.22 | ) | (0.21 | ) | ||||||||
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE | 34,115,051 | 54,632,788 | 31,725,364 | 50,306,892 | ||||||||||||
BioLineRx Ltd. | ||||||||||
CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS |
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(UNAUDITED) |
||||||||||
Nine months ended
September 30, |
||||||||||
2014 | 2015 | |||||||||
in USD thousands | ||||||||||
CASH FLOWS - OPERATING ACTIVITIES | ||||||||||
Comprehensive loss for the period | (6,883 | ) | (10,748 | ) | ||||||
Adjustments required to reflect net cash used in operating activities (see appendix below) | (4,094 | ) | (232 | ) | ||||||
Net cash used in operating activities | (10,977 | ) | (10,980 | ) | ||||||
CASH FLOWS - INVESTING ACTIVITIES | ||||||||||
Investments in short-term deposits | (40,045 | ) | (51,262 | ) | ||||||
Maturities of short-term deposits | 24,584 | 34,878 | ||||||||
Maturities of restricted deposits | - | 166 | ||||||||
Purchase of property and equipment | (156 | ) | (2,466 | ) | ||||||
Purchase of intangible assets | (3 | ) | (22 | ) | ||||||
Net cash used in investing activities | (15,620 | ) | (18,706 | ) | ||||||
CASH FLOWS - FINANCING ACTIVITIES | ||||||||||
Issuances of share capital, net | 22,612 | 28,844 | ||||||||
Proceeds of bank loan | - | 467 | ||||||||
Repayments of bank loan | - | (8 | ) | |||||||
Net cash provided by financing activities | 22,612 | 29,303 | ||||||||
DECREASE IN CASH AND CASH EQUIVALENTS | (3,985 | ) | (383 | ) | ||||||
CASH AND CASH EQUIVALENTS – BEGINNING
OF PERIOD |
8,899 | 5,790 | ||||||||
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | (211 | ) | (87 | ) | ||||||
CASH AND CASH EQUIVALENTS - END OF PERIOD | 4,703 | 5,320 | ||||||||
BioLineRx Ltd. | ||||||||||
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS |
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(UNAUDITED) |
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Nine months ended |
||||||||||
2014 | 2015 | |||||||||
in USD thousands | ||||||||||
Adjustments required to reflect net cash used in operating activities: | ||||||||||
Income and expenses not involving cash flows: | ||||||||||
Depreciation and amortization | 211 | 322 | ||||||||
Long-term prepaid expenses | 10 | (7 | ) | |||||||
Interest on restricted deposits | (11 | ) | - | |||||||
Interest and exchange rate differences on short-term deposits | (1,609 | ) | (113 | ) | ||||||
Share-based compensation | 781 | 770 | ||||||||
Exchange differences on cash and cash equivalents | (220 | ) | 87 | |||||||
Gain on adjustment of warrants to fair value | (3,693 | ) | (1,096 | ) | ||||||
Commitment fee paid by issuance of share capital | 303 | - | ||||||||
(4,228 | ) | (37 | ) | |||||||
Changes in operating asset and liability items: | ||||||||||
Decrease (increase) in trade accounts receivable and other receivables |
365 | (700 | ) | |||||||
Increase (decrease) in accounts payable and accruals | (231 | ) | 505 | |||||||
134 | (195 | ) | ||||||||
(4,094 | ) | (232 | ) | |||||||
Supplementary information on investing activities not involving cash flows: |
||||||||||
Property and equipment acquired on supplier trade credit | - | 228 | ||||||||
Supplementary information on interest received in cash | 51 | 105 |
View source version on businesswire.com: http://www.businesswire.com/news/home/20151116005623/en/
Source:
PCG Advisory
Vivian Cervantes
Investor Relations
212-554-5482
vivian@pcgadvisory.com
or
for
BioLineRx Ltd.
Tsipi Haitovsky
Public Relations
+972-3-624-0871
tsipihai5@gmail.com