BioLineRx Reports Year End 2012 Financial Results
JERUSALEM--(BUSINESS WIRE)--Mar. 12, 2013--
“BioLineRx is rapidly approaching a significant landmark in the evolution of the Company,” stated
“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
“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
“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,
“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
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
Financial Results for Year Ended
During the years ended
Research and development expenses for the year ended
Sales and marketing expenses for the year ended
General and administrative expenses for the year ended
The Company’s operating loss for the year ended
Non-operating income, net, for the year ended
The Company recognized net financial income of
Net loss for the year ended
As of
Net cash used in operating activities was
Net cash provided by investing activities for the year ended
Net cash provided by financing activities for the year ended
Conference Call and Webcast Information
BioLineRx will hold a conference call to discuss its year-end 2012 results today,
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
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
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
BioLineRx Ltd. | ||||||||
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION | ||||||||
Convenience | ||||||||
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 bank loan | 307 | 137 | 37 | |||||
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 maturities | 110 | - | - | |||||
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) |
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Year ended December 31, |
Convenience |
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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, NET | (54,966 | ) | (42,623 | ) | (64,304 | ) | (17,226 | ) | |||||||
SALES AND MARKETING EXPENSES
|
(4,609 | ) | (3,308 | ) | (3,227 | ) | (864 | ) | |||||||
GENERAL AND ADMINISTRATIVE EXPENSES | (14,875 | ) | (12,722 | ) | (14,026 | ) | (3,757 | ) | |||||||
OPERATING INCOME (LOSS) | 13,139 | (58,653 | ) | (81,557 | ) | (21,847 | ) | ||||||||
NON-OPERATING INCOME, NET | - | - | 3,958 | 1,060 | |||||||||||
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 (LOSS) |
7,440 | (50,186 | ) | (76,270 | ) | (20,432 | ) | ||||||||
NIS | USD | ||||||||||||||
EARNINGS (LOSS) PER ORDINARY SHARE - BASIC |
0.06 | (0.41 | ) | (0.45 | ) | (0.12 | ) | ||||||||
EARNINGS (LOSS) PER ORDINARY SHARE - DILUTED |
0.06 | (0.41 | ) | (0.45 | ) | (0.12 | ) | ||||||||
BioLineRx Ltd. |
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CONSOLIDATED CASH FLOW STATEMENTS |
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Year ended December 31, |
Convenience |
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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) operating activities (see appendix below) | 33,231 | 7,445 | 1,125 | 301 | ||||||||||
Net cash provided by (used in) operating activities | 40,671 | (42,711 | ) | (75,145 | ) | (20,131 | ) | |||||||
CASH FLOWS - INVESTING ACTIVITIES | ||||||||||||||
Investments in short-term deposits | (28,333 | ) | (63,456 | ) | (12,025 | ) | (3,221 | ) | ||||||
Maturities of short-term deposits | - | 27,308 | 64,801 | 17,359 | ||||||||||
Investments in restricted deposits | (206 | ) | (1,000 | ) | (775 | ) | (208 | ) | ||||||
Maturities of restricted deposits | 1,353 | 675 | - | - | ||||||||||
Purchase of property and equipment | (1,853 | ) | (951 | ) | (598 | ) | (160 | ) | ||||||
Purchase of intangible assets | (492 | ) | (133 | ) | (61 | ) | (16 | ) | ||||||
Net cash provided by (used in) investing activities | (29,531 | ) | (37,557 | ) | 51,342 | 13,754 | ||||||||
CASH FLOWS - FINANCING ACTIVITIES | ||||||||||||||
Issuance of share capital and warrants, net of issuance expenses | - | - | 59,207 | 15,861 | ||||||||||
Proceeds of bank loan | 1,020 | - | - | - | ||||||||||
Repayments of bank loan | (281 | ) | (308 | ) | (300 | ) | (80 | ) | ||||||
Proceeds from exercise of employee stock options | 26 | 1 | 2 | 1 | ||||||||||
Net cash provided by (used in) financing activities | 765 | (307 | ) | 58,909 | 15,782 | |||||||||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | 11,905 | (80,605 | ) | 35,106 | 9,405 | |||||||||
CASH AND CASH EQUIVALENTS - BEGINNING OF YEAR
|
105,890 | 111,746 | 33,061 | 8,856 | ||||||||||
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | (6,049 | ) | 1,920 | 172 | 46 | |||||||||
CASH AND CASH EQUIVALENTS - END OF YEAR | 111,746 | 33,061 | 68,339 | 18,307 | ||||||||||
* Less than 1,000. |
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BioLineRx Ltd. |
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CONSOLIDATED CASH FLOW STATEMENTS |
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Year ended December 31, |
Convenience |
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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 amortization | 1,814 | 1,563 | 1,524 | 409 | ||||||||||
Impairment of intangible assets | 1,846 | 88 | - | - | ||||||||||
Retirement benefit obligations | 79 | 53 | 60 | 16 | ||||||||||
Long-term prepaid expenses | 954 | (8 | ) | - | - | |||||||||
Exchange differences on cash and cash equivalents | 6,049 | (1,920 | ) | (172 | ) | (46 | ) | |||||||
Warrant issuance costs | - | - | 1,204 | 323 | ||||||||||
Gain on adjustment of warrants to fair value | - | - | (7,265 | ) | (1,946 | ) | ||||||||
Commitment fee paid by issuance of share capital | - | - | 880 | 235 | ||||||||||
Share-based compensation | 6,557 | 3,983 | 3,138 | 841 | ||||||||||
Interest and exchange differences on short-term deposits | 296 | (1,597 | ) | 1,547 | 414 | |||||||||
Interest and linkage on bank loan | - | (14 | ) | 20 | 5 | |||||||||
Interest and exchange differences on restricted deposits | 143 | (7 | ) | 8 | 2 | |||||||||
17,738 | 2,141 | 944 | 253 | |||||||||||
Changes in operating asset and liability items: | ||||||||||||||
Decrease in trade accounts receivable and other receivables | 34,798 | 1,847 | 1,454 | 389 | ||||||||||
Increase (decrease) in accounts payable and accruals | (19,305 | ) | 3,457 | (1,273 | ) | (341 | ) | |||||||
15,493 | 5,304 | 181 | 48 | |||||||||||
33,231 | 7,445 | 1,125 | 301 | |||||||||||
|
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Supplementary information on investing and financing activities not involving cash flows: | ||||||||||||||
Credit received in connection with purchase of property and equipment | 104 | 265 | 10 | 3 | ||||||||||
Credit received in connection with purchase of intangible assets | 100 | - | - | - | ||||||||||
Supplementary information on interest received in cash | 1,013 | 1,825 | 1,720 | 461 |
Source: BioLineRx
KCSA Strategic Communications
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or
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or
Tsipi Haitovsky, Public Relations
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