Exhibit 2
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
AS OF SEPTEMBER 30, 2022
BioLineRx Ltd.
CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
AS OF SEPTEMBER 30, 2022
TABLE OF CONTENTS
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BioLineRx Ltd.
(UNAUDITED)
December 31, | September 30, | |||||||
2021 | 2022 | |||||||
in USD thousands | ||||||||
Assets | ||||||||
CURRENT ASSETS | ||||||||
Cash and cash equivalents | 12,990 | 13,105 | ||||||
Short-term bank deposits | 44,145 | 44,157 | ||||||
Prepaid expenses | 127 | 537 | ||||||
Other receivables | 142 | 143 | ||||||
Total current assets | 57,404 | 57,942 | ||||||
NON-CURRENT ASSETS | ||||||||
Property and equipment, net | 952 | 726 | ||||||
Right-of-use assets, net | 1,331 | 1,289 | ||||||
Intangible assets, net | 21,704 | 21,716 | ||||||
Total non-current assets | 23,987 | 23,731 | ||||||
Total assets | 81,391 | 81,673 | ||||||
Liabilities and equity | ||||||||
CURRENT LIABILITIES | ||||||||
Current maturities of long-term loan | 2,757 | 802 | ||||||
Accounts payable and accruals: | ||||||||
Trade | 5,567 | 5,829 | ||||||
Other | 1,227 | 1,351 | ||||||
Current maturities of lease liabilities | 168 | 151 | ||||||
Total current liabilities | 9,719 | 8,133 | ||||||
NON-CURRENT LIABILITIES | ||||||||
Warrants | 1,859 | 8,156 | ||||||
Long-term loan, net of current maturities | - | 8,353 | ||||||
Lease liabilities | 1,726 | 1,507 | ||||||
Total non-current liabilities | 3,585 | 18,016 | ||||||
COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
Total liabilities | 13,304 | 26,149 | ||||||
EQUITY | ||||||||
Ordinary shares | 21,066 | 27,098 | ||||||
Share premium | 339,346 | 338,841 | ||||||
Warrants | 975 | 1,408 | ||||||
Capital reserve | 13,157 | 13,854 | ||||||
Other comprehensive loss | (1,416 | ) | (1,416 | ) | ||||
Accumulated deficit | (305,041 | ) | (324,261 | ) | ||||
Total equity | 68,087 | 55,524 | ||||||
Total liabilities and equity | 81,391 | 81,673 |
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
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BioLineRx Ltd.
(UNAUDITED)
Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
2021 | 2022 | 2021 | 2022 | |||||||||||||
in USD thousands | in USD thousands | |||||||||||||||
RESEARCH AND DEVELOPMENT EXPENSES | (4,923 | ) | (4,369 | ) | (14,340 | ) | (14,199 | ) | ||||||||
SALES AND MARKETING EXPENSES | (247 | ) | (1,317 | ) | (731 | ) | (3,112 | ) | ||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | (1,047 | ) | (1,392 | ) | (3,108 | ) | (3,448 | ) | ||||||||
OPERATING LOSS | (6,217 | ) | (7,078 | ) | (18,179 | ) | (20,759 | ) | ||||||||
NON-OPERATING INCOME (EXPENSES), NET | 710 | 389 | (4,068 | ) | 2,115 | |||||||||||
FINANCIAL INCOME | 52 | 109 | 299 | 256 | ||||||||||||
FINANCIAL EXPENSES | (261 | ) | (267 | ) | (802 | ) | (832 | ) | ||||||||
NET LOSS AND COMPREHENSIVE LOSS | (5,716 | ) | (6,847 | ) | (22,750 | ) | (19,220 | ) | ||||||||
in USD | in USD | |||||||||||||||
LOSS PER ORDINARY SHARE - BASIC AND DILUTED | (0.01 | ) | (0.01 | ) | (0.04 | ) | (0.03 | ) | ||||||||
WEIGHTED AVERAGE NUMBER OF SHARES USED IN CALCULATION OF LOSS PER ORDINARY SHARE | 708,473,164 | 740,767,492 | 646,427,790 | 723,805,390 |
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
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BioLineRx Ltd.
(UNAUDITED)
Ordinary | Share | Capital | Other Comprehensive | Accumulated | ||||||||||||||||||||||||
Shares | premium | Warrants | reserve | loss | deficit | Total | ||||||||||||||||||||||
in USD thousands | ||||||||||||||||||||||||||||
BALANCE AT JANUARY 1, 2021 | 9,870 | 279,241 | - | 12,322 | (1,416 | ) | (277,987 | ) | 22,030 | |||||||||||||||||||
CHANGES FOR NINE MONTHS ENDED SEPTEMBER 30, 2021: | ||||||||||||||||||||||||||||
Issuance of share capital and warrants, net | 8,764 | 39,569 | 975 | - | - | - | 49,308 | |||||||||||||||||||||
Warrants exercised | 2,235 | 18,967 | - | - | - | - | 21,202 | |||||||||||||||||||||
Employee stock options exercised | 5 | 41 | - | (39 | ) | - | - | 7 | ||||||||||||||||||||
Employee stock options expired | - | 233 | - | (233 | ) | - | - | - | ||||||||||||||||||||
Share-based compensation | - | - | - | 1,104 | - | - | 1,104 | |||||||||||||||||||||
Comprehensive loss for the period | - | - | - | - | - | (22,750 | ) | (22,750 | ) | |||||||||||||||||||
BALANCE AT SEPTEMBER 30, 2021 | 20,874 | 338,051 | 975 | 13,154 | (1,416 | ) | (300,737 | ) | 70,901 |
Ordinary | Share | Capital | Other Comprehensive | Accumulated | ||||||||||||||||||||||||
Shares | premium | Warrants | reserve | Loss | deficit | Total | ||||||||||||||||||||||
in USD thousands | ||||||||||||||||||||||||||||
BALANCE AT JANUARY 1, 2022 | 21,066 | 339,346 | 975 | 13,157 | (1,416 | ) | (305,041 | ) | 68,087 | |||||||||||||||||||
CHANGES FOR NINE MONTHS ENDED SEPTEMBER 30, 2022: | ||||||||||||||||||||||||||||
Issuance of share capital and warrants, net | 6,030 | (1,008 | ) | 433 | - | - | - | 5,455 | ||||||||||||||||||||
Employee stock options exercised | 2 | 12 | - | (12 | ) | - | - | 2 | ||||||||||||||||||||
Employee stock options expired | - | 491 | - | (491 | ) | - | - | - | ||||||||||||||||||||
Share-based compensation | - | - | - | 1,200 | - | - | 1,200 | |||||||||||||||||||||
Comprehensive loss for the period | - | - | - | - | - | (19,220 | ) | (19,220 | ) | |||||||||||||||||||
BALANCE AT SEPTEMBER 30, 2022 | 27,098 | 338,841 | 1,408 | 13,854 | (1,416 | ) | (324,261 | ) | 55,524 |
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
3
BioLineRx Ltd.
(UNAUDITED)
Nine months ended September 30, | ||||||||
2021 | 2022 | |||||||
in USD thousands | ||||||||
CASH FLOWS - OPERATING ACTIVITIES | ||||||||
Net loss for the period | (22,750 | ) | (19,220 | ) | ||||
Adjustments required to reflect net cash used in operating activities (see appendix below) | 4,680 | (1,337 | ) | |||||
Net cash used in operating activities | (18,070 | ) | (20,557 | ) | ||||
CASH FLOWS - INVESTING ACTIVITIES | ||||||||
Investments in short-term deposits | (70,000 | ) | (36,000 | ) | ||||
Maturities of short-term deposits | 27,813 | 36,232 | ||||||
Purchase of property and equipment | - | (74 | ) | |||||
Purchase of intangible assets | (35 | ) | (14 | ) | ||||
Net cash provided by (used in) investing activities | (42,222 | ) | 144 | |||||
CASH FLOWS - FINANCING ACTIVITIES | ||||||||
Issuance of share capital and warrants, net of issuance costs | 49,308 | 14,359 | ||||||
Exercise of warrants | 10,907 | - | ||||||
Employee stock options exercised | 7 | 2 | ||||||
Repayments of loan | (2,502 | ) | (2,832 | ) | ||||
Proceeds of long-term loan, net of issuance costs | - | 9,126 | ||||||
Repayments of lease liabilities | (145 | ) | (126 | ) | ||||
Net cash provided by financing activities | 57,575 | 21,085 | ||||||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (2,717 | ) | 672 | |||||
CASH AND CASH EQUIVALENTS - BEGINNING OF PERIOD | 16,831 | 12,990 | ||||||
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS | (37 | ) | (557 | ) | ||||
CASH AND CASH EQUIVALENTS - END OF PERIOD | 14,077 | 13,105 |
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
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BioLineRx Ltd.
APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS
(UNAUDITED)
Nine months ended September 30, | ||||||||
2021 | 2022 | |||||||
in USD thousands | ||||||||
Adjustments required to reflect net cash used in operating activities: | ||||||||
Income and expenses not involving cash flows: | ||||||||
Depreciation and amortization | 529 | 467 | ||||||
Exchange differences on cash and cash equivalents | 37 | 557 | ||||||
Fair value adjustments of warrants | 4,090 | (2,778 | ) | |||||
Share-based compensation | 1,104 | 1,200 | ||||||
Warrant issuance costs | - | 171 | ||||||
Interest and exchange differences on short-term deposits | (185 | ) | (244 | ) | ||||
Interest on loans | 245 | 104 | ||||||
Exchange differences on lease liability | (3 | ) | (233 | ) | ||||
Long-term loan issuance costs | - | (556 | ) | |||||
5,817 | (1,312 | ) | ||||||
Changes in operating asset and liability items: | ||||||||
Increase in prepaid expenses and other receivables | (348 | ) | (411 | ) | ||||
Increase (decrease) in accounts payable and accruals | (789 | ) | 386 | |||||
(1,137 | ) | (25 | ) | |||||
4,680 | (1,337 | ) | ||||||
Supplemental information on interest received in cash | 77 | 244 | ||||||
Supplemental information on interest paid in cash | 541 | 307 | ||||||
Supplemental information on warrant issuance costs paid in cash | - | 591 | ||||||
Supplemental information on non-cash transactions: | ||||||||
Changes in right-of-use asset | 143 | 123 | ||||||
Warrant issuance costs | - | 262 | ||||||
Exercise of warrants (portion related to accumulated fair value adjustments) | 10,295 | - |
The accompanying notes are an integral part of these condensed consolidated interim financial statements.
5
NOTE 1 – GENERAL INFORMATION
a. | General |
BioLineRx Ltd. (“BioLineRx”), headquartered in Modi’in, Israel, was incorporated and commenced operations in April 2003. BioLineRx and its subsidiaries (collectively, the “Company”) are engaged in the development of therapeutics, primarily in pre-commercialization and clinical stages, with a focus on the field of oncology.
The Company’s American Depositary Shares (“ADSs”) are traded on the NASDAQ Capital Market, and its ordinary shares are traded on the Tel Aviv Stock Exchange (“TASE”). Each ADS represents 15 ordinary shares.
In March 2017, the Company acquired Agalimmune Ltd. (“Agalimmune”), a privately held company incorporated in the United Kingdom, with a focus on the field of immuno-oncology. In April 2022, the Company re-activated BioLineRx USA, Inc., a previously inactive subsidiary incorporated in the US, to engage in pre-commercialization and commercialization activities associated with the potential launch of Motixafortide for stem-cell mobilization in the US.
Although the Company has succeeded in generating significant revenues from a number of out-licensing transactions in the past, it cannot determine with reasonable certainty if and when it will become profitable on a current basis. Management believes that the Company’s current cash and other resources will be sufficient to fund its projected cash requirements into the first half of 2024. However, in the event that the Company does not begin to generate sustainable cash flows from its operating activities in the future, the Company will need to carry out significant cost reductions or raise additional funding.
b. | Approval of financial statements |
The condensed consolidated interim financial statements of the Company as of September 30, 2022, and for the three and nine months then ended, were approved by the Board of Directors on November 14, 2022, and signed on its behalf by the Chairman of the Board, the Chief Executive Officer and the Chief Financial Officer.
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BioLineRx Ltd.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 2 – BASIS OF PREPARATION
The Company’s condensed consolidated interim financial statements as of September 30, 2022 and for the three and nine months then ended (the “interim financial statements”) have been prepared in accordance with International Accounting Standard No. 34, “Interim Financial Reporting” (“IAS 34”). These interim financial statements, which are unaudited, do not include all disclosures necessary for a fair statement of financial position, results of operations, and cash flows in conformity with International Financial Reporting Standards (“IFRS”). The condensed consolidated interim financial statements should be read in conjunction with the Company’s annual financial statements as of December 31, 2021 and for the year then ended and their accompanying notes, which have been prepared in accordance with IFRS. The results of operations for the three and nine months ended September 30, 2022 are not necessarily indicative of the results that may be expected for the entire fiscal year or for any other interim period.
The preparation of financial statements in conformity with IFRS requires management to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity and expenses, as well as the related disclosures of contingent assets and liabilities, in the process of applying the Company’s accounting policies. These inputs also consider, among other things, the implications of pandemics and wars across the globe on the Company’s activities, and the resultant effects on critical and significant accounting estimates, most significantly in relation to the value of intangible assets. In this regard, U.S. and global markets are currently experiencing volatility and disruption following the escalation of geopolitical tensions and the ongoing military conflict between Russia and Ukraine. Although the length and impact of the ongoing military conflict are highly unpredictable, the conflict in Ukraine could lead to market disruptions, including significant volatility in commodity prices, credit and the capital markets. As of the date of release of these financial statements, the Company estimates there are no material effects of this conflict on its financial position and results of operations.
NOTE 3 – SIGNIFICANT ACCOUNTING POLICIES
The accounting policies and calculation methods applied in the preparation of these interim financial statements are consistent with those applied in the preparation of the annual financial statements as of December 31, 2021 and for the year then ended.
7
BioLineRx Ltd.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 4 – AT-THE-MARKET (“ATM”) SALES AGREEMENT WITH HCW
The Company maintains an ATM facility with H.C. Wainwright & Co., LLC (“HCW”) pursuant to an ATM sales agreement entered into in September 2021. In accordance with the agreement, the Company is entitled, at its sole discretion, to offer and sell through HCW, acting as a sales agent, ADSs having an aggregate offering price of up to $25.0 million throughout the period during which the ATM facility remains in effect. The Company has agreed to pay HCW a commission of 3.0% of the gross proceeds from the sale of ADSs under the facility. During the nine months ended September 30, 2022, the Company issued a total of 206,324 ADSs under the program for total gross proceeds of approximately $0.3 million. From the effective date of the agreement through the issuance date of this report, 608,651 ADSs have been sold under the program for total gross proceeds of approximately $1.4 million.
NOTE 5- LONG-TERM LOAN
In September 2022, the Company entered into a $40 million loan agreement with Kreos Capital VII Aggregator SCSp (“Kreos Capital”). Pursuant to the agreement, the first tranche of $10 million was drawn down by the Company following execution of the definitive agreement, after completion of certain customary conditions to closing. The remaining $30 million will be made available in two additional tranches subject to the achievement of pre-specified milestones. The tranches are available for drawdown at the Company’s discretion at various time points through October 1, 2024.
Each tranche carries a pre-defined interest-only payment period, followed by a loan principal amortization period of up to 36 months subsequent to the interest-only period. The interest-only periods are subject to possible extension based on certain pre-defined milestones. Borrowings under the financing will bear interest at a fixed rate of 9.5% per annum (~11.0%, including associated cash fees). As security for the loan, Kreos Capital received a first-priority, secured interest in all Company assets, including intellectual property. In addition, Kreos Capital will be entitled to mid-to-high single-digit royalties on Motixafortide sales, up to a pre-defined cap.
8
BioLineRx Ltd.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 6 – REGISTERED DIRECT OFFERING
In September 2022, the Company completed a registered direct offering of 13,636,365 ADSs at a price of $1.10 per ADS. In concurrent private placements, the Company issued to investors in the offering unregistered warrants to purchase 13,636,365 ADSs. The warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $1.15 per ADS. In addition, the Company granted to the placement agent in the offering, as part of the placement fee, warrants to purchase 681,818 ADSs. These warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $1.375 per ADS. Gross proceeds from the offering totaled $15.0 million, with net proceeds of $13.5 million, after deducting fees and expenses. The offering consideration allocated to the placement agent warrants amounted to $0.4 million.
The warrants issued to the investors have been classified as a non-current financial liability due to a net settlement provision. This liability was initially recognized at its fair value on the issuance date and is subsequently accounted for at fair value at each balance sheet date. The fair value changes are charged to non-operating income and expense in the statement of comprehensive loss.
The fair value of the warrants is computed using the Black-Scholes option pricing model. The fair value of the warrants upon issuance was computed based on the then-current price of an ADS, a risk-free interest rate of 3.62%, and an average standard deviation of 82.5%. The gross consideration initially allocated to the investor warrants amounted to $9.1 million, with total issuance costs initially allocated to the warrants amounting to $0.8 million.
The fair value of the warrants amounted to $8.1 million as of September 30, 2022, and was based on the then current price of an ADS, a risk-free interest rate of 4.06%, an average standard deviation of 82.8%, and on the remaining contractual life of the warrants.
The placement agent warrants have been classified in shareholders’ equity, with initial recognition at fair value on the date issued, using the same assumptions as the investor warrants.
9
BioLineRx Ltd.
NOTES TO CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
(UNAUDITED)
NOTE 7 – SHAREHOLDERS’ EQUITY
As of December 31, 2021, and September 30, 2022, the Company’s share capital is composed of ordinary shares, as follows:
Number of ordinary shares | ||||||||
December 31, | September 30, | |||||||
2021 | 2022 | |||||||
Authorized share capital | 1,500,000,000 | 2,500,000,000 | ||||||
Issued and paid-up share capital | 715,156,008 | 922,867,375 |
In USD and NIS | ||||||||
December 31, | September 30, | |||||||
2021 | 2022 | |||||||
Authorized share capital (in NIS) | 150,000,000 | 250,000,000 | ||||||
Issued and paid-up share capital (in NIS) | 71,515,600 | 92,286,737 | ||||||
Issued and paid-up share capital (in USD) | 21,066,368 | 27,097,603 |
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