BioLineRx Ltd. Files 20-F/A Amendment

TL;DR

<b>BioLineRx Ltd. filed an amendment to its 20-F filing for the fiscal year ending December 31, 2023, on March 26, 2024.</b>

AI Summary

BioLineRx Ltd. (BLRX) filed a Amended Foreign Annual Report (20-F/A) with the SEC on March 26, 2024. BioLineRx Ltd. filed an amendment to its 20-F filing on March 26, 2024. The filing covers the fiscal year ending December 31, 2023. Key dates mentioned include license agreements in October 2023 and purchase agreements in August 2023. Financial data points from December 31, 2022, and December 31, 2023, are referenced. The company's SIC code is Pharmaceutical Preparations [2834].

Why It Matters

For investors and stakeholders tracking BioLineRx Ltd., this filing contains several important signals. This amendment provides updated information and disclosures for the fiscal year 2023, which is crucial for investors to assess the company's current financial health and strategic direction. The inclusion of specific dates for license and purchase agreements offers insight into recent business development activities and potential future revenue streams or operational changes.

Risk Assessment

Risk Level: medium — BioLineRx Ltd. shows moderate risk based on this filing. The company operates in the pharmaceutical sector, which is subject to significant regulatory hurdles, clinical trial risks, and market competition, as indicated by its SIC code and the nature of its business.

Analyst Insight

Review the detailed financial statements and disclosures within the 20-F/A filing to understand the impact of recent agreements and the company's performance in fiscal year 2023.

Key Numbers

• 2023-12-31 — Fiscal Year End (Period covered by the filing)
• 2024-03-26 — Filing Date (Date the amendment was submitted)
• 2834 — SIC Code (Pharmaceutical Preparations)
• 2023-10-12 — License Agreement End Date (Specific license agreement period)
• 2023-08-27 — Purchase Agreement End Date (Specific purchase agreement period)

Key Players & Entities

• BioLineRx Ltd. (company) — Filer of the 20-F/A amendment
• 20-F/A (filing) — Type of filing submitted
• 2024-03-26 (date) — Filing date of the amendment
• 2023-12-31 (date) — Fiscal year end date
• 2834 (industry_code) — Standard Industrial Classification for Pharmaceutical Preparations
• 972-2-548-9100 (phone_number) — Business phone number
• Kreos Capital (company) — Mentioned in relation to loan agreements
• 2023-10-01 (date) — Start date of license agreements

FAQ

Risk Factors

• Regulatory Compliance [high — regulatory]: The company operates in the pharmaceutical industry, which is subject to extensive and evolving regulations from health authorities worldwide.
• Financing and Liquidity [medium — financial]: The company has historically relied on external financing, and future funding needs may impact its operations and growth prospects.
• Product Development and Commercialization [high — operational]: Success is dependent on the development and successful commercialization of its product candidates, which involves significant risks and uncertainties.
• Competition [medium — market]: The pharmaceutical market is highly competitive, with many companies developing similar therapies.

Key Financial Figures

• $27.1 million — r operations. We recorded net losses of $27.1 million in 2021, $25.0 million in 2022 and $60.
• $25.0 million — ed net losses of $27.1 million in 2021, $25.0 million in 2022 and $60.6 million in 2023. As o
• $60.6 million — lion in 2021, $25.0 million in 2022 and $60.6 million in 2023. As of December 31, 2023, we ha
• $391 million — 2023, we had an accumulated deficit of $391 million. We expect to continue to incur signifi
• $43.0 million — ents. As of December 31, 2023, we held $43.0 million of cash, cash equivalents and short-ter
• $40 million — an aggregate principal amount of up to $40 million in three tranches as follows: (a) a loa
• $10 m — the aggregate principal amount of up to $10 million, (b) a loan in the aggregate prin
• $20 m — the aggregate principal amount of up to $20 million, available for drawdown upon achi
• $10 million — 24. We drew down the initial tranche of $10 million following execution of the agreement in

Filing Documents

• zk2431202.htm (20-F/A) — 3162KB
• exhibit_2-1.htm (EX-2.1) — 176KB
• exhibit_12-1.htm (EX-12.1) — 11KB
• exhibit_12-2.htm (EX-12.2) — 12KB
• exhibit_13-1.htm (EX-13.1) — 6KB
• exhibit_13-2.htm (EX-13.2) — 6KB
• exhibit_15-1.htm (EX-15.1) — 4KB
• image0.jpg (GRAPHIC) — 12KB
• image1.jpg (GRAPHIC) — 229KB
• image00002.jpg (GRAPHIC) — 34KB
• 0001178913-24-001095.txt (&nbsp;) — 13724KB
• blrx-20231231.xsd (EX-101.SCH) — 110KB
• blrx-20231231_cal.xml (EX-101.CAL) — 64KB
• blrx-20231231_def.xml (EX-101.DEF) — 253KB
• blrx-20231231_lab.xml (EX-101.LAB) — 872KB
• blrx-20231231_pre.xml (EX-101.PRE) — 438KB
• zk2431202_htm.xml (XML) — 2903KB

Item 18

Item 17 Item 18 If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No BioLineRx Ltd. Form 20-F/A (Amendment No. 1) For the Fiscal Year Ended December 31, 2023 EXPLANATORY NOTE This Amendment No. 1 to Form 20-F (this "Amendment") amends the annual report on Form 20-F of BioLineRx Ltd. for the year ended December 31, 2023, which was filed with the U.S. Securities and Exchange Commission (the "SEC") on March 26, 2024 (the "Original Report"). This Amendment is being filed solely to correct a typographical error in the Report of Independent Registered Public Accounting Firm of Kesselman & Kesselman, a member firm of PricewaterhouseCoopers International Limited, and to re-file Exhibit 2.1 in the Original Report. As required by Rule 12b-15 under the Exchange Act, as amended, new certifications by our principal executive officer and principal financial officer are being filed as Exhibits 12.1, 12.2, 13.1 and 13.2 to this Amendment. A new consent of our independent registered public accounting firm also is being filed as an exhibit hereto. This Amendment does not reflect events occurring after the filing of the Original Report and does not modify or update the disclosure therein in any way except as described above or herein. No other changes have been made to the Original Report. The filing of this Amendment should not be understood to mean that any statements contained in the Original Report, as amended by this Amendment, are true or complete as of any date subsequent to the original filing date of the Original Report. Unless otherwise stated herein, all disclosures referenced as being made "as of the date of this Annual Report" or similar language are speaking as of the date of the Original Report. INTRODUCTION i PART I. 1 ITEM 1 . IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS 1 ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE 1 ITEM 3 . KEY IN

INFORMATION

ITEM 4. INFORMATION ON THE COMPANY 28 ITEM 4A UNRESOLVED STAFF COMMENTS 51 ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS 51 ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES 60 ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS 79 ITEM 8. FINANCIAL INFORMATION 81 ITEM 9. THE OFFER AND LISTING 81 ITEM 10. ADDITIONAL INFORMATION 82 ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURE ON MARKET RISK 93 ITEM 12.

DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES

DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES 94 ITEM 13. DEFAULTS, DIVIDENDS ARREARAGES AND DELINQUENCIES 96 ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS 96 ITEM 15.

CONTROLS AND PROCEDURES

CONTROLS AND PROCEDURES 96 ITEM 16. [RESERVED] 97 ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERTS 97 ITEM 16B. CODE OF ETHICS 97 ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES 97 ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES 97 ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS 97 ITEM 16F. CHANGE IN REGISTRANT'S CERTIFYING ACCOUNTANT 98 ITEM 16G. CORPORATE GOVERNANCE 98 ITEM 16H. MINE SAFETY DISCLOSURE 99 ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 99 ITEM 16J. INSIDER TRADING POLICIES 99 ITEM 16K. CYBERSECURITY 99 ITEM 17.

FINANCIAL STATEMENTS

FINANCIAL STATEMENTS 100 ITEM 18.

FINANCIAL STATEMENTS

FINANCIAL STATEMENTS 100 ITEM 19. EXHIBITS 100

SIGNATURES

SIGNATURES 103 INTRODUCTION Certain Definitions In this Annual Report on Form 20-F, unless the context otherwise requires: references to "BioLineRx," the "Company," "us," "we" and "our" refer to BioLineRx Ltd., an Israeli company, and its consolidated subsidiaries; references to "ordinary shares," "our shares" and similar expressions refer to the Company's ordinary shares, NIS 0.10 nominal (par) value per share; references to "ADS" or "ADSs" refer to the Company's American Depositary Shares; references to "dollars," "U.S. dollars" and "$" are to United States Dollars; references to "shekels" and "NIS" are to New Israeli Shekels, the Israeli currency; references to the "Companies Law" are to Israel's Companies Law, 5759-1999, as amended; and references to the "SEC" are to the U.S. Securities and Exchange Commission.

Forward-Looking Statements

Forward-Looking Statements Some of the statements under the sections entitled "Item 3. Key Information – Risk Factors," "Item 4. Information on the Company" and "Item 5. Operating and Financial Review and Prospects" and elsewhere in this Annual Report on Form 20-F constitute forward-looking statements. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, the potential benefits of APHEXDA, the ongoing commercialization of APHEXDA and the plans and objectives of management for future operations and expectations and commercial potential of APHEXDA, as well as its potential investigational uses. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms including "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would," and similar expressions intended to identify forward-looking statements. Forward-looking statements reflect our current views with respect to future events and are based on assumptions, and are subject to risks and uncertainties. In addition, the section of this Annual Report on Form 20-F entitled "Item 4. Information on the Company" contains information obtained from independent industry and other sources that we have not independently verified. You should not put undue reliance on any forward-looking to do so under U.S. federal securities laws or other applicable laws, we do not intend to update or revise any forward-looking statements. Readers are encouraged to consult the Company'

IDENTITY OF

ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS Not applicable.

OFFER STATISTICS

ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE Not applicable.

KEY INFORMATION

ITEM 3. KEY INFORMATION A. [Reserved] B. Capitalization and Indebtedness Not applicable. C. Reasons for the Offer and Use of Proceeds Not applicable. D. Risk Factors You should carefully consider the risks we describe below, in addition to the other information set forth elsewhere in this Annual Report on Form 20-F, including our consolidated financial statements and the related notes beginning on page F-1, before deciding to invest in our ordinary shares and ADSs. These material risks could adversely impact our results of operations, possibly causing the trading price of our ordinary shares and ADSs to decline, and you could lose all or part of your investment. Summary Risk Factors Investing in our ordinary shares involves a high degree of risk, as fully described below. The principal factors and uncertainties that make investing in our ordinary shares risky, include, among others: Risks Related to Our Financial Condition and Capital Requirements We have incurred significant losses since inception and expect to incur additional losses in the future and may never be profitable. We cannot assure investors that our existing cash and investment balances will be sufficient to meet our future capital requirements. If we default under our secured loan agreement with Kreos, all or a portion of our assets could be subject to forfeiture. Risks Related to Our Business and Regulatory Matters We have only recently transitioned from a development stage biopharmaceutical company to a commercial stage biopharmaceutical company, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability. APHEXDA has been launched in the United States and there is significant competition in this marketplace. Since this is our first independently marketed therapeutic, the timing of uptake and distribution efforts are unpredictable and there is a risk that we may not achieve and sustain commercial success for APHEXDA. APHEXD

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View this 20-F/A filing on SEC EDGAR