UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 20-F
(Mark One)
☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE
ACT OF 1934
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
For the fiscal year ended December 31, 2020
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) of the Securities Exchange Act of 1934
OR
Date of event requiring this shell company report
For the transition period from __________ to __________
Commission file number _______________
BioLineRx Ltd.
(Exact name of Registrant as specified in its charter)
(Translation of Registrant’s name into English)
Israel
(Jurisdiction of incorporation or organization)
2 HaMa’ayan Street
Modi’in 7177871, Israel
(Address of principal executive offices)
Philip A. Serlin
+972 (8) 642-9100
+972 (8) 642-9101 (facsimile)
phils@biolinerx.com
2 HaMa’ayan Street
Modi’in 7177871, Israel
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
Securities registered or to be registered pursuant to Section 12(b) of the Act:
Title of each class
American Depositary Shares, each representing 15
ordinary shares, par value NIS 0.10 per share
Name of each exchange on which registered
Nasdaq Capital Market
Ordinary shares, par value NIS 0.10 per share
Nasdaq Capital Market*
*Not for trading; only in connection with the registration of American Depositary Shares.
Securities registered or to be registered pursuant to Section 12(g) of the Act.
None
(Title of Class)
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act.
None
(Title of Class)
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of December 31,
2020: 349,169,545 ordinary shares
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports
pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
Yes ☐ No ☒
Yes ☐ No ☒
Note — Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934 from their obligations under those Sections.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to
file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for
such shorter period that the registrant was required to submit and post such files).
Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an
emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in
Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐
Accelerated filer ☐
Non-accelerated filer ☒
Emerging growth company ☐
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial
accounting standards† provided pursuant to Section 13(a) of the Exchange Act. ☐
The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting
Standards Board to its Accounting Standards Codification after April 5, 2012.
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in
this filing:
U.S. GAAP ☐
International Financial Reporting Standards as issued by the
International Accounting Standards Board ☒
Other ☐
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item
the registrant has elected to follow. N/A
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).
☐ Item 17 ☐ Item 18
Yes ☐ No ☒
(APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE YEARS)
Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13
or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.
N/A
Yes ☐ No ☐
TABLE OF CONTENTS
INTRODUCTION
PART I
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE
ITEM 3. KEY INFORMATION
ITEM 4. INFORMATION ON THE COMPANY
ITEM 4A. UNRESOLVED STAFF COMMENTS
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
ITEM 8. FINANCIAL INFORMATION
ITEM 9. THE OFFER AND LISTING
ITEM 10. ADDITIONAL INFORMATION
ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURE ON MARKET RISK
ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
ITEM 13. DEFAULTS, DIVIDENDS ARREARAGES AND DELINQUENCIES
ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
ITEM 15. CONTROLS AND PROCEDURES
ITEM 16. [RESERVED]
ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERTS
ITEM 16B. CODE OF ETHICS
ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES
ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT
ITEM 16G. CORPORATE GOVERNANCE
ITEM 17. FINANCIAL STATEMENTS
ITEM 18. FINANCIAL STATEMENTS
ITEM 19. EXHIBITS
SIGNATURES
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INTRODUCTION
Certain Definitions
In this Annual Report on Form 20-F, unless the context otherwise requires:
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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
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 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, but
these are not the only ways these statements are identified. Forward-looking statements reflect our current views with respect to
future events and are based on assumptions and 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 statements. Unless
we are required 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’s filings made on Form 6-K, which are periodically
filed with or furnished to the SEC.
Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking
statements include, but are not limited to:
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the initiation, timing, progress and results of our preclinical studies, clinical trials and other therapeutic candidate development efforts;
the impact of the COVID-19 pandemic on our operations;
our ability to advance our therapeutic candidates into clinical trials or to successfully complete our preclinical studies or clinical trials;
our receipt of regulatory approvals for our therapeutic candidates and the timing of other regulatory filings and approvals;
the clinical development, commercialization and market acceptance of our therapeutic candidates;
our ability to establish and maintain corporate collaborations;
our ability to integrate new therapeutic candidates and new personnel;
the interpretation of the properties and characteristics of our therapeutic candidates and of the results obtained with our therapeutic candidates in
preclinical studies or clinical trials;
the implementation of our business model and strategic plans for our business and therapeutic candidates;
the scope of protection we are able to establish and maintain for intellectual property rights covering our therapeutic candidates and our ability to
operate our business without infringing the intellectual property rights of others;
estimates of our expenses, future revenues, capital requirements and our needs for and ability to access sufficient additional financing;
risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere;
competitive companies, technologies and our industry; and
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statements as to the impact of the political and security situation in Israel on our business.
ii
PART I
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not applicable.
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE
Not applicable.
ITEM 3. KEY INFORMATION
A. Selected Financial Data
The following table sets forth our selected consolidated financial data for the periods ended and as of the dates indicated.
The following selected historical consolidated financial data for the Company should be read in conjunction with “Item 5.
Operational and Financial Review and Prospects” and other information provided elsewhere in this Annual Report on Form 20-
F and our consolidated financial statements and related notes. The selected consolidated financial data in this section is not
intended to replace the consolidated financial statements and is qualified in its entirety thereby.
On July 15, 2019, we implemented a change in the ratio of the Company’s ADSs to ordinary shares, from one ADS
representing one ordinary share to a new ratio of one ADS representing 15 ordinary shares. The change in exchange ratio for the
ADSs had the same effect as a 1-for-15 reverse stock split of the ADSs. In light of this change, all ADS amounts in this Annual
Report have been stated based on the new ratio (i.e., subsequent to the 1-for-15 ratio change). The Company’s ordinary shares,
which are not affected by the change, continue to trade on the Tel Aviv Stock Exchange.
The selected consolidated statements of operations data for the years ended December 31, 2018, 2019, 2020, and the
selected consolidated balance sheet data as of December 31, 2019 and 2020, have been derived from our audited consolidated
financial statements set forth elsewhere in this Annual Report on Form 20-F. The selected consolidated statements of operations
data for the years ended December 31, 2016 and 2017, and the selected consolidated balance sheet data as of December 31, 2016,
2017 and 2018, have been derived from our audited consolidated financial statements not included in this Annual Report on Form
20-F.
Our consolidated financial statements included in this Annual Report on Form 20-F were prepared in accordance with
International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, and reported in
dollars.
Consolidated Statements of Operations Data:(1)
2016
Year Ended December 31,
2018
(in thousands of U.S. dollars, except share and per share data)
2019
2017
Research and development expenses
Sales and marketing expenses
General and administrative expenses
Operating loss
Non-operating income (expenses), net
Financial income
Financial expenses
Net loss and comprehensive loss
Net loss per ordinary share
Number of ordinary shares used in computing loss per
ordinary share
(11,177)
(1,352)
(3,984)
(16,513)
214
480
(22)
(15,841)
(0.28)
(19,510)
(1,693)
(4,037)
(25,240)
(260)
1,169
(21)
(24,352)
(0.27)
(19,808)
(1,362)
(4,435)
(25,605)
2,397
719
(473)
(22,962)
(0.21)
(23,438)
(857)
(3,816)
(28,111)
4,165
777
(2,277)
(25,446)
(0.17)
2020
(18,173)
(840)
(3,914)
(22,927)
(5,701)
236
(1,629)
(30,021)
(0.12)
56,144,727
89,970,713 108,595,702 146,407,055 252,844,394
Consolidated Balance Sheet Data:
2016
Cash and cash equivalents
Short-term bank deposits
Property, plant and equipment, net
Total assets
Total liabilities
Total shareholders’ equity
2,469
33,154
2,605
38,939
3,912
35,027
2017
As of December 31,
2018
(in thousands of U.S. dollars)
5,110
44,373
2,505
60,965
8,084
52,881
3,404
26,747
2,227
56,233
14,912
41,321
2019
2020
5,297
22,192
1,816
53,567
20,187
33,380
16,831
5,756
1,341
47,290
25,260
22,030
(1) Data on diluted loss per share was not presented in the financial statements because the effect of the exercise of options or
warrants is either immaterial or is anti-dilutive.
1
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
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We are a clinical-stage biopharmaceutical development company with a history of operating losses, 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.
Risks Related to Our Business and Regulatory Matters
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Our business is subject to risks arising from a widespread outbreak of an illness or any other communicable disease, or any other public
health crisis, such as the COVID-19 pandemic, which has impacted and could continue to impact our business.
If we or our licensees are unable to obtain U.S. and/or foreign regulatory approval for our therapeutic candidates, we will be unable to
commercialize our therapeutic candidates.
Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be
predictive of future trial results.
Even if we obtain regulatory approvals, our therapeutic candidates will be subject to ongoing regulatory review and if we fail to comply
with continuing U.S. and applicable foreign regulations, we could lose those approvals and our business would be seriously harmed.
We generally depend on out-licensing arrangements for late-stage development, marketing and commercialization of our therapeutic
candidates.
If we cannot meet requirements under our in-license agreements, we could lose the rights to our therapeutic candidates, which could have
a material adverse effect on our business.
If we do not meet the requirements under our agreement with the Agalimmune selling shareholders, we could lose the rights to the
therapeutic candidates in Agalimmune’s pipeline, including, but not limited to, AGI-134.
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We seek to partner with third-party collaborators with respect to the development and commercialization of motixafortide, and we may
not succeed in establishing and maintaining collaborative relationships, which may significantly limit our ability to develop and
commercialize our product candidates successfully, if at all.
Modifications to our therapeutic candidates, or to any other therapeutic candidates that we may develop in the future, may require new
regulatory clearances or approvals or may require us or our licensees, as applicable, to recall or cease marketing these therapeutic
candidates until clearances are obtained.
If our competitors develop and market products that are more effective, safer or less expensive than our current or future therapeutic
candidates, our prospects will be negatively impacted.
We have no experience selling, marketing or distributing products and no internal capability to do so.
Our business could suffer if we are unable to attract and retain key employees.
Risks Related to Our Industry
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Even if our therapeutic candidates receive regulatory approval or do not require regulatory approval, they may not become commercially
viable products.
Healthcare reforms and related reductions in pharmaceutical pricing, reimbursement and coverage by governmental authorities and third-
party payors may adversely affect our business.
If third-party payors do not adequately reimburse customers for any of our therapeutic candidates that are approved for marketing, they
might not be purchased or used, and our revenues and profits will not develop or increase.
Our business has a substantial risk of clinical trial and product liability claims. If we are unable to obtain and maintain appropriate levels
of insurance, a claim could adversely affect our business.
Significant disruptions of our information technology systems or breaches of our data security could adversely affect our business.
Risks Related to Intellectual Property
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Our access to most of the intellectual property associated with our therapeutic candidates results from in-license agreements with
biotechnology companies and a university, the termination of which would prevent us from commercializing the associated therapeutic
candidates.
Patent protection for our products is important and uncertain.
If we are unable to protect the confidentiality of our trade secrets or know-how, such proprietary information may be used by others to
compete against us.
Legal proceedings or third-party claims of intellectual property infringement may require us to spend substantial time and money and
could prevent us from developing or commercializing products.
We may be subject to other patent-related litigation or proceedings that could be costly to defend and uncertain in their outcome.
3
Risks Related to our Ordinary Shares and ADSs
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The market prices of our ordinary shares and ADSs are subject to fluctuation, which could result in substantial losses by our investors.
Future sales of our ordinary shares or ADSs could reduce the market price of our ordinary shares and ADSs.
Raising additional capital by issuing securities may cause dilution to existing shareholders.
Risks Related to our Operations in Israel
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We conduct our operations in Israel and therefore our results may be adversely affected by political, economic and military instability in
Israel and its region.
Due to a significant portion of our expenses and revenues being denominated in non-dollar currencies, our results of operations may be
harmed by currency fluctuations.
We have received Israeli government grants and loans for certain research and development expenditures. The terms of these grants and
loans may require us to satisfy specified conditions in order to manufacture products and transfer technologies outside of Israel. We may
be required to pay penalties in addition to repayment of the grants and loans.
Provisions of Israeli law may delay, prevent or otherwise impede a merger with, or an acquisition of, our company, which could prevent a
change of control, even when the terms of such a transaction are favorable to us and our shareholders.
It may be difficult to enforce a U.S. judgment against us and our officers and directors in Israel or the United States, or to serve process
on our officers and directors.
Your rights and responsibilities as a shareholder will be governed by Israeli law, which may differ in some respects from the rights and
responsibilities of shareholders of U.S. companies.
Risks Related to Our Financial Condition and Capital Requirements
We are a clinical-stage biopharmaceutical development company with a history of operating losses, expect to incur
additional losses in the future and may never be profitable.
We are a clinical-stage biopharmaceutical development company that was incorporated in 2003. Since our incorporation,
we have been focused on research and development. Only one of our therapeutic candidates has begun to be commercialized. We,
or our licensees, as applicable, will be required to conduct significant additional clinical trials before we or they can seek the
regulatory approvals necessary to begin commercial sales of our other therapeutic candidates. We have incurred losses since
inception, principally as a result of research and development and general administrative expenses in support of our operations.
We recorded net losses of $23.0 million in 2018, $25.4 million in 2019 and $30.0 million in 2020. As of December 31, 2020, we
had an accumulated deficit of $278 million. We anticipate that we will incur significant additional losses as we continue to focus
our resources on prioritizing, selecting and advancing our most promising therapeutic candidates. We may never be profitable,
and we may never achieve significant sustained revenues.
We cannot assure investors that our existing cash and investment balances will be sufficient to meet our future capital
requirements.
As of December 31, 2020, we held cash and short-term investments of $22.6 million. In January 2021, we raised net
proceeds of $31.4 million in an underwritten public offering and, in January and February 2021, we received another $9.8 million
in gross proceeds from the exercise of outstanding warrants. Based on our current projected cash requirements, we believe that
our existing cash and investment balances and other sources of liquidity, not including potential milestone and royalty payments
under our existing out-licensing and other collaboration agreements, will be sufficient to meet our capital requirements into the
second half of 2023. We have funded our operations primarily through public and private offerings of our securities, payments
received under our strategic licensing and collaboration arrangements and interest earned on investments. The adequacy of our
available funds to meet our operating and capital requirements will depend on many factors, including: the number, breadth,
progress and results of our research, product development and clinical programs; the costs and timing of obtaining regulatory
approvals for any of our therapeutic candidates; the terms and conditions of in-licensing and out-licensing therapeutic candidates;
and costs incurred in enforcing and defending our patent claims and other intellectual property rights.
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While we expect to continue to explore alternative financing sources, including the possibility of future securities
offerings and government funding, we cannot be certain that in the future these liquidity sources will be available when needed
on commercially reasonable terms or at all, or that our actual cash requirements will not be greater than anticipated. We expect to
also continue to seek to finance our operations through other sources, including out-licensing arrangements for the development
and commercialization of our therapeutic candidates or other partnerships or joint ventures, as well as grants from government
agencies and foundations. If we are unable to obtain future financing through the methods we describe above or through other
means, we may be unable to complete our business objectives and may be unable to continue operations, which would have a
material adverse effect on our business and financial condition.
We may be unable to make payments due under our secured loan agreement.
In October 2018, we entered into a $10 million loan agreement with Kreos Capital V (Expert Fund) L.P., or Kreos
Capital. As security for the loan, Kreos Capital received a first-priority secured interest in all of our assets, including intellectual
property. The loan had a 12-month interest-only period, which concluded in September 2019, followed by a 36-month repayment
period beginning in October 2019. Borrowings under the loan bear interest at a fixed rate of 9.5% per annum.
Our ability to make the scheduled payments under the loan agreement or to refinance our debt obligations with Kreos
Capital depends on numerous factors including, but not limited to, the amount of our cash reserves, our capital requirements and
our ability to raise additional capital. We may be unable to maintain a level of cash reserves sufficient to permit us to pay the
principal and accrued interest on the loan. If our cash reserves, cash flows and capital resources are insufficient to fund our debt
obligations to Kreos Capital, we may be required to seek additional capital, restructure or refinance our indebtedness, or delay or
abandon our research and development projects or other capital expenditures, which could have a material adverse effect on our
business, financial condition, prospects or results of operations. There is no assurance that we would be able to take any of such
actions, or that such actions would permit us meet our scheduled debt obligations under the Kreos Capital loan agreement.
Risks Related to Our Business and Regulatory Matters
Our business is subject to risks arising from a widespread outbreak of an illness or any other communicable disease,
or any other public health crisis, such as the COVID-19 pandemic, which has impacted and could continue to impact our
business.
The novel coronavirus outbreak, or COVID-19, has affected segments of the global economy and may materially affect
our operations, including potentially interrupting our supply chain, clinical trial and commercialization activities. COVID-19
originated in Wuhan, China, in December 2019 and was declared a pandemic by the World Health Organization in March 2020.
The virus has since spread to multiple countries, including to the United States, Europe and Israel, where we currently have our
therapeutic candidates manufactured and conduct our clinical trials. The COVID-19 pandemic has negatively impacted the global
economy, disrupted global supply chains and created significant volatility and disruption of financial markets. The COVID-19
pandemic has resulted in travel and other restrictions in order to reduce the spread of the disease, including public health
directives and orders in Israel, the United States and Europe that, among other things and for various periods of time, directed
individuals to shelter at their places of residence, directed businesses and governmental agencies to cease non-essential
operations at physical locations, prohibited certain non-essential gatherings and events and ordered cessation of non-essential
travel. Israel is currently experiencing a “third wave” of COVID-19 which has resulted in the reinstatement of restrictions on
movement and other measures to control the spread of the virus. In addition, due to clinical operating issues associated with the
COVID-19 pandemic, we previously reported the expectation of a delay of approximately nine months in the phase 1/2a study we
are currently conducting for AGI-134, our second lead compound. The uncertainty surrounding the severity and continued spread
of the coronavirus may result in a period of prolonged business disruption. COVID-19 may continue to impact our future
operations, including potential interruptions to supply chains, clinical trials, commercialization activities and regulatory reviews
and approvals. COVID-19 may also affect our employees and employees and operations at suppliers that may result in delays or
disruptions in supply. In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect
our business and the value of our shares. Additionally, if the COVID-19 pandemic has a significant impact on our business and
financial results for an extended period of time, our liquidity and cash resources could be negatively impacted. Capital and credit
markets have been disrupted by the crisis and exchanges have experienced increased volatility. As a result, access to additional
financing may be challenging and is largely dependent upon evolving market conditions and other factors. We have taken
precautionary measures, including, for example, a Company-wide salary reduction related to the COVID-19 pandemic carried out
in the second and third quarters of 2020, and may take additional measures, intended to minimize the risk of COVID-19 to our
employees and operations. The extent of the impact of COVID-19 on our operational and financial performance, including our
ability to execute our business strategies in the expected time frame or at all, will depend on future developments, such as the
duration and spread of the COVID-19 pandemic and related restrictions and implications and the effectiveness of actions taken to
contain and treat the disease, all of which are uncertain and cannot be predicted. The impact of the COVID-19 pandemic may
also have the effect of heightening many of the other risks described in the “Risk Factors” section of this Annual Report on Form
20-F.
5
If we or our licensees are unable to obtain U.S. and/or foreign regulatory approval for our therapeutic candidates, we
will be unable to commercialize our therapeutic candidates.
To date, only one of our products, BL-5010, a legacy asset for the treatment of benign skin lesions, has been approved for
marketing and sale. Currently, we have two clinical-stage therapeutic candidates in development: motixafortide (formerly
referred to as BL-8040), a novel peptide for the treatment of solid tumors, hematological malignancies and stem cell
mobilization, and AGI-134, an immuno-oncology agent in development for solid tumors. Our therapeutic candidates are subject
to extensive governmental regulations relating to development, clinical trials, manufacturing and commercialization of drugs and
devices. We may not obtain marketing approval for any other of our therapeutic candidates in a timely manner or at all. In
connection with the clinical trials for motixafortide and AGI-134 and other therapeutic candidates that we are may seek to
develop in the future, either on our own or through out-licensing or co-development arrangements, we face the risk that:
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a therapeutic candidate or medical device may not prove safe or efficacious;
the results with respect to any therapeutic candidate may not confirm the positive results from earlier preclinical studies or clinical trials;
the results may not meet the level of statistical significance required by the U.S. Food and Drug Administration, or FDA, or other regulatory
authorities; and
the results will justify only limited and/or restrictive uses, including the inclusion of warnings and contraindications, which could significantly
limit the marketability and profitability of the therapeutic candidate.
Any delay in obtaining, or the failure to obtain, required regulatory approvals will materially and adversely affect our
ability to generate future revenues from a particular therapeutic candidate. Any regulatory approval to market a product may be
subject to limitations on the indicated uses for which we may market the product or may impose restrictive conditions of use,
including cautionary information, thereby limiting the size of the market for the product. We and our licensees, as applicable, also
are, and will be, subject to numerous foreign regulatory requirements that govern the conduct of clinical trials, manufacturing and
marketing authorization, pricing and third-party reimbursement. The foreign regulatory approval process includes all the risks
associated with the FDA approval process that we describe above, as well as risks attributable to the satisfaction of foreign
requirements. Approval by the FDA does not ensure approval by regulatory authorities outside the United States. Foreign
jurisdictions may have different approval processes than those required by the FDA and may impose additional testing
requirements for our therapeutic candidates.
Clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and
trials may not be predictive of future trial results.
We have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approvals,
including FDA approval. Clinical trials are expensive and complex, can take many years and have uncertain outcomes. We
cannot necessarily predict whether we or our licensees will encounter problems with any of the completed, ongoing or planned
clinical trials that will cause us, our licensees or regulatory authorities to delay or suspend clinical trials, or to delay the analysis
of data from completed or ongoing clinical trials. In addition, because some of our clinical trials are investigator-initiated studies
(i.e., we are not the study sponsor), we may have less control over these studies. We estimate that clinical trials of our most
advanced therapeutic candidates will continue for several years, but they may take significantly longer to complete. Failure can
occur at any stage of the testing, and we may experience numerous unforeseen events during, or as a result of, the clinical trial
process that could delay or prevent commercialization of our current or future therapeutic candidates, including, but not limited
to:
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delays in securing clinical investigators or trial sites for the clinical trials;
delays in obtaining institutional review board and other regulatory approvals to commence a clinical trial;
slower-than-anticipated patient recruitment and enrollment;
negative or inconclusive results from clinical trials;
unforeseen safety issues;
uncertain dosing issues;
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an inability to monitor patients adequately during or after treatment; and
problems with investigator or patient compliance with the trial protocols.
A number of companies in the pharmaceutical, medical device and biotechnology industries, including those with greater
resources and experience than us, have suffered significant setbacks in advanced clinical trials, even after seeing promising
results in earlier clinical trials. Despite the results reported in earlier clinical trials for our therapeutic candidates, we do not know
whether any Phase 3 or other clinical trials we or our licensees may conduct will demonstrate adequate efficacy and safety to
result in regulatory approval to market our therapeutic candidates. If later-stage clinical trials of any therapeutic candidate do not
produce favorable results, our ability to obtain regulatory approval for the therapeutic candidate may be adversely impacted,
which will have a material adverse effect on our business, financial condition and results of operations.
Even if we obtain regulatory approvals, our therapeutic candidates will be subject to ongoing regulatory review and if
we fail to comply with continuing U.S. and applicable foreign regulations, we could lose those approvals and our business
would be seriously harmed.
Even if products we or our licensees develop receive regulatory approval or clearance, we or our licensees, as applicable,
will be subject to ongoing reporting obligations, and the products and the manufacturing operations will be subject to continuing
regulatory review, including FDA inspections. The outcome of this ongoing review may result in the withdrawal of a product
from the market, the interruption of the manufacturing operations and/or the imposition of labeling and/or marketing limitations.
Since many more patients are exposed to drugs and medical devices following their marketing approval, serious but infrequent
adverse reactions that were not observed in clinical trials may be observed during the commercial marketing of the product. In
addition, the manufacturer and the manufacturing facilities we or our licensees, as applicable, will use to produce any therapeutic
candidate will be subject to periodic review and inspection by the FDA and other, similar foreign regulators. Later discovery of
previously unknown problems with any product, manufacturer or manufacturing process, or failure to comply with regulatory
requirements, may result in actions such as:
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restrictions on such product, manufacturer or manufacturing process;
warning letters from the FDA or other regulatory authorities;
withdrawal of the product from the market;
suspension or withdrawal of regulatory approvals;
refusal to approve pending applications or supplements to approved applications that we or our licensees submit;
voluntary or mandatory recall;
fines;
refusal to permit the import or export of our products;
product seizure or detentions;
injunctions or the imposition of civil or criminal penalties; or
adverse publicity.
If we, or our licensees, suppliers, third-party contractors, partners or clinical investigators are slow to adapt, or are unable
to adapt, to changes in existing regulatory requirements or the adoption of new regulatory requirements or policies, we or our
licensees may lose marketing approval for any of our products, if any of our therapeutic products are approved, resulting in
decreased or lost revenue from milestones, product sales or royalties.
7
We generally rely on third parties to conduct our preclinical studies and clinical trials and to provide other services,
and those third parties may not perform satisfactorily, including by failing to meet established deadlines for the completion of
such services.
We do not have the ability to conduct certain preclinical studies and clinical trials independently for our therapeutic
candidates, and we rely on third parties, such as contract laboratories, contract research organizations, medical institutions and
clinical investigators to conduct these studies and clinical trials. Our reliance on these third parties limits our control over these
activities. The third-party contractors may not assign as great a priority to our clinical development programs or pursue them as
diligently as we would if we were undertaking such programs directly. Accordingly, these third-party contractors may not
complete activities on schedule, or may not conduct the studies or our clinical trials in accordance with regulatory requirements
or with our trial design. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, or
if their performance is substandard, we may be required to replace them or add more sites to the studies. Although we believe that
there are a number of other third-party contractors that we could engage to continue these activities, replacement of these third
parties will result in delays and/or additional costs. As a result, our efforts to obtain regulatory approvals for, and to
commercialize, our therapeutic candidates may be delayed. The third-party contractors may also have relationships with other
commercial entities, some of whom may compete with us. If the third-party contractors assist our competitors, our competitive
position may be harmed.
In addition, our ability to bring future products to market depends on the quality and integrity of data that we present to
regulatory authorities in order to obtain marketing authorizations. Although we attempt to audit and control the quality of third-
party data, we cannot guarantee the authenticity or accuracy of such data, nor can we be certain that such data has not been
fraudulently generated. The failure of these third parties to carry out their obligations would materially adversely affect our
ability to develop and market new products and implement our strategies.
We generally depend on out-licensing arrangements for late-stage development, marketing and commercialization of
our therapeutic candidates.
We generally depend on out-licensing arrangements for late-stage development, marketing and commercialization of our
therapeutic candidates. We have limited experience in late-stage development, marketing and commercializing therapeutic
candidates. Dependence on out-licensing arrangements subjects us to a number of risks, including the risk that:
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we have limited control over the amount and timing of resources that our licensees devote to our therapeutic candidates;
our licensees may experience financial difficulties;
our licensees may fail to secure adequate commercial supplies of our therapeutic candidates upon marketing approval, if at all;
our future revenues depend heavily on the efforts of our licensees;
business combinations or significant changes in a licensee’s business strategy may adversely affect the licensee’s willingness or ability to complete
its obligations under any arrangement with us;
a licensee could move forward with a competing therapeutic candidate developed either independently or in collaboration with others, including
our competitors; and
out-licensing arrangements are often terminated or allowed to expire, which would delay the development and may increase the development costs
of our therapeutic candidates.
If we or any of our licensees breach or terminate their agreements with us, or if any of our licensees otherwise fail to
conduct their development and commercialization activities in a timely manner or there is a dispute about their obligations, we
may need to seek other licensees, or we may have to develop our own internal sales and marketing capability for our therapeutic
candidates. Our dependence on our licensees’ experience and the rights of our licensees will limit our flexibility in considering
alternative out-licensing arrangements for our therapeutic candidates. Any failure to successfully develop these arrangements or
failure by our licensees to successfully develop or commercialize any of our therapeutic candidates in a competitive and timely
manner will have a material adverse effect on the commercialization of our therapeutic candidates.
We depend on our ability to identify and in-license technologies and therapeutic candidates.
We employ a number of methods to identify therapeutic candidates that we believe are likely to achieve commercial
success. In certain instances, disease-specific third-party advisors evaluate therapeutic candidates as we deem necessary.
However, there can be no assurance that our internal research efforts or our screening system will accurately or consistently select
among various therapeutic candidates those that have the highest likelihood to achieve, and that ultimately achieve, commercial
success. As a result, we may spend substantial resources developing therapeutic candidates that will not achieve commercial
success, and we may not advance those therapeutic candidates with the greatest potential for commercial success.
An important element of our strategy is maintaining relationships with universities, medical institutions and
biotechnology companies in order to in-license potential therapeutic candidates. We may not be able to maintain relationships
with these entities, and they may elect not to enter into in-licensing agreements with us or to terminate existing agreements. The
existence of global companies with significantly greater resources than we have may increase the competition with respect to the
in-licensing of promising therapeutic candidates. We may not be able to acquire licenses on commercially reasonable terms or at
all. Failure to license or otherwise acquire necessary technologies could materially and adversely affect our business, financial
condition and results of operations.
8
If we cannot meet requirements under our in-license agreements, we could lose the rights to our therapeutic
candidates, which could have a material adverse effect on our business.
We depend on in-licensing agreements with third parties to maintain the intellectual property rights to our therapeutic
candidates. We have in-licensed rights from Biokine Therapeutics Ltd., or Biokine, with respect to our motixafortide therapeutic
candidate; from the University of Massachusetts and from Kode Biotech Limited, or Kode Biotech, with respect to our AGI-134
therapeutic candidate; and from Innovative Pharmaceutical Concepts, Inc., or IPC, with respect to our BL-5010 therapeutic
candidate. See “Item 4. Information on the Company — Business Overview — In-Licensing Agreements.” Our in-license
agreements require us to make payments and satisfy performance obligations in order to maintain our rights under these
agreements. The royalty rates and revenue sharing payments vary from case to case but range from 20% to 29.5% of the
consideration we receive from sublicensing the applicable therapeutic candidate and a substantially lower percentage (generally
less than 5%) if we elect to commercialize the subject therapeutic candidate independently. Due to the relatively advanced stage
of development of the compound licensed from Biokine, our license agreement with Biokine provides for royalty payments of
10% of net sales, subject to certain limitations, should we independently sell products. These in-license agreements last either
throughout the life of the patents that are the subject of the agreements, or with respect to other licensed technology, for a number
of years after the first commercial sale of the relevant product.
In addition, we are responsible for the cost of filing and prosecuting certain patent applications and maintaining certain
issued patents licensed to us. If we do not meet our obligations under our in-license agreements in a timely manner, we could lose
the rights to our proprietary technology, which could have a material adverse effect on our business, financial condition and
results of operations.
If we do not meet the requirements under our agreement with the Agalimmune selling shareholders, we could lose the
rights to the therapeutic candidates in Agalimmune’s pipeline, including, but not limited to, AGI-134.
In March 2017, we acquired substantially all the outstanding shares of Agalimmune Ltd., or Agalimmune, a privately held
company incorporated in the United Kingdom. In conjunction with the acquisition, we entered into a development agreement
with Agalimmune and its selling shareholders, or the Agalimmune Development Agreement, which, among other things, grants
us an option to purchase any remaining Agalimmune shares. If we do not exercise this option within a certain period of time after
achieving certain milestones or we commit a material breach of the Agalimmune Development Agreement, the selling
shareholders have a reversionary option to acquire all the Agalimmune shares we hold for nominal consideration. If the exercise
of this reversionary option is completed and our development work subsequently generates revenues for Agalimmune, we will
only be entitled to a percentage of Agalimmune’s net proceeds, until such time as we have recouped the expenses we incurred in
connection with the Agalimmune Development Agreement. Completion of the exercise of the reversionary option would result in
the loss of our rights in the proprietary technology held by Agalimmune, which could have a material adverse effect on our
business, financial condition and results of operations.
We seek to partner with third-party collaborators with respect to the development and commercialization of
motixafortide, and we may not succeed in establishing and maintaining collaborative relationships, which may significantly
limit our ability to develop and commercialize our product candidates successfully, if at all.
Our business strategy relies on partnering with pharmaceutical companies to complement our internal development
efforts. We will be competing with many other companies as we seek partners for motixafortide and for any other therapeutic
candidate and we may not be able to compete successfully against those companies. If we are not able to enter into collaboration
arrangements for for motixafortide and for any other therapeutic candidate, we may be required to undertake and fund further
development, clinical trials, manufacturing and commercialization activities solely at our own expense and risk. If we are unable
to finance and/or successfully execute those expensive activities, or we delay such activities due to capital availability, our
business could be materially and adversely affected, and potential future product launch could be materially delayed, be less
successful, or we may be forced to discontinue clinical development of these product candidates. Furthermore, if we are unable to
enter into a commercial agreement for the development and commercialization of motixafortide and for any other therapeutic
candidate, then this could have a material adverse effect on our business, financial condition or results of operations.
The process of establishing and maintaining collaborative relationships is difficult, time-consuming and involves
significant uncertainty, including:
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a collaboration partner may shift its priorities and resources away from our therapeutic candidates due to a change in business strategies,
or a merger, acquisition, sale or downsizing;
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a collaboration partner may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical results,
manufacturing issues, a change in business strategy, a change of control or other reasons;
a collaboration partner may cease development in therapeutic areas which are the subject of our strategic collaboration;
a collaboration partner may not devote sufficient capital or resources towards our therapeutic candidates;
a collaboration partner may change the success criteria for a therapeutic candidate thereby delaying or ceasing development of such
candidate;
a significant delay in initiation of certain development activities by a collaboration partner will also delay payment of milestones tied to
such activities, thereby impacting our ability to fund our own activities;
a collaboration partner could develop a product that competes, either directly or indirectly, with our therapeutic candidate;
a collaboration partner with commercialization obligations may not commit sufficient financial or human resources to the marketing,
distribution or sale of a product;
a collaboration partner with manufacturing responsibilities may encounter regulatory, resource or quality issues and be unable to meet
demand requirements;
a partner may exercise a contractual right to terminate a strategic alliance;
a dispute may arise between us and a partner concerning the research, development or commercialization of a therapeutic candidate
resulting in a delay in milestones, royalty payments or termination of an alliance and possibly resulting in costly litigation or arbitration
which may divert management attention and resources; and
a partner may use our products or technology in such a way as to invite litigation from a third party.
Any collaborative partners we enter into agreements with in the future may shift their priorities and resources away from
our therapeutic candidates or seek to renegotiate or terminate their relationships with us. If any collaborator fails to fulfill its
responsibilities in a timely manner, or at all, our research, clinical development, manufacturing or commercialization efforts
related to that collaboration could be delayed or terminated, or it may be necessary for us to assume responsibility for expenses or
activities that would otherwise have been the responsibility of our collaborator. If we are unable to establish and maintain
collaborative relationships on acceptable terms or to successfully transition terminated collaborative agreements, we may have to
delay or discontinue further development of one or more of our product candidates, undertake development and
commercialization activities at our own expense or find alternative sources of capital.
Modifications to our therapeutic candidates, or to any other therapeutic candidates that we may develop in the future,
may require new regulatory clearances or approvals or may require us or our licensees, as applicable, to recall or cease
marketing these therapeutic candidates until clearances are obtained.
Modifications to our therapeutic candidates, after they have been approved for marketing, if at all, or to any other
pharmaceutical product or medical device that we may develop in the future, may require new regulatory clearance or approvals,
and, if necessitated by a problem with a marketed product, may result in the recall or suspension of marketing of the previously
approved and marketed product until clearances or approvals of the modified product are obtained. The FDA requires
pharmaceutical products and device manufacturers to initially make and document a determination of whether a modification
requires a new approval, supplement or clearance. A manufacturer may determine in conformity with applicable regulations and
guidelines that a modification may be implemented without pre-clearance by the FDA; however, the FDA can review a
manufacturer’s decision and may disagree. The FDA may also on its own initiative determine that a new clearance or approval is
required. If the FDA requires new clearances or approvals of any pharmaceutical product or medical device for which we or our
licensees receive marketing approval, if any, we or our licensees may be required to recall such product and to stop marketing the
product as modified, which could require us or our licensees to redesign the product and will have a material adverse effect on
our business, financial condition and results of operations. In these circumstances, we may be subject to significant enforcement
actions.
If a manufacturer determines that a modification to an FDA-cleared device could significantly affect the safety or efficacy
of the device, would constitute a major change in its intended use, or otherwise requires pre-clearance, the modification may not
be implemented without the requisite clearance. We or our licensees may not be able to obtain those additional clearances or
approvals for the modifications or additional indications in a timely manner, or at all. For those products sold in the European
Union, or EU, we or our licensees, as applicable, must notify the applicable EU Notified Body, an organization appointed by a
member state of the EU either for the approval and monitoring of a manufacturer’s quality assurance system or for direct product
inspection, if significant changes are made to the product or if there are substantial changes to the quality assurance systems
affecting the product. Delays in obtaining required future clearances or approvals would materially and adversely affect our
ability to introduce new or enhanced products in a timely manner, which in turn would have a material adverse effect on our
business, financial condition and results of operations.
10
If our competitors develop and market products that are more effective, safer or less expensive than our current or
future therapeutic candidates, our prospects will be negatively impacted.
The life sciences industry is highly competitive, and we face significant competition from many pharmaceutical,
biopharmaceutical and biotechnology companies that are researching and marketing products designed to address the indications
for which we are currently developing therapeutic candidates or for which we may develop therapeutic candidates in the future.
Specifically, we are aware of other companies that currently market and/or are in the process of developing products that address
stem cell mobilization, acute myeloid leukemia, or AML, solid malignancies and skin lesions.
An important element of our strategy for identifying future products is maintaining relationships with universities,
medical institutions and biotechnology companies in order to in-license potential therapeutic candidates, and we compete with
respect to this in-licensing with a number of global pharmaceutical companies. The presence of these global companies with
significantly greater resources than we have may increase the competition with respect to the in-licensing of promising
therapeutic candidates. Our failure to license or otherwise acquire necessary technologies could materially and adversely affect
our business, financial condition and results of operations.
Our contract manufacturers are, and will be, subject to FDA and other comparable agency regulations.
Our contract manufacturers are, and will be, required to adhere to FDA regulations setting forth current good
manufacturing practices, or GMP, for drugs and Quality System Regulations, or QSR, for devices. These regulations cover all
aspects of the manufacturing, testing, quality control and recordkeeping relating to our therapeutic candidates. Our manufacturers
may not be able to comply with applicable regulations. Our manufacturers are and will be subject to unannounced inspections by
the FDA, state regulators and similar regulators outside the United States. The failure of our third-party manufacturers to comply
with applicable regulations could result in the imposition of sanctions on us, including fines, injunctions, civil penalties, failure of
regulatory authorities to grant marketing approval of our therapeutic candidates, delays, suspension or withdrawal of approvals,
license revocation, seizures or recalls of our candidates or products, operating restrictions and criminal prosecutions, any of
which could significantly and adversely affect regulatory approval and supplies of our therapeutic candidates, and materially and
adversely affect our business, financial condition and results of operations.
We have no experience selling, marketing or distributing products and no internal capability to do so.
We currently have no sales, marketing or distribution capabilities and no experience in building a sales force or
distribution capabilities. To be able to commercialize any of our therapeutic candidates upon approval, if at all, we must either
develop internal sales, marketing and distribution capabilities, which will be expensive and time-consuming, or enter into out-
licensing arrangements with third parties to perform these services.
If we decide to market any of our other therapeutic candidates on our own, we must commit significant financial and
managerial resources to develop a marketing and sales force with technical expertise and with supporting distribution
capabilities. Factors that may inhibit our efforts to commercialize our products directly and without strategic partners include:
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our inability to recruit and retain adequate numbers of effective sales and marketing personnel;
the inability of sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe our therapeutic candidates;
the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with
more extensive product lines; and
unforeseen costs and expenses associated with creating and sustaining an independent sales and marketing organization.
We may not be successful in recruiting the sales and marketing personnel necessary to sell any of our therapeutic
candidates upon approval, if at all, and, even if we do build a sales force, we may not be successful in marketing our therapeutic
candidates, which would have a material adverse effect on our business, financial condition and results of operations.
Our business could suffer if we are unable to attract and retain key employees.
Our success depends upon the continued service and performance of our senior management and other key personnel. The
loss of the services of these personnel could delay or prevent the successful completion of our planned clinical trials or the
commercialization of our therapeutic candidates or otherwise affect our ability to manage our company effectively and to carry
out our business plan. We do not maintain key-man life insurance. Although we have entered into employment agreements with
all of the members of our senior management team, members of our senior management team may resign at any time. High
demand exists for senior management and other key personnel in the pharmaceutical industry. There can be no assurance that we
will be able to continue to retain and attract such personnel.
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Our growth and success also depend on our ability to attract and retain additional highly qualified scientific, technical,
sales, managerial and finance personnel. We experience intense competition for qualified personnel, and the existence of non-
competition agreements between prospective employees and their former employers may prevent us from hiring those individuals
or subject us to suit from their former employers. In addition, if we elect to independently commercialize any therapeutic
candidate, we will need to expand our marketing and sales capabilities. While we attempt to provide competitive compensation
packages to attract and retain key personnel, many of our competitors are likely to have greater resources and more experience
than we have, making it difficult for us to compete successfully for key personnel. If we cannot attract and retain sufficiently
qualified technical employees on acceptable terms, we may not be able to develop and commercialize competitive products.
Further, any failure to effectively integrate new personnel could prevent us from successfully growing our company.
We rely upon third-party manufacturers to produce therapeutic supplies for the clinical trials, and commercialization,
of our therapeutic candidates. If we manufacture any of our therapeutic candidates in the future, we will be required to incur
significant costs and devote significant efforts to establish and maintain manufacturing capabilities.
We do not currently have laboratories that are compliant with cGMP and therefore cannot independently manufacture
drug products for our current clinical trials. We rely on third-party manufacturers to produce the therapeutic supplies that will
enable us to perform clinical trials and, if we choose to do so, commercialize therapeutic candidates ourselves. We have limited
personnel with experience in drug or medical device manufacturing and we lack the resources and capabilities to manufacture
any of our therapeutic candidates on a commercial scale. The manufacture of pharmaceutical products and medical devices
requires significant expertise and capital investment, including the development of advanced manufacturing techniques and
process controls. Manufacturers of pharmaceutical products and medical devices often encounter difficulties in production,
particularly in scaling up initial production. These problems include difficulties with production costs and yields and quality
control, including stability of the therapeutic candidate.
We do not currently have any long-term agreements with third-party manufacturers that guarantee the supply of any of
our therapeutic candidates. When we require additional supplies of our therapeutic candidates to complete our clinical trials or if
we elect to commercialize our products independently, we may be unable to enter into agreements for clinical or commercial
supply, as applicable, with third-party manufacturers, or may be unable to do so on acceptable terms. Even if we enter into these
agreements, it is likely that the manufacturers of each therapeutic candidate will be single-source suppliers to us for a significant
period of time.
Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured therapeutic
candidates ourselves, including:
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reliance on the third party for regulatory compliance and quality assurance;
limitations on supply availability resulting from capacity and scheduling constraints of the third parties;
impact on our reputation in the marketplace if manufacturers of our products, once commercialized, fail to meet customer demands;
the possible breach of the manufacturing agreement by the third party because of factors beyond our control; and
the possible termination or nonrenewal of the agreement by the third party, based on its own business priorities, at a time that is costly or
inconvenient for us.
The failure of any of our contract manufacturers to maintain high manufacturing standards could result in injury or death
of clinical trial participants or patients being treated with our products. Such failure could also result in product liability claims,
product recalls, product seizures or withdrawals, delays or failures in testing or delivery, cost overruns or other problems, which
would have a material adverse effect on our business, financial condition and results of operations.
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Risks Related to Our Industry
Even if our therapeutic candidates receive regulatory approval or do not require regulatory approval, they may not
become commercially viable products.
Even if our therapeutic candidates are approved for commercialization, they may not become commercially viable
products. For example, if we or our licensees receive regulatory approval to market a product, approval may be subject to
limitations on the indicated uses or subject to labelling or marketing restrictions, which could materially and adversely affect the
marketability and profitability of the product. In addition, a new product may appear promising at an early stage of development
or after clinical trials but never reach the market, or it may reach the market but not result in sufficient product sales, if any. A
therapeutic candidate may not result in commercial success for various reasons, including:
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difficulty in large-scale manufacturing;
low market acceptance by physicians, healthcare payors, patients and the medical community as a result of lower demonstrated clinical safety or
efficacy compared to other products, prevalence and severity of adverse side effects, or other potential disadvantages relative to alternative
treatment methods;
insufficient or unfavorable levels of reimbursement from government or third-party payors;
infringement on proprietary rights of others for which we or our licensees have not received licenses;
incompatibility with other therapeutic products;
other potential advantages of alternative treatment methods;
ineffective marketing and distribution support;
significant changes in pricing due to pressure from public opinion, non-governmental organizations or governmental authorities;
lack of cost-effectiveness; or
timing of market introduction of competitive products.
If we are unable to develop commercially viable products, either on our own or through licensees, our business, results of
operations and financial condition will be materially and adversely affected.
Healthcare reforms and related reductions in pharmaceutical pricing, reimbursement and coverage by governmental
authorities and third-party payors may adversely affect our business.
The continuing increase in expenditures for healthcare has been the subject of considerable government attention,
particularly as public resources have been stretched by financial and economic crises in the United States, Western Europe and
elsewhere. Both private health insurance funds and government health authorities continue to seek ways to reduce or contain
healthcare costs, including by reducing or eliminating coverage for certain products and lowering reimbursement levels. In many
countries and regions, including the United States, Western Europe, Israel, Russia, certain countries in Central and Eastern
Europe and several countries in Latin America, pharmaceutical prices are subject to new government policies designed to reduce
healthcare costs. These changes frequently adversely affect pricing and profitability and may cause delays in market entry. We
cannot predict which additional measures may be adopted or the impact of current and additional measures on the marketing,
pricing and demand for our approved products, if any of our therapeutic products are approved.
Significant developments that may adversely affect pricing in the United States include (i) the enactment of federal
healthcare reform laws and regulations, including the Medicare Prescription Drug Improvement and Modernization Act of 2003
and the Patient Protection and Affordable Care Act of 2010, or PPACA, and (ii) trends in the practices of managed care groups
and institutional and governmental purchasers, including the impact of consolidation of our customers. Changes to the healthcare
system enacted as part of healthcare reform in the United States, as well as the increased purchasing power of entities that
negotiate on behalf of Medicare, Medicaid, and private sector beneficiaries, may result in increased pricing pressure by
influencing, for instance, the reimbursement policies of third-party payors. Healthcare reform legislation has increased the
number of patients who would have insurance coverage for our approved products, if any of our therapeutic products are
approved, but provisions such as the assessment of a branded pharmaceutical manufacturer fee and an increase in the amount of
the rebates that manufacturers pay for coverage of their drugs by Medicaid programs may have an adverse effect on us. It is
uncertain how current and future reforms in these areas will influence the future of our business operations and financial
condition, as federal, state and foreign governmental authorities are likely to continue efforts to control the price of drugs and
reduce overall healthcare costs. These efforts could have an adverse impact on our ability to market products and generate
revenues in the United States and foreign countries.
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If third-party payors do not adequately reimburse customers for any of our therapeutic candidates that are approved
for marketing, they might not be purchased or used, and our revenues and profits will not develop or increase.
Our revenues and profits will depend heavily upon the availability of adequate reimbursement for the use of our approved
candidates, if any, from governmental or other third-party payors, both in the United States and in foreign markets.
Reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that
the use of an approved product is:
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a covered benefit under its health plan;
safe, effective and medically necessary;
appropriate for the specific patient;
cost-effective; and
neither experimental nor investigational.
Obtaining reimbursement approval for a product from each government or other third-party payor is a time-consuming
and costly process that could require us or our licensees to provide supporting scientific, clinical and cost-effectiveness data for
the use of our products to each payor. Even when a payor determines that a product is eligible for reimbursement, the payor may
impose coverage limitations that preclude payment for some uses that are approved by the FDA or comparable foreign regulatory
authorities. Reimbursement rates may vary according to the use of the product and the clinical setting in which it used, may be
based on payments allowed for lower-cost products that are already reimbursed, may be incorporated into existing payments for
other products or services, and may reflect budgetary constraints and/or imperfections in Medicare, Medicaid or other data used
to calculate these rates.
Regardless of the impact of the PPACA on us, the U.S. government, other governments and commercial payors have
shown significant interest in pursuing healthcare reform and reducing healthcare costs. Any government-adopted reform
measures could cause significant pressure on the pricing of healthcare products and services, including those biopharmaceuticals
currently being developed by us or our licensees, in the United States and internationally, as well as the amount of reimbursement
available from governmental agencies or other third-party payors. The continuing efforts of the U.S. and foreign governments,
insurance companies, managed care organizations and other payors to contain or reduce healthcare costs may compromise our
ability to set prices at commercially attractive levels for our products that we may develop, which in turn could adversely impact
how much or under what circumstances healthcare providers will prescribe or administer our products, if approved. Changes in
healthcare policy, such as the creation of broad limits for diagnostic products, could substantially diminish the sale of or inhibit
the utilization of diagnostic tests, increase costs, divert management’s attention and adversely affect our ability to generate
revenues and achieve consistent profitability. This could materially and adversely impact our business by reducing our ability to
generate revenue, raise capital, obtain additional collaborators and market our products, if approved.
Further, the Centers for Medicare and Medicaid Services, or CMS, frequently change product descriptors, coverage
policies, product and service codes, payment methodologies and reimbursement values. Third-party payors often follow
Medicare coverage policy and payment limitations in setting their own reimbursement rates, and both CMS and other third-party
payors may have sufficient market power to demand significant price reductions.
Our business has a substantial risk of clinical trial and product liability claims. If we are unable to obtain and
maintain appropriate levels of insurance, a claim could adversely affect our business.
Our business exposes us to significant potential clinical trial and product liability risks that are inherent in the
development, manufacturing and sales and marketing of human therapeutic products. Claims could be made against us based on
the use of our therapeutic candidates in clinical trials and in marketed products. We currently carry life science liability insurance
covering general liability with an annual coverage amount of $30.0 million per occurrence and product liability and clinical trials
coverage with an annual coverage amount of $30.0 million each claim and in the aggregate. The annual aggregate as well as the
maximum indemnity for a single occurrence, claim or circumstances under this insurance is $30.0 million. However, our
insurance may not provide adequate coverage against potential liabilities. Furthermore, clinical trial and product liability
insurance is becoming increasingly expensive. As a result, we may be unable to maintain current amounts of insurance coverage
or to obtain additional or sufficient insurance at a reasonable cost to protect against losses that could have a material adverse
effect on us. If a claim is brought against us, we might be required to pay legal and other expenses to defend the claim, as well as
damages awards beyond the coverage of our insurance policies resulting from a claim brought successfully against us.
Furthermore, whether or not we are ultimately successful in defending any claims, we might be required to direct significant
financial and managerial resources to such defense, and adverse publicity is likely to result.
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Significant disruptions of our information technology systems or breaches of our data security could adversely affect
our business.
A significant invasion, interruption, destruction or breakdown of our information technology systems and/or infrastructure
by persons with authorized or unauthorized access could negatively impact our business and operations. We could experience
business interruption, information theft and/or reputational damage from cyber-attacks or cyber-intrusions over the Internet,
computer viruses, malware, natural disasters, terrorism, war, telecommunication and electrical failures, and attachments to
emails. Any of the foregoing may compromise our systems and lead to data leakage either internally or at our third-party
providers. The risk of a security breach or disruption, particularly through cyber-attacks or cyber-intrusion, including by
computer hackers, foreign governments and cyber terrorists, has generally increased as the number, intensity and sophistication
of attempted attacks and intrusions from around the world have increased. If such an event were to occur and cause interruptions
in our operations, it could result in a material disruption of our product development programs. For example, the loss of clinical
trial data from completed or ongoing or planned clinical trials could result in delays in our regulatory approval efforts and
significantly increase our costs to recover or reproduce the data. Our systems have been, and are expected to continue to be, the
target of malware and other cyber-attacks. Although we have invested in measures to reduce these risks, we cannot assure you
that these measures will be successful in preventing compromise and/or disruption of our information technology systems and
related data.
We deal with hazardous materials and must comply with environmental, health and safety laws and regulations, which
can be expensive and restrict how we do business.
Our activities and those of our third-party manufacturers on our behalf involve the controlled storage, use and disposal of
hazardous materials, including microbial agents, corrosive, explosive and flammable chemicals, as well as cytotoxic, biologic,
radio-labeled and other hazardous compounds. We and our manufacturers are subject to U.S. federal, state, local, Israeli and other
foreign laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials.
Although we believe that our safety procedures for handling and disposing of these materials comply with the standards
prescribed by these laws and regulations, we cannot eliminate the risk of accidental contamination or injury from these materials.
In addition, if we develop a manufacturing capacity, we may incur substantial costs to comply with environmental regulations
and would be subject to the risk of accidental contamination or injury from the use of hazardous materials in our manufacturing
process.
In the event of an accident, government authorities may curtail our use of these materials and interrupt our business
operations. In addition, we could be liable for any civil damages that result, which may exceed our financial resources and may
seriously harm our business. Although our Israeli insurance program covers certain unforeseen sudden pollutions, we do not
maintain a separate insurance policy for any of the foregoing types of risks. In addition, although the general liability section of
our life sciences policy covers certain unforeseen, sudden environmental issues, pollution in the United States and Canada is
excluded from the policy. In the event of environmental discharge or contamination or an accident, we may be held liable for any
resulting damages, and any liability could exceed our resources. In addition, we may be subject to liability and may be required to
comply with new or existing environmental laws regulating pharmaceuticals or other medical products in the environment.
Risks Related to Intellectual Property
Our access to most of the intellectual property associated with our therapeutic candidates results from in-license
agreements with biotechnology companies and a university, the termination of which would prevent us from commercializing
the associated therapeutic candidates.
We do not conduct our own initial research with respect to the identification of our therapeutic candidates. Instead, we
rely upon research and development work conducted by third parties as the primary source of our therapeutic candidates. As
such, we have obtained our rights to our therapeutic candidates through in-license agreements entered into with biotechnology
companies and a university that invent and own the intellectual property underlying our candidates. There is no assurance that
such in-licenses or rights will not be terminated or expire due to a material breach of the agreements, such as a failure on our part
to achieve certain progress milestones set forth in the terms of the in-licenses or due to the loss of the rights to the underlying
intellectual property by any of our licensors. There is no assurance that we will be able to renew or renegotiate an in-licensing
agreement on acceptable terms if and when the agreement terminates. We cannot guarantee that any in-license is enforceable or
will not be terminated or converted into a non-exclusive license in the future. The termination of any in-license or our inability to
enforce our rights under any in-license would materially and adversely affect our ability to commercialize certain of our
therapeutic candidates.
We currently have in-licensing agreements relating to our therapeutic candidates that are in development or being
commercialized. In 2012, we in-licensed the rights to motixafortide under a license agreement from Biokine. Under the license
agreement for motixafortide, we are obligated to make commercially reasonable, good faith efforts to sublicense or
commercialize motixafortide for fair consideration. Agalimmune in-licensed rights to AGI-134 under a license from the
University of Massachusetts in 2013 and under a license from Kode Biotech in 2015. Under each of those license agreements,
Agalimmune is obligated to use diligent efforts or cause its affiliates and sublicensees to use diligent efforts to develop the
respective licensed technology and introduce licensed products into the commercial market. In 2007, we in-licensed the rights to
BL-5010 under a license agreement with IPC. Under the BL-5010 license agreement, we are obligated to use commercially
reasonable efforts to develop the licensed technology in accordance with a specified development plan, including meeting certain
specified diligence goals.
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Each of the foregoing in-licensing agreements, or the obligation to pay royalties thereunder, will generally remain in
effect until the expiration, under the applicable agreement, of all the licensing, royalty and sublicense revenue obligations to the
applicable licensors, determined on a product-by-product and country-by-country basis. We may terminate the motixafortide in-
licensing agreement upon 90 days’ prior written notice to Biokine. Agalimmune may terminate each of the in-licensing
agreements with University of Massachusetts and Kode Biotech relating to AGI-134, on 90 days’ notice. We may terminate the
BL-5010 in-licensing agreement upon 30 days’ prior written notice to IPC.
Any party to any of the foregoing in-licensing agreements may terminate the respective agreement for material breach by
the other party if the breaching party is unable to cure the breach within an agreed-upon period, generally 30 days to 90 days,
after receiving written notice of the breach from the non-breaching party.
Patent protection for our products is important and uncertain.
Our success depends, in part, on our ability, and the ability of our licensees and licensors to obtain patent protection for
our therapeutic candidates, maintain the confidentiality of our trade secrets and know-how, operate without infringing on the
proprietary rights of others and prevent others from infringing our proprietary rights.
We try to protect our proprietary position by, among other things, filing U.S., European, Israeli and other patent
applications related to our proprietary products, technologies, inventions and improvements that may be important to the
continuing development of our therapeutic candidates. As of February 22, 2021, we owned or exclusively licensed for uses
within our field of business 36 patent families that collectively contain over 105 issued patents, four allowed patent applications
and over 87 pending patent applications relating to our therapeutic candidates.
Because the patent position of biopharmaceutical companies involves complex legal and factual questions, we cannot
predict the validity and enforceability of patents with certainty. Our issued patents and the issued patents of our licensees or
licensors may not provide us with any competitive advantages or may be held invalid or unenforceable as a result of legal
challenges by third parties. Thus, any patents that we own or license from others may not provide any protection against
competitors. Our pending patent applications, those we may file in the future or those we may license from third parties may not
result in patents being issued. If these patents are issued, they may not provide us with proprietary protection or competitive
advantages against competitors with similar technology. The degree of future protection to be afforded by our proprietary rights is
uncertain because legal means afford only limited protection and may not adequately protect our rights or permit us to gain or
keep our competitive advantage.
Patent rights are territorial; thus, the patent protection we do have will only extend to those countries in which we have
issued patents. Even so, the laws of certain countries do not protect our intellectual property rights to the same extent as do the
laws of the United States. For example, the patent laws of China and India are relatively new and are not as developed as are
older, more established patent laws of other countries. Competitors may successfully challenge our patents, produce similar drugs
or products that do not infringe our patents, or produce drugs in countries where we have not applied for patent protection or that
do not respect our patents. Furthermore, it is not possible to know the scope of claims that will be allowed in published
applications and it is also not possible to know which claims of granted patents, if any, will be deemed enforceable in a court of
law.
Our technology may infringe the rights of third parties. The nature of claims contained in unpublished patent filings
around the world is unknown to us and it is not possible to know which countries patent holders may choose for the extension of
their filings under the Patent Cooperation Treaty, or other mechanisms. Any infringement by us of the proprietary rights of third
parties may have a material adverse effect on our business, financial condition and results of operations.
If we are unable to protect the confidentiality of our trade secrets or know-how, such proprietary information may be
used by others to compete against us.
We rely on a combination of patents, trade secrets, know-how, technology, trademarks and regulatory exclusivity to
maintain our competitive position. We generally try to protect trade secrets, know-how and technology by entering into
confidentiality or non-disclosure agreements with parties that have access to it, such as our licensees, employees, contractors and
consultants. We also enter into agreements that purport to require the disclosure and assignment to us of the rights to the ideas,
developments, discoveries and inventions of our employees, advisors, research collaborators, contractors and consultants while
we employ or engage them. However, these agreements can be difficult and costly to enforce or may not provide adequate
remedies. Any of these parties may breach the confidentiality agreements and willfully or unintentionally disclose our
confidential information, or our competitors might learn of the information in some other way. The disclosure to, or independent
development by, a competitor of any trade secret, know-how or other technology not protected by a patent could materially
adversely affect any competitive advantage we may have over any such competitor.
To the extent that any of our employees, advisors, research collaborators, contractors or consultants independently
develop, or use independently developed, intellectual property in connection with any of our projects, disputes may arise as to the
proprietary rights to this type of information. If a dispute arises with respect to any proprietary right, enforcement of our rights
can be costly and unpredictable, and a court may determine that the right belongs to a third party.
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Legal proceedings or third-party claims of intellectual property infringement may require us to spend substantial time
and money and could prevent us from developing or commercializing products.
The development, manufacture, use, offer for sale, sale or importation of our therapeutic candidates may infringe on the
claims of third-party patents. A party might file an infringement action against us. The cost to us of any patent litigation or other
proceeding, even if resolved in our favor, could be substantial. Some of our competitors may be able to sustain the costs of such
litigation or proceedings more effectively because of their substantially greater financial resources. Uncertainties resulting from
the initiation and continuation or defense of a patent litigation or other proceedings could have a material adverse effect on our
ability to compete in the marketplace. Patent litigation and other proceedings may also absorb significant management time.
Consequently, we are unable to guarantee that we will be able to manufacture, use, offer for sale, sell or import our therapeutic
candidates in the event of an infringement action. At present, we are not aware of pending or threatened patent infringement
actions against us.
In the event of patent infringement claims, or to avoid potential claims, we may choose or be required to seek a license
from a third party and would most likely be required to pay license fees or royalties or both. These licenses may not be available
on acceptable terms, or at all. Even if we were able to obtain a license, the rights may be non-exclusive, which could potentially
limit our competitive advantage. Ultimately, we could be prevented from commercializing a therapeutic candidate or be forced to
cease some aspect of our business operations if, as a result of actual or threatened patent infringement claims, we are unable to
enter into licenses on acceptable terms. This inability to enter into licenses could harm our business significantly. At present, we
have not received any written demands from third parties that we take a license under their patents nor have we received any
notice form a third party accusing us of patent infringement.
Our license agreements with our licensees contain, and any contract that we enter into with licensees in the future will
likely contain, indemnity provisions that obligate us to indemnify the licensee against any losses arising from infringement of
third-party intellectual property rights. In addition, our in-license agreements contain provisions that obligate us to indemnify the
licensors against any damages arising from the development, manufacture and use of products developed on the basis of the in-
licensed intellectual property.
We may be subject to other patent-related litigation or proceedings that could be costly to defend and uncertain in their
outcome.
In addition to infringement claims against us, we may in the future become a party to other patent litigation or
proceedings, including interference or re-examination proceedings filed with the U.S. Patent and Trademark Office or opposition
proceedings in other foreign patent offices regarding intellectual property rights with respect to our products and technology, as
well as other disputes regarding intellectual property rights with licensees, licensors or others with whom we have contractual or
other business relationships. Post-issuance oppositions are not uncommon and we, our licensee or our licensor will be required to
defend these opposition procedures as a matter of course. Opposition procedures may be costly, and there is a risk that we may
not prevail.
We may be subject to damages resulting from claims that we or our employees or contractors have wrongfully used or
disclosed alleged trade secrets of their former employers.
Many of our employees and contractors were previously employed at universities or other biotechnology or
pharmaceutical companies, including our competitors or potential competitors. Although no claims against us are currently
pending, we may be subject to claims that we or any employee or contractor has inadvertently or otherwise used or disclosed
trade secrets or other proprietary information of his or her former employers. Litigation may be necessary to defend against these
claims. If we fail in defending such claims, in addition to paying monetary damages, we may lose valuable intellectual property
rights or personnel. A loss of key research personnel or their work product could hamper or prevent our ability to commercialize
certain therapeutic candidates, which could severely harm our business, financial condition and results of operations. Even if we
are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management.
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Risks Related to our Ordinary Shares and ADSs
We may be a passive foreign investment company, or PFIC, for U.S. federal income tax purposes for our taxable year
ending December 31, 2021 or in any subsequent year. There may be negative tax consequences for U.S. taxpayers that are
holders of our ordinary shares or our ADSs if we are a PFIC.
We will be treated as a PFIC for U.S. federal income tax purposes in any taxable year in which either (i) at least 75% of
our gross income is “passive income” or (ii) on average at least 50% of our assets by value produce passive income or are held
for the production of passive income. Passive income for this purpose generally includes, among other things, certain dividends,
interest, royalties, rents and gains from commodities and securities transactions and from the sale or exchange of property that
gives rise to passive income. Passive income also includes amounts derived by reason of the temporary investment of funds,
including those raised in a public offering. In determining whether a non-U.S. corporation is a PFIC, a proportionate share of the
income and assets of each corporation in which it owns, directly or indirectly, at least a 25% interest (by value) is taken into
account. We believe that we were a PFIC during certain prior taxable years, although we believe that we were not a PFIC for the
year ended December 31, 2020. Although we have not determined whether we will be a PFIC for our taxable year ending
December 31, 2021, or in any subsequent year, our operating results for any such years may cause us to be a PFIC. Because PFIC
status is determined annually and is based on our income, assets and activities for the entire taxable year, it is not possible to
determine with certainty whether we will be characterized as a PFIC for the 2021 taxable year until after the close of the year, and
there can be no assurance that we will not be classified as a PFIC in any future year. If we are a PFIC for our taxable year ending
December 31, 2021, or any subsequent year, and a U.S. Investor (as defined below) does not make an election to treat us as a
“qualified electing fund,” or QEF, or make a “mark-to-market” election, then “excess distributions” to a U.S. Investor, and any
gain realized on the sale or other disposition of our ordinary shares or ADSs will be subject to special rules. Under these rules: (i)
the excess distribution or gain would be allocated ratably over the U.S. Investor’s holding period for the ordinary shares (or
ADSs, as the case may be); (ii) the amount allocated to the current taxable year and any period prior to the first day of the first
taxable year in which we were a PFIC would be taxed as ordinary income; and (iii) the amount allocated to each of the other
taxable years would be subject to tax at the highest rate of tax in effect for the applicable class of taxpayer for that year, and an
interest charge for the deemed deferral benefit would be imposed with respect to the resulting tax attributable to each such other
taxable year. In addition, if the U.S. Internal Revenue Service, or the IRS, determines that we are a PFIC for a year with respect
to which we have determined that we were not a PFIC, it may be too late for a U.S. Investor to make a timely QEF or mark-to-
market election. U.S. Investors who hold our ordinary shares or ADSs during a period when we are a PFIC will be subject to the
foregoing rules, even if we cease to be a PFIC in subsequent years, subject to exceptions for U.S. Investors who made a timely
QEF or mark-to-market election. A U.S. Investor can make a QEF election by completing the relevant portions of and filing IRS
Form 8621 in accordance with the instructions thereto. A QEF election generally may not be revoked without the consent of the
IRS. Upon request, we intend to annually furnish U.S. Investors with information needed in order to complete IRS Form 8621
(which form would be required to be filed with the IRS on an annual basis by the U.S. Investor) and to make and maintain a valid
QEF election for any year in which we or any of our subsidiaries are a PFIC. See also “Item 10. Additional Information—E.
Taxation— Certain U.S. Federal Income Tax Considerations.”
The market prices of our ordinary shares and ADSs are subject to fluctuation, which could result in substantial losses
by our investors.
The stock market in general and the market prices of our ordinary shares on the TASE and ADSs on Nasdaq, in particular,
are subject to fluctuation, and changes in these prices may be unrelated to our operating performance. We expect that the market
prices of our ordinary shares and ADSs will continue to be subject to wide fluctuations. The market price of our ordinary shares
and ADSs are and will be subject to a number of factors, including:
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announcements of technological innovations or new products by us or others;
announcements by us of significant acquisitions, strategic partnerships, in-licensing, out-licensing, joint ventures or capital commitments;
expiration or terminations of licenses, research contracts or other collaboration agreements;
public concern as to the safety of drugs we, our licensees or others develop;
general market conditions;
the volatility of market prices for shares of biotechnology companies generally;
success of research and development projects;
departure of key personnel;
developments concerning intellectual property rights or regulatory approvals;
variations in our and our competitors’ results of operations;
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changes in earnings estimates or recommendations by securities analysts, if our ordinary shares or ADSs are covered by analysts;
statements about the Company made in the financial media or by bloggers on the Internet;
statements made about drug pricing and other industry-related issues by government officials;
changes in government regulations or patent decisions;
developments by our licensees; and
general market conditions and other factors, including factors unrelated to our operating performance.
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These factors and any corresponding price fluctuations may materially and adversely affect the market price of our
ordinary shares and ADSs, and result in substantial losses by our investors.
Additionally, market prices for securities of biotechnology and pharmaceutical companies historically have been very
volatile. The market for these securities has from time to time experienced significant price and volume fluctuations for reasons
unrelated to the operating performance of any one company. Furthermore, our business may be adversely impacted by risks, or
the public perception of the risks, related to a pandemic or other health crisis, such as the COVID-19 pandemic. A significant
outbreak of contagious diseases could result in a widespread health crisis that could adversely affect the economies and financial
markets of many countries, resulting in an economic downturn. In the past, following periods of market volatility, shareholders
have often instituted securities class action litigation. If we were involved in securities litigation, it could have a substantial cost
and divert resources and attention of management from our business, even if we are successful.
Our ordinary shares are traded on the TASE and our ADSs are listed on Nasdaq. Trading in our securities on these
markets takes place in different currencies (dollars on Nasdaq and NIS on the TASE), and at different times (resulting from
different time zones, different trading days and different public holidays in the United States and Israel). The trading prices of our
securities on these two markets may differ due to these factors, the factors listed above, or other factors. Any decrease in the price
of our securities on one of these markets could cause a decrease in the trading price of our securities on the other market.
Future sales of our ordinary shares or ADSs could reduce the market price of our ordinary shares and ADSs.
Substantial sales of our ordinary shares or ADSs, either on the TASE or on Nasdaq, may cause the market price of our
ordinary shares or ADSs to decline. Sales by us or our securityholders of substantial amounts of our ordinary shares or ADSs, or
the perception that these sales may occur in the future, could cause a reduction in the market price of our ordinary shares or
ADSs.
As of February 22, 2021, as a result of previous financings, we had warrants outstanding (i) for the purchase of 198,230
ADSs at an exercise price of $30.00 per ADS, (ii) for the purchase of 198,230 ADSs at an exercise price of $60.00 per ADS, (iii)
for the purchase of 63,837 ADSs at an exercise price of $14.10 per ADS, (iv) for the purchase of 2,675,874 ADSs at an exercise
price of $11.25 per ADS, (vi) for the purchase of 6,778,145 ADSs at an exercise price of $2.25 per ADS and (vii) for the
purchase of 120,537 ADSs at an exercise price of $2.185 per ADS.
On September 25, 2020, we entered into an offering agreement, or the Wainwright Offering Agreement, with H.C.
Wainwright & Co., LLC, or Wainwright, pursuant to which we may offer and sell, from time to time, at our option, up to $25.0
million of our ADSs through an “at-the-market” equity offering program under which Wainwright has agreed to act as sales
agent. As of February 22, 2021, we have sold 3,077,851 of our ADSs for total gross proceeds of approximately $7.3 million
under the Wainwright Offering Agreement.
As of February 22, 2021, in the framework of our Share Incentive Plan, there are outstanding stock options, restricted
stock units and performance stock units (granted to directors, employees and consultants) for the purchase of 36.1 million
ordinary shares with a weighted average exercise price of $0.47 per ordinary share.
The issuance of any additional ordinary shares, any additional ADSs, or any securities that are exercisable for or
convertible into our ordinary shares or ADSs, may have an adverse effect on the market price of our ordinary shares and ADSs
and will have a dilutive effect on our shareholders.
Raising additional capital by issuing securities may cause dilution to existing shareholders.
We may need to raise substantial future capital to continue to complete clinical development and commercialize our
products and therapeutic candidates and to conduct the research and development and clinical and regulatory activities necessary
to bring our therapeutic candidates to market. Our future capital requirements will depend on many factors, including:
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the failure to obtain regulatory approval or achieve commercial success of our therapeutic candidates;
our success in effecting out-licensing arrangements with third parties;
our success in establishing other out-licensing or co-development arrangements;
the success of our licensees in selling products that utilize our technologies;
the results of our preclinical studies and clinical trials for our earlier stage therapeutic candidates, and any decisions to initiate clinical trials if
supported by the preclinical results;
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the costs, timing and outcome of regulatory review of our therapeutic candidates that progress to clinical trials;
the costs of establishing or acquiring specialty sales, marketing and distribution capabilities, if any of our therapeutic candidates are approved, and
we decide to commercialize them ourselves;
the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our issued patents and defending intellectual property-
related claims;
the extent to which we acquire or invest in businesses, products or technologies and other strategic relationships; and
the costs of financing unanticipated working capital requirements and responding to competitive pressures.
If we raise additional funds through licensing arrangements with third parties, we may have to relinquish valuable rights
to our therapeutic candidates or grant licenses on terms that are not favorable to us. If we raise additional funds by issuing equity
or convertible debt securities, we will reduce the percentage ownership of our then-existing shareholders, and these securities
may have rights, preferences or privileges senior to those of our existing shareholders. See also “— Future sales of our ordinary
shares or ADSs could reduce the market price of our ordinary shares and ADSs.”
As a foreign private issuer, we are permitted to follow certain home country corporate governance practices instead of
applicable SEC and Nasdaq requirements, which may result in less protection than is accorded to investors under rules
applicable to domestic issuers.
As a foreign private issuer, we are permitted to follow certain home country corporate governance practices instead of
those otherwise required under the Listing Rules of the Nasdaq Stock Market, or the Nasdaq Rules, for U.S. domestic issuers. For
instance, we may follow home country practice in Israel with regard to, among other things, composition of the board of
directors, director nomination procedure, composition of the compensation committee, approval of compensation of officers, and
quorum at shareholders’ meetings. In addition, we will follow our home country law, instead of the Nasdaq Rules, which require
that we obtain shareholder approval for certain dilutive events, such as for the establishment or amendment of certain equity-
based compensation plans, an issuance that will result in a change of control of the company, certain transactions other than a
public offering involving issuances of a 20% or more interest in the company and certain acquisitions of the stock or assets of
another company. Following our home country governance practices as opposed to the requirements that would otherwise apply
to a U.S. company listed on Nasdaq may provide less protection than is accorded to investors under the Nasdaq Rules applicable
to U.S. domestic issuers. See “Item 16G — Corporate Governance — Nasdaq Listing Rules and Home Country Practices.”
In addition, as a foreign private issuer, we are exempt from the rules and regulations under the U.S. Securities Exchange
Act of 1934, as amended, or the Exchange Act, related to the furnishing and content of proxy statements, and our officers,
directors and principal shareholders are exempt from the reporting and short-swing profit recovery provisions contained in
Section 16 of the Exchange Act. In addition, we are not required under the Exchange Act to file annual, quarterly and current
reports and financial statements with the SEC as frequently or as promptly as domestic companies whose securities are registered
under the Exchange Act.
Risks Related to our Operations in Israel
We conduct our operations in Israel and therefore our results may be adversely affected by political, economic and
military instability in Israel and its region.
Our headquarters, our operations and some of our suppliers and third-party contractors are located in central Israel and
our key employees, officers and most of our directors are residents of Israel. Accordingly, political, economic and military
conditions in Israel and the surrounding region may directly affect our business. Since the establishment of the State of Israel in
1948, a number of armed conflicts have taken place between Israel and its Arab neighbors. Any hostilities involving Israel or the
interruption or curtailment of trade within Israel or between Israel and its trading partners could adversely affect our operations
and results of operations and could make it more difficult for us to raise capital. During the autumn of 2012, Israel was engaged
in armed conflicts with Hamas, a militia group and political party operating in the Gaza Strip; during the summer of 2014,
another escalation in violence among Israel, Hamas and other groups took place; and since October 2015, and to a lesser extent
since August 2016, Israel has been facing another escalation in violence with the Palestinian population. These conflicts involved
missile strikes against civilian targets in various parts of Israel, as well as civil insurrection of Palestinians in the West Bank, on
the border with the Gaza Strip and in Israeli cities, and negatively affected business conditions in Israel. In addition, Israel faces
threats from more distant neighbors, in particular Iran. Iran is also believed to have a strong influence among extremist groups in
the region, such as Hamas in Gaza, Hezbollah (a Lebanese Islamist Shiite militia group and political party), and various rebel
militia groups in Syria. Recent political uprisings and social unrest in various countries in the Middle East and North Africa are
affecting the political stability of those countries. The year 2014 saw the rise of an Islamic fundamentalist group known as ISIS.
Following swift operations, ISIS gained control of large areas in the Middle East, including in Iraq and Syria, which have
contributed to the turmoil experienced in these areas. As a result, the United States and Russian armed forces have engaged in
limited operations in Syria, resulting in the defeat of ISIS and other rebel groups and their withdrawal in 2017 from most of the
areas they had previously held in Syria, including places along the Israeli-Syrian border. Iranian forces have supported operations
of the Syrian army during the years of fighting in Syria, adding to the instability in the area. This instability may lead to
deterioration of the political relationships that exist between Israel and these countries, and has raised concerns regarding security
in the region and the potential for armed conflict. These situations may escalate in the future to more violent events that may
affect Israel and us. Among other things, this instability may affect the global economy and marketplace through changes in oil
and gas prices. Any armed conflicts, terrorist activities or political instability in the region could adversely affect business
conditions and could harm our results of operations. For example, any major escalation in hostilities in the region could result in
a portion of our employees being called up to perform military duty for an extended period of time. Parties with whom we do
business have sometimes declined to travel to Israel during periods of heightened unrest or tension, forcing us to make alternative
arrangements when necessary. In addition, the political and security situation in Israel may result in parties with whom we have
agreements involving performance in Israel claiming that they are not obligated to perform their commitments under those
agreements pursuant to force majeure provisions in the agreements.
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Our commercial insurance does not cover losses that may occur as a result of events associated with the security situation
in the Middle East. Although the Israeli government currently covers the reinstatement value of direct damages that are caused by
terrorist attacks or acts of war, we cannot assure you that this government coverage will be maintained. Any losses or damages
incurred by us could have a material adverse effect on our business. Any armed conflicts or political instability in the region
would likely negatively affect business conditions and could harm our results of operations.
Further, in the past, the State of Israel and Israeli companies have been subjected to an economic boycott. Several
countries still restrict business with the State of Israel and with Israeli companies. These restrictive laws and policies may have an
adverse impact on our operating results, financial condition or the expansion of our business. If the BDS Movement, the
movement for boycotting, divesting and sanctioning Israel and Israeli institutions (including universities) and products become
increasingly influential in the United States and Europe, this may also adversely affect our financial condition.
Due to a significant portion of our expenses and revenues being denominated in non-dollar currencies, our results of
operations may be harmed by currency fluctuations.
Our reporting and functional currency is the dollar. However, we pay a significant portion of our expenses in NIS and in
euro, and we expect this to continue. If the dollar weakens against the NIS or the euro in the future, there may be a negative
impact on our results of operations. The revenues from our current out-licensing arrangements are payable in dollars and euros.
Although we expect our revenues from future licensing arrangements to be denominated primarily in dollars, we are exposed to
the currency fluctuation risks relating to the recording of our revenues in currencies other than dollars. For example, if the euro
strengthens against the dollar, our reported revenues in dollars may be lower than anticipated. From time to time, we engage in
currency hedging transactions to decrease the risk of financial exposure from fluctuations in the exchange rates of the currencies
mentioned above in relation to the dollar. These measures, however, may not adequately protect us from material adverse effects.
We have received Israeli government grants and loans for certain research and development expenditures. The terms
of these grants and loans may require us to satisfy specified conditions in order to manufacture products and transfer
technologies outside of Israel. We may be required to pay penalties in addition to repayment of the grants and loans.
Our research and development efforts were previously financed, in part, through grants and loans that we received from
the Israel Innovation Authority, or the IIA (formerly the Office of the Chief Scientist of Israel’s Ministry of Economy and
Industry, or the OCS). In addition, before we in-licensed motixafortide, Biokine had received funding for the project from the
IIA, and as a condition to IIA consent to our in-licensing of motixafortide, we were required to agree to abide by any obligations
resulting from such funding. We therefore must comply with the requirements of the Israeli Law for the Encouragement of
Industrial Research, Development and Technological Innovation, 1984, and related regulations, as amended, or the Research
Law, with respect to these projects. Through December 31, 2020, we received approximately $22.0 million in funding from the
IIA and paid the IIA approximately $7.0 million in royalties under our approved programs. As of December 31, 2020, we have
no contingent obligation to the IIA other than for motixafortide as agreed when we in-licensed the project. The contingent
liability to the IIA assumed by us relating to this transaction (which liability has no relation to the funding actually received by
us) amounts to $3.5 million as of December 31, 2020. We have a full right of offset for amounts payable to the IIA from
payments that we may owe to Biokine in the future.
The transfer or licensing to third parties of know-how or technologies developed under the programs submitted to the IIA
and derivatives thereof and as to which we or our licensors received grants, or manufacturing or rights to manufacture based on
and/or incorporating such know-how to third parties, might require the consent of the IIA, and may require certain payments to
the IIA. There is no assurance that we will be able to obtain such consent on terms acceptable to us, or at all. Although such
restrictions do not apply to the export from Israel of our products developed with such know-how, without receipt of the
aforementioned consent, such restrictions may prevent or limit us from engaging in transactions with our affiliates, customers or
other third parties outside Israel, involving transfer or licensing of manufacturing rights or other know-how or assets that might
otherwise be beneficial to us.
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Provisions of Israeli law may delay, prevent or otherwise impede a merger with, or an acquisition of, our company,
which could prevent a change of control, even when the terms of such a transaction are favorable to us and our shareholders.
Israeli corporate law regulates mergers, requires tender offers for acquisitions of shares above specified thresholds,
requires special approvals for transactions involving directors, officers or significant shareholders and regulates other matters that
may be relevant to these types of transactions. For example, a merger may not be consummated unless at least 50 days have
passed from the date that a merger proposal was filed by each merging company with the Israel Registrar of Companies and at
least 30 days from the date that the shareholders of both merging companies approved the merger. In addition, a majority of each
class of securities of the target company must approve a merger. Moreover, a full tender offer can only be completed if the
acquirer receives the approval of at least 95% of the issued share capital (provided that a majority of the offerees that do not have
a personal interest in such tender offer shall have approved the tender offer, except that if the total votes to reject the tender offer
represent less than 2% of the company’s issued and outstanding share capital, in the aggregate, approval by a majority of the
offerees that do not have a personal interest in such tender offer is not required to complete the tender offer), and the
shareholders, including those who indicated their acceptance of the tender offer, may, at any time within six months following the
completion of the tender offer, claim that the consideration for the acquisition of the shares did not reflect their fair market value
and petition the court to alter the consideration for the acquisition accordingly (unless the acquirer stipulated in the tender offer
that a shareholder that accepts the offer may not seek appraisal rights, and the acquirer or the company published all required
information with respect to the tender offer prior to the date indicated for response to the tender offer).
Furthermore, Israeli tax considerations may make potential transactions unappealing to us or to our shareholders whose
country of residence does not have a tax treaty with Israel exempting such shareholders from Israeli tax. For example, Israeli tax
law does not recognize tax-free share exchanges to the same extent as U.S. tax law. With respect to mergers, Israeli tax law
allows for tax deferral in certain circumstances but makes the deferral contingent on the fulfilment of numerous conditions,
including a holding period of two years from the date of the transaction during which sales and dispositions of shares of the
participating companies are restricted. Moreover, with respect to certain share swap transactions, the tax deferral is limited in
time, and when such time expires, the tax becomes payable, even if no actual disposition of the shares has occurred.
These and other similar provisions could delay, prevent or impede an acquisition of us or our merger with another
company, even if such an acquisition or merger would be beneficial to us or to our shareholders.
We have received Israeli government grants and loans for certain research and development expenditures. The terms of
these grants and loans may require us to satisfy specified conditions in order to manufacture products and transfer technologies
outside of Israel. We may be required to pay penalties in addition to repayment of the grants and loans. Such grants and loans
may be terminated or reduced in the future, which would increase our costs. See “Business — Government Regulation and
Funding — Israeli Government Programs.”
It may be difficult to enforce a U.S. judgment against us and our officers and directors in Israel or the United States,
or to serve process on our officers and directors.
We are incorporated in Israel. All of our executive officers and the majority of our directors reside outside of the United
States, and all of our assets and most of the assets of our executive officers and directors are located outside of the United States.
Therefore, a judgment obtained against us or any of our executive officers and directors in the United States, including one based
on the civil liability provisions of the U.S. federal securities laws, may not be collectible in the United States and may not be
enforced by an Israeli court. It also may be difficult for you to effect service of process on these persons in the United States or to
assert U.S. securities law claims in original actions instituted in Israel.
Your rights and responsibilities as a shareholder will be governed by Israeli law, which may differ in some respects
from the rights and responsibilities of shareholders of U.S. companies.
We are incorporated under Israeli law. The rights and responsibilities of the holders of our ordinary shares are governed
by our Articles of Association and Israeli law. These rights and responsibilities differ in some respects from the rights and
responsibilities of shareholders in typical U.S.-based corporations. In particular, a shareholder of an Israeli company has a duty to
act in good faith toward the company and other shareholders and to refrain from abusing its power in the company, including,
among other things, in voting at the general meeting of shareholders on matters such as amendments to a company’s articles of
association, increases in a company’s authorized share capital, mergers and acquisitions and interested party transactions
requiring shareholder approval. In addition, a shareholder who knows that it possesses the power to determine the outcome of a
shareholder vote or to appoint or prevent the appointment of a director or executive officer in the company has a duty of fairness
toward the company. There is limited case law available to assist us in understanding the implications of these provisions that
govern shareholders’ actions. These provisions may be interpreted to impose additional obligations and liabilities on holders of
our ordinary shares that are not typically imposed on shareholders of U.S. corporations.
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ITEM 4. INFORMATION ON THE COMPANY
A. History and Development of the Company
Our legal and commercial name is BioLineRx Ltd. We are a company limited by shares organized under the laws of the
State of Israel. Our principal executive offices are located at 2 HaMa’ayan Street, Modi’in 7177871, Israel, and our telephone
number is +972 (8) 642-9100.
We were founded in 2003 by leading institutions in the Israeli life sciences industry. We completed our initial public
offering in Israel in February 2007 and our ordinary shares are traded on the TASE under the symbol “BLRX.” In July 2011, we
listed our ADSs on Nasdaq and they are traded under the symbol “BLRX.”
In March 2017, we acquired Agalimmune Ltd., a private U.K.-based company, and its U.S. subsidiary, Agalimmune Inc.
Agalimmune Inc. was dissolved on December 31, 2017.
Our capital expenditures for the year ended December 31, 2018, 2019 and 2020 were immaterial. Our current capital
expenditures involve acquisitions of laboratory equipment, computers and communications equipment.
The SEC maintains an Internet site that contains reports, proxy and information statements, and other information
regarding issuers like BioLineRx that file electronically with the SEC. The address of that site is www.sec.gov. We maintain a
corporate website at www.biolinerx.com
Other than as described in “Item 5. Operating and Financial Review and Prospects—Contractual Obligations”, we have
not had any material commitments for capital expenditures, including any anticipated material acquisition of plant and equipment
or interests in other companies.
B. Business Overview
We are a late clinical-stage biopharmaceutical development company with a strategic focus on oncology. Our current
development and commercialization pipeline consists of two clinical-stage therapeutic candidates – motixafortide (BL-8040), a
novel peptide for the treatment of stem cell mobilization, solid tumors and AML, and AGI-134, an immuno-oncology agent in
development for solid tumors. In addition, we have an off-strategy, legacy therapeutic product called BL-5010 for the treatment
of skin lesions. We have generated our pipeline by systematically identifying, rigorously validating and in-licensing therapeutic
candidates that we believe exhibit a high probability of therapeutic and commercial success. To date, except for BL-5010, none of
our therapeutic candidates have been approved for marketing or sold commercially. Our strategy includes commercializing our
therapeutic candidates through out-licensing arrangements with biotechnology and pharmaceutical companies and evaluating, on
a case-by-case basis, the commercialization of our therapeutic candidates independently.
In January 2016, we entered into a clinical collaboration with MSD (a tradename of Merck & Co., Inc., Kenilworth, New
Jersey) in the field of cancer immunotherapy, in the framework of which we have completed a clinical trial in pancreatic cancer.
Our Product Development Approach
We seek to develop a pipeline of promising therapeutic candidates that exhibit distinct advantages over currently available
therapies or address unmet medical needs. Our resources are focused on advancing our therapeutic candidates through
development and toward commercialization. Our current drug development pipeline consists of two clinical-stage therapeutic
candidates.
We have established close relationships with various universities, academic and research institutions and biotechnology
companies that permit us to identify and select compounds at various stages of clinical and pre-clinical development. Our
approach is consistent with our objective of proceeding only with therapeutic candidates that we believe exhibit a relatively high
probability of therapeutic and commercial success.
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Our Product Pipeline
The table below summarizes our current pipeline of therapeutic candidates, including the target indications and status of
each candidate and our development partners:
Motixafortide
Our clinical-stage lead therapeutic candidate, motixafortide, is a novel, short peptide that functions as a high-affinity
antagonist for CXCR4. We are developing motixafortide for the treatment of stem cell mobilization, solid tumors and AML.
CXCR4 is expressed by normal hematopoietic cells and overexpressed in various human cancers where its expression correlates
with disease severity. CXCR4 is a chemokine receptor that mediates the homing and retention of hematopoietic stem cells, or
HSCs, in the bone marrow, and also mediates tumor progression, angiogenesis (growth of new blood vessels in the tumor),
metastasis (spread of tumor to other organs) and survival. Before “motixafortide” was approved by the World Health
Organization in 2019 as an International Nonproprietary Name, this therapeutic candidate was known as BL-8040.
Inhibition of CXCR4 by motixafortide leads to the mobilization of HSCs from the bone marrow to the peripheral blood,
enabling their collection for subsequent autologous or allogeneic transplantation in cancer patients. Clinical data has
demonstrated the ability of motixafortide to mobilize higher numbers of long-term engrafting HSCs (CD34+CD38-CD45RA-
CD90+CD49f+) as compared to G-CSF.
Motixafortide also mobilizes cancer cells from the bone marrow, detaching them from their survival signals and
sensitizing them to chemotherapy. In addition, motixafortide has demonstrated a direct anti-cancer effect by inducing apoptosis
(cell death) and inhibiting proliferation in various cancer cell models (multiple myeloma, non-Hodgkin’s lymphoma, leukemia,
non-small-cell lung carcinoma, neuroblastoma and melanoma).
In the field of immuno-oncology, motixafortide mediates infiltration of T-cells while reducing immune regulatory cells in
the tumor microenvironment. In clinical studies, the combination of motixafortide with immune checkpoint inhibitors, such as
anti PD-1, has shown T-cell activation and a reduction in tumor cell numbers.
The following is a summary of the clinical trials being carried out with motixafortide.
Stem cell mobilization
In March 2015, we reported successful top-line results from a Phase 1 safety and efficacy trial for the use of motixafortide
as a novel stem cell mobilization treatment for allogeneic bone marrow transplantation at Hadassah Medical Center in Jerusalem.
In March 2016, we initiated a Phase 2 trial for motixafortide in allogeneic stem cell transplantation, conducted in
collaboration with the Washington University School of Medicine, Division of Oncology and Hematology. In May 2018, we
announced positive top-line results of this study showing, among other things, that a single injection of motixafortide mobilized
sufficient amounts of CD34+ cells required for transplantation at a level of efficacy similar to that achieved by using 4-6
injections of G-CSF, the current standard of care.
In December 2017, we commenced a randomized, placebo-controlled Phase 3 registrational trial for motixafortide, known
as the GENESIS trial, for the mobilization of HSCs for autologous transplantation in patients with multiple myeloma. The trial
began with a lead-in period for dose confirmation, which was to include 10-30 patients and then progress to the placebo-
controlled main part, which was designed to include 177 patients in more than 25 centers. Following review of the positive
results from treatment of the first 11 patients, the Data Monitoring Committee, or DMC, recommended that the lead-in part of the
study be stopped and that we should move immediately to the second part. Additional positive results from the lead-in period
were reported at the annual meeting of the European Society for Blood and Marrow Transplantation held in March 2019, where it
was announced that HSCs mobilized by motixafortide in combination with G-CSF were successfully engrafted in all 11 patients.
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In August 2020, we announced a decision to perform an interim analysis on approximately 65% of the original study
sample size, primarily based on a significantly lower-than-anticipated patient-dropout rate in the study. In October 2020, we
announced positive results from the interim analysis. Based on the statistically significant evidence favoring treatment with
motixafortide, the study’s independent DMC issued a recommendation to us that patient enrollment may be ceased immediately,
without the need to recruit all 177 patients originally planned for the study. In accordance with the DMC’s recommendation,
study enrollment was complete at 122 patients. Top-line results for the study, including full primary and secondary efficacy
endpoints, will be announced after the last patient enrolled reaches 100 days of follow-up post-transplantation, which is expected
to occur in early second quarter of 2021. In parallel, we are proceeding with all activities in support of a New Drug Application,
or NDA, submission in this indication anticipated in the first half of 2022, including a pre-NDA meeting with the FDA planned
for the second half of 2021.
Solid tumors
In January 2016, we entered into a clinical collaboration with MSD (a tradename of Merck & Co., Inc., Kenilworth, New
Jersey) in the field of cancer immunotherapy. Based on this collaboration, in September 2016 we initiated a Phase 2a study,
known as the COMBAT/KEYNOTE-202 study, focusing on evaluating the safety and efficacy of motixafortide in combination
with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy, in 37 patients with metastatic pancreatic adenocarcinoma, or
PDAC. The study was an open-label, multicenter, single-arm trial designed to evaluate the clinical response, safety and
tolerability of the combination of these therapies as well as multiple pharmacodynamic parameters, including the ability to
improve infiltration of T-cells into the tumor and their reactivity. Top-line results showed that the dual combination demonstrated
encouraging disease control and overall survival in patients with metastatic pancreatic cancer. In addition, assessment of patient
biopsies supported motixafortide’s ability to induce infiltration of tumor-reactive T-cells into the tumor, while reducing the
number of immune regulatory cells.
In July 2018, we announced the expansion of the COMBAT/KEYNOTE-202 study under the collaboration to include a
triple combination arm investigating the safety, tolerability and efficacy of motixafortide, KEYTRUDA and chemotherapy. We
initiated this arm of the trial in December 2018. In December 2019, we announced that preliminary data from the study indicated
that the triple combination therapy showed a high level of disease control, including seven partial responders and 10 patients with
stable disease out of 22 evaluable patients. In February 2020, we completed recruiting a total of 43 patients for the study and in
December 2020, we announced the final results of the study. The results of the study showed substantial improvement as
compared to comparable historical results of other pancreatic cancer studies across all study endpoints. Of the 38 evaluable
patients, median overall survival was 6.5 months, median progression free survival was 4.0 months, confirmed overall response
rate was 13.2%, overall response rate was 21.2% and disease control rate was 63.2%. The combination was generally well
tolerated, with a safety profile consistent with the individual safety profile of each component alone; adverse event and severe
adverse event profiles were as expected with chemotherapy-based treatment regimens. We are currently planning next
development steps for this program, including discussions with potential collaboration partners and development of a protocol for
a randomized controlled study.
In August 2016, in the framework of an agreement with MD Anderson Cancer Center, or MD Anderson, we entered into
an additional collaboration for the investigation of motixafortide in combination with KEYTRUDA in pancreatic cancer. The
focus of this study, in addition to assessing clinical response, was the mechanism of action by which both drugs might synergize,
as well as multiple assessments to evaluate the biological anti-tumor effects induced by the combination. We supplied
motixafortide for this Phase 2b study, which commenced in January 2017. Final results from this study (based on a cut-off in July
2019 from 20 enrolled patients out of which 15 were evaluable) showed that the dual combination demonstrated clinical activity
and encouraging overall survival in patients with metastatic pancreatic cancer. In addition, assessment of patient biopsies
supported motixafortide’s ability to induce infiltration of tumor-reactive T-cells into the tumor.
In October 2020, we announced that motixafortide will be tested in combination with the anti-PD-1 cemiplimab
(LIBTAYO®) and standard-of-care chemotherapy (gemcitabine and nab-paclitaxel) in first-line PDAC. This investigator-initiated
Phase 2 study, led by Columbia University, will initially enroll 10-12 PDAC patients, and will be expanded to a total of 40
patients following an evaluation of the initial 10-12 patients based on pre-defined criteria. The primary endpoint of the study is
the overall response rate. Secondary endpoints include safety and tolerability, progression free survival, duration of clinical
benefit and overall survival. Data from the study is anticipated in mid-2022 (although timelines are ultimately controlled by the
independent investigator and are therefore subject to change).
AML
During 2016, we completed and reported on a Phase 2a proof-of-concept trial for the treatment of relapsed or refractory
acute myeloid leukemia, or r/r AML, which was conducted on 42 patients at six world-leading cancer research centers in the
United States and at five premier sites in Israel. The study included both a dose-escalation and a dose-expansion phase. Results
from the trial showed positive safety and response rate data for subjects treated with a combination of motixafortide and high-
dose cytarabine (Ara-C), or HiDAC. At the annual meeting of the European Hematology Association, or EHA, in June 2018, we
presented positive overall survival data from the long-term follow-up part of this study. We continue to monitor long-term
survival data for patients in the study and, in parallel, are evaluating our next clinical development steps in this indication.
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Since August 2015, we have been conducting a double-blind, placebo-controlled, randomized, multi-center, Phase 2b trial
in Germany, in collaboration with the German Study Alliance Leukemia Group, to assess the efficacy of motixafortide in addition
to standard consolidation therapy (cytarabine) in AML patients who have responded to standard induction treatment and are in
complete remission. Earlier this year, we finalized plans with our collaboration partners to conduct an interim analysis on 2/3
(N=128) of the 194 patients originally planned in the study, all of which had already completed treatment. Based on the interim
analysis, the investigational arm of motixafortide combined with cytarabine did not demonstrate a statistically significant effect in
the study’s primary endpoint, and therefore, the DMC recommended not to continue the study. We continue to believe in the
relevance of CXCR4 as a viable target in other AML treatment lines, such as rr/AML and induction treatment, and we intend to
decide on next steps in AML once we have had an opportunity to review and analyze the unblinded data, including detailed
biomarker and subpopulation data, from the study.
Other matters
In addition to the above, we are currently conducting, or planning to conduct, a number of investigator-initiated, open-
label studies in a variety of indications to support the interest of the scientific and medical communities in exploring additional
uses for motixafortide. These studies serve to further elucidate the mechanism of action for motixafortide. The results of studies
such as these are presented from time to time at relevant professional conferences.
Motixafortide has been granted three Orphan Drug Designations by the FDA: for use to mobilize HSCs from the bone
marrow to peripheral blood for collection in autologous or allogeneic transplantation (granted in July 2012); for the treatment of
AML (granted in September 2013); and for the treatment of pancreatic cancer (granted in February 2019). In January 2020, the
European Medicines Agency, or EMA, granted Orphan Drug Designation to motixafortide for the treatment of pancreatic cancer.
AGI-134
AGI-134, a clinical therapeutic candidate in-licensed by our subsidiary, Agalimmune Ltd., is a synthetic alpha-Gal
glycolipid immunotherapy in development for solid tumors. AGI-134 harnesses the body’s pre-existing, highly abundant, anti-
alpha-Gal antibodies to induce a hyper-acute, systemic, specific anti-tumor response to the patient’s own tumor neo-antigens.
This response not only kills the tumor cells at the site of injection, but also brings about a durable, follow-on, anti-metastatic
immune response. In August 2018, we initiated a Phase 1/2a clinical study for AGI-134 that is primarily designed to evaluate the
safety and tolerability of AGI-134, given both as monotherapy and in combination with an immune checkpoint inhibitor, in
unresectable metastatic solid tumors. The multi-center, open-label study is currently being carried out in the UK, US and Israel.
Initial safety results from the first part of the study were announced at the beginning of September 2019; at the end of the same
month, the second part of the study was commenced. Due to clinical operating issues associated with the COVID-19 pandemic,
in April 2020, enrollment to the clinical trial was temporarily suspended. In August 2020, we renewed study enrollment. Initial
proof-of-mechanism of action and efficacy results from the second part of the study are expected in the second half of 2021.
BL-5010
Our commercialized, legacy therapeutic product, BL-5010, is a customized, proprietary pen-like applicator containing a
novel, acidic, aqueous solution for the non-surgical removal of skin lesions. In December 2014, we entered into an exclusive out-
licensing arrangement with Perrigo Company plc, or Perrigo, for the rights to BL-5010 for over-the-counter, or OTC, indications
in Europe, Australia and additional selected countries. In March 2016, Perrigo received CE Mark approval for BL-5010 as a
novel OTC treatment for the non-surgical removal of warts. The commercial launch of products for treatment of this first OTC
indication (warts/verrucas) commenced in Europe in the second quarter of 2016. Since then, Perrigo has invested in improving
the product and during 2019 launched an improved version of the product in several European countries. In March 2020, we
agreed that Perrigo could relinquish its license rights for certain countries that had been included in its territory according to the
original license agreement and was also no longer obligated to develop, obtain regulatory approval for and commercialize
products for a second OTC indication. In turn, in March 2020, we agreed with our licensor of the rights to BL-5010, Innovative
Pharmaceutical Concepts (IPC) Inc., or IPC, to return to IPC those license rights no longer out-licensed to Perrigo as a result of
the agreement described in the preceding sentence, in consideration of the payment to us of royalties or fees on sublicense
receipts.
Our Strategy
Our objective is to become a leader in the development of novel therapeutics for the treatment of cancer. We have
successfully advanced a number of therapeutic candidates into clinical development. We intend to commercialize our two clinical
candidates, motixafortide and AGI-134, and any future candidates through out-licensing or co-development arrangements with
third parties that may perform any or all of the following tasks: completing development, securing regulatory approvals, securing
reimbursement codes from insurance companies and health maintenance organizations, manufacturing and/or marketing. If
appropriate, we may also enter into co-development and similar partnering arrangements with respect to any therapeutic
candidate with third parties or commercialize a therapeutic candidate ourselves.
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Therapeutic Candidates
Motixafortide
The following paragraphs are a high-level summary of the therapeutic areas we are currently investigating for
motixafortide:
Stem cell mobilization. High-dose chemotherapy followed by stem cell transplantation has become an established
treatment modality for a variety of hematologic malignancies, including multiple myeloma (MM), as well as various forms of
lymphoma and leukemia. Stem cells are mobilized from the bone marrow of the patient (i.e., autologous transplant) or donor (i.e.,
allogeneic transplant) using granulocyte-colony stimulating factor (G-CSF), harvested from the peripheral blood by apheresis,
and infused to the patient after intensive myeloablation (chemo/radiotherapy). This type of treatment often replaces the use of
traditional surgical bone marrow harvesting, because the stem cells are easier to collect, and the treatment allows for a quicker
recovery time and fewer complications. In 2018 approximately 45,000 autologous transplants were conducted in the EU and US.
Patients that fail to mobilize 6M cells (for MM) will usually go to rescue apheresis therapy, where plerixafor will be added.
Estimated mobilization failure rates are 5-30% for MM.
Solid tumors. Novel, emerging therapeutic approaches for targeting solid tumors are being developed and tested.
Combinational therapies of immune checkpoint inhibitors with immuno-oncology supporting agents, with or without
chemotherapy, are among the most promising experimental treatments for solid malignancies.
Pancreatic cancer has a low rate of early diagnosis, a high mortality rate and a poor five-year survival prognosis.
Symptoms are usually non-specific and as a result, pancreatic cancer is often not diagnosed until it reaches an advanced stage.
Once the disease has metastasized, or spread to other organs, it becomes especially hard to treat. Each year, about 185,000
individuals globally are diagnosed with this condition, and an estimated 56,700 individuals were diagnosed with pancreatic
cancer in the US during 2019. The overall five-year survival rate among pancreatic cancer patients is 7-8%, which constitutes the
highest mortality rate among solid tumor malignancies; among those diagnosed with metastatic disease, the overall five-year
survival rates is only 3%. Recent developments that have improved the survival in many cancer types have not been effective for
pancreatic cancer patients, highlighting the need for the development of new therapeutic options.
Furthermore, second-line patients that were diagnosed already with metastatic disease have very few therapeutic options.
The only approved regimen for second-line patients is Onivyde® in combination with 5FU and LV. For these Stage IV at
diagnosis patients reaching second-line therapy, median overall survival is only 4.7 months (Macarulla et al, Pancreas 2020).
Acute Myeloid Leukemia (AML), is a cancer of the blood and bone marrow and is the most common type of acute
leukemia in adults. The Surveillance, Epidemiology and End Results program, or SEER, of the National Cancer Institute
estimated that in the United States there would be approximately 21,450 new cases of AML diagnosed during 2019. AML is
generally a disease of older people and is uncommon before the age of 45. The average age of newly diagnosed AML patients is
68. The first treatment line for patients with AML includes a combination of chemotherapy drugs and is called induction
treatment. The majority of patients achieving complete response, or CR, will eventually relapse, most of them during the first
three years of receiving induction chemotherapy. The next step of treatment after relapse is salvage therapy. A common approach
is to induce a second remission and follow treatment with allogeneic hematopoietic stem cell transplantation or allo-SCT to
consolidate second CR in eligible patients, although the duration of second remission is usually short than the first remission.
Due to relapsed or refractory disease (where the disease is not responsive to standard treatments), the overall five-year survival
rate for AML ranges between 10% and 40%. With current standard chemotherapy treatments, approximately 25-30% of adults
under the age of 60 will survive more than five years, while in the elderly patient population, only less than 10% will survive
more than five years.
Regulatory Approvals.
United States
In September 2013, the FDA granted an Orphan Drug Designation to motixafortide as a therapeutic for the treatment of
AML. In January 2014, the FDA granted an Orphan Drug Designation to motixafortide for use, in combination with G-CSF, in
mobilizing human stem cells from the bone marrow to the peripheral blood for collection for autologous or allogeneic (donor-
based) transplantation. In January 2015, the FDA modified this Orphan Drug Designation for motixafortide for use either as a
single agent or in combination with G-CSF. In February 2019, the FDA granted Orphan Drug Designation to motixafortide for
use in the treatment of pancreatic cancer. Orphan Drug Designation is granted to therapeutics intended to treat rare diseases that
affect not more than 200,000 people in the United States. Orphan Drug Designation entitles the sponsor to a seven-year
marketing exclusivity period and clinical protocol assistance with the FDA, as well as federal grants and tax credits.
European Union
In January 2020, the EMA granted an Orphan Drug Designation to motixafortide for the treatment of pancreatic cancer.
The EMA grants orphan medicinal product designation to investigational drugs intended to treat, prevent or diagnose a life-
threatening or chronically debilitating disease affecting fewer than five in 10,000 people in the EU and for which no satisfactory
treatment is available or, if such treatment exists, the medicine must be of significant benefit to those affected by the condition.
Orphan medicinal product designation provides regulatory and financial incentives for companies to develop and market
therapies, including ten years of market exclusivity, protocol assistance, fee reductions and EU-funded research.
27
Preclinical Results.
In vitro and in vivo studies have shown that motixafortide binds CXCR4 with high affinity (7.9 pM) and occupies it for
prolonged periods of time (>48h). These studies have shown that motixafortide mobilizes cancer cells from the bone marrow and
may therefore detach these cells from survival signals in the bone marrow microenvironment as well as sensitize them to chemo-
and bio-based anti-cancer therapies. In addition, motixafortide directly induces apoptosis of cancer cells. Motixafortide was
efficient, both alone and in combination with chemotherapy, in reducing malignant bone marrow cells and stimulating their cell
death.
In August 2013, we announced that motixafortide has been shown in preclinical trials to be effective for the treatment of
thrombocytopenia, or reduced platelet production.
In December 2013, we presented preclinical data at the annual meeting of the American Society of Hematology (ASH),
showing that motixafortide directly inhibits AML cell growth and induces cell death, both in cell cultures and in mice engrafted
with human AML cells. In addition, motixafortide showed the ability to induce mobilization of AML cells from the bone marrow
into the blood circulation, thereby enhancing the chemotherapeutic effect of ARA-C (one of the standard-of-care chemotherapies
for AML). The data also showed that motixafortide’s effects were even more robust in cells harboring the FLT3 mutation, and a
synergistic effect was observed when motixafortide was combined with the FLT3 inhibitor AC220 (Quizartinib).
At the annual meeting of ASH in December 2016, detailed preclinical data on the mechanism-of-action by which
motixafortide directly induces apoptosis of AML cells was presented by Prof. Amnon Peled of the Hadassah Medical Center and
Biokine. The results of the preclinical studies showed that motixafortide treatment in vivo triggered mobilization of AML blasts
from their protective bone marrow microenvironment and induced their terminal differentiation, further supporting the data we
presented at the American Association for Cancer Research annual conference earlier in 2016. In addition, the studies illustrate
how motixafortide increases the expression and activity of a special class of microRNA precursors termed miR-15a/16-1. These
microRNA molecules have been previously linked to cancer and shown to suppress the activity of several tumor-related pro-
survival proteins. Therefore, by increasing the expression of miR-15a/16-1 microRNA molecules, motixafortide decreases the
expression of tumor-survival proteins and promotes tumor cell death. Importantly, in both in vitro and in vivo experiments,
motixafortide was found to synergize with a selective Bcl-2 inhibitor (Venetoclax) and an FLT3 inhibitor (Quizartinib, also
known as AC220) in inducing AML cell death, pointing at potential drug combination treatments.
At the ASCO-SITC Clinical Immuno-Oncology Symposium, or ASCO-SITC, in January 2018, we presented preclinical
data showing that motixafortide augments the ability of the immune system to fight cancer by increasing the infiltration of anti-
tumor-specific T-cells into the TME, resulting in decreased tumor growth and prolonged survival in a murine model of cancer. In
the preclinical study, a murine model of cancer was used to assess the effects of motixafortide in combination with a cancer
vaccine that primes the immune system against the tumor. The results of the study show that combining motixafortide with the
cancer vaccine leads to a significantly enhanced anti-tumor immune response, which attenuates tumor growth and prolongs
mouse survival better than either agent administered alone. The results go on to demonstrate that motixafortide significantly
increases the abundance of tumor-specific T-cells in the TME, suggesting an explanation for the enhanced efficacy of the
combination over either agent when administered alone.
At the annual meeting of SITC in November 2019, we presented positive preclinical results further elucidating the
mechanism of action of motixafortide in combination with an anti PD-1 and chemotherapy. The pre-clinical study assessed the
effects of motixafortide, anti-PD-1 and chemotherapy (Irinotecan, Fluorouracil and Leucovorin), both alone and in various
combinations, on tumor growth and immune cell constitution in a mouse model for pancreatic cancer. The key findings were that
the triple combination of motixafortide+anti-PD-1+chemotherapy (a) had a significantly better effect on tumor growth compared
to chemotherapy alone or any dual combination with chemotherapy and (b) showed the best effect in modulation of the tumor
microenvironment, resulting in reduction in immunosuppressive cells, and accompanied by increase of activated T effector cells.
Clinical Trials.
Stem cell mobilization
Phase 1/2a and Phase 1 study
In a Phase 1/2a, open-label, dose escalation, safety and efficacy clinical trial in 18 multiple myeloma patients,
motixafortide demonstrated a good safety profile at all doses tested and was highly effective in combination with G-CSF, in the
mobilization of hematopoietic stem cells from the bone marrow to the peripheral blood for autologous transplantation. All
patients receiving transplants (n=17) exhibited rapid engraftment, with median time to neutrophil and platelet recovery of 12 and
14 days, respectively, at the highest dose given (0.9 mg/kg).
28
In March 2015, we announced successful top-line results from a Phase 1 trial for motixafortide as a novel treatment for
the mobilization of stem cells from the bone marrow to the peripheral blood circulation in healthy volunteers, where they can be
potentially harvested for allogeneic transplant supporting the treatment of hematological indications. The study was conducted at
the Hadassah Medical Center in Jerusalem and consisted of two parts. The first part of the study was a randomized, double-blind,
placebo-controlled, dose-escalation study in three cohorts of eight participants each, with each participant receiving two
consecutive injections of motixafortide. Results show that motixafortide is safe and well tolerated up to the maximal tested dose
of one mg/kg, and that dramatic mobilization of CD34+ hematopoietic stem and progenitor cells, or HSPCs, was observed across
all doses tested. The robust mobilization supports the further use of a single injection of motixafortide for HSPC collection.
In the second part of the Phase 1 study, eight healthy participants received a single injection of motixafortide at the
highest tested dose of 1 mg/kg, and four hours later underwent a single, standard leukapheresis procedure. Robust and rapid stem
cell mobilization was evident in all treated participants, supporting a novel approach to stem cell collection. The median level of
collected stem cells was higher than 11 x 106 cells per kg, which is more than two-fold higher than the target concentration, and
five-fold higher than the minimum concentration, necessary for transplantation. In addition, the level of HPSCs in the peripheral
blood circulation 24 hours after injection of motixafortide enabled an additional apheresis on Day 2, if needed. These data
support the use of motixafortide as a single-agent, single-injection, one-day regimen for the collection of stem cells.
Phase 2 study
In March 2016, we initiated a Phase 2 trial for motixafortide as a novel approach for the mobilization and collection of
bone marrow stem cells from the peripheral blood circulation for allogeneic bone marrow transplantation. The open-label study
was conducted in collaboration with the Washington University School of Medicine, Division of Oncology and Hematology, and
enrolled up to 24 donor/recipient pairs, aged 18-70. The trial was designed to evaluate the ability of motixafortide, as a single
agent, to promote stem cell mobilization for allogeneic transplantation. On the donor side, the primary endpoint of the study was
the ability of a single injection of motixafortide to mobilize 2x106 CD34 cells for transplantation following up to two apheresis
collections. On the recipient side, the study aimed to evaluate the functionality and engraftment following transplantation of the
motixafortide collected graft. The study also evaluated the safety and tolerability of motixafortide in healthy donors, as well as
graft durability, the incidence of grade 2-4 acute graft versus host disease, or GVHD, chronic GVHD, relapse and other recipient-
related parameters in patients who have undergone transplantation of hematopoietic cells mobilized with motixafortide.
In May 2018, we announced positive results from the study. Single-agent treatment with motixafortide showed efficacy
similar to standard of care (currently, a four- to five-day treatment cycle with G-CSF and a one- to two-day apheresis procedure)
in only one administration of motixafortide. In addition, motixafortide showed results that were comparable to the standard of
care in recipient engraftment, with all transplanted recipients successfully engrafting with motixafortide-mobilized grafts.
Phase 3 study
In December 2017, we initiated a Phase 3 registration study for motixafortide in autologous stem cell mobilization. The
trial, known as the GENESIS study, is a randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and
efficacy of motixafortide and G-CSF, compared to placebo and G-CSF, for the mobilization of HSCs for autologous
transplantation in multiple myeloma patients. The study began with an open-label, single-arm lead-in period, which was to
include 10-30 patients in order to assess safety and efficacy following treatment with motixafortide plus G-CSF. Results of the
first 11 patients showed that motixafortide in combination with standard G-CSF treatment is safe and tolerable. In addition, the
data showed that 9/11 patients (82%) reached the primary endpoint threshold of ≥ 6x106 CD34 cells/kg with only one dose of
motixafortide and in up to 2 apheresis sessions. Furthermore, seven of the 11 patients (64%) reached the threshold of ≥ 6x106
CD34 cells/kg in a single apheresis session only. These data demonstrated the potential of motixafortide treatment to reduce the
number of administrations and apheresis sessions, as well as hospitalization costs, related to the preparation of multiple myeloma
patients for autologous HSC transplantation. Following review of these positive results, the DMC recommended that the lead-in
part of the study should be stopped and that we should move immediately to the placebo-controlled main part, which was
designed to include 177 patients in more than 15 centers. Additional positive results from the lead-in period were reported at the
annual meeting of the European Society for Blood and Marrow Transplantation held in March 2019, where it was announced that
HSCs mobilized by motixafortide in combination with G-CSF were successfully engrafted in all 11 patients. Treatment in the
main part of the study included five to eight days of G-CSF, with a single dose of motixafortide or placebo on Day 4 and an
optional additional dose of motixafortide or placebo on Day 6. Apheresis for stem cell collection was performed on day 5.
Further apheresis sessions were conducted if needed in order to reach the benchmark of ≥ 6x106 mobilized CD34+ cells. The
primary objective of the study was to demonstrate that motixafortide on top of G-CSF is superior to G-CSF alone in the ability of
mobilize ≥ 6x106 CD34+ cells in up to two apheresis sessions. Secondary objectives included time to engraftment of neutrophils
and platelets and durability of engraftment, as well as other efficacy and safety parameters.
29
In August 2020, we announced a decision to perform an interim analysis on approximately 65% of the original study
sample size, primarily based on a significantly lower-than-anticipated patient-dropout rate in the study. In October 2020, we
announced positive results from the interim analysis. Based on the statistically significant evidence favoring treatment with
motixafortide, the study’s independent DMC issued a recommendation to us that patient enrollment may be ceased immediately,
without the need to recruit all 177 patients originally planned for the study. In accordance with the DMC’s recommendation,
study enrollment was complete at 122 patients. Top-line results for the study, including full primary and secondary efficacy
endpoints, will be announced after the last patient enrolled reaches 100 days of follow-up post-transplantation, which is expected
to occur in early second quarter of 2021. In parallel, we are proceeding with all activities in support of an NDA submission in this
indication anticipated in the first half of 2022, including a pre-NDA meeting with the FDA planned for the second half of 2021.
Solid tumors
COMBAT-KEYNOTE-202 Dual Combination Study
In January 2016, we entered into a clinical collaboration with MSD in the field of cancer immunotherapy. In the
framework of this collaboration, in September 2016 we initiated a Phase 2a study, known as the COMBAT/KEYNOTE-202
study, focusing on evaluating the safety and efficacy of motixafortide in combination with KEYTRUDA, MSD’s anti-PD-1
therapy, in patients with metastatic PDAC. Findings in the field of immuno-oncology suggest that CXCR4 antagonists such as
motixafortide may be effective in inducing the migration of anti-tumor T-cells into the tumor micro-environment. KEYTRUDA
is a humanized monoclonal antibody that works by blocking co-inhibitory T-cell activation signals, thereby increasing the ability
of the body’s immune system to help detect and fight tumor cells. KEYTRUDA blocks the interaction between PD-1 and its
ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells. The study
was an open-label, multicenter, single-arm trial designed to evaluate the clinical response, safety and tolerability of the
combination of motixafortide and KEYTRUDA as well as multiple pharmacodynamic parameters, including the ability to
improve infiltration of T-cells into the tumor and their reactivity. According to the terms of our collaboration agreement with
MSD, we sponsored and performed the COMBAT/KEYNOTE-202 study and MSD supplied its compound for purposes of the
study. Upon completion of the study, or at any earlier point, both parties will have the option to expand the collaboration to
include a pivotal registration study.
Partial results from the motixafortide monotherapy portion of this trial were presented at ASCO-GI in January 2018.
These results showed that motixafortide was safe and well-tolerated, and that it induced an increase in the number of total
immune cells in the peripheral blood, while the frequency of peripheral blood regulatory T-cells (Tregs), known to impede the
anti-tumor immune response, was decreased. In addition, analysis of available biopsies (N=7) showed infiltration of effector T-
cells, known to attack cancer cells, into the tumor periphery and tumor micro-environment (TME). In this regard, the results
show up to a 15-fold increase in CD3+ T-cells, and up to a two-fold increase in CD8+ T-cells, in the TME of 43% (3/7) of the
patients, after five days of motixafortide monotherapy.
from
results
top-line
the dual combination arm of
In October 2018, we announced encouraging
the
COMBAT/KEYNOTE-202 study at the European Society for Medical Oncology 2018 Congress. The data showed that the
treatment regimen was safe and well tolerated. The disease control rate (patients exhibiting a response or stable disease) was
34.5% for the evaluable population (N=29), including one patient (3.4%) with a partial response showing a 40% reduction in
tumor burden, as well as nine patients (31%) with stable disease, with a median treatment time of 72 days (37-267). Median
overall survival (OS) in all patients (N=37) was 3.3 months with a six-month survival rate of 34.4%. A significant observation
was made in the subpopulation of patients receiving the study drugs as a second-line treatment (N=17), where the median overall
survival was 7.5 months, with a six-month survival rate of 51.5%. This compared favorably with historical median overall
survival data of 6.1 months for the only currently approved second-line PDAC treatment (a chemotherapy combination of
Onivyde®, 5-FU and leucovorin). Additional data from in-depth analyses of biopsies taken at screening and following
monotherapy or combination treatment of motixafortide and KEYTRUDA demonstrate that in 75% of the available biopsies,
motixafortide treatment promotes an increase in the number of infiltrating CD4+, CD8+ and CD8+Granzyme B+ cytotoxic T-
cells. The greatest improvement in T-cell infiltration was observed following combination treatment of motixafortide and
KEYTRUDA and was correlated with stable disease for eight cycles of treatment. Furthermore, increased infiltration of activated
CD4 and CD8 T-cells was accompanied by a pronounced decrease in the number of tumor cells, as well as by a decrease in
myeloid-derived suppressor cells, a cell type known to impede the antitumor immune response.
COMBAT-KEYNOTE-202 Triple Combination Study
As a result of the encouraging data, the collaboration with MSD was expanded to include an additional cohort that tested
the effect of the triple combination of motixafortide, KEYTRUDA and chemotherapy (Onivyde®/5-fluorouracil/leucovorin). We
initiated this additional arm of the trial in December 2018 to investigate the safety, tolerability and efficacy of this triple
combination. The triple combination arm focused on second-line pancreatic cancer patients and included approximately 40
patients with unresectable metastatic PDAC who have progressed following first-line therapy prior to enrollment. Patients
received motixafortide monotherapy priming treatment for five days, followed by repeat cycles of the combination of
chemotherapy, KEYTRUDA and motixafortide until progression. The primary endpoint of the study was the objective response
rate (ORR) assessed by RECIST v1.1 criteria. Secondary endpoints included overall survival, progression free survival, and the
disease control rate.
30
At the European Society of Medical Oncology Immuno-Oncology Congress (ESMO IO) 2019 in December 2019, we
presented partial results from the triple combination arm of the study. Out of 36 enrolled patients, 30 patients were evaluable for
safety and 22 were evaluable for efficacy. The best response for the evaluable population of 22 patients showed 7 partial response
(PR) and 10 stable disease (SD) patients, resulting in an overall response rate (ORR) of 32% and a disease control rate (DCR) of
(Onivyde®/5-
77%. These data compared
fluorouracil/leucovorin) in second-line patients with ORR of 17% and DCR of 52%. The combination showed continuity of
effect, in that 5 patients with stable disease became partial responders as treatment continued. Out of the 7 partial responders, 5
were still on treatment as of the presentation date, with a current maximum treatment time of 330+ days; and 4 responders
showed a reduction in tumor burden of >50%. The median duration of clinical benefit until progression for the 17 patients with
disease control (7 PR and 10 SD patients) was 7.8 months. The combination was generally well tolerated, with a safety profile
consistent with the individual safety profile of each component alone; adverse event and severe adverse event profiles were as
expected with chemotherapy-based treatment regimens.
the current chemotherapy standard-of-care
favorably with
treatment
In February 2020, we completed recruiting a total of 43 patients for the triple combination study and in December 2020,
we announced the final results of the study. The results of the study showed substantial improvement as compared to comparable
historical results of other pancreatic cancer studies across all study endpoints. Of the 38 evaluable patients, median overall
survival was 6.5 months (versus comparable historical data of 4.7 months), median progression free survival was 4.0 months
(versus comparable historical data of 2.7-3.1 months), confirmed overall response rate was 13.2% (versus comparable historical
data of 7.7%), overall response rate was 21.2% (versus comparable historical data of 16%) and disease control rate was 63.2%
(versus comparable historical data of 29-52%). The combination was generally well tolerated, with a safety profile consistent
with the individual safety profile of each component alone; adverse event and severe adverse event profiles were as expected
with chemotherapy-based treatment regimens. We are currently planning next development steps for this program, including
discussions with potential collaboration partners and development of a protocol for a randomized controlled study.
MD Anderson Cancer Center Study
In August 2016, we entered into an agreement with MD Anderson in regard to an additional collaboration for the
investigation of motixafortide in combination with KEYTRUDA in pancreatic cancer. The study was conducted as an
investigator-sponsored study, as part of a strategic clinical research collaboration between Merck and MD Anderson aimed at
evaluating KEYTRUDA in combination with various treatments and novel drugs, including motixafortide. The open-label, single
center, single-arm Phase 2b study focused on the mechanism of action by which both drugs might synergize. In addition to
assessing clinical response, the study included multiple assessments to evaluate the biological anti-tumor effects induced by the
combination. We supplied motixafortide for the study, which commenced in January 2017.
Final results of the MD Anderson study were presented at the SITC annual meeting in November 2019. Of the 20 patients
enrolled, 15 were evaluable for the primary endpoint of radiologic response. Of these 15 evaluable patients, one patient showed a
partial response, two patients had stable disease and 12 patients experienced disease progression, resulting in a disease control
rate of 20%. The overall median time to progression was two months, while the median time to progression for patients showing
disease control was seven months. Median overall survival was seven months, while median survival for the patients showing
disease control was 12 months. The combination was generally well tolerated with injection site discomfort being the most
commonly reported adverse event. Four patients experienced grade 3 toxicities and one patient had a grade 4 dyspnea.
Investigator-Initiated LIBTAYO Study
In October 2020, we announced that motixafortide will be tested in combination with the anti-PD-1 cemiplimab
(LIBTAYO®) and standard-of-care chemotherapy (gemcitabine and nab-paclitaxel) in first-line PDAC. This investigator-initiated
Phase 2 study, led by Columbia University, will initially enroll 10-12 PDAC patients, and will be expanded to a total of 40
patients following an evaluation of the initial 10-12 patients based on pre-defined criteria. The primary endpoint of the study is
the overall response rate. Secondary endpoints include safety and tolerability, progression free survival, duration of clinical
benefit and overall survival. Data from the study is anticipated in mid-2022 (although timelines are ultimately controlled by the
independent investigator and are therefore subject to change).
AML
Phase 2a Study
During 2016, we completed and reported on the results of a Phase 2a clinical trial studying the use of motixafortide for
the treatment of relapsed/refractory AML, or r/r AML. The study was conducted at six sites in the United States, including MD
Anderson in Houston, Memorial Sloan-Kettering Cancer Center in New York, Mayo Clinic in Jacksonville, Johns Hopkins
University in Baltimore, Northwestern Memorial Hospital in Chicago and Washington University in St. Louis, as well as at five
well-known sites in Israel. The study was an open-label study under an IND, designed to evaluate the safety and efficacy profile
of repeated escalating doses of motixafortide in combination with HiDAC in adult subjects with r/r AML. The study was
comprised of two parts – a dose escalation Phase and an expansion Phase at the highest tolerated dose found during the escalation
Phase. The primary endpoints of the study were the safety and tolerability of the drug. Secondary endpoints included the
pharmacokinetic profile of the drug and an efficacy evaluation, indicated by the extent of mobilization of cancer cells from the
bone marrow to the peripheral blood, the level of cancer cell death (apoptosis) and clinical responses.
31
Final results for the Phase 2a trial were presented at the annual meetings of the Society of Hematologic Oncology and
ASH in September and December 2016, respectively. The reported data set includes 45 patients, including three compassionate-
use patients treated at the study sites under the identical treatment protocol. The majority of patients in the study were heavily
pretreated, with 45% of patients being refractory to one or two remission induction treatments, 19% of patients having relapsed
after a short first remission of less than 12 months, and 17% of patients having undergone two or more relapses. In addition, the
treated patient population included patients that had relapsed post allogeneic stem cell transplantation (17%), as well as
secondary AML patients (24%), both conditions which represent difficult-to-treat populations with poor prognoses.
The results showed that treatment with motixafortide in combination with HiDAC, was safe and well tolerated at all doses
tested up to and including the highest dose level of 2.0 mg/kg. Response to treatment was associated with efficient CXCR4
inhibition, resulting in high mobilization of blasts. The composite complete remission rate, including both CR and CRi, was 38%
in subjects receiving up to two cycles of motixafortide treatment at doses of 1 mg/kg and higher (n=39). In the 1.5 mg/kg dose
selected for the expansion Phase of the study (n=23), the composite complete remission rate was 39%. These response rates were
superior to the historical response rate of approximately 19% reported for high-risk AML patients treated with Ara-C alone in
Phase 3 randomized trials. The ongoing follow-up of patients participating in the study’s expansion Phase and responding to the
combination treatment suggests long durability of the remissions achieved. Results further showed that motixafortide
monotherapy had a substantial therapeutic effect. Treatment with motixafortide as a single agent triggered robust mobilization of
AML blasts from the bone marrow to the peripheral blood stream, and the extent of mobilization was correlated with a positive
response to treatment. The preferential mobilization of AML blasts over normal cells (4.7-fold vs. 1.4-fold, respectively) was
further confirmed by analysis using the fluorescence in situ hybridization, or FISH, technique in a subset of patients. In addition,
motixafortide monotherapy resulted in a 40% increase in AML blast apoptosis.
In June 2018, at the 23rd Congress of the EHA in Stockholm, Sweden, we reported long-term survival data from the study
that showed significantly enhanced overall survival of r/r AML patients treated with a combination of motixafortide and HiDAC.
The response rate for all dosing levels was 29% and median overall survival was 9.1 months, compared with historical data on
overall survival of 6.1 months for HiDAC alone. In addition, a statistically significant correlation between patient response and
the mobilization of AML blasts was reported. Responding patients demonstrated a clear and significant increase in the number of
AML blasts in the peripheral blood following motixafortide treatment, whereas non-responding patients were largely unaffected.
In patients receiving the 1.5 mg/kg dose selected for expansion (n=23), the response rate was 39% and median overall survival
was 10.7 months with one-year, two-year and three-year survival rates of 38.1%, 23.8% and 23.8%, respectively. Furthermore,
median overall survival for responding patients at the 1.5 mg/kg dose (n=9) was 21.8 months, with one-year, two-year and three-
year survival rates of 66.7%, 44.4% and 44.4%, respectively. Responding patients also demonstrated a statistically significant
mean 6.3-fold increase (p=0.003) in the number of AML blasts in the peripheral blood following motixafortide monotherapy
treatment, whereas in non-responding patients the mean-fold increase was minor and non-significant (1.66-fold; p=0.21).
BLAST Study
We also investigated a second AML treatment line – consolidation therapy – in a large randomized, controlled Phase 2b
trial in Germany, known as the BLAST study. This study examined motixafortide as part of a second-stage treatment, termed
consolidation therapy (cytarabine), to improve outcomes for the approximately 70% of AML patients who achieved remission
after the standard initial treatment regimen, known as induction therapy. The consolidation therapy was aimed at eliminating the
minimal residual disease left in the bone marrow after induction therapy that can lead to relapse in 40-60% of the patients within
12-18 months after entering remission.
The Phase 2b trial, which was conducted in collaboration with the University of Halle as sponsor and with the
participation of two large leukemia study groups in Germany, was a double-blind, placebo-controlled, randomized, multi-center
study aimed at assessing the efficacy of motixafortide in addition to standard consolidation therapy in AML patients. The primary
endpoint of the study was to compare the RFS time in AML subjects in their first remission during a minimum follow-up time of
18 months after randomization. In addition, pharmacodynamic measurements were conducted in order to assess the minimal
residual disease, and biomarker analyses was performed to identify predictors of motixafortide response. The study, which was
carried out at 29 sites in Germany. AML patients between 18 and 75 years of age with documented first remission were
randomized in a 1:1 ratio to receive HiDAC, either with motixafortide or with a matching placebo, as consolidation therapy.
During 2020, we finalized plans with our collaboration partners to conduct an interim analysis on 2/3 (N=128) of the 194
patients originally planned in the study, all of which had already completed treatment. In November 2020, we announced that
based on the interim analysis, the investigational arm of motixafortide combined with cytarabine did not demonstrate a
statistically significant effect in the study’s primary endpoint, and therefore, the DMC recommended not to continue the study.
We continue to believe in the relevance of CXCR4 as a viable target in other AML treatment lines, such as rr/AML and induction
treatment, and we intend to decide on next steps in AML once we have had an opportunity to review and analyze the unblinded
data, including detailed biomarker and subpopulation data, from the study.
32
COVID-19
During 2020, we evaluated motixafortide as a potential therapy for COVID-19-induced inflammatory lung disorders,
including acute respiratory distress syndrome, or ARDS. In this regard, substantial data is emerging regarding the involvement of
neutrophils, neutrophil extracellular traps (NETs), monocytes and macrophages in the development of ARDS secondary to
COVID-19 and other viral infections; as well as the key involvement of CXCR4 as a mediator of those cells in the inflamed
pulmonary tissue. Based on the scientific data indicating the importance of blocking the CXCR4/CXCL12 axis during ARDS, we
believe that motixafortide may be of potential benefit for patients with ARDS.
Following our initial evaluation, in November 2020, we announced initiation of a Phase 1b study in patients with ARDS
secondary to COVID-19 and other respiratory viral infections. The study is an investigator-initiated study, led by Wolfson
Medical Center, in Israel, to evaluate motixafortide in patients hospitalized with ARDS. The primary endpoint of the study is to
assess the safety of motixafortide in these patients; respiratory parameters and inflammatory biomarkers will be assessed as
exploratory endpoints. Up to 25 patients will be enrolled in the study, with a preliminary analysis planned after ten patients have
completed the initial treatment period. Results of the preliminary analysis are expected in the second half of 2021 (although
timelines are ultimately controlled by the independent investigator and are therefore subject to change).
Other clinical results
At the annual meeting of ASH in December 2017, clinical data supporting motixafortide as a robust mobilizer of HSCs
associated with long-term engraftment was presented by Prof. Amnon Peled. HSCs are cells found in the bone marrow,
peripheral blood or umbilical cord blood that are responsible for generation and replenishment of all blood cell progenitors and
eventually mature cells. It is therefore believed to be beneficial for a variety of therapeutic purposes, such as transplantation for
people with hematological malignancies or for the therapy of blood or immune system disorders. The success of long-term HSC
engraftment depends largely on the amount and quality of HSCs (CD34+ CD38- CD45RA- CD90+ CD49f+). The data presented
demonstrate that human CD34+ cells from motixafortide-mobilized grafts contain high numbers of HSC (CD34+, CD38-,
CD45RA-, CD90+, CD49f+) associated with long-term engraftment, compared to cells mobilized by granulocyte colony
stimulating factor (G-CSF). An associated in vivo study further showed that motixafortide-mobilized HSCs can successfully
engraft the bone marrow and spleen of immunodeficient mice. In addition, a robust long-term engraftment of motixafortide-
mobilized human CD34+ cells was seen in these mice in primary and secondary transplants.
AGI-134
AGI-134 entered our pipeline following our acquisition of Agalimmune in March 2017. The compound is a synthetic
alpha-gal immunotherapy in development for solid tumors. AGI-134 harnesses the body’s pre-existing, highly abundant, anti-
alpha-gal, or anti-Gal, antibodies to induce a systemic, specific anti-tumor response to the patient’s own tumor neo-antigens. This
response not only kills the tumor cells at the site of injection, but also brings about a durable, follow-on, anti-metastatic immune
response. Alpha-gal is a cell-surface carbohydrate antigen that is not expressed by humans, unlike virtually all other mammals
and bacteria. Therefore, humans universally produce and maintain high levels of anti-Gal antibodies, due to exposure to alpha-gal
on bacteria in the digestive system.
AGI-134 is injected into the tumor, where it coats the tumor cell membranes, resulting in alpha-gal being exposed on the
tumor cell surface. Anti-Gal antibodies bind to the alpha-gal part of AGI-134 to produce an initial immune response that activates
complement-dependent and antibody-dependent cellular cytotoxicity (cell death). This cytotoxicity generates immune-tagged
cells and cellular debris that trigger an uptake of tumor-associated antigens by antigen-presenting cells (APCs). These APCs
induce a follow-on systemic immune response by the activation and clonal expansion of T-cells to the patient’s own neo-antigens.
This approach not only targets the primary injectable tumor but has also demonstrated efficacy against existing distant secondary
tumors. Furthermore, the mechanism of action suggests the potential of long-term protection against future metastases.
AGI-134 has completed numerous proof-of-concept studies, demonstrating regression of established primary tumors after
injection with AGI-134 and robust protection against the development of secondary tumors in a model of melanoma with a single
dose only. Synergy has also been demonstrated in the same model when combined with a PD-1 immune checkpoint inhibitor,
offering the potential to broaden the utility of such immunotherapies and improve the rate and duration of responses in multiple
cancer types. A 28-day, repeated-administration GLP toxicology study in monkeys with AGI-134 has also been successfully
completed.
At ASCO-SITC in January 2018, we presented preclinical findings demonstrating successful results in the treatment of
primary tumors. Intratumoral administration of AGI-134 induced regression of established tumors in two murine melanoma
models. Moreover, treatment with AGI-134 showed a beneficial effect on survival, compared to the control group, with fewer
mice dying or requiring euthanasia due to tumor burden. In addition, the results show that injection of AGI-134 into the tumors
induces activation of the complement system, an important component of the innate immune system. Activation of the
complement system within tumors by AGI-134 is predicted to destroy tumor cells and create a pro-inflammatory tumor
microenvironment that attracts and activates other immune cells, ultimately resulting in adaptive anti-tumor immunity.
In August 2018, we initiated a Phase 1/2a clinical study for AGI-134 that is primarily designed to evaluate the safety and
tolerability of AGI-134 given as monotherapy in unresectable metastatic solid tumors. Additional objectives are to perform a
wide array of biomarker studies, to demonstrate the mechanism of AGI-134 and to assess its efficacy by clinical and
pharmacodynamic parameters. The multicenter, open-label study is being carried out in the United Kingdom, United States and
Israel.
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The study is comprised of two parts: (i) an accelerated dose-escalation part to assess the safety and tolerability of
intratumorally injected AGI-134 as a monotherapy, as well as to determine the maximum tolerated dose and the recommended
dose for part 2 of the study and (ii) a dose expansion part at the recommended dose, designed to assess the safety, tolerability and
anti-tumor activity of AGI-134 as a monotherapy in a basket cohort of multiple solid tumor types. The first part of the study was
completed in September 2019, with AGI-134 being found to be safe and well tolerated, with no serious drug-related adverse
events or dose-limiting toxicities reported. The maximal tolerated dose was not reached and the recommended dose for the
second part of the study was determined. We commenced the second part of the study in September 2019. Due to clinical
operating issues associated with the COVID-19 pandemic, in April 2020, the clinical trial was temporarily suspended. In August
2020, we renewed study enrollment. Initial proof-of-mechanism of action and efficacy results from the second part of the study
are expected in the second half of 2021.
In November 2018, the FDA granted the Biological Product Designation for AGI-134. This designation provides us with
eligibility to obtain 12 years of market exclusivity upon approval of the product for commercial use by the FDA. This regulatory
market exclusivity adds an incremental layer of protection in addition to that afforded by existing patents granted in the United
States and Europe, and pending in other countries, covering the use of AGI-134 for the treatment of solid cancer tumors.
Commercialized Product
BL-5010
BL-5010 is a novel medical device containing an acidic, aqueous solution and applicator for the non-surgical removal of
benign skin lesions. It offers an alternative to painful, invasive and expensive removal treatments including cryotherapy, laser
treatment and surgery. Since the treatment is non-invasive, it poses minimal infection risk and eliminates the need for anesthesia,
antiseptic precautions and bandaging. The pre-filled device controls and standardizes the volume of solution applied to a lesion,
ensuring accurate administration directly on the lesion and preventing both accidental exposure of the healthy surrounding tissue
and unintentional dripping. It has an ergonomic design, making it easy to handle, and has been designed with a childproof cap.
BL-5010 is applied topically on a skin lesion in a treatment lasting a few minutes with the pen-like applicator and causes the
lesion to gradually dry out and fall off within one to four weeks. We received European confirmation from British Standards
Institute of the regulatory pathway classification of BL-5010 as a Class IIa medical device. We in-licensed the exclusive,
worldwide rights to develop, market and sell BL-5010 from IPC in November 2007.
Development and Commercialization Arrangement. In December 2014, we entered into an exclusive out-licensing
arrangement with Perrigo for the rights to BL-5010 for OTC indications in Europe, Australia and additional selected countries.
We retain the OTC rights to BL-5010 in the United States and the rest of the world, as well as the non-OTC rights on a global
basis. Under the original terms of our out-licensing arrangement with Perrigo, Perrigo was obligated to use commercially
reasonable best efforts to obtain regulatory approval in the licensed territory for at least two OTC indications and to
commercialize BL-5010 for those two OTC indications. In addition, Perrigo agreed to sponsor and manufacture BL-5010 in the
relevant regions. Compensation by Perrigo for the exclusive license includes the payment to us of an agreed percentage of the
gross revenue of sales of licensed products. We agreed to pay a portion of all net consideration we receive from Perrigo, within
our standard range of sublicense receipt consideration, to IPC, the company from which we initially in-licensed the development
rights to BL-5010. We have the right to prosecute and maintain the patents for BL-5010 in the licensed territories, and Perrigo
agreed to bear the cost of all renewal fees for patents and the other costs of prosecution and maintenance up to an agreed limit. In
addition, we were granted full access to all clinical and research and development data generated during the performance of the
development plan and may use these data in order to develop or license the product in other territories and fields of use where we
retain the rights. Our agreement with Perrigo will continue in effect until the cessation of all commercialization in the licensed
territory. After the fifth anniversary of the first commercial sale of a licensed product, either party may terminate the agreement
by giving at least 18 months’ prior written notice to the other party. Either party may terminate the agreement (a) by providing 60
days’ written notice of a material breach of the agreement by the other party if the breaching party does not cure the breach
during that time or (b) with immediate effect on written notice to the other party if there is a change of control of the other party.
The parties have agreed that the announced acquisition of Perrigo by Perrigo Company Plc is a change of control event that will
not give rise to a right on our part to terminate the license agreement. In addition, we have the right to terminate the agreement if
Perrigo does not fulfill any of its obligations of diligence with respect to launching a licensed product or obtaining regulatory
approval for, and commercializing, licensed products as described above.
In March 2016, Perrigo received CE Mark approval for BL-5010 as a novel OTC treatment for the non-surgical removal
of warts. The commercial launch of products for treatment of this first OTC indication (warts/verrucas) commenced in Europe in
the second quarter of 2016. Since then, Perrigo has invested in improving the product and during 2019 launched an improved
version of the product in several European countries.
In March 2020, we agreed that Perrigo could relinquish its license rights for certain countries that had been included in its
territory according to the original license agreement and was also no longer obligated to develop, obtain regulatory approval for
and commercialize products for a second OTC indication. In turn, in March 2020, we agreed with our licensor of the rights to
BL-5010, IPC, to return to IPC those license rights no longer out-licensed to Perrigo as a result of the agreement described in the
preceding sentence, in consideration of the payment to us of royalties or fees on sublicense receipts.
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As a result of our out-licensing arrangement, as well as the previous discussions with other potential partners for this
product, the commercialization activities for BL-5010 are currently focused on OTC indications. However, we may decide to
seek collaboration partners for development of BL-5010 for non-OTC indications, or for OTC indications in territories not out-
licensed to Perrigo, primarily the U.S.
Collaboration and Out-Licensing Agreements
Collaboration Agreement with MSD
See “—Therapeutic Candidates — Motixafortide — Clinical Trials — Solid tumors” for details regarding our
collaboration with MSD.
Investment and Collaboration Agreement with Novartis
In December 2014, we entered into a multi-year strategic collaboration agreement with Novartis designed to facilitate
development and commercialization of Israeli-sourced drug candidates. As part of the collaboration agreement, Novartis made an
initial equity investment in us of $10 million. We in-licensed three pre-clinical projects in the framework of the collaboration. All
those projects were subsequently terminated due to lack of efficacy and other scientific considerations, as well as market
considerations. The collaboration agreement with Novartis expired at the end of November 2019.
Out-Licensing Agreement with Perrigo
See “—Commercialized Product— BL-5010— Development and Commercialization Arrangement” for details regarding
our out-licensing agreement with Perrigo.
In-Licensing Agreements
We have in-licensed and intend to continue to in-license development, production and marketing rights from selected
research and academic institutions in order to capitalize on the capabilities and technology developed by these entities. We also
seek to obtain technologies that complement and expand our existing technology base by entering into license agreements with
pharmaceutical and biotechnology companies. When entering into in-license agreements, we generally seek to obtain unrestricted
sublicense rights consistent with our primarily partner-driven strategy. We are generally obligated under these agreements to
diligently pursue product development, make development milestone payments, pay royalties on any product sales and make
payments upon the grant of sublicense rights. We generally insist on the right to terminate any in-license for convenience upon
prior written notice to the licensor.
The scope of payments we are required to make under our in-licensing agreements is comprised of various components
that are paid commensurate with the progressive development and commercialization of our drug products.
Our in-licensing agreements generally provide for the following types of payments:
•
•
•
•
Revenue sharing payments. These are payments to be made to licensors with respect to revenue we receive from sub-licensing to third
parties for further development and commercialization of our drug products. These payments are generally fixed at a percentage of the
total revenues we earn from these sublicenses.
Milestone payments. These payments are generally linked to the successful achievement of milestones in the development and approval
of drugs, such Phases 1, 2 and 3 of clinical trials and approvals of NDAs.
Royalty payments. To the extent we elect to complete the development, licensing and marketing of a therapeutic candidate, we are
generally required to pay our licensors royalties on the sales of the end drug product. These royalty payments are generally based on the
net revenue from these sales. In certain instances, the rate of the royalty payments decreases upon the expiration of the drug’s underlying
patent and its transition into a generic drug. Certain of our agreements provide that if a licensed drug product is developed and sold
through a different corporate entity, the licensors may elect to receive shares in such company instead of a portion of the royalties.
Additional payments. In addition to the above payments, certain of our in-license agreements provide for a one-time or periodic
payment that is not linked to milestones. Periodic payments may be paid until the commercialization of the product, either by direct sales
or sublicenses to third parties. Other agreements provide for the continuation of these payments even following the commercialization of
the licensed drug product.
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The royalty and revenue-sharing rates we agree to pay in our in-licensing agreements vary from case to case but in most
cases range from 20% to 29.5% of the consideration we receive from sublicensing the applicable therapeutic candidate. We are
required to pay a substantially lower percentage, generally less than 5%, if we elect to commercialize the subject therapeutic
candidate independently. Due to the relatively advanced stage of development of the compound licensed from Biokine, our
license agreement with Biokine provides for royalty payments of 10% of net sales, subject to certain limitations, should we
independently sell products. In addition, milestone payments are not generally payable if the revenue-sharing from an out-
licensing transaction is greater than any relevant payments due under our in-licensing agreements.
The following are descriptions of our in-licensing agreements associated with our therapeutic candidates. In addition to
the in-licensing agreements discussed herein, we have entered into other in-licensing arrangements in connection with our
therapeutic candidates in clinical, advanced preclinical and feasibility stages.
Motixafortide
In September 2012, we in-licensed the rights to motixafortide under a license agreement with Biokine. Pursuant to the
agreement, Biokine granted us an exclusive, worldwide, sublicensable license to develop, manufacture, market and sell certain
technology relating to a short peptide that functions as a high-affinity antagonist for CXCR4 and the uses thereof.
There were no upfront payments due under the agreement. We are obligated to pay a monthly development fee of $27,500
for certain development services that Biokine has committed to provide to us under the agreement. The payment of this monthly
fee will continue until the completion of the last clinical trial in which motixafortide is planned to be tested, or is being tested
with, at least 20 subjects.
We are responsible for paying all development costs incurred by the parties in carrying out the development plan.
Should we independently develop manufacture and sell products (excluding sublicensing) containing the licensed
technology, we are obligated to make royalty payments of 10% of net sales, subject to certain limitations.
The agreement also grants us the right to grant sublicenses for the licensed technology. Initially, we were required to pay
Biokine a royalty payment of 40% of the amounts we receive as consideration in connection with any sublicensing, development,
manufacture, marketing, distribution or sale of the licensed technology. In October 2018, Biokine agreed to reduce the royalty
payment for sublicensing to 20% in return for the payment by us of $10 million in cash plus $5 million in our restricted shares.
Biokine is also eligible to receive up to a total of $5 million in future milestone payments.
Before we in-licensed motixafortide, Biokine had received funding for the project from the IIA, and as a condition to IIA
giving its consent to our in-licensing of motixafortide, we were required to agree to abide by any obligations resulting from such
funding. However, if we become legally required to make payments to the IIA in respect of grants made to Biokine, we have the
right to offset the full amount of such grants from any payments otherwise due to Biokine as sublicensing royalties as described
above.
We are obligated under the agreement with Biokine to make commercially reasonable, good faith efforts to sublicense or
commercialize motixafortide for fair consideration. If we do not fulfill this obligation within 24 months after completion of the
development plan, all of the rights and responsibilities with respect to commercialization of the licensed technology will revert to
Biokine, and our obligation to pay royalties for sales of any licensed products or sublicensing as described above will revert to
Biokine.
We have the first right to prepare, file, prosecute and maintain any patent applications and patents, in respect of the
licensed technology and any part thereof, at our expense, provided that we are required to consult with Biokine regarding patent
prosecution and patent maintenance. In addition, we have the right to take action in the prosecution, prevention, or termination of
any patent infringement of the licensed technology. We are responsible for all the expenses of any patent infringement suit that
we bring, including any expenses incurred by Biokine in connection with such suits, with such expenses reimbursable from any
sums recovered in such suit or in the settlement thereof for. After such reimbursement, if any funds remain, both we and Biokine
are each entitled to a certain percentage of any remaining sums.
The agreement will remain in effect until the expiration of all of our royalty and sublicense revenue obligations to
Biokine, determined on a product-by-product and country-by-country basis. We may terminate the agreement for any reason on
90 days’ prior written notice to Biokine. Either party may terminate the agreement for a material breach by the other party if the
breaching party is unable to cure the breach within 30 days after receiving written notice of the breach from the non-breaching
party. With respect to any termination for a material breach, if the breach is not susceptible to cure within the stated period and
the breaching party uses diligent, good faith efforts to cure such breach, the stated period will be extended by an additional 30
days. In addition, either party may terminate the agreement upon the occurrence of certain bankruptcy events.
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Termination of the agreement will result in a loss of all of our rights to the drug and the licensed technology, which will
revert to Biokine. In addition, any sublicense of ours will terminate provided that, upon such termination and at the request of the
sublicensee, Biokine will be required to enter into a separate license agreement with the sublicensee on substantially the same
terms as those contained in the applicable sublicense agreement.
AGI-134
Acquisition Agreements with Agalimmune
In March 2017, we acquired substantially all of the outstanding shares of Agalimmune and entered into the Agalimmune
Development Agreement with the selling shareholders. We control the Agalimmune board of directors, and subject to the
protections in favor of the selling shareholders, we will direct and be responsible for the planning, execution and day-to-day
management of Agalimmune and its pipeline, including AGI-134.
The Agalimmune Development Agreement provides the selling shareholders with a reversionary option, in the event of a
breach of that agreement and certain other limited triggering events, that permits the selling shareholders to re-acquire our equity
interests in Agalimmune for nominal consideration. See “Risk Factors — Risks Related to Our Business Regulatory Matters — If
we do not meet the requirements under our agreement with the Agalimmune selling shareholders, we could lose the rights to the
therapeutic candidates in Agalimmune’s pipeline, including but not limited to AGI-134.”
License from the University of Massachusetts
In 2013, Agalimmune entered into an exclusive license agreement with the University of Massachusetts, which was
amended and restated in February 2017, for rights to intellectual property related to AGI-134. Pursuant to the agreement,
Agalimmune has an exclusive, worldwide, royalty-bearing, sublicensable license to develop, manufacture, use, import and sell
licensed products. Agalimmune is obligated to use diligent efforts to develop the licensed products and to introduce them into the
commercial market. The agreement sets forth specific development milestones that Agalimmune is required to fulfill. In
consideration of the grant of the license, Agalimmune is obligated to pay upfront license fees, annual maintenance fees, milestone
payments, and low, single digit royalty payments on the net sales of licensed products. In addition, the agreement provides that
following a change of control event, Agalimmune will allot to the University 6% of its shares on a fully diluted basis. The
agreement will remain in full effect until the later of expiration or abandonment of all valid claims in the licensed patents or 10
years from the date of first sale of a licensed product. Agalimmune may terminate the agreement for any reason on 90 days’ prior
written notice to the University.
License from Kode Biotech
In March 2015, Agalimmune entered into an evaluation license and option agreement with Kode Biotech for the rights to
intellectual property related to certain water dispersible glycan-lipid conjugates (the “KODETM Constructs”), including AGI-134.
Pursuant to the agreement, Agalimmune had an exclusive license to pursue preclinical assessment of the use of the KODETM
Constructs in Agalimmune’s method of promoting tumor anticancer therapy, and the exclusive right to require Kode Biotech to
grant Agalimmune an exploitation license to pursue clinical development and commercialization of the use of the KODETM
Constructs in its method.
In September 2017, Agalimmune exercised its option to enter into the exploitation license agreement with Kode Biotech
that grants Agalimmune a worldwide, exclusive, royalty-bearing transferable license to develop, manufacture, use, import and
sell licensed products, including AGI-134. Agalimmune is obligated to use reasonable, diligent efforts to develop licensed
products and to introduce licensed products into the commercial market. In consideration of the grant of the license, Agalimmune
paid a license issue fee and is obligated to pay annual maintenance fees, milestone payments and low, single-digit royalty
payments on the net sales of the licensed products. Agalimmune also has the right to grant sublicenses for the licensed
technology and is required to pay Kode Biotech a payment based on the revenues from sublicense net sales. The agreement will
remain in effect, unless terminated earlier in accordance with its terms, until the later of expiration or abandonment of all
enforceable patent claims within the licensed patents.
BL-5010
In November 2007, we in-licensed the rights to develop and commercialize BL-5010 under a license agreement with IPC.
Under the agreement, IPC granted us an exclusive, worldwide, sublicensable license to develop, manufacture, market and sell
certain technology relating to an acid-based formulation for the non-surgical removal of skin lesions and the uses thereof. We are
obligated to use commercially reasonable efforts to develop the licensed technology in accordance with a specified development
plan, including meeting certain specified diligence goals. We are required to make low, single-digit royalty payments on the net
sales of the licensed technology if we manufacture and sell it on our own, subject to certain limitations. Our royalty payment
obligations are payable on a product-by-product and country-by-country basis, until the last to expire of any patent included
within the licensed technology in such country. We also have the right to grant sublicenses for the licensed technology and are
required to pay IPC a payment, within our standard range of sublicense receipt consideration, based on the revenues we receive
as consideration in connection with any sublicensing, development, manufacture, marketing, distribution or sale of the licensed
technology.
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The license agreement remains in effect until the expiration of all of our license, royalty and sublicense revenue
obligations to IPC, determined on a product-by-product and country-by-country basis, unless we terminate the license agreement
earlier. We may terminate the license agreement for any reason on 30 days’ prior written notice. Either party may terminate the
agreement for material breach if the breach is not cured within 30 days after written notice from the non-breaching party. If the
breach is not susceptible to cure within the stated period and the breaching party uses diligent, good faith efforts to cure such
breach, the stated period will be extended by an additional 30 days. In addition, either party may terminate the agreement upon
the occurrence of certain bankruptcy events.
Termination of the agreement will result in a loss of all of our rights to the licensed technology, which would revert to
IPC. In addition, any sublicense of the licensed technology will terminate provided that, upon termination, at the request of the
sublicensee, IPC is required to enter into a license agreement with the sublicensee on substantially the same terms as those
contained in the sublicense agreement.
Intellectual Property
Our success depends in part on our ability to obtain and maintain proprietary protection for our therapeutic candidates,
technology and know-how, to operate without infringing the proprietary rights of others and to prevent others from infringing our
proprietary rights. Our policy is to seek to protect our proprietary position by, among other methods, filing U.S. and foreign
patent applications related to our proprietary technology, inventions and improvements that are important to the development of
our business. We also rely on trade secrets, know-how and continuing technological innovation, as well as on regulatory
exclusivity, such as Orphan Drug designation or new chemical entity, or NCE, protection to develop and maintain our proprietary
position.
Patents
As of February 22, 2021, we owned or exclusively licensed for uses within our field of business 36 patent families that
collectively contain over 105 issued patents, four allowed patent applications and over 87 pending patent applications relating to
the three candidates listed below. We are also pursuing patent protection for other drug candidates in our pipeline. Patents related
to our therapeutic candidates may provide future competitive advantages by providing exclusivity related to the composition of
matter, formulation, and method of administration of the applicable compounds and could materially improve the value of our
therapeutic candidates. The patent positions for our three therapeutic candidates are described below and include both issued
patents and pending patent applications we exclusively license. We vigorously defend our intellectual property to preserve our
rights and gain the benefit of our investment.
•
The motixafortide drug product candidate is covered as a composition of matter by a provisional patent application. Corresponding patents, if
granted, will expire in December 2041, not including any applicable patent term extension, which may add an additional term of up to five years
on the patent. We also have an exclusive license to a patent family that covers the active ingredient molecule per se. Patents of this family have
been granted in the U.S., Europe, Japan and Canada. The patents will expire in August 2023, not including any applicable patent term extension.
We have an exclusive license to a patent family that covers motixafortide combined with a PD1 antagonist for the treatment of cancer. A patent of
this family has been granted in the U.S., and member patent applications are pending in Europe, Japan, China, Canada, Australia, India, Korea,
Mexico, Brazil and Israel. The granted U.S. patent and patents to issue in the future based on pending patent applications in this family will expire
in 2036, not including any applicable patent term extension. In addition, we have an exclusive license to nineteen other patent families pending or
granted worldwide directed to methods of synthesis of motixafortide and methods of use of motixafortide either alone or in combination with
other drugs for the treatment of certain types of cancer and other indications. Furthermore, we have Orphan Drug status for AML, pancreatic
cancer and stem cell mobilization, as well as data exclusivity protection afforded to motixafortide as an NCE.
• With respect to AGI-134, Agalimmune owns or has an exclusive license to three patent families that cover the AGI-134 compound and its use for
treating cancer. The use of AGI-134 for treating solid tumors is covered by patents granted in the U.S., Europe, China, Japan and other countries.
The patents will expire in 2035, not including any applicable patent term extensions. The compound AGI-134 is covered by patents granted in the
United States, Europe, Japan and other countries. The patents will expire in 2025, not including any applicable patent term extensions. In
addition, the future drug product is eligible for obtaining regulatory Biological Product exclusivity (12 years of market exclusivity in the U.S.).
• With respect to BL-5010, we have an exclusive license to a patent family directed to a novel applicator uniquely configured for applying the BL-
5010 composition to targeted skin tissue safely and effectively. Patents in this family have been granted in the U.S., Europe, Israel, Japan and
China. The patents will expire in 2034.
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The patent positions of companies like ours are generally uncertain and involve complex legal and factual questions. Our
ability to maintain and solidify our proprietary position for our technology will depend on our success in obtaining effective
claims and enforcing those claims once granted. We do not know whether any of our patent applications or those patent
applications that we license will result in the issuance of any patents. Our issued patents and those that may issue in the future, or
those licensed to us, may be challenged, narrowed, circumvented or found to be invalid or unenforceable, which could limit our
ability to stop competitors from marketing related products or the length of term of patent protection that we may have for our
products. Neither we nor our licensors can be certain that we were the first to invent the inventions claimed in our owned or
licensed patents or patent applications. In addition, our competitors may independently develop similar technologies or duplicate
any technology developed by us, and the rights granted under any issued patents may not provide us with any meaningful
competitive advantages against these competitors. Furthermore, because of the extensive time required for development, testing
and regulatory review of a potential product, it is possible that, before any of our products can be commercialized, any related
patent may expire or remain in force for only a short period following commercialization, thereby reducing any advantage of the
patent.
Trade Secrets
We may rely, in some circumstances, on trade secrets to protect our technology. However, trade secrets can be difficult to
protect. We seek to protect our proprietary technology and processes, in part, by confidentiality agreements and assignment of
invention agreements with our employees, consultants, scientific advisors and contractors. We also seek to preserve the integrity
and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic
security of our information technology systems. While we have confidence in these individuals, organizations and systems, such
agreements or security measures may be breached, and we may not have adequate remedies for any breach. In addition, our trade
secrets may otherwise become known or be independently discovered by competitors.
Manufacturing
Our laboratories are located in our headquarters in Modi’in, Israel, and are in part compliant with FDA regulations setting
forth current good laboratory practices, or GLP. While our bioanalytical laboratory complies with these regulations, the chemistry
and formulation, as well as the analytical laboratories are limited in manufacturing scale and resources, and are intended to
support our projects for research and development activities only. These laboratories are not compliant with cGMP. Hence, we
cannot independently manufacture drug substances or drug products for our current clinical trials or for commercial distribution.
The manufacturers of the drug substances and drug products used for our current clinical trials do have these necessary approvals.
There can be no assurance that our therapeutic candidates, if approved, can be manufactured in sufficient commercial
quantities, in compliance with regulatory requirements, and at an acceptable cost. Our contract manufacturers are, and will be,
subject to extensive governmental regulation in connection with the manufacture of any pharmaceutical products or medical
devices. Our contract manufacturers must ensure that all of the processes, methods and equipment are compliant with cGMP on
an ongoing basis, mandated by the FDA and other regulatory authorities, and conduct extensive audits of vendors, contract
laboratories and suppliers.
Contract Research Organizations
We outsource certain preclinical and clinical development activities to CROs, which meet FDA or European Medicines
Agency regulatory standards. We create and implement the drug development plans and, during the preclinical and clinical
Phases of development, manage the CROs according to the specific requirements of the therapeutic candidate under
development.
Competition
The pharmaceutical, medical device and biotechnology industries are intensely competitive. Our therapeutic candidates, if
commercialized, would compete with existing drugs and therapies. In addition, there are many pharmaceutical companies,
biotechnology companies, medical device companies, public and private universities, government agencies and research
organizations actively engaged in research and development of products targeting the same markets as our therapeutic candidates.
Many of these organizations have substantially greater financial, technical, manufacturing and marketing resources than we do. In
certain cases, our competitors may also be able to use alternative technologies that do not infringe upon our patents to formulate
the active materials in our therapeutic candidates. They may, therefore, bring to market products that are able to compete with our
candidates, or other products that we may develop in the future.
Motixafortide
There are a number of potentially competitive compounds under development that act as CXCR4 inhibitors, including,
among others, Mozobil® (plerixafor), which is being marketed by Sanofi Genzyme as a stem cell mobilizer for autologous stem
cell transplantation; POL-6326 (balixafortide) developed by Polyphor Ltd. for Breast Cancer; BMS-936564 (MDX-1338;
ulocuplumab) developed by Bristol-Myers Squibb for Waldenstrom Macroglobulemia; TG-0054 (burixafor) developed by
TaiGen Biotechnology Co for AML; X4P-001 (mavorixafor) developed by X4 Pharmaceuticals Inc for WHIM syndrome; GMI-
1359 developed by Glyco-Mimetics Inc for Breast Cancer that has spread to the bone.
In the field of stem cell mobilization, in addition to the above-referenced Mozobil, MGTA-145 is a compound under
development that could potentially be approved for stem cell mobilization in patients with genetic and autoimmune diseases
Immuno-oncology is an area of great interest in the pharmaceutical market, specifically, immuno-oncology combination
therapies. Currently there are hundreds of immuno-oncology combination treatments being tested in clinical trials that aim to
transform scientific innovation into practice-changing cancer drugs.
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In the field of pancreatic cancer, motixafortide, if approved, will compete with the few, currently approved treatments for
PDAC. In the first line setting, Gemcitabine in combination with Abraxane® or FOLFIRINOX regimen are the current standard
of care. Oncologists have limited options of existing therapies for second-line metastatic patients. The only FDA-approved
second-line treatment is Onivyde® in combination with 5FU and LV for gemcitabine-treated patients. In addition to
chemotherapy, Merck’s KEYTRUDA® was approved for MSI-H cancers (approximately 1% of all cases) and Lynparza® was
recently approved for maintenance of BRCA mutated pancreatic cancer (approximately 7% of all cases).
In addition, there are many ongoing clinical trials using combination therapies to try to address this great unmet need for
patients. Potentially competitive compounds or combinations in development to treat PDAC include, among others, APX005
plus nivolumab (Apexigen & Bristol Myers Squibb); devimistat plus chemotherapy (Rafael Pharmaceuticals); eryaspase plus
chemotherapy (Erytech); NOX-A12 plus pembrolizumab (Noxxon Pharma).
In the last years we have seen a number of late-stage clinical failures of compounds for advanced PDAC. Most notably
pegilodecakin (ARMO/Lilly) and PEGPH20 (Halozyme). Most of these failed trials have been based on a single promising
endpoint.
The field of AML has seen quite a few approvals in recent years, most of them being for specific subpopulations in
specific lines of therapy. If approved, motixafortide will compete with many currently approved treatments for AML that include
chemotherapy (doxorubicin, cytarabine, vincristine); radiation therapy; stem cell transplantation; hypomethylating agents
Dacogen® (decitabine, Eisai and Johnson & Johnson) and Vidaza® (azacitidine, Celgene); FLT3 Inhibitors Xospata®
(gilteritinib), Vanflyta® (quizartinib) and Rydapt® (midostaurin); IDH inhibitors Idhifa® (enasidenib) and Tibsovo® (ivosidenib).
Other approved drugs for AML are Vyxeos® (liposomal cytarabine) Venclexta/Venclyxto® (Venetoclax, AbbVie), Daunorubicin®
(Jazz Pharmaceuticals), Revlimid® (lenalidomide, Celgene), Daurismo® (glasdegib, Pfizer) as well as Mylotarg® (gemtuzumab,
Pfizer).
In addition there are a number of potentially competitive compounds in development to treat AML including, among
others, crenolanib (Arog Phramaceuticals), oral azacytidine (Celgene/Bristol Myers Squibb); guadecitabine (Astex
Pharmaceuticals / Otsuka); uprolesan (Glycomimetics); pracinostat (MEI Pharma/Helsinn); devimistat (Rafael Pharmaceuticals);
ibrutinib (AbbVie); enasidenib (Bristol Myers Squibb); alvocidib (Tolero Pharmaceuticals); daratumumab (Johnson & Johnson);
brentuximab (Seattle Genetics); selinexor (Karyopharm Therapeutics and Ono Pharmaceutical Co Ltd.); Nexavar (sorafenib,
Bayer).
AGI-134
The field of cancer immunotherapy is rapidly growing, targeting CTLA-4, PD1 or PDL1 via antibody blockade. In recent
years, approval has been granted for use of these agents for various oncology- related indications such as melanoma, non-small
cell lung cancer, renal cell carcinoma, head and neck, gastric and colorectal cancer, liver cancer and bladder cancer. As noted
above, there are currently hundreds of immuno-oncology combination treatments being tested in clinical trials. Many of these
combinations could be competitive with AGI-134.
In general, the competitive landscape is comprised of compounds that target tumor specific neoantigens and create
adaptive, anti-tumor immune response. Examples of such therapeutic approaches include oncolytic viruses, dendritic cell
vaccines, personalized neoantigen-based cancer vaccines, pathogen-associated molecular patterns (PAMPs), damage-associated
molecular pattern (DAMPs) and cancer vaccines.
If approved, AGI-134 will compete with approved treatments such as the oncolytic viruses Imlygic® (T-VEC; Amgen)
and dendritic cell cancer vaccine Provenge® (sipuleucel-T; Dendreon Corp). In addition, there are several potentially-competitive
compounds that are currently under development, including, among others, Pexa-Vec (pexastimogene devacirepvec, SillaJen and
Transgene); Reolysin (pelareorep, Adlai Nortye Pharmaceutical Co Ltd and Oncolytics Biotech Inc.); Cavatak (MSD/Viralytics);
NeoVax (BioNTech/Neon Therapeutics); IVAC Mutanome (BioNTech); TLR9 agonists such as lefitolimod (MGN-1703,
Mologen Ag), tilsotolimod (IMO-2125, Idera Pharmaceuticals Inc.), SD-101 (TriSalus Life Sciences) CMP-001 (Checkmate
Pharmaceuticals); ADU-S100 (Aduro BioTech Inc./Novartis); imprime PGG® (HiberCell), and MG1MA3 (Turnstone Biologics
Inc/AbbVie). Most of these competitors have ongoing combination trials with the approved checkpoint inhibitors.
BL-5010
BL-5010 competes with a variety of approved destructive and non-destructive treatments for skin lesions. Both
Endwarts® (Meda Health) and Eskata® (Aclaris therapeutics) are medical device-based treatments marketed for removal of
warts.
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Insurance
We maintain insurance for our offices and laboratory in Israel. This insurance covers approximately $4.8 million of
equipment, consumables and lease improvements against risk of fire, lightning, natural perils and burglary (the latter coverage
limited to $250,000), and $1.5 million of consequential damages (covering fixed damages and extra expenses). For our clinical
activities, we carry life science liability insurance covering general liability with an annual coverage amount of $30.0 million per
occurrence and product liability and clinical trials coverage with an annual coverage amount of $30.0 million each claim and in
the aggregate. The annual aggregate as well as the maximum indemnity for a single occurrence, claim or circumstances under
this insurance is $30.0 million. In addition, we maintain the following insurance: employer’s liability with coverage of $10.0
million for each occurrence and in the aggregate; third-party liability with coverage of $5.0 million for each occurrence and in the
aggregate; all risk coverage of approximately $2.6 million for electronic and mechanical equipment; directors’ and officers’
liability with coverage of $15.0 million for each occurrence and in the aggregate; stock throughput insurance covering the API,
clinical trials materials; and a global travel insurance policy.
We procure stock throughput insurance (cargo marine) coverage when we ship substances for our clinical studies. Such
insurance is customized to the special requirements of the applicable shipment, such as temperature and/or climate sensitivity. If
required, we insure the substances to the extent they are stored in central depots and at clinical sites.
We believe that the amounts of our insurance policies are adequate and customary for a business of our kind. However,
because of the nature of our business, we cannot assure you that we will be able to maintain insurance on a commercially
reasonable basis or at all, or that any future claims will not exceed our insurance coverage.
Environmental Matters
We are subject to various environmental, health and safety laws and regulations, including those governing air emissions,
water and wastewater discharges, noise emissions, the use, management and disposal of hazardous, radioactive and biological
materials and wastes and the cleanup of contaminated sites. We believe that our business, operations and facilities are being
operated in compliance in all material respects with applicable environmental and health and safety laws and regulations. Based
on information currently available to us, we do not expect environmental costs and contingencies to have a material adverse
effect on us. The operation of our facilities, however, entails risks in these areas. Significant expenditures could be required in the
future if we are required to comply with new or more stringent environmental or health and safety laws, regulations or
requirements. See “Business — Government Regulation and Funding — Israel Ministry of Environment — Toxin Permit.”
Government Regulation and Funding
We operate in a highly controlled regulatory environment. Stringent regulations establish requirements relating to
analytical, toxicological and clinical standards and protocols in respect of the testing of pharmaceuticals and medical devices.
Regulations also cover research, development, manufacturing and reporting procedures, both pre- and post-approval. In many
markets, especially in Europe, marketing and pricing strategies are subject to national legislation or administrative practices that
include requirements to demonstrate not only the quality, safety and efficacy of a new product, but also its cost-effectiveness
relating to other treatment options. Failure to comply with regulations can result in stringent sanctions, including product recalls,
withdrawal of approvals, seizure of products and criminal prosecution.
Before obtaining regulatory approvals for the commercial sale of our therapeutic candidates, we or our licensees must
demonstrate through preclinical studies and clinical trials that our therapeutic candidates are safe and effective. Historically, the
results from nonclinical studies and early clinical trials often have not accurately predicted results of later clinical trials. In
addition, a number of pharmaceutical products have shown promising results in early clinical trials but subsequently failed to
establish sufficient safety and efficacy results to obtain necessary regulatory approvals. We have incurred and will continue to
incur substantial expense for, and devote a significant amount of time to, preclinical studies and clinical trials. Many factors can
delay the commencement and rate of completion of clinical trials, including the inability to recruit patients at the expected rate,
the inability to follow patients adequately after treatment, the failure to manufacture sufficient quantities of materials used for
clinical trials, and the emergence of unforeseen safety issues and governmental and regulatory delays. If a therapeutic candidate
fails to demonstrate safety and efficacy in clinical trials, this failure may delay development of other therapeutic candidates and
hinder our ability to conduct related preclinical studies and clinical trials. Additionally, as a result of these failures, we may also
be unable to find additional licensees or obtain additional financing.
Governmental authorities in all major markets require that a new pharmaceutical product or medical device be approved
or exempted from approval before it is marketed, and have established high standards for technical appraisal, which can result in
an expensive and lengthy approval process. The time to obtain approval varies by country. In the past, it generally took from six
months to four years from the application date, depending upon the quality of the results produced, the degree of control
exercised by the regulatory authority, the efficiency of the review procedure and the nature of the product. Some products are
never approved. In recent years, there has been a trend towards shorter regulatory review times in the United States as well as
certain European countries, despite increased regulation and higher quality, safety and efficacy standards.
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Historically, different requirements by different countries’ regulatory authorities have influenced the submission of
applications. However, a trend toward harmonization of drug and medical device approval standards, starting in individual
countries in Europe and then in the EU as a whole, in Japan, and in the United States under the aegis of what is now known as the
International Council on Harmonisation, or ICH (created as the International Conference on Harmonisation in 1990), is gradually
narrowing these differences. In many cases, compliance with ICH standards can help avoid duplication of non-clinical and
clinical trials and enable companies to use the same basis for submissions to each of the respective regulatory authorities. The
adoption of the Common Technical Document format by the ICH has greatly facilitated use of a single regulatory submission for
seeking approval in the ICH regions and many other countries worldwide.
Summaries of the United States, EU and Israeli regulatory processes follow below.
United States
In the United States, drugs are subject to rigorous regulation by the FDA. The U.S. Federal Food, Drug and Cosmetic Act,
or FDCA, and other federal and state statutes and regulations govern, among other things, the research, development, testing,
manufacture, storage, record-keeping, packaging, labeling, adverse event reporting, advertising, promotion, marketing,
distribution and import and export of pharmaceutical products. Failure to comply with the applicable U.S. requirements may
subject us to stringent administrative or judicial sanctions, such as agency refusal to approve pending applications, warning
letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions or criminal
prosecution.
Unless a drug is exempt from the NDA process or the Biologics License Application, or BLA, process or subject to
another regulatory procedure, the steps required before a drug may be marketed in the United States include:
•
•
•
•
•
•
preclinical laboratory tests, animal studies and formulation development;
submission to the FDA of an Investigational New Drug, or IND, application to conduct human clinical testing;
adequate and well controlled clinical trials to determine the safety and efficacy of the drug for each indication as well as to establish the exposure
levels;
submission to the FDA of an application for marketing approval;
satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is manufactured; and
FDA review and approval of the drug for marketing.
Preclinical studies include laboratory evaluation of product chemistry, toxicity, formulation and stability, as well as animal
studies. For studies conducted in the United States, and certain studies carried out outside the United States, we submit the results
of the nonclinical studies, together with manufacturing information and analytical results, to the FDA as part of an IND, which
must become effective before we may commence human clinical trials. An IND will automatically become effective 30 days after
receipt by the FDA, unless before that time the FDA raises concerns or questions about issues such as the conduct of the trials as
outlined in the IND. In such a case, the IND sponsor and the FDA must resolve any outstanding FDA concerns or questions
before clinical trials can proceed. Submission of an IND does not always result in the FDA allowing clinical trials to commence
and the FDA may halt a clinical trial if unexpected safety issues surface or the study is not being conducted in compliance with
applicable requirements.
The FDA may refuse to accept an IND for review if applicable regulatory requirements are not met. Moreover, the FDA
may delay or prevent the start of clinical trials if the manufacturing of the study drug fails to meet cGMP requirements or the
clinical trials are not adequately designed. Such government regulation may delay or prevent the study and marketing of potential
products for a considerable time period and may impose costly procedures upon a manufacturer’s activities. In addition, the FDA
may, at any time, impose a clinical hold on ongoing clinical trials. If the FDA imposes a clinical hold, clinical trials cannot
continue without FDA authorization and then only under terms authorized by the FDA.
Success in early-stage clinical trials does not assure success in later-stage clinical trials. Results obtained from clinical
activities are not always conclusive and may be susceptible to varying interpretations that could delay, limit or prevent regulatory
approval. Even if a therapeutic candidate receives regulatory approval, later discovery of previously unknown problems with a
product may result in restrictions on the product or even withdrawal of marketing approval for the product.
Clinical Trials (INDs)
Clinical trials involve the administration of the investigational drug to people under the supervision of qualified
investigators in accordance with the principles of good clinical practice, or GCP. We conduct clinical trials under protocols
detailing the trial objectives, the parameters to be used in monitoring safety, and the effectiveness criteria to be evaluated. We
must submit each U.S. study protocol to the FDA as part of an IND. Foreign clinical trials may or may not be conducted under an
IND. However, their safety assessments should be submitted annually.
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We conduct clinical trials typically in three sequential phases (1-3), but the phases may overlap or be combined. An
institutional review board, or IRB, must review and approve each trial before it can begin. Phase 1 includes the initial
administration of a tested drug to a small number of humans. These trials are closely monitored and may be conducted in
patients, but are usually conducted in healthy volunteer subjects. These trials are designed to determine the metabolic and
pharmacologic actions of the drug in humans and the side effects associated with increasing doses as well as, if possible, to gain
early evidence on effectiveness. Phase 2 usually involves trials in a limited patient population to evaluate dosage tolerance and
appropriate dosage, identify possible adverse effects and safety risks and preliminarily evaluate the efficacy of the drug for
specific indications. Phase 3 trials are large trials used to further evaluate clinical efficacy and test further for safety by using the
drug in its final form in an expanded patient population. There can be no assurance that we or our licensees will successfully
complete Phase 1, Phase 2 or Phase 3 testing with respect to any therapeutic candidate within any specified period of time, if at
all. Furthermore, clinical trials may be suspended at any time on various grounds, including a finding that the subjects or patients
are being exposed to an unacceptable health risk. We and our licensees perform some of our nonclinical and clinical testing
outside of the United States. The acceptability of the results of our preclinical and clinical testing by the FDA will be dependent
upon adherence to applicable U.S. and foreign standards and requirements, including GLP, GCP and the Declaration of Helsinki
for protection of human subjects.
Marketing Applications (NDAs and BLAs)
After successful completion of the required clinical testing, an NDA, or in the case of certain biological products a BLA,
is prepared and submitted to the FDA. FDA approval of the NDA or BLA is required before product marketing may begin in the
United States. The NDA/BLA must include the preclinical and clinical testing results and a compilation of detailed information
relating to the product’s pharmacology, toxicology, chemistry, manufacture and manufacturing controls. The cost of preparing
and submitting an NDA may be substantial. Under U.S. federal law, the submission of NDAs is generally subject to substantial
application user fees, and the manufacturer and/or sponsor under an NDA approved by the FDA is also subject to annual product
and establishment user fees. These fees are typically increased annually.
The FDA has 60 days from its receipt of an NDA/BLA to determine whether the application will be accepted for filing
based on the FDA threshold determination that the application is sufficiently complete to permit substantive review. Once the
submission is accepted for filing, the FDA begins an in-depth review of the submitted application. Under U.S. federal law, the
FDA has agreed to certain performance goals in the review of NDAs/BLAs. Most such applications for non-priority drug
products are to be reviewed within 10 months. The review process may be significantly extended by FDA requests for additional
information or clarification or if the applicant submits a major amendment during the review. The FDA may also refer
applications to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation and a
recommendation as to whether the application should be approved. This often, but not exclusively, occurs for novel drug products
or drug products that present difficult questions of safety or efficacy. The FDA is not bound by the recommendation of an
advisory committee.
Before approving an application, the FDA typically will inspect the facility or facilities where the product is
manufactured. The FDA will not approve the application unless the FDA determines that the product is manufactured in
substantial compliance with GMP. If the FDA determines that the NDA or BLA is supported by adequate data and information,
the FDA may issue an approval letter. During review, the FDA may request additional information via an information request, or
IR letter, or state deficiencies via a deficiency letter, or DR letter. Upon compliance with the conditions stated, the FDA will
typically issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing
information for specific indications. As a condition of approval, the FDA may require additional trials or post-approval testing
and surveillance to monitor the drug’s safety or efficacy, the adoption of risk evaluation and mitigation strategies, and may
impose other conditions, including labeling and marketing restrictions on the use of the drug, which can materially affect its
potential market and profitability. Once granted, product approvals may be withdrawn if compliance with regulatory standards for
manufacturing and quality control are not maintained or if additional safety problems are identified following initial marketing.
If the FDA’s evaluation of the NDA or BLA submission or manufacturing processes and facilities is not favorable, the
FDA may refuse to approve the NDA or BLA and may issue a complete response letter. The complete response letter, or CRL,
indicates that the review cycle for an application is complete and that the application is not ready for approval. The complete
response letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take
in order to place the application in condition for approval. Following receipt of a CRL, the company may submit additional
information and start a new review cycle, withdraw the application or request a hearing. Failure to take any of the above actions
may result in the FDA considering the application withdrawn following one year from issuance of the CRL. In such cases, the
FDA will notify the company and the company will have 30 days to respond and request an extension of time in which to
resubmit the application. The FDA may grant reasonable requests for extension. If the company does not respond within 30 days
of the FDA’s notification, the application will be considered withdrawn. Even with submission of additional information for a
new review cycle, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.
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The Pediatric Research Equity Act, or PREA, requires NDAs and BLAs (or supplements) for a new active ingredient,
new indication, new dosage form, new dosing regimen or new route of administration to contain results assessing the safety and
efficacy for the claimed indication in all relevant pediatric subpopulations. Data to support dosing and administration also must
be provided for each pediatric subpopulation for which the drug is safe and effective. The FDA may grant deferrals for the
submission of results or full or partial waivers from the PREA requirements (for example, if the product is ready for approval in
adults before pediatric studies are complete, if additional safety data is needed, among others). In addition, under the Best
Pharmaceuticals for Children Act, or BPCA, the FDA may issue a written request to the company to conduct clinical trials in the
pediatric population that are related to the moiety and expand on the claimed indication. The studies are voluntary but may award
the company with 6 months of marketing exclusivity if conducted according to good scientific principles and address the written
request. Finally, a sponsor can request that a product that must be studied under PREA to be studied also under the BPCA to
allow the sponsor to be eligible for six-months of pediatric exclusivity. The pediatric studies requested under BPCA are usually
more extensive and would generally also fulfill the PREA requirement; however, even if the sponsor does not complete the
studies outlined in the BPCA written request, it is still required to complete any studies required under PREA.
Post-Marketing Requirements
Once an NDA or BLA is approved, the drug sponsor will be subject to certain post-approval requirements, including
requirements for adverse event reporting, submission of periodic reports, manufacturing, labeling, packaging, advertising,
promotion, distribution, record-keeping and other requirements. For example, the approval may be subject to limitations on the
uses for which the product may be marketed or conditions of approval, or contain requirements for costly post-marketing testing
and surveillance to monitor the safety or efficacy of the product or require the adoption of risk evaluation and mitigation
strategies. In addition, the FDA requires the reporting of any adverse effects observed after the approval or marketing of a
therapeutic candidate and such events could result in limitations on the use of such approved product or its withdrawal from the
marketplace. Also, some types of changes to the approved product, such as manufacturing changes and labeling claims, are
subject to further FDA review and approval. Additionally, the FDA strictly regulates the promotional claims that may be made
about prescription drug products. In particular, the FDA requires substantiation of any claims of superiority of one product over
another including, in many cases, requirements that such claims be proven by adequate and well controlled head-to-head clinical
trials. To the extent that market acceptance of our therapeutic candidates may depend on their superiority over existing products,
any restriction on our ability to advertise or otherwise promote claims of superiority, or any requirements to conduct additional
expensive clinical trials to provide proof of such claims, could negatively affect the sales of our therapeutic candidates and our
costs.
Orphan Drug Designation
The Orphan Drug Act, or ODA, provides for granting special status to a drug or biological product to treat a rare disease
or condition (i.e., a disease or condition that affects fewer than 200,000 individuals in the United States) upon request of a
sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). For a therapeutic candidate to qualify for
orphan designation, both the candidate and the disease or condition must meet certain criteria specified in the ODA’s
implementing regulations (set forth at 21 CFR Part 316). Orphan designation qualifies the sponsor of the candidate for various
development incentives of the ODA, including tax credits for qualified clinical testing, waiver of NDA/BLA user fees and
eligibility for seven-year marketing exclusivity, referred to as orphan exclusivity upon marketing approval. The granting of an
orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval.
Safety and effectiveness of a candidate must still be established through adequate and well-controlled studies.
Expedited Programs for Serious Conditions
The FDA has put in place four programs intended to facilitate and expedite development and review of a new drug
intended to address an unmet medical need in the treatment of a serious or life-threatening condition: fast track designation,
breakthrough therapy designation, accelerated approval and priority review designation. Each program offers the sponsor a
defined set of opportunities such as expedited development and review, intensive FDA guidance during development, marketing
approval based on an effect on a surrogate endpoint or an intermediate clinical endpoint that is reasonably likely to predict the
drug’s clinical benefit, and a shorter time for review of marketing application. Fast Track and Breakthrough Therapy designations
may be requested during development, while Accelerated Approval and Priority Review relate to the marketing approval stage.
European Union/European Economic Area
Clinical Trials
Within the European Union (EU)/European Economic Area (EEA), which is composed of the 27 member states of the
EU plus Norway, Iceland and Liechtenstein, the authorization of clinical trials occurs at member state level. The European
Medicines Agency, or EMA, plays a key role in ensuring that GCP standards are applied across the European Economic Area, or
EEA in cooperation with the member states. It also manages a database of clinical trials carried out in the EU.
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Clinical trials are currently regulated under Directive 2001/20/EC. EU directives are not directly applicable in the member
states. They have to be transposed into national law. National law transposing EU directives often varies to a great extent.
However, in April 2014 a new regulation on clinical trials on medicinal products for human use was adopted. Regulations are
directly applicable in the member states, so they generally lead to greater harmonization. Regulation 536/2014, or the CTR,
entered into force in June 2014 and is anticipated to become applicable in December 2021. The CTR will harmonize the
assessment and supervision processes for clinical trials throughout the EU via a Clinical Trials Information System, or CTIS,
which will contain a centralized EU portal and database for clinical trials. The exact timing of the Regulation’s application
depends on confirmation of full functionality of CTIS through an independent audit. The CTR will become applicable six months
after the European Commission publishes notice of this confirmation. The CTR will require:
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Consistent rules for conducting clinical trials throughout the EU; and
Publicly available information on the authorization, conduct and results of each clinical trial carried out in the EU
The key benefits of the CTR include:
o Harmonized electronic submission and assessment process for clinical trials conducted in multiple member states;
o
o
Improved collaboration, information sharing and decision-making between and within member states;
Increased transparency of information on clinical trials;
o Higher standards of safety for all participants in EU clinical trials.
The authorization of a clinical trial (Phase I-III) in an EU member state requires the submission of a clinical trial
application (CTA) to the competent authority of that specific member state. The application and approval process is under the
current law still subject to member states’ national law. In general, the CTA should include, among other documents, the study
protocol, results of the nonclinical studies and manufacturing information and analytical results. According to Directive
2001/20/EC, the review of a valid request for authorization shall be carried out as rapidly as possible and may generally not
exceed 60 days. An extension of the 60 day period is permissible for medicinal products listed in Art. 9 para. 6 of Directive
2001/83/EC, namely gene therapy, somatic cell therapy including xenogenic cell therapy and all medicinal products containing
genetically modified organisms.
Marketing Authorization Procedures
A medicinal product may only be placed on the market in the EEA if it has obtained a marketing authorization according
to the applicable EU and/or member state law. A marketing authorization may either be granted in a national procedure, or in a
coordinated procedure of several member states pursuant to Directive 2001/83/EC, as amended, or under the centralized EU
procedure in accordance with Regulation (EC) No. 726/2004, as amended, or its predecessor, Regulation 2309/93. Depending on
the nature of the medicinal product, several different legal frameworks of the EU and the member states may be relevant for the
market clearance.
Centralized Procedure (CP)
The Centralized Procedure according to Regulation 726/2004/EC allows a marketing authorization holder to market the
medicine and make it available to patients and healthcare professionals throughout the entire EEA on the basis of a single
marketing authorization, granted by the European Commission, acting in its capacity as the European Licensing Authority on the
advice of the EMA. The EMA is the administrative body responsible for coordinating the existing scientific resources available
in the member states for evaluation, supervision and pharmacovigilance of medicinal products. Certain medicinal products (e.g.,
products derived from biotechnology, orphan medicinal products and medicinal products for human use, which contain an active
substance authorized in the Union after 20 May 2004 and which are intended for the treatment of AIDS, cancer,
neurodegenerative disorders or diabetes) must be authorized centrally. For each application submitted to the EMA for scientific
assessment, the EMA is required to ensure that the opinion of the Committee for Medicinal Products for Human Use, or CHMP,
is given within 210 days after receipt of a valid application or within 150 days by means of an accelerated procedure (excluding
clock stops); the review period can be extended. If the opinion is positive, the EMA is required to send the opinion to the
European Commission, which is responsible for preparing the decision granting a marketing authorization. If the initial opinion
of the CHMP is negative, the applicant is afforded an opportunity to seek a re-examination of the opinion. The CHMP is required
to re-examine its opinion within 60 days following receipt of the request by the applicant. A refusal of a centralized marketing
authorization constitutes a prohibition on placing the given medicinal product on the market in the EU.
The EMA’s Committee for Advanced Therapies (CAT) is responsible for assessing the quality, safety and efficacy of
advanced therapy medicinal products (ATMP). ATMP include gene therapy medicinal products, somatic cell therapy medicinal
products and tissue engineered products. The role of the CAT is to prepare a draft opinion on an application for marketing
authorization for an ATMP candidate that is submitted to the EMA. The EMA then provides a final opinion regarding the
application for marketing authorization. The European Commission grants or refuses marketing authorization after the EMA has
delivered its opinion. ATMP are further regulated under Regulation (EC) No 1394/2007 on advanced therapy medicinal products.
National Authorization Procedure
A National Authorization Procedure is used when applying for a marketing authorization in one individual EEA state. The
national procedure can only be used if the medicinal product does not already have a marketing authorization in another EEA
state.
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Mutual Recognition Procedure (MRP)
The mutual recognition procedure (Art. 28 et seq. Directive 2001/83/EC) should be used if a medicinal product already
has a marketing authorization in one EEA member state, and the authorization holder would like to extend the authorization to
other member states. An application for mutual recognition may be addressed to one or more EEA countries. The country in
which the national marketing authorization has been granted acts as the Reference Member State, and the other countries
concerned (Concerned Member States) can, upon successful completion of the procedure, recognize the marketing authorization.
The assessment time is 180 days plus 30 days.
Decentralized Procedure (DCP)
The decentralized procedure (introduced by Directive 2004/27/EU) is used in cases where the medicinal product has not
received a marketing authorization in the EU at the time of application. It allows the common assessment of an application
submitted simultaneously to several member states. One of the member states will take the lead in evaluating the application as
Reference Member State. The Reference Member State should prepare an assessment report that is then used to facilitate
agreement with the Concerned Member States and the grant of a national marketing authorization in all of these member states.
The assessment time is 210 days + 30 days.
Manufacturing Requirements
Any medicinal product placed on the market in the EEA must be manufactured in accordance with the principles of good
manufacturing practice as set out in Directive 2003/94/EC for medicines and investigational medicines for human use and
Volume 4 of the “Rules Governing Medicinal Products in the European Community” or Directive 2017/1572/EU that will
replace Directive 2003/94/EC once the notice according Art. 82(3) CTR has been filed. Furthermore, distribution of medicinal
products in the EU is subject to Directive 2001/83/EC, 92/25/EEC and current guidance on good distribution practice, or GDP.
Moreover, EU law requires the clinical results in support of clinical safety and efficacy to be based upon clinical trials conducted
in the EU in compliance with the requirements of Directives 2001/20/EC and 2005/28/EC, which implement good clinical
practice in the conduct of clinical trials on medicinal products for human use. Clinical trials conducted outside the EU and used to
support applications for marketing within the EU must have been conducted in a way consistent with the principles set out in
Directive 2001/20/EC. The conduct of a clinical trial in the EU requires, pursuant to Directive 2001/20/EC, authorization by the
relevant national competent authority where a trial takes place, and an ethics committee to have issued a favorable opinion in
relation to the arrangements for the trial. It also requires that the sponsor of the trial, or a person authorized to act on his behalf in
relation to the trial, be established in the EU. As stated above, directive 2001/20/EC will be replaced by the CTR in the future,
however, the exact time of the replacement is still uncertain.
Law Relating to Pediatric Research
Regulation (EC) 1901/2006 (as amended by Regulation (EC) 1902/2006 and Regulation (EU) 2019/5), or the Pediatric
Regulation, was adopted on December 12, 2006. This Regulation governs the development of medicinal products for human use
in order to meet the specific therapeutic needs of the pediatric population (children aged 0 to 17 years). It requires any application
for marketing authorization made after July 26, 2008 in respect of a medicinal product not authorized in the EU on January 26,
2007, the time the Regulation entered into force, to include studies in children conducted in accordance with a pediatric
investigation plan agreed to by the relevant European authorities. This does not apply if the product is subject to an agreed waiver
or deferral or if the product is excluded from the scope of Regulation 1901/2006, which is the case for inter alia generics,
homeopathic and traditional (herbal) medicinal products. Waivers can be granted in certain circumstances where pediatric studies
are not required or desirable. Deferrals can be granted in certain circumstances where the initiation or completion of pediatric
studies should be deferred until appropriate studies in adults have been performed. Moreover, this regulation imposes the same
obligation from January 26, 2009 on an applicant seeking approval of a new indication, pharmaceutical form or route of
administration for a product already authorized and still protected by a supplementary protection certificate granted under
Regulation (EC) no. 469/2009 or its precursor Regulation (EEC) 1768/92 by a patent that qualifies for the granting of such a
supplementary protection certificate. The pediatric Regulation 1901/2006 also provides, subject to certain conditions, a reward
for performing such pediatric studies, regardless of whether the pediatric results provided resulted in the grant of a pediatric
indication. This reward comes in the form of an extension of six months to the supplementary protection certificate granted in
respect of the product, unless the product is subject to Orphan Drug designation, in which case the 10-year market exclusivity
period for such orphan products is extended to 12 years. If any of the non-centralized procedures for marketing authorization
have been used, the six-month extension of the supplementary protection certificate is only granted if the medicinal product is
authorized in all member states. Where the product is no longer covered by a patent or supplementary protection certificate, the
applicant may make a separate application for a Pediatric Use Marketing Authorization, or PUMA, which, on approval, will
provide eight years’ protection for data and 10 years’ marketing protection for the pediatric results.
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Post-authorization Obligations
An authorization to market a medicinal product in the EU carries with it an obligation to comply with many post-
authorization regulations relating to the marketing and other activities of authorization holders. These include requirements
relating to provision of a risk management plan and provision of annual periodic safety update reports, carrying out of post-
authorization efficacy studies and/or post-authorization safety studies, maintenance of a pharmacovigilance system master file,
adverse event reporting, signal detection and management and other pharmacovigilance activities conducted under an established
quality system, advertising, packaging and labelling, patient package leaflets, and distribution. The regulations frequently operate
within a criminal law framework, and failure to comply with the requirements may not only affect the authorization, but also can
lead to financial and other sanctions levied on the company in question and responsible officers. EU pharmacovigilance
legislation has been significantly modified by the Pharmacovigilance Directive, Directive 2010/84/EU which amended the legal
framework of pharmacovigilance for medicines marketed within the EU provided in Regulation (EC) No 726/2004 with respect
to EU authorized medicinal products and in Directive 2001/83/EC with respect to nationally authorized medicinal products
(including
the mutual recognition and decentralized systems). Furthermore, EU good
pharmacovigilance practice (GVP) rules apply. With the amended pharmacovigilance requirements, the financial and
organizational burden on market authorization holders increased significantly, such as the obligation to maintain a
pharmacovigilance system master file that applies to all holders of marketing authorizations granted in accordance with Directive
2001/83/EC or Regulation (EC) No 726/2004. Marketing authorization holders must furthermore collect data on adverse events
associated with use of the authorized product outside the scope of the authorization. Pharmacovigilance for biological products
and medicines with a new active substance is strengthened by subjecting their authorization to additional monitoring activities.
those authorized
through
Another relevant aspect in the EU regulatory framework is the “sunset clause”: a provision leading to the cessation of the
validity of any marketing authorization if it is not followed by marketing within three years or, if marketing is interrupted for a
period of three consecutive years.
Approval of Medical Devices
On May 26, 2021 the new Regulation EU No. 2017/745 on Medical Devices (Medical Devices Regulation) will become
applicable and replace the existing regulatory framework for medical devices in the EU. The Medical Devices Regulation
strengthens the medical devices rules in the EU. In particular, the Medical Devices Regulation will result in several medical
devices being classified in higher risk classes and therefore face elevated regulatory requirements. In addition, the Medical
Devices Regulation will generally elevate regulatory requirements to medical devices. With regard to in vitro diagnostic medical
devices, the new Regulation EU 746/2017 on in vitro diagnostic medical devices will replace the current legal framework on 26
May, 2022 and will also result in a stricter regime.
Both under the existing and the future regime, EU law on medical devices requires that manufacturers of medical devices
obtain the right to affix the CE mark to their products, which shows that the device has undergone a conformity assessment
procedure, before selling them in EU member countries. The CE mark is an international symbol of adherence to quality
assurance standards and compliance with applicable European law. In order to obtain the right to affix the CE mark to products, a
manufacturer has to conduct the applicable conformity assessment procedure that may include a certification process involving a
notified body. The type of conformity procedure that is applicable varies according to the nature of the device. Once the
procedure has been successfully completed, the manufacturer is entitled to affix the CE mark on its products and commercially
distribute those products throughout the EU without further conformance tests being required in other member states.
Data Privacy in the EU
The EU has a strict regime on data privacy under the General Regulation on Data Protection, Regulation 2016/679
(GDPR) that has become applicable on May 25, 2018. The GDPR as an EU regulation does not have to be implemented into
member states’ national law, but applies directly in all member states. It applies to companies with an establishment in the
European Economic Area (EEA) that includes the 27 member states of the EU and Norway, Iceland and Liechtenstein.
Furthermore, the GDPR applies to companies not located in the EEA but processing personal data of individuals located in the
EEA (e.g., through online business). The GDPR implements stringent operational requirements for controllers of personal data,
including, for example, obligations to justify the collection, use and other processing of personal data (e.g., based on the
individual’s consent), to notify the individuals concerned about data processing activities, to protect all processed personal data
through appropriate technical and organisational measures, and to implement a data protection compliance management.
Furthermore, the GDPR defines high data security and compliance standards for the transfer of personal data to third countries,
including the U.S. The operational requirements under the GDPR are even stricter in case of sensitive personal data, such as
health or genetic data, that typically have to be stored in a pseudonymized (i.e., key-coded) manner. The GDPR provides that EU
member states may in certain areas deviate from GDPR standards which results in varying laws and regulations at member states
level. The applicable data protection laws in the EEA may limit our ability to share and otherwise process personal data. If our
business falls below the GDPR standards, we may be subject to severe administrative fines (under the GDPR, in the amount of up
to 4 % of the total worldwide annual turnover of our preceding financial year) and suffer significant loss of reputation.
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United Kingdom
The withdrawal of the United Kingdom (UK) from the EU took effect on January 1, 2021, and there are 27 member states
remaining in the EU. As of January 1, 2021, the UK is a “third country” with regard to the EU (subject to the terms of the EU UK
Trade Agreement) and EU law ceased to apply directly in the UK. However, the UK has retained the EU regulatory regime with
certain modifications as standalone UK legislation. Therefore, the UK regulatory regime is currently similar to EU regulations,
but under proposed legislation, the Medicines and Medical Devices Bill, the UK may adopt changed regulations that may diverge
from the EU legislative regime for medicines and their research, development and commercialization. For a two- year period
starting January 1, 2021, the UK has adopted transitional provisions, which inter alia apply to the importation of medicines into
the UK and rely on certain EMA marketing authorization application procedures.
Israel
Israel Ministry of the Environment — Toxin Permit
In accordance with the Israeli Dangerous Substances Law - 1993, the Israeli Ministry of the Environment is required to
grant a permit in order to use toxic materials. Because we utilize toxic materials in the course of operation of our laboratories, we
were required to apply for a permit to use these materials. Our current toxin permit will remain in effect until December 2021.
Clinical Testing in Israel
In order to conduct clinical testing on humans in Israel, special authorization must first be obtained from the ethics
committee and general manager of the institution in which the clinical studies are scheduled to be conducted, as required under
the Guidelines for Clinical Trials in Human Subjects implemented pursuant to the Israeli Public Health Regulations (Clinical
Trials in Human Subjects), as amended from time to time, and other applicable legislation. These regulations require
authorization by the institutional ethics committee and general manager as well as from the Israeli Ministry of Health, except in
certain circumstances, and in the case of genetic trials, special fertility trials and complex clinical trials, an additional
authorization of the Israeli Ministry of Health’s overseeing ethics committee. The institutional ethics committee must, among
other things, evaluate the anticipated benefits that are likely to be derived from the project to determine if it justifies the risks and
inconvenience to be inflicted on the human subjects, and the committee must ensure that adequate protection exists for the rights
and safety of the participants as well as the accuracy of the information gathered in the course of the clinical testing. Since we
intend to perform a portion of the clinical studies on certain of our therapeutic candidates in Israel, we will be required to obtain
authorization from the ethics committee and general manager of each institution in which we intend to conduct our clinical trials,
and in most cases, from the Israeli Ministry of Health.
Other Countries
In addition to regulations in the United States, the EU and Israel, we are subject to a variety of other regulations
governing clinical trials and commercial sales and distribution of drugs in other countries. Whether or not our products receive
approval from the FDA, approval of such products must be obtained by the comparable regulatory authorities of countries other
than the United States before we can commence clinical trials or marketing of the product in those countries. The approval
process varies from country to country, and the time may be longer or shorter than that required for FDA approval. The
requirements governing the conduct of clinical trials and product licensing vary greatly from country to country.
Related Matters
From time to time, legislation is drafted, introduced and passed in governmental bodies that could significantly change the
statutory provisions governing the approval, manufacturing and marketing of products regulated by the FDA or EMA and other
applicable regulatory bodies to which we are subject. In addition, regulations and guidance are often revised or reinterpreted by
the national agency in ways that may significantly affect our business and our therapeutic candidates. It is impossible to predict
whether such legislative changes will be enacted, whether FDA or EMA regulations, guidance or interpretations will change, or
what the impact of such changes, if any, may be. We may need to adapt our business and therapeutic candidates and products to
changes that occur in the future.
Israeli Government Programs
Israel Innovation Authority
Research and Development Grants. A number of our therapeutic products have been financed, in part, through funding
from the IIA in accordance with Research Law. Through December 31, 2020 we have received approximately $22.0 million in
aggregate funding from the IIA and have paid the IIA approximately $7.0 million in royalties under our approved programs. As
of December 31, 2020, we have no contingent obligation to the IIA other than for motixafortide. In connection with the in-
licensing of motixafortide from Biokine, and as a condition to IIA consent to the transaction, we agreed to abide by any
obligations resulting from funds previously received by Biokine from the IIA. The contingent liability to the IIA assumed by us
relating to this transaction (which liability has no relation to the funding actually received by us) amounts to $3.5 million as of
December 31, 2020. We have a full right of offset for amounts payable to the IIA from payments that we may owe to Biokine in
the future.
48
Under the Research Law and the terms of the grants, royalties on the revenues derived from sales of products developed
with the support of the IIA were payable to the Israeli government, generally at the rate of 3% although these terms would be
different if we were to receive IIA approval to manufacture or to transfer the rights to manufacture our products developed with
IIA grants outside of Israel. The obligation to make these payments terminates upon repayment of the amount of the received
grants as adjusted for fluctuation in the dollar/shekel exchange rate, plus interest and any additional amounts as described below.
Pursuant to the Research Law and the tracks published by the IIA, recipients of funding from the IIA are prohibited from
manufacturing products developed using IIA grants or derived from technology developed with IIA grants outside of Israel and
from transferring rights to manufacture such products outside of Israel. However, the IIA could, in special cases, approve the
transfer of manufacture or of manufacturing rights of a product developed in an approved program or which resulted therefrom,
outside of Israel. If we were to receive approval to manufacture or to transfer the rights to manufacture our products developed
with IIA grants outside of Israel, we would be required to pay an increased total amount of royalties (possibly up to 300% of the
grant amounts plus interest), depending on the portion of total manufacturing that was performed outside of Israel. In addition,
the royalty rate applicable to us could possibly increase. Such increased royalties constituted the total repayment amount required
in connection with the transfer of manufacturing rights of IIA-funded products outside Israel. The tracks published by the IIA do
enable companies to seek prior approval for conducting manufacturing activities outside of Israel without being subject to
increased royalties (but resulting in a lower grant amount); however, the IIA rarely granted such prior approval.
Under the Research Law and the tracks published by the IIA, we are prohibited from transferring or licensing our IIA-
financed technologies, technologies derived therefrom and related intellectual property rights and know-how outside of Israel
except under limited circumstances and only with the approval of the IIA and generally upon making a payment to the IIA. The
required approvals may not be received for any proposed transfer and, if received, we could be required to pay the IIA an amount
calculated in accordance with the applicable formula set out in the tracks published by the IIA. The scope of the support received,
the royalties that we already paid to the IIA, the amount of time that elapsed between the date on which the technology was
transferred and the date on which the applicable project performance period for the IIA grants was completed, and the sale price
and the form of transaction are to be taken into account in order to calculate the amount of the payment to the IIA. The repayment
amount is subject to a maximum limit calculated in accordance with a formula set forth in guidelines published by the IIA. In
addition, any decrease in the percentage of manufacture performed in Israel of any product or technology, as originally declared
in the application to the IIA with respect to the product or technology, could require us to notify, or to obtain the approval of, the
IIA, and could result in increased royalty payments to the IIA of up to 300% of the total grant amounts received in connection
with the product or technology, plus interest, depending on the portion of total manufacturing that was performed outside of
Israel.
Approval of the transfer or license of technology to residents of Israel is required and could be granted in specific
circumstances, but only if the recipient agrees to abide by the provisions of applicable laws, including the restrictions on the
transfer of know-how and the obligation to pay royalties.
The State of Israel does not own intellectual property rights in technology developed with IIA funding and there is no
restriction on the export of products manufactured using technology and know-how developed with IIA funding. The technology
and know-how are, however, subject to transfer of technology and manufacturing rights restrictions as described above.
Israel Ministry of Health
Israel’s Ministry of Health, which regulates medical testing, has adopted protocols that correspond, generally, to those of
the FDA and the EMA, making it comparatively straightforward for studies conducted in Israel to satisfy FDA and the EMA
requirements, thereby enabling medical technologies subjected to clinical trials in Israel to reach U.S. and EU commercial
markets in an expedited fashion. Many members of Israel’s medical community have earned international prestige in their chosen
fields of expertise and routinely collaborate, teach and lecture at leading medical centers throughout the world. Israel also has
free trade agreements with the United States and the EU.
C. Organizational Structure
Our corporate structure consists of BioLineRx Ltd., a substantially wholly owned U.K. subsidiary, Agalimmune Ltd., and
one wholly owned inactive subsidiary, BioLineRx USA Inc.
D. Property, Plant and Equipment
We are headquartered in Modi’in, Israel. We entered into a lease agreement in August 2014, for an aggregate of 1,663
square meters (approximately 17,900 square feet) of space. Monthly rent is approximately $32,000 per month, including
maintenance fees and parking. The initial term of the lease expired in June 2020, and we exercised our option to extend the lease
through June 30, 2025. We have the option to extend the lease for two additional lease periods totaling up to an additional 5
years, each option at a 5% increase to the preceding lease payment amount.
49
This facility houses both our administrative and research operations and our central laboratory. The central laboratory
consists of approximately 380 square meters (approximately 4,200 square feet) and includes a bioanalytical laboratory, a
formulation laboratory and a tissue culture laboratory. Our bioanalytical laboratory has received GLP certification. All of our
employees are based in this facility.
ITEM 4A. UNRESOLVED STAFF COMMENTS
None.
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
You should read the following discussion of our financial condition and results of operations in conjunction with the
financial statements and the notes thereto included elsewhere in this Annual Report on Form 20-F. The following discussion
contains forward-looking statements that reflect our plans, estimates and beliefs. Our actual results could differ materially from
those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those
discussed below and elsewhere in this Annual Report on Form 20-F, particularly those in “Item 3. Key Information — Risk
Factors.”
We are a late clinical-stage biopharmaceutical development company with a strategic focus on oncology. Our current
development and commercialization pipeline consists of two clinical-stage therapeutic candidates – motixafortide (BL-8040), a
novel peptide for the treatment of stem cell mobilization, solid tumors and AML, and AGI-134, an immuno-oncology agent in
development for solid tumors. In addition, we have an off-strategy, legacy therapeutic product called BL-5010 for the treatment
of skin lesions. We have generated our pipeline by systematically identifying, rigorously validating and in-licensing therapeutic
candidates that we believe exhibit a high probability of therapeutic and commercial success. To date, except for BL-5010, none of
our therapeutic candidates have been approved for marketing or sold commercially. Our strategy includes commercializing our
therapeutic candidates through out-licensing arrangements with biotechnology and pharmaceutical companies and evaluating, on
a case-by-case basis, the commercialization of our therapeutic candidates independently.
A. Operating Results
History of Losses
Since our inception in 2003, we have generated significant losses in connection with our research and development. As of
December 31, 2020, we had an accumulated deficit of $278 million. We may continue to generate losses in connection with the
research and development activities relating to our pipeline of therapeutic candidates. Such research and development activities
are budgeted to expand over time and will require further resources if we are to be successful. As a result, we expect to continue
to incur operating losses, which may be substantial over the next several years, and we expect to need to obtain additional funds
to further pursue our research and development programs.
We have funded our operations primarily through the sale of equity securities (both in public and private offerings),
payments received under our strategic licensing and collaboration arrangements, interest earned on investments and funding
received from the IIA. We expect to continue to fund our operations over the next several years through our existing cash
resources, potential future upfront, milestone, royalty or other payments that we may receive from our existing out-licensing
agreements, potential future upfront or milestone payments that we may receive from out-licensing transactions for our other
therapeutic candidates, interest earned on our investments and additional capital to be raised through public or private equity
offerings or debt nancings. As of December 31, 2020, we held $22.6 million of cash, cash equivalents and short-term bank
deposits.
Revenues
Our revenues to date have been generated primarily from milestone payments under current and previously existing out-
licensing agreements.
We expect our revenues for the next several years to be derived primarily from payments under collaboration and
partnering arrangements, including future royalties on product sales.
Research and Development
Our research and development expenses consist primarily of salaries and related personnel expenses, fees paid to external
service providers, up-front and milestone payments under our license agreements, patent-related legal fees, costs of preclinical
studies and clinical trials, drug and laboratory supplies and costs for facilities and equipment. We primarily use external service
providers to manufacture our product candidates for clinical trials and for the majority of our preclinical and clinical development
work. We charge all research and development expenses to operations as they are incurred. We expect our research and
development expense to remain our primary expense in the near future as we continue to develop our therapeutic candidates.
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The following table identifies our current pipeline projects:
Project
Status
1. Phase 3
registration study
in autologous stem cell
mobilization (GENESIS) ongoing, positive results from
interim analysis announced October 2020; as recommended
by DMC, study enrollment was completed at 122 patients
Expected Near Term Milestones
1. a. Top-line results for the study expected in early
second quarter of 2021
b. Pre-NDA meeting with FDA in second half of
2021
c. NDA submission in first half of 2022
motixafortide
2. Phase 2a study in pancreatic cancer (COMBAT/KEYNOTE-
202) completed; full results showing improvement in all
endpoints announced December 2020
2. Evaluation and planning of next clinical
development steps, including discussions towards
potential collaborations
3. Phase 2a study for relapsed or refractory AML completed
3. Follow-up
is ongoing;
for overall survival
evaluation and decision regarding next clinical
development steps
4. Phase 2 investigator-initiated study in first-line PDAC
4. Data from the study is anticipated in mid-2022*
patients
5. Phase 1b study in patients with ARDS secondary to COVID-
5. Results of the preliminary analysis are expected in
19 and other respiratory viral infections
the second half of 2021*
AGI-134
Phase 1/2a study, ongoing
Initial proof-of-mechanism efficacy results of part 2 of
study expected in second half of 2021
*These studies are investigator-initiated studies; therefore, the timelines are ultimately controlled by the independent
investigators and are subject to change
We expect that a large percentage of our research and development expense in the future will be incurred in support of our
current and future preclinical and clinical development projects. Due to the inherently unpredictable nature of preclinical and
clinical development processes, we are unable to estimate with any certainty the costs we will incur in the continued development
of the therapeutic candidates in our pipeline for potential commercialization. Clinical development timelines, the probability of
success and development costs can differ materially from expectations. We expect to continue to test our product candidates in
preclinical studies for toxicology, safety and efficacy, and to conduct additional clinical trials for each product candidate. If we
are not able to enter into an out-licensing arrangement with respect to any therapeutic candidate prior to the commencement of
later stage clinical trials, we may fund the trials for the therapeutic candidate ourselves.
While we are currently focused on advancing each of our product development projects, our future research and
development expenses will depend on the clinical success of each therapeutic candidate, as well as ongoing assessments of each
therapeutic candidate’s commercial potential. In addition, we cannot forecast with any degree of certainty which therapeutic
candidates may be subject to future out-licensing arrangements, when such out-licensing arrangements will be secured, if at all,
and to what degree such arrangements would affect our development plans and capital requirements. See “Item 3. Key
Information — Risk Factors — If we or our licensees are unable to obtain U.S. and/or foreign regulatory approval for our
therapeutic candidates, we will be unable to commercialize our therapeutic candidates.”
As we obtain results from clinical trials, we may elect to discontinue or delay clinical trials for certain therapeutic
candidates or projects in order to focus our resources on more promising therapeutic candidates or projects. Completion of
clinical trials by us or our licensees may take several years or more, but the length of time generally varies according to the type,
complexity, novelty and intended use of a therapeutic candidate.
The cost of clinical trials may vary significantly over the life of a project as a result of differences arising during clinical
development, including, among others:
•
the number of sites included in the clinical trials;
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•
•
•
•
•
•
•
the length of time required to enroll suitable patients;
the cost of drug substance/product manufacturing, storage and shipment;
the number of patients that participate in the clinical trials;
the duration of patient follow-up;
whether the patients require hospitalization or can be treated on an out-patient basis;
the development stage of the therapeutic candidate; and
the efficacy and safety profile of the therapeutic candidate.
We expect our research and development expenses to remain our most significant cost as we continue the advancement of
our clinical trials and preclinical product development projects and place significant emphasis on in-licensing new product
candidates. The lengthy process of completing clinical trials and seeking regulatory approval for our product candidates requires
expenditure of substantial resources. Any failure or delay in completing clinical trials, or in obtaining regulatory approvals, could
cause a delay in generating product revenue and cause our research and development expenses to increase and, in turn, have a
material adverse effect on our operations. Due to the factors set forth above, we are not able to estimate with any certainty when
we would recognize any net cash inflows from our projects.
Sales and Marketing Expenses
Sales and marketing expenses consist primarily of compensation for employees in business development and marketing
functions. Other signicant sales and marketing costs include costs for marketing and communication materials, professional fees
for outside market research and consulting, legal services related to partnering transactions and travel costs.
General and Administrative Expenses
General and administrative expenses consist primarily of compensation for employees in executive and operational
functions, including accounting, finance, legal, investor relations, information technology and human resources. Other significant
general and administration costs include facilities costs, professional fees for outside accounting and legal services, travel costs,
insurance premiums and depreciation.
Non-Operating Expense and Income
Non-operating expense and income includes fair-value adjustments of derivative liabilities on account of the warrants
issued in equity financings we carried out in July 2017, February 2019, May 2020 and June 2020, as well as from a debt
financing in October 2018. These fair-value adjustments are highly influenced by our share price at each period end (revaluation
date). Non-operating expense and income also includes issuance expenses of the ATM and the pro-rata share of issuance
expenses from the placements related to the warrants, as well as the capital gain from realization of our investment in iPharma, a
joint venture our holdings in which we sold in April 2018. Sales-based royalties and other revenue from the license agreement
with Perrigo have also been included as part of non-operating income, as the out-licensed product is not an integral part of our
strategy and the amounts are not material.
Financial Expense and Income
Financial expense and income consist of interest earned on our cash, cash equivalents and short-term bank deposits;
interest expense related to our loan from Kreos Capital; bank fees and other transactional costs. In addition, it may also include
gains/losses on foreign exchange hedging transactions, which we carry out from time to time to protect against a portion of our
NIS-denominated expenses (primarily compensation) in relation to the dollar.
Critical Accounting Policies and Estimates
We describe our significant accounting policies more fully in Note 2 to our consolidated financial statements for the year
ended December 31, 2020. We believe that the accounting policies below are critical for one to fully understand and evaluate our
financial condition and results of operations.
The discussion and analysis of our financial condition and results of operations is based on our financial statements,
which we prepare in accordance with IFRS. The preparation of these financial statements requires us to make estimates using
assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the
date of the financial statements, as well as the reported revenues and expenses during the reporting periods. On an ongoing basis,
we evaluate such estimates, including those described in greater detail below. We base our estimates on historical experience and
on various assumptions that we believe are reasonable under the circumstances, the results of which impact the carrying value of
our assets and liabilities that are not readily apparent from other sources. Actual results will differ from these estimates and such
differences may be significant.
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Revenue Recognition
We recognize revenues in accordance with International Financial Reporting Standards No. 15, or IFRS 15. IFRS 15,
“Revenue from Contracts with Customers,” which was issued in May 2014, amends revenue recognition requirements and
establishes principles for reporting information about the nature, amount, timing and uncertainty of revenue and cash flows
arising from contracts with customers. The standard replaces International Auditing Standard, or IAS, 18, “Revenue” and IAS 11,
“Construction Contracts” and related interpretations. The standard is effective for annual periods beginning on or after January 1,
2018, and we have adopted it as of that date.
IFRS 15 introduces a five-step model for recognizing revenue from contracts with customers, as follows:
•
•
•
•
•
identify the contract with a customer;
identify the performance obligations in the contract;
determine the transaction price;
allocate the transaction price to the performance obligations in the contract; and
recognize revenue when (or as) the entity satisfies a performance obligation.
Accrued Expenses
We are required to estimate accrued expenses as part of our process of preparing financial statements. This process
involves estimating the level of service performed on our behalf and the associated cost incurred in instances where we have not
been invoiced or otherwise notified of actual costs. Examples of areas in which subjective judgments may be required include
costs associated with services provided by contract organizations for preclinical development, clinical trials and manufacturing of
clinical materials. We account for expenses associated with these external services by determining the total cost of a given study
based on the terms of the related contract. We accrue for costs incurred as the services are being provided by monitoring the
status of the trials and the invoices received from our external service providers. In the case of clinical trials, the estimated cost
normally relates to the projected costs of treating the patients in our trials, which we recognize over the estimated term of the trial
according to the number of patients enrolled in the trial on an ongoing basis, beginning with patient enrollment. As actual costs
become known to us, we adjust our accruals.
Investments in Financial Assets
The primary objective of our investment activities is to preserve principal while maximizing the income that we receive
from our investments without significantly increasing risk and loss. Our investments are exposed to market risk due to
fluctuations in interest rates, which may affect our interest income and the fair market value of our investments. We manage this
exposure by performing ongoing evaluations of our investments. Due to the short-term maturities of our investments to date, their
carrying value has always approximated their fair value.
A financial asset is classified in this category if our management has designated it as a financial asset upon initial
recognition, because it is managed, and its performance is evaluated, on a fair-value basis in accordance with a documented risk
management or investment strategy. Our investment policy with regard to excess cash, as adopted by our Board of Directors, is
composed of the following objectives: (i) preserving investment principal; (ii) providing liquidity; and (iii) providing optimum
yields pursuant to the policy guidelines and market conditions. The policy provides detailed guidelines as to the securities and
other financial instruments in which we are allowed to invest. In addition, in order to maintain liquidity, investments are
structured to provide flexibility to liquidate at least 50% of all investments within 15 business days. Information about these
assets, including details of the portfolio and income earned, is provided internally on a quarterly basis to our key management
personnel and on a semi-annual basis to the Investment Monitoring Committee of our Board of Directors. Any divergence from
this investment policy requires approval from our Board of Directors.
Stock-based Compensation
We account for stock-based compensation arrangements in accordance with the provisions of IFRS 2. IFRS 2 requires
companies to recognize stock compensation expense for awards of equity instruments based on the grant-date fair value of those
awards (with limited exceptions). The cost is recognized as compensation expense over the life of the instruments, based upon
the grant-date fair value of the equity or liability instruments issued. The fair value of our stock-based compensation grants is
computed as of the grant date based on the Black-Scholes model, using the standard parameters established in that model
including estimates relating to volatility of our stock, risk-free interest rates, estimated life of the equity instruments issued and
the market price of our stock. As our ordinary shares are publicly traded on the TASE, we do not need to estimate their fair
market value. Rather, we use the actual closing market price of our ordinary shares on the date of grant, as reported by the TASE.
53
Warrants
In connection with the direct placement to BVF Partners L.P., or BVF Partners, of 566,372 ADSs in July 2017, we issued
(i) Series A warrants to purchase 198,230 ADSs at an exercise price of $30.00 per ADS and (ii) Series B warrants to purchase
198,230 ADSs at an exercise price of $60.00 per ADS. All the warrants are exercisable for a period of four years from the date of
issuance. Since the exercise price was not deemed to be fixed, the warrants are not qualified for classification as an equity
instrument and have therefore been classified as a non-current financial liability.
In connection with a loan transaction entered into with Kreos Capital, we issued a warrant to purchase 63,837 ADSs at an
exercise price of $14.10 per ADS. The warrant is exercisable for a period of ten years from the date of issuance. Since the
exercise price was not deemed to be fixed, the warrant is not qualified for classification as an equity instrument and has therefore
been classified as a non-current financial liability.
In connection with a public offering we completed in February 2019, we issued warrants to purchase 1,866,667 ADSs at
an exercise price of $11.25 per ADS. The warrants are exercisable for a period of five years from the date of issuance. Since the
exercise price was not deemed to be fixed, the warrant is not qualified for classification as an equity instrument and has therefore
been classified as a non-current financial liability.
In connection with a registered direct offering we completed in May 2020, we issued warrants to purchase 5,142,859
ADSs at an exercise price of $2.25 per ADS and also issued warrants to purchase 257,143 ADSs at an exercise price of $2.1875
per ADS. The warrants are exercisable for a period of two and one-half years from the date of issuance. Since the exercise price
was not deemed to be fixed, the warrant is not qualified for classification as an equity instrument and has therefore been
classified as a non-current financial liability.
In connection with a registered direct offering we completed in June 2020, we issued warrants to purchase 2,510,286
ADSs at an exercise price of $2.25 per ADS and also issued warrants to purchase 125,514 ADSs at an exercise price of $2.1875
per ADS. The warrants are exercisable for a period of five years from the date of issuance. Since the exercise price was not
deemed to be fixed, the warrant is not qualified for classification as an equity instrument and has therefore been classified as a
non-current financial liability.
Recent Accounting Changes and Pronouncements
We adopted International Financial Reporting Standard No. 16 “Leases,” or IFRS 16, retrospectively from January 1,
2019 but have not restated comparatives for the 2018 reporting period, as permitted under the specific transitional provisions in
the standard. On adoption of IFRS 16, the Company recognized lease liabilities for leases which had previously been classified as
“operating leases” under the principles of International Accounting Standard 17, “Leases.” For further information on the
application of IFRS 16, see Note 2r to our consolidated financial statements for the year ended December 31, 2020 included
elsewhere in this report.
Results of Operations -- Overview
Revenues
We did not record any revenues for the years ended December 31, 2018, 2019 and 2020.
Cost of revenues
We did not record any cost of revenues for the years ended December 31, 2018, 2019 and 2020.
Comparison of the Year Ended December 31, 2020 to the Year Ended December 31, 2019
Research and development expenses
Research and development expenses for the year ended December 31, 2020 were $18.2 million, a decrease of $5.2
million, or 22.5%, compared to $23.4 million for the year ended December 31, 2019. The decrease resulted primarily from
termination of the BATTLE clinical study for motixafortide in 2019, from lower expenses associated with the motixafortide
COMBAT clinical trial and from lower expenses associated with the AGI-134 study, as well as a decrease in share-based
compensation and payroll due to a company-wide salary reduction related to the COVID-19 pandemic.
54
Sales and marketing expenses
Sales and marketing expenses for the year ended December 31, 2020 were $0.8 million, similar to the year ended
December 31, 2019.
General and administrative expenses
General and administrative expenses for the year ended December 31, 2020 were $3.9 million, an increase of $0.1, or
2.6% compared to $3.8 million for the year ended December 31, 2019. The increase resulted primarily from an increase in
directors’ and officers’ insurance expenses and share-based compensation, offset by small decreases in a number of G&A
expenses.
Non-operating income (expense), net
We recognized net non-operating expenses of $5.7 million for the year ended December 31, 2020 compared to net non-
operating income of $4.2 million for the year ended December 31, 2019. Non-operating expenses for the year ended December
31, 2020 primarily relate to fair-value adjustments of warrant liabilities on our balance sheet, warrant offering expenses and ATM
issuance expenses. Non-operating income for the year ended December 31, 2019 primarily relates to fair-value adjustments of
warrant liabilities on our balance sheet, offset by warrant offering expenses.
Financial income (expense), net
We recognized net financial expenses of $1.4 million for the year ended December 31, 2020 compared to net financial
expenses of $1.5 million for the year ended December 31, 2019. Net financial expenses for both periods primarily relate to
interest paid on loans, offset by investment income earned on our bank deposits.
Comparison of the Year Ended December 31, 2019 to the Year Ended December 31, 2018
Research and development expenses
Research and development expenses for the year ended December 31, 2019 were $23.4 million, an increase of $3.6
million, or 18.3%, compared to $19.8 million for the year ended December 31, 2018. The increase resulted primarily from higher
expenses associated with the motixafortide GENESIS and COMBAT clinical trials, offset by a decrease in expenses related to
BL-1230, a project that was terminated in 2018, as well as a decrease in payroll and share-based compensation.
Sales and marketing expenses
Sales and marketing expenses for the year ended December 31, 2019 were $0.9 million, a decrease of $0.5 million, or
37.0%, compared to $1.4 million for the year ended December 31, 2018. The decrease resulted primarily from a decrease in
payroll and related expenses, including a one-time compensation payment in the 2018 period.
General and administrative expenses
General and administrative expenses for the year ended December 31, 2019 were $3.8 million, a decrease of $0.6, or
14.0% compared to $4.4 million for the year ended December 31, 2018. The decrease resulted primarily from a decrease in share-
based compensation.
Non-operating income (expense), net
We recognized net non-operating income of $4.2 million for the year ended December 31, 2019 compared to net non-
operating income of $2.4 million for the year ended December 31, 2018. Non-operating income for the year ended December 31,
2019 primarily relates to fair-value adjustments of warrant liabilities on our balance sheet, offset by warrant offering expenses.
Non-operating income for the year ended December 31, 2018 primarily relates to fair-value adjustments of warrant liabilities on
our balance sheet and the capital gain from realization of our investment in iPharma.
Financial income (expense), net
We recognized net financial expenses of $1.5 million for the year ended December 31, 2019 compared to net financial
income of $0.2 million for the year ended December 31, 2018. Net financial expenses for the year ended December 31, 2019
period primarily relate to interest paid on loans, offset by investment income earned on our bank deposits. Net financial income
for the year ended December 31, 2018 primarily relates to investment income earned on our bank deposits, offset by interest paid
on loans.
55
Quarterly Results of Operations
The following tables show our unaudited quarterly statements of operations for the periods indicated. We have prepared
this quarterly information on a basis consistent with our audited consolidated financial statements and we believe it includes all
adjustments, consisting of normal recurring adjustments necessary for a fair statement of the information shown. Operating
results for any quarter are not necessarily indicative of results for a full fiscal year.
March 31
June 30 Sept. 30 Dec. 31 March 31 June 30 Sept. 30 Dec. 31
Three Months Ended
2019
–
–
–
–
(in thousands of U.S. dollars)
–
–
–
–
–
–
2020
–
–
–
–
–
–
(4,392)
(5,302)
(5,558)
(8,186)
(5,422)
(4,640)
(3,484)
(4,627)
(256)
(226)
(201)
(174)
(175)
(182)
(309)
(174)
(930)
(5,578)
(949)
(6,477)
(884)
(6,643)
(1,053)
(9,413)
(1,243)
(6,840)
(744)
(5,566)
(856)
(4,649)
(1,071)
(5,872)
(340)
210
(447)
(6,155)
1,261
171
(440)
(5,485)
3,055
247
(597)
(3,938)
189
149
(793)
(9,868)
469
140
(414)
(6,645)
(843)
35
(396)
(6,770)
294
39
(302)
(4,618)
(5,621)
22
(517)
(11,988)
Consolidated Statements of
Operations
Revenues
Cost of revenues
Research and development
expenses
Sales and marketing
expenses
General and administrative
expenses
Operating loss
Non-operating income
(expenses), net
Financial income
Financial expenses
Net loss
Our quarterly revenues and operating results of operations have varied in the past and can be expected to vary in the
future due to numerous factors. We believe that period-to-period comparisons of our operating results are not necessarily
meaningful and should not be relied upon as indications of future performance.
B. Liquidity and Capital Resources
Since our inception, we have funded our operations primarily through public and private offerings of our equity securities,
payments received under our strategic licensing and collaboration arrangements, interest earned on investments and funding from
the IIA. At December 31, 2020, we held $22.6 million in cash, cash equivalents and short-term bank deposits. We have invested
substantially all of our available cash funds in short-term bank deposits. Subsequent to year end, we raised gross proceeds of
$34.5 million in an underwritten public offering, and received another $9.8 million in gross proceeds from the exercise of
outstanding warrants.
On October 31, 2017, we entered into that certain At-the-Market Sales Agreement, or the BTIG Sales Agreement, dated
October 31, 2017, by and between us and BTIG, LLC, or BTIG. Pursuant to the BTIG Sales Agreement, we could elect from
time to time, to offer and sell through BTIG, acting as sales agent, our ADSs having an aggregate offering price of up to $30
million through an “at the market offering” as defined in Rule 415(a)(4), or the BTIG ATM Offering. From the effective date of
the BTIG Sales Agreement through September 24, 2020, we had sold an aggregate of 2,923,553 ADSs for an aggregate offering
price of $13.0 million. On May 26, 2020, we terminated the prospectus supplement dated April 17, 2020 related to the BTIG
ATM Offering, and we terminated the BTIG Sales Agreement, effective September 24, 2020.
On May 28, 2020, we sold to certain institutional investors an aggregate of 5,142,859 ADSs in a registered direct offering
at $1.75 per ADS, resulting in gross proceeds of 9.0 million. In addition, we issued to the investors unregistered warrants to
purchase up to an aggregate of 5,142,859 ADSs in a private placement. The warrants are immediately exercisable and will expire
two and one-half years from issuance at an exercise price of $2.25 per ADS, subject to adjustment as set forth therein. The
warrants may be exercised on a cashless basis if on or following three months after issuance there is no effective registration
statement registering the ADSs underlying the warrants. We paid an aggregate of $0.6 million in placement agent fees plus
certain expenses and issued unregistered placement agent warrants to purchase up to an aggregate of 257,143 ADSs on
substantially the same terms as the warrants except they have an exercise price of $2.1875 per ADS.
On June 3, 2020, we sold to certain institutional investors an aggregate of 2,510,286 ADSs in a registered direct offering
at $1.75 per ADS, resulting in gross proceeds of $4.4 million. In addition, we issued to the investors unregistered warrants to
purchase up to an aggregate of 2,510,286 ADSs in a private placement. The warrants are immediately exercisable and will expire
two and one-half years from issuance at an exercise price of $2.25 per ADS, subject to adjustment as set forth therein. The
warrants may be exercised on a cashless basis if on or following three months after issuance there is no effective registration
statement registering the ADSs underlying the warrants. We paid an aggregate of $0.3 million in placement agent fees plus
certain expenses and issued unregistered placement agent warrants to purchase up to an aggregate of 125,514 ADS on
substantially the same terms as the warrants except they have an exercise price of $2.1875 per ADS.
56
On September 25, 2020, we entered into the an offering agreement, or the Wainwright Offering Agreement, with H.C.
Wainwright & Co., LLC, or Wainwright, pursuant to which we may offer and sell, from time to time, at our option, up to $25.0
million of our ADSs through an “at-the-market” equity offering program under which Wainwright has agreed to act as sales
agent. As of February 22, 2021, we have sold 3,077,851 ADSs having an aggregate offering price of $7.3 million under the
Wainwright Offering Agreement.
On January 22, 2021, we sold 14,375,000 ADSs at a price to the public of $2.40 per ADS, resulting in gross proceeds of
$34.5 million. Wainwright acted as the sole book-running manager for the offering. We paid an aggregate of $2.4 million in
placement agent fees and expenses and issued placement agent warrants to purchase 718,750 ADS. The placement agent warrants
are immediately exercisable at a price of $3.00 per ADS, subject to adjustment in certain circumstances, and expire five years
from the commencement of sales under the offering.
Net cash used in operating activities for the year ended December 31, 2020 was $23.2 million, compared to $22.7 million
for the year ended December 31, 2019 and $24.2 million for the year ended December 31, 2018. The $0.5 million increase in
2020 was primarily the result of a decrease in accounts payable and accruals. The $1.5 million decrease in 2019 was primarily the
result of changes in operating asset and liability items in the two periods, i.e., a decrease in prepaid expenses and other
receivables in 2019 versus an increase in 2018, as well as an increase in accounts payable and accruals in 2019 versus a decrease
in 2018.
Net cash provided by investing activities for the year ended December 31, 2020 was $16.7 million, compared to $5.3
million for the year ended December 31, 2019 and $9.6 million for the year ended December 31, 2018. The changes in cash flows
from investing activities relate primarily to investments in, and maturities of, short-term bank deposits during the respective
periods, the acquisition of an additional 20% economic interest in motixafortide in 2018 and a realization of our investment in
iPharma during 2018.
Net cash provided by financing activities for the year ended December 31, 2020 was $17.9 million, compared to $19.2
million for the year ended December 31, 2019 and $13.1 million for the year ended December 31, 2018. The cash flows in 2020
primarily reflect the registered direct offerings of our ADSs in May and June 2020, as well as net proceeds from the ATM
program, offset by repayments of the loan from Kreos Capital. The cash flows in 2019 primarily reflect the underwritten public
offering of our ADSs in February 2019, as well as net proceeds from the ATM program. The cash flows in 2018 primarily reflect
the net proceeds of the loan from Kreos Capital, as well as net proceeds from the ATM program.
Developing drugs, conducting clinical trials and commercializing products is expensive and we will need to raise
substantial additional funds to achieve our strategic objectives. Although we believe our existing cash and other resources will be
sufficient to fund our current projected cash requirements into the second half of 2023, we will require additional financing in the
future to fund our operations. Additional financing may not be available on acceptable terms, if at all. Our future capital
requirements will depend on many factors, including:
•
•
•
•
•
•
•
•
•
•
the progress and costs of our preclinical studies, clinical trials and other research and development activities;
the impact of the COVID-19 pandemic on our operations;
the scope, prioritization and number of our clinical trials and other research and development programs;
the amount of revenues we receive under our collaboration or licensing arrangements;
the costs of the development and expansion of our operational infrastructure;
the costs and timing of obtaining regulatory approval of our therapeutic candidates;
the ability of our collaborators to achieve development milestones, marketing approval and other events or developments under our collaboration
agreements;
the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;
the costs and timing of securing manufacturing arrangements for clinical or commercial production;
the costs of establishing sales and marketing capabilities or contracting with third parties to provide these capabilities for us;
57
•
•
•
•
the costs of acquiring or undertaking development and commercialization efforts for any future product candidates;
the magnitude of our general and administrative expenses;
interest and principal payments on the loan from Kreos Capital;
any cost that we may incur under current and future licensing arrangements relating to our therapeutic candidates;
• market conditions; and
•
payments to the IIA.
Until we can generate significant continuing revenues, we expect to satisfy our future cash needs through payments
received under our collaborations, debt or equity financings, or by out-licensing other product candidates. We cannot be certain
that additional funding will be available to us on acceptable terms, or at all.
If funds are not available, we may be required to delay, reduce the scope of, or eliminate one or more of our research or
development programs or our commercialization efforts.
C. Research and Development, Patents and Licenses
For our research and development policies, see “Item 4 — Information on the Company — Business Overview — Our
Strategy.” For information regarding patents, see Item 4 — Information on the Company — Intellectual Property.” For
information regarding licenses, see “Item 4 — Information on the Company — Collaboration and Out-Licensing Arrangements”
and Item 4 — Information on the Company — In-Licensing Agreements.”
D. Trend Information
We are a biopharmaceutical company that focuses on the development of our therapeutic candidates. It is not possible for
us to predict with any degree of accuracy the outcome of our research and development or commercialization efforts with regard
to any of our therapeutic candidates. Our research and development expenditure is our primary expenditure, although we may
incur substantial expenditure should we acquire any new therapeutic candidates. Increases or decreases in research and
development expenditure are primarily attributable to the level and results of our preclinical and clinical trial activities and the
amount of expenditure on those trials.
E. Off-Balance Sheet Arrangements
Since our inception, we have not entered into any transactions with unconsolidated entities whereby we have financial
guarantees, subordinated retained interests, derivative instruments or other contingent arrangements that expose us to material
continuing risks, contingent liabilities, or any other obligations under a variable interest in an unconsolidated entity that provides
us with financing, liquidity, market risk or credit risk support.
F. Contractual Obligations
The following table summarizes our significant contractual obligations at December 31, 2020:
Total
Less than
1 year
1-3 years
(in thousands of U.S. dollars)
4-5 years
More than
5 years
Car leasing obligations
Premises leasing obligations
Purchase commitments
Total
127
1,998
6,891
9,016
105
444
6,580
7,129
22
844
291
1,157
-
666
20
668
-
-
-
-
The premises leasing obligations in the foregoing table include our commitments under the lease agreement for our
facility in Modi’in. See “Item 4. Information on the Company — Property, Plant and Equipment.” The initial term of the lease
began on June 15, 2015 and expired June 2020. We have exercised an option to extend the lease through June 30, 2025 and have
the option to extend the lease for two additional lease periods totaling up to an additional 5 years, each option at a 5% increase to
the preceding lease payment amount. The monthly lease fee is $24,000. In addition, we pay building maintenance charges of
$8,000 per month.
58
The foregoing table does not include our in-licensing agreements. Under our in-licensing agreements, we are obligated to
make certain payments to our licensors upon the achievement of agreed-upon milestones. We are unable at this time to estimate
the actual amount or timing of the costs we will incur in the future under these agreements; however, we do not expect any
material financial milestone obligations to be achieved within the next 12 months. Some of the in-licensing agreements are
accompanied by consulting, support and cooperation agreements, pursuant to which we are required to pay the licensors a fixed
monthly amount, over a period stipulated in the applicable agreement, for their assistance in the continued research and
development under the applicable license. All of our in-licensing agreements are terminable at-will by us upon prior written
notice of 30 to 90 days. We are unable at this time to estimate the actual amount or timing of the costs we will incur in the future
under these agreements. See “Item 4. Information on the Company — Business Overview — In-Licensing Agreements.”
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A. Executive Officers and Directors
The following table sets forth information for our executive officers and directors as of February 22, 2021. Unless
otherwise stated, the address for our directors and officers is c/o BioLineRx Ltd., 2 HaMa’ayan Street, Modi’in 7177871, Israel.
Name
Age
Position(s)
Philip A. Serlin, CPA, MBA
Mali Zeevi, CPA
Ella Sorani, Ph.D.
Abi Vainstein-Haras, M.D.
Aharon Schwartz, Ph.D. (1)
Michael J. Anghel, Ph.D. (1)(4)
Nurit Benjamini, MBA (1)(2)(3)(4)
B.J. Bormann, Ph.D. (1)
Raphael Hofstein, Ph.D. (1)(2)(3)
Avraham Molcho, M.D. (1)(2)(3)
Sandra Panem, Ph.D. (1)
60
45
53
46
78
82
54
62
71
63
74
Chief Executive Officer
Chief Financial Officer
Chief Development Officer
Chief Medical Officer
Chairman of the Board
Director
External Director
Director
Director
External Director
Director
(1)
(2)
(3)
(4)
Independent director under applicable Nasdaq Capital Market and SEC rules, as affirmatively determined by our Board.
A member of our audit committee.
A member of our compensation committee.
A member of our investment monitoring committee.
Philip A. Serlin, CPA, MBA, has served as our Chief Executive Officer since October 2016. From May 2009 to October
2016, Mr. Serlin served as our Chief Financial and Operating Officer. From January 2008 to August 2008, Mr. Serlin served as
the Chief Financial Officer and Chief Operating Officer of Kayote Networks Inc. From January 2006 to December 2007, he
served as the Chief Financial Officer of Tescom Software Systems Testing Ltd., an IT services company publicly traded in both
Tel Aviv and London. His background also includes senior positions at Chiaro Networks Ltd. and at Deloitte, where he was head
of the SEC and U.S. Accounting Department at the National Office in Tel Aviv, as well as seven years at the SEC at its
Washington, D.C., headquarters. Mr. Serlin is a CPA and holds a B.Sc. in accounting from Yeshiva University and a Master’s
degree in economics and public policy from The George Washington University.
59
Mali Zeevi, CPA, has served as our Chief Financial Officer since October 2016. Prior to becoming Chief Financial
Officer, Ms. Zeevi served as our Senior Director of Finance and Reporting beginning in 2011 and as our Director of Finance and
Reporting beginning in 2009. Before joining BioLineRx, Ms. Zeevi was employed by Tescom Software Systems Testing Ltd., her
last position there being Vice President Finance. Ms. Zeevi also served as a CPA at Kesselman & Kesselman, a member firm of
PricewaterhouseCoopers International Limited. She holds a B.A. in business and accountancy from the College of Management
Academic Studies in Israel.
Ella Sorani, Ph.D., has served as our Chief Development Officer since January 2021. From February 2017 to December
2020, Dr. Sorani served as our Vice President Research and Development. Before joining BioLineRx, from 2000 through 2016,
Dr. Sorani served in a number of management positions in the global R&D division at Teva Pharmaceutical Industries Ltd. In her
most recent position as Senior Director and Global Project Leader, Dr. Sorani led the development of one of Teva’s leading
innovative late stage compounds. Dr. Sorani holds a B.Sc. in chemistry and an M.Sc. and Ph.D. in pharmacology, all from Tel
Aviv University.
Abi Vainstein-Haras, M.D., has served as our Chief Medical Officer since January 2021. From January 2017 to December
2020, Dr. Vainstein-Haras served as our Vice President Clinical Development. From June 2014 to January 2017, Dr. Vainstein-
Haras served as our Senior Medical Director responsible for the clinical development of all our clinical phase projects. Prior to
joining the Company, from 2012 to 2014, she served as the Director and Clinical Program Leader for COPAXONE® at Teva, and
from 2007 to 2012, she served in several medical positions in Innovative R&D at Teva. Dr. Vainstein-Haras holds an M.D. from
the University of Buenos Aires and is licensed to practice medicine in Israel.
Aharon Schwartz, Ph.D., has served as the Chairman of our Board of Directors since 2004. He served in a number of
positions in Teva from 1975 through 2011, the most recent being Vice President, Head of Teva Innovative Ventures from 2008.
Dr. Schwartz is currently a member of the board of directors of Protalix Ltd. (NYSE American:PLX), Foamix Pharmaceuticals
Ltd. (NASDAQ:FOMX) and Barcode Ltd. He also works as an independent consultant. Dr. Schwartz received his Ph.D. in
organic chemistry from the Weizmann Institute, his M.Sc. in organic chemistry from the Technion and a B.Sc. in chemistry and
physics from the Hebrew University of Jerusalem. In addition, Dr. Schwartz holds a Ph.D. from the Hebrew University of
Jerusalem in the history and philosophy of science.
Michael J. Anghel, Ph.D., has served on our Board of Directors since 2010 and on our Investment Monitoring Committee
since 2010. From 1977 to 1999, he led the Discount Investment Corporation Ltd. (of the IDB Group) activities in the fields of
technology and communications. Dr. Anghel was instrumental in founding Tevel, one of the first Israeli cable television operators
and later in founding Cellcom Israel Ltd. (NYSE:CEL), the second Israeli cellular operator. In 1999, he founded CAP Ventures,
an advanced technology investment company. From 2004 to 2005, Dr. Anghel served as CEO of DCM, the investment banking
arm of the Israel Discount Bank (TASE:DSCT). Over the years, Dr. Anghel has been involved in founding and managing various
technology enterprises and has served on the Boards of Directors of various major Israeli corporations and financial institutions,
many of them publicly traded in the U.S. and Israel. During the past two years, he completed long term tenures as director on the
boards of: Partner Communications Company, Ltd. (Nasdaq:PTNR, TASE:PTNR), Strauss Group Ltd. (TASE:STRS), and
Orbotech Ltd. (Nasdaq:ORBK), He currently serves as director on the boards of InMode Ltd. (Nasdaq:INMD) and Ellomay
Capital Ltd. (NYSE American: ELLO). Prior to launching his business career, Dr. Anghel served as a full-time member of the
faculty of the Recanati Graduate School of Business Administration of the Tel Aviv University, where he taught finance and
corporate strategy. He currently serves as Chairman of the Tel Aviv University’s Executive Program. Dr. Anghel holds a B.A.
(Economics) from the Hebrew University in Jerusalem and an MBA and Ph.D. (Finance) from Columbia University, New York.
Nurit Benjamini, MBA, has served as an external director on our Board of Directors and as the chairperson of our Audit
Committee of our Board of Directors since 2010. In addition, Ms. Benjamini has served on our Investment Monitoring
Committee since 2010 and on our Compensation Committee since 2012. Since December 2013, Ms. Benjamini has served as the
Chief Financial Officer of Crazy Labs Ltd. (formerly TabTale Ltd.), a company that creates fresh mobile content for everyone.
From 2011 to 2013, Ms. Benjamini served as the Chief Financial Officer of Wix.com Ltd. (Nasdaq:WIX); from 2007 through
2011, she served as the Chief Financial Officer of CopperGate Communications Ltd. (now Sigma Designs Israel Ltd., a
subsidiary of Sigma Designs Inc. (Nasdaq:SIGM)); and from 2000 through 2007, she served as the Chief Financial Officer of
Compugen Ltd. (Nasdaq: CGEN). Ms. Benjamini serves on the board of directors, and as chairperson of the audit committee, of
Allot Ltd. (Nasdaq:ALLT, TASE:ALLT), Gamida Cell Ltd. (Nasdaq:GMDA) and Caesarstone Ltd. (Nasdaq: CSTE). Ms.
Benjamini holds a B.A. in economics and business and an M.B.A. in finance, both from Bar Ilan University, Israel.
BJ Bormann, Ph.D., has served on our Board of Directors since August 2013. Dr. Bormann currently serves as the Vice
President of Translational Science and Network Alliances at The Jackson Laboratory, a non-profit organization focused on the
genetic basis of disease. Dr. Bormann was previously the Chief Executive Officer of Supportive Therapeutics, LLC, a Boston
based company that is developing two molecules for use in the supportive care of oncology patients. In the past several years Dr.
Bormann has held executive positions in several biotechnology companies including NanoMedical Systems (Austin, Texas),
Harbour Antibodies (Rotterdam, The Netherlands) and Pivot Pharmaceuticals (PVTF: OTC listed). Prior to these engagements,
Dr. Bormann was Senior Vice President responsible for world-wide alliances, licensing and business development at Boehringer
Ingelheim Pharmaceuticals, Inc. from 2007 to 2013. From 1996 to 2007, she served in a number of positions at Pfizer, Inc., the
last one being Vice President of Pfizer Global Research and Development and world-wide Head of Strategic Alliances. Dr.
Bormann serves on the board of directors of various companies, including Xeris Pharmaceuticals, Inc (NASDAQ:XERS). Dr.
Bormann received her Ph.D. in biomedical science from the University of Connecticut Health Center and her B.Sc. from Fairfield
University in biology. Dr. Bormann completed postdoctoral training at Yale Medical School in the department of pathology.
60
Raphael Hofstein, Ph.D., has served on our Board of Directors since 2003, our Audit Committee since 2007 and our
Compensation Committee since 2012. Dr. Hofstein has served as the President and Chief Executive Officer of MaRS Innovation
(a commercialization company for 15 of Toronto’s universities, institutions and research institutes plus the MaRS Discovery
District) since June 2009. From 2000 through June 2009, Dr. Hofstein was the President and Chief Executive Officer of Hadasit
Medical Research Services and Development Ltd., or Hadasit, the technology transfer company of Hadassah University
Hospitals. He has served as chairman of the board of directors of Hadasit since 2006. Prior to joining Hadasit, Dr. Hofstein was
the President of Mindsense Biosystems Ltd. and the Business Unit Director of Ecogen Inc. and has held a variety of other
positions, including manager of R&D and chief of immunochemistry at the International Genetic Science Partnership. Dr.
Hofstein serves on the board of directors of numerous companies. Dr. Hofstein received his Ph.D. and M.Sc. from the Weizmann
Institute of Science, and his B.Sc. in chemistry and physics from the Hebrew University in Jerusalem. Dr. Hofstein completed
postdoctoral training at Harvard Medical School in both the departments of biological chemistry and neurobiology.
Avraham Molcho, M.D., has served as an external director on our Board of Directors and on our Audit Committee since
2010. In addition, Dr. Molcho has served on our Compensation Committee since 2012. Dr. Molcho is the co-founder of Biolojic
Design Ltd., a technology platform that encourages human antibody discovery. In 2012, he became the co-founder of Ayana
Pharma Ltd. (formerly DoxoCure), a privately-held company engaged in the manufacturing of liposome-based therapeutics. He
served as Ayana’s Chief Executive Officer and director until 2019. From 2006 through 2008, Dr. Molcho served as the Chief
Executive Officer and Chairman of Neovasc Medical, a privately-held Israeli medical device company. From 2006 until 2019, Dr.
Molcho was a venture partner at Forbion Capital Partners, a Dutch life sciences venture capital firm. From 2001 through 2006,
Dr. Molcho was a managing director and the head of life sciences of Giza Venture Capital and, in that capacity, was involved in
the founding of our company. He was also the Deputy Director General of Abarbanel Mental Health Center, the largest acute
psychiatric hospital in Israel, from 1999 to 2001. Dr. Molcho holds an M.D. from Tel-Aviv University School of Medicine and an
MBA from Tel-Aviv University Recanati Business School.
Sandra Panem, Ph.D., has served on our Board of Directors since February 2014. She is currently a managing partner at
Cross Atlantic Partners, which she joined in 2000. She is also co-founder and President of NeuroNetworks Fund, a not-for-profit
venture capital fund focusing on epilepsy, schizophrenia and autism. From 1994 to 1999, Dr. Panem was President of Vector
Fund Management, the then asset management affiliate of Vector Securities International. Prior thereto, Dr. Panem served as Vice
President and Portfolio Manager for the Oppenheimer Global BioTech Fund, a mutual fund that invested in public and private
biotechnology companies. Previously, she was Vice President at Salomon Brothers Venture Capital, a fund focused on early and
later-stage life sciences and technology investments. Dr. Panem was also a Science and Public Policy Fellow in economic studies
at the Brookings Institution, and an Assistant Professor of Pathology at the University of Chicago. Dr. Panem currently serves on
the board of directors of Acorda Therapeutics, Inc. (Nasdaq:ACOR). Previously, Dr. Panem served on numerous boards of public
and private companies, including Martek Biosciences (Nasdaq:MATK), IBAH Pharmaceuticals (Nasdaq:IBAH), Confluent
Surgical, Molecular Informatics and Labcyte, Inc. She received a B.S. in biochemistry and a Ph.D. in microbiology from the
University of Chicago.
B. Compensation
Employment Agreements
We have entered into written employment agreements with each of our executive officers, the terms of which are
consistent with the provisions of our Compensation Policy for Executives and Directors, or Compensation Policy, which was
approved by our shareholders in July 2019. All of these agreements contain customary provisions regarding noncompetition,
confidentiality of information and assignment of inventions. However, the enforceability of the noncompetition provisions may
be limited under applicable law.
In addition, we have entered into agreements with each executive officer and director pursuant to which we have agreed
to indemnify each of them to the fullest extent permitted by law to the extent that these liabilities are not covered by directors’
and officers’ insurance. The terms of these agreements and of our directors’ and officers’ insurance are consistent with the
provisions of the Compensation Policy.
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Compensation of Directors and Senior Management
The following table presents in the aggregate all compensation we paid to all of our directors and senior management as a
group for the year ended December 31, 2020. The table does not include any amounts we paid to reimburse any of such persons
for costs incurred in providing us with services during this period.
All directors and senior management as a group, consisting of [11] persons
Pension,
retirement,
options and
other similar
benefits
Salaries, fees,
commissions
and bonuses
(in thousands of U.S. dollars)
1,259
1,505
In accordance with the Companies Law, the following table presents information regarding compensation actually
received by our four executive officers during the year ended December 31, 2020
Bonuses
Value of
Options Granted(2)
(in thousands of U.S. dollars)
All Other
Compensation(3)
Total
198
98
100
102
403
136
140
140
21
17
19
18
958
450
487
497
(1) “Social Benefits” include payments to the National Insurance Institute, advanced education funds, managers’
insurance and pension funds, vacation pay and recuperation pay as mandated by Israeli law.
(2) Consists of amounts recognized as share-based compensation expense on the Company’s statement of
comprehensive loss for the year ended December 31, 2020.
(3) “All Other Compensation” includes automobile-related expenses pursuant to the Company’s automobile leasing
program, telephone, basic health insurance and holiday presents.
For additional information concerning our equity compensation plan, see “— Beneficial Ownership of Executive Officers
and Directors — Equity Compensation Plan.”
C. Board Practices
Board of Directors
According to the Companies Law, the management of our business is vested in our Board of Directors. However, certain
of our committees are required to have a majority of independent directors. Our Board of Directors may exercise all powers and
may take all actions that are not specifically granted to our shareholders. Our executive officers are responsible for our day-to-
day management and have individual responsibilities established by our Board of Directors. Executive officers are appointed by
and serve at the discretion of our Board of Directors, subject to any applicable employment agreements we have entered into with
the executive officers.
Under the Companies Law, we are not required to have a majority of independent directors. We are required to appoint at
least two external directors, unless we qualify as an Eligible Company (as defined below) and opt to follow an exemption
provided under the Relief Regulations (as defined below). See “— External Directors.”
According to our Articles of Association, our Board of Directors must consist of at least five and not more than 10
directors, including external directors. Currently, our Board of Directors consists of seven directors, including two external
directors as required by the Companies Law. Pursuant to our Articles of Association, other than the external directors, for whom
special election requirements apply under the Companies Law (unless the company is an Eligible Company and opted to follow
the exemption provided under the Relief Regulations regarding appointment of external directors and composition of the audit
and compensation committees) as detailed below, our directors are elected at a general or extraordinary meeting of our
shareholders and serve on the Board of Directors until they are removed by the majority of our shareholders at a general or
extraordinary meeting of our shareholders or upon the occurrence of certain events, in accordance with the Companies Law and
our Articles of Association. In addition, our Articles of Association allow our Board of Directors to appoint directors, other than
external directors, to fill vacancies on the Board of Directors to serve until the next general meeting or extraordinary meeting, or
earlier if required by our Articles of Association or applicable law. We have held elections for each of our non-external directors
at each annual meeting of our shareholders since our initial public offering in Israel. External directors are elected for an initial
term of three years and may be elected, under certain conditions, to two additional terms, although the term of office for external
directors for Israeli companies traded on certain foreign stock exchanges, including Nasdaq, may be further extended under
certain conditions. External directors may be removed from office only pursuant to the terms of the Companies Law. Our last
annual meeting of shareholders was held in September 2020. For additional information concerning external directors, see “—
External Directors.”
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The Companies Law provides that an Israeli company may, under certain circumstances, exculpate an office holder from
liability with respect to a breach of his duty of care toward the company if appropriate provisions allowing such exculpation are
included in its articles of association. See “— Exculpation, insurance and indemnification of office holders.” Our Articles of
Association contain such provisions, and we have entered into agreements with each of our office holders undertaking to
indemnify them to the fullest extent permitted by law, to the extent that these liabilities are not covered by insurance.
In accordance with the exemption available to foreign private issuers under applicable Nasdaq rules, we do not follow the
requirements of the Nasdaq Rules with regard to the process of nominating directors, and instead follow Israeli law and practice,
in accordance with which our Board of Directors is authorized to recommend to our shareholders director nominees for election,
and, in some circumstances, our shareholders may nominate candidates for election as directors by the shareholders’ general
meeting.
In addition, under the Companies Law, our Board of Directors must determine the minimum number of directors who are
required to have financial and accounting expertise. Under applicable regulations, a director with financial and accounting
expertise is a director who, by reason of his or her education, professional experience and skill, has a high level of proficiency in
and understanding of business accounting matters and financial statements. He or she must be able to thoroughly comprehend the
financial statements of the listed company and initiate debate regarding the manner in which financial information is presented.
In determining the number of directors required to have such expertise, a company’s board of directors must consider, among
other things, the type and size of the company and the scope and complexity of its operations. Our Board of Directors has
determined that we require at least one director with the requisite financial and accounting expertise. Ms. Nurit Benjamini and Dr.
Michael J. Anghel have such financial and accounting expertise.
The term office holder is defined in the Companies Law as a general manager, chief business manager, deputy general
manager, vice general manager, executive vice president, vice president, or any other person assuming the responsibilities of any
of the foregoing positions, without regard to such person’s title, or a director or any other manager directly subordinate to the
general manager. Each person listed above under “Executive Officers and Directors” is an office holder under the Companies
Law.
Chairman of the Board. Under the Companies Law, a person cannot hold the role of both chairman of the board of
directors and chief executive officer of a company, without shareholder approval by special majority and for periods of time not
exceeding three years each. Furthermore, a person who is directly or indirectly subordinate to a chief executive officer of a
company may not serve as the chairman of the board of directors of that company and the chairman of the board of directors may
not otherwise serve in any other capacity in a company or in a subsidiary of that company other than as a director or the chairman
of the board of directors of such a subsidiary.
External Directors
Under Israeli law, the boards of directors of companies whose shares are publicly traded are required to include at least
two members who qualify as external directors. Each of our current external directors, Dr. Avraham Molcho and Ms. Nurit
Benjamini, was re-elected as an external director by our shareholders in July 2019 for an additional three-year term.
External directors must be elected by majority vote of the shares present and voting at a shareholders meeting, provided
that either:
•
•
the majority of the shares that are voted at the meeting, including at least a majority of the shares held by non-controlling shareholders or
shareholders who do not have a personal interest in the election of the external director (other than a personal interest not deriving from a
relationship with a controlling shareholder) who voted at the meeting, excluding abstentions, vote in favor of the election of the external director;
or
the total number of shares held by non-controlling, disinterested shareholders (as described in the preceding bullet point) that are voted against the
election of the external director does not exceed 2% of the aggregate voting rights in the company.
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After an initial term of three years, external directors may be re-elected to serve in that capacity for up to two additional
terms of three years provided that either (a) the board of directors has recommended such re-election and such re-election is
approved by a majority vote at a shareholders’ meeting, subject to the conditions described above for election of external
directors, (b) (1) the re-election has been recommended by one or more shareholders holding at least 1% of the company’s voting
rights and is approved by a majority of non-controlling, disinterested shareholders who hold among them at least 2% of the
company’s voting rights; and (2) the external director who has been nominated in such fashion by the shareholders is not a linked
or competing shareholder, and does not have or has not had, on or within the two years preceding the date of such person’s
appointment to serve as another term as external director, any affiliation with a linked or competing shareholder, or (c) the
external director has proposed himself for reappointment and the reappointment was approved by the majority described in (b)(1)
above. The term “linked or competing shareholder” means the shareholder(s) who nominated the external director for
reappointment or a material shareholder of the company holding more than 5% of the shares in the company, provided that at the
time of the reappointment, such shareholder(s) of the company, the controlling shareholder of such shareholder(s) of the
company, or a company under such shareholder(s) of the company’s control, has a business relationship with the company or are
competitors of the company; the Israeli Minister of Justice, in consultation with the Israeli Securities Authority, or ISA, may
determine that certain matters will not constitute a business relationship or competition with the company. The term of office for
external directors for Israeli companies traded on certain foreign stock exchanges, including Nasdaq, may be extended beyond
the initial three terms permitted under the Companies Law indefinitely in increments of additional three-year terms, provided in
each case that the following conditions are met: (a) the audit committee and the board of directors confirm that, in light of the
external director’s expertise and special contribution to the work of the board of directors and its committees, the re-election for
such additional period(s) is beneficial to the company; (b) the re-election is approved by the shareholders by a special majority
required for the re-election of external directors; and (c) the term of office of the external director, and the considerations of the
audit committee and the board of directors in deciding to recommend re-election of the external director for such additional term
of office, are presented to the shareholders prior to the vote on re-election. External directors may be removed from office by the
same percentage of shareholders required for their election or by a court, in each case, only under limited circumstances,
including ceasing to meet the statutory qualification for appointment or violating the duty of loyalty to the company. If an
external directorship becomes vacant and there are less than two external directors on the board of directors at the time, then the
board of directors is required under the Companies Law to call a shareholders’ meeting immediately to appoint a replacement
external director. Each committee of the board of directors that exercises the powers of the board of directors must include at
least one external director (unless the company is an Eligible Company and opted to follow the exemption provided under the
Relief Regulations regarding appointment of external directors and composition of the audit and compensation committees).
Under the Companies Law external directors of a company are prohibited from receiving, directly or indirectly, any
compensation from the company other than for their services as external directors pursuant to the provisions and limitations set
forth in regulations promulgated under the Companies Law.
A person may not serve as an external director if (a) the person is a relative of a controlling shareholder of a company or
(b) at the date of the person’s appointment or within the prior two years, the person, the person’s relatives, entities under the
person’s control, the person’s partner, the person’s employer, or anyone to whom that person is subordinate, whether directly or
indirectly, have or have had any affiliation with (1) a company, (2) a company’s controlling shareholder at the time of such
person’s appointment or (3) any entity that is either controlled by the company or under common control with the company at the
time of such appointment or during the prior two years. If a company does not have a controlling shareholder or a shareholder
who holds company shares entitling him to vote at least 25% of the votes in a shareholders meeting, then a person may not serve
as an external director if, such person or such person’s relative, partner, employer or any entity under the person’s control, has or
had, on or within the two years preceding the date of the person’s appointment to serve as external director, any affiliation with
the chairman of the company’s board, chief executive officer, a substantial shareholder who holds at least 5% of the issued and
outstanding shares of the company or voting rights which entitle him to vote at least 5% of the votes in a shareholders meeting, or
the chief financial officer of the company.
The term “affiliation” includes:
an employment relationship;
a business or professional relationship even if not maintained on a regular basis (excluding insignificant relationships);
control; and
service as an office holder, excluding service as a director in a private company prior to the first offering of its shares to the public if such director
was appointed as a director of the private company in order to serve as an external director following the public offering.
•
•
•
•
The term “relative” is defined as a spouse, sibling, parent, grandparent or descendant; a spouse’s sibling, parent or
descendant; and the spouse of each of such persons.
In addition, no person may serve as an external director if that person’s professional activities create, or may create, a
conflict of interest with that person’s responsibilities as a director or otherwise interfere with that person’s ability to serve as an
external director or if the person is an employee of the ISA or of an Israeli stock exchange. Furthermore, a person may not
continue to serve as an external director if he or she received direct or indirect compensation from us for his or her role as a
director. This prohibition does not apply to compensation paid or given for service as an external director in accordance with
regulations promulgated under the Companies Law or amounts paid pursuant to indemnification and/or exculpation contracts or
commitments and insurance coverage.
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Following the termination of an external director’s service on a board of directors, such former external director and his or
her spouse and children may not be provided a direct or indirect benefit by the company, its controlling shareholder or any entity
under its controlling shareholder’s control. This includes engagement to serve as an executive officer or director of the company
or a company controlled by its controlling shareholder or employment by, or providing services to, any such company for
consideration, either directly or indirectly, including through a corporation controlled by the former external director, for a period
of two years (and for a period of one year with respect to relatives of the former external director).
If at the time an external director is appointed all members of the board of directors are of the same gender, the external
director must be of the other gender. A director of one company may not be appointed as an external director of another company
if a director of the other company is acting as an external director of the first company at such time.
The Companies Law provides that an external director must meet certain professional qualifications or have financial and
accounting expertise and that at least one external director must have financial and accounting expertise. However, if at least one
of our other directors (1) meets the independence requirements of the Exchange Act, (2) meets the standards of the Nasdaq Rules
for membership on the audit committee and (3) has financial and accounting expertise as defined in the Companies Law and
applicable regulations, then neither of our external directors is required to possess financial and accounting expertise as long as
both possess other requisite professional qualifications. Our Board of Directors is required to determine whether a director
possesses financial and accounting expertise by examining whether, due to the director’s education, experience and
qualifications, the director is highly proficient and knowledgeable with regard to business-accounting issues and financial
statements, to the extent that the director is able to engage in a discussion concerning the presentation of financial information in
the company’s financial statements, among others. Furthermore, our Board of Directors is also required to take into consideration
a director’s education, experience and knowledge in any of the following: (1) accounting issues and accounting control issues
characteristic to the segment in which the company operates and to companies of the size and complexity of the company, (2) the
functions of the external auditor and the obligations imposed on such auditor, and (3) preparation of financial reports and their
approval in accordance with the Companies Law and the Israeli Securities Law, 5728-1968, or the Israeli Securities Law. The
regulations define a director with the requisite professional qualifications as a director who satisfies one of the following
requirements: (1) the director holds an academic degree in either economics, business administration, accounting, law or public
administration; (2) the director either holds an academic degree in any other field or has completed another form of higher
education in the company’s primary field of business or in an area which is relevant to the office of an external director; or (3) the
director has at least five years of experience serving in any one of the following, or at least five years of cumulative experience
serving in two or more of the following capacities: (1) a senior business management position in a corporation with a substantial
scope of business; (2) a senior position in the company’s primary field of business; or (3) a senior position in public
administration. Our Board of Directors has determined that Ms. Nurit Benjamini possesses “accounting and financial” expertise,
and that both of our external directors possess the requisite professional qualifications.
In addition, the Companies Regulations (Relief for Companies the Shares of which are Registered for Trading Outside of
Israel) – 2000, or the Relief Regulations, provide an exemption for companies the shares of which are listed for trading on
specified exchanges outside of Israel, including Nasdaq, provided that: (i) such company does not have a controlling shareholder;
and (ii) the company complies with the requirements of the foreign securities laws and stock exchange regulations applicable to
companies which are incorporated under the laws of such foreign countries with regard to appointing independent directors and
composition of the audit and compensation committees, or collectively, Eligible Companies. Any Eligible Company which opts
to comply with the applicable foreign securities laws and stock exchange regulations shall be exempt from the following rules
under the Companies Law: (i) the requirement to have at least two external directors appointed to serve in a public company; (ii)
that at least one of the external directors is required to have financial and accounting expertise and the rest are required to have
professional expertise; and (iii) that all of the board committees which are empowered and authorized to exercise any of the
board’s authorities must consist of at least one external director. The exemption from these rules under the Relief Regulations
requires that the board be composed of both male and female directors.
Audit Committee
Under the Companies Law, the board of directors of a public company must appoint an audit committee. The audit
committee must be comprised of at least three directors, including all of the external directors, and one of the external directors
must serve as chairperson of the committee. Additionally, a majority of the members of the committee must be independent
directors. The audit committee of a company may not include:
•
•
•
the chairman of the company’s board of directors;
a controlling shareholder or a relative of a controlling shareholder of the company (as each such term is defined in the Companies Law); or
any director employed by the company, by a controlling shareholder of the company or by any other entity controlled by a controlling shareholder
of the company, or any director who provides services to the company, to a controlling shareholder of the company or to any other entity
controlled by a controlling shareholder of the company on a regular basis (other than as a member of the board of directors), or any other director
whose main source of income derives from a controlling shareholder of the company.
65
The term “controlling shareholder” is defined in the Companies Law as a shareholder with the ability to direct the
activities of the company, other than by virtue of being an office holder. A shareholder is presumed to be a controlling
shareholder if the shareholder holds 50% or more of the voting rights in a company or has the right to appoint the majority of the
directors of the company or its general manager.
A majority of the total number of then-serving members of an audit committee shall constitute a quorum for the
transaction of business at the audit committee meetings, provided, that the majority of the members present at such meeting are
unaffiliated directors and at least one of such members is an external director.
The audit committee of a publicly traded company must consist of a majority of independent directors. An “independent
director” is defined as either an external director or as a director who meets the following criteria:
•
•
he or she meets the qualifications for being appointed as an external director, except for (i) the requirement that the director be an Israeli resident
(which does not apply to companies such as ours whose securities have been offered outside of Israel or are listed outside of Israel) and (ii) the
requirement for accounting and financial expertise or professional qualifications; and
he or she has not served as a director of the company for a period exceeding nine consecutive years. For this purpose, a break of less than two
years in the service shall not be deemed to interrupt the continuation of the service.
Any person who is not eligible to serve on the audit committee is further restricted from participating in its meetings and
votes, unless the chairman of the audit committee determines that such person’s presence is necessary in order to present a certain
matter, provided however, that company employees who are not controlling shareholders or relatives of such shareholders may be
present in the meetings but not for the actual votes, and likewise, company counsel or company secretary who are not controlling
shareholders or relatives of such shareholders may be present in the meetings and for the decisions if such presence is requested
by the audit committee.
The members of our Audit Committee are Ms. Nurit Benjamini (Chairperson), Dr. Avraham Molcho and Dr. Raphael
Hofstein. Pursuant to Nasdaq Rules, our Board of Directors may appoint one director to our Audit Committee who (1) is not an
Independent Director as defined in Nasdaq Marketplace Rule 5605(a)(2), (2) meets the criteria set forth in Section 10A(m)(3)
under the Exchange Act, and (3) is not one of our current officers or employees or “family member,” as defined in Nasdaq
Marketplace Rule 5605(a)(2), of an officer or employee, if our Board of Directors, under exceptional and limited circumstances,
determines that the appointment is in our best interests and the best interest of our shareholders, and our Board of Directors
discloses, in our next annual report subsequent to the determination, the nature of the relationship and the reasons for that
determination.
Our Board of Directors has determined that Ms. Nurit Benjamini (Chairperson) qualifies as an audit committee financial
expert as defined by rules of the SEC.
In November 2012, our Board of Directors adopted an audit committee charter that added to the responsibilities of our
Audit Committee under the Companies Law, setting forth the responsibilities of the audit committee consistent with the rules of
the SEC and the Nasdaq Rules, including the following:
•
•
•
oversight of the company’s independent registered public accounting firm and recommending the engagement, compensation or termination of
engagement of our independent registered public accounting firm to our Board of Directors in accordance with Israeli law;
recommending the engagement or termination of the office of our internal auditor; and
reviewing and pre-approving the terms of audit and non-audit services provided by our independent auditors.
Our Audit Committee provides assistance to our Board of Directors in fulfilling its legal and fiduciary obligations in
matters involving our accounting, auditing, financial reporting, internal control and legal compliance functions by pre-approving
the services performed by our independent accountants and reviewing their reports regarding our accounting practices and
systems of internal control over financial reporting. Our Audit Committee also oversees the audit efforts of our independent
accountants and takes those actions it deems necessary to satisfy itself that the accountants are independent of management.
Pursuant to the Companies Law, the audit committee of a company shall be responsible for: (i) determining whether there are
delinquencies in the business management practices of a company, including in consultation with an internal auditor or
independent auditor, and making recommendations to the company’s board of directors to improve such practices; (ii)
determining whether to approve certain related party transactions (including compensation of office holders or transactions in
which an office holder has a personal interest and whether such transaction is material or otherwise an extraordinary transaction);
(iii) where the company’s board of directors approves the working plan of the internal auditor, examining such working plan
before its submission to the board and proposing amendments thereto; (iv) examining internal control and the internal auditor’s
performance, including whether the internal auditor has sufficient resources and tools to dispose of his responsibilities (taking
into consideration the special needs and size of a company); (v) examining the scope of the auditor’s work and compensation and
submitting its recommendation with respect thereto to the corporate body considering the appointment thereof (either the board
or the general meeting of shareholders); and (vi) establishing procedures for the handling of employees’ complaints as to the
management of the business and the protection to be provided to such employees. The responsibilities of the audit committee
under the Companies Law also include the following matters: (i) the establishment of procedures to be followed in respect of
related party transactions with a controlling shareholder (where such are not extraordinary transactions), which may include,
where applicable, the establishment of a competitive process for such transaction, under the supervision of the audit committee,
or individual, or other committee or body selected by the audit committee, in accordance with criteria determined by the audit
committee; and (ii) to determine procedures for approving certain related party transactions with a controlling shareholder, which
having been determined by the audit committee not to be extraordinary transactions, were also determined by the audit committee
not to be negligible transactions. Under the Companies Law, the approval of the audit committee is required for specified actions
and transactions with office holders and controlling shareholders. See “— Approval of Related Party Transactions under Israeli
Law.”
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Pursuant to the Relief Regulations, companies the shares of which are listed for trading on specified exchanges outside of
Israel, including Nasdaq, and which qualify as Eligible Companies, are exempt from the following rules regarding the audit
committee under the Companies Law: (i) the committee shall be comprised of at least three members, who shall include all of the
external directors, and the majority of the members shall be independent; (ii) certain persons may not be members of the audit
committee; (iii) the controlling shareholder or his relatives shall not be members of the audit committee; (iv) the chairman of the
audit committee shall be an external director; (v) a person who is prohibited from being a member of the audit committee shall
not be present at the committee’s meetings; (vi) if the committee also serves as a financial reports committee, the rules applicable
to the financial reports committee shall apply; and (vii) the legal quorum shall be the majority of the committee members,
provided that the majority of directors present are independent, at least one of whom is an external director.
Compensation Committee
Pursuant to the Companies Law, the board of directors of an Israeli publicly-traded company is required to appoint a
compensation committee comprised of at least three members, including all of the external directors of a company, and one of the
external directors must serve as chairman of the committee. Additionally, a majority of the members of the Compensation
Committee are required to be independent directors. Such compensation committee may not include:
•
•
•
the chairman of the company’s board of directors;
a controlling shareholder or a relative of a controlling shareholder of the company (as each such term is defined in the Companies Law); or
any director employed by the company, by a controlling shareholder of the company or by any other entity controlled by a controlling shareholder
of the company, or any director who provides services to the company on a permanent basis, to a controlling shareholder of the company or to any
other entity controlled by a controlling shareholder of the company on a regular basis (other than as a member of the board of directors), or any
other director whose main source of income derives from a controlling shareholder of the company.
The term “controlling shareholder” is defined in the Companies Law as a shareholder with the ability to direct the
activities of the company, other than by virtue of being an office holder. A shareholder is presumed to be a controlling
shareholder if the shareholder holds 50% or more of the voting rights in a company or has the right to appoint the majority of the
directors of the company or its general manager.
A majority of the total number of then-serving members of a compensation committee shall constitute a quorum for the
transaction of business at the compensation committee meetings. The compensation committee of a publicly-traded company
must consist of a majority of external directors.
Pursuant to the Relief Regulations, companies the shares of which are listed for trading on specified exchanges outside of
Israel, including Nasdaq and qualify as Eligible Companies are exempt from the following rules regarding the compensation
committee under the Companies Law: (i) the board of a public company is required to appoint a compensation committee; and
(ii) the compensation committee shall be comprised of at least three members, all of the external directors shall be members and
shall constitute the majority of its members and the rest of the members shall be members whose terms of service are as required
under the Companies Law.
Any person who is not eligible to serve on the compensation committee is further restricted from participating in its
meetings and votes, unless the chairman of the compensation committee determines that such person’s presence is necessary in
order to present a certain matter, provided however, that company employees who are not controlling shareholders or relatives of
such shareholders may be present in the meetings but not for the actual votes, and likewise, company counsel and secretary who
are not controlling shareholders or relatives of such shareholders may be present in the meetings and for the decisions if such
presence is requested by the compensation committee.
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The responsibilities of the compensation committee include the following:
•
•
•
•
•
to make recommendations to the board of directors as to a compensation policy for officers, as well as to recommend once every three years to
extend the compensation policy, subject to receipt of the required corporate approvals;
to make recommendations to the board of directors as to any updates to the compensation policy which may be required;
to review the implementation of the compensation policy by the company;
to approve transactions relating to terms of office and employment of certain company office holders, that require the approval of the
compensation committee pursuant to the Companies Law; and
to exempt, under certain circumstances, a transaction relating to terms of office and employment from the requirement of approval of the
shareholders meeting.
In November 2012, in order to comply with certain requirements of the Companies Law which had been enacted shortly
prior to that, our Board of Directors established a Compensation Committee, comprised of Ms. Nurit Benjamini and Dr. Avraham
Molcho, our two external directors, and Dr. Raphael Hofstein. Ms. Nurit Benjamini serves as the Chairperson of our
Compensation Committee.
Under the Companies Law, a board of directors of an Israeli publicly-traded company, following the recommendation of
the compensation committee, is required to establish a compensation policy, to be approved by the shareholders of the company,
and pursuant to which the terms of office and compensation of the company’s officer holders will be decided.
A company’s compensation policy shall be determined based on, and take into account, certain parameters set forth in
Section 267B(a) and Parts A and B of Annex 1A of the Companies Law, which were legislated as part of Amendment 20.
Under the Companies Law, the board of directors of a publicly traded company is obligated, after considering the
recommendations of the compensation committee, to adopt a compensation policy according to which the compensation of the
company’s office holders will be determined. The final adoption of the compensation policy is subject to the approval of the
shareholders of the company, and such approval is subject to certain special majority requirements, as set forth in the Companies
Law, pursuant to which one of the following must be met:
(i)
(ii)
the majority of the votes includes at least a majority of all the votes of shareholders who are not controlling shareholders of the company
or who do not have a personal interest in the compensation policy and participating in the vote; abstentions shall not be included in the
total of the votes of the aforesaid shareholders; or
the total of opposing votes from among the shareholders described in subsection (i) above does not exceed 2% of all the voting rights in
the company.
For this purpose, under the Companies Law “personal interest” is defined as: (1) a shareholder’s personal interest in the
approval of an act or a transaction of the company, including (i) the personal interest of his or her relative (which includes for
these purposes any members of his/her (or his/her spouse’s) immediate family or the spouses of any such members of his or her
(or his/her spouse’s) immediate family); and (ii) a personal interest of a body corporate in which a shareholder or any of his/her
aforementioned relatives serves as a director or the chief executive officer, owns at least 5% of its issued share capital or its
voting rights or has the right to appoint a director or chief executive officer, but (2) excluding a personal interest arising solely
from the fact of holding shares in the company or in a body corporate.
Nonetheless, even if the shareholders of the company do not approve the compensation policy, the board of directors of a
company may approve the compensation policy, provided that the compensation committee and, thereafter, the board of directors
resolved, based on detailed, documented, reasons and after a second review of the compensation policy, that the approval of the
compensation policy is for the benefit of the company.
In December 2013, a general meeting of our shareholders approved our first Executive Compensation Policy which had
been recommended by our Compensation Committee and approved by our Board of Directors. At the annual general meeting of
our shareholders in July 2019, our shareholders approved an amended Compensation Policy, which will be in effect for three
years from the date of its approval, or until it is amended or re-approved at a meeting of our shareholders, whichever occurs
sooner. Below is a summary discussion of the provisions of the Compensation Policy:
The Compensation Policy includes, among other issues prescribed by the Companies Law, a framework for establishing
the terms of office and employment of our office holders, a recoupment policy and guidelines with respect to the structure of the
variable pay of our office holders.
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Compensation is considered performance-based to the extent that a direct link is maintained between compensation and
performance and that rewards are consistent with long-term stakeholder value creation. At the company level, we analyze the
overall compensation trends of the market in order to make informed decisions about our compensation approach.
According to the Compensation Policy, the fixed components of our office holder compensation will be examined at least
every two years and compared to the market. Our Board of Directors may change the amount of the fixed components for one or
more of our office holders after receiving a recommendation for such from our Compensation Committee, provided such change
is within the limits determined by the Compensation Policy. The change may be made if our Board of Directors concludes that
such a change would promote our goals, operating plans and objectives and after taking into account the business and legal
implications of the proposed change and its impact on our internal labor relations. Any such changes are subject to formal
approval by the relevant parties. Our Board of Directors will has the authority to approve a change in the incentive structure of all
executive officers, including but not limited to the chief executive officer, up to an immaterial amount in any one year
(immaterial being defined as a change of up to 5% of an officer’s total compensation). The fixed component of compensation
remunerates the specific role covered and scope of responsibilities. It also reflects the experience and skills required for each
position, as well as the level of excellence demonstrated and the overall quality of the office holder’s contribution to our business.
The weighting of fixed compensation within the overall package is designed to reduce the risk of excessively risk-oriented
behavior, to discourage initiatives focused on short-term results which might jeopardize our mid and long-term business
sustainability and value creation, and to allow us a flexible compensation approach. We offer our employees benefit plans based
on common practice in the local labor market of the office holder.
As for the variable components of compensation, the types and amounts of such components will be determined with an
aim at creating maximum matching between the Compensation Policy and our operating plan and objectives. Variable
components of compensation will be primarily based on measurable long-term criteria. Nevertheless, we are allowed to base a
non-material part of variable compensation on qualitative non-measurable criteria which focus on the office holder’s contribution
to the Company. Our variable compensation aims to remunerate for achievements by directly linking pay to performance
outcomes in the short and long term. To strengthen the alignment of shareholder interests and the interests of management and
employees, performance measurements reflect our actual results overall, as well as of the individual office holder. To support the
aforementioned principles, we provide two types of variable compensation: short-term - annual bonus; and long-term - stock
option plans.
Annual bonuses will be based on achievement of the business goals set out in our annual operating plan approved by the
board of directors at the beginning of each year. The operating plan encompasses all aspects of our activities and as such sets the
business targets for each member of the management team. Consequently, our Compensation Committee and Board of Directors
should be able to judge the suitability of a bonus payment by deliberating retrospectively at year end and comparing actual
performance and target achievements against the forecasted operating plan. The annual bonus mechanism will be directly tied to
meeting objectives - both our business objectives and the office holder’s personal objectives. The Board of Directors’ satisfaction
with the officer’s performance will also affect the bonus amount. Annual bonus payments are subject to the limitations set out in
the Compensation Policy and also subject to the discretion of our Compensation Committee and approval by the Board of
Directors. In order to maintain some measure of flexibility, after calculating the compensation amount, the Board of Directors
may exercise discretion about the final amount of the bonus.
Equity-based compensation may be granted in any form permitted under our share incentive plan in effect from time to
time and shall be made in accordance with the terms of such share incentive plan. Equity-based compensation to office holders
shall be granted from time to time and be individually determined and awarded according to the performance, educational
background, prior business experience, qualifications, role and the personal responsibilities of each officer. The vesting period
will generally be four years, with the vesting schedule to be determined in accordance with market compensation trends. Our
policy is to grant equity-based compensation with exercise prices at market value. Furthermore, in order to create a ceiling for the
variable compensation: (1) the aggregate value of annual grants to any one office holder (based on the Black Scholes calculation
on the date of grant) will be no more than the higher of 2% of our market capitalization at the end of the measurement period or
$1.5 million; and (2) it is our intention that the maximum outstanding equity awards under its share incentive plan will not exceed
12% of our total fully-diluted share capital. Our Board of Directors may, following approval by our Compensation Committee,
make provisions with respect to the acceleration of the vesting period of any office holder’s awards, including, without limitation,
in connection with a corporate transaction involving a change of control.
We have also established a defined ratio between the variable and the fixed components of compensation, as well as a
maximum amount for all variable components as of the date on which they are paid (or as of the grant date for non-cash variable
equity components), and subject to the limitations on variable compensation components which are set out in the Compensation
Policy.
In addition, we have established guidelines under which an office holder will refund to us part of the compensation
received, if it was paid based on information that was retroactively restated in our financial reports. Office holders shall be
required to make restitution for any payments made based on our operating performance, if such payments were based on false or
restated financial statements prepared at any time during the three years preceding discovery of the error.
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All compensation arrangements of office holders are to be approved in the manner prescribed by applicable law. Our
Compensation Committee will review the Compensation Policy on an annual basis, and monitor its implementation, and
recommend to our Board of Directors and shareholders to amend the Compensation Policy as it deems necessary from time to
time. The term of the Compensation Policy is three years from the date of its adoption, or July 2, 2022. Following such three-year
term, the Compensation Policy, including any revisions recommended by our Compensation Committee and approved by our
Board of Directors, as applicable, will be brought once again to the shareholders for approval.
Nominating Committee
Our Board of Directors does not currently have a nominating committee, having availed BioLineRx of the exemption
available to foreign private issuers under the Nasdaq Rules. See “Item 16G. Corporate Governance.”
Investment Monitoring Committee
Our Board of Directors has established an Investment Monitoring Committee which consists of the following four
members: Directors Dr. Michael Anghel (Chairperson) and Ms. Nurit Benjamini; Ms. Mali Zeevi, our Chief Financial Officer;
and Mr. Raziel Fried, our Treasurer and Budgetary Control Director. The function of the Investment Monitoring Committee
includes providing recommendations to our Board of Directors regarding investment guidelines and performing an on-going
review of the fulfillment of established investment guidelines. The Investment Monitoring Committee convenes for a meeting in
accordance with our needs, but in any event at least twice per year.
Internal Auditor
Under the Companies Law, the board of directors of an Israeli public company must appoint an internal auditor
recommended by the audit committee and nominated by the board of directors. An internal auditor may not be:
•
•
•
•
a person (or a relative of a person) who holds more than 5% of the company’s shares;
a person (or a relative of a person) who has the power to appoint a director or the general manager of the company;
an executive officer or director of the company; or
a member of the company’s independent accounting firm.
The role of the internal auditor is to examine, among other things, our compliance with applicable law and orderly
business procedures. Our internal auditor is Tali Yaron Adv. (LLB, LLM), a director at Deloitte Israel.
Approval of Related Party Transactions under Israeli Law
Fiduciary duties of office holders
The Companies Law imposes a duty of care and a duty of loyalty on all office holders of a company. The duty of care of
an office holder is based on the duty of care set forth in connection with the tort of negligence under the Israeli Torts Ordinance
(New Version) 5728-1968. This duty of care requires an office holder to act with the degree of proficiency with which a
reasonable office holder in the same position would have acted under the same circumstances. The duty of care includes a duty to
use reasonable means, in light of the circumstances, to obtain:
•
•
•
•
•
information on the advisability of a given action brought for his or her approval or performed by virtue of his or her position; and
all other important information pertaining to these actions.
The duty of loyalty requires an office holder to act in good faith and for the benefit of the company, and includes the duty to:
refrain from any act involving a conflict of interest between the performance of his or her duties in the company and his or her other duties or
personal affairs;
refrain from any activity that is competitive with the business of the company;
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•
•
refrain from exploiting any business opportunity of the company for the purpose of gaining a personal advantage for himself or herself or others;
and
disclose to the company any information or documents relating to the company’s affairs which the office holder received as a result of his or her
position as an office holder.
We may approve an act performed in breach of the duty of loyalty of an office holder provided that the office holder acted
in good faith, the act or its approval does not harm the company, and the office holder discloses his or her personal interest, as
described below.
Disclosure of personal interests of an office holder and approval of acts and transactions
The Companies Law requires that an office holder promptly disclose to the company any personal interest that he or she
may have and all related material information or documents relating to any existing or proposed transaction by the company. An
interested office holder’s disclosure must be made promptly and in any event no later than the first meeting of the board of
directors at which the transaction is considered. An office holder is not obliged to disclose such information if the personal
interest of the office holder derives solely from the personal interest of his or her relative in a transaction that is not considered as
an extraordinary transaction.
The term personal interest is defined under the Companies Law to include the personal interest of a person in an action or
in the business of a company, including the personal interest of such person’s relative or the interest of any corporation in which
the person is an interested party, but excluding a personal interest stemming solely from the fact of holding shares in the
company. A personal interest furthermore includes the personal interest of a person for whom the office holder holds a voting
proxy or the interest of the office holder with respect to his or her vote on behalf of the shareholder for whom he or she holds a
proxy even if such shareholder itself has no personal interest in the approval of the matter. An office holder is not, however,
obliged to disclose a personal interest if it derives solely from the personal interest of his or her relative in a transaction that is not
considered an extraordinary transaction.
Under the Companies Law, an extraordinary transaction which requires approval is defined as any of the following:
•
•
•
a transaction other than in the ordinary course of business;
a transaction that is not on market terms; or
a transaction that may have a material impact on the company’s profitability, assets or liabilities.
Under the Companies Law, once an office holder has complied with the disclosure requirement described above, a
company may approve a transaction between the company and the office holder or a third party in which the office holder has a
personal interest, or approve an action by the office holder that would otherwise be deemed a breach of duty of loyalty. However,
a company may not approve a transaction or action that is adverse to the company’s interest or that is not performed by the office
holder in good faith.
Under the Companies Law, unless the articles of association of a company provide otherwise, a transaction with an office
holder, a transaction with a third party in which the office holder has a personal interest, and an action of an office holder that
would otherwise be deemed a breach of duty of loyalty requires approval by the board of directors. Our Articles of Association
do not provide otherwise. If the transaction or action considered is (i) an extraordinary transaction or (ii) an action of an office
holder that would otherwise be deemed a breach of duty of loyalty and may have a material impact on a company’s profitability,
assets or liabilities, then audit committee approval is required prior to approval by the board of directors.
Under the Companies Law, a transaction with an office holder in a public company regarding his or her terms of office
and employment should be determined in accordance with the company’s compensation policy. Nonetheless, provisions were
established that allow a company, under special circumstances, to approve terms of office and employment that are not in line
with the approved compensation policy. The following are required for the approval of the terms of office or employment of the
officers of a public company:
•
A transaction with an office holder in a public company that is neither a director nor the chief executive officer regarding his or her terms of office
and employment requires approval by the (i) compensation committee; and (ii) the board of directors. Approval of terms of office and employment
for such officers which do not comply with the compensation policy may nonetheless be approved subject to two cumulative conditions: (i) the
compensation committee and thereafter the board of directors, approved the terms after having taken into account the various considerations and
mandatory requirements set forth in the Companies Law with respect to office holder compensation, and (ii) the shareholders of the company have
approved the terms by means of the following special majority requirements, or the Special Majority Requirements, as set forth in the Companies
Law, pursuant to which the shareholder approval must either include at least one-half of the shares held by non-controlling and disinterested
shareholders who actively participate in the voting process (without taking abstaining votes into account), or, alternatively, the total shareholdings
of the non-controlling and disinterested shareholders who vote against the transaction must not represent more than 2% of the voting rights in the
company. However, the transaction may still be approved despite shareholder rejection, provided that a company’s compensation committee and
thereafter the board of directors have determined to approve the proposal, based on detailed reasoning, after having re-examined the terms of
office and employment, and taken the shareholder rejection into consideration.
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•
•
A transaction with the chief executive officer in a public company regarding his or her terms of office and employment requires approval by the (i)
compensation committee; (ii) the board of directors; and (iii) the shareholders of the company by the Special Majority Requirements. Approval of
terms of office and employment for the chief executive officer which do not comply with the compensation policy may nonetheless be approved
subject to two cumulative conditions: (i) the compensation committee and thereafter the board of directors, approved the terms after having taken
into account the various considerations and mandatory requirements set forth in the Companies Law with respect to office holder compensation
and (ii) the shareholders of the company have approved the terms by means of the Special Majority Requirements, as detailed above. However, a
transaction with a chief executive officer that is not approved by shareholders may still be approved despite shareholder rejection, provided that a
company’s compensation committee and thereafter the board of directors have determined to approve the proposal, based on detailed reasoning,
after having re-examined the terms of office and employment, and taken the shareholder rejection into consideration. In addition, the
compensation committee may exempt the transaction regarding terms of office and employment with a candidate for the office of chief executive
officer where such officer has no relationship with the controlling shareholder or the company from shareholder approval if it has found, based on
detailed reasons, that bringing the transaction to the approval of the shareholders meeting shall prevent the employment of such candidate by the
company. Such approval may be given only in respect of terms of office and employment which are in accordance with the company’s
compensation policy.
A transaction with a director who is not the chief executive officer of a public company regarding his or her terms of office and engagement
requires approval by the (i) compensation committee; (ii) the board of directors; and (iii) the shareholders of the company. Approval of terms of
office and employment for directors of a company which do not comply with the compensation policy may nonetheless be approved subject to two
cumulative conditions: (i) the compensation committee and thereafter the board of directors, approved the terms after having taken into account
the various considerations and mandatory requirements set forth in the Companies Law with respect to office holder compensation and (ii) the
shareholders of the company have approved the terms by means of the Special Majority Requirements, as detailed above. In addition, pursuant to
a relief provided under the Companies Regulations (Relief in Interested Party Transactions), 2000, the compensation committee may exempt the
transaction regarding terms of office and engagement with a non-executive director, if the compensation committee and board of directors
determined that such terms of office are only for the benefit of the company, or if the compensation terms of the director do not exceed the
maximum compensation paid to external directors pursuant to the applicable regulations.
A director who has a personal interest in a matter that is considered at a meeting of the board of directors or the audit
committee may generally not be present at the meeting or vote on the matter unless a majority of the directors or members of the
audit committee have a personal interest in the matter, or, unless the chairman of the audit committee or board of directors (as
applicable) determines that he or she should be present to present the transaction that is subject to approval. If a majority of the
directors have a personal interest in the matter, such matter also requires approval of the shareholders of the company by the
Special Majority Requirements.
Disclosure of personal interests of a controlling shareholder and approval of transactions
Under the Companies Law, the disclosure requirements that apply to an office holder also apply to a controlling
shareholder of a public company. See “— Audit Committee” for the general definition of controlling shareholder under the
Companies Law. The definition of “controlling shareholder” in connection with matters governing: (i) extraordinary transactions
with a controlling shareholder or in which a controlling shareholder has a personal interest, (ii) certain private placements in
which the controlling shareholder has a personal interest, (iii) certain transactions with a controlling shareholder or relative with
respect to services provided to or employment by the company, (iv) the terms of employment and compensation of the general
manager, and (v) the terms of employment and compensation of office holders of the company when such terms deviate from the
compensation policy previously approved by the company’s shareholders, also includes shareholders that hold 25% or more of
the voting rights if no other shareholder owns more than 50% of the voting rights in the company (and the holdings of two or
more shareholders which each have a personal interest in such matter will be aggregated for the purposes of determining such
threshold).
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Under the Companies Law, extraordinary transactions with a controlling shareholder or in which a controlling shareholder
has a personal interest, including a private placement in which a controlling shareholder has a personal interest, as well as
transactions for the provision of services whether directly or indirectly by a controlling shareholder or his or her relative, or a
company such controlling shareholder controls, require the approval of the audit committee, the board of directors and the
shareholders, in that order. Transactions concerning the terms of engagement of a controlling shareholder or a controlling
shareholder’s relative, whether as an office holder or an employee, require the approval of the compensation committee, the
board of directors and the shareholders, in that order. In addition, the approval of such extraordinary transactions by the
shareholders require at least a majority of the shares voted by the shareholders of the company participating and voting in a
shareholders’ meeting, provided that one of the following requirements is fulfilled:
•
•
at least a majority of the shares held by shareholders who have no personal interest in the transaction and are voting at the meeting must be voted
in favor of approving the transaction, excluding abstentions; or
the shares voted by shareholders who have no personal interest in the transaction who vote against the transaction represent no more than 2% of
the voting rights in the company.
If such transaction concerns the terms of office and employment of such controlling shareholder, in his capacity as an
office holder or an employee of the company, such terms of office and employment approved by the compensation committee and
board of directors shall be in accordance with the compensation policy of the company. Nonetheless, the compensation
committee and the board of directors may approve terms of office and compensation of a controlling shareholder which do not
comply with the company’s compensation policy, provided that the compensation committee and, thereafter, the board of
directors approve such terms, based on, among other things, the considerations listed under Section 267B(a) and Parts A and B of
Annex 1A of the Companies Law, as those are described above. Following such approval by the compensation committee and
board of directors, shareholder approval would be required.
To the extent that any such transaction with a controlling shareholder is for a period extending beyond three years,
approval, in the same manner described above, is required once every three years, unless, with respect to extraordinary
transactions with a controlling shareholder or in which a controlling shareholder has a personal interest, the audit committee
determines that the duration of the transaction is reasonable given the circumstances related thereto.
Duties of shareholders
Under the Companies Law, a shareholder has a duty to refrain from abusing its power in the company and to act in good
faith and in an acceptable manner in exercising its rights and performing its obligations to the company and other shareholders,
including, among other things, voting at general meetings of shareholders on the following matters:
•
•
•
•
an amendment to the articles of association;
an increase in the company’s authorized share capital;
a merger; and
the approval of related party transactions and acts of office holders that require shareholder approval.
A shareholder also has a general duty to refrain from discriminating against other shareholders.
The remedies generally available upon a breach of contract will also apply to a breach of the above-mentioned duties, and
in the event of discrimination against other shareholders, additional remedies are available to the injured shareholder.
In addition, any controlling shareholder, any shareholder that knows that its vote can determine the outcome of a
shareholder vote and any shareholder that, under a company’s articles of association, has the power to appoint or prevent the
appointment of an office holder, or has another power with respect to a company, is under a duty to act with fairness towards the
company. The Companies Law does not describe the substance of this duty except to state that the remedies generally available
upon a breach of contract will also apply in the event of a breach of the duty to act with fairness, taking the shareholder’s position
in the company into account.
Exculpation, insurance and indemnification of office holders
Under the Companies Law, a company may not exculpate an office holder from liability for a breach of the duty of
loyalty. An Israeli company may exculpate an office holder in advance from liability to the company, in whole or in part, for
damages caused to the company as a result of a breach of duty of care but only if a provision authorizing such exculpation is
included in its articles of association. Our Articles of Association include such a provision. An Israeli company may not
exculpate a director from liability arising out of a prohibited dividend or distribution to shareholders.
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An Israeli company may indemnify an office holder in respect of the following liabilities and expenses incurred for acts
performed as an office holder, either in advance of an event or following an event, provided a provision authorizing such
indemnification is contained in its articles of association:
•
•
•
financial liability imposed on him or her in favor of another person pursuant to a judgment, settlement or arbitrator’s award approved by a court.
However, if an undertaking to indemnify an office holder with respect to such liability is provided in advance, then such an undertaking must be
limited to events which, in the opinion of the board of directors, can be foreseen based on the company’s activities when the undertaking to
indemnify is given, and to an amount or according to criteria determined by the board of directors as reasonable under the circumstances, and such
undertaking shall detail the abovementioned events and amount or criteria;
reasonable litigation expenses, including attorneys’ fees, incurred by the office holder as a result of an investigation or proceeding instituted
against him or her by an authority authorized to conduct such investigation or proceeding, provided that (1) no indictment was filed against such
office holder as a result of such investigation or proceeding; and (2) no financial liability, such as a criminal penalty, was imposed upon him or her
as a substitute for the criminal proceeding as a result of such investigation or proceeding or, if such financial liability was imposed, it was imposed
with respect to an offense that does not require proof of criminal intent; and
reasonable litigation expenses, including attorneys’ fees, incurred by the office holder or imposed by a court in proceedings instituted against him
or her by the company, on its behalf or by a third party or in connection with criminal proceedings in which the office holder was acquitted or as a
result of a conviction for an offense that does not require proof of criminal intent.
An Israeli company may insure an office holder against the following liabilities incurred for acts performed as an office
holder if and to the extent provided in the company’s articles of association:
•
•
•
a breach of duty of loyalty to the company, to the extent that the office holder acted in good faith and had a reasonable basis to believe that the act
would not prejudice the company;
a breach of duty of care to the company or to a third party, including a breach arising out of the negligent (but not grossly negligent) conduct of the
office holder; and
a financial liability imposed on the office holder in favor of a third party.
An Israeli company may not indemnify or insure an office holder against any of the following, and any provision in a
company's articles of association which allows for any of the following is invalid:
•
•
•
•
a breach of duty of loyalty, except to the extent that the office holder acted in good faith and had a reasonable basis to believe that the act would
not prejudice the company;
a breach of duty of care committed intentionally or recklessly, excluding a breach arising out of the negligent conduct of the office holder;
an act or omission committed with intent to derive illegal personal benefit; or
a fine or forfeit levied against the office holder.
Under the Companies Law and the regulations promulgated thereunder, exculpation, indemnification and insurance of
office holders must be approved by the compensation committee and the board of directors and must be provided in accordance
with the Company’s Compensation Policy duly adopted by the shareholders.
An amendment to the Israeli Securities Law and a corresponding amendment to the Companies Law authorize the ISA to
impose administrative sanctions against companies like ours, and their office holders for certain violations of the Israeli
Securities Law or the Companies Law. These sanctions include monetary sanctions and certain restrictions on serving as a
director or senior officer of a public company for certain periods of time. The amendments to the Israeli Securities Law and to the
Companies Law provide that only certain types of such liabilities may be reimbursed by indemnification and insurance.
Specifically, legal expenses (including attorneys’ fees) incurred by an individual in the applicable administrative enforcement
proceeding and certain compensation payable to injured parties for damages suffered by them are permitted to be reimbursed via
indemnification or insurance, provided that such indemnification and insurance are authorized by the company’s articles of
association and receive the requisite corporate approvals.
Our Articles of Association allow us to indemnify and insure our office holders for any liability imposed on them as a
consequence of an act (including any omission) which was performed by virtue of being an office holder. In November 2011, our
shareholders approved (i) the amendment of our Articles of Association to authorize indemnification and insurance in connection
with administrative enforcement proceedings, including without limitation, the specific amendments to the Israeli Securities Law
and the Companies Law described above and (ii) a new form of indemnification letter for our directors and officers so as to
reflect the amendment to our Articles of Association, which new form of letter was also approved in October 2011 by our Audit
Committee and Board of Directors, and in November 2011 by our shareholders. The terms of such agreements are consistent with
the provisions of the Compensation Policy which was approved by our shareholders in July 2019.
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Our office holders are currently covered by a directors’ and officers’ liability insurance policy. The terms of such
directors’ and officers’ insurance are consistent with the provisions of the Compensation Policy which was approved by our
shareholders in July 2019 and in March 2020. The Compensation Policy authorizes us to purchase insurance policies (including
run-off policies) to cover the liability of directors and office holders that are in office at such time and that shall be in office from
time to time, including directors and office holders that may have a controlling interest in the Company. Such insurance policies
are authorized within the following limits: (1) the premium for each policy period shall not exceed $550,000, (2) the maximum
aggregate limit of liability pursuant to the policies shall not exceed $20 million for each insurance period, and (3) the maximum
deductible shall not exceed $250,000. In addition, the Compensation Committee is authorized to increase the coverage purchased
and/or the premium paid for such policies by up to 30% per year, as compared to the previous year, or cumulatively for a number
of years, without an additional shareholders’ approval to the extent permitted under the Companies Law. See also “Related Party
Transactions — Indemnification Agreements.”
As of the date of this Annual Report on Form 20-F, no claims have been filed under our directors’ and officers’ liability
insurance policy, there is no pending litigation or proceeding against any of our directors or officers as to which indemnification
is being sought, nor are we aware of any pending or threatened litigation that may result in claims for indemnification by any
director or officer.
For significant ways in which our corporate governance practices differ from those required by the Nasdaq Rules, see
“Item 16G. Corporate Governance.”
D. Employees
As of December 31, 2020, we had 38 employees, all of whom are employed in Israel. Of our employees, 14 hold M.D. or
Ph.D. degrees.
Management and administration
Research and development
Sales and marketing
Total
2018
December 31,
2019
2020
10
34
4
48
10
30
2
42
9
27
2
38
While none of our employees are party to any collective bargaining agreements, in Israel we are subject to certain labor
statutes and national labor court precedent rulings, as well as to certain provisions of the collective bargaining agreements
between the Histadrut (General Federation of Labor in Israel) and the Coordination Bureau of Economic Organizations
(including the Industrialists’ Associations) which are applicable to our employees by virtue of expansion orders issued in
accordance with relevant labor laws by the Israel Ministry of Labor and Welfare, and which apply such agreement provisions to
our employees even though they are not directly part of a union that has signed a collective bargaining agreement. The laws and
labor court rulings that apply to our employees principally concern the minimum wage laws, procedures for dismissing
employees, determination of severance pay, leaves of absence (such as annual vacation or maternity leave), sick pay and other
conditions for employment. The expansion orders which apply to our employees principally concern the requirement for length
of the workday and work week, mandatory contributions to a pension fund, annual recreation allowance, travel expenses payment
and other conditions of employment. We generally provide our employees with benefits and working conditions beyond the
required minimums.
We have never experienced any employment-related work stoppages and believe our relationship with our employees is
good.
75
E. Share Ownership
The following table sets forth information regarding the beneficial ownership of our outstanding ordinary shares as of
February 22, 2021 of each of our directors and executive officers individually and as a group.
Directors
Aharon Schwartz(1)
Michael J. Anghel(2)
Nurit Benjamini(3)
B.J. Bormann(4)
Raphael Hofstein(5)
Avraham Molcho(6)
Sandra Panem(7)
Executive officers
Philip A. Serlin(8)
Mali Zeevi(9)
Ella Sorani(10)
Abi Vainstein-Haras(11)
Number of
Ordinary
Shares
Beneficially Percent of
Held
Class
2,011,666
256,666
236,666
256,666
256,666
236,666
269,166
2,436,817
1,019,687
812,842
1,006,917
*
*
*
*
*
*
*
*
*
*
*
All directors and executive officers as a group (11 persons)(12)
8,800,425
1.38%
*
Less than 1.0%.
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
Includes 256,666 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 133,334
ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of February 22, 2021.
Includes 256,666 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 133,334
ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of February 22, 2021.
Includes 236,666 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 133,334
ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of February 22, 2021.
Includes 256,666 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 133,334
ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of February 22, 2021.
Includes 256,666 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 133,334
ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of February 22, 2021.
Includes 236,666 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 133,334
ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of February 22, 2021.
Includes 269,166 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 133,334
ordinary shares issuable upon exercise of outstanding options that are not exercisable within 60 days of February 22, 2021.
Includes 2,264,899 issued ordinary shares upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 1,180,657
ordinary shares issuable upon exercise of outstanding equity instruments that are not exercisable within 60 days of February 22, 2021.
Includes 942,337 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 1,631,733
ordinary shares issuable upon exercise of outstanding equity instruments that are not exercisable within 60 days of February 22, 2021.
(10)
Includes 746,692 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 1,636,658
ordinary shares issuable upon exercise of outstanding equity instruments that are not exercisable within 60 days of February 22, 2021.
(11)
Includes 924,167 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 1,649,783
ordinary shares issuable upon exercise of outstanding equity instruments that are not exercisable within 60 days of February 22, 2021.
(12)
Includes 6,647,257 ordinary shares issuable upon exercise of outstanding options within 60 days of February 22, 2021. Does not include 7,032,169
ordinary shares issuable upon exercise of outstanding equity instruments that are not exercisable within 60 days of February 22, 2021.
76
Change in Control
To our knowledge, (i) we are not directly or indirectly owned or controlled by another corporation, by any foreign
government or by any other natural or legal person severally or jointly, except as disclosed in the above table regarding our major
shareholders, and (ii) there are no arrangements which would result in our change in control at a subsequent date.
Significant Changes in the Ownership of Major Shareholders
To our knowledge, other than as disclosed in the table above, our other filings with the SEC and this Annual Report, there
has been no significant change in the percentage ownership held by any major shareholder since January 1, 2018.
Major Shareholders Voting Rights
Our major shareholders do not have different voting rights.
Record Holders
Bank of New York Mellon, or BNY, is the holder of record for the Company’s American Depositary Receipt program,
pursuant to which each ADS represents 15 ordinary shares. As of February 19, 2020, BNY held 577,530,326 ordinary shares
representing 90.7% of our issued share capital held at that date. Certain of these ordinary shares were held by brokers or other
nominees. As a result, the number of holders of record or registered holders in the United States is not representative of the
number of beneficial holders or of the residence of beneficial holders.
Equity Compensation Plan
2003 Share Incentive Plan
In 2003, we adopted the BioLineRx Ltd. 2003 Share Incentive Plan, or the Plan. The Plan provides for the granting of
options, ordinary shares, restricted stock units and performance stock units to our directors, employees, consultants and service
providers, and to the directors, employees, consultants and service providers of our subsidiaries and affiliates. The Plan provides
for equity grants to be made at the determination of our Board of Directors in accordance with applicable law. As of February 22,
2021, there were 36.1 million ordinary shares issuable upon the exercise of outstanding equity grants under the Plan.
In August 2013, our Board of Directors approved amendments to the Plan to take into account changes in laws and
regulations that had occurred since its adoption and to extend the term of the plan until November 2023. In January 2016, our
Board of Directors approved amendments to the Plan in order to permit the granting of restricted stock units, or RSUs, and
performance stock units, or PSUs, to eligible grantees.
From time to time, our Board of Directors has approved an increase in the number of shares reserved for the purpose of
equity grants pursuant to the Plan. As of February 22, 2021, the number of shares so reserved was 8.6 million.
Administration of Our Plan
Our Plan is administered by our Board of Directors for the purposes of making equity grants and approving the terms of
those grants, including, in the case of options, exercise price, method of payment, vesting schedule, acceleration of vesting and
the other matters necessary in the administration of these plans. Equity grants made under the Plan to eligible employees and
office holders are made under Section 102 of the Israel Income Tax Ordinance pursuant to which the securities granted must be
allocated or issued to a trustee and be held in trust for two years from the date upon which such grant was made, provided that
securities granted prior to January 1, 2006, or the ordinary shares issued upon exercise of options, are subject to being held in
trust for two years from the end of the year in which the securities are granted. Under Section 102, any tax payable by an
employee from the grant of securities or the exercise of options is deferred until the transfer of the securities (or ordinary shares
issued upon the exercise of options) by the trustee to the employee or upon the sale of the securities or ordinary shares, as the
case may be, and gains may qualify to be taxed as capital gains at a rate equal to 25%, subject to compliance with specified
conditions.
Options granted under the Plan generally vest over four years, and they expire 10 years from the grant date. If we
terminate an employee for cause, all of the employee’s vested and unvested options expire immediately from the time of delivery
of the notice of discharge, unless determined otherwise by the Audit Committee or the Board of Directors. Upon termination of
employment for any other reason, including due to death or disability of the employee, vested options may be exercised within
three months of the termination date, unless otherwise determined by the Compensation Committee or the Board of Directors.
Vested options which are not exercised and unvested options return to the pool of reserved ordinary shares under the Plan for
reissuance. The right to receive ordinary shares pursuant to PSUs granted under the Plan will vest upon the achievement by
BioLineRx of certain performance goals to be established by the Board of Directors.
In the event of a merger, consolidation, reorganization or similar transaction or our voluntary liquidation or dissolution, all
of our unexercised vested equity grants and any unvested equity grants will be automatically terminated. However, in the event of
a change of control, or merger, consolidation, reorganization or similar transaction resulting in the acquisition of at least 50% of
our voting power, or the sale or transfer of all or substantially all of our outstanding shares assets, the equity grants then
outstanding may be assumed or substituted for an appropriate number of shares of each class of shares or other securities and/or
assets of the successor company in such transaction (or a parent or subsidiary or another affiliate of such successor company) as
were distributed to our shareholders in respect of the transaction. In addition to the foregoing, our Board of Directors has
approved the inclusion in the option agreements of the Company’s officers of a provision for accelerated vesting of options if
both a change of control of the Company occurs and, following such change of control, the officer’s employment is terminated or
there is a significant demotion in the officer’s new job or position.
To our knowledge the significant changes in the percentage of ownership held by our major shareholders reported in our
Annual Reports on Form 20-F during the past three have been the decrease in 2020 below 5% in the percentage ownership held
by BVF Partners L.P. and Senvest Management, LLC.
77
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A. Major Shareholders
Except as set forth in “Item 6. Directors, Senior Management and Employees—E. Share Ownership,” to the best of our
knowledge, no other person who we know beneficially owns 5.0% or more of the Company’s ordinary shares outstanding as of
February 22, 2020.
B. Related Party Transactions
Agreements with Directors and Officers
Employment Agreements
We have entered into employment agreements with each of our executive officers. See “Item 6. Directors, Senior
Management and Employees — Compensation of Directors and Senior Management.”
Indemnification Agreements
Our Articles of Association and Compensation Policy approved by our shareholders permit us to exculpate, indemnify
and insure our directors and office holders to the fullest extent permitted by the Companies Law. We have entered into
agreements with each of our office holders undertaking to indemnify them to the fullest extent permitted by law, including with
respect to liabilities resulting from this offering to the extent that these liabilities are not covered by insurance. We have obtained
directors’ and officers’ insurance for each of our officers and directors. See “Item 6. Directors, Senior Management and
Employees — Board Practices — Exculpation, insurance and indemnification of office holders.”
C. Interests of Experts and Counsel
Not applicable.
ITEM 8. FINANCIAL INFORMATION
A. Consolidated Statements and other Financial Information
See “Item 18. Financial Statements.”
Legal Proceedings
We are not involved in any material legal proceedings.
Dividend Distributions
We have never declared or paid cash dividends to our shareholders. Currently we do not intend to pay cash dividends. We
currently intend to reinvest any future earnings in developing and expanding our business. Any future determination relating to
our dividend policy will be at the discretion of our Board of Directors and will depend on a number of factors, including future
earnings, our financial condition, operating results, contractual restrictions, capital requirements, business prospects, applicable
Israeli law and other factors our Board of Directors may deem relevant.
B. Significant Changes
None.
ITEM 9. THE OFFER AND LISTING
A. Offer and Listing Details
Our ADSs have been trading on Nasdaq under the symbol “BLRX” since July 2011. Our ordinary shares have been
trading on the TASE under the symbol “BLRX” since February 2007.
B. Plan of Distribution
Not applicable.
78
C. Markets
Our ADSs trade on Nasdaq under the symbol “BLRX.” Our ordinary shares trade on the TASE under the symbol
“BLRX.”
D. Selling Shareholders
Not applicable.
E. Dilution
Not applicable.
F. Expenses of the Issue
Not applicable.
ITEM 10. ADDITIONAL INFORMATION
A. Share Capital
Not applicable.
B. Articles of Association
A copy of our Articles of Association is attached as Exhibit 2.1 to this Annual Report. Other than as disclosed below, the
information called for by this Item is set forth in Exhibit 2.2 to this Annual Report and is incorporated by reference into this
Annual Report.
79
C. Material Contracts
For a discussion of our out-licensing and in-licensing agreements, see “Item 4. Information on the Company.” The
following are summary descriptions of certain other material contracts to which we are a party. The descriptions provided below
do not purport to be complete and are qualified in their entirety by the complete agreements, which are attached as exhibits to this
Annual Report on Form 20-F.
Clinical Trial Collaboration and Supply Agreement with MSD
In January 2016, we entered into a clinical collaboration agreement with MSD, to support a Phase 2 study investigating
our motixafortide in combination with KEYTRUDA® (pembrolizumab), MSD’s anti-PD-1 therapy, in patients with metastatic
pancreatic cancer. The Phase 2 study will evaluate the clinical response, safety and tolerability of the combination of these
therapies as well as multiple pharmacodynamic parameters, including the ability to improve infiltration of T-cells into the tumor
and their reactivity. According to the terms of the agreement, we are sponsoring and performing the study, which was initiated in
September 2016, and MSD is supplying its compound for purposes of the study. The parties have agreed on the establishment of
a joint development committee which has the responsibility of coordinating all regulatory and other activities under the
agreement.
In July 2018, the collaboration agreement with MSD was amended in light of the parties’ agreement to expand the study
under the collaboration to include a triple combination arm investigating the safety, tolerability and efficacy of motixafortide,
KEYTRUDA and chemotherapy. See “Item 4 — Information on the Company — Business Overview — Therapeutic Candidates
— motixafortide.” Upon completion of the study, or at any earlier point, both parties have the option to expand the collaboration
to include a pivotal registration study.
Loan Agreement with Kreos Capital
In October 2018, we entered into a loan agreement with Kreos Capital. The purpose of the loan was to finance the $10
million payment made by the Company to Biokine as part of the consideration for amending the license agreement for
motixafortide. See “Item 4. Information on the Company — Business Overview — In-Licensing Agreements — motixafortide.”
The loan had a 12-month interest-only period, which concluded in September 2019, followed by a 36-month repayment period
beginning in October 2019. Borrowings under the loan will bear interest at a fixed rate of 9.5% per annum. As security for the
loan, Kreos Capital received a first-priority, secured interest in all Company assets, including intellectual property. In connection
with providing the loan, Kreos Capital received a warrant to purchase 63,837 ADSs at an exercise price of $14.10 per ADS. The
warrant is exercisable for a period of ten years from the date of issuance.
D. Exchange Controls
There are no Israeli government laws, decrees or regulations that restrict or that affect our export or import of capital or
the remittance of dividends, interest or other payments to non-resident holders of our securities, including the availability of cash
and cash equivalents for use by us and our wholly-owned subsidiaries, except or otherwise as set forth under “Item 10E.
Additional Information — Taxation.”
E. Taxation
The following description is not intended to constitute a complete analysis of all tax consequences relating to the
ownership or disposition of our ordinary shares or ADSs, both referred to in this Item 10E as the ordinary shares. You should
consult your own tax advisor concerning the tax consequences of your particular situation, as well as any tax consequences that
may arise under the laws of any state, local, non-U.S., including Israeli, or other taxing jurisdiction.
Israeli Tax Considerations
The following is a summary of the material Israeli tax laws applicable to us. This section also contains a discussion of
material Israeli tax consequences concerning the ownership and disposition of our shares. This summary does not discuss all the
aspects of Israeli tax law that may be relevant to a particular investor in light of his or her personal investment circumstances or
to some types of investors subject to special treatment under Israeli law. Examples of this kind of investor include residents of
Israel or traders in securities who are subject to special tax regimes not covered in this discussion. Because certain parts of this
discussion are based on new tax legislation that has not yet been subject to judicial or administrative interpretation, we cannot
assure you that the appropriate tax authorities or the courts will accept the views expressed in this discussion.
80
General Corporate Tax Structure in Israel
Israeli companies are generally subject to corporate tax on their taxable income. The regular corporate tax rate in Israel
was 24% for the year 2017, and 23% for the year 2018 and thereafter. Capital gains derived by an Israeli company are now
generally subject to tax at the same rate as the corporate tax rate.
In May 2012, the Israeli Tax Authority, or ITA, approved our eligibility for tax benefits as a “Benefited Enterprise” under
the Law for the Encouragement of Capital Investments, 5719-1959, as amended, or Investments Law, with respect to a portion of
the consideration deriving from certain of our development programs, or Eligible Projects. Subject to compliance with the
applicable requirements, the portion of our undistributed income derived from our Benefited Enterprise programs will be entitled
to a seven-year period of tax benefits due to the Company’s location in Modi’in (a tax exemption for a period of two years,
followed by five years at the corporate tax rate of between 10% to 25% depending on the level of foreign investment in the
company), commencing in the first year in which we generate taxable income after setting off our losses for Israeli tax purposes
from prior years in the amount of approximately $278 million. The seven-year period may not extend beyond 12 years from the
beginning of the Benefited Enterprise’s election year. We received Benefited Enterprise status with respect to the Eligible
Projects in 2009 and 2012 tax years, so depending on when the Benefited Enterprise programs begin to generate taxable income
after offsetting tax losses, the benefit period could continue through 2020 and 2023, respectively. However, any distribution of
income derived from exempt income sourced in our Benefited Enterprise programs will result in such income being subject to a
rate of corporate tax rate of between 10% to 25% depending on the level of foreign investment in the company.
In addition, the ITA approved certain of our operations as an “Industrial Enterprise” under the Investments Law, meaning
that we are eligible for accelerated depreciation with respect to certain tangible assets belonging to our Benefited Enterprise.
Should we not meet the requirements for maintaining these benefits, they may be reduced or cancelled and, among other
things, our income deriving from the Eligible Projects (assuming we are profitable for tax purposes after offsetting losses) would
be subject to the regular corporate tax rate in Israel. If these tax benefits are reduced or eliminated, the amount of taxes that we
pay would likely increase, as all of our operations would consequently be subject to corporate tax at the standard rate, which
could adversely affect our results of operations.
Taxation of Israeli Individual Shareholders on Receipt of Dividends. Israeli residents who are individuals are generally
subject to Israeli income tax for dividends paid on our ordinary shares (other than bonus shares or share dividends) at a rate of
either 25% or 30%, if the recipient of such dividend is a substantial shareholder (as defined below) at the time of distribution or at
any time during the preceding 12-month period.
Taxation of Israeli Resident Corporations on Receipt of Dividends. Israeli resident corporations are generally exempt
from Israeli corporate tax for dividends paid on our ordinary shares.
However, in the case of both Israeli individual shareholders and Israeli resident corporations, under the Investments Law,
dividends distributed from taxable income accrued during the period of benefit of a Benefited Enterprise and which are
attributable to a Benefited Enterprise are subject to tax at the rate of 15%, if the dividend is distributed during the tax benefit
period under the Investment Law or within 12 years after that period. A weighted average rate may be set if the dividend is
distributed from mixed types of income (regular and Benefited Enterprise income). Different tax rates might apply to dividends
sourced from profits attributable to a Preferred Enterprise, but this matter is not currently relevant to the Company.
Taxation of Non-Israeli Shareholders on Receipt of Dividends. Non-residents of Israel (individuals or corporations) are
generally subject to Israeli income tax on the receipt of dividends paid on our ordinary shares at the rate of 25% (or 30% if such
person is a “substantial shareholder” at the time receiving the dividend or on any date in the 12 months preceding such date),
which tax will be withheld at the source, unless a lower rate is provided in a tax treaty between Israel and the shareholder’s
country of residence and subject to the receipt in advance of a valid certificate from the Israeli Tax Authorities. If the income out
of which the dividend is being paid is sourced from profits attributable to a Benefited Enterprise under the Investments Law, the
rate is generally not more than 15%.
Under the U.S.-Israel Tax Treaty, Israeli withholding tax on dividends paid to a U.S. resident for treaty purposes may not,
in general, exceed 25%, or 15% in the case of dividends paid out of the profits of a Benefited Enterprise, subject to certain
conditions. Where the recipient is a U.S. corporation owning 10% or more of the voting stock of the paying corporation during
the part of the paying corporation’s taxable year which precedes the date of payment of the dividend and during the whole of its
prior taxable year (if any) and the dividend is not paid from the profits of a Benefited Enterprise, the Israeli tax withheld may not
exceed 12.5%, subject to certain conditions.
A “substantial shareholder” is generally a person who alone, or together with his relative or another person who
collaborates with him on a regular basis, holds, directly or indirectly, at least 10% of any of the “means of control” of the
corporation. “Means of control” generally include the right to vote, receive profits, nominate a director or an officer, receive
assets upon liquidation, or instruct someone who holds any of the aforesaid rights regarding the manner in which he or she is to
exercise such right(s), and all regardless of the source of such right.
81
A non-resident of Israel who receives dividends from which tax was withheld is generally exempt from the duty to file
returns in Israel in respect of such income, provided that: (1) such income was not derived from a business conducted in Israel by
the taxpayer (2) the taxpayer has no other taxable sources of income in Israel with respect to which a tax return is required to be
filed and (3) the taxpayer is not obliged to pay excess tax.
Payers of dividends on our shares, including the Israeli stockbroker effectuating the transaction or the financial institution
through which the securities are held, are required, subject to any of the foregoing exemptions, reduced tax rates and the
demonstration of a shareholder of his, her or its foreign residency, to withhold taxes upon the distribution of dividends at a rate of
25%, provided that the shares are registered with a nominee company.
Taxation of Capital Gains. Israeli law imposes a capital gains tax on the sale of any capital assets by residents of Israel, as
defined for Israeli tax purposes, and on the sale of assets located in Israel, including shares in Israeli companies, by non-residents
of Israel, unless a specific exemption is available or unless a tax treaty between Israel and the shareholder’s country of residence
provides otherwise and subject to the receipt in advance of a valid certificate from the Israeli Tax Authorities. The law
distinguishes between real capital gain and inflationary surplus. The inflationary surplus is a portion of the total capital gain that
is equivalent to the increase of the relevant asset’s purchase price which is attributable to the increase in the Israeli consumer
price index or, in certain circumstances, a foreign currency exchange rate, between the date of purchase and the date of sale. The
real capital gain is the excess of the total capital gain over the inflationary surplus.
Capital Gains Taxes Applicable to Israeli Resident Shareholders. An individual is subject to a tax at a rate of 25% on real
capital gains derived from the sale of shares, as long as the individual is not a substantial shareholder at the time of sale or at any
time during the 12-month period preceding the company’s issuance of the shares.
An individual who is a substantial shareholder at the time of sale or at any time during the preceding 12-month period is
subject to tax at a rate of 30% in respect of real capital gains derived from the sale of shares issued by the company in which he
or she is a substantial shareholder.
Capital Gains Taxes Applicable to Non-Israeli Resident Shareholders. Shareholders that are not Israeli residents are
generally exempt from Israeli capital gains tax on any gains derived from the sale, exchange or disposition of our ordinary shares,
provided that such shareholders did not acquire their ordinary shares prior to our initial public offering on the TASE and such
gains were not derived from a permanent establishment or business activity of such shareholders in Israel. However, non-Israeli
corporations will not be entitled to the foregoing exemptions if one or more Israeli residents (a) have a controlling interest of
more than 25% in such non-Israeli corporation or (b) are the beneficiaries of or are entitled to 25% or more of the revenues or
profits of such non-Israeli corporation, whether directly or indirectly.
In addition, under the U.S.-Israel Tax Treaty, the sale, exchange or disposition of our ordinary shares by a shareholder
who is a U.S. resident (for purposes of the U.S.-Israel Tax Treaty) holding the ordinary shares as a capital asset is exempt from
Israeli capital gains tax unless (1) the shareholder holds, directly or indirectly, shares representing 10% or more of our voting
capital during any part of the 12-month period preceding such sale, exchange or disposition; (2) the capital gains arising from
such sale are attributable to a permanent establishment of the shareholder located in Israel; (3) a shareholder who is an individual
is present in Israel for a period or periods aggregating 183 days or more during a taxable year. In either case, the sale, exchange
or disposition of ordinary shares would be subject to Israeli tax, to the extent applicable (subject to the receipt in advance of a
valid certificate from the Israeli tax authorities); however, under the U.S.-Israel Tax Treaty, the U.S. resident would be permitted
to claim a credit for the tax against the U.S. federal income tax imposed with respect to the sale, exchange or disposition, subject
to the limitations in U.S. laws applicable to foreign tax credits. The U.S.-Israel Tax Treaty does not relate to U.S. state or local
taxes.
Shareholders may be required to demonstrate that they are exempt from tax on their capital gains in order to avoid
withholding at source at the time of sale.
The purchaser, the Israeli stockbrokers or financial institution through which the shares are held are obliged, subject to the
above mentioned exemptions, to withhold tax upon the sale of securities on the amount of the consideration paid upon the sale of
the securities (or on the Real Capital Gain realized on the sale, if known), at the rate of 25% in respect of an individual or at a
corporate rate in respect of a corporation (23%).
Upon the sale of securities traded on a stock exchange, a detailed return, including a computation of the tax due, must be
filed and an advance payment must be paid on January 31 and July 31 of every tax year in respect of sales of securities made
within the previous six months. However, if all tax due was withheld at source according to applicable provisions of the Israel
Income Tax Ordinance and regulations promulgated thereunder, the aforementioned return need not be filed and no advance
payment must be paid. Capital gain is also reportable on the annual income tax returns.
82
Excess Tax. Individuals who are subject to tax in Israel (whether such individual is an Israeli resident or non-Israeli
resident) are also subject to an additional tax at a rate of 3% on annual income exceeding a certain threshold NIS 651,600 for
2020 and thereafter, which amount is linked to the annual change in the Israeli consumer price index), including, but not limited
to, dividends, interest and capital gains.
U.S. Federal Income Tax Considerations
The following is a general summary of certain material U.S. federal income tax considerations relating to the purchase,
ownership and disposition of our ordinary shares and ADSs by U.S. Investors (as defined below) that are initial purchasers of
such ordinary shares or ADSs and that hold such ordinary shares or ADSs as capital assets for U.S. federal income tax purposes
(generally, property held for investment). This summary is based on the Internal Revenue Code of 1986, as amended, or the
Code, the regulations of the U.S. Department of the Treasury issued pursuant to the Code, or the Treasury Regulations, and
administrative and judicial interpretations thereof, all as in effect on the date hereof and all of which are subject to change,
possibly with retroactive effect, or to different interpretation. No ruling has been sought from the IRS with respect to any U.S.
federal income tax consequences described below, and there can be no assurance that the IRS or a court will not take a contrary
position. This summary is for general information only and does not address all of the tax considerations that may be relevant to
specific U.S. Investors in light of their particular circumstances or to U.S. Investors subject to special treatment under U.S.
federal income tax law (such as, without limitation, banks, insurance companies, tax-exempt entities, retirement plans, regulated
investment companies, partnerships, dealers in securities, brokers, real estate investment trusts, certain former citizens or
residents of the United States, persons who acquire our ordinary shares or ADSs as part of a straddle, hedge, conversion
transaction or other integrated investment, persons that have a “functional currency” other than the Dollar, persons that own (or
are deemed to own, indirectly or by attribution) 10% or more of our ordinary shares or ADSs (by vote or value), persons subject
to special tax accounting rules under section 451(b), or persons that generally mark their securities to market for U.S. federal
income tax purposes). This summary does not address any U.S. state or local or non-U.S. tax considerations, any U.S. federal
estate, gift or alternative minimum tax considerations or any additional U.S. federal tax consequences other than U.S. federal
income tax consequences.
As used in this summary, the term “U.S. Investor” means a beneficial owner of our ordinary shares or ADSs that is, for
U.S. federal income tax purposes, (i) an individual citizen or resident of the United States, (ii) a corporation, or other entity
taxable as a corporation for U.S. federal income tax purposes, created or organized in or under the laws of the United States, any
state thereof, or the District of Columbia, (iii) an estate the income of which is subject to U.S. federal income tax regardless of its
source or (iv) a trust with respect to which a court within the United States is able to exercise primary supervision over its
administration and one or more U.S. persons have the authority to control all of its substantial decisions, or a trust that has validly
elected to be treated as a U.S. person for U.S. federal income tax purposes, whose status as a U.S. person is not overwritten by an
applicable tax treaty.
If an entity treated as a partnership for U.S. federal income tax purposes holds our ordinary shares or ADSs, the tax
treatment of such entity and each person treated as a partner thereof will generally depend upon the status and activities of the
entity and such person. An investor that is treated as a partnership for U.S. federal income tax purposes should consult its own tax
advisor regarding the U.S. federal income tax considerations applicable to it and its partners of the purchase, ownership and
disposition of its ordinary shares or ADSs.
Prospective investors should be aware that this summary does not address the tax consequences to investors who
are not U.S. Investors. Prospective investors should consult their own tax advisors as to the particular tax considerations
applicable to them relating to the purchase, ownership and disposition of their ordinary shares or ADSs, including the
applicability of U.S. federal, state and local tax laws and non-U.S. tax laws.
Taxation of U.S. Investors
The discussions under “— Distributions,” and under “— Sale, Exchange or Other Disposition of Ordinary Shares or
ADSs” below assumes that we will not be treated as a passive foreign investment company, or PFIC, for U.S. federal income tax
purposes. However, we have not determined whether we will be a PFIC for the taxable year ending December 31, 2021, and it is
possible that we will be a PFIC for the taxable year ending December 31, 2021 or in any subsequent year. For a discussion of the
rules that would apply if we are treated as a PFIC, see the discussion under “— Passive Foreign Investment Company.”
Distributions. We have no current plans to pay dividends. To the extent we pay any dividends, a U.S. Investor will be
required to include in gross income as a taxable dividend the amount of any distributions made on the ordinary shares or ADSs,
including the amount of any Israeli taxes withheld, when actually or constructively received, to the extent that those distributions
are paid out of our current or accumulated earnings and profits as determined for U.S. federal income tax purposes. Any
distributions in excess of our earnings and profits will be applied against and will reduce the U.S. Investor’s tax basis in its
ordinary shares or ADSs and to the extent they exceed that tax basis, will be treated as gain from the sale or exchange of those
ordinary shares or ADSs. We do not intend to calculate our earnings and profits under U.S. federal income tax principles.
Therefore, a U.S. Investor should expect that a distribution will be treated as a dividend even if that distribution would otherwise
be treated as a non-taxable return of capital or as capital gain under the rules described above. If we were to pay dividends to
holders of our ordinary shares, we expect to pay such dividends in NIS; however, dividends paid to holders of our ADSs will be
paid in dollars. A dividend paid in NIS, including the amount of any Israeli taxes withheld, will be includible in a U.S. Investor’s
income as a dollar amount calculated by reference to the exchange rate in effect on the date such dividend is received, regardless
of whether the payment is in fact converted into dollars. If the dividend is converted to dollars on the date of receipt, a U.S.
Investor generally will not recognize a foreign currency gain or loss. However, if the U.S. Investor converts the NIS into dollars
on a later date, the U.S. Investor must include, in computing its income, any gain or loss resulting from any exchange rate
fluctuations. The gain or loss will be equal to the difference between (i) the dollar value of the amount included in income when
the dividend was received and (ii) the amount received on the conversion of the NIS into dollars. Such gain or loss will generally
be ordinary income or loss and United States source for U.S. foreign tax credit purposes. U.S. Investors should consult their own
tax advisors regarding the tax consequences to them if we pay dividends in NIS or any other non-U.S. currency.
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Subject to certain significant conditions and limitations, including potential limitations under the United States-Israel
income tax treaty, any Israeli taxes paid on or withheld from distributions from us and not refundable to a U.S. Investor may be
credited against the investor’s U.S. federal income tax liability or, alternatively, may be deducted from the investor’s taxable
income. This election is made on a year-by-year basis and applies to all foreign taxes paid by a U.S. Investor or withheld from
amounts paid to a U.S. Investor that year. Dividends paid on the ordinary shares or ADSs generally will constitute income from
sources outside the United States and be categorized as “passive category income” or, in the case of some U.S. Investors, as
“general category income” for U.S. foreign tax credit purposes.
Since the rules governing foreign tax credits are complex, U.S. Investors should consult their own tax advisor regarding
the availability of foreign tax credits in their particular circumstances.
Dividends paid on the ordinary shares and ADSs will not be eligible for the “dividends-received” deduction generally
allowed to corporate U.S. Investors with respect to dividends received from U.S. corporations.
Distributions treated as dividends that are received by an individual U.S. Investor from “qualified foreign corporations”
generally qualify for a reduced maximum tax rate so long as certain holding period and other requirements are met. A non-U.S.
corporation (other than a PFIC for the taxable year in which the dividend is paid or the preceding taxable year) generally will be
considered to be a qualified foreign corporation (i) if it is eligible for the benefits of a comprehensive tax treaty with the United
States which the Secretary of Treasury of the United States determines is satisfactory for purposes of this provision and which
includes an exchange of information program, or (ii) with respect to any dividend it pays on stock which is readily tradable on an
established securities market in the United States. Any dividend paid by us in a taxable year in which we are a PFIC (or with
respect to which we were a PFIC in the preceding taxable year) will be subject to tax at regular ordinary income rates. As
mentioned above, we believe we were not a PFIC for our 2020 taxable year and have not determined whether we will be a PFIC
for our 2021 taxable year. U.S. Investors should consult their own tax advisors regarding the availability of the lower rate for
dividends paid with respect to our ordinary shares and ADSs.
The additional 3.8% Medicare tax (described below) may apply to dividends received by certain U.S. Investors who meet
certain modified adjusted gross income thresholds.
Sale, Exchange or Other Disposition of Ordinary Shares and ADSs. Subject to the discussion under “— Passive Foreign
Investment Company” below, a U.S. Investor generally will recognize capital gain or loss upon the sale, exchange or other
taxable disposition of ordinary shares or ADSs in an amount equal to the difference between the amount realized on the sale,
exchange or other taxable disposition and the U.S. Investor’s adjusted tax basis in such ordinary shares or ADSs. This capital
gain or loss will be long-term capital gain or loss if the U.S. Investor’s holding period in the ordinary shares or ADSs exceeds one
year. Preferential tax rates for long-term capital gain will apply to individual U.S. Investors. The deductibility of capital losses is
subject to limitations. The gain or loss will generally be income or loss from sources within the United States for U.S. foreign tax
credit purposes, subject to certain possible exceptions under the U.S.-Israel Tax Treaty. The additional 3.8% Medicare tax
(described below) may apply to gains recognized upon the sale, exchange, or other taxable disposition of our ordinary shares or
ADSs by certain U.S. Investors who meet certain modified adjusted gross income thresholds.
U.S. Investors should consult their own tax advisors regarding the U.S. federal income tax consequences of receiving
currency other than Dollars upon the disposition of ordinary shares or ADSs.
Medicare Tax. In addition, certain U.S. persons, including individuals, estates and trusts, will be subject to an additional
3.8% Medicare tax, or net investment income tax, on unearned income. For individuals, the additional Medicare tax applies to the
lesser of (i) “net investment income” or (ii) the excess of “modified adjusted gross income” over $200,000 ($250,000 if married
and filing jointly or $125,000 if married and filing separately). “Net investment income” generally equals the taxpayer’s gross
investment income reduced by the deductions that are allocable to such income. Investment income generally includes passive
income such as interest, dividends, annuities, royalties, rents, and capital gains. U.S. Investors are urged to consult their own tax
advisors regarding the implications of the additional Medicare tax resulting from their ownership and disposition of ordinary
shares or ADSs.
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Passive Foreign Investment Company
In general, a corporation organized outside the United States will be treated as a PFIC for U.S. federal income tax
purposes in any taxable year in which either (i) at least 75% of its gross income is “passive income” or (ii) on average at least
50% of its assets by value produce passive income or are held for the production of passive income. Passive income for this
purpose generally includes, among other things, certain dividends, interest, royalties, rents and gains from commodities and
securities transactions and from the sale or exchange of property that gives rise to passive income. Passive income also includes
amounts derived by reason of the temporary investment of funds, including those raised in the public offering. Assets that
produce or are held for the production of passive income may include cash, even if held as working capital or raised in a public
offering, as well as marketable debt securities and other assets that may produce passive income. In determining whether a non-
U.S. corporation is a PFIC, a proportionate share of the income and assets of each corporation in which it owns, directly or
indirectly, at least a 25% interest (by value) is taken into account.
Under the tests described above, whether or not we are a PFIC will be determined annually based upon the composition of
our income and the composition and valuation of our assets, all of which are subject to change.
We believe that we were a PFIC for U.S. federal income tax purposes for taxable years ended prior to December 31, 2009
and for taxable years ended December 31, 2011, 2012 and 2014 through 2019. We believe we were not a PFIC for taxable years
ended 2009, 2010, 2013 and 2020, and we have not determined whether we will be a PFIC for the taxable year ending December
31, 2021. Because the PFIC determination is highly fact intensive and made at the end of each taxable year, there can be no
assurance that we will not be a PFIC for taxable year ending December 31, 2021 or in any subsequent year. Upon request, we
intend to annually inform U.S. Investors if we and any of our subsidiaries were a PFIC with respect to the preceding year.
U.S. Investors should be aware of certain tax consequences of investing directly or indirectly in us if we are a PFIC. A
U.S. Investor is subject to different rules depending on whether the U.S. Investor makes an election to treat us as a “qualified
electing fund,” known as a QEF election, for the first taxable year that the U.S. Investor holds ordinary shares or ADSs, which is
referred to in this disclosure as a “timely QEF election,” makes a “mark-to-market” election with respect to the ordinary shares or
ADSs (if such election is available) or makes neither election.
QEF Election. A U.S. Investor who makes a timely QEF election, referred to in this disclosure as an “Electing U.S.
Investor,” with respect to us must report for U.S. federal income tax purposes his pro rata share of our ordinary earnings and net
capital gain, if any, for our taxable year that ends with or within the taxable year of the Electing U.S. Investor. The “net capital
gain” of a PFIC is the excess, if any, of the PFIC’s net long-term capital gains over its net short-term capital losses. The amount
so included in income generally will be treated as ordinary income to the extent of such Electing U.S. Investor’s allocable share
of the PFIC’s ordinary earnings and as long-term capital gain to the extent of such Electing U.S. Investor’s allocable share of the
PFIC’s net capital gains. Such Electing U.S. Investor generally will be required to translate such income into Dollars based on the
average exchange rate for the PFIC’s taxable year with respect to the PFIC’s functional currency. Such income generally will be
treated as income from sources outside the United States for U.S. foreign tax credit purposes. Amounts previously included in
income by such Electing U.S. Investor under the QEF rules generally will not be subject to tax when they are distributed to such
Electing U.S. Investor. The Electing U.S. Investor’s tax basis in ordinary shares or ADSs generally will increase by any amounts
so included under the QEF rules and decrease by any amounts not included in income when distributed.
An Electing U.S. Investor will be subject to U.S. federal income tax on such amounts for each taxable year in which we
are a PFIC, regardless of whether such amounts are actually distributed to such Electing U.S. Investor. However, an Electing U.S.
Investor may, subject to certain limitations, elect to defer payment of current U.S. federal income tax on such amounts, subject to
an interest charge. If an Electing U.S. Investor is an individual, any such interest will be treated as non-deductible “personal
interest.”
Any net operating losses or net capital losses of a PFIC will not pass through to the Electing U.S. Investor and will not
offset any ordinary earnings or net capital gain of a PFIC recognized by Electing U.S. Investors in subsequent years.
So long as an Electing U.S. Investor’s QEF election with respect to us is in effect with respect to the entire holding period
for ordinary shares or ADSs, any gain or loss recognized by such Electing U.S. Investor on the sale, exchange or other
disposition of such ordinary shares or ADSs generally will be long-term capital gain or loss if such Electing U.S. Investor has
held such ordinary shares or ADSs for more than one year at the time of such sale, exchange or other disposition. Preferential tax
rates for long-term capital gain will apply to individual U.S. Investors. The deductibility of capital losses is subject to limitations.
A U.S. Investor makes a QEF election by completing the relevant portions of and filing IRS Form 8621 in accordance
with the instructions thereto. A QEF election generally may not be revoked without the consent of the IRS. Upon request, we
intend to annually furnish U.S. Investors with information needed in order to complete IRS Form 8621 (which form would be
required to be filed with the IRS on an annual basis by the U.S. Investor) and to make and maintain a valid QEF election for any
year in which we or any of our subsidiaries are a PFIC. A QEF election will not apply to any taxable year during which we are
not a PFIC, but will remain in effect with respect to any subsequent taxable year in which we become a PFIC. Each U.S. Investor
is encouraged to consult its own tax advisor with respect to tax consequences of a QEF election with respect to us.
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Mark-to-Market Election. Alternatively, if our ordinary shares or ADSs are treated as “marketable stock,” a U.S. Investor
would be allowed to make a “mark-to-market” election with respect to our ordinary shares or ADSs, provided the U.S. Investor
completes and files IRS Form 8621 in accordance with the relevant instructions and related Treasury Regulations. If that election
is made, the U.S. Investor generally would include as ordinary income in each taxable year the excess, if any, of the fair market
value of the ordinary shares or ADSs at the end of the taxable year over such investor’s adjusted tax basis in the ordinary shares
or ADSs. Thus, the U.S. Investor may recognize taxable income without receiving any cash to pay its tax liability with respect to
such income. The U.S. Investor would also be permitted an ordinary loss in respect of the excess, if any, of the U.S. Investor’s
adjusted tax basis in the ordinary shares or ADSs over their fair market value at the end of the taxable year, but only to the extent
of the net amount previously included in income as a result of the mark-to-market election. A U.S. Investor’s tax basis in the
ordinary shares or ADSs would be adjusted to reflect any such income or loss amount. Gain realized on the sale, exchange or
other disposition of the ordinary shares or ADSs would be treated as ordinary income, and any loss realized on the sale, exchange
or other disposition of the ordinary shares or ADSs would be treated as ordinary loss to the extent that such loss does not exceed
the net mark-to-market gains previously included in income by the U.S. Investor, and any loss in excess of such amount will be
treated as capital loss. Amounts treated as ordinary income will not be eligible for the favorable tax rates applicable to qualified
dividend income or long-term capital gains.
Generally, stock will be considered marketable stock if it is “regularly traded” on a “qualified exchange” within the
meaning of applicable Treasury Regulations. A class of stock is regularly traded on an exchange during any calendar year during
which such class of stock is traded, other than in de minimis quantities, on at least 15 days during each calendar quarter. To be
marketable stock, our ordinary shares or ADSs must be regularly traded on a qualifying exchange (i) in the United States that is
registered with the SEC or a national market system established pursuant to the Exchange Act or (ii) outside the United States
that is properly regulated and meets certain trading, listing, financial disclosure and other requirements. A mark-to-market
election will not apply to our ordinary shares or ADSs held by a U.S. Investor for any taxable year during which we are not a
PFIC, but will remain in effect with respect to any subsequent taxable year in which we become a PFIC unless our ordinary
shares or ADSs cease to be marketable. A mark-to-market election generally may not be revoked without the consent of the IRS.
Such election will not apply to any PFIC subsidiary that we own. Each U.S. Investor is encouraged to consult its own tax advisor
with respect to the availability and tax consequences of a mark-to-market election with respect to our ordinary shares or ADSs.
Default PFIC Rules. A U.S. Investor who does not make a timely QEF election or a mark-to-market election, referred to
in this disclosure as a “Non-Electing U.S. Investor,” will be subject to special rules with respect to (a) any “excess distribution”
(generally, the portion of any distributions received by the Non-Electing U.S. Investor on the ordinary shares or ADSs in a
taxable year in excess of 125% of the average annual distributions received by the Non-Electing U.S. Investor in the three
preceding taxable years, or, if shorter, the Non-Electing U.S. Investor’s holding period for the ordinary shares or ADSs), and (b)
any gain realized on the sale or other disposition of such ordinary shares or ADSs. Under these rules:
•
•
•
the excess distribution or gain would be allocated ratably over the Non-Electing U.S. Investor’s holding period for the ordinary shares or ADSs;
the amount allocated to the current taxable year and any year prior to us becoming a PFIC would be taxed as ordinary income; and
the amount allocated to each of the other taxable years would be subject to tax at the highest rate of tax in effect for the applicable class of
taxpayer for that year, and an interest charge for the deemed deferral benefit would be imposed with respect to the resulting tax attributable to each
such other taxable year.
If a Non-Electing U.S. Investor who is an individual dies while owning our ordinary shares or ADSs, the Non-Electing
U.S. Investor’s successor would be ineligible to receive a step-up in tax basis of the ordinary shares or ADSs. Non-Electing U.S.
Investors are encouraged to consult their tax advisors regarding the application of the PFIC rules to their specific situation.
A Non-Electing U.S. Investor who wishes to make a QEF election for a subsequent year may be able to make a special
“purging election” pursuant to Section 1291(d) of the Code. Pursuant to this election, a Non-Electing U.S. Investor would be
treated as selling his or her ordinary shares or ADSs for fair market value on the first day of the taxable year for which the QEF
election is made. Any gain on such deemed sale would be subject to tax under the rules for Non-Electing U.S. Investors as
discussed above. Non-Electing U.S. Investors are encouraged to consult their tax advisors regarding the availability of a “purging
election” as well as other available elections.
To the extent a distribution on our ordinary shares or ADSs does not constitute an excess distribution to a Non-Electing
U.S. Investor, such Non-Electing U.S. Investor generally will be required to include the amount of such distribution in gross
income as a dividend to the extent of our current or accumulated earnings and profits (as determined for U.S. federal income tax
purposes) that are not allocated to excess distributions. The tax consequences of such distributions are discussed above under “—
Taxation of U.S. Investors — Distributions.” Each U.S. Investor is encouraged to consult its own tax advisor with respect to the
appropriate U.S. federal income tax treatment of any distribution on our ordinary shares or ADSs.
86
If we are treated as a PFIC for any taxable year during the holding period of a Non-Electing U.S. Investor, we will
continue to be treated as a PFIC for all succeeding years during which the Non-Electing U.S. Investor is treated as a direct or
indirect Non-Electing U.S. Investor even if we are not a PFIC for such years. A U.S. Investor is encouraged to consult its tax
advisor with respect to any available elections that may be applicable in such a situation, including the “deemed sale” election of
Code Section 1298(b)(1). In addition, U.S. Investors should consult their tax advisors regarding the IRS information reporting
and filing obligations that may arise as a result of the ownership of shares in a PFIC, including IRS Form 8621.
We may invest in the equity of foreign corporations that are PFICs or may own subsidiaries that own PFICs. U.S.
Investors will be subject to the PFIC rules with respect to their indirect ownership interests in such PFICs, such that a disposition
of the shares of the PFIC or receipt by us of a distribution from the PFIC generally will be treated as a deemed disposition of such
shares or the deemed receipt of such distribution by the U.S. Investor, subject to taxation under the PFIC rules. There can be no
assurance that a U.S. Investor will be able to make a QEF election or a mark-to-market election with respect to PFICs in which
we invest. Each U.S. Investor is encouraged to consult its own tax advisor with respect to tax consequences of an investment by
us in a corporation that is a PFIC.
The U.S. federal income tax rules relating to PFICs are complex. U.S. Investors are urged to consult their own tax
advisors with respect to the purchase, ownership and disposition of ordinary shares or ADSs, any elections available with
respect to such ordinary shares or ADSs and the IRS information reporting obligations with respect to the purchase,
ownership and disposition of ordinary shares or ADSs.
Certain Reporting Requirements
Certain U.S. Investors may be required to file IRS Form 926, Return by U.S. Transferor of Property to a Foreign
Corporation and IRS Form 5471, Information Return of U.S. Persons With Respect to Certain Foreign Corporations, reporting
transfers of cash or other property to us and information relating to the U.S. Investor and us. Substantial penalties may be
imposed upon a U.S. Investor that fails to comply.
Certain U.S. Investors owning “specified foreign financial assets” with an aggregate value in excess of $50,000 on the last
day of the taxable year or $75,000 at any time during the taxable year (or such higher dollar amount as may be prescribed by
applicable IRS guidance) may be required to file IRS Form 8938, Statement of Specified Foreign Financial Assets, with respect
to such assets with their tax returns. “Specified foreign financial assets” generally include any financial accounts maintained by
foreign financial institutions, as well as any of the following held for investment and not held in accounts maintained by financial
institutions: (i) stocks and securities issued by non-U.S. persons, which may include the ordinary shares or ADSs, (ii) financial
instruments and contracts held for investment that have non-U.S. issuers or counterparties and (iii) interests in foreign entities.
The IRS has issued guidance exempting “specified foreign financial assets” held in a financial account from reporting under this
provision (although the financial account itself, if maintained by a foreign financial institution, may remain subject to this
reporting requirement). U.S. Investors are urged to consult their tax advisors regarding the application of these requirements to
their ownership of the ordinary shares or ADSs.
If we are treated as a PFIC, U.S. Investors may be required to file annual tax returns (including on IRS Form 8621)
containing such information as the U.S. Treasury requires. A U.S. Investor that is not otherwise required to file a U.S. tax return
must still file IRS Form 8621 in accordance with the instructions for the Form.
Backup Withholding Tax and Information Reporting Requirements
Generally, information reporting requirements will apply to distributions on our ordinary shares or ADSs or proceeds on
the disposition of our ordinary shares or ADSs paid within the United States (and, in certain cases, outside the United States) to
U.S. Investors other than certain exempt recipients, such as corporations. Furthermore, backup withholding may apply to such
amounts if the U.S. Investor fails to (i) provide a correct taxpayer identification number, (ii) report interest and dividends required
to be shown on its U.S. federal income tax return, or (iii) make other appropriate certifications in the required manner. U.S.
Investors who are required to establish their exempt status generally must provide such certification on IRS Form W-9.
Backup withholding is not an additional tax. Amounts withheld as backup withholding from a payment may be credited
against a U.S. Investor’s U.S. federal income tax liability and such U.S. Investor may obtain a refund of any excess amounts
withheld by timely filing the appropriate claim for refund with the IRS and furnishing any required information in a timely
manner.
U.S. Investors should consult their own tax advisors concerning the tax consequences relating to the purchase,
ownership and disposition of the ordinary shares or ADSs.
F. Dividends and Paying Agents
Not applicable.
G. Statement by Experts
Not applicable.
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H. Documents on Display
We are currently subject to the information and periodic reporting requirements of the Exchange Act, and file periodic
reports and other information with the SEC through its electronic data gathering, analysis and retrieval (EDGAR) system. As a
foreign private issuer, all documents which were filed after September 24, 2010 on the SEC’s EDGAR system are available for
retrieval on the SEC’s website at www.sec.gov.
As a foreign private issuer, we are exempt from the rules under the Exchange Act related to the furnishing and content of
proxy statements, and our officers, directors and principal shareholders are exempt from the reporting and short-swing profit
recovery provisions contained in Section 16 of the Exchange Act. In addition, we are not required under the Exchange Act to file
annual, quarterly and current reports and financial statements with the SEC as frequently or as promptly as United States
companies whose securities are registered under the Exchange Act.
In addition, since our ordinary shares are traded on the TASE, we also file periodic and immediate reports with, and
furnish information to, the TASE and the ISA, or the ISA, as required under Chapter Six of the Israel Securities Law, 1968 and
the regulations enacted pursuant thereof, as applicable to a public company which also trades on Nasdaq. Copies of our filings
with the ISA can be retrieved electronically through the MAGNA distribution site of the ISA (www.magna.isa.gov.il) and the
TASE website (www.maya.tase.co.il).
We maintain a corporate website at www.biolinerx.com. Information contained on, or that can be accessed through, our
website does not constitute a part of this Annual Report on Form 20-F. We have included our website address in this Annual
Report on Form 20-F solely as an inactive textual reference.
I. Subsidiary Information
Not applicable.
ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURE ON MARKET RISK
Market risk is the risk of loss related to changes in market prices, including interest rates and foreign exchange rates, of
financial instruments that may adversely impact our consolidated financial position, results of operations or cash flows. We do
not use derivative financial instruments for trading purposes. Accordingly, we have concluded that there is no material market
risk exposure of the type contemplated by Item 11, and that no quantitative tabular disclosures are required. We are exposed to
certain other types of market risks, as described below.
Risk of Interest Rate Fluctuation
Our investments consist primarily of cash, cash equivalents and short-term bank deposits. We may also invest in
investment-grade marketable securities with maturities of up to three years, including commercial paper, money market funds,
and government/non-government debt securities. The primary objective of our investment activities is to preserve principal while
maximizing the income that we receive from our investments without significantly increasing risk and loss. Our investments are
exposed to market risk due to fluctuation in interest rates, which may affect our interest income and the fair market value of our
investments. We manage this exposure by performing ongoing evaluations of our investments. Due to the short-term maturities of
our investments to date, their carrying value has always approximated their fair value. It will be our policy to hold investments to
maturity in order to limit our exposure to interest rate fluctuations.
Foreign Currency Exchange Risk
Our reporting and functional currency is the dollar. However, we pay a significant portion of our expenses in NIS and in
euro, and we expect this to continue. If the dollar weakens against the NIS or the euro in the future, there may be a negative
impact on our results of operations. The revenues from our current out-licensing and co-development arrangements are payable in
dollars and euros. Although we expect our revenues from future licensing arrangements to be denominated primarily in dollars,
we are exposed to the currency fluctuation risks relating to the recording of our revenues in currencies other than dollars. For
example, if the euro strengthens against the dollar, our reported revenues in dollars may be lower than anticipated. To date,
fluctuations in the exchange rates have not materially affected our results of operations or financial condition for the periods
under review.
From time to time, we have engaged in currency hedging transactions to decrease the risk of financial exposure from
fluctuations in the exchange rates of our principal operating currencies, and we may continue to do so in the future. These
measures, however, may not adequately protect us from the material adverse effects of such fluctuations.
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ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
A. Debt Securities
Not applicable.
B. Warrants and Rights
Not applicable.
C. Other Securities
Not applicable.
D. American Depositary Shares
Set forth below is a summary of some of the material terms of the deposit agreement among BioLineRx, The Bank of
New York Mellon as depositary, or the Depositary, and the owners and holders from time to time of our ADSs.
Description of the ADSs
Each of our ADSs represents 15 of our ordinary shares deposited with the principal Tel Aviv office of either Bank
Hapoalim B.M. or Bank Leumi Le-Israel, as Custodian for the Depositary. Our ADSs trade on Nasdaq.
The form of the deposit agreement for the ADS and the form of American Depositary Receipt (ADR) that represents an
ADS have been incorporated by reference as exhibits to this Annual Report on Form 20-F. Copies of the deposit agreement are
available for inspection at the principal office of The Bank of New York Mellon, located at 101 Barclay Street, New York, New
York 10286.
Charges of Depositary
We will pay the fees, reasonable expenses and out-of-pocket charges of the Depositary and those of any registrar only in
accordance with agreements in writing entered into between us and the Depositary from time to time. The following charges shall
be incurred by any party depositing or withdrawing ordinary shares or by any party surrendering ADRs or to whom ADRs are
issued (including, without limitation, issuance pursuant to a stock dividend or stock split declared by us or an exchange of stock
regarding the ADRs or deposited ordinary shares or a distribution of ADRs pursuant to the terms of the deposit agreement):
•
•
•
•
•
•
•
•
•
•
taxes and other governmental charges;
any applicable transfer or registration fees;
certain cable, telex and facsimile transmission charges as provided in the deposit agreement;
any expenses incurred in the conversion of foreign currency;
a fee of $5.00 or less per 100 ADSs (or a portion thereof) for the execution and delivery of ADRs and the surrender of ADRs, including if the
deposit agreement terminates;
a fee of $.05 or less per ADS (or portion thereof) for any cash distribution made pursuant to the deposit agreement;
a fee for the distribution of securities pursuant to the deposit agreement;
in addition to any fee charged for a cash distribution, a fee of $.05 or less per ADS (or portion thereof) per annum for depositary services;
a fee for the distribution of proceeds of rights that the Depositary sells pursuant to the deposit agreement; and
any other charges payable by the Depositary, any of the Depositary’s agents, or the agents of the Depositary’s agents in connection with the
servicing of ordinary shares or other Deposited Securities.
The Depositary may own and deal in our securities and in ADSs.
89
The Depositary collects its fees for delivery and surrender of ADSs directly from investors depositing shares or
surrendering ADSs for the purpose of withdrawal or from intermediaries acting for them. The Depositary collects fees for making
distributions to investors by deducting those fees from the amounts distributed or by selling a portion of distributable property to
pay the fees. The Depositary may collect its annual fee for depositary services by deduction from cash distributions or by directly
billing investors or by charging the book-entry system accounts of participants acting for them. The Depositary may collect any
of its fees by deduction from any cash distribution payable (or by selling a portion of securities or other property distributable) to
ADS holders that are obligated to pay those fees. The Depositary may generally refuse to provide fee-attracting services until its
fees for those services are paid.
From time to time, the Depositary may make payments to us to reimburse us for costs and expenses generally arising out
of establishment and maintenance of the ADS program, waive fees and expenses for services provided to us by the Depositary or
share revenue from the fees collected from ADS holders. In performing its duties under the deposit agreement, the Depositary
may use brokers, dealers, foreign currency dealers or other service providers that are owned by or affiliated with the Depositary
and that may earn or share fees, spreads or commissions.
The Depositary may convert currency itself or through any of its affiliates and, in those cases, acts as principal for its own
account and not as agent, advisor, broker or fiduciary on behalf of any other person and earns revenue, including, without
limitation, transaction spreads, that it will retain for its own account. The revenue is based on, among other things, the difference
between the exchange rate assigned to the currency conversion made under the deposit agreement and the rate that the Depositary
or its affiliate receives when buying or selling foreign currency for its own account. The Depositary makes no representation that
the exchange rate used or obtained in any currency conversion under the deposit agreement will be the most favorable rate that
could be obtained at the time or that the method by which that rate will be determined will be the most favorable to ADS holders,
subject to the Depositary’s obligations under the deposit agreement. The methodology used to determine exchange rates used in
currency conversions is available upon request.
Liability of Holders for Taxes, Duties or Other Charges
Any tax or other governmental charge with respect to ADSs or any deposited ordinary shares represented by any ADS
shall be payable by the holder of such ADS to the Depositary. The Depositary may refuse to effect transfer of such ADS or any
withdrawal of deposited ordinary shares represented by such ADS until such payment is made, and may withhold any dividends
or other distributions or may sell for the account of the holder any part or all of the deposited ordinary shares represented by such
ADS and may apply such dividends or distributions or the proceeds of any such sale in payment of any such tax or other
governmental charge and the holder of such ADS shall remain liable for any deficiency.
ITEM 13. DEFAULTS, DIVIDENDS ARREARAGES AND DELINQUENCIES
Not applicable.
ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
Not applicable.
ITEM 15. CONTROLS AND PROCEDURES
(a) Disclosure Controls and Procedures
We have performed an evaluation of the effectiveness of our disclosure controls and procedures that are designed to
ensure that the material financial and non-financial information required to be disclosed to the SEC is recorded, processed,
summarized and reported timely. Based on our evaluation, our management, including the Chief Executive Officer, or the CEO,
and the Chief Financial Officer, or the CFO, has concluded that our disclosure controls and procedures (as defined in Rules 13a-
15(e) and 15d-15(e) of the Exchange Act) as of the end of the period covered by this report are effective. Notwithstanding the
foregoing, there can be no assurance that our disclosure controls and procedures will detect or uncover all failures of persons
within the Company to disclose material information otherwise required to be set forth in our reports.
(b) Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as
such term is defined in Rule 13a-15(f) promulgated under the Exchange Act. Our internal control system was designed to provide
reasonable assurance to our management and board of directors regarding the reliability of financial reporting and the preparation
and fair presentation of published financial statements for external purposes in accordance with generally accepted accounting
principles. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems
determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation
and may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to
the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with policies or
procedures may deteriorate.
Our management, including the CEO and CFO, conducted an evaluation, pursuant to Rule 13a-15(c) promulgated under
the Exchange Act, of the effectiveness, as of the end of the period covered by this Annual Report, of its internal control over
financial reporting based on the framework in Internal Control—Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (2013). Based on the results of this evaluation, management concluded that our
internal control over financial reporting was effective as of December 31, 2020.
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(c) Attestation Report of Registered Public Accounting Firm
This annual report does not include an attestation report of our registered public accounting firm, as we are a non-
accelerated filer and, accordingly, are exempt from this requirement.
(d) Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during the year ended December 31,
2020 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
ITEM 16. [RESERVED]
ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERTS
Our Board of Directors has determined that Ms. Nurit Benjamini is the audit committee financial expert. Ms. Benjamini is
one of our independent directors for the purposes of the Nasdaq Rules.
ITEM 16B. CODE OF ETHICS
In July 2011, our Board of Directors adopted a Code of Business Conduct and Ethics, or the Code of Conduct, that applies
to all our employees, including without limitation our CEO, CFO and controller. Our Code of Conduct may be viewed on our
website at www.biolinerx.com. A copy of our Code of Conduct may be obtained, without charge, upon a written request
addressed to our investor relations department, 2 HaMa’ayan Street, Modi’in 7177871, Israel (Telephone no. +972-8-642-9100)
(e-mail: info@BioLineRx.com).
ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES
Fees Paid to Independent Registered Public Accounting Firm
The following table sets forth, for each of the years indicated, the fees billed by Kesselman & Kesselman, a member firm
of PricewaterhouseCoopers International Ltd., our independent registered public accounting firm.
Services Rendered
Audit Fees(1)
Audit-Related Fees(2)
Tax Fees(3)
All Other Fees
Total
Year Ended December 31,
2019
2020
(in thousands of U.S. dollars)
110
10
9
-
129
110
38
16
-
164
(1) Audit fees consist of services that would normally be provided in connection with statutory and regulatory filings
or engagements, including services that generally only the independent accountant can reasonably provide.
(2) Audit-related services relate to reports to the IIA and work regarding a public listing or offering.
(3) Tax fees relate to tax compliance, planning and advice.
Our Audit Committee, in accordance with its charter, reviews and pre-approves all audit services and permitted non-audit
services (including the fees and other terms) to be provided by our independent auditors.
ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
Not applicable.
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ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
Not applicable.
ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT
Not applicable.
ITEM 16G. CORPORATE GOVERNANCE
Nasdaq Listing Rules and Home Country Practices
The Sarbanes-Oxley Act, as well as related rules subsequently implemented by the SEC, requires foreign private issuers,
such as us, to comply with various corporate governance practices. In complying with the Nasdaq Rules, we have elected to
follow certain corporate governance practices permitted under the Companies Law and the rules of the TASE in lieu of
compliance with certain corporate governance requirements otherwise required by the Nasdaq Rules.
In accordance with Israeli law and practice and subject to the exemption set forth in Rule 5615 of the Nasdaq Rules, we
follow the provisions of the Companies Law, rather than the Nasdaq Rules, with respect to the following requirements:
•
•
•
•
Distribution of annual and quarterly reports to shareholders. Under Israeli law, as a public company whose shares are traded on the TASE, we are
not required to distribute annual and quarterly reports directly to shareholders and the generally accepted business practice in Israel is not to
distribute such reports to shareholders but to make such reports publicly available through the website of the ISA and the TASE. In addition, we
make our audited financial statements available to our shareholders at our offices. As a foreign private issuer, we are generally exempt from the
SEC’s proxy solicitation rules.
Quorum. While the Nasdaq Rules require that the quorum for purposes of any meeting of the holders of a listed company’s common voting stock,
as specified in the company’s bylaws, be no less than 33 1/3% of the company’s outstanding common voting stock, under Israeli law, a company is
entitled to determine in its articles of association the number of shareholders and percentage of holdings required for a quorum at a shareholders
meeting. Our Articles of Association provide that a quorum of two or more shareholders holding at least 25% of the voting rights in person or by
proxy is required for commencement of business at a general meeting. However, the quorum set forth in our Articles of Association with respect
to an adjourned meeting consists of any number of shareholders present in person or by proxy.
Independent Directors. Our Board of Directors includes two external directors in accordance with the provisions contained in Sections 239-249 of
the Companies Law and Rule 10A-3 of the general rules and regulations promulgated under the Securities Act, rather than a majority of external
directors. Israeli law does not require, nor do our independent directors conduct, regularly scheduled meetings at which only they are present. We
are required, however, to ensure that all members of our Audit Committee are “independent” under the applicable Nasdaq and SEC criteria for
independence (as a foreign private issuer we are not exempt from the SEC independence requirement), and we must also ensure that a majority of
the members of our Audit Committee are independent directors as defined in the Companies Law. Furthermore, Israeli law does not require, nor
do our independent directors conduct, regularly scheduled meetings at which only they are present, which the Nasdaq Rules otherwise require. If
we qualify as an Eligible Company and opt to follow the exemption provided under the Relief Regulations regarding appointment of external
directors and composition of the audit and compensation committees, we will be required at all times to comply with the U.S. rules and regulations
governing the appointment of independent directors and composition of the audit and compensation committees applicable to U.S. domestic
issuers instead of complying with the Companies Law provisions relating to external directors and composition of the audit and compensation
committees.
Audit Committee. Our Audit Committee complies with all of the requirements under Israeli law, and is composed of two external directors, which
are all of our external directors, and only one other director, who cannot be the chairman of our Board of Directors. Consistent with Israeli law, the
independent auditors are elected at a meeting of shareholders instead of being appointed by the Audit Committee. If we qualify as an Eligible
Company and opt to follow the exemption provided under the Relief Regulations regarding appointment of external directors and composition of
the audit and compensation committees, we will be required at all times to comply with the U.S. rules and regulations governing the appointment
of independent directors and composition of the Audit Committee applicable to U.S. domestic issuers instead of complying with the Companies
Law provisions relating to external directors and composition of the Audit Committee.
92
•
•
•
•
•
Nomination of our Directors. With the exception of our external directors and directors elected by our Board of Directors due to vacancy, our
directors are elected by a general or extraordinary meeting of our shareholders, to hold office until they are removed from office by the majority of
our shareholders at a general or extraordinary meeting of our shareholders. See “Item 6. Directors, Senior Management and Employees — Board
Practices — Board of Directors.” The nominations for directors, which are presented to our shareholders, are generally made by our directors, but
nominations may be made by one or more of our shareholders as provided under the Companies Law or in an agreement between us and our
shareholders. Currently, there is no agreement between us and any shareholder regarding the nomination of directors. In accordance with our
Articles of Association, under the Companies Law, any one or more shareholders holding, in the aggregate, either (1) at least 5% of our
outstanding shares and at least 1% of our outstanding voting power or (2) at least 5% of our outstanding voting power, may nominate one or more
persons for election as directors at a general or special meeting by delivering a written notice of such shareholder’s intent to make such nomination
or nominations to our registered office. Each such notice must set forth all of the details and information as required to be provided in the
Companies Law.
Compensation Committee and Compensation of Officers. Israeli law, and our Articles of Association, do not require that a compensation
committee composed solely of independent members of our Board of Directors determine (or recommend to the board of directors for
determination) an executive officer’s compensation, as required under Nasdaq’s listing standards related to compensation committee independence
and responsibilities; nor do they require that the Company adopt and file a compensation committee charter. Instead, our Compensation
Committee has been established and conducts itself in accordance with provisions governing the composition of and the responsibilities of a
compensation committee as set forth in the Companies Law, and is comprised of all of our external directors (who must comprise the majority of
the members of the Compensation Committee), and at least one additional director who is entitled to the same compensation payable to our
external directors, and who is not the chairman of our Board of Directors or otherwise employed by or a provider of services to, the Company. If
we qualify as an Eligible Company and opt to follow the exemption provided under the Relief Regulations regarding appointment of external
directors and composition of the audit and compensation committees, we will be required at all times to comply with the U.S. rules and regulations
governing the appointment of independent directors and composition of the compensation committee applicable to U.S. domestic issuers instead
of complying with the Companies Law provisions relating to external directors and composition of the compensation committee. Additionally, we
comply with the requirements set forth under the Companies Law, pursuant to which transactions with office holders regarding their terms of
office and employment, and a transaction with a controlling shareholder in a company regarding his or her employment and/or his or her terms of
office with the company, may require the approval of the compensation committee, the board of directors and under certain circumstances the
shareholders, either in accordance with our previously approved compensation policy or, in special circumstances in deviation therefrom, taking
into account certain considerations set forth in the Companies Law. See “Item 6. Directors, Senior Management and Employees — Board
Practices — Compensation Committee” for information regarding the Compensation Committee, and “Item 6. Directors, Senior Management and
Employees — Approval of Related Party Transactions under Israeli Law” for information regarding the special approvals required with respect to
approval of terms of office and employment of office holders, pursuant to the Companies Law. The requirements for shareholder approval of any
office holder compensation, and the relevant majority or special majority for such approval, are all as set forth in the Companies Law. Thus, we
will seek shareholder approval for all corporate actions with respect to office holder compensation requiring such approval under the requirements
of the Companies Law, including seeking prior approval of the shareholders for the compensation policy and for certain office holder
compensation, rather than seeking approval for such corporate actions in accordance with Nasdaq Listing Rules.
Approval of Related Party Transactions. All related party transactions are approved in accordance with the requirements and procedures for
approval of interested party acts and transactions, set forth in sections 268 to 275 of the Companies Law, and the regulations promulgated
thereunder, which require the approval of the audit committee, the compensation committee, the board of directors and shareholders, as may be
applicable, for specified transactions, rather than approval by the audit committee or other independent body of our Board of Directors as required
under the Nasdaq Rules.
Shareholder Approval. We seek shareholder approval for all corporate actions requiring such approval in accordance with the requirements of the
Companies Law, which are different or in addition to the requirements for seeking shareholder approval under Nasdaq Listing Rule 5635, rather
than seeking approval for corporation actions in accordance with such listing rules.
Equity Compensation Plans. We do not necessarily seek shareholder approval for the establishment of, and amendments to, stock option or equity
compensation plans (as set forth in Nasdaq Listing Rule 5635(c)), as such matters are not subject to shareholder approval under Israeli law. Our
equity compensation plan is available to our employees, none of whom are currently U.S. employees, and provides features necessary to comply
with applicable non-U.S. tax laws.
ITEM 16H. MINE SAFETY DISCLOSURE
Not applicable.
ITEM 17. FINANCIAL STATEMENTS
The Registrant has responded to Item 18 in lieu of responding to this Item.
93
ITEM 18. FINANCIAL STATEMENTS
See the financial statements beginning on page F-1. The following financial statements are filed as part of this Annual
Report on Form 20-F together with the report of the independent registered public accounting firm.
ITEM 19. EXHIBITS
Exhibit
Number
2.1
2.2
2.3(1)
2.4(1)
4.1(2)
4.2
4.3(2)
4.4
4.5(2)
4.6
4.7(2)
4.8
4.9†(3)
4.10(4)
4.11(5)
4.12(6)†
4.13(6)
4.14(6)
4.15(7)
4.16(8)
4.17(9)†
4.18(5)†
Articles of Association, as amended September 24, 2020
Description of Securities Registered under Section 12
Exhibit Description
Deposit Agreement dated as of July 21, 2011 among the Registrant, The Bank of New York Mellon, as Depositary, and all Owners and
Holders from time to time of American Depositary Shares issued thereunder
Form of American Depositary Receipt; the Form is Exhibit A of the deposit agreement which is Exhibit 2.2 above.
Employment Agreement with Philip Serlin, dated May 24, 2009
Amendment to Employment Agreement between BioLineRx Ltd. and Philip Serlin, dated September 24, 2020
Employment Agreement with Mali Zeevi, dated September 16, 2009
Amendment to Employment Agreement between BioLineRx Ltd and Mali Zeevi, dated September 24, 2020
Employment Agreement with Abi Vainstein-Hara, dated April 2, 2014
Amendment to Employment Agreement between BioLineRx Ltd and Abi Vainstein-Hara, dated September 24, 2020
Employment Agreement with Ella Sorani, dated January 11, 2017
Amendment to Employment Agreement between BioLineRx Ltd and Ella Sorani, dated September 24, 2020
License Agreement entered into as of November 25, 2007 between BioLine Innovations Jerusalem L.P. and Innovative Pharmaceutical
Concepts, Inc.
BioLineRx Ltd. Amended and Restated 2003 Share Incentive Plan
License Agreement entered into as of September 2, 2012 by and between the Registrant and Biokine Therapeutics Ltd.
Amendment Agreement entered into as of October 2, 2018 by and between the Registrant and Biokine Therapeutics Ltd.
Loan Agreement entered into as of October 2, 2018, by and between the Registrant and Kreos Capital V (Expert Fund) L.P.
Warrant issued to Kreos Capital V dated October 2, 2018
Compensation Policy for Executives and Directors, as amended
Lease Agreement entered into as of August 7, 2014 between S.M.L. Solomon Industrial Buildings Ltd. and Infrastructure Management
and Development Established by C.P.M. Ltd. as Lessor and the Registrant as Lessee, as amended (English summary of the Hebrew
original)
License Agreement entered into as of December 22, 2014 between the Registrant and Wartner Europe BV
Clinical Trial Collaboration and Supply Agreement entered into as of January 11, 2016 between the Registrant and Merck Sharp &
Dohme B.V.
94
4.19(10)†
Amendment No. 2 to Clinical Trial Collaboration and Supply Agreement entered into as of July 24, 2018 between the Registrant and
Merck Sharp & Dohme B.V.
4.20(2)†
4.21(2)†
4.22(10)†
4.23(10)†
4.24(10)†
4.25(7)
4.26(11)
4.27(11)
4.28(11)
4.29(12)
4.30(13)
4.31(14)
4.32 (14)
4.33(14)
4.34(15)
4.35(15)
4.36(15)
4.38(16)
Combination Study Agreement entered into as of September 6, 2016 between the Registrant and Genentech, Inc.
Amended and Restated Exclusive License Agreement entered into as of April 30, 2013 between the University of Massachusetts and
Agalimmune Ltd.
Patent and Know-how License Agreement entered into as of September 19, 2017 between Kode Biotech Limited and Agalimmune Ltd.
Second Amendment Agreement entered into as of October 16, 2018 between the University of Massachusetts and Agalimmune Ltd.
Amendment No. 1 to License Agreement entered into as of June 18, 2018 between the Registrant and Wartner Europe BV
First Addendum to License Agreement entered into as of October 16, 2019 by and between the Registrant and Biokine Therapeutics
Ltd., as amended.
Form of Series A Warrant issued to the BVF Investors
Form of Series B Warrant issued to the BVF Investors
Voting and Standstill Agreement entered into as of July 26, 2017 among the Registrant and the BVF Investors
Form of Warrant issued February 7, 2019
At-the-Market Sales Agreement, dated September 25, 2020, between BioLineRx Ltd. and H.C. Wainwright & Co., LLC
Form of Securities Purchase Agreement dated as of May 26, 2020 by and between BioLineRx Ltd. and the Purchasers signatory thereto
Form of Warrant issued by BioLineRx Ltd. on May 28, 2020
Form of Placement Agent Warrant issued by BioLineRx Ltd. on May 28, 2020
Form of Securities Purchase Agreement dated as of June 1, 2020 by and between BioLineRx Ltd. and the Purchasers signatory thereto
Form of Warrant issued by BioLineRx Ltd. on June 3, 2020
Form of Placement Agent Warrant issued by BioLineRx Ltd. on June 3, 2020
Amended and Restated Underwriting Agreement, dated January 19, 2021, by and between BioLineRx Ltd. and H.C. Wainwright &
Co., LLC
4.39(16)
Form of Underwriter Warrant to be issued by BioLineRx Ltd. on January 22, 2021
8.1
12.1
12.2
13.1
13.2
15.1
List of Subsidiaries of BioLineRx Ltd.
Certification by Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Certification by Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Certification by Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
Certification by Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002
Consent of Kesselman & Kesselman, Certified Public Accountant (Isr.), a member of PricewaterhouseCoopers International Limited,
independent registered public accounting firm for the Registrant
95
101
The following financial information from BioLineRx Ltd.’s Annual Report on Form 20-F for the fiscal year ended December 31, 2020
formatted in XBRL (Extensible Business Reporting Language): (i) Consolidated Statements of Financial Position at December 31,
2020 and 2019; (ii) Consolidated Statements of Comprehensive Loss for the years ended December 31, 2020, 2019 and 2018; (iii)
Statements of Changes in Equity for the years ended December 31, 2020, 2019 and 2018; (iv) Consolidated Cash Flow Statements for
the years ended December 31, 2020, 2019 and 2018; and (v) Notes to the Consolidated Financial Statements.
Portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission pursuant to a
confidential treatment request.
(1) Incorporated by reference to Exhibit 1 of the Registration Statement on Form F-6EF (No. 333-218969) filed by
the Bank of New York Mellon on June 26, 2017 with respect to the Registrant’s American Depositary Shares.
(2) Incorporated by reference to the Registrant’s Annual Report on Form 20-F filed on March 23, 2017.
(3) Incorporated by reference to the Registrant’s Registration Statement on Form 20-F (No. 001-35223) filed on
July 1, 2011.
(4) Incorporated by reference to the Registrant’s Annual Report on Form 20-F filed on March 10, 2016.
(5) Incorporated by reference to the Registrant’s Annual Report on Form 20-F/A filed on May 31, 2016.
(6) Incorporated by reference to the Registrant’s Form 6-K filed on October 3, 2018.
(7) Incorporated by reference to the Registrant’s Annual Report on Form 20-F filed on March 12, 2020.
(8) Incorporated by reference to the Registrant’s Annual Report on Form 20-F filed on March 23, 2015.
(9) Incorporated by reference to the Registrant’s Annual Report on Form 20-F/A filed on September 22, 2015.
(10) Incorporated by reference to the Registrant’s Annual Report on Form 20-F filed on March 28, 2019.
(11) Incorporated by reference to the Registrant’s Form 6-K filed on July 31, 2017.
(12) Incorporated by reference to the Registrant’s Form 6-K filed on February 7, 2019.
(13) Incorporated by reference to the Registrant’s Form 6-K filed on September 25, 2020.
(14) Incorporated by reference to the Registrant’s Form 6-K filed on May 28, 2020.
(15) Incorporated by reference to the Registrant’s Form 6-K filed on June 3, 2020.
(16) Incorporated by reference to the Registrant’s Form 6-K filed on January 22, 2021.
96
The Registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and
authorized the undersigned to sign this annual report on its behalf.
SIGNATURES
Date: February 23, 2021
BIOLINERX LTD.
By: /s/ Philip A. Serlin
Philip A. Serlin
Chief Executive Officer
97
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of BioLineRx Ltd.
Opinion on the Financial Statements
We have audited the accompanying consolidated statements of financial position of BioLineRx Ltd. and its subsidiaries (the
“Company”) as of December 31, 2020 and 2019, and the related consolidated statements of comprehensive loss, changes in
equity and cash flows for each of the three years in the period ended December 31, 2020, including the related notes (collectively
referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all
material respects, the financial position of the Company as of December 31, 2020 and 2019, and the results of its operations and
its cash flows for each of the three years in the period ended December 31, 2020 in conformity with International Financial
Reporting Standards as issued by the International Accounting Standards Board.
Change in Accounting Principle
As discussed in Note 2(r) to the consolidated financial statements, the Company changed the manner in which it accounts for
leases in 2019.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an
opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with
the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to
the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and
Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those
standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial
statements are free of material misstatement, whether due to error or fraud.
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.
As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the
purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we
express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements,
whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a
test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included
evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall
presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial
statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or
disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or
complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated
financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate
opinion on the critical audit matter or on the accounts or disclosures to which it relates.
F - 1
Intellectual Property Impairment Assessment
As described in Notes 4 and 9 to the consolidated financial statements, the Company's intangible assets relating to intellectual
property balance was $21.7 million at December 31, 2020. Management conducts an impairment test as of December 31 of each
year, or more frequently if events or circumstances indicate that the carrying value of the Intellectual Property may be impaired.
Potential impairment is identified by comparing the fair value of the Intellectual Property to its carrying value. Fair value is
estimated by management using a discounted cash flow model. Management's cash flow projections included significant
judgments and assumptions relating to weighted average cost of capital and the amount and timing of projected future cash flows.
The principal considerations for our determination that performing procedures relating to the intellectual property impairment
assessment is a critical audit matter are the significant judgment by management in developing the weighted average cost of
capital and the amount and timing of projected future cash flows. This in turn led to a high degree of auditor judgment,
subjectivity, and effort in performing procedures to evaluate these assumptions. In addition, the audit effort involved the use of
professionals with specialized skill and knowledge to assist in performing these procedures and evaluating the audit evidence
obtained.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall
opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to
management's intangible asset impairment assessment, including controls over the determination of the cash flow projections and
the significant assumptions used. These procedures also included, among others, testing management’s process for developing the
fair value estimate; evaluating the appropriateness of the discounted cash flow model; testing the completeness, accuracy, and
relevance of underlying data used in the model; and evaluating the significant assumptions used by management, including the
weighted average cost of capital and the amount and timing of projected future cash flows. Evaluating management’s
assumptions related to the weighted average cost of capital and the amount and timing of projected future cash flows involved
evaluating whether the assumptions used by management were reasonable considering the consistency with external market and
industry data. Professionals with specialized skill and knowledge were used to assist in the evaluation of management’s valuation
model and certain significant assumptions.
/s/ Kesselman & Kesselman
Kesselman & Kesselman
Certified Public Accountants (Isr.)
A member firm of PricewaterhouseCoopers International Ltd.
Tel Aviv, Israel
February 22, 2021
We have served as the Company’s auditor since 2003.
F - 2
BioLineRx Ltd.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
Assets
CURRENT ASSETS
Cash and cash equivalents
Short-term bank deposits
Prepaid expenses
Other receivables
Total current assets
NON-CURRENT ASSETS
Property and equipment, net
Right-of-use assets, net
Intangible assets, net
Total non-current assets
Total assets
Liabilities and equity
CURRENT LIABILITIES
Current maturities of long-term loans
Accounts payable and accruals:
Trade
Other
Lease liabilities
Total current liabilities
NON-CURRENT LIABILITIES
Warrants
Long-term loans, net of current maturities
Lease liabilities
Total non-current liabilities
COMMITMENTS AND CONTINGENT LIABILITIES
Total liabilities
EQUITY
Ordinary shares
Share premium
Capital reserve
Other comprehensive loss
Accumulated deficit
Total equity
Total liabilities and equity
Note
5
6
17a
8
10
9
11, 19
17b
17b
10
12c, 19
11, 19
10
15
12
December 31,
2019
2020
in USD thousands
5,297
22,192
108
613
28,210
1,816
1,650
21,891
25,357
53,567
16,831
5,756
152
141
22,880
1,341
1,355
21,714
24,410
47,290
2,692
3,092
7,794
1,280
202
11,968
658
5,799
1,762
8,219
5,918
1,440
191
10,641
10,218
2,740
1,661
14,619
20,187
25,260
4,692
265,938
12,132
(1,416)
(247,966)
33,380
53,567
9,870
279,241
12,322
(1,416)
(277,987)
22,030
47,290
The accompanying notes are an integral part of the consolidated financial statements.
F - 3
BioLineRx Ltd.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
RESEARCH AND DEVELOPMENT EXPENSES
SALES AND MARKETING EXPENSES
GENERAL AND ADMINISTRATIVE EXPENSES
OPERATING LOSS
NON-OPERATING INCOME (EXPENSES), NET
FINANCIAL INCOME
FINANCIAL EXPENSES
NET LOSS AND COMPREHENSIVE LOSS
LOSS PER ORDINARY SHARE – BASIC AND DILUTED
WEIGHTED AVERAGE NUMBER OF SHARES USED IN
CALCULATION OF LOSS PER ORDINARY SHARE
Note
17c
17d
17e
17f
17g
17h
14
14
2018
Year ended December 31,
2019
in USD thousands
2020
(19,808)
(1,362)
(4,435)
(25,605)
2,397
719
(473)
(22,962)
(23,438)
(857)
(3,816)
(28,111)
4,165
777
(2,277)
(25,446)
(18,173)
(840)
(3,914)
(22,927)
(5,701)
236
(1,629)
(30,021)
in USD
(0.21)
(0.17)
(0.12)
108,595,702 146,407,055 252,844,394
The accompanying notes are an integral part of the consolidated financial statements.
F - 4
BioLineRx Ltd.
STATEMENTS OF CHANGES IN EQUITY
Ordinary
shares
Share
premium
Capital
reserve
Other
comprehensive
loss
Accumulated
deficit
Total
2,836
240,682
10,337
(1,416)
(199,558)
52,881
in USD thousands
263
11
-
-
-
3,110
1,580
2
-
-
-
4,692
4,777
393
8
-
-
-
9,870
8,567
415
528
-
-
250,192
14,165
83
1,498
-
-
265,938
9,395
2,826
228
854
-
-
279,241
-
(380)
(528)
2,526
-
11,955
-
(84)
(1,498)
1,759
-
12,132
-
-
(228)
(854)
1,272
-
12,322
-
-
-
-
-
(1,416)
-
-
-
-
-
(1,416)
-
-
-
-
-
-
-
(22,962)
(222,520)
-
-
-
-
(25,446)
(247,966)
-
-
-
-
-
-
(1,416)
-
-
(30,021)
(277,987)
8,830
46
-
2,526
(22,962)
41,321
15,745
1
-
1,759
(25,446)
33,380
14,172
3,219
8
-
1,272
(30,021)
22,030
BALANCE AT JANUARY 1, 2018
CHANGES IN 2018:
Issuance of share capital, net
Employee stock options exercised
Employee stock options forfeited and
expired
Share-based compensation
Comprehensive loss for the year
BALANCE AT DECEMBER 31, 2018
CHANGES IN 2019:
Issuance of share capital, net
Employee stock options exercised
Employee stock options forfeited and
expired
Share-based compensation
Comprehensive loss for the year
BALANCE AT DECEMBER 31, 2019
CHANGES IN 2020:
Issuance of share capital, net
Warrants exercised
Employee stock options exercised
Employee stock options forfeited and
expired
Share-based compensation
Comprehensive loss for the year
BALANCE AT DECEMBER 31, 2020
The accompanying notes are an integral part of the consolidated financial statements.
F - 5
BioLineRx Ltd.
CONSOLIDATED CASH FLOW STATEMENTS
CASH FLOWS - OPERATING ACTIVITIES
Net loss
Adjustments required to reflect net cash used in operating activities (see appendix below)
Net cash used in operating activities
CASH FLOWS - INVESTING ACTIVITIES
Realization of long-term investment
Investments in short-term deposits
Maturities of short-term deposits
Purchase of property and equipment
Purchase of intangible assets
Net cash provided by investing activities
CASH FLOWS - FINANCING ACTIVITIES
Issuance of share capital and warrants, net of issuance cost
Employee stock options exercised
Proceeds of long-term loan and warrants, net of issuance costs
Repayment of loans
Repayments of lease liabilities
Net cash provided by financing activities
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
CASH AND CASH EQUIVALENTS - BEGINNING OF YEAR
EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS
CASH AND CASH EQUIVALENTS - END OF YEAR
2018
Year ended December 31,
2019
in USD thousands
2020
(22,962)
(1,230)
(24,192)
(25,446)
2,780
(22,666)
1,500
(26,500)
44,771
(173)
(10,043)
9,555
3,830
46
9,632
(411)
-
13,097
(1,540)
5,110
(166)
3,404
-
(43,545)
48,875
(67)
(6)
5,257
20,297
1
-
(889)
(215)
19,194
1,785
3,404
108
5,297
(30,021)
6,815
(23,206)
-
(33,500)
50,168
-
-
16,668
21,215
8
-
(3,133)
(224)
17,866
11,328
5,297
206
16,831
The accompanying notes are an integral part of the consolidated financial statements.
F - 6
BioLineRx Ltd.
CONSOLIDATED CASH FLOW STATEMENTS
APPENDIX
Adjustments required to reflect net cash used in operating activities:
Income and expenses not involving cash flows:
Depreciation and amortization
Long-term prepaid expenses
Exchange differences on cash and cash equivalents
Fair value adjustments of warrants
Share-based compensation
Interest and exchange differences on short-term deposits
Interest on loans
Gain on realization of long-term investment
Warrant issuance costs
Exchange differences on lease liability
Changes in operating asset and liability items:
Decrease (increase) in prepaid expenses and other receivables
Increase (decrease) in accounts payable and accruals
2018
Year ended December 31,
2019
in USD thousands
2020
545
5
166
(1,743)
2,526
(645)
123
(500)
-
-
477
(934)
(773)
(1,707)
940
56
(108)
(4,634)
1,759
(775)
647
-
417
154
(1,544)
934
-
(206)
5,142
1,272
(232)
474
-
594
125
8,103
1,106
3,218
4,324
428
(1,716)
(1,288)
(1,230)
2,780
6,815
Supplemental information on interest received in cash
834
868
Supplemental information on interest paid in cash (see Notes 10 and 15)
165
1,198
381
994
Supplemental information on non-cash transactions (see Notes 18, 19 and 12c)
5,000
147
1,251
The accompanying notes are an integral part of the consolidated financial statements.
F - 7
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
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 clinical stages, with a focus on the field of oncology.
In February 2007, BioLineRx listed its ordinary shares on the Tel Aviv Stock Exchange (“TASE”) and they have
been traded on the TASE since that time. Since July 2011, BioLineRx’s American Depositary Shares (“ADSs”)
have also been traded on the NASDAQ Capital Market.
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. See Note 18.
The Company has incurred accumulated losses in the amount of $278 million through December 31, 2020, and
cannot determine with reasonable certainty when and if it will have sustainable profits. See Note 3c with regard to
the Company's management of liquidity risk.
b. Approval of consolidated financial statements
The consolidated financial statements of the Company for the year ended December 31, 2020 were approved by
the Board of Directors on February 22, 2021, and signed on its behalf by the Chairman of the Board, the Chief
Executive Officer and the Chief Financial Officer.
c. Change in ratio of ADSs
On July 15, 2019, the Company effected a change in the ratio of its ADSs to ordinary shares, from one ADS
representing one ordinary share to a new ratio of one ADS representing 15 ordinary shares. All ADSs and per
ADSs amounts in these financial statements have been retroactively adjusted as if the change in ratio had been
effected at the earliest date of these financial statements.
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES
a.
Basis of presentation
The Company’s consolidated financial statements as of December 31, 2020 and 2019, and for each of the three
years in the period ended December 31, 2020, have been prepared in accordance with International Financial
Reporting Standards (“IFRS”), as issued by the International Accounting Standards Board (“IASB”). The
significant accounting policies described below have been applied on a consistent basis for all years presented,
unless noted otherwise.
The consolidated financial statements have been prepared on the basis of historical cost, subject to adjustment of
financial assets and liabilities to their fair value through profit or loss.
The Company classifies its expenses on the statement of comprehensive loss based on the operating characteristics
of such expenses.
F - 8
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES (cont.)
a.
Basis of presentation (cont.)
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 the COVID-19 pandemic 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. The COVID-19 pandemic has spread to many countries throughout the
world, including to the United States, Europe and Israel, where the Company currently manufactures its
therapeutic candidates and conducts its clinical trials. The Company has previously experienced some recruitment
delays from the deepening and extended impact of COVID-19 on its clinical trials; however, at present, the
Company does not believe these delays will significantly impact its clinical development plans. Future
developments related to COVID-19 are highly uncertain, including as a result of new information that may emerge
concerning COVID-19 and the actions taken to contain or treat it, as well as its overall economic impact, and more
specifically its effects on the financial markets. All estimates made by the Company related to the impact of
COVID-19 in its financial statements may change in future periods. Actual results could differ from those
estimates
Areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are
significant to the consolidated financial statements, are disclosed in Note 4. Actual results may differ materially
from estimates and assumptions used by the Company’s management.
b.
Principles of consolidation
Consolidated entities are all entities over which BioLineRx has control. BioLineRx controls an entity when it is
exposed to, or has rights to, variable returns from its involvement with the entity and has the ability to affect those
returns through its power over the entity. Consolidated entities are fully consolidated from the date on which
control of such entities is transferred to BioLineRx and they are de-consolidated from the date that control ceases.
c.
Functional and reporting currency
The functional and reporting currency in these financial statements is the U.S. dollar (“dollar”, “USD” or “$”),
which is the primary currency of the economic environment in which the Company operates. Foreign currency
transactions are translated into the functional currency using the exchange rates at the dates of the transactions.
Foreign exchange gains and losses resulting from the settlement of such transactions and from the translation of
monetary assets and liabilities denominated in foreign currencies at year-end exchange rates are generally
recognized in profit or loss.
Foreign exchange gains and losses that relate to borrowings are presented in the statement of comprehensive loss,
within financial expenses. All other foreign exchange gains and losses are presented in the statement of
comprehensive loss on a net basis within non-operating income or expenses.
F - 9
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES (cont.)
d. Cash equivalents and short-term bank deposits
Cash and cash equivalents include cash on hand and short-term bank deposits (up to three months from date of
deposit) that are not restricted as to withdrawal or use, and are therefore considered to be cash equivalents. Bank
deposits with original maturity dates of more than three months and with a current maturity date of less than one
year from the balance sheet date are included in short-term bank deposits. The fair value of cash equivalents and
short-term bank deposits approximate their carrying value, since they bear interest at rates close to the prevailing
market rates. See also Note 6.
e.
Property and equipment
Property and equipment are stated at historical cost less depreciation. Historical cost includes expenditures that are
directly attributable to the acquisition of the items. Assets are depreciated by the straight-line method over the
estimated useful lives of the assets, provided that the Company’s management believes the residual values of the
assets to be negligible, as follows:
Computers and communications equipment
Office furniture and equipment
Laboratory equipment
%
20-33
6-15
15-20
The assets’ residual values, methods of depreciation and useful lives are reviewed and adjusted, if appropriate, at
each balance sheet date. An asset’s carrying amount is written down immediately to its recoverable amount if the
asset’s carrying amount is greater than its estimated recoverable amount.
Leasehold improvements are amortized by the straight-line method over the shorter of the lease term or the
estimated useful life of the improvements.
f.
Intangible assets
The Company applies the cost method of accounting for initial and subsequent measurements of intangible assets.
Under this method of accounting, intangible assets are carried at cost less any accumulated amortization and any
accumulated impairment losses.
Intellectual property
The Company recognizes in its financial statements intangible assets developed by the Company to the extent that
the conditions stipulated in g. below are met. Intellectual property acquired by the Company is initially measured
at cost. Intellectual property acquired by the Company for development purposes is not amortized and is tested
annually for impairment. See g. below.
Computer software
Acquired computer software licenses are capitalized on the basis of the costs incurred to acquire and bring to use
the specific software. These costs are amortized over the estimated useful lives of the software (3-5 years).
F - 10
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES (cont.)
g.
Impairment of non-amortized non-financial assets
Impairment of intellectual property is required when the Company decides to terminate or suspend the
development of a project based on such intellectual property. In addition, the Company performs impairment
reviews on an annual basis, or more frequently if events or changes in circumstances indicate a potential
impairment. Property and equipment, as well as computer software, are tested for impairment whenever events or
changes in circumstances indicate that the carrying amount may not be recoverable. An impairment loss is
recognized equal to the amount by which the asset’s carrying amount exceeds its recoverable amount. The
recoverable amount is the higher of an asset’s fair value less costs to sell and the asset’s value in use to the
Company.
h. Financial assets
The Company accounts for financial assets in accordance with IFRS 9 “Financial Instruments.”
1) Classification
The financial assets of the Company are classified as financial assets at amortized cost. The classification is
done on the basis of the Company’s business model for managing the financial assets and the contractual cash
flow characteristics of the financial assets.
Financial assets at amortized cost
Financial assets at amortized cost are assets held pursuant to a business model whose objective is to hold
assets in order to collect contractual cash flows and the contractual terms of the financial assets give rise on
specified dates to cash flows that are solely payments of principal and interest on the principal amount
outstanding.
Financial assets at amortized cost are included in current assets, except for those with maturities greater than
12 months after the balance sheet date (in which case they are classified as non-current assets).
The Company’s financial assets at amortized cost are included in other receivables and bank deposits in the
consolidated statements of financial position.
F - 11
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES (cont.)
h. Financial assets (cont.)
2) Recognition and measurement
Regular purchases and sales of financial assets are recognized on the settlement date, which is the date on
which the asset is delivered to the Company or delivered by the Company. Investments are initially recognized
at fair value plus transaction costs, except for trade receivables, which are recognized initially at the amount of
consideration that is unconditional unless they contain significant financing components.
Financial assets are derecognized when the rights to receive cash flows from the investments have expired or
have been transferred and the Company has transferred substantially all risks and rewards of ownership.
Financial assets at amortized cost are measured in subsequent periods at amortized cost using the effective
interest method.
3)
Impairment
The Company recognizes a loss allowance for expected credit losses on financial assets at amortized cost. At
each reporting date, the Company assesses whether the credit risk on a financial instrument has increased
significantly since initial recognition. If the financial instrument is determined to have low credit risk at the
reporting date, the Company assumes that the credit risk on a financial instrument has not increased
significantly since initial recognition.
i. Warrants
Receipts in respect of warrants are classified as equity to the extent that they confer the right to purchase a fixed
number of shares for a fixed exercise price. In the event that the exercise price or the numbers of shares to be
issued are not deemed to be fixed, the warrants are classified as a non-current derivative financial liability. This
liability is initially recognized at its fair value on the date the contract is entered into and subsequently accounted
for at fair value at each reporting date. The fair value changes are charged to non-operating income and expense on
the statement of comprehensive loss. Issuance costs allocable to warrants are also recorded as non-operating
expense on the statement of comprehensive loss.
F - 12
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES (cont.)
j.
Share capital
The Company’s ordinary shares are classified as equity. Incremental costs directly attributable to the issuance of
new shares are shown in equity as a deduction from the issuance proceeds.
k. Trade payables
Trade payables are obligations to pay for goods or services that have been acquired in the ordinary course of
business from suppliers. These payables are classified as current liabilities if payment is due within one year or
less. If not, they are presented as non-current liabilities. Trade payables are recognized initially at fair value and
subsequently measured at amortized cost using the effective interest method.
l.
Deferred taxes
Deferred taxes are recognized using the liability method, on temporary differences arising between the tax bases of
assets and liabilities and their carrying amounts in the consolidated financial statements. Deferred income tax
assets are recognized only to the extent that it is probable that future taxable income will be available against
which the temporary differences can be utilized.
As the Company is currently engaged primarily in development activities and is not expected to generate taxable
income in the foreseeable future, no deferred tax assets are included in the financial statements.
m. Borrowings
Borrowings are initially recognized at fair value, net of transaction costs incurred. Borrowings are subsequently
measured at amortized cost. Any difference between the proceeds (net of transaction costs) and the redemption
amount is recognized in profit or loss over the period of the borrowings using the effective interest method.
Borrowings are classified as current liabilities unless the Company has an unconditional right to defer settlement
of the liability for at least 12 months after the reporting period.
F - 13
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES (cont.)
n. Revenue from contracts with customers
The Company accounts for revenue in accordance with IFRS 15, “Revenue from Contracts with Customers.”
IFRS 15 introduces a five-step model for recognizing revenue from contracts with customers, as follows:
•
•
•
•
•
identify the contract with a customer;
identify the performance obligations in the contract;
determine the transaction price;
allocate the transaction price to the performance obligations in the contract; and
recognize revenue when (or as) the entity satisfies a performance obligation.
During the years included in these financial statements, the Company did not generate revenues, other than
immaterial amounts received from an out-licensing agreement signed in 2014 with Perrigo Company plc., which
have been included in non-operating income.
o. Research and development expenses
Research expenses are charged to profit or loss as incurred.
An intangible asset arising from development (or from the development phase of an internal project) is recognized
if all of the following conditions are fulfilled:
•
•
•
•
•
technological feasibility exists for completing development of the intangible asset so that it will be available for use or sale.
it is management’s intention to complete development of the intangible asset for use or sale.
the Company has the ability to use or sell the intangible asset.
it is probable that the intangible asset will generate future economic benefits, including existence of a market for the output of the
intangible asset or the intangible asset itself or, if the intangible asset is to be used internally, the usefulness of the intangible asset.
adequate technical, financial and other resources are available to complete development of the intangible asset, as well as the use
or sale thereof.
•
the Company has the ability to reliably measure the expenditure attributable to the intangible asset during its development.
Other development costs that do not meet the foregoing conditions are charged to profit or loss as incurred.
Development costs previously expensed are not recognized as an asset in subsequent periods. As of December 31,
2020, the Company has not yet capitalized development expenses.
F - 14
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES (cont.)
p. Employee benefits
1)
Pension and severance pay obligations
Israeli labor laws and the Company’s employment agreements require the Company to pay retirement
benefits to employees terminated or leaving their employment in certain other circumstances. Most of the
Company’s employees are covered by a defined contribution plan under Section 14 of the Israel Severance
Pay Law.
With respect to the remaining employees, the Company records a liability on its balance sheet for defined
benefit plans that represents the present value of the defined benefit obligation as of each reporting date,
net of the fair value of plan assets. The present value of the defined benefit liability is determined by
discounting the anticipated future cash outflows, using interest rates that are denominated in the currency in
which the benefits will be payable.
The amounts recorded as an employee benefit expense in respect of pension and severance pay obligations
for the years 2018, 2019 and 2020 were $618,000, $580,000 and $668,000, respectively.
2)
Vacation and recreation pay
Labor laws in Israel entitle every employee to vacation and recreation pay, both of which are computed
annually. The entitlement with respect to each employee is based on the employee’s length of service at the
Company. The Company recognizes a liability and an expense in respect of vacation and recreation pay
based on the individual entitlement of each employee.
3)
Share-based payments
The Company operates an equity-settled, share-based compensation plan, under which it grants equity
instruments (options, restricted stock units and performance stock units) of the Company as additional
consideration for services from employees and service providers. The fair value of the employee services
received in exchange for grant of the equity instruments is recognized as an expense. The total amount to
be expensed is determined by reference to the fair value of the equity instruments granted:
•
•
including any market performance conditions (for example, the Company’s share price); and
excluding the impact of any service and non-market performance vesting conditions (for example, profitability, sales
growth targets and the employee remaining with the entity over a specified time period).
Non-market performance and service conditions are included in assumptions about the number of equity
instruments that are expected to vest. The total expense is recognized over the vesting period, which is the
period over which all of the specified vesting conditions are to be satisfied. Performance stock unit
expenses are recognized only if it is probable that the performance condition will be achieved.
When the equity instruments are exercised, the Company issues new shares. The proceeds received, net of
any directly attributable transaction costs, are credited to share capital (at par value) and share premium
when the equity instruments are exercised.
F - 15
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES (cont.)
q. Loss per share
1) Basic
The basic loss per share is calculated by dividing the loss attributable to the holders of ordinary shares by the
weighted average number of ordinary shares outstanding during the year.
2) Diluted
The diluted loss per share is calculated by adjusting the weighted average number of outstanding ordinary
shares, assuming conversion of all dilutive potential shares. The Company’s dilutive potential shares consist
of warrants issued to investors, as well as equity instruments granted to employees and service providers. The
dilutive potential shares were not taken into account in computing loss per share in 2018, 2019 and 2020, as
their effect would have been anti-dilutive.
r.
Leases
The Company adopted International Financial Reporting Standard No. 16 “Leases” (“IFRS16”) retrospectively
from January 1, 2019 (the "commencement date") but has not restated comparatives for the 2018 reporting period,
as permitted under the specific transitional provisions in the standard. On adoption of IFRS 16, the Company
recognized lease liabilities for leases which had previously been classified as “operating leases” under the
principles of IAS 17, “Leases.” These liabilities were measured at the present value of the remaining lease
payments, discounted using the Company’s incremental borrowing rate as of January 1, 2019.
The Company’s leases include property and motor vehicle leases. At inception of a contract, the Company assesses
whether a contract is, or contains, a lease. A contract is, or contains, a lease if the contract conveys the right to
control the use of an identified asset for a period of time in exchange for consideration. The Company reassesses
whether a contract is, or contains, a lease only if the terms and conditions of the contract are changed.
At the commencement date, the Company measures the lease liability at the present value of the lease payments
that are not paid at that date, including, inter alia, the exercise price of a purchase option if the Company is
reasonably certain to exercise that option. Simultaneously, the Company recognizes a right-of-use asset in the
amount of the lease liability.
Since the interest rate implicit in the lease cannot be readily determined, the Company uses the Company’s
incremental borrowing rate. This rate is the rate of interest that the Company would have to pay to borrow over a
similar term, and with a similar security, the funds necessary to obtain an asset of a similar value to the right-of-use
asset in a similar economic environment.
The lease term is the non-cancellable period for which the Company has the right to use an underlying asset,
together with both the periods covered by an option to extend the lease, if the Company is reasonably certain to
exercise that option, and periods covered by an option to terminate the lease, if the Company is reasonably certain
not to exercise that option.
F - 16
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES (cont.)
r.
Leases (cont.)
After the commencement date, the Company measures the right-of-use asset applying the cost model, less any
accumulated depreciation and any accumulated impairment losses and adjusted for any remeasurement of the lease
liability
Assets are depreciated by the straight-line method over the estimated useful lives of the right of use assets or the
lease period, which is shorter:
Property
Motor vehicles
Years
11
3
Interest on the lease liability is recognized in profit or loss in each period during the lease term, in an amount that
produces a constant periodic rate of interest on the remaining balance of the lease liability.
Prior to the implementation of IFRS 16, leases were accounted for in accordance with IAS 17, pursuant to which a
lease was classified as an operating lease if it did not transfer substantially all the risks and rewards incidental to
ownership. Lease payments under an operating lease (reduced by any incentives received from the lessor) were
recognized as an expense on a straight‑line basis over the lease term.
s. New standards and interpretations not yet adopted
Classification of Liabilities as Current or Non-current (Amendment to IAS 1)
The narrow-scope amendments to IAS 1, “Presentation of Financial Statements,” clarify that liabilities are
classified as either current or non-current, depending on the rights that exist at the end of the reporting period.
Classification is unaffected by the expectations of the entity or events after the reporting date (e.g., the receipt of a
waiver or a breach of covenant). The amendments also clarify what IAS 1 means when it refers to the “settlement”
of a liability. The amendments could affect the classification of liabilities, particularly for entities that previously
considered management’s intentions to determine classification and for some liabilities that can be converted into
equity. They must be applied retrospectively in accordance with the normal requirements in IAS 8, “Accounting
Policies, Changes in Accounting Estimates and Errors.” The amendment should be applied retrospectively for
annual periods beginning on or after January 1, 2023. Earlier application is permitted. The adoption of the
amendment is not expected to have a material impact on the Company’s financial statements.
F - 17
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 3 – FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT
Based on assessments by Company management, the Company’s exposure to credit risk as of December 31, 2020 is
immaterial (see Note 3b). The activities of the Company expose it to market risk, primarily as a result of currency risk.
The Company’s Finance Department is responsible for carrying out risk management activities in accordance with
policies approved by its Board of Directors. In this regard, the Finance Department identifies, defines and assesses
financial risks in close cooperation with other Company departments. The Board of Directors provides written
guidelines for overall risk management, as well as written policies dealing with specific areas, such as exchange rate
risk, interest rate risk, credit risk, use of financial instruments and investment of excess cash.
a. Market risk
1) Concentration of currency risk
The Company’s activities are partly denominated in non-dollar currencies (primarily the New Israeli Shekel,
or “NIS,” and the Euro), which exposes the Company to risks resulting from changes in exchange rates.
The effect of fluctuations in various exchange rates on the Company’s income and equity is as follows:
Sensitive instrument
10%
increase
Income (loss)
Income (loss)
5% increase
5% decrease
10%
decrease
December 31, 2020
Value on
balance
sheet
in USD thousands
NIS-linked balances:
Cash and cash equivalents
Other receivables
Trade payables
Other payables
Total NIS-linked balances
Euro-linked trade payables
Total
(341)
(13)
47
117
(190)
(203)
(393)
(179)
(7)
25
61
(100)
(106)
(206)
3,755
141
(518)
(1,286)
2,092
(2,232)
(140)
198
7
(27)
(68)
110
248
358
417
16
(58)
(143)
232
117
349
Sensitive instrument
10%
increase
Income (loss)
Income (loss)
5% increase
5% decrease
10%
decrease
December 31, 2019
Value on
balance
sheet
in USD thousands
NIS-linked balances:
Cash and cash equivalents
Other receivables
Trade payables
Other payables
Total NIS-linked balances
Euro-linked trade payables
Total
(53)
(56)
227
71
189
(168)
21
(28)
(29)
119
37
99
(88)
11
583
613
(2,501)
(780)
(2,085)
(1,851)
(3,936)
65
68
(278)
(87)
(232)
206
(26)
31
32
(132)
(41)
(110)
97
(13)
The Company also maintains cash and cash equivalent balances in other currencies in amounts that are not
material.
F - 18
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 3 – FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT (cont.)
a. Market risk (cont.)
1) Concentration of currency risk (cont.)
Set forth below is certain data regarding dollar exchange rates:
As of December 31:
2018
2019
2020
Percentage increase (decrease) in USD exchange rate:
2019
2020
Set forth below is information on the linkage of monetary items:
Exchange
rate of NIS
per $1
Exchange
rate of Euro
per $1
3.748
3.456
3.215
0.873
0.891
0.815
(7.8)%
(7.0)%
2.1%
(8.5)%
Assets:
Current assets:
Cash and cash equivalents
Short term bank deposits
Other receivables
Liabilities:
Current liabilities:
Current maturities of long-term
loans
Accounts payable and accruals:
Trade
Other
Non-current liabilities
Long-term loans, net of current
maturities
Net asset value
December 31, 2019
December 31, 2020
Dollar
NIS
USD in thousands
Other
currencies
Dollar
NIS
USD in thousands
Other
Currencies
4,082
22,192
-
26,274
583
-
613
1,196
632
-
-
632
12,488
5,756
-
18,244
3,755
-
141
3,896
588
-
-
588
2,692
-
-
3,092
-
-
2,772
500
2,501
780
2,521
-
2,455
154
518
1,286
2,945
-
5,799
11,763
14,511
-
3,281
(2,085)
-
2,521
(1,889)
2,740
8,441
9,803
-
1,804
2,092
-
2,945
(2,357)
F - 19
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 3 – FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT (cont.)
a. Market risk (cont.)
2)
Fair value of financial instruments
As of December 31, 2020, the financial instruments of the Company consist of non-derivative assets and
liabilities (primarily working capital items, deposits and long-term loan), as well as warrants classified as a
liability.
With regard to non-derivative assets and liabilities, given their nature, the fair value of the financial
instruments included in working capital is generally close or identical to their carrying amount.
With regard to the warrants classified as a liability, see Notes 12c and 19. With regard to the long-term loan,
see Notes 11 and 19.
3)
Exposure to market risk and management thereof
In the opinion of Company management, the market risk to which the Company is exposed is primarily
related to currency risk exposure, as mentioned above. Additionally, Company management does not consider
the interest rate risk mentioned in paragraph 4 below to be material.
4)
Interest rate risk
Company management does not consider interest rate risk to be material, as the Company holds deposits and
short-term government bonds whose fair value and/or cash flows are not materially affected by changes in
interest rates.
b. Credit risk
Credit risk is managed at the Company level. These risks relate to cash and cash equivalents, bank deposits and
other receivables.
The Company’s cash, cash equivalents and short-term bank deposits at December 31, 2019, and 2020 were
deposited with highly rated major Israeli and U.S. banks. In the Company’s opinion, the credit risk associated with
these balances is remote.
The Company considers its maximum exposure to credit risk to be as follows:
Assets:
Cash and cash equivalents
Short-term bank deposits
Other receivables
Total
F - 20
December 31,
2019
in USD thousands
2020
5,297
22,192
613
28,102
16,831
5,756
141
22,728
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 3 – FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT (cont.)
c. Liquidity risk
Company management monitors rolling forecasts of the Company’s liquidity reserves on the basis of anticipated
cash flows and maintains the liquidity balances at a level that is sufficient to meet its needs.
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 second half of 2023. 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.
d. Fair value of financial instruments
The different levels of valuation of financial instruments are defined as follows:
Level 1
Quoted prices (unadjusted) in active markets for identical assets or liabilities.
Level 2
Inputs, other than quoted prices included within level 1 that are observable for the asset or liability, either directly (as
prices) or indirectly (derived from prices).
Level 3
Inputs for the asset or liability that are not based on observable market data (unobservable inputs).
The Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of
unobservable inputs to the extent possible, and also considers counterparty credit risk, in its assessment of fair
value. The fair value of the financial instruments included in the working capital of the Company, as well as the
long-term loan, is usually identical or close to their carrying value. The fair value of the warrants is based on Level
3 measurements.
The fair value of the warrants, calculated based on the Black-Scholes model, was $10,218,000 as of December 31,
2020.
For more information on the parameters used to value the warrants, see Notes 12c and 19.
F - 21
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 3 – FINANCIAL INSTRUMENTS AND FINANCIAL RISK MANAGEMENT (cont.)
e. Changes in financial liabilities with cash flows included in financing activities
Long-term
loans
Balance as of January 1, 2019
Changes during the year 2019:
Cash flows received
Cash flows paid
Amounts recognized through profit and loss
Balance as of December 31, 2019
Changes during the year 2020:
Cash flows received
Cash flows paid
Share premium resulting from exercise of warrants
Amounts recognized through profit and loss
Balance as of December 31, 2020
Warrants
in USD thousands
323
8,733
-
(889)
647
8,491
-
(3,133)
-
474
5,832
4,969
-
(4,634)
658
5,669
-
(1,251)
5,142
10,218
Total
9,056
4,969
(889)
(3,987)
9,149
5,669
(3,133)
(1,251)
5,616
16,050
See Note 10 for information on changes in lease liabilities.
f. Fair value measurement of warrants using significant unobservable inputs (level 3)
The following table presents the changes in level 3 instruments for the years ended December 31, 2018, 2019 and
2020:
Balance as of January 1, 2018
Changes during 2018:
Issuances
Changes in fair value through profit and loss
Balance as of December 31, 2018
Changes during 2019:
Issuances
Changes in fair value through profit and loss
Balance as of December 31, 2019
Changes during 2020:
Issuances
Exercises
Changes in fair value through profit and loss
Balance as of December 31, 2020
F - 22
Warrants
in USD
thousands
1,205
861
(1,743)
323
4,969
(4,634)
658
5,669
(1,251)
5,142
10,218
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 4 – CRITICAL ACCOUNTING ESTIMATES AND JUDGMENTS
As part of the financial reporting process, Company management is required to make estimates that affect the value of
assets, liabilities, income, expenses and certain disclosures included in the Company’s consolidated financial
statements. By their very nature, such estimates are subjective and complex and consequently may differ from actual
results.
The accounting estimates used in the preparation of the financial statements are continually evaluated and adjusted
based on historical experience and other factors, including expectation of future events that are believed to be
reasonable under the circumstances.
Described below are the critical accounting estimates used in the preparation of the financial statements, the
formulation of which required Company management to make assumptions as to circumstances and events that involve
significant uncertainty. In using its judgment to determine the accounting estimates, the Company takes into
consideration, as appropriate, the relevant facts, past experience, the effect of external factors and reasonable
assumptions under the circumstances.
Impairment of intangible assets
The Company performs impairment reviews of intangible assets on an annual basis, or more frequently if events or
changes in circumstances indicate a potential impairment. In light of the clinical progress and additional expenses
incurred with regard to the clinical development of BL-8040 and AGI-134, the Company has concluded that the value
of its intangible assets is higher than their carrying value as of December 31, 2019 and 2020.
Fair value estimations of warrants
As described in Notes 3d, 12 and 19, BioLineRx completed financing transactions in which it issued ADSs and
warrants to purchase additional ADSs. The fair value of the warrants, which are not traded on an active market, is
determined by using valuation techniques. These valuation techniques maximize the use of observable market data
where it is available and rely as little as possible on entity specific estimates.
NOTE 5 – CASH AND CASH EQUIVALENTS
Cash on hand and in bank
Short-term bank deposits
December 31,
2019
2020
in USD thousands
4,922
375
5,297
11,550
5,281
16,831
The short-term bank deposits included in cash and cash equivalents bear interest at annual rate of between 0.15% and
0.41%. The carrying amount of cash and cash equivalents approximates their fair value, since they bear interest at rates
similar to prevailing market interest rates.
F - 23
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 6 – SHORT-TERM BANK DEPOSITS
The short-term bank deposits are in dollars and bear interest at annual rates of between 0.26% and 2.85%.
NOTE 7 – LONG-TERM INVESTMENT
In 2016, the Company established a joint venture with I-Bridge Capital, a Chinese venture capital fund focused on
developing innovative therapies in China, with each party contributing initial seed capital to the venture of $1.0
million. The joint venture, named iPharma, focused on the development of innovative clinical and pre-clinical
therapeutic candidates to serve the Chinese and global healthcare markets. In April 2018, the Company sold its
holdings in the joint venture to I-Bridge Capital for cash consideration of $1.5 million. The gain of $0.5 million is
included in non-operating income on the statement of comprehensive loss.
F - 24
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 8 – PROPERTY AND EQUIPMENT
Set forth below are the composition of property and equipment and the related accumulated depreciation, grouped by
major classifications, as well as the changes therein for the respective years:
Cost
Accumulated depreciation
Balance
at
Additions Deletions
Balance
at
Balance
at
Additions Deletions
Balance
at
Net book value
beginning during during end of beginning during during end of December 31,
of year
year 2017 2018
year of year
year
year
year
year
Composition in 2018
Office furniture and
equipment
Computers and
communications
equipment
Laboratory equipment
Leasehold
improvements
Composition in 2019
Office furniture and
equipment
Computers and
communications
equipment
Laboratory equipment
Leasehold
improvements
in USD thousands
in USD thousands
in USD
thousands
200
-
-
200
60
22
-
82
140
118
755
1,368
2,028
4,351
9
164
-
173
Cost
764
-
- 1,532
438
829
- 2,028
- 4,524
519
1,846
60
153
216
451
-
-
498
982
317
539
266
550
-
735 1,509 1,293
- 2,297 2,505 2,227
Accumulated depreciation
Balance
at
Additions Deletions
Balance
at
Balance
at
Additions Deletions
Balance
at
Net book value
beginning during during end of beginning during during end of December 31,
of year
year 2018 2019
year of year
year
year
year
year
in USD thousands
in USD thousands
in USD
thousands
200
7
-
207
82
13
-
95
118
112
764
1,532
2,028
4,524
31
29
-
67
-
795
- 1,561
498
982
- 2,028
- 4,591
735
2,297
63
185
217
478
-
561
- 1,167
266
550
234
394
-
952 1,293 1,076
- 2,775 2,227 1,816
F - 25
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 8 – PROPERTY AND EQUIPMENT (cont.)
Cost
Accumulated depreciation
Balance
at
Additions Deletions
Balance
at
Balance
at
Additions Deletions
Balance
at
Net book value
beginning during during end of beginning during during end of December 31,
of year
year 2019 2020
year of year
year
year
year
year
Composition in 2020
Office furniture and
equipment
Computers and
communications
equipment
Laboratory equipment
Leasehold
improvements
in USD thousands
in USD thousands
in USD
thousands
207
-
-
207
95
14
-
109
112
98
795
1,561
2,028
4,591
-
-
-
-
795
-
- 1,561
561
1,167
- 2,028
- 4,591
952
2,775
48
184
229
475
609
-
- 1,351
234
394
186
210
- 1,181 1,076
847
- 3,250 1,816 1,341
NOTE 9 – INTANGIBLE ASSETS
The fair value of intellectual property was calculated with the assistance of an external appraiser, based on the
Company's estimates and assumptions. The value in use of the assets was estimated by using the decision-tree
approach to valuing research products. This approach incorporates the option of abandonment at each development
stage. The traditional Discounted Cash Flows (DCF) model is implemented at the final node of the decision tree. The
DCF analysis estimates the future cash flows the Company expects to derive from the asset, incorporates expectations
about possible variations in the amount or timing of those future cash flows, and the uncertainty inherent in the assets.
As of December 31, 2020, the fair value of the intellectual property according to the impairment testing exceeds its
book value by more than 50%. Therefore, no impairment was recognized.
F - 26
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 9 – INTANGIBLE ASSETS (cont.)
Set forth below are the composition of intangible assets and the related accumulated depreciation, grouped by major
classifications, as well as the changes therein for the respective years:
Cost
Accumulated depreciation and impairment
Balance
at
Additions Deletions
Balance
at
Balance
at
Additions Deletions
Balance
at
Net book value
beginning during during end of beginning during during end of December 31,
of year
year of year
year
year
in USD thousands
year 2017 2018
in USD thousands
year
year
in USD thousands
Composition in 2018
Intellectual property
Computer software
6,896
567
7,463
15,000
43
15,043
- 21,896
610
-
- 22,506
96
344
440
-
94
94
-
-
-
96 6,800 21,800
172
223
438
534 7,023 21,972
Cost
Accumulated depreciation and impairment
Balance
at
Additions Deletions
Balance
at
Balance
at
Additions Deletions
Balance
at
Net book value
beginning during during end of beginning during during end of December 31,
of year
year of year
year
year
in USD thousands
year 2018 2019
in USD thousands
year
year
in USD thousands
Composition in 2019
Intellectual property
Computer software
21,896
610
22,506
-
6
6
Cost
- 21,896
-
616
- 22,512
96
438
534
-
87
87
-
-
-
96 21,800 21,800
525
91
172
621 21,972 21,891
Accumulated depreciation and impairment
Balance
at
Additions Deletions
Balance
at
Balance
at
Additions Deletions
Balance
at
Net book value
beginning during during end of beginning during during end of December 31,
of year
year of year
year
year
in USD thousands
year 2019 2020
in USD thousands
year
year
in USD thousands
Composition in 2020
Intellectual property
Computer software
21,896
616
22,512
-
-
-
104 21,792
616
104 22,408
-
96
525
621
-
73
73
-
-
-
96 21,800 21,696
598
18
694 21,891 21,714
91
F - 27
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 10 – LEASES
a. Right-of-use assets
Cost
Accumulated depreciation
Balance
at
Additions Deletions
Balance
at
Balance
at
Additions Deletions
Balance
at
Net book value
beginning during during end of beginning during during end of December 31,
of year
year 2018 2019
year of year
year
year
year
year
in USD thousands
in USD thousands
in USD
thousands
Composition in 2019
Property
Motor vehicles
1,552
326
1,878
-
172
172
Cost
- 1,552
433
(65)
(65) 1,985
-
-
-
135
240
375
-
(40)
(40)
135
200
335
- 1,417
233
-
- 1,650
Accumulated depreciation
Balance
at
Additions Deletions
Balance
at
Balance
at
Additions Deletions
Balance
at
Net book value
beginning during during end of beginning during during end of December 31,
of year
year 2019 2020
year of year
year
year
year
year
in USD thousands
in USD thousands
in USD
thousands
Composition in 2020
Property
Motor vehicles
1,552
433
1,985
-
-
-
- 1,552
396
(37)
(37) 1,948
135
200
335
135
147
282
-
(24)
(24)
270 1,417 1,282
73
323
593 1,650 1,355
233
F - 28
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 10 – LEASES (cont.)
b. Lease liabilities
Balance at
Additions
Deletions
beginning
of year
during
year
during
year
Interest
expense
during
year
in USD thousands
Exchange
differences Payments Balance at
during
year
during
year
end of
year
Composition in 2019
Property
Motor vehicles
1,552
326
1,878
-
172
172
-
(25)
(25)
257
73
330
127
27
154
(272)
(273)
(545)
1,664
300
1,964
Balance at
Additions
Deletions
beginning
of year
during
year
during
year
Interest
expense
during
year
in USD thousands
Exchange
differences Payments Balance at
during
year
during
year
end of
year
Composition in 2020
Property
Motor vehicles
1,664
300
1,964
-
-
-
-
(20)
(20)
228
22
250
122
10
132
(281)
(193)
(474)
1,733
119
1,852
Composition of lease liabilities:
Current lease liabilities
Property
Motor vehicles
Non-current lease liabilities
Property
Motor vehicles
F - 29
Year ended December 31,
2019
2020
in USD thousands
53
149
202
1,611
151
1,762
1,964
81
110
191
1,658
3
1,661
1,852
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 10 – LEASES (cont.)
c. Additional disclosures
1)
2)
The Company leases its premises under an operating lease agreement entered into in August 2014. Payments under the lease commenced
in June 2015, and the initial term of the lease expired in June 2020. The Company has exercised its option to extend the lease through
June 30, 2025 and has the option to extend the lease for two additional lease periods totaling up to 5 additional years, each option at a 5%
increase to the preceding lease payment amount. The monthly lease fee is $24,000. In addition, the Company pays building maintenance
charges of $8,000 per month.
The Company has entered into operating lease agreements in connection with a number of vehicles. The lease periods are generally for
three years. The annual lease fees, linked to the CPI, are $275,000. To secure the terms of the lease agreements, the Company has
prepaid approximately two months of lease payments to the leasing companies. These amounts were recorded as prepaid expenses until
2018.
3) As of December 31, 2020, minimum future rental payments (taking into consideration the aforementioned extension periods) under the
leases were as follows:
Year
2021
2022
2023
2024
2025-2030
Property
Motor
vehicles
in USD thousands
105
22
-
-
-
127
314
314
314
329
1,868
3,139
Total
419
336
314
329
1,868
3,266
Extension and termination options are included in most of the property and motor vehicle leases. These are used to
maximize operational flexibility in terms of managing the assets used in the Company’s operations. The
substantial majority of extension and termination options are exercisable solely by the Company and not by the
respective lessor.
F - 30
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 11 – LONG-TERM LOANS
a. Composition
Bank loan
Loan from Kreos Capital (see Note 19)
Less current maturities:
Bank loan
Loan from Kreos Capital
Total current maturities
Total long-term loans
December 31,
2019
in USD thousands
2020
63
8,428
8,491
(63)
(2,629)
(2,692)
5,799
-
5,832
5,832
-
(3,092)
(3,092)
2,740
The bank loan was denominated in dollars and bore interest at an annual rate of 3.75%. It was repaid in full during
2020.
b.
Future repayments
Future repayments of the long-term loans indicated above in the years subsequent to the balance sheet date are as
follows:
2021
2022
F - 31
in USD
thousands
3,092
2,740
5,832
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 12 – EQUITY
a.
Share capital
As of December 31, 2019 and 2020, the Company’s share capital is composed of ordinary shares, as follows:
Authorized share capital
Issued and paid-up share capital
Authorized share capital (in NIS)
Issued and paid-up share capital (in NIS)
Issued and paid-up share capital (in USD)
b. Rights related to shares
Number of Ordinary Shares
December 31,
2019
2020
500,000,000 1,500,000,000
171,269,528
349,169,545
In USD and NIS Amounts
December 31,
2019
2020
50,000,000 150,000,000
17,126,953 34,916,955
4,691,734
9,869,795
The ordinary shares confer upon their holders voting and dividend rights and the right to receive assets of the
Company upon its liquidation. As of December 31, 2019 and 2020, all outstanding share capital consisted of
ordinary shares.
F - 32
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 12 – EQUITY (cont.)
c. Changes in the Company’s equity
1)
In July 2017, the Company completed a direct placement to one of its shareholders for aggregate gross proceeds of $9.6 million. The
placement consisted of 566,372 ADSs, Series A warrants to purchase an additional 198,230 ADSs and Series B warrants to purchase
an additional 198,230 ADSs. The Series A warrants have an exercise price of $30.00 per ADS and are exercisable for a term of four
years. The Series B warrants have an exercise price of $60.00 per ADS and are also exercisable for a term of four years. Net
proceeds from the transaction were $9.5 million, after deducting fees and expenses.
The warrants issued 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 date the contract was entered into 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 amount of the direct placement
consideration initially allocated to the warrants was $1.1 million. Total issuance costs allocable to the warrants
were not material.
As of the issuance date, the fair value of the warrants was 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 1.66% and an average standard deviation of 57.8%.
The fair value of the warrants as of December 31, 2019 and 2020 was immaterial and was based on the then-
current price of an ADS, a risk-free interest rate of 0.09% (December 31, 2019 – 1.59%), an average standard
deviation of 90.8% (December 31, 2019 – 80.5%), and on the remaining contractual life of the warrants.
The changes in fair value for the years ended December 31, 2018, 2019 and 2020 of $1,151,000, $51,000 and
$3,000, respectively, have been recorded as non-operating income on the statement of comprehensive loss.
As of December 31, 2020, none of the warrants had been exercised.
2)
In October 2018, the Company entered into a loan agreement with Kreos Capital. In connection with the loan, Kreos Capital
received warrants to purchase 63,837 ADSs at an exercise price of $14.10 per ADS. For more information see Note 19.
F - 33
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 12 – EQUITY (cont.)
c. Changes in the Company’s equity (cont.)
3)
In February 2019, the Company completed an underwritten public offering of 1,866,667 of its ADSs and warrants to purchase
1,866,667 ADSs, at a public offering price of $8.25 per ADS and accompanying warrant. The warrants are exercisable immediately,
expire five years from the date of issuance and have an exercise price of $11.25 per ADS. The offering raised a total of $15.4
million, with net proceeds of $14.1 million, after deducting fees and expenses. The amount of the offering consideration initially
allocated to the warrants was $5.0 million. Total issuance costs initially allocated to the warrants were $0.4 million.
The warrants issued 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 date the contract was entered into 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
2.50% and an average standard deviation of 62.8%.
The fair value of the warrants as of December 31, 2019 and 2020 was $591,000 and $969,000, respectively,
and was based on the then current price of an ADS, a risk-free interest rate of 0.17% (December 31, 2019 –
1.70%) , an average standard deviation of 82.6% (December 31, 2019 – 64.2%), and on the remaining
contractual life of the warrants.
The changes in fair value for the years ended December 31, 2019 and 2020 of $4,378,000 and $377,000 have
been recorded as non-operating income (expenses), respectively, on the statement of comprehensive loss.
As of December 31, 2020, none of the warrants had been exercised.
4)
In May and June 2020, the Company sold in registered direct offerings an aggregate of 7,653,145 ADSs at a price of $1.75 per ADS.
In concurrent private placements, the Company issued to investors in the offerings unregistered warrants to purchase 7,653,145
ADSs. The warrants are exercisable immediately, expire two and half years from the date of issuance and have an exercise price of
$2.25 per ADS. In addition, the Company granted to the placement agent’s designees, as part of the placement fees, warrants to
purchase 382,657 ADSs. These warrants are exercisable immediately, expire two and half years from the date of issuance and have
an exercise price of $2.1875 per ADS. The offerings raised a total of $13.4 million, with net proceeds of $12.0 million, after
deducting fees and expenses. The amount of the offering consideration initially allocated to the warrants was $5.7 million. Total
issuance costs initially allocated to the warrants were $0.6 million.
F - 34
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 12 – EQUITY (cont.)
c. Changes in the Company’s equity (cont.)
4)
(cont.)
The warrants issued 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 date the contract was entered into 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
0.20% and an average standard deviation of 80.2%.
The fair value of the warrants as of December 31, 2020 was $9,194,000 and was based on the then current
price of an ADS, a risk-free interest rate of 0.13%, an average standard deviation of 93.0%, and on the
remaining contractual life of the warrants.
The change in fair value from the date of issuance through December 31, 2020 of $4,776,000 has been
recorded as non-operating expenses on the statement of comprehensive loss.
As of December 31, 2020, 875,000 of these warrants had been exercised.
5)
See Note 20 for information regarding the issuance of ADSs and warrants after the balance sheet date.
d.
Share purchase agreements
1)
2)
In October 2017, the Company entered into an at-the-market (“ATM”) sales agreement with BTIG, LLC (“BTIG”), pursuant to which
the Company was entitled, at its sole discretion, to offer and sell through BTIG, acting as sales agent, ADSs having an aggregate
offering price of up to $30.0 million throughout the period during which the ATM facility remained in effect. The Company agreed to
pay BTIG a commission of 3.0% of the gross proceeds from the sale of ADSs under the facility. During the year ended December 31,
2020, the Company issued a total of 676,750 ADSs, for total net proceeds of $1.4 million, under the ATM facility. In September
2020, the Company terminated the agreement with BTIG. During the entire term of the agreement, an aggregate of 2,923,552 ADSs
were sold under the facility for total gross proceeds of $13.0 million.
In September 2020, the Company entered into a new ATM sales agreement with H.C. Wainwright & Co., LLC (“HCW”), pursuant to
which the Company is entitled, at its sole discretion, to offer and sell through HCW, acting as 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 agreed to
pay HCW a commission of 3.0% of the gross proceeds from the sale of ADSs under the facility. Expenses associated with
establishment of the ATM facility with HCW, amounting to $0.2 million, were recorded in non-operating expenses during the period.
As of December 31, 2020, an aggregate of 2,635,733 ADSs had been sold under the facility, resulting in net proceeds of $5.9 million.
F - 35
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 12 – EQUITY (cont.)
e.
Share-based payments
1) Share Incentive plan – general
In 2003, BioLineRx adopted the 2003 Share Incentive Plan (the “Plan”). The Plan provides for the granting of
stock options and ordinary shares to the Company’s employees, directors, consultants and other service
providers. Options are issued at the determination of the Board of Directors in accordance with applicable law.
The options are generally exercisable for a ten-year period and the grants generally vest over a four-year
period. In 2013, the Company’s Board of Directors approved amendments to the Plan to take into account
changes in laws and regulations that had occurred since its adoption and to extend the term of the plan until
November 2023. In 2016, the Board of Directors approved amendments to the Plan to allow the grant of
restricted stock units (“RSUs”) and performance stock units (“PSUs”).
PSUs are RSUs that are linked to any one or more performance goals (in addition to, or in lieu of, time-based
vesting terms) determined appropriate by the Board of Directors. The specific performance goals, as well as
the time period associated with achieving such goals, are approved by the Board and are set forth in the
grantee’s grant agreement. To date, each PSU grant has had between three to five performance goals on which
vesting is based, each such goal being either a specified Company milestone and or the success of a specific
project, with vesting of 20-40% on the achievement of each goal. The tranche of PSUs associated with a given
milestone expires 12 months after the target date established for that milestone. During 2020, 884,581 PSUs
were vested in accordance with their original terms.
As of December 31, 2020, there were 36,501,579 ordinary shares issuable upon the exercise of outstanding
equity instruments under the Plan.
Ordinary shares resulting from grants under the Plan confer the same rights as all other ordinary shares of
BioLineRx.
Company employees and directors are granted options under Section 102 of the Israeli Income Tax Ordinance
(the “Ordinance”), primarily under the “capital gains” track. Non-employees of the Company (consultants and
other service providers), as well as controlling shareholders in BioLineRx (as this term is defined in Section
32(9) of the Ordinance), are granted options under Section 3(i) of the Ordinance.
In November 2014, December 2015, December 2017, March 2019 and November 2020, the Company’s Board
of Directors approved increases of 1.6 million, 5.0 million, 5.2 million, 9.0 million and 22.4 million shares
respectively, to the total pool of authorized ordinary shares reserved for purposes of the Plan and any other
present or future share incentive plans of the Company, bringing the pool to an aggregate of 46.2 million
shares. As of December 31, 2020, there were 8.1 million remaining authorized but unissued ordinary shares in
the pool reserved for future share-based incentive grants.
F - 36
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 12 – EQUITY (cont.)
e.
Share-based payments (cont.)
2)
Employee share incentive plan:
The following table contains additional information concerning equity instruments granted to employees and
directors under the existing share incentive plans.
2018
Year ended December 31,
2019
2020
Outstanding at beginning of year
Granted
Forfeited and expired
Exercised
Outstanding at end of year*
Number
of options
10,651,097
2,853,080
(1,649,090)
(395,390)
11,459,697
Weighted
average
exercise
price
(in NIS)
Weighted
average
exercise
price
(in NIS)
Weighted
average
exercise
price
(in NIS)
Number
of options
Number
of options
4.4 11,459,697
2.8 11,057,600
(3,084,834)
4.0
0.4
(73,550)
4.2 19,358,913
4.2 19,358,913
1.3 18,689,300
(1,776,037)
3.9
0.1
(290,597)
2.6 35,981,579
2.6
0.5
2.2
0.1
1.5
3.2
Exercisable at end of year
4,489,816
5.9
5,353,089
5.1 11,535,679
* As of December 31, 2018, 2019 and 2020, includes 1,163,018, 2,225,704 and 2,421,799 PSUs at an exercise price of 0.10 NIS (par
value of ordinary shares), for which performance obligations have not been met.
F - 37
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 12 – EQUITY (cont.)
e.
Share-based payments (cont.)
2)
Employee share incentive plan (cont.):
The total consideration received from the exercise of equity instruments during 2018, 2019 and 2020 was not
material.
Set forth below is data regarding the range of exercise prices and weighted-average remaining contractual life
(in years) for the equity instruments outstanding at the end of each of the years indicated.
Range of
exercise
prices
(in NIS)
Up to 2.00
2.01-5.00
5.01-10.00
10.01-20.00
2018
Number
of options
outstanding
Weighted
average
remaining
contractual life
(in yrs.)
As of December 31,
2019
Number
of options
outstanding
Weighted
average
remaining
contractual life
(in yrs.)
2020
Number
of options
outstanding
Weighted
average
remaining
contractual life
(in yrs.)
1,416,176
8,215,166
1,089,875
738,480
11,459,697
8.8
8.1
4.3
3.3
7.5
11,676,900
6,341,033
822,300
518,680
19,358,913
9.9
7.3
3.9
3.2
8.6
28,888,767
5,866,532
707,600
518,680
35,981,579
9.3
6.3
3.1
1.9
8.6
The fair value of equity instruments granted to employees through December 31, 2020 has been determined
using the Black-Scholes option-pricing model. These values are based on the following assumptions as of the
applicable grant dates:
Expected dividend yield
Expected volatility
Risk-free interest rate
Expected life of options (in years)
2018
2019
2020
0%
63%
2%
6
0%
61%
3%
6
0%
63%
1%
6
The remaining unrecognized deferred compensation expense as of December 31, 2020 was $2.4 million. This
amount will be expensed in full over the remaining vesting period of the equity instruments.
F - 38
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 12 – EQUITY (cont.)
e.
Share-based payments (cont.)
3) Repricing of employee stock options
In September 2020, the Board of Directors approved the re-pricing of outstanding “underwater” employee
stock options for the purchase of 12.3 million ordinary shares, out of total employee stock options for the
purchase of 15.1 million ordinary shares outstanding at that time. The weighted average exercise price of the
options subject to re-pricing was NIS 2.64 per share, with the proposed new exercise price of the options at
NIS 1.00 per share. Execution of the re-pricing was subject to approval from the Israeli tax authorities, which
was received in January 2021. The total compensation cost associated with the re-pricing of approximately
$200,000 will be recorded as an expense beginning in 2021 over the remaining vesting period of the re-priced
options.
4) Stock options to consultants
From inception through December 31, 2017, the Company issued to consultants options for the purchase of
336,523 ordinary shares at a weighted average exercise price of NIS 8.32 per share.
In 2018, the Company issued additional options to consultants for the purchase of 35,000 ordinary shares at a
weighted average price of NIS 3.48 per share
In 2019, the Company issued additional options to consultants for the purchase of 225,000 ordinary shares at a
weighted average price of NIS 0.90 per share
In 2020, the Company did not issue additional options to consultants.
The options to consultants generally vest over four years and may be exercised for periods of between five and
ten years. As of December 31, 2020, 520,000 options to consultants were outstanding with a weighted average
exercise price of NIS 2.83 per share and a weighted average contractual life of 7.08 years.
Company management estimates the fair value of the options granted to consultants based on the value of
services received over the vesting period of the applicable options. The value of such services (primarily in
respect of clinical advisory services) is estimated based on the additional cash compensation the Company
would need to pay if such options were not granted. The value of services recorded in each of the years 2018,
2019 and 2020 was not material.
F - 39
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 13 – TAXES ON INCOME
a. Corporate taxation in Israel
The taxable income of BioLineRx, not subject to benefits as detailed below, is taxed at the standard Israeli
corporate tax rate, which was 23% for all years included in these financial statements.
b. Approved enterprise benefits
In May 2012, the Israeli Tax Authority (“ITA”) approved BioLineRx’s eligibility for tax benefits as a “Benefited
Enterprise” under the Law for the Encouragement of Capital Investments, 5719-1959, as amended (the
“Investments Law”), with respect to certain development programs (the “Eligible Projects”).
Subject to compliance with the applicable requirements, the portion of income eligible for benefits under the
Benefited Enterprise regime will be entitled to a tax exemption for a period of two years, followed by five years at
the Benefited Enterprise tax rate of 25%, commencing in the first year in which BioLineRx generates taxable
income after setting off losses for Israeli tax purposes from prior years (see c. below). The seven-year period may
not extend beyond 12 years from the beginning of the Benefited Enterprise’s election year. BioLineRx received
Benefited Enterprise status with respect to Eligible Projects in the 2009 and 2012 tax years, so depending on when
the Benefited Enterprise programs begin to generate taxable income, the benefits period could continue through
2023. However, any distribution of dividends derived from exempt income sourced in the Benefited Enterprise
programs will be subject to a “claw back” of corporate tax at a rate no greater than 25%. In addition, dividends
distributed by a publicly traded Israeli company to non-Israeli residents or Israeli individuals are generally subject
to withholding tax of 25%. Under an applicable tax treaty, the withholding tax might be lower.
BioLineRx has the option to transition to a “Preferred Enterprise” regime under the Investments Law. Upon an
irrevocable election made by a company, a uniform corporate tax rate will apply to all qualifying industrial income
of such company, as opposed to the previous incentives under the Investments Law, which were limited to income
from Benefited Enterprises during the benefits period. Under the Investments Law, when the election is made, the
uniform tax rate would be 16% for BioLineRx’s location in Israel. Preferred Enterprise profits are freely
distributable as dividends, subject to a 20% withholding tax, or lower under an applicable tax treaty.
In addition, the ITA approved BioLineRx’s operations as an “Industrial Enterprise” under the Investments Law in
2012, meaning that BioLineRx is eligible for accelerated depreciation with respect to certain tangible assets
belonging to its Benefited Enterprise. Should BioLineRx not meet the requirements for maintaining these benefits,
they may be reduced or cancelled and, among other things, income deriving from the Eligible Projects would be
subject to Israeli corporate tax at the standard rates.
F - 40
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 13 – TAXES ON INCOME (cont.)
c.
Tax loss carryforwards
As of December 31, 2020, the tax loss carryforwards of BioLineRx were approximately $293 million. The tax loss
carryforwards have no expiration date.
The Company has not created deferred tax assets in respect of these tax loss carryforwards. See Note 2, paragraph
1.
d. Tax assessments
In accordance with Israeli tax regulations, the tax returns filed by BioLineRx through the 2015 tax year are
considered final.
e.
Theoretical taxes
As described in Note 2, paragraph 1, the Company has not recognized any deferred tax assets in the financial
statements, as it does not expect to generate taxable income in the foreseeable future. The reported tax on the
Company’s income before taxes differs from the theoretical amount that would arise using the weighted average
tax rate applicable to income of the consolidated entities as follows:
Loss before taxes
Theoretical tax benefit
Disallowed deductions (tax exempt
income):
Loss (gain) on adjustment of
warrants to fair value
Share-based compensation
Other
Increase in taxes for tax losses and
timing differences incurred in the
reporting year for which deferred
taxes were not created
Taxes on income for the reported year
2018
in USD
thousands
(22,962)
23.0%
Year ended December 31,
2019
in USD
thousands
(25,446)
23.0%
2020
in USD
thousands
(30,021)
23.0%
(5,281)
(5,853)
(6,905)
(401)
581
10
5,091
-
F - 41
(1,054)
405
10
6,492
-
(1,280)
292
11
7,882
-
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 14 – LOSS PER SHARE
The following table contains the data used in the computation of the basic loss per share:
Loss attributed to ordinary shares
Number of shares used in basic calculation
Basic and diluted loss per ordinary share
2018
Year ended December 31,
2019
in USD thousands
2020
(22,962)
(25,446)
(30,021)
in thousands
108,596
146,407
252,844
in USD
(0.21)
(0.17)
(0.12)
All outstanding options and warrants have been excluded from the calculation of the diluted loss per share for all years
presented, since their effect was anti-dilutive.
NOTE 15 – COMMITMENTS AND CONTINGENT LIABILITIES
a. Commitments
1) Obligation to pay royalties to the State of Israel
The Company is required to pay royalties to the State of Israel (represented by the Israel Innovation Authority,
or IIA), computed on the basis of proceeds from the sale or license of products whose development was
supported by grants from the predecessor of the IIA, the Office of the Chief Scientist. This obligation relates
solely to financial participation in the development of products by the Company.
In accordance with the terms of grants provided by the IIA, the State is entitled to royalties on the sale or
license of any product whose development was supported with State participation. These royalties are
generally 3% in the first three years from initial repayment, 4% of sales in the three subsequent years and 5%
of sales in the seventh year until repayment of 100% of the grants (linked to the dollar) received by the
Company, plus annual interest at the LIBOR rate. Under certain circumstances, the royalty rate is calculated
according to a formula based on the ratio of participation by the IIA in the project to the total project costs
incurred by the Company
In connection with the in-licensing of BL-8040 from Biokine Therapeutics Ltd. (“Biokine”), and as a
condition to IIA consent to the transaction, the Company agreed to abide by any obligations resulting from
funds previously received by Biokine from the IIA. The contingent liability to the IIA assumed by the
Company relating to this transaction amounts to $3.5 million as of December 31, 2020. The Company has a
full right of offset for amounts payable to the IIA from payments due to Biokine in the future.
F - 42
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 15 – COMMITMENTS AND CONTINGENT LIABILITIES (cont.)
a. Commitments (cont.)
2)
Licensing agreements
From time to time, the Company enters into in-licensing agreements with academic institutions, research
institutions and companies (the “licensors”) in connection with the development of therapeutic compounds.
Pursuant to these licensing agreements, the Company generally obtains the rights for one or more therapeutic
compounds in pre-clinical and early-clinical stages of development, in order to continue development of the
compounds through more advanced stages of development and, subsequently, to manufacture, distribute and
market the drugs or to out-license the development, manufacturing and commercialization rights to third
parties. Such development activities are carried out by either the Company and/or by companies or institutions
to which the Company has entered into an out-license agreement, subject to certain restrictions stipulated in
the various agreements.
The licenses that have been granted to the Company are broad and comprehensive, and generally include
various provisions and usage rights as follows: (i) territorial scope of the license (global); (ii) term of the
license (unrestricted but not shorter than the life of the patent); and (iii) development of the therapeutic
compound (allowing the Company to perform all development activities on its own, or by outsourcing under
Company supervision, as well as out-licensing development under the license to other companies, subject to
the provisions of the licensing agreements).
According to the provisions of the licensing agreements, the intellectual property rights in the development of
any licensed technology, through the date the applicable license agreement is effective, remain with the
licensor, while the rights in products and/or other deliverables developed by the Company after the license is
granted belong to the Company. In cases where the licensor has a claim to an invention that was jointly
developed with the Company, the licensor also co-owns the related intellectual property. In any event, the
scope of the license also covers these intellectual property rights.
In addition, the Company generally undertakes in the licensing agreements to protect registered patents
resulting from developments under the various licenses, to promote the registration of patents covering new
developments in cooperation with the licensor, and to bear responsibility for all related costs. Pursuant to the
various agreements, the Company generally works to register the various patents on a broad basis worldwide,
and if the Company decides not to initiate or continue a patent registration proceeding in a given country, the
Company is required to notify the applicable licensor to this effect and the licensor is entitled to take action
for registration of the patent in such country.
F - 43
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 15 – COMMITMENTS AND CONTINGENT LIABILITIES (cont.)
a. Commitments (cont.)
2)
Licensing agreements (cont.)
The consideration paid pursuant to the licensing agreements generally includes several components that may
be payable over the license period and that relate, inter alia, to the progress made in research and development
activities, as well as commercial success, as follows: (a) one-time, up-front payment and/or periodic
payments; (b) payments through the early stages of development (i.e., through the end of phase 2); (c)
payments upon the achievement of milestones necessary for advancing to phase 3; (d) payments from the end
of a successful phase 3 trial through approval of the therapeutic compound; and e) royalties on sales of the
final product resulting from development under the license or including any component thereof, ranging
between 3%-5% of the Company’s net sales of the product, although in specific instances the royalty rate has
been higher or lower than this range. In instances where the Company has out-licensed the product for further
development, the Company pays a percentage of the net consideration received from the licensee (“Sublicense
Receipts”) to the upstream licensor that generally range from 20% to 29.5% of such consideration, although in
specific instances the percentage paid has been higher or lower than this range. These Sublicense Receipts
generally take the place of most or all of the milestone and royalty payments set forth in (b) through (e) above.
The license agreements may be cancelled by the licensor only in specific circumstances, generally upon the
occurrence of one of the following events: (a) the Company’s failure to meet certain milestones stipulated in
the applicable license agreement and appended timetables; (b) default, insolvency, receivership, liquidation,
etc. of the Company that is not imposed and/or lifted within the timeframe stipulated in the license agreement;
and (c) fundamental breach of the license agreement that is not corrected within the stipulated timeframe. The
Company may generally cancel a license agreement with prior notice of 30 to 90 days, due to unsuccessful
development or any other cause.
The Company has undertaken to indemnify certain licensors, their employees, officers, representatives or
anyone acting on their behalf for any damage and/or expense that they may incur in connection with the
Company’s use of a license granted to it, all in accordance with the terms stipulated in the applicable license
agreements.
Some of the license agreements are accompanied by consulting, support and cooperation agreements, pursuant
to which the Company is committed to pay the various licensers a fixed monthly amount over the period
stipulated in the agreement for their assistance in the continued research and development under the license.
3) Commitments in respect of Agalimmune
See Note 18 for information relating to royalties and other commitments in respect of Agalimmune.
4)
Purchase orders
The Company’s outstanding open purchase order commitments as of December 31, 2020 amounted to $6.9
million.
F - 44
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 15 – COMMITMENTS AND CONTINGENT LIABILITIES (cont.)
b. Contingent liabilities
To secure the Company’s lease obligation on its premises, the Company has provided a bank guarantee in the
amount of $100,000 for the benefit of the lessor, which remains outstanding as of December 31, 2020.
NOTE 16 – TRANSACTIONS AND BALANCES WITH RELATED PARTIES
Transactions with related parties
Expenses:
Benefits to related parties:
Compensation and benefits to senior management, including benefit component of
equity instrument grants
Number of individuals to which this benefit related
Compensation and benefits to directors, including benefit component of equity
instrument grants
Number of individuals to which this benefit related
Key management compensation
2018
Year ended December 31,
2019
in USD thousands
2020
2,680
1,934
6
4
307
7
280
7
2,391
4
373
7
Key management includes directors and executive officers. The compensation paid or payable to key management
for services during each of the years indicated is presented below.
Salaries and other short-term employee benefits
Post-employment benefits
Other long-term benefits
Share-based compensation
F - 45
2018
Year ended December 31,
2019
in USD thousands
1,415
115
31
653
2,214
1,669
137
35
1,146
2,987
2020
1,656
126
33
949
2,764
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 17 – SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION
a. Other receivables
Government institutions
Other
b. Accounts payable and accruals
1) Trade:
Accounts payable:
Overseas
In Israel
2) Other:
Accrued expenses
Accrual for vacation and recreation pay
Payroll and related expenses
Other
December 31,
2019
in USD thousands
2020
612
1
613
139
2
141
December 31,
2019
in USD thousands
2020
5,178
2,616
7,794
727
253
293
7
1,280
4,795
1,123
5,918
884
287
266
3
1,440
The carrying amounts of accounts payable and accruals approximate their fair value, as the effect of discounting is
not material.
F - 46
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 17 – SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (cont.)
c. Research and development expenses
Research and development services
Payroll and related expenses
Lab, occupancy and telephone
Professional fees
Depreciation and amortization
Other
d.
Sales and marketing expenses
Marketing
Payroll and related expenses
Overseas travel
e. General and administrative expenses
Payroll and related expenses
Professional fees
Insurance
Depreciation
Other
f.
Non-operating income (expenses), net
Issuance costs
Changes in fair value of warrants
Gain from realization of long-term investment
Other
F - 47
2018
Year ended December 31,
2019
in USD thousands
16,029
4,977
782
504
862
284
23,438
11,609
5,704
993
688
424
390
19,808
2018
Year ended December 31,
2019
in USD thousands
296
503
58
857
291
973
98
1,362
2018
Year ended December 31,
2019
in USD thousands
1,881
1,193
298
78
366
3,816
2,510
1,142
221
27
535
4,435
2018
Year ended December 31,
2019
in USD thousands
(417)
4,634
-
(52)
4,165
(90)
1,743
500
244
2,397
2020
11,696
4,087
771
680
864
75
18,173
2020
585
234
21
840
2020
2,098
1,044
603
70
99
3,914
2020
(784)
(5,142)
-
225
(5,701)
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 17 – SUPPLEMENTARY FINANCIAL STATEMENT INFORMATION (cont.)
g.
Financial income
Interest income and exchange differences
h.
Financial expenses
Interest expense
Exchange differences
Bank commissions
NOTE 18 – AGALIMMUNE ACQUISITION
2018
Year ended December 31,
2019
in USD thousands
777
777
719
719
2020
236
236
2018
Year ended December 31,
2019
in USD thousands
1,829
424
24
2,277
290
162
21
473
2020
1,470
137
22
1,629
In March 2017, the Company acquired substantially all the outstanding shares of Agalimmune Ltd. for initial
consideration of $6.0 million, of which $3.0 million was in cash and the remainder in the Company’s ADSs. The
acquisition expanded the Company’s pipeline to include Agalimmune’s primary asset, AGI-134, a novel immuno-
oncology agent for various cancer indications at the near-clinical stage of development. Due in part to the early stage of
development of AGI-134 and other elements evaluated by the Company’s management as required by IFRS, the
acquisition was accounted for in the Company’s financial statements as an asset transaction. Total costs associated with
bringing the asset into the Company’s pipeline include additional expenses of $0.7 million, resulting in a total increase
in intangibles at the date of acquisition of $6.7 million.
Additional consideration may be due to Agalimmune shareholders based on certain development and commercial
milestones, including future sales of Agalimmune products. In addition, the selling shareholders of Agalimmune have
certain reversionary rights in the event of a breach of the transaction agreement and certain other limited triggering
events.
F - 48
BioLineRx Ltd.
NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS
NOTE 19 – AMENDMENT TO BL-8040 LICENSE AND LONG-TERM LOAN
In October 2018, the Company amended its license agreement with Biokine, originally entered into in September 2012,
relating to the in-licensing rights to BL-8040. The amendment reduced the payment owed by the Company to Biokine
on sublicense receipts (as defined in the license agreement) from 40% to 20% of sublicense receipts in exchange for:
(i) a cash payment from the Company to Biokine of $10 million; (ii) the issuance of 332,005 ADSs with a value of $5
million and (iii) the payment of certain future milestone payments, up to an aggregate of $5 million in total, as
specified in the amendment.
The $10 million payment referred to above was financed in full via the receipt of a $10 million loan from Kreos
Capital V (Expert Fund) L.P. (“Kreos Capital”). As security for the loan, Kreos Capital received a first-priority, secured
interest in all Company assets, including intellectual property. The loan has a 12-month, interest-only period, followed
by a 36-month repayment period. Borrowings under the loan bear interest at a fixed rate of 9.5% per annum. In
connection with providing the loan, Kreos Capital received a warrant to purchase 63,837 ADSs at an exercise price of
$14.10 per ADS. The warrant is exercisable for a period of ten years from the date of issuance.
The fair value of the warrant at the date of issuance, computed using the Black-Scholes option pricing model,
amounted to $861,000. The fair value was computed based on the then current price of an ADS, a risk-free interest rate
of 3.05% and an average standard deviation of 69.1%. The fair value of the warrants as of December 31, 2020 was
$55,000 (December 31, 2019 – $63,000) and was based on the then current price of an ADS, a risk-free interest rate of
0.65%, an average standard deviation of 67.6%, and on the remaining contractual life of the warrants. The change in
fair value for the year ended December 31, 2018, 2019 and 2020 of $593,000, $206,000, $8,000, respectively, has been
recorded as non-operating income on the statement of comprehensive loss.
As of December 31, 2020, none of the warrants had been exercised.
The warrant issued has 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 date the contract was entered into and is subsequently
accounted for at fair value at each balance sheet date. The total net proceeds from Kreos Capital were initially allocated
to the warrant based on its fair value, with the remainder of the net proceeds allocated to the loan. The loan is treated as
a liability at amortized cost.
NOTE 20 – EVENTS SUBSEQUENT TO THE BALANCE SHEET DATE
a.
In January 2021, the Company completed an underwritten public offering of 14,375,000 of its ADSs at a public offering price of $2.40
per ADS. The offering raised total gross proceeds of $34.5 million, with net proceeds of $31.4 million after deducting fees and expenses.
In addition, warrants to purchase 718,750 ADSs were granted to the underwriters. These warrants are exercisable immediately, expire five
years from the date of issuance and have an exercise price of $3.00 per ADS.
b. During January and February 2021, 4,364,391 warrants for the purchase of ADSs, issued in the May and June 2020 financings (see Note
12c(4)), were exercised, resulting in gross proceeds to the Company of $9.8 million.
F - 49
Exhibit 2.1
BioLineRx Ltd.
Articles of Association of a Public Company
In accordance with
The Companies Law, 5759-1999
As of September 24, 2020
BioLineRx Ltd.
1.
2.
3.
Name of Company
The name of the Company is BioLineRx Ltd.
Goals of the Company
The goal of the Company is to engage in any lawful business.
Interpretation
3.1
Any statement in the singular shall also include the plural and vice versa; any statement in the masculine shall also include the feminine and
vice versa.
3.2
3.3
Except insofar as these Articles include special definitions of certain terms, any word and expression in these Articles shall have the meaning
attributed thereto in the Companies Law, 5759-1999 (in these Articles – “the Companies Law,”) unless this contradicts the written matter or
the content thereof.
To prevent doubt it is clarified that regarding matters regulated in the Companies Law in such manner that the arrangements in these matters
may be conditioned in the Articles, and in cases in which these Articles do not include different provisions from those in the Companies Law,
the provisions of the Companies Law shall apply.
3.4
It is hereby clarified that the provisions of the Articles of Association of the Company as detailed below are subject to the provisions of the
Companies Law, the Securities Law, and any law.
4.
The Share Capital of the Company and the Rights Attached to Shares
4.1
The registered capital of the Company is NIS 150,000,000, divided into 1,500,000,000 ordinary shares with a nominal value of NIS 0.10
each.
4.2
The ordinary shares shall entitle their owners to –
4.2.1
An equal right to participate in and vote at the general meetings of the Company, whether ordinary meetings or extraordinary
meetings. Each of the shares in the Company shall entitle its owner present at the meeting and participating in the vote in person, by
proxy, or by means of a letter of voting, to one vote;
4.2.2
4.2.3
An equal right to participate in the distribution of dividends, whether in cash or in benefit shares, in the distribution of assets, or in
any other distribution, according to the proportionate nominal value of the shares held thereby;
An equal right to participate in the distribution of the surplus assets of the Company in the event of its liquidation in accordance with
the proportionate nominal value of the shares held thereby.
5.
6.
4.3
The Board of Directors is entitled to issue shares and other convertible securities or securities that may be realized as shares up to the limit of
the Company’s registered capital. For the purpose of calculating the limit of the registered capital, convertible securities or securities that may
be realized as shares shall be considered to have been converted or realized as of their date of issue.
Limited Liability
The liability of the shareholders for the Company’s debts shall be limited to the full amount (nominal value with the
addition of premium) they shall be required to pay the Company for the shares and which they have not yet paid.
Joint Shares and Share Certificates
6.1
The owner of a share registered in the registry of shareholders is entitled to receive from the Company, without payment and within a period
of three months following the allocation or the registration of transfer, one share certificate stamped with the Company’s stamp regarding all
the shares registered in his name, which certificate shall detail the number of shares. In the event of a jointly owned share, the Company shall
issue one share certificate for all the joint owners of the share, and the delivery of such a certificate to one of the partners shall be considered
delivery to them all.
Each share certificate shall bear the signature of at least one director, the Chief Executive Officer or the Chief Financial and Operating
Officer, together with the Company stamp or its printed name.
2
6.2
A share certificate that has been defaced, destroyed, or lost may be renewed on the basis of such proof and guarantees as shall be required by
the Company from time to time.
7.
The Company’s Reliefs relating to Shares that Have Not Been Fully Paid
7.1
If any or all of the remuneration the shareholder undertook to pay the Company in return for his shares has not been paid by such date and on
such conditions as established in the conditions for the allocation of his shares and/or in the payment request as stated in section 7.2 below,
the Company is entitled, by way of a decision of the Board of Directors, to forfeit the shares whose remuneration has not been fully paid. The
forfeiture of shares shall take place provided that the Company has sent the shareholder written warning of its intention to forfeit the shares
after at least 7 days from the date of receipt of the warning, insofar as payment shall not be made during the period determined in the letter of
warning.
The Board of Directors is entitled, at any time prior to the date on which the forfeited share is sold, reallocated, or
otherwise transferred, to nullify the forfeiture on such conditions as it shall see fit.
The forfeited shares shall be held by the Company as retired shares or shall be sold to another.
7.2
If, in accordance with the conditions of allocation of the shares, there is no fixed date for the payment of any part of the price to be paid on
account thereof, the Board of Directors is entitled, from time to time, to present payment requests to the shareholders on account of monies
not yet removed for the shares they hold, and each shareholder shall be obliged to pay the Company the amount requested on the date
determined as stated, provided that he shall receive prior notice of 14 days of the date and place of payment (hereinafter – “the Payment
Request.”) The notification shall specify that non-payment by or before the determined date and in the specified place may lead to the
forfeiture of the shares regarding which payment is requested. A Payment Request may be nullified or postponed to another date, all as shall
be decided by the Board of Directors.
3
7.3
7.4
7.5
Unless otherwise determined in the conditions of allocations of the shares, a shareholder shall not be entitled to receive a dividend or to
exercise any right as a shareholder on account of shares that have not yet been fully paid.
Persons who are the joint owners of a share shall be liable jointly and severally for payment of the amounts due to the Company on account
of the share.
The content of this section shall not derogate from any other relief of the Company vis-à-vis a shareholder who fails to pay his debt to the
Company on account of his shares.
8.
Transfer of Shares
8.1
The Company’s shares are transferable.
8.2
8.3
8.4
The transfer of shares must be made in writing, and it shall be recorded only if –
8.2.1
A proper certificate for the transfer of shares, together with the certificates of the share intended for transfer, if such were issued, is
delivered to the Company at its registered office. The certificate of transfer shall be signed by the transferor and by a witness
confirming the signature of the transferor. In the event of the transfer of shares that are not fully paid as of the date of transfer, the
certificate of transfer shall also be signed by the recipient of the share and by a witness testifying to the signature of the recipient; or
A court order for the amendment of the registration shall be delivered to the Company; or
It shall be proved to the Company that lawful conditions pertain for the transfer of the right to the share.
8.2.2
8.2.3
The transfer of shares that have not been fully paid requires the authorization of the Board of Directors, which is entitled to refuse to grant its
authorization at its absolute discretion and without stating grounds therefore.
The recipient of the transfer shall be considered the shareholder regarding the transferred shares from the moment of the registration of his
name in the registry of shareholders.
4
9.
Changes in Capital
9.1
The general meeting is entitled to increase the Company’s registered share capital by creating new shares of an existing type or a new type,
all as shall be determined in the decision of the general meeting.
9.2
9.3
The general meeting is entitled to nullify registered share capital that has not yet been allocated, provided that there is no commitment,
including a conditioned commitment, by the Company to allocate the shares.
The general meeting shall be entitled, subject to the provisions of any law:
9.3.1
To unify and redivide its share capital, or any part thereof, into shares of a nominal value greater than the nominal value of the
existing shares.
To divide, by way of the redivision of any or all of the existing shares, its share capital into shares of a nominal value smaller than
the nominal value of the existing shares.
To reduce its share capital and any reserved fund for the repayment of capital in such manner and on such conditions and with the
receipt of such authorization as shall be required by the Companies Law.
9.3.2
9.3.3
10.
Changes in the Rights of Share Types
10.1 Unless otherwise stated in the conditions of issue of the shares, and subject to the provisions of any law, the rights of any share type may be
changed following a decision of the Company’s Board of Directors, and with the authorization of the general meeting of shareholders of that
type, or with the written consent of all the shareholders of that type. The provisions of the Company’s Articles of Association regarding
general meetings shall apply, mutatis mutandis, to a general meeting of type shareholders.
10.2 The rights granted to the holders of shares of a specific type issued with special rights shall not be considered to have been changed by virtue
of the creation or issue of additional shares of equal grade, unless otherwise conditioned in the conditions of issue of the said shares.
5
11.
General Meetings
11.1 Company decisions on the following matters shall be taken at the general meeting –
11.1.1 Changes to the Articles;
11.1.2 Exercising the authorities of the Board of Directors in the event that the Board of Directors is unable to perform its function;
11.1.3 Appointment of the auditing accountant of the Company and the cessation of employment thereof;
11.1.4 Appointment of directors, including external directors;
11.1.5 Authorization of actions and transactions requiring the authorization of the general meeting in accordance with the provisions of the
Companies Law and any other law;
Increasing and decreasing the registered share capital;
11.1.6
11.1.7 Merger as defined in the Companies Law.
11.2 Subject to the provisions of the law, the general meeting is entitled to assume authorities granted to another organ in the Company, including
the Board of Directors, for a particular matter or for a given period of time.
If the general meeting has assumed authorities granted to the Board of Directors in accordance with the Companies
Law, the shareholders shall bear the same rights, obligations, and liability as apply to the Board of Directors
regarding the exercising of those same authorities, as detailed in Article 50 of the Companies Law, as this shall be
amended from time to time.
12.
Convening of General Meetings
12.1 General meetings shall be convened at least once a year at such a venue and on such a date as shall be determined by the Board of Directors,
and subject to the provisions of the law, but not later than 15 months after the previous general meeting. These general meetings shall be
called “annual meetings.” The remaining meetings of the Company shall be called “extraordinary meetings.”
12.2 The agenda at the annual meeting shall include discussion of the report of the Board of Directors and financial statements as required by law.
The annual meeting shall appoint an auditing accountant; shall appoint the directors in accordance with these Articles; and shall discuss all
other matters to be discussed at the annual meeting of the Company in accordance with these Articles or in accordance with the Companies
Law, as well as any other matter as shall be determined by the Board of Directors.
6
12.3 The Board of Directors is entitled to convene an extraordinary meeting in accordance with its decision, and must convene a general meeting
if a written request is received from any of the following (hereinafter – “Request to Convene:”)
12.3.1 Two directors or one-fourth of the incumbent directors; and/or
12.3.2 One or more shareholders holding at least five percent of the issued capital and at least one percent of the voting rights in the
Company; and/or
12.3.3 One or more shareholders holding at least five percent of the voting rights in the Company.
12.4 Any Request to Convene must specify the goals for whose purpose the meeting is to be convened, and shall be signed by those requesting the
convening and delivered at the Company’s registered office. The request may consist of a number of documents of identical format, each
signed by one or more individuals making the request.
12.5 A Board of Directors required to convene an extraordinary meeting shall convene such meeting within twenty-one days from the date on
which the Request to Convene was submitted thereto, for a date determined in an invitation in accordance with section 12.6 below and
subject to any law.
12.6 Notification of the members of the Company regarding the convening of a general meeting shall be published or delivered to all the
shareholders registered in the registry of shareholders in the Company in accordance with the requirements of the law. The notification shall
include the agenda, the proposed decisions, and arrangements regarding voting in writing.
7
13.
Discussion at General Meetings
13.1 The discussion at the general meeting shall be opened only if a legal quorum is present at the time the discussion begins. A legal quorum is
the presence of at least two shareholders holding at least 25 percent of the voting rights (including presence by means of proxy or through a
letter of voting) within one half-hour from the time specified for the opening of the meeting.
13.2
If, at the end of one half-hour from the time specified for the opening of the meeting, no legal quorum is present, the meeting shall be
postponed by one week, to the same day, the same hour, and the same venue, or to a later date, if specified on the invitation to the meeting or
in the notification of the meeting (hereinafter – “the Postponed Meeting.”) Notification and invitation regarding a Postponed Meeting
postponed for a period of not more than 21 days shall be made not later than seventy-two hours prior to the Postponed Meeting. Notification
of a Postponed Meeting shall be made as stated in section 12.6, mutatis mutandis.
13.3 The legal quorum for commencing a Postponed Meeting shall be any number of participants.
13.4 The chairperson of the Board of Directors shall serve as the chairperson of the general meeting. If the chairperson of the Board of Directors is
absent from the meeting after 15 minutes from the time specified for the meeting, or if he refuses to serve as the chairperson of the meeting,
the chairperson shall be elected by the general meeting.
13.5 A general meeting with a legal quorum is entitled to decide on the postponement of the meeting to another date and to such venue as shall be
determined and, in this case, notifications and invitations to the Postponed Meeting shall be made as stated in section 13.2 above.
14.
Voting at a General Meeting
14.1 A shareholder in the Company shall be entitled to vote at general meetings in person or by means of a proxy or a letter of voting.
Shareholders entitled to participate in and vote at the general meeting are the shareholders as of such date as shall be
determined by the Board of Directors in the decision to convene the general meeting, and subject to any law.
8
14.2
In any vote, each shareholder shall have a number of votes equivalent to the number of shares in their possession entitling the holder to a
vote.
14.3 A decision at the general meeting shall be taken by an ordinary majority unless another majority is determined in the Companies Law or in
these Articles.
14.4 The declaration by the chairperson of the meeting that a decision has been adopted unanimously or by a given majority, or rejected or not
adopted by a given majority, shall constitute prima facie evidence of the content thereof.
14.5
If the votes at the meeting are equally divided, the chairperson of the meeting shall not have an additional or casting opinion and the decision
presented for voting shall be rejected.
14.6 Subject to any law, the shareholders in the Company are entitled to vote in any matter on the agenda of a general meeting (including type
meetings) by means of a letter of voting, provided that the Board of Directors, subject to any law, has not negated in its decision to convene
the general meeting the possibility of voting by means of a letter of voting on that matter.
If the Board of Directors has prohibited voting by means of a letter of voting, the fact of the negation of the
possibility of voting by means of a letter of voting shall be stated in the notification of the convening of the meeting
in accordance with section 12.6 above.
14.7 A shareholder is entitled to state the manner of his vote in the letter of voting and to deliver this to the Company up to 48 hours prior to the
time of commencement of the meeting. A letter of voting stating the manner of voting of the shareholder reaching the Company at least 48
hours prior to the time of commencement of the meeting shall be considered tantamount to presence at the meeting, including for the matter
of the presence of the legal quorum as stated in section 13.1 above.
9
14.8 Appointment of a proxy shall be in writing, signed by the appointer (hereinafter – “Power of Attorney.”) A corporation shall vote by means
of its representatives, who shall be appointed in a document signed properly by the corporation (hereinafter – “Letter of Appointment.”)
14.9 A vote in accordance with the conditions of a Power of Attorney shall be lawful even if the appointer dies before the voting, or becomes
legally incompetent, is liquidated, becomes bankrupt, nullifies the Letter of Appointment, or transfers the share regarding which it was given,
unless written notification is received at the Company’s office prior to the meeting that the shareholder has died, become legally incompetent,
been liquidated, become bankrupt, or has nullified the Letter of Appointment or transferred the shares as stated.
14.10 The Letter of Appointment and the Power of Attorney, or a copy authorized by an attorney, shall be deposited at the Company’s registered
offices at least forty eight (48) hours prior to the time determined for the meeting or for the Postponed Meeting at which the person
mentioned in the document intends to vote in accordance therewith.
14.11 A shareholder in the Company shall be entitled to vote at the Company’s meetings by means of several proxies appointed thereby, provided
that each proxy shall be appointed on account of different sections of the shares held by the said shareholder. There shall be no impediment to
each proxy as stated voting in a different manner in the Company’s meetings.
14.12 If a shareholder is legally incompetent, he is entitled to vote by means of his trustees, the recipient of his assets, his natural guardian or other
legal guardian, and these are entitled to vote in person or by proxy or a Letter of Voting.
14.13 When two or more persons are the joint owners of a share, in a vote on any matter the vote of the person whose name is registered first in the
registry of shareholders as the owner of that share shall be accepted, whether in person or by proxy, and he is entitled to deliver Letters of
Voting to the Company.
10
15.
16.
The Board of Directors
The Board of Directors shall set the Company’s policy, supervise the execution of the functions and actions of the general
director, and, within this, shall act and shall enjoy all the authorities detailed in Article 92 of the Companies Law. In
addition, any authority not granted in the Companies Law or in these Articles to another organ may be exercised by the
Board of Directors, in addition to the authorities and functions of the Board of Directors in accordance with the content of
any law.
Appointment of the Board of Directors and Cessation of Office Thereof
16.1 The number of directors in the Company shall be determined from time to time by the annual general meeting, provided that this shall not be
fewer than 5 and not more than 10 directors, including external directors. The number of external directors in the Company shall not be less
than the number determined in the Companies Law.
16.2 The directors in the Company shall be elected at an annual meeting and/or an extraordinary meeting, and shall serve in their office for so long
as they have not been replaced by the shareholders of the Company at an annual meeting and/or at an extraordinary meeting, or until they
cease to serve in their office in accordance with the provisions of the Articles or any law, whichever is the earlier.
16.3
In addition to the content of section 16.2 above, the Board of Directors is entitled to appoint a director in place of a director whose position
has become vacant and/or by way of an addition to the Board of Directors, subject to the maximum number of directors on the Board of
Directors as stated in section 16.1 above. The appointment of a director by the Board of Directors shall remain valid through the next annual
meeting or until the director shall cease to serve in their office in accordance with the provisions of these Articles or of any law, whichever is
the earlier.
16.4 A director whose period of office has expired may be reelected, with the exception of an external director, who may be reelected for an
additional period of office subject to the provisions of the law.
11
16.5 The office of a director shall commence on the date of their appointment by the annual meeting and/or the extraordinary meeting and/or the
Board of Directors, or on a later date if this date is determined in the decision of appointment of the annual meeting and/or the extraordinary
meeting and/or the Board of Directors.
16.6 The Board of Directors shall elect one of its members as the chairperson of the Board of Directors. The elected chairperson shall run the
meetings of the Board of Directors and shall sign the minutes of the discussion. If no chairperson is elected, or if the chairperson of the Board
of Directors is not present after 15 minutes from the time set for the meeting, the directors present shall choose one of their number to serve
as the chairperson at that meeting, and the chosen member shall run the meeting and sign the minutes of the discussion.
The chairperson of the Board of Directors shall not be the general director of the Company unless the conditions
stipulated in Article 121(C) of the Companies Law apply.
16.7 The general meeting is entitled to transfer any director from their office prior to the end of the period of their office, inter alia whether the
director was appointed thereby in accordance with section 16.2 above or was appointed by the Board of Directors in accordance with section
16.3 above, provided that the director shall be given a reasonable opportunity to state their case before the general meeting.
16.8 Any director is entitled, with the agreement of the Board of Directors, to appoint a substitute for themselves (hereinafter – “a Substitute
Director,”) provided that a person who is not competent shall not be appointed to serve as a Substitute Director, nor a person who has been
appointed as a Substitute Director for another director and/or a person who is already serving as a director in the Company.
The appointment or cessation of office of a Substitute Director shall be made in a written document signed by the
director who appointed him; in any case, however, the office of a Substitute Director shall be terminated if one of the
cases stipulated in the paragraphs in section 16.9 below shall apply, or if the office of the member of the Board of
Directors for whom he serves as a substitute shall become vacant for any reason.
A Substitute Director is considered tantamount to a director and all the legal provisions and the provisions of these
Articles shall apply, with the exception of the provisions regarding the appointment and/or dismissal of a director as
established in these Articles.
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16.9 The office of a director shall become vacant in any of the following cases:
16.9.1 He resigns from his office by means of a letter signed in his hand, submitted to the Company and detailing the reasons for his
resignation;
16.9.2 He is removed from his office by the general meeting;
16.9.3 He is convicted of an offense as stated in Article 232 of the Companies Law;
16.9.4
16.9.5 He is declared legally incompetent;
16.9.6 He is declared bankrupt and, if the director is a corporation – it opted for voluntary liquidation or a liquidation order was issued
In accordance with a court decision as stated in Article 233 of the Companies Law;
against it.
16.10 In the event that the position of a director becomes vacant, the remaining directors shall be entitled to continue to act, provided the number of
directors remaining shall not be less than the minimum number of directors as stated above in section 16.1 above. If the number of directors
falls below the above-mentioned minimum number, the remaining directors shall be entitled to act solely in order to fill the place of the
director that has become vacant as stated in section 16.3 above, or in order to convene a general meeting of the Company, and pending the
convening of the general meeting of the Company as stated they may act to manage the Company’s affairs solely in matters that cannot be
delayed.
16.11 The conditions of office of the members of the Board of Directors shall be authorized in accordance with the provisions of the Companies
Law.
17. Meetings of the Board of Directors
17.1 The Board of Directors shall convene for a meeting in accordance with the needs of the Company, and at least once every three months.
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17.2 The chairperson of the Board of Directors is entitled to convene the Board at any time. In addition, the Board of Directors shall hold a
meeting on such subject as shall be specified in the following cases:
17.2.1
17.2.2
17.2.3
17.2.4
In accordance with the request of two directors; however, if at the time the Board of Directors comprises five directors or less – in
accordance with the request of one director;
In accordance with the request of one director if, in his request to convene the Board, he states that he has learned of a matter in the
Company ostensibly entailing a violation of the law or infringement of proper business practice;
If a general director has been appointed in the Company or if a notification or report by the general director require an action on the
part of the Board of Directors;
If the auditing accountant has informed the chairperson of the Board of Directors – or, in the event that no chairperson was
appointed for the Board of Directors, has informed the Board of Directors – of substantial defects in the accounting control of the
Company.
17.3 Notification of the meeting of the Board of Directors shall be delivered to all members of the Board at least three days prior to the date of
convening of the Board, or with shorter prior notice insofar as the chairperson of the Board decided that, in the circumstances of the matter, it
is vital and reasonable to convene the Board of Directors with notice shorter than three days. Notification shall be delivered to the address of
the director as forwarded to the Company in advance, and shall stipulate the time of the meeting and the venue at which it shall convene, as
well as reasonable detail of all subjects on the agenda.
Notwithstanding the above, the Board of Directors is entitled to convene a meeting without notification, with the
consent of all the directors.
17.4 The agenda of the meetings of the Board of Directors shall be determined by the chairperson of the Board and shall include: Subjects
determined by the chairperson of the Board; subjects deriving from the report of the general director and/or the auditing accountant; any
subject a director of the general director have requested of the chairperson of the Board to include on the agenda, at least two days prior to the
convening of the meeting of the Board.
If no chairperson has been appointed for the Board of Directors, the agenda for the meetings of the Board shall be
determined by the directors in such manner that each director shall send to the Company, at least two days before the
convening of the meeting of the Board, the subjects that, in his opinion, should be included in the meeting of the
Board. The agenda for the meetings of the Board shall also include subjects deriving from the report of the general
director and/or the auditing accountant.
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17.5 The details of the subjects on the agenda as stated in section 17.4 above do not prevent discussion of a subject or subjects not mentioned in
the notification of the meeting of the Board of Directors (hereinafter: “a New Subject.”)
If a New Subject is discussed at the meeting of the Board of Directors, a director not present at the meeting of the
Board of Directors at which the New Subject was discussed may express in writing his opposition to the decision
and/or request that the subject be discussed again, within three days from the date on which he received a copy of the
decision. If a further discussion is requested as stated, this shall be held by the Board of Directors on such date as
shall determined by the chairperson of the Board of Directors or, in his absence, by the Board of Directors, and not
later than seven days after the receipt of the request. However, the objection of the director to the decision on the New
Subject shall not impair the validity of actions regarding third parties undertaken on the basis thereof.
17.6 The legal quorum for the commencement of a meeting of the Board of Directors shall be a majority of the members of the Board of Directors.
If, at the end of one half-hour from the time set for the commencement of the meeting, no quorum is present, the meeting shall be postponed
to another date as decided by the chairperson of the Board, or, in his absence, by the directors present at the convened meeting, provided that
prior notification of three days shall be given to all directors regarding the date of the Postponed Meeting. The legal quorum for the opening
of a Postponed Meeting shall be any number of participants.
15
17.7 The Board of Directors is entitled to hold meetings by use of any means of communication, providing that all the participating directors can
hear each other simultaneously.
17.8 The Board of Directors is entitled to take decisions without actually convening, provided that all the directors entitled to participate in the
discussion and to vote on the subject brought for decision agree thereto. If decisions are made as stated in this section, the chairperson of the
Board of Directors shall record minutes of the decisions stating the manner of voting of each director on the subjects brought for decision, as
well as the fact that all the directors agreed to take the decision without convening.
Voting on the Board of Directors
18.1
Each director shall have one vote when voting on the Board of Directors.
18.2 Decisions of the Board of Directors shall be taken by a majority vote. The chairperson of the Board of Directors shall not have any additional
or casting opinion, and in the event of a tie vote, the decision brought for voting shall be rejected.
Committees of the Board of Directors
19.1 The Board of Directors is entitled to establish committees and to appoint members thereto (hereinafter – “the Committees of the Board of
Directors.”) If Committees of the Board of Directors are established, the Board of Directors shall determine, in the conditions of
empowerment thereof, whether specific authorities of the Board of Directors shall be delegated to the Committees of the Board of Directors,
in such manner that the decision of the Committee of the Board of Directors shall be considered tantamount to a decision of the Board of
Directors, or whether the decision of the Committee of the Board of Directors shall merely constitute a recommendation, subject to the
authorization of the Board of Directors; provided that authorities to make decisions in the matters stated in Article 112 of the Companies Law
shall not be delegated to a committee.
18.
19.
16
19.2 A person who is not a director shall not serve in a Committee of the Board of Directors to which the Board of Directors has delegated
authorities. Persons who are not members of the Board of Directors may serve in a Committee of the Board of Director whose function is
merely to advise or submit recommendations to the Board of Directors.
19.3 The provisions included in these Articles relating to the meetings of the Board of Directors and voting therein shall apply, mutatis mutandis
and subject to the decisions of the Board of Directors regarding the procedures for the meetings of the committee (if any), to any Committee
of the Board of Directors comprising two or more members.
20.
Audit Committee
20.1 The Board of Directors of the Company shall appoint an audit committee from among its members. The number of members of the audit
committee shall be not less than three, and any external director may be a member thereof. The chairperson of the Board of Directors or any
director employed by the Company, or providing it with services on a regular basis, or a controlling shareholder in the Company, or a relative
thereof shall not be appointed to the committee.
20.2 The functions of the audit committee shall be –
20.2.1 To identify defects in the business management of the Company, inter alia through consultation with the internal auditor of the
Company or the auditing accountant, and to propose methods to the Board of Directors for correcting these;
20.2.2 To decide whether to authorize actions and transactions requiring the authorization of the audit committee in accordance with the
Companies Law.
21. General Director
The Board of Directors of the Company shall appoint a general director, and is entitled to appoint more than one general
director. The general director shall be responsible for the routine management of the Company’s affairs within the
framework of the policy set by the Board of Directors and subject to its guidelines.
17
22.
Exemption, Insurance, and Indemnification
Subject to the provisions of the Companies Law and the Israeli Securities law, 5728-1968 (the “Israeli Securities Law”), the
Company may:
22.1
enter into a contract for the insurance of the liability, in whole or in part, of any of its “Office Holders” (as defined in the Companies Law)
with respect to an obligation imposed on such Office Holder due to an act performed by the Office Holder in the Office Holder’s capacity as
an Office Holder of the Company arising from any of the following:
22.1.1 a breach of duty of care to the Company or to any other person;
22.1.2 a breach of the duty of loyalty to the Company provided that the Office Holder acted in good faith and had
reasonable grounds to assume that the act would not harm the interests of the Company;
22.1.3 a financial liability imposed on such Office Holder in favor of any other person:
22.1.4 reasonable litigation expenses, including attorneys fees, incurred by the Office Holder as a result of an ongoing
administrative enforcement proceeding instituted against him in accordance with the Israeli Securities Law. Without
derogating from the generality of the foregoing, such expenses will include, and the Company may procure insurance
for, a payment imposed on the Office Holder in favor of an injured party as set forth in Section 52CIV(a)(1)(a) of the
Israeli Securities Law and expenses that the Office Holder incurred in connection with a proceeding under Chapters
VIII”3, VIII”4 or IX”1 of the Israeli Securities Law, including reasonable legal expenses, which term includes
attorney fees; and
22.1.5 any other incident for which it is or shall be permitted to insure the liability of an officer.
22.2
undertake, in advance to indemnify, or may indemnify retroactively, an Office Holder of the Company with respect to any of the following
liabilities or expenses that arise from an act performed by the Office Holder by virtue of being an Office Holder of the Company:
22.2.1 a financial liability imposed on an Office Holder in favor of another person by any judgment, including a
judgment given as a result of a settlement or an arbitrator’s award which has been confirmed by a court;
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22.2.2 reasonable litigation expenses including attorney’s fees, incurred by him as a result of an investigation or
proceeding instituted against him by an authority empowered to conduct an investigation or proceedings, which are
concluded without the filing of an indictment against the Office Holder and without the levying of a monetary
obligation in lieu of criminal proceedings upon the Office Holder, or which are concluded without the filing of an
indictment against the Office Holder but with levying a monetary obligation in substitute of such criminal
proceedings upon the Office Holder for a crime that does not require proof of criminal intent; or in connection with
an administrative enforcement proceeding or a financial sanction. Without derogating from the generality of the
foregoing, such expenses will include, and the Company may undertake to indemnify an Office Holder of the
Company as aforesaid, for a payment imposed on the Office Holder in favor of an injured party as set forth in Section
52LIV(a)(1)(a) of the Israeli Securities Law and expenses that the Office Holder incurred in connection with a
proceeding under Chapters VIII”3, VIII”4 or IX’1 of the Israeli Securities Law, including reasonable legal expenses,
which term includes attorney fees; and
22.2.3 reasonable litigation expenses, including attorney’s fees, expended by an Office Holder or which were imposed
on an Office Holder by a court in proceedings filed against the Office Holder by the Company or in its name or by
any other person or in a criminal charge on which the Office Holder was acquitted or in a criminal charge on which
the Office Holder was convicted for an offense which did not require proof of criminal intent; and
22.2.4 any other obligation or expense for which it is or shall be permitted to indemnify an officer, provided however,
that in the event the Company wishes to indemnify an Office Holder in advance for financial liabilities under Article
22 it may only do so if the undertaking to indemnify the Office Holder for such liabilities was restricted to those
events that the Board may deem foreseeable in light of the Company’s actual activities, at the time of giving of such
undertaking, and to a specific sum or a reasonable criterion under such circumstances as determined by the Board.
23.
Subject to the provisions of the Law and the Israeli Securities Law, the Company hereby releases, in advance, its Office Holders from liability to the
Company for damage that arises from the breach of the Office Holder’s duty of care to the Company.
19
24.
The provisions of Articles 22 and 23 are not intended, and shall not be interpreted, to restrict the Company in any manner in respect of the
procurement of insurance or in respect of indemnification (i) in connection with any person who is not an Office Holder, including, without
limitation, any employee, agent, consultant or contractor of the Company who is not an Office Holder, or (ii) in connection with any Office Holder
to the extent that such insurance and/ or indemnification is not specifically prohibited under the Companies Law; provided that the procurement of
any such insurance or the provision of any such indemnification shall be approved by the Board. Any modification of Articles 22 through 24, and
any amendment to the Companies Law, the Israeli Securities Law or any other applicable law, shall be prospective in effect and shall not affect the
Company’s obligation or ability to indemnify an Office Holder for any act or omission occurring prior to such modification or amendment, unless
otherwise provided by the Companies Law, the Israeli Securities Law or such applicable law.
25.
Internal Auditor
25.1 The Board of Directors of the Company shall appoint an internal auditor in accordance with the proposal of the audit committee. A person
who is an interested party in the Company, an office holder therein, or the relative or either of the above, as well as the auditing accountant or
any person on his behalf, shall not serve as an internal auditor in the Company.
25.2 The Board of Directors shall determine which office holder shall be organizationally accountable for the internal auditor and, in the absence
of such determination; this shall be the chairperson of the Board of Directors.
25.3 The internal audit plan prepared by the auditor shall be submitted to the audit committee for authorization; however, the Board of Directors is
permitted to determine that the plan shall be submitted to the Board of Directors for authorization.
26.
Auditing Accountant
26.1 The general meeting shall appoint an auditing accountant for the Company. The auditing accountant shall service in his office through the end
of the following annual meeting, or for a longer period as determined by the annual meeting, provided that the period of office shall not be
extended beyond the end of the third annual meeting following that at which he was appointed.
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26.2 The fee of the auditing accountant for the auditing operations shall be determined by the Board of Directors. The Board of Directors shall
report to the annual meeting on the fee of the auditing accountant.
27.
Signing in the Company’s Name
27.1 The rights to sign in the Company’s name shall be determined from time to time by the Board of Directors of the Company.
27.2 The Company’s authorized signatory shall do so together with the Company’s stamp, or alongside its printed name.
28.
Dividend and Benefit Shares
28.1 The decision by the Company to allocate a dividend and/or to allocate benefit shares shall be taken by the Company’s Board of Directors.
28.2 Unless determined otherwise by the Board of Directors, it shall be permitted to pay any dividend by way of check or payment order to be sent
by mail in accordance with the registered address of the shareholder or the personal eligible thereto or, in the case of joint registered owners
of the same share, to that shareholder whose name is mentioned first in the registry of shareholders with regard to the joint ownership. Any
such check shall be made out to order of the person to whom it is sent. A receipt from a person whose name, as of the date of declaration of
the dividend, is registered in the registry of shareholders as the owner of any share or, in the case of joint owners, of one of the joint owners,
shall serve as authorization regarding all payments made in connection with that share and regarding which the receipt was received.
28.3 For the purpose of executing any decision in accordance with the provisions of this section, the Board of Directors is entitled to resolve as it
sees fit any difficulty that emerges regarding distribution of the dividend and/or the benefit shares, including determining the value for the
purpose of the said division of certain assets, and to determine that payments in cash shall be made to members on the basis of the value so
determined; to determine provisions regarding fractions of shares; or to determine that sums of less than NIS 50 shall not be paid to a
shareholder.
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29.
30.
Redeemable Securities
The Company is entitled, subject to any law, to issue redeemable securities on such conditions as shall be determined by the
Board of Directors, provided that the general meeting shall approve the recommendation of the Board of Directors and the
conditions established thereby.
Donations
The Company is entitled to donate a reasonable sum of money for a fit purpose. The Board of Directors of the Company is
entitled to determine, at its discretion, rules for the making of donations by the Company.
31.
Accounts
31.1 The Company shall maintain accounts and shall prepare financial statements in accordance with the Securities Law and in accordance with
any law.
31.2 The account ledgers shall be held at the Company’s registered offices or in any other place as the directors shall see fit, and shall always be
open for inspection by the directors.
32.
Notifications
32.1 Subject to any law, a notification or any other document that shall be delivered by the Company, and which it is entitled or required to issue in
accordance with the provisions of the Articles and/or the Companies Law, the Securities Law, or any law, shall be delivered by the Company
to any person in one of the following manners as decided by the Company in each individual case: (A) By dispatch by registered mail in a
letter addressed in accordance with the registered address of that shareholder in the registry of shareholders, or in accordance with such
address as stated by the shareholder in a letter to the Company as the letter for the delivery of notifications or other documents; or (B) By
dispatch by facsimile in accordance with the number stated by the shareholder as the number for the delivery of facsimile notifications; or (C)
By way of publication in two daily newspapers appearing in Israel; or (D) By way of publication in the distribution site of the Securities
Authority and the Tel Aviv Stock Exchange Ltd.
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32.2 Any notification to be made to shareholders shall be made, regarding jointly owned shares, to that person whose name is mentioned first in
the registry of shareholders as the holder of that share, and any notification made in this manner shall be sufficient notification for the holders
of that share.
32.3 Any notification or other document sent in accordance with the provisions of section 30.1 above shall be considered to have reached its
destination: (A) Within 3 business days – if sent by registered mail in Israel; or (B) On the first business day after its dispatch, if delivered by
hand or sent by facsimile; or (C) On the date of publication, if published in a newspaper or on the distribution site of the Securities Authority
and the Tel Aviv Stock Exchange Ltd.
In proving delivery, it shall be sufficient to prove that the letter sent by mail included the notification and that the
document was addressed properly and was delivered to the post office as a letter bearing stamps, or as a registered
letter bearing stamps, and, regarding a facsimile, it shall be sufficient to produce a dispatch confirmation sheet from
the dispatching facsimile machine.
32.4 Any record made in an ordinary manner in the company’s registry shall be considered prima facie evidence of dispatch as recorded in that
registry.
32.5 When it is necessary to provide prior notification of a certain number of days, or when notification is valid for a certain period, the date of
delivery shall be included in reckoning the number of days or the period.
**************
[The Articles were adopted on November 29, 2007 and amended by approval of the shareholders at the Annual General Meeting
held on September 24, 2020]
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DESCRIPTION OF SECURITIES
REGISTERED UNDER SECTION 12 OF THE EXCHANGE ACT
Exhibit 2.2
As of December 31, 2020, BioLineRx Ltd. had two classes of securities registered under Section 12 of the Securities
Exchange Act of 1934, as amended, or Exchange Act: our ordinary shares and our American Depositary Shares, or ADSs.
References herein to “we,” “us,” “our” and the “Company” refer to BioLineRx Ltd. and its subsidiary.
General
We were incorporated under the laws of the State of Israel in 2003 under the name “BioLineRx Ltd.”. We are currently
authorized to issue 1,500,000,000 ordinary shares, par value NIS 0.1 per share. Our number with the Israeli Registrar of
Companies is 513398750.
The Nasdaq Global Market
Our American Depositary Shares have been trading on Nasdaq under the symbol “BLRX” since July 2011.
Articles of Association
Our purpose is set forth in Section 2 of our Articles of Association and includes every lawful purpose.
Our ordinary shares that are fully paid for are issued in registered form and may be freely transferred under our Articles of
Association, unless the transfer is restricted or prohibited by applicable law or the rules of a stock exchange on which the shares
are traded. The ownership or voting of our ordinary shares by non-residents of Israel is not restricted in any way by our Articles
of Association or the laws of the State of Israel.
Pursuant to the Companies Law and our Articles of Association, our Board of Directors may exercise all powers and take
all actions that are not required under law or under our Articles of Association to be exercised or taken by our shareholders,
including the power to borrow money for company purposes.
Our Articles of Association enable us to increase or reduce our share capital. Any such changes are subject to the
provisions of the Companies Law and must be approved by a resolution duly passed by our shareholders at a general or
extraordinary meeting by voting on such change in the capital. In addition, transactions that have the effect of reducing capital,
such as the declaration and payment of dividends in the absence of sufficient retained earnings and profits and an issuance of
shares for less than their nominal value (under certain circumstances), require a resolution of our Board of Directors and court
approval.
At the Annual General Meeting in September 2020, the shareholders approved an increase to our share capital from NIS
50,000,000 divided into 500,000,000 ordinary shares of a nominal value of NIS 0.10 each to NIS 150,000,000 divided into
1,500,000,000 ordinary shares of a nominal value of NIS 0.10 each, and a corresponding amendment to our Articles of
Association.
Dividends
We may declare a dividend to be paid to the holders of our ordinary shares in proportion to their respective shareholdings.
Under the Companies Law, dividend distributions are determined by the board of directors and do not require the approval of the
shareholders of a company unless the company’s articles of association provide otherwise. Our Articles of Association do not
require shareholder approval of a dividend distribution and provide that dividend distributions may be determined by our Board
of Directors.
Pursuant to the Companies Law, we may only distribute dividends out of the higher of (a) cash surplus and (b) cash
accrued over the previous two years, as such terms are defined in the Companies Law, according to our then last reviewed or
audited financial reports, provided that the date of the financial reports is not more than six months prior to the date of
distribution, or we may distribute dividends with court approval. In each case, we are only permitted to pay a dividend if there is
no reasonable concern that payment of the dividend will prevent us from satisfying our existing and foreseeable obligations as
they become due.
In the event of our liquidation, after satisfaction of liabilities to creditors, our assets will be distributed to the holders of
our ordinary shares in proportion to their shareholdings. This right, as well as the right to receive dividends, may be affected by
the grant of preferential dividend or distribution rights to the holders of a class of shares with preferential dividend or distribution
rights that may be authorized in the future.
Election of Directors
Our ordinary shares do not have cumulative voting rights in the election of directors. As a result, the holders of a majority
of the voting power represented at a shareholders meeting have the power to elect all of our directors, other than with respect to
the special approval requirements for the election of external directors (unless we qualify as an Eligible Company and opt to
follow the exemption provided under the Relief Regulations regarding appointment of external directors and composition of the
Audit and Compensation Committees) described under “Item 6. Directors, Senior Management and Employees — Board
Practices — External Directors” in our most recent Annual Report on Form 20-F.
Pursuant to our Articles of Association, other than the external directors, for whom special election requirements apply
under the Companies Law (unless we qualify as an Eligible Company and opt to follow the exemption provided under the Relief
Regulations regarding appointment of external directors and composition of the Audit and Compensation Committees), our
directors are elected at a general or extraordinary meeting of our shareholders and serve on the Board of Directors until they are
removed by the majority of our shareholders at a general or extraordinary meeting of our shareholders or upon the occurrence of
certain events, in accordance with the Companies Law and our Articles of Association. In addition, our Articles of Association
allow our Board of Directors to appoint directors (who are not external directors) to fill vacancies on the Board of Directors to
serve until the next general meeting or extraordinary meeting, or earlier if required by our Articles of Association or applicable
law. We have held elections for each of our non-external directors at each annual meeting of our shareholders since our initial
public offering in Israel. Unless we qualify as an Eligible Company and opt to follow the exemption provided under the
Amendment to the Relief Regulations regarding appointment of external directors and composition of the Audit and
Compensation Committees, external directors are elected for an initial term of three years and may be removed from office
pursuant to the terms of the Companies Law. See “Item 6. Directors, Senior Management and Employees — Board Practices —
External Directors” in our most recent Annual Report on Form 20-F.
Shareholder Meetings
Under Israeli law, we are required to hold an annual general meeting of our shareholders once every calendar year that
must be no later than 15 months after the date of the previous annual general meeting. All meetings other than the annual general
meeting of shareholders are referred to as extraordinary meetings. Our Board of Directors may call extraordinary meetings
whenever it sees fit, at such time and place, within or outside of Israel, as it may determine. In addition, the Companies Law and
our Articles of Association provide that our Board of Directors is required to convene an extraordinary meeting upon the written
request of (a) any two of our directors or one quarter of our Board of Directors or (b) one or more shareholders holding, in the
aggregate, either (1) at least 5% of our outstanding shares and at least 1% of our outstanding voting power or (2) at least 5% of
our outstanding voting power.
Subject to the provisions of the Companies Law and the regulations promulgated thereunder, shareholders entitled to
participate and vote at general meetings are the shareholders of record on a date to be decided by the board of directors, which
may be between four and 40 days prior to the date of the meeting. Furthermore, the Companies Law and our Articles of
Association require that resolutions regarding the following matters must be passed at a general meeting of our shareholders:
•
amendments to our Articles of Association;
•
•
•
•
•
•
•
appointment or termination of our auditors;
appointment of directors and appointment and dismissal of external directors;
approval of acts and transactions requiring general meeting approval pursuant to the Companies Law;
director compensation, indemnification and change of the principal executive officer;
increases or reductions of our authorized share capital;
a merger; and
the exercise of our Board of Director’s powers by a general meeting, if our Board of Directors is unable to exercise its powers and the exercise of
any of its powers is required for our proper management.
The Companies Law requires that a notice of any annual or extraordinary shareholders meeting be provided at least 21
days prior to the meeting and if the agenda of the meeting includes the appointment or removal of directors, the authorization of
the chairman of the board (or his or her close relative) to serve as the chief executive officer or exercise the powers of that office,
the authorization of the chief executive officer (or his or her close relative) to serve as the chairman of the board, or exercise the
powers of that office, the approval of transactions with office holders, a controlling shareholder or parties related to the foregoing,
the approval of a compensation policy with respect to office holders or an approval of a merger, notice must be provided at least
35 days prior to the meeting.
Pursuant to our Articles of Association, holders of our ordinary shares have one vote for each ordinary share held on all
matters submitted to a vote before the shareholders at a general meeting.
Quorum
The quorum required for our general meetings of shareholders consists of at least two shareholders present in person, by
proxy or written ballot who hold or represent between them at least 25% of the total outstanding voting rights.
A meeting adjourned for lack of a quorum is adjourned to the same day in the following week at the same time and place
or on a later date if so specified in the summons or notice of the meeting. At the reconvened meeting, any number of our
shareholders present in person or by proxy shall constitute a lawful quorum.
Resolutions
Our Articles of Association provide that all resolutions of our shareholders require a simple majority vote, unless
otherwise required by applicable law.
Israeli law provides that a shareholder of a public company may vote in a meeting and in a class meeting by means of a
written ballot in which the shareholder indicates how he or she votes on resolutions relating to the following matters:
•
•
•
•
an appointment or removal of directors;
an approval of transactions with office holders, a controlling shareholder or parties related to the foregoing;
an approval of a merger;
authorizing the chairman of the board of directors or his relative to act as the company’s chief executive officer or act with such authority; or
authorize the company’s chief executive officer or his relative to act as the chairman of the board of directors or act with such authority;
•
•
any other matter in respect of which there is a provision in the articles of association providing that decisions of the general meeting may also be
passed by written ballot; and
other matters which may be prescribed by Israel’s Minister of Justice.
The provision allowing the vote by written ballot does not apply where the voting power of the controlling shareholder is
sufficient to determine the vote.
The Companies Law provides that a shareholder, in exercising his or her rights and performing his or her obligations
toward the company and its other shareholders, must act in good faith and in a customary manner, and avoid abusing his or her
power. This is required when voting at general meetings on matters such as changes to the articles of association, increasing the
company’s registered capital, mergers and approval of related party transactions. A shareholder also has a general duty to refrain
from depriving any other shareholder of its rights as a shareholder. In addition, any controlling shareholder, any shareholder who
knows that its vote can determine the outcome of a shareholder vote and any shareholder who, under the company’s articles of
association, can appoint or prevent the appointment of an office holder, is required to act with fairness towards the company. The
Companies Law does not describe the substance of this duty except to state that the remedies generally available upon a breach of
contract will also apply to a breach of the duty to act with fairness.
Access to Corporate Records
Under the Companies Law, all shareholders of a company generally have the right to review minutes of the company’s
general meetings, its shareholders register and principal shareholders register, articles of association, financial statements and any
document it is required by law to file publicly with the Israeli Companies Registrar and the ISA. Furthermore, any of our
shareholders may request access to review any document in our possession that relates to any action or transaction with a related
party, interested party or office holder that requires shareholder approval under the Companies Law. However, we may deny such
a request to review a document if we determine that the request was not made in good faith, that the document contains a trade
secret or a patent or that the document’s disclosure may otherwise prejudice our interests.
Acquisitions under Israeli Law
Full Tender Offer
A person wishing to acquire shares of a public Israeli company and who would as a result hold over 90% of the target
company’s issued and outstanding share capital is required by the Companies Law to make a tender offer to all of the company’s
shareholders for the purchase of all of the issued and outstanding shares of the company. A person wishing to acquire shares of a
public Israeli company and who would as a result hold over 90% of the issued and outstanding share capital of a certain class of
shares is required to make a tender offer to all of the shareholders who hold shares of the same class for the purchase of all of the
issued and outstanding shares of the same class. If the shareholders who do not accept the offer hold less than 5% of the issued
and outstanding share capital of the company or of the applicable class, all of the shares that the acquirer offered to purchase will
be transferred to the acquirer by operation of law (provided that a majority of the offerees that do not have a personal interest in
such tender offer shall have approved the tender offer except that if the total votes to reject the tender offer represent less than 2%
of the company’s issued and outstanding share capital, in the aggregate, then the condition that the majority approval include the
approval by a majority of the offerees that do not have a personal interest in such tender offer is not required to complete the
tender offer). However, a shareholder that had its shares so transferred may petition the court within six months from the date of
acceptance of the full tender offer, whether or not such shareholder agreed to the tender, to determine whether the tender offer
was for less than fair value and whether the fair value should be paid as determined by the court unless the acquirer stipulated in
the tender offer that a shareholder that accepts the offer may not seek appraisal rights. If the shareholders who did not accept the
tender offer hold 5% or more of the issued and outstanding share capital of the company or of the applicable class, the acquirer
may not acquire shares of the company that will increase its holdings to more than 90% of the company’s issued and outstanding
share capital or of the applicable class from shareholders who accepted the tender offer.
Special Tender Offer
The Companies Law provides that an acquisition of shares of a public Israeli company must be made by means of a
special tender offer if as a result of the acquisition, the purchaser would become a holder of 25% or more of the voting rights in
the company, unless one of the exemptions in the Companies Law is met. This rule does not apply if there is already another
holder of at least 25% of the voting rights in the company. Similarly, the Companies Law provides that an acquisition of shares in
a public company must be made by means of a tender offer if as a result of the acquisition the purchaser would become a holder
of 45% or more of the voting rights in the company, if there is no other shareholder of the company who holds 45% or more of
the voting rights in the company, unless one of the exemptions in the Companies Law is met.
A special tender offer must be extended to all shareholders of a company. A special tender offer may be consummated
only if (i) at least 5% of the voting power attached to the company’s outstanding shares will be acquired by the offeror and (ii) the
number of shares tendered in the offer exceeds the number of shares whose holders objected to the offer.
If a special tender offer is accepted, then the purchaser or any person or entity controlling it or under common control
with the purchaser or such controlling person or entity may not make a subsequent tender offer for the purchase of shares of the
target company and may not enter into a merger with the target company for a period of one year from the date of the offer,
unless the purchaser or such person or entity undertook to effect such an offer or merger in the initial special tender offer.
Merger
The Companies Law permits merger transactions if approved by each party’s board of directors and, unless certain
requirements described under the Companies Law are met, a majority of each party’s shares voted on the proposed merger at a
shareholders’ meeting called with at least 35 days’ prior notice.
For purposes of the shareholder vote, unless a court rules otherwise, the merger will not be deemed approved if, in a
company in which the other merging company holds shares, or in which shares are held by any person who either (a) holds 25%
or more of the outstanding shares or (b) has the right to appoint 25% or more of the directors of the other merging company (or
Controlling Shareholders), the majority of the shareholders voting in such meeting (who are not also shareholders or Controlling
Shareholders of the other merging company) vote against the merger. If the aforementioned majority of the shareholders was not
obtained, a court may still approve the merger upon the request of holders of at least 25% of the voting rights of a company, if the
court holds that the merger is fair and reasonable, taking into account the value of the parties to the merger and the consideration
offered to the shareholders.
Upon the request of a creditor of either party to the proposed merger, the court may delay or prevent the merger if it
concludes that there exists a reasonable concern that, as a result of the merger, the surviving company will be unable to satisfy the
obligations of any of the parties to the merger, and may further give instructions to secure the rights of creditors.
In addition, a merger may not be completed unless at least 50 days have passed from the date that a proposal for approval
of the merger was filed by each party with the Israeli Registrar of Companies and 30 days have passed from the date the merger
was approved by the shareholders of each party.
Antitakeover Measures
The Companies Law allows us to create and issue shares having rights different from those attached to our ordinary
shares, including shares providing certain preferred rights, distributions or other matters and shares having preemptive rights. As
of the date hereof, we do not have any authorized or issued shares other than our ordinary shares. In the future, if we do create
and issue a class of shares other than ordinary shares, such class of shares, depending on the specific rights that may be attached
to them, may delay or prevent a takeover or otherwise prevent our shareholders from realizing a potential premium over the
market value of their ordinary shares. The authorization of a new class of shares will require an amendment to our Articles of
Association which requires the prior approval of the holders of a majority of our shares at a general meeting. Shareholders voting
in such meeting will be subject to the restrictions provided in the Companies Law as described above. In addition, the Israeli
Securities Law and the rules and regulations of the TASE also limit the terms permitted with respect to a new class of shares
created by a public company whose shares are traded on the TASE, and prohibit any such new class of shares from having voting
rights.
Debt Securities
We do not have any debt securities that are registered under Section 12 of the Securities Exchange Act of 1934 (the
“Securities Act”).
Warrants and Rights
We do not have any warrants or rights that are registered under Section 12 of the Securities Act..
Other Securities
We do not have any other securities that are registered under Section 12 of the Securities Act.
American Depositary Shares
Description of the ADSs
Each of our ADSs represents 15 of our ordinary shares deposited with the principal Tel Aviv office of either Bank
Hapoalim B.M. or Bank Leumi Le-Israel, as Custodian for the Depositary. Our ADSs trade on Nasdaq.
The form of the deposit agreement for the ADS and the form of American Depositary Receipt (ADR) that represents an
ADS have been incorporated by reference as exhibits to our most recent Annual Report on Form 20-F. Copies of the deposit
agreement are available for inspection at the principal office of The Bank of New York Mellon, located at 101 Barclay Street,
New York, New York 10286.
Charges of Depositary
We will pay the fees, reasonable expenses and out-of-pocket charges of the Depositary and those of any registrar only in
accordance with agreements in writing entered into between us and the Depositary from time to time. The following charges shall
be incurred by any party depositing or withdrawing ordinary shares or by any party surrendering ADRs or to whom ADRs are
issued (including, without limitation, issuance pursuant to a stock dividend or stock split declared by us or an exchange of stock
regarding the ADRs or deposited ordinary shares or a distribution of ADRs pursuant to the terms of the deposit agreement):
•
•
•
•
•
•
•
taxes and other governmental charges;
any applicable transfer or registration fees;
certain cable, telex and facsimile transmission charges as provided in the deposit agreement;
any expenses incurred in the conversion of foreign currency;
a fee of $5.00 or less per 100 ADSs (or a portion thereof) for the execution and delivery of ADRs and the surrender of ADRs, including if the
deposit agreement terminates;
a fee of $.05 or less per ADS (or portion thereof) for any cash distribution made pursuant to the deposit agreement;
a fee for the distribution of securities pursuant to the deposit agreement;
•
•
•
in addition to any fee charged for a cash distribution, a fee of $.05 or less per ADS (or portion thereof) per annum for depositary services;
a fee for the distribution of proceeds of rights that the Depositary sells pursuant to the deposit agreement; and
any other charges payable by the Depositary, any of the Depositary’s agents, or the agents of the Depositary’s agents in connection with the
servicing of ordinary shares or other Deposited Securities.
The Depositary may own and deal in our securities and in ADSs.
The Depositary collects its fees for delivery and surrender of ADSs directly from investors depositing shares or
surrendering ADSs for the purpose of withdrawal or from intermediaries acting for them. The Depositary collects fees for making
distributions to investors by deducting those fees from the amounts distributed or by selling a portion of distributable property to
pay the fees. The Depositary may collect its annual fee for depositary services by deduction from cash distributions or by directly
billing investors or by charging the book-entry system accounts of participants acting for them. The Depositary may collect any
of its fees by deduction from any cash distribution payable (or by selling a portion of securities or other property distributable) to
ADS holders that are obligated to pay those fees. The Depositary may generally refuse to provide fee-attracting services until its
fees for those services are paid.
From time to time, the Depositary may make payments to us to reimburse us for costs and expenses generally arising out
of establishment and maintenance of the ADS program, waive fees and expenses for services provided to us by the Depositary or
share revenue from the fees collected from ADS holders. In performing its duties under the deposit agreement, the Depositary
may use brokers, dealers, foreign currency dealers or other service providers that are owned by or affiliated with the Depositary
and that may earn or share fees, spreads or commissions.
The Depositary may convert currency itself or through any of its affiliates and, in those cases, acts as principal for its own
account and not as agent, advisor, broker or fiduciary on behalf of any other person and earns revenue, including, without
limitation, transaction spreads, that it will retain for its own account. The revenue is based on, among other things, the difference
between the exchange rate assigned to the currency conversion made under the deposit agreement and the rate that the Depositary
or its affiliate receives when buying or selling foreign currency for its own account. The Depositary makes no representation that
the exchange rate used or obtained in any currency conversion under the deposit agreement will be the most favorable rate that
could be obtained at the time or that the method by which that rate will be determined will be the most favorable to ADS holders,
subject to the Depositary’s obligations under the deposit agreement. The methodology used to determine exchange rates used in
currency conversions is available upon request.
Liability of Holders for Taxes, Duties or Other Charges
Any tax or other governmental charge with respect to ADSs or any deposited ordinary shares represented by any ADS
shall be payable by the holder of such ADS to the Depositary. The Depositary may refuse to effect transfer of such ADS or any
withdrawal of deposited ordinary shares represented by such ADS until such payment is made, and may withhold any dividends
or other distributions or may sell for the account of the holder any part or all of the deposited ordinary shares represented by such
ADS and may apply such dividends or distributions or the proceeds of any such sale in payment of any such tax or other
governmental charge and the holder of such ADS shall remain liable for any deficiency.
Exhibit 4.2
Modi'in Technology Park
2 HaMa'ayan Street
Modi'in 7177871, Israel
Phone: 972-8-642-9100
Fax: 972-8-642-9101
web: www.BioLineRx.com
September 24, 2020
Re: Amendment to Employment Agreement
Dear Phil:
This letter shall serve as an amendment (the "Amendment") to that certain Employment
Agreement, dated May 24, 2009, by and between BiolineRx Ltd. ("Bioline") and Philip Serlin (the
"Employee"), as amended, (the "Employment Agreement"). Defined terms used herein and not otherwise
defined herein shall have the meaning ascribed to them in the Employment Agreement.
Bioline and Employee hereby mutually agree to the following revisions to the Employment
Agreement:
Section 5.2 of the Employment Agreement shall be replaced with the following:
"5.2 Termination.
(a) In the event of termination without Cause (as defined below) by Bioline of Employee's
employment, Bioline may terminate the Employment Agreement by giving the Employee prior written notice
of 180 days.
(b) In the event Employee resigns his employment for any reason that would constitute
constructive dismissal under Israeli law, Employee may terminate the Employment Agreement by giving
Bioline prior written notice of 60 days, but will be entitled to be compensated for a Notice Period of 180 days.
(c) In the event Employee resigns his employment for any reason other than as stated in section
(b) above, Employee may terminate the Employment Agreement by giving Bioline prior written notice of 60
days.
Each of the notice periods in this Section 5.2 shall be deemed a "Notice Period" for the purpose of Section 5.4
below."
Except as modified by this letter, the terms, provisions and requirements of the Employment Agreement shall
remain the same and In full force and effect in accordance with the terms and provisions thereof.
Very truly yours,
BioLineRx Ltd.
/s/ Mali Zeevi
By: Mali Zeevi
Title: Chief Financial Officer
Accepted and agreed as of the date first written above:
/s/ Philip Serlin
Philip Serlin
Exhibit 4.4
Modi'in Technology Park
2 HaMa'ayan Street
Modi'in 7177871, Israel
Phone: 972-8-642-9100
Fax: 972-8-642-9101
web: www.BioLineRx.com
September 24, 2020
Re: Amendment to Employment Agreement
Dear Mali:
This letter shall serve as an amendment (the "Amendment") to that certain Employment Agreement,
dated September 16, 2009, by and between BiolineRx Ltd. ("Bioline") and Mali Zeevi (the "Employee"), as
amended, (the "Employment Agreement"). Defined terms used herein and not otherwise defined herein shall
have the meaning ascribed to them in the Employment Agreement.
Bioline and Employee hereby mutually agree to the following revisions to the Employment
Agreement:
Section 5.2 of the Employment Agreement shall be replaced with the following:
"5.2 Termination.
(a) In the event of termination without Cause (as defined below) by Bioline of Employee's
employment, Bioline may terminate the Employment Agreement by giving the Employee prior written notice of
180 days.
(b) In the event Employee resigns his employment for any reason that would constitute
constructive dismissal under Israeli law, Employee may terminate the Employment Agreement by giving
Bioline prior written notice of 60 days, but will be entitled to be compensated for a Notice Period of 180 days.
(c) In the event Employee resigns his employment for any reason other than as stated in section
(b) above, Employee may terminate the Employment Agreement by giving Bioline prior written notice of 60
days.
Each of the notice periods in this Section 5.2 shall be deemed a "Notice Period" for the purpose of
Section 5.4 below."
Except as modified by this letter, the terms, provisions and requirements of the Employment Agreement shall
remain the same and In full force and effect in accordance with the terms and provisions thereof.
Very truly yours,
BioLineRx Ltd.
/s/ Philip Serlin
By: Philip Serlin
Title: Chief Executive Officer
Accepted and agreed as of the date first written above:
/s/ Mali Zeevi
Mali Zeevi
Exhibit 4.6
Modi'in Technology Park
2 HaMa'ayan Street
Modi'in 7177871, Israel
Phone: 972-8-642-9100
Fax: 972-8-642-9101
web: www.BioLineRx.com
September 24, 2020
Re: Amendment to Employment Agreement
Dear Abi:
This letter shall serve as an amendment (the "Amendment") to that certain Employment Agreement,
dated April 2, 2014, by and between BiolineRx Ltd. ("Bioline") and Abi Vainstein (the "Employee"), as
amended, (the "Employment Agreement"). Defined terms used herein and not otherwise defined herein shall
have the meaning ascribed to them in the Employment Agreement.
Bioline and Employee hereby mutually agree to the following revisions to the Employment
Agreement:
Section 5.2 of the Employment Agreement shall be replaced with the following:
"5.2 Termination.
(a) In the event of termination without Cause (as defined below) by Bioline of Employee's
employment, Bioline may terminate the Employment Agreement by giving the Employee prior written notice of
180 days.
(b) In the event Employee resigns his employment for any reason that would constitute
constructive dismissal under Israeli law, Employee may terminate the Employment Agreement by giving Bioline prior written
notice of 60 days, but will be entitled to be compensated for a Notice Period of 180 days.
(c) In the event Employee resigns his employment for any reason other than as stated in section (b)
above, Employee may terminate the Employment Agreement by giving Bioline prior written notice of 60 days.
Each of the notice periods in this Section 5.2 shall be deemed a "Notice Period" for the purpose of
Section 5.4 below."
Except as modified by this letter, the terms, provisions and requirements of the Employment Agreement shall
remain the same and In full force and effect in accordance with the terms and provisions thereof.
Very truly yours,
BioLineRx Ltd.
/s/ Philip Serlin
By: Philip Serlin
Title: Chief Executive Officer
Accepted and agreed as of the date first written above:
/s/ Abi Vainstein
Abi Vainstein
Exhibit 4.8
Modi'in Technology Park
2 HaMa'ayan Street
Modi'in 7177871, Israel
Phone: 972-8-642-9100
Fax: 972-8-642-9101
web: www.BioLineRx.com
September 24, 2020
Re: Amendment to Employment Agreement
Dear Ella:
This letter shall serve as an amendment (the "Amendment") to that certain Employment Agreement,
dated January, 2017, by and between BiolineRx Ltd. ("Bioline") and Ella Sarani (the "Employee"), as
amended, (the "Employment Agreement"). Defined terms used herein and not otherwise defined herein shall
have the meaning ascribed to them in the Employment Agreement.
Bioline and Employee hereby mutually agree to the following revisions to the Employment
Agreement:
Section 5.2 of the Employment Agreement shall be replaced with the following:
"5.2 Termination.
(a) In the event of termination without Cause (as defined below) by Bioline of Employee's
employment, Bioline may terminate the Employment Agreement by giving the Employee prior written notice of
180 days.
(b) In the event Employee resigns his employment for any reason that would constitute
constructive dismissal under Israeli law, Employee may terminate the Employment Agreement by giving
Bioline prior written notice of 60 days, but will be entitled to be compensated for a Notice Period of 180 days..
(c) In the event Employee resigns his employment for any reason other than as stated in section
(b) above, Employee may terminate the Employment Agreement by giving Bioline prior written notice of 60
days.
Each of the notice periods in this Section 5.2 shall be deemed a "Notice Period" for the purpose of
Section 5.4 below."
Except as modified by this letter, the terms, provisions and requirements of the Employment Agreement shall
remain the same and in full force and effect in accordance with the terms and provisions thereof.
Very truly yours,
BioLineRx Ltd.
/s/ Philip Serlin
By: Philip Serlin
Title: Chief Executive Officer
Accepted and agreed as of the date first written above:
/s/ Ella Sorani
Ella Sorani
The following table sets forth the name and jurisdiction of incorporation of our subsidiaries.
Subsidiaries of BioLineRx Ltd.
Name of Subsidiary
Agalimmune Ltd.
Jurisdiction of
Incorporation
England and Wales
Exhibit 8.1
CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER UNDER SECTION 302 OF
THE SARBANES-OXLEY ACT
I, Philip A. Serlin, certify that:
Exhibit 12.1
1.
2.
3.
4.
I have reviewed this annual report on Form 20-F of BioLineRx Ltd.;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered
by this report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects
the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined
in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and
15d-15(f)) for the company and have:
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles;
Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the
annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting;
and
5.
The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting,
to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control
over financial reporting.
Date: February 23, 2021
/s/ Philip A. Serlin
Philip A. Serlin
Chief Executive Officer
CERTIFICATION OF THE CHIEF FINANCIAL OFFICER UNDER SECTION 302 OF
THE SARBANES-OXLEY ACT
I, Mali Zeevi, certify that:
Exhibit 12.2
1.
2.
3.
4.
I have reviewed this annual report on Form 20-F of BioLineRx Ltd.;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered
by this report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects
the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
The company’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined
in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and
15d-15(f)) for the company and have:
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to
ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for
external purposes in accordance with generally accepted accounting principles;
Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the
effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the
annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting;
and
5.
The company’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting,
to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably
likely to adversely affect the company’s ability to record, process, summarize and report financial information; and
Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control
over financial reporting.
Date: February 23, 2021
/s/ Mali Zeevi
Mali Zeevi
Chief Financial Officer
Exhibit 13.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER UNDER SECTION 906 OF THE
SARBANES-OXLEY ACT
Pursuant to 18 U.S.C. Section 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of
BioLineRx Ltd. (the “Company”) hereby certifies to such officer’s knowledge that:
(i) the accompanying Annual Report on Form 20-F of the Company for the year ended December 31, 2020 (the
“Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act
of 1934, as amended; and
(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of
operations of the Company.
Dated: February 23, 2021
/s/ Philip A. Serlin
Philip A. Serlin
Chief Executive Officer
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. Section 1350, and is not
being filed for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by
reference to any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation
language in such filing.
Exhibit 13.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER UNDER SECTION 906 OF THE
SARBANES-OXLEY ACT
Pursuant to 18 U.S.C. Section 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned officer of
BioLineRx Ltd. (the “Company”) hereby certifies to such officer’s knowledge that:
(i) the accompanying Annual Report on Form 20-F of the Company for the year ended December 31, 2020 (the
“Report”) fully complies with the requirements of Section 13(a) or Section 15(d), as applicable, of the Securities Exchange Act
of 1934, as amended; and
(ii) the information contained in the Report fairly presents, in all material respects, the financial condition and results of
operations of the Company.
Dated: February 23, 2021
/s/ Mali Zeevi
Mali Zeevi
Chief Financial Officer
The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. Section 1350, and is not
being filed for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by
reference to any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation
language in such filing.
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (No. 333-176419, 333-183976,
333-201326 and 333-208865) and on Form F-3 (No. 333-251857 and 333-229021) of BioLineRx Ltd. of our report dated
February 22, 2021 relating to the financial statements, which appears in this Form 20-F.
Tel-Aviv, Israel
February 23, 2021
/s/ Kesselman & Kesselman
Kesselman & Kesselman
Certified Public Accountants (Isr.)
A member firm of PricewaterhouseCoopers International Limited
Exhibit 15.1