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 March 31, 2022
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
OR
☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
For the transition period from ________ to ________
Date of event requiring this shell company report___________
Commission file number 001-35463
TARO PHARMACEUTICAL INDUSTRIES LTD.
(Exact name of Registrant as specified in its charter)
N/A
(Translation of Registrant’s name into English)
Israel
(Jurisdiction of incorporation or organization)
14 Hakitor Street, Haifa Bay 2624761, Israel
(Address of principal executive offices)
William Coote
Chief Financial Officer
Taro Pharmaceutical Industries Ltd.
c/o Taro Pharmaceuticals U.S.A., Inc.
3 Skyline Drive
Hawthorne, NY 10532
Tel: 914-345-9000
Fax: 914-345-6169
Email: William.Coote@Taro.com
(Name, telephone, email 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
Ordinary Shares, NIS 0.0001 nominal
(par) value per share
Trading Symbol(s)
TARO
Name of each exchange on which registered
New York Stock Exchange
Securities registered or to be registered pursuant to Section 12(g) of the Act:
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:
None
(Title of Class)
None
(Title of Class)
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the Annual
Report:
37,584,631 Ordinary Shares, NIS 0.0001 nominal (par) value per share, and 2,600 Founders’ Shares NIS 0.00001 nominal (par) value per share
outstanding as of March 31, 2022
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ☐ Yes ☑ No
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
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 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 such files).
☑ Yes ☐ No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, non-accelerated filer or an emerging growth company. See
definition of “accelerated filer and large accelerated filer” 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 whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control
over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or
issued its audit report. ☑
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. ☐ Item 17 ☐ Item 18
If this is an Annual Report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☑
No
INTRODUCTION
We, among other business activities, develop, manufacture and market prescription (“Rx”) and over-the-counter (“OTC”) pharmaceutical products
primarily in the United States (the “U.S.”), Canada and Israel. We also develop and manufacture active pharmaceutical ingredients (“APIs”) primarily for
use in our finished dosage form products. We were incorporated in 1959 under the laws of the State of Israel. In 1961, we completed the initial public
offering of our ordinary shares in the U.S. Our ordinary shares have been listed on the New York Stock Exchange (the “NYSE”) under the symbol
“TARO,” since March 22, 2012.
As used in this Annual Report on Form 20-F for the fiscal year ended March 31, 2022 (the “2022 Annual Report”), the terms “we,” “us,” “our,”
“Taro” and the “Company” mean Taro Pharmaceutical Industries Ltd. (“Taro Israel”) and its subsidiaries, unless otherwise indicated.
This 2022 Annual Report is being filed in respect of the fiscal year ended March 31, 2022, and contains the audited consolidated financial
statements for the year then ended.
FORWARD-LOOKING STATEMENTS
Except for the historical information contained in this 2022 Annual Report, the statements contained herein, in particular with respect to our
business, financial condition and results of operations, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act
of 1995 and Section 21E of the Securities Exchange Act of 1934 (“Exchange Act”). Actual results could differ materially from those anticipated in these
forward-looking statements as a result of various factors, including all the risks discussed in “Item 3D – Risk Factors” and elsewhere in this 2022 Annual
Report. We urge you to consider that statements which use the terms “believe,” “expect,” “plan,” “intend,” “estimate,” “anticipate,” “should,” “will,”
“may,” “hope” and similar expressions are intended to identify forward-looking statements. These statements reflect our current views with respect to
future events and are based on assumptions and are subject to risks and uncertainties. Except as required by applicable law, including the securities laws of
the U.S., we do not intend to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
PRESENTATION OF FINANCIAL INFORMATION
Our consolidated financial statements appearing in this 2022 Annual Report are reported in the U.S. dollars in thousands, unless otherwise indicated,
and are prepared in accordance with generally accepted accounting principles in the U.S. (“U.S. GAAP”). Totals presented in this 2022 Annual Report
may not total correctly due to rounding of numbers.
All references in this 2022 Annual Report to “dollars,” “USD” or “$” are to U.S. dollars, all references to “NIS” are to New Israeli Shekel, and all
references to “CAD” are to Canadian dollars. The published (1) representative exchange rate between the NIS and the dollar for March 31, 2022 was NIS
3.18 per $1.00. The published (2) representative exchange rate between the CAD and the dollar for March 31, 2022 was CAD 1.25 per $1.00. No
representation is made that the NIS amounts or CAD amounts could have been, or could be, converted into dollars at rates specified herein or any other
rate.
(1)
(2)
As published by The Bank of Israel.
As published by J.P. Morgan Chase.
i
PART I
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE
ITEM 3. KEY INFORMATION
TABLE OF CONTENTS
A. RESERVED
B. CAPITALIZATION AND INDEBTEDNESS
C. REASONS FOR THE OFFER AND USE OF PROCEEDS
D. RISK FACTORS
ITEM 4. INFORMATION ON THE COMPANY
A. HISTORY AND DEVELOPMENT OF THE COMPANY
B. BUSINESS OVERVIEW
C. ORGANIZATIONAL STRUCTURE
D. PROPERTY, PLANT AND EQUIPMENT
ITEM 4A. UNRESOLVED STAFF COMMENTS
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
A. OPERATING RESULTS
B. LIQUIDITY AND CAPITAL RESOURCES
C. RESEARCH AND DEVELOPMENT, PATENTS, TRADEMARKS AND LICENSES
D. TREND INFORMATION
E. OFF-BALANCE SHEET ARRANGEMENTS
F. TABULAR DISCLOSURE OF CONTRACTUAL OBLIGATIONS
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A. DIRECTORS AND SENIOR MANAGEMENT
B. COMPENSATION
C. BOARD PRACTICES
D. EMPLOYEES
E. SHARE OWNERSHIP
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A. MAJOR SHAREHOLDERS
B. RELATED PARTY TRANSACTIONS
C. INTERESTS OF EXPERTS AND COUNSEL
ITEM 8. FINANCIAL INFORMATION
A. CONSOLIDATED STATEMENTS AND OTHER FINANCIAL INFORMATION
B. SIGNIFICANT CHANGES
ITEM 9. THE OFFER AND LISTING
A. OFFER AND LISTING DETAILS
B. PLAN OF DISTRIBUTION
C. MARKETS
D. SELLING SHAREHOLDERS
E. DILUTION
F. EXPENSES OF THE ISSUE
ITEM 10. ADDITIONAL INFORMATION
A. SHARE CAPITAL
B. MEMORANDUM AND ARTICLES OF ASSOCIATION
C. MATERIAL CONTRACTS
D. EXCHANGE CONTROLS
E. TAXATION
F. DIVIDENDS AND PAYING AGENTS
G. STATEMENT BY EXPERTS
H. DOCUMENTS ON DISPLAY
I. SUBSIDIARY INFORMATION
ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
PART II
ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
ITEM 14. MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS AND USE OF PROCEEDS
ITEM 15. CONTROLS AND PROCEDURES
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ITEM 16. [RESERVED]
ITEM 16A. AUDIT COMMITTEE FINANCIAL EXPERT
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 16H. MINE SAFETY DISCLOSURE
PART III
ITEM 17. FINANCIAL STATEMENTS
ITEM 18. FINANCIAL STATEMENTS
ITEM 19. EXHIBITS
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PART I
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not applicable.
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE
Not applicable.
1
ITEM 3. KEY INFORMATION
A. RESERVED
Dividends
We had never paid cash dividends until the fiscal year ended March 31, 2019. On November 5, 2018, our board of directors (the “Board of
Directors” or the “Board”) declared a $500 million special cash dividend on Taro’s ordinary shares. The special dividend of $12.86 per share was paid on
December 28, 2018, to shareholders of record at the close of business on December 11, 2018. Our dividend policy is set forth below in “Item 8.A. –
Consolidated Statements and Other Financial Information.”
B. CAPITALIZATION AND INDEBTEDNESS
Not applicable.
C. REASONS FOR THE OFFER AND USE OF PROCEEDS
Not applicable.
D. RISK FACTORS
Our business, operating results and financial condition may be seriously harmed due to any of the following risks, among others. If we do not
successfully address the risks facing us, we may experience a material adverse change in our business, results of operations and financial condition and
our share price may decline. We cannot assure you that we will successfully address any of these risks.
Risks Relating to Our Industry
The pharmaceutical industry in which we operate is intensely competitive. We are particularly subject to the risks of competition. For example, the
competition we encounter may have a negative impact upon the prices we charge for our products, the market share of our products and our revenue
and profitability.
The pharmaceutical industry in which we operate is intensely competitive. The competition that we encounter has an effect on our product prices,
market share, revenue and profitability. Depending upon how we respond to this competition, it may have a material adverse effect on us. We compete
with:
•
•
•
•
•
generic manufacturers of our brand-name drugs;
the original manufacturers of the brand-name equivalents of our generic products;
drug manufacturers (including brand-name companies that also manufacture generic drugs);
generic drug manufacturers; and
manufacturers of new drugs that may compete with our generic drugs and proprietary products.
Most of the products that we sell are either generic drugs or drugs for which related patents have expired. Most of these products do not benefit
from patent protection and are therefore subject to an increased risk of competition. In addition, because many of our competitors have substantially
greater financial, production and research and development resources, substantially larger sales and marketing organizations and substantially greater name
recognition than we have, we are particularly subject to the risks inherent in competing with them. For example, many of our competitors may be able to
develop products and processes competitive with, or superior to, our own. Furthermore, we may not be able to differentiate our products from those of our
competitors, successfully develop or introduce new products that are less costly or offer better performance than those of our competitors or offer
purchasers of our products payment and other commercial terms as favorable as those offered by our competitors.
2
Other pharmaceutical companies frequently take actions to prevent or discourage the use of generic drug products such as ours.
Other pharmaceutical companies have increasingly taken actions, including the use of state and federal legislative and regulatory mechanisms, to
prevent, delay or discourage the use of generic equivalents to their products, including generic products that we manufacture or market. If these efforts to
delay or prevent generic competition are successful, our ability to sell our generic versions of products may be limited or prevented. This could have a
material adverse effect on our future results of operations. These efforts have included, among others:
•
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•
•
•
•
•
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filing new patents or extensions of existing patents on products whose original patent protection is about to expire, which could extend patent
protection for the product and delay launch of generic equivalents;
developing patented controlled-release products or other product improvements;
developing and marketing branded products as Rx and OTC products;
pursuing pediatric exclusivity for brand-name products;
submitting citizen petitions to request that the Commissioner of the U.S. Food and Drug Administration (“FDA”) take administrative action
with respect to an abbreviated new drug application (“ANDA”) approval;
attaching special patent extension amendments to unrelated federal legislation;
engaging in state-by-state initiatives to enact legislation that restricts the substitution of some brand-name drugs with generic drugs;
making arrangements with managed care companies and insurers to reduce the economic incentives to purchase generic pharmaceuticals;
introducing authorized generics or their own generic equivalents to the marketplace; and
setting the price of brand-name drugs at or below the price of generic equivalents.
Generally, no additional regulatory approvals are required for brand-name manufacturers to sell directly or through a third party to the generic
market. Brand-name products that are licensed to third parties and are marketed under their generic names at discounted prices are known as authorized
generics. Such licensing facilitates the sale of generic equivalents of a company’s own brand-name products. Because many brand-name companies are
substantially larger than we are and have substantially greater resources than we have, we are particularly subject to the risks of their undertaking to prevent
or discourage the use of our products that compete with theirs. Moreover, the introduction of authorized generics may make competition in the generic
market more intense. It may also reduce the likelihood that a generic company that obtains the first ANDA approval for a particular product will be the
first to market and/or the only generic alternative offered to the market and thus may diminish the economic benefit associated with this position.
We may experience declines in the sales volume and prices of our products as the result of the continuing trend of consolidation of certain customer
groups, such as the wholesale drug distribution and retail pharmacy industries, as well as the emergence of large buying groups.
We make a significant portion of our sales to a relatively small number of wholesalers, retail drug chains, food chains, and mass merchandisers. If
demand decreases significantly, our profitability could be negatively impacted. Also, these customers constitute an essential part of the distribution chain
for generic pharmaceutical products and continue to undergo significant consolidation. This consolidation may result in these groups gaining additional
purchasing leverage and consequently increasing product pricing pressures facing us. In addition, the emergence of large buying groups representing
independent retail pharmacies and the prevalence and influence of managed care organizations and similar institutions potentially enables those groups to
negotiate price discounts on our products.
Our net sales and quarterly growth comparisons may also be affected by fluctuations in the buying patterns of retail chains, major distributors and
other trade buyers, whether resulting from seasonality, pricing, wholesaler buying decisions or other factors. In addition, since such a significant portion of
our U.S. revenue is derived from relatively few customers, any financial difficulties experienced by a single customer, or any delay in receiving payments
from a single customer could have a material adverse effect on our business, financial position and results of operations, and could cause the market value
of our ordinary shares to decline.
New developments by others could make our products or technologies non-competitive or obsolete.
The markets in which we compete and intend to compete continue to undergo rapid and significant technological change. Our competitors may
succeed in developing products and technologies that are more effective or less costly than any that we are developing, or that would render our products
obsolete and non-competitive.
3
We anticipate that we will face increased competition and product price erosion in the future as new companies enter the market and novel or
advanced technologies emerge. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative
arrangements with large and established companies. Many of our competitors have significantly greater research and development, financial, sales and
marketing, manufacturing and other resources than we have. As a result, they may be able to devote greater resources to the development, manufacture,
marketing or sale of their products, initiate or withstand substantial price competition, or more readily take advantage of acquisitions or other opportunities.
Our ability to market products successfully depends, in part, upon the acceptance of our products not only by consumers, but also by independent third
parties.
Our ability to market generic or proprietary pharmaceutical products successfully depends, in part, on the acceptance of the products by independent
third parties (including physicians, pharmacies, government formularies, managed care providers, insurance companies and retailers), as well as patients.
In addition, unanticipated side effects or unfavorable publicity concerning any of our products, or any brand-name product of which our generic product is
the equivalent, could have an adverse effect on our ability to achieve acceptance by prescribing physicians, managed care providers, pharmacies and other
retailers, customers and patients.
Reductions in pharmaceutical pricing may adversely affect our business.
Pharmaceutical pricing, through the current U.S. administration, political, social, and other pressure, has been subjected to increased scrutiny. Our
pricing and profitability may be affected, which may have a material adverse effect on our business, financial condition and results of operation.
Our future profitability depends upon our ability to continue monitoring our inventory levels in the distribution channel.
Our future profitability depends, in part, upon our ability to continue monitoring our inventory levels in the distribution channel. We obtain reports
of the amount of our products held in inventory by our wholesaler customers. We use these reports as part of our process for monitoring inventory levels in
our distribution channel and our exposure to product returns. If we lose access to these reports, we may not be able to adequately monitor our inventory
levels in the distribution channel. The loss of our visibility into the distribution channel could cause inventory levels to build, exceeding market demand
and resulting in us incurring significant and unanticipated expenditures to reimburse these wholesaler customers for product returns, which could materially
affect our profitability and cash flows in an adverse manner.
Our future profitability depends upon our ability to introduce new generic or innovative products on a timely basis.
Our future profitability depends, to a significant extent, upon our ability to introduce, on a timely basis, new generic or innovative products for
which we either are the first to market (or among the first to market) or can otherwise gain significant market share. Our ability to achieve any of these
objectives is dependent upon, among other things, the timing of regulatory approval of these products and the number and timing of regulatory approvals of
competing products. Inasmuch as this timing is not within our control, we may not be able to develop and introduce new generic and innovative products
on a timely basis, if at all.
To the extent that we succeed in being the first to market generic version of a significant product, and particularly if we obtain the 180-day period of
market exclusivity for the U.S. market provided under the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”),
our sales, profits and profitability may be substantially increased in the period following the introduction of such product and prior to a competitor’s
introduction of an equivalent product. However, after the end of the 180-day exclusivity period, these sales, along with the profits therefrom, may diminish
precipitously.
Our revenue and profits from individual generic pharmaceutical products typically decline as our competitors introduce their own generic equivalents.
Revenue and gross profit derived from generic pharmaceutical products tend to follow a pattern based on regulatory and competitive factors unique
to the generic pharmaceutical industry. As the patents for a brand-name product and the related exclusivity periods expire, the first generic manufacturer to
receive regulatory approval for a generic equivalent of the product is often able to capture a substantial share of the market. However, as other generic
manufacturers receive regulatory approvals for competing products, or brand-name manufacturers introduce authorized generics, that market share and the
price of that product typically decline. Our overall profitability depends on, among other things, our ability to continuously, and on a timely basis,
introduce new products.
4
We may be unable to take advantage of the increasing number of high-value biosimilar opportunities.
Biosimilar products are expected to make up an increasing proportion of the high-value generic opportunities in upcoming years. The development,
manufacture and commercialization of biosimilar products require specialized expertise and are very costly and subject to complex regulation, which is still
evolving. We will require significant investments and collaborations with third parties to take advantage of these opportunities. We cannot assure you that
any future investments and collaborations regarding biosimilar products will be successful.
Risks Relating to Regulatory Matters
We are subject to extensive government regulation that increases our costs and could delay or prevent us from marketing or selling our products.
We are subject to extensive regulation by the U.S., Canada, Israel and other jurisdictions. These jurisdictions regulate, among other things, the
approval, testing, manufacture, labeling, marketing, sale, import and export of pharmaceutical products. For example, approval by the FDA is generally
required before any new drug or the generic equivalent to any previously approved drug may be marketed in the U.S. In order to receive approval from the
FDA for each new drug product we wish to market, we must demonstrate, through rigorous pre-clinical and clinical trials, that the new drug product is safe
and effective for its intended use and that our manufacturing process for that product candidate complies with current Good Manufacturing Practices
(“cGMP”). We cannot provide an assurance that the FDA will, in a timely manner, or ever, approve our applications for new drug products. The FDA may
require substantial additional clinical testing or find that our drug product does not satisfy the standards for approval. In addition, in order to obtain
approval for our product candidates that are generic versions of brand-name drugs, we must demonstrate to the FDA that each generic product candidate is
bioequivalent to a drug previously approved by the FDA through the new drug approval process, known as an innovator, or brand-name reference drug. In
addition to bioequivalence testing, the generic product must also have the same dosage form, strength, route of administration and intended use as the
innovator drug product. If the FDA determines that an ANDA for a generic drug product is not adequate to support approval, it could deny our application
or request additional information, including clinical trials, which could delay approval of the product and impair our ability to compete with other versions
of the generic drug product.
If our product candidates receive FDA approval, the labeling claims and marketing statements that we can make for our products are limited by
statutes and regulations and, with respect to our generic drugs, by the claims approved by the FDA for the brand-name product. In addition, if the FDA
and/or a foreign regulatory authority approves any of our products, the labeling, packaging, adverse event reporting, storage conditions, advertising and
promotion for the product will be subject to extensive and ongoing regulatory requirements. Further, as a manufacturer of pharmaceutical products
distributed in the U.S., we must also continue to comply with cGMP regulations, which include requirements related to production processes, quality
control and quality assurance and recordkeeping. Products that we manufacture and distribute in foreign jurisdictions may be regulated under comparable
laws and regulations in those jurisdictions. The facilities of Taro Pharmaceuticals U.S.A., Inc. (“Taro U.S.A.”), our manufacturing facilities and procedures
and those of our suppliers are subject to periodic inspection by the FDA and foreign regulatory agencies. Any material deviations from cGMPs or other
applicable standards identified during such inspections may result in enforcement actions, including delaying or preventing new product approvals, a delay
or suspension in manufacturing operations, warning or untitled letters, consent decrees or civil or criminal penalties. Taro shares common ownership with
Ranbaxy Inc. (“Ranbaxy”) through acquisitions made by Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:
SUNPHARMA, BSE: 524715) (“Sun Pharma” and together with its affiliates, “Sun”). In 2012, Ranbaxy entered into a Consent Decree of Permanent
Injunction with the FDA which decree gives the FDA authority to impose its terms and obligations on any “subsidiary” or “affiliate” of Ranbaxy. Also, if
such deviations occurred, it is unclear if the FDA could extend the existing Consent Decree of Permanent Injunction, applicable to Ranbaxy to a facility
owned or operated by Taro in light of the companies' common ownership by Sun. Further, discovery of previously unknown problems with a product or
manufacturer may result in restrictions or sanctions with respect to the product, including withdrawal of the product from the market.
In addition, because we market drugs that are classified as controlled substances in the U.S., Israel and Canada, we must meet the requirements of
the federal Controlled Substances Act (“CSA”) in the U.S., state laws and equivalent laws in Israel and Canada, as well as the regulations promulgated
thereunder in each country and/or state. These regulations include stringent requirements for handling and receipt of controlled substances including
import, export, manufacture, storage, distribution and dispensing. These requirements include registration/licensing, manufacturing controls (e.g., quotas),
import permits/declarations, inventory, recordkeeping, monitoring, reporting, disposal and security to prevent diversion of, or unauthorized access to, the
controlled substances at each stage of the production and distribution process. The U.S. Drug Enforcement Administration (“DEA”), state agencies and
comparable regulatory authorities in Israel and Canada may periodically inspect our facilities for compliance with the CSA, state laws and their equivalents
in Israel and Canada. Any failure to comply with these laws and regulations could lead to a variety of sanctions, including restrictions, revocation, or a
denial of renewal, of our DEA registration or state license (or Israeli or Canadian equivalent), injunctions, and civil or criminal penalties.
5
Furthermore, all of the products that we manufacture, and most of the products we distribute, are manufactured outside the U.S. and must be
imported into the U.S. Importation of drugs, including controlled substances, is subject to additional restrictions and review by the FDA and the DEA.
The FDA and the DEA, in conjunction with the U.S. Customs and Border Protection, have the authority and discretion to scrutinize and potentially prohibit
the importation of foreign goods into the U.S. that extend beyond authority related to distribution of products manufactured and distributed in the U.S.
Although we devote significant time, effort and expense into addressing the extensive government regulations applicable to our business and
obtaining regulatory approvals, we remain subject to the risk of being unable to obtain necessary approvals on a timely basis, if at all. Delays in receiving
regulatory approvals could adversely affect our ability to market our products.
Product approvals by the FDA and by comparable foreign regulatory authorities may be withdrawn if compliance with regulatory standards is not
maintained or if problems relating to the products are experienced after initial approval. In addition, if we fail to comply with governmental regulations,
we may be subject to warning or untitled letters, fines, unanticipated compliance expenditures, interruptions of our production and/or sales, prohibition of
importation, seizures and recalls of our products, criminal prosecution and debarment of us and our employees from the generic drug approval process.
Changes in regulatory environment may prevent us from utilizing the exclusivity periods that are important for the success of some of our generic
products.
The Medicare Prescription Drug, Improvement and Modernization Act of 2003 (the “Medicare Act”) provides that the 180-day market exclusivity
period provided under the Hatch-Waxman Act is only triggered by commercial marketing of the product. However, the Medicare Act also contains
forfeiture provisions which could deprive the first “Paragraph IV” filer (as described below) of eligibility for such exclusivity if certain conditions are met.
Accordingly, in situations where we are the first “Paragraph IV” filer, we may face the risk of forfeiture and therefore may not be able to exploit a given
exclusivity period for specific products.
Under the terms of the Hatch-Waxman Act, a generic applicant must make certain certifications with respect to the patent status of the listed drug
that it references in its ANDA. In the event that such applicant plans to challenge the validity or enforceability of an existing listed patent or asserts that the
proposed product does not infringe an existing listed patent, it files a Paragraph IV certification. The Hatch-Waxman Act provides for a potential 180-day
period of generic exclusivity for the first company that submits an ANDA with a Paragraph IV certification and that also lawfully maintains such
certification. Such exclusivity prevents the approval for 180 days of a subsequently submitted ANDA containing a Paragraph IV certification. The
Medicare Act modified certain provisions of the Hatch-Waxman Act. Under the Medicare Act, final ANDA approval for a product subject to Paragraph IV
patent litigation may be obtained upon the earlier of a favorable district court decision or 30 months from receipt of notification to the patent holder of the
Paragraph IV filing, provided there are no other issues preventing the FDA from granting final approval. Exclusivity rights for the first Paragraph IV filer
may be forfeited pursuant to the Medicare Act under specified circumstances including, for example, if tentative approval is not timely obtained. Some of
the changes made by the Medicare Act apply to ANDAs where the first certification was filed after the enactment of the Medicare Act; other earlier
submitted ANDAs are generally governed by the previous version of the law.
From time to time, the U.S. Congress (“Congress”) considers and enacts legislation amending the Hatch-Waxman Act, including with respect to
180-day exclusivity. If further changes to the law are enacted, it might affect our ability to qualify for or otherwise benefit from the statutory 180-day
exclusivity period.
Pharmaceutical companies are required by international law to comply with adverse event reporting requirements.
We are required by international law to comply with adverse event reporting requirements. Our failure to meet these reporting requirements in any
jurisdiction could result in actions by regulatory authorities in that and/or other jurisdictions, including any of the following: warning letters, public
announcements, restriction or suspension of marketing authorizations, revocation of marketing authorizations, fines or a combination of any of these
actions.
Healthcare reform changes may have an impact on all segments of the healthcare industry.
In March 2010, the U.S. government enacted the Patient Protection and Affordable Care Act, as amended by the Health Care Education and
Reconciliation Act of 2010 (collectively, “PPACA”), which represented the most comprehensive overhaul of both the public and private healthcare systems
ever enacted in the U.S. The PPACA substantially expanded the number of insured individuals in the U.S. through a combination of expanded Medicaid
eligibility, establishment of an insurance exchange through which individuals and groups without coverage may purchase commercial health insurance,
prohibiting coverage exclusions for pre-existing conditions and other measures. PPACA also imposed on manufacturers a variety of additional rebates,
discounts, fees, taxes and reporting and regulatory requirements.
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We face uncertainties due to litigation brought against the federal government by a number of state attorneys general in 2018, who seek a ruling that
the PPACA is unconstitutional. In November 2020, the Supreme Court heard an appeal of a lower court ruling brought by other attorneys general and the
U.S. House of Representatives. On June 17, 2021, the U.S. Supreme Court dismissed a challenge on procedural grounds that argued the PPACA is
unconstitutional in its entirety because the “individual mandate” was repealed by Congress. Thus, the PPACA remains in effect in its current form. It is
possible that the PPACA will be subject to judicial or Congressional challenges in the future. It is uncertain how any such challenges and the healthcare
measures of the Biden administration will impact the PPACA and our business.
Reimbursement policies of third parties, cost containment measures and healthcare reform as well as governmental regulation of prices could
adversely affect the demand for our products and limit our ability to sell our products.
Our ability to market our products depends, in part, on prices and reimbursement levels for them and related treatment established by federal and
state government healthcare programs, private health insurers and other third-party payor organizations, including health maintenance organizations and
managed care organizations. Reimbursement may not be available for some of our products and, even if granted, may not be maintained. Limits placed on
our prices or reimbursement could make it more difficult for people to buy our products and reduce, or possibly eliminate, the demand for our products. In
the event that any federal, state or other governmental authority enacts any additional legislation or adopts any additional regulations or policies that affect
third-party coverage, price levels or reimbursement, demand for our products may be reduced with a consequent adverse effect, which may be material, on
our sales and profitability.
In addition, the purchase of our products could be significantly influenced by the following factors, among others:
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trends in managed healthcare in the U.S.;
developments in health maintenance organizations, managed care organizations and similar enterprises;
judicial invalidation of major federal health care legislation;
legislative proposals to reform healthcare, drug prices and government insurance programs; and
price regulation and controls and reimbursement policies.
The PPACA is a sweeping measure intended to expand healthcare coverage in the U.S., primarily through the establishment of an exchange to
facilitate the purchase of health insurance, premium and cost-sharing subsidies for certain low-income individuals and expansion of the Medicaid program.
Among other things, the PPACA contained provisions that changed payment levels for pharmaceuticals under Medicaid and increased pharmaceutical
rebates under the Medicaid Drug Rebate Program. Effective October 1, 2010, the law changed the formula for calculating federal upper limits (“FULs”),
which are a type of cap on the amount a state Medicaid program can reimburse pharmacies for multiple source drugs (i.e., drugs for which there are at least
two therapeutically equivalent versions on the market). The FULs are calculated based on the weighted-average of the average manufacturer prices
(“AMPs”) of the equivalent drugs on the market when there are at least three therapeutically equivalent versions. In addition, the law changed the
preexisting definition of AMP so that it is based only on direct sales to retail community pharmacies and sales to wholesalers for drugs distributed to retail
community pharmacies. The Centers for Medicare & Medicaid Services (“CMS”) issued final regulations regarding the FUL and the calculation of AMP
and rebates under the Medicaid Drug Rebate Program. These regulations were effective as of April 1, 2016. Even though the weighted-average does not
disclose our AMP, the release of such FULs to the public and our customers may affect our pricing.
In addition, in its final regulations for the Medicaid Drug Rebate Program, CMS required state Medicaid programs, beginning April 1, 2017, to base
their reimbursement rates for brand drugs and other drugs not subject to a FUL on pharmacies’ actual acquisition costs, rather than using the previous
methodologies based on published benchmarks such as average wholesale price (“AWP”) or wholesaler acquisition cost (“WAC”).
Effective January 1, 2010, the PPACA also increased the minimum Medicaid rebate rate from 15.1% to 23.1% of AMP for most drugs approved
under a new drug application (“NDA”), including authorized generics. The PPACA also increased the Medicaid rebate from 11% to 13% of AMP for most
drugs approved under an ANDA. Further, the volume of rebated drugs was expanded to include drugs dispensed to beneficiaries in Medicaid managed care
organizations. In addition, an alternative, higher rebate may be imposed on drugs that are line extensions of previously approved oral dosage form drugs.
CMS’s final regulations also expanded the Medicaid Drug Rebate Program such that manufacturers will be required to pay rebates to the U.S. Territories
(Puerto Rico, the U.S. Virgin Islands, Guam, the Northern Mariana Islands and American Samoa), effective January 1, 2023. These measures have
increased or will increase our cost of selling to the Medicaid market.
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Furthermore, as a result of legislative changes in the Bipartisan Budget Act of 2015 (“BBA”), generic drugs are subject to an additional rebate if the
AMP for a given quarter exceeds an inflation-adjusted baseline AMP. This price increase penalty previously applied only to innovator drugs. Currently,
the price increase penalty for innovator and generic drugs, together with the basic Medicaid rebate, is limited to 100% of the AMP of the drug. Under an
amendment to the Medicaid Rebate statute enacted on March 11, 2021, the 100% limit will be removed beginning on January 1, 2024, so that the rebate on
a unit of drug could possibly exceed the average price of the drug.
Both Congress and the current administration have proposed or are currently considering a wide variety of actions intended to reduce drug prices
and/or reduce the amount of reimbursement for drugs under federal government programs such as Medicare. These actions include basing payment for
drugs under Medicare Part B on an index of prices in other countries, allowing Medicare Part D to negotiate lower prices with drug manufacturers,
requiring rebates for drugs whose prices increase greater than the rate of inflation, permitting the importation of less expensive versions of drugs from
Canada and other countries and other measures. These proposals, if finalized or enacted, could adversely affect us and may have a material adverse effect
on our business, results of operations, financial condition and cash flows.
Our relationships with customers and third-party payors are subject to applicable anti-kickback, fraud and abuse and other healthcare laws and
regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future
earnings.
Healthcare providers, physicians and third-party payors play a primary role in the recommendation and prescription of any products we market. Our
arrangements with third-party payors, prescribers, and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and
regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute any products for which
we obtain marketing approval. Restrictions under applicable federal and state healthcare laws and regulations include the following:
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the federal healthcare program anti-kickback statute prohibits persons from, among other things, knowingly and willfully soliciting, offering,
receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce, or in return for, either the referral of an individual
for, or the purchase, order or recommendation of, any good or service for which payment may be made under a federal healthcare program
such as Medicare and Medicaid;
the federal False Claims Act imposes criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or
entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or
making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) imposes criminal and civil liability for executing a
scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and its implementing regulations, also
imposes obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of
individually identifiable health information;
federal law requires applicable manufacturers of covered drugs to report payments and other transfers of value to physicians, teaching
hospitals, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists and anesthesiologist
assistants and certified nurse-midwives on an annual basis, which includes data collection and reporting obligations. The information is
made publicly available on a searchable website; and
analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, may apply to sales or marketing
arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private
insurers.
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Some state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant
compliance guidance promulgated by the federal government and require drug manufacturers to report information related to payments and other transfers
of value to healthcare providers or marketing expenditures. Still other states require the reporting of certain pricing information, pricing controls, or patient
access constraints, including information pertaining to the justification of launch prices or price increases greater than a specified threshold. State and
foreign laws also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways
and often are not preempted by HIPAA, thus complicating compliance efforts.
Efforts to ensure that our business arrangements with third parties comply with applicable healthcare laws and regulations involve substantial costs.
It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law
involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any
other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines,
imprisonment, exclusion of products from government funded healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of
our operations. If any of the physicians or other healthcare providers or entities with whom we expect to do business is found to be not in compliance with
applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.
Any failure to comply with the complex reporting and payment obligations under the Medicare and Medicaid programs may result in further litigation
or sanctions, in addition to the lawsuits.
The U.S. laws and regulations regarding Medicare and/or Medicaid reimbursement and rebates and other governmental programs are complex.
Some of the applicable laws may impose liability even in the absence of specific intent to defraud. The subjective decisions and complex methodologies
used in calculating prices that are reportable under these programs are subject to review and challenge, and it is possible that such reviews could result in
material changes. The federal government and a number of state attorneys general and others have filed lawsuits alleging that pharmaceutical companies
reported inflated AWP, Medicaid rebate best prices or average sales prices (which are used to set Medicaid Part B payment rates for drugs) leading to
excessive payments by Medicare and/or Medicaid for prescription drugs. Additional actions are possible. These actions, if successful, could adversely
affect us and may have a material adverse effect on our business, results of operations, financial condition and cash flows.
Due to increasing numbers of securities claims over the last several years and related payouts under insurance policies, in addition to increased
settlement values in “event-driven” litigation and a growing number of plaintiff shareholder law firms eager to bring claims, premiums and deductibles for
insurance, including director and officers liability ("D&O") insurance, have been increasing and some insurers are reducing the number of companies they
insure, causing the supply of insurance to lag behind demand. This could increase our premiums, reduce the scope and capacity of our coverage, and
adversely affect our ability to maintain and renew our existing insurance policies on favorable terms or at all. While we continue to maintain insurance
coverage intended to address certain risks, such coverage may be insufficient to cover claims and losses we may face.
We are susceptible to product liability claims that may not be covered by insurance and could require us to pay substantial sums.
We face the risk of loss resulting from, and adverse publicity associated with, product liability lawsuits, whether or not such claims are valid. We
may not be able to avoid such claims. In addition, our product liability insurance may not be adequate to cover such claims or we may not be able to obtain
adequate insurance coverage in the future at acceptable costs. A successful product liability claim that exceeds our policy limits could require us to pay
substantial sums. In addition, in the future, we may not be able to obtain the type and amount of coverage we desire or to maintain our current coverage.
Our success depends, in part, on the quality, efficacy and safety of our products.
Our success depends, in part, on the quality, efficacy and safety of our products. Product recalls or product field alerts may be issued at our
discretion or as recommended or required by the FDA, other governmental agencies or other companies having regulatory authority over pharmaceutical
product sales. From time to time, we may recall products for various reasons, including failure of our products to maintain their stability through their
expiration dates. Any recall or product field alert has the potential of damaging the reputation of the product or our reputation. Any significant recalls
could materially affect our sales. In these cases, our business, financial condition, results of operations and cash flows could be materially adversely
affected. If our products are found to be defective or unsafe, our product claims are found to be deceptive, or our products otherwise fail to meet our
consumers' expectations, our relationships with customers or consumers could suffer, the appeal of our brands could be diminished, and we could lose sales
and become subject to liability or claims, any of which could result in a material adverse effect on our business.
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Our reputation among consumers and our customers in the pharmacy trade may be negatively impacted by incidents of counterfeiting of our products.
Counterfeit versions of some of our products may be sold by third parties, which may pose safety risks, may fail to meet consumers’ expectations,
and may have a negative impact on our business. The counterfeiting of pharmaceutical products is a widely reported problem for pharmaceutical
manufacturers, distributors, retailers and consumers in the U.S., which is our largest market. Such counterfeiting may take the form of illicit producers
manufacturing cheaper and less effective counterfeit versions of our products, or producing imitation products containing no active ingredients, and then
packaging such counterfeit products in a manner, which makes them look like our products. If incidents occurred in which such products prove to be
ineffective, or even harmful, to the individuals who used them, consumers and our customers might not buy our products out of fear that they might be
ineffective or dangerous counterfeits. In addition, sales of counterfeit products could reduce sales of our legitimate products, which could have a material
negative impact on our sales and net income.
The manufacture and storage of pharmaceutical and chemical products are subject to environmental regulation and inherent risk.
Because chemical ingredients are used in the manufacture of pharmaceutical products and due to the nature of the manufacturing process itself, there
is a risk of property damage or personal injury caused by or during the storage or manufacture of both the chemical ingredients and the finished
pharmaceutical products. Although we have never incurred any material liability for damage of this nature, we may be subject to liability in the future. In
addition, while we believe our insurance coverage is adequate, it is possible that a successful claim would exceed our coverage, requiring us to pay a
substantial sum.
The pharmaceutical industry is also subject to extensive environmental regulation. We therefore face the risk of incurring liability for damages or
the costs of remedying environmental harms because of the chemical ingredients contained in our products and the processes involved with their
manufacture. For example, we could be held liable for costs to investigate or remediate contamination resulting from the presence or release of hazardous
materials at or from any of our properties or the disposal of any such materials at third party sites. Although we have never incurred any such liability in
any material amount, we may be subject to liability in the future. We may also be required to increase expenditures to address environmental issues and to
comply with applicable regulations. If we fail to comply with environmental regulations or the conditions of our operating licenses, the licenses could be
revoked and we could be subject to criminal sanctions and substantial liability. We could also be required to suspend or modify our manufacturing
operations.
Climate change, and laws, regulations and policies regarding climate change, could also pose additional legal or regulatory requirements related to
greenhouse gas emissions reporting, carbon pricing, and mandatory reduction targets. These more stringent requirements could increase our costs of
sourcing, production, and transportation, as well as have negative reputational impacts if we fail to meet such requirements. Failure to respond to risks
regarding climate change may have a material adverse effect on our business, financial condition, results of operations and reputation.
Our business could be negatively impacted by social impact and sustainability matters.
There is an increased focus from certain investors, customers, consumers, and other stakeholders concerning social impact and sustainability
matters. From time to time, we announce certain initiatives, including goals and commitments, regarding our focus areas, which include environmental
matters, packaging, responsible sourcing, social investments and inclusion and diversity. We could fail, or be perceived to fail, in our achievement of such
initiatives, or in accurately reporting our progress on such initiatives. Such failures could be due to changes in our business (e.g., shifts in business among
distribution channels or acquisitions). Moreover, the standards by which sustainability efforts and related matters are measured are developing and
evolving, and certain areas are subject to assumptions that could change over time. Social impact and sustainability matters could have a material adverse
effect on our business.
Testing required for the regulatory approval of our products is sometimes conducted by independent third parties. Any failure by any of these third
parties to perform this testing properly may have an adverse effect upon our ability to obtain regulatory approvals.
Our applications for the regulatory approval of our products incorporate the results of testing and other information that are sometimes provided by
independent third parties (including, for example, manufacturers of raw materials, testing laboratories, contract research organizations or independent
research facilities). The likelihood that the products being tested will receive regulatory approval is, to some extent, dependent upon the quality of the
work performed by these third parties, the quality of the third parties’ facilities and the accuracy of the information provided by these third parties. We
have little or no control over any of these factors.
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If third-party manufacturers and logistic service providers upon whom we rely fail to meet our requirements, we may face delays in the manufacturing
or delivery of certain products or be unable to meet demand for them.
We use third-party manufacturers and logistic service providers to manufacture and deliver some of our products. If our relationship with any of
these third-party manufacturers or service providers is terminated or impaired, the manufacturing or delivery of our products to customers may be delayed,
which could harm our business and financial results. Further, although we have customary contract manufacturing agreements and service agreements with
those third-party manufacturers and service providers, we cannot guarantee that any third-party manufacturer or service provider will allocate sufficient
capacity to us in order to meet our requirements or that alternative manufacturing or distribution capacity will be available when required on terms that are
acceptable to us, or at all.
In addition, quality control problems, such as the use of materials or subcontractors that do not meet our quality control standards and specifications
or comply with applicable laws or regulations, could harm our business. Quality control problems could result in regulatory action, such as revocation or
suspension of regulatory approvals, restrictions on importation, products of inferior quality or product stock outages or shortages, harming our sales, and
creating inventory write-downs for unusable products.
Further, our third-party manufacturers and service providers may:
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have economic or business interests or goals that are inconsistent with ours;
take actions contrary to our instructions, requests, policies or objectives;
be unable or unwilling to fulfill their obligations under relevant agreements, purchase orders or statements of work, including obligations to
meet our production deadlines, quality standards, pricing guidelines, product specifications, standard operation procedures, and to comply
with applicable regulations, including those regarding the safety and quality of products;
have financial difficulties;
encounter raw material or labor shortages or increases in raw material or labor costs which may affect our procurement costs or service fees;
engage in activities or employ practices that may harm our reputation; and
work with, be acquired by, or come under control of, our competitors.
Governmental investigations and litigation relating to sales and marketing practices may result in material penalties and/or settlement amounts.
We are a party to numerous claims and several investigations brought under federal and state antitrust laws by various plaintiffs, including state
governments, and federal and state governmental agencies, alleging that we, together with other pharmaceutical manufacturers and in some cases the entire
industry, engaged in conspiracies to fix drug prices and/or allocate customers and market share of generic pharmaceutical products in the U.S. Responding
to such investigations and claims and litigating these cases is costly. Our defense and the proceedings themselves are unpredictable and may develop over
lengthy periods of time. If we were to enter into settlements to bring the investigations to closure or to resolve the litigation, those settlements could
require us to pay a material sum. See Note 13 to our consolidated financial statements for additional information. We operate around the world in complex
legal and regulatory environments. Following calls in recent years from policy makers and other stakeholders in many countries for governmental
intervention against high prices of certain pharmaceutical products, we are currently and/or may be subject to governmental investigations, claims or other
legal action or regulatory action regarding our products. It is not possible to predict the ultimate outcome of any such investigations or claims or what other
investigations or litigation or regulatory responses may result from such assertions.
Risks Relating to Our Company and Our Operations
Sun Pharmaceutical Industries Ltd. and its affiliates control 85.7% of the voting power in our Company.
Our Chairman, Mr. Dilip Shanghvi, and members of his immediate family (one of whom is a member of our Board of Directors) control, through
their beneficial ownership of 78.5% of our outstanding ordinary shares and 100% of our founders’ shares through Sun Pharma, 85.7% of the voting power
in our Company as of March 31, 2022. Mr. Dilip Shanghvi, along with entities controlled by him and members of his family, control 54.5% of Sun Pharma
as of March 31, 2022. Sun is able to control the outcome of shareholder votes of the Company requiring a majority of the votes.
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Wholesaler customers account for a substantial portion of our consolidated sales.
We have no long-term agreements with the wholesalers that require them to purchase our products and they may therefore reduce or cease their
purchases from us at any time. Any cessation or significant reduction of their purchases from us would likely have a material adverse effect on our results
of operations and financial condition. Furthermore, changes in their buying patterns or in their policies and practices in relation to their working capital and
inventory management may result in a reduction of, or a change in the timing of, their purchases of our products. While we receive periodic inventory
reports from the wholesalers, we have no ability to obtain advance knowledge of such changes. We base our manufacturing schedules, inventories and
internal sales projections principally on historical data. To the extent that actual orders from these wholesalers differ substantially from our internal
projections, we may either find ourselves with excess inventory or in an out-of-stock position, which could have a material adverse effect upon our
operating results.
The nature of our business requires us to estimate future charges against wholesaler accounts receivable. If these estimates are not accurate, our
results of operations and financial condition could be adversely affected.
Sales to third parties, including government institutions, hospitals, hospital buying groups, pharmacy buying groups, pharmacy chains and others
generally are made through wholesalers. We sell our products to wholesalers, and the wholesalers resell the products to third parties at times and in
quantities ordered by the third parties. Typically, we have a contract price with a third party to which a wholesaler resells our products that may be equal to
or less than the price at which we sold the products to the wholesaler. In such a case, following the purchase of the product by a third-party purchaser from
the wholesaler, the wholesaler charges us back for any shortfall. At the time of any individual sale by us to a wholesaler, we do not know under which
contracts the wholesaler will resell products to third parties. Therefore, we estimate the amount of chargebacks and other credits that may be associated
with these sales and we reduce our revenue accordingly. One factor in calculating these estimates is information on customer inventory levels provided to
us by our customers. We obtain official reports of the amount of our products held in inventory by our wholesaler customers. If this information is
inaccurate or not forthcoming, this may result in erroneously estimated reserves for chargebacks, returns or other deductions. In addition, from time to
time, the amount of such chargebacks and other credits reported by a wholesaler may be different from our estimates. Discrepancies of this nature may
result in a reduction in the value of our accounts receivable and a related charge to net income. The reconciliation of our accounts with wholesalers may,
from time to time, delay, or otherwise impact the collection of our accounts receivable or result in a decrease in their value and in a related charge to our net
income.
Our inventories of finished goods have expiration dates after which they cannot be sold.
Industry standards require that pharmaceutical products be made available to customers from existing stock levels rather than on a made-to-order
basis. Therefore, in order to accommodate market demand adequately, we strive to maintain sufficiently high levels of inventories. However, inventories
prepared for sales that are not realized as or when anticipated may approach their expiration dates and may have to be written off. These write-offs, if any,
could have an adverse effect on our results of operations and financial condition.
Our future success depends on our ability to develop, manufacture and sell new products.
Our future success is largely dependent upon our ability to develop, manufacture and market new commercially viable pharmaceutical products and
generic equivalents of proprietary pharmaceutical products whose patents and other exclusivity periods have expired. Delays in the development,
manufacture and marketing of new products could negatively impact our results of operations. Each of the steps in the development, manufacture and
marketing of our products involves significant time and expense. We are, therefore, subject to the risks, among others, that:
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any products under development, if and when fully developed and tested, will not perform in accordance with our expectations;
any generic product under development will, when tested, not be bioequivalent to its brand-name counterpart;
necessary regulatory approvals will not be obtained in a timely manner, if at all;
any new product cannot be successfully and profitably produced and marketed;
quality control problems may adversely impact our reputation for high-quality production;
other companies may launch their version of generic products, either prior to or following the launch of our newly approved generic version
of the same product;
brand-name companies may launch their products, either themselves or through third parties, in the form of authorized generic products
which can reduce sales, prices and profitability of our newly approved generic products;
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generic companies may launch generic versions of our brand-name drugs; or
our products may not be priced at levels acceptable to our customers.
If we are unable to obtain raw materials, our operations could be seriously impaired.
While the majority of our products are either synthesized by us or are derived from multiple source materials, some raw materials and certain
products are currently obtained from single domestic or foreign suppliers. Most of these materials are subject to regulatory inspections and if found to be
non-compliant we could be prevented from obtaining them. Although we have not experienced significant difficulty in obtaining raw materials to date,
material supply interruptions may occur in the future and we may have to obtain substitute raw materials or products. For most raw materials we do not
have any long-term supply agreements and therefore we are subject to the risk that our suppliers of raw materials may not continue to supply to us on
satisfactory terms or at all.
Furthermore, obtaining the regulatory approvals required for adding alternative suppliers of raw materials for finished products we manufacture may
be a lengthy process. We strive to maintain adequate inventories of single source raw materials in order to ensure that any delays in receiving regulatory
approvals will not have a material adverse effect upon our business. However, we may not be successful in doing so, and consequently, we may be unable
to sell some products pending approval of one or more alternate sources of raw materials. Any significant interruption in our supply stream could have a
material adverse effect on our operations.
Research and development efforts invested in our innovative pipeline may not achieve expected results.
We invest increasingly greater resources to develop our innovative pipeline, both through our own efforts and through collaborations with third
parties, which results in higher risks.
The time from discovery to a possible commercial launch of an innovative product is substantial and involves multiple stages during which the
product may be abandoned as a result of serious developmental problems, the inability to achieve our clinical goals, the inability to obtain necessary
regulatory approvals in a timely manner, if at all, or the inability to produce and market such innovative products successfully and profitably. In addition,
we face the risk that some of the third parties we collaborate with may fail to perform their obligations. Accordingly, our investment in research and
development of innovative products can involve significant costs with no assurances of future revenues or profit.
We are continuing our efforts to develop new proprietary pharmaceutical products, but these efforts are subject to risk and may not be successful.
Our principal business has traditionally been the development, manufacture and marketing of generic equivalents of pharmaceutical products first
introduced by other companies. However, we have increased our efforts to develop new proprietary products.
Expanding our focus beyond generic products and broadening our product pipeline to include new proprietary products may require additional
internal expertise or external collaboration in areas in which we currently do not have substantial resources and personnel. We may have to enter into
collaborative arrangements with others that may require us to relinquish rights to some of our technologies or products that we would otherwise pursue
independently. We may not be able to acquire the necessary expertise or enter into collaborative agreements on acceptable terms, if at all, to develop and
market new proprietary products.
In addition, although a newly developed product may be successfully manufactured in a laboratory setting, difficulties may be encountered in
scaling up for manufacture in commercially-sized batches. For this reason and others, in the pharmaceutical industry only a small minority of all new
proprietary research and development programs ultimately result in commercially successful drugs.
In order to obtain regulatory approvals for the commercial sale of new proprietary products, we are required to complete extensive clinical trials in
humans to demonstrate the safety and efficacy of the products to the satisfaction of FDA and regulatory authorities abroad. Conducting clinical trials is a
lengthy, time-consuming and expensive process, and the results of such trials are inherently uncertain.
A clinical trial may fail for a number of reasons, including:
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failure to enroll a sufficient number of patients meeting eligibility criteria;
failure of the new product to demonstrate safety and/or efficacy;
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the development of serious (including life threatening) adverse events including, for example, side effects caused by or connected with
exposure to the new product; or
the failure of clinical investigators, trial monitors and other consultants or trial subjects to comply with the trial plan or protocol.
The results from early clinical trials may not be predictive of results obtained in later clinical trials. Clinical trials may not demonstrate the safety
and efficacy of a product sufficient to obtain the necessary regulatory approvals, or to support a commercially viable product. Any failure of a clinical trial
for a product in which we have invested significant time or other resources could have a material adverse effect on our results of operations and financial
condition.
Even if launched commercially, our proprietary products may face competition from existing or new products of other companies. These other
companies may have greater resources, market access, and consumer recognition than we have. Thus, there can be no assurance that our proprietary
products will be successful or profitable. In addition, advertising and marketing expenses associated with the launch of a proprietary product may, if not
successful, adversely affect our results of operations and financial condition.
We may not be able to successfully identify, consummate and integrate licensing deals or future acquisitions.
We have in the past, and may in the future, pursue licensing deals (both in-license and out-license deals) or acquisitions of product lines and/or
companies and seek to integrate them into our operations. Licensing deals and acquisitions of additional product lines and companies involve risks that
could adversely affect our future results of operations. Any one or more of the following examples may apply:
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we may encounter issues with intellectual property, manufacturing or financial complications with in-license or out-license deals;
we may not be able to identify suitable licensing deals, acquisition targets or acquire companies on favorable terms;
we compete with other companies that may have stronger financial positions and are therefore better able to acquire licenses, product lines
and companies. We believe that this competition will increase and may result in decreased availability or increased prices for suitable
licenses or acquisition targets;
we may not be able to obtain the necessary financing, on favorable terms or at all, to finance any of our potential license deals or
acquisitions;
we may not be able to obtain the necessary regulatory approvals, including the approval of antitrust regulatory bodies, in any of the countries
in which we may seek to consummate potential licenses or acquisitions;
we may ultimately fail to complete a licensing deal or an acquisition after we announce that we plan to license a product or acquire a product
line or a company;
we may fail to license products or integrate our acquisitions successfully in accordance with our business strategy;
we may choose to license a product or acquire a business that is not profitable, either at the time of the license or acquisition or thereafter;
licensing deals or acquisitions may require significant management resources and divert attention away from our daily operations, resulting
in the loss of key customers and personnel, and expose us to unanticipated liabilities;
we may not be able to retain the skilled employees and experienced management that may be necessary to maximize an in-license’s
profitability or operate businesses we acquire, and if we cannot retain such personnel, we may not be able to locate and hire new skilled
employees and experienced management to replace them; and
we may license a product or purchase a company that has contingent liabilities that include, among others, known or unknown intellectual
property or product liability claims.
Our tax liabilities could be larger than anticipated.
We are subject to tax in many jurisdictions, and significant judgment is required in determining our provision for income taxes. Likewise, we are
subject to audit by tax authorities in many jurisdictions. In such audits, our interpretation of tax legislation might be challenged and tax authorities in
various jurisdictions may disagree with, and subsequently challenge, the amount of profits taxed in such jurisdictions under our intercompany agreements.
Although we believe our estimates are reasonable, the ultimate outcome of such audits and related litigation could be different from our provision for taxes
and might have a material adverse effect on our consolidated financial statements.
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On March 27, 2020, the U.S. enacted the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) which, among other provisions,
allows U.S. corporations to carry existing losses back to the preceding five years. The Company expects to receive a benefit due to the increased value of
its losses when carried back to preceding years in which the U.S. federal corporate income tax rate was 35% versus the current 21%.
We are in the process of enhancing and further developing our global enterprise resource planning systems and associated business applications,
which could result in business interruptions if we encounter difficulties.
We are enhancing and further developing our global enterprise resource planning (“ERP”), quality control laboratory operations systems and other
business critical information technology (“IT”) infrastructure systems and associated applications to provide more operating efficiencies and effective
management of our business and financial operations. Such changes to ERP systems and related software, quality control systems, and other IT
infrastructure carry risks such as cost overruns, project delays and business interruptions and delays. If we experience a material business interruption as a
result of our ERP enhancements, it could have a material adverse effect on our business, financial position, and results of operations and/or cash flow.
We intend to outsource certain finance and accounting functions to a third party, which may subject us to risks, including potential disruptions of our
business, financial reporting process and increased costs.
We intend to outsource certain finance and accounting functions, such as account payables and recording of transactional data, to a third party.
Failure of such third party to provide timely and adequate services or our inability to arrange for alternative providers on favorable terms in a timely
manner could disrupt our business, adversely impact the quality or timeliness of our financial reporting process, increase our costs or otherwise adversely
affect our business and financial results. These adverse effect may include, but are not limited to:
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changes in the public’s perception of our reputation;
possible data losses or information security lapses that result in unauthorized use or disclosure of confidential information; and
non-compliance with our policies and procedures or with laws and regulations, including laws and regulations governing the use and
safeguarding of information.
We are increasingly dependent on information technology and our systems and infrastructure face certain risks, including cybersecurity and data
leakage risks.
We are increasingly dependent on sophisticated information technology systems and infrastructure to operate our business. In the ordinary course of
business, we collect, store and transmit large amounts of confidential information, trade secrets, intellectual property, proprietary business information,
customer credit card information, and employee personal information, and it is critical that we do so in a secure manner to maintain the confidentiality and
integrity of such confidential information. We have contracted with third-party vendors to enhance our operations and, as part of our service arrangements
with Sun as described in greater detail under Item 7B – “Related Party Transactions—Related Party Transactions—Arrangements with Sun,” we also have
outsourced elements of our operations to Sun, including significant elements of our information technology infrastructure. The size and complexity of our
information technology systems, and those with whom we contract, make such systems potentially vulnerable to service interruptions, security breaches
from inadvertent or intentional actions by employees, partners or vendors, or from attacks by malicious third parties. Any significant disruptions to our
information technology systems, including breaches of information security or cybersecurity, or failure to integrate new and existing information
technology systems could adversely affect our business, financial condition or results of operations. While we exercise care in selecting vendors that
maintain adequate information security controls and monitor our relationships with our vendors, we and our vendors or Sun, could be susceptible to third-
party attacks on our information security systems, which attacks are of ever increasing levels of sophistication and are made by groups and individuals with
a wide range of motives and expertise, including state and quasi-state actors, criminal groups, “hackers” and others. Certain aspects of the security of such
technologies are unpredictable or beyond our control, and the failure by mobile technology, third party and cloud service providers to adequately safeguard
their systems and prevent cyber-attacks could disrupt our operations, including our ability to timely ship and track product orders and project inventory
requirements, and lead to interruptions or delays in our supply chain. Additionally, these types of problems could result in an actual or perceived breach of
confidential information (including personal information), which could result in damage to our reputation, litigation, complaints, negative publicity, breach
notification obligations, regulatory or administrative sanctions, inquiries, orders or investigations, indemnity obligations, or penalties for violations of
applicable laws or regulations. The increased use of smartphones, tablets and other mobile devices may also heighten these and other operational risks.
Sustained or repeated system disruptions that interrupt our ability to process orders and deliver products to the stores, impact our customers' ability to
access our websites in a timely manner, or expose confidential information (including personal information) could have a material adverse effect on our
results of operations, financial condition and cash flows. We may also incur losses from various
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types of fraud, including stolen credit card numbers, claims that a customer did not authorize a purchase, merchant fraud, and customers who have closed
bank accounts or have insufficient funds in open bank accounts to satisfy payments, and any such losses may be significant. Although the aggregate impact
on our operations and financial condition has not been material to date, we have been the target of events of this nature and expect them to continue as
cybersecurity threats have been rapidly evolving in sophistication and becoming more prevalent in the industry. In addition, although we have cybersecurity
insurance, such insurance may not adequately cover the losses and damages that we may sustain as a result of a cyber-attack. We may also not be able to
obtain adequate insurance coverage in the future at acceptable costs. Furthermore, the public perception that a cyber-attack on our systems has been
successful, whether or not this perception is correct, may damage our reputation with customers and third parties with whom we do business.
Maintaining the secrecy of our confidential information, trade secrets, intellectual property, proprietary business information, and employee personal
information is important to our competitive business position. However, such information can be difficult to protect. While we have taken steps to protect
such information and invested heavily in information technology, data security and preventing data leakages, there can be no assurance that our efforts will
prevent service interruptions or security breaches in our systems or the unauthorized or inadvertent wrongful use or disclosure of data that could adversely
affect our business operations or result in the loss, dissemination, or misuse of critical or sensitive information. In addition, there is a risk that encryption
and other protective measures, despite their sophistication, may be defeated, particularly to the extent that new computing technologies vastly increase the
speed and computing power available. A breach of our security measures or the accidental loss, inadvertent disclosure, unapproved dissemination,
misappropriation or misuse of our data, whether as a result of theft, hacking, fraud, trickery or other forms of deception, or for any other cause, could
enable others to produce competing products, use our data to gain an advantage, and/or adversely affect our business position. Applicable data privacy and
security obligations may require us to notify relevant stakeholders of security incidents. Such disclosures are costly, and the disclosures or the failure to
comply with such requirements could lead to adverse consequences. Any such breach or the accidental loss, inadvertent disclosure, unapproved
dissemination, misappropriation or misuse of our data could also result in a violation of applicable privacy and other laws in the U.S. and abroad, litigation
exposure, regulatory fines, penalties or intervention, reimbursement or other compensatory costs, additional compliance costs and our internal controls or
disclosure controls being rendered ineffective. Further, any such interruption, security breach, loss or disclosure of confidential information, could result in
financial, legal, business and reputational harm to us and could have a material adverse effect on our business, financial condition, results of operations,
cash flows, and/or share price.
Our obligations related to data privacy and security are quickly changing in an increasingly stringent fashion, creating some uncertainty as to the
effective future legal framework. Additionally, these obligations may be subject to differing applications and interpretations, which may be inconsistent or
conflict among jurisdictions. Preparing for and complying with these obligations requires significant resources and may necessitate changes to our
information technologies, systems, and practices and to those of any third parties that process data on our behalf. Although we endeavor to comply with all
applicable data privacy and security obligations, we may at times fail (or be perceived to have failed) to do so. Moreover, despite our efforts, our personnel
or third parties upon whom we rely may fail to comply with such obligations, which could negatively impact our business operations and compliance
posture.
Social media presents potential internal and external risks for our company.
The internal unauthorized, inappropriate or illicit use of social media could cause reputational harm to our business and/or create adverse
consequences, including the inadvertent release of non-public information or personally identifiable information. Externally, our brand and reputation
could suffer harm in the event of negative comments or altered information being disseminated through social media. If we were to suffer reputational or
brand harm or adverse consequences through social media, it may have a material adverse effect on our business, financial condition and results of
operations. Customer complaints or negative publicity about our website, products, merchandise quality, product delivery times, customer data handling
and security practices or customer support, could have a material adverse effect, especially on our direct-to-customer skincare business.
A public health crisis, such as the COVID-19 pandemic, any widespread outbreak of an illness or communicable disease, or any other pandemic could
have a material adverse effect on our business, results of operations, cash flows and financial position.
COVID-19, a disease caused by a strain of coronavirus, was first reported in December 2019 and later declared a pandemic by the World Health
Organization in March 2020, spreading globally. It has affected Israel and Canada, where most of our manufacturing takes place, and has spread
throughout each state in the U.S., our largest market. The COVID-19 pandemic has disrupted global supply chains, created significant volatility in global
financial markets and negatively impacted the global economy. Additionally, it has impacted our business and may materially affect our operations,
including manufacturing, supply chain, pre-commercial launch and clinical trial activities should the pandemic persist. Countries, states and local
governments instituting measures to reduce the spread of COVID-19 have impacted our operations with significant disruptions, uncertainty and economic
volatility, higher costs, and capital expenditures, such measures include quarantines, government restrictions on movement, business closures and
suspensions, canceled events and activities, self-isolation, and other voluntary and/or mandated changes in behavior. Our offices are or have been
operating under work from home protocols, and our manufacturing and distribution facilities have instituted policies and procedures to protect our
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employees and operations, including social distancing, the supply and use of personal protective equipment, split shifts and health assessments. We had
and, in some instances, continue to have to suspend in-person activities of our field employees because of restrictions on meetings instituted by our
customers. These protocols, policies, procedures, and suspension of activities have affected our business operations. In the event of illnesses at or closure
of one of our facilities, it is possible that such illness or closure could affect our production, shipping, and supply of products to our customers, which
would cause us to incur higher costs and have a negative impact on our financial results.
The COVID-19 pandemic has affected and may continue to affect the operations of our suppliers, third-party manufacturers, or partners in our
supply chains (transportation, shipping, and logistics), which resulted and may continue to result in higher costs and delays in the manufacturing and supply
of products to our customers, which has and will continue to have a negative impact on our financial results. If we need to find alternate suppliers, third-
party manufacturers, or partners in our supply chain, such alternates may come with increased costs, which could have a negative impact on our financial
results.
The COVID-19 pandemic may affect regulatory agencies globally, causing disruptions that limit our ability to supply products or bring new or
improved products to market, which could negatively impact our business operations and financial results. Currently, regulatory agencies globally,
including the FDA, are experiencing slower response times and offering limited inspections of manufacturing facilities, affecting approval of new products,
regulatory submissions and inspections.
Due to reductions in healthcare benefits as a result of unemployment and patient visits to doctors’ offices, pharmacies and healthcare facilities, we
may experience a decline in revenue or slower revenue growth related to such reductions. Our customers may increase demand for certain Company
products that exceeds our ability to meet such demand, which could negatively affect our operations and strain relationships with our customers.
The impact of COVID-19 could cause our customers, third-party manufacturers or suppliers to have liquidity issues, impacting our collection on
receivables and negatively impacting our ability to procure products or materials.
The continued impact of the COVID-19 pandemic could have a significant negative impact on our business, financial results, cash flow and
liquidity. We may need to seek additional sources of financing to fund our operations. Capital and credit markets have experienced disruptions due to
COVID-19 and foreign exchanges have experienced increased volatility. Because of these disruptions and volatility, seeking additional financing may be
difficult and is dependent upon evolving market conditions, among other factors.
The impact of the COVID-19 pandemic on the global and U.S. economies is uncertain, but a sustained economic downturn could negatively impact
demand for our products and materially affect our business, financial condition and results of operations, and the value of our shares.
Additionally, on September 9, 2021, President Biden issued an executive order requiring all employers with the U.S. government contracts to
require that their U.S.-based employees, contractors, and certain subcontractors that work on or in support of the U.S. government contracts are fully
vaccinated against COVID-19, except for any employees with a medical or religious exemption. There has been several preliminary injunctions blocking
enforcement of the executive order in whole or in part and the Safer Federal Workforce Task Force has indicated that the government will take no action to
enforce the contract clause enforcing the executive order. However, if such requirements are implemented, it may result in employee attrition. If we were to
lose employees, it may be difficult or costly in the current competitive labor market to find and recruit replacement employees, and this could have a
material adverse effect on our business, future results of operations and cash flows.
Risks Relating to Our Intellectual Property
We depend on our ability to protect our intellectual property and proprietary rights, but we may not be able to maintain the confidentiality, or assure the
protection, of these assets.
Our success depends, in large part, on our ability to protect our current and future technologies and products and to defend our intellectual property
rights. If we fail to protect our intellectual property adequately, competitors may manufacture and market products similar to ours. Numerous patents
covering our technologies have been issued to us, and we have filed, and expect to continue to file, patent applications seeking to protect newly developed
technologies and products in various countries, including the U.S. Some patent applications in the U.S. are maintained in secrecy until the patent is issued.
Because the publication of discoveries tends to follow their actual discovery by many months, we may not be the first to invent, or file patent applications
on any of our discoveries. Patents may not be issued with respect to any of our patent applications and existing or future patents issued to or licensed by us
may not provide competitive advantages for our products. Patents that are issued may be challenged, invalidated or circumvented by our competitors.
Furthermore, our patent rights may not prevent our competitors from developing, using or commercializing products that are similar or
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functionally equivalent to our products. Where trade secrets are our sole protection, we may not be able to prevent third parties from marketing generic
equivalents to our products, reducing prices in the marketplace and reducing our profitability.
We also rely on trade secrets, non-patented proprietary expertise and continuing technological innovation that we seek to protect, in part, by entering
into confidentiality agreements with licensees, suppliers, employees, consultants and others. These agreements may be breached and we may not have
adequate remedies in the event of a breach. Disputes may arise concerning the ownership of intellectual property or the applicability of confidentiality
agreements. Moreover, our trade secrets and proprietary technology may otherwise become known or be independently developed by our competitors. If
patents are not issued with respect to products arising from our research, we may not be able to maintain the confidentiality of information relating to these
products.
Third parties may claim that we infringe on their proprietary rights and may prevent us from manufacturing and selling such products, or may
challenge our own proprietary rights.
There has been substantial litigation in the pharmaceutical industry with respect to the manufacture, use and sale of new products. These lawsuits
often relate to the validity and infringement of patents or proprietary rights of third parties. We have in the past and may be required to in the future
commence or defend against charges relating to the infringement of patent or proprietary rights. Any such litigation could:
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require us to incur substantial expenses, even if we are insured or successful in the litigation;
require us to divert significant time and effort of our technical and management personnel;
result in the loss of our rights to develop or make certain products;
require us to pay substantial monetary damages or royalties in order to license proprietary rights from third parties;
prevent us from launching a developed, tested and approved product; or
result in our loss of certain patent or proprietary rights.
Although patent and intellectual property disputes within the pharmaceutical industry have often been settled through licensing or similar
arrangements, costs associated with these arrangements may be substantial and could include the long-term payment of royalties. These arrangements may
be investigated by U.S. regulatory agencies and, if improper, may be invalidated. Furthermore, the required licenses may not be made available to us on
acceptable terms. Accordingly, an adverse determination in a judicial or administrative proceeding or a failure to obtain necessary licenses could prevent
us from manufacturing and selling some of our products or increase our costs to market these products.
From time to time, we seek to market patented products before the related patents expire. In order to do so in the U.S., we must challenge the patent
under the procedures set forth in the Hatch-Waxman Act. In the U.S., in order to obtain a final approval for a generic product prior to expiration of certain
of the innovator’s patents, we must, under the terms of the Hatch-Waxman Act, as amended by the Medicare Act, notify the patent holder as well as the
owner of an NDA, that we believe that the patents listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange
Book”) for the marketed product are invalid, unenforceable or not infringed by our product. To the extent that we engage in patent challenge procedures,
we are involved and expect to be involved in patent litigation regarding the validity, enforceability or infringement of the originator’s patent. In addition,
when seeking regulatory approval for some of our products, we are required to certify to the FDA and its equivalents in foreign countries, that such
products do not infringe upon third-party patent rights, or that those patents are invalid or unenforceable. Filing a certification against a patent gives the
patent holder the right to bring a patent infringement lawsuit against us. Any lawsuit in the U.S. would delay regulatory approval by the FDA until the
earlier of the resolution of such claim or 30 months from the patent holder’s receipt of notice of certification.
A third party might challenge any of our patent rights. If successful, such a challenge could result in a loss of market exclusivity with respect to one
or more of our products.
In addition, it is not required that all pharmaceutical patents be listed with the FDA or other regulatory authorities. For example, patents relating to
antibiotics or a manufacturing process might not be listed in the Orange Book. Any launch of a pharmaceutical product by us that may infringe a patent,
whether listed or not, may involve us in litigation.
Patent challenges are complex, costly and can take a significant amount of time to complete. A claim of infringement and the resulting delay could
result in substantial expenses and even prevent us from manufacturing and selling products and, in certain circumstances, such litigation may result in
significant damages which could have a material adverse effect on our results of operations and financial condition.
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Our launch of a product prior to a final court decision, settlement with the patent owner or the expiration of a patent held by a third party may result
in substantial damages to us. Depending upon the circumstances, a court may award the patent holder damages up to three times the patent holder’s loss of
profit or other actual damages, and not less than a reasonable royalty. If we are found to infringe a patent held by a third party and become subject to
significant damages, these damages could have a material adverse effect on our results of operations and financial condition.
Risks Relating to Our Compliance with the Sarbanes-Oxley Act of 2002 (“Sarbanes-Oxley”)
We have, in the past, and could in the future, fail to maintain effective internal controls in accordance with Section 404 of Sarbanes-Oxley.
Sarbanes-Oxley imposes certain duties on us and our executives and directors. Our efforts to comply with the requirements of Sarbanes-Oxley, and
in particular with Section 404 thereof, have resulted in diversion of our management’s time and attention, and we expect these efforts to require the
continued commitment of resources.
We have in the past, and may, in the future, identify material weaknesses in our internal controls that evidence that we fail to maintain effective
internal controls in accordance with Section 404 of Sarbanes-Oxley. As of March 31, 2022, we did not identify any material weaknesses in internal
controls. Failure to maintain adequate internal controls could negatively affect shareholder and customer confidence.
Material weaknesses in our disclosure controls and procedures could negatively affect shareholder and customer confidence.
Under Sarbanes-Oxley, we are required to assess the effectiveness of our disclosure controls and procedures on an annual basis. If we were to
conclude that our disclosure controls and procedures were ineffective, shareholder and customer confidence could be negatively affected, which could have
a material adverse impact on the market price of our ordinary shares.
Risks Relating to Investment in Our Ordinary Shares
Volatility of the market price of our ordinary shares could adversely affect us and our shareholders.
The market price of our ordinary shares has been volatile, and may, in the future, be subject to wide fluctuations, for the following reasons, among
others:
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actual or anticipated variations in our quarterly operating results or those of our competitors;
announcements by us or our competitors of new or enhanced products;
market conditions or trends in the pharmaceutical industry;
developments or disputes concerning proprietary rights;
failure by us to develop new products;
introduction of technologies or product enhancements by others that reduce the need for our products;
general economic and political conditions;
departures of key personnel;
changes in the market valuations of our competitors;
regulatory considerations; and
the other risk factors listed in this section of this 2022 Annual Report.
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No citizen or resident of the U.S. who acquired or acquires any of our ordinary shares at any time after October 21, 1999, is permitted to exercise more
than 9.9% of the voting power in our Company, with respect to such ordinary shares, regardless of how many shares the shareholder owns.
In order to reduce our risk of being classified as a “Controlled Foreign Corporation” under the U.S. Internal Revenue Code of 1986, as amended (the
“Code”), we amended our articles of association (“Articles of Association” or “Articles”) in 1999 to provide that no owner of any of our ordinary shares is
entitled to any voting right of any nature whatsoever with respect to such ordinary shares if (a) the ownership or voting power of such ordinary shares was
acquired, either directly or indirectly, by the owner after October 21, 1999, and (b) the ownership would result in our being classified as a Controlled
Foreign Corporation. This provision has the practical effect of prohibiting each citizen or resident of the U.S. who acquired or acquires our ordinary shares
after October 21, 1999, from exercising more than 9.9% of the voting power in our Company, with respect to such ordinary shares, regardless of how many
shares the shareholder owns. The provision may therefore discourage U.S. persons from seeking to acquire, or from accumulating, 15% or more of our
ordinary shares (which, due to the voting power of the founders’ shares, would represent 10% or more of the voting power of our Company). As of March
31, 2022, no citizen or resident of the U.S. held an amount of ordinary shares that would represent 10% or more of the voting power of our Company.
Risks Relating to Our International Operations
We face risks related to foreign currency exchange rates.
Because some of our revenue, operating expenses, assets and liabilities are denominated in foreign currencies, we are subject to foreign exchange
risks that could adversely affect our operations and reported results. To the extent that we incur expenses in one currency but earn revenue in another, any
change in the values of those foreign currencies relative to the USD could cause our profits to decrease or our products to be less competitive against those
of our competitors. To the extent that our foreign currency holdings and other assets denominated in a foreign currency are greater or less than our
liabilities denominated in a foreign currency, we have foreign exchange exposure.
Current and changing economic conditions may adversely affect our industry, business, partners and suppliers, financial position, results of operations
and/or cash flow.
The global economy continues to experience significant volatility, and the economic environment may continue to be, or become, less favorable
than that of past years. Higher costs for goods and services, inflation, deflation, the imposition of tariffs or other measures that create barriers to or increase
the costs associated with international trade, overall economic slowdown or recession and other economic factors in Israel, the U.S., Canada or in any of
the other markets in which we operate could adversely affect our net sales or otherwise materially adversely affect our operations and operating results.
Among other matters, the continued risk of a debt default by one or more European countries, related financial restructuring efforts in Europe, and/or
evolving deficit and spending reduction programs instituted by the U.S. and other governments could negatively impact the global economy and/or the
pharmaceutical industry. This has led, and/or could lead, to reduced consumer and customer spending and/or reduced or eliminated governmental or third-
party payor coverage or reimbursement in the foreseeable future, and this may include spending on healthcare, including but not limited to pharmaceutical
products. While generic drugs present an alternative to higher-priced branded products, our sales could be negatively impacted if patients forego obtaining
healthcare, patients and customers reduce spending or purchases, and/or if governments and/or third-party payors reduce or eliminate coverage or
reimbursement amounts for pharmaceuticals and/or impose price or other controls adversely impacting the price or availability of pharmaceuticals. In
addition, reduced consumer and customer spending, and/or reduced government and/or third-party payor coverage or reimbursement, and/or new
government controls, may drive us and our competitors to decrease prices and/or may reduce the ability of customers to pay and/or may result in reduced
demand for our products. The occurrence of any of these risks could have a material adverse effect on our industry, business, financial position, results of
operations and/or cash flow.
Moreover, financial volatility and geopolitical instability outside the U.S. may impact our operations or affect global markets. For example, the
outbreak of war between Russia and Ukraine and the resulting sanctions implemented by U.S. and European governments, together with any additional
future sanctions, could impact other markets where we do business, including our supply chain, business partners and customers, which could result in lost
sales, supply shortages, increase manufacturing costs and lost efficiencies. Further, the conflict may adversely impact macroeconomic conditions and
increase volatility in and affect our ability to access capital markets and external financing sources on acceptable terms or at all. Given the international
scope of our operations, any of the above-mentioned effects of war between Russia and Ukraine, and others we cannot anticipate, could adversely affect
our business, business opportunities, operations, and financial results.
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Our business requires us to move goods across international borders. Any events that interfere with, or increase the costs of, the transfer of products
across international borders could have a material adverse effect on our business.
We transport most of our products across international borders, primarily those of the U.S., Canada, and Israel. Since September 11, 2001, there has
been more intense scrutiny of products that are transported across international borders. As a result, we may face delays, and increases in costs due to such
delays, in delivering products to our customers. Any events that interfere with, or increase the costs of, the transfer of products across international borders
could have a material adverse effect on our business.
Risks Relating to Key Employees
Our future success is highly dependent on our continued ability to attract and retain key personnel. Any failure to do so could have a material adverse
effect on our business, financial position, and results of operations and could cause the market value of our ordinary shares to decline.
The pharmaceutical industry, and our company in particular, is science based. It is therefore imperative that we attract and retain qualified personnel
in order to develop new products and compete effectively. If we fail to attract and retain key scientific, technical, or management personnel, our business
could be affected adversely. If we are unsuccessful in retaining or replacing key employees, it could have a material adverse effect on our business,
financial position, and results of operations and could cause the market value of our ordinary shares to decline.
Our operations could suffer if we are unable to attract and retain key employees in the markets in which we operate where competition for highly
skilled technical and other personnel is intense.
Our success depends, in part, upon the continued service and performance of our highly skilled scientific and technical personnel. A significant
amount of our research and development and manufacturing activities are conducted at our facilities in Israel, the U.S., and Canada, and we face substantial
competition for suitably skilled employees in those markets. While there has been intense competition for qualified human resources in the pharmaceutical
and high-tech industries historically, there has been an increase in job openings in both high-tech and pharmaceutical companies and greater intensification
of competition between these employers to attract qualified employees. As a result, these industries have experienced significant levels of employee
attrition and are currently facing a shortage of skilled human capital, including but not limited to engineering, manufacturing, and research and
development personnel. Companies with which we compete for qualified personnel may have greater resources than we do, and we may not succeed in
recruiting additional experienced or professional personnel, retaining personnel, or effectively replacing current personnel who may depart with qualified or
effective successors. If we cannot attract and retain sufficiently qualified technical employees for our research and development and/or manufacturing
activities, we may be unable to successfully develop and commercialize new pharmaceutical products. In addition, as a result of the intense competition for
qualified human resources, the high-tech and pharmaceutical markets have also experienced and may continue to experience significant wage inflation.
Accordingly, our efforts to attract, retain, and develop personnel may also result in significant additional expenses, which could adversely affect our
profitability.
In light of the foregoing, there can be no assurance that qualified employees will remain in our employ or that we will be able to attract and retain
qualified personnel in the future. Failure to retain or attract qualified personnel could have a material adverse effect on our business, financial condition,
and results of operations.
Risks Relating to Our Location in Israel
Conditions in Israel affect our operations and may limit our ability to produce and sell our products.
We are incorporated under Israeli law and a significant component of our manufacturing and research and development facilities are located in
Israel. Political, economic, and military conditions in Israel may directly affect our operations, and we could be adversely affected by hostilities involving
Israel, the interruption or curtailment of trade between Israel and its trading partners, or a significant downturn in the economic or financial condition of
Israel. Unprecedented (from an Israeli perspective) political instability, under which there was recently a two-year period during which there was no
permanent government and no budget adopted, may, if it reoccurs, also adversely impact the Israeli economy and, indirectly, our Israeli operations.
Although Israel has entered into various agreements with Egypt, Jordan, and the Palestinian Authority, as well as, more recently, the United Arab
Emirates and other countries in the Middle East, Israel frequently has been subject to civil unrest and terrorist activity, with varying levels of severity. Any
armed conflicts, terrorist activities, or political instability in the region could adversely affect our operations. Furthermore, certain parties with whom we
do business periodically have declined to travel to Israel, forcing us to make alternative arrangements where necessary, and the U.S. Department of State
has issued, from time to time, an advisory regarding travel to Israel. As a result, the FDA has at various times curtailed or prohibited its inspectors from
traveling to Israel to inspect the facilities of Israeli companies, which, should it occur with respect to our Company, could result in the FDA withholding
approval for new products we intend to produce at those facilities.
21
If terrorist acts were to result in substantial damage to our facilities, our business activities would be disrupted since, with respect to some of our
products, we would need to obtain prior FDA approval for a change in manufacturing site. Our business interruption insurance may not adequately
compensate us for losses that may occur, and any losses or damages sustained by us could have a material adverse effect on our business.
Many male Israeli citizens, including our employees, are subject to compulsory annual reserve military service until they reach the age of 45 (or
older, for citizens who hold certain positions in the Israeli armed forces reserves) and, in the event of a military conflict, may be called to active duty. In
response to increases in terrorist activity, there have been periods of significant call-ups of military reservists, and some of our Israeli employees have been
called up in connection with armed conflicts. It is possible that there will be similar large-scale military reserve duty call-ups in the future. Our operations
could be disrupted by the absence for a significant period of one or more of our executive officers or key employees, or a significant number of our other
employees due to obligatory military service requirements. Any disruption in our operations could harm our business.
We may be affected by fluctuations in the NIS relative to the USD.
A substantial portion of our expenses in Israel, primarily labor and occupancy expenses, are incurred in NIS. As a result, the cost of our operations
in Israel, as measured in USD, is subject to the risk of exchange rate fluctuations between the USD and the NIS. During the years ended March 31, 2022
and March 31, 2021, the value of the NIS increased by 4.5% and 6.72%, respectively, relative to the USD based on the change in the exchange rate from
the start to the end of the fiscal year. This trend was furthermore reflected in exchange rate movements throughout the fiscal year, as the value of the NIS
appreciated relative to the USD, which had a negative impact on our results of operations by increasing the USD value of our NIS-incurred expenses. If the
NIS continues to appreciate relative to the USD, that would further negatively affect our USD-measured results of operations.
Our operations may be affected by negative labor conditions in Israel.
Strikes and work-stoppages occur relatively frequently in Israel. If Israeli trade unions threaten strikes or work-stoppages and such strikes or work-
stoppages occur, those may, if prolonged, have a material adverse effect on the Israeli economy and on our business, including our ability to deliver
products to our customers and to receive raw materials from our suppliers in a timely manner.
Environmental requirements related to our Haifa Bay manufacturing facility.
Our Haifa Bay manufacturing facility is located among a large concentration of industrial and other facilities that release emissions into the air in the
Haifa Bay region. The Israeli Ministry of Environmental Protection (the “MoEP”) has declared the reduction of air pollution in Haifa Bay to be a primary
goal and has taken a stringent approach in enforcing environmental protection laws for the industrial plants in Haifa Bay. We may be subject to
enforcement action, including penalties, if we do not adhere to those strict rules.
Government pricing or price control policies can materially impede our profitability or ability to set prices for our products.
The Israeli government typically purchases pharmaceutical products at the lowest prices in the market, which may affect our profitability. All
pharmaceutical products sold in Israel are subject to government price controls. Permitted price increases and decreases are enacted by the Israeli
government as part of a formal review process. The inability to control the prices of our products may adversely affect our operations.
We may benefit from government programs and tax benefits, both or either of which may be discontinued or reduced.
We have, in the past, received grants and substantial tax benefits under Israeli government programs, including the Approved Enterprise program
and programs of the Israeli National Authority for Technological Innovation (the “Authority” or “IIA”) (formerly operating as Office of the Chief Scientist
of the Ministry of Economy of the State of Israel). In order to be eligible for these programs and benefits, we must meet specified conditions, including
making specified investments in fixed assets from our equity and paying royalties with respect to grants received. In addition, some of these programs
could restrict our ability to manufacture particular products and transfer particular technology outside of Israel. If we fail to comply with these conditions
in the future, the benefits received could be canceled and we could be required to refund payments previously received under these programs or pay
increased payments and/or taxes. In the future, the government of Israel may discontinue or curtail these and the tax benefits available under these
programs. If the government of Israel ends these programs and tax benefits while we are recipients, our business, financial condition, and results of
operations could be materially adversely affected.
22
Provisions of Israeli law may delay, prevent, or make more difficult a merger or acquisition. This could prevent a change of control and depress the
market price of our ordinary shares.
Provisions of Israeli corporate and tax law may have the effect of delaying, preventing, or making more difficult a merger or acquisition. The Israeli
Companies Law, 5759 - 1999 (the “Israeli Companies Law”) and the regulations promulgated thereunder, generally require that a merger be approved by a
company’s board of directors and by a shareholder vote at a shareholders’ meeting that has been called on at least 35 days’ advance notice by each of the
merger parties. Under our Articles of Association, the required shareholder vote is a supermajority of at least 75% of the shares voting in person or by
proxy on the matter. Any creditor of a merger party may seek a court order blocking a merger if there is a reasonable concern that the surviving company
will not be able to satisfy all of the obligations of any party to the merger. Moreover, a merger may not be completed until at least 50 days have passed
from the time that a merger proposal has been delivered to the Israeli Registrar of Companies and at least 30 days have passed from the time each merging
company has received shareholder approval for the merger. In addition, a majority of each class of securities of the target company must approve a merger.
Moreover, a tender offer for all of a company’s issued and outstanding shares can only be completed if the acquirer receives sufficient responses such that
the acquirer will hold at least 95% of the issued share capital upon consummation of the shareholders’ tenders. Completion of the tender offer also requires
approval of a majority of shareholders who do not have a personal interest in the tender offer, unless, following consummation of the tender offer, the
acquirer would hold at least 98% of the company’s outstanding shares. Furthermore, 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, petition an Israeli court to alter the consideration for the
acquisition, unless the acquirer stipulated in its tender offer that a shareholder that accepts the offer may not seek such appraisal rights.
Other potential means of acquiring a public Israeli company such as ours might involve additional obstacles. A significant body of case law has not
yet developed with respect to the Israeli Companies Law. Until that happens, uncertainties will exist regarding its interpretation, especially with regard to
mergers and acquisitions, which may inhibit such transactions.
Finally, Israeli tax law treats some acquisitions, such as stock-for-stock exchanges between an Israeli company and a foreign company, less
favorably than do U.S. tax laws. The provisions of Israeli corporate and tax law and the uncertainties surrounding such laws may have the effect of
delaying, preventing, or making more difficult a merger or acquisition. This could prevent a change of control of the Company and depress the market
price of our ordinary shares, which otherwise might rise as a result of such a change of control. With respect to mergers, Israeli tax law allows for tax
deferral in certain circumstances but makes the deferral contingent on the fulfillment of a number of 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 subject to certain restrictions. Generally,
with respect to other share swap transactions, the tax deferral is limited in time, and when that time expires, the tax becomes payable even if no disposition
of the shares has occurred.
It may be difficult to effect service of process and enforce judgments against our directors and officers.
We are incorporated in Israel. Several of our executive officers and directors are non-residents of the U.S. and a substantial portion of our assets and
the assets of such persons are located outside the U.S. Therefore, it may be difficult to enforce a judgment obtained in the U.S. against us or any of those
persons or to effect service of process upon those persons. It may also be difficult to enforce civil liabilities under U.S. federal securities laws in original
actions instituted in Israel. Israeli courts may refuse to hear a claim based on a violation of U.S. securities laws because Israel is not the most appropriate
forum in which such a claim should be brought. Even if an Israeli court agrees to hear a claim, it may determine that Israeli law and not U.S. law is
applicable to the claim. If U.S. law is found to be applicable, the applicable U.S. law must be proved as a factual matter, which can be a time-consuming
and costly process. Also, certain matters of procedure will be governed by Israeli law.
We are subject to government regulation that increases our costs and could prevent us from marketing or selling our products.
We are subject to extensive pharmaceutical industry regulations in countries where we operate. We cannot predict the extent to which we may be
affected by legislative and other regulatory developments concerning our products.
In Israel, the manufacture and sale of pharmaceutical products is regulated in a manner substantially similar to that of the U.S. Legal requirements
generally prohibit the handling, manufacture, marketing, and importation of any pharmaceutical product unless it is properly registered in accordance with
applicable law. The registration file relating to any particular product must contain medical data related to product efficacy and safety, including results of
clinical testing and references to medical publications, as well as detailed information regarding production methods and quality control. Health ministries
are authorized to cancel the registration of a product if it is found to be harmful or ineffective or manufactured and marketed other than in accordance with
registration conditions.
We are subject to legislation in Israel, primarily relating to patents and data exclusivity provisions. Modifications of this legislation or court
decisions regarding this legislation may adversely affect us and may prevent us from exporting Israeli-manufactured
23
products in a timely fashion. Additionally, the existence of third-party patents in Israel, with the attendant risk of litigation, may cause us to move
production outside of Israel or otherwise adversely affect our ability to export certain products from Israel.
Risks Relating to Our Location in Canada
Government price control policies can materially impede our ability to set prices for our products.
In Canada, the Patented Medicine Prices Review Board (“PMPRB”) monitors and controls the prices of patented drug products marketed in Canada.
The PMPRB requires patentees to report pricing and assess whether pricing is excessive based on a number of factors, including the price of comparable
drugs sold in Canada and the price of patented medicine in other jurisdictions. While price increases are permitted, they are generally limited to the amount
of the annual increase of the Canadian Consumer Price Index. Consequently, the existence of one or more patents relating to a drug product, while
providing some level of proprietary protection for the product, also triggers a governmental price control regime that significantly affects the Canadian
pharmaceutical industry’s ability to set pricing. Additionally, generic pricing is affected by the PMPRB given that generic pricing is tied to the price of the
interchangeable brand product. To the extent we have products covered by a patent in Canada or generic products affected by the PMPRB, our inability to
control the prices of any such products may adversely affect our operations. The risk associated with the PMPRB’s jurisdiction has also been affected by
recent changes to the regulatory landscape within which the PMPRB operates.
Sales of our products in Canada depend, in part, upon their eligibility for reimbursement from drug benefit formularies.
Each Canadian province establishes its own drug benefit formulary that lists the drugs for which a provincial government will reimburse qualifying
persons and sets the prices at which the government will reimburse such persons. There is not complete uniformity among provinces, which could result in
the listing of products in some provinces but not others. However, provincial governments generally will reimburse the lowest available price of the
generic equivalents of any drug listed on its formulary. The formularies can also provide for automatic drug substitution, even for patients who do not
qualify for government reimbursement. The effect of these provincial formulary regimes is to encourage the sale of lower-priced versions of
pharmaceutical products. Further, legislation in some provinces limits the price at which generic pharmaceuticals are reimbursed based on the number of
generic competitors in the market and the price of their brand equivalent. Therefore, the potential lack of reimbursement due to a refusal to list on a
provincial formulary may adversely affect our ability to profitably market our products. Additionally, legislative price controls on generic products may
affect profitability by limiting selling price.
We may be affected by fluctuations in the CAD relative to the USD.
A substantial portion of our expenses in Canada, primarily labor, packaging materials, occupancy, selling, marketing, and administrative expenses,
are incurred in CAD. As a result, the cost of our operations in Canada, as measured in USD, is subject to the risk of exchange rate fluctuations between the
USD and the CAD. During the year-ended March 31, 2022, the value of the CAD increased 0.8% relative to the USD based on the change in the exchange
rate from the start to the end of the fiscal year. This trend was furthermore reflected in exchange rates movement throughout the fiscal year, as the value of
the CAD appreciated relative to the USD, which had a negative impact on our results of operations by increasing the USD value of our CAD-incurred
expenses. If the CAD continues to appreciate relative to the USD, that would further negatively affect our USD-measured results of operations.
ITEM 4. INFORMATION ON THE COMPANY
A. HISTORY AND DEVELOPMENT OF THE COMPANY
The legal and commercial name of our company is Taro Pharmaceutical Industries Ltd. We were incorporated under the laws of the State of Israel
in 1959 under the name Taro-Vit Chemical Industries Ltd. In 1984, we changed our name to Taro Vit Industries Ltd. and in 1994 we changed our name to
Taro Pharmaceutical Industries Ltd., which was the name of a subsidiary of Taro Vit Industries Ltd. incorporated under the laws of the State of Israel in
1950.
24
In 1961, we completed the initial public offering of our ordinary shares. In that year, we also acquired 97% of the outstanding stock of an Israeli
corporation, then known as Taro Pharmaceutical Industries Ltd. (“TPIL”). In 1981, we sold 37% of our interest in TPIL. In 1993, after acquiring all of the
outstanding shares of TPIL, we merged TPIL into our company. In July 2001, we completed a stock split by distributing one ordinary share for each
ordinary share then outstanding and one ordinary share for every ten founders’ shares then outstanding. In October 2001, we sold 3,950,000 of our
ordinary shares, and shareholders sold 1,800,000 of our ordinary shares, in a public offering. In 2007, we sold 6,787,500 of our ordinary shares to Sun. In
September 2010, the Levitt and Moros families and Sun Pharma reached an agreement to transfer their interest in Taro to Sun in accordance with an option
agreement entered into by the parties in May 2007. Since March 22, 2012, our ordinary shares have been traded on the NYSE under the symbol “TARO.”
Our registered office is located at 14 Hakitor Street, Haifa Bay 2624761, Israel. Our telephone number at that address is +972-4-847-5700. Our
agent for service of process in the U.S. is Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Drive, Hawthorne, NY 10532. Our telephone number at that
address is +1-914-345-9000.
The U.S. Securities and Exchange Commission (“SEC”) maintains an internet site at www.sec.gov that contains reports and information statements
and other information regarding registrants like us that file electronically with the SEC.
We routinely post important information on our website at https://www.taro.com/. This website and the information contained therein or connected
thereto shall not be deemed to be incorporated into this 2022 Annual Report.
Capital Expenditures
During the years ended March 31, 2022, 2021, and 2020, our capital expenditures were $11.8 million, $17.0 million, and $26.6 million, respectively.
The focus of our capital expenditure program has been the expansion and upgrade of our manufacturing facilities, laboratories, and information technology
systems in order to enable us to increase operational efficiencies, remain in compliance with cGMP, accommodate anticipated increased demand for our
products, and maintain a competitive position in the marketplace.
The major projects undertaken during these three years, as part of our capital expenditure program, include:
•
•
•
the acquisition of additional production and packaging equipment;
expanding and upgrading our research and development laboratories in Israel and Canada; and
the upgrade of our information technology and serialization systems, in addition to general improvements to our facilities.
For a detailed presentation of our property, plant, and equipment, see Note 7 to our consolidated financial statements included elsewhere in this 2022
Annual Report. Also see Item 4.D. – “Property, Plant and Equipment.”
B. BUSINESS OVERVIEW
We are a multinational, science-based pharmaceutical company. We develop, manufacture, and market Rx and OTC pharmaceutical products
primarily in the U.S., Canada, Israel, and Japan. Our primary focus includes semi-solids formulations, such as creams and ointments and other dosage
forms such as liquids, capsules, and tablets, in the dermatological and topical, cardiovascular, neuropsychiatric, and anti-inflammatory therapeutic
categories.
25
We operate principally through Taro Israel and its following subsidiaries (including indirect): Taro Pharmaceuticals Inc. (“Taro Canada”), Taro
U.S.A., and those entities relating to the Alchemee business, including Alchemee LLC, The Proactiv Company KK, and The Proactiv Company
Corporation (collectively, “Taro Proactiv”). The principal activities and primary product lines of Taro Israel and these subsidiaries may be summarized as
follows:
Entity
Principal Activities
Primary Product Lines
Taro Israel
(cid:0) Manufactures more than 100 finished dosage form
(cid:0) Dermatology: Rx and OTC semi-solid (creams,
Taro Canada
Taro U.S.A.
pharmaceutical products for sale in Israel and for
export
(cid:0) Produces APIs used in the manufacture of finished
dosage form pharmaceutical products
(cid:0) Markets and distributes both proprietary and
generic products in the local Israeli market
(cid:0) Performs research and development
ointments, lotions, foams and gels) and liquid
products
(cid:0) Cardiology and Neurology: Prescription oral
dosage products
(cid:0) Analgesics, Rx and OTC oral dosage products
(cid:0) Central Nervous System (CNS) – Rx oral dosage
products
(cid:0) Allergy (Antihistamine): OTC oral dosage
products
(cid:0) Manufactures more than 200 finished dosage form
pharmaceutical products for sale in Canada and for
export to the U.S. and other markets
(cid:0) Markets and distributes both proprietary and
generic products in the Canadian market
(cid:0) Performs research and development
(cid:0) Dermatology: Rx and OTC semi-solid products
(creams, ointments, lotions and gels) and liquid
products
(cid:0) Allergy (Antihistamine): OTC oral dosage
products
(cid:0) Markets and distributes both proprietary and
generic products in the U.S. market
(cid:0) Performs regulatory, post marketing and clinical
activities
(cid:0) Dermatology: Rx and OTC semi-solid products
(creams, ointments, lotions, foams and gels) and
liquid products
(cid:0) Cardiology and Neurology: Rx oral dosage
products
(cid:0) Other Rx and OTC products
Taro Proactiv
(cid:0) Markets and distributes dermatologic products in
(cid:0) Dermatology products (creams, ointments,
the U.S., Canada, Japan and other markets
lotions, and solutions) Proactiv solution, Proactiv+,
and ProactivMD
As of March 31, 2022, 15 (excluding tentative approvals) of our ANDAs are being reviewed by the FDA. During the fiscal year ended March 31,
2022, we filed 3 ANDAs with the FDA. In addition, there are numerous products for which either development or internal regulatory work is in process.
The applications pending before the FDA are at various stages in the review process, and there can be no assurance that we will be able to successfully
complete any remaining testing or that, upon completion of such testing, approvals will be granted. In addition, there can be no assurance that the FDA
will not grant approvals for competing products submitted by our competitors prior to, simultaneous with or after granting approval to us.
On February 28, 2022, Taro U.S.A. acquired the Alchemee business, formerly The Proactiv Company, from Galderma. The acquisition includes
Alchemee’s business and assets worldwide, including the Proactiv® brand. The acquisition expands the Company’s product portfolio in prescription and
OTC dermatology products.
The Generic Pharmaceutical Industry
Generic pharmaceuticals are the chemical and therapeutic equivalents of brand-name drugs and are typically marketed after the patents for brand-
name drugs have expired. Generic pharmaceuticals generally must undergo clinical testing that demonstrates that they are bioequivalent to their branded
equivalents and are manufactured to the same standards. Proving bioequivalence generally requires data demonstrating that the generic formulation results
in a product whose rate and extent of absorption are within an acceptable range of the results achieved by the brand-name reference drug. In some
instances, bioequivalence can be established by demonstrating that the therapeutic effect of the generic formula falls within an acceptable range of the
therapeutic effects achieved by the brand-name reference drug.
26
Generic pharmaceutical products must meet the same quality standards as branded pharmaceutical products although they are generally sold at
prices that are substantially lower than those of their branded counterparts. As a result, generic pharmaceuticals represent a much larger percentage of total
drug prescriptions dispensed than their corresponding percentage of total sales. This discount tends to increase (and margins tend to decrease) as the
number of generic competitors increases for a given product. Because of this pricing dynamic, companies that are among the first to develop and market a
generic pharmaceutical product tend to earn higher profits than companies that subsequently enter the market for that product. Furthermore, products that
are difficult to develop or are intended for niche markets generally attract fewer generic competitors and therefore may offer higher profit margins than
those products that attract a larger number of competitors. However, profit is influenced by many factors other than the number of competitors for a given
drug or the size of the market. Depending on the actions of each of our competitors, price discounts can be just as significant for a specific product with
only a few competitors or a small market, as for a product with many competitors or a large market.
In recent years, the market for generic pharmaceuticals has grown. We believe that this growth has been driven by the following factors, among
others:
•
•
•
•
Products
efforts by governments, employers, third-party payers, and consumers to control healthcare costs;
increased acceptance of generic products by physicians, pharmacists, and consumers;
the increasing number of pharmaceutical products whose patents have expired and are therefore subject to competition from, and substitution
by, generic equivalents; and
a higher ANDA approval rate by the FDA.
We currently market more than 200 pharmaceutical products in over 25 countries. The following represents key therapeutic categories and dosage
forms.
Therapeutic Categories
The following represents various key therapeutic categories: allergy, analgesic, antibacterial, antibiotic, anticonvulsant, antiemetic, antifungal, anti-
inflammatory, anti cancer, antiplatelet agent, antipyretic, cardiovascular, CNS, corticosteroid, cosmetic, cough and cold, dermatology, diuretic, endocrine,
gastrointestinal, laxative, narcotics, neuropathic pain, neuropsychiatric, sedative/hypnotic, and topical anti neoplastic.
Dosage Forms
The following represents various dosage forms of products: capsule, cream, drops, emulsion, gel/gel kit, granules, injectable, lotion, oil, ointment,
paste (including dental), powder/powder for solution, rectal suppository, shampoo, solution/solution for infusion, spray, suspension, syrup, tablets,
toothpaste and mouthwash, topical foam, and topical solution.
Topical corticosteroids are used in the treatment of some dermatologic conditions (including psoriasis, eczema, and various types of skin rashes).
Topical antineoplastics are used in the treatment of cancer (including skin cancer). Antifungals are used in the treatment of some infections (including
athlete’s foot, ringworm and vaginal yeast infections). Anticonvulsants are used in the treatment of various seizure disorders (including epilepsy).
Cardiovascular products are used in the treatment of heart disease. There are several categories of cardiovascular drugs, including anticoagulants,
antihypertensive, and antiarrhythmic. Anticoagulants, commonly known as blood thinners, are used in the treatment of heart disease and stroke associated
with heart disease.
Some of our products are subject to seasonality, such as allergy drugs; however, in the aggregate our products are not materially subject to
seasonality.
For the years ended March 31, 2022, 2021, and 2020, no product comprised 10% of our total consolidated sales.
Sales and Marketing
In the U.S., Israel, and Canada, our sales are primarily generated by our own dedicated sales force. In other countries, we sell through agents and
other distributors. Our sales force is supported by our customer service and marketing employees.
27
The following is a breakdown of our net sales by geographic region, including the percentage of our total consolidated net sales for each period:
2022
Year ended March 31,
2021
2020
Sales
(in thousands)
% of
total sales
Sales
(in thousands)
% of
total sales
Sales
(in thousands)
% of
total sales
$
$
376,677
130,066
47,915
6,689
561,347
67%
23%
9%
1%
100%
$
$
383,829
110,167
46,574
8,400
548,970
70%
20%
8%
2%
100%
$
$
495,673
97,997
42,817
8,282
644,769
77%
15%
7%
1%
100%
United States
Canada
Israel
Other
Total
In the year ended March 31, 2022, revenue in the U.S. accounted for 67% of total consolidated net sales. In addition to marketing Rx drugs, we
market our generic OTC products primarily as store brands under its customers’ labels to wholesalers, drug chains, food chains, and mass merchandisers.
A significant portion of our revenue is derived from sales to a limited number of customers. If the Company were to experience a significant reduction in
or loss of business with one or more of such customers, or if one or more such customers were to experience difficulty in paying us on a timely basis, our
business, financial condition, and results of operations could be materially adversely affected. During the year ended March 31, 2022, we sold to
approximately 200 customers in the U.S. The following table represents sales to our largest customers greater than 10% of consolidated net sales:
Customer
Customer A
Customer B
Customer C
* Less than 10%.
2022
10.1%
*
*
Year ended March 31,
2021
12.6%
10.5%
*
2020
*
13.0%
11.5%
The following table sets forth the percentage of consolidated net sales by each type of customer in the U.S. in the year ended March 31, 2022:
Customer Type
Drug wholesalers and store chains
Mass merchandisers, food and retail chains
Managed care organizations
Generic drug distributors
Other
Percentage of
Consolidated Sales
36%
15%
*
*
*
* Less than 10%.
In the year ended March 31, 2022, sales in Canada accounted for 23% of our total consolidated net sales and Taro Canada sold to approximately 400
customers.
The PMPRB monitors and controls prices of patented drug products marketed in Canada by persons holding, or licensed under, one or more patents.
The existence of one or more patents relating to a drug product triggers a governmental price control regime that significantly affects the Canadian
pharmaceutical industry’s ability to set pricing. Furthermore, in each province of Canada there is a drug benefit formulary. A formulary lists the drugs for
which a provincial government will reimburse qualifying persons and the prices at which the government will reimburse such persons. Provincial
governments generally will reimburse the lowest available price of the generic equivalents of any drug listed on the formulary list of a province.
Consequently, provincial formulary regimes tend to encourage the sale of lower-priced versions of pharmaceutical products.
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The following table sets forth the percentage of consolidated net sales by each type of customer in Canada in the year ended March 31, 2022:
Customer Type
Drug wholesalers
Drug chains, independent pharmacies and others
Percentage of
Consolidated Sales
15%
*
* Less than 10%.
In the year ended March 31, 2022, sales in Israel accounted for less than 10% of our total consolidated net sales. The marketing, sales, and
distribution of Rx pharmaceuticals and OTC products in Israel is closely monitored by the Israeli government. The market for these products is dominated
by institutions that are similar to health maintenance organizations in the U.S., as well as private pharmacies. Most of our marketing efforts in Israel focus
on selling directly to these groups.
All pharmaceutical products sold in Israel are subject to price controls. Permitted price increases and decreases are enacted by the Israeli
government as part of a formal review process. There are no restrictions on the import of pharmaceuticals, provided that they comply with registration
requirements of the Israeli Ministry of Health.
In Israel, the pharmaceutical market generally is divided into two market segments: (i) the private market, which includes drug store chains, private
pharmacies, and wholesalers; and (ii) the institutional market, which includes Kupat Holim Clalit (the largest health maintenance organization in Israel),
other health maintenance organizations, the Israel Ministry of Health, the Armed Forces, and sales to the Palestinian authorities through third parties.
The percentage of consolidated net sales in the year ended March 31, 2022 for each type of institutional customers, private customers, and other
international customers in Israel and other international markets is less than 5%:
We have expanded the production capacity of our Israeli and Canadian operations to meet anticipated greater demand for our products in future
years. As discussed below under “Industry Practice Relating to Working Capital Items,” future demand for our products may not increase at a rate we
previously anticipated. In addition, we utilize contract manufacturers for certain products to satisfy customer demand in a timely manner. As a result, in
each of the years ended March 31, 2022, 2021, and 2020, backorders represented less than 5% of our consolidated net sales.
Competition and Pricing
The pharmaceutical industry is intensely competitive. We compete with the original manufacturers of the brand-name equivalents of our generic
products, other generic drug manufacturers (including brand-name companies that also manufacture generic drugs or license their products to other generic
drug manufacturers) and manufacturers of new drugs that may compete with our generic drugs. Many of our competitors have greater financial,
production, and research and development resources, substantially larger sales and marketing organizations, and substantially greater name recognition than
we have. In the recent past, the barriers to entry for new entrants to the generic industry have significantly reduced, thus resulting in a larger competitive
field. At the same time, the customer base for the generic manufacturers has seen significant consolidation at the purchasing level, resulting in increased
purchasing power for the customer. This dual effect of increased competition and increased purchasing power has resulted in a downward trend for prices
for our generic products.
Additionally, brand-name drug companies have historically attempted to prevent generic drug manufacturers from producing certain products and to
prevent competing generic drug products from being accepted as equivalent to their brand-name products. We expect such efforts to continue in the future.
Also, some brand-name competitors, in an attempt to participate in the generic drug sales of their branded products, have introduced generic equivalents of
their own branded products, both prior and subsequent to the expiration of their patents or FDA exclusivity periods for such drugs. These competitors have
also introduced authorized generics or generic equivalents of brand-name drug products. Our brand-name drug competitors are increasingly selling their
branded products through controlled distribution channels, further limiting our access, and increasing competitive intensity with those generic
manufacturers.
Competitive factors in the major markets in which we participate can be summarized as follows:
North America
The U.S. pharmaceutical market is undergoing, and is expected to continue to undergo, rapid and significant market and technological changes and
we expect competition to intensify as these market and scientific advances are made. We intend to effectively
29
compete in this marketplace by focusing on a niche product development strategy highlighted by differentiated technologies and dedicated focus on
therapeutic areas which play to our strengths.
In the U.S., we compete with branded pharmaceutical manufacturers such as Bristol-Myers Squibb Company, Celgene Corporation,
GlaxoSmithKline Inc., Merck & Co., Inc., Novartis AG, Pfizer Inc., Bausch Health Companies Inc. and Galderma Laboratories, LP., as well as with
generic companies such as Teva Pharmaceuticals U.S.A., Viatris Inc., Perrigo Company PLC, Glenmark Generics, Inc., USA and Sandoz Pharmaceuticals
(the generics subsidiary of Novartis). Many of these companies have more resources, market, and name recognition and better access to customers than we
have. Therefore, there can be no assurance that we can compete successfully with them.
A significant portion of our sales are made to a relatively small number of wholesalers, retail drug chains, food chains, and mass merchandisers,
which continue to undergo significant consolidation. We face increasing product pricing pressures as a result of this consolidation as well as the emergence
of large buying groups who are able to negotiate price discounts on our products.
There can be no guarantee that Taro will not continue to experience challenges during the current year in comparison to prior years, especially for
our generic drug division, due to price erosion from our customers increased focus on lower pricing, customer consolidation, and increased competition in
specific product segments due to new entrants in our markets. These challenges could have a material impact on our business, cash flows, and results of
operations or result in impairment charges, and the market value of our share price may decline.
In Canada, our competition includes Merck Canada Inc., Pfizer Canada Inc., Janssen Inc., Novartis Pharmaceuticals Canada Inc., GlaxoSmithKline
Inc., Valeant Canada, AstraZeneca Canada, Johnson & Johnson Inc., Bayer Inc. and Bristol-Myers Squibb Canada. We also compete with other
manufacturers of generic products, such as Apotex Inc., Teva Canada Limited, Viatris Inc., Sandoz Canada Incorporated and Pharmascience Inc.
Depending on the product, pricing in Canada is established by competitive factors or by Canadian provincial formulary price lists published by the
Canadian provinces.
Israel
In Israel, we compete with Teva Pharmaceutical Industries Ltd., Perrigo Israel Pharmaceuticals Ltd., Dexcel Pharma Israel, and Rafa Laboratories
Ltd., among others. In addition, many leading multinational companies, including Bayer AG, Eli Lilly and Company, Merck & Co., Inc. and Pfizer Inc.
market their products in Israel.
In Israel, the government establishes the prices for pharmaceutical products as part of a formal review process. There are no restrictions on the
import of pharmaceuticals provided that they comply with registration requirements of the Israeli Ministry of Health.
Manufacturing and Raw Materials
We currently manufacture finished pharmaceutical products at our government approved facilities in Canada and Israel and APIs in our Israel
facility.
For the manufacture of our finished dosage form pharmaceutical products, we use pharmaceutical chemicals that we either produce ourselves or
purchase from chemical manufacturers in the open market globally. Substantially all of such chemicals are obtainable from a number of sources, subject to
regulatory approval. However, we purchase certain raw materials from single source suppliers. The decision to purchase APIs is a function of our sales
forecast and prevailing prices in the market. When appropriate purchasing opportunities arise, the Company may acquire certain APIs in excess of its
ordinary requirements or rate of growth. Obtaining the regulatory approvals required to add alternative suppliers of such raw materials for products sold in
the U.S. or Canada may be a lengthy process. We strive to maintain adequate inventories of single-source raw materials in order to ensure that any delays
in receiving such regulatory approvals will not have a material adverse effect on our business. However, we may become unable to sell certain products in
the U.S., Canada, or Israel pending approval of one or more alternate sources of raw materials.
We synthesize the APIs used in some of our key products, including steroids, anti-fungals, CNS, NSAIDS, anticoagulants, and dermatological
preparations. We plan to continue the strategic selection of APIs for synthesis in order to maximize the advantages from this scientific and manufacturing
capability.
Although, prices of principal raw materials have been relatively stable, the Company has programs to keep the cost of APIs consistent or to improve
upon them; for example, through the qualification of alternate suppliers and process improvements.
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Industry Practices Relating to Working Capital Items
Certain customary industry selling practices affect our working capital, including, but not limited to, providing favorable payment terms to
customers and discounting selling prices through the issuance of free products as well as other incentives within a specified time frame if a customer
purchases more than a specified threshold of a product. These incentives are provided principally with the intention of maintaining or expanding our
distribution to the detriment of competing products.
Industry practice requires that pharmaceutical products be made available to customers from existing stock rather than on a made-to-order basis.
Therefore, in order to accommodate market demand adequately, we strive to maintain a sufficient level of inventory.
Government Regulation
We are subject to extensive regulations in the U.S., Canada, Israel, and other jurisdictions, and may be subject to future legislative and other
regulatory developments concerning our products and the healthcare field generally. Any failure by us to comply with applicable policies and regulations
of any of the numerous authorities that regulate our industry could have a material adverse effect on our results of operations.
Prescription Drugs
In the U.S., the Federal Food, Drug, and Cosmetic Act (the “FDC Act”) and other federal and state statutes and regulations, govern, among other
things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval
monitoring and reporting, sampling, and import and export of pharmaceutical products. Failure to comply with applicable U.S. requirements may subject a
company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending new drug applications (“NDAs”) or ANDAs, warning
or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties, and criminal
prosecution. In Canada, Israel and other jurisdictions, the manufacture and sale of pharmaceutical products are regulated in a similar manner. Legal
requirements generally prohibit the handling, manufacture, marketing and importation of any pharmaceutical product unless it is properly registered in
accordance with applicable law. In addition, approval is required before any new drug or a generic equivalent to a previously approved drug can be
marketed. Furthermore, each country requires successful inspections or approval of manufacturing facilities, including adherence to cGMPs during the
production and storage of pharmaceutical components, including, but not limited to, raw materials and finished products. As a result, we have had periodic
inspections of our facilities and records.
Regulatory authorities in each country also have extensive enforcement powers over the activities of pharmaceutical manufacturers, including the
power to seize, force the recall of and prohibit the sale or import of non-complying products and to halt the operations of and criminally prosecute and fine
non-complying manufacturers. These regulatory authorities also have the power to revoke approvals previously granted and remove from the market
previously approved drug products.
In the U.S., Canada, Israel, and other jurisdictions, we, as well as other manufacturers of drugs, are dependent on obtaining timely approvals for
products. The approval process in each country has become more rigorous and costly in recent years. There can be no assurance that approvals will be
granted in a timely manner or at all. In addition, the procedure for drug product approvals, if such approval is ultimately granted, generally takes longer
than one year. The review processes in Canada and Israel are substantively similar to the review process in the U.S.
In the U.S., any drug that is not generally recognized as safe and effective by qualified experts for its intended use is deemed to be a new drug,
which generally requires FDA approval. Approval is obtained, either by the submission of an ANDA or an NDA. If the new drug is a new dosage form, a
strength not previously approved, a new indication or an indication for which the ANDA procedure is not available, an NDA is required. Pharmaceutical
product development for a new product or certain changes to an approved product in the U.S. typically involves preclinical laboratory and animal tests, the
submission to the FDA of an investigational new drug application (“IND”), which must become effective before clinical testing may commence, and
adequate and well-controlled clinical trials to establish the safety and effectiveness of the drug for each indication for which FDA approval is sought.
Satisfaction of FDA approval to market requirements typically takes many years and the actual time required may vary substantially based upon the type,
complexity, and novelty of the product or disease.
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Preclinical tests include laboratory evaluation of product chemistry, formulation, and toxicity, as well as animal trials to assess the characteristics
and potential safety and efficacy of the product. The conduct of the preclinical tests must comply with federal regulations and requirements, including
good laboratory practices. The results of preclinical testing are submitted to the FDA as part of an IND along with other information, including
information about product chemistry, manufacturing and controls, and a proposed clinical trial protocol. Long-term preclinical tests, such as animal tests of
reproductive toxicity and carcinogenicity, may continue after the IND is submitted.
A 30-day waiting period after the submission of each IND is required prior to the commencement of clinical testing in humans. If the FDA has
neither commented on nor questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin.
Clinical trials involve the administration of the investigational new drug to healthy volunteers or patients under the supervision of a qualified
investigator. Clinical trials must be conducted: (i) in compliance with federal regulations; (ii) in compliance with good clinical practice (“GCP”), an
international standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators, and monitors; as
well as (iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety, and the effectiveness criteria to be
evaluated. Each protocol involving testing on U.S. patients and subsequent protocol amendments must be submitted to the FDA as part of the IND.
The FDA may order the temporary, or permanent, discontinuation of a clinical trial at any time, or impose other sanctions, if it believes that the
clinical trial either is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial patients. The study
protocol and informed consent information for patients in clinical trials must also be submitted to an institutional review board (“IRB”), for approval. An
IRB may also require the clinical trial at the site to be halted, either temporarily or permanently, for failure to comply with the IRB’s requirements, or may
impose other conditions.
We generally receive approval for generic products by submitting an ANDA to the FDA. Generally, an ANDA provides for marketing of a drug
product that contains the same active ingredient and has the same route of administration, dosage form, and strength as a previously approved drug (also
known as the reference listed drug) and has been shown to be bioequivalent to the reference listed drug. Other than the requirement for bioequivalence
testing, ANDA applicants are not required to conduct, or submit results of, pre-clinical or clinical tests to prove the safety or effectiveness of their drug
product. For a systemically absorbed drug, bioavailability is generally determined by the rate and extent of absorption and levels of concentration of a drug
product in the blood stream needed to produce a therapeutic effect. Bioequivalence compares the bioavailability of one drug product with another and,
when established, indicates that the rate and extent of absorption of a generic drug in the body are substantially equivalent to the previously approved
brand-name reference listed drug. For a topical drug, and other drug products not amenable to blood level studies, clinical endpoint studies are typically
used as an indirect measure of formulation difference in bioavailability between the test and reference products. ANDA approvals are granted after the
review by the FDA of detailed information submitted as part of the ANDA regarding the pharmaceutical ingredients, drug production methods, quality
control, labeling, and demonstration that the product is bioequivalent to the brand-name reference listed drug. Demonstrating bioequivalence generally
requires data demonstrating that the generic formula results in a product whose rate and extent of absorption are within an acceptable range of the results
achieved by the brand-name reference listed drug. In some instances, bioequivalence can be established by demonstrating that the therapeutic effect of the
generic product falls within an acceptable range of the therapeutic effects achieved by the brand-name reference listed drug. Generic drug user fees
pursuant to the Generic Drug User Fee Amendments must be paid to FDA upon submission of each ANDA and Drug Master File as well as for any
manufacturing facilities. In addition, an applicant under an approved ANDA is subject to an annual program fee based on the number of ANDAs held.
Products resulting from our proprietary drug program may require us to submit an NDA to the FDA. An NDA must include the results of all
preclinical, clinical, and other testing and a compilation of data relating to the product’s pharmacology, chemistry, manufacture, and controls. The clinical
studies required prior to the NDA submission are both costly and time consuming, and often take five to seven years or longer, depending, among other
factors, on the nature of the chemical ingredients involved and the indication for which the approval is sought. The cost of preparing and submitting an
NDA is also substantial. The submission of most NDAs is additionally subject to a substantial application user fee, and the applicant under an approved
NDA is also subject to an annual program fee for each prescription drug product pursuant to the Prescription Drug User Fee Act. The FDA has 60 days
from its receipt of an NDA to determine whether the application will be filed based on the agency’s threshold determination that it is sufficiently complete
to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review. The FDA has agreed to certain performance
goals in the review of NDAs. A majority of such applications for standard review drug products are reviewed within 10 to 12 months; most applications
for priority review drugs are reviewed in six to eight months. Priority review can be applied to drugs that the FDA determines offer major advances in
treatment, or provide a treatment where no adequate therapy exists. For biologics, priority review is further limited only for drugs intended to treat a
serious or life-threatening disease relative to the currently approved products. The review process for both standard and priority review may be extended
by FDA for three additional months to consider certain late-submitted information, or information intended to clarify information already provided in the
submission.
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The FDA may also refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, 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. The FDA is not bound by the recommendation of an advisory committee, but it generally follows such recommendations. Before approving
an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the FDA will inspect the facility or the
facilities at which the drug is manufactured. The FDA will not approve the product unless compliance with cGMP is satisfactory, and the NDA contains
data that provide substantial evidence that the drug is safe and effective in the indication studied.
Among the requirements for drug approval by the FDA is that manufacturing procedures and operations conform to cGMP. The cGMP regulations
must be followed at all times during the manufacture of pharmaceutical products. During the review of an NDA or ANDA, the FDA will typically inspect
the facility or the facilities at which the drug is manufactured. The FDA will not approve the product unless compliance with cGMP is satisfactory. In
addition, quality-control, drug manufacture, packaging, and labeling procedures must continue to conform to cGMPs after approval. Drug manufacturers
and certain of their subcontractors are required to register their establishments with the FDA and certain state agencies. Registration with the FDA subjects
entities to periodic unannounced inspections by the FDA, during which the agency inspects manufacturing facilities to assess compliance with cGMPs.
Accordingly, manufacturers must continue to expend time, money, and effort in the areas of production and quality-control to maintain compliance with
cGMPs. If the FDA believes a company is not in compliance with cGMP, certain sanctions may be imposed, including: (i) withholding new drug approvals
as well as approvals for supplemental changes to existing applications; (ii) preventing the receipt of necessary licenses to export products; (iii) preventing
the importation of certain products into the U.S.; (iv) classifying the company as an unacceptable supplier and thereby disqualifying the company from
selling products to federal agencies; and (v) pursuing a consent decree or court action that limits company operations and/or imposes monetary fines.
After the FDA evaluates the NDA and the manufacturing facilities, it issues either an approval letter or a complete response letter. A complete
response letter generally outlines the deficiencies in the submission and may require substantial additional testing, or information, in order for the FDA to
reconsider the application. If, or when, those deficiencies have been addressed to the FDA’s satisfaction in the resubmission of the NDA, the FDA will
issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications.
Changes to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes or
facilities, require submission and FDA approval of a new NDA or NDA supplement before the change can be implemented. An NDA supplement for a
new indication typically requires clinical data similar to that in the original application, and the FDA uses the same procedures and actions in reviewing
NDA supplements as it does in reviewing NDAs.
As a condition of ANDA or NDA approval, the FDA may require a risk evaluation and mitigation strategy (“REMS”), to help ensure that the
benefits of the drug outweigh the potential risks. REMS can include medication guides, communication plans for healthcare professionals, and elements to
assure safe use (“ETASU”). ETASU can include, but are not limited to, special training or certification for prescribing or dispensing, dispensing only under
certain circumstances, special monitoring, and the use of patient registries. The requirement for REMS can materially affect the potential market and
profitability of the drug. Moreover, product approval may require substantial post-approval testing and surveillance to monitor the drug’s safety or efficacy.
Once granted, product approvals may be withdrawn if compliance with regulatory standards is not maintained, or problems are identified following initial
marketing.
In addition, because we market drugs that are classified as controlled substances in the U.S., Canada and Israel, we must meet the requirements of
the federal CSA and relevant state laws and regulations in the U.S. as well as equivalent laws in Canada and Israel. These regulations include stringent
requirements for handing and receipt of controlled substances including import, export, manufacture, storage, distribution and dispensing. These
requirements include registration/licensing, manufacturing controls (e.g., quotas), import permits/declarations, inventory, recordkeeping, monitoring,
disposal, reporting, and security to ensure accountability and prevent diversion of, or the unauthorized access to, the controlled substances in each stage of
the production, storage and distribution process. The DEA and state agencies (e.g., relevant state boards of pharmacy) inspect manufacturers, distributors,
importers, and exporters that are registered with the DEA and licensed by state agencies to review and ensure compliance with the federal CSA and
comparable state laws, and DEA regulations with respect to security, record keeping, inventory and reporting prior to issuing a federal controlled substance
registration or state license. The specific security requirements vary by the type of business activity (e.g., manufacturing as opposed to pharmacy
dispensing) and the classification or schedule of the controlled substances (e.g., Schedule II narcotics as opposed to Schedule IV benzodiazepines) handled
by the registrant. Once registered, manufacturing, distributing, exporting or importing facilities must maintain records documenting the manufacture,
receipt, distribution, storage, import, or export of all controlled substances. Manufacturers are required to obtain quotas for certain Schedule I and II
controlled substances. Also, manufacturers and distributors must submit periodic reports to the DEA on the distribution of Schedule I and II controlled
substances, Schedule III narcotic substances, and other designated substances. All DEA registrants must report any potentially suspicious orders for
controlled substances and any thefts or significant losses. DEA registrants must also follow appropriate disposal procedures and in some cases, obtain
authorization to destroy or dispose of controlled substances. Most states impose similar licensing, recordkeeping, monitoring, reporting and security
requirements. In addition to maintaining an importer and/or exporter registration, importers and exporters of controlled substances must obtain a permit for
every import or export of a Schedule I or II substance and a narcotic substance in Schedule III, IV, and V. For all other drugs in Schedule III, IV, and V,
importers and exporters must submit an import or export declaration. Failure to maintain the appropriate registrations and licenses, both federal and state,
or to obtain sufficient quota or approval for imports and
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exports could have a material adverse effect on our business. Failure to comply with applicable requirements, particularly resulting in the theft, loss or
diversion of controlled substances, can result in significant enforcement action that could have a material adverse effect on our business, operations and
financial condition. The DEA and/or state authorities may seek civil monetary penalties, refuse to renew necessary registrations or licenses, or initiate
proceedings to revoke those registrations/licenses. In certain circumstances, violations could lead to criminal prosecution.
In May 1992, the Generic Drug Enforcement Act of 1992 (the “Generic Act”) was enacted. The Generic Act, a result of legislative hearings and
investigations into the generic drug approval process, allows the FDA to impose debarment and other penalties on individuals and companies that commit
certain illegal acts relating to the generic drug approval process. In some situations, the Generic Act requires the FDA not to accept or review, for a period
of time, ANDAs from a company or an individual that has committed certain violations. It also provides for temporary denial of approval of applications
during the investigation of certain violations that could lead to debarment and also, in more limited circumstances, provides for the suspension of the
marketing of approved drugs by the affected company.
The Generic Act also allows for civil penalties and withdrawal of previously approved applications. To our knowledge, neither we, nor any of our
employees has ever been subject to debarment.
Any distribution of prescription drug products in their finished dosage form and pharmaceutical samples must comply with the U.S. Prescription
Drug Marketing Act (“PDMA”), a part of the FDC Act. In addition, Title II of the Federal Drug Quality and Security Act of 2013, known as the Drug
Supply Chain Security Act (“DSCSA”), has imposed new “track and trace” requirements on the distribution of prescription drug products by
manufacturers, distributors, and other entities in the drug supply chain. These requirements are being phased in over a ten-year period. The DSCSA
requires the transmission of transaction information, transaction history and a transaction statement with finished dosage form drug products introduced
into interstate commerce in the U.S. In addition, the products may only be sold to entities that are authorized trading partners as defined in the DSCSA.
The DSCSA also requires drug manufacturers, distributors and other entities in the supply chain to investigate, quarantine and report drug products that are
either suspect or illegitimate, as more fully described in the DSCSA. The DSCSA also requires manufacturers to include product identifiers (i.e.,
serialization) on prescription drug products and will eventually require the establishment of an electronic interoperable prescription product system to
identify and trace certain prescription drugs distributed in the U.S. These requirements will result in increased expenses and may create additional
administrative encumbrances. Failing to comply with these requirements could result in enforcement actions by the FDA, including but not limited to the
imposition of penalties or fines.
Cosmetics and Over-the-Counter Drugs
Cosmetics and OTC drug products are subject to regulation by the FDA, as well as various other federal, state, local, and foreign regulatory
authorities. These laws and regulations principally relate to the ingredients, design, safety, clearance, approval or authorization, manufacture, packaging,
recordkeeping, proper labeling, advertising, marketing, shipment, and disposal of such products. In addition, the Federal Trade Commission (“FTC”) is
specifically authorized to regulate advertising of OTC products to prevent unfair or deceptive acts or practices in such advertising. Failure to comply with
applicable requirements may subject a cosmetic and an OTC drug product and its manufacturer to a variety of administrative sanctions, such as FDA
issuance of warning letters or untitled letters, mandatory product recalls, import detentions, civil monetary penalties and judicial sanctions, such as product
seizures, injunctions and criminal prosecution.
Under the FDC Act, a “cosmetic” is defined as a product that is applied to the human body and intended to cleanse, beautify, or alter its appearance.
The labeling of cosmetic products is subject to the requirements of the FDC Act, the Fair Packaging and Labeling Act, and FDA implementing regulations.
The FDC Act prohibits marketing of adulterated cosmetics (e.g., products that contain unsafe ingredients, products with deficiencies in the manufacturing
process, or products with labeling that render the product adulterated). It is also unlawful under the FDC Act to market a cosmetic that is misbranded. The
FDA relies heavily on voluntary compliance by the cosmetics industry. There is no premarket ingredient or label review requirement and no list of
approved ingredients, and there are no regulations governing cGMPs. As such, FDA enforcement activities generally target either unsafe cosmetics or
cosmetics that, by virtue of inappropriate claims in the product’s labeling or promotional materials, are subject to the regulatory regime that governs drugs.
Under the FDC Act, a “drug” is defined, in relevant part, as a product intended for use in the treatment or prevention of disease or intended to affect
the structure or any function of the body. The FDA may consider labeling claims in determining the intended use of a product. Generally, any “new drug”
must undergo FDA review for safety and efficacy to obtain marketing approval before it may be legally marketed. However, if the drug is generally
recognized as safe and effective, then it is exempt from regulation as a “new drug” and may be marketed without prior approval.
Most OTC drugs are marketed pursuant to FDA regulations (known as “monographs”) that permit whole classes of drugs to be marketed without
premarket approval if certain conditions are met. The FDA’s OTC Drug Monograph Review was a rulemaking process that established conditions under
which certain active ingredients, in certain amounts, and with specific labeling, may be marketed as OTC drugs without requiring FDA approval of an
NDA. The FDA developed monographs for many categories of drug products, including sunscreen drug products and acne drug products. Monographs do
not specify which inactive ingredients may or may not be
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used. It is the responsibility of the manufacturer, marketer, and distributor to ensure that the finished product, including all inactive ingredients, is safe and
effective for its intended use.
Recent legislation included OTC monograph reform provisions addressing the reform of the monograph review process. The reform is designed to
move the OTC monograph drug review framework from one of notice and comment rulemaking to an administrative order process exempt from certain
requirements of the Administrative Procedures Act. As a result of the OTC monograph reform, several drug products that were previously marketed under
the FDA’s compliance policy became unapproved drugs. Whereas monographs establish the FDA’s determination that certain active ingredients are
GRASE for specific uses under specific conditions of use—that is, that they are not new drugs—a product that does not meet the requirements of a
monograph must meet the statutory and regulatory requirements for all new drugs. Such products may be marketed only if the FDA first reviews and
approves an NDA or an ANDA for the product.
The FTC regulates cosmetic and OTC drug advertising and promotional materials under the Federal Trade Commission Act (“FTC Act”), which
prohibits unfair or deceptive acts or practices as well as the dissemination of any false advertisement that is likely to induce the purchase of cosmetics or
drugs. The FTC requires that all express and implied claims must be substantiated and that advertisers have a reasonable basis for all claims. The FTC has
historically applied a standard of competent and reliable scientific evidence for health-related claims and defined the standard generally to require tests,
analyses, research or studies that have been conducted and evaluated in an objective manner by qualified persons and are generally accepted in the
profession to yield accurate and reliable results. More recently, the FTC has interpreted this standard as requiring, in some instances, randomized, double-
blind, placebo-controlled clinical trials. The FTC is authorized to issue cease-and-desist orders enforceable by injunctions and criminal contempt
proceedings as penalties for violating the FTC Act, as well as to proceed directly in federal court for injunctive relief.
Other Healthcare Laws
Several types of state and federal laws have been applied to prohibit or restrict certain marketing practices in the pharmaceutical industry. These
laws include anti-kickback statutes and false claims statutes. The federal healthcare program anti-kickback statute prohibits, among other things,
knowingly and willfully offering, paying, soliciting or receiving remuneration to induce, or in return for, purchasing, leasing, ordering, recommending or
arranging for the purchase, lease or order of any healthcare item or service reimbursable under Medicare, Medicaid, or other federally financed healthcare
programs. The PPACA, enacted in March 2010, amended the intent element of the federal anti-kickback statute so that a person or entity no longer needs
to have actual knowledge of the statute or specific intent to violate it. This statute has been interpreted to apply to arrangements between pharmaceutical
manufacturers on the one hand and prescribers, purchasers, and formulary managers on the other. Violations of the anti-kickback statute are punishable by
imprisonment, criminal fines, civil monetary penalties, and/or exclusion from participation in federal healthcare programs. Although there are a number of
statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution or other regulatory sanctions, the exemptions and
safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchases, or recommendations may be subject to
scrutiny if they do not qualify for an exemption or safe harbor.
The Federal False Claims Act prohibits any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal
government, or knowingly making, or causing to be made, a false statement material to a false claim. This includes claims made to programs where the
federal government reimburses, such as Medicare and Medicaid, as well as programs where the federal government is a direct purchaser, such as when it
purchases off the Federal Supply Schedule. Numerous pharmaceutical companies have been sued under this law for allegedly inflating drug prices they
report to pricing services or to the federal government, which in turn were used by the government to set Medicare and Medicaid reimbursement rates or
Medicaid rebates. In addition, certain marketing practices, including off-label promotion, may also violate the Federal False Claims Act. Additionally, the
PPACA amended the federal anti-kickback statute such that a violation of that statute can also serve as a basis for liability under the Federal False Claims
Act. The majority of states also have statutes or regulations similar to the federal anti-kickback law and the Federal False Claims Act, which apply to items
and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.
There are also an increasing number of state laws with requirements for manufacturers and/or marketers of pharmaceutical products. Some states
require the reporting of expenses relating to the marketing and promotion of drug products and the reporting of gifts and payments to individual healthcare
practitioners in these states. Other states prohibit various marketing-related activities, such as the provision of certain kinds of gifts or meals. Still other
states require the reporting of certain pricing information, including information pertaining to and justification of launch prices or price increases greater
than a specified threshold. In addition, states such as California, Connecticut, Nevada, and Massachusetts require pharmaceutical companies to implement
compliance programs and/or marketing codes. Many of these laws contain ambiguities as to what is required to comply with the laws. In addition, as
discussed below, a similar federal requirement requires manufacturers to track and report to the federal government certain payments made to teaching
hospitals, physicians and certain other types of health care professionals made in the previous calendar year. These laws may affect our sales, marketing
and other promotional activities by imposing administrative and compliance burdens on us, and companies that do not comply with these state laws face
civil penalties.
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Federal law requires that a pharmaceutical manufacturer, as a condition of having its products receive federal reimbursement under Medicaid and
Medicare Part B, must pay rebates to state Medicaid programs for all units of its covered outpatient drugs dispensed to Medicaid beneficiaries and paid for
by a state Medicaid program under either a fee-for-service arrangement or through a managed care organization. The rebates are based on prices reported
to CMS by manufacturers for their covered outpatient drugs (AMP for generic drugs, and AMP and best price for brand drugs). CMS issued final
regulations regarding the calculation of AMP and rebates under the Medicaid Drug Rebate Program, effective as of April 1, 2016. The terms of
participation in the Medicaid Drug Rebate Program impose an obligation to correct the prices reported in previous quarters, as may be necessary. Any such
corrections could result in additional or lesser rebate liability, depending on the direction of the correction. In addition to retroactive rebates, if a
manufacturer were found to have knowingly submitted false information to the government, federal law provides for civil monetary penalties for failing to
provide required information, late submission of required information, and false information.
A manufacturer must also participate in a federal program known as the 340B drug discount program in order for federal funds to be available to
pay for the manufacturer’s drugs under Medicaid and Medicare Part B. Under this program, the participating manufacturer agrees to charge certain
federally funded clinics and safety net hospitals, known as covered entities, no more than an established discounted price for its covered outpatient drugs.
The formula for determining the discounted price is defined by statute and is based on the AMP and the unit rebate amount as calculated under the
Medicaid Drug Rebate Program, discussed above. Civil monetary penalties can be imposed on manufacturers for each instance of overcharging a covered
entity. Manufacturers are required to report certain pricing information to the Office of Pharmacy Affairs within the Health Resources & Services
Administration.
Federal law also requires that manufacturers report data on a quarterly basis to CMS regarding the pricing of drugs that are separately reimbursable
under Medicare Part B. These are generally drugs, such as injectable products, that are administered “incident to” a physician service and are not generally
self-administered, as well as certain vaccines, oral dosage form chemotherapy and immunosuppressive therapy drugs and drugs used with durable medical
equipment such as infusion pumps. The pricing information submitted by manufacturers is used to set payment rates to health care providers and suppliers
for drugs covered under Medicare Part B. As with the Medicaid Drug Rebate Program, federal law provides for civil monetary penalties for failing to
provide required information, late submission of required information, and false information.
Manufacturers are also required to make their covered drugs, which are generally drugs approved under NDAs or biologics license applications
(“BLAs”), available to federal government departments and agencies and other authorized users of the Federal Supply Schedule (“FSS”) of the General
Services Administration. The law also requires manufacturers to offer discounted FSS contract pricing for purchases of their covered drugs by certain
government agencies in order for federal funding to be available for reimbursement or purchase of the manufacturer’s drugs under certain federal programs.
The discounts are determined based on prices that are calculated and reported to the government by manufacturers. The accuracy of a manufacturer’s
reported prices may be audited by the government. Among the remedies available to the government for inaccuracies is recoupment of any overcharges to
the government. If a manufacturer were found to have knowingly reported false prices, in addition to other penalties available to the government, the law
provides for civil monetary penalties per incorrect item.
The PPACA, as well as subsequent legislation, such as the BBA, have had an impact on all segments of the health care industry. Pharmaceutical and
medical device manufacturers have seen an increase in revenues by virtue of additional Americans who have access to health insurance beginning in 2014;
however, the legislation imposes on manufacturers a variety of additional rebates, discounts and fees that have curtailed that increase in revenues. For
example, manufacturers subsidize 70% of the cost of providing brand drugs (approved via an NDA) to Medicare Part D beneficiaries within the coverage
gap. As another example, the PPACA increased the minimum Medicaid rebate rate from 15.1% to 23.1% of AMP for most drugs approved under an NDA,
and increased the Medicaid rebate from 11% to 13% of AMP for drugs approved under an ANDA. In another example, under the BBA, generic drugs
approved under an ANDA are subject to an additional Medicaid rebate if the AMP for a given quarter exceeds the inflation-adjusted baseline AMP,
effective for the first calendar quarter of 2017. This price increase penalty previously applied only to innovator drugs. For generic drugs, the baseline
AMP will depend on when the drug was launched. For innovator drugs, the baseline AMP is the AMP for the first full quarter after launch. Also, annual
fees are imposed on each manufacturer and importer of branded prescription drugs or biologics, based on the ratio of its sales reimbursed or purchased by
government agencies to such sales made by all drug manufacturers during the prior year, and based on different sales dollar tiers (the highest being over
$400 million in brand sales, and the lowest being at least $5 million in brand sales).
The PPACA also imposed reporting and regulatory requirements. For example, the “sunshine” provisions impose tracking and reporting
requirements and public disclosure requirements on a drug manufacturer’s payments to physicians, physician assistants, certain types of advanced practice
nurses and teaching hospitals. Annual reports are due in March of each year. The data reported under the “sunshine” provisions are posted in searchable
form on a public website.
36
In addition, the legislation advances the policy of comparative clinical effectiveness research on medical treatments, services and items, including
drugs and devices. Taken together, these government health care reform measures may adversely impact the pricing of healthcare products and services in
the U.S. and the amount of reimbursement available from governmental agencies or other third-party payors. Government cost control initiatives could
decrease the price that we or any current or potential collaborators could receive for any of our products and could adversely affect our profitability.
Environmental Compliance
We believe that we are currently in compliance with all applicable environmental laws and regulations in all of the countries in which we operate.
C. ORGANIZATIONAL STRUCTURE
The legal and commercial name of our company is Taro Pharmaceutical Industries Ltd. We were incorporated under the laws of the State of Israel
in 1959 under the name Taro-Vit Chemical Industries Ltd. In 1984, we changed our name to Taro Vit Industries Ltd., and in 1994, we changed our name to
Taro Pharmaceutical Industries Ltd.
The following is a list of our significant subsidiaries and their countries of incorporation as of March 31, 2022:
Name of Subsidiary
Taro Pharmaceuticals U.S.A., Inc.
Taro Pharmaceuticals Inc.
Taro Pharmaceuticals North America, Inc.
Taro Pharmaceuticals Europe B.V.
Taro International Ltd.
The Proactiv Company Holdings, Inc.
Proactiv YK
The Proactiv Company Corporation
Country of Incorporation
United States
Canada
Cayman Islands
Netherlands
Israel
United States
Japan
Canada
On June 1, 2021, the Company and The Taro Development Corporation each transferred its ownership of the shares of Taro U.S.A. to Taro Canada.
Taro U.S.A. is now 100% owned by Taro Canada, which remains 100% owned by the Company.
On February 28, 2022, as part of the Alchemee acquisition, Taro U.S.A. acquired 100% ownership of The Proactiv Company Holdings, Inc.,
Proactive YK and The Proactiv Company Corporation, including their respective subsidiaries. Taro U.S.A. assigned its entire ownership of the shares of
those entities to the Company.
The Company owns 100% of the shares of Taro International Ltd., Taro Pharmaceuticals North America, Inc., and Taro Canada. The Company
owns 99.75% of Taro Pharmaceuticals Europe B.V. and Taro Pharmaceuticals North America, Inc. owns the remaining 0.25%.
On January 25, 2022, a wholly-owned subsidiary of Taro U.S.A., Taro Pharmaceutical Laboratories, Inc., a Delaware corporation, merged with and
into Taro U.S.A.
Sun beneficially owns 85.7% of the voting power of the Company as of March 31, 2022.
37
D. PROPERTY, PLANT AND EQUIPMENT
The following is a list of our principal facilities as of March 31, 2022:
Location
Haifa Bay, Israel
Brampton, Canada
Brampton, Canada
Hawthorne, New York
Cranbury, New Jersey
Santa Monica, California
Square Footage
Main Use
912,000
159,000
73,000
Pharmaceutical
manufacturing, production and
research laboratories,
administration, warehousing
and chemical production
(including tank farm and
chemical finishing plant)
Pharmaceutical
manufacturing, production and
research laboratories,
administration, distribution,
and warehousing
Administration and
warehousing
124,000
315,000
13,423
Administrative offices
Distribution facility
Administrative offices
Own/Lease
Long-term Lease /
Own (1)
Own
Lease
Own
Own
Lease
(1)
The land housing the majority of our manufacturing, production laboratories and research facilities, as described above is held by the Company
under a long-term lease from the Israel Land Authority (“ILA”). The buildings and the vast majority of the equipment on this land are owned by the
Company.
From April 1, 2019 through March 31, 2022, we invested $55.4 million in property, plant, and equipment. Most of these projects have been
completed and are subject to depreciation in accordance with our accounting policy of capitalizing costs that are direct and incremental to the activities
required to bring the facilities to commercial production.
Our manufacturing plant, research and office facilities in Haifa Bay, Israel are located in a complex of buildings with an aggregate area of 912,000
square feet. We lease much of the land underlying these facilities from the ILA pursuant to long-term ground leases that expire between 2018 and 2060. In
accordance with the regulations of the ILA, the Company is entitled to extend the lease agreement ending 2018 for an additional period of 49 years and is
in the process of extending the lease agreement. For additional information, please refer to Note 2.i. and 2.j. to our consolidated financial statements
included elsewhere in this 2022 Annual Report.
We have owned our main manufacturing facility in Brampton, Canada since 1992. Since then, we have purchased additional adjacent square
footage and engaged in projects to develop and expand the facility to meet our growing manufacturing needs. As of March 31, 2022, we owned a total of
159,000 square feet at our main manufacturing facility. In addition to our owned space, since September 2000, Taro Canada has leased 73,000 square feet
of office and warehouse space, adjacent to our main manufacturing facilities, which lease term continues to September 2025.
A subsidiary of Taro U.S.A. has owned its 124,000 square foot building in Hawthorne, New York since February 2005. The mortgage was repaid on
this building in December 2015.
A subsidiary of Taro U.S.A. owns a 315,000 square foot distribution facility in Cranbury, New Jersey. The mortgage was repaid on this facility in
February 2012. To enhance the management of warehousing and transportation services at and from our Cranbury distribution facility, on December 2,
2020, Taro U.S.A. entered into a services agreement with a leading third-party warehousing and transportation management provider. The transition of
services to the third party started in February 2021. Once the transition is completed, the third party will provide warehousing, managed transportation, and
other logistics services to the Cranbury distribution facility.
In the pharmaceutical industry, both manufacturing plants and equipment must be constructed and installed in accordance with regulations designed
to meet stringent quality and sterility guidelines, among others. In order to meet these requirements, certain validation processes are required to be
completed prior to commencing commercial production.
38
Design qualification (“DQ”), installation qualification (“IQ”), operational qualification (“OQ”), performance qualification (“PQ”) and validation are
the steps required by cGMPs to bring plants and/or equipment to the status of their intended use. In the performance of these activities, the Company uses
both internal and external resources. The Company capitalizes external costs and those internal costs that are direct and incremental to the activities
required to bring the facilities and activities to commercial production.
In the pharmaceutical industry, project life cycles (e.g., the construction of a new manufacturing facility) are typically longer than those in other
industries. Such projects are technically complicated due to the highly regulated nature of the industry and the necessity of complying with specific
detailed demands of regulatory authorities such as the FDA.
Certain internal resources utilized in bringing these facilities to the status required for their intended use are completely dedicated to these projects.
The costs of personnel involved in such a process are capitalized only to the extent that they are directly dedicated to the completion of the facilities.
As described below, the nature of the activities performed by the employees whose salaries were capitalized include only the work and the direct
costs associated with the factory acceptance test (“FAT”), the installation of equipment and the qualification and testing of the equipment prior to its
commercial use.
The typical stages for defining the beginning and the completion of such construction projects include: planning and design of the facilities;
construction; purchase, transportation, and installation of equipment; equipment and facility validation (run in tests); and process and product validation.
All new equipment must undergo DQ, IQ, OQ, and PQ in order to test and verify, according to written protocols, that all aspects of the equipment
meet pre-determined specifications. IQ is defined as the documented evidence that the equipment has been installed according to the approved drawings
and specifications. OQ is the documented evidence that all aspects of the equipment and the facility operate as intended within pre-determined ranges,
according to the operational specifications. PQ is defined as the documented evidence that all aspects of the facility, utility or equipment that can affect
product quality perform as intended in the pre-determined acceptance criteria.
Such qualification and validation activities are required for all equipment and systems that have an impact on or affect product quality and are
required prior to commencing commercial production. At the time of installation and validation, all employees who will operate and maintain the
equipment from the engineering, technology, and maintenance departments are appropriately trained. At this stage in the installation and validation
process, experts from the equipment manufacturer are on site, as part of the purchase contract, to provide training to Company employees in the operation
and maintenance of the equipment.
This phase, which is necessary to bring the asset to the condition required for its intended use, is handled by a multi-functional team of engineers
and technologists. The direct costs are the direct labor and the material consumed during this stage of installation and validation such as bottles, ampoules
and raw materials. Incremental costs, which have arisen in direct response to the additional activity, include the expenses directly attributable to any
employee’s time fully dedicated to the project in question. After the equipment has passed all DQ, IQ, OQ, and PQ tests, it is then tested for its ability to
actually manufacture the specific products that are intended to be produced on the equipment. Three consecutive successful validation batches must be
produced. This process is performed jointly by the technology and the manufacturing departments. In addition, the cleaning of the equipment must be
validated to assure that there is no carry-over residue to the next product to be manufactured using the equipment. Only after the validation batches that are
manufactured using the new equipment pass quality control and quality assurance tests can they be released for sale, completing the validation process. No
further costs are capitalized. This process is performed for all products.
During the installation process, materials from inventory are consumed. For example, in order to qualify a tablet press machine or an ampoule
filling machine, we use raw materials, including APIs and excipients, to run the qualification test. As part of this test, actual tablets are manufactured, and
costs are incurred. These tablets may neither be distributed nor sold. These qualification procedures are part of cGMPs mandated by the FDA and its
international counterparts. The amount of inventory capitalized as part of these projects is less than one percent of the total cost of the assets. We do not
capitalize, as part of the asset cost, inventories that are routinely produced in commercial quantities on a repetitive basis.
ITEM 4A. UNRESOLVED STAFF COMMENTS
None.
39
ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS
A. OPERATING RESULTS
The following discussion should be read in conjunction with our consolidated financial statements and related notes for the years ended March 31,
2022, 2021, and 2020, which are included elsewhere in this 2022 Annual Report.
OVERVIEW
We are a multinational, science-based pharmaceutical company. We develop, manufacture and market Rx and OTC pharmaceutical products,
primarily in the U.S., Canada, and Israel. We also develop and manufacture APIs primarily for use in our finished dosage form products. Our primary
areas of focus include topical creams and ointments, liquids, capsules, and tablets. We operate principally through three entities: Taro Israel and two of its
subsidiaries, Taro Canada and Taro U.S.A.
The pharmaceutical industry is affected by demographic and socioeconomic trends, such as aging populations and increased demand for
pharmaceuticals, as well as broad economic trends, resulting in a corresponding increase in healthcare costs, effects on reimbursement pricing, and
spending decisions of healthcare organizations, all of which lead to increased recognition of the importance of generics as providing access to affordable
pharmaceuticals. We believe our business model is appropriately structured to take advantage of these trends.
The following is a the percentage of our total consolidated net sales by geographic region for each period:
United States
Canada
Israel
Other
Total
* Less than 10%.
2022
% of total
net sales
67%
23%
*
*
100%
Year ended March 31,
2021
% of total
net sales
70%
20%
*
*
100%
2020
% of total
net sales
77%
15%
*
*
100%
We generate most of our revenue from the sale of Rx and OTC pharmaceutical products. Portions of our OTC products are sold as private label
products primarily to chain drug stores, food stores, drug wholesalers, drug distributors, and mass merchandisers in the U.S. A significant portion of our
revenue is derived from sales to a limited number of customers. If the Company were to experience a significant reduction in or loss of business with one
or more of such customers, or if one or more such customers were to experience difficulty in paying us on a timely basis, our business, financial condition,
and results of operations could be materially adversely affected. The following customers accounted for the following percentage of our total consolidated
net sales:
Customer
Customer A
Customer B
Customer C
* Less than 10%.
2022
% of total
net sales
10.1%
*
*
Year ended March 31,
2021
% of total
net sales
12.6%
10.5%
*
2020
% of total
net sales
*
13.0%
11.5%
Due to increased competition from other generic pharmaceutical manufacturers as they gain regulatory approvals to market generic products, selling
prices, and related profit margins tend to decrease as products mature. Thus, our future operating results are dependent on, among other factors, our ability
to introduce new products. In addition, our operating results are dependent on the impact of pricing pressures on existing products. These pricing
pressures are inherent in the generic pharmaceutical industry.
40
For the years ended March 31, 2022, 2021, and 2020, no product comprised 10% of our total consolidated sales.
Our sales are subject to market conditions and other factors. We are therefore unable to predict the extent, if any, to which the relative contribution
to our total revenue of this product line as well as other product lines may increase or decrease in the future.
Cost of goods sold consists of direct costs and allocated costs. Direct costs consist of raw materials, packaging materials, royalties, and direct labor
identified with a specific product. Allocated costs are costs not associated with a specific product.
Certain customary industry selling practices affect our level of working capital; for example, industry practice requires that pharmaceutical products
be made available to customers on demand from existing stock levels rather than on a made-to-order basis. Therefore, in order to accommodate market
demand, we try to maintain adequate levels of inventory. Increased demand for existing products and preparation for new product launches, the exact
timing of which cannot be determined accurately, have generally resulted in higher levels of inventory. However, anticipated growth in sales of any
individual product, or of all products, may not materialize. Consequently, inventories prepared for these sales may become obsolete and have to be written
off.
Another industry practice causes us to provide our customers with limited rights to return products, receive rebates, assert chargebacks and take
other deductions with respect to sales that we make to them. See Item 5.A. – “Operating Results – Critical Accounting Policies – Allowance for Sales
Deductions and Product Returns.” The exercise of these rights by customers to whom we have granted them has an impact, which may be substantial,
upon our working capital.
We continuously monitor our aged receivables and our customers’ creditworthiness. We also engage in active and intensive collection efforts as
necessary.
CRITICAL ACCOUNTING POLICIES
Our significant accounting policies are described in Note 2 to our consolidated financial statements, which are prepared in conformity with U.S.
GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities,
revenues, and expenses. We evaluate, on an ongoing basis, our estimates, including those related to bad debts, sales deductions, income taxes, and
contingencies. We base our estimates on currently available information, our historical experience and various other assumptions that we believe to be
reasonable under the circumstances. The results of these assumptions are the basis for determining the carrying values of assets and liabilities that are not
readily apparent from other sources. Since the factors underlying these assumptions are subject to change over time, the estimates on which they are based
are subject to change accordingly.
The following is a summary of certain policies that have a critical impact upon our financial statements and, we believe, are most important to keep
in mind in assessing our financial condition and operating results.
Use of Estimates. In preparing the consolidated financial statements, we use certain estimates and assumptions that affect reported amounts and
disclosures. These estimates and underlying assumptions can impact all elements of our financial statements. We use estimates when accounting for sales
incentives reserves, accounts receivable allowance, inventory reserves, income taxes, uncertain tax positions, fixed assets, intangible assets, derivative
instruments and contingencies. We regularly evaluate our estimates and assumptions, using historical experience, third-party data, and market and external
factors. Our estimates are often based on complex judgments, probabilities and assumptions that we believe to be reasonable but that are inherently
uncertain and unpredictable. As future events and their effects cannot be determined with precision, our estimates and assumptions may prove to be
incomplete or inaccurate, or unanticipated events and circumstances may occur that might cause us to change those estimates and assumptions. We adjust
our estimates and assumptions when facts and circumstances indicate the need for change. It is possible that other professionals, applying reasonable
judgment to the same facts and circumstances, could develop and support a range of alternative estimated amounts.
Functional Currency Change to USD for Taro Canada. Prior to April 1, 2019, the functional currency of the Company’s Canadian subsidiary was
the CAD. Accordingly, the financial statements of the Canadian subsidiary were translated into USD. All balance sheet accounts were translated using the
exchange rates in effect at the balance sheet date. Amounts recorded in the Consolidated Statements of Operations were translated using the average
exchange rate prevailing during the year. The resulting translation adjustments were reported as a component of shareholders’ equity under accumulated
other comprehensive income.
Effective as of the Company’s fiscal year beginning April 1, 2019, Taro Canada’s functional currency became the USD. FASB ASC Topic 830,
“Foreign Currency Matters,” requires a change in functional currency to be reported as of the date it is determined there has been a change, and it is
generally accepted practice that the change is made at the start of the most recent period that approximates the date of the change. Management determined
it would enact this change effective on April 1, 2019. While the change was based on a factual assessment, the determination of the date of the change
required management’s judgement given the change in the primary economic and business environment, in which Taro Canada operates, have evolved over
time. As part of management’s
41
functional currency assessment, changes in economic facts and circumstances were considered. This included analysis of changes in management of
operations, process, and composition of cash and marketable securities balances. The Company has centralized different functions, including treasury and
investment portfolio measurement, which resulted in a stronger focus on the USD currency for Taro Canada. Additionally, as budgeting has also been
centralized for the Company, Taro Canada has implemented budgeting in USD, whereas this was previously performed in CAD. Taro Canada’s cash
inflows consist primarily of USD cash balances and less of CAD, as also reflected in the budget. The transfer of significant intangible assets to Taro
Canada, as a result of the winding down of TNA, has reduced the relevance of the foreign currency position on the balance sheet of Taro Canada. The
Group decided to focus Taro Canada's sales market as the U.S. market, with the majority of sales to the U.S.-denominated in USD. This was followed by
centralizing budgets and facilitating effective netting and hedging activities. Assuming current business operating model stays constant, management
believes that the USD cash balances will continue to increase, while CAD cash balances will continue to produce a net outflow.
Management re-evaluated all indicators established in ASC 830-10-55-5 to determine the functional currency of Taro Canada. Such indicators
include i) cash flow, ii) sales price, iii) sales market, iv) expense, v) financing, and vi) intercompany transactions and arrangements. Management
determined that the cash flow indicators and the sales market indicators were most relevant to Taro Canada operations and its primary economic
environment. At the time of the assessment adopted on April 1, 2019, cash flows generated by Taro Canada that relate to its individual assets and liabilities
now directly affect the Company’s cash flows and are readily available for remittance to the Company. The majority of cash flow from Taro Canada’s
operations is denominated in USD with the sales market for Taro Canada’s products now mostly in the U.S. Approximately 75% of Taro Canada’s revenue
is to the U.S. market with over 80% of Taro Canada’s plant production, in terms of units, being produced for the U.S. market. Significant asset and liability
line items on Taro Canada’s balance sheet are comprised almost solely (greater than 90%) of USD denominated transactions. Furthermore, most of Taro
Canada’s generated cash flows are now invested in USD based cash and cash equivalents or marketable securities. Since such investments are short-term,
cash is readily available for remittance to other Taro entities. Thus, the USD is the primary currency from which Taro Canada generates and accumulates
cash.
When considering all relevant facts together, management concluded that the USD best reflects the currency of the primary economic environment
in which Taro Canada currently operates. Therefore, USD is the functional currency as a result of the change in the most significant economic facts and
circumstances from cash flow and sales market indicators, as well as intra-entity transactions and arrangements, which are material to Taro Canada. As a
result, the Company adopted USD as the functional currency for Taro Canada effective April 1, 2019.
The change was accounted for prospectively from the date of the change in accordance with FASB ASC Topic 830. The translated balances of
monetary and nonmonetary assets and liabilities recorded in Taro Canada’s financial statements as of the end of the prior reporting period became the new
accounting basis for those assets and liabilities in the period of the change. To the extent the entity had monetary assets and liabilities denominated in the
old functional currency, such balances created transactional gains and losses subsequent to the change in functional currency. The amount recorded in the
currency translation adjustment account for prior periods was not reversed upon the change in functional currency. The exchange rate on the date of the
change became the historical rate for subsequent re-measurement of nonmonetary assets and liabilities into the new functional currency.
The following table summarizes the impact on both consolidated net income and other comprehensive income (loss) utilizing USD as the functional
currency of Taro Canada as of March 31, 2020, compared to the related impact if the functional currency of Taro Canada would have remained CAD
(excluding foreign exchange from transactions denominated in CAD recorded in the respective period):
USD
as Functional Currency
(in USD)*
CAD
as Functional Currency
(in USD)**
(Unaudited Pro Forma)
Financial (income) expense, net - attributed to foreign translation
gain
Other comprehensive loss - attributed to foreign currency
translation adjustments
$
$
(14,838 ) $
(1 ) $
(46,667 )
(92,959 )
* Based on consolidated amounts of the Group for the fiscal year ended March 31, 2020, which was the first fiscal year Taro Canada utilized USD
as the functional currency. Includes Taro Canada amounts reported in USD with USD as functional currency.
** Based on unaudited pro forma consolidated amounts of the Group for the fiscal year ended March 31, 2020. Includes Taro Canada unaudited pro
forma amounts reported in USD with CAD as functional currency.
42
Revenue Recognition. We sell our products directly to wholesalers, retail drug store chains, mass merchandisers, grocery chains, other direct
purchasers, and customers that acquire our products indirectly through wholesalers.
The Company ships products to its customers only in response to, and to the extent of, the orders that customers submit to the Company. Depending
on the terms of our customer arrangements, revenue is generally recognized when the product is received by the customer (“FOB Destination Point”) or at
the time of shipment (“FOB Shipping Point”).
Allowance for Sales Deductions and Product Returns. When we recognize and record revenue from the sale of our pharmaceutical products, we
record an estimate in the same financial reporting period for product returns, chargebacks, rebates and other sales deductions, which are reflected as
reductions of the related gross revenue. We regularly monitor customer inventory information at our three largest wholesale customers to assess whether
any excess product inventory levels may exist. We review this information along with historical product and customer experience, third-party prescription
data, industry, and regulatory changes and other relevant information and revise our estimates as necessary.
Our estimates of inventory in the distribution channel are based on inventory information reported to us by our major wholesale customers,
historical shipment and return information from our accounting records and third-party data on prescriptions filled. Our estimates are subject to inherent
limitations pertaining to reliance on third-party information.
Product returns. Consistent with industry practice, we generally offer our customers the right to return inventory within three to six months prior to
product expiration and up to 12 months thereafter (the “return period”). Product returns are identified by their manufacturing lot number. Because we
manufacture in bulk, lot sizes are generally large and, therefore, shipments of a particular lot may occur over a one- to six-month period. As a result,
although we cannot associate a product return with the actual shipment in which such lot was included, we can reasonably estimate the period (in months)
over which the entire lot was shipped and sold. We use this information to estimate the average time period between lot shipment (and sale) and return for
each product, which we refer to as the “return lag.” The shelf life of most of our products ranges between 18-36 months. Because returns of expired
products are heavily concentrated during the return period, and given our historical data, we are able to reasonably estimate return lags for each of our
products. These return lags are periodically reviewed and updated, as necessary, to reflect our best knowledge of facts and circumstances. Using sales and
return data (including return lags), the Company determines a return rate to estimate our return reserves. We supplement this calculation with additional
information including customer and product specific channel inventory levels, competitive developments, external market factors, our planned
introductions of similar new products and other qualitative factors in evaluating the reasonableness of our return reserve. We continuously monitor factors
that could affect our estimates and revise the reserves as necessary. Our estimates of expected future returns are subject to change based on unforeseen
events and uncertainties.
We monitor the levels of inventory in our distribution channels to assess the adequacy of our product returns reserve and to identify potential excess
inventory on hand that could have an impact on our revenue recognition. We do not ship products to our wholesalers when it appears that they have an
excess of inventory on hand, based on demand and other relevant factors, for that particular product.
Chargebacks. We have arrangements with certain customers that allow them to buy our products directly from wholesalers at specific prices.
Typically these price arrangements are lower than the wholesalers’ acquisition costs or invoice prices. In exchange for servicing these third party contracts,
our wholesalers can submit a “chargeback” claim to us for the difference between the price sold to the third party and the price at which it purchased the
product from us. We generally pay chargebacks on generic products, whereas branded products are typically not eligible for chargeback claims. We
consider many factors in establishing our chargeback reserves including inventory information from our largest wholesale customers and the completeness
of their reports, estimates of Taro inventory held by smaller wholesalers and distributors, processing time lags, contract and non-contract sales trends,
average historical contract pricing, actual price changes, actual chargeback claims received from the wholesalers, Taro sales to the wholesalers and other
relevant factors. Our chargeback provision and related reserve varies with changes in product mix, changes in pricing, and changes in estimated wholesaler
inventory. We review the methodology utilized in estimating the reserve for chargebacks in connection with analyzing our product return reserve each
quarter and make revisions as considered necessary to reasonably estimate our potential future obligation.
Rebates and other deductions. We offer our customers various rebates and other deductions based primarily on their volume of purchases of our
products. Chain wholesaler rebates are rebates that certain chain customers claim for the difference in price between what the chain customer paid a
wholesaler for a product purchase and what the chain customer would have paid if such customer had purchased the same product directly from us. Cash
discounts, which are offered to our customers, are generally 2% of the gross sales price, and provide our customers an incentive for paying within a
specified time period after receipt of invoice. Medicaid rebates are earned by states based on the amount of our products dispensed under the Medicaid
plan. Billbacks are special promotions or discounts provided over a specific time period to a defined customer base, and for a defined product group.
Distribution allowances are a fixed percentage of gross purchases for inventory shipped to a national distribution facility that we pay to our top wholesalers
on a monthly basis. Administration fees are paid to certain wholesalers, buying groups, and other customers for stocking our products and managing
contracts and servicing other customers. Shelf stock adjustments, which are customary in the generic pharmaceutical industry, are based
43
on customers’ existing levels of inventory and the decrease in the market price of the related product. When market prices for our products decline, we
may, depending on our contractual arrangements, elect to provide shelf-stock adjustments and thereby allow our customers with existing inventories to
compete at the lower product price. We use these shelf-stock adjustments to support our market position and to promote customer loyalty.
The Company establishes reserves for rebates and these other various sales deductions based on contractual terms and customer purchasing activity,
tracking and analysis of rebate programs, processing time lags, the level of inventory in the distribution channel and other relevant information. Based on
our historical experience, substantially all claims for rebates and other sales deductions are received within 24 months.
Three-year summary
The following tables summarize the activities for sales deductions and product returns for the years ended March 31, 2022, 2021, and 2020:
Accounts Receivable Reserves
Chargebacks
Rebates and Other
Total
Current Liabilities
Returns
Other (2)
Total
Accounts Receivable Reserves
Chargebacks
Rebates and Other
Total
Current Liabilities
Returns
Other (2)
Total
Accounts Receivable Reserves
Chargebacks
Rebates and Other
Total
Current Liabilities
Returns
Other (2)
Total
For the year ended March 31, 2022
Beginning
balance
Provision
recorded
for current
period sales (1)
Credits
processed/
Payments
Ending
balance
(119,090 )
(76,569 )
(195,659 )
(52,236 )
(18,560 )
(70,796 )
$
$
$
$
(1,182,744 ) $
(165,174 )
(1,347,918 ) $
(52,282 ) $
(52,279 )
(104,561 ) $
1,190,526
167,692
1,358,218
48,978
50,474
99,452
For the year ended March 31, 2021
Beginning
balance
Provision
recorded
for current
period sales (1)
Credits
processed/
Payments
(104,552 )
(70,630 )
(175,182 )
(61,406 )
(41,562 )
(102,968 )
$
$
$
$
(1,173,810 ) $
(180,079 )
(1,353,889 ) $
(37,011 ) $
(26,036 )
(63,047 ) $
1,159,272
174,140
1,333,412
46,181
49,038
95,219
For the year ended March 31, 2020
Beginning
balance
Provision
recorded
for current
period sales (1)
Credits
processed/
Payments
(1,104,946 ) $
(305,098 )
(1,410,044 ) $
(37,258 ) $
(77,537 )
(114,795 ) $
1,110,157
348,125
1,458,282
39,670
69,472
109,142
(109,763 )
(113,657 )
(223,420 )
(63,818 )
(33,497 )
(97,315 )
$
$
$
$
44
$
$
$
$
$
$
$
$
$
$
$
$
(111,308 )
(79,216 )
(190,524 )
(56,033 )
(20,719 )
(76,752 )
Ending
balance
(119,090 )
(76,569 )
(195,659 )
(52,236 )
(18,560 )
(70,796 )
Ending
balance
(104,552 )
(70,630 )
(175,182 )
(61,406 )
(41,562 )
(102,968 )
$
$
$
$
$
$
$
$
$
$
$
$
(1)
(2)
Includes immaterial amounts of reversals of provisions recorded for prior years’ sales.
Includes indirect rebates and amounts due to customers.
Inventory. Inventories are stated at the lower of cost or market. Cost is determined as follows: raw and packaging materials mainly on a weighted-
average cost basis; finished goods products and products still in process, mainly on a weighted-average production cost including direct and indirect, or
overhead, manufacturing expenses. Our finished goods inventories generally have a limited shelf life and are subject to obsolescence as they approach
their expiration dates. As a result, we record a reserve against our entire finished goods inventory with expiration dates of less than 12 months and use
historical experience to estimate the reserve for products with expiration dates of more than 12 months from the balance sheet date. When available, we
use actual data to validate our estimates. We regularly evaluate our policies and the carrying value of our inventories and establish a reserve against the
carrying value of our inventories. The determination that a valuation reserve is required, as well as the appropriate level of such reserve, requires us to
utilize significant judgment. Although we make every effort to ensure the accuracy and reasonableness of our forecasts of future demand for our products,
any significant unanticipated decreases in demand, or unanticipated changes in our major customer inventory management policies, could have a material
impact on the carrying value of our inventories and reported operating results.
Valuation of Long-Lived Assets and Goodwill. We evaluate our long-lived assets for impairment and perform annual impairment testing for
goodwill and other indefinite-lived intangible assets and other long-lived assets on March 31, when impairment indicators exist. Impairments are recorded
for the excess of a long-lived assets’ carrying value over fair value. Some examples of impairment indicators are as follows:
•
•
•
Changes in legal or business climate that could affect an asset’s value. For example, a failure to gain regulatory approval for a product or the
extension of an existing patent that prevents our ability to produce a generic equivalent.
Changes in our ability to continue using an asset. For example, restrictions imposed by the FDA could reduce our production and sales
volume.
Decreases in the pricing of our products. For example, consolidation among our wholesale and retail customers could place further
downward pressure on the prices of some of our products.
We estimate the fair value of our long-lived assets other than goodwill, such as product rights, using a discounted cash flow analysis or market
approach where appropriate when required under applicable U.S. GAAP. Under the discounted cash flow method, we estimate cash flows based on our
forecasts and discount these cash flows using the appropriate rate to determine the net present value of the asset. The net present value of our assets is
affected by several estimates, such as:
•
•
•
•
•
•
•
The timing and amount of forecasted cash flows
Discount rates
Tax rates
Regulatory actions
Amount of competition
Manufacturing efficiencies
The number and size of our customers
For the years ended March 31, 2022, 2021 and 2020, the Company did not record any impairment charges.
Effective for the Company’s fiscal year beginning April 1, 2020, fair value of goodwill is estimated using a one-step method in accordance with
ASU 2017-04. We compare the market value of our equity to the carrying value of our equity. If the carrying value exceeds the market value of our equity,
impairment will be recorded for the difference. We did not record any impairment of goodwill for the years ended March 31, 2022, 2021, and 2020.
Income Taxes. We determine deferred taxes by utilizing the asset and liability method based on the estimated future tax effects of differences
between the financial accounting and tax basis of assets and liabilities under the applicable tax laws. Deferred taxes are measured using the enacted tax
rates and laws that will be in effect when the differences are expected to reverse. On an annual basis, management determines if it is more likely than not
that we will not benefit from the deferred tax assets in certain subsidiaries. For any locations where this is determined, a full valuation allowance is
provided against the deferred tax assets. In future years, if it is more likely than not that we will be in a position to utilize its deferred tax asset, the
valuation allowance for such assets may be modified.
45
Recent Accounting Pronouncements that were recently adopted
In August 2018, the FASB issued ASU No. 2018-13, “Fair Value Measurement (Topic 820).” The guidance focuses on modification of disclosures,
which includes the consideration of costs and benefits. The guidance was effective for the Company’s fiscal year beginning April 1, 2020, including
interim periods within that year. The adoption of ASU 2018-13 does not have a material impact on our financial position or results of operations.
In January 2017, the FASB issued ASU No. 2017-04, “Intangibles – Goodwill and Other (Topic 350).” The new guidance reduces the complexity
of goodwill impairment tests by no longer requiring entities to determine goodwill impairment by calculating the implied fair value of goodwill by
assigning the fair value of a modification reporting unit to all of its assets and liabilities as if that reporting unit had been acquired in a business
combination. The guidance was effective for the Company’s fiscal year beginning April 1, 2020, including interim periods within that year on a
prospective basis. The adoption of ASU 2017-04 does not have a material impact on our financial position or results of operations.
In June 2016, the FASB issued ASU No. 2016-13, “Financial Instruments – Credit Losses (Topic 326).” The guidance replaces the current incurred
loss impairment methodology with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and
supportable information to inform credit loss estimates. Guidance in Topic 326 applies to our financial instruments, such as investments that are generally
of high credit quality and trade receivables. Prior to Topic 326, under U.S. GAAP, an entity generally considered past events and current conditions when
measuring credit losses. The new guidance requires an entity to measure the allowance for expected credit losses by utilizing information, including
historical data and current economic conditions, plus the use of reasonable supportable forecasts. The guidance was effective for the Company’s fiscal year
beginning April 1, 2020, including interim periods within that year. The adoption of ASU 2016-13 does not have a material impact on our financial
position or results of operations.
Recent Accounting Pronouncements that may have an impact on future consolidated financial statements.
In March 2020, the FASB issued ASU 2020-04 “Reference Rate Reform (Topic 848).” The guidance provides optional expedients and exceptions
for applying U.S. GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. The
guidance applies only to contracts, hedging relationships, and other transactions that reference the London Interbank Offered Rate (LIBOR) or another
reference rate expected to be discontinued because of reference rate reform. In January 2021, the FASB issued ASU No. 2021-01, “Reference Rate Reform
- Scope (Topic 848)” which focuses on expanding the scope of Topic 848 to include derivative instruments impacted by discounting transition. The
guidance will be effective for the Company fiscal year beginning April 1, 2021, including interim periods within that year. The Company is currently
assessing the impact of the adoption on our financial position and results of operations.
In December 2019, the FASB issued ASU No. 2019-12, “Simplifying the Accounting for Income Taxes (Topic 740).” The guidance focuses on
simplifying accounting for income taxes by removing certain exceptions and simplifying certain requirements under Topic 740. The guidance will be
effective for the Company’s fiscal year beginning April 1, 2021. The Company does not currently anticipate the adoption to have a material impact on our
financial position or results of operations.
In August 2018, the FASB issued ASU No. 2018-14, “Compensation – Retirement Benefits – Defined Benefit Plans – General (Subtopic 715-20).”
The guidance focuses on additional disclosure of reasons for significant gains and losses to changes in the benefit obligation for the period, in addition to
removal and clarification of existing disclosures. The guidance will be effective for the Company fiscal year beginning April 1, 2021, on a retrospective
basis. The Company does not currently anticipate the adoption to have a material impact on our financial position or results of operations.
46
RESULTS OF OPERATIONS
The following table sets forth selected items from our Consolidated Statements of Operations as a percentage of total sales:
Consolidated Statements of Operations
Sales, net
Cost of sales
Gross profit
Operating expenses:
Research and development
Selling, marketing, general and administrative
Settlements and loss contingencies
Total operating expenses
Operating income (loss)
Financial income, net
Other gain, net
Income (loss) before income taxes
Tax expense
Net income (loss)
Net (loss) income attributable to non-
controlling interest
Net income (loss) attributable to Taro
* Less than 0.05%
2022
100.0%
47.8%
52.2%
9.7%
20.3%
10.9%
40.9%
11.3%
(1.8%)
0.8%
13.9%
3.5%
10.4%
0.0%
10.4%
For the year ended March 31,
2020
100.0%
46.0%
54.0%
11.0%
16.6%
101.8%
129.4%
(75.4%)
(3.6%)
0.5%
(71.2%)
1.8%
(73.0%)
-2.6%
(70.4%)
2019
100.0%
38.0%
62.0%
9.3%
14.5%
0.0%
23.8%
38.2%
(7.5%)
0.5%
46.2%
8.3%
37.9%
*
37.9%
YEAR ENDED March 31, 2022 COMPARED WITH YEAR ENDED March 31, 2021
Sales. For the year ended March 31, 2022, sales increased $12.4 million, or 2.3%, compared to the same period in 2021. Sales in the U.S. during
the year ended March 31, 2022, decreased $(7.2) million or (1.9%), compared to the same period in 2021. We continue to experience a difficult generic
pricing environment, particularly in the U.S., driven by more intense competition among manufacturers, new entrants to the market, buying consortium
pressures, and a higher ANDA approval rate from the FDA. The U.S. generic and OTC sales during the year ended March 31, 2021, was also negatively
impacted by the COVID-19 pandemic. There are no products in the year ended March 31, 2022 or 2021 that represent more than 10.0% of consolidated
net sales. The Company actively manages its product portfolio to assess pricing relative to market dynamics. Sales in Israel and other international
markets decreased $(0.4) million, or (0.7%), primarily due to decreased market share on certain products. Sales in Canada increased $19.9 million, or
18.1%, compared to the year ended March 31, 2021, due to new launches, new contracts and increased market share on certain products.
Cost of Sales. Cost of sales of $268.2 million, or 47.8% of net sales, in the year ended March 31, 2022, increased $15.9 million compared to $252.3
million, or 46.0% of net sales in the same period in 2021. This increase is primarily related to one-time costs and the challenging pricing environment
affecting net selling price, offset by lower royalties.
Gross Profit. The Company’s gross profit was $293.1 million, or 52.2% of net sales, in the year ended March 31, 2022, while gross profit was
$296.7 million, or 54.0% of net sales in the same period in 2021. The decrease in 2022 was primarily the result of product mix, pricing pressure in the U.S.
generic business, and negative impact from the COVID-19 pandemic.
Research and Development. Research and development (“R&D”) expenses decreased $(5.6) million in the year ended March 31, 2022, compared
to the previous year. This decrease is principally due to timing and types of clinical studies and our continuous evaluation and rationalization of our
portfolio. As a percentage of net sales, R&D expenses decreased (1.3%) to 9.7% in the year ended March 31, 2022, compared to the previous year.
47
Selling, Marketing, General and Administrative. In the year ended March 31, 2022, selling, marketing, general, and administrative (“SMG&A”)
expenses increased $22.3 million. This increase is primarily related to lower personnel costs, legal fees, and marketing delays, in addition to higher
insurance and other one-time expenses, partially offset by higher freight costs, depreciation, and COVID-19 related expenses. As a percentage of net sales,
SMG&A increased to 20.3% from 16.6%.
Settlements and Loss Contingencies. Settlements and loss contingencies was $61.4 million in the year ended March 31, 2022, consisting of an
additional legal contingency of $60.0 million related to ongoing multi-jurisdiction civil antitrust matters and $1.4 million related to the global resolution
with the Department of Justice (“DOJ”) in connection with its investigations into the U.S. generic pharmaceutical industry. This compared to $558.9
million in the year ended March 31, 2021, which consisted of settlement charge of $418.9 million related to the global resolution of the DOJ investigations
into the U.S. generic pharmaceutical industry and an additional provision of $140.0 million related to ongoing multi-jurisdiction civil antitrust matters.
However, there can be no assurance as to the ultimate outcome thereof.
Operating Income (Loss). In the year ended March 31, 2022, the Company had operating income of $63.5 million compared to operating (loss) of
$(413.8) million in the same period in 2021, an increase of $477.2 million. In 2021, the (loss) was primarily the result of the aforementioned settlements
and loss contingencies.
Financial Income, Net. Financial income, net, results principally from interest income and the impact of foreign currency exchange rate
fluctuations. Net financial income was $10.2 million in the year ended March 31, 2022, compared to $19.8 million for the year ended March 31, 2021.
The change in financial income, net, is the result of foreign exchange income of $2.0 million in 2022, compared to foreign exchange expense of $(0.4)
million in 2021 ─ a favorable impact of $2.4 million. Interest and other financial income was $8.2 in 2022, compared to $20.2 in 2021, a decrease of $12.0
million, reflecting the low global interest rate environment.
Taxes. Tax expense in the year ended March 31, 2022 was $19.6 million, compared to $9.7 million in the same period in 2021, an increase of $9.9
million, principally as a result of non-recurring items in the current year. The effective tax rate decreased to 25.2% from (2.5)%, primarily as a result of the
non-deductible portion of settlements.
Net Income (Loss) attributable to Taro. Net (loss) income increased $444.9 million to net income of $58.3 million for the year ended March 31,
2022, compared to net loss of $(386.7) million in the prior year, by reason of the factors noted above.
YEAR ENDED March 31, 2021 COMPARED WITH YEAR ENDED MARCH 31, 2020
Sales. For the year ended March 31, 2021, sales decreased $95.8 million, or 14.9%, compared to the same period in 2020. Sales in the U.S. during
the year ended March 31, 2021, decreased $111.8 million or 22.6%, compared to the same period in 2020. We continue to experience a difficult generic
pricing environment, particularly in the U.S., driven by more intense competition among manufacturers, new entrants to the market, buying consortium
pressures, and a higher ANDA approval rate from the FDA. The U.S. generic and OTC sales during the year ended March 31, 2021, was also negatively
impacted by the COVID-19 pandemic. There are no products in the year ended March 31, 2021 or 2020 that represent more than 10.0% of consolidated net
sales. The Company actively manages its product portfolio to assess pricing relative to market dynamics. Sales in Israel and other international markets
increased $3.9 million, or 7.6%, primarily due to new launches and increased market share on certain products. Sales in Canada increased $12.2 million, or
12.4%, compared to the year ended March 31, 2020, due to new launches and increased market share on certain products.
Cost of Sales. Cost of sales of $252.3 million, or 46.0% of net sales, in the year ended March 31, 2021, increased $7.3 million compared to $245.0
million, or 38.0% of net sales in the same period in 2020. This increase is primarily related to one-time costs and the challenging pricing environment
affecting net selling price, offset by lower royalties and lower product costs due to sales volumes.
Gross Profit. The Company’s gross profit was $296.7 million, or 54.0% of net sales, in the year ended March 31, 2021, while gross profit was
$399.7 million, or 62.0% of net sales in the same period in 2020. The decrease in 2021 was primarily the result of product mix, pricing pressure in the U.S.
generic business, and negative impact from the COVID-19 pandemic.
Research and Development. R&D expenses increased $0.4 million in the year ended March 31, 2021, compared to the previous year. This increase
is principally due to timing and types of clinical studies and our continuous evaluation and rationalization of our portfolio. As a percentage of net sales,
R&D expenses increased 1.7% to 11.0% in the year ended March 31, 2021, compared to the previous year.
Selling, Marketing, General and Administrative. In the year ended March 31, 2021, SMG&A expenses increased $2.1 million. This increase is
primarily related to higher freight, personnel costs, and marketing promotion. As a percentage of net sales, SMG&A increased to 16.6% from 14.5%.
48
Settlements and Loss Contingencies. Settlements and loss contingencies was $558.9 million in the year ended March 31, 2021, compared to $0.0
million in the year ended March 31, 2020, primarily due to the one-time settlement charge consisting of $418.9 million related to the global resolution of
the DOJ investigations into the U.S. generic pharmaceutical industry and an additional provision of $140.0 million related to ongoing multi-jurisdiction
civil antitrust matters. However, there can be no assurance as to the ultimate outcome thereof.
Operating Income. In the year ended March 31, 2021, the Company had operating (loss) of $(413.8) million compared to operating income of
$246.5 million in the same period in 2020, a decrease of $660.3 million. The (loss) is primarily the result of the aforementioned settlements and loss
contingencies in 2021.
Financial Income, Net. Financial income, net, results principally from interest income and the impact of foreign currency exchange rate
fluctuations. Net financial income was $19.8 million in the year ended March 31, 2021, compared to $48.5 million for the year ended March 31, 2020. The
change in financial income, net, is the result of interest and other financial income of $20.2 in 2021, compared to $33.6 in 2020, a decrease of $13.4
million, reflecting the low global interest rate environment. Foreign exchange income was $0.4 million in 2021, compared to foreign exchange income of
$14.8 million in 2020 ─ an unfavorable impact of $14.4 million.
Taxes. Tax expense in the year ended March 31, 2021 was $9.7 million, compared to $53.5 million in the same period in 2020, a decrease of $43.8
million, principally the result of non-recurring items in the current year. The effective tax rate decreased to (2.5)% from 17.9%, primarily as a result of the
non-deductible portion of settlements.
Net Income attributable to Taro. Net (loss) income decreased $630.9 million to net (loss) of $(386.7) million for the year ended March 31, 2021,
compared to net income of $244.2 million in the prior year, by reason of the factors noted above.
IMPACT OF INFLATION, DEVALUATION (APPRECIATION) AND EXCHANGE RATES ON RESULTS OF OPERATIONS, LIABILITIES
AND ASSETS
We conduct manufacturing, marketing and research and development operations primarily in Israel, Canada and the U.S. As a result, we are subject
to risks associated with fluctuations in the rates of inflation and foreign exchange in each of these countries.
The following table sets forth the annual rate of (deflation) inflation, the (appreciation) devaluation rate of the NIS and the CAD against the USD
and the exchange rates between the USD and each of the NIS and the CAD at the end of the period indicated:
Period ended
3/31/2022
3/31/2021
3/31/2020
Rate of (Deflation) Inflation
Israel (1)
3.48%
0.20%
0.00%
Canada (2)
6.66%
2.20%
0.89%
Rate of (Appreciation) Devaluation
Against USD
Israel (1)
(4.50%)
(6.72%)
(1.65%)
Canada (2)
(0.79%)
(10.64%)
6.02%
Rate of Exchange of USD
Israel (1)
Canada (2)
3.18
3.33
3.57
1.25
1.26
1.41
(1)
(2)
Bank of Israel.
J.P. Morgan Chase.
B. LIQUIDITY AND CAPITAL RESOURCES
Cash, including short-term bank deposits and short-term marketable securities, decreased $202.9 million from March 31, 2021 to $820.7 million at
March 31, 2022. Total shareholders’ equity increased from $1,695.5 million at March 31, 2021, to $1,711.4 million at March 31, 2022.
On November 5, 2018, the Company announced that its Board of Directors declared a $500 million special cash dividend on Taro ordinary shares.
The special dividend of $12.86 was paid on December 28, 2018, to shareholders of record at the close of business on December 11, 2018.
On November 4, 2019, the Company announced that its Board of Directors approved a $300 million share repurchase of ordinary shares. On
November 15, 2019, the Company commenced a modified “Dutch auction” tender offer to repurchase up to $225 million in value of its ordinary shares. In
accordance with the terms and conditions of the tender offer, which expired on December 16, 2019, the Company accepted for payment 280,719 ordinary
shares at the final purchase price of $91.00 per share. During the year ended March 31, 2022, in accordance with a Rule 10b5-1 program, the Company
repurchased 341,413 shares at an average price of $73.03), leaving $224.5 million remaining under the current Board authorization.
49
Net cash (used in) provided by operating activities for the year ended March 31, 2022 was ($158.7) million, compared to $45.8 million, in the year
ended March 31, 2021. For the year ended March 31, 2022, the Company had net cash (used in) provided by investing activities of ($170.6) million
compared to net cash provided by investing activities of $67.7 million for the year ended March 31, 2021. For the year ended March 31, 2022, the
Company had net cash used in financing activities of $24.9 million compared to $24.2 million for the year ended March 31, 2021.
The change in our liquidity for the year ended March 31, 2022 resulted from a number of factors, including:
Net cash provided by operating activities consists primarily of a decrease in other accounts payable and accrued expenses of $263.7 million;
a decrease in trade payables of $(2.1) million; depreciation and amortization of $25.9 million; increase in trade receivables of $(6.2) million;
and a loss from marketable securities of $13.3 million. This was offset by net income of $58.3 million; deferred income taxes, net of $23.2
million; increase in inventories, net of $2.1 million; increase in income tax receivables of $2.4 million; increase in other receivables, prepaid
expenses, and other of $3.0 million; foreign exchange effect of marketable securities and bank deposits of $0.4 million; and an increase in
income tax payables $0.5 million.
Net cash provided by investing activities consists principally of proceeds from marketable securities of $809.1 million; offset by investment
in marketable securities of $828.2 million; investment in acquisition, net of cash of $91.9 and purchase of property, plant, and equipment of
$11.8 million.
Net cash used in financing activities consists of purchase of treasury stock for $24.9 million, in accordance with our repurchase program.
•
•
•
Debt
As of March 31, 2022, the Company did not have any debt outstanding.
During the year ended March 31, 2022, we did not incur any indebtedness, including increases in our borrowing capacity under any refinancing.
Liquidity
On March 31, 2022, we had total cash and cash equivalents, short-term bank deposits and short-term marketable securities of $0.8 billion and no
indebtedness. We expect that existing cash resources and cash from operations will be sufficient to finance our foreseeable working capital requirements.
None of our cash and cash equivalents is held captive by any financial covenants or government regulation. As of March 31, 2022 and 2021, we had no
commitment for capital expenditures which we consider to be material to our consolidated financial position. The Company had no available and undrawn
credit facilities in place on March 31, 2022.
Capital Expenditures
We invested $11.8 million in capital equipment and facilities in the year ended March 31, 2022, and $17.0 million in the year ended March 31, 2021.
These investments are principally related to our pharmaceutical and chemical manufacturing facilities, expanding and upgrading our research and
development laboratories in Israel and Canada, expanding our serialization capabilities, and maintaining compliance with cGMPs. In addition to facility-
related investments, we acquired certain research and development, manufacturing, and packaging equipment to increase production capacity. We also
continued to upgrade our information systems infrastructure to enable more efficient production scheduling and enhanced inventory analysis. See Note 7 to
our consolidated financial statements included in this 2022 Annual Report.
C. RESEARCH AND DEVELOPMENT, PATENTS, TRADEMARKS AND LICENSES
We believe that our research and development activities have been a principal contributor to our achievements to date and that our future
performance will depend, to a significant extent, upon the results of these activities.
Recruiting talented scientists is essential to the success of our research and development programs. Approximately 18% of our employees work in
our worldwide research and development programs.
50
We currently conduct research and development in three principal areas:
•
•
•
generic pharmaceuticals, where our programs have resulted in our developing and introducing a wide range of pharmaceutical products
(including tablets, sachets, capsules, patches, suspensions, solutions, syrups, sprays, foams, creams, ointments, and gels) that are equivalent
to numerous brand-name products whose patents and FDA exclusivity periods have expired or been challenged under the Hatch-Waxman
Act;
proprietary pharmaceuticals; and
organic and steroid chemistry, where our programs have enabled us to synthesize the active ingredients used in many of our products.
For the years ended March 31, 2022, 2021 and 2020, we spent $54.5 million, $60.2 million and $59.8 million, respectively, on research and
development activities. We estimate that research and development expenses were allocated 70% to generic pharmaceuticals, 20% to proprietary
pharmaceuticals and delivery systems and 10% to organic and steroid chemistry for the year ended March 31, 2022.
Pharmaceutical Products
In the year ended March 31, 2022, we received 5 ANDA final approvals. As of March 31, 2022, we have 4 tentatively approved products
developed/manufactured in Canada and Israel. The following table sets forth the final approvals received in the U.S. from the FDA from April 1, 2021
through March 31, 2022, and tentative approvals as of March 31, 2022:
FINAL ANDA APPROVALS
Tavaborole Topical Solution 5%
Oxymetazoline Topical Cream 1.0%
Clindamycin Topical lotion 1%
Adapalene Topical Gel 0.1%
Sildenafil Powder for Oral Suspension 10mg/ml
Azelaic Acid Topical Foam 15%
Perampanel Tablets 2mg, 4mg, 6mg, 8mg, 10mg, 12mg
Diclofenac Sodium Topical Solution 2%*
Magnesium Sulfate; Potassium Sulfate; Sodium Sulfate Oral Solution 1.6g; 3.13g; 17.5g/bottle
TENTATIVE ANDA APPROVALS
* Indicates tentative approval received during the year ended March 31, 2017.
Brand Name
Kerydin®
Vicept®
Cleocin T®
Differin®
Revatio®
Finacea®
Fycompa®
Pennsaid®
Suprep®
As of March 31, 2022, 15 of our ANDAs, not including the tentative approvals listed above, were being reviewed by the FDA. In addition, there are
multiple products for which either developmental or internal regulatory work is in process. The applications pending before the FDA are at various stages
in the review process, and there can be no assurance that we will be able to successfully complete any remaining testing or that, upon completion of such
testing, approvals for any of the applications currently under review at the FDA will be granted. In addition, there can be no assurance that the FDA will
not grant approvals for competing products.
Patents, Trademarks and Licenses
We have filed and received patents, and obtained licenses in the U.S. and other countries for a variety of products, processes, formulations,
syntheses, and methods of treatment.
We do not believe that any single patent is of material importance to us in relation to our current commercial activities.
We have registered trademarks in the U.S., Canada and other countries. Taro U.S.A. typically does not use product trademarks in the sale and
marketing of its generic multi-source non-innovator products.
From time to time, we seek to develop products for sale in various countries prior to patent expiration. In the U.S., in order to obtain a final
approval for a generic product prior to expiration of certain innovator’s patents, we must, under the terms of the Hatch-Waxman Act, as amended by the
Medicare Prescription Drug Improvement and Modernization Act of 2003, notify the patent holder as well as the owner of an NDA, that we believe that the
patents listed in the Orange Book for the new drug are either invalid or not
51
infringed by our product. To the extent that we seek to utilize this mechanism to obtain approval to sell products, we are involved and expect to be
involved in patent litigation regarding the validity, enforceability, or infringement of patents listed in the Orange Book, as well as other patents, for a
particular product for which we have sought approval. We may also be involved in patent litigation with third parties to the extent that claims are made that
our finished product, an ingredient in our product or our manufacturing process, may infringe the innovator’s or third party’s process patents. We may also
become involved in patent litigation in other countries where we conduct business, including Israel, Canada and various countries in Europe. From time to
time, we may settle such litigations and obtain licenses to the asserted patents that allow us to market our products.
D. TREND INFORMATION
See Item 4 – “Information on the Company” and Item 5 – “Operating and Financial Review and Prospects” for trend information.
E. OFF-BALANCE SHEET ARRANGEMENTS
The Company does not have any off-balance sheet arrangements.
F. TABULAR DISCLOSURE OF CONTRACTUAL OBLIGATIONS
The following table describes the payment schedules of our contractual obligations as of March 31, 2022:
Payments due by period (in millions)
Type of Contractual Obligation
Total
Less than 1 year
1-3 years
3-5 years
More than 5 years
Operating lease obligations
Other long-term liabilities (1)
Total
$
$
6.16
32.80
38.96
$
$
2.24 $
24.23
26.47 $
2.87 $
6.88
9.75 $
1.06 $
1.27
2.33 $
—
0.42
0.42
(1)
Includes tax liabilities, deferred revenue, severance commitments, and other.
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A. DIRECTORS AND SENIOR MANAGEMENT
The following table lists our directors and executive officers as of March 31, 2022:
Name
Dilip Shanghvi
Abhay Gandhi
Sudhir Valia
Uday Baldota
Linda Benshoshan
Robert Stein, M.D., Ph.D.
Dov Pekelman
James Kedrowski
William Coote
Certain Familial Relationships
Age
66
57
65
52
56
71
82
70
67
Position
Director and Chairman of the Board
Director and Vice Chairman of the Board
Director
Director and Chief Executive Officer
Director and Chairwoman of the Audit Committee and the
Compensation Committee
Director
Director and Chairman of the Social Responsibility Committee
Director
Vice President, Chief Financial Officer and Chief Accounting
Officer
Mr. Sudhir Valia is a brother-in-law of Mr. Dilip Shanghvi. Mr. Dilip Shanghvi is the beneficial majority owner of Sun.
Business Experience
Dilip Shanghvi became a director of our Board in September 2010. Dilip Shanghvi also became the Chairman of our Board in August 2013, after
previously serving as the Chairman from September 2010 to April 2012. He is the founder and Managing Director of Sun Pharma and has extensive
industrial experience in the pharmaceutical industry. As a first generation entrepreneur, Mr. Shanghvi has won numerous awards and recognitions,
including the 2017 Entrepreneur of the Year Award from AIMA (All India Management Association), the 2016 PADMA SHRI (Fourth Highest Civilian
Award in the Republic of India) from the Government of India and the
52
2016 NDTV Business Leadership Award (Pharmaceutical), as well as various other awards including, the Forbes Entrepreneur of the Year award in 2014,
Outstanding Business Leader of the Year from CNBC TV18 in 2014, the Economic Times’ Business Leader of the Year Award in 2014, the JRD TATA
Corporate Leadership Award AIMA (All India Association) in 2014, CNN IBN’s Indian of the Year (Business) in 2011, Business India’s Businessman of
the Year in 2011 and Ernst and Young’s World Entrepreneur of the Year in 2011. He has also been awarded the Entrepreneur of the Year, Ernst and Young
in 2010, CNBC TV 18’s First Generation Entrepreneur of the Year in 2007 and Entrepreneur of the Year (Healthcare and Life Sciences), Ernst and Young
in 2005. A prestigious non-profit management association of India, Indore Management Association (IMA), presented Mr. Shanghvi with the IMA
Lifetime Outstanding Achievement Award in 2018. Tel Aviv University, Israel’s largest and most comprehensive institution of higher learning, granted Mr.
Shanghvi an honorary doctorate in 2019. Chemtech Foundation presented Mr. Shanghvi with the “Lifetime Achievement” - Chemtech CEO Leadership &
Excellence Award for 2019. In 2020 and 2021, Indian Today magazine included Mr. Shanghvi in its annual Power List of 50 influential personalities in
India. Mr. Shanghvi is a director of various companies, including Shantilal Shanghvi Foundation and is also the Chairman of Sun Pharma Advanced
Research Company Ltd.
Abhay Gandhi became a director in December 2016 and Vice Chairman of our Board in February 2017. Mr. Gandhi has served as Chief Executive
Officer of Sun Pharma since November 2016. Mr. Gandhi also served as Interim Chief Executive Officer of Taro from January 2017 until Mr. Uday
Baldota’s assumption of these duties in August 2017. Prior to joining Sun Pharma, Mr. Gandhi served as a Director starting in November 2014, and as the
CEO – India Subcontinent, of Sun Pharmaceutical Laboratories Ltd. (“SPLL”) starting in November 2013, where he was responsible for domestic
operations of the business as well as certain international markets, including sales & marketing, integration efforts, business development, portfolio
management and other allied functions. Prior to that appointment, Mr. Gandhi was President – India Subcontinent of SPLL from March 2012 to November
2013, Executive Vice President – International Marketing from April 2007 to March 2012 and has served in various other positions within the Sun Pharma
organization for over 20 years. Prior to joining Sun Pharma, Mr. Gandhi held positions at Boehringer Mannheim Gmbh, and Nestle India Ltd. From 2013
to 2015, he was a Member of the Executive Committee of the Indian Drug Manufacturers Association (IDMA) and a Member of the Confederation of
Indian Industry (CII) National Committee on Drugs and Pharmaceuticals from 2013 to 2014. Mr. Gandhi holds a Bachelor of Science and a Masters in
Marketing Management from the University of Mumbai, and a Diploma in Business Management from the Institute of Chartered Financial Analysts of
India (ICFAI University).
Sudhir Valia became a member of our Board in September 2010. Mr. Valia joined Sun Pharma as a director in January 1994 and was a whole-time
director until May 2019. He is now a non-executive director of Sun Pharma. Mr. Valia is the recipient of the CNBC TV 18’s CFO Awards for best
performing CFO in the Pharma/Healthcare sector in 2012, 2009 and 2006. He also received the “Adivasi Sevak Puraskar” award from the Government of
Maharashtra in 2008-2009. Prior to joining Sun Pharma, Mr. Valia was a chartered accountant in private practice. Mr. Valia is a Director of various
companies, including Shantilal Shanghvi Foundation and Sun Pharma Advanced Research Company Ltd. Mr. Valia is a qualified chartered accountant in
India.
Uday Baldota became a member of our Board in December 2016 and assumed the role of Chief Executive Officer in August 2017. He continues as
a member of the global Core Management Team of Sun Pharma. Mr. Baldota serves on the board of directors of the Association for Accessible Medicines.
Mr. Baldota was formerly Executive Vice President & Chief Financial Officer of Sun Pharma. He led their global Finance function from June 2012 and
was designated as the Chief Financial Officer in August 2014. From June 2005 to May 2012, Mr. Baldota served in various leadership positions as a Vice
President and later Senior Vice President reporting to the Chairman and Managing Director of Sun Pharma. Mr. Baldota’s areas of responsibility over his
tenure at Sun Pharma have included accounting, M&A, business finance, tax, treasury, insurance, controllership, legal, corporate secretarial, corporate
communication, and internal audit. Mr. Baldota was the Vice President Purchasing of Lafarge India Limited from March 2003 to June 2005 and served as
its Head of Information Technology from November 1999 to March 2003. Prior to that, Mr. Baldota served in various IT and marketing roles with Sun
Pharma between May 1995 and November 1999. Mr. Baldota earned a Bachelor of Technology in Chemical Engineering from Indian Institute of
Technology, Delhi, and a Masters of Business Administration from the Indian Institute of Management, Ahmedabad.
Linda Benshoshan became a member of our Board in December 2016 and serves as the Chairwoman of the Audit Committee and the Chairwoman
of the Compensation Committee. She served as a member of the board of Israel Discount Bank from November 2014 until May 2017. Mrs. Benshoshan is
a Member of Advisory Committee at MONETA Venture Capital since July 2018 and has been a partner at FORMA Real Estate Funds since November
2016 and a board member of Energix Renewable Energies Ltd. (TASE: ENRG). She is an External Director at MRR Thirteen Limited, External Director at
PRIORTECH LTD and External Director at MIGDALINSURANCE & FINANCIAL HOLDINGS Ltd. Over the last twenty-four years, Mrs. Benshoshan
has served in various capacities within the finance and academic sphere, including, as a member of the advisory board at ALTO Real Estate Funds; and an
External Director and Chairwoman of the investments committee at ‘Rom’ Study Fund. Mrs. Benshoshan holds a B.A. in Economics and Sociology and an
M.B.A.in Finance and Banking, from the Hebrew University of Jerusalem.
Robert Stein, M.D., Ph.D. became a member of our Board of Directors in February 2020 and serves on the Audit and Compensation Committee.
Dr. Stein has medical and scientific training and has over 40 years of Research and Development leadership
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experience in both pharmaceutical and biotechnology companies. He currently is an Operating Partner at Samsara Biocapital, Executive Vice President of
Research & Development for MiMedx, and also consults widely for pharma, biotech, and academia. Dr. Stein has led R&D across all the major therapeutic
areas and has made significant contributions to over nine registered medicines and thirteen monoclonal antibodies currently in late-stage clinical
development. From 1980 to 1990, he was at Merck, Sharpe, and Dohme Research Labs where he was Head of Pharmacology. From 1990 to 1996 he was
the first head of R&D at Ligand Pharmaceuticals. From 1996 to 2001, he was EVP of Research and Preclinical Development at DuPont-Merck / DuPont
Pharmaceuticals. He then spent five years as President of R&D at Incyte, five years as President of Roche Palo Alto (formerly Syntex), three years as CEO
of Kinemed, and five years as President, R&D at Agenus. Dr. Stein holds a B.S. with Honors in Biology and Chemistry from Indiana University, where he
was a National Merit Scholar. He has an M.D. and a Ph.D. in Physiology and Pharmacology from Duke University Medical and Graduate Schools. He is a
member of Phi Beta Kappa, Alpha Omega Alpha, and Sigma Xi Honor Societies. Dr. Stein completed his Internship and Residency at Duke, as well, and
is Board Certified in Anatomic and Clinical Pathology. He is a member of the College of American Pathology, the New York Academy of Sciences, the
American Association of Cancer Research, and the American Society of Clinical Oncology. Dr. Stein also has served on the board of directors for Geron,
DiaDexus, and Archemix. He currently is a member of the boards of directors for Protagenic Therapeutics, Polypid and Immunogenesis. Dr. Stein is a
member of the Scientific Advisory Board for the Drug Development Institute of the James Comprehensive Cancer Center of Ohio State University and a
Scientific Advisor to Washington University in St. Louis.
Dov Pekelman became a member of our Board and Audit Committee in August 2011, Chairman of the Special Committee in November 2011
(disbanded in February 2013), the Stock Option Committee in March 2012 (disbanded in January 2015) and the Compensation Committee in February
2013. Professor Pekelman is currently a major shareholder of Atera Networks Ltd. and a board member of Mapi Pharma, Ltd. He holds a founding share
of Reichman University, Herzlya, the only private university in Israel, serving as Dean of the Business School, and Chairman of Mifalot - the University
economic arm. Professor Pekelman served as a senior consultant to Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) from 1985 to 2008 and also
founded and ran a leading, Israeli-based management-consulting firm, P.O.C. Ltd. Professor Pekelman served on the board of directors of several large
industrial corporations, including Enzymotec (NASDAQ:ENZY), Koor Industries Ltd. (TASE: KOR) and served for 22 years on the board of directors of
Makhteshim Agan Industries Ltd. (TASE: MAIN). Professor Pekelman was also a member of the advisory committee of the Bank of Israel. He holds a
Ph.D. from the University of Chicago and a B.S. from the Technion, Israeli Institute of Technology. Professor Pekelman is a published author writing on
various aspects of business operations.
James Kedrowski became a member of our Board in May 2011. In addition, Mr. Kedrowski served as the Company’s Interim Chief Executive
Officer from October 2010 until August 2013. Mr. Kedrowski was with Chattem Chemicals, Inc., an indirect subsidiary of Sun Pharma since 1997 and
served as its President. Mr. Kedrowski’s prior experience includes over 20 years with Alcoa Inc., starting in sales, then purchasing roles culminating as
senior purchasing agent for all chemicals, energy, and carbon. Subsequently, Mr. Kedrowski was in progressive P&L business management positions in the
U.S. before heading to Tokyo for four years of international experience running Alcoa’s Industrial Chemicals business in Asia. Mr. Kedrowski then
returned to the U.S. as Operational Vice President for seven North American Industrial Chemicals plants.
William Coote joined our Company in 2008 as Associate Vice President, Treasurer. He is currently Vice President, Chief Financial Officer and
Chief Accounting Officer and is responsible for Taro’s global finance function. Mr. Coote has over 45 years of significant financial executive experience;
most recently serving as Taro’s Associate Vice President, Treasurer and Business Finance since 2008. Prior to joining Taro, Mr. Coote held finance
positions with a variety of global companies such as Bowne & Co., Prudential Realty, Merrill Lynch, and Ernst & Young. Throughout his career, he has
been accountable for areas such as Accounting, Treasury, Budgeting, Financial Planning and Analysis, Acquisitions, Investor Relations, Financial, and SEC
Reporting.
B. COMPENSATION
Aggregate Compensation of Executive Officer (and Office Holders) and Directors
We incurred an aggregate of approximately $6.0 million in compensation expenses for all of our then-current directors and executive officers plus
additional eight individuals who were considered our executive office holders for services rendered to us in all capacities during the year ended March 31,
2022. In addition, approximately $0.9 million was set aside in fiscal 2022 to provide certain executive officers (and office holders) and directors with
pension, retirement or similar benefits. During the year ended March 31, 2022, our executive officers (and office holders) and directors did not receive any
options to purchase Taro’s ordinary shares or other equity incentive awards under our equity incentive plans.
As of March 31, 2022, our executive officers (and office holders) and directors held no options to purchase ordinary shares or other equity incentive
awards.
54
Director Compensation
Our directors, other than those identified in this paragraph, are paid NIS 149,012, or approximately $46,500 (based on the average representative
exchange rate in effect during the year ended March 31, 2022) per year for their service as directors and NIS 5,732, or approximately $1,800, for each
board and committee meeting they attend, linked to the Israeli Consumer Price Index, or CPI, for their service as directors. Dilip Shanghvi earned
approximately $1.5 million during the year ended March 31, 2022, for his service in addition to his duties as a director. The compensation for our
statutory external directors, as defined under Israeli law, is not in excess of the amounts set forth in the Israeli Companies Law and regulations promulgated
thereunder.
Approval of Compensation
Directors
Under the Israeli Companies Law, the compensation of a public company’s directors requires the approval of (i) its compensation committee, (ii) its
board of directors and (iii) the approval of its shareholders at a general meeting, unless exempted pursuant to regulations promulgated under the Israeli
Companies Law. In addition, if the compensation of a public company’s directors is inconsistent with the company’s compensation policy, then those
inconsistent provisions must be separately considered by the compensation committee and board of directors, and approved by the shareholders by a
special vote in one of the following two ways:
•
•
at least a majority of the shares held by all shareholders who are not controlling shareholders and do not have a conflict of interest (referred
to under the Israeli Companies Law as a “personal interest”) in such matter, present and voting at such meeting, vote in favor of the
inconsistent provisions of the compensation package, excluding abstentions; or
the total number of shares of non-controlling shareholders who do not have a personal interest in such matter voting against the inconsistent
provisions of the compensation package does not exceed two percent (2%) of the aggregate voting rights in the Company.
Executive Officers other than the Chief Executive Officer
The Israeli Companies Law requires the approval of the compensation of a public company’s executive officers (other than the Chief Executive
Officer) by the following corporate bodies, in the following order: (i) the compensation committee, and (ii) the company’s board of directors. If such
compensation arrangement is inconsistent with the company’s stated compensation policy, then the company’s shareholders (by a special majority vote, as
discussed above with respect to the approval of director compensation that is inconsistent with a compensation policy) must also approve the
compensation. However, if the shareholders of the company decline to approve a compensation arrangement with an executive officer that is inconsistent
with the company’s stated compensation policy, the compensation committee and board of directors may override the shareholders’ decision if each of the
compensation committee and the board of directors provide detailed reasons for their decision.
An amendment to an existing arrangement with an office holder requires only the approval of the compensation committee, if the compensation
committee determines that the amendment is not material in comparison to the existing arrangement. However, according to regulations promulgated
under the Israeli Companies Law, an amendment to an existing arrangement with an office holder (who is not a director) who is subordinate to the Chief
Executive Officer shall not require the approval of the compensation committee, if (i) the amendment is approved by the Chief Executive Officer, (ii) the
company’s compensation policy provides that a non-material amendment to the terms of service of an office holder (other than the Chief Executive Officer)
may be approved by the Chief Executive Officer and (iii) the engagement terms are consistent with the company’s compensation policy.
Chief Executive Officer
Under the Israeli Companies Law, the compensation of a public company’s Chief Executive Officer is required to be approved by: (i) the company’s
compensation committee; (ii) the company’s board of directors, and (iii) the company’s shareholders (by a special majority vote as discussed above with
respect to the approval of director compensation that is inconsistent with a compensation policy). However, if the shareholders of the company decline to
approve the compensation arrangement with the Chief Executive Officer, the compensation committee and board of directors may override the
shareholders’ decision if each of the compensation committee and the board of directors provide a detailed report for their decision. The approval of each
of the compensation committee and the board of directors should be provided in accordance with the company’s stated compensation policy. However, in
special circumstances, they may approve compensation terms of a Chief Executive Officer that are inconsistent with such policy, provided that they have
considered those provisions that must be included in the compensation policy according to the Israeli Companies Law and that shareholder approval was
obtained by a special majority vote as discussed above with respect to the approval of director compensation that is inconsistent with a compensation
policy. In addition, the compensation committee may waive the shareholder approval requirement with regard to the approval of the engagement terms of a
candidate for the Chief Executive Officer position, if they determine that (i) the compensation arrangement is consistent with the company’s stated
compensation policy; (ii) the Chief Executive Officer candidate did not have a prior business relationship with the company or a controlling shareholder of
the company; and (iii) subjecting the approval of the engagement to a shareholder vote would impede the company’s ability to employ the Chief Executive
Officer candidate.
55
C. BOARD PRACTICES
We are incorporated in Israel and, therefore, we are subject to the provisions of the Israeli Companies Law, in addition to the relevant provisions of
U.S. laws.
Board of Directors
Under the Israeli Companies Law, the Board sets the policy of a company and supervises the general manager (i.e., the chief executive officer) of a
company in the performance of his or her role. The Board has residual powers so that it can exercise any power of the company not granted to any other
body either by law or by our Articles of Association. Our Chief Executive Officer is responsible for our day-to-day management. Our Chief Executive
Officer is appointed by, and serves at the discretion of, our Board of Directors, subject to the employment agreement that we have entered into with him.
All other executive officers are appointed by the Chief Executive Officer, subject to applicable corporate approvals, and are subject to the terms of any
applicable employment or consulting agreements that we may enter into with them. According to our Articles of Association, as part of its powers, our
Board may cause us to borrow or secure payments of any sum or sums of money for our purposes, at times and upon conditions as it deems fit, including
the grant of security interests on all or any part of our property.
Under our Articles of Association, other than external directors, for whom special election requirements apply under the Israeli Companies Law, our
Board may consist of between five and 25 directors.
Our directors, other than our statutory external directors, are elected at annual general meetings of our shareholders, which are required to be held at
least once during every calendar year and not more than 15 months after the last preceding meeting. Directors may also be appointed to fill vacancies, or
may be appointed to serve as additional members of the Board, by an ordinary resolution passed at an extraordinary general meeting of our shareholders.
Likewise, in the event of a vacancy, the Board is empowered to appoint a director to fill such vacancy until the next annual general meeting of
shareholders. A director, other than a statutory external director, holds office until the next annual general meeting, unless such directorship is earlier
vacated in accordance with the provisions of any applicable law or regulation or under our Articles of Association.
Under the Israeli Companies Law, nominations for director may be made by any shareholder holding at least 1% of our outstanding voting power.
However, any such shareholder may make such a nomination only if a written notice of such shareholder’s intent to make such nomination has been given
to our company within seven days after we publish notice of our upcoming annual general meeting (or within 14 days after we publish a preliminary
notification of an upcoming annual general meeting). Any such nomination must include certain information, the consent of the proposed director
nominee(s) to serve as our director(s) if elected and a declaration signed by the nominee(s) declaring that they have the required skills and availability to
carry out their duties and providing details of such skills and affirming that there is no limitation under the Israeli Companies Law preventing their election
and that all of the information that is required to be provided to us in connection with such election under the Israeli Companies Law has been provided.
We do not have any service contracts with any of our directors that would provide for benefits upon termination of employment.
Our Board currently consists of eight directors. The following members of our Board have been determined to be independent within the meaning
of applicable NYSE regulations: Linda Benshoshan, Dr. Robert Stein and Dov Pekelman.
Under the Israeli Companies Law, the board of directors of a public company must hold at least one meeting every three months. The Company
complies with this requirement.
Chairperson of the Board of Directors
Our Articles of Association provide that the Chairperson of the Board of Directors is appointed by the members of the Board of Directors from
among them. Under the Israeli Companies Law, the Chief Executive Officer of a public company, or a relative of the Chief Executive Officer, may not
serve as the chairperson of the board of directors, and the chairperson of the board of directors, or a relative of the chairperson, may not be vested with
authorities of the Chief Executive Officer unless approved by a special majority of the company’s shareholders. The shareholders’ approval can be
effective for a period of five years following an initial public offering, and subsequently, for additional periods of up to three years.
In addition, a person who is subordinated, directly or indirectly, to the Chief Executive Officer may not serve as the chairperson of the board of
directors; the chairperson of the board of directors may not be vested with authorities that are granted to persons who are subordinated to the Chief
Executive Officer; and the chairperson of the board of directors may not serve in any other position in the company or in a controlled subsidiary, but may
serve as a director or chairperson of a controlled subsidiary.
56
Statutory External Directors
Exemption from Statutory External Director Requirement
Under regulations promulgated under the Israeli Companies Law, Israeli public companies whose shares are traded on certain U.S. stock exchanges,
such as the NYSE, that lack a controlling shareholder (as defined under the Israeli Companies Law) may elect to exempt themselves from the requirement
to appoint statutory external directors. Any such company may also exempt itself from the Israeli Companies Law requirements related to the composition
of the audit and compensation committees of the Board. Eligibility for these exemptions is conditioned on compliance with U.S. stock exchange listing
rules related to majority Board independence and the composition of the audit and compensation committees of the Board, as applicable to all listed
domestic U.S. companies. Because we have a controlling shareholder (Sun), we are not eligible for these exemptions.
Qualifications of Statutory External Directors
Under the Israeli Companies Law, companies incorporated under the laws of the State of Israel whose shares, inter alia, are listed for trading on a
stock exchange or have been offered to the public by a prospectus and are held by the public, are generally required to have at least two statutory external
directors. The Israeli Companies Law provides that a person may not be elected as a statutory external director if the person is a relative of a controlling
shareholder and/or the person or the person’s relative (as defined below), partner, employer, anyone to whom the person is subordinate, directly or
indirectly, or any entity under the person’s control has, as of the date of the person’s election to serve as a statutory external director, or had, during the two
years preceding that date, any affiliation (as defined below) with:
•
•
•
our company;
any entity controlling our company or relative thereof as of the date of the election; or
any entity controlled by our company or under common control with our company as of the date of the election or during the two years
preceding that date.
Under the Israeli Companies Law, “relative” is defined as: a spouse, brother or sister, parent, grandparent, or child; a child/brother/sister/parent of a
person’s spouse; or the spouse of any of the preceding people.
The term “affiliation” and the similar types of disqualifying relationships include (subject to certain exceptions) an employment relationship; a
business or professional relationship even if not maintained on a regular basis (but excluding insignificant relationships) or control of the company; and
service as an office holder (as defined below), excluding service as a director in a private company prior to the initial public offering of its shares if such
director was appointed as a director of the private company in order to serve as an external director following the initial public offering.
The Israeli Companies Law defines the term “office holder” as general manager (i.e., Chief Executive Officer), chief business manager, deputy
general manager, vice general manager, any other person assuming the responsibilities of any of the foregoing positions without regard to such person’s
title, and any director or manager who reports directly to the general manager.
The Israeli Companies Law provides that no person can serve as a statutory external director if the person’s other positions or other business creates,
or may create, a conflict of interest with the person’s responsibilities as a statutory external director or may otherwise interfere with the person’s ability to
serve as a statutory external director, or if the person is an employee of the Israel Securities Authority or of an Israeli stock exchange. Until the lapse of
two years from termination of office as a statutory external director, a company, its controlling shareholder and any entity controlled by the controlling
shareholder, may not grant a former statutory external director, his/her spouse or child any benefits, directly or indirectly, including engaging the former
statutory external director, his/her spouse or child to serve as an office holder in the company or in any company controlled by the controlling shareholder
of the company and cannot employ or receive professional services from that person for consideration, either directly or indirectly, including through a
corporation controlled by such former statutory external director. The same shall apply to a relative, who is not a former statutory external director’s
spouse or child, for a period of one year from termination of office as a statutory external director.
A person shall be qualified to serve as a statutory external director only if he or she possesses accounting and financial expertise or professional
qualifications, as defined in the regulations promulgated under the Israeli Companies Law. At least one statutory external director must possess accounting
and financial expertise. A director with accounting and financial expertise is a director who, due to his or her education, experience and skills, possesses an
expertise in, and an understanding of, financial and accounting matters and financial statements, such that he or she is able to understand the financial
statements of the company and initiate a discussion about the presentation of financial data. A director is deemed to have professional qualifications if he or
she has any of (i) an academic degree in economics, business management, accounting, law or public administration; (ii) an academic degree or has
completed another form of higher education in the primary field of business of the company or in a field which is relevant to his/her position in the
company; or (iii) at least five years of experience serving in one of the following capacities, or at least five years of cumulative experience serving in
57
two or more of the following capacities: (a) a senior business management position in a company with a significant volume of business, (b) a senior
position in the company’s primary field of business or (c) a senior position in public administration or service. The board of directors is charged with
determining whether a director possesses financial and accounting expertise or professional qualifications. Notwithstanding the foregoing, if at least one of
the other directors (i) is independent for purposes of serving on the audit committee under Rule 10A-3 of the Exchange Act and under the NYSE Listed
Company Manual and (ii) has accounting and financial expertise as defined under the Israeli Companies Law, then neither of the external directors is
required to possess accounting and financial expertise as long as each possesses the requisite professional qualifications.
The Israeli Companies Law also provides that a shareholders’ general meeting at which the appointment of a statutory external director is to be
considered will not be called unless the nominee has declared to the company that he or she complies with the qualifications for appointment as a statutory
external director.
Election of Statutory External Directors
The Israeli Companies Law provides that statutory external directors must be elected by a majority vote at a shareholders’ meeting, provided that
either:
•
•
the majority includes the majority of the total votes of non-controlling shareholders (as defined in the Israeli Companies Law) who do not
have a personal interest in the election of the subject external director, other than a personal interest that is not derived from a relationship
with a controlling shareholder, in such election present at the meeting in person or by proxy (abstentions are not taken into account); or
the total number of votes against the election of the statutory external director by the non-controlling disinterested shareholders (as described
in the previous bullet point) may not exceed two percent of the aggregate voting rights in the company.
For purposes of determining a controlling shareholder, Section 1 of the Israeli Companies Law defines “control” by reference to the definition of the
Israeli Securities Law, 5728-1968 (the “Securities Law”), which defines “control” as the ability to direct the activity of a corporation, excluding an ability
deriving merely from holding an office of director or another office in the corporation, and a person shall be presumed to control a corporation if he or she
holds half or more of a certain type of means of control of the corporation. 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 a majority of the directors of the company or its general manager. With
respect to certain matters (various related party transactions), a controlling shareholder is deemed to include a shareholder that holds 25% or more of the
voting rights in a public company if no other shareholder holds more than 50% of the voting rights in the company, but excludes a shareholder whose
power derives solely from his or her position as a director of the company or from any other position with the company. “Means of control” in Section 1 of
the Securities Law is defined as any one of the following: (1) the right to vote at a general meeting of a company or a corresponding body of another
corporation; or (2) the right to appoint directors of the corporation or its general manager.
The definition of “personal interest” under the Israeli Companies Law is provided in Item 10.B. below, under “Approval of Specified Related Party
Transactions Under Israeli Law and Our Articles of Association—Disclosure of Personal Interest of an Office Holder.”
The initial term of a statutory external director is three years and may be extended for two additional consecutive terms of three years each, provided
that either (i) his or her service for each such additional term is recommended by one or more shareholders holding at least one percent (1%) of the
company’s voting rights and is approved by a majority at a shareholders meeting, which majority must include either of the criteria described above with
respect to his or her initial election; or (ii) his or her service for each such additional term is recommended by the board of directors and is approved by a
majority at a shareholders meeting, which majority must include either of the criteria described above with respect to his or her initial election. In
accordance with the regulations under the Israeli Companies Law, companies whose securities are listed on one of a number of non-Israeli stock exchanges
(including the NYSE, where our ordinary shares are listed) may re-appoint an external director for additional three-year terms, in excess of the nine years
described above, if the audit committee and the board of directors confirm that, due to the expertise and special contribution of the external director to the
work of the board and its committees, his or her re-appointment is in the best interests of the company. The same special majority is required for election
of the statutory external director for each additional three-year term (as was required for the initial term), with the additional requirement that the arguments
of the board of directors and audit committee in favor of election for such additional term, and the number of terms already served by the external director,
be presented to the general meeting prior to the vote.
58
Statutory external directors may be removed from office by shareholders at a special general meeting of shareholders called by the board of
directors, where the removal is based on the same percentage of votes as is required for election or by a court, if the statutory external director ceases to
meet the statutory qualifications for his or her appointment or if he or she violates his or her duty of loyalty to the company. The court may also remove an
external director from office, if it determines, at the request of the company, a board member, a shareholder or a creditor that the board member is not able
to fulfill his role or if such board member was convicted by a court of certain specific offenses.
If an external directorship becomes vacant and there are fewer than two external directors on the board of directors at the time, then the board of
directors is required under the Israeli Companies Law to call a shareholders’ meeting immediately to elect a replacement external director.
Each committee of a company’s board of directors that is empowered to exercise one of the functions of the board of directors is required to include
at least one statutory external director, except for the audit committee and compensation committee, which are required to include all of the statutory
external directors, and an external director must serve as chair thereof.
Under the Israeli Companies Law, a statutory external director of a company is prohibited from receiving, directly or indirectly, any compensation
from the company other than compensation determined by the board within the scope provided in regulations adopted under the Israeli Companies Law.
Compensation of an external director is determined prior to his or her appointment and may not be changed during his or her term, subject to certain
exceptions.
Linda Benshoshan and Dr. Robert Stein currently serve as statutory external directors on the Company’s Board. Our Board has determined that
Linda Benshoshan possesses accounting and financial expertise, whereas Dr. Robert Stein possesses professional qualifications, as required of our statutory
external directors under the Israeli Companies Law.
Qualifications of Directors Generally Under the Israeli Companies Law
Under the Israeli Companies Law, the board of directors of a publicly traded company is required to make a determination as to the minimum
number of directors (not merely statutory external directors) who must have accounting and financial expertise (according to the same criteria described
above with respect to statutory external directors). In accordance with the Israeli Companies Law, the determination of the board should be based on,
among other things, the type of the company, its size, the volume and complexity of its activities and the number of directors. Based on the foregoing
considerations, our Board of Directors determined that the number of directors with accounting and financial expertise in our company shall not be less
than one. As described above, currently Linda Benshoshan has been determined by the board to possess such accounting and financial expertise.
Unaffiliated Directors Under the Israeli Companies Law
Under the Israeli Companies Law, the audit committee of a publicly traded company must consist of a majority of unaffiliated directors. An
“unaffiliated director” is defined as a statutory external director or a director who meets the following criteria:
•
•
he or she meets the qualifications for being appointed as a statutory external director, as approved by the audit committee, except for (i) the
requirement that the director be an Israeli resident (in the case of a company 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.
Board Committees
Subject to the provisions of the Israeli Companies Law, our Board may delegate its powers to certain committees comprised exclusively of Board
members. Pursuant to the Israeli Companies Law, any committee of the board of directors that is authorized to perform any function of the board (other
than committees constituted solely as advisory committees) must include at least one statutory external director. The audit committee and compensation
committee must be composed of at least three directors and include all statutory external directors. Our Board currently has three committees—an Audit
Committee, a Compensation Committee and a Social Responsibility Committee.
59
Audit Committee
Composition
Under the Israeli Companies Law and our Articles of Association, our Board is required to appoint an audit committee of at least three directors, a
majority of whom must be unaffiliated directors, and which must include all statutory external directors (at least two), but excludes:
•
•
•
the Chairman of the Board of Directors;
a director employed by our Company, or by the Company’s controlling shareholder, directly or indirectly, or who provides services to any of
the foregoing on a regular basis and a director whose main livelihood stems from the controlling shareholder; and
a controlling shareholder or a relative of a controlling shareholder.
The chairperson of the audit committee is required to be a statutory external director.
A person who is not qualified to serve as a member of the audit committee may not be present at the committee’s meetings and at the time
resolutions are adopted thereby, unless such person’s participation is requested by the committee in order to present to the committee a particular matter.
Currently, our Audit Committee consists of the following directors: Linda Benshoshan, Dr. Robert Stein, and Dov Pekelman, all of whom have been
determined by our Board to be independent as defined by the applicable rules of the NYSE and the SEC. Linda Benshoshan and Dr. Robert Stein are
statutory external directors. Linda Benshoshan is the chairwoman of our Audit Committee. Each member of our audit committee is also an unaffiliated
director under the Israeli Companies Law, thereby fulfilling the foregoing Israeli law requirement for the composition of the audit committee. Our Board
has determined that Linda Benshoshan is an audit committee financial expert as defined by the SEC rules and has the requisite financial experience as
defined by the corporate governance rules of the NYSE.
Duties and Authorities
Under the Israeli Companies Law and our Audit Committee charter, our Audit Committee is responsible for (i) determining whether there are
delinquencies in the business management practices of the company, including, in consultation with the company’s internal auditor or the independent
auditor, making recommendations to the Board to improve such practices; (ii) determining whether to approve certain related party transactions or
transactions in which an office holder has a personal interest; (iii) determining standards and policies for determining whether a transaction with a
controlling shareholder or a transaction in which a controlling shareholder has a personal interest is deemed negligible or not and the approval requirements
(including, potentially, the approval of the audit committee) for transactions that are not negligible, including the types of transactions that are not
negligible; (iv) where the Board approves the working plan of the internal auditor, examining such working plan before its submission to the Board and
proposing amendments thereto; (v) examining the company’s internal controls and internal auditor’s performance, including whether the internal auditor
has sufficient resources and tools to dispose of his responsibilities (taking into consideration the company’s special needs and size); (vi) examining the
scope of the company’s auditor’s work and compensation and submitting its recommendation with respect thereto to the corporate organ considering the
appointment thereof (either the Board or the general meeting of shareholders); and (vii) determining procedures with respect to the treatment of company
employees’ complaints as to the management of the company’s business and the protection to be provided to such employees. Our Audit Committee also
approves our financial statements in its role as a committee of the Board. Our Audit Committee may not approve an action or a related party transaction, or
take any other action required under the Israeli Companies Law, unless at the time of approval a majority of the committee’s members are present, a
majority of whom consists of unaffiliated directors including at least one statutory external director.
In accordance with Sarbanes-Oxley requirements and our Audit Committee charter, our Audit Committee is directly responsible for the
appointment, compensation and oversight of our independent auditors. In addition, the Audit Committee is also responsible for, among other things,
assisting the Board in reviewing, and recommending actions to the Board with respect to, our financial statements, the effectiveness of our internal controls
and our compliance with legal and regulatory requirements.
The Audit Committee has reviewed and discussed with our management our audited consolidated financial statements as of and for the year ended
March 31, 2022. The Audit Committee has also discussed with our independent registered public accounting firm the matters required to be discussed by
Auditing Standards No. 1310, “Communications with Audit Committees,” issued by the Public Company Accounting Oversight Board. Based on the
reviews and discussions referred to above, the Audit Committee has recommended to the Board that the audited consolidated financial statements referred
to above be included in this 2022 Annual Report.
60
Approval of Interested Party Transactions
Under the Israeli Companies Law, the approval of the Audit Committee (or, for transactions involving compensatory matters, the approval of the
Compensation Committee) is required to effect certain actions and transactions with office holders, controlling shareholders, and entities in which they
have a personal interest. Such interested party transactions (including matters described in the following paragraph) require the approval of the Audit
Committee (or the Compensation Committee, if involving a compensatory matter), the Board and in certain cases, the shareholders. Such shareholders’
approval, in certain cases, also requires a special voting majority. See Item 10.B – “Approval of Specified Related Party Transactions under Israeli Law
and Our Articles of Association –Disclosure of Personal Interests of a Controlling Shareholder” below.
Compensation Committee
Composition
Under the Israeli Companies Law, the board of directors of a public company must appoint a compensation committee. The compensation
committee generally (subject to certain exceptions that do not apply to our company) must be comprised of at least three directors, including all of the
external directors, who must constitute a majority of the members of the compensation committee, and one of whom must serve as chairman. Each
compensation committee member who is not an external director must be a director whose compensation is similar to the amount that may be paid to an
external director. The compensation committee is subject to the same restrictions under Israeli Companies Law as the audit committee as to who may not
be a member of the compensation committee.
Under the corporate governance rules of the NYSE, we are required to maintain a compensation committee consisting of at least two independent
directors. On February 4, 2013, the Company established a Compensation Committee to comply with the requirements of Amendment No. 20 to the Israeli
Companies Law (“Amendment 20”), which was effective as of December 2012. Currently, our Compensation Committee consists of the following
directors: Linda Benshoshan (who serves as chairwoman of the committee), Dr. Robert Stein, and Dov Pekelman, each of whom has been determined by
our Board to be “independent” as defined by the applicable rules of the NYSE and the SEC. All of our statutory external directors are members of the
Compensation Committee.
Compensation Committee Role
Our Compensation Committee is responsible for recommending our executive compensation policy to our Board for its approval (and subsequent
approval by our shareholders) and is charged with duties related to the compensation policy and to the compensation of our office holders, as well as
functions related to approval of the terms of engagement of office holders, including:
o
o
o
o
recommending whether our compensation policy should continue in effect, if the then-current policy has a term of greater than three
years (approval of either a new compensation policy or the continuation of an existing compensation policy must in any case occur
every three years for a company such as ours);
recommending to our Board periodic updates to the compensation policy;
assessing implementation of the compensation policy; and
determining whether the compensation terms of our Chief Executive Officer need not be brought to approval of the shareholders
(under special circumstances).
An “office holder” is defined in the Israeli Companies Law as a director and also a general manager, chief business manager, deputy general
manager, vice general manager, any other person assuming the responsibilities of any of these positions regardless of such person’s title, and any other
manager directly subordinate to the general manager. Each person listed in the table under Item 6.A “Directors, Senior Management and Employees –
Directors and Senior Management” is an office holder under the Israeli Companies Law.
Under Amendment 20, the terms of employment of office holders require the approval of the compensation committee and the board of directors
(assuming that they are consistent with the then-effective compensation policy). The terms of employment of directors and the Chief Executive Officer (or
any other office holder whose compensation deviates from the then-effective compensation policy, as described below) must also be approved by
shareholders.
Changes to existing terms of employment of office holders (other than directors) can be made with the approval of the compensation committee
only, if the committee determines that the change is not substantially different from the existing terms.
Under certain circumstances, the Compensation Committee and the Board may approve a compensatory arrangement for an office holder that deviates from
the compensation policy, provided that such arrangement is approved by the special majority of the company’s shareholders mentioned above, or, in certain
cases, even if that shareholder approval is not achieved.
61
Our Board of Directors has adopted a compensation committee charter setting forth the responsibilities of the committee, which are consistent with
the Israeli Companies Law and NYSE rules, which include, among others, the responsibilities set forth in the compensation policy.
Authorities Related to Compensation and Compensation Policy
Amendment 20 also required us to adopt a compensation policy regarding the terms of office and employment of office holders, including
compensation, equity awards, severance, and other benefits, and exemption from liability and indemnification. For a company such as ours that is not a
new public company, the Israeli Companies Law (based on Amendment 20) requires that we adopt a new compensation policy, or renew our existing
compensation policy, at least once every three years, via the approval of our Compensation Committee, Board and shareholders (including a special
majority of our non-controlling, disinterested shareholders). Under the Israeli Companies Law, the Board may adopt the compensation policy even if it is
not approved by the shareholders, provided that following non-approval of such policy by the shareholders, the Compensation Committee and the Board
revisit the matter and determine that the adoption of the compensation policy is beneficial to the company. Our current compensation policy was approved
by our Board, upon the recommendations of our Compensation Committee, and was approved by the requisite special majority of the non-controlling,
disinterested shareholders at our December 2020 annual general meeting of shareholders. The renewed version of the compensation policy proscribes
compensatory terms for our office holders, and includes (i) a maximum coverage level of $100 million under our D&O insurance policy and (ii) a
requirement that premiums and deductibles paid by our company under our D&O insurance policy be consistent with market terms and not material to our
company.
The compensation policy serves as the basis for setting the employment and compensation terms of our officers. The compensation policy also
relates to certain other factors, including advancement of our objectives, our work schedule and long-term strategy, and creation of appropriate incentives
for executives. The policy also takes into account our risk management, size and the nature of our operations. As required under the Israeli Companies
Law, our compensation policy also considers the following factors:
•
•
•
•
•
•
the knowledge, skills, expertise and accomplishments of the relevant director or executive;
the director’s or executive’s roles and responsibilities and prior compensation agreements with him or her;
the relationship between the terms offered and the average compensation of the other employees of our company, including any persons
employed through manpower companies;
the impact of disparities in salary upon work relationships at our company;
the possibility of reducing variable compensation at the discretion of the Board of Directors, and the possibility of setting a limit on the
exercise value of non-cash variable compensation; and
as to severance compensation, the period of service of the executive, the terms of his or her compensation during such service period, our
company’s performance during their period of service, the person’s contribution towards our company’s achievement of its goals and the
maximization of its profits, and the circumstances under which the person is leaving our company.
As further required under the Israeli Companies Law, our compensation policy also addresses the following principles:
•
•
•
•
•
the link between variable compensation and long-term performance and measurable criteria;
the relationship between variable and fixed compensation, and a cap on the value of variable compensation;
the conditions under which a director or executive would be required to repay compensation paid to him or her if it was later shown that the
data upon which such compensation was based was inaccurate and was required to be restated in our financial statements;
the minimum holding or vesting period for variable, long-term compensation; and
a limit to retirement grants.
The compensation policy also considers appropriate incentives from a long-term perspective and maximum limits for severance compensation.
Our compensation policy provides detailed information concerning the elements of compensation paid to our management office holders, as well as
non-management directors.
Our compensation policy also provides for compensation to our external directors in accordance with the amounts provided in the Companies
Regulations (Rules Regarding the Compensation and Expenses of an External Director) of 2000, as amended by the Companies Regulations (Relief for
Public Companies Traded in Stock Exchange Outside of Israel) of 2000, as such regulations may be amended from time to time.
62
For further information concerning our compensation policy, please see the text of the compensation policy, which serves as Exhibit 4.4 to this 2022
Annual Report.
Social Responsibility Committee
On February 9, 2017, the Board established a Social Responsibility Committee to assist the Company in overseeing its corporate social
responsibility activities at its sites worldwide. These activities may include community outreach programs, philanthropy, employee volunteer activities,
academic relations and patient assistance. Dov Pekelman is the chairman of our Social Responsibility Committee.
Nominating Committee
Our Board does not currently have a nominating committee, as director nominations are made in accordance with the terms of our Articles, as
described in Item 6.C. – “Board Practices – Board of Directors” above. We rely upon the exemption available to foreign private issuers under the Listed
Company Manual of the NYSE from the NYSE listing requirements related to creation of a nominating committee. Also see Item 16.G. – “Corporate
Governance” below.
Internal Auditor
Under the Israeli Companies Law, the board of directors of a public company is required to appoint an internal auditor proposed by the Audit
Committee. The internal auditor may not be an interested party (i.e., a holder of 5% or more of the voting rights in the company or of the issued share
capital), the Chief Executive Officer of the company or any of its directors, or a person who has the authority to appoint the company’s Chief Executive
Officer or any of its directors, or a relative of an office holder or of an interested party, nor may the internal auditor be our external independent auditors or
their representatives. The Audit Committee is required to oversee the activities and to assess the performance of the internal auditor, as well as to review
the internal auditor’s work plan. The role of the internal auditor is to examine, among other things, whether our actions comply with the law and orderly
business procedure. On February 6, 2019, David Kinzelberg became the internal auditor of the Company. The internal auditor has the right to demand that
the chairman of the Audit Committee convene an Audit Committee meeting, and the internal auditor may furthermore participate in all Audit Committee
meetings.
D. EMPLOYEES
The following table sets forth the number of full-time equivalents as of March 31, 2022:
Sales and Marketing
Administration
Research and Development
Production and Quality
Control
Total
United States
*
98
73
16
3
190
Canada
Israel
Japan
Total
44
35
75
380
534
32
48
165
456
701
21
9
—
3
33
195
165
256
839
1,455
The following table sets forth the number of full-time equivalents as of March 31, 2021:
Sales and Marketing
Administration
Research and Development
Production and Quality
Control
Total
United States
*
53
72
15
—
140
Canada
Israel
Japan
Total
40
37
73
403
553
33
47
168
476
724
—
—
—
—
—
126
156
256
879
1,417
63
The following table sets forth the number of full-time equivalents as of March 31, 2020:
Sales and Marketing
Administration
Research and Development
Production and Quality
Control
Total
United States
*
124
72
15
—
211
Canada
Israel
Japan
Total
41
40
73
399
553
31
45
166
458
700
—
—
—
—
—
196
157
209
902
1,464
* In the U.S., distribution employees are included in the Sales and Marketing category.
In general, we believe that our relationship with our employees is satisfactory. Since we are members of the Manufacturers Association, certain
general collective agreements apply to us. These agreements concern principally the length of the workday, minimum daily wages for professional
workers, insurance for work-related accidents, procedures for dismissing employees, pension payments, and other conditions of employment. We generally
provide our employees with benefits and working conditions beyond the required minimums.
The Collective Bargaining Agreement dated April 6, 2011, as amended and extended by the collective bargaining agreement dated January 5, 2017
and July 2, 2020 among Taro Israel, the Histadrut Trade Union and Taro’s Israel’s Employees Committee (the “Collective Bargaining Agreement”). The
Collective Bargaining Agreement is valid until December 31, 2023, and automatically renews for one-year periods unless notice is provided by a party
three months prior to the end of a term. The Collective Bargaining Agreement memorialized current employee-employer relations practices of Taro as well
as additional rights relating to job security, compensation and other benefits. Israeli law generally requires severance pay upon the retirement or death of an
employee or termination of employment in certain other circumstances. Under Section 14 of the Severance Pay Law (“Section 14”), in the event of
termination of the employer-employee relationship, all payments made to pension funds or any other similar funds serve as severance pay and the
Company is not obliged to pay the employee any other severance pay. Since 2011, the Company’s obligations to the employees’ pension plan have been
governed by the Collective Bargaining Agreement, including our severance obligations and the provision rates to the various provident funds. We are
complying with these obligations. We fund our ongoing severance obligations by contributing a sum equal to 8.3% of the employee’s wages to funds
known as Pension Funds or Managers’ Insurance. These funds provide different combinations of savings plan, life insurance and severance pay benefits to
our employees, and each employee, according to the fund chosen by them, receives a pension or a lump sum payment upon retirement and severance pay, if
the employee is legally entitled to it, upon termination of employment. In addition to the severance pay, each employee contributes an amount equal to
5.75%-7.0% of their salary towards their pension plan. The Company contributes an additional sum between 6.25%-7.5% of the employee’s salary.
Beginning in July 2016, the minimum numbers increased according to Israeli law. Since January 2017, employees contribute at least 6% of their salary
toward their pension plan, and the Company contributes an additional sum of at least 6.5% of the employee's salary towards pension and 6% of the
employee’s salary towards severance pay. Israeli employees and employers are required to pay predetermined sums to the National Insurance Institute (an
agency similar to the U.S. Social Security Administration), which include payments for national health insurance. The payments to the National Insurance
Institute are approximately 19.5% of an employee’s wages (up to a specified amount), of which the employee contributes approximately 12.0% and we
contribute approximately 7.5%.
64
E. SHARE OWNERSHIP
The following table sets forth certain information regarding the ownership of our ordinary shares by our directors and executive officers as of March
31, 2022. The percentage of ownership is based on ordinary shares outstanding as of March 31, 2022. None of the ordinary shares owned by any of our
directors and executive officers has voting rights different from those possessed by other holders of our ordinary shares.
Name
Dilip Shanghvi (1)
Abhay Gandhi
Sudhir Valia (2)
Uday Baldota
Linda Benshoshan
Robert Stein, M.D., Ph.D.
Dov Pekelman
James Kedrowski
William Coote
Total for all directors and officers
(9 persons) listed above, as a group
Number of
Ordinary
Shares
Percentage of
Outstanding
Ordinary Shares
—
—
—
—
—
—
—
—
—
—
0.0 %
0.0 %
0.0 %
0.0 %
0.0 %
0.0 %
0.0 %
0.0 %
0.0 %
0.00 %
(1)
(2)
Dilip Shanghvi, as the Managing Director of Sun Pharma’s board of directors and along with entities controlled by him and members of his family,
control 54.5% of Sun Pharma. As of March 31, 2022, Sun Pharma and its affiliates owned 78.5% of Taro’s outstanding ordinary shares.
Sudhir Valia is also a director of Sun Pharma. As of March 31, 2022, Sun Pharma and its affiliates owned 78.5% of Taro’s outstanding ordinary
shares.
As of March 31, 2022, the directors and executive officers listed above held no options to purchase our ordinary shares.
The following table sets forth certain information regarding the ownership of our founders’ shares as of March 31, 2022. The percentage of
ownership is based on 2,600 founders’ shares outstanding as of March 31, 2022.
Name
Alkaloida Chemical Company Exclusive Group Ltd. (1)
Number of
Founders’
Shares
Percentage of
Outstanding
Founders’
Shares
2,600
100.00 %
(1)
Alkaloida Chemical Company Exclusive Group Ltd. (“Alkaloida”), a subsidiary of Sun, owns all 2,600 of our outstanding founders’ shares and is
entitled to exercise one-third of the total voting power in our Company regardless of the number of ordinary shares then outstanding. As a result of
the control that may be deemed to be held by Alkaloida, each of Dilip Shanghvi and Sudhir Valia may be deemed to beneficially own the founders’
shares held by Alkaloida. Each of Mr. Shanghvi and Mr. Valia disclaims beneficial ownership of such shares, except to the extent of his pecuniary
interest therein.
65
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A. MAJOR SHAREHOLDERS
Ordinary Shares
The following table sets forth certain information as of March 31, 2022, with respect to the ownership of our ordinary shares by all persons who are
known to us to beneficially own 5% or more of our outstanding ordinary shares. Beneficial ownership is determined in accordance with rules of the SEC
and generally includes voting and investment power with respect to our ordinary shares, as well as the right to receive the economic benefit of ownership of
such shares. The holder of the ordinary shares listed in the below table does not have voting rights with respect to such shares that are different from those
possessed by other holders of our ordinary shares. Percentage ownership is based on 37,584,631 ordinary shares outstanding as of March 31, 2022.
Name
Sun
Ordinary Shares
Beneficially
Owned
Percent of
Ordinary Shares
Outstanding
29,497,813 (1)
78.5 %
(1)
As reported on the Schedule 13D/A filed by Sun on November 27, 2013.
During the year ended March 31, 2019, the percentage of ordinary shares owned by Sun increased to 76.5% due to the repurchase of 888,719 shares
during the year. As of March 31, 2020, Sun’s ownership percentage increased 0.6% to 77.1%, due to the repurchase of 280,719 ordinary shares during the
year. As of March 31, 2021, the percentage of ordinary shares owned by Sun increased to 77.8%, due to the repurchase of 332,033 shares during the year.
Founders’ Shares
At the formation of our Company in 1959, two classes of shares were created, founders’ shares and ordinary shares. One-third of the voting power
of all of our voting shares is allocated to the founders’ shares. Alkaloida, which is a subsidiary of Sun Pharma, owns all of the 2,600 outstanding founders’
shares.
Voting Power
As of March 31, 2022, Sun controlled 85.7% of the voting power in our Company by reason of its (i) beneficial ownership of an aggregate of 78.5%
of our ordinary shares and (ii) ownership of the founders’ shares.
B. RELATED PARTY TRANSACTIONS
In addition to Sun controlling 85.7% of the voting power in our Company as of March 31, 2022, Taro has substantial relationships with Sun.
Certain Taro Board members are also members of various Sun entities’ boards of directors, including our Chairman, Dilip Shanghvi, who is also Managing
Director of Sun Pharma’s board of directors. In addition, certain Taro officers and executives are also executives of Sun.
Arrangements with Sun
Since 2013, in the ordinary course of business, Taro has entered into various commercial transactions, including product distribution and logistics,
manufacturing and service agreements, with Sun. The Company reviews each of these transactions and believes that the terms of these transactions are
comparable to those offered by or that could be obtained from unrelated third parties. Pursuant to Israeli requirements, all material transactions with Sun
have been presented to the Audit Committee, which has determined whether any such transaction is considered extraordinary, as defined in the Israeli
Companies Law and whether shareholder approval is required for such transaction. The Audit Committee has further determined the Israeli Companies
Law approval requirements that are applicable to the different types of transactions entered into with Sun.
Services Arrangement
Sun and Taro renewed a services arrangement (the “Services Agreement”), effective April 1, 2021, that allows the companies to share the services of
certain employees of the respective companies involved in certain North American management and operations functions in North America.
66
The companies are required to maintain records (the “Service Reports”) of the costs associated with the provision of the services under the Services
Agreement, and allocate such costs between companies, based upon approved allocation methodologies. The Services Agreement requires our Audit
Committee to review the Service Reports on a semi-annual basis and the Services Agreement, as a whole, on an annual basis to determine its efficacy and
whether it is in the Company’s best interests.
Each of the employees providing services under the Services Agreement is required to sign a written acknowledgment of his/her receipt of, and
agreement to be bound by (a) the confidentiality and non-disclosure agreement between Sun and Taro, and (b) guidelines for consideration in the
performance of such services, including the identification of potential conflicts of interest.
Products Related Arrangements
In May 2018, Taro Canada signed an agreement with Sun’s affiliate Ranbaxy Pharmaceuticals Canada Inc., which is now Sun Pharma Canada Inc.,
under which Taro Canada acts as the exclusive distributor for a portfolio of Sun and Ranbaxy products in Canada. Under this agreement, Taro Canada
purchases and controls inventory, and additionally, Sun and Ranbaxy pay Taro Canada a sales and distribution fee.
C. INTERESTS OF EXPERTS AND COUNSEL
Not applicable.
ITEM 8. FINANCIAL INFORMATION
A. CONSOLIDATED STATEMENTS AND OTHER FINANCIAL INFORMATION
The financial statements required by this item are found at the end of this 2022 Annual Report, beginning on page F-1.
Other Financial Information
We manufacture pharmaceutical products in our facilities in Israel and Canada. A substantial amount of these products are exported, both to our
affiliates and non-affiliates. For a breakdown of our sales by geographic market for the past three years, see Item 4B – “Business Overview – Sales and
Marketing.”
Legal Proceedings
From time to time, we are a party to routine litigation incidental to our business, including patent litigation resulting from our use of the patent
challenge procedures set forth in the Hatch Waxman Act, product liability litigations, and employment litigations, none of which, individually or in the
aggregate, are expected to have a material effect on our financial position or profitability. Other litigation, as disclosed herein, may have a material adverse
effect on our financial position or profitability.
Taro U.S.A. reached a global resolution with the DOJ Antitrust Division and Civil Division in connection with DOJ’s multi-year investigation into
the U.S. generic pharmaceutical industry. Under a Deferred Prosecution Agreement (the “Agreement”) entered into with the Antitrust Division on July 23,
2020, the DOJ filed an information relating to conduct allegedly occurring between 2013 and 2015. If Taro U.S.A. adheres to the terms of the Agreement,
including paying a penalty of $205.7 million, the DOJ will dismiss the information after three years. Taro U.S.A. has paid this amount in full to the
Antitrust Division. Taro U.S.A. also reached an agreement with the DOJ Civil Division on September 30, 2021, pursuant to which Taro U.S.A. voluntarily
entered into a five-year corporate integrity agreement with the U.S. Department of Health and Human Services’ Office of Inspector General, and agreed to
pay $213.3 million to resolve all claims related to federal healthcare programs. Taro U.S.A. has paid this amount in full to the Civil Division.
The Company, its subsidiaries and, with respect to a complaint brought by U.S. State Attorneys General (“AG”) and a complaint brought by putative
classes of indirect reseller plaintiffs (“IRPs”), a former member of Taro U.S.A.’s commercial team have been named as defendants in numerous putative
class action lawsuits and additional lawsuits brought by and/or on behalf of purchasers and payors of several generic pharmaceutical products in the U.S.
and Canada. The lawsuits allege that the Company, its subsidiaries, and the concerned individual in the AG and IRP complaints, have conspired with
competitors to fix prices, rig bids, or allocate customers with respect to certain products, and also allege an industry-wide conspiracy as to nearly all generic
pharmaceutical products. Each of the cases that were filed in U.S. federal court has been transferred to the U.S. District Court for the Eastern District of
Pennsylvania for coordinated proceedings under the caption In re: Generic Drug Pricing Antitrust Litigation, MDL No. 2724. The Court had sequenced the
lawsuits into separate groups for purposes of briefing motions to dismiss. Defendants filed motions to dismiss complaints in the first group. On October
16, 2018, the Court denied the motions with respect to the federal law claims. On February 15, 2019, the Court granted in part and denied in part the
motions with respect to the state law claims. Certain cases are proceeding in discovery. The Court
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designated certain complaints naming Taro U.S.A. as “bellwether” cases to begin the sequencing of proceedings, and in December 2021, the Court issued
an order setting certain bellwether schedules across 2022 and 2023, including related to discovery and motions practice. On November 4, 2021, a
settlement was reached with the putative Direct Purchaser Plaintiff class (“DPPs”), a putative class generally comprised of wholesalers and distributors that
purchased generic drug products from manufacturers, subject to final Court approval, pursuant to which Taro U.S.A. will pay a maximum of $67.6 million,
subject to a reduction of up to $8 million depending on the volume of certain class members that may opt-out of the settlement.
Further, the Company has made a provision of $200.0 million for ongoing multi-jurisdiction civil antitrust matters. An amount of $140.0 million
was accounted for in the year ended March 31, 2021; and an additional provision of $60.0 million was recognized in the quarter ended June 30, 2021;
however, the ultimate outcome of these matters cannot be predicted with certainty. These provisions have been disclosed in the consolidated financial
statements.
The Company and two of its former officers are named as defendants in a putative shareholder class action entitled Speakes v. Taro Pharmaceutical
Industries, Ltd., filed October 25, 2016, which is now pending in the U.S. District Court for the Southern District of New York and asserts claims under
Section 10(b) of the Exchange Act against all defendants and Section 20(a) of the Exchange Act against the individual defendants. It generally alleges that
the defendants made material misstatements and omissions in connection with an alleged conspiracy to fix drug prices. On September 24, 2018, the Court
granted in part and denied in part the Company’s motion to dismiss. The case is proceeding with limited discovery.
On June 22, 2020, a motion seeking documents before filing a shareholder derivative action was filed by a single shareholder against the Company
and Taro U.S.A. in the Haifa District Court related to alleged U.S. antitrust violations. On September 22, 2020, a subsequent motion seeking documents
was filed by a single shareholder against the Company related to alleged misreporting to U.S. Medicaid and three prior state settlements. Both motions
were consolidated on February 16, 2021, and remain pending before the Haifa District Court. The Company has filed a motion to stay proceedings pending
resolution of the related U.S. litigation.
The Company has completed its tax assessments with the Israel Tax Authority (“ITA”) for years through March 31, 2016. On March 28, 2022, the
ITA issued a tax assessment with respect to the period ending March 31, 2017, and the total tax liability arising from the assessment as of the date of its
issuance amounts to NIS 38.5 million ($12.3 million), including interest and linkage to the Israeli Customer Price Index. The Company intends to timely
submit a tax objection to the ITA. With respect to the years ending March 31, 2018 and through March 31, 2020, the Company is under examination by the
ITA. The Company may be also subject to examination by the ITA for the years ending March 31, 2021 and onward. The Company believes that its tax
provision is adequate to satisfy any assessments resulting from examination of these years.
In June 2020, the Company was named as a defendant in a putative opioids-related class action pending in Israel, in which the claimant alleges that
the Company did not provide sufficient disclosure regarding the risks associated with opioid use in alleged violation of the Israeli Consumer Protection
Act. The Company filed its defense to the application for class action approval on May 2, 2021, and a preliminary hearing to address the issue may be
scheduled for late 2022.
In June 2020, the Company and Taro U.S.A. were named as defendants in a complaint filed in the Zantac/Ranitidine Multi-District Litigation
(“MDL”) consolidated in the U.S. District Court for the Southern District of Florida. The lawsuits name over 100 defendants, including brand
manufacturers, generic manufacturers, repackagers, distributors, and retailers, involving allegations of injury caused by nitrosamine impurities. On
September 4, 2020 and October 3, 2020, the MDL Court dismissed the Company and Taro U.S.A., respectively, from the master complaints without
prejudice. Despite having been voluntarily dismissed from the master complaints, the Company and Taro U.S.A. were named in approximately 20 short
form complaints filed by plaintiffs represented by attorneys unaffiliated with MDL leadership counsel. On July 8, 2021, the MDL court granted the generic
Defendants’ motion to dismiss, the effect of which was to dismiss the Company and Taro U.S.A. with prejudice. That decision, which involves the issue of
federal preemption, is up on appeal. Neither the Company nor Taro U.S.A. have been named as defendants in any of the pending state court cases
involving ranitidine/Zantac of which we are aware.
In July 2019, the Company received a motion to approve a class action against 30 companies located in Haifa Bay, Israel, including the Company.
The claimant, a civil association in Haifa Bay, claims that the industrial activity of the 30 companies allegedly caused higher percentages of lung cancer
among Haifa Bay residents compared to the average in Israel. At this stage, the claimant seeks to receive district court approval for the motion to approve a
class action. The 30 companies, including the Company, filed their defense to the class action on January 9, 2022.
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Dividend Policy
We had never paid cash dividends until the fiscal year ended March 31, 2019, and we do not anticipate paying any regular cash dividends in the
foreseeable future. We currently intend to retain our earnings to finance the development of our business, but such policy may change depending upon,
among other things, our earnings, financial condition and capital requirements.
B. SIGNIFICANT CHANGES
Subsequent to March 31, 2022, the Company received five approvals from the FDA. The Company currently has a total of twenty ANDAs awaiting
FDA approval, including five tentative approvals.
ITEM 9. THE OFFER AND LISTING
A. OFFER AND LISTING DETAILS
Our ordinary shares are listed on the NYSE as of March 22, 2012, under the symbol “TARO.”
B. PLAN OF DISTRIBUTION
Not applicable.
C. MARKETS
Our ordinary shares have been listed on the NYSE under the symbol “TARO” since March 22, 2012. Our ordinary shares are not offered, listed or
traded on any other exchange or regulated market.
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. MEMORANDUM AND ARTICLES OF ASSOCIATION
Our registration number at the Israeli Registrar of Companies is 52-002290-6.
Objects and Purposes
Our Memorandum of Association provides that our main objects and purposes include any business connected with the developing, manufacturing,
processing, supplying, marketing and distributing of Rx, OTC medical and other health care products.
In February 2000, the Israeli Companies Ordinance (New Version—1983) was replaced with the Israeli Companies Law. Because our Articles of
Association were adopted before the enactment of the Israeli Companies Law, they are not always consistent with the provisions of the new law. In all
instances in which the Israeli Companies Law changes or amends provisions in the Companies Ordinance, and, as a result, our Articles of Association are
not consistent with the Israeli Companies Law, the provisions of the Israeli Companies Law apply unless specifically stated otherwise in the Israeli
Companies Law.
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Approval of Specified Related Party Transactions Under Israeli Law and Our Articles of Association
The Israeli Companies Law requires the approval of the audit committee, the board of directors and, in certain cases, the approval of the
shareholders in that sequence, in order to effect specified related parties' transactions, other than compensatory arrangements, for which the approval of the
compensation committee, board of directors and, in certain cases, the shareholders is required.
Pursuant to the provisions of the Israeli Companies Law, our Audit Committee has (i) preapproved criteria for the classification of transactions with
related parties as extraordinary or ordinary transactions, (ii) with respect to those classified as ordinary transactions, determined whether they are negligible
or non-negligible, as defined in the Israel Companies Law, and (iii) determined the approval requirements for transactions that are not negligible.
According to the Company’s policy, if a transaction is deemed an ordinary transaction as per the preapproved criteria, the transaction will only require
approval by our Board; if, however, a transaction is not covered by the preapproved criteria, it has to be first brought before the Audit Committee for its
determination. Under the Israeli Companies Law, an “extraordinary transaction” is generally a transaction other than in the ordinary course of business,
other than according to prevailing market terms, or that is likely to have a material impact on a company’s profitability, assets or liabilities.
Fiduciary Duties of Office Holders
The Israeli Companies Law imposes fiduciary duties that “office holders” (as defined in the Israeli Companies Law and described above in this 2022
Annual Report) owe to a company. An office holder’s fiduciary duties consist of a duty of care and a duty of loyalty. The duty of care requires an office
holder to act with the level of care that a reasonable office holder in the same position would have acted with under the same circumstances. The duty of
care includes a duty to use reasonable means to obtain:
•
•
information on the advisability of a given action brought for the office holder’s approval or performed by the office holder by virtue of his or
her position; and
all other information of importance with respect to these actions.
The duty of loyalty generally requires an office holder to act in good faith and for the benefit of the company, and this includes a duty to:
•
•
•
•
refrain from any conflict of interest between the performance of his or her duties to the company and his or her other positions or personal
affairs;
refrain from any activity that is competitive with the company;
refrain from exploiting any business opportunity of a company to receive personal gain for himself, herself, or others; and
disclose to the company any information or documents relating to the company’s affairs that the office holder has received as a result of his
or her position in the company.
Under the Israeli Companies Law, a company may approve an act specified above which would otherwise constitute a breach of the office holder’s
fiduciary duty, provided that the office holder acted in good faith, neither the act nor its approval harms the company, and the office holder discloses
his, her, or its personal interest, including any substantial fact or document, a sufficient time before the date for discussion of the approval of such
act. Any such approval is subject to the terms of the Israeli Companies Law setting forth, among other things, the appropriate bodies of the
company required to provide such approval and the methods of obtaining such approval.
Compensation of Office Holders
Under the Israeli Companies Law, arrangements as to compensation of a public company’s office holders who are directors or the Chief Executive
Officer require the approval of the compensation committee, the board of directors and the shareholders, in that order, except where the regulations adopted
under the Israeli Companies Law provide for certain easements from those requirements. Arrangements as to compensation of a public company’s office
holders who are not directors or the Chief Executive Officer generally (assuming that the arrangement conforms to the then-effective compensation policy)
require the approval of the compensation committee and the board of directors in that order as detailed above in Item 6.C. –“Board Practices – Board
Committees – Compensation Committee.”
Disclosure of Personal Interest of an Office Holder
The Company’s Articles of Association provide that a director must disclose his or her interest in a contract or arrangement at the meeting of the
Board of Directors at which such contract or arrangement is first taken into consideration. The Israeli Companies Law
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requires that an office holder (including a director) or a controlling shareholder who is aware that he or she has a personal interest in connection with any
existing or proposed transaction by the company, promptly disclose to the company the nature of any conflict of interest (referred to as a “personal interest”
under the Israeli Companies Law) that he or she may have, including all related material information or documents known to him or her. “Personal
interest,” as defined by the Israeli Companies Law, includes an interest of any person in an act or transaction of the company, including interest of his or her
relative or of a corporate body in which such person or his or her relative is either a holder of 5% or more of the corporate body shares or voting power, is a
director or the Chief Executive Officer, or is entitled to appoint at least one director or the Chief Executive Officer and including the personal interest of a
person voting by a proxy granted to him or her by another person, even if the person so granting the proxy does not have a personal interest in the
transaction. In addition, the vote of a person who was granted a proxy from a shareholder who has a personal interest shall be deemed the vote of a
shareholder having a personal interest, even if the proxy holder has discretion on how to vote. An interest stemming merely from ownership of shares in
the company is not deemed a personal interest. In the case of a non-extraordinary transaction, the office holder’s duty to disclose does not apply to a
personal interest of the office holder’s relative.
Under the Israeli Companies Law, the office holder must disclose his personal interest without delay and no later than the first meeting of the
company’s board that discusses the particular transaction. Once disclosure is made in compliance with the above disclosure requirement, if it is determined
by the audit committee that the subject transaction is a non-extraordinary transaction (meaning any transaction that is in the ordinary course of business, on
market terms, or that is not likely to have a material impact on the company's profitability, assets or liabilities), then the board of directors may approve the
transaction, unless the company’s articles of association provide otherwise (our Articles of Association do not provide otherwise). A transaction that is
adverse to the company’s interest or that is not performed by the officer holder in good faith may not be approved. If it is determined by the audit
committee that the subject transaction with an office holder is an extraordinary transaction, then approval first by the company’s audit committee and
subsequently by the board of directors is required. If the transaction concerns compensation, exemption, indemnification or insurance of an office holder,
then it must first be approved by the company’s compensation committee and then by the board of directors, and, under certain circumstances (for directors,
the Chief Executive Officer, and any executive officer whose compensation terms do not conform to the then-existing compensation policy), by the
shareholders of the company, in that order. Compensation of an individual office holder, including the Chief Executive Officer (but excluding a director),
that does not conform to the company’s compensation policy may be adopted under special circumstances despite failure to obtain shareholder approval if,
following the relevant shareholder vote, the compensation committee followed by the board once again approves the compensation, based on renewed and
specific analysis of relevant factors.
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 (other than a non-
extraordinary transaction) or the compensation committee may not be present at this meeting, unless the chairman of the audit committee, compensation
committee or the board of directors determined that the participation of such director is required in order to present the transaction. A director who has a
personal interest in a matter that is considered at a meeting of the board of directors, the audit committee or compensation committee may not vote on this
matter, unless a majority of the members of the board of directors or such committee, as the case may be, has a personal interest in the matter, in which case
shareholder approval is also required.
Disclosure of Personal Interests of a Controlling Shareholder
Under the Israeli Companies Law, the disclosure requirements that apply to an office holder also apply to a controlling shareholder of a public
company. For these purposes, a controlling shareholder is a shareholder who has the ability to direct the activities of a company (other than solely from his
or her position on the board of directors or any other position with the company), including a shareholder who holds 25% or more of the voting rights if no
other shareholder owns more than 50% of the voting rights. For purposes of attribution, the Israeli Companies Law provides that if two or more persons,
holding voting rights in the company, each have a personal interest in the approval of the same transaction, such persons will be deemed to be one holder.
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Extraordinary transactions with a controlling shareholder or in which a controlling shareholder has a personal interest, including a private offering in
which the controlling shareholder has a personal interest, and the engagement of a controlling shareholder or his or her relative with a public company, as
an office holder or employee, require the approval of the audit committee, the board of directors and the shareholders of the company, in that order. The
compensation, indemnification of, or insurance covering a controlling shareholder or his or her relative with a public company requires the approval of the
compensation committee, the board of directors and the shareholders, in that order (subject to certain leniencies with respect to the approval of directors
and officers liability insurance, for which shareholder approval may not be required under certain circumstances).
The shareholder approval must, in each case be by a majority of the votes cast at the meeting, whether in person or by proxy, provided that:
•
•
the majority includes at least the majority of the total votes of the shareholders who lack a conflict of interest (referred to as a personal
interest under the Israeli Companies Law) in approval of the transaction or compensation (as applicable), or anyone voting on their behalf
present at the meeting in person or by proxy; or
the total number of votes of the disinterested shareholders that are voted against the transaction does not exceed two percent (2%) of the
voting rights in the company.
To the extent that any such transaction with a controlling shareholder is for a period extending beyond three years, approval is required once every
three years, unless the audit committee determines that the duration of the transaction is reasonable given the circumstances related thereto.
All transactions (other than compensatory transactions, which are subject to approval by the compensation committee) with a controlling
shareholder, or in which a controlling shareholder has a personal interest, regardless of whether such transactions are extraordinary, are subject to the
oversight of the audit committee. The audit committee is required to establish procedures for a competitive process to be used by the company prior to
entering into any such transaction, or other procedures where appropriate.
Director Qualifications
Our Articles of Association do not require directors to hold shares in the Company. According to the Articles, the number of directors of the
Company should be not less than five or more than 25. Under the Israeli Companies Law, we must have at least two statutory external directors on the
Board of Directors. See Item 6.C. – “Board Practices – Statutory External Directors –Qualifications of Statutory External Directors.”
Voting, Rights Attached to Shares, Shareholders’ Meetings and Resolutions
Our directors, other than our statutory external directors, are elected at annual general meetings of our shareholders. A director holds office until the
next annual general meeting, unless he or she resigns or is earlier removed from office by an ordinary resolution passed at an extraordinary general meeting
of our shareholders.
Our share capital is divided into founders’ shares and ordinary shares. Holders of each paid-up share are entitled to participate equally in the
payment of dividends and other distributions and, in the event of liquidation, in all distributions after the discharge of liabilities to creditors. All ordinary
shares together entitle their holders to two-thirds of the voting power of our Company. All founders’ shares together entitle their holders to one-third of the
voting power of our Company. Under our Articles of Association, an increase to the share capital, creation of preferred shares or shares with special rights,
consolidation or division of share capital, cancelation of shares and reduction in share capital, require a special resolution of the shareholders, i.e. an
affirmative vote of 75% of the voting power voting in person or by proxy. The rights attached to any class of shares may be modified with the consent in
writing of the holders of three-fourths of the issued shares of that class or by way of a special resolution of the shareholders.
Under our Articles of Association, dividends on our ordinary shares may be paid out of profits and other surplus, as defined in the Israeli Companies
Law or as otherwise approved by a court of law, provided that there is no reasonable concern that the dividend will prevent us from satisfying our existing
and foreseeable obligations as they become due.
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Under the Israeli Companies Law and our Articles of Association, an ordinary resolution of the shareholders (for example, with respect to the
appointment of auditors) requires the affirmative vote of a majority of the voting power voting in person or by proxy, whereas a special resolution (for
example, a resolution amending the Articles of Association or authorizing changes in capitalization or in the rights attached to a class of shares) requires
the affirmative vote of at least 75% of the voting power voting in person or by proxy. Rights pertaining to a particular class of shares require the vote of
75% of such class of shares in order to change such rights in addition to the approval of 75% of the voting power of the shareholders voting in person, or by
proxy, on such resolution. The quorum required for a meeting of shareholders consists of at least three shareholders present, in person or by proxy, who
hold or represent between them at least one-third of the outstanding voting power unless otherwise required by applicable rules. A meeting adjourned for
lack of a quorum generally is adjourned to the same day in the following week at the same time and place or any time and place as the Board of Directors
may designate. If at such reconvened meeting the required quorum is not present, any two shareholders present in person, or by proxy, shall constitute a
quorum.
Shareholder Meetings
Under our Articles of Association and the Israeli Companies Law, an annual general meeting of the shareholders must be held at least once in every
calendar year, but not more than 15 months after the last preceding meeting. All general meetings must be held in Israel. The Board of Directors may call
an extraordinary general meeting of the shareholders at any time. The Board shall convene an extraordinary general meeting of the shareholders, at the
request of (i) any two of our directors or one-quarter of the members of our Board of Directors or (ii) one or more shareholders holding, in the aggregate,
either (a) 5% or more of our outstanding issued shares and 1% of our outstanding voting power or (b) 5% or more of our outstanding voting power,
provided that the request complies with the requirements provided by the Articles of Association, including but not limited to statement of the object of the
meeting. Any shareholder may appoint by power of attorney a person to act as his or her representative at a meeting. The original instrument appointing a
representative or a notarized copy must be deposited at the principal office of the Company at least 48 hours before the meeting.
The Israeli Companies Law requires that notice of any annual general meeting or extraordinary general meeting be provided to shareholders at least
21 days prior to the meeting and if the agenda of the meeting includes, among other matters, the appointment or removal of directors, the approval of
transactions with office holders or interested or related parties, approval of the company’s Chief Executive Officer to serve as the chairman of its board of
directors or an approval of a merger, notice must be provided at least 35 days prior to the meeting.
The Israeli Companies Law allows one or more of our shareholders holding at least 1% of the voting power of a company to request the inclusion of
an additional agenda item for an upcoming shareholders meeting, assuming that it is appropriate for debate and action at a shareholders meeting (as
determined by our Board of Directors). Under related regulations, such a shareholder request must be submitted within three days or, for certain requested
agenda items, seven days following our publication of notice of the meeting. If the requested agenda item includes the appointment of director(s), the
requesting shareholder must comply with particular procedural and documentary requirements. If our Board of Directors determines that the requested
agenda item is appropriate for consideration by our shareholders, we must publish an updated notice that includes such item within seven days following
the deadline for submission of agenda items by our shareholders. The publication of the updated notice of the shareholders meeting does not impact the
record date for the meeting. In lieu of this process, we may opt to provide pre-notice of our shareholders meeting at least 21 days prior to publishing
official notice of the meeting. In that case, our 1% shareholders are given a 14-day period in which to submit proposed agenda items, after which we must
publish notice of the meeting that includes any accepted shareholder proposals.
Under the Israeli Companies Law, shareholders of a public company are not permitted to take action by way of written consent in lieu of a meeting.
Restriction on Voting
In order to reduce our risk of being classified as a Controlled Foreign Corporation under the Code, we amended our Articles of Association in 1999
to provide that no owner of any of our ordinary shares is entitled to any voting right of any nature whatsoever with respect to such ordinary shares if (a) the
ownership or voting power of such ordinary shares was acquired, either directly or indirectly, by the owner after October 21, 1999, and (b) the ownership
would result in our being classified as a Controlled Foreign Corporation. This provision has the practical effect of prohibiting each citizen or resident of
the U.S. who acquired or acquires our ordinary shares after October 21, 1999, from exercising more than 9.9% of the voting power in our Company, with
respect to such ordinary shares, regardless of how many shares the shareholder owns. The provision may therefore discourage U.S. persons from seeking
to acquire, or from accumulating, 15% or more of our ordinary shares (which, due to the voting power of the founders’ shares, would represent 10% or
more of the voting power of our Company).
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Duties of Shareholders
Under the Israeli Companies Law, each and every shareholder has a duty to act in good faith and in an acceptable manner in exercising his, her or its
rights and fulfilling his, her, or its obligations towards the company and other shareholders and to refrain from abusing his, her or its power, such as in
voting in the general meeting of shareholders and/or in a meeting of a different class of shares, on the following matters:
•
•
•
•
any amendment to the articles of association;
an increase of the authorized share capital;
a merger; or
the approval of actions of office holders in breach of their duty of loyalty and of interested party transactions.
In addition, each and every shareholder has the general duty to refrain from depriving other shareholders of their rights.
Furthermore, a duty to act in fairness towards the company applies to any controlling shareholder, any shareholder who knows that he or she
possesses the power to determine the outcome of a shareholder vote and any shareholder that, pursuant to the provisions of the articles of association, has
the power to appoint or to prevent the appointment of an office holder in the company or any other power in regard to the company. The Israeli Companies
Law does not describe the substance of this duty to act in fairness.
These various shareholder duties may restrict the ability of a shareholder to act in what the shareholder perceives to be his, her or its own best
interests.
Transfer of Shares
Fully paid ordinary shares are issued in registered form and may be freely transferred under our Articles of Association unless the transfer is
restricted or prohibited by another instrument (or by any other limitation described herein).
Mergers and Acquisitions under Israeli Law
The Israeli Companies Law and the regulations promulgated thereunder include provisions that allow a merger transaction, in general, and require
that each company that is a party to a merger has the transaction approved by its board of directors and a majority of the voting power of its shares at a
shareholders’ meeting called on at least 35 days’ prior notice. Under the Articles of Association, the required shareholder vote for approval of a merger is a
supermajority of at least 75% of the shares voting in person or by proxy on the matter. A court may determine that a company duly approved a merger, in
certain cases, upon the request of shareholders holding 25% or more of the voting power in the company. A court may not approve a merger unless it is
convinced that the merger offer is fair and reasonable, in light of the valuation of the merging companies and the consideration which has been offered to
the shareholders. Upon the request of a creditor of either party of 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.
In addition, a merger may not be completed unless at least 30 days have passed from the time that the shareholders of each company have approved the
merger and 50 days have passed from the time that a merger proposal has been delivered to the Israeli Registrar of Companies.
In general, the Israeli Companies Law also provides that an acquisition of shares of a public company is required to 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 if there is no existing
holder of 25% or more of the voting rights in the company. If there is no existing holder of more than 45% of the voting rights in the company, in general,
the Israeli Companies Law provides that an acquisition of shares of a public company is required to be made by means of a special tender offer if as a result
of the acquisition the purchaser would become a holder of more than 45% of the voting rights in the company.
These requirements do not apply if, in general, the acquisition (1) was made in a private placement that received shareholders’ approval (confirming
that the purchaser would become a holder of 25% or greater than 45%, of the voting power in the company), (2) was from a holder of 25% or more, of the
voting power in the company which resulted in the acquirer becoming a holder of 25% or more of the voting power in the company, or (3) was from a
holder of greater than 45% of the voting power in the company which resulted in the acquirer becoming a holder of greater than 45% of the voting power in
the company. The tender offer must be extended to all shareholders, but the offeror is not required to purchase more than 5% of the company’s outstanding
shares, regardless of how many shares are tendered by shareholders. The tender offer may be consummated only if (i) at least 5% of 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.
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If as a result of any acquisition of shares, the acquirer will hold more than 90% of the company’s issued and outstanding share capital or of a class of
shares, or more than 90% of the voting power of the company, the acquisition must be made through a tender offer to acquire all of the shares or all of the
shares of such class. If the shares represented by the shareholders who did not tender their shares in the tender offer constitute less than 5% of the issued
and outstanding share capital of the company or of a class of shares (or voting power thereof), and a majority of the shareholders offered such tender who
do not have a personal interest in receipt of such tender accepted such tender (which condition shall not apply if, following consummation of the tender
offer, the acquirer holds at least 98% of all of the company’s outstanding shares or voting rights), all of the shares that the acquirer offered to purchase will
be transferred to the acquirer by operation of law. If the dissenting shareholders hold 5% or more of the issued and outstanding share capital (or voting
power) of the company or of a class of shares, the acquirer may not acquire additional shares of the company from shareholders who accepted the tender
offer to the extent that following such acquisition the acquirer would then own over 90% of the company’s issued and outstanding share capital or of a class
of shares. Shareholders may petition the court to alter the consideration for the acquisition to reflect a fair value. Such petition may be submitted within
six months from the date the tender offer has been accepted. However, the acquirer may provide in the tender offer documents that a shareholder that
accepts the offer may not seek such a court appraisal.
Israeli tax law may treat stock-for-stock acquisitions between an Israeli company and a foreign company less favorably than does U.S. tax law. For
example, unless the stock-for-stock transaction is considered a tax-deferred merger which relates to a transfer of at least 80% of the shares in the transferred
company, generally Israeli tax law subjects a shareholder who exchanges his ordinary shares for shares in another corporation (which is listed for trading on
a stock exchange) to taxation on half of the shareholder’s shares two years following the exchange and on the balance four years thereafter even if the
shareholder has not yet sold the new shares.
Indemnification and Insurance of Office Holders
Insurance of Office Holders
Subject to the provisions of the Israeli Companies Law, our Articles of Association provide that we may enter into an insurance contract that would
provide coverage in respect of liability imposed on any of our office holders with respect to an act performed in the capacity of an office holder for:
•
•
•
a breach of the office holder’s duty of care to the company or to another person, to the extent such a breach arises out of the negligent
conduct of the officer holder;
a breach of the office holder’s duty of loyalty to the company, provided that the office holder acted in good faith and had reasonable cause to
assume that his or her act would not prejudice the good of the company; or
a financial liability imposed upon him or her in favor of another person.
We have obtained liability insurance covering our officers and directors. Under our current compensation policy approved by our shareholders at
our December 2020 annual general meeting of shareholders, we have set (i) a maximum coverage level of $100 million for our D&O insurance policy and
(ii) a requirement that premiums and deductibles paid by our Company under our D&O insurance policy be consistent with market terms and not material
to our Company.
Indemnification of Office Holders
Subject to the provisions of the Israeli Companies Law, our Articles of Association provide that we may indemnify any of our office holders, in
advance and retroactively, against the following liabilities imposed or expenses incurred on the office holder with respect to an act performed in the
capacity of an office holder:
•
•
•
a monetary obligation imposed on him or her in favor of another person by a court judgment, including a compromise judgment or an
arbitrator’s award approved by the court;
reasonable litigation expenses, including attorneys’ fees, expended by the office holder due to an investigation or a proceeding instituted
against him or her by an authority competent to administer such an investigation or proceeding that was either finalized without the filing of
an indictment (as defined in the Israeli Companies Law) against him or her and “without any monetary obligation imposed in lieu of criminal
proceedings” (as defined in the Israeli Companies Law) or finalized “without the filing of an indictment” against him or her with a “monetary
obligation imposed in lieu of criminal proceedings” relating to an offense that does not require proof of criminal intent;
reasonable litigation expenses, including attorneys’ fees, expended by the office holder or charged to him or her by a court in connection with
proceedings we institute against him or her or that are instituted on our behalf or by another person or a criminal charge from which he or she
is acquitted, or a criminal charge in which he or she is convicted of an offense that does not require proof of criminal intent;
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•
•
expenses, including reasonable litigation expenses and legal fees, incurred by an office holder as a result of a proceeding instituted against
such office holder in relation to (1) infringements that may impose financial sanction pursuant to the provisions of Chapter H’3 under the
Securities Law or (2) administrative infringements pursuant to the provisions of Chapter H’4 under the Securities Law or (3) infringements
pursuant to the provisions of Chapter I’1 under the Securities Law; and
payments to an injured party of infringement under Section 52(54)(a)(1)(a) of the Securities Law.
Under the Israeli Companies Law, indemnification in advance in respect to monetary liabilities to third parties is limited to those events which, in
the opinion of the board of directors, are to be expected in light of the company’s actual activities when the indemnification is granted and to a sum or a
standard which the board of directors determines is reasonable in the circumstances.
Exemption of Office Holders
The Israeli Companies Law provides that a company may exempt an office holder in advance from liability for damages related to a breach of his
duty of care to the company, but only if a provision authorizing such exemption is included in its articles of association. Our Articles of Association
include such a provision. The company may not exempt in advance a director from liability arising out of a prohibited dividend or distribution to
shareholders.
Limitations on Exemption, Insurance, and Indemnification
The Israeli Companies Law provides that a company may not exempt or indemnify an office holder for, or enter into an insurance contract that
would provide coverage for any monetary liability incurred as a result of, any of the following:
•
•
•
•
a breach by the office holder of his or her duty of loyalty unless, with respect to indemnification and insurance coverage, the office holder
acted in good faith and had a reasonable basis to believe that the act would not prejudice the good of the company;
a breach by the office holder of his or her duty of care, which was committed intentionally or recklessly, except when it was committed solely
by negligence;
any act or omission committed with the intent to derive an illegal personal benefit; or
any civil fine, monetary sanction, or forfeiture imposed against the office holder.
In addition, under the Israeli Companies Law, exemption, indemnification, and procurement of insurance coverage (except where the regulations
provide for certain leniencies from such requirements with respect to insurance) for office holders must be approved by the compensation committee and
board of directors of a company and, if the beneficiary is a director or the Chief Executive Officer (or a controlling shareholder and his or her relative), by
the shareholders, in that order.
Following approval by the Audit Committee and Board of Directors and, in the case of directors, approval by our shareholders, we entered into
exemption and indemnification agreements with our directors and certain officers. For further information concerning the exemption and indemnification
that we provide to our office holders, please see the form of director and office indemnification agreement that serves as Exhibit 4.5 to this 2022 Annual
Report.
C. MATERIAL CONTRACTS
During the two years preceding the date of this 2022 Annual Report, neither we nor any of our affiliates and subsidiaries entered into any material
contracts, other than contracts entered into in the ordinary course of business.
D. EXCHANGE CONTROLS
Israeli law and regulations do not impose any material foreign exchange restrictions on non-Israeli holders of our ordinary shares, except with
respect to citizens of countries which are in a state of war with Israel. However, legislation remains in effect pursuant to which currency controls can be
imposed by administrative action at any time.
Dividends, if any, paid to our ordinary shareholders, and any amounts payable upon our dissolution, liquidation or winding up, as well as the
proceeds of any sale in Israel of our ordinary shares to an Israeli resident, may be paid in non-Israeli currency or, if paid in Israeli currency, may be
converted into freely repatriated dollars at the rate of exchange prevailing at the time of conversion. Payments of dividends may be subject to withholding
taxes. Israeli residents have an obligation to file reports with the Bank of Israel regarding certain transactions.
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E. TAXATION
General
The following is a brief summary of the material, current income tax aspects applicable to companies in Israel with reference to its effect on us. The
following also contains a discussion of material Israeli and U.S. tax consequences to our shareholders and Israeli government programs benefiting us. We
cannot assure you that the tax authorities, the courts, or any other judicial or administrative authority will accept the views expressed in the discussion in
question. This summary is based on the laws and regulations in effect as of the date hereof. The discussion is not intended, and should not be construed, as
legal or professional tax advice and is not exhaustive of all possible tax considerations. Holders of our ordinary shares should consult their own tax
advisors as to the U.S., Israeli or other tax consequences of the purchase, ownership and disposition of ordinary shares, including, in particular,
the effect of any foreign, state, or local taxes.
Israeli Tax Considerations and Government Programs
General Corporate Tax Structure
Generally, Israeli companies are subject to corporate tax on their worldwide taxable income. As of calendar year 2022, 2021 and 2020, the
corporate tax rate has been 23.0%. However, the effective tax rate payable by a company that derives income from an Approved Enterprise, a Benefited
Enterprise, a Preferred/Special Preferred Enterprise, or a Preferred/Special Preferred Technological Enterprise, as discussed below, may be considerably
less. In general, Israeli companies are subject to regular corporate tax rate for their capital gain.
Tax Benefits under the Law for the Encouragement of Capital Investments, 1959
The Law for the Encouragement of Capital Investments, 5719-1959 (the “Investment Law”), provides certain incentives for productive activity, as
under the regimes stipulated in the Investment Law. Generally, an investment program that is implemented in accordance with the provisions of the
Investment Law, referred to as an Approved Enterprise, a Benefited Enterprise, a Preferred/Special Preferred Enterprise, or a Preferred/Special Preferred
Technological Enterprise, is entitled to benefits as discussed below. These benefits may include cash grants from the Israeli government and tax benefits,
based upon, among other things, the location of the facility within Israel or the election of the grantee. In order to qualify for these incentives, an Approved
Enterprise, a Benefited Enterprise, a Preferred/Special Preferred Enterprise, or a Preferred/Special Preferred Technological Enterprise is required to comply
with the requirements of the Investment Law. Several of our production and development facilities in Israel have been granted “Approved Enterprise” and
“Benefited Enterprise” status, which provided certain benefits, including tax exemptions and reduced tax rates for a defined period. The “Approved
Enterprise” and “Benefited Enterprise” statuses were applicable to our production and development facilities through the year ending on March 31, 2020,
as the Company made an irrevocable election to forego previously granted benefits and apply the tax benefits under the 2011 Amendment and/or the 2017
Amendment (as defined below).
The Investment Law was significantly amended as of April 1, 2005 (the “2005 Amendment”), as of January 1, 2011 (the “2011 Amendment”), and
as of January 1, 2017 (the “2017 Amendment”). Pursuant to the 2005 Amendment, tax benefits granted in accordance with the provisions of the
Investment Law prior to its revision by the 2005 Amendment remained in force, but any benefits granted subsequently were subject to the provisions of the
2005 Amendment. Similarly, the 2011 Amendment introduced new benefits instead of the benefits granted in accordance with the provisions of the
Investment Law in effect prior to the 2011 Amendment. However, companies entitled to benefits under the Investment Law in effect up to January 1, 2011,
were entitled to choose to continue to enjoy such benefits, provided that certain conditions are met, or elect instead irrevocably, to forego such benefits and
elect the benefits of the 2011 Amendment. The 2017 Amendment introduced new benefits for Preferred/Special Preferred Technological Enterprises,
alongside the existing tax benefits, as prescribed under previous amendments.
The following discussion is a summary of the Investment Law from the period prior to the 2005 Amendment through the 2017 Amendment as well
as the relevant changes contained in such amendments and in the new legislation.
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Tax Benefits Before the 2005 Amendment
An investment program that is implemented in accordance with the provisions of the Investment Law prior to the 2005 Amendment, generally
referred to as an “Approved Enterprise”, is entitled to certain benefits. These benefits may include cash grants from the Israeli government and tax
benefits, based upon, among other things, the location of the facility within Israel in which the investment is made or the election of the grantee. A
company that wished to receive benefits had to receive an approval from the Israeli Authority for Investments and Development of the Industry and
Economy (formerly the Ministry of Industry, Trade, and Labor) (the “Investment Center”), in order to obtain such Approved Enterprise status. Each
certificate of approval for an Approved Enterprise relates to a specific investment program, delineated both by the financial scope of the investment,
including sources of funds, and by the physical characteristics of the facility or other assets. The tax benefits available under any certificate of approval
relate only to taxable income attributable to the specific program and are contingent upon meeting the criteria set forth in the certificate of approval.
Income derived from activity that is not integral to the activity of the Approved Enterprise will not enjoy tax benefits.
A company owning an Approved Enterprise may elect to forego certain government cash grants extended to an Approved Enterprises in return for
an alternative package of tax benefits (the “Alternative Benefits Program”). Under the Alternative Benefits Program, a company’s undistributed income
derived from an Approved Enterprise is exempt from corporate tax for a period of between two and ten years (the “Exemption Period”), beginning on the
first year in which the company derives taxable income under the program after the commencement of production, depending on the geographic location of
the Approved Enterprise in Israel. After the Exemption Period, the company will be eligible for the reduced tax rates of 10% - 25% for the remainder of
the benefits period, depending on the level of foreign investment in the company in each year. These tax benefits are granted for a limited period not
exceeding seven years, or ten years for a company whose foreign investment level exceeds 25%, from the first year in which the Approved Enterprise has
taxable income, after the year in which production commenced (as determined by the Investment Center). However, the benefits period may in no event
exceed the lesser of 12 years from the year in which the enterprise commences its operations (as determined by the Investment Center) or 14 years from the
year of receipt of Approved Enterprise status, whichever ends earlier. If a company has more than one Approved Enterprise program or if only a portion of
its capital investments are approved, the company’s effective tax rate reflects the weighted-average of the applicable rates. The tax benefits available under
any certificate of approval relate only to taxable income attributable to the specific program and are contingent upon meeting the criteria set out in the
certificate of approval.
The tax benefits under the Investment Law also apply to a company’s income that is generated from (i) the grant of a right of use with respect to
know-how developed by the Approved Enterprise, (ii) income generated from royalties and (iii) income derived from a service which is ancillary to such
right of use or royalties, provided that such income is attributable to the Approved Enterprise’s ordinary course of business. The tax benefits under the
Investment Law may generally not be available with respect to income derived from products manufactured outside of Israel (subject to certain de-minims
thresholds, and attribution formulas).
A company that has an Approved Enterprise program is eligible for further tax benefits if it qualifies as a Foreign Investors’ Company (“FIC”). A
FIC that is eligible for benefits is essentially a company with a level of foreign investment, as defined in the Investment Law, of more than 25%. The level
of foreign investment is measured as the percentage of rights in the company (in terms of shares, rights to profits, voting and appointment of directors), and
of combined share and loan capital, that are owned, directly or indirectly, by persons who are not residents of Israel. The determination as to whether or
not a company qualifies as an FIC is made on an annual basis. A FIC that has an Approved Enterprise program will be eligible for an extension of the
period during which it is entitled to tax benefits under its Approved Enterprise status (so that the benefit periods may be up to ten years) and for further tax
benefits if the level of foreign investment is 49% or more. If a company that has an Approved Enterprise program is a wholly-owned subsidiary of another
company, then the percentage of foreign investments is determined based on the percentage of foreign investment in the parent company.
The following table sets forth the corporate tax rates and related levels of foreign investments with respect to a FIC that has an Approved Enterprise
program.
Percentage of non-Israeli ownership
49% or more but less than 74%
74% or more but less than 90%
90% or more
Corporate Tax Rate
20%
15%
10%
Dividends paid out of income attributed to an Approved Enterprise (or out of dividends received from a company whose income is attributed to an
Approved Enterprise) are generally subject to withholding tax at source at the rate of 15% (in the case of non-Israeli shareholders, subject to the receipt, in
advance, of a valid certificate from the ITA allowing for such rate, or a lower rate under an applicable tax treaty). This withholding tax is deducted at
source by the company. The 15% tax rate is limited to dividends and distributions out of income derived during the benefits period and actually paid at any
time up to 12 years thereafter. After such period, the withholding tax is applied at a rate of up to 30%, or at the lower rate under an applicable tax treaty
(subject to the receipt in advance of a valid certificate from the ITA). In the case of a FIC, the 12-year limitation on reduced withholding tax on dividends
does not apply. In addition, a company that pays a dividend out of tax-exempt income attributed to its Approved Enterprise will be subject to tax in
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respect of the amount of the dividend distributed (grossed up to reflect the pre-tax income that it would have had to earn in order to distribute the dividend)
at the corporate tax rate that would have otherwise been applicable. This rate generally ranges from 10% to 25%, depending on the level of foreign
investment in the company in each year, as explained above. We have elected to use the Alternative Benefits Program through the year ended March 31,
2020, but currently intend to reinvest any income derived from our Approved Enterprise program and not to distribute such income as a dividend.
On November 15, 2021, the Investment Law was amended to provide, on a temporary basis, a reduced corporate income tax on the distribution or
release within a year from such amendment of tax-exempt profits derived by Approved and Benefited Enterprises (“Exempt Profits”). The amount of the
reduced tax will be determined based on a formula. In order to qualify for the reduction, the company must invest certain amounts in productive assets and
research and development in Israel. In parallel to the temporary amendment, the law was also amended to reduce the ability of companies to retain the tax-
exempt profits. Effective August 15, 2021, dividend distributions will be treated as if made on a pro-rata basis from all types of earnings, including
Exempt Profits.
The Investment Law also provides that an Approved Enterprise is entitled to accelerated depreciation on its property and equipment that are
included in an Approved Enterprise during the first five years in which the equipment is used. This benefit is an incentive granted by the Israeli
government regardless of whether an Alternative Benefits Program is elected.
The benefits available to an Approved Enterprise are subject to the fulfillment of the conditions stipulated in the Investment Law and the regulations
published thereunder and criteria in the specific certificate of approval with respect thereto, as described above. In the event of failure to comply with these
conditions, the company is required to refund the amount of tax benefits, adjusted to the Israel consumer price index and interest, or other monetary
penalty.
Tax Benefits Subsequent to the 2005 Amendment
The 2005 Amendment applies to new investment programs commencing after 2004 but does not apply to investment programs approved prior to
April 1, 2005. The 2005 Amendment provides that terms and benefits included in any certificate of approval that was granted before the date on which the
2005 Amendment entered into effect (April 1, 2005) will remain subject to the provisions of the Investment Law as in effect on the date of such approval.
Pursuant to the 2005 Amendment, the Investment Center will continue to grant Approved Enterprise status to qualifying investments. The 2005
Amendment, however, limits the scope of enterprises that may be approved by the Investment Center by setting criteria for the approval of a facility as an
Approved Enterprise.
The 2005 Amendment provides that a certificate of approval from the Investment Center is required only for Approved Enterprises that receive cash
grants. As a result, a company is no longer required to obtain the advance approval of the Investment Center in order to receive the tax benefits previously
available under the Alternative Benefits Program. Rather, a company may claim the tax benefits offered by the Investment Law directly in its tax returns,
provided that its facilities meet the criteria for tax benefits set forth in the 2005 Amendment (a “Benefited Enterprise”). A company that has a Benefited
Enterprise may, at its discretion, approach the ITA for a pre-ruling confirming that it is in compliance with the provisions of the Investment Law.
Tax benefits are available under the 2005 Amendment for production facilities (or other eligible facilities), which are generally required to derive
more than 25% of their business income from export (and subject to certain conditions stipulated under law). In order to receive the tax benefits, the 2005
Amendment states that a company must make an investment in fixed assets in the Benefited Enterprise that meets all the conditions set forth in the
amendment for tax benefits and that exceeds a minimum investment amount specified in the Investment Law. Such investment entitles a company to
receive a Benefited Enterprise status with respect to the investment and may be made over a period of no more than three years ending on the year in which
the company requested to have the tax benefits apply to the Benefited Enterprise (the “Year of Election”). Where a company requests to have the tax
benefits apply to an expansion of existing facilities, then only the expansion will be considered a Benefited Enterprise and the company’s effective tax rate
will be the result of a weighted-average of the applicable rates.
The benefits period is subject to a limitation of 7 to 10 years from the Commencement Year (the “Commencement Year” being defined as the later
of: (i) the first tax year in which the company derives income for tax purposes from the Benefited Enterprise or (ii) the Year of Election) provided that 12
years have not elapsed from the first day of the Year of Election. The tax benefits granted to a Benefited Enterprise depend on, among other things, the
geographic location in Israel of the Benefited Enterprise. Such tax benefits include an exemption from corporate tax on undistributed income for a period
of between two to ten years, depending on the geographic location of the Benefited Enterprise within Israel, and a reduced corporate tax rate of between
10% to 25% for the remainder of the benefits period, depending on the level of foreign investment in the company in each year, as explained above.
Under the alternative benefits program, dividends paid out of income attributed to a Benefited Enterprise will be treated similarly to payment of
dividends by an Approved Enterprise. Therefore, dividends paid to Israeli shareholders out of income attributed to a Benefited Enterprise (or out of
dividends received from a company whose income is attributed to a Benefited Enterprise) are generally subject to withholding tax at the rate of 15% (in the
case of non-Israeli shareholders - subject to the receipt in advance of a valid
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certificate from the ITA allowing for a reduced tax rate of 15% or such lower rate as may be provided in an applicable tax treaty). The reduced rate of 15%
is limited to dividends and distributions out of income attributed to a Benefited Enterprise during the benefits period and actually paid at any time up to 12
years thereafter except with respect to an FIC, in which case the 12-year limit does not apply.
Furthermore, a company qualifying for tax benefits under the 2005 Amendment, which pays a dividend out of income attributed to its Benefited
Enterprise during the tax exemption period, will be subject to tax in respect of the amount of the dividend distributed (grossed-up to reflect the pre-tax
income that it would have had to earn in order to distribute the dividend) at the corporate tax rate which would have otherwise been applicable.
The Investment Law also provides that a Benefited Enterprise is entitled to accelerated depreciation on its property and equipment that are
productive assets as defined by the 2005 Amendment.
The benefits available to a Benefited Enterprise are subject to the fulfillment of conditions stipulated in the Investment Law and its regulations. If a
company does not meet these conditions, then it would be required to refund the amount of tax benefits, adjusted to the Israeli consumer price index and
interest, or other monetary penalty.
Our facilities in Israel have received Approved Enterprise status which entitles us to receive certain tax benefits, which were applicable through the
tax year ended on March 31, 2020. In the years ended March 31, 2020 and March 31, 2019, we had two active plans, one Approved Enterprise under the
Alternative Benefits Program (Plan 5) and one Benefited Enterprise (Plan 6), granting us a package of benefits, subject to compliance with applicable
requirements. Under Plan 5 (benefit period starting 2007), we were entitled to an exemption from corporate income tax on undistributed profits for a
period of two years following implementation of such plan and to a reduced tax rate of 10% to 25% (depending on the level of foreign investment) for eight
additional years thereafter. With respect to Plan 5, given the high level of investments in such plan, we met the conditions to qualify as a “High Level
Foreign Investment Company” which entitled Plan 5 to an additional five years of benefits, subject to receipt of approval from the Israeli Investment Center
(“IIC,” now called the “Authority for Investments and Development of the Economy and Industry”). On November 5, 2019, we received an approval for
additional five years of reduced tax rates for such plan subject to meeting certain pre-agreed additional conditions that will be examined by the IIC at the
end of the extension period. Under Plan 6 (benefit period starting 2010), we were entitled to an exemption from corporate income tax on undistributed
profits for a period of two years and a reduced tax rate of 10% to 25% (depending on the level of foreign investment) for eight additional years thereafter.
All of these programs were subject to the time limits imposed by the Investment Law and based upon the level of foreign ownership in the company
in each tax year.
Tax benefits under the 2011 Amendment and 2017 Amendment
The 2011 Amendment canceled the availability of the benefits granted in accordance with the provisions of the Investment Law prior to 2011 and,
instead, introduced new benefits for income generated by a “Preferred Company” through its Preferred Enterprise (as such terms are defined in the
Investment Law) as of January 1, 2011. A Preferred Company is defined as either (i) a company incorporated in Israel which is not wholly-owned by a
governmental entity or (ii) a limited partnership that (a) was registered under the Israeli Partnerships Ordinance and (b) all of its limited partners are
companies incorporated in Israel, but not all of them are governmental entities; which has, among other things, Preferred Enterprise status and is controlled
and managed from Israel. Pursuant to the 2011 Amendment, a Preferred Company is entitled to reduced corporate tax rates. These corporate tax rates were
changed through the years and from 2017 and thereafter, the corporate tax rate for a Preferred Enterprise which is located in a specified development zone
is 7.5% while the reduced corporate tax rate for other development zones is 16%. Income derived by a Preferred Company from a “Special Preferred
Enterprise” (as that term is defined in the Investment Law) would be entitled, during a benefits period of ten years, to further reduced tax rates of 8%, or to
5%, if the Special Preferred Enterprise is located in a specified development zone.
Dividends paid out of preferred income attributed to a Preferred Enterprise or to a Special Preferred Enterprise are generally subject to withholding
tax at source at the rate of 20% (in the case of non-Israeli shareholders, subject to the receipt, in advance, of a valid certificate from the ITA allowing for
such tax rate or such lower rate as may be provided in an applicable tax treaty). However, if such dividends are paid to an Israeli company, no tax will be
withheld (although if such dividends are subsequently distributed to individuals or a non-Israeli company, the previously mentioned tax rate will apply).
The 2011 Amendment also included transitional provisions to address companies already enjoying existing tax benefits under the Investment Law.
These transitional provisions provide, among other things, that unless an irrevocable request is made to apply the provisions of the Investment Law as
amended in 2011 with respect to income to be derived as of January 1, 2011: (i) the terms and benefits included in any certificate of approval that was
granted to an Approved Enterprise, which chose to receive grants, before the 2011 Amendment became effective, will remain subject to the provisions of
the Investment Law as in effect immediately prior to the date of the 2011 Amendment, and subject to certain conditions; (ii) the terms and benefits included
in any certificate of approval that was granted to an Approved Enterprise, which had participated in an Alternative Benefits Program, before the 2011
Amendment became effective will remain subject to the provisions of the Investment Law as in effect immediately prior to the date of the 2011
Amendment,
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provided that certain conditions are met.; and (iii) a Benefited Enterprise can elect to continue to benefit from the benefits provided to it before the 2011
Amendment became effective, provided that certain conditions are met.
On August 24, 2020, the Company submitted to the ITA an announcement declaring its irrevocable choice to forego the benefits granted to it prior
to the 2011 Amendment, and the application of the tax benefits under the 2011 Amendment and/or the 2017 Amendment, starting with the fiscal year
beginning on April 1, 2020.
The New Technological Enterprise Incentives Regime – Amendment 73 to the Investment Law
The 2017 Amendment was enacted as part of the Economic Efficiency Law that was published on December 29, 2016 and is effective as of January
1, 2017. The 2017 Amendment is based on OECD guidelines published as part of the Base Erosion and Profit Shifting (BEPS) project and introduced the
incentive regimes of “Preferred Technological Enterprise” and of “Special Preferred Technological Enterprise,” as described below. These new regimes are
in addition to the other existing tax incentives regimes under the Investment Law. The new incentives regime will apply to “Preferred Technological
Enterprises” that meet the “Preferred Enterprise” conditions and certain additional conditions, including, all of the following:
•
•
The Enterprise’s R&D expenses in the three years prior to the current tax year must be greater than or equal to 7% on average, out of the total
revenue of the Company owning the Enterprise or exceed NIS 75 million (approximately $23 million) per year; and
The Company owning the Enterprise must also satisfy one of the following conditions: (1) at least 20% of the workforce (or at least 200
employees) are employees of which their salaries are fully allocated to R&D expenses; (2) a venture capital investment of an amount of NIS
eight million (approximately $2.4 million) was previously made in the company, provided that the company did not change its field of
business after the investment; or (3) growth in sales (assuming the Company’s sales in the current tax year and in each of the three preceding
years was at least NIS ten million (approximately $3 million)) or workforce (assuming the Company’s workforce in the current tax year and
in each of the three preceding years included a least 50 employees) by an average of 25% in the course of three years preceding the tax year
in comparison to the prior tax year.
Alternatively, in lieu of meeting the above conditions, it is possible to meet the conditions prescribed by the Chief Scientist in the Ministry of
Economy and Industry in consultation with the Director General of the Ministry of Finance and with the approval of the Minister of Finance, as prescribed
within the Encouragement of Capital Investments (conditions indicating that the enterprise is promoting innovation for the purpose of its characterization
as a Preferred Technological Enterprise) - 2019 (“Innovation Promoting Enterprise Regulations”), and receive an approval from the Ministry of Economy
and Industry confirming the compliance with the aforesaid conditions, indicating that the enterprise is an “Innovation Promoting Enterprise”.
A “Special Preferred Technological Enterprise” is an enterprise that meets the “Preferred Technological Enterprises” conditions, and in addition is a
part of a group of companies that have total annual consolidated revenues of at least NIS ten billion (approximately $3 billion).
A “Preferred Technological Enterprise” satisfying the required conditions will enjoy a reduced corporate tax rate of 12% on income that qualifies as
“Preferred Technological Income”, as defined in the Investment Law. The tax rate is further reduced to 7.5% for a Preferred Technological Enterprise
located in development zone A. These corporate tax rates shall generally be limited to the portion of intellectual property developed in Israel, subject to the
“NEXUS approach.” In addition, a Preferred Technological Enterprise will enjoy a reduced corporate tax rate of 12% on capital gain derived from the sale
of certain “Benefited Intangible Assets” (as defined in the Investment Law) to a related foreign company if the Benefited Intangible Assets were acquired
from a foreign company on or after January 1, 2017, for at least NIS 200 million, if the sale was pre-approved by the IIA.
A “Special Preferred Technological Enterprise” satisfying the required conditions will enjoy a further reduced corporate tax rate of 6% on “Preferred
Technological Income” regardless of the company’s geographic location within Israel, subject to the “NEXUS approach.” In addition, a Special Preferred
Technological Enterprise will enjoy a reduced corporate tax rate of 6% on capital gain derived from the sale of certain “Benefited Intangible Assets” to a
related foreign company if the Benefited Intangible Assets were either developed by the Special Preferred Technological Enterprise or acquired from a
foreign company on or after January 1, 2017, and the sale received prior approval from the IIA. A Special Preferred Technological Enterprise that acquires
Benefited Intangible Assets from a foreign company for more than NIS 500 million will be eligible for these benefits for at least ten years, subject to
certain approvals as specified in the Investment Law.
Dividends distributed by a Preferred Technological Enterprise or a Special Preferred Technological Enterprise, paid out of Preferred Technological
Income, are generally subject to withholding tax at source at the rate of 20% (in the case of non-Israeli shareholders, subject to the receipt, in advance, of a
valid certificate from the ITA allowing for such rate, or such lower rate as may be
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provided in an applicable tax treaty). However, if such dividends are paid to an Israeli company, no tax is required to be withheld. If such dividends are
distributed to a foreign company that holds solely or together with other foreign companies 90% or more in the Israeli company and other conditions are
met, the withholding tax rate may be reduced to 4% (or a lower rate under a tax treaty, if applicable, subject to the receipt in advance of a valid certificate
from the ITA allowing for a reduced tax rate).
We have evaluated the likely effect of the 2017 Amendment as well as the Company’s compliance with the applicable threshold conditions and
believe that the Company qualifies as a Special Preferred Technological Enterprise starting with the fiscal year beginning on April 1, 2020.
Also, on October 4, 2021, the Company received an approval from the Ministry of Economy and Industry stating that it is in compliance with
Section 2 of the Innovation Promoting Enterprise Regulations, indicating that the enterprise is an “Innovation Promoting Enterprise” starting from 2019
and through 2021.
The Company is currently pursuing the renewal of the Innovation Promoting Enterprise approval for 2022 to 2024.
Tax Benefits under the Law for the Encouragement of Industry (Taxes), 1969
The Law for the Encouragement of Industry (Taxes), 1969 (the “Industry Encouragement Law”) provides several tax benefits for Industrial
Companies. Pursuant to the Industry Encouragement Law, a company qualifies as an Industrial Company if it is an Israeli resident company, and at least
90% of its income in any tax year (other than income from certain government loans), is generated from an “Industrial Enterprise” owned by it and located
in Israel or in the “Area”, in accordance with the definition under Section 3A of the Israeli Income Ordinance (New Version) 1961. An Industrial
Enterprise is defined as an enterprise whose major activity in a given tax year is industrial production.
Under the Industry Encouragement Law, an Industrial Company is entitled to certain corporate tax benefits, including:
•
•
•
Deduction of the cost of purchase of know-how, patents and rights to use a patent or know-how used for the development or promotion of the
Industrial Enterprise, over an eight-year period commencing on the year in which such rights were first exercised;
The right to elect, under specified conditions, to file a consolidated tax return together with Israeli industrial companies controlled by it; and
A straight-line deduction of expenses related to a public offering over a three-year period commencing in the year of offering.
Under some tax laws and regulations, an Industrial Enterprise may be eligible for special depreciation rates for machinery, equipment and buildings.
These rates differ based on various factors, including the date the operations begin and the number of work shifts. An Industrial Company owning an
Approved Enterprise may choose between these special depreciation rates and the depreciation rates available to the Approved Enterprise.
Eligibility for benefits under the Industry Encouragement Law is not subject to receipt of prior approval from any governmental authority.
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We believe that we currently qualify as an Industrial Company within the definition of the Industry Encouragement Law. As any unilateral tax
position, we cannot assure that it will not be challenged, or that we will continue to qualify as an Industrial Company or that the benefits described above
will be available to us in the future.
Economic Efficiency Law (Legislative amendments for the purpose of achieving the objectives of the 2020-2021 budget)
On November 2, 2021, the Economic Efficiency Law (legislative amendments for the purpose of achieving the objectives of the 2020-2021 budget)
(“Budget Bill”) was legislated. As part of the Budget Bill, Section 74 of the Investment Law was amended. Section 74(d)(4)(b) of the Investment Law was
canceled, which had enabled companies with accumulated tax-exempt profits that were distributing dividends to source such dividends wholly using their
non-exempt income. Hence, any distribution out of Approved Enterprise or Benefitted Enterprise profits now entails the distribution of a pro-rata portion
of tax-exempt profits (and the recapture of tax thereof). The tax recapture (“Clawback Tax”) is the tax from which the company was exempt at the time
such tax-exempt profits were generated, depending on the level of foreign investment in the company at such time (at a rate of 10%-25%).
Also, Section 74(d1) of the Investment Law, which compels companies with accumulated tax-exempt profits to attribute a pro-rata portion of the
distribution to their tax-exempt profits upon a deemed dividend distribution (in accordance with the provisions of Section 51(h) and 51B(b) of the
Encouragement Law) or an actual dividend distribution, and apply Clawback Tax thereof, was legislated. These changes are in effect with regards to
dividends distributed starting from August 15, 2021.
“Trapped Profits” Law - Temporary Order
The Budget Bill also enables Israeli companies that have accumulated tax-exempt profits (“trapped profits”), which are generally subject to
Clawback Tax upon their distribution, to “release” such profits with up to a 60% “discount” on the applicable capital income tax (CIT) (Clawback Tax), but
not less than a 6% CIT rate. The applicable CIT rate is determined based on a formula that considers the ratio of the “released” profits out of the tax-
exempt profits and the original CIT the company was exempt from (maximum benefit is reached if the entire amount of tax-exempt profits is “released”).
To be eligible for this benefit, the company must meet the “designated investment” requirement within five years from the tax year in which it
“released” the trapped profits (detailed rules apply). This amount should be invested in the purchase of productive assets, research and development
expenses in Israel, or the salaries of additional employees. This Temporary Order is in force for tax-exempt profits that will be “released” (without the
requirement to distribute those profits) during a one-year period beginning on November 15, 2021.
Grants under the Encouragement of Research, Development and Technological Innovation Law, 5744-1984
The IIA established pursuant to the Encouragement of Research, Development and Technological Innovation in the Industry Law, 5744-1984 (the
“Research Law”, as amended) incentives for R&D programs of Israeli companies that meet specified criteria and are approved by the IIA. Such companies
are generally eligible for grants of up to 50% of the project’s approved expenditures, as determined by the IIA, and are committed to return such grants by
the payment of royalties from the sale of products developed as part of the programs under which the grants were given.
The Company received grants from the IIA. Regulations under the Research Law, as amended generally provide for the payment of royalties to the
IIA of 3%-6% on sales of products and services derived from a technology developed using these grants until 100% of the dollar-linked grant is repaid.
Our obligation to pay these royalties is contingent on our actual sale of such products and services. In the absence of such sales, no payment of such
royalties is required. The outstanding balance of the grants will be subject to interest at a rate equal to the 12-month LIBOR applicable to dollar deposits
that is published on the first business day of each calendar year in which the program has been approved. In this regard, the United Kingdom’s Financial
Conduct Authority, which regulates LIBOR, announced that it will no longer persuade or require banks to submit rates for LIBOR after January 1, 2022.
Accordingly, there is an uncertainty regarding the interest accrued to the IIA funding. To date, IIA has not issued any clarification regarding an alternative
interest to be used instead of the LIBOR. Following the full repayment of all the outstanding liabilities in connection with such grants, including the
accrued interest thereof, there is no further liability for such royalties. However, even after the repayment of such liabilities in full, we will remain subject
to the limitations set forth under the Research Law, including inter alia on the sale, transfer or assignment outside of Israel of know-how developed as part
of the programs under which the grants were given. Grant recipients are required to notify the IIA of events enumerated in the Research Law and the IIA
directives.
The terms of the grants under the Research Law also require that generally the manufacture of products developed as part of the programs under
which the grants were given be undertaken in Israel. However, under the regulations pursuant to the Research Law, the manufacturing may be undertaken
outside of Israel, assuming we receive prior approval from the IIA for the foreign manufacturing, which approval is given in special circumstances upon the
fulfillment of certain conditions. If we receive that approval and manufacture
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outside of Israel, we may be required to pay royalties at an increased rate and an increased cap of royalties. The increased cap depends upon the extent of
the manufacturing volume that is performed outside of Israel, as follows:
Extent of manufacturing volume outside of Israel
Less than 50%
between 50% and 90%
90% and more
Royalties to the IIA as a percentage of grant
120%
150%
300%
Despite the general approval requirement, a transfer outside of Israel of up to 10% of the manufacturing rights will not require the pre-approval of
the IIA, but rather a notification to the IIA, which may block such transfer within 30 days.
The know-how developed within the framework of the IIA programs may not be transferred to third parties outside Israel without the prior approval
of the IIA. The approval, however, is not required for the export of any products developed using grants received from the IIA. The IIA approval to
transfer know-how created, in whole or in part, in connection with an IIA-funded program to a third party outside Israel is subject to payment of a
redemption fee to the IIA calculated according to a formula provided under the IIA directives, which cannot exceed six times of the total grant amount plus
interest. Upon payment of such redemption fee, the know-how and the production rights for the products supported by such funding cease to be subject to
the Research Law.
Under the Research Law and the regulations thereunder with regard to know-how developed with IIA funding outside of Israel (the “Licensing
Rules”), grant recipient may enter into licensing arrangements or grant other rights in know-how developed under IIA programs outside of Israel, subject to
the prior consent of IIA and payment of license fees, calculated in accordance with the Licensing Rules. The payment of the license fees will not discharge
grant recipient from the obligations to pay royalties or other payments to the IIA or from other restrictions under the Research Law. The maximum amount
payable to the IIA under the Licensing Rules shall not exceed 6 times the amount of the grants received plus LIBOR interest.
Transfer of know-how within Israel is subject to an undertaking of the recipient Israeli entity to comply with the provisions of the Research Law and
related regulations, including the restrictions on the transfer of manufacturing rights or know-how and the obligation to pay royalties, if applicable, as
further described in the Research Law and related regulations.
Tax Benefits and Grants for Research and Development
Israeli tax law allows, under certain conditions, a deduction of research and development expenditures in the year in which they are incurred, subject
to a pre-approval. The amount of such deductible expenses is reduced by the sum of any funds received through government grants for the finance of such
scientific research and development projects.
Expenditures that are not approved, but qualify for deduction, are deductible over a three-year period, from the first year that the expenditures were
made. However, the amount of any government grants made available are subtracted from the amount of expenses which may be deducted.
Taxation of Non-Israeli Resident Holders of our Ordinary Shares
The following is a brief summary of the material Israeli tax consequences concerning the ownership and disposition of our ordinary shares by our
shareholders. This summary does not discuss all the aspects of Israeli tax law that may be relevant to a particular investor in light of his, her or its personal
investment circumstances or to some types of investors which are subject to special treatment under Israeli law. Examples of such investors include
residents of Israel or traders in securities who are subject to special tax regimes not covered in this discussion. Because parts of this discussion are based
on tax legislation that has not yet been subject to judicial or administrative interpretation, we cannot assure you that the tax authorities or the courts will
accept the views expressed in this discussion. The discussion below is subject to change, including due to amendments under Israeli law or changes to the
applicable judicial or administrative interpretations of Israeli law, which may have retroactive effect.
Taxation of Non-Israeli Resident Shareholders on Receipt of Dividends. Non-Israeli residents (whether 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 the dividend recipient is a “Substantial
Shareholder” at the time of distribution or at any time during the preceding 12-month period). Such dividends are generally subject to Israeli withholding
tax at the rate of 25% so long as the shares are traded on a stock exchange and are registered with a Nominee Company (whether the recipient is a
substantial shareholder or not). A “substantial shareholder” is generally a person who alone or together with such person’s relative or another person who
collaborates with such person on a permanent basis, holds, directly or indirectly, at least 10% of any of the “means of control” of the corporation. “Means
of control” generally includes the right to vote, receive profits, nominate a director or an officer, receive assets upon liquidation, or order someone who
holds any of the aforesaid rights how to act, and all regardless of the source of such right. However, distribution of dividends from
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income attributed to an Approved Enterprise or a Benefited Enterprise is subject to Israeli income tax at a rate of 15% (and 20% with respect to
Preferred/Special Preferred Enterprise or Preferred/Special Preferred Technological Enterprise), unless a further reduced tax rate is provided under an
applicable tax treaty, all subject to the receipt in advance of a valid certificate from the ITA allowing for such reduced rate. For example, under the
Convention Between the Government of the U.S. and the Government of Israel with Respect to Taxes on Income, as amended (the “U.S.-Israel Tax
Treaty”), the maximum rate of tax withheld in Israel on dividends paid to a holder of our ordinary shares who is a U.S. resident (for purposes of the U.S.-
Israel Tax Treaty) is 25%. However, generally, the maximum rate of withholding tax on dividends, not generated by an Approved Enterprise, Benefited
Enterprise, Preferred/Special Preferred Enterprise, or Preferred/Special Preferred Technological Enterprise that are paid to a U.S. corporation holding 10%
or more of the outstanding voting rights throughout the tax year in which the dividend is distributed as well as the previous tax year, is 12.5%, provided that
not more than 25% of the gross income for such preceding year consists of certain types of dividends and interest. Notwithstanding the foregoing,
dividends distributed from income attributed to an Approved Enterprise, Benefited Enterprise, Preferred/Special Preferred Enterprise or Preferred/Special
Preferred Technological Enterprise that are subject, under certain conditions stipulated in the treaty, to withholding at the rate of 15%. We cannot assure
you that we will designate the profits that are being distributed in a way that will reduce shareholders’ tax liability. If the dividend is partly attributable to
income derived from an Approved Enterprise, Benefited Enterprise, Preferred/Special Preferred Technological Enterprise, and partly to other sources of
income, the withholding rate will be a blended rate reflecting the relative portions of the various types of income. U.S. residents who are subject to Israeli
withholding tax on a dividend may be entitled to a credit or deduction for U.S. federal income tax purposes in the amount of the taxes withheld, subject to
detailed rules contained in U.S. tax legislation.
A non-Israeli resident who receives dividends from which tax was duly withheld is generally exempt from the duty to file returns in Israel in respect
of such income, provided that (i) such income was not derived from a business conducted in Israel by the taxpayer, and (ii) the taxpayer has no other
taxable sources of income in Israel with respect to which a tax return is required to be filed and (iii) the taxpayer is not obliged to pay excess tax (as further
explained below).
Capital Gains Taxes Applicable to Non-Israeli Resident Shareholders. Israeli capital gain tax is imposed on the disposal of capital assets by a non-
Israeli resident if such assets are either (i) located in Israel; (ii) shares or rights to shares in an Israeli company, (iii) represent, directly or indirectly, rights
to assets located in Israel, or (iv) right in a foreign resident company, which in essence represents, directly or indirectly, right to property located in Israel,
unless a specific exemption is available or unless a tax treaty between Israel and the shareholder’s country of residence provides otherwise. The law
distinguishes between real capital gain and inflationary surplus. The inflationary surplus is, generally, a portion of the total capital gain which is equivalent
to the increase of the relevant asset’s purchase price which is attributable to the increase in the Israeli consumer price index, between the date of purchase
and the date of sale (under certain circumstances, linkage to a foreign currency may or shall be used to determine the inflationary surplus). The real capital
gain is the excess of the total capital gain over the inflationary surplus. Real capital gain on a disposition of listed shares is generally subject to tax at the
corporate tax rate of 23.0% since the start of calendar year 2018, if generated by a company, or at the rate of 25.0% (or 30.0% for Substantial Shareholder),
if generated by an individual from the sale of an asset purchased on or after January 1, 2012. Individual and corporate shareholders dealing in securities in
Israel are taxed at the tax rates applicable to business income (a corporate tax rate for a corporation and a marginal tax rate of up to 47%, excluding excess
tax, for an individual in 2021).
Notwithstanding the foregoing, shareholders that are not Israeli residents (individuals and corporations) are generally exempt from Israeli capital
gains tax on any gains derived from the sale, exchange or disposition of shares of Israeli resident Company, listed on a non-Israeli stock exchange,
provided, inter alia, that certain conditions are met. The main conditions are that (i) such gains are not derived through a permanent establishment that the
non-Israeli resident maintains in Israel; (ii) the shares were not purchased from a “relative” or as part of a tax-exempt reorganization; and (iii) the capital
gains from shares being sold are neither subject to section 101 of the Israeli Income Tax Ordinance, nor to the Israeli Income Tax Law (Inflationary
Adjustments) 5745-1985. However, non-Israeli corporations will not be entitled to the foregoing exemption if Israeli residents (i) have a controlling
interest of more than 25% in such non-Israeli corporation, or (ii) 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, alone or together with another. Furthermore, such an exemption is not applicable to a person whose
gains from selling or otherwise disposing of the shares are deemed to be business income.
Additionally, a sale of shares may be exempt from Israeli capital gains tax under the provisions of an applicable tax treaty (subject to the receipt in
advance of a valid certificate from the ITA). For example, under the U.S.-Israel Tax Treaty, the sale, exchange (whether from merger, acquisition or similar
transaction) or disposition of our ordinary shares by a shareholder who is both a U.S. resident (for purposes of that treaty) holding the ordinary shares as a
capital asset and entitled to claim the benefits afforded to such resident by the U.S.-Israel Tax Treaty (called a “Treaty U.S. Resident”) is generally exempt
from Israeli capital gains tax unless either (i) such Treaty U.S. Resident if an individual has been present in Israel for a period or periods aggregating to 183
days or more during the applicable taxable year; or (ii) such Treaty U.S. Resident holds, directly or indirectly, shares representing 10% or more of our
voting rights during any part of the 12-month period preceding such sale, exchange or disposition, subject to certain conditions; or (iii) the capital gain
arising from such sale, exchange, or disposition is attributable to a permanent establishment of the Treaty U.S. Resident maintained in Israel; or (iv) the
capital gains arising from such sale, exchange or disposition is attributed to real estate located in Israel or to royalties. In any of these cases, the sale,
exchange or disposition of our ordinary shares would be subject to Israeli tax, to the extent applicable; however,
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under the U.S.-Israel Tax Treaty, such Treaty 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.
In some instances, whether or not our shareholders are liable for Israeli tax on the sale of their ordinary shares, the payment of the consideration may
be subject to the withholding of Israeli tax at source. Shareholders may be required to demonstrate that they are exempt from tax on their capital gain in
order to avoid withholding at source at the time of sale. Specifically, in transactions involving a sale of all of the shares of an Israeli resident company, in
the form of a merger or otherwise, the ITA may require from shareholders who are not liable for Israeli tax to sign declarations in forms specified by this
authority or obtain a specific exemption from the ITA to confirm their status as a non-Israeli resident, and, in the absence of such declarations or
exemptions, may require the purchaser of the shares to withhold taxes at source.
Excess Tax. Individuals who are subject to tax in Israel are also subject to an additional tax at a rate of 3% on annual income exceeding NIS
647,640 in 2021 (the amount is linked to the annual change in the Israeli consumer price index). Such excess tax is imposed on almost any type of income,
including, but not limited to, dividends, interest and capital gain.
Israeli Transfer Pricing Regulations
Section 85A of the Tax Ordinance and the regulations promulgated thereunder generally require that all cross-border transactions carried out
between related parties be conducted on an arm’s length principle basis and will be taxed accordingly.
U.S. Federal Income Tax Considerations
Subject to the limitations described in the next paragraph, the following discussion describes the material U.S. federal income tax consequences to a
holder of our ordinary shares (a “U.S. Holder”) that is:
•
•
•
•
a citizen or resident of the U.S.;
a corporation, or other entity taxable as a corporation for U.S. federal income tax purposes, created or organized in the U.S. or under the laws
of the U.S., any state thereof or the District of Columbia;
an estate, the income of which is includable in gross income for U.S. federal income tax purposes regardless of its source; or
a trust, if a court within the U.S. is able to exercise primary supervision over the administration of the trust and one or more U.S. persons
have the authority to control all substantial decisions of the trust or if the trust has validly elected to be treated as a U.S. person under
applicable Treasury regulations.
In addition, certain material aspects of U.S. federal income tax relevant to a holder who is not a partnership and is not a U.S. Holder (a “Non-U.S.
Holder”) are discussed below.
If a partnership, or other entity or arrangement treated as a partnership for U.S. federal income tax purposes, holds ordinary shares, the tax treatment
of a partner generally will depend upon the status of the partner and the activities of the partnership. A partner in a partnership that holds ordinary shares is
urged to consult its own tax advisor regarding the specific tax consequences of owning and disposing of ordinary shares.
This summary is for general information purposes only. It does not purport to be a comprehensive description of all of the tax considerations that
may be relevant to each person’s decision to own our ordinary shares.
This discussion is based on current provisions of the Code, current and proposed Treasury regulations promulgated thereunder, and administrative
and judicial decisions as of the date hereof, all of which are subject to change, possibly on a retroactive basis. Any such change could materially affect the
continued validity of this discussion and the tax consequences described herein. This discussion does not address all aspects of U.S. federal income
taxation that may be relevant to any particular shareholder based on such shareholder’s individual circumstances. In particular, this discussion considers
only U.S. Holders that will own ordinary shares as capital assets and does not address the potential application of the alternative minimum tax or U.S.
federal income tax consequences to U.S. Holders that are subject to special treatment, including U.S. Holders that:
•
•
•
are broker-dealers or insurance companies;
are certain former citizens or long-term residents of the U.S.;
are persons subject to the alternative minimum tax;
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•
•
•
•
•
•
•
•
have elected mark-to-market accounting;
are tax-exempt organizations;
are financial institutions or financial services entities;
hold ordinary shares as part of a straddle, hedge or conversion transaction with other investments;
own directly, indirectly or by attribution at least 10% of our Company (by vote or value);
have a functional currency that is not the U.S. dollar;
are carrying on a trade or business in Israel through a permanent establishment; or
acquire ordinary shares as compensation.
In addition, this discussion does not address any aspect of state, local, or non-U.S. tax laws and does not consider the possible application of U.S.
federal gift or estate tax or the Medicare tax on net investment income.
Each holder of ordinary shares is advised to consult such person’s own tax advisor with respect to the specific tax consequences to such
person of purchasing, holding or disposing of our ordinary shares.
Taxation of Ordinary Shares
Taxation of Distributions Paid On Ordinary Shares
Subject to the discussion below under “Tax Consequences if We Are a Passive Foreign Investment Company,” a U.S. Holder will be required to
include in gross income as ordinary income the amount of any distribution paid on our ordinary shares, including any Israeli taxes withheld from the
amount paid, on the date the distribution is actually or constructively received to the extent the distribution is paid out of our current or accumulated
earnings and profits as determined for U.S. federal income tax purposes. Distributions in excess of such earnings and profits will be applied against and
will reduce the U.S. Holder’s basis in the ordinary shares and, to the extent in excess of such basis, will be treated as gain from the sale or exchange of
ordinary shares.
With respect to non-corporate U.S. Holders, including individual U.S. Holders, dividends may constitute “qualified dividend income” eligible to be
taxed at the preferential rate applicable to long-term capital gains (currently a maximum rate of 20%), provided that (1) (a) our ordinary shares are readily
tradable on an established securities market in the U.S. or (b) we qualify for benefits under an income tax treaty with the U.S. which includes an
information exchange program and such treaty is determined by the U.S. Internal Revenue Service (“IRS”), to be satisfactory, (2) we are not a passive
foreign investment company (“PFIC”) (as discussed below) for either our taxable year in which the dividend was paid or the preceding taxable year, and (3)
the U.S. holders satisfy certain minimum holding period requirements. Our shares are now traded on the NYSE and we believe the requirements of (1)(a),
(1)(b) and (2) are met. Therefore, dividends on our shares would qualify as qualified dividend income so long as a U.S. Holder meets requirement (3).
You should consult your tax advisor regarding the availability of the lower rate for any dividends paid with respect to our ordinary shares.
Any dividends paid by us to a U.S. Holder on our ordinary shares will be treated as foreign source income and will generally be categorized as
“passive income” for U.S. foreign tax credit purposes. Subject to the limitations in the Code, as modified by the U.S.-Israel Tax Treaty, a U.S. Holder may
elect to claim a foreign tax credit against its U.S. federal income tax liability for Israeli income tax withheld from dividends received in respect of ordinary
shares. U.S. Holders who do not elect to claim the foreign tax credit may instead claim a deduction for Israeli income tax withheld, but only for a year in
which the U.S. Holder elects to do so with respect to all foreign income taxes. A deduction does not reduce U.S. tax on a dollar-for-dollar basis like a tax
credit. The deduction, however, is not subject to the limitations applicable to foreign tax credits. The rules relating to the determination of the foreign tax
credit are complex. Accordingly, if you are a U.S. Holder of ordinary shares you should consult your own tax advisor to determine whether and to what
extent you would be entitled to the credit.
Taxation of the Disposition of Ordinary Shares
Subject to the discussion below under “Tax Consequences if We Are a Passive Foreign Investment Company,” upon the sale, exchange, or other
taxable disposition of our ordinary shares, a U.S. Holder will recognize a capital gain or loss in an amount equal to the difference between such U.S.
Holder’s basis in the ordinary shares, which is usually the cost of such shares in USD, and the amount realized on the disposition in USD. Any gain or loss
recognized upon the sale, exchange, or other taxable disposition of the ordinary shares will be treated as long-term capital gain or loss if, at the time of the
sale, exchange, or other taxable disposition, the holding period of the ordinary shares exceeds one year. In the case of individual U.S. Holders, capital gains
generally are subject to U.S. federal
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income tax at preferential rates if specified minimum holding periods are met. The deductibility of capital losses is subject to significant limitations. U.S.
Holders should consult their own tax advisors in this regard.
In general, gain or loss recognized by a U.S. Holder on the sale, exchange, or other taxable disposition of our ordinary shares will be U.S. source
income or loss for U.S. foreign tax credit purposes. In certain instances, a U.S. Holder who is subject to tax in Israel on the sale of our shares and who is
entitled to the benefits of the U.S.-Israel Tax Treaty may treat such gain as Israeli source income and thus could, subject to other U.S. foreign tax credit
limitations, credit the Israeli tax on such sale against such U.S. Holder’s U.S. federal income tax on the gain from that sale.
Tax Consequences if We Are a Passive Foreign Investment Company
We will be a PFIC if 75% or more of our gross income in a taxable year, including the pro rata share of the gross income of any company, U.S. or
foreign, in which we are considered to own, directly or indirectly, 25% or more of the shares by value, is passive income. Alternatively, we will be
considered to be a PFIC if at least 50% of our assets in a taxable year, averaged quarterly over the year and ordinarily determined based on fair market
value and including the pro rata share of the assets of any company in which we are considered to own, directly or indirectly, 25% or more of the shares by
value, are held for the production of, or produce, passive income. Passive income includes, among other amounts, amounts derived by reason of the
temporary investment of funds raised in our public offerings.
Based on our income, assets, and business activities, we do not believe that we are a PFIC. However, the tests for determining PFIC status are
applied annually, and it is difficult to make accurate predictions of future income and assets, which are relevant to this determination. Accordingly, there
can be no assurance that we will not become a PFIC. If we were characterized as a PFIC for any taxable year, a U.S. Holder would suffer adverse tax
consequences. These consequences may include having the gains that are realized on the disposition of ordinary shares treated as ordinary income rather
than capital gains and being subject to punitive interest charges with respect to certain dividends and gains and on the sale or other disposition of the
ordinary shares. Furthermore, dividends paid by a PFIC are not eligible to be treated as “qualified dividend income” (as discussed above). In addition, if a
U.S. Holder holds ordinary shares in any year in which we are treated as a PFIC, such U.S. Holder will be subject to additional tax form filing and
reporting requirements (including additional filing requirements under recently-enacted legislation).
If we determine that we have become a PFIC, we will notify our U.S. Holders and provide them with the information necessary to comply with the
“qualified electing fund” (“QEF”) rules (which can mitigate some of the adverse effects of our being a PFIC). U.S. Holders are urged to consult their tax
advisors about the PFIC rules, including the consequences to them of making any elections with respect to our ordinary shares in the event that we qualify
as a PFIC.
Tax Consequences for Non-U.S. Holders of Ordinary Shares
Except as described in “Information Reporting and Backup Withholding” below, a Non-U.S. Holder of ordinary shares will not be subject to U.S.
federal income or withholding tax on the payment of dividends on, and the proceeds from the sale, exchange or other taxable disposition of our ordinary
shares, unless:
•
•
•
such item is effectively connected with the conduct by the Non-U.S. Holder of a trade or business in the U.S. and, in the case of a resident of
a country which has a tax treaty with the U.S., such item is attributable to a permanent establishment or, in the case of an individual, a fixed
place of business, in the U.S.;
the Non-U.S. Holder is an individual who holds the ordinary shares as a capital asset and is present in the U.S. for 183 days or more in the
taxable year of the disposition and certain other conditions are met; or
the Non-U.S. Holder is subject to tax pursuant to the provisions of U.S. tax law applicable to U.S. expatriates.
Information Reporting and Backup Withholding
U.S. Holders generally are subject to information reporting requirements with respect to dividends paid in the U.S. on, or the proceeds from the
taxable disposition of, our ordinary shares, unless the U.S. Holder is an exempt recipient. U.S. Holders are also generally subject to backup withholding on
dividends paid in the U.S. on, or the proceeds from the taxable disposition of, our ordinary shares unless the U.S. Holder provides IRS Form W-9 or
otherwise establishes an exemption.
Non-U.S. Holders generally are not subject to information reporting or backup withholding with respect to dividends paid on, or upon the taxable
disposition of, ordinary shares. Such holders, however, may be required to provide certification of non-U.S. status (generally on IRS Form W-8BEN) in
connection with payments received in the U.S. or through certain U.S.-related financial intermediaries.
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The amount of any backup withholding may be allowed as a credit against a U.S. or Non-U.S. Holder’s U.S. federal income tax liability and may
entitle such holder to a refund, provided that certain required information is timely furnished to the IRS.
U.S. Holders should also be aware that additional reporting requirements apply with respect to the holding of certain foreign financial assets,
including stock of foreign issuers that is not held in an account maintained by a financial institution, if the aggregate value of all such assets exceeds U.S.
$50,000. U.S. Holders should consult their own tax advisors regarding the application of these and other information reporting rules applicable to an
investment in our ordinary shares based on their particular situation.
F. DIVIDENDS AND PAYING AGENTS
Not applicable.
G. STATEMENT BY EXPERTS
Not applicable.
H. DOCUMENTS ON DISPLAY
We are subject to the informational requirements of the Exchange Act applicable to foreign private issuers and fulfill the obligation with respect to
such requirements by filing reports with the SEC. You may inspect and copy such material at the public reference facilities maintained by the SEC, 100 F
Street, N.E., Washington, D.C. 20549. The SEC maintains an Internet website at http://www.sec.gov that contains reports, proxy statements, information
statements and other material that are filed through the SEC’s Electronic Data Gathering, Analysis and Retrieval (“EDGAR”) system.
As a foreign private issuer, we are exempt from the rules under the Exchange Act prescribing 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 periodic reports and financial statements with the SEC as frequently or as
promptly as U.S. companies whose securities are registered under the Exchange Act. A copy of each report submitted in accordance with applicable U.S.
law is available for public review at our principal executive offices and on our website at www.taro.com. The information contained on our website does
not constitute part of this 2022 Annual Report.
I. SUBSIDIARY INFORMATION
Not applicable.
ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are exposed to market risk, which primarily consists of interest rate and foreign exchange risk. We use derivative instruments to partially
mitigate our exposure to these risks. Our objective is to reduce volatility in cash flows due to changes in interest and foreign exchange rates.
Foreign Exchange Rate Risk
We and Taro U.S.A. use the USD as our reporting currency and are exposed to foreign exchange rate risk from transactions conducted in different
currencies.
In 2022, 67% of our revenue was generated in USD. However, the remainder of our sales was primarily denominated in the local currencies of the
countries in which the sales occurred. As a result, our reported profits and cash flows are exposed to changing exchange rates. If these foreign currencies
weaken relative to the USD, the earnings generated in these foreign currencies will, in effect, decrease when converted into USD, and vice versa.
Therefore, from time to time we attempt to manage exposures that arise in the normal course of business related to fluctuations in foreign currency
exchange rates by entering into offsetting positions through the use of foreign exchange forward contracts.
Due to the relatively low level of non-USD revenues, the effects of currency fluctuations on consolidated net sales and operating income were not
significant in 2022.
89
Foreign Exchange Transactions
During the year ended March 31, 2022, Taro Canada recorded a gain of $1.7 million compared to a gain of $0.1 million in 2021, reflecting the
unfavorable impact of the change in foreign currency exchange rates related primarily to cash and cash equivalents and marketable securities in Canada.
Prior to April 1, 2019, the functional currency of the Company’s Canadian subsidiary was the CAD. Effective as of the Company’s fiscal year beginning
April 1, 2019, Taro Canada’s functional currency became the USD. As a result of this change, there is no longer an effect of exchange differences on
intercompany balances related to Taro Canada’s transactions with Taro U.S.A. Refer to Item 5 and Note 2.b. for additional details on Taro Canada’s change
in functional currency.
During the year ended March 31, 2022, Taro Israel recorded a gain of $0.2 million compared to a loss of $0.5 million in 2021.
The Company enters into separate forward contracts to purchase the NIS and the CAD on a monthly basis at agreed upon spot rates to hedge the
variability of cash flows in USD due to changes in the respective exchange rates.
On March 31, 2022, the forward contracts to purchase the NIS are for a total amount of $55,250, at a weighted-average forward rate of 3.17 NIS per
USD, which are settled in seventeen (17) monthly settlements of $3,750 for ten (10) months, $3,250 for one (1) months, and $2,500 for five (5) months.
The Company recorded a net gain (loss) of $93, $190, and $178 for the years ended March 31, 2022, 2021, and 2020, respectively, for the contracts to
purchase the NIS.
The forward contracts to purchase the CAD are for a total amount of $20,842, at a weighted-average forward rate of CAD 1.25 per USD, which are
settled in ten (10) monthly installments of approximately $2,105 for ten (10) months. The Company recorded a net gain (loss) of $0, $267, and ($629) for
the years ended March 31, 2022, 2021, and 2020, respectively, for the contracts to purchase the CAD.
On March 31, 2022, the Company had derivative instruments designated as hedging instruments. Refer to Note 10 for additional details on hedging
instruments. There is no collateral for these hedges.
Interest Rate Risk
Under current conditions, we do not believe that our exposure to market risks will have a material impact on future earnings.
ITEM 12. DESCRIPTION OF SECURITIES OTHER THAN EQUITY SECURITIES
Not applicable.
90
ITEM 13. DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
None.
PART II
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
Taro’s Chief Executive Officer and Chief Financial Officer, after evaluating the effectiveness of Taro’s disclosure controls and procedures (as
defined in Exchange Act Rule 13a-15(e)) as of the end of the period covered by this 2022 Annual Report, have concluded that, as of such date, Taro’s
disclosure controls and procedures were effective to ensure that the information required in the reports that it files or submits under the Exchange Act is
recorded, processed, summarized, and reported, within the time periods specified in the SEC’s rules and forms, and such information is accumulated and
communicated to its Management, including its Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding
required disclosure.
b.
Report of Taro Management on Internal Control Over Financial Reporting
Taro’s Management is responsible for establishing and maintaining adequate internal control over financial reporting. Taro’s internal control system
was designed to provide reasonable assurance to Taro’s Management and Board regarding the reliability of financial reporting and the preparation and fair
presentation of its published consolidated financial statements.
Because of its inherent limitations, internal control over financial reporting 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 the policies or procedures may deteriorate.
Taro’s Management assessed the effectiveness of the Group’s internal control over financial reporting as of March 31, 2022. In making this
assessment, it used the criteria established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the
Treadway Commission (COSO). Based on such assessment, Management has concluded that, as of March 31, 2022, Taro’s internal control over financial
reporting is effective based on those criteria.
In the fourth quarter of fiscal year ending March 31, 2022, we completed the Alchemee acquisition. Management excluded Alchemee from our
evaluation of internal control over financial reporting. This exclusion is in accordance with the guidance issued by the SEC that allows companies to
exclude acquired companies from management’s report on internal control over financial reporting for the first year after the acquisition. The combined
total assets, excluding goodwill and identifiable intangible assets, for Alchemee represent less than 5% of our consolidated assets as of March 31, 2022.
The combined total revenues of Alchemee represent less than 5% of our consolidated revenues for the year ended March 31, 2022.
c.
Attestation Report of the Registered Public Accounting Firm
Taro’s internal control over financial reporting as of March 31, 2022, has been audited by Ziv Haft, a BDO Member Firm (“Ziv Haft”), an
independent registered public accounting firm in Israel, as stated in their report, which is included on pages F-2 and F-3 of this 2022 Annual Report.
d.
Changes in Internal Control Over Financial Reporting
There were no changes to Taro’s internal control over financial reporting that occurred during the fiscal year ended March 31, 2022, that have
materially affected, or are reasonably likely to materially affect, Taro’s internal control over financial reporting. We are in the process of integrating
Alchemee, formerly The Proactiv Company (TPC), which was recently acquired, into our overall internal control over financial reporting process. Other
than this ongoing integration, there were no changes to our internal control over financial reporting that occurred during the fiscal year ended March 31,
2022, 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 EXPERT
Our Board has determined that Linda Benshoshan, the Chairwoman of the Audit Committee, is an audit committee financial expert, as defined by
applicable SEC regulations, and is independent in accordance with applicable SEC and NYSE regulations. See
91
Item 6.A. – “Directors, Senior Management and Employees – Directors and Senior Management” for a summary of Linda Benshoshan’s relevant
professional experience.
ITEM 16B. CODE OF ETHICS
We have adopted a code of conduct applicable to our directors and all employees (“Code of Conduct”). We have also adopted a code of ethics that
applies to our Chief Executive Officer, Chief Financial Officer and other senior officers (“Code of Ethics”). A copy of the Code of Conduct or the Code of
Ethics may be obtained, without charge, upon a written request addressed to: Corporate Affairs Department, Taro Pharmaceutical Industries Ltd., c/o Taro
Pharmaceuticals U.S.A., Inc., 3 Skyline Drive, Hawthorne, NY 10532. The Code of Conduct and the Code of Ethics are also available on the Company’s
website at www.taro.com. Any waivers of the Code of Conduct or the Code of Ethics will be disclosed through the filing of a Report on Form 6-K.
ITEM 16C. PRINCIPAL ACCOUNTANT FEES AND SERVICES
Principal Accountant Fees and Services
We paid the following fees for professional services rendered by Ziv Haft – BDO Member Firm, for the years ended March 31, 2022 and 2021,
respectively.
Audit fees
Tax fees
Other fees
Total
Year ended
Year ended
March 31, 2022
March 31, 2021
$
$
(in millions)
0.77 $
0.07
0.02
0.86 $
0.74
0.03
0.02
0.79
The audit fees for the years ended March 31, 2022 and 2021, respectively, represent fees for professional services rendered for the audits of our
annual consolidated financial statements, statutory, or regulatory audits of us and our subsidiaries, consents, and assistance with review of documents filed
with the SEC. All services provided by the Company’s independent auditors, including those set forth in the table above, were approved by the Audit
Committee.
Tax fees represent fees for professional services related to tax compliance, including the preparation of tax returns and claims for refund, and tax
planning and tax advice, including assistance with tax audits and appeals, tax services for employee benefit plans and assistance with respect to requests for
rulings from tax authorities.
Other fees represent fees for additional professional services performed for certain legal entities.
Policy on Pre-Approval of Audit and Non-Audit Services of Independent Auditors
Our Audit Committee is responsible for the oversight of our independent auditors’ work. The Audit Committee’s policy is to pre-approve all audit
and non-audit services provided by our independent registered public accounting firm, Ziv Haft. These services may include audit services, audit-related
services, tax services, and other services, as further described below. The Audit Committee sets forth the basis for its pre-approval in detail, listing the
particular services or categories of services that are pre-approved, and setting forth a specific budget for such services. Additional services may be pre-
approved by the Audit Committee on an individual basis. Once services have been pre-approved, Ziv Haft and our management then report to the Audit
Committee on a periodic basis regarding the extent of services actually provided in accordance with the applicable pre-approval, and regarding the fees for
the services performed.
ITEM 16D. EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
Not applicable.
ITEM 16E. PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
On November 23, 2016, the Company announced that its Board of Directors approved a $250 million repurchase of ordinary shares, which was
completed on January 11, 2019. Under the program, the Company bought back 2,493,378 of its ordinary shares in open market transactions, in accordance
with a Rule 10b5-1 program, at an average price of $100.28 per share.
92
On November 4, 2019, the Company announced that its Board of Directors approved a $300 million share repurchase of ordinary shares. On
November 15, 2019, the Company commenced a modified “Dutch auction” tender offer to repurchase up to $225 million in value of its ordinary shares. In
accordance with the terms and conditions of the tender offer, which expired on December 16, 2019, the Company accepted for payment 280,719 ordinary
shares at the final purchase price of $91.00 per share. During the year ended March 31, 2022, in accordance with a Rule 10b5-1 program, the Company
repurchased 341,413 shares at an average price of $73.03 per share. Through May 31, 2022, under the $300 million authorization, the Company has
repurchased, in total, 954,165 shares (280,719 at an average price of $91.00, 332,033 at an average price of $75.23 and 341,413 shares at an average price
of $73.03), leaving $224.5 million remaining under the current board authorization.
The table below presents a summary of the ordinary shares repurchased by the Company under the new authorization and classified as treasury
stock:
Period
November 1, 2019 - November 30, 2019
December 1, 2019 - December 31, 2019 (1)
January 1, 2020 - November 30, 2020
December 1, 2020 - December 31, 2020 (2)
January 1, 2021 - January 31, 2021
February 1, 2021 - February 28, 2021
March 1, 2021 - March 31, 2021
April 1, 2021 - April 30, 2021
May 1, 2021 - May 31, 2021
June 1, 2021 - June 30, 2021
July 1, 2021 - July 30, 2021
August 1, 2021 - August 31, 2021
September 1, 2021 - May 31, 2022
Total
Total Number of
Shares Purchased
Average Price Paid
per Share
—
280,719
—
53,328
95,816
85,345
97,544
92,360
83,615
78,742
83,259
3,437
—
954,165
$
$
$
$
$
$
$
$
$
$
$
$
$
$
—
91.00
—
71.29
76.23
76.17
75.58
74.41
72.94
73.37
71.29
72.59
—
79.08
Dollar Value of
Shares that May
Yet be Purchased
Under the Program
(in thousands)
Total Number of
Shares Purchased
as Part of the
Current Program
—
280,719
280,719
334,047
429,863
515,208
612,752
705,112
788,727
867,469
950,728
954,165
954,165
$
224,542
(1) Shares repurchased in December 2019 were in accordance with a modified “Dutch auction” tender offer.
(2) Shares repurchased during December 2020 through May 2021 were in accordance with a Rule 10b5-1 program.
ITEM 16F. CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT
Not applicable.
93
ITEM 16G. CORPORATE GOVERNANCE
Under the NYSE Listed Company Manual, foreign private issuers may elect to be subject to a more limited set of corporate governance
requirements than U.S. domestic issuers. Despite any such election, Taro, as a foreign private issuer, must comply with four principal NYSE corporate
governance rules: (1) Taro must satisfy the requirements of Exchange Act Rule 10A-3; (2) Taro’s Chief Executive Officer must promptly notify the NYSE
in writing after any executive officer becomes aware of any material non-compliance with the applicable NYSE corporate governance rules; (3) Taro must
provide the NYSE with annual and interim written affirmations as required under the NYSE corporate governance rules; and (4) Taro must provide a brief
description of any significant differences between its corporate governance practices and those followed by U.S. companies under NYSE listing standards.
The table below briefly describes the significant differences between Taro’s domestic practice and the NYSE corporate governance rules.
Section
303A.01
NYSE Corporate Governance Rule for
U.S. Domestic Issuers
Taro’s Approach
A listed company must have a majority of independent
Taro is a controlled company because more than a majority of
directors.
“Controlled companies” are not required to comply with this
requirement.
303A.03
The non-management directors of a listed company must meet
at regularly scheduled executive sessions without management.
303A.04
A listed company must have a nominating/corporate
303A.05
governance committee composed entirely of independent
directors, with a written charter that covers certain minimum
specified duties.
“Controlled companies” are not required to comply with this
requirement.
A listed company must have a compensation committee
composed entirely of independent directors, with a written
charter that covers certain minimum specified duties.
“Controlled companies” are not required to comply with this
requirement.
303A.06/303A.07
A listed company must have an audit committee with a
minimum of three independent directors who satisfy the
independence requirements of Rule 10A-3 under the Exchange
Act, with a written charter that covers certain minimum
specified duties.
its voting power is controlled by Sun. As a controlled company,
Taro would not be required to comply with the majority of
independent directors’ requirements if it were a U.S. domestic
issuer. There is not a similar requirement under Israeli practice
or the Israeli Companies Law that requires Taro to have a
majority of independent directors. Rather, the statutory external
director provisions under the Israeli Companies Law only
require Taro, as a public company, to have at least two external
directors.
There is not a similar requirement under Israeli practice or the
Israeli Companies Law, and non-management directors of Taro
do not meet at regularly scheduled executive sessions without
management.
Taro does not have a nominating committee. As a controlled
company, Taro would not be required to comply with the
nominating/corporate governance committee requirements if it
were a U.S. domestic issuer. There is not a similar requirement
under the Israeli Companies Law.
Taro has a compensation committee currently comprised of
three directors. Under the Israeli Companies Law, which
provides standards for the independence of the compensation
committee, the compensation committee shall have no less than
three members and all of the statutory external directors shall be
members thereof.
Taro has an Audit Committee currently comprised of three
directors. Under the Israeli Companies Law, which provides
standards for the independence of the audit committee, the
Audit Committee shall have no less than three members and all
of the statutory external directors shall be members thereof. All
of the directors that are members of the Audit Committee meet
the NYSE independence requirements as well as the SEC
independence requirements that would apply to the Audit
Committee members in absence of our reliance on the
exemption provided by Exchange Act Rule 10A-3(c)(3).
94
303A.07
The audit committee of a listed company must be directly
responsible, to the extent permitted by law, for the appointment,
compensation, retention and oversight of the work of any
registered public accounting firm engaged for the purpose of
preparing or issuing an audit report or performing other audit,
review, or attest services, and each such firm must report
directly to the audit committee.
Pursuant to the Israeli Companies Law, Taro’s Audit Committee
is responsible for determining the scope of the work of, and the
compensation to be paid to, Taro’s external auditors, whereas
the actual appointment of the external auditors and approval of
their compensation is carried out by Taro’s shareholders at the
annual meeting of shareholders. Furthermore, pursuant to the
Israeli Companies Law, Taro’s Audit Committee is responsible
for supervising the work of Taro’s external auditors with respect
to the audit of Taro’s financial statements, whereas actual final
approval of the financial statements is provided by Taro’s Board
as a whole.
Shareholders must be given the opportunity to vote on all
equity-compensation plans and material revisions thereto, with
limited exemptions set forth in the NYSE rules.
Under the Israeli Companies Law, shareholder pre-approval is
not required for the adoption or material amendment of equity
compensation plans. Shareholder approval is required prior to
any grants under the plan to directors or the Chief Executive
Officer of Taro.
A listed company must adopt and disclose corporate
governance guidelines that cover certain minimum specified
subjects.
Taro does not have formal corporate governance guidelines that
address all of the matters specified in the NYSE rules. There is
not a similar requirement under the Israeli Companies Law.
303A.08
303A.09
303A.10
A listed company must adopt and disclose a code of business
conduct and ethics for directors, officers and employees, and
promptly disclose any waivers of the code for directors or
executive officers.
Taro has adopted a formal code of ethical and compliant
conduct, which applies to its directors, officers and employees.
Taro reports each year under Item 16B of its Annual Report on
Form 20-F any waivers of the code of ethical conduct granted
for directors and executive officers. Taro’s code of ethical
conduct has a scope that is similar, but not identical, to that
required for a U.S. domestic company under the NYSE rules.
Taro also has a Code of Ethics that applies specifically to Taro’s
Chief Executive Officer, Chief Financial Officer and other
senior officers.
Taro’s CEO will promptly notify the NYSE in writing if any
executive officer of Taro becomes aware of any material
noncompliance with any applicable provisions of the NYSE
corporate governance rules.
303A.12
Each listed company CEO must certify to the NYSE each year
that he or she is not aware of any violation by the company of
NYSE corporate governance listing standards.
ITEM 16H. MINE SAFETY DISCLOSURE
Not applicable.
95
PART III
ITEM 17. FINANCIAL STATEMENTS
We have responded to Item 18 – “Financial Statements” in lieu of this item.
ITEM 18. FINANCIAL STATEMENTS
The financial statements required by this item are found at the end of this 2022 Annual Report, beginning on page F-1.
The Financial Statement Schedule II—Valuation and Qualifying Accounts is found on page S-1 following the financial statements.
ITEM 19. EXHIBITS
The exhibits filed with or incorporated into this 2022 Annual Report are listed on the index of exhibits below.
Exhibit
No.
1.1
1.2
2.1
Memorandum of Association of Taro Pharmaceutical Industries Ltd. (1) (P)*
Articles of Association of Taro Pharmaceutical Industries Ltd., as amended (2)
Form of ordinary share certificate (1) (P)*
Description
2.2*
Description of Taro Pharmaceutical Industries Ltd. Ordinary Shares
4.1
4.2
4.3
4.4*
4.5*
8*
12.1*
12.2*
13*
Taro Pharmaceutical Industries 1999 Stock Incentive Plan (3) (P)*
Amendment No. 1 to Taro Pharmaceutical Industries 1999 Stock Incentive Plan (4)
Amendment No. 2 to Taro Pharmaceutical Industries 1999 Stock Incentive Plan (4)
Compensation Policy for Office Holders
Indemnification Agreement Template
List of Subsidiaries (See “Organizational Structure” in Item 4.C of this Form 20-F)
Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Certification of the Chief Executive Officer, Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002
101 INS*
Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are
embedded within the Inline XBRL document.
101 SCH*
Inline XBRL Taxonomy Extension Schema Document
101 CAL*
Inline XBRL Taxonomy Extension Calculation Linkbase Document
101 DEF*
Inline XBRL Taxonomy Extension Definition Linkbase Document
101 LAB*
Inline XBRL Taxonomy Extension Label Linkbase Document
101 PRE*
Inline XBRL Taxonomy Extension Presentation Linkbase Document
104*
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
* filed herewith
(P)
(1)
(2)
(3)
(4)
(5)
Paper exhibits
Previously filed as an exhibit to our Registration Statement on Form F-4 (No. 333-63464), as amended, and incorporated herein by reference.
Previously filed as an exhibit to our Annual Report on Form 20-F for the fiscal year ended March 31, 2013, and incorporated herein by reference.
Previously filed as an exhibit to our Registration Statement on Form S-8 (No. 333-13840) and incorporated herein by reference.
Previously filed as an exhibit to our Annual Report on Form 20-F for the fiscal year ended December 31, 2005, and incorporated herein by
reference.
Previously filed as an exhibit to our Annual Report on Form 20-F for the fiscal year ended December 31, 2003, and incorporated herein by
reference.
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 2022 Annual Report on its behalf.
SIGNATURE
TARO PHARMACEUTICAL INDUSTRIES LTD.
By:
/s/ William Coote
William Coote
Vice President, Chief Financial Officer and Chief Accounting
Officer
Dated: July 25, 2022
97
TARO PHARMACEUTICAL INDUSTRIES LTD.
Report of Independent Registered Public Accounting Firm (BDO Ziv Haft; Tel-Aviv, Israel; PCAOB ID#1185)
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statements of Comprehensive Income
Statements of Changes in Shareholders’ Equity
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
Page
F-2
F-7
F-9
F-10
F-11
F-12
F-14
TARO PHARMACEUTICAL INDUSTRIES LTD.
Report of Independent Registered Public Accounting Firm
Shareholders and Board of Directors
Taro Pharmaceutical Industries Ltd.
Haifa, Israel
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Taro Pharmaceutical Industries Ltd. and its subsidiaries (the “Group”) as of
March 31, 2022 and 2021, the related consolidated statements of income and comprehensive income, shareholders’ equity, and cash flows for each
of the three years in the period ended March 31, 2022, and 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 Group at March 31, 2022 and
2021, and the results of its operations and its cash flows for each of the three years in the period ended March 31, 2022, in conformity with
accounting principles generally accepted in the United States of America.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”), the
Group's internal control over financial reporting as of March 31, 2022, based on criteria established in Internal Control – Integrated Framework
(2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) and our report dated July 21, 2022 expressed
an unqualified opinion thereon.
Basis for Opinion
These consolidated financial statements are the responsibility of the Group’s management. Our responsibility is to express an opinion on the
Group’s consolidated financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be
independent with respect to the Group 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 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.
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 matters communicated below are matters arising from the current period audit of the consolidated financial statements that were
communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the
consolidated financial statements and (2) 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 matters below, providing separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
Revenue recognition – sales deductions
As described in Notes 2 and 5 to the consolidated financial statements, when the Group records revenue from the sale of its pharmaceutical
products, the Group records an estimate of various sale deductions in the same financial reporting period. These sales deductions include
chargebacks, product returns, rebates and other sale deductions and require significant management’s judgment. These sale deductions mainly apply
to the sales within the United States. As of March 31, 2022 the consolidated reserves for chargebacks, product returns, rebates and other sale
deductions were $267 million.
F-2
We identified management’s judgments and assumptions used in recording sales deductions as a critical audit matter. The principle considerations
included measurement uncertainty involved in developing these estimates, as the sales deductions are based on judgments and assumptions
developed using estimated wholesaler inventory, historical data, contractual terms and customer purchasing activity. Auditing these judgments
involved especially challenging auditor judgment due to the nature and extent of audit evidence and effort required to address these matters.
The primary procedures we performed to address this critical audit matter included the following:
TARO PHARMACEUTICAL INDUSTRIES LTD.
•
•
Testing the design and operating effectiveness of controls related to management’s assessment of: (i) the reasonableness of
assumptions used to estimate sales deductions, and (ii) the reasonableness of the methodology used and appropriateness of the
computations of sales deductions.
Evaluating the reasonableness of management’s assumptions relating to sales deductions through: (i) evaluating the reasonableness of
the methodology and the accuracy of computations used by management, (ii) assessing historical accuracy of the Group’s estimates in
previous years and the effect of any adjustments to prior years’ accruals in the current year’s results, (iii) assessing the reasonableness
of assumptions used against current year activity and other relevant data, (iv) assessing the completeness and accuracy of inventory
information at wholesale customers, and(v) testing a sample of sales deductions processed by the Group, including evaluating those
deductions for consistency with the contractual terms of the Group’s revenue arrangements.
Contingent liabilities
As described in Note 13 to the consolidated financial statements, the Group has several significant legal actions including, generic drug industry
pricing investigations and related litigation. Management’s assessment as to whether or not to recognize contingent liabilities involved a series of
complex judgments about future events and relied heavily on estimates and assumptions. This requires significant judgment by management when
assessing the likelihood of a loss being incurred and management’s determination of whether a reasonable estimate of the loss or range of loss for
each claim can be made.
We identified management’s judgments used in evaluating contingent liabilities as a critical audit matter due to the complex and significant auditor
judgments required to assess the magnitude and probability of potential losses identified and evaluate the progress of and changes to expected
outcomes. Auditing these judgments involved especially challenging auditor judgment due to the nature and extent of audit evidence and effort
required to address these matters.
The primary procedures we performed to address this critical audit matter included:
•
•
Evaluating the methodology, assumptions and criteria used by the Group in the recognition, measurement and disclosure of contingent
liabilities in the consolidated financial statements.
Obtaining and evaluating letters of audit inquiry with internal and external legal counsel with knowledge of the proceedings to
evaluate: (i) the existence and current status of the proceedings, and (ii) the respective assessment of ranges of losses involved based
on the appropriateness of legal positions asserted by the Group.
Assessment of recognition of uncertain tax positions
As discussed in Notes 2 and 15 to the consolidated financial statements, the Group has recognized uncertain tax positions including associated
interest and penalties. The Group’s tax positions are subject to audit by local taxing authorities across multiple global subsidiaries and the resolution
of such audits may span multiple years. Tax law is complex and often subject to varied interpretations, accordingly, the ultimate outcome with
respect to taxes the Group may owe may differ from the amounts recognized.
We identified the evaluation of uncertain tax positions as a critical audit matter because a higher degree of auditor judgment was required in
evaluating the Group’s interpretation of, and compliance with tax law globally across its multiple subsidiaries. In addition, a higher degree of
auditor judgment was required in evaluating the Group’s estimate of the ultimate resolution of its tax positions. Auditing these elements involved
especially challenging auditor judgment due to the nature and extent of auditor
F-3
TARO PHARMACEUTICAL INDUSTRIES LTD.
judgment required in evaluating the Group’s interpretation of, and compliance with global tax laws across its multiple global subsidiaries, including
the extent of specialized skill or knowledge needed.
The primary procedures we performed to address this critical audit matter included the following:
•
•
Testing certain internal controls over the Group’s process to assess uncertain tax positions to: (i) interpret tax law and identify
uncertain tax positions, (ii) evaluate which of the Group’s tax positions may not be sustained upon audit, and (iii) estimate the
uncertain tax positions.
Utilizing personnel with specialized skill and knowledge in tax to assist in evaluating technical merits, reasonableness of
management’s judgments and assumptions used in uncertain tax positions calculations and the overall reasonableness of conclusions
reached through: (i) obtaining an understanding and assessing tax positions, transfer pricing studies and the Group’s compliance with
applicable laws and regulations, (ii) developing an independent assessment based on our understanding and interpretation of tax laws,
(iii) inspecting settlement documents with applicable taxing authorities, and (iv) assessing the expiration of statutes of limitations.
/s/ Ziv Haft
Ziv Haft
Certified Public Accountants (Isr)
BDO Member Firm
We have served as the Group's auditor since 2010.
Tel Aviv, Israel
July 21, 2022
F-4
TARO PHARMACEUTICAL INDUSTRIES LTD.
Report of Independent Registered Public Accounting Firm
Shareholders and Board of Directors of
Taro Pharmaceutical Industries Ltd.
Haifa, Israel
Opinion on Internal Control over Financial Reporting
We have audited Taro Pharmaceutical Industries Ltd. and its subsidiaries (the “Group’s”) internal control over financial reporting as of March 31,
2022, based on criteria established in Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the
Treadway Commission (the “COSO criteria”). In our opinion, the Group maintained, in all material respects, effective internal control over financial
reporting as of March 31, 2022, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (“PCAOB”), the
consolidated balance sheets of the Group as of March 31, 2022 and 2021, the related consolidated statements of income and comprehensive income,
shareholders’ equity, and cash flows for each of the three years in the period ended March 31, 2022, and the related notes and our report dated July
21, 2022 expressed an unqualified opinion thereon.
Basis for Opinion
The Group’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness
of internal control over financial reporting, included in the accompanying Item 15, Controls and Procedures. Our responsibility is to express an
opinion on the Group’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and
are required to be independent with respect to the Group in accordance with U.S. federal securities laws and the applicable rules and regulations of
the Securities and Exchange Commission and the PCAOB.
We conducted our audit of internal control over financial reporting in accordance with the standards of the PCAOB. Those standards require that we
plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all
material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material
weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audit also
included performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis
for our opinion.
As indicated in the accompanying Item 15b., Report of Taro Management on Internal Control Over Financial Reporting, management’s assessment
of and conclusion on the effectiveness of internal control over financial reporting did not include the internal controls of Alchemee, which was
acquired on February 28, 2022, and which is included in the consolidated balance sheets of the Company as of March 31, 2022, and the related
consolidated statements of operations and comprehensive income, shareholders’ equity, and cash flows for the year then ended. Alchemee
constituted 4% and 3% of total assets and net assets, respectively, as of March 31, 2022, and 2% and 5% of revenues and net income, respectively,
for the year then ended. Management did not assess the effectiveness of internal control over financial reporting of Alchemee because of the timing
of the acquisition which was completed on February 28, 2022. Our audit of internal control over financial reporting of the Company also did not
include an evaluation of the internal control over financial reporting of Alchemee.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed 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. A group’s
internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable
detail, accurately and fairly reflect the transactions and dispositions of the assets of the group; (2) provide reasonable assurance that transactions are
recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts
and expenditures of the group are being made only in accordance with authorizations of management and directors of the group; and (3) provide
reasonable
F-5
assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the group’s assets that could have a material
effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting 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 the policies or procedures may deteriorate.
TARO PHARMACEUTICAL INDUSTRIES LTD.
/s/ Ziv Haft
Ziv Haft
Certified Public Accountants (Isr)
BDO Member Firm
Tel Aviv, Israel
July 21, 2022
F-6
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
Short-term bank deposits
Marketable securities
Accounts receivable and other:
Trade, net
Other receivables and prepaid expenses
Inventories
TOTAL CURRENT ASSETS
LONG-TERM MARKETABLE SECURITIES
PROPERTY, PLANT AND EQUIPMENT, NET
DEFERRED INCOME TAXES
GOODWILL
OTHER ASSETS
TOTAL ASSETS
The accompanying notes are an integral part of these consolidated financial statements.
F-7
TARO PHARMACEUTICAL INDUSTRIES LTD.
March 31,
2022
2021
$
$
251,134 $
47,586
522,028
246,972
59,727
210,439
1,337,886
435,189
199,692
124,882
11,820
66,893
2,176,362 $
605,177
—
418,480
213,539
53,347
180,292
1,470,835
557,209
205,508
142,007
7,191
24,123
2,406,873
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable:
Trade payables
Other current liabilities
TOTAL CURRENT LIABILITIES
LONG-TERM LIABILITIES:
Deferred income taxes
Other long-term liabilities
TOTAL LONG-TERM LIABILITIES
COMMITMENTS AND CONTINGENT LIABILITIES
TOTAL LIABILITIES
SHAREHOLDERS’ EQUITY:
Taro shareholders' equity:
Ordinary shares of NIS 0.0001 par value:
Authorized at March 31, 2022 and March 31, 2021: 200,000,000 shares;
Issued at March 31, 2022 and March 31, 2021: 45,116,262 shares
Outstanding at March 31, 2022 and March 31, 2021:
37,584,631 and 37,926,044 shares, respectively
Founders’ shares of NIS 0.00001 par value:
Authorized, issued and outstanding at March 31, 2022 and March 31, 2021:
2,600 shares
Additional paid-in capital
Accumulated other comprehensive loss, net of taxes
Treasury stock at March 31, 2022 and March 31, 2021:
7,531,631 and 7,190,218 shares, respectively
Accumulated earnings
Taro shareholders' equity
Non-controlling interest
TOTAL SHAREHOLDERS’ EQUITY
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
The accompanying notes are an integral part of these consolidated financial statements.
F-8
TARO PHARMACEUTICAL INDUSTRIES LTD.
March 31,
2022
2021
68,232 $
363,886
432,118
—
32,799
32,799
464,917
61,166
615,135
676,301
1,907
33,208
35,115
711,416
679
679
1
262,445
(168,965 )
(771,406 )
2,388,691
1,711,445
—
1,711,445
2,176,362 $
1
262,445
(151,621 )
(746,472 )
2,338,617
1,703,649
(8,192 )
1,695,457
2,406,873
$
$
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars and shares in thousands (except per share data)
Sales, net
Cost of sales
Impairment
Gross profit
Operating expenses:
Research and development
Selling, marketing, general and administrative
Settlements and loss contingencies
Operating income (loss)
Financial income, net
Other gain, net
Income (loss) before income taxes
Tax expense
Net income (loss)
Net (loss) income attributable to non-controlling interest
Net income (loss) attributable to Taro
Net (loss) income per ordinary share attributable to Taro:
Basic and Diluted
Weighted-average number of ordinary shares used to compute net income (loss) per
share:
Basic and Diluted
The accompanying notes are an integral part of these consolidated financial statements.
F-9
TARO PHARMACEUTICAL INDUSTRIES LTD.
$
$
$
2022
Years ended March 31,
2021
2020
561,347 $
268,212
13
293,122
54,540
113,677
61,446
229,663
63,459
(10,172 )
4,227
77,858
19,592
58,266
—
58,266 $
548,970 $
252,314
—
296,656
60,152
91,355
558,924
710,431
(413,775 )
(19,809 )
2,893
(391,073 )
9,667
(400,740 )
(14,087 )
(386,653 ) $
644,769
245,044
—
399,725
59,777
93,413
—
153,190
246,535
(48,482 )
3,018
298,035
53,485
244,550
309
244,241
1.55 $
(10.12 ) $
6.35
37,641
38,210
38,460
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
U.S. dollars in thousands
Net income (loss) attributable to Taro
Other comprehensive (loss) income:
Change in unrealized (loss) gain from marketable securities
Change in unrealized (loss) gain from hedging instruments
Foreign currency translation adjustments
Total other comprehensive (loss) income attributable to Taro
Total comprehensive income (loss) attributable to Taro
The accompanying notes are an integral part of these consolidated financial statements.
F-10
TARO PHARMACEUTICAL INDUSTRIES LTD.
2022
Years ended March 31,
2021
2020
58,266 $
(386,653 ) $
244,241
(17,029 )
(315 )
—
(17,344 )
40,922 $
7,738
3,678
—
11,416
(375,237 ) $
(16,415 )
(2,513 )
(1 )
(18,929 )
225,312
$
$
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
U.S. dollars and shares in thousands
TARO PHARMACEUTICAL INDUSTRIES LTD.
Number
of
Shares
Capita
l
Taro Shareholders' Equity
Accumulated
Additio
nal
Share
Paid-in
Other
Comprehensi
ve
Treasur
y
Retained
controlling
Total Taro
Shareholder
s'
Non-
Total
Shareholders
’
38,539
$
680
(281 )
—
—
—
—
—
Capital
262,44
5
$
(Loss)
Shares Earnings
Equity
Interest
Equity
$
(144,108 ) $
(694,5
10 ) $ 2,481,029
$ 1,905,536 $
5,586
$
1,911,122
—
—
—
—
(18,929 )
—
(26,98
4 )
—
—
—
—
244,241
(26,984 )
(18,929 )
244,241
—
—
309
(26,984 )
(18,929 )
244,550
38,258
$
680
$
262,44
5
$
(163,037 ) $
(721,4
94 ) $ 2,725,270
(24,97
$ 2,103,864 $
5,895
$
2,109,759
(332 )
—
—
—
—
—
—
—
—
—
8 )
—
(24,978 )
—
(24,978 )
11,416
—
—
—
—
(386,653 )
11,416
(386,653 )
—
(14,087 )
11,416
(400,740 )
37,926
$
680
$
262,44
5
$
(151,621 ) $
(746,4
72 ) $ 2,338,617
(24,93
$ 1,703,649 $
(8,192 ) $
1,695,457
(341 )
—
—
—
4 )
—
(24,934 )
—
(24,934 )
—
—
—
(17,344 )
—
—
(17,344 )
—
(17,344 )
—
—
—
—
—
—
—
—
—
—
(8,192 )
58,266
(8,192 )
58,266
8,192
—
—
58,266
37,585
$
680
$
262,44
5
$
(168,965 ) $
(771,4
06 ) $ 2,388,691
$ 1,711,445 $
—
$
1,711,445
Balance at March 31, 2019
Repurchase of treasury stock
Comprehensive loss, net of tax
Net income
Balance at March 31, 2020
Repurchase of treasury stock
Comprehensive income, net of
tax
Net loss
Balance at March 31, 2021
Repurchase of treasury stock
Comprehensive income, net of
tax
Transaction with minority
interest
Net income
Balance at March 31, 2022
The accompanying notes are an integral part of these consolidated financial statements.
F-11
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
Cash flows from operating activities:
Net income (loss)
Adjustments required to reconcile net income (loss) to net cash
(used in) provided by operating activities:
Depreciation and amortization
Realized loss on sale of long-lived assets
Change in derivative instruments, net
Effect of exchange differences on intercompany balances
Foreign exchange effect of marketable securities and bank deposits
Deferred income taxes, net
(Increase) decrease in trade receivables, net
(Increase) decrease in other receivables, prepaid expenses and other
Increase in inventories, net
(Increase) decrease in income tax receivables
(Decrease) increase in trade payables
(Decrease) increase in other accounts payable and accrued expenses
Increase (decrease) in income tax payables
Expense from amortization of marketable securities bonds, net
Net cash (used in) provided by operating activities
The accompanying notes are an integral part of these consolidated financial statements.
F-12
TARO PHARMACEUTICAL INDUSTRIES LTD.
2022
Years ended March 31,
2021
2020
$
58,266
$
(400,740 ) $
244,550
25,915
689
(631 )
(2 )
(447 )
23,200
(6,229 )
(3,010 )
(2,069 )
(2,441 )
(2,129 )
(263,661 )
512
13,339
(158,698 )
23,680
92
(236 )
—
(4,588 )
(38,413 )
21,683
(7,235 )
(27,219 )
(9,090 )
32,308
454,609
(4,397 )
5,316
45,770
21,383
28
(2,649 )
—
(11,600 )
7,584
2,724
1,247
(4,994 )
10,890
(6,202 )
1,423
5,561
1,660
271,605
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
Cash flows from investing activities:
Purchase of property, plant and equipment
Investment in other intangible assets
Investment in short-term bank deposits, net
Investment in marketable securities
Proceeds from marketable securities
(Investment in) proceeds from acquisitions, net of sale of long-lived assets
Cash acquired from acquisition
Net cash (used in) provided by investing activities
Cash flows from financing activities:
Repurchase of treasury stock
Net cash used in financing activities
Effect of exchange rate changes on cash and cash equivalents
(Decrease) increase in cash and cash equivalents
Cash and cash equivalents at the beginning of the period
Cash and cash equivalents at the end of the period
Supplemental disclosure of cash flow transactions:
Cash paid during the year for:
Income taxes
Cash received during the year for:
Income taxes
Non-cash investing transactions:
Purchase of property, plant and equipment included in accounts payable
Investment in intangible assets on credit
Non-cash financing transactions:
Purchase of treasury stock
Purchase of marketable securities
The accompanying notes are an integral part of these consolidated financial statements.
F-13
TARO PHARMACEUTICAL INDUSTRIES LTD.
2022
Years ended March 31,
2021
2020
(11,800 )
(243 )
(47,586 )
(828,203 )
809,119
(99,275 )
7,407
(170,581 )
(24,934 )
(24,934 )
170
(354,043 )
605,177
251,134
7,753
2,351
1,468
—
—
3,848
$
$
$
$
$
$
$
(16,991 )
(161 )
—
(1,132,501 )
1,217,386
8
—
67,741
(24,196 )
(24,196 )
2,508
91,823
513,354
605,177
29,377
4,093
2,997
15
782
9,417
$
$
$
$
$
$
$
(26,631 )
(1,783 )
—
(1,222,190 )
952,421
21
—
(298,162 )
(26,984 )
(26,984 )
(556 )
(54,097 )
567,451
513,354
54,536
24,331
1,477
—
—
9,159
$
$
$
$
$
$
$
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
NOTE 1: — GENERAL
TARO PHARMACEUTICAL INDUSTRIES LTD.
Taro Pharmaceutical Industries Ltd. (the “Company” or “Taro”) is an Israeli corporation, which operates in Israel and elsewhere through its
Israeli, North American, and European subsidiaries (the “Group”). The principal business activities of the Group are the production,
research, development and marketing of pharmaceutical products. As of March 22, 2012, the Company’s ordinary shares are traded on the
New York Stock Exchange (the “NYSE”), under the symbol “TARO.” As used herein, the terms “we,” “us,” “our,” “Taro,” and the
“Company” mean Taro Pharmaceutical Industries Ltd. and its subsidiaries, unless otherwise indicated.
The activities of the Group in North America are performed by Taro Pharmaceuticals Inc. (“Taro Canada”) and Taro Pharmaceuticals U.S.A.,
Inc. (“Taro U.S.A.”). Taro International Ltd. in Israel is engaged in the pharmaceutical activities of the Group outside North America.
The Group manufactures generic and proprietary drug products in facilities located in Israel and Canada, and manufactures bulk active
pharmaceutical ingredients in its Israel facility. The Group’s research and development facilities are located in Israel and Canada. The
majority of the Group’s sales are in North America, primarily in the U.S.A.
In North America, the Company sells and distributes its products principally to drug industry wholesalers, drug store chains, and mass
merchandisers. In Canada, the Group also sells and distributes to hospitals. In Israel, the Group sells and distributes its products principally
to healthcare institutions, drug store chains, and private pharmacies.
In the generic pharmaceutical industry, selling prices and related profit margins tend to decrease as products mature due to increased
competition from other generic pharmaceutical manufacturers as they gain approval from the U.S. Food and Drug Administration (the
“FDA”), the Canadian Health Products and Food Branch Inspectorate, and the Israeli and other Ministries of Health (“Government
Agencies”) to manufacture equivalent products. The Group’s future operating results are dependent on, among other things, its ability to
introduce new products and maintain its approvals to market existing drugs.
While non-compliance with Government Agencies’ regulations can result in refusal to allow country entry, seizure, fines, or injunctive
actions to prevent the sale of products, no material actions against the Group or its products have recently occurred. The Group believes that
it is in material compliance with all Government Agencies’ regulations.
While the majority of the Company’s products are either synthesized by the Company itself or are derived from multiple source materials,
some raw materials and certain products are currently obtained from single suppliers. The Company does not believe that any interruption of
supply from a single supplier would have a material adverse effect on the Company’s results of operations and financial position. To date,
the Group has not experienced difficulties in obtaining raw materials or other materials.
Sun Pharmaceutical Industries Ltd. (“Sun”), the Company’s majority shareholder, owns, or controls as of March 31, 2022, 29,497,813, or
78.5%, of the Company’s ordinary shares, and with the Company’s founders’ shares, 85.7% of the vote attributable to the share equity of the
Company. As of July 20, 2022, Sun owns, or controls 78.5% of the Company’s ordinary shares and 85.7% of the voting power in the
Company.
On November 4, 2019, the Company announced that its Board of Directors approved a $300 million share repurchase of ordinary shares. On
November 15, 2019, the Company commenced a modified “Dutch auction” tender offer to repurchase up to $225 million in value of its
ordinary shares. In accordance with the terms and conditions of the tender offer, which expired on December 16, 2019, the Company
accepted for payment 280,719 ordinary shares at the final purchase price of $91.00 per share. During the year ended March 31, 2022, in
accordance with a Rule 10b5-1 program, the Company repurchased 341413 shares at an average price of $73.03 per share. Through May 31,
2022, under the $300 million authorization, the Company has repurchased, in total, 954,165 shares (280,719 at an average price of $91.00,
332,033 at an average price of $75.23 and 341,413 shares at an average price of $73.03), leaving $224.5 million remaining under the current
board authorization.
In December 2019, COVID-19, a disease caused by a strain of coronavirus, was first reported, and later declared a pandemic by the World
Health Organization in March 2020, spreading globally. It has affected Israel and Canada, where most of our manufacturing takes place, and
spread throughout each state in the U.S., our largest market. The COVID-19 pandemic has disrupted global supply chains, created
significant volatility of global financial markets, negatively impacted the global economy, and also our U.S. sales. Additionally, it has
impacted our business and may materially affect our operations, including manufacturing, supply chain, pre-commercial launch, and clinical
trial activities should the pandemic persist.
F-14
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
Countries, states, and local governments instituting measures to reduce the spread of COVID-19 have impacted our operations with
significant disruptions, uncertainty and economic volatility, higher costs, and capital expenditures. Such measures include quarantines,
government restrictions on movement, business closures and suspensions, canceled events and activities, self-isolation, and other voluntary
and/or mandated changes in behavior. Our offices are or have been operating under work from home protocols, and our manufacturing and
distribution facilities have instituted policies and procedures to protect our employees and operations, including social distancing, the supply
and use of personal protective equipment, split shifts and health assessments. We had and, in some instances, continue to have to suspend in-
person activities of our field employees because of restrictions on meetings instituted by our customers. These protocols, policies,
procedures, and suspension of activities have affected our business operations.
On July 31, 2020, Taro Pharmaceuticals, Inc. completed the purchase of Aquinox Pharmaceuticals (Canada) Inc. (“Aquinox”), a wholly-
owned subsidiary of Neoleukin Therapeutics, Inc., including intellectual property rights to various early stage molecules. Pursuant to the
agreement, Taro acquired all issued and outstanding shares of Aquinox for $8 million.
On June 1, 2021, Taro Pharmaceuticals Inc. purchased 100% of the issued and outstanding shares of Taro Pharmaceuticals U.S.A., Inc. for
nominal value. The shares were purchased from Taro Pharmaceutical Industries Ltd. and The Taro Development Corporation (a company
owned indirectly by Sun Pharmaceutical Industries Ltd.) as follows: Five (5) class A shares of common stock and one-hundred fifty (150
class B shares were acquired from Taro Pharmaceutical Industries Ltd., and five (5) class A shares were acquired from The Taro
Development Corporation.
On February 28, 2022, the Company acquired 100% ownership of Alchemee LLC (“Alchemee”), pursuant to a Share and Asset Purchase
Agreement. Taro paid an all-cash purchase price for Alchemee of approximately $99 million, which included all outstanding shares of
Alchemee, product-related intellectual properties, intangible assets, and assembled workforce. This acquisition qualified as a business
combination and the one month's financial results from the acquisition have been included in the Company's consolidated financial
statements commencing February 28, 2022.
NOTE 2: — SIGNIFICANT ACCOUNTING POLICIES
The consolidated financial statements are prepared in conformity with accounting principles generally accepted in the U.S. (“U.S. GAAP”).
a.
Use of estimates:
The consolidated financial statements are prepared in conformity with U.S. GAAP. The preparation of the consolidated financial statements
in conformity with U.S. GAAP requires management to make estimates, judgements, and assumptions. Management believes that the
estimates, judgements and assumptions used are reasonable based upon information available at the time they are made. These estimates,
judgements and assumptions can affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the
dates of the financial statements, and the reported amounts of revenue and expenses during the reporting period. Actual results could differ
from those estimates.
The Group’s most critical estimates are used in its determination of its sales incentives reserves, accounts receivable allowance, inventory
reserves, income taxes, uncertain tax positions, fixed assets, intangible assets, derivative instruments, and contingencies. Estimates are
periodically reviewed in light of changes in circumstances, facts and experience.
b.
Financial statements in U.S. dollars (“USD”):
A majority of the revenue of the Company and certain of its subsidiaries is generated in USD. In addition, a substantial portion of the costs
of the Company and these subsidiaries is incurred in USD. Management believes that the USD is the primary currency of the economic
environment in which the Company and these subsidiaries operate. Thus, the functional and reporting currency of the Company and its
subsidiaries is the USD, requiring re-measurement from the local currency into USD for each of these entities. All exchange gains and losses
resulting from the re-measurement are reflected in the Consolidated Statements of Operations as financial income or expense, as appropriate.
Prior to April 1, 2019, the functional currency of the Company’s Canadian subsidiary was the Canadian dollar (“CAD”). Accordingly, the
financial statements of the Canadian subsidiary were translated into USD. All balance sheet accounts were translated using the exchange
rates in effect at the balance sheet date. Amounts recorded in the Consolidated Statements of Operations were translated using the average
exchange rate prevailing during the year. The resulting translation adjustments were reported as a component of shareholders’ equity under
accumulated other comprehensive income.
F-15
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
Effective as of the Company’s fiscal year beginning April 1, 2019, Taro Canada’s functional currency became the USD. FASB ASC Topic
830, “Functional Currency Matters,” requires a change in functional currency to be reported as of the date it is determined there has been a
change, and it is generally accepted practice that the change is made at the start of the most recent period that approximates the date of the
change. Management determined it would enact this change effective on April 1, 2019. While the change was based on a factual
assessment, the determination of the date of the change required management’s judgement given the change in the primary economic and
business environment, in which Taro Canada operates, have evolved over time. As part of management’s functional currency assessment,
changes in economic facts and circumstances were considered. This included analysis of changes in: management of operations, process,
and in the composition of cash and marketable securities balances. The Company has centralized different functions, including treasury and
investment portfolio measurement, which resulted in a stronger focus on the USD currency for Taro Canada. Additionally, as budgeting has
also been centralized for the Company, Taro Canada has implemented budgeting in USD, whereas this was previously performed in CAD.
Taro Canada’s cash inflows consist primarily of USD cash balances and less of CAD, as also reflected in the budget. The transfer of
significant intangible assets to Taro Canada, as a result of the winding down of TNA, has reduced the relevance of the foreign currency
position on the balance sheet of Taro Canada. The Group decided to focus Taro Canada’s sales market as the U.S. market, with the majority
of all sales to the U.S. denominated in USD. This was followed by centralizing budgets and facilitating effective netting and hedging
activities. Assuming current business operating model stays constant, management believes that the USD cash balances will continue to
increase, while CAD cash balances will continue to produce a net outflow.
Management re-evaluated all indicators established in ASC 830-10-55-5 to determine the functional currency of Taro Canada. Such
indicators include i) cash flow, ii) sales price, iii) sales market, iv) expense, v) financing and vi) intercompany transactions and arrangements.
Management determined that the cash flow indicators and the sales market indicators were most relevant to Taro Canada operations and its
primary economic environment. At the time of the assessment adopted on April 1, 2019, cash flows generated by Taro Canada that relate to
its individual assets and liabilities now directly affect the Company’s cash flows and are readily available for remittance to the Company.
The majority of cash flow from Taro Canada’s operations is denominated in USD, with the sales market for Taro Canada’s products now
mostly in the U.S. Approximately 75% of Taro Canada’s revenue is to the U.S. market, with over 80% of Taro Canada’s plant production, in
terms of units, being produced for the US market. Significant asset and liability line items on Taro Canada’s balance sheet are comprised
almost solely (greater than 90%) of USD denominated transactions. Furthermore, most of Taro Canada’s generated cash flows are now
invested in USD based cash and cash equivalents or marketable securities. Since such investments are short-term, cash is readily available
for remittance to other Taro entities. Thus, the USD is the primary currency from which Taro Canada generates and accumulates cash.
When considering all relevant facts together, management concluded that the USD best reflects the currency of the primary economic
environment in which Taro Canada currently operates. Therefore, USD is the functional currency as a result of the change in the most
significant economic facts and circumstances from cash flow and sales market indicators, as well as intra-entity transactions and
arrangements, which are material to Taro Canada. As a result, the Company adopted USD as the functional currency for Taro Canada
effective April 1, 2019.
The change was accounted for prospectively from the date of the change in accordance with FASB ASC Topic 830, “Foreign Currency
Matters.” The translated balances of monetary and nonmonetary assets and liabilities recorded in Taro Canada’s financial statements as of
the end of the prior reporting period became the new accounting basis for those assets and liabilities in the period of the change. To the
extent the entity had monetary assets and liabilities denominated in the old functional currency, such balances created transactional gains and
losses subsequent to the change in functional currency. The amount recorded in the currency translation adjustment account for prior periods
was not reversed upon the change in functional currency. The exchange rate on the date of the change became the historical rate for
subsequent re-measurement of nonmonetary assets and liabilities into the new functional currency.
F-16
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
The following table summarizes the impact on both consolidated net income and other comprehensive income (loss) utilizing USD as the
functional currency of Taro Canada as of March 31, 2020, compared to the related impact if the functional currency of Taro Canada would
have remained CAD (excluding foreign exchange from transactions denominated in CAD recorded in the respective period):
Financial (income) expense, net - attributed to foreign
translation gain
Other comprehensive loss - attributed to foreign currency
translation adjustments
$
$
USD
as Functional
Currency
(in USD)*
CAD
as Functional
Currency
(in USD)**
(Unaudited Pro Forma)
(14,838 ) $
(1 ) $
(46,667 )
(92,959 )
*Based on consolidated amounts of the Group for the fiscal year ended March 31, 2020, which was the first fiscal year Taro Canada utilized
USD as the functional currency. Includes Taro Canada amounts reported in USD with USD as functional currency.
**Based on unaudited pro forma consolidated amounts of the Group for the fiscal year ended March 31, 2020. Includes Taro Canada
unaudited pro forma amounts reported in USD with CAD as functional currency.
c.
Principles of consolidation:
The consolidated financial statements include the accounts of the Company and its subsidiaries. Intercompany transactions and balances
have been eliminated in consolidation and non-controlling interest is included in shareholders’ equity.
On June 1, 2021, the Company and The Taro Development Corporation each transferred its ownership of the shares of Taro U.S.A. to Taro
Canada. Taro U.S.A. is now 100% owned by Taro Canada, which remains 100% owned by the Company.
During the year ended March 31, 2022, the board of directors of Taro Canada approved two capital contributions in the amounts of $265.0
million and $107.6 million to Taro U.S.A. by reducing the Taro U.S.A.’s indebtedness to Taro Canada.
d.
Cash and cash equivalents:
Cash equivalents are highly-liquid investments that are readily convertible into cash, typically with an original maturity of three months or
less.
Short-term bank deposits:
F-17
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
Bank deposits with maturities of more than three months, but less than one year, are included in short-term deposits. Such deposits are stated
at cost which approximates market value. The Company has short-term deposits on March 31, 2022, of $47.6 million and $0 on March 31,
2021.
e.
Business combination
The Company allocates the purchase price of an acquired business to the tangible and intangible assets acquired and liabilities assumed based
upon their estimated fair values on the acquisition date. Any excess of the purchase price over the fair value of the net assets acquired is
recorded as goodwill. The amounts of revenues and earnings of the acquired business since the acquisition date are included in the
Consolidated Statements of Operations.
Determining the fair value of assets acquired and liabilities assumed is judgmental in nature and can involve the use of significant estimates
and assumptions. Fair value and useful life determinations are based on, among other factors, estimates of future expected cash flows,
revenue growth rates, operating margins and appropriate discount rates used in computing present values. These estimates may materially
impact the net income or loss in periods subsequent to acquisition through depreciation and amortization, and in certain instances through
impairment charges, if assets become impaired in the future.
Transaction costs associated with the business combination are expensed as incurred and reflected in operating expenses. The allocation of
the consideration transferred in certain cases may be subject to revision based on the final determination of fair values during the
measurement period, which may be up to one year from the acquisition date. The Company includes the results of operations of the business
that it has acquired in its consolidated results prospectively from the date of acquisition.
f.
Marketable securities:
Marketable securities, consisting of both debt securities and equity securities, are comprised primarily of corporate bonds, government
securities, U.S. Treasuries, certificates of deposit, municipal bonds, preferred stock, and commercial paper. The marketable debt securities
were designated as available-for-sale (“AFS”). Accordingly, these securities are stated at fair value, with unrealized gains and losses reported
in accumulated other comprehensive income, a separate component of shareholders’ equity. The equity securities with readily determinable
fair values are carried at fair value, with changes in fair value reported in consolidated statements of operation.
Realized gains and losses on the sale of investments are included in financial income, net and are derived using the specific identification
method for determining the cost of securities.
The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization
together with interest and dividends on securities are included in financial income, net.
The Company recognizes an impairment charge when a decline in the fair value of its investments in debt securities results in the value of the
investments being below the cost basis of such securities and when such decline is judged to be other-than-temporary. Factors considered in
making such a determination include the duration and severity of the impairment, the reason for the decline in value, the potential recovery
period and the Company’s intent to sell, including whether it is more likely than not that the Company will be required to sell the investment
before recovery of cost basis. For securities that are deemed other-than-temporarily impaired, the amount of impairment is recognized in
financial income, net in the Consolidated Statements of Operations and is limited to the amount related to credit losses, while impairment
related to other factors is recognized in other comprehensive income.
The Company adopted ASU No. 2016-13, “Financial Instruments – Credit Losses (Topic 326)” on April 1, 2020. In accordance with ASC
326-30, for an AFS debt security for which there is neither an intent nor a more-likely-than-not requirement to sell, an entity will record
credit losses as an allowance, rather than a write-down of the amortized cost basis. As a result, entities will be able to record reversals of
credit losses in current period income as they occur. Additionally, the allowance is limited by the amount that the fair value is less than the
amortized cost basis, considering that an entity can sell its investment at fair value to avoid realization of credit losses. An entity should not
consider the length of time that the security has been in an unrealized loss position to avoid recording a credit loss. Further, in determining
whether a credit loss exists, the historical and implied volatility and recoveries or additional declines in the fair value after the balance sheet
date should no longer be considered. Changes in the allowance will be recorded in the period of the change as credit loss expense (or
reversal of credit loss expense). As of March 31, 2022, the adoption of ASU 2016-13 did not have a material impact on our financial
position and results of operations.
During the years ended March 31, 2022, 2021, and 2020, the Company did not own or sell any marketable securities previously impaired.
F-18
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
The Company adopted ASU No. 2016-01, “Financial Instruments – Overall (Subtopic 825-10).” The amended guidance focuses on the
recognition and measurement of financial assets and liabilities. The adoption of ASU 2016-01 did not have a material impact on our
financial position and results of operations.
g.
Allowance for doubtful accounts:
The allowance for doubtful accounts is calculated primarily with respect to specific balances, for which, in the opinion of management,
collection of such balances is doubtful. The allowance, in the opinion of management, is sufficient to cover probable uncollectible balances.
The Company adopted ASU No. 2016-13, “Financial Instruments – Credit Losses (Topic 326)” on April 1, 2020. The new guidance requires
an entity to measure the allowance for expected credit losses by utilizing information including historical data and current economic
conditions, plus the use of reasonable supportable forecasts. The adoption of ASU 2016-13 did not have a material impact on our financial
position and results of operations.
h.
Inventories:
Inventories are stated at the lower of cost or net realizable value. Inventory reserves are provided to cover risks arising from slow-moving
items, short-dated inventory, excess inventory, or obsolescence. Changes in these provisions are charged to cost of sales. Cost is determined
as follows:
Raw and packaging materials – weighted-average cost basis.
Finished goods and work in progress – weighted-average production costs including materials, labor and direct and indirect manufacturing
expenses.
Purchased products for commercial purposes – weighted-average cost basis.
i.
Taxes:
(1)
Deferred income taxes:
Deferred income taxes are determined utilizing the “asset and liability” method based on the estimated future tax effects of temporary
differences between the financial accounting and tax basis of assets and liabilities under the applicable tax laws, and on tax rates
anticipated to be in effect when the deferred taxes are expected to be paid or realized. A valuation allowance is provided if, based
upon the weight of available evidence, it is “more likely than not” that a portion of the deferred tax assets will not be realized. For the
years ended March 31, 2022 and 2021, in accordance with the required updates in ASU No. 2015-17, all deferred tax liabilities and
assets are classified as non-current.
(2)
Tax contingencies:
The Company follows a two-step approach to recognizing and measuring a liability for uncertain tax positions. The first step is to
evaluate the tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that
it is more likely than not that, on an evaluation of the technical merits, the tax position will be sustained on audit, including resolution
of any related appeals or litigation processes. The second step is to measure the tax benefit as the largest amount that is more than
50% likely to be realized upon ultimate settlement. In addition, the Company classifies interest and penalties recognized in the
financial statements relating to uncertain tax positions under the provision for income taxes. A liability for unrecognized tax benefits
was recorded in accordance with ASC 740 amounting to $34,578 and $26,921 as of March 31, 2022 and 2021, respectively.
(3)
Income taxes:
Income taxes are accounted for in accordance with the use of the liability method, whereby deferred tax asset and liability account
balances are determined for temporary differences between the financial reporting and tax basis of assets and liabilities, and for
carryforward losses and credits. Deferred taxes are measured using tax rates and laws that will be in effect when the differences are
expected to reverse. In certain cases management determined that it was more likely than not that the Company will not benefit from
the deferred tax assets in subsidiaries, and a valuation allowance was provided against the deferred tax assets carried by such
subsidiaries. In future years, if it is more likely than not that the subsidiary will be in a position to utilize its deferred tax asset, the
valuation allowance for such assets will be modified.
j.
Property, plant and equipment:
F-19
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
(1)
(2)
(3)
(4)
Property, plant and equipment is stated at cost, net of accumulated depreciation. Payroll and other costs that are direct incremental
costs necessary to bring an asset to the condition of its intended use incurred during the construction and validation period of property,
plant, and equipment are capitalized to the cost of such assets.
Depreciation is calculated utilizing the straight-line method over the estimated useful lives of the assets, from the date the assets are
ready for their intended use, at the following annual rates:
Building
Machinery and equipment
Motor vehicles
Furniture, fixtures, office equipment, computer equipment
and software
%
2.5 - 10
5 - 10
20
6 - 33
Leasehold improvements are depreciated using the straight-line method over the shorter of their useful lives or the terms of the leases
(generally five-ten years).
Certain costs incurred for computer software developed or obtained for internal use is required to be capitalized. As of March 31,
2022 and 2021, the Group capitalized $20,298 and $17,332 of software costs, respectively. As of March 31, 2022, 2021 and 2020,
capitalized internal costs, were $0 for all three years.
Software costs are amortized using the straight-line method over their estimated useful life (generally three to five years). The
Company capitalizes qualifying internally developed software development costs incurred during the application development stage,
as long as it is probable the project will be completed, and the software will be used to perform the function intended, Capitalization
of such costs ceases once the project is substantially complete and ready for its intended use. Costs related to maintenance of internal-
use software are expensed in the period incurred. If capitalized projects are determined to no longer be in use, they are impaired, and
the costs and accumulated depreciation are removed from the accounts. The resulting loss on impairment, if any, is included in the
consolidated statements of operations in the period of impairment.
k.
Lease of land from the Israel Land Authority (“ILA”):
The Company leases several parcels of land from the ILA. The lease period of the industrial parcels ends between 2018 and 2060. The
Company has the right to extend the lease agreement ended 2018 for an additional period of 49 years and is currently in the process of
extending the lease agreement. The ILA lease agreements are standard agreements covering substantial portions of the land of Israel. The
standard agreements call for a lease period of 49 years, with an option for one additional Lease Period (i.e., total of 98 years). A majority of
the Company’s leases are in the beginning of the second 49 year period, and the remaining leases still in the first 49 year period have the
option for the one additional lease period. The ownership of the land is not transferred at the end of the lease period, however, in certain
conditions the lessee may purchase the land from the ILA. The expectation, based on practice and accumulated experience is that the
renewal price would be substantially below fair market value. Since such leases do not qualify as a capital lease, they are being accounted
for as operating leases. The prepaid lease amount is included in long-term receivables and other assets and amortized over the term of the
lease.
As of April 1, 2019, the Company commenced lease accounting in accordance with ASU 2016-02, “Leases (Topic 842).” Refer to Note 9
and Note 13 for additional details on lease accounting.
l.
Goodwill:
The goodwill of the Company is not amortized, but rather is subject to an annual impairment test on March 31 (or more frequently if
impairment indicators arise).
The Group operates in one operating segment, comprising its only reporting unit. As of April 1, 2020, the Company adopted ASU 2017-04
in which the goodwill impairment tests are now conducted in one step. In this step, if it is determined that the net book value of the reporting
unit exceeds its fair value, impairment will be recorded for the difference.
The Company determined the fair value using the market approach, which is based on the market capitalization by using the share price of
the Company on the NYSE and an appropriate control premium. As of March 31, 2022 and 2021, the market capitalization of the Company
was higher than the net book value, therefore no impairment was recorded.
F-20
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
m.
Contingencies:
TARO PHARMACEUTICAL INDUSTRIES LTD.
The Company may be involved in various patent, product liability, consumer, commercial, or environmental claims, government
investigations, and other legal proceedings that arise from time to time in the ordinary course of business. Except for income tax
contingencies, the Company records accruals for these types of contingencies to the extent that the Company concludes their occurrence is
probable and that the related liabilities are estimable. The Company records anticipated recoveries under existing insurance contracts that are
virtually certain of occurring and at the gross amount that is expected to be collected.
n.
Intangible assets and deferred charges and long-lived assets:
Intangible assets and deferred charges:
Acquired intangible assets and product rights to be held and used are amortized over their useful life of a weighted-average amortization
period of between five to 20 years using a straight-line method of amortization that reflects the pattern in which the economic benefits of the
intangible assets are consumed or otherwise used up.
Long-lived assets:
The Group’s long-lived assets, excluding goodwill, are reviewed for impairment whenever events or changes in circumstances indicate that
the carrying amount of an asset may not be recoverable. Impairment exists when the carrying amount of the asset exceeds the aggregate
future undiscounted cash flows expected to be generated by the asset. The impairment to be recognized is measured by the amount by which
the carrying amount of the assets exceeds the fair value of the asset. During the years ended March 31, 2022 and 2021, the Company did not
record any impairment charge.
o.
Comprehensive income:
The comprehensive income statement establishes standards for the reporting and display of comprehensive income and its components in a
full set of general purpose financial statements. Comprehensive income generally represents all changes in shareholders’ equity during the
period except those resulting from investments by, or distributions to, shareholders. The Company determined that its items of other
comprehensive income relates to unrealized gains and losses on available for sale securities and foreign currency translation adjustments.
p.
Treasury shares:
The Company repurchases its ordinary shares from time to time on the open market and holds such shares as treasury stock. The Company
presents the cost to repurchase treasury stock as a reduction of shareholders’ equity. During the years ended March 31, 2022, 2021, and
2020, the Company repurchased 341,413 shares, 332,033 shares, and 280,719 shares, respectively.
For the year ended March 31, 2022, the shares were repurchased in accordance with a Rule 10b5-1 program.
F-21
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
On November 15, 2019, the Company commenced a modified “Dutch auction” tender offer to repurchase up to $225 million in value of its
ordinary shares. In accordance with the terms and conditions of the tender offer, which expired on December 16, 2019, the Company
accepted for payment 280,719 ordinary shares at the final purchase price of $91.00 per share.
When treasury stock is reissued, the Company charges the excess of the purchase cost, including related share-based compensation expenses,
over their issuance price (loss) to retained earnings. The purchase cost is calculated based on the specific identification method. The
Company did not reissue treasury shares during the three years ended March 31, 2022, 2021 and 2020.
In cases where the purchase cost is lower than the re-issuance price, the Company credits the difference to additional paid-in capital.
q.
Revenue recognition:
The Company ships products to its customers only in response to, and to the extent of, the orders that customers submit to the Company.
Depending on the terms of our customer arrangements, revenue is generally recognized when the product is received by the customer (“FOB
Destination Point”) or at the time of shipment (“FOB Shipping Point”).
When the Company recognizes and records revenue from the sale of its pharmaceutical products, the Company, in the same financial
reporting period, records an estimate of various future deductions related to the sale. This has the effect of reducing the amount of reported
product sales. These deductions include the Company’s estimates, which may require significant judgement of chargebacks, product returns,
rebates, and other sales deductions.
Chargebacks result from pricing arrangements the Company has with end-user customers establishing contract prices which are lower than
the wholesalers’ acquisition costs or invoice prices. When these customers buy the Company’s products from their wholesaler of choice, the
wholesaler issues a credit memo (chargeback) to the Company for the difference between the invoice price and the end-user contract price.
Chargeback reserves are estimated using current wholesaler inventory data and historical data.
Product returns result from agreements allowing the Company’s customers to return unsold inventory that is expired or close to expiration
and such returns are deducted from revenue. Product return reserves are calculated using the average lag period between sales and product
expiry, historical product returns experience, and specific return exposures to estimate the potential obligation for returns of inventory in the
distribution channel.
Rebates result from contractual agreements with the Company’s customers and are earned based on the Company’s direct sales to customers
or the Company’s customers’ sales to third parties. Rebate reserves from the Company’s direct sales to customers and the Company’s
customers’ sales to third parties are estimated using historical and contractual data.
The Company generally offers discounts to its customers for payments within a certain period of time. Cash discount reserves are calculated
by multiplying the specified discount percentage by the outstanding receivable at the end of each period.
Reserves for returns, Medicaid and indirect rebates are included in current liabilities. All other sales deductions allowances are recorded as
accounts receivable reserves. The reserve for returns is included in current liabilities as substantially all of these returns will not be realized
until after the year-end accounts receivable balances are settled. Medicaid and indirect rebates are included in current liabilities because the
Company does not have direct customer relationships with any of the payees.
The Company offers incentives to certain resellers and retailers through various marketing programs where the Company agrees to reimburse
them for advertising costs incurred to include the Company’s products. The Company accounts for these in accordance with FASB ASU No.
2014-09, “Revenue from Contracts with Customers (Topic 606),” as reductions of revenue unless the customer receives an identifiable benefit
in exchange for the consideration that is sufficiently separable from the customer’s purchase of the products and the fair value of the benefits
can be reasonably estimated.
r.
Research and development:
Research and development expenses are charged to expense as incurred. Payments made for research and development services prior to the
services being rendered are recorded as prepaid expenses on our Consolidated Balance Sheet and expensed as provided.
F-22
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
s.
Royalty-bearing grants:
TARO PHARMACEUTICAL INDUSTRIES LTD.
Royalty-bearing grants from the government of Israel through the Israeli National Authority for Technological Innovation (the “IIA”)
(formerly operating as Office of the Chief Scientist of the Ministry of Economy of the State of Israel) for funding approved research and
development projects are recognized at the time the Company is entitled to such grants, on the basis of the related costs incurred. The
Company did not earn any grants during the years ended March 31, 2022, 2021 and 2020.
t.
Advertising expenses:
The Group expenses advertising costs as incurred. Product samples are recorded within prepaid expenses on the Consolidated Balance Sheet
and recorded within advertising expenses when provided to potential customers. Advertising expenses were $8,280, $5,681, and $4,902 for
the years ended March 31, 2022, 2021 and 2020, respectively.
u.
Sales and other taxes collected and remitted to governmental authorities:
The Company collects various taxes from customers and remits them to governmental authorities. These taxes are recorded on a net basis
and therefore do not impact the Statement of Operations.
v.
Basic and diluted net (loss) income per ordinary share attributable to Taro:
Basic net (loss) income per ordinary share is calculated based on the weighted-average number of ordinary shares outstanding during each
year. Diluted net (loss) income per ordinary share is calculated based on the weighted-average number of ordinary shares outstanding during
each year, plus potential dilutive ordinary shares considered outstanding during the year (except where anti-dilutive).
w.
Freight and distribution costs:
The Company’s accounting policy is to classify shipping and handling costs as a part of sales and marketing expense. Freight, distribution
costs, and distribution warehousing costs related to shipping and handling to customers, primarily through the use of common carriers or
external distribution services amounted to $22,576, $13,202, and $11,954 for the years ended March 31, 2022, 2021 and 2020, respectively.
x.
Concentrations of credit risk:
Financial instruments that potentially subject the Group to concentrations of credit risk consist principally of cash and cash equivalents, short
and long-term marketable securities, and trade receivables. Cash and cash equivalents are principally invested in major banks in Israel, the
U.S., and Canada. Such deposits in the U.S. may be in excess of insured limits and are not insured in other jurisdictions. Management
believes that the financial institutions that hold the Group’s cash and cash equivalents, and the investments that comprise the short and long-
term marketable securities, are financially sound and a low credit risk therefore exists with respect to these financial instruments. These
deposits may be redeemed upon demand and, therefore, bear minimal risk.
The Group’s trade accounts receivables are mainly derived from sales to customers in the U.S., Canada, Europe, and Israel. On March 31,
2022, two different customers represented approximately 41.6% and 22.6% of the Company’s trade accounts receivable. The Group has
adopted credit policies and standards intended to mitigate inherent risk while accommodating sales growth. The Group performs ongoing
credit evaluations of its customers’ financial condition when deemed necessary, but does not require collateral for its customers’ accounts
receivable.
y.
Fair value of financial instruments:
The carrying amount of cash and cash equivalents, trade and other receivables, trade payables and other payables approximate their fair
value, due to the short-term maturities of these instruments.
As of March 31, 2022 and 2021, the Company did not have any amounts outstanding under borrowing arrangements.
The fair value of currency and interest rate contracts is determined by discounting to the present all future cash flows of the currencies to be
exchanged at interest rates prevailing in the market for the period the currency exchanges are due and expressing the results in USD at the
current spot foreign currency exchange rate.
F-23
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
z.
Accounting for derivatives:
TARO PHARMACEUTICAL INDUSTRIES LTD.
The Company recognizes all of its derivative instruments as either assets or liabilities at fair value, in the Consolidated Balance Sheet. The
accounting for changes (i.e., gains or losses) in the fair value of a derivative instrument depends on whether the instrument has been
designated and qualifies as part of a hedging relationship and on the type of hedging relationship. For derivative instruments that are
designated and qualify as hedging instruments, a company must designate the hedging instrument as a fair value hedge, cash flow hedge, or a
hedge of a net investment in a foreign operation. For derivatives which qualify as a fair value hedge, changes in fair value are reported with
the carrying amount of the hedged asset or liability with cash flows reported on the Consolidated Statement of Cash Flows consistent with
the classification of cash flows from the underlying items being hedged. For derivatives that qualify as a cash flow hedge, the effective
portion of these derivatives’ fair value is initially reported as a component of other comprehensive income with cash flows reported on the
Consolidated Statement of Cash Flows consistent with the classification of cash flows from the underlying items being hedged. The
designation is based upon the nature of the exposure being hedged. On March 31, 2022, 2021, and 2020, the Company had derivative
instruments designated as hedging instruments.
As of October 1, 2018, the Company commenced hedging accounting for Israel in accordance with ASU No. 2017-12, “Derivatives and
Hedging (Topic 815).” The effective date of this standard is for annual periods beginning after December 15, 2018, however the Company
early adopted as a result of hedging accounting implementation. The Company elected to designate the entire change in the hedging
derivatives’ value including the forward component, using the “critical terms match” method. Since the Company uses the “critical terms
match,” no effectiveness test is needed and the entire change in the designated value of the derivative is assumed to be effective. The
Company assesses the critical terms as follows: the forward is for the purchase of the same quantity, at the same currency, at the same time
and at the same location as the hedged forecasted payment.
According to ASU 2017-12, for purposes of assessing whether the qualifying criteria for the critical terms match method are met for a group
of forecasted transactions, an entity may assume that the hedging derivative matures at the same time as the forecasted transactions if both
the derivative maturity and the forecasted transactions occur within the same 31-day period or fiscal month. The Company elected to deem
the time criterion as qualified according to the 31-day period method. The company is aware that if any of the critical terms cease to exist or
if the counterparty credit rating becomes significant, then the critical terms method cannot be continued. In such a case the company will use
a “long haul method” in order to assess the hedge effectiveness or will discontinue the hedging relationship. The effective portion of the
designated value is reported under a hedging reserve in other comprehensive income during the hedge period. Once the hedged item affects
statement of operations, the hedging reserve value is reclassified to the same item. The ineffective portion, if any, is reported in statement of
operations.
For derivative instruments not designated as hedging instruments for accounting purposes, the gain or loss is recognized in financial income,
net in the Consolidated Statement of Operations during the period of change with the cash flows reported on the Consolidated Statements of
Cash Flows consistent with the classification of cash flows from the underlying items being hedged. See Note 10.
aa.
Fair value measurements:
There is a fair value hierarchy that distinguishes between assumptions based on market data obtained from independent sources (observable
inputs) and those based on an entity’s own assumptions (unobservable inputs).
bb.
Impact of recently adopted accounting standards:
In March 2020, the FASB issued ASU 2020-04 “Reference Rate Reform (Topic 848).” The guidance provides optional expedients and
exceptions for applying U.S. GAAP to contracts, hedging relationships, and other transactions affected by reference rate reform if certain
criteria are met. The guidance applies only to contracts, hedging relationships, and other transactions that reference LIBOR or another
reference rate expected to be discontinued because of reference rate reform. In January 2021, the FASB issued ASU No. 2021-01,
“Reference Rate Reform - Scope (Topic 848)” which focuses on expanding the scope of Topic 848 to include derivative instruments impacted
by discounting transition. The guidance was effective for the Company fiscal year beginning April 1, 2021, including interim periods within
that year. The adoption of ASU 2021-01 does not have a material impact on our financial position or results of operations.
In December 2019, the FASB issued ASU No. 2019-12, “Simplifying the Accounting for Income Taxes.” The guidance focuses on
simplifying accounting for income taxes by removing certain exceptions and simplifying certain requirements under Topic 740. The
guidance was effective for the Company’s fiscal year beginning April 1, 2021. The adoption of ASU 2019-12 does not have a material
impact on our financial position or results of operations.
F-24
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
In August 2018, the FASB issued ASU No. 2018-14, “Compensation – Retirement Benefits – Defined Benefit Plans – General (Subtopic 715-
20).” The guidance focuses on additional disclosure of reasons for significant gains and losses to changes in the benefit obligation for the
period, in addition to removal and clarification of existing disclosures. The guidance was effective for the Company’s fiscal year beginning
April 1, 2021, on a retrospective basis. The adoption of ASU 2018-14 does not have a material impact on our financial position or results of
operations.
Impact of recently issued accounting standards not yet adopted:
In March 2022, the FASB issued ASU 2022-01, “Derivatives and Hedging (Topic 815) - Fair Value Hedging - Portfolio Layer Method.”
ASU 2022-01 clarifies the guidance in ASC Topic 815 on fair value hedge accounting of interest rate risk for portfolios of financial assets,
and amends the guidance in ASU 2017-12, “Derivatives and Hedging (Topic 815): Targeted Improvements to Accounting for Hedging
Activities”, that, among other things, established the “last-of-layer” method for making the fair value hedge accounting for these portfolios
more accessible. ASU 2022-01 renames that method the “portfolio layer” method. The provisions of ASU No. 2022-01 are effective for
annual periods beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted. The
Company is currently evaluating the impact of this ASU on its consolidated financial statements.
In November 2021, the FASB issued ASU 2021-10, “Government Assistance (Top 832): Disclosures by Business Entities about Government
Assistance.” ASU 2021-10 is intended to increase the transparency of government assistance including the disclosure of (1) the types of
assistance, (2) an entity’s accounting for the assistance, and (3) the effect of the assistance on an entity’s financial statements. Diversity
currently exists in the recognition, measurement, presentation, and disclosure of government assistance received by business entities because
of the lack of specific authoritative guidance. Requiring disclosures about government assistance in the notes to financial statements will
provide comparable and transparent information to investors and other financial statement users to enable them to understand an entity’s
financial results and prospects for future cash flows. This standard is effective for all entities, for fiscal years beginning after December 15,
2022, including interim periods within those fiscal years. Early adoption is permitted. The Company does not expect ASU No. 2021-10 to
have a significant impact on its results of operations, financial position and cash flows and related disclosures
In October 2021, the FASB issued ASU 2021-08, “Business Combinations (Topic 805), Accounting for Contract Assets and Contract
Liabilities from Contracts with Customers.” ASU 2021-08 improves the accounting for acquired revenue contracts with customers in a
business combination by addressing diversity in practice and inconsistency related to (1) Recognition of an acquired contract liability, and (2)
Payment terms and their effect on subsequent revenue recognized by the acquirer. This amendment is effective for all entities, for fiscal
years beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted. The adoption of
ASU 2021-08 does not currently impact the Company’s financial statements. The Company is currently evaluating the impact of this ASU
on its consolidated financial statements.
In July 2021, the FASB issued ASU 2021-05, “Lease (Topic 842), Lessors - Certain Leases with Variable Lease Payments.” ASU 2021-05
amends the lease classification requirements for lessors when classifying and accounting for a lease with variable lease payments that do not
depend on a reference rate index or a rate. The update provides criteria, that if met, the lease would be classified and accounted for as an
operating lease. It is intended to increase transparency and comparability among organizations. This amendment is effective for all entities,
for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted. The
Company is currently evaluating the impact of the adoption of this ASU on the Company’s consolidated financial statements, but does not
believe the adoption of this standard will have a material impact on the Company’s consolidated financial statements.
In May 2021, the FASB issued ASU 2021-04, “Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50),
Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40).” The
ASU addresses issuer’s accounting for certain modifications or exchanges of freestanding equity-classified written call options. This
amendment is effective for all entities, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal
years. Early adoption is permitted. The Company does not intend to early adopt and does not believe adoption of this ASU will have a
material impact on its consolidated financial statements.
In August 2020, the FASB issued ASU 2020-06, “Debt – Debt with Conversion and Other Options (Subtopic 470- 20) and Derivatives and
Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own
Equity (ASU 2020-06)”, to reduce complexity in applying GAAP to certain financial instruments with characteristics of liabilities and equity.
The guidance in ASU 2020-06 simplifies the accounting for convertible debt instruments and convertible preferred stock by removing the
existing guidance in ASC 470-20, “Debt:
F-25
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
Debt with Conversion and Other Options,” that requires entities to account for beneficial conversion features and cash conversion features in
equity, separately from the host convertible debt or preferred stock. The guidance in ASC 470-20 applies to convertible instruments for
which the embedded conversion features are not required to be bifurcated from the host contract and accounted for as derivatives.
In addition, the amendments revise the scope exception from derivative accounting in ASC 815-40 for freestanding financial instruments and
embedded features that are both indexed to the issuer’s own stock and classified in stockholders’ equity, by removing certain criteria required
for equity classification. These amendments are expected to result in more freestanding financial instruments qualifying for equity
classification (and, therefore, not accounted for as derivatives), as well as fewer embedded features requiring separate accounting from the
host contract.
The amendments in ASU 2020-06 further revise the guidance in ASC 260, “Earnings Per Share,” to require entities to calculate diluted
earnings per share (EPS) for convertible instruments by using the if-converted method. In addition, entities must presume share settlement
for purposes of calculating diluted EPS when an instrument may be settled in cash or shares.
ASU 2020-06 is applicable for fiscal years beginning after December 15, 2021, with early adoption permitted no earlier than fiscal years
beginning after December 15, 2020. The Company did not early adopt and continues to evaluate the impact of the provisions of ASU 2020-
06 on its consolidated financial statements.
NOTE 3: — MARKETABLE SECURITIES
a.
Marketable securities:
Short-term marketable securities
Long-term marketable securities
March 31,
2022
2021
$
$
522,028 $
435,189
957,217 $
418,480
557,209
975,689
b.
The following is a summary of both short-term and long-term marketable securities by type:
2022
March 31,
Amortized Cost
Gross Unrealized Gain
(Loss) through Other
Comprehensive Income
Gross Unrealized
Gain (Loss)
through Profit &
Loss
Market Value
Amortized
Cost
2021
Gross Unrealized
Gain (Loss) through
Other
Comprehensive
Income
Gross
Unrealized Gain
(Loss) through
Profit & Loss
Market Value
Marketable securities:
Corporate bonds
Government securities
Commercial paper
Preferred stock - debt
instrument
Preferred stock - equity
instrument
Certificates of deposit
Municipal bonds
Other securities
Total marketable securities
$
$
743,624
106,235
22,678
2,685
11,649
46,296
26,683
12,261
972,111
$
$
(11,840 ) $
(531 )
(121 )
(235 )
—
(144 )
(276 )
(132 )
(13,279 ) $
$
—
—
—
—
(1,616 )
—
—
—
(1,616 ) $
$
731,784
105,703
22,557
679,315
146,057
47,934
$
2,449
2,990
10,034
46,152
26,408
12,129
957,217
$
10,475
42,897
23,479
17,115
970,262
$
4,823
249
4
44
—
27
82
120
5,350
$
$
—
—
—
—
77
—
—
—
77
$
$
684,138
146,306
47,938
3,033
10,553
42,924
23,562
17,235
975,689
On March 31, 2022 and 2021, the gross unrealized gain (loss) excludes $149 and $423 of other comprehensive income relating to marketable
securities for foreign exchange gain, respectively.
As of March 31, 2022, no other than temporary impairment charges were recorded.
F-26
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
c.
The estimated fair value of marketable securities as of March 31, 2022 and 2021, by contractual maturity, are as follows:
Available-for-sale marketable securities:
Matures in less than five years
Matures in more than five years
Investment at fair value through Profit & Loss
2022
2021
Amortized
Cost
Market
Value
Amortized
Cost
Market
Value
March 31,
$
$
953,150 $
7,312
960,462
11,649
972,111 $
940,212 $
6,971
947,183
10,034
957,217 $
956,797 $
2,990
959,787
10,475
970,262 $
962,103
3,033
965,136
10,553
975,689
NOTE 4: — ACCOUNTS RECEIVABLE AND OTHER
a.
Trade, net:
The following table summarizes the impact of accounts receivable reserves and allowance for doubtful accounts on the gross trade accounts
receivable balances at each balance sheet date:
Trade accounts receivable, gross
$
437,557 $
409,198
March 31,
2022
2021
Reserves for sales deductions:
Chargebacks
Other sales deductions
Customer rebates
Allowance for doubtful accounts
Trade accounts receivable, net
a.
Other receivables and prepaid expenses:
Government authorities
Prepaid expenses
Due from related parties
Advances to suppliers
Interest receivable
Other
NOTE 5: — SALES INCENTIVES
(111,308 )
(52,343 )
(10,708 )
(16,226 )
246,972 $
March 31,
2022
2021
27,752 $
13,229
14,371
991
311
3,073
59,727 $
(119,090 )
(53,058 )
(22,498 )
(1,013 )
213,539
26,112
12,891
9,835
1,134
143
3,232
53,347
$
$
$
When the Company recognizes and records revenue from the sale of its pharmaceutical products, it records an estimate in the same financial
reporting period for product returns, chargebacks, rebates, and other sales deductions, which are reflected as reductions of the related gross
revenue. The Company regularly monitors customer inventory information at its three largest wholesale customers to assess whether any
excess product inventory levels may exist. The Company reviews this information together with historical product and customer experience,
third-party prescription data, industry and regulatory changes, and other relevant information and revises its estimates as necessary.
The Company’s estimates of inventory in the distribution channel are based on inventory information reported to it by its major wholesale
customers, historical shipment, and return information from its accounting records, and third-party data on
F-27
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
prescriptions filled. The Company’s estimates are subject to inherent limitations pertaining to reliance on third-party information.
The Company considers all information available subsequent to the balance sheet date, but before the issuance of the financial statements,
that provides additional evidence with respect to conditions existing at the balance sheet date and adjusts the reserves accordingly.
Product returns:
Consistent with industry practice, the Company generally offers its customers the right to return inventory within three to six months prior to
product expiration and up to 12 months thereafter (the “return period”). Product returns are identified by their manufacturing lot number.
Because the Company manufactures in bulk, lot sizes are generally large and, therefore, shipments of a particular lot may occur over a one-
to six-month period. As a result, although the Company cannot associate a product return with the actual shipment in which such lot was
included, the Company can reasonably estimate the period (in months) over which the entire lot was shipped and sold. The Company uses
this information to estimate the average time period between lot shipment (and sale) and return for each product, which the Company refers
to as the “return lag.” The shelf life of most of the Company’s products ranges between 18-36 months. Because returns of expired products
are heavily concentrated during the return period, and given the Company’s historical data, it is able to reasonably estimate return lags for
each of its products. These return lags are periodically reviewed and updated, as necessary, to reflect the Company’s best knowledge of facts
and circumstances. Using sales and return data (including return lags), the Company determines a return rate to estimate its returns reserve.
The Company supplements this calculation with additional information including customer and product specific channel inventory levels,
competitive developments, external market factors, the Company’s planned introductions of similar new products, and other qualitative
factors in evaluating the reasonableness of the returns reserve. The Company continuously monitors factors that could affect its estimates
and revises the reserves as necessary. The Company’s estimates of expected future returns are subject to change based on unforeseen events
and uncertainties.
The Company monitors the levels of inventory in its distribution channels to assess the adequacy of the product returns reserve and to
identify potential excess inventory on hand that could have an impact on its revenue recognition. The Company does not ship products to its
wholesalers when it appears they have an excess of inventory on hand, based on demand and other relevant factors, for that particular
product.
Chargebacks:
The Company has arrangements with certain customers that allow them to buy its products directly from its wholesalers at specific prices.
Typically, these price arrangements are lower than the wholesalers’ acquisition costs or invoice prices. In exchange for servicing these third-
party contracts, the Company’s wholesalers can submit a “chargeback” claim to the Company for the difference between the price sold to the
third party and the price at which they purchased the product from us. The Company generally pays chargebacks on generic products,
whereas branded proprietary products are typically not eligible for chargeback claims. The Company considers many factors in establishing
its chargeback reserves including inventory information from its largest wholesale customers and the completeness of their reports, estimates
of Taro inventory held by smaller wholesalers and distributors, processing time lags, contract and non-contract sales trends, average historical
contract pricing, actual price changes, actual chargeback claims received from the wholesalers, Taro sales to the wholesalers, and other
relevant factors. The Company’s chargeback provision and related reserve varies with changes in product mix, changes in pricing, and
changes in estimated wholesaler inventory. The Company reviews the methodology utilized in estimating the reserve for chargebacks in
connection with analyzing its product returns reserve each quarter and makes revisions as considered necessary to reasonably estimate its
potential future obligation.
Rebates and other deductions:
The Company offers its customers various rebates and other deductions based primarily on their volume of purchases of its products. Chain
wholesaler rebates are rebates that certain chain customers claim for the difference in price between what the chain customer paid a
wholesaler for a product purchase and what the chain customer would have paid if such customer had purchased the same product directly
from the Company. Cash discounts, which are offered to the Company’s customers, are generally 2% of the gross sales price, and provide
the Company’s customers an incentive for paying within a specified time period after receipt of invoice. Medicaid rebates are earned by
states based on the amount of the Company’s products
F-28
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
dispensed under the Medicaid plan. Billbacks are special promotions or discounts provided over a specific time period to a defined customer
base and for a defined product group. Distribution allowances are a fixed percentage of gross purchases for inventory shipped to a national
distribution facility that the Company pays to its top wholesalers on a monthly basis. Administration fees are paid to certain wholesalers,
buying groups, and other customers for stocking the Company’s products and managing contracts and servicing other customers. Shelf-stock
adjustments, which are customary in the generic pharmaceutical industry, are based on customers’ existing levels of inventory and the
decrease in the market price of the related product. When market prices for the Company’s products decline, the Company may, depending
on its contractual arrangements, elect to provide shelf-stock adjustments and thereby allow its customers with existing inventories to compete
at the lower product price. The Company uses these shelf-stock adjustments to support its market position and to promote customer loyalty.
The Company establishes reserves for rebates and other various sales deductions based on contractual terms and customer purchasing
activity, tracking and analysis of rebate programs, processing time lags, the level of inventory in the distribution channel and other relevant
information. Based on the Company’s historical experience, substantially all claims for rebates and other sales deductions are received
within 24 months.
As discussed above, the Company believes it has the experience and information necessary to reasonably estimate the amounts of reserves
for its sales incentives programs. Several of the assumptions used by the Company for certain estimates are based on information received
from third parties, such as wholesale customer inventory levels, market data, and other factors beyond the Company’s control. The most
critical estimates in determining these reserves, and the ones therefore that would have the largest impact if these estimates were not accurate,
are related to contract sales volumes, average contract price, customer inventories, and return volumes. The Company regularly reviews the
information related to these estimates and adjusts its reserves accordingly, if and when actual experience differs from previous estimates.
Use of estimates in reserves:
The Company believes that its reserves, allowances, and accruals for items that are deducted from gross revenue are reasonable and
appropriate based on current facts and circumstances. Changes in actual experience or changes in other qualitative factors could cause the
Company’s allowances and accruals to fluctuate, particularly with newly launched or acquired products. The Company regularly reviews the
rates and amounts in its reserve estimates. If future estimated rates and amounts are significantly greater than those reflected in the
Company’s recorded reserves, the resulting adjustments to those reserves would decrease the Company’s reported net revenue; conversely, if
actual product returns, rebates, and chargebacks are significantly less than those reflected in the Company’s recorded reserves, the resulting
adjustments to those reserves would increase the Company’s reported net revenue. If the Company were to change its assumptions and
estimates, its reserves would change, impacting the net revenue that the Company reports. The Company regularly reviews the information
related to these estimates and adjusts its reserves accordingly, if and when actual experience differs from previous estimates.
The following tables summarize the activities for sales deductions and product returns for the years ended March 31, 2022, 2021, and 2020:
Accounts Receivable Reserves
Chargebacks
Rebates and Other
Total
Current Liabilities
Returns
Other (2)
Total
For the year ended March 31, 2022
Beginning
balance
Acquired
Provision recorded
for current period
sales (1)
Credits
processed /
Payments
Ending
balance
$
$
$
$
(119,090 )
(76,569 )
(195,659 )
(52,236 )
(18,560 )
(70,796 )
$
$
$
$
— $
(5,165 )
(5,165 ) $
(493 ) $
(354 )
(847 ) $
(1,182,744 ) $
(165,174 )
(1,347,918 ) $
1,190,526 $
167,692
1,358,218 $
(52,282 ) $
(52,279 )
(104,561 ) $
48,978 $
50,474
99,452 $
(111,308 )
(79,216 )
(190,524 )
(56,033 )
(20,719 )
(76,752 )
F-29
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
Accounts Receivable Reserves
Chargebacks
Rebates and Other
Total
Current Liabilities
Returns
Other (2)
Total
Accounts Receivable Reserves
Chargebacks
Rebates and Other
Total
Current Liabilities
Returns
Other (2)
Total
For the year ended March 31, 2021
Beginning
balance
Acquired
Provision recorded
for current period
sales (1)
Credits
processed /
Payments
Ending
balance
(104,552 )
(70,630 )
(175,182 )
(61,406 )
(41,562 )
(102,968 )
$
$
$
$
— $
—
— $
— $
—
— $
(1,173,810 ) $
(180,079 )
(1,353,889 ) $
1,159,272 $
174,140
1,333,412 $
(37,011 ) $
(26,036 )
(63,047 ) $
46,181 $
49,038
95,219 $
(119,090 )
(76,569 )
(195,659 )
(52,236 )
(18,560 )
(70,796 )
For the year ended March 31, 2020
Beginning
balance
Acquired
Provision recorded
for current period
sales (1)
Credits
processed /
Payments
Ending
balance
(109,763 )
(113,657 )
(223,420 )
$
$
(63,818 )
(33,497 )
(97,315 )
$
$
— $
—
— $
— $
—
— $
(1,104,946 ) $
(305,098 )
(1,410,044 ) $
1,110,157 $
348,125
1,458,282 $
(37,258 ) $
(77,537 )
(114,795 ) $
39,670 $
69,472
109,142 $
(104,552 )
(70,630 )
(175,182 )
(61,406 )
(41,562 )
(102,968 )
$
$
$
$
$
$
$
$
(1)
(2)
Includes immaterial amounts of reversals of provisions recorded for prior years’ sales.
Includes Medicaid, indirect rebates, and amounts due to customers.
NOTE 6: — INVENTORIES
Finished goods
Raw and packaging materials
Work in progress
Other
March 31,
2022
2021
$
$
105,873 $
62,466
36,367
5,733
210,439 $
85,956
60,299
28,185
5,852
180,292
As of March 31, 2022 and 2021, reserves recorded against inventories for slow-moving, short-dated, excess, and obsolete inventory totaled
$49,889 and $32,423, respectively.
As of March 31, 2022 and 2021, there were no pledges of inventory.
F-30
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
NOTE 7: — PROPERTY, PLANT AND EQUIPMENT
a.
Composition of assets grouped by major classifications are as follows:
TARO PHARMACEUTICAL INDUSTRIES LTD.
Cost:
Land
Buildings
Leasehold improvements
Machinery and equipment
Computer software and equipment
Motor vehicles
Furniture, fixtures and office equipment
Accumulated depreciation and impairment charges:
Buildings
Leasehold improvements
Machinery and equipment
Computer software and equipment
Motor vehicles
Furniture, fixtures and office equipment
Depreciated cost
$
$
March 31,
2022
2021
$
7,628 $
192,922
5,211
225,626
64,164
80
15,051
510,682
92,378 $
3,171
163,266
40,474
80
11,621
310,990
199,692
$
7,628
190,617
3,552
219,210
46,087
80
15,542
482,716
85,139
2,084
153,628
25,445
80
10,832
277,208
205,508
b.
c.
d.
e.
Depreciation expenses were $24,077, $21,849, and $19,161 for the years ended March 31, 2022, 2021, and 2020, respectively.
Cost of property, plant, and equipment includes capitalized interest expense, capitalized direct incremental costs (such as payroll and related
expenses), and other internal costs incurred in order to bring the assets to their intended use in the amount of $15,333 as of March 31, 2022
and 2021. There were no additional capitalized interest and other costs as of March 31, 2022 and 2021.
Cost of computer equipment includes capitalized development costs of computer software developed for internal use in the amount of
$20,298 and $17,332 as of March 31, 2022 and 2021, respectively.
Asset disposals were $906 and $124 for the years ended March 31, 2022 and 2021, respectively, mainly relating to the write-off of fully
depreciated computer equipment, software, and production equipment.
NOTE 8: — INTANGIBLE ASSETS AND DEFERRED COSTS
a.
Composition:
Cost:
Product and distribution rights
Accumulated amortization:
Product and distribution rights
March 31,
2022
2021
$
$
127,766 $
127,766
80,432
80,432
47,334
$
85,359
85,359
78,593
78,593
6,766
F-31
TARO PHARMACEUTICAL INDUSTRIES LTD.
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
b.
c.
d.
e.
Amortization expenses related to product and distribution rights were $1,839, $1,831, and $2,222 for the years ended March 31, 2022, 2021
and 2020, respectively.
As of March 31, 2022, the estimated amortization expense of product and distribution rights for 2023 to 2027 is as follows: 2023—$7,016;
2024—$5,627; 2025—$5,629; 2026—$5,628; 2027—$5,620.
The weighted-average amortization period for product rights is approximately 8 years.
During the years ended March 31, 2022 and 2021, the Company did not record any impairment charge related to intangible assets.
NOTE 9: — OTHER ASSETS
Prepayment of land leased from ILA (1)
Right-of-use (ROU) assets (2)
Intangible assets and deferred costs, net (3)
Severance pay fund (4)
Other
March 31,
2022
2021
$
$
12,790 $
5,422
47,334
1,190
157
66,893 $
13,020
2,729
6,766
1,211
397
24,123
(1)
(2)
(3)
(4)
The ILA lease agreements are standard agreements covering substantial portions of the land of Israel. The standard agreements call for a lease
period of 49 years, with an option for one additional lease period (i.e., total of 98 years). A majority of the Company’s leases are in the beginning of
the second 49 year period, and the remaining leases still in the first 49 year period have the option for the one additional lease period. This amount
was prepaid. See Note 2.j.
As of April 1, 2019, the Company commenced lease accounting in accordance with ASU 2016-02, “Leases (Topic 842).” The Company currently
has leased offices, warehouse space, and equipment under operating leases for periods through 2026. See Note 13.
See Note 8.
Under Israeli law, the Company is required to make severance or pension payments to dismissed employees and to employees terminating
employment under certain other circumstances. Deposits are made with a pension fund or other insurance plans to secure pension and severance
rights for the employees in Israel. These amounts represent the balance of the deposits in those funds (including profits) that will be used to cover
the Company’s severance obligations. See Note 12.b.
Taro U.S.A. maintains defined contribution retirement savings plans covering substantially all of their employees. Taro Canada maintains a
Registered Retirement Savings Plan (“RRSP”). Under the plans, contributions are based on specific percentages of pay and are subject to
statutory limits. The Company’s matching contribution to the plans was $1,273, $1,369, and $1,133 for the years ended March 31, 2022,
2021, and 2020, respectively.
Pension, retirement savings and severance expenses
$
6,732 $
8,064 $
6,654
Years ended March 31,
2021
2020
2022
NOTE 10: — DERIVATIVE INSTRUMENTS AND FINANCIAL RISK MANAGEMENT
The Company’s operations are exposed to market risks from changes in interest rates and currency exchange rates. Exposure to these risks is
managed through normal operating and financing activities and, when appropriate, through derivative instruments.
Currency exchange rates:
The Company manages its exposure to debt obligations denominated in currencies other than its functional currency by opportunistically
using cross-currency hedges to convert its foreign currency payments into its functional currency.
F-32
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
The following table sets forth the annual rate of inflation, the devaluation (appreciation) rate of the New Israeli Shekel (“NIS”) and the CAD
against the USD and the exchange rates between the USD and each of the NIS and the CAD at the end of the year indicated:
Rate of Inflation
Rate of Devaluation
(Appreciation)
Against USD
Rate of Exchange of
USD
Period ended
3/31/2022
3/31/2021
Israel (1)
3.48%
0.20%
Canada (2)
6.66%
2.20%
Israel (1)
(4.50%)
(6.72%)
Canada (2)
(0.79%)
(10.64%)
Israel (1)
Canada (2)
3.18
3.33
1.25
1.26
(1)
(2)
Per Bank of Israel.
Per J.P. Morgan Chase.
The Company enters into separate forward contracts to purchase the NIS and the CAD on a monthly basis at agreed upon spot rates to hedge
the variability of cash flows in USD due to changes in the respective exchange rates. On March 31, 2022, the forward contracts to purchase
the NIS are for a total amount of $55,250, at a weighted-average forward rate of 3.17 NIS per USD, which are settled in seventeen (17)
monthly settlements of $3,750 for ten (10) months, $3,250 for one (1) months, and $2,500 for five (5) months. The Company recorded a net
gain of $93, $190, and $178 for the years ended March 31, 2022, 2021, and 2020, respectively, for the contracts to purchase the NIS.
The forward contracts to purchase the CAD are for a total amount of $20,842, at a weighted-average forward rate of CAD 1.25 per USD,
which are settled in ten (10) monthly installments of approximately $2,105 for ten (10) months. The Company recorded a net gain (loss) of
$0, $267, and ($629), for the years ended March 31, 2022, 2021, and 2020, respectively, for the contracts to purchase the CAD.
There is no collateral for these hedges.
On March 31, 2022, the Company had derivative instruments designated as hedging instruments, which have been accounted for in
accordance with ASU No. 2017-12, “Derivatives and Hedging (Topic 815).”
NOTE 11: — FAIR VALUE MEASUREMENTS
FASB ASC Topic 820 defines fair value as the price that would be received for an asset or paid to transfer a liability, from a selling party’s
perspective, in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on
the measurement date. ASC Topic 820 requires that assets and liabilities carried at fair value be classified and disclosed in one of the
following three categories:
Level 1: Quoted market prices in active markets for identical assets and liabilities. Active market means a market in which transactions for
assets or liabilities occur with “sufficient frequency” and volume to provide pricing information on an ongoing unadjusted basis.
Level 2: Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; or other inputs that are observable
or can be corroborated by observable market data for substantially the full term of the assets or liabilities. The Company’s Level 2 assets
primarily include derivative instruments. The Level 2 asset values are determined using valuation techniques that maximize the use of
observable inputs and minimize the use of unobservable inputs to the extent possible and consider counterparty credit risk in the assessment
of fair value.
Level 3: Significant unobservable inputs that are not corroborated by market data. The Company has no Level 3 assets or liabilities.
F-33
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
The fair value of the Company’s financial assets measured at fair value on a recurring basis as of March 31, 2022 and 2021 were as follows:
March 31, 2022
March 31, 2021
Quoted
Market Prices of
Identical Assets
(Level 1)
Significant Other
Observable Inputs
(Level 2)
Quoted
Market Prices of
Identical Assets
(Level 1)
Significant Other
Observable Inputs
(Level 2)
Assets
Short-term marketable securities *
Long-term marketable securities *
Long-term debt instruments *
Long-term equity instruments *
Forward contracts
Liabilities
Forward contracts
$
$
$
522,028 $
422,706
2,449
10,034
—
957,217 $
— $
—
—
—
808
808 $
418,480 $
543,623
3,033
10,553
—
975,689 $
—
$
(281 )
$
—
$
—
—
—
—
680
680
(591 )
*Refer to Note 3 for additional details on marketable securities.
NOTE 12: — OTHER LIABILITIES
a.
Other current liabilities:
Settlements and loss contingencies (1)
Returns reserve
Accrued expenses
Employees and payroll accruals
Accrued income taxes
Medicaid and indirect rebates
Deferred revenue
Marketable securities
Lease liability
Royalties
Suppliers of property, plant and equipment
Due to customers
Legal and audit fees
Derivative instruments
Other
(1)
See Note 13.
March 31,
2022
2021
202,036 $
56,033
25,181
23,863
19,695
19,347
5,788
3,869
2,204
1,819
1,452
1,372
1,045
281
(99 )
363,886
$
457,674
52,236
20,557
20,179
18,114
16,796
7,583
10,266
1,689
2,911
2,951
1,764
1,197
299
919
615,135
$
$
F-34
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
b.
Other long-term liabilities:
TARO PHARMACEUTICAL INDUSTRIES LTD.
Deferred credits
Long-term incentive plan
Accrued severance pay
Deferred revenue
Other
March 31,
2022
2021
$
$
22,643 $
3,786
1,319
919
4,132
32,799 $
29,227
—
1,315
1,095
1,571
33,208
NOTE 13: — COMMITMENTS AND CONTINGENT LIABILITIES
a.
Companies of the Group have leased offices, warehouse space, and equipment under operating leases for periods through 2026. The
minimum annual rental payments, under non-cancelable lease agreements, are as follows:
3/31/2023
3/31/2024
3/31/2025
3/31/2026
$
$
March 31, 2022
2,238
1,578
1,289
1,057
6,162
Total rent expenses were $1,684, $1,951, and $1,875 for the years ended March 31, 2022, 2021, and 2020, respectively.
Effective April 1, 2019, the Company adopted ASU 2016-02, using the modified retrospective method. The adoption of ASU 2016-02 does
not have a material impact on our financial position or results of operations.
b.
Royalty commitments:
The Company is committed to pay royalties at the rate of 3.0% to 3.5% to the government of Israel through the IIA on proceeds from the sale
of products in which the government participates in the research and development by way of grants. The obligation to pay these royalties is
contingent on actual sales of the products and, in the absence of such sales, no payment is required. The commitment is on a product by
product basis, in an amount not exceeding the total of the grants received by the Company, including interest accrued thereon, and is linked to
the USD. Grants are subject to interest at a rate of LIBOR (cost of borrowing funds in USD). As of March 31, 2022 and 2021, the aggregate
contingent liability to the IIA was $14,072 and $13,805, respectively.
Royalty payments to the IIA were $0, $0, and $0 for the years ended March 31, 2022, 2021, and 2020, respectively.
c.
Legal proceedings:
From time to time, we are a party to routine litigation incidental to our business, including patent litigation resulting from our use of the
patent challenge procedures set forth in the Hatch Waxman Act, product liability litigations, and employment litigations, none of which,
individually or in the aggregate, are expected to have a material effect on our financial position or profitability. Other litigation, as disclosed
herein, may have a material adverse effect on our financial position or profitability. The Company records a provision in its financial
statements to the extent that it concludes that a contingent liability is probable, and the amount thereof is estimable. Because litigation
outcomes and contingencies are unpredictable, and because excessive verdicts can occur, these assessments involve complex judgments
about future events and can rely heavily on estimates and assumptions.
1.Legal actions commenced by the Company:
The Company has completed its tax assessments with the Israeli tax authorities for years through March 31, 2016. On March 28,
2022, the ITA issued a tax assessment with respect to March 31, 2017, and the total tax liability arising from the assessment as of the
date of its issuance amounts to NIS 38.5 million ($12.3 million), including interest and linkage to the Israeli Customer Price Index.
The Company filed its tax objection to the ITA on May 26, 2022. The
F-35
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
ITA has one year, until May 25, 2023 to ask additional questions and either affirm, modify or withdraw their assessment. With respect
to the years ending March 31, 2018 and through March 31, 2020, the Company is under examination by the ITA. The Company may
be also subject to examination by the Israeli tax authorities for the years ending March 31, 2021 and onward. The Company believes
that its tax provision is adequate to satisfy any assessments resulting from examination of these years.
2.Generic drug industry pricing investigations and related litigation:
Taro U.S.A. reached a global resolution with the DOJ Antitrust Division and Civil Division in connection with DOJ’s multi-year
investigation into the U.S. generic pharmaceutical industry. Under a Deferred Prosecution Agreement (the “Agreement”) entered into
with the Antitrust Division on July 23, 2020, the DOJ filed an information relating to conduct allegedly occurring between 2013 and
2015. If Taro U.S.A. adheres to the terms of the Agreement, including paying a penalty of $205.7 million, the DOJ will dismiss the
information after three years. Taro U.S.A. has paid this amount in full to the Antitrust Division. Taro U.S.A. also reached an
agreement with the DOJ Civil Division on September 30, 2021, pursuant to which Taro U.S.A. voluntarily entered into a five-year
corporate integrity agreement with the U.S. Department of Health and Human Services’ Office of Inspector General, and agreed to pay
$213.3 million to resolve all claims related to federal healthcare programs. Taro U.S.A. has paid this amount in full to the Civil
Division.
The Company, its subsidiaries and, with respect to a complaint brought by U.S. State Attorneys General (“AG”) and a complaint
brought by putative classes of indirect reseller plaintiffs (“IRPs”), a former member of Taro U.S.A.’s commercial team have been
named as defendants in numerous putative class action lawsuits and additional lawsuits brought by and/or on behalf of purchasers and
payors of several generic pharmaceutical products in the U.S. and Canada. The lawsuits allege that the Company, its subsidiaries, and
the concerned individual in the AG and IRP complaints, have conspired with competitors to fix prices, rig bids, or allocate customers
with respect to certain products, and also allege an industry-wide conspiracy as to nearly all generic pharmaceutical products. Each of
the cases that were filed in U.S. federal court has been transferred to the U.S. District Court for the Eastern District of Pennsylvania for
coordinated proceedings under the caption In re: Generic Drug Pricing Antitrust Litigation, MDL No. 2724. The Court had sequenced
the lawsuits into separate groups for purposes of briefing motions to dismiss. Defendants filed motions to dismiss complaints in the
first group. On October 16, 2018, the Court denied the motions with respect to the federal law claims. On February 15, 2019, the
Court granted in part and denied in part the motions with respect to the state law claims. Certain cases are proceeding in discovery.
The Court designated certain complaints naming Taro U.S.A. as “bellwether” cases to begin the sequencing of proceedings, and in
December 2021, the Court issued an order setting certain bellwether schedules across 2022 and 2023, including related to discovery
and motions practice. On November 4, 2021, a settlement was reached with the putative Direct Purchaser Plaintiff class (“DPPs”), a
putative class generally comprised of wholesalers and distributors that purchased generic drug products from manufacturers, subject to
final Court approval, pursuant to which Taro U.S.A. will pay a maximum of $67.6 million, subject to a reduction of up to $8 million
depending on the volume of certain class members that may opt-out of the settlement.
Further, the Company has made a provision of $200 million (which includes the $67.6 million settlement amount) for ongoing multi-
jurisdiction civil antitrust matters. An amount of $140 million was accounted for in the year ended March 31, 2021; and an additional
provision of $60 million was recognized in the quarter ended June 30, 2021; however, the ultimate outcome of these matters cannot be
predicted with certainty.
The Company and two of its former officers are named as defendants in a putative shareholder class action entitled Speakes v. Taro
Pharmaceutical Industries, Ltd., filed October 25, 2016, which is now pending in the U.S. District Court for the Southern District of
New York and asserts claims under Section 10(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) against all defendants
and Section 20(a) of the Exchange Act against the individual defendants. It generally alleges that the defendants made material
misstatements and omissions in connection with an alleged conspiracy to fix drug prices. On September 24, 2018, the Court granted in
part and denied in part the Company’s motion to dismiss. The case is proceeding with limited discovery.
On June 22, 2020, a motion seeking documents before filing a shareholder derivative action was filed by a single shareholder against
the Company and Taro U.S.A. in the Haifa District Court related to alleged U.S. antitrust violations. On September 22, 2020, a
subsequent motion seeking documents was filed by a single shareholder against the Company related to alleged misreporting to U.S.
Medicaid and three prior state settlements. Both motions were
F-36
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
consolidated on February 16, 2021, and remain pending before the Haifa District Court. The Company has filed a motion to stay
proceedings pending resolution of the related U.S. litigation.
3.Other matters:
In June 2020, the Company was named as a defendant in a putative opioids-related class action pending in Israel, in which the
claimant alleges that the Company did not provide sufficient disclosure regarding the risks associated with opioid use in alleged
violation of the Israeli Consumer Protection Act. The Company filed its defense to the application for class action approval on May 2,
2021, and a preliminary hearing to address the issue may be scheduled for late 2022.
In June 2020, the Company and Taro U.S.A. were named as defendants in a complaint filed in the Zantac/Ranitidine Multi-District
Litigation (“MDL”) consolidated in the U.S. District Court for the Southern District of Florida. The lawsuits name over 100
defendants, including brand manufacturers, generic manufacturers, repackagers, distributors, and retailers, involving allegations of
injury caused by nitrosamine impurities. On September 4, 2020, and October 3, 2020, the MDL Court dismissed the Company and
Taro U.S.A., respectively, from the master complaints without prejudice. Despite having been voluntarily dismissed from the master
complaints, the Company and Taro U.S.A. were named in approximately 20 short form complaints filed by plaintiffs represented by
attorneys unaffiliated with MDL leadership counsel. On July 8, 2021, the MDL court granted the generic Defendants’ motion to
dismiss, the effect of which was to dismiss the Company and Taro U.S.A. with prejudice. That decision, which involves the issue of
federal preemption, is up on appeal. Neither the Company nor Taro U.S.A. have been named as defendants in any of the pending state
court cases involving ranitidine/Zantac of which we are aware.
In July 2019, the Company received a motion to approve a class action against 30 companies located in Haifa Bay, Israel, including
the Company. The claimant, a civil association in Haifa Bay, claims that the industrial activity of the 30 companies allegedly caused
higher percentages of lung cancer among Haifa Bay residents compared to the average in Israel. At this stage, the claimant seeks to
receive district court approval for the motion to approve a class action. The 30 companies, including the Company, filed their defense
to the class action on January 9, 2022.
d.
Other:
Payments to pharmacies for Medicaid-covered outpatient prescription drugs are set by the states. For many multiple source drugs for which
FDA has rated at least three drugs as therapeutically equivalent, the amount that states may reimburse pharmacies in the aggregate is subject
to a Federal upper limit (FUL) ceiling price. The Affordable Care Act enacted in March 2010 changed the methodology by which the
Centers for Medicare & Medicaid Services (CMS) calculates the FULs so that the FUL is based on no less than 175% of the weighted-
average of the monthly average manufacturer prices (AMPs) reported to the government by manufacturers of each of the therapeutically-
equivalent multiple source drugs. In addition, under the Medicaid Drug Rebate Program, manufacturers are required, as a condition of
Federal payment for their drugs under Medicaid, to pay rebates to state Medicaid programs on drugs dispensed to Medicaid beneficiaries in
the state. The amount of the basic rebate is calculated for non-innovator multiple source drugs as 13% of AMP, and for innovator drugs as
the greater of 23.1% of AMP or AMP minus the best price of the drug. Both innovator and non-innovator drugs are also subject to an
additional rebate if AMP raises faster than inflation when compared to a base period AMP.
Before implementation of the new FUL methodology on April 1, 2016, CMS used average wholesale price (“AWP”) or Wholesale
Acquisition Cost (“WAC”) in the calculation of FULs. States have also historically used AWP or WAC in setting Medicaid reimbursement
rates for drugs. Under the Affordable Care Act, States were required to shift from an estimated acquisition cost-based methodology to an
actual acquisition cost-based methodology for reimbursing pharmacies for drugs dispensed to Medicaid beneficiaries. Most states’ actual
acquisition-cost based reimbursement formulas are survey based with many states utilizing the CMS-contractor produced National Average
Drug Acquisition Cost (“NADAC”) survey data. Many of the legislative changes to the Medicaid Drug Rebate Program and Medicaid
reimbursement formulas under the Affordable Care Act stemmed from civil lawsuits brought by states against pharmaceutical manufacturers
in which there were allegations that the defendants overstated AWPs or WACs, which were used by state agencies to calculate drug
reimbursements to healthcare providers.
The Collective Bargaining Agreement dated April 6, 2011, as amended and extended by the collective bargaining dated January 5, 2017 and
July 2, 2020, among Taro Israel, the Histadrut Trade Union and Taro Israel’s Employees Committee (the “Collective Bargaining Agreement”)
is valid until December 31, 2023, and automatically renews for one-year periods unless notice is provided by a party three months prior to the
end of a term. The Collective Bargaining Agreement
F-37
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
memorializes current employee-employer relations practices of Taro as well as additional rights relating to job security, compensation and
other benefits.
NOTE 14: — SHAREHOLDERS’ EQUITY
a.
Pertinent rights and privileges of ordinary shares:
1.
2.
3.
100% of the rights to profits are allocated to the ordinary shares.
100% of the dissolution rights are allocated to the ordinary shares.
Two-thirds of the voting power of all of the Company’s shares is allocated to the ordinary shares.
b.
c.
Founders’ shares:
One-third of the voting power of all of the Company’s shares is allocated to the founders’ shares.
Stock option plans:
The Company’s 1999 Stock Incentive Plan (“1999 plan”) provided for the issuance of incentive stock options, non-qualified stock options, or
stock appreciation rights to key employees and associates of the Group.
As of March 31, 2022, 2021, and 2020, no options were outstanding, and no further options are available for future grants.
d.
Net (loss) income per share:
Year ended March 31, 2022
Year ended March 31, 2021
Year ended March 31, 2020
Net (loss)
attributable to
Taro
(numerator)
Shares
(denominator)
Per
Share
Amount
Net income
attributable to
Taro
(numerator)
Shares
(denominator)
Per
Share
Amount
Net income
attributable to
Taro
(numerator)
Shares
(denominator)
Per
Share
Amount
Basic and diluted
EPS
$
58,266
37,641,087
$
1.55
$
(386,653 )
38,209,726
$
(10.12 ) $
244,241
38,460,056
$
6.35
e.
As of March 31, 2022, the accumulated other comprehensive (loss) comprised of unrealized (loss) from hedge accounting of ($157,220) and
unrealized (loss) from available for sale securities of ($11,745). As of March 31, 2021, the accumulated other comprehensive (loss)
comprised of unrealized (loss) from hedge accounting of ($156,905), and unrealized gain from available for sale securities of $5,284.
Unrealized gains (losses) on marketable securities reclassified out of accumulated other comprehensive (loss) to financial income (expense)
on the income statement were $565, $2,421, and $420 during the years ended March 31, 2022, 2021, and 2020, respectively.
NOTE 15: — INCOME TAXES
a.
Corporate income tax rate in Israel:
Taxable income of Israeli companies is subject to corporate income tax at the rate of 23.0% for the years ended March 31, 2022, 2021, and
2020.
b.
Tax benefits under the Law for the Encouragement of Industry (Taxes), 1969:
The Company is an “industrial company” as defined by this law and, as such, is entitled to certain income tax benefits, mainly increased
depreciation rates in respect of machinery and equipment (as prescribed by regulations published under the Inflationary Adjustments Law)
and the right to claim public issuance expenses, amortization of acquired patents and other intangible property rights as deductions for tax
purposes.
c.
Tax benefits under the Law for the Encouragement of Capital Investments, 1959 (the “Investments Law”):
Various production and development facilities of the Company have been granted “Approved Enterprise” and “Benefited Enterprise” status,
which provided certain benefits, including tax exemptions and reduced tax rates for a defined period. The benefits available to an Approved
Enterprise and Benefited Enterprise relate only to taxable income attributable to the specific investment program and are conditioned upon
terms stipulated in the Investments Law and the related regulations and the criteria set forth in the applicable certificate of approval (for an
Approved Enterprise). If the Company does not fulfill these conditions, in whole or in part, the benefits can be canceled and the Company
may be required to pay additional tax to refund the benefits, in an amount linked to the Israeli consumer price index plus interest and
potential penalties.
F-38
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
The Company qualified as a foreign investors’ company, or FIC. FICs are entitled to further reductions in the tax rate normally applicable to
Approved or Benefited Enterprises, depending on the level of foreign ownership. The tax rate ranges between 10% (when foreign ownership
is 90% or more) to 25% (when the foreign ownership is below 49%).
In the years ended March 31, 2020 and 2019, the Company had two active plans, one Approved Enterprise under the Alternative Benefits
Program (Plan 5) and one Benefited Enterprise (Plan 6), granting us a package of benefits, subject to compliance with applicable
requirements. Under Plan 5 (benefit period starting 2007), the Company was entitled to an exemption from corporate income tax on
undistributed profits for a period of two years following implementation of such plan and to a reduced tax rate of 10% to 25% (depending on
the level of foreign investment) for eight additional years thereafter. With respect to Plan 5, given the high level of investments in such plan,
we met the conditions to qualify as a “High Level Foreign Investment Company” which entitled Plan 5 to an additional five years of benefits,
subject to receipt of approval from the Israeli Investment Center (“IIC,” now called the “Authority for Investments and Development of the
Economy and Industry”). On November 5, 2019, we received the approval from the IIC regarding the five-year extension of Plan 5, subject
to meeting certain pre-agreed additional conditions that will be examine by the IIC at the end of the extension period. Under Plan 6 (benefit
period starting 2010), the Company was entitled to an exemption from corporate income tax on undistributed profits for a period of two years
and a reduced tax rate of 10% to 25% (depending on the level of foreign investment) for eight additional years thereafter.
The entitlement to these benefits was conditional upon the Company fulfilling the requirements of the Investments Law, regulations
published thereunder and the certificate of approval for the specific investments in the case of Approved Enterprises. In the event of failure
to comply with these requirements, the benefits may be reduced or canceled and the Company may be required to refund the amount of the
benefits it received, in whole or in part, including linkage and interest. As of March 31, 2022, Management believes that the Company
complied with all of the aforementioned requirements.
The “Approved Enterprise” and “Benefited Enterprise” statuses were applicable to our production and development facilities through the
year ending on March 31, 2020, as the Company made an irrevocable election to forego previously granted benefits and apply the tax
benefits under the 2011 Amendment and/or the 2017 Amendment.
Following the Budget Bill, if the Company pays a dividend (deemed or actual), Clawback Tax shall be applicable to the pro-rata portion of
the dividend, which is attributed to the tax-exempt profits, on the gross amount of such dividend.
The Company has decided not to declare dividends out of such tax-exempt income. Accordingly, no deferred income taxes have been
provided on income attributable to the Company’s Approved and/or Benefited Enterprises.
Dividends paid by a company, the source of which is income derived from the Approved Enterprise accrued during the benefits period, are
generally subject to withholding tax at a rate of 15% (which is withheld and paid by or on behalf of the company paying the dividend), and
such withholding tax may be reduced by an applicable treaty if such dividends were paid during the benefits period or at any time up to 12
years thereafter. The 12-year limitation does not apply to a FIC.
For the years ended March 31, 2022 and 2021, income not eligible for Approved/Benefited/Special Preferred Technological Enterprise
benefits is taxed at the regular corporate income tax rate.
d.
The New Incentives Regime—Amendment 68 to the Investment Law
Under Amendment 68 to the Investment Law (“Amendment 68”), upon an irrevocable election made by a company, a uniform corporate tax
rate will apply to all qualifying industrial income of such company (an “Industrial Company”), as opposed to the previous law’s incentives,
which were limited to income from Approved/Benefited Enterprises during the benefits period. Under the law, when the election is made,
the uniform tax rate for 2014 and onwards will be 9% in areas in Israel designated as Development Zone A (decreased to 7.5% as of January
1, 2017) and 16% elsewhere in Israel. The decrease of the uniform tax rate to 7.5% was effective for the reporting periods starting April 1,
2017. The profits of these Industrial Companies will be freely distributable as dividends, subject to withholding tax of 20% or lower, under
an applicable tax treaty and a certificate from the ITA allowing for such withholding taxes. Certain “Special Preferred Enterprise” that meet
more stringent criteria (significant investment, R&D or employment thresholds), and will enjoy further reduced tax rates of 5% in Zone A
and 8% elsewhere. In order to be classified as a “Special Preferred Enterprise,” the approval of three governmental authorities in Israel is
required.
On August 24, 2020, the Company submitted to the ITA an announcement declaring its irrevocable choice to forego the benefits granted to it
prior to the 2011 Amendment, and the application of the tax benefits under the 2011 Amendment and/or the 2017 Amendment, starting with
the fiscal year ending March 31, 2020.
F-39
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
e.
The New Technological Enterprise Incentives Regime – 2017 Amendment to the Investment Law
TARO PHARMACEUTICAL INDUSTRIES LTD.
Amendment 73 to the Investment Law (the "2017 Amendment”), was enacted as part of the Economic Efficiency Law that was published on
December 29, 2016, and is effective as of January 1, 2017. The 2017 Amendment is based on the OECD guidelines published as part of the
Base Erosion and Profit Shifting (BEPS) project and introduced the incentive regimes of “Preferred Technological Enterprise” and of
"Special Preferred Technological Enterprise", as described below. These new regimes are in addition to the other existing post Amendment
68 tax incentives regimes under the Investment Law.
The new incentives regime will apply to "Preferred Technological Enterprises" that meet the “Preferred Enterprise” requirements and certain
additional conditions, including all of the following:
1.
2.
The Enterprise’s R&D expenses in the three years prior to the current tax year must be greater than or equal to 7%, on average, out of
the total revenue of the Company owning the Enterprise or exceed NIS 75 million (approximately $23 million) per year; and
The Company which owns the Enterprise must also satisfy one of the following conditions:
•
•
•
at least 20% of the workforce (or at least 200 employees) are employees of which their salaries are fully allocated to R&D
expenses;
a venture capital investment of an amount of NIS 8 million (approximately $2.4 million) was previously made in the company,
provided that the company did not change its field of business after the investment; or
growth in sales (assuming the Company’s sales in the current tax year and in each of the three preceding years was at least NIS
10 million (approximately $3 million)) or workforce (assuming the Company’s workforce in the current tax year and in each of
the three preceding years included at least 50 employees) by an average of 25% in the course of three years preceding the tax
year in comparison to the prior tax year.
Alternatively, in lieu of meeting the above conditions, it is possible to meet the conditions prescribed by the Chief Scientist in the Ministry of
Economy and Industry in consultation with the Director General of the Ministry of Finance and with the approval of the Minister of Finance,
as prescribed within the Encouragement of Capital Investments (conditions indicating that the enterprise is promoting innovation for the
purpose of its characterization as a Preferred Technological Enterprise) - 2019 ("Innovation Promoting Enterprise Regulations”), and receive
an approval from the Ministry of Economy and Industry confirming the compliance with the aforesaid conditions, indicating that the
enterprise in an “Innovation Promoting Enterprise”.
A “Special Preferred Technological Enterprise” is an enterprise that meets the “Preferred Technological Enterprise” conditions, and in
addition is a part of a group of companies that have total annual consolidated revenues of at least NIS 10 billion (approximately $3 billion).
Preferred Technological Enterprises will be subject to a corporate tax rate of 7.5% for operations in Development Zone A or 12% for
operations outside of Development Zone A with respect to the portion of their income derived from certain types of proprietary IP as defined
within the Investment Law and which were generally developed in Israel, while Special Preferred Technological Enterprises will be subject
to 6% with respect to income related to such IP, all subject to the “NEXUS approach”. The withholding tax on dividends from these
enterprises will be 4% for dividends paid to a foreign company and the distributing company is held by foreign companies at a rate of at least
90% and for other dividend distributions, the withholding tax rate shall be 20% or a lower rate under a tax treaty, if applicable, and subject to
a certificate from the ITA allowing for such withholding taxes.
We have evaluated the likely effect of the 2017 Amendment, as well as the Company’s compliance with the applicable threshold conditions,
and believe that the Company qualifies as a Special Preferred Technological Enterprise starting with the fiscal year beginning on April 1,
2020.
Also, on October 4, 2021, the Company received an approval from the Ministry of Economy and Industry stating that it is in compliance with
Section 2 of the Innovation Promoting Enterprise Regulations, indicating that the enterprise is an “Innovation Promoting Enterprise” starting
from 2019 and through 2021. The Company is currently pursuing the renewal of the Innovation Promoting Enterprise certificate for 2022-
2024.
f.
Economic Efficiency Law (legislative amendments for the purpose of achieving the objectives of the 2020-2021 budget)
On November 2, 2021, the Economic Efficiency Law (legislative amendments for the purpose of achieving the objectives of the 2020-2021
budget) (“Budget Bill”) was legislated. As part of the Budget Bill, Section 74 of the Investment Law was
F-40
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
amended in the following manner. Section 74(d)(4)(b) of the Investment Law that enabled companies with accumulated tax-exempt profits,
which were distributing dividends, to source such dividends wholly using their non-exempt income, was canceled. Hence, any distribution
out of Approved/Benefitted Enterprise profits entails the distribution of a pro-rata portion of tax-exempt profits (and the recapture of tax
thereof). The tax recapture (“Clawback Tax”), is the tax from which the company was exempt at the time such tax-exempt profits were
generated, depending on the level of foreign investment in the company at such time (at a rate of 10%-25%).
Also, Section 74(d1) of the Investment Law, which compels companies with accumulated tax-exempt profits to attribute a pro-rata portion of
the distribution to their tax-exempt profits upon a deemed dividend distribution (in accordance with the provisions of Section 51(h) and
51B(b) of the Encouragement Law) or an actual dividend distribution, and apply Clawback Tax thereof, was legislated. These changes are in
effect with regards to dividends distributed starting from August 15, 2021.
“Trapped Profits” Law- Temporary Order
The Budget Bill also enables Israeli companies that have trapped profits, which are generally subject to Clawback Tax upon their distribution,
to “release” such profits with up to a 60% “discount” on the applicable capital income tax (CIT) (Clawback Tax), but not less than a 6% CIT
rate. The applicable CIT rate is determined based on a formula that considers the ratio of the “released” profits out of the tax-exempt profits
and the original CIT the company was exempt from (maximum benefit is reached if the entire amount of tax-exempt profits is “released”).
In order to enjoy the said benefit, the company must meet the “designated investment” requirement within five years from the tax year in
which it “released” the trapped profits (detailed rules apply). This amount should be invested in the purchase of productive assets, research
and development expenses in Israel or the salaries of additional employees.
This Temporary Order is in force for tax-exempt profits that will be “released” (without the requirement to distribute those profits) during a
one-year period from November 15, 2021.
g. Measurement of taxable income under the Income Tax (Inflationary Adjustments) Law, 1985 of Israel:
With respect to the Israeli entity, commencing in taxable year 2003, the Company elected to measure its taxable income and file its tax
returns in USD in keeping with Israeli Income Tax Regulations, 1986 (Principles Regarding the Management of Books of Account of
Foreign Invested Companies and Certain Partnerships and the Determination of Their Taxable Income). Such an election was binding to the
Company for three years. Accordingly, commencing taxable year 2003, results for tax purposes are measured in USD terms. After the initial
three-year term, the Company must make the election on an annual basis. Through taxable year 2021, the Company has consistently elected,
for tax purposes, to measure its earnings in USD.
h.
(Loss) income before income taxes is comprised of the following:
Domestic (Israel)
Foreign (North America and the Cayman Islands)
Income (loss) before taxes
i.
Taxes on income are comprised of the following:
Current taxes
Prior years' benefits
Deferred income taxes
Domestic (Israel)
Foreign (North America)
Year ended March 31,
2021
2022
2020
(39,781 ) $
117,639
77,858
$
14,338 $
(405,411 )
(391,073 ) $
99,182
198,853
298,035
Year ended March 31,
2021
2022
2020
(112 ) $
(3,495 )
23,199
19,592
$
8,658
10,934
19,592
$
$
5,234 $
(3,462 )
7,895
9,667 $
7,459 $
2,208
9,667 $
55,895
(9,995 )
7,585
53,485
4,177
49,308
53,485
$
$
$
$
$
$
F-41
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
Included within current and deferred income tax expense are benefits relating to research and development tax credits in Taro Canada of
$686, $649, and $664 for the years ended March 31, 2022, 2021, and 2020, respectively. Taro Canada uses the “flow-through” method and
therefore records the benefits in earnings in the period the tax credits are utilized.
On March 27, 2020, the U.S. enacted the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) which, among other
provisions, allows U.S. corporations to carry existing losses back to the preceding five years. The Company expects to receive a benefit due
to the increased value of its losses when carried back to preceding years in which the U.S. federal corporate income tax rate was 35% versus
the current 21%.
j.
Reconciliation of the statutory tax rate of the parent company in Israel to the effective consolidated tax rate:
Statutory tax rate (in Israel)
(Decrease) increase in effective tax rate due to:
Utilization of net operating losses
FX on tax payments
Write-down and amortization of TNA transferred IP
Taxable capital gain
Non-deductible expenses (unrecognized income)
Change in deferred taxes due to change in tax rate
Taxes from prior years
Uncertain tax positions, net
Change in valuation allowance on deferred tax asset
Different tax rates applicable to non-Israeli subsidiaries
Non-deductible portion of settlements
Net operating loss carryback (1)
Tax benefits from reduced tax rates under benefit programs and
other
Effective consolidated tax rate
Year ended March 31,
2021
23.0%
2022
23.0%
2020
23.0%
(8.5%)
(2.0%)
0.2%
(0.0%)
(0.4%)
(4.2%)
0.9%
14.2%
(3.8%)
2.5%
0.0%
0.0%
3.3%
25.2%
2.6%
0.8%
0.1%
0.1%
(0.1%)
(0.3%)
(0.5%)
(0.9%)
(1.2%)
(2.5%)
(23.6%)
0.0%
0.0%
(2.5%)
0.0%
0.4%
0.0%
0.0%
0.0%
0.0%
(0.8%)
(0.6%)
0.0%
1.3%
0.0%
(1.3%)
(4.1%)
17.9%
(1)
Net operating loss carryback is attributed to the CARES Act which was enacted in the U.S. on March 27, 2020. The CARES Act, among
other provisions, allows U.S. corporations to carry existing losses back to the preceding five years. The Company expects to receive a
benefit due to the increased value of its losses when carried back to preceding years in which the U.S. federal corporate income tax rate was
35% versus the current 21%.
k.
Current taxes are calculated at the following combined federal and local rates:
On Israeli operations (not including “Approved Enterprise”)
On U.S. operations *
On Canadian operations *
Year ended March 31,
2021
23.0%
21.0%
25.0%
2022
23.0%
21.0%
25.0%
2020
23.0%
21.2%
25.0%
* The U.S. and Canadian subsidiaries are taxed on the basis of the tax laws prevailing in their countries of residence. The Canadian
subsidiary qualifies for research and development tax credits and manufacturing and processing credits, thereby reducing its effective tax
rate.
F-42
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
l.
Deferred income taxes:
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial
reporting purposes and the amounts used for income tax purposes and carryforward losses.
TARO PHARMACEUTICAL INDUSTRIES LTD.
Deferred tax assets:
Operating loss carryforward
Capital loss carryforward
Deferred revenue
Property, plant, and equipment
Intangible assets
Accrued expenses
Bad debt allowance
Hedge accounting
Marketable securities
Other, net
Total deferred tax assets
Valuation allowance for deferred tax assets
Net deferred tax assets
Deferred tax liabilities:
Property, plant, and equipment
Marketable securities
Hedge accounting
Other, net
Total deferred tax liabilities
Net deferred tax assets
Domestic (Israel)
Foreign (North America)
March 31,
2022
2021
$
$
$
$
37,479 $
17,568
10,564
2,549
31,969
46,943
152
23
1,348
5,517
154,112
(22,175 )
131,937
(6,770 )
—
(48 )
(238 )
(7,055 )
124,882 $
4,499 $
120,383
124,882 $
35,404
17,705
17,169
1,438
34,836
60,862
212
—
—
10,077
177,704
(27,857 )
149,847
(8,991 )
(541 )
(17 )
(198 )
(9,747 )
140,100
4,888
135,212
140,100
The deferred income taxes are presented on the Consolidated Balance Sheets as follows:
Among non-current assets
Among long-term liabilities
m.
Carryforward tax losses:
March 31,
2022
2021
$
$
124,882 $
-
124,882 $
142,007
(1,907 )
140,100
1.
2.
3.
The Company:
As of March 31, 2022, the Company has $233,665 carryforward capital losses.
Canadian subsidiary:
As of March 31, 2022, this subsidiary has carryforward losses of $104,714.
U.S. subsidiary
As of March 31, 2022, this subsidiary has carryforward losses of $16,119.
n.
The Company’s Board of Directors has determined that its U.S. subsidiary will not pay any dividends for the foreseeable future.
F-43
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
o.
p.
q.
At March 31, 2022, deferred income taxes were not provided for on a cumulative total of $1.3 billion of the undistributed earnings of Taro
Canada, which are not taxable provided earnings remain undistributed.
Foreign withholding taxes have been accrued as necessary by the Company and its subsidiaries.
Federal tax assessments:
The Company completed its tax assessments with the Israeli tax authorities for years through March 31, 2016. On March 28, 2022, the ITA
issued a tax assessment with respect to the year ending March 31, 2017. The total tax liability arising from the assessment as of the date of
its issuance amounts to NIS 38.5 million ($12.3 million), including interest and linkage to the Israeli Customer Price Index. The Company
intends to timely submit a tax objection to the ITA. With respect to the years ending March 31, 2018 and through March 31, 2020, the
Company is under examination by the ITA. The Company may also be subject to examination by the Israeli tax authorities for the years
ending March 31, 2021 and onward. The Company believes that its tax provision is adequate to satisfy any assessments resulting from
examination of these years.
Taro U.S.A. completed its tax assessments with the U.S. tax authorities for the years through March 31, 2015. The U.S. federal tax return for
the period ending March 31, 2016 is open to examination, due to the filing of a refund claim arising from the carryback of net operating
losses. The period in which Taro U.S.A.’s tax return for the years ending March 31, 2017 through March 31, 2018 may be examined have
expired and these years are no longer subject to federal audit.
Taro Canada completed its tax assessments with the Canadian tax authorities for the periods through March 15, 2017. The Company’s tax
provision was materially adequate to satisfy these assessments. Taro Canada remains subject to examination by the Canadian tax authorities
for periods after March 15, 2017, according to the statute of limitations. The Company believes that its tax provision is adequate to satisfy
any assessments resulting from examinations related to these years.
r.
Uncertain tax positions:
The Company adopted FASB ASC Section 740-10-25, “Income Taxes-Overall-Recognition,” effective January 1, 2007, which prescribes a
model for how a company should recognize, measure, present and disclose in its financial statements uncertain tax positions that it has taken
or expects to take on a tax return. See Note 2.h.
Unrecognized tax exposure at beginning of year
Increases as a result of positions taken in prior period
Decreases as a result of positions taken in prior period
Increases as a result of positions taken in current period
Unrecognized tax exposure at end of year
Year ended March 31,
2021
2022
2020
$
$
26,921 $
1,389
—
6,268
$
34,578
25,258 $
769
(5,025 )
5,919
26,921 $
28,188
382
(7,913 )
4,601
25,258
The total amount of interest and linkage to Consumer Price Index recognized on the Consolidated Statement of Operations for the years
ended March 31, 2022, 2021, and 2020 were $3,859, $1,236, and $1,224, respectively. The total amount of interest and linkage to Consumer
Price Index recognized on the Consolidated Balance Sheets on March 31, 2022 and 2021 were $7,643 and $3,783, respectively.
The total amount of unrecognized tax benefits, which would impact the effective tax rate if recognized, was $34,578 and $26,921 on March
31, 2022 and 2021, respectively.
F-44
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
NOTE 16: — SELECTED STATEMENTS OF INCOME DATA
TARO PHARMACEUTICAL INDUSTRIES LTD.
United States
Canada
Israel
Other
Sales, net
Selling, marketing, general and administrative expenses:
Selling and marketing
Advertising
General and administrative *
Settlements and loss contingencies
* Including provision for doubtful accounts
Financial (income) expenses:
Interest and exchange differences on long-term liabilities
Income in respect of deposits
Interest from marketable securities
Foreign currency transaction (loss) gain
Year ended March 31,
2021
2022
2020
376,677
130,066
47,915
6,689
561,347
48,340
8,280
57,057
61,446
175,123
15,213
$
$
$
$
$
1,653
$
(1,331 )
(8,509 )
(1,985 )
(10,172 ) $
383,829 $
110,167
46,574
8,400
548,970 $
32,861 $
5,681
52,813
558,924
650,279 $
(1,761 ) $
1,363 $
(2,432 )
(19,105 )
365
(19,809 ) $
495,673
97,997
42,817
8,282
644,769
31,754
4,902
56,757
—
93,413
2,382
725
(11,714 )
(22,655 )
(14,838 )
(48,482 )
$
$
$
$
$
$
$
NOTE 17: — SEGMENT INFORMATION
a.
Geographic Area Information:
The Group operates in one industry segment, which produces, researches, develops, and markets pharmaceutical products. Management
organizes the Company’s operations based on geographic segments, which are presented below in accordance with FASB ASC Paragraph
280-10-50-1, “Segment Reporting – Overall – Disclosure – Operating Segments.”
Israel
Canada
U.S.A.
Other
Consolidated
Year ended March 31, 2022 and as of
March 31, 2022:
Net sales *
Long-lived assets **
Year ended March 31, 2021 and as of
March 31, 2021:
Net sales *
Long-lived assets **
Year ended March 31, 2020 and as of
March 31, 2020:
Net sales *
Long-lived assets **
$
$
$
$
$
$
47,915 $
117,913 $
130,066 $
101,387 $
376,677 $
31,191 $
6,689 $
8,355 $
561,347
258,846
46,574 $
122,983 $
110,167 $
61,027 $
383,829 $
35,455 $
8,400 $
— $
548,970
219,465
42,817 $
123,679 $
97,997 $
63,506 $
495,673 $
38,379 $
8,282 $
— $
644,769
225,564
* Based on customer’s location, including sales to unaffiliated customers and Sun.
** Includes property, plant and equipment, net; goodwill and intangible assets, net.
b.
For the year ended March 31, 2022, the Company had net sales to two different U.S. customers of 10.1% and 8.9% of consolidated net sales.
For the year ended March 31, 2021, the Company had net sales to two different U.S. customers of 12.6% and 10.5% of consolidated net
sales. For the year ended March 31, 2020, the Company had net sales to two different U.S. customers of 13.0% and 11.5% of consolidated
net sales.
F-45
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
c.
Sales by therapeutic category, as a percentage of total net sales for the years ended March 31, 2022, 2021, and 2020, were as follows:
TARO PHARMACEUTICAL INDUSTRIES LTD.
Category
Dermatological and topical
Neuropsychiatric
Cardiovascular
Anti-inflammatory
Other
Total
NOTE 18: — RELATED PARTY TRANSACTIONS
Year ended March 31,
2021
2020
2022
60 %
13 %
6 %
3 %
18 %
100 %
58 %
16 %
7 %
3 %
16 %
100 %
63 %
17 %
6 %
3 %
11 %
100 %
In addition to Sun controlling 85.7% of the voting power in the Company as of March 31, 2022, the Company has substantial relationships
with Sun. Certain Taro Board members are also members of various Sun entities board of directors, including Taro’s Chairman, Dilip
Shanghvi who is also Managing Director of Sun Pharma’s board of directors. In addition, certain Taro officers and executives are also
executives of Sun.
Arrangements with Sun
Since 2013, in the ordinary course of business, Taro has entered into various commercial transactions, including product distribution and
logistics, manufacturing and service agreements, with Sun. The Company reviews each of these transactions and believes that the terms of
these transactions are comparable to those offered by or that could be obtained from unrelated third parties. Pursuant to Israeli requirements,
all material transactions were presented to the Audit Committee, which determined that each such transaction was not considered
extraordinary, as defined in the Israeli Companies Law and therefore did not require shareholder approval. The Audit Committee further
determined the approval requirements for the different types of transactions.
Sun and Taro renewed a services arrangement (the “Services Agreement”) effective April 1, 2021, that allows the companies to share the
services of certain employees of the respective companies involved in certain North American management and operations functions in North
America.
The companies are required to maintain records (the “Service Reports”) of the costs associated with the provision of the services under the
Services Agreement, and allocate such costs between the companies, based upon approved allocation methodologies. The Services
Agreement requires our Audit Committee to review the Service Reports on a semi-annual basis and, the Services Agreement, as a whole, on
an annual basis to determine its efficacy and whether it is in the Company’s best interests.
Each of the employees providing services under the Services Agreement is required to sign a written acknowledgment of his/her receipt of,
and agreement to be bound by (a) the confidentiality and non-disclosure agreement between Sun and Taro, and (b) guidelines for
consideration in the performance of such services, including the identification of potential conflicts of interest.
In May 2018, Taro Canada signed an agreement with Sun’s affiliate, Ranbaxy Pharmaceuticals Canada Inc., which is now Sun Pharma
Canada Inc., under which Taro Canada acts as the exclusive distributor for a portfolio of Sun and Ranbaxy, Inc. products in Canada. Under
this agreement, Taro Canada purchases and controls inventory, and additionally, Sun and Ranbaxy Inc. pay Taro Canada a sales and
distribution fee.
NOTE 19: — BUSINESS COMBINATION
Alchemee Acquisition
On February 28, 2022, the Company acquired 100% ownership of Alchemee LLC (“Alchemee”), pursuant to a Share and Asset Purchase
Agreement, dated February 28, 2022. The aggregate purchase price for the acquisition totaled $100 million, which is inclusive of a working
capital adjustment of $1 million. Upon closing, the Company paid an all-cash purchase price of approximately $99 million funded from
available liquidity. As a result of the purchase, the Company acquired Proactiv®, an over-the-counter dermatology brand. The acquisition of
Alchemee was intended to build on the Company’s
F-46
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
existing consumer health business and is expected to strengthen the leadership position in dermatology by providing consumer health
coverage through the Proactiv® product line.
Acquisition-related expenses consist of transaction costs which represent external costs directly related to the acquisition of Alchemee and
primarily include expenditures for professional fees such as legal, accounting and other directly related incremental costs incurred to close
the acquisition by both the Company and Alchemee. The Company incurred transaction costs of approximately $1 million in connection
with the transaction.
The acquisition of Alchemee has been accounted for as a business combination and is included in the Company’s consolidated financial
statements commencing February 28, 2022. The fair value of all the acquired assets and liabilities summarized below is provisional pending
finalization of the Company’s acquisition accounting. The Company retained the services of third-party valuation specialists in determining
the fair value of certain tangible and intangible assets, under the supervision of management. The Company believes that such preliminary
allocations provide a reasonable basis for estimating the fair values of assets acquired and liabilities assumed. Final determination of the fair
value may result in further adjustments to the amounts presented below. The Company expects to finalize the valuation as soon as
practicable, but not later than one year from the acquisition date. Measurement period adjustment will reflect new information obtained
about facts and circumstances that existed as of the acquisition date.
The following table summarizes the allocation of purchase price to the preliminary fair values of the assets acquired and liabilities assumed
as of the date of acquisition.
(in millions)
Cash and cash equivalents
Accounts receivable and other:
Trade, net
Other receivables and prepaid expenses
Inventories
Property, plant and equipment, net
Intangible assets ─ software
Deferred tax assets
Intangible assets ─ brand
Right-to-use assets
Goodwill
Total assets acquired
Accounts payable:
Trade payables
Other current liabilities
Right-of-use liability
Other liabilities
Total liabilities assumed
Total consideration transferred
Preliminary Values as of
February 28, 2022
$
$
8
28
4
19
1
8
6
44
3
10
131
21
6
3
1
31
100
In connection with this acquisition, the Company recorded goodwill of $10 million based on the amount by which the purchase price
exceeded the preliminary estimate of the fair value of the net assets acquired. The primary items that generate goodwill include the value of
the synergies between the acquired company and the Company and the acquired assembled workforce, none of which qualifies for
recognition as an intangible asset. The primary areas that remain preliminary as of March 31, 2022, relate to the fair values of the Alchemee
brand (the “Brand”). The goodwill recognized upon acquisition is expected to be deductible for U.S. federal income tax purposes.
The Company engaged a third-party valuation specialist to aid in the analysis of the fair value of the acquired intangibles. All estimates, key
assumptions, and forecasts were either provided by or reviewed by the Company. While the Company chose to utilize a third-party valuation
specialist for assistance, the fair value analysis and related valuations reflect the conclusions of management and not those of any third party.
F-47
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
Intangible assets (i.e. Brand) were estimated using a Multi-period Excess Earnings Method (“MEEM”). Under this method, an intangible
asset’s fair value is equal to net earnings attributable to the brand being measured. This is based on present value of the incremental after-tax
cash flows (excess earnings) attributable solely to the brand over its remaining useful life. An income and expenses forecast were built based
upon revenue and expense estimates.
The estimated useful lives and fair values of the identifiable intangible assets at acquisition date were as follows:
(in millions)
Brand
Pro forma Impact of Business Combination
Weighted-Average
Useful Life - Years
15
Estimated Fair Values
44
$
The unaudited pro forma financial results have been prepared using the acquisition method of accounting and are based on the historical
financial information of the Company and Alchemee. The unaudited pro forma condensed financial information does not reflect any
operating efficiencies and expected realization of cost savings or synergies associated with the acquisition. The unaudited pro forma
information presented below is for informational purposes only and do not purport to be indicative of the consolidated results of operations
had the acquisitions actually occurred at the beginning of applicable comparable prior reporting period or of the results of future operations
of the consolidated business. Since the Company's financial results for the year ended March 31, 2022, reflect only one month of Alchemee's
actual results, the impact is immaterial.
Revenues
Net earnings (loss)
March 31, 2022
March 31, 2021
(unaudited)
(unaudited)
$
$
736,875
41,118
$
$
738,211
(398,799 )
The pro forma financial information for all periods presented above has been calculated after adjusting the results of Alchemee to reflect the
business combination accounting effects resulting from this acquisition.
NOTE 20: — SUBSEQUENT EVENTS
Subsequent to March 31, 2022, the Company received one approval from the FDA. The Company currently has a total of nineteen ANDAs
awaiting FDA approval, including four tentative approvals.
Regarding the Generic Drug Pricing Antitrust Litigation, MDL No. 2724, the Court granted preliminary approval on May 11, 2022 of Taro’s
settlement with the DPP class plaintiffs. As a result, on June 8, 2022, within the required time period, Taro paid the $67.6 million settlement
payment to the DPP class plaintiffs, subject to a reduction of up to $8 million depending on the volume of certain class members that may
opt-out of the settlement.
End of consolidated financial statements.
SCHEDULE II: — VALUATION AND QUALIFYING ACCOUNTS
Schedules have been omitted as the required information is provided elsewhere in these financial statements.
F-48
Exhibit 2.2
Description of Taro Pharmaceutical Industries Ltd. Ordinary Shares Registered Under Section 12 of the Exchange Act
As of March 31, 2022, Taro Pharmaceuticals Industries Ltd. (hereinafter, “we,” “us,” “our,” “our company” or similar expressions) had one class
of securities registered under Section 12(b) of the Securities Exchange Act of 1934 – ordinary shares, NIS 0.0001 par value per share.
Authorized Share Capital
Our authorized share capital consists of NIS 20,000.026, divided into 2,600 founders’ shares, par value NIS 0.00001 each, and 200,000,000
ordinary shares, par value NIS 0.0001 each. As of July 1, 2022, 2,600 founders’ shares and 37,584,631 ordinary shares were issued and outstanding.
Memorandum and Articles of Association
Registration Number and Purposes of the Company
Our registration number with the Israeli Registrar of Companies is 52-002290-6. Our main object and purpose, as set forth in our memorandum
of association, is any business connected with the developing, manufacturing, processing, supplying, marketing and distributing of Rx, OTC medical and
other health care products.
Voting Rights
One-third of the voting power of all of our voting shares is allocated to our founders’ shares. Two-thirds of the voting power of all of our voting
shares is allocated to our ordinary shares. Each ordinary share possesses identical voting rights as every other ordinary share.
Restriction on Voting
In order to reduce our risk of being classified as a Controlled Foreign Corporation under the Internal Revenue Code of 1986, as amended, we
amended our Articles of Association, or Articles, in 1999 to provide that no owner of any of our ordinary shares is entitled to any voting right of any nature
whatsoever with respect to such ordinary shares if (a) the ownership or voting power of such ordinary shares was acquired, either directly or indirectly, by
the owner after October 21, 1999, and (b) the ownership would result in our being classified as a Controlled Foreign Corporation. This provision has the
practical effect of prohibiting each citizen or resident of the United States who acquired or acquires our ordinary shares after October 21, 1999, from
exercising more than 9.9% of the voting power in our company, with respect to such ordinary shares, regardless of how many shares the shareholder owns.
The provision may therefore discourage United States persons from seeking to acquire, or from accumulating, 15% or more of our ordinary shares (which,
due to the voting power of the founders’ shares, would represent 10% or more of the voting power of our company).
Transfer of Shares
Our fully paid ordinary shares are issued in registered form and may be freely transferred under our Articles, unless the transfer is restricted or
prohibited by another instrument, applicable law or the rules of a stock exchange on which the shares are listed for trade. The ownership or voting of our
ordinary shares by non-residents of Israel is not restricted in any way by our Articles or the laws of the State of Israel, except for ownership by nationals of
some countries that are, or have been, in a state of war with Israel.
Election of Directors
Our ordinary shares do not have cumulative voting rights for 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, subject to the special approval requirements for the election of statutory
external directors.
Under our Articles, our Board of Directors, or Board, must consist of not less than 5 but no more than 25 directors, including two statutory
external directors who serve pursuant to the Israeli Companies Law, 5759-1999, or the Companies Law. Pursuant to our Articles, each of our directors
(other than statutory external directors, for whom special election requirements apply under the Companies Law) is elected on an annual basis by a simple
majority vote of holders of our voting shares, participating and voting at an annual general meeting of our shareholders, which is required to be held at least
once during every calendar year and not more than 15 months after the last preceding meeting. Directors may also be appointed to fill vacancies, or may be
appointed to serve as additional members of the Board, by an ordinary resolution passed at an extraordinary general meeting of our shareholders. Likewise,
in the event of a vacancy, the Board is empowered to appoint a
director to fill such vacancy until the next annual general meeting of shareholders. A director, other than a statutory external director, holds office until the
next annual general meeting, unless such directorship is earlier vacated in accordance with the provisions of any applicable law or regulation or under our
Articles of Association.
Under the Companies Law, nominations for directors may be made by any shareholder holding at least 1% of our outstanding voting power.
However, any such shareholder may make such a nomination only if a written notice of such shareholder’s intent to make such nomination has been given
to our company within seven days after we publish notice of our upcoming annual general meeting (or within 14 days after we publish a preliminary
notification of an upcoming annual general meeting). Any such nomination must include certain information, the consent of the proposed director
nominee(s) to serve as our director(s) if elected and a declaration signed by the nominee(s) declaring that they have the required skills and availability to
carry out their duties and providing details of such skills and affirming that there is no limitation under the Companies Law preventing their election and
that all of the information that is required to be provided to us in connection with such election under the Companies Law has been provided.
Under the Companies Law, the board of directors of a public company must hold at least one meeting every three months. Our Board complies with
this requirement.
Chairperson of the Board of Directors
Our Articles provide that the Chairperson of the Board of Directors is appointed by the members of the Board of Directors from among them.
Under the Companies Law, the chief executive officer of a public company, or a relative of the chief executive officer, may not serve as the chairperson of
the board of directors, and the chairperson of the board of directors, or a relative of the chairperson, may not be vested with authorities of the chief
executive officer, unless, in each case, approved by a special majority of the company’s shareholders. The shareholders’ approval can be effective for a
period of five years following an initial public offering, and subsequently, for additional periods of up to three years.
In addition, a person who is subordinated, directly or indirectly, to the chief executive officer may not serve as the chairperson of the board of
directors; the chairperson of the board of directors may not be vested with authorities that are granted to persons who are subordinated to the chief
executive officer; and the chairperson of the board of directors may not serve in any other position in the company or in a controlled subsidiary, but may
serve as a director or chairperson of a controlled subsidiary.
Statutory External Directors
Qualifications of Statutory External Directors
Under the Companies Law, companies incorporated under the laws of the State of Israel whose shares, inter alia, are listed for trading on a stock
exchange or have been offered to the public by a prospectus and are held by the public, are generally required to have at least two statutory external
directors. The Companies Law provides that a person may not be elected as a statutory external director if the person is a relative of a controlling
shareholder and/or the person or the person’s relative (as defined below), partner, employer, anyone to whom the person is subordinate, directly or
indirectly, or any entity under the person’s control has, as of the date of the person’s election to serve as a statutory external director, or had, during the two
years preceding that date, any affiliation (as defined below) with:
•
•
•
our company;
any entity controlling our company or relative thereof as of the date of the election; or
any entity controlled by our company or under common control with our company as of the date of the election or during the two years
preceding that date.
Under the Companies Law, “relative” is defined as: a spouse, brother or sister, parent, grandparent, or child; a child/brother/sister/parent of a
person’s spouse; or the spouse of any of the preceding people.
The term “affiliation” and the similar types of disqualifying relationships include (subject to certain exceptions) an employment relationship; a
business or professional relationship even if not maintained on a regular basis (but excluding insignificant relationships) or control of the company; and
service as an office holder (as defined below), excluding service as a director in a private company prior to the initial public offering of its shares if such
director was appointed as a director of the private company in order to serve as an external director following the initial public offering.
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The Companies Law defines the term “office holder” as the general manager (i.e., chief executive officer), chief business manager, deputy
general manager, vice general manager, any other person assuming the responsibilities of any of the foregoing positions without regard to such person’s
title, and any director or manager who reports directly to the general manager.
The Companies Law provides that no person can serve as a statutory external director if the person’s other positions or other business creates, or
may create, a conflict of interest with the person’s responsibilities as a statutory external director or may otherwise interfere with the person’s ability to
serve as a statutory external director, or if the person is an employee of the Israel Securities Authority or of an Israeli stock exchange. Until the lapse of
two years from termination of office as a statutory external director, a company, its controlling shareholder and any entity controlled by the controlling
shareholder, may not grant a former statutory external director, his/her spouse or child any benefits, directly or indirectly, including engaging the former
statutory external director, his/her spouse or child to serve as an office holder in the company or in any company controlled by the controlling shareholder
of the company and cannot employ or receive professional services from that person for consideration, either directly or indirectly, including through a
corporation controlled by such former statutory external director. The same shall apply to a relative, who is not a former statutory external director’s
spouse or child, for a period of one year from termination of office as a statutory external director.
A person shall be qualified to serve as a statutory external director only if he or she possesses accounting and financial expertise or professional
qualifications, as defined in the regulations promulgated under the Companies Law. Generally, at least one statutory external director must possess
accounting and financial expertise. A director with accounting and financial expertise is a director who, due to his or her education, experience and skills,
possesses an expertise in, and an understanding of, financial and accounting matters and financial statements, such that he or she is able to understand the
financial statements of the company and initiate a discussion about the presentation of financial data. A director is deemed to have professional
qualifications if he or she has any of (i) an academic degree in economics, business management, accounting, law or public administration; (ii) an academic
degree or has completed another form of higher education in the primary field of business of the company or in a field which is relevant to his/her position
in the company; or (iii) at least five years of experience serving in one of the following capacities, or at least five years of cumulative experience serving in
two or more of the following capacities: (a) a senior business management position in a company with a significant volume of business, (b) a senior
position in the company’s primary field of business or (c) a senior position in public administration or service. The board of directors is charged with
determining whether a director possesses accounting and financial expertise or professional qualifications. Notwithstanding the foregoing, if at least one of
the other directors (i) is independent for purposes of serving on the audit committee under Rule 10A-3 of the Exchange Act and under the NYSE Listed
Company Manual, and (ii) has accounting and financial expertise as defined under the Companies Law, then neither of the external directors is required to
possess accounting and financial expertise as long as each possesses the requisite professional qualifications.
The Companies Law also provides that a shareholders’ general meeting at which the appointment of a statutory external director is to be
considered will not be called unless the nominee has declared to the company that he or she complies with the qualifications for appointment as a statutory
external director.
Election of Statutory External Directors
The Companies Law provides that statutory external directors must be elected by a majority vote at a shareholders’ meeting, provided that either:
•
•
the majority includes the majority of the total votes of non-controlling shareholders (as defined in the Companies Law) who do not have a
personal interest in the election of the subject external director, other than a personal interest that is not derived from a relationship with a
controlling shareholder in such election present at the meeting in person or by proxy (abstentions are not taken into account); or
the total number of votes against the election of the statutory external director by the non-controlling disinterested shareholders (as
described in the previous bullet point) may not exceed two percent of the aggregate voting rights in the company.
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For purposes of determining a controlling shareholder, Section 1 of the Companies Law defines “control” by reference to the definition of the
Israeli Securities Law, 5728-1968, or the Securities Law, which defines “control” as the ability to direct the activity of a corporation, excluding an ability
deriving merely from holding an office of director or another office in the corporation, and a person shall be presumed to control a corporation if he or she
holds half or more of a certain type of means of control of the corporation. With respect to certain matters (various related party transactions), a controlling
shareholder is deemed to include a shareholder that holds 25% or more of the voting rights in a public company if no other shareholder holds more than
50% of the voting rights in the company. “Means of control” in Section 1 of the Securities Law is defined as any one of the following: (1) the right to vote
at a general meeting of a company or a corresponding body of another corporation; or (2) the right to appoint directors of the corporation or its general
manager.
The initial term of a statutory external director is three years and may be extended for two additional consecutive terms of three years each,
provided that either (i) his or her service for each such additional term is recommended by one or more shareholders holding at least one percent (1%) of
the company’s voting rights and is approved by a majority at a shareholders meeting, which majority must include either of the criteria described above
with respect to his or her initial election; or (ii) his or her service for each such additional term is recommended by the board of directors and is approved
by a majority at a shareholders meeting, which majority must include either of the criteria described above with respect to his or her initial election. In
accordance with the regulations under the Companies Law, companies whose securities are listed on one of a number of non-Israeli stock exchanges
(including the NYSE, where our ordinary shares are listed) may re-appoint an external director for additional three-year terms, in excess of the nine years
described above, if the audit committee and the board of directors confirm that, due to the expertise and special contribution of the external director to the
work of the board and its committees, his or her re-appointment is in the best interests of the company. The same special majority is required for election
of the statutory external director for each additional three-year term (as was required for the initial term), with the additional requirement that the arguments
of the board of directors and audit committee in favor of election for such additional term, and the number of terms already served by the external director,
be presented to the general meeting prior to the vote.
Statutory external directors may be removed from office by shareholders at a special general meeting of shareholders called by the board of
directors, where the removal is based on the same percentage of votes as is required for election or by a court, if the statutory external director ceases to
meet the statutory qualifications for his or her appointment or if he or she violates his or her duty of loyalty to the company. The court may also remove an
external director from office, if it determines, at the request of the company, a board member, a shareholder or a creditor that the board member is not able
to fulfil his role or if such board member was convicted by a foreign court of certain specific offences.
If an external directorship becomes vacant and there are fewer 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 elect a replacement external director.
Each committee of a company’s board of directors that is empowered to exercise one of the functions of the board of directors is required to
include at least one statutory external director, except for the audit committee and compensation committee, which are required to include all of the
statutory external directors and an external director must serve as chair thereof.
Under the Companies Law, a statutory external director of a company is prohibited from receiving, directly or indirectly, any compensation from
the company other than compensation determined by the board within the scope provided in regulations adopted under the Companies Law. Compensation
of an external director is determined prior to his or her appointment and may not be changed during his or her term, subject to certain exceptions.
Exemption from Statutory External Director Requirement
Under regulations promulgated under the Companies Law, Israeli public companies whose shares are traded on certain U.S. stock exchanges,
such as the NYSE, that lack a controlling shareholder (as defined under the Companies Law) are exempt from the requirement to appoint statutory external
directors. Any such company is also exempt from the Companies Law requirements related to the composition of the audit and compensation committees
of the Board. Eligibility for these exemptions is conditioned on compliance with U.S. stock exchange listing rules related to majority Board independence
and the composition of the audit and compensation committees of the Board, as applicable to all listed domestic U.S. companies. Because we currently
have a controlling shareholder (Sun Pharmaceutical Industries Ltd.), we are not eligible for these exemptions.
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Dividends and Liquidation Rights
Holders of each paid-up share (whether a founders’ share or an ordinary share) are entitled to participate equally in the payment of dividends and
other distributions and, in the event of liquidation, in all distributions after the discharge of liabilities to creditors. 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, dividends on our ordinary shares may be paid out of profits and other surplus, as defined in the Companies Law.
A distribution amount is limited to the greater of retained earnings or earnings generated over the previous two years, according to our then last reviewed or
audited financial statements, provided that the end of the period to which the financial statements relate is not more than six months prior to the date of the
distribution. If we do not meet such criteria, we may only distribute dividends with court approval. In each case, we are only permitted to distribute a
dividend if our Board of Directors and the court, if applicable, determines that there is no reasonable concern that payment of the dividend will prevent us
from satisfying our existing and foreseeable obligations as they become due.
Exchange Controls
The Companies Law and Israeli regulations do not impose any material foreign exchange restrictions on non-Israeli holders of our ordinary
shares, except for shareholders who are subjects of countries that are, or have been, in a state of war with Israel.
Dividends, if any, paid to our ordinary shareholders, and any amounts payable upon our dissolution, liquidation or winding up, as well as the
proceeds of any sale in Israel of our ordinary shares to an Israeli resident, may be paid in non-Israeli currency or, if paid in Israeli currency, may be
converted into freely repatriated dollars at the rate of exchange prevailing at the time of conversion. Payments of dividends may be subject to withholding
taxes.
Shareholder Meetings
Under the Companies Law, we are required to hold an annual general meeting of our shareholders once every calendar year that must be held 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 in our Articles as extraordinary general meetings. Our Board of Directors may call extraordinary general meetings whenever it sees fit, at such time and
place, within or outside of Israel, as it may determine. In addition, the Companies Law provides that our Board of Directors is required to convene an
extraordinary general meeting upon the written request of (i) any two of our directors or one-quarter of the members of our Board of Directors or (ii) one or
more shareholders holding, in the aggregate, either (a) 5% or more of our outstanding issued shares and 1% of our outstanding voting power or (b) 5% or
more of our outstanding voting power. Any shareholder may appoint by power of attorney a person to act as his or her representative at a meeting. The
original instrument appointing a representative or a notarized copy must be deposited at the principal office of the Company at least 48 hours before the
meeting.
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 requires that resolutions regarding the following matters must be passed at a general meeting of our
shareholders:
•
•
•
•
•
•
•
amendments to our articles;
appointment or termination of our auditors;
appointment of external directors;
approval of certain related party transactions;
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 notice of any annual general meeting or extraordinary general meeting be provided to shareholders at least 21
days prior to the meeting and if the agenda of the meeting includes, among other matters, the
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appointment or removal of directors, the approval of transactions with office holders or interested or related parties, approval of the company’s general
manager to serve as the chairman of its board of directors or an approval of a merger, notice must be provided at least 35 days prior to the meeting.
The Companies Law allows one or more of our shareholders holding at least 1% of the voting power of a company to request the inclusion of an
additional agenda item for an upcoming shareholders meeting, assuming that it is appropriate for debate and action at a shareholders meeting. Under
applicable regulations, such a shareholder request must be submitted within three or, for certain requested agenda items, seven days following our
publication of notice of the meeting. If the requested agenda item includes the appointment of director(s), the requesting shareholder must comply with
particular procedural and documentary requirements. If our Board of Directors determines that the requested agenda item is appropriate for consideration
by our shareholders, we must publish an updated notice that includes such item within seven days following the deadline for submission of agenda items by
our shareholders. The publication of the updated notice of the shareholders meeting does not impact the record date for the meeting. In lieu of this process,
we may opt to provide pre-notice of our shareholders meeting at least 21 days prior to publishing official notice of the meeting. In that case, our 1%
shareholders are given a 14-day period in which to submit proposed agenda items, after which we must publish notice of the meeting that includes any
accepted shareholder proposals.
Under the Companies Law and under our Articles, shareholders are not permitted to take action by way of written consent in lieu of a meeting.
Voting Rights
Quorum Requirements
The quorum required for a meeting of shareholders consists of at least three shareholders present, in person or by proxy, who hold or represent
between them at least one-third of the outstanding voting power unless otherwise required by applicable rules. A meeting adjourned for lack of a quorum
generally is adjourned to the same day in the following week at the same time and place or any time and place as the board of directors may designate. If at
such reconvened meeting the required quorum is not present, any two shareholders present in person, or by proxy, shall constitute a quorum.
Vote Requirements
Our Articles provide that all resolutions of our shareholders require a simple majority vote, unless otherwise required by the Companies Law or
by our Articles. Under the Companies Law, each of (i) the approval of an extraordinary transaction with a controlling shareholder, and (ii) the terms of
employment or other engagement of the controlling shareholder of the company or such controlling shareholder’s relative (even if such terms are not
extraordinary), require the approval of the company’s audit committee (or compensation committee with respect to compensation arrangements), board of
directors and shareholders, in that order. In addition, the shareholder approval must, in each case, be by a majority of the votes cast at the meeting, whether
in person or by proxy, provided that:
•
•
the majority includes at least the majority of the total votes of the shareholders who lack a conflict of interest (referred to as a personal
interest under the Companies Law) in approval of the transaction or compensation (as applicable), or anyone voting on their behalf present
at the meeting in person or by proxy; or
the total number of votes of the disinterested shareholders that are voted against the transaction does not exceed two percent (2%) of the
voting rights in the company.
Additionally:
(i) The approval and extension of a compensation policy and certain deviations therefrom require the approval of the compensation committee,
board of directors and shareholders, in that order. In addition, the shareholder approval must be by a majority vote of the shares present and voting at a
meeting of shareholders called for such purpose, provided that either: (a) such majority includes at least a majority of the shares held by all shareholders
who are not controlling shareholders and do not have a personal interest in such compensation policy; or (b) the total number of shares of non-controlling
shareholders who do not have a personal interest in the compensation policy and who vote against the arrangement does not exceed 2% of the company’s
aggregate voting rights.
(ii) The terms of employment or other engagement of the chief executive officer of the company require compensation committee, board of
directors and shareholders, in that order. The shareholder approval must be by a majority vote of the shares present and voting at a meeting of shareholders
called for such purpose, provided that either: (a) such majority includes at least a majority of the shares held by all shareholders who are not controlling
shareholders and do not have a personal interest in
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such compensation; or (b) the total number of shares of non-controlling shareholders who do not have a personal interest in the compensation and who vote
against the arrangement does not exceed 2% of the company’s aggregate voting rights).
(iii) The chairman of a company’s board of directors also serving as its chief executive officer requires the same approval as applies to (i) and (ii)
above (substituting the personal interest in the service of the chairman as chief executive officer in place of personal interest in the compensation).
Another exception to the simple majority vote requirement is a resolution for the voluntary winding up, or an approval of a scheme of
arrangement or reorganization of the company, pursuant to Section 350 of the Companies Law, which requires the approval of holders of 75% of the voting
rights represented at the meeting, in person or by proxy and voting on the resolution.
Access to Corporate Records
Under the Companies Law, shareholders are provided access to: minutes of our general meetings; our shareholders register and principal
shareholders register, articles of association and annual audited financial statements; and any document that we are required by law to file publicly with the
Israeli Companies Registrar or the Israel Securities Authority. These documents are publicly available and may be found and inspected at the Israeli
Registrar of Companies. In addition, shareholders may request to be provided with any document related to an action or transaction requiring shareholder
approval under the related party transaction provisions of the Companies Law. We may deny this request if we believe it has not been made in good faith
or if such denial is necessary to protect our interest or protect a trade secret or patent.
Modification of Class Rights
Under our Articles, the rights attached to any class of shares may be modified with the consent in writing of the holders of 75% of the issued
shares of that class or by way of a special resolution of all shareholders, i.e., an affirmative vote of 75% of the voting power of our shareholders, voting in
person or by proxy.
Acquisitions under Israeli Law
Full Tender Offer
A person wishing to acquire shares of an Israeli public 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 relevant
class for the purchase of all of the issued and outstanding shares of that 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, and more than half of the shareholders who do not have a personal interest in
the offer accept the offer, all of the shares that the acquirer offered to purchase will be transferred to the acquirer by operation of law. However, a tender
offer will also be accepted if the shareholders who do not accept the offer hold less than 2% of the issued and outstanding share capital of the company or
of the applicable class of shares.
Upon a successful completion of such a full tender offer, any shareholder that was an offeree in such tender offer, whether such shareholder
accepted the tender offer or not, may, within six months from the date of acceptance of the tender offer, petition an Israeli court to determine whether the
tender offer was for less than fair value and that the fair value should be paid as determined by the court. However, under certain conditions, the offeror
may include in the terms of the tender offer that an offeree who accepted the offer will not be entitled to petition the Israeli court as described above.
If a tender offer is not accepted in accordance with the requirements set forth above, the acquirer may not acquire shares from shareholders who
accepted the tender offer that will increase its holdings to more than 90% of the company’s issued and outstanding share capital or of the applicable class.
Special Tender Offer
The Companies Law provides that an acquisition of shares of an Israeli public 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. This requirement 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 special tender offer if, as a result of the acquisition, the purchaser would become a holder of more than 45%
of the voting
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rights in the company, if there is no other shareholder of the company who holds more than 45% of the voting rights in the company, subject to certain
exceptions.
A special tender offer must be extended to all shareholders of a company, but the offeror is not required to purchase shares representing more
than 5% of the voting power attached to the company’s outstanding shares, regardless of how many shares are tendered by shareholders. A special tender
offer may be consummated only if (i) the offeror acquired shares representing at least 5% of the voting power in the company, and (ii) the number of shares
tendered by shareholders who accept the offer exceeds the number of shares held by shareholders who object to the offer (excluding the purchaser,
controlling shareholders, holders of 25% or more of the voting rights in the company or any person having a personal interest in the acceptance of the
tender offer, including their relatives and companies under their control). If a special tender offer is accepted, 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, by a majority vote of each party’s shareholders. In the case of the target company, approval of the merger further requires a
majority vote of each class of its shares.
For purposes of the shareholder vote, unless a court rules otherwise, the merger will not be deemed approved if a majority of the votes of shares
represented at the meeting of shareholders that are held by parties other than the other party to the merger, or by any person (or group of persons acting in
concert) who holds (or hold, as the case may be) 25% or more of the voting rights or the right to appoint 25% or more of the directors of the other party,
vote against the merger. If, however, the merger involves a merger with a company’s own controlling shareholder or if the controlling shareholder has a
personal interest in the merger, then the merger is instead subject to the same special majority approval that governs all extraordinary transactions with
controlling shareholders (as described above under “Vote Requirements”).
If the transaction would have been approved by the shareholders of a merging company but for the separate approval of each class or the
exclusion of the votes of certain shareholders as provided above, a court may still approve the merger upon the petition of holders of at least 25% of the
voting rights of a company. For such petition to be granted, the court must find that the merger is fair and reasonable, taking into account the respective
values assigned to each of the parties to the merger and the consideration offered to the shareholders of the target company.
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 the merging entities, and may further
give instructions to secure the rights of creditors.
In addition, a merger may not be consummated unless at least 50 days have passed from the date on which a proposal for approval of the merger
is filed with the Israeli Registrar of Companies and at least 30 days have passed from the date on which the merger was approved by the shareholders of
each party.
Anti-Takeover Measures under Israeli Law
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 with respect to voting, distributions or other matters and shares having preemptive rights. No preferred shares are
authorized under our Articles. In the future, if we do authorize, create and issue a specific class of preferred shares, such class of shares, depending on the
specific rights that may be attached to it, may have the ability to frustrate or prevent a takeover or otherwise prevent our shareholders from realizing a
potential premium over the market value of their ordinary shares. The authorization and designation of a class of preferred shares will require an
amendment to our Articles, which requires the prior approval of the holders of a majority of the voting power attaching to our issued and outstanding
shares at a general meeting. The convening of the meeting, the shareholders entitled to participate, and the majority vote required to be obtained at such a
meeting will be subject to the requirements set forth in the Companies Law as described above in “Voting Rights.”
Borrowing Powers
According to our Articles, as part of its powers, our Board may cause us to borrow or secure payments of any sum or sums of money for our
purposes, at times and upon conditions as it deems fit, including the grant of security interests on all or any part of our property.
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Changes in Capital
Under our Articles of association, an increase to the share capital, creation of preferred shares or shares with special rights, consolidation or
division of share capital, cancellation of shares and reduction in share capital, require a special resolution of the shareholders, i.e. an affirmative vote of
75% of the voting power voting in person or by proxy. The rights attached to any class of shares may be modified with the consent in writing of the
holders of 75% of the issued shares of that class or by way of a special resolution of the shareholders.
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Exhibit 4.4
Taro Pharmaceutical Industries Ltd.
Compensation Policy for Office Holders
(effective December 14, 2020)
1. Introduction and Establishment
1.1 Taro Pharmaceutical Industries Ltd. (hereinafter: “Taro” or the “Company”) is a multinational, science-based pharmaceutical company, operating
primarily in the United States, Canada and Israel, through three entities: (i) Taro Israel, and two of its subsidiaries, (ii) Taro Pharmaceuticals Inc. (Taro’s
indirect Canadian subsidiary) and (iii) Taro Pharmaceuticals U.S.A., Inc. (Taro’s U.S. subsidiary). Operating in an intensely competitive pharmaceutical
industry, the Company develops, manufactures and markets generic and branded prescription and over-the-counter pharmaceutical products. Taro competes
with the original manufacturers of the brand-name, other generic drug manufacturers and manufacturers of new drugs that may compete with the
Company’s generic drugs. Many of Taro’s competitors have greater financial, production and research and development resources, substantially larger sales
and marketing organizations, and substantially greater name recognition. Because the pharmaceutical industry in which Taro operates is science based, it is
imperative that Taro attract and retain qualified personnel, including management personnel, in order to develop new products and compete effectively. The
Company’s compensation practices are therefore aimed at retaining key personnel, including management members.
1.2 Taro’s 2020 Compensation Policy for Office Holders (this “Compensation Policy” or this “Policy”) is set forth in this document. Upon approval at the
2020 Annual General Meeting of Shareholders, the Policy will become effective as of December 14, 2020 (the “Effective Date”) and will remain in effect
for a maximum period of three years from the Effective Date, as provided under the Israeli Companies Law, 5759-1999 (the “Companies Law”), unless
terminated earlier by the Company’s board of directors (the “Board”).
2. Purpose
2.1 The Compensation Policy seeks to promote the Company’s objectives and its short and long term business plans, and create appropriate incentives for
the Company’s Office Holders (as defined in Section 3.1), by:
2.1.1 Linking pay to performance, thereby aligning the Office Holders’ interests with those of the Company and its stakeholders;
2.1.2 Acting to ensure that the Office Holders are aligned in achieving the Company’s short and long term financial and strategic objectives; and
2.1.3 Enabling the Company to attract, retain, reward and motivate highly skilled Office Holders.
3. Applicability
3.1 The Compensation Policy shall apply to any “Office Holder”, as defined under the Companies Law (each, an “Office Holder”), consisting of the
following: a Director, the chief executive officer, an executive or senior vice president, a vice president, any person fulfilling or assuming any of the
foregoing positions without regard to such person’s title and any manager who is directly subordinate to the chief executive officer. As of the adoption of
this Policy, in addition to the seven non-employee members of our Board, the Company considers an additional sixteen individuals to be Office Holders,
subject to change based on the approval of the compensation committee of the Board (the “Compensation Committee” or “Committee”) and the Board in
the event of any Company organizational structure change.
3.2 The Compensation Policy is intended to apply to the Office Holders serving in the Company at the date of its entry into force and all Office Holders
who will commence their service with the Company while the Policy is in effect.
3.3 For clarity, Section 6 of this Compensation Policy is intended to apply to all Officer Holders other than non-management Directors (each, a
“Management Office Holder”) and Section 8 of this Compensation Policy is intended to apply to all Officer Holders that are non-management Directors
(each, a “Non-Management Director”). The chief executive officer of the Company is intended to be Management Officer Holder and not a Non-
Management Director as referenced above, whether or not a director of the Company.
4. Principles of the Compensation Policy
4.1 The Company has established this Compensation Policy in accordance with the following considerations:
4.1.1 Promoting the Company’s strategic objectives, work plans and policies in order to enhance both long term and short term value for all of Taro’s
stakeholders.
4.1.2 Creating appropriate incentives for the Office Holders of the Company, taking into consideration the Company’s risk management strategies.
4.1.3 The size of the Company and the nature and scope of its activities.
4.1.4 With respect to variable components – the contribution of the Office Holder to the achievement of the Company’s objectives and the maximization of
its profits, by balancing long term considerations with short term considerations and in accordance with the position of the Office Holder.
4.2 In determining an Office Holder’s compensation, the following criteria, among others, will be examined:
· The Office Holder’s education, qualifications, skills, professional experience and achievements.
· The Office Holder’s position and areas of responsibility, the impact associated with, and scope of, the Office Holder’s position, and the Office Holder’s
previous salary arrangements with the Company.
· The difference between the annual cost of the employment terms of the Office Holder and the average and median annual salary of Taro’s employees and
outsourced service providers, by geographic location, as well as whether such disparity has an effect on employment relations at the Company.
· The ratio between the variable compensation components and the fixed compensation components.
· Compensation practices of other companies that are active in similar markets.
4.3 As of the Effective Date of this Compensation Policy, all existing employment agreements and employment terms of the Company’s Office Holders are
consistent with this Compensation Policy, its principles and guidelines.
5. Compensation Committee Responsibility
5.1 The Compensation Committee of the Board is responsible for reviewing the Company’s compensation policies (including the Compensation Policy) in
light of the Company’s compensation philosophy expressed and adopted by the Board from time to time. The Committee also evaluates the performance of
the Company’s Office Holders, makes recommendations to the Board regarding the compensation of the Office Holders (including Directors), and reviews
any organizational restructuring pertaining to the roles, responsibilities and selection of Office Holders.
5.2 The Committee is responsible for ensuring that any arrangement between the Company and a Director as to such Director’s terms of service (including,
if applicable, employment), is generally consistent with this Compensation Policy. Any such arrangement generally requires the approval of the
Committee, and subject to such approval and a favorable recommendation by the Committee, also requires Board and shareholder approval.
6. Components of the compensation of Management Office Holders
The compensation of Management Office Holders may include the following components:
6.1 Base salary, social and other benefits (“Fixed Compensation”)
6.2 The base salary of Management Office Holders shall be determined based on the following:
6.2.1 The factors specified in Section 4.2 above.
6.2.2 Executive compensation survey (benchmark) of companies operating in similar industries and/or with similar financial performance, per geographic
location.
6.2.3 A performance review and performance based merit increase process conducted by the Committee, which, subject to the parameters specified in
Section 4.2 and Section 6.2.2, may result in an adjustment to base salary in an amount that does not exceed 20% of the base salary prior to such adjustment.
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6.3 Fixed Compensation may include additional benefits. In light of the Company’s global nature and the fact that its Management Office Holders are
employed in geographic locations worldwide (US, Canada and Israel), under different legal systems, social benefits shall be adjusted according to the local
laws, and customary employment terms. Management Office Holders shall be eligible to participate in and receive benefits from the standard and
customary benefit plans provided to the Company’s employees.
Fixed Compensation may include any of the following additional benefits (including gross-up of the benefit value of any of the following for tax purposes):
(a) Pension
(b) Education fund
(c) Severance pay
(d) Manager's insurance (for Israel employees)
(e) Employer’s allocations for 401(k) funds (for US employees) or RRSP funds (for Canada employees)
(f) Medical insurance (general, prescription, vision and dental), life insurance, including with respect to immediate family members, and accidental
death/dismemberment insurance
(g) Disability insurance
(h) Periodic medical examination
(i) Leased car or company car (as well as related expenses), or the value of the use of a car, or transportation allowance
(j) Telecommunication and electronic devices and communication expenses, including cellular telephone and other devices, personal
computer/laptop, internet, etc. or the value of the use of such device
(k) Paid vacation, including, if applicable, redemption of accrued unused vacation
(l) Sick days
(m) Holiday and special occasion gifts
(n) Recuperation pay
(o) Expense reimbursement
(p) Payments or participation in relocation and related costs, perquisites and expenses
(q) COBRA (for US employees)
(r) Change-of-control provisions
(s) Loans or advances (to the extent permitted under applicable law)
(t) Professional or academic courses or studies
(u) Newspaper or online subscriptions
(v) Professional membership dues or subscription fees
(w) Professional advice or analysis (such as pension, insurance and tax)
(x) Other benefits generally provided to Company employees (or any applicable affiliate or division)
(y) Other benefits or entitlements mandated by applicable law
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6.4 In addition, to attract qualified talent in the competitive employment markets in which the Company operates, on a limited, case by case basis, an
Management Office Holder may be eligible to receive a sign-on bonus, at the discretion of the Committee and the Board, that is generally three (3) months
or less of base salary, but in no event shall exceed six (6) months’ base salary, and, subject to applicable law, the Company will have the authority to
recover all or a portion of any sign-on bonus paid to an Management Office Holder in the event of the Management Office Holder’s voluntary separation
within a specified period of time of joining the Company.
6.5 Annual Cash Bonus Plan
6.5.1 An Management Office Holder’s compensation may include an annual cash bonus (“Bonus”) based upon the Company’s, business unit’s (if
applicable), and individual’s, achievement of defined performance objectives for each Performance Period, as defined in Section 6.5.2, subject to the
receipt of all approvals required by applicable law and to the terms of the Compensation Policy.
6.5.2 The “Performance Period” shall mean April 1 through March 31 of each applicable fiscal year (which dates represent the start and finish of the
Company’s fiscal year).
6.5.3 Subject to the parameters specified in Section 4.1.4, the target annual cash bonus for Management Office Holders, excluding the chief executive
officer, for one hundred percent (100%) achievement of Company, business unit, as applicable, and individual performance objectives (the “Target Bonus”)
will be no less than fifteen percent (15%) and no more than forty percent (40%) of base salary, calculated on a pro-rata basis for any partial Performance
Period worked.
6.5.4 The Target Bonus for the chief executive officer will be no more than fifty percent (50%) of base salary, calculated on a pro-rata basis for any partial
Performance Period worked.
The Target Bonus Amounts of Management Office Holders can be summarized as follows:
Target Bonus Amounts of Management Office Holders
Title of Officer
Target Bonus (as a % of Base Salary)
Chief Executive Officer
All Other Management Office Holders
Up to 50% of Base Salary
15%-40% of Base Salary
6.5.5 The Target Bonus for an Management Office Holder, other than one who serves in a sales and marketing leadership capacity having profit and loss
responsibility for a defined commercial segment(s) of the Company’s business and as designated by the Compensation Committee as such (such excluded
Management Office Holders, “Commercial Office Holders”), is comprised of two components (which shall be allocated relative proportional weight as
described in Section 6.5.6 below): (i) Company achievement of budgeted net sales, budgeted earnings before taxes (“EBT”), and percent of relative sales
growth as compared to market peers (these three types of Company-wide achievement, collectively, “Company Performance”) and (ii) individual
achievement of personal objectives (“Individual Performance”) as specified in Section 6.5.12.4.
6.5.6 The Bonus for an Management Office Holder, other than a Commercial Office Holder, will be based seventy-five percent (75%) on Company
Performance and twenty-five percent (25%) on Individual Performance, which proportions may be adjusted at the discretion of the Compensation
Committee, subject to Board approval.
6.5.7 The Target Bonus for a Commercial Office Holder is based on achievement in each of the following three categories (based on the relative
proportions described in Section 6.5.8 below): (i) Assigned business unit(s) achievement of the combined parameters of budgeted net sales, budgeted
earnings before taxes (“EBT”), and percent of relative sales growth as compared to business unit(s) peers, (these three types of business-unit(s) wide
achievement, collectively, “Business Unit Performance”), as described in Section 6.5.10, (ii) Company achievement of budgeted net sales, budgeted
earnings before taxes (“EBT”), and percent of relative sales growth as compared to market peers (these three types of Company-wide achievement,
collectively, “Company Performance”), as described in Section 6.5.9, and (iii) individual achievement of personal objectives (“Individual Performance”) as
specified in Section 6.5.11.
6.5.8 The Bonus for a Commercial Office Holder will be based fifty percent (50%) on Business Unit Performance, twenty-five percent (25%) on Company
Performance, and twenty-five percent (25%) on Individual Performance, which proportions may be adjusted at the discretion of the Compensation
Committee, subject to Board approval.
The criteria used for calculating Target Bonus Amounts of Management Office Holders can be summarized as follows:
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Performance Criteria for Calculating Target Bonus Amounts of Management Officers
Category of Office Holder
Criteria
Commercial Office Holders
All Other Management Office Holders
6.5.9 Determining Bonus Linked to Company Performance
Business Unit Performance: 50%;
Company Performance: 25%
Individual Performance: 25%
Company Performance: 75%
Individual Performance: 25%
6.5.9.1 A minimum of 90% achievement of a combination of the Company’s budgeted net sales and budgeted EBT targets, with each given equal weight,
(“Company Threshold Performance”) must be met for Management Office Holders to be eligible to receive the Company Performance component of the
Bonus. If the Company Threshold Performance is not met, then the Management Office Holder, other than Commercial Office Holders, will only be
eligible for the Individual Performance component of the Bonus, subject to and determined by achievement of defined individual objectives as specified in
Section 6.5.11. For Commercial Office Holders, if the Company Threshold Performance is not met, then the Commercial Office Holder will be eligible for
the Business Unit Performance component of the Bonus (subject to the achievement of BU Threshold Performance as specified in Section 6.5.10.1), and
for the Individual Performance component of the Bonus, subject to and determined by achievement of defined individual objectives as specified in Section
6.5.11.
6.5.9.2 Subject to Company Threshold Performance achievement, a payout multiplier will be applied to the Company Performance component of the
Target Bonus based on two linked parameters: (i) level of achievement at or greater than Company Threshold Performance and (ii) the percent of relative
sales growth as compared to market peers (“Relative Sales Growth”), as specified in Section 6.5.9.6.
6.5.9.3 A minimum payout multiplier of twenty percent (20%) will be applied to the Company Performance component of the Target Bonus for Company
Threshold Performance coupled with less than zero percent (0%) of Relative Sales Growth.
6.5.9.4 A maximum payout multiplier of one hundred and fifty percent (150%) will be applied to the Company Performance component of the Target
Bonus for combined achievement of budgeted net sales and budgeted EBT, with each given equal weight, of greater than one hundred percent (100%),
coupled with a maximum level of achievement of a pre-defined Relative Sales Growth target, as determined annually by the Compensation Committee and
the Board.
6.5.9.5 Payouts for Company Performance between the threshold (range from 20% to 75% of the Company Performance component of the Target Bonus,
based on Relative Sales Growth achievement), target, and maximum will be determined using a slab approach with payout multipliers applied in a stepwise
manner for achievement from threshold to maximum, with accelerated stepwise payout multipliers from target to maximum, subject to the maximum
payout multiplier specified in Section 6.5.9.4.
6.5.9.6 The Company will consider the following factors in determining comparable market peer companies for purposes of calculating Relative Sales
Growth: (i) annual revenues, (ii) product portfolio, and (iii) markets in which the peer company operates.
6.5.9.7 Consistent with the Compensation Policy, and subject to the limitations set forth herein, the Company may determine the Relative Sales Growth
targets each year to accurately reflect market conditions or factors, subject to the approval of the Compensation Committee and Board.
6.5.10 Determining Bonus Linked to Business Unit Performance (Commercial Office Holders)
6.5.10.1 A minimum of 90% achievement of Business Unit Performance (“BU Threshold Performance”) must be met for Commercial Office Holders to be
eligible to receive the Business Unit Performance component of the Bonus. If the Business Unit Threshold Performance is not met, then a Commercial
Office Holder may be eligible for: (i) the Company Performance component of Bonus, subject to the Company Threshold Performance being met, and (ii)
the Individual Performance component of Bonus, subject to and determined by achievement of defined individual objectives as specified in Section
6.5.11.4.
6.5.10.2 Subject to BU Threshold Performance achievement, a payout multiplier will be applied to the Business Unit Performance component of the Target
Bonus based on two linked parameters: (i) level of achievement at or greater than BU Threshold Performance and (ii) the percent of relative sales growth as
compared to business unit peer(s) (“BU Relative Sales Growth”), as specified in Section 6.5.10.6.
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6.5.10.3 A minimum payout multiplier of twenty percent (20%) will be applied to the Business Unit Performance component of the Target Bonus for BU
Threshold Performance coupled with less than zero percent (0%) BU Relative Sales Growth.
6.5.10.4 A maximum payout multiplier of one hundred fifty percent (150%) will be applied to the Business Unit Performance component of the Target
Bonus for combined achievement of budgeted net sales and budgeted EBT, with each given equal weight, of greater than one hundred percent (100%),
coupled with maximum level of achievement of a pre-defined BU Relative Sales Growth target, as determined annually by the Compensation Committee
and the Board.
6.5.10.5 Payouts for Business Unit Performance between the threshold (range from 20% to 75% of the Business Unit Performance component of the Target
Bonus, based on BU Relative Sales Growth achievement), target, and maximum will be determined using a slab approach with payout multipliers applied
in a stepwise manner for achievement from threshold to maximum, with accelerated stepwise payout multipliers from target to maximum, subject to the
maximum payout multiplier specified in Section 6.5.10.4.
6.5.10.6 The Company will consider the following factors in determining comparable business unit(s) peer companies for purposes of calculating BU
Relative Sales Growth: (i) annual revenues, (ii) product portfolio, and (iii) markets in which the business unit peer company operates.
6.5.10.7 Consistent with this Compensation Policy, and subject to the limitations set forth herein, the Company may determine the BU Relative Sales
Growth targets each year to accurately reflect market conditions or factors, subject to the approval of the Compensation Committee and Board.
6.5.11 Determining Bonus Linked to Individual Performance
6.5.11.1 A Management Office Holder’s Bonus will be linked to attainment of individual performance objectives as specified in Section 6.5.11.4.
6.5.11.2 Individual performance objectives for the chief executive officer are determined and approved by the Compensation Committee and the Board
based on general objectives approved for the Company as part of its annual work plan.
6.5.11.3 Individual performance objectives for the all other Management Office Holders are directly linked to the general objectives approved for the
Company as part of its annual work plan and are approved by the chief executive officer.
6.5.11.4 Individual performance objectives include specified targets or levels of change in one or more of the following business criteria: (i) earnings,
including net earnings, total earnings, operating earnings, earnings growth, operating income, earnings before or after taxes, earnings before or after
interest, depreciation, amortization, or extraordinary or special items; (ii) revenue, revenue growth, or rate of revenue growth; (iii) sales or sales growth;
(iv) operating expenses; (v) cash flow (including, but not limited to, operating cash flow and free cash flow); (vi) operating margin, profit margin, or gross
margin; (vii) balance sheet requirements; (viii) implementation or completion of critical projects or processes; (ix) cost or expense targets, reductions and
savings, productivity and efficiencies; (x) strategic business criteria, consisting of one or more objectives based on meeting specified market penetration,
market share, geographic expansion, customer satisfaction, research and development collaboration, employee engagement, human resources management,
information technology, compliance or litigation and goals related to acquisitions, joint ventures and similar transactions; (xi) personal and professional
objectives; or (xii) other measures of performance selected by the Compensation Committee and Board.
6.5.11.5 A Management Office Holder’s achievement of Individual Performance Objectives determines his or her performance evaluation score, defined on
a multi point scale, for the Performance Period. A payout multiplier, with a minimum of zero percent (0%) and a maximum of one hundred and twenty
percent (120%), will be applied to the Individual Performance component of the Target Bonus based on the performance evaluation score. If a
Management Office Holder receives a performance evaluation score in the lowest scoring tier for the Performance Period, then he or she will not be
entitled to any Bonus for the Performance Period.
6.5.12 Amendment and Termination
6.5.12.1 The Board at any time, and from time to time, may amend the Annual Cash Bonus Plan. The Board or the Compensation Committee at any time,
and from time to time, may amend the terms of any Bonus.
6.6 Discretionary Bonus Payments
6.6.1 Notwithstanding the performance criteria specified in Section 6.5 for payment of a Bonus, the Compensation Committee in its sole discretion may
grant a smaller Bonus, or no Bonus at all, instead of the Bonus amount determined
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under Section 6.5, for partial achievement of performance criteria or based on other performance criteria or discretionary criteria, but may not, in any case,
grant a Bonus in excess of the maximum Bonus determined under Section 6.5.
6.6.2 In the following situations the Compensation Committee may approve a discretionary bonus payment to a Management Office Holder not to exceed
three (3) months of the Management Office Holder’s base salary, upon the recommendation of the Chairman of the Board and subject to approval of the
Board of Directors: (i) extraordinary contribution to achievement of Company Performance, (ii) exceptional execution of a business strategy or initiative,
(iii) attainment of significant project milestones, and/or (iv) other similar exceptional achievement that creates sustainable value for the Company.
6.6.3 In all events, the final Bonus granted to an Management Office Holder for an applicable Performance Period will be consistent with and subject to the
Company’s Compensation Policy then in effect.
6.7 Treatment of Bonus in Case of Separation, Accident, Illness or Death
6.7.1 In the event an of a Management Office Holder’s termination for any reason prior to the payment of the Bonus other than (i) the Management Office
Holder’s disabling illness, accident or death, or (ii) involuntary termination due to restructuring, reorganization, reduction in force, or any other reason as
determined by the Company, subject to the approval of the Compensation Committee, not by the Employer for Cause, as defined in Section 6.7.3, the
Bonus for such Performance Period will be forfeited.
6.7.2 Subject to applicable law, if the Compensation Committee shall find that any Management Office Holder to whom any amount is payable under the
annual cash bonus plan is unable to care for his or her affairs because of illness, accident or death, then any payment due to such Management Office
Holder or his or her estate (unless a prior claim has been made by a duly appointed legal representative) may, if the Compensation Committee so directs the
Company, be paid to his or her spouse, child, relative, an institution maintaining or having custody of such Management Office Holder, or any other person
deemed by the Compensation Committee to be an appropriate recipient on behalf of such Management Office Holder otherwise entitled to payment. Any
such payment shall be complete discharge of the liability of the Compensation Committee and the Company thereafter.
6.7.3 As used in this Compensation Policy, “Cause” means a good faith determination by the Company of: (i) gross negligence, willful misconduct, or
neglect in the performance of the Management Office Holders duties and services as an employee; (b) violation of any material policy of the Company; (c)
violation of any federal, state, or local law or regulation in the performance of your employment duties; or (d) conviction of a felony or other crime
involving moral turpitude.
6.7.4 In the event of a Management Office Holder’s termination prior to Bonus payment by reason of the Management Office Holder’s voluntary
retirement, such Management Office Holder will be eligible to receive the Bonus accordance with the terms set forth in this Compensation Policy and the
Bonus payment will be paid to such Management Office Holder at the same time as paid to active Management Office Holders.
6.8 Long Term Variable Compensation
6.8.1 In addition to the annual cash bonus, a Management Office Holder’s compensation may include a long term cash incentive (“Long Term Incentive” or
“LTI”) which will consist of a cash award based on achievement of long term performance goals of the Company, subject to the receipt of all approvals
required by applicable law and to the terms of the Compensation Policy.
6.8.2 The inclusion of a Long Term Incentive for Management Office Holders shall be determined on a limited case by case basis and, if granted, may
differ from one Management Office Holder to another based on the parameters specified in Section 4.2.
6.8.3 The target Long Term Incentive for eligible Management Office Holders will be no less than twenty percent (20%) and no more than forty percent
(40%) of base salary, calculated on a pro-rata basis for any partial Performance Period worked, for one hundred percent (100%) achievement of Company
and individual performance objectives determined as follows: (i) the achievement of a combination of budgeted net sales and budgeted EBT targets, with
each given equal weight, over not less than a three year Performance Period (“LTI Company Performance”), and (ii) individual performance as defined in
Section 6.5.11.4 and scored over the same not-less-than three year Performance Period (“LTI Individual Performance”), with the LTI Company
Performance and LTI Individual Performance given equal weight.
6.8.4 The LTI Company Performance and LTI Individual Performance payout multipliers applied to the target Long Term Incentive will be capped at a
maximum of one hundred and fifty percent (150%).
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6.8.5 For eligible Management Office Holders, following the close of each Performance Period, the Company may award a Long Term Incentive for such
Performance Period, as determined by the Company, with the approval of the Compensation Committee and the Board. Such Long Term Incentive, to the
extent earned, will be paid to the eligible Management Office Holder no earlier than following the financial close of the third Performance Period following
the Performance Period for which the Long Term Incentive was awarded.
6.8.6 Except as otherwise provided by the Company, an eligible Management Office Holder will not be entitled to receive any Long Term Incentive cash
payment if the Management Office Holder is not employed by and actively working for the Company at the time such Long Term Incentive cash payment
is to be paid.
6.8.7 Notwithstanding the above, the Management Office Holder will forfeit all accrued Long Term Incentive cash payments if the Management Office
Holder is terminated by the Company for Cause.
6.9 Maximum Variable Compensation
6.9.1 The maximum variable compensation, including the annual cash Bonus, Long Term Incentive and any discretionary payment awarded pursuant to
Section 6.6.1, as a percentage of the base salary, may differ from one Management Office Holder to another based on the criteria specified in Section 4.2
above, but, in any case, will not exceed one hundred and fifty percent (150%) of base salary, for each Performance Period.
6.10 Ratio of the Management Office Holder’s compensation to the average and median salary in the Company
6.10.1 Due to the Company’s global operations, the Compensation Committee has taken and will take into consideration while determining the
Management Office Holders’ compensation, the fact that the Company’s employees are employed in various countries worldwide, under different terms of
employment. Therefore, the Compensation Committee shall consider the relationship between the terms of service and employment of the Management
Office Holder and the salary of the other employees of the Company in each Management Office Holder’s geographic location, and in particular the ratio of
the total compensation for the Management Office Holders of the Company to the average and median salary of the Company’s employees in each
geographic location. The Company estimates that the gap between the compensation of Management Office Holders and other employees, assuming
implementation of this Policy, will have no adverse effect on the working relationships in the Company. The possible ramifications of that gap on the daily
working environment in the Company were examined and will continue to be examined by the Compensation Committee from time to time in order to
ensure that levels of executive compensation, as compared to those of the overall workforce, will not have a negative impact on work relations in the
Company.
6.11 Termination Related Terms
6.11.1 Statutory Severance related terms and payments will be made in accordance and subject to the applicable law in each geographic location of the
Company’s Management Office Holders, and according to the actual terms of termination determined for each Management Office Holder in his or her
employment agreement.
6.11.2 Subject to applicable law, should the Company decide to make termination payments to a departing Management Office Holder, such payments may
include, but not exceed an aggregate of fifteen (15) months’ pay for the combined advanced notice period and severance pay.
6.11.3 When considering any termination payments, the Compensation Committee may consider certain criteria, including, but not limited to, the length of
the Management Office Holder’s employment period, his or her performance during his or her employment, the circumstances surrounding the termination
of employment, etc.
7. Non-Material Amendments to Existing Compensation
7.1 In accordance with Section 1B3 to the Companies Law Regulations (Relief in Transactions With Related Parties), 2000, a non-material change in the
terms of compensation of an Office Holder who reports to the chief executive officer will not require the approval of the Compensation Committee, as
stated in Section 272(C) to the Companies Law, so long as the change in compensation does not exceed 5% of the annual cost of the Fixed Compensation
component, has been approved by the chief executive officer, and is consistent with the terms of this Compensation Policy.
8. Compensation of Non-Management Directors
8.1 The Companies Law regulations generally require an Israeli public company to have at least two external directors with no prior linkage to the
company or to any controlling shareholder (“External Directors”).
8.2 External Directors are elected by shareholders for terms of three years.
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8.3 For so long as the Company is required to, and actually does, elect External Directors, the compensation of the External Directors shall be fixed in
accordance with the Companies Law Regulations (Rules Regarding Remuneration and Expenses for an External Director) 5760-2000 (such compensation,
the “External Director Fees”).
8.4 The compensation paid to Non-Management Directors, excluding External Directors governed by External Director Fees, in their capacity as such shall
be determined, taking into account: (i) the field in which the Company operates, (ii) comparison with companies of a similar size with global operations
and structure of a similar magnitude, whether listed for trading in Israel or overseas, or privately-held, and (iii) the contribution and active involvement in
the business of the Company. Such compensation may be paid to the Director or to a company controlled by such Director.
8.5 The Company shall reimburse, or cover in advance for, its Non-Management Directors, expenses (including travel expenses) incurred in connection
with attending meetings of the Board and its committees or performing other services for the Company in their capacity as Non-Management Directors in
accordance with this Policy and Israeli law.
8.6 Non-Management Directors (other than External Directors, whose compensation is fixed in accordance with the Companies Law regulations) who
provide additional professional and/or consulting services outside of their capacity as Non-Management Directors may be entitled to additional
compensation as shall be determined by the Company, consisting of: (i) management or consulting fees, and/or (ii) annual cash bonus.
8.7 Mr. Dilip Shanghvi (a Director and Chairman of the Board) and Mr. Sudhir Valia (a Director) are eligible to participate in the Company’s annual cash
bonus plan based upon the Company’s achievement of defined performance objectives, subject to the receipt of all approvals required by applicable law
and to the terms of this Compensation Policy.
8.7.1 The Target Bonus for Mr. Dilip Shanghvi shall be equal to one hundred percent (100%) of his annual director fee.
8.7.2 The Bonus for Mr. Dilip Shanghvi will be based one hundred percent (100%) on Company Performance.
8.7.3 The Target Bonus for Mr. Sudhir Valia shall be equal to one hundred percent (100%) of his annual director fee.
8.7.4 The Bonus for Mr. Sudhir Valia will be based one hundred percent (100%) on Company Performance.
8.7.5 The Bonuses that may be paid to Mr. Dilip Shanghvi and Mr. Sudhir Valia shall be determined in accordance with same process for Management
Office Holders set forth in Section 6.5.9 of this Policy.
9. Clawback/Recoupment
9.1 Notwithstanding anything contained herein to the contrary, the Company shall have the authority to recover all or a portion of any compensation paid to
an Office Holder that was paid on the basis of financial data included in its financial statements, in any Performance Period, that were found to be
inaccurate and were subsequently restated.
9.2 In such event, the Company will seek reimbursement from the Office Holder to the extent such Office Holder would not have been entitled to all or a
portion of such compensation, based on the financial data included in the restated financial statements. The Compensation Committee will be responsible
for approving the amounts to be recouped and for setting terms for such recoupment from time to time.
10. Withholding Obligations
10.1 Any tax consequences arising from any grant or payment of any cash compensation award or from any other event or act of the Company hereunder
shall be borne solely by the Office Holder. The Company shall withhold taxes according to the requirements under the applicable laws, rules, and
regulations.
11. No Limitation on Compensation
11.1 Subject to receipt of the requisite approvals under the Companies Law, nothing in this Policy shall be construed to limit the right of the Company to
establish other incentive plans or to pay compensation to its employees, Office Holders (including Directors) in cash or property, that are aimed at the
achievement of short and/or long-term Company objectives, in a manner that is not expressly authorized under this Policy.
12. Office Holders Insurance, Indemnification and Exemption.
12.1 The Company may exempt its Office Holders from liability and provide them with indemnification to the fullest extent permitted by law and its
Articles of Association, and may provide them with indemnification and release agreement
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providing for same. In addition, the Company’s Office Holders may be covered by the Company’s directors’ and officers’ liability insurance policies. The
coverage under the Company’s directors’ and officers’ liability insurance policies — both per claim and in the aggregate— will be no more than $100
million, in the aggregate, including directors’ and officers’ insurance coverage, any Side A -DIC policy covering directors and officers individually or any
other type of directors’ and officers’ liability insurance. The coverage, including the limit of liability, the premiums and the deductibles, and each extension
or renewal of such coverage, shall be approved by the Committee (and, if required by law, by the Board) which shall determine that (x) the total amount of
the coverage is reasonable considering the Company’s exposures, the scope of coverage and the market conditions, and (y) the amounts of the premiums
and the deductibles for such insurance coverage reflect then-current market conditions and shall not materially affect the Company’s profitability, assets or
liabilities.
12.2 The Committee and the Board may review, from time to time, the Company’s indemnification and release agreements and its directors’ and officers’
liability insurance policies, in order to ascertain whether they provide appropriate coverage. However, the Committee and the Board will not be obligated to
recommend amendments to the Company’s Articles of Association or to its indemnification and release agreements, nor shall they be required to
recommend procurement of additional insurance for Office Holders.
13. Reliance on Reports
13.1 Each member of the Compensation Committee and each member of the Board shall be fully justified in relying, acting or failing to act, and shall not
be liable for having so relied, acted, or failed to act in good faith, upon any report made by the independent public accountants of the Company and upon
any information furnished in connection with the Compensation Policy by any person or persons other than such member.
14. Processes for the supervision and control of the Compensation Policy.
14.1 The responsibility for determining the rules for interpreting the Compensation Policy, the control thereof and the updating thereof shall rest with the
Compensation Committee and the Board, based on the Compensation Committee’s recommendations.
14.2 The Compensation Committee shall periodically review the Policy and monitor its implementation, and recommend to the Board and shareholders to
amend the Policy as it deems necessary from time to time.
14.3 Other than as permitted otherwise under the Companies Law, the approval of compensation for an Office Holder shall be determined by the
Compensation Committee, and subsequently approved by the Board; the Company shall be subject to any existing and future provision of applicable law
which relates to the Compensation Policy of the Company. Further to the foregoing, it is hereby clarified that in case of any amendment made to provisions
of the Companies Law and any other applicable rules and regulations in a manner that will facilitate the Company’s ability to more readily approve or pay
Office Holder compensation, the Company shall be entitled to follow those provisions even if they contradict the principles of this Compensation Policy.
14.4 The Compensation Committee and the Board of the Company based on the Committee’s recommendations shall reserve the possibility of reducing the
variable components or setting maximum amounts with respect thereto, provided that these changes shall be in accordance with the considerations and the
criteria which have been set forth in Section 2 above, according to law and subject to the circumstances of the matter.
14.5 Stringent control procedures shall be exercised in order to ensure that the Compensation Policy is appropriately implemented.
9
INDEMNIFICATION AGREEMENT
Exhibit 4.5
THIS INDEMNIFICATION AGREEMENT (the “Agreement”), dated as of January 1, 2018, is entered into by and between Taro Pharmaceutical
Industries Ltd., an Israeli company whose address is 14 Hakitor St., Haifa Bay 26110, Israel (the “Company”), and ____________, a ________ of the
Company whose address is ______________________ (the “Indemnitee”).
WHEREAS, Indemnitee is an Office Holder (“Nosse Misra”), as such term is defined in the Companies Law, 5759–1999 (the “Companies Law” and
“Office Holder” respectively), of the Company;
WHEREAS, the Articles of Association of the Company authorize the Company to indemnify and advance expenses to its Office Holders and provide for
insurance and exculpation to its Office Holders, in each case, to the fullest extent permitted by applicable law and this Agreement is
provided to Indemnitee in accordance with applicable law, the Articles of the Association of the Company and all requisite corporate
approvals;
WHEREAS, the Company has determined that (i) the increased difficulty in attracting and retaining competent persons is detrimental to the best interests
of the Company’s shareholders and that the Company should act to assure such persons that there will be increased certainty of such
protection in the future, (ii) and it is reasonable, prudent and necessary for the Company contractually to obligate itself to indemnify,
and to advance expenses on behalf of, such persons to the fullest extent permitted by applicable law.
WHEREAS, the Company acknowledges that Indemnitee is relying on the obligations of the Company set forth in this Agreement in agreeing to continue
to serve the Company, which obligations are therefore irrevocable;
WHEREAS, in recognition of Indemnitee’s need for substantial protection against loss arising from the Indemnitee's liability, including costs and
expenses incurred by the Indemnitee due to his position as Office Holder, in order to assure Indemnitee’s continued service to the
Company in an effective manner and, in part, in order to provide Indemnitee with specific contractual assurance that the
indemnification, insurance and exculpation afforded by the Articles of Association will be available to Indemnitee, the Company
wishes to undertake in this Agreement for the indemnification of and the advancing of expenses to Indemnitee to the fullest extent
permitted by applicable law and as set forth in this Agreement and provide for insurance and exculpation of Indemnitee as set forth in
this Agreement.
NOW, THEREFORE, the parties hereto agree as follows:
1. INDEMNIFICATION AND INSURANCE.
1.1.
The Company hereby undertakes to indemnify Indemnitee to the fullest extent permitted by applicable law for any liability and expense specified
in Sections 1.1.1 through 1.1.4 below, imposed on Indemnitee due to or in connection with an act performed by such Indemnitee, either prior to
or after the date hereof, in Indemnitee’s capacity as an Office Holder, including, without limitation, as a director, officer, employee, agent or
fiduciary of the Company, any subsidiary thereof or any other corporation, collaboration, partnership, joint venture, trust or other enterprise, in
which Indemnitee serves at any time at the request of the Company (the “ Corporate Capacity ”). The term “act performed in Indemnitee’s
capacity as an Office Holder” shall include, without limitation, any act, omission and failure to act and any other circumstances relating to or
arising from Indemnitee’s service in a Corporate Capacity. Notwithstanding the foregoing, in the event that the Office Holder is the beneficiary
of an indemnification undertaking provided by a subsidiary of the Company or any other entity (other than a Secondary Indemnitor (as defined
below), if applicable), with respect to his Corporate Capacity with such subsidiary or entity, then the indemnification obligations of the Company
hereunder with respect to such Corporate Capacity shall only apply to the extent that the indemnification by such subsidiary or other entity does
not actually fully cover the indemnifiable liabilities and
expenses relating thereto. The following shall be hereinafter referred to as “Indemnifiable Events”:
1.1.1.
1.1.2.
1.1.3.
1.1.4.
Financial liability imposed on Indemnitee in favor of any person pursuant to a judgment, including a judgment rendered in the context
of a settlement or an arbitrator’s award approved by a court. For purposes of Section 1 of this Agreement, the term “person” shall
include, without limitation, a natural person, firm, partnership, joint venture, trust, company, corporation, limited liability entity,
unincorporated organization, estate, government, municipality, or any political, governmental, regulatory or similar agency or body;
Reasonable Expenses (as defined below) incurred by Indemnitee as a result of an investigation or any proceeding instituted against him
by an authority that is authorized to conduct an investigation or proceeding to the full extent permitted by the applicable law.
Reasonable Expenses incurred by or charged to Indemnitee by a court, in a proceeding instituted against him by the Company or on its
behalf or by another person, or in a criminal charge from which he was acquitted or in which he was convicted of an offence that does
not require proof of mens rea ;
A financial obligation imposed upon Indemnitee and reasonable Expenses expended Indemnitee as a result of an administrative
proceeding instituted against Indemnitee. Without derogating from the generality of the foregoing, such obligation or Expense will
include a payment which Indemnitee is obligated to make to an injured party as set forth in Section 52(54)(a)(1)(a) of the Israeli
Securities Law, 1968 – 5728 (the “Securities Law”) and Expenses that Indemnitee incurred in connection with a proceeding under
Chapters H'3, H'4 or I'1 of the Securities Law; and
1.1.5.
Any other event, occurrence or circumstances in respect of which the Company may lawfully indemnify an Office Holder of the
Company.
For the purpose of this Agreement, “Expenses” shall include, without limitation, attorneys’ fees and all other costs, expenses and
obligations paid or incurred by Indemnitee in connection with investigating, defending, being a witness in or participating in (including on
appeal), or preparing to defend, be a witness in or participate in any claim relating to any matter for which indemnification hereunder may
be provided, and expenses paid or incurred by Indemnitee in successfully enforcing this Agreement. Expenses shall be considered paid or
incurred by Indemnitee at such time as Indemnitee is required to pay or incur such cost or expenses, including upon receipt of an inoice or
payment demand. The Company shall pay the Expenses in accordance with the provisions of Section 1.3.
1.2.
Notwithstanding anything herein to the contrary, the Company shall indemnify the Indemnitee under Section 1.1.1 only with respect to events
described in Exhibit A hereto. The Board of Directors of the Company (the “Board”) has determined that the events listed in Exhibit A are
likely to occur in light of the operations of the Company. The maximum amount of indemnification payable by the Company under Section 1.1.1
of this Agreement for each event described in Exhibit A shall be as set forth in Exhibit A (the “Limit Amount”). The Limit Amount payable by
the Company for each event described in Exhibit A is deemed by the Company to be reasonable in light of the circumstances. The
indemnification provided under Section 1.1.1 herein shall not be subject to the limitations imposed by this Section 1.2 and Exhibit A if and to the
extent such limits are no longer required by the Companies Law.
The Company hereby declares that according to its Articles of Association it is authorized to indemnify the Indemnitee for liability, costs and
expenses arising from events which are not described in Exhibit A, and it undertakes to consider any request made by the Indemnitee for such
indemnification in accordance with the intent and purpose of this Agreement.
1.3.
If so requested by Indemnitee, and subject to the Company’s repayment and reimbursements rights set forth in Sections 3 and 5 below, the
Company shall pay amounts to cover Indemnitee’s
1.4.
1.5.
1.6.
1.7.
Expenses with respect to which Indemnitee is entitled to be indemnified under Section 1.1 above, as and when incurred. The payments of such
amounts shall be made by the Company directly to the Indemnitee’s legal and other advisors, as soon as practicable, but in any event no later
than fifteen (15) days after written demand by such Indemnitee therefor to the Company, and any such payment shall be deemed to constitute
indemnification hereunder. As part of the aforementioned undertaking, the Company will make available to Indemnitee any security or guarantee
that Indemnitee may be required to post in accordance with an interim decision given by a court, governmental or administrative body, or an
arbitrator, including for the purpose of substituting liens imposed on Indemnitee’s assets.
The Company’s obligation to indemnify Indemnitee and advance Expenses in accordance with this Agreement shall apply to any actual, possible
or threatened claim, action, suit, demand or proceeding or any inquiry or investigation, whether civil, criminal or investigative, arising out of the
Indemnitee’s service in the Corporate Capacity as described in Section 1.1 above, whether or not Indemnitee is still serving in such position.
The Company undertakes that, subject to the mandatory limitations under applicable law, as long as the Indemnitee is exposed to any actual or
potential claim, action, suit, demand, proceeding or any inquiry or investigation, due to the Indemnitee's position as an Office Holder, the
Company will purchase and maintain in effect directors and officers liability insurance, which will include coverage for the benefit of the
Indemnitee, providing coverage in amounts as determined by the Board. The Company hereby undertakes to notify the Indemnitee 30 days prior
to the expiration or termination of the directors and officers’ liability insurance.
The Company undertakes to give prompt written notice of the commencement of any claim hereunder or of circumstances which may lead to a
claim hereunder, to the insurers in accordance with the procedures set forth in each of the policies. The Company shall thereafter diligently take
all actions reasonably necessary under the circumstances to cause such insurers to pay, on behalf of Indemnitee, all amounts payable as a result of
such action, suit, proceeding, inquiry or investigation in accordance with the terms of such policies. The above shall not derogate from
Company’s authority to freely negotiate or reach any compromise with the insurer which is reasonable at the Company’s sole discretion provided
that the Company shall act in good faith and in a diligent manner. Despite the above, the Company shall not reach a compromise which releases
the insurer from its duty to reimburse the Indemnitee for Expenses which Indemnitee personally incurred, without the Indemnitee's prior written
approval.
In making a determination with respect to entitlement to indemnification hereunder, the person or persons or entity making such determination
shall presume that Indemnitee is entitled to indemnification under this Agreement if Indemnitee has requested it, and the Company shall have the
burden of proof to overcome that presumption in connection with the making of any determination contrary to that presumption. In the event that
the Company denies Indemnitee's request for indemnification in whole or in part, upon Indemnitee's written request, a determination with respect
to Indemnitee's entitlement thereto shall be made in the specific case by an Independent Counsel agreed upon by the Company and the
Indemnitee, and in the absence of such agreement - appointed by the head of the Israeli Bar Association.
“Independent Counsel” means a law firm, or a member of a law firm, that is experienced in matters of Israeli corporate law and neither
presently is, nor in the past five years has been, retained to represent: (i) the Company, an “interested party” (as defined in the Companies Law)
of the Company or Indemnitee in any matter material to either such party (other than in the capacity of Independent Counsel with this respect
to this Agreement or similar indemnification agreements of the Company), or (ii) any other party to the proceeding giving rise to a claim for
indemnification hereunder. Notwithstanding the foregoing, the term “Independent Counsel” shall not include any person who, under the
applicable standards of professional conduct then prevailing, would have a conflict of interest in representing either the Company or
Indemnitee in an action to determine Indemnitee's rights under this Agreement. The Company agrees to pay the reasonable fees of the
Independent Counsel referred to above and to fully indemnify such counsel against any and all expenses, claims,
liabilities and damages arising out of or relating to this Agreement or its engagement pursuant hereto, provided, however, that the Independent
Counsel shall have the authority, in his sole discretion, to oblige Indemnitee to reimburse the Company for all or a portion of his fees if he
believes that Indemnitee's claims against the Company were made arbitrarily, vexatiously or not in good faith.
2. SPECIFIC LIMITATIONS ON INDEMNIFICATION.
Notwithstanding anything to the contrary in this Agreement, the Company shall not indemnify or advance Expenses to Indemnitee with respect to (i)
any act, event or circumstance with respect to which it is prohibited to do so under the Companies Law, or (ii) a counter claim made by the Company or
in its name in connection with a claim against the Company filed by the Indemnitee.
3. REPAYMENT OF EXPENSES.
3.1.
3.2.
In the event that the Company provides or is required to provide indemnification with respect to Expenses hereunder and at any time thereafter
the Company determines, based on advice from its legal counsel, that the Indemnitee was not entitled to such payments, the amounts so
indemnified by the Company will be promptly repaid by Indemnitee, unless the Indemnitee disputes the Company’s determination, in which case
the Indemnitee’s obligation to repay to the Company shall be postponed until such dispute is resolved by a court of competent jurisdiction in a
final and non-appealable order.
Indemnitee’s obligation to repay to the Company for any Expenses or other sums paid hereunder shall be deemed as a loan given to Indemnitee
by the Company subject to the minimum interest rate prescribed by Section 3(9) of the Income Tax Ordinance [New Version], 1961, or any other
legislation replacing it, which is not considered a taxable benefit.
4. SUBROGATION.
4.1.
4.2.
Except as set forth in Section 4.2 below (to the extent applicable), in the event of payment under this Agreement, the Company shall be
subrogated to the extent of such payment to all of the rights of recovery of Indemnitee, who shall execute all documents required and shall do
everything that may be necessary to secure such rights, including the execution of such documents necessary to enable the Company effectively
to bring suit to enforce such rights.
The Company hereby acknowledges that Indemnitee may have certain rights to indemnification, advancement of Expenses and/or insurance
provided by shareholder(s) of the Company and certain of their affiliates (collectively, the “Secondary Indemnitors”). In such event, the
Company hereby agrees (i) that it is the indemnitor of first resort (i.e., its obligations to Indemnitee are primary and any obligation of the
Secondary Indemnitors to advance Expenses or to provide indemnification for the same Expenses or liabilities incurred by Indemnitee are
secondary), (ii) that it shall be required to advance the full amount of Expenses incurred by Indemnitee and shall be liable for the full amount of
all Expenses, judgments, penalties, fines and amounts paid in settlement to the extent legally permitted and as required by the terms of this
Agreement and the Articles of Association of the Company (or any other agreement between the Company and Indemnitee), without regard to
any rights Indemnitee may have against the Secondary Indemnitors, and, (iii) that it irrevocably waives, relinquishes and releases the Secondary
Indemnitors from any and all claims against the Secondary Indemnitors for contribution, subrogation or any other recovery of any kind in respect
thereof. The Company further agrees that no advancement or payment by the Secondary Indemnitors on behalf of Indemnitee with respect to any
claim for which Indemnitee has sought indemnification from the Company shall affect the foregoing and the Secondary Indemnitors shall have a
right of contribution and/or be subrogated to the extent of such advancement or payment to all of the rights of recovery of Indemnitee against the
Company. The Company and Indemnitee agree that the Secondary Indemnitors are express third party beneficiaries of the terms of this Section
4.2.
5. REIMBURSEMENT.
Except as set forth in Section 4.2 above (to the extent applicable), the Company shall not be liable under this Agreement to make any payment in
connection with any Indemnifiable Event to the extent Indemnitee has otherwise actually received payment under any insurance policy or otherwise
(without any obligation of Indemnitee to repay any such amount) of the amounts otherwise indemnifiable hereunder. Any amounts paid to Indemnitee
under such insurance policy or otherwise after the Company has indemnified Indemnitee for such liability or Expense shall be repaid to the Company
promptly upon receipt by Indemnitee, in accordance with the terms set forth in Section 3.2.
6. EFFECTIVENESS.
The Company represents and warrants that this Agreement is valid, binding and enforceable in accordance with its terms and was duly adopted and
approved by the Company, and shall be in full force and effect immediately upon its execution.
7. NOTIFICATION AND DEFENSE OF CLAIM.
Indemnitee shall notify the Company of the commencement of any action, suit or proceeding, and of the receipt of any notice or threat that any such
legal proceeding has been or shall or may be initiated against Indemnitee (including any proceedings by or against the Company and any subsidiary
thereof), promptly upon Indemnitee first becoming so aware; but the omission so to notify the Company will not relieve the Company from any
liability which it may have to Indemnitee under this Agreement unless and to the extent that such failure to provide notice materially and adversely
prejudices the Company’s ability to defend such action. Notice to the Company shall be directed to the Chief Executive Officer or Chief Financial
Officer of the Company at the address shown in the preamble to this Agreement (or such other address as the Company shall designate in writing to
Indemnitee). With respect to any such action, suit or proceeding as to which Indemnitee notifies the Company of the commencement thereof and
without derogating from Sections 1.1 and 2:
7.1.
7.2.
7.3.
7.4.
The Indemnitee will have the right to select a defense counsel unless the Company has notified him, within 10 days after it receives the
Indemnitee's notice as mentioned above, of its decision to assume the Indemnitee's defense, subject to Section 7.2.
Except as otherwise provided below, the Company, alone or jointly with any other indemnifying party similarly notified, will be entitled to
assume the defense thereof, with counsel selected by the Company which counsel is reasonably reputable with experience in the relevant field. In
such case, the fees and expenses of such counsel shall be paid by the Company. Indemnitee shall have the right to employ his or her own counsel
in such action, suit or proceeding, but the fees and expenses of such counsel incurred after notice from the Company of its assumption of the
defense thereof shall be at the expense of Indemnitee, unless: (i) the employment of counsel by Indemnitee has been authorized in writing by the
Company; (ii) Indemnitee shall have, in good faith, reasonably concluded that there may be a conflict of interest under the law and rules of
attorney professional conduct applicable to such claim between the Company and Indemnitee in the conduct of the defense of such action; or (iii)
the Company has not in fact employed counsel to assume the defense of (or perform any other act that requires prompt action in connection with)
such action, in which case the reasonable fees and expenses of counsel shall be at the expense of the Company. The Company shall not be
entitled to assume the defense of any action, suit or proceeding brought by or on behalf of the Company or as to which Indemnitee shall have
reached the conclusion specified in (ii) above.
The Company shall not be liable to indemnify Indemnitee under this Agreement for any amounts or expenses paid in connection with a
settlement of any action, claim or otherwise, effected without the Company’s prior written consent.
Subject to the provisions of Section 7.2, the Company shall have the right to conduct the defense as it sees fit in its sole discretion (provided that
the Company shall conduct the defense in good faith and in a diligent manner), including the right to settle or compromise any claim or to
consent to the entry of any judgment against Indemnitee without the consent of the Indemnitee, provided that, the amount of such settlement,
compromise or judgment does not exceed the
Limit Amount (if applicable) and is fully indemnifiable pursuant to this Agreement (subject to Section 1.2 of this Agreement) and/or applicable
law, and any such settlement, compromise or judgment does not impose any penalty or limitation on Indemnitee without the Indemnitee’s prior
written consent. The Indemnitee’s consent shall not be required if the settlement includes a complete release of Indemnitee, does not contain any
admission of wrong-doing by Indemnitee, and includes monetary sanctions only as provided above. In the case of criminal proceedings the
Company and/or its legal counsel will not have the right to plead guilty or agree to a plea-bargain in the Indemnitee’s name without the
Indemnitee’s prior written consent. Neither the Company nor Indemnitee will unreasonably withhold or delay their consent to any proposed
settlement.
7.5.
Indemnitee shall fully cooperate with the Company and shall give the Company all information and access to documents, files and to his advisors
and representatives as shall be within Indemnitee’s power, in every reasonable way as may be required by the Company with respect to any claim
which is the subject matter of this Agreement and in the defense of other claims asserted against the Company (other than claims asserted by
Indemnitee), except to the extent Indemnitee has a conflict of interest with the Company in respect thereto, provided that the Company shall
cover all expenses, costs and fees incidental thereto such that the Indemnitee will not be required to pay or bear such expenses, costs and fees.
8. EXCULPATION.
Subject to the provisions of the Companies Law, the Company hereby releases, in advance, the Office Holder from liability to the Company for any
damage that arises from the breach of the Office Holder’s duty of care to the Company (within the meaning of such terms under Sections 252 and 253
of the Companies Law), other than breach of the duty of care towards the Company in a distribution (as such term is defined in the Companies Law).
9. NON-EXCLUSIVITY.
The rights of the Indemnitee hereunder shall not be deemed exclusive of any other rights Indemnitee may have under the Company’s Articles of
Association, applicable law or otherwise, and to the extent the indemnification rights of the then serving directors and officers are more favorable to
such directors or officers than the indemnification rights provided under this Agreement to Indemnitee, Indemnitee shall be entitled to the full benefits
of such more favorable indemnification rights to the extent permitted by law.
10. PARTIAL INDEMNIFICATION.
If Indemnitee is entitled under any provision of this Agreement to indemnification by the Company for some or a portion of the Expenses, judgments,
fines or penalties actually or reasonably incurred by Indemnitee in connection with any proceedings, but not, however, for the total amount thereof, the
Company shall nevertheless indemnify Indemnitee for the portion of such Expenses, judgments, fines or penalties to which Indemnitee is entitled under
any provision of this Agreement. Subject to the provisions of Section 5 above, any amount received by Indemnitee (under any insurance policy or
otherwise) shall not reduce the Limit Amount hereunder and shall not derogate from the Company’s obligation to indemnify the Indemnitee in
accordance with the provisions of this Agreement up to the Limit Amount, as set forth in Section 1.2.
11. BINDING EFFECT.
This Agreement shall be binding upon and inure to the benefit of and be enforceable by the parties hereto and their respective successors, permitted
assigns (including any direct or indirect successor in the event of a Transaction) and a receiver, liquidator or the like of the Company, heirs, executors
and personal and legal representatives. In the event of a reorganization, acquisition, change of control merger or consolidation of the Company or a
transfer or disposition of all or substantially all of the business or assets of the Company (each a “Transaction”), the Company shall, or cause its
successor (if applicable) to undertake toward the Indemnitee to, fulfill and honor in all respects the obligations of the Company pursuant to this
Agreement, and the Company's Articles of Association will contain provisions with respect to exculpation, insurance and indemnification that are at
least as favorable to
the Indemnitee as those contained in the Articles of Association of the Company as in effect on the date hereof, which provisions will not be amended,
repealed or otherwise modified in any manner that would adversely affect the rights thereunder of Indemnitee, unless such modification is required by
applicable law. In the event that the Company consolidates with or merges into any other entity and shall not be the continuing or surviving company or
entity of such consolidation or merger or transfers or conveys all or a majority of its properties and assets, then, and in each such case, proper
provisions shall be made so that the successors and assigns of the Company, as applicable, shall succeed to the obligations of the Company set forth in
this Section 11.
In the event that in connection with a Transaction the Company purchases a directors and officers’ “tail” or “run-off” policy for the benefit of its then
serving Office Holders, then such policy shall cover Indemnitee and such coverage shall be deemed to be in satisfaction of the insurance requirements
under this Agreement. This Agreement shall continue in effect regardless of whether Indemnitee continues to serve in a Corporate Capacity.
12. SEVERABILITY.
The provisions of this Agreement shall be deemed severable and the invalidity or unenforceability of any provision shall not affect the validity or
enforceability of the other provisions hereof. If any provision of this Agreement, or the application thereof or any circumstance, is invalid or
unenforceable, (a) a suitable and equitable provision shall be substituted therefor in order to carry out, so far as may be valid and enforceable, the intent
and purpose of such invalid or unenforceable provision and (b) the remainder of this Agreement and the application of such provision or circumstances
shall not be affected by such invalidity or unenforceability, nor shall such invalidity or unenforceability affect the validity or enforceability of such
provision, or the application thereof, in any other jurisdiction.
13. NOTICE.
All notices and other communications pursuant to this Agreement shall be in writing and shall be deemed provided if delivered personally, telecopied,
sent by electronic facsimile, email, reputable overnight courier or mailed by registered or certified mail (return receipt requested), postage prepaid, to
the parties at the addresses shown in the preamble to this Agreement, or to such other address as the party to whom notice is to be given may have
furnished to the other party hereto in writing in accordance herewith. Any such notice or communication shall be deemed to have been delivered and
received (i) in the case of personal delivery, on the date of such delivery, (ii) in the case of telecopier or an electronic facsimile or email, one business
day after the date of transmission if confirmation of receipt is received, (iii) in the case of a reputable overnight courier, three business days after
deposit with such reputable overnight courier service, and (iv) in the case of mailing, on the seventh business day following that on which the mail
containing such communication is posted.
14. GOVERNING LAW; JURISDICTION.
This Agreement shall be governed by and construed and enforced in accordance with the laws of the State of Israel, without giving effect to the
conflicts of law provisions of those laws. The Company and Indemnitee each hereby irrevocably consent to the exclusive jurisdiction and venue of the
courts of Tel Aviv, Israel for all purposes in connection with any action or proceeding which arises out of or relates to this Agreement.
15. ENTIRE AGREEMENT AND TERMINATION.
This Agreement represents the entire agreement between the parties and supersedes any other agreements, contracts or understandings between the
parties, whether written or oral, with respect to the subject matter of this Agreement. It is hereby expressly agreed and understood that this Agreement
amends, restates and supersedes the previous indemnification agreement between Indemnitee and the Company in its entirety. In the event of any
contradiction between this Agreement and a previous indemnification agreement between Indemnitee and the Company, the provisions of this
Agreement will prevail.
16. NO MODIFICATION AND NO WAIVER.
No supplement, modification or amendment, termination or cancellation of this Agreement shall be binding unless executed in writing by both of the
parties hereto. No waiver of any of the provisions of this Agreement shall be deemed or shall constitute a waiver of any other provisions hereof
(whether or not similar) nor shall such waiver constitute a continuing waiver. Any waiver shall be in writing. The Company hereby undertakes not to
amend its Articles of Association in a manner which will adversely affect the provisions of this Agreement.
17. ASSIGNMENTS; NO THIRD PARTY RIGHTS.
Neither party hereto may assign any of its rights or obligations hereunder except with the express prior written consent of the other party. Nothing
herein shall be deemed to create or imply an obligation for the benefit of a third party. Without limitation of the foregoing, nothing herein shall be
deemed to create any right of any insurer that provides directors' and officers’ liability insurance, to claim, on behalf of Indemnitee, any rights
hereunder.
18. INTERPRETATION.
The obligations of the Company according to this Agreement shall be interpreted broadly and in a manner that shall facilitate its execution, to the
extent permitted by law, and for the purposes for which it was intended. For example, the obligations of the Company shall apply to any type of legal
proceeding, including without limitation, a proceeding brought against Indemnitee alone or jointly with other defendants, and whether the plaintiff is a
third party, the Company or Office Holders or shareholders thereof. In addition, the Company agrees that it shall not contend that an act was committed
by the Indemnitee recklessly unless it can prove that such recklessness attained a level equivalent to that of an act committed with actual deliberate
intent. In the event of a conflict between any provision of this Agreement and any provision of the law, said provision of the law shall supersede the
specific provision in this Agreement, but shall not limit or diminish the validity of the remaining provisions of this Agreement.
19. COUNTERPARTS.
This Agreement may be executed in any number of counterparts, each of which shall be deemed an original and enforceable against the parties actually
executing such counterpart, and all of which together shall constitute one and the same instrument; it being understood that parties need not sign the
same counterpart. The exchange of an executed Agreement (in counterparts or otherwise) by facsimile or by electronic delivery in pdf format shall be
sufficient to bind the parties to the terms and conditions of this Agreement, as an original.
[SIGNATURE PAGE TO FOLLOW]
IN WITNESS WHEREOF, the parties, each acting under due and proper authority, have executed this Indemnification Agreement as of the
date first mentioned above, in one or more counterparts.
Taro Pharmaceutical Industries Ltd.
By:
__________________
Name and title:
_____________
Title:
____________________
Signature:
__________________
EXHIBIT A*
TYPE OF EVENT
1. Claims in connection with employment relationships with employees of the Company, and in connection with business
relations between the Company and its employees, independent contractors, customers, suppliers and various service
providers.
2. Negotiations, execution, delivery and performance of agreements of any kind or nature, anti-competitive acts, acts of
commercial wrongdoing, approval of corporate actions including the approval of the acts of the Company’s management,
their guidance and their supervision, actions concerning the approval of transactions with Office Holders or shareholders,
including controlling persons and claims of failure to exercise business judgment and a reasonable level of proficiency,
expertise and care with respect to the Company’s business.
3. Violation, infringement and other misuse of copyrights, patents, designs, trade secrets and any other intellectual property
rights, breach of confidentiality obligations, acts in regard of invasion of privacy including with respect to databases, acts
in connection with slander and defamation, and claims in connection with publishing or providing any information,
including any filings with any governmental authorities, whether or not required under any applicable laws.
4. Violations of securities laws of any jurisdiction, including without limitation, fraudulent disclosure claims, failure to
comply with any securities authority or any stock exchange disclosure or other rules and any other claims relating to
relationships with investors, debt holders, shareholders and the investment community; claims relating to or arising out of
financing arrangements, any breach of financial covenants or other obligations towards lenders or debt holders of the
Company, class actions, violations of laws requiring the Company to obtain regulatory and governmental licenses, permits
and authorizations in any jurisdiction; actions taken in connection with the issuance of any type of securities of Company,
including, without limitation, the grant of options to purchase any of the same.
LIMIT
AMOUNT
US$20,000,000
US$20,000,000
US$20,000,000
US$20,000,000
5. Liabilities arising in connection with any products or services developed, distributed, sold, provided, licensed or
marketed by the Company, and any actions in connection with the distribution, sale, license or use of such products.
US$20,000,000
6. The offering of securities by the Company to the public and/or to private investors or the offer by the Company to
purchase securities from the public and/or from private investors or other holders pursuant to a prospectus, agreements,
notices, reports, tenders and/or other proceedings.
7. Events in connection with change in ownership or in the structure of the Company, its reorganization, dissolution, or any
decision concerning any of the foregoing, including but not limited to, merger, sale or acquisition of assets, division or
change in capital.
US$20,000,000
US$50,000,000
8. Any claim or demand made in connection with any transaction not in the ordinary course of business of the Company,
including the sale, lease or purchase of any assets or business.
US$20,000,000
9. Any claim or demand made by any third party suffering any personal injury and/or bodily injury or damage to business
or personal property or any other type of damage through any act or omission attributed to the Company, or its employees,
agents or other persons acting or allegedly acting on its behalf.
US$20,000,000
10. Any claim or demand made directly or indirectly in connection with complete or partial failure, by the Company or its
directors, officers and employees, to pay, report, keep applicable records or otherwise, of any foreign, federal, state, county,
local, municipal or city taxes or other compulsory payments of any nature whatsoever, including, without limitation,
income, sales, use, transfer, excise, value added, registration, severance, stamp, occupation, customs, duties, real property,
personal property, capital stock, social security, unemployment, disability, payroll or employee withholding or other
withholding, including any interest, penalty or addition thereto, whether disputed or not.
11. Any administrative, regulatory, judicial or civil actions, orders, decrees, suits, demands, demand letters, directives,
claims, liens, investigations, proceedings or notices of noncompliance or violation by any governmental entity or other
person alleging potential responsibility or liability (including potential responsibility or liability for costs of enforcement
investigation, cleanup, governmental response, removal or remediation, for natural resources damages, property damage,
personal injuries or penalties or for contribution, indemnification, cost recovery, compensation or injunctive relief) arising
out of, based on or related to (a) the presence of, release, spill, emission, leaning, dumping, pouring, deposit, disposal,
discharge, leaching or migration into the environment (each a “Release”) or threatened Release of, or exposure to, any
hazardous, toxic, explosive or radioactive substances, wastes or other pollutants, including petroleum or petroleum
distillates, asbestos or asbestos-containing material, polychlorinated biphenyls (“PCBs”) or PCB-containing materials or
equipment, radon gas, infectious or medical wastes and all other substances or wastes of any nature regulated pursuant to
any environmental law, at any location, whether or not owned, operated, leased or managed by the Company or any of its
subsidiaries, or (b) circumstances forming the basis of any violation of any environmental law or environmental permit,
license, registration or other authorization required under applicable environmental law.
US$20,000,000
US$20,000,000
12. Any administrative, regulatory or judicial actions, orders, decrees, suits, demands, demand letters, directives, claims,
liens, investigations, proceedings or notices of noncompliance or violation by any governmental entity or other person
alleging the failure to comply with any statute, law, ordinance, rule, regulation, order or decree of any governmental entity
applicable to the Company or any of its businesses, assets or operations, or the terms and conditions of any operating
certificate or licensing agreement.
US$20,000,000
13. Participation and/or non-participation at the Company’s Board meetings, bona fide expression of opinion and/or voting
and/or abstention from voting at the Company’s Board meetings.
US$20,000,000
14. Review and approval of the Company’s financial statements, including any action, consent or approval related to or
arising from the foregoing, including, without limitations, execution of certificates for the benefit of third parties related to
the financial statements.
15. All actions, consents and approvals relating to a distribution of dividends, in cash or otherwise.
16. Liabilities arising out of advertising, including misrepresentations regarding the Company's products and unlawful
distribution of emails.
US$20,000,000
US$20,000,000
US$20,000,000
* Any reference in this Exhibit A to the Company shall include the Company and any entity in which the Indemnitee serves in a Corporate Capacity.
I, Uday Baldota, certify that:
CERTIFICATION
Exhibit 12.1
1.
2.
3.
4.
I have reviewed this annual report on Form 20-F of Taro Pharmaceutical Industries 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:
a)
b)
c)
d)
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):
a)
b)
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: July 25, 2022
/s/ Uday Baldota
Name:
Title:
Uday Baldota
Chief Executive Officer and Director
I, William Coote, certify that:
CERTIFICATION
Exhibit 12.2
1.
2.
3.
4.
I have reviewed this annual report on Form 20-F of Taro Pharmaceutical Industries 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:
a)
b)
c)
d)
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):
a)
b)
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: July 25, 2022
/s/ William Coote
Name:
Title:
William Coote
Vice President, Chief Financial Officer and Chief Accounting
Officer
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT 2002
Exhibit 13
In connection with the Annual Report of Taro Pharmaceutical Industries Ltd. (the “Company”) on Form 20-F for the period ended March 31, 2022 as filed
with the Securities and Exchange Commission on the date hereof (the “Report”), we, Uday Baldota, Chief Executive Officer and Director of the Company,
and William Coote, Vice President, Chief Financial Officer and Chief Accounting Officer of the Company, certify, pursuant to 18 U.S.C. §1350, as adopted
pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:
(1)
(2)
The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the
Company.
Date: July 25, 2022
By:
By:
/s/ Uday Baldota
Uday Baldota
Chief Executive Officer and Director
/s/ William Coote
William Coote
Vice President, Chief Financial Officer and Chief
Accounting Officer