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
OR
☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended March 31, 2020
OR
☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For the transition period from to
OR
☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
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)
Daphne Huang
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: Daphne.Huang@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:
38,258,077 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, 2020
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 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 United States. 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, 2020 (the “2020 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 2020 Annual Report is being filed in respect of the fiscal year ended March 31, 2020, and contains the audited consolidated financial
statements for the year then ended.
FORWARD-LOOKING STATEMENTS
Except for the historical information contained in this 2020 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. 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 2020 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 United States,
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 2020 Annual Report are reported in U.S. dollars in thousands, unless otherwise indicated,
and are prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). Totals presented in this
2020 Annual Report may not total correctly due to rounding of numbers.
All references in this 2020 Annual Report to “dollars,” “USD,” or “$,” are to U.S. dollars, all references in this Annual Report to “NIS” are to New
Israeli Shekel, and all references in this Annual Report to “CAD” are to Canadian dollars. The published (1) representative exchange rate between the NIS
and the dollar for March 31, 2020, was NIS 3.57 per $1.00. The published (2) representative exchange rate between the CAD and the dollar for March 31,
2020, was CAD 1.41 CAD 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. SELECTED FINANCIAL DATA
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
ii
1
1
1
2
2
3
3
3
23
23
24
35
35
37
37
37
47
48
50
50
50
51
51
54
54
61
62
63
63
64
64
65
65
66
66
66
66
66
66
66
66
67
67
67
73
73
73
84
84
85
85
85
86
87
87
87
87
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
87
87
88
88
88
88
89
90
91
92
92
92
92
iii
ITEM 1.
IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not applicable.
PART I
ITEM 2.
OFFER STATISTICS AND EXPECTED TIMETABLE
Not applicable.
1
ITEM 3.
KEY INFORMATION
A. SELECTED FINANCIAL DATA
We have derived the following selected consolidated financial data for the years ended March 31, 2020, 2019 and 2018, and as of March 31, 2020
and 2019, from our audited consolidated financial statements set forth elsewhere in this 2020 Annual Report, which have been prepared in accordance with
U.S. GAAP. We have derived the consolidated selected financial data for the years ended March 31, 2017 and 2016, from our audited consolidated
financial statements not included in this Annual Report. You should read the selected consolidated financial data together with “Item 5—Operating and
Financial Review and Prospects” and our consolidated financial statements, related notes and other financial information included elsewhere in this 2020
Annual Report.
Consolidated Statements of Operations 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
Financial (income) expenses, net
Other gain, net
Income before income taxes
Tax expense
Income from continuing operations
Net loss from discontinued operations attributable to Taro
Net income
Net income (loss) attributable to non-controlling interest
Net income attributable to Taro
Net income from continuing operations attributable to Taro
Net loss from discontinued operations attributable to Taro
Net income attributable to Taro
Net income per ordinary share from continuing operations
attributable to Taro:
Basic and Diluted
Net loss per ordinary share from discontinued operations attributable
to Taro:
Basic and Diluted
Net income per ordinary share attributable to Taro:
Basic and Diluted
Weighted-average number of ordinary shares used to compute net
income per share:
$
$
$
$
$
$
$
2020
Year Ended March 31,
2018
U.S. dollars and shares in thousands (except per share data)
2017
2019
644,769 $
245,044
—
399,725
59,777
93,413
—
153,190
246,535
(48,482)
3,018
298,035
53,485
244,550
—
244,550
309
244,241 $
$
669,893
224,169
—
445,724
63,238
89,971
(3,678)
149,531
296,193
(58,851)
1,810
356,854
74,732
282,122
—
282,122
345
281,777
$
661,913 $
198,405
—
463,508
70,418
88,196
1,884
160,498
303,010
12,531
1,889
292,368
81,954
210,414
(335)
210,079
(1,071)
211,150 $
879,387 $
207,860
276
671,251
70,644
85,656
—
156,300
514,951
(34,636)
11,211
560,798
103,780
457,018
(352)
456,666
310
456,356 $
244,241 $
—
244,241 $
281,777
—
281,777
$
$
211,485 $
(335)
211,150 $
456,708 $
(352)
456,356 $
2016
950,751
169,743
2,042
778,966
71,160
92,365
973
164,498
614,468
(19,672)
2,680
636,820
95,313
541,507
(236)
541,271
339
540,932
541,168
(236)
540,932
6.35 $
7.23
$
5.27 $
11.06 $
12.63
— $
—
$
(0.01) $
(0.01) $
(0.01)
6.35 $
7.23
$
5.26 $
11.05 $
12.62
Basic and Diluted
38,460
38,990
40,155
41,301
42,832
2
Consolidated Balance Sheet Data:
Working capital
Property, plant and equipment, net
Total assets
Shareholders’ equity
Dividends
2020
2019
As of March 31,
2018
U.S. dollars in thousands
2017
2016
$
$
$
$
1,309,867 $
209,961 $
2,341,252 $
2,109,759 $
1,265,899 $
$
206,242
$
2,135,326
$
1,911,122
1,680,879 $
$
193,727
$
2,433,210
$
2,210,399
1,789,187 $
$
180,085
$
2,289,753
$
2,073,806
1,632,133
159,459
2,188,033
1,937,144
We had never paid cash dividends until Fiscal Year 2019. On November 5, 2018, the Taro Board of Directors declared a $500 million special cash
dividend on Taro 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 which 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.
3
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:
•
•
•
•
•
•
•
•
•
•
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.
4
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.
5
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 United States, 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 United States. 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 United States, 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 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 Inc. 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 a controlled substance in the United States and other controlled substances in Israel and Canada, we must meet the
requirements of the Controlled Substances Act in the United States and its equivalents in Israel and Canada, as well as the regulations promulgated
thereunder in each country. These regulations include stringent requirements for registration, manufacturing controls, importation, distribution,
exportation, receipt and handling procedures and security to prevent diversion of, or unauthorized access to, the controlled substances in each stage of the
production and distribution process. The United States Drug Enforcement Administration (“DEA”) and comparable regulatory authorities in Israel and
Canada may periodically inspect our facilities for compliance with the Controlled Substances Act and its equivalents in Israel and Canada. Any failure to
comply with these laws and regulations could lead to a variety of sanctions, including the revocation, or a denial of renewal, of our DEA registration (or
Israeli or Canadian equivalent), injunctions, or civil or criminal penalties.
6
Furthermore, all of the products that we manufacture, and most of the products we distribute, are manufactured outside the United States and must
be shipped into the United States. The FDA and the DEA, in conjunction with the United States Customs and Border Protection, have greater discretion to
prohibit the importation of foreign goods into the United State than they have to stop the distribution of products that are manufactured in the United States.
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, 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 United States. 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.
7
We face uncertainties due to litigation brought against the federal government by a number of state attorneys general in 2018 and supported by the
current administration, who seek a ruling that the PPACA is unconstitutional. The Supreme Court has decided to hear an appeal of a lower court ruling
brought by other attorneys general and the U.S. House of Representatives. The Supreme Court is expected to rule on the case in its next session, which
begins in October 2020. We cannot predict whether PPACA will be invalidated by the Supreme Court, and if so, whether Congress will replace it with an
alternative health care framework or what the impact of any such new framework will have on drug coverage, reimbursement, required discounts, and
regulatory requirements. There is no assurance that any future repeal, replacement, or modification of the PPACA will not adversely affect our business
and financial results, and we cannot predict how future federal or state legislative or administrative changes relating to healthcare reform will affect 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:
•
•
•
•
•
trends in managed healthcare in the United States;
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 (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 current
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 has been 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 April 1, 2020. These measures have
increased or will increase our cost of selling to the Medicaid market.
8
Furthermore, as a result of legislative changes in the Bipartisan Budget Act of 2015 (“BBA”), effective for the first calendar quarter of 2017, 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.
The full effects of the PPACA and the BBA on Medicaid payments and on our Medicaid rebates cannot be known at this time, in part because not all
of these provisions have been implemented yet, but they may have an adverse impact on our results of operations. In addition, a number of attorneys
general, supported by the current administration, have sought the total repeal of PPACA in litigation challenging its constitutionality, and Congress has
enacted legislation that repealed key portions of the PPACA. There is uncertainty with respect to the impact that a potential repeal or other changes, if any,
may have, and any changes likely will take time to unfold. Any additional federal healthcare reform measures adopted in the future could limit the amounts
that federal and state governments will pay for healthcare products and services, and in turn could significantly reduce the projected value of certain
development projects and reduce our profitability.
Both Congress and the current administration have proposed or are currently considering a wide variety of actions intended to reduce drug prices.
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 certain low-income Medicare Part D enrollees, 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:
•
•
•
•
•
•
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 and teaching
hospitals 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.
9
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.
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.
Product recalls could harm our business.
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.
Our reputation among consumers and our customers in the pharmacy trade may be negatively impacted by incidents of counterfeiting of our products.
The counterfeiting of pharmaceutical products is a widely reported problem for pharmaceutical manufacturers, distributors, retailers and consumers
in the United States, 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.
10
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.
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.
Some of our products are manufactured by independent third-parties. Any failure by any of these third-parties to perform this manufacturing properly
or follow cGMPs, may have an adverse effect upon our ability to maintain regulatory approvals or continue marketing our products.
Certain products are manufactured by independent third-parties. Their compliance with cGMPs and other regulatory requirements is essential to our
obtaining and maintaining regulatory approvals and marketing authorization for these products in the countries in which they are sold. Any failure by any
of these third-parties to perform this manufacturing properly or follow cGMPs may have an adverse effect upon our ability to obtain or maintain regulatory
approvals or continue marketing our products.
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 United
States. 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.
11
Risks Relating to Our Company and Our Operations
Sun Pharmaceutical Industries Ltd., and its affiliates, currently controls 84.7% 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) currently control,
through their beneficial ownership of 77.1% of our outstanding ordinary shares and 100% of our founders’ shares through Sun Pharmaceutical Industries
Ltd., 84.7% of the voting power in our Company, as of March 31, 2020. Mr. Dilip Shanghvi, along with entities controlled by him and members of his
family, control 54.7% of Sun Pharma as of March 31, 2020. Sun is able to control the outcome of shareholder votes of the Company requiring a majority
of the votes.
50% of the voting power in our subsidiary Taro U.S.A. is held by a corporation which is controlled by Sun.
The share capital of Taro U.S.A. is divided into two classes. Taro Israel owns 96.9% of the shares that have economic rights and 50% of the shares
that have voting rights in Taro U.S.A. Taro Development Corporation (“TDC”) owns 3.1% of the shares that have economic rights and 50% of the shares
that have voting rights in Taro U.S.A. Sun owns all of the outstanding voting shares of TDC and thereby controls TDC. Although TDC has agreed to vote
all of its shares in Taro U.S.A. for the election to its board of directors of such persons as Taro Israel may designate, TDC may terminate the agreement
upon one year written notice. In the event that TDC were to cease voting its shares in Taro U.S.A. for our designees, or otherwise, in accordance with Taro
Israel’s preference, TDC could prevent Taro Israel from electing a majority of the board of directors of Taro U.S.A., effectively block actions that require
approval of a majority of the voting power in Taro U.S.A. and potentially preclude the Company from consolidating Taro U.S.A. into the Company’s
financial statements. Taro U.S.A. accounted for approximately 75%, 79% and 81% of the Company’s consolidated revenue for the years ended March 31,
2020, 2019 and 2018, respectively.
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.
12
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:
•
•
•
•
•
•
•
•
•
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;
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.
13
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:
•
•
•
•
failure to enroll a sufficient number of patients meeting eligibility criteria;
failure of the new product to demonstrate safety and/or efficacy;
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:
•
•
•
•
•
•
•
•
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;
14
•
•
•
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.
On December 22, 2017, the United States enacted the Tax Cuts and Jobs Act (the “Tax Act”), which among other provisions, reduced the U.S.
corporate tax rate from 35% to 21%, effective January 1, 2018. Fiscal year filers, such as Taro U.S.A., recognize a partial reduction in the U.S. corporate
tax rate for their year ending after January 1, 2018, and thereafter recognize the full reduction in the U.S. corporate tax rate. For the year ended March 31,
2018, Taro U.S.A. was subject to a 31.5% federal tax rate, and for subsequent years Taro U.S.A. is subject to a 21% federal tax rate.
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 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, 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 and result in misappropriation, corruption or loss of
15
confidential and other information. 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. 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, 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. 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.
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.
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 United States, 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 employees and
operations, including social distancing, the supply and use of personal protective equipment, split shifts and health assessments. We have incurred
increased costs to put in place additional protection for the health and safety of our employees within our offices and facilities. 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.
16
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 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.
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 United States. Some patent applications in the United States 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
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:
•
•
•
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;
17
•
•
•
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 United States 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 United States, we must challenge
the patent under the procedures set forth in the Hatch-Waxman Act. In the United States, 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 United States 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.
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, 2020, we did not identify any material weaknesses in internal
controls. Failure to maintain adequate internal controls could negatively affect shareholder and customer confidence.
18
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:
•
•
•
•
•
•
•
•
•
•
•
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 2020 Annual Report.
No citizen or resident of the United States 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 United States Internal Revenue Code of 1986, as
amended (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 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). As of
March 31, 2020, no citizen or resident of the United States 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 U.S. dollar 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.
19
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. 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.
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 United States, 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.
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 has been no permanent government and no budget adopted since
December 2018, may 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, 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 United States Department of State has issued 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.
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.
20
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 requirement. Any disruption in our operations could harm our business.
We may be affected by fluctuations in the NIS relative to the U.S. Dollar.
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 U.S. dollars, is subject to the risk of exchange rate fluctuations between the U.S. dollar and the NIS. During the year-ended
March 31, 2020, the value of the NIS increased 1.7% relative to the U.S. dollar based on the change in the exchange rate from the start to the end of the
fiscal year. However, for much of the fiscal year, the value of the NIS appreciated relative to the U.S. Dollar, which had a negative impact on our results of
operations by increasing the U.S. dollar value of our NIS-incurred expenses. If the NIS were to appreciate once again relative to the U.S. dollar, that would
negatively affect our U.S. dollar-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 National Technological Innovation Authority (the “Authority”) (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.
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
21
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 United States 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. 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 United States and a substantial portion of our
assets and the assets of such persons are located outside the United States. Therefore, it may be difficult to enforce a judgment obtained in the United
States 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 United
States 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 in the United States. 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
decision regarding this legislation may adversely affect us and may prevent us from exporting Israeli-manufactured 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.
22
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
comparative 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 adversely affected if the rate of inflation in Canada exceeds the rate of devaluation of the CAD against the U.S. dollar.
A substantial portion of our expenses, primarily labor, packaging materials, occupancy, selling, marketing and administrative expenses in Canada,
are incurred in CAD. As a result, the cost of our operations in Canada, as measured in U.S. dollars, is subject to the risk of exchange rate fluctuations
among the U.S. dollar and the CAD. During the year-ended March 31, 2020, the value of the CAD decreased 6.0% with respect to the U.S. dollar. That
change had a positive impact on our results of operations. If the CAD were to depreciate relative to the U.S. dollar, it would positively affect our U.S.
dollar-measured results of operations. If the CAD were to appreciate ever further relative to the U.S. dollar, it would negatively affect our U.S. dollar-
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.
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 United States is Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Drive, Hawthorne, NY 10532. Our telephone number at
that address is +1-914-345-9000.
23
The 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 annual report.
Capital Expenditures
During the years ended March 31, 2020, 2019 and 2018, our capital expenditures were $26.6 million, $27.0 million and $26.9 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
2020 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 United States, Canada and Israel. 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.
24
We operate principally through three entities: Taro Israel, and two of its subsidiaries (including indirect), Taro Pharmaceuticals Inc. (“Taro Canada”)
and Taro U.S.A. The principal activities and primary product lines of these subsidiaries may be summarized as follows:
Entity
Principal Activities
Primary Product Lines
Taro Israel
Taro Canada
• Manufactures more than 100 finished dosage form
pharmaceutical products for sale in Israel and for
export
• Dermatology: Rx and OTC semi-solid (creams,
ointments, lotions, foams and gels) and liquid
products
• Produces APIs used in the manufacture of finished
• Cardiology and Neurology: Prescription oral dosage
dosage form pharmaceutical products
• Markets and distributes both proprietary and
generic products in the local Israeli market
• Performs research and development
products
• Analgesics, Rx and OTC oral dosage products
• Central Nervous System (CNS) – Rx oral dosage
products
• Allergy (Antihistamine): OTC oral dosage products
• Manufactures more than 200 finished dosage form
pharmaceutical products for sale in Canada and for
export to the U.S. and other markets
• Dermatology: Rx and OTC semi-solid products
(creams, ointments, lotions and gels) and liquid
products
• Markets and distributes both proprietary and
generic products in the Canadian market
• Performs research and development
• Allergy (Antihistamine): OTC oral dosage products
Taro U.S.A.
• Markets and distributes both proprietary and
• Dermatology: Rx and OTC semi-solid products
generic products in the U.S. market
• Performs regulatory, post marketing and clinical
activities
(creams, ointments, lotions, foams and gels) and
liquid products
• Cardiology and Neurology: Rx oral dosage products
• Other Rx and OTC products
As of March 31, 2020, 18 (excluding tentative approvals) of our ANDAs are being reviewed by the FDA. During the fiscal year ended March 31,
2020, we filed 5 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.
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.
25
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; and
the increasing number of pharmaceutical products whose patents have expired and are therefore subject to competition from, and substitution
by, generic equivalents.
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 & 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, 2020, 2019 and 2018, no product comprised 10% of our total consolidated sales.
Sales and Marketing
In the United States, 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.
26
The following is a breakdown of our net sales by geographic region, including the percentage of our total consolidated net sales for each period:
United States
Canada
Israel
Other
Total
2020
Sales
(in thousands)
$
495,673
97,997
42,817
8,282
$
644,769
Year ended March 31,
2019
2018
% of
total sales
Sales
(in thousands)
% of
total sales
Sales
(in thousands)
% of
total sales
77% $
15%
7%
1%
100% $
537,111
83,970
40,050
8,762
669,893
80% $
13%
6%
1%
100% $
549,174
67,226
38,223
7,290
661,913
83%
10%
6%
1%
100%
In the year ended March 31, 2020, revenue in the United States accounted for 77% 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 revenues 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,
2020, we sold to approximately 150 customers in the United States. The following table represents sales to our three largest customers as a percent of
consolidated net sales:
Customer
Customer A
Customer B
Customer C
2020
Year ended March 31,
2019
2018
13.0%
11.5%
7.9%
12.1%
11.0%
9.2%
15.3%
11.5%
11.4%
The following table sets forth the percentage of consolidated net sales by each type of customer in the United States in the year ended March 31,
2020:
Customer Type
Drug wholesalers and store chains
Mass merchandisers, food and retail chains
Managed care organizations
Generic drug distributors
Other
Percentage of
Consolidated Sales
43%
18%
9%
4%
3%
In the year ended March 31, 2020, sales in Canada accounted for 15% of our total consolidated net sales and Taro Canada sold to approximately 45
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.
27
The following table sets forth the percentage of consolidated net sales by each type of customer in Canada in the year ended March 31, 2020:
Customer Type
Drug wholesalers
Drug chains, independent pharmacies and others
Percentage of
Consolidated Sales
11%
4%
In the year ended March 31, 2020, sales in Israel accounted for 7% 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 United States, 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 following table sets forth the percentage of consolidated net sales by each type of customer in Israel and other international markets in the year
ended March 31, 2020:
Customer Type
Institutional
Private
Other international
Percentage of
Consolidated Sales
3%
4%
1%
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, 2020, 2019 and 2018, 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.
28
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 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 United States, 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., Mylan 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, Mylan Pharmaceuticals ULC, 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 United States 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 United States, Canada, or Israel pending approval of one or more alternate sources of raw materials.
29
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.
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 pharmaceutical industry regulations in the United States, 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.
In the United States, 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 United States, 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 the United States, Canada, Israel and other jurisdictions, 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
United States.
In the United States, 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 United States 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.
30
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 accepted for filing 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 6 to 8 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.
31
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 United States; (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 a controlled substance in the United States and other controlled substances in Canada and Israel, we must meet the
requirements of the federal Controlled Substances Act and relevant state laws and regulations in the United States as well as equivalent laws in Canada and
Israel. These regulations include stringent requirements for registration, manufacturing controls, receipt and handling procedures, recordkeeping and
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 inspects manufacturers, distributors, importers, and exporters that are registered with the DEA to
review and ensure compliance with the Controlled Substances Act and DEA regulations including security, record keeping and reporting prior to issuing a
controlled substance registration. The specific security requirements vary by the type of business activity and the DEA schedule of the controlled
substances handled by the registrant. Once registered, manufacturing, distribution, 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 controlled substance thefts
or significant losses, and must obtain authorization to destroy or dispose of controlled substances. 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
exports could have a material adverse effect on our business. Failure to maintain compliance with applicable requirements, particularly as manifested in
the loss or diversion of controlled substances, can result in enforcement action that could have a material adverse effect on our business, operations and
financial condition. The DEA may seek civil penalties, refuse to renew necessary registrations, or initiate proceedings to revoke those registrations. In
certain circumstances, violations could lead to criminal prosecution.
32
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 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 United States. These requirements will result in increased
expenses and may create additional administrative encumbrances. Failing to comply with these requirements could result in penalties or fines.
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 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 physicians
and teaching hospitals 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.
33
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 safety
net healthcare providers, 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 the basis for reimbursement to physicians 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 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, Medicare Part D beneficiaries within the coverage gap receive a manufacturer funded, 70% point-of-sale discount off of negotiated prices for
brand drugs (approved via an NDA or BLA). 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 and teaching hospitals, and a 2018 amendment will
expand these requirements to include tracking of payments to additional types of health care professionals beginning on January 1, 2021, for reporting in
2022. 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.
34
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-adopted health care reform measures may adversely impact the pricing of healthcare products and
services in the United States 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, 2020:
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.
Country of Incorporation
United States
Canada
Cayman Islands
Netherlands
Israel
The share capital of Taro U.S.A. is divided into two classes. The Company owns 96.9% of the shares that have economic rights and 50% of the
shares that have voting rights in Taro U.S.A. TDC owns 3.1% of the shares that have economic rights and 50% of the shares that have voting rights in Taro
U.S.A. TDC has agreed to vote all of its shares in Taro U.S.A. for such persons as we may designate for any election to its board of directors; however,
TDC may terminate the agreement upon one year’s written notice.
The Company owns 100% of the shares of Taro International Ltd. and 100% of Taro Pharmaceuticals North America, Inc., which owns 100% of
Taro Canada. The Company owns 99.75% of Taro Pharmaceuticals Europe B.V. and Taro Pharmaceuticals North America, Inc. owns the remaining 0.25%.
Sun beneficially owns 84.7% of the voting power of the Company as of March 31, 2020.
D. PROPERTY, PLANT AND EQUIPMENT
The following is a list of our principal facilities as of March 31, 2020:
Location
Haifa Bay, Israel
Square Footage
912,000
Brampton, Canada
Brampton, Canada
Hawthorne, New York
Cranbury, New Jersey
159,000
89,000
124,000
315,000
Main Use
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
Administrative offices
Distribution facility
Own/Lease
Long-term Lease/
Own (1)
Own
Lease
Own
Own
(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 Israeli Land Authority (“ILA”). The buildings and the vast majority of the equipment on this land are owned by
the Company.
35
From April 1, 2017 through March 31, 2020, we invested $80.5 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. The Ireland facility was sold in July 2017.
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 Israel Land Authority, 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 2020 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, 2020, 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 75,000 square feet
of office and warehouse space, adjacent to our main manufacturing facilities, which lease term continues to September 2025. In December 2013, Taro
Canada leased an additional 14,000 square feet of warehouse space near the two other facilities, which lease term continues to December 2021. The
mortgage on this building was repaid in November 2010.
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.
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.
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.
36
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.
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,
2020, 2019 and 2018, which are included elsewhere in this 2020 Annual Report.
OVERVIEW
We are a multinational, science-based pharmaceutical company. We develop, manufacture and market Rx and OTC pharmaceutical products,
primarily in the United States, 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.
37
The following is a breakdown of net sales by geographic region, including the percentage of our total consolidated net sales for each period:
2020
Year ended March 31,
2019
2018
United States
Canada
Israel
Other
Total
Sales
(in thousands)
$
495,673
97,997
42,817
8,282
644,769
$
Sales
net sales
Sales
(in thousands)
537,111
83,970
40,050
8,762
669,893
77% $
15%
7%
1%
100% $
% of total
net sales
Sales
(in thousands)
549,174
67,226
38,223
7,290
661,913
% of total
net sales
83%
10%
6%
1%
100%
80% $
13%
6%
1%
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 United States. A significant portion
of our revenues 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. Three customers in the United States accounted for the following proportion of
our total consolidated net sales:
2020
Year ended March 31,
2019
2018
Customer
Customer A
Customer B
Customer C
Sales
(in millions)
% of total
net sales
Sales
(in millions)
% of total
net sales
Sales
(in millions)
% of total
net sales
$
$
$
83.9
74.1
50.7
13.0% $
11.5% $
7.9% $
81.4
74.0
61.3
12.1% $
11.0% $
9.2% $
101.2
76.2
75.1
15.3%
11.5%
11.4%
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.
For the years ended March 31, 2020, 2019 and 2018, 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.
38
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
product returns and sales deductions from revenues, determining the valuation and recoverability of assets (for example: accounts receivables, inventories,
and intangible assets), and the reported amounts of accrued liabilities. 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 Canadian dollar (“CAD”). Accordingly, the financial statements of the Canadian subsidiary were translated into U.S. dollars (“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 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 winding down of TNA, has reduced the relevance of the foreign currency position on
the balance sheet of Taro Canada. The company decided to focus Taro Canada's sales market as the US market, with the majority of sales to the US
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
39
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 FX 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. Includes Taro Canada amounts reported in USD with USD as functional currency.
** Based on unaudited pro forma consolidated amounts of the Group. Includes Taro Canada unaudited pro forma amounts reported in USD with
CAD as functional currency.
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 adopted the new accounting standard ASC 606, “Revenue from Contracts with Customers,” and all the related amendments (“new
revenue standard”) to all contracts using the modified retrospective method. The cumulative effect of initially applying the new revenue standard was
immaterial. 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.
40
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 product 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. Additionally, as a general practice, we do not ship
products that have less than 12 months until expiration (i.e., “short-dated sales”).
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 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.
41
Three-year summary
The following tables summarize the activities for sales deductions and product returns for the years ended March 31, 2020, 2019 and 2018:
For the year ended March 31, 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
Beginning
balance
Provision
recorded
for current
period sales (1)
Credits
processed/
Payments
Ending
balance
(109,763) $ (1,104,946) $
(305,098)
(113,657)
(223,420) $ (1,410,044) $
1,110,157
348,125
1,458,282
$
$
(104,552)
(70,630)
(175,182)
(63,818) $
(33,497)
(97,315) $
(37,258) $
(77,537)
(114,795) $
39,670
69,472
109,142
$
$
(61,406)
(41,562)
(102,968)
$
$
$
$
For the year ended March 31, 2019
Beginning
balance
Provision
recorded
for current
period sales (1)
Credits
processed/
Payments
Ending
balance
(116,632) $ (1,086,800) $
(133,221)
(377,568)
(249,853) $ (1,464,368) $
1,093,669
397,132
1,490,801
$
$
(109,763)
(113,657)
(223,420)
(70,865) $
(40,968)
(111,833) $
(38,247) $
(64,405)
(102,652) $
45,294
71,876
117,170
$
$
(63,818)
(33,497)
(97,315)
$
$
$
$
For the year ended March 31, 2018
Beginning
balance
Provision
recorded
for current
period sales (1)
Credits
processed/
Payments
Ending
balance
(112,071) $ (1,107,353) $
(193,255)
(432,060)
(305,326) $ (1,539,413) $
1,102,792
492,094
1,594,886
$
$
(116,632)
(133,221)
(249,853)
(82,494) $
(43,370)
(125,864) $
(49,265) $
(60,677)
(109,942) $
60,894
63,079
123,973
$
$
(70,865)
(40,968)
(111,833)
$
$
$
$
(1)
(2)
Includes immaterial amounts of reversals of provisions recorded for prior years’ sales.
Includes indirect rebates and amounts due to customers.
42
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, 2020, 2019 and 2018, the Company did not record any impairment charges.
We estimate the fair value of goodwill using a two-step procedure. First, 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, we calculate the implied fair value of our goodwill by taking the excess of our market
capitalization over the fair value of our assets other than goodwill and obligations. An impairment is recorded for the difference between the implied fair
value and carrying value of goodwill. The implied fair value of goodwill and any potential impairment is sensitive to estimates of the fair value of other
assets and liabilities. We have not recorded any impairments of goodwill for the years ended March 31, 2020, 2019 and 2018. Effective for the Company’s
fiscal year beginning April 1, 2020, fair value of goodwill will be estimated using a one-step method in accordance with ASU 2017-04.
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.
43
Recent Accounting Pronouncements that were recently adopted
In June 2018, the FASB issued, ASU No. 2018-07, “Compensation—Stock Compensation (Topic 718).” The guidance focuses on expansion of
scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The guidance was effective for the
Company fiscal year beginning April 1, 2019, including interim periods within that year. The adoption of ASU 2018-07 does not have a material impact on
our financial position and results of operations.
In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842).” The new guidance requires that the lessee recognize the assets and
liabilities that arise from leases. In July 2018, the FASB issued ASU No. 2018-10, “Codification Improvements to Topic 842, Leases.” The updated
guidance focuses on codification improvements to Topic 842 as part of the FASB improvement project. The guidance was effective for the Company fiscal
year beginning April 1, 2019 and interim periods within that year. The adoption of ASU 2016-02 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 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 is currently evaluating the potential effect of the adoption of ASU 2018-04 on our financial position and results of
operations.
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 will be effective for the Company fiscal year beginning April 1, 2020, including
interim periods within that year. The Company does not currently anticipate the adoption will 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 reporting unit to all of its assets and liabilities as if that reporting unit had been acquired in a business combination. The guidance will be
effective for the Company fiscal year beginning April 1, 2020, including interim periods within that year on a prospective basis. The Company does not
currently anticipate the adoption will 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 will be effective for the Company fiscal
year beginning April 1, 2020, including interim periods within that year. The Company is currently assessing the impact of the adoption of ASU 2016-13
on our financial position and results of operations.
44
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
Financial (income) expense, net
Other gain, net
Income before income taxes
Tax expense
Income from continuing operations
Net loss from discontinued operations attributable to
Taro
Net income
Net income (loss) attributable to non-controlling interest
Net income attributable to Taro
For the year ended March 31,
2019
2018
2020
100.0%
38.0%
62.0%
100.0%
33.5%
66.5%
100.0%
30.0%
70.0%
9.3%
14.5%
0.0%
23.8%
38.2%
(7.5%)
0.5%
46.2%
8.3%
37.9%
*
37.9%
*
37.9%
9.4%
13.4%
(0.5%)
22.3%
44.2%
(8.8%)
0.3%
53.3%
11.2%
42.1%
*
42.1%
0.1%
42.2%
10.6%
13.3%
0.3%
24.2%
45.8%
1.9%
0.3%
44.2%
12.4%
31.8%
*
31.8%
(0.2%)
32.0%
*
Less than 0.05%
YEAR ENDED March 31, 2020 COMPARED WITH YEAR ENDED March 31, 2019
Sales. For the year ended March 31, 2020, sales decreased $25.1 million, or 3.7%, compared to the same period in 2019. Sales in the United States
during the year ended March 31, 2020 decreased $41.4 million or 7.7%, compared to the same period in 2019. 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. There are no products in the year ended March 31, 2020 or 2019 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 $2.3 million, or 4.7%, primarily due to new launches and increased market share on certain products. Sales
in Canada increased $14.0 million, or 16.7%, compared to the year ended March 31, 2019, due to Taro’s distribution of Sun and Ranbaxy products in
Canada beginning in the year ended March 31, 2019, and new launches and increased market share on certain products. Total Company volumes increased
3.2% as compared to 2019.
Cost of Sales. Cost of sales, as a percentage of net sales, increased to 38.0% in the year ended March 31, 2020, compared to 33.5% in 2019. This
increase is primarily related to higher product costs due to increased sales volumes compared to prior year, one-time costs and the challenging pricing
environment affecting net selling price.
Gross Profit. The Company’s gross profit was $399.7 million, or 62.0% of net sales, in the year ended March 31, 2020, while gross profit was
$445.7 million, or 66.5% of net sales in the same period in 2019. The decrease in 2020 was primarily the result of the product mix throughout the year.
Research and Development. Research and development (“R&D”) expenses decreased $3.5 million in the year ended March 31, 2020, 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 0.1% to 9.3% in the year ended March 31, 2020, compared to the previous year.
45
Selling, Marketing, General and Administrative. In the year ended March 31, 2020, selling, marketing, general and administrative (“SMG&A”)
expenses increased $3.4 million. As a percentage of net sales, SMG&A increased to 14.5% from 13.4%. This increase is primarily related to increased
legal fees and freight costs, in addition to higher insurance and other one-time expenses, partially offset by an overall decrease in personnel costs.
Settlements and Loss Contingencies. Settlements and loss contingencies income was $0.0 million in the year ended March 31, 2020, compared to
an income of $3.7 million in 2019, primarily due to a settlement on IP litigation in Israel in 2019.
Operating Income. In the year ended March 31, 2020, the Company had operating income of $246.5 million compared to $296.2 million in the
same period in 2019, a decrease of $49.7 million. Operating income, as a percentage of sales, decreased to 38.2% in the year ended March 31, 2020 from
44.2% in the same period in 2019.
Financial (Income) Expense, Net. Financial (income) expense, net, results principally from interest income and the impact of foreign currency
exchange rate fluctuations. Net financial income was $48.5 million in the year ended March 31, 2020, compared to income of $58.9 million for the year
ended March 31, 2019. The change in financial (income) expense, net, is the result of FX income of $14.8 million in 2020, compared to FX income of
$25.3 million in 2019 ─ an unfavorable impact of $10.5 million, principally the result of the commencement of hedging accounting in accordance with
ASU No. 2017-12 and the change in our Canadian subsidiary’s functional currency to the U.S. dollar. Taro Canada’s FX income decreased $12.5 million
compared to 2019, offset by an increase in interest and other financial income of $0.1 million from $33.5 million in 2019, to $33.6 million in 2020.
Taxes. Tax expense in the year ended March 31, 2020 was $53.5 million, compared to $74.7 million in the same period in 2019, a decrease of
$21.2 million, principally the result of non-recurring items in the current year. The effective tax rate decreased to 17.9% from 20.9%.
Net Income attributable to Taro. Net income decreased $37.5 million to $244.2 million for the year ended March 31, 2020, compared to $281.8
million in the prior year, by reason of the factors noted above.
YEAR ENDED March 31, 2019 COMPARED WITH YEAR ENDED MARCH 31, 2018
Sales. For the year ended March 31, 2019, sales increased $8.0 million, or 1.2%, compared to the same period in 2018. Sales in the United States
during the year ended March 31, 2019, decreased $12.1 million or 2.2%, compared to the same period in 2018. 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. There are no products in the year ended March 31, 2019 or 2018 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 $3.3 million, or 7.2%, primarily due to new launches and increased market share on certain products. Sales
in Canada increased $16.7 million, or 24.9%, compared to the year ended March 31, 2018, due to Taro’s distribution of Sun and Ranbaxy products in
Canada in the year ended March 31, 2019, new launches and increased market share on certain products. Total Company volumes increased 7.5% as
compared to 2018.
Cost of Sales. Cost of sales, as a percentage of net sales, increased to 33.5% in the year ended March 31, 2019, compared to 30.0% in 2018. This
increase is primarily related to increased sales volumes compared to the prior year and challenging pricing environment affecting net selling price, partially
offset by the product mix and the favorable foreign exchange.
Gross Profit. The Company’s gross profit was $445.7 million, or 66.5% of net sales, in the year ended March 31, 2019, while gross profit was
$463.5 million, or 70.0% of net sales, in the same period in 2018. The decrease in 2019 was primarily the result of a higher cost of sales, as noted above.
Research and Development. Research and development (“R&D”) expenses decreased $7.2 million in the year ended March 31, 2019, compared to
the previous year. This decrease is principally due to our continuous evaluation of our portfolio and adjusting for viable development of products. As a
percentage of net sales, R&D expenses decreased 1.2% to 9.4% in the year ended March 31, 2019, compared to the previous year.
Selling, Marketing, General and Administrative. In the year ended March 31, 2019, selling, marketing, general and administrative (“SMG&A”)
expenses increased $1.8 million. As a percentage of net sales, SMG&A increased to 13.4% from 13.3%.
Settlements and Loss Contingencies. Settlements and loss contingencies income was $3.7 million in the year ended March 31, 2019, compared to
an expense of $1.9 million in 2018, primarily due to a settlement on IP litigation in Israel.
46
Operating Income. In the year ended March 31, 2019, the Company had operating income of $296.2 million compared to $303.0 million in the
same period in 2018, a decrease of $6.8 million. Operating income, as a percentage of sales, decreased to 44.2% in the year ended March 31, 2019, from
45.8% in the same period in 2018.
Financial (Income) Expense, Net. Financial (income) expense, net, results principally from interest income and the impact of foreign currency
exchange rate fluctuations. Net financial income was $58.9 million in the year ended March 31, 2019, compared to an expense of $12.5 million for the
year ended March 31, 2018. The change in financial (income) expense, net, is the result of FX income of $25.3 million in 2019, compared to FX expense
of $32.5 million in 2018 ─ a favorable impact of $57.8 million, principally the result of the strengthening of the U.S. dollar versus the CAD, in addition to
an increase in interest and other financial income from $19.9 million in 2018, to $33.5 million in 2019.
Taxes. Tax expense in the year ended March 31, 2019, was $74.7 million, compared to $82.0 million in the same period in 2018, a decrease of $7.2
million. The effective tax rate decreased to 20.9% from 28.0%. During the third quarter of year ended March 31, 2018, the Company recorded a $38.0
million expense for the impact of the re-measurement of the Company’s estimated net deferred tax asset as a result of the Tax Cuts and Job Act. Excluding
the impact from the one-time re-measurement, tax expense would have been $44.0 million with an effective tax rate of 15.0%. The Company recognized
$0.9 million of investment tax credits.
Net Income attributable to Taro. Net income increased $70.6 million to $281.8 million for the year ended March 31, 2019, compared to $211.2
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 United States. 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 U.S.
dollar and the exchange rates between the U.S. dollar and each of the NIS and the CAD at the end of the period indicated:
Rate of (Deflation) Inflation
Canada (2)
Israel (1)
Rate of (Appreciation)
Devaluation
Against U.S. Dollar
Rate of Exchange of
U.S. Dollar
Israel (1)
Canada (2)
Israel (1)
Canada (2)
0.00%
1.40%
0.20%
0.89%
1.88%
2.31%
(1.65%)
3.42%
(3.31%)
6.02%
3.10%
(3.01%)
3.57
3.63
3.51
1.41
1.33
1.29
Period ended
3/31/2020
3/31/2019
3/31/2018
(1)
(2)
Bank of Israel.
J.P. Morgan Chase.
B. LIQUIDITY AND CAPITAL RESOURCES
Cash, including short-term marketable securities, increased $59.4 million from March 31, 2019 to $1,108.7 million at March 31, 2020. Total
shareholders’ equity increased from $1,911.1 million at March 31, 2019, to $2,109.8 million at March 31, 2020.
On November 5, 2018, the Company announced that its Taro 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.
47
Net cash provided by operating activities for the year ended March 31, 2020 was $271.6 million, compared to $323.7 million, in the year ended
March 31, 2019. For the year ended March 31, 2020, the Company had net cash used in investing activities of $298.2 million compared to net cash
provided by investing activities of $257.1 million for the year ended March 31, 2019. For the year ended March 31, 2020, the Company had net cash used
in financing activities of $27.0 million compared to $588.8 million for the year ended March 31, 2019.
The change in our liquidity for the year ended March 31, 2020 resulted from a number of factors, including:
Net cash provided by operating activities consists primarily of net income of $244.6 million; in addition to depreciation and amortization of
$21.4 million; a decrease in income tax receivable of $10.9 million; deferred income taxes, net, of $7.6 million; an increase in income tax
payables of $5.6 million; a decrease in trade receivables, net, of $2.7 million; and an increase in other accounts payable and accrued expenses
of $1.4 million. This was offset by foreign exchange effect of marketable securities and bank deposits of $11.6 million; a decrease in trade
payables of $6.2 million; an increase in inventories, net, of $5.0 million; and a change in derivative instruments, net, of $2.6 million.
Net cash used in investing activities consists principally of investment in marketable securities of $1,222.2 million; and purchase of property,
plant, and equipment of $26.6 million; offset by proceeds from marketable securities of $952.4 million.
Net cash used in financing activities consists of purchase of treasury stock for $27.0 million in accordance with our repurchase program.
•
•
•
Debt
As of March 31, 2020, the Company did not have any debt outstanding.
During the year ended March 31, 2020, we did not incur any indebtedness, including increases in our borrowing capacity under any refinancing.
Liquidity
On March 31, 2020, we had total cash and cash equivalents and short-term marketable securities of $1.1 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, 2020 and 2019, 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
at March 31, 2020.
Capital Expenditures
We invested $26.6 million in capital equipment and facilities in the year ended March 31, 2020 and $27.0 million in the year ended March 31,
2019. 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 2020 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 14% of our employees work in
our worldwide research and development programs.
48
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, 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, 2020, 2019 and 2018, we spent $59.8 million, $63.2 million and $70.4 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, 2020.
Pharmaceutical Products
In the year ended March 31, 2020, we received 8 ANDA approvals. As of March 31, 2020, we have 6 tentatively approved products
developed/manufactured in Canada and Israel. The following table sets forth the final approvals received in the United States from the FDA from April 1,
2019 through March 31, 2020, and tentative approvals as of March 31, 2020:
FINAL ANDA APPROVALS
Naftifine HCl Topical Gel 2%
Clobazam Oral Suspension 2.5mg/ml
Dapsone Topical Gel 7.5%
Iloperidone Tablets 1mg, 2mg, 4mg, 6mg, 8mg, 10mg, 12mg
Benzoyl Peroxide; Clindamycin Phosphate Topical Gel 2.5%;1.2%
Azelaic Acid Topical Gel 15%
Azithromycin Powder for Oral Suspension 100mg/5ml, 200mg/5ml
Clindamycin Phosphate Topical Foam 1%
Brand Name
Naftin®
Onfi®
Aczone®
Fanap®
Acanya ®
Finacea®
Zithromax®
Evoclin®
TENTATIVE ANDA APPROVALS
Ivermectin Topical Lotion 0.5%
Imiquimod Topical Cream 3.75%
Magnesium Sulf.; Potassium Sulf.; Sodium Sulf. Oral Solution 1.6g/3.13g;17.5g/bottle
Tavaborole Topical Solution 5%
Perampanel Tablets 2mg, 4mg, 6mg, 8mg, 10mg, 12mg
Diclofenac Sodium Topical Solution 2%*
Sklice®
Zyclara®
Suprep Bowel Prep Kit®
Kerydin®
Fycompa®
Pennsaid®
*Indicates tentative approval received during the year ended March 31, 2017.
As of March 31, 2020, 18 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.
49
Patents, Trademarks and Licenses
We have filed and received patents, and obtained licenses in the United States 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 United States, 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 United States, 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 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, 2020:
Type of Contractual Obligation
Operating lease obligations
Other long-term liabilities (1)
Total
Payments due by period (in millions)
Total
Less than 1
year
$
$
$
2.67
8.76
11.43
$
1.66
3.01
4.67
$
$
1-3 years
3-5 years
1.00
2.70
3.70
$
$
—
1.88
1.88
More than 5 years
$
—
1.17
$
1.17
(1)
Includes tax liability, deferred revenue, severance commitments, and other.
50
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, 2020:
Age
64
55
63
50
54
69
80
68
49
40
55
48
54
64
57
54
46
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
Director
Director and Chairman of the Social Responsibility Committee
Director
Vice President, Chief Financial Officer and Chief Accounting Officer
Vice President, General Counsel and Secretary
Vice President, Head of R&D
Vice President, Head of Operations
Vice President, Head of Human Resources
Head of Procurement
Vice President, Head of Quality
Vice President, Head of Information Technology
Vice President, Head of U.S. Generics Rx
Name
Dilip Shanghvi
Abhay Gandhi
Sudhir Valia
Uday Baldota
Linda Benshoshan
Robert Stein, M.D., Ph.D.
Dov Pekelman
James Kedrowski
Daphne Huang*
Erik Zwicker**
Avi Avramoff, Ph.D.
Itamar Karsenti
Michele Visosky
Jayesh Shah
Chantal LeBlanc
Richard Glaze
Ori Gutwerg
*
**
Joined the Company on April 6, 2020
Joined the Company on April 13, 2020
Certain Familial Relationships
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 the Chairman of the Taro Board in August 2013, after previously serving as Director and 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. 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
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 2012, Business India’s Businessman of
the Year in 2012 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. Mr. Shanghvi is a Director of various companies, including Shantilal Shanghvi Foundation and is also the Chairman and
Managing Director of Sun Pharma Advanced Research Company Ltd.
Abhay Gandhi became a Director in December 2016 and Vice Chairman of the Taro Board in February 2017. Mr. Gandhi has served as Chief
Executive Officer of Sun Pharmaceutical Industries, Inc. (“Sun Pharmaceuticals”) since November 2016. Mr. Gandhi also served as Interim Chief
Executive Officer of Taro from November 2017 until Mr. Uday Baldota’s assumption of these duties in August 2017. Prior to joining Sun Pharmaceuticals,
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
51
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 the Taro 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 the Taro 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 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 the Taro Board in December 2016 and serves as the Chairwoman of the Audit Committee and is a member
of the Compensation Committee. She served as a member of the board of Israel Discount Bank from November 2014 until May 2017. Mrs. Benshoshan
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
External Director at MRR Thirteen Limited and External Director at PRIORTECH LTD. Over the last five 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 the Taro Board of Directors in February 2020 and serves on the Audit and Compensation
Committee. Dr. Stein has medical and scientific training and has 40 years of Research and Development leadership experience in both pharmaceutical and
biotechnology companies. He currently is an Operating Partner at Samsara Biocapital 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 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.
52
Dov Pekelman became a member of the Taro 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 serves as Dean of the
Business School at the Interdisciplinary Center (IDC), Herzliya, Israel, and is Chairman of the IDC Corporation, the center’s 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 the Taro 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
United States before heading to Tokyo for four years of international experience running Alcoa’s Industrial Chemicals business in Asia. Mr. Kedrowski
then returned to the United States as Operational Vice President for seven North American Industrial Chemicals plants.
Daphne Huang became Vice President, CFO and Chief Accounting Officer in April 2020. Ms. Huang has over 20 years of senior executive
experience in finance, most recently serving as Chief Financial Officer at Humanwell Healthcare USA & Puracap International, having financial oversight
of their generic pharmaceutical and OTC portfolios. Prior to Humanwell, Ms. Huang held progressively responsible positions in the financial service
sector and debt capital markets working for companies such as PriceWaterhouseCoopers, FleetBoston, GE Capital and HSBC. Ms. Huang earned an MBA
in Finance and Management from the Leonard N. Stern School of Business at New York University, and a BBA in Accounting from Baruch College.
Erik Zwicker, J.D., joined our Company in April 2020 as Vice President, General Counsel and Secretary. He is currently responsible for the
Company’s global legal function. Prior to joining Taro, Mr. Zwicker was Head of Legal and Chief Compliance Officer at Roivant Sciences, Inc. Prior to
Roivant, Mr. Zwicker was Deputy Chief Governance Officer at Bridgewater Associates, LP. In addition, Mr. Zwicker’s experience includes serving as an
Assistant U.S. Attorney in the United States Attorney’s Office for the District of Columbia and as an Assistant Attorney General in the Connecticut
Attorney General’s Office. He has also penned various publications in the field of law. Mr. Zwicker holds a Bachelor of Arts degree from Princeton
University, a Masters of Bioethics degree, which he earned while on a Fulbright Scholarship at Monash University in Melbourne, Australia, and a J.D. from
Harvard Law School.
Avi Avramoff, Ph.D. joined our Company in October 2011 as Vice President, Head of R&D. He is responsible for the Company’s generic and
innovative new product development, the management of the R&D Pharma and Chemistry, R&D Analytical Laboratories, Preclinical, Pharmacokinetic and
Clinical Studies, Regulatory Affairs, R&D Project Management and Pharmacovigilance in all of Taros’ sites. In addition, he is involved in the new product
introduction process from selection to launch and Portfolio Management. He has penned various publications and abstracts in the field of pharmacy, as
well as several patents and patent applications. Prior to joining our Company, Dr. Avramoff worked as Vice President, Research & Development at Dexcel
Pharma.
Itamar Karsenti joined our Company in December 2014 and currently serves as Vice President, Head of Operations. Mr. Karsenti is the operations
lead for our Israeli and Canadian manufacturing facilities. He is responsible for Pharma and API Manufacturing, Supply Chain Management, Engineering
and Environmental Health and Safety (EH&S). Mr. Karsenti also provides leadership and guidance in sales and marketing, human resources, IT and
finance. Prior to joining Taro, Mr. Karsenti worked for Teva Pharmaceutical Industries Ltd. since 2002, where he served as Executive Director, Jerusalem
OSD site manager.
Michele Visosky joined our Company in January 2004 in the Human Resources department. She is currently Vice President, Head of Human
Resources and heads the department in Canada, Israel and the United States. Ms. Visosky has over 27 years of human resources experience, the majority of
which were spent in management level roles. Prior to joining Taro, Ms. Visosky worked at Micro Warehouse, Inc. and PricewaterhouseCoopers LLP,
holding progressively responsible human resources positions, with the last one as Senior Vice President, Human Resources.
Jayesh Shah joined our Company in December 2011 as Head of Procurement. His responsibilities include procurement of raw materials, capital
items and services for North America. Prior to joining Taro, Mr. Shah worked at Caraco Pharmaceutical Laboratories, Ltd. (now known as Sun
Pharmaceutical Industries, Inc.), a subsidiary of Sun Pharma, in 2000 and worked there until 2011. Prior to that, Mr. Shah worked at Sun Pharma in India
from 1997 to 2000. From 1977 to 1997, Mr. Shah was a proprietor of J.B. Trading Corporation, an import/export company located in Mumbai, India.
53
Chantal LeBlanc joined our Company in August 2014 and currently serves as Vice President, Head of Quality. Ms. LeBlanc is responsible for the
Quality and cGMP compliance activities at our Canada and Israel manufacturing locations as well as our operations in the United States. Ms. LeBlanc has
35 years of experience in the biotechnology and pharmaceutical industries. Prior to joining Taro, Ms. LeBlanc was the Global Quality Director of GSK
Vaccines in Belgium from 2007 to 2014. Prior to GSK, Ms. LeBlanc was a Quality/Compliance expert for 10 years. Ms. LeBlanc started her career as a
Quality site Director for Kempac- Polylab Inc. then Pharmascience Inc. in Montreal for a cumulative of 12 years. Ms. LeBlanc qualified as a Health
Canada field inspector in 2001.
Richard (“Rich”) Glaze joined our Company in June 2016 as Vice President, Head of Information Technology. Mr. Glaze is responsible for
overseeing the development and maintenance of a secure Information Technology environment as well as leading innovative IT programs to enable the
Company’s strategic business vision. He has over 25 years of global professional IT experience. Most recently, Rich served as the Vice President and
Head of IT for the Critical Care Division of Mallinckrodt Pharmaceuticals Inc. (Ikaria). Prior to Mallinckrodt, he held senior IT leadership roles at Hospira,
a large global generics pharmaceutical concern and at Johnson & Johnson where he held a number of IT assignments during his ten-year tenure there. Rich
began his IT career in consulting and worked at Accenture, IBM, as well as Bearing Point LLP. Rich holds a Bachelor of Science degree in Engineering
from Princeton University, and an MBA from New York University Stern School of Business.
Ori Gutwerg joined our Company in April 1, 2019, as Vice President, Head of US Generics Rx. Mr. Gutwerg is responsible for Taro's US Generic
Rx business including developing and executing strategies to meet targets, promoting sales growth, and building the pipeline portfolio. Mr. Gutwerg has
over 17 years of experience in the pharmaceutical industry. Prior to joining Taro, he held positions with Xiromed US, Perrigo Pharmaceuticals, and Agis
Group. He has managed sales teams, built a commercial operations team, led M&A due diligence activities, and negotiated new business development and
joint venture agreements. Mr. Gutwerg has an MBA from Recanati School of Business Administration and a Bachelor of Science in Communications and
Economics from The College of Management.
B. COMPENSATION
Our directors, other than those identified in this paragraph, are paid NIS 148,575 (NIS 149,012 effective March 1, 2020) per year for their service as
directors and NIS 5,715 (NIS 5,732 effective March 1, 2020) for each board and committee meeting they attend, linked to the Israeli consumer price index,
or CPI, for their service as directors. Dilip Shanghvi and Sudhir Valia earned approximately $1.7 million and $0.5 million during the year ended March 31,
2020, respectively, for their duties as directors. During the year ended March 31, 2020, Mr. Dov Pekelman received an annual fee of NIS 244,725 (NIS
245,545 effective March 1, 2020) due to his role in the establishment of a Social Responsibility Committee. 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.
We incurred an aggregate of approximately $6.1 million in compensation expenses paid to all of our then current directors and executive officers for
services rendered to us in all capacities during the year ended March 31, 2020. In addition, approximately $0.3 million was set aside in fiscal 2020 to
provide certain executive officers and directors with pension, retirement or similar benefits. During the year ended March 31, 2020, the Company’s
executive officers and directors did not receive any options to purchase Taro’s ordinary shares or other equity incentive awards.
As of March 31, 2020, the Company’s executive officers and directors held no options to purchase ordinary shares or other equity incentive awards.
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 may exercise any power of the company not granted to any other
body either by law or by our Articles of Association. 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, our Board may consist of between 5 and 25 directors.
54
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 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 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.
Statutory External Directors
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” includes 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).
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.
55
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
competence, as defined in the regulations promulgated under the Israeli Companies Law. At least one statutory external director must possess accounting
and financial expertise.
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. “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.
56
Statutory external directors may be removed from office only by the shareholders, 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.
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.
A statutory external director is entitled to compensation determined by the board within the scope provided in regulations adopted under the Israeli
Companies Law.
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 competence, as required of our statutory
external directors under the Israeli Companies Law.
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) are exempt from the requirement to appoint statutory
external directors. Any such company is also exempt 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 new exemptions.
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.
57
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 chairman 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.
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, 2020. 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 2020 Annual Report.
58
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 “Approval of Specified Related Party Transactions under Israeli Law and Our Articles of
Association—Disclosure of Personal Interests of a Controlling Shareholder” in Item 10.B below.
Compensation Committee
Composition
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, and all of our statutory external directors are members of the
Compensation Committee.
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 initial compensation policy was approved
by our Board, upon the recommendations of our Compensation Committee, and was approved by our shareholders on September 12, 2013, and ratified and
approved again on March 27, 2014. In December 2016, following its approval by our Compensation Committee and Board, our renewed compensation
policy was approved by a majority of our shareholders, but not by the requisite special majority of the non-controlling, disinterested shareholders. As
permitted under the foregoing provision of the Israeli Companies Law, our Compensation Committee and Board reconsidered the renewed compensation
policy, determined that its adoption was beneficial to our Company based on several factors, and adopted it on February 9, 2017. Despite that approval, we
committed to reviewing our renewed compensation policy in light of the feedback that we received from our shareholders and shareholder advocacy
organizations and brought an amended version for shareholder vote at our 2018 annual shareholder meeting. Upon recommendation of our Compensation
Committee, the Board and requisite special majority of non-controlling, disinterested shareholders approved the compensation policy on December 19,
2018.
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.
59
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; and
the minimum holding or vesting period for variable, long-term compensation.
The compensation policy also considers appropriate incentives from a long-term perspective and maximum limits for severance compensation.
Our Compensation Committee is responsible for recommending the 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:
•
•
•
•
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).
Under Amendment 20, the terms of employment of office holders require the approval of the Compensation Committee and the Board (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 an arrangement 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.
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 “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.
60
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, 2020:
Sales and Marketing
Administration
Research and Development
Production and Quality Control
Total
United States *
124
72
15
—
211
Canada
Israel
Total
41
40
73
399
553
31
45
121
503
700
The following table sets forth the number of full-time equivalents as of March 31, 2019:
Sales and Marketing
Administration
Research and Development
Production and Quality Control
Total
United States *
119
73
14
—
206
Canada
Israel
Total
41
37
70
393
541
34
45
128
510
717
The following table sets forth the number of full-time equivalents as of March 31, 2018:
Sales and Marketing
Administration
Research and Development
Production and Quality Control
Total
United States *
Canada
Israel
Total
173
74
15
—
262
37
35
75
377
524
32
45
129
498
704
196
157
209
902
1,464
194
155
212
903
1,464
242
154
219
875
1,490
*
In the United States, 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.
61
The Collective Bargaining Agreement dated April 6, 2011, as amended and extended by the collective bargaining agreement dated January 5, 2017,
among Taro Israel, the Histadrut Trade Union and Taro’s Israel’s Employees Committee on behalf of Taro’s Israeli employees ended December 31, 2019
(the “Collective Bargaining Agreement”). The Collective Bargaining Agreement has a term of three years and automatically renews for one-year periods
unless notice is provided by a party three months prior to the end of a term. We received notice and have negotiated a new collective bargaining agreement,
which is being drafted by the parties. 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. Israeli employees and
employers are required to pay predetermined sums to the National Insurance Institute (an agency similar to the United States 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%.
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, 2020. The percentage of ownership is based on ordinary shares outstanding as of March 31, 2020. 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
Daphne Huang**
Erik Zwicker***
Avi Avramoff, Ph.D.
Itamar Karsenti
Michele Visosky
Jayesh Shah
Chantal LeBlanc
Richard Glaze
Ori Gutwerg
Total for all directors and officers (17 persons) listed above, as a
group
*
**
Less than 0.1%
Joined the Company on April 6, 2020
62
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%
0.0%
0.0%
0.0%
*
0.0%
0.0%
0.0%
0.0%
*
***
Joined the Company on April 13, 2020
(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 54.7% of Sun Pharma. As of March 31, 2020, Sun Pharma and its affiliates owned 77.1% of Taro’s outstanding ordinary shares.
Sudhir Valia is also a director of Sun Pharma. As of March 31, 2020, Sun Pharma and its affiliates owned 77.1% of Taro’s outstanding ordinary
shares.
The following table sets forth certain information regarding the ownership of our founders’ shares as of March 31, 2020. The percentage of
ownership is based on 2,600 founders’ shares outstanding as of March 31, 2020.
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.
As of March 31, 2020, the directors and executive officers listed above held no options to purchase our ordinary shares.
ITEM 7.
MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A. MAJOR SHAREHOLDERS
Ordinary Shares
The following table sets forth certain information as of March 31, 2020, 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 38,258,077 ordinary shares outstanding as of March 31, 2020.
Name
Sun
Ordinary Shares
Beneficially
Owned
Percent of
Ordinary Shares
Outstanding
29,497,813 (1)
77.1%
(1)
As reported on the Schedule 13D/A filed by Sun on November 27, 2013.
During the year ended March 31, 2014, the percent of ordinary shares owned by Sun increased from 65.9% to 68.9% due to our repurchase of
1,959,514 ordinary shares in December 2013. During each of the years ended March 31, 2015 and 2016, there was no significant change in Sun’s
ownership of our ordinary shares. During the year ended March 31, 2017, the percentage of ordinary shares owned by Sun increased to 72.8% due to the
repurchase of 2,252,725 shares during the year. During the year ended March 31, 2018, the percentage of ordinary shares owned by Sun increased to
74.8% due to the repurchase of 1,085,694 shares during the year. 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.
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.
63
Voting Power
As of March 31, 2020, Sun controlled 84.7% of the voting power in our Company by reason of its (i) beneficial ownership of an aggregate of 77.1%
of our ordinary shares and (ii) ownership of the founders’ shares.
B. RELATED PARTY TRANSACTIONS
In addition to Sun controlling 84.7% of the voting power in our Company as of March 31, 2020, 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, 2019, 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 in the
following areas: Human Resources, Information Technology, Legal (including intellectual property matters), OTC, Management, Procurement, certain
aspects of Commercial and Customer Service, Finance (Accounts Receivable, Accounts Payable, Government Pricing, Gross-to-Net and Tax Compliance),
Regulatory Affairs (Canada only), Supply Chain, Travel Related Services, and Generic Rx (chargeback and rebate maintenance) (each a “Service Area”).
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 the approved allocation methodologies for each Service Area. 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 April 2017, our Board of Directors approved for Taro to negotiate an agreement with Sun whereby Taro's U.S. branded products team will
advertise and promote a combined portfolio of Taro and Sun corticosteroid products. The agreement between Taro U.S.A. and Sun went into effect on May
1, 2017. Under this agreement, Sun sold its products to customers and paid Taro a percentage of the net sales for Taro's promotional services. Taro
discontinued the promotion of its U.S. branded products effective March 31, 2019, and terminated the agreement.
In May 2018, Taro Canada signed an agreement with Sun’s affiliate Ranbaxy Pharmaceuticals Canada Inc., 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; additionally, Sun and Ranbaxy pay Taro Canada a sales and distribution fee.
C. INTERESTS OF EXPERTS AND COUNSEL
Not applicable.
64
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 2020 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.
On September 8, 2016, Taro U.S.A. received a grand jury subpoena from the United States Department of Justice, Antitrust Division, seeking
documents relating to corporate and employee records, generic pharmaceutical products and pricing, communications with competitors and others
regarding the sale of generic pharmaceutical products, and certain other related matters. Taro U.S.A. is in the process of responding to the grand jury
subpoena. Certain current and former officers and employees in Taro U.S.A.’s commercial team have also received related subpoenas. On February 4,
2020, a former member of Taro U.S.A.’s commercial team was indicted for alleged violations of U.S. antitrust laws.
The Company, Taro U.S.A. 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. The
lawsuits allege that the Company, Taro U.S.A., and/or, in the AG and IRP complaints, the concerned individual, have conspired with competitors to fix
prices, rig bids, or allocate customers with respect to Taro U.S.A. products, and also allege an industry-wide conspiracy as to nearly all generic
pharmaceutical products. Each of these cases has been transferred to the United States 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.
On May 10, 2018, Taro U.S.A. received a Civil Investigative Demand from the United States Department of Justice pursuant to the False Claims
Act seeking information relating to corporate and employee records, generic pharmaceutical products and pricing, communications and/or agreements with
competitors and others regarding the sale of generic pharmaceutical products, and certain other related matters. Taro U.S.A. is in the process of responding
to the Civil Investigative Demand.
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 United States 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.
In February 2017, after consulting with its tax advisors, the Company filed an appeal pursuant to Section 153 of the Income Tax Ordinance (New
Version), 1961 in the Haifa District Court. The appeal challenged the Israel Tax Authority’s (“ITA”) tax assessment for the period of January 1, 2010
through March 31, 2014 in the amount of $40.8 million (before interest, linkage and penalties), and denial of an unutilized capital loss in an amount of
$74.6 million that had been claimed by the Company.
In March 2018, the Company reached a settlement with the ITA, under which the Company is obligated to pay a reduced tax assessment of $15.0
million, and the Company was permitted to record the unutilized capital loss, transfer intellectual property from TNA to Taro Israel and Taro Canada and
reorganize assets held by our subsidiaries without triggering an Israeli tax event (the “Settlement”). The Settlement finalized all tax disputes between the
parties for the tax years 2010 through 2014 as well as related tax issues with respect to the tax years 2015 through 2016, which years were not subject to the
disputes.
65
In April 2019, the Company entered into a conditional settlement with the Israeli Ministry of Environmental Protection (the “MoEP”) and submitted
it to the Haifa Magistrate’s Court, which approved the settlement in July 2019. The conditional settlement concerns one current and one former employees’
and the Company's non-compliance with the performance obligations of periodic sampling of emissions from the facility's stacks between 2010 and 2013
as instructed by the Company's business license and the Israeli business license law. In the settlement, the Company and the concerned individuals
undertook to refrain from repeating the described violations for a term of one year commencing on July 2019 and to conditional fines to be imposed in case
these violations are repeated. In exchange, the MoEP agreed to a non-conviction by the court.
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 have filed a preliminary response to the court in which they have moved the court to dismiss the motion in
light of the requirements of Israeli Class Action Law.
Dividend Policy
We had never paid cash dividends until Fiscal Year 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, 2020, the Company received final approvals from the FDA for four additional ANDAs: Clocortolone Pivalate Cream USP,
0.1% and Mupirocin Cream USP, 2% in April 2020; Ivermectin Lotion, 0.5% in May 2020; and Betamethasone Dipropionate Spray, 0.05% in June
2020. The Company currently has a total of twenty-one 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.
66
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.
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 2020
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.
67
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─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 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, the board of
directors may approve the transaction between the company and an office holder or a third party in which an office holder has a personal interest, unless the
company’s articles of association 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. Approval first by the company’s audit committee and subsequently by the board of directors is required for an
extraordinary transaction with an office holder. 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.
68
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 twenty-five. 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, 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 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.
69
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 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).
70
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.
71
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 United States 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, 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.
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; and
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.
72
Under the Israeli Companies Law, indemnification in advance in respect to monetary liabilities to third parties are 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.
C. MATERIAL CONTRACTS
During the two years preceding the date of this 2020 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.
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.
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 United States 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 United States, 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.
73
Israeli Tax Considerations and Government Programs
General Corporate Tax Structure
Generally, Israeli companies are subject to corporate tax on their taxable income. As of calendar year 2020, the corporate tax rate is 23.0% (in 2019,
and 2018, the corporate tax rate was 23.0% and 24.0%, respectively). 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 provides certain benefits, including tax exemptions and reduced tax rates for a defined period.
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.
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.
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.
74
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%, or at the lower rate under an applicable tax treaty (subject to the
receipt in advance of a valid certificate from the ITA). 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. Under the Investment Law, a company
that has elected the Alternative Benefits Program is not obligated to distribute retained profits, and may generally decide from which year’s profits to
declare dividends. In addition, a company that pays a dividend out of tax-exempt income attributed to its Approved Enterprise 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 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, but currently intend to reinvest any
income derived from our Approved Enterprise program and not to distribute such income as a dividend.
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 in 2004 and thereafter, 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.
75
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 from the end of 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, according to one of the following new tax routes, which may be applicable to a company:
•
•
Similar to the Alternative Benefits Program, exemption from corporate tax on undistributed income for a period of 2 to 10 years, depending
on the geographic location of the Benefited Enterprise in Israel, and a reduced corporate tax rate of 10% to 25% for the remainder of the
benefits period, depending on the level of foreign investment in a company in each year. The benefits period is limited to 12 or 14 years from
the year the company requested to have the tax benefits apply, depending on the location of the company. 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 corporate 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. Dividends
paid 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 source at a rate of 15%, or at a lower rate as may be provided in an
applicable tax treaty (subject to the receipt in advance of a valid certificate from the ITA). The reduced rate of 15% 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 this period, the
withholding tax is applied at a rate of up to 30%, or at a 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.
A special tax route, which enables companies owning facilities in certain geographical locations in Israel to pay corporate tax at the rate of
11.5% on income of the Benefited Enterprise. The benefits period is 10 years. Upon payment of dividends, the company is required to
withhold tax at source at a rate of 15% for Israeli residents and at a rate of 4% for foreign residents.
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. We currently have 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 5 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.
76
All of these programs are 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. To retain the most favorable rates we must maintain a foreign shareholders’ level of at least 90%. We believe that we currently exceed
this level but there can be no assurance that we will be able to reach or maintain this level of foreign ownership for each subsequent year.
Tax benefits under the 2011 Amendment and 2017 Amendment
The 2011 Amendment cancelled 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 10 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% or such lower rate as may be provided in an applicable tax treaty (subject to the receipt in advance of a valid certificate from
the ITA allowing for a reduced tax rate). 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, withholding tax at a rate of 20%, will apply, subject to any lower rate as may be provided
in an applicable tax treaty subject to the receipt in advance of a valid certificate from the ITA allowing for a reduced tax rate). In 2017 - 2019, dividends
paid out of preferred income attributed to a Special Preferred Enterprise, directly to a foreign parent company, are subject to withholding tax at source at
the rate of 5% (temporary provisions).
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, 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.
We have evaluated the likely effect of the 2011 Amendment and have currently decided not to file a request to apply the new benefits under the 2011
Amendment. We may decide in the future to make the above-mentioned election.
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 average R&D expenses in the three years prior to the current tax year must be greater than or equal to 7%, out of the
Enterprise’s total revenue or exceed NIS 75 million (approximately $21 million) per year; and
A company 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 8 million (approximately $2
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 or workforce by an average of 25% in the course of three years preceding the tax year in comparison to the prior tax year.
77
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 10 billion (approximately $2.8 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. In addition,
a Preferred Technological Enterprise will enjoy a reduced corporate tax rate of 12% on capital gain derived from the sale of certain “Benefitted Intangible
Assets” (as defined in the Investment Law) to a related foreign company if the Benefitted 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 Israel Innovation Authority (“IIA”), formally known as the Office of
the Chief Scientist.
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. 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 “Benefitted Intangible Assets” to a related foreign company if the
Benefitted Intangible Assets were either developed by an Israeli company or acquired from a foreign company on or after January 1, 2017, and the sale
received prior approval from IIA. A Special Preferred Technological Enterprise that acquires Benefitted 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% or such lower rate as may be provided in an applicable tax treaty (subject to
the receipt in advance of a valid certificate from the Israel Tax Authority allowing for a reduced tax rate). 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 Israel Tax Authority allowing for a reduced tax rate).
We have evaluated the likely effect of the 2017 Amendment and have currently decided not to file a request to apply the new benefits under the
2017 Amendment. We may decide in the future to make the above-mentioned election.
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” located in Israel that it
owns. 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;
Accelerated depreciation rates on equipment and buildings; 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.
78
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.
Grants under the Encouragement of Research, Development and Technological Innovation Law, 5744-1984
On January 1, 2016, the Encouragement of Research, Development and Technological Innovation Law, 5744-1984 (the “Research Law”, as
amended), was enacted, which amended the Encouragement of Industrial Research and Development Law, 1984. Under the Research Law development
programs that meet specified criteria and are approved by the IIA are generally eligible for grants of up to 50% of the project’s approved expenditures, as
determined by the IIA, in exchange for 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. Effective for grants received from the IIA under programs approved after January 1, 1999, 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 May 2017, the IIA issued new directives, inter alia, regarding the royalty rates ("The New Directives"). According to the
New Directives, the royalty rates range generally from 1.3% to 5%, depending on the company's size and sector. The New Directives are in effect starting
from July 1, 2017, except for with respect to "Large Companies" (companies whose revenues exceed 70 million USD), for whom the New Directives are in
effect starting from January 1, 2018. According to the New Directives, companies whose last IIA file was approved prior to January 1, 1994, will continue
to be subject to the Old Regulations. 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.
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 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
Royalties to the Chief Scientist as a percentage of grant
Less than 50%
between 50% and 90%
90% and more
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 6 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.
The New Directives contains new rules for licensing know-how developed with IIA funding outside of Israel (the “Licensing Rules”), which allow
grant recipient to 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. 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.
79
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 not so approved, but otherwise qualifying 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 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 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 reduced tax rate is provided under an applicable tax treaty (subject to the receipt in advance of a valid certificate from
the ITA). For example, under the Convention Between the Government of the United States of America 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 or Benefited Enterprise
are subject, under certain conditions, 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
or Preferred Enterprise, and partly to other sources of income, the withholding rate will be a blended rate reflecting the relative portions of the two 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 United States 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).
80
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, or (iii) represent, directly or indirectly, rights
to assets 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 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 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% as of calendar year 2019 (in 2019, and 2018, the corporate tax rate was 23.0% and 24.0%, respectively), 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% for an individual in 2019).
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 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 purchased after being listed and were not purchased from a “relative” or as part of a tax-exempt; 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. 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, 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
640,000 in 2017, NIS 641,880 in 2018 and NIS 649,560 in 2019 (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.
81
United States Federal Income Tax Considerations
Subject to the limitations described in the next paragraph, the following discussion describes the material United States federal income tax
consequences to a holder of our ordinary shares (a “U.S. Holder”) that is:
•
•
•
•
a citizen or resident of the United States;
a corporation, or other entity taxable as a corporation for United States federal income tax purposes, created or organized in the United States
or under the laws of the United States, any state thereof or the District of Columbia;
an estate, the income of which is includable in gross income for United States federal income tax purposes regardless of its source; or
a trust, if a court within the United States is able to exercise primary supervision over the administration of the trust and one or more United
States persons have the authority to control all substantial decisions of the trust or if the trust has validly elected to be treated as a United
States person under applicable Treasury regulations.
In addition, certain material aspects of United States 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 United States 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 United States 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
United States 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 United States;
are persons subject to the alternative minimum tax;
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-United States tax laws and does not consider the possible application of
United States federal gift or estate tax or the Medicare tax on net investment income.
82
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 United States 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 United States or (b) we qualify for benefits under an income tax treaty with the United States which
includes an information exchange program and such treaty is determined by the United States 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 United States 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 United States 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 United States 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 U.S. dollars, and the amount realized on the disposition in U.S.
dollars. 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 United States federal 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 United States
source income or loss for United States 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 United
States foreign tax credit limitations, credit the Israeli tax on such sale against such U.S. Holder’s United States 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, United
States 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.
83
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 United
States 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 United States and, in the case of a
resident of a country which has a tax treaty with the United States, such item is attributable to a permanent establishment or, in the case of an
individual, a fixed place of business, in the United States;
the Non-U.S. Holder is an individual who holds the ordinary shares as a capital asset and is present in the United States 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 United States tax law applicable to United States expatriates.
Information Reporting and Backup Withholding
U.S. Holders generally are subject to information reporting requirements with respect to dividends paid in the United States 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 United States 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 United States or through certain U.S.-related financial intermediaries.
The amount of any backup withholding may be allowed as a credit against a U.S. or Non-U.S. Holder’s United States 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.
84
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 United States companies whose securities are registered under the Exchange Act. A copy of each report submitted in accordance with
applicable United States 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 2020 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 U.S. dollar as our reporting currency and are exposed to foreign exchange rate risk from transactions conducted in
different currencies.
In 2020, 77% of our revenue was generated in U.S. dollars. However, the remainder of our sales was 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 U.S. dollar, the earnings generated in these foreign currencies will, in effect, decrease when converted into U.S. dollars, 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-U.S. dollar revenues, the effects of currency fluctuations on consolidated net sales and operating income were
not significant in 2020.
Intercompany Foreign Exchange Transactions
During the year ended March 31, 2020, Taro Canada recorded a gain of $14.8 million compared to a gain of $27.3 million in 2019, reflecting the
unfavorable impact of the change in foreign currency exchange rates related primarily to cash and cash equivalents, marketable securities and intercompany
balances 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, 2020, Taro Israel recorded a gain of $0.02 million compared to a loss of $2.0 million in 2019.
In April 2016, the Company began entering 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 U.S. dollars due to changes in the respective exchange rates.
At March 31, 2020, the forward contracts to purchase the NIS are for a total amount of $49,000, at a weighted-average forward rate of 3.44 NIS per
U.S. dollar, which are settled in seventeen (17) monthly settlements of $3,250 for ten (10) months, $2,000 for six (6) months, and $4,500 for one (1)
month. The Company recorded a net gain (loss) of $178, ($2,530) and $97 for the years ended March 31, 2020, 2019, and 2018, respectively, for the
contracts to purchase the NIS.
85
The forward contracts to purchase the CAD are for a total amount of $40,024, at a weighted-average forward rate of CAD 1.31 per U.S. dollar,
which are settled in sixteen (16) monthly installments of approximately $2,453 for nine (9) months, $3,999 for three (3) months, $1,708 for three (3)
months, and $826 for one (1) month. The Company recorded a net (loss) gain of ($629), $2,545 and $2,068, for the years ended March 31, 2020, 2019, and
2018, respectively, for the contracts to purchase the CAD.
At March 31, 2020, 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.
86
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 2020 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 Company’s internal control over financial reporting as of March 31, 2020. 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, 2020, Taro’s internal control over financial
reporting is effective based on those criteria.
c.
Attestation Report of the Registered Public Accounting Firm
Taro’s internal control over financial reporting as of March 31, 2020, 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 2020 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, 2020, that have
materially affected, or are reasonably likely to materially affect, Taro’s 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 Item 6.A for a summary of Linda
Benshoshan’s relevant professional experience.
87
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, 2020 and 2019,
respectively.
Audit fees
Tax fees
Other fees
Total
$
Year ended
Year ended
March 31, 2020 March 31, 2019
(in millions)
0.70 $
0.03
0.03
0.76 $
0.69
0.03
0.04
0.76
$
The audit fees for the years ended March 31, 2020 and 2019, 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 10b5-1 program, at an average price of $100.28 per share.
88
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.
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
January 1, 2020 - January 31, 2020
February 1, 2020 - February 28, 2020
March 1, 2020 - March 31, 2020
Total
Total Number of
Shares Purchased
Average Price Paid
per Share
280,719 $
— $
— $
— $
— $
280,719 $
91.00
—
—
—
—
91.00
Total Number of
Shares Purchased
as Part of the
Current Program
Dollar Value of
Shares that May
Yet be Purchased
Under the
Program (in
thousands)
280,719
280,719
280,719
280,719
280,719
$
274,454,571
ITEM 16F.
CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT
Not applicable.
89
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
303A.03
303A.04
303A.05
303A.06/303A.07
NYSE Corporate Governance Rule for
U.S. Domestic Issuers
Taro’s Approach
A listed company must have a majority of independent directors.
“Controlled companies” are not required to comply with this
requirement.
The non-management directors of a listed company must meet at
regularly scheduled executive sessions without management.
A listed company must have a nominating/corporate 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.
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.
90
Taro is a controlled company because more than a majority of 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).
Section
303A.07
303A.08
303A.09
303A.10
NYSE Corporate Governance Rule for
U.S. Domestic Issuers
Taro’s Approach
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.
A listed company must adopt and disclose corporate governance
guidelines that cover certain minimum specified subjects.
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.
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.
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.
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.
91
ITEM 17.
FINANCIAL STATEMENTS
We have responded to Item 18—“Financial Statements” in lieu of this item.
PART III
ITEM 18.
FINANCIAL STATEMENTS
The financial statements required by this item are found at the end of this 2020 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 2020 Annual Report are listed on the index of exhibits below.
Exhibit
No.
1.1
1.2
2.1
2.2
4.1
4.2
4.3
8
12.1
12.2
13
Description
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 of Taro Pharmaceutical Industries Ltd. Ordinary Shares
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)
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).
(1)
(2)
(3)
(4)
(5)
*
(P)
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.
filed herewith
Paper exhibits
92
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 2020 Annual Report on its behalf.
SIGNATURE
TARO PHARMACEUTICAL INDUSTRIES LTD.
By:
/s/ Daphne Huang
Daphne Huang
Vice President, Chief Financial Officer and Chief Accounting
Officer
Dated: June 19, 2020
93
TARO PHARMACEUTICAL INDUSTRIES LTD.
Report of Independent Registered Public Accounting Firm
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-6
F-8
F-9
F-10
F-11
F-13
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 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,
2020 and 2019, 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, 2020, 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, 2020 and 2019, and the results of
its operations and its cash flows for each of the three years in the period ended March 31, 2020, 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, 2020, 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 June 16, 2020 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 Public Company Accounting Oversight Board
(United States) (“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, 2020, the consolidated reserves for chargebacks, product returns, rebates and other sale deductions were $278 million.
F-2
TARO PHARMACEUTICAL INDUSTRIES LTD.
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:
•
•
Testing the design and operating effectiveness of controls related to management’s assessment of: (i) the reasonableness of assumptions used
to estimate sales deductions, (ii) the reasonableness of the methodology used and appropriates 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.
Functional currency related to Taro Canada
As described in Note 2b to the consolidated financial statements, the Group changed Taro Canada’s functional currency to the USD effective as of April 1,
2019. The change in the functional currency involved significant management’s judgment in evaluating relevant facts and circumstances.
We identified the accounting evaluation supporting the change in the functional currency as a critical audit matter which involved especially challenging
auditor judgment due to the nature and extent of audit effort required, including the extent of specialized skill or knowledge needed.
F-3
The primary procedures we performed to address this critical audit matter included:
•
Utilizing personnel with specialized knowledge and skill in technical accounting to assist in: (i) evaluating the relevant facts and
circumstances related to the determination of the functional currency, (ii) reviewing position papers and analysis prepared by management
and management’s specialist, and (iii) assessing the appropriateness of conclusions reached by the Group with respect to the accounting
related to the change of the functional currency.
TARO PHARMACEUTICAL INDUSTRIES LTD.
/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
June 16, 2020
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, 2020,
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, 2020, 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, 2020 and 2019, 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, 2020, and the related notes and our report dated June 16, 2020 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.
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 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.
/s/ Ziv Haft
Ziv Haft
Certified Public Accountants (Isr)
BDO Member Firm
Tel Aviv, Israel
June 16, 2020
F-5
CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
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
OTHER ASSETS
TOTAL ASSETS
The accompanying notes are an integral part of these consolidated financial statements.
F-6
TARO PHARMACEUTICAL INDUSTRIES LTD.
March 31,
2020
2019
$
$
513,354 $
595,383
235,221
35,567
153,073
1,532,598
459,639
209,961
106,693
32,361
2,341,252 $
567,451
481,883
237,945
47,362
148,079
1,482,720
304,322
206,242
110,974
31,068
2,135,326
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, 2020 and March 31, 2019: 200,000,000 shares;
Issued at March 31, 2020 and March 31, 2019: 45,116,262 shares
Outstanding at March 31, 2020 and March 31, 2019:
38,258,077 and 38,538,796 shares, respectively
Founders’ shares of NIS 0.00001 par value:
Authorized, issued and outstanding at March 31, 2020 and March 31, 2019:
2,600 shares
Additional paid-in capital
Accumulated other comprehensive loss, net of taxes
Treasury stock at March 31, 2020 and March 31, 2019: 6,858,185 and
6,577,466 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-7
TARO PHARMACEUTICAL INDUSTRIES LTD.
March 31,
2020
2019
28,858 $
193,873
222,731
3,395
5,367
8,762
35,060
181,761
216,821
2,985
4,398
7,383
231,493
224,204
679
679
1
262,445
(163,037)
(721,494)
2,725,270
2,103,864
5,895
2,109,759
2,341,252 $
1
262,445
(144,108)
(694,510)
2,481,029
1,905,536
5,586
1,911,122
2,135,326
$
$
CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars and shares in thousands (except per share data)
Sales, net
Cost of sales
Gross profit
Operating expenses:
Research and development
Selling, marketing, general and administrative
Settlements and loss contingencies
Operating income
Financial (income) expense, net
Other gain, net
Income before income taxes
Tax expense
Income from continuing operations
Net loss from discontinued operations attributable to Taro
Net income
Net income (loss) attributable to non-controlling interest
Net income attributable to Taro
Net income from continuing operations attributable to Taro
Net loss from discontinued operations attributable to Taro
Net income attributable to Taro
Net income per ordinary share from continuing operations attributable to Taro:
Basic and Diluted
Net loss per ordinary share from discontinued operations attributable to Taro:
Basic and Diluted
Net income per ordinary share attributable to Taro:
Basic and Diluted
TARO PHARMACEUTICAL INDUSTRIES LTD.
2020
Years ended March 31,
2019
2018
644,769 $
245,044
399,725
59,777
93,413
—
153,190
246,535
(48,482)
3,018
298,035
53,485
244,550
—
244,550
309
244,241 $
669,893 $
224,169
445,724
63,238
89,971
(3,678)
149,531
296,193
(58,851)
1,810
356,854
74,732
282,122
—
282,122
345
281,777 $
244,241 $
281,777 $
—
—
244,241 $
281,777 $
661,913
198,405
463,508
70,418
88,196
1,884
160,498
303,010
12,531
1,889
292,368
81,954
210,414
(335)
210,079
(1,071)
211,150
211,485
(335)
211,150
6.35 $
7.23 $
5.27
— $
— $
(0.01)
6.35 $
7.23 $
5.26
$
$
$
$
$
$
$
Weighted-average number of ordinary shares used to compute net income per share:
Basic and Diluted
38,460
38,990
40,155
The accompanying notes are an integral part of these consolidated financial statements.
F-8
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
U.S. dollars in thousands
Net income attributable to Taro
Other comprehensive (loss) income:
Change in unrealized (loss) gain from marketable securities
Change in unrealized loss from hedging instruments
Foreign currency translation adjustments
Total other comprehensive (loss) income attributable to Taro
TARO PHARMACEUTICAL INDUSTRIES LTD.
2020
Years ended March 31,
2019
2018
$
244,241 $
281,777 $
211,150
(16,415)
(2,513)
(1)
(18,929)
11,919
—
(45,742)
(33,823)
1,917
—
35,931
37,848
Total comprehensive income attributable to Taro
$
225,312 $
247,954 $
248,998
The accompanying notes are an integral part of these consolidated financial statements.
F-9
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
U.S. dollars and shares in thousands
Taro Shareholders' Equity
TARO PHARMACEUTICAL INDUSTRIES LTD.
Balance at March 31, 2017
Repurchase of treasury stock
Comprehensive income, net of tax
Net income
Balance at March 31, 2018
Repurchase of treasury stock
Comprehensive loss, net of tax
Dividend paid
Cumulative-effect adjustment for income
taxes resulting from intra-entity transfers
Net income
Balance at March 31, 2019
Repurchase of treasury stock
Comprehensive loss, net of tax
Net income
Balance at March 31, 2020
Number of
Shares
Share
Capital
40,513
$
(1,085)
—
—
39,428
$
(889)
—
—
—
—
38,539
$
(281)
—
—
38,258
$
Additional
Paid-in
Capital
$ 262,445
$ 262,445
Accumulated
Other
Comprehensive
(Loss) Income
(148,133)
$
—
—
37,848
—
—
—
(110,285)
$
—
—
(33,823)
—
—
—
Treasury
Shares
$ (498,675)
(111,334)
—
—
$ (610,009)
Retained
Earnings
$ 2,451,177
—
—
211,150
$ 2,662,327
—
—
(84,501)
—
—
(500,000)
$
Total Taro
Shareholders'
Equity
2,067,494
$
(111,334)
37,848
211,150
2,205,158
$
$
(84,501)
(33,823)
(500,000)
Non-
controlling
Interest
$
Total
Shareholders’
Equity
2,073,806
(111,334)
37,848
210,079
2,210,399
(84,501)
(33,823)
(500,000)
$
6,312
—
—
(1,071)
5,241
—
—
—
—
—
$
—
—
—
$
$ 262,445
$ 262,445
—
—
(144,108)
—
(18,929)
—
(163,037)
—
—
$ (694,510)
(26,984)
—
—
$ (721,494)
36,925
281,777
$ 2,481,029
—
—
244,241
$ 2,725,270
36,925
281,777
1,905,536
$
(26,984)
(18,929)
244,241
2,103,864
$
$
$
—
345
5,586
—
—
309
5,895
$
$
36,925
282,122
1,911,122
(26,984)
(18,929)
244,550
2,109,759
680
—
—
—
680
—
—
—
—
—
680
—
—
—
680
The accompanying notes are an integral part of these consolidated financial statements.
F-10
CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
Cash flows from operating activities:
Net income
Adjustments required to reconcile net income to net cash
provided by operating activities:
Depreciation and amortization
Realized loss on sale of long-lived assets and marketable securities
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
Decrease (increase) in trade receivables, net
Decrease in other receivables, prepaid expenses and other
Increase in inventories, net
Decrease in income tax receivables
(Decrease) increase in trade payables
Increase (decrease) in other accounts payable and accrued expenses
Increase (decrease) in income tax payables
Loss (income) from marketable securities, net
Net cash provided by operating activities
TARO PHARMACEUTICAL INDUSTRIES LTD.
2020
Years ended March 31,
2019
2018
$
244,550
$
282,122
$
210,079
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
18,597
27
3,115
(2,517)
(27,016)
12,262
(32,088)
675
(5,515)
73,581
9,881
(5,683)
(3,669)
(63)
323,709
16,496
275
(893)
9,467
25,503
56,007
(2,297)
2,020
(1,978)
10,624
9,049
(12,012)
2,027
(678)
323,689
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 investing activities:
Purchase of property, plant and equipment
Investment in other intangible assets
Proceeds from short-term bank deposits, net
Proceeds from long-term deposits and other assets
Investment in marketable securities
Proceeds from marketable securities
Proceeds from (investment in) sale of long-lived assets
Net cash (used in) provided by investing activities
Cash flows from financing activities:
Repurchase of treasury stock
Dividends paid
Net cash used in financing activities
Effect of exchange rate changes on cash and cash equivalents
Decrease 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
Non-cash financing transactions:
Purchase of treasury stock
Purchase of marketable securities
TARO PHARMACEUTICAL INDUSTRIES LTD.
2020
Years ended March 31,
2019
2018
(26,631)
(1,783)
—
—
(1,222,190)
952,421
21
(298,162)
(26,992)
(3,666)
225,503
70,685
(1,165,685)
1,157,317
(26)
257,136
(26,984)
—
(26,984)
(556)
(54,097)
567,451
513,354
$
(88,849)
(500,000)
(588,849)
(1,156)
(9,160)
576,611
567,451
$
(26,886)
(2,650)
161,032
396,281
(1,140,853)
370,363
1,075
(241,638)
(106,986)
—
(106,986)
1,147
(23,788)
600,399
576,611
54,536
$
71,096
$
55,051
24,331
$
69,436
$
36,668
1,477
$
4,740
$
—
9,159
$
$
—
2,003
$
$
2,281
4,348
3,491
$
$
$
$
$
$
The accompanying notes are an integral part of these consolidated financial statements.
F-12
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”), Taro Pharmaceuticals North
America, Inc. (“TNA”) 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 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, 2020, 29,497,813, or
77.1%, of the Company’s ordinary shares, and with the Company’s founders’ shares, 84.7% of the vote attributable to the share equity of the
Company.
On October 1, 2015, Taro entered into a share purchase Agreement with EPIRUS Biopharmaceuticals, Inc. (“EPIRUS”) for all of the shares
of Zalicus Pharmaceuticals Ltd. (“Zalicus”), including its product candidate Z944 and certain related assets, a novel, oral, T-type calcium
channel modulator in development for the treatment of pain. As a result of the acquisition, Taro paid CAD $5,000 in cash and a non-interest
bearing, limited recourse promissory note in the amount of CAD $5,000 with a maturity date of July 1, 2017. In July 2017, Taro elected not
to repay the promissory note and the Z944 assets were transferred back to EPIRUS.
On November 23, 2016, the Company announced that its Board of Directors authorized a $250,000 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 10b5-1 program, at an average price of $100.28 per share.
On November 5, 2018, the Company announced that its Board of Directors declared a $500,000 special cash dividend on Taro 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.
F-13
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
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.
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 United States, our largest market. The COVID-19 pandemic has disrupted global supply chains, created
significant volatility of global financial markets and impacted negatively 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 employees and operations, including social
distancing, the supply and use of personal protective equipment, split shifts and health assessments. We have incurred increased costs to put
in place additional protection for the health and safety of our employees within our offices and facilities. 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.
NOTE 2: — SIGNIFICANT ACCOUNTING POLICIES
The consolidated financial statements are prepared according to U.S. GAAP.
a.
Use of estimates:
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 Company’s most critical estimates are used in its determination of its sales incentives reserves, inventory reserves, income taxes, fixed
assets, intangible assets, derivative instruments and contingencies.
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-14
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 winding down of TNA, has reduced the relevance of the foreign currency position on the
balance sheet of Taro Canada. The company decided to focus Taro Canada's sales market as the US market, with the majority of all sales to
the US 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-15
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 FX 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. Includes Taro Canada amounts reported in USD with USD as functional currency.
**Based on unaudited pro forma consolidated amounts of the Group. 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.
Sun, through its wholly owned subsidiary, Taro Development Corporation (“TDC”) owns 3.1% of the shares that have economic rights and
has 50.0% of the voting rights in Taro U.S.A.; with the Company owning the remaining shares and voting rights. In 1993, TDC signed an
agreement with the Company to vote all of its shares in Taro U.S.A. in all elections of directors of Taro U.S.A. as the Company shall
instruct. In May 2020, TDC renewed its commitment to the Company. TDC may terminate the agreement upon one year written notice and
no such notice of termination has been provided. TDC is a minority shareholder in the Company by way of its ownership of Taro U.S.A.
shares that have economic rights.
d.
Cash and cash equivalents:
Cash equivalents are highly-liquid investments that are readily convertible into cash.
Short-term bank deposits:
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 does not have any short-term deposits at March 31, 2020, or 2019.
e.
Marketable securities:
Marketable securities, consisting of both debt securities and equity securities, are comprised primarily of corporations bonds, sovereign
bonds, U.S. Treasuries, certificates of deposit, 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.
F-16
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
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. ASU No. 2016-13, “Financial Instruments—Credit Losses (Topic
326)” will be effective for the Company’s fiscal year beginning April 1, 2020. In accordance with ASC 326-30, AFS debt securities will be
impaired if its fair value is below its amortized cost basis. Under the new guidance, the impairment model no longer allows consideration of
the length of time during which the fair value has been less than its amortized cost when determine whether a credit loss exists.
During the years ended March 31, 2020, 2019 and 2018, the Company did not own or sell any marketable securities previously impaired.
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 does not have a material impact on our
financial position and results of operations.
f.
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.
g.
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.
h.
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, 2020 and 2019, 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 $25,258 and $28,188 as of March 31, 2020 and 2019, respectively.
F-17
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
(3)
Income taxes:
TARO PHARMACEUTICAL INDUSTRIES LTD.
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.
i.
Property, plant and equipment:
(1)
(2)
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 5-10 years).
(3)
Certain costs incurred for computer software developed or obtained for internal use is required to be capitalized. As of March 31,
2020 and 2019, the Group capitalized $13,912 and $7,854 of software costs, respectively. Software costs are amortized using the
straight-line method over their estimated useful life (generally 3 - 5 years).
j.
Lease of land from Israel Land Administration:
The Company leases several parcels of land from the Israel Land Administration (“ILA”). The lease period of the industrial parcels ends
between 2018 and 2060. The Company has the right to extend the lease agreement ending 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 2.bb.
for additional details on lease accounting.
F-18
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
k.
Goodwill:
TARO PHARMACEUTICAL INDUSTRIES LTD.
The goodwill of the Company is not amortized, but rather is subject to an annual impairment test (or more frequently if impairment indicators
arise).
The Company operates in one operating segment, comprising its only reporting unit. The goodwill impairment tests are conducted in two
steps. In the first step, if it is determined that the net book value of the reporting unit exceeds its fair value, the Company would then perform
the second step of the impairment test. This requires the allocation of the reporting unit’s fair value of all of its assets and liabilities in a
manner similar to an acquisition cost allocation, with any residual fair value being allocated to goodwill. The implied fair value of the
goodwill is then compared to the carrying value to determine impairment, if any.
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, 2020, the market capitalization of the Company was
significantly higher than the net book value, therefore there was no need to continue to step two. Taro determined the goodwill was not
impaired as of March 31, 2020 and 2019.
l.
Contingencies:
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.
m.
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 5 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, 2020 and 2019, the Company did not
record any impairment charge.
n.
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.
o.
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, 2020, 2019 and 2018,
the Company repurchased 280,719 shares, 888,719 shares, and 1,085,694 shares, respectively.
On November 15, 2019, the Company commenced a modified “Dutch auction” tender offer to repurchase up to $225.0 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.
F-19
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
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, 2020.
In cases where the purchase cost is lower than the re-issuance price, the Company credits the difference to additional paid-in capital.
p.
Revenue recognition:
The Company adopted the new accounting standard ASC 606, “Revenue from Contracts with Customers,” and all the related amendments
(“new revenue standard”) to all contracts using the modified retrospective method. The cumulative effect of initially applying the new
revenue standard was immaterial. 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.
q.
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-20
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
r.
Royalty-bearing grants:
TARO PHARMACEUTICAL INDUSTRIES LTD.
Royalty-bearing grants from the government of Israel through the National Technological Innovation Authority (the “Authority”) (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, 2020, 2019 and 2018.
s.
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 $4,902, $6,527, and $9,913 for
the years ended March 31, 2020, 2019 and 2018, respectively.
t.
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.
u.
Basic and diluted net income per ordinary share attributable to Taro:
Basic net income per ordinary share is calculated based on the weighted-average number of ordinary shares outstanding during each
year. Diluted net 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).
v.
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 $11,954, $13,187, and $12,170 for the years ended March 31, 2020, 2019 and 2018, respectively.
w.
Concentrations of credit risk:
Financial instruments that potentially subject the Group to concentrations of credit risk consist principally of cash and cash equivalents, and
trade receivables. Cash and cash equivalents and bank deposits are principally invested in major banks in Israel, the United States and
Canada. Such deposits in the United States 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 are financially sound and that 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 United States, Canada, Europe and Israel. At
March 31, 2020, two different customers represented approximately 39.2% and 19.6% 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.
x.
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, 2020 and 2019, 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-21
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
y.
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. At March 31, 2020, and 2019, the Company had derivative instruments
designated as hedging instruments. At March 31, 2018, no derivative instruments were 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
P&L, the hedging reserve value is reclassified to the same item. The ineffective portion, if any, is reported in P&L.
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.
z.
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). Additional disclosure about fair value measurements is also
required.
aa.
Discontinued operations:
When a component of an entity has been disposed of or is classified as held for sale, the results of its operations, including the gain or loss on
the disposed component, should be classified as discontinued operations and the assets and liabilities of such component should be classified
as assets and liabilities attributed to discontinued operations; that is, provided the operations, assets and liabilities of the component have
been eliminated from the Company’s Consolidated Statements of Operations and the Company will no longer have any significant continuing
involvement in the operations of the component.
F-22
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
bb.
Impact of recently adopted accounting standards:
TARO PHARMACEUTICAL INDUSTRIES LTD.
In June 2018, the FASB issued, ASU No. 2018-07, “Compensation—Stock Compensation (Topic 718).” The guidance focuses on expansion
of scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. The guidance was
effective for the Company’s fiscal year beginning April 1, 2019, including interim periods within that year. The adoption of ASU 2018-07
does not have a material impact on our financial position and results of operations.
In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842).” The new guidance requires that the lessee recognize the assets
and liabilities that arise from leases. In July 2018, the FASB issued ASU No. 2018-10, “Codification Improvements to Topic 842,
Leases.” The updated guidance focuses on codification improvements to Topic 842, as part of the FASB improvement project. The guidance
was effective for the Company’s fiscal year beginning April 1, 2019, and interim periods within that year. The adoption of ASU 2016-02
does not have a material impact on our financial position or results of operations.
Impact of recently issued accounting standards not yet adopted:
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’s fiscal year
beginning April 1, 2021, on a retrospective basis. The Company is currently evaluating the potential effect of the adoption of ASU 2018-04
on our financial position and results of operations.
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 will be effective for the Company’s fiscal year beginning
April 1, 2020, including interim periods within that year. The Company does not currently anticipate the adoption to 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 reporting unit to all of its assets and liabilities as if that reporting unit had been acquired in
a business combination. The guidance will be effective for the Company’s fiscal year beginning April 1, 2020, including interim periods
within that year on a prospective basis. The Company does not currently anticipate the adoption to 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 will be effective for the Company’s fiscal year beginning April 1, 2020, including interim periods within
that year. The Company is currently assessing the impact of the adoption of ASU 2016-13 on our financial position and results of operations.
NOTE 3: — MARKETABLE SECURITIES
a.
Marketable securities:
Short-term marketable securities
Long-term marketable securities
March 31,
2020
2019
595,383 $
459,639
1,055,022 $
481,883
304,322
786,205
$
$
F-23
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
b.
The following is a summary of both short-term and long-term marketable securities by type:
TARO PHARMACEUTICAL INDUSTRIES LTD.
2020
Gross
Unrealized
Gain (Loss)
through
Other
Comprehensive
Income
Gross
Unrealized
Gain (Loss)
through
Profit &
Loss
Amortized
Cost
March 31,
Market
Value
Amortized
Cost
2019
Gross
Unrealized
Gain (Loss)
through
Other
Comprehensive
Income
Gross
Unrealized
Gain (Loss)
through
Profit &
Loss
Market
Value
$
686,365 $
271,004
45,329
(6,305) $
2,438
(21)
— $
—
—
680,060 $
273,442
45,308
464,443 $
118,659
60,692
1,145 $
13
—
— $ 465,588
— 118,672
— 60,692
6,195
(1,129)
—
5,066
750
(7)
—
743
7,099
45,405
1,061,397 $
—
(260)
(5,277) $
(1,098)
—
(1,098) $
6,001
45,145
1,055,022 $
750
139,687
784,981 $
—
61
1,212 $
12
762
— 139,748
12 $ 786,205
Marketable securities:
Bonds
Government securities
Commercial paper
Preferred stock - debt
instrument
Preferred stock - equity
instrument
Other securities
Total marketable securities
$
At March 31, 2020 and 2019, the gross unrealized gain excludes $2,502 and $14,655 of other comprehensive income relating to marketable
securities for foreign exchange gain, respectively.
As of March 31, 2020, no other than temporary impairment charges were recorded.
c.
The estimated fair value of marketable securities as of March 31, 2020 and 2019, 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
March 31,
2020
2019
Amortized
Cost
Market
Value
Amortized
Cost
Market
Value
$
$
1,044,537 $
9,761
1,054,298
7,099
1,061,397 $
F-24
1,040,549 $
8,472
1,049,021
6,001
1,055,022 $
783,481 $
750
784,231
750
784,981 $
784,700
743
785,443
762
786,205
TARO PHARMACEUTICAL INDUSTRIES LTD.
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
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
$
410,403 $
461,365
March 31,
2020
2019
Reserves for sales deductions:
Chargebacks
Other sales deductions
Customer rebates
Allowance for doubtful accounts
Trade accounts receivable, net
b.
Other receivables and prepaid expenses:
Government authorities
Due from related parties
Prepaid expenses
Advances to suppliers
Interest receivable
Other
NOTE 5: — SALES INCENTIVES
(104,552)
(50,844)
(17,012)
(2,774)
235,221 $
March 31,
2020
2019
16,257 $
7,839
6,638
1,868
760
2,205
35,567 $
(109,763)
(78,508)
(34,757)
(392)
237,945
28,857
8,987
7,075
1,062
825
556
47,362
$
$
$
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 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.
F-25
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
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. Additionally, as a general practice, the Company does not ship products that have less than 12 months until expiration (i.e., “short-
dated sales”).
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 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
F-26
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
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, 2020, 2019, and 2018:
Accounts Receivable Reserves
Chargebacks
Rebates and Other
Total
Current Liabilities
Returns
Other (2)
Total
For the year ended March 31, 2020
Beginning
balance
Provision recorded
for current period
sales (1)
Credits
processed /
Payments
Ending
balance
$
$
$
$
(109,763) $
(113,657)
(223,420) $
(1,104,946) $
(305,098)
(1,410,044) $
1,110,157 $
348,125
1,458,282 $
(63,818) $
(33,497)
(97,315) $
F-27
(37,258) $
(77,537)
(114,795) $
39,670 $
69,472
109,142 $
(104,552)
(70,630)
(175,182)
(61,406)
(41,562)
(102,968)
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, 2019
Beginning
balance
Provision recorded
for current period
sales (1)
Credits
processed /
Payments
Ending
balance
$
$
$
$
$
$
$
$
(116,632) $
(133,221)
(249,853) $
(1,086,800) $
(377,568)
(1,464,368) $
1,093,669 $
397,132
1,490,801 $
(70,865) $
(40,968)
(111,833) $
(38,247) $
(64,405)
(102,652) $
45,294 $
71,876
117,170 $
(109,763)
(113,657)
(223,420)
(63,818)
(33,497)
(97,315)
For the year ended March 31, 2018
Beginning
balance
Provision recorded
for current period
sales (1)
Credits
processed /
Payments
Ending
balance
(112,071) $
(193,255)
(305,326) $
(1,107,353) $
(432,060)
(1,539,413) $
1,102,792 $
492,094
1,594,886 $
(82,494) $
(43,370)
(125,864) $
(49,265) $
(60,677)
(109,942) $
60,894 $
63,079
123,973 $
(116,632)
(133,221)
(249,853)
(70,865)
(40,968)
(111,833)
(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,
2020
2019
$
$
63,686 $
49,970
34,084
5,333
153,073 $
65,558
44,979
32,593
4,949
148,079
As of March 31, 2020 and 2019, reserves recorded against inventories for slow-moving, short-dated, excess and obsolete inventory totaled
$28,902 and $26,026, respectively.
As of March 31, 2020 and 2019, there were no pledges of inventory.
F-28
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,
2020
2019
$
7,628 $
187,570
3,383
212,480
39,156
80
15,047
465,344
78,150 $
1,847
144,437
20,857
80
10,012
255,383
209,961
$
7,628
183,496
2,291
200,375
33,789
215
14,900
442,694
71,279
1,689
135,801
18,294
215
9,174
236,452
206,242
b.
c.
d.
e.
Depreciation expenses were $19,161, $17,017, and $14,727 for the years ended March 31, 2020, 2019 and 2018, 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, 2020
and 2019. There were no additional capitalized interest and other costs as of March 31, 2020 and 2019.
Cost of computer equipment includes capitalized development costs of computer software developed for internal use in the amount of
$13,912 and $7,854 as of March 31, 2020 and 2019, respectively.
Asset disposals were $279 and $12,707 for the years ended March 31, 2020 and 2019, 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,
2020
2019
$
$
85,174 $
85,174
76,762
76,762
8,412
$
83,391
83,391
74,539
74,539
8,852
F-29
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 $2,222, $1,580 and $1,769 for the years ended March 31, 2020, 2019
and 2018, respectively.
As of March 31, 2020, the estimated amortization expense of product and distribution rights for 2021 to 2025 is as follows: 2021—$1,834;
2022—$1,845; 2023—$1,710; 2024—$311; 2025—$577.
The weighted-average amortization period for product rights is approximately 5 years.
During the years ended March 31, 2020 and 2019, the Company did not record any impairment charge.
NOTE 9: — OTHER ASSETS
Prepayment of land leased from ILA (1)
Intangible assets and deferred costs, net (2)
Goodwill (3)
Right-of-use (ROU) assets (4)
Severance pay fund (5)
Other
March 31,
2020
2019
$
$
13,250 $
8,412
7,191
2,195
1,187
126
32,361 $
13,480
8,852
7,191
—
1,350
195
31,068
(1)
(2)
(3)
(4)
(5)
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.
See Note 8.
See Note 2.k.
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 2023. See Note 2.bb. and Note 13.
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 $1,133, $1,254 and $1,195 for the years ended March 31, 2020,
2019 and 2018, respectively.
Pension, retirement savings and severance expenses
$
6,654 $
5,924 $
6,058
2020
Years ended March 31,
2019
2017
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-30
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 NIS and the CAD against the U.S. dollar
and the exchange rates between the U.S. dollar and each of the NIS and the CAD at the end of the year indicated:
Rate of Inflation
Rate of Devaluation
(Appreciation)
Against U.S. Dollar
Rate of Exchange of
U.S. Dollar
Period ended
3/31/2020
3/31/2019
Israel (1)
Canada (2)
Israel (1)
Canada (2)
Israel (1)
Canada (2)
0.00%
1.40%
0.89%
1.88%
(1.65%)
3.42%
6.02%
3.10%
3.57
3.63
1.41
1.33
(1)
(2)
Per Bank of Israel.
Per J.P. Morgan Chase.
In April 2016, the Company began entering 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 U.S. dollars due to changes in the respective exchange rates. At March 31, 2020, the
forward contracts to purchase the NIS are for a total amount of $49,000, at a weighted-average forward rate of 3.44 NIS per U.S. dollar,
which are settled in seventeen (17) monthly settlements of $3,250 for ten (10) months, $2,000 for six (6) months, and $4,500 for one (1)
month. The Company recorded a net gain (loss) of $178, ($2,530) and $97 for the years ended March 31, 2020, 2019, and 2018, respectively,
for the contracts to purchase the NIS.
The forward contracts to purchase the CAD are for a total amount of $40,024, at a weighted-average forward rate of CAD 1.31 per U.S.
dollar, which are settled in sixteen (16) monthly installments of approximately $2,453 for nine (9) months, $3,999 for three (3) months,
$1,708 for three (3) months, and $826 for one (1) months. The Company recorded a net (loss) gain of ($629), $2,545 and $2,068, for the
years ended March 31, 2020, 2019, and 2018, respectively, for the contracts to purchase the CAD.
There is no collateral for these hedges.
At March 31, 2020, 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-31
TARO PHARMACEUTICAL INDUSTRIES LTD.
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
The fair value of the Company’s financial assets measured at fair value on a recurring basis as of March 31, 2020 and 2019 were as follows:
Assets
Short-term marketable securities *
Long-term marketable securities *
Long-term debt instruments *
Long-term equity instruments *
Forward contracts
Liabilities
Forward contracts
March 31, 2020
March 31, 2019
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)
$
$
$
$
595,383 $
448,572
5,066
6,001
—
1,055,022 $
— $
—
—
—
35
35 $
481,883 $
302,817
743
762
—
786,205 $
—
—
—
—
—
—
— $
$
—
(4,667) $
$
(4,667)
— $
$
—
(4,063)
(4,063)
*Refer to Note 3 for additional details on marketable securities.
NOTE 12: — OTHER LIABILITIES
a.
Other current liabilities:
Returns reserve
Medicaid and indirect rebates
Accrued income taxes
Employees and payroll accruals
Accrued expenses
Marketable securities
Royalties
Due to customers
Derivative instruments
Legal and audit fees
Lease liability
Suppliers of property, plant and equipment
Settlements and loss contingencies
Deferred revenue
Other
March 31,
2020
2019
61,406 $
37,110
22,511
20,195
15,616
9,168
8,523
4,452
3,811
2,743
1,514
1,418
961
237
4,208
193,873
$
63,818
31,947
16,950
21,057
16,308
2,005
863
1,550
3,769
2,253
—
4,654
1,841
9,439
5,307
181,761
$
$
F-32
TARO PHARMACEUTICAL INDUSTRIES LTD.
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
b.
Other long-term liabilities:
Deferred revenue
Accrued severance pay
Other
March 31,
2020
2019
$
$
1,347 $
1,278
2,742
5,367 $
1,572
1,345
1,481
4,398
NOTE 13: — COMMITMENTS AND CONTINGENT LIABILITIES
a.
Companies of the Group have leased offices, warehouse space and equipment under operating leases for periods through 2023. The minimum
annual rental payments, under non-cancelable lease agreements, are as follows:
3/31/2021
3/31/2022
3/31/2023
$
$
March 31, 2020
1,664
767
235
2,666
Total rent expenses were $1,875, $2,905 and $2,966 for the years ended March 31, 2020, 2019 and 2018, 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. Prior period amounts were not adjusted and continue to be
reported in accordance with ASC 840.
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 Authority 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 U.S. dollar. Grants are subject to interest at a rate of LIBOR (cost of borrowing funds in U.S. dollars). As of March 31, 2020
and 2019, the aggregate contingent liability to the Authority was $12,950 and $12,697, respectively.
Royalty payments to the Authority were $0, $89 and $100 for the years ended March 31, 2020, 2019 and 2018, 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.
F-33
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
1.
Legal actions commenced by the Company:
Company’s lawsuit related to tax assessment:
TARO PHARMACEUTICAL INDUSTRIES LTD.
In February 2017, after consulting with its tax advisors, the Company filed an appeal pursuant to Section 153 of the Income Tax
Ordinance (New Version), 1961 in the Haifa District Court. The appeal challenged the Israel Tax Authority’s (“ITA”) tax assessment
for the period of January 1, 2010 through March 31, 2014 in the amount of $40,782 (before interest, linkage and penalties), and denial
of an unutilized capital loss in an amount of $74,551 that had been claimed by the Company.
In March 2018, the Company reached a settlement with the ITA, under which the Company paid a reduced tax assessment of $15,000,
and the Company was permitted to record the unutilized capital loss, transfer intellectual property from TNA to Taro Israel and Taro
Canada and reorganize assets held by our subsidiaries without triggering an Israeli tax event (the “Settlement”). The Settlement
finalized all tax disputes between the parties for the tax years 2010 through 2014 as well as related tax issues with respect to the tax
years 2015 through 2016, which years were not subject to the disputes.
2.
Generic drug industry pricing investigations and related litigation:
On September 8, 2016, Taro U.S.A. received a grand jury subpoena from the United States Department of Justice, Antitrust Division,
seeking documents relating to corporate and employee records, generic pharmaceutical products and pricing, communications with
competitors and others regarding the sale of generic pharmaceutical products, and certain other related matters. Taro U.S.A. is in the
process of responding to the grand jury subpoena. Certain current and former officers and employees of Taro U.S.A.’s commercial
team have also received related subpoenas. On February 4, 2020, a former member of Taro U.S.A.’s commercial team was indicted
for alleged violations of U.S. antitrust laws.
The Company, Taro U.S.A. 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. The lawsuits allege that the Company, Taro U.S.A., and/or, in the AG and IRP complaints,
the concerned individual, have conspired with competitors to fix prices, rig bids, or allocate customers with respect to Taro U.S.A.
products, and also allege an industry-wide conspiracy as to nearly all generic pharmaceutical products. Each of these cases has been
transferred to the United States 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.
On May 10, 2018, Taro U.S.A. received a Civil Investigative Demand from the United States Department of Justice pursuant to the
False Claims Act seeking information relating to corporate and employee records, generic pharmaceutical products and pricing,
communications and/or agreements with competitors and others regarding the sale of generic pharmaceutical products, and certain
other related matters. Taro U.S.A. is in the process of responding to the Civil Investigative Demand.
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 United States 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.
F-34
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
3.
Other matters:
TARO PHARMACEUTICAL INDUSTRIES LTD.
In April 2019, the Company entered into a conditional settlement with the Israeli Ministry of Environmental Protection (the “MoEP”)
and submitted it to the Haifa Magistrate’s Court, which approved the settlement in July 2019. The conditional settlement concerns one
current and one former employees’ and the Company's non-compliance with the performance obligations of periodic sampling of
emissions from the facility's stacks between 2010 and 2013 as instructed by the Company's business license and the Israeli business
license law. In the settlement, the Company and the concerned individuals undertook to refrain from repeating the described violations
for a term of one year commencing on July 2019 and to conditional fines to be imposed in case these violations are repeated. In
exchange, the MoEP agreed to a non-conviction by the court.
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 have filed a preliminary response to the
court in which they have moved the court to dismiss the motion in light of the requirements of Israeli Class Action Law.
d.
Other:
Payments to pharmacies for Medicaid-covered outpatient prescription drugs are set by the states. For many multiple source drugs with
respect to 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. Health care reform legislation 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 percent 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 and Medicare Part B, to pay rebates to state Medicaid programs
on drugs dispensed to Medicaid beneficiaries in the state. The amount of the rebate is calculated for non-innovator multiple source drugs as
13 percent of AMP and for innovator drugs as the lower of 23.1 percent 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 price increases exceed the rate of inflation.
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. Effective April 1, 2017, states are now required to use actual acquisition cost as the basis of reimbursement. Many of the
legislative changes noted above stemmed from civil lawsuits being 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,
among Taro Israel, the Histadrut Trade Union and Taro Israel’s Employees Committee on behalf of Taro’s Israeli employees ended December
31, 2019 (the “Collective Bargaining Agreement”). The Collective Bargaining Agreement has a term of three years and automatically
renews for one-year periods unless notice is provided by a party three months prior to the end of a term. We received notice and have
negotiated a new collective bargaining agreement, which is being drafted by the parties. The Collective Bargaining Agreement 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.
F-35
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
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, 2020, 2019 and 2018, no options were outstanding. No further options in respect of the 1999 plan are available for future
grants. There were no options exercised in the years ended March 31, 2020, 2019 and 2018, respectively.
d.
Net income per share:
Year ended March 31, 2020
Year ended March 31, 2019
Year ended March 31, 2018
Net income
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)
Basic and diluted EPS $
244,241
38,460,056 $
6.35 $
281,777
38,990,058 $
7.23
$
211,150
40,155,087 $
Per
Share
Amount
5.26
e.
As of March 31, 2020, the accumulated other comprehensive income comprised of loss from foreign currency translation adjustments and
hedge accounting of $160,583, and unrealized loss from available for sale securities of $2,454. As of March 31, 2019, the accumulated other
comprehensive income comprised of loss from foreign currency translation adjustments and hedge accounting of $158,069, and unrealized
gain from available for sale securities of $13,961. Unrealized gains (losses) on marketable securities reclassified out of accumulated other
comprehensive income to financial income (expense) on the income statement were $420, ($1,003) and ($86) during the years ended March
31, 2020, 2019, and 2018, 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%, 23.0% and 24.0% for the years ended March 31,
2020, 2019 and 2018, respectively.
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 provides 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 cancelled 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.
The Company qualifies 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%).
F-36
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
The Company has two active plans, one Approved Enterprises 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 5 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 5 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 is 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, 2020, management believes that the Company complied with
all of the aforementioned requirements.
If the Company pays a dividend, the source of which is income derived from the Approved and/or Benefited Enterprises during the tax
exempt period, the Company will be subject to corporate tax at the rate ordinarily applicable to the Approved/Benefited Enterprise from
which it was exempt, 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, 2020 and 2019, income not eligible for Approved and/or Benefited 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. 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. We did not elect to apply for Amendment 68 in tax
year 2019 or 2018. The Company currently continues to apply the pre Amendment 68 regime, however, may still decide in the future to
make the above-mentioned election.
e.
The New Technological Enterprise Incentives Regime – 2017 Amendment to the Investment Law
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.
F-37
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
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 average R&D expenses in the three years prior to the current tax year must be greater than or equal to 7%, in average,
of the Enterprise-owning company’s total revenue or exceed NIS 75 million (approximately $21,000) per year;
A company must also satisfy one of the following conditions:
•
•
•
at least 20% of the workforce (or at least 200 employees) are employees of which salaries are fully allocated to R&D expenses;
a venture capital investment of an amount approximately equivalent to at least $2.2 million was previously made in the
company and the company did not change its field of business after the investment; or
growth in sales or workforce by an average of 25% in the three years preceding the tax year in comparison to the prior tax year.
A "Special Preferred Technological Enterprise" is an enterprise that meets conditions 1 and 2 above, and in addition is a part of a group of
companies that have total annual consolidated revenues above NIS 10 billion (approximately $2.6 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. 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%. For other dividend distributions, the
withholding tax rate shall be 20% (or a lower rate under a tax treaty, if applicable).
The Company continues to apply the pre Amendment 68 regime.
f.
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 U.S. dollars 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 U.S. Dollar terms. After the
initial three-year term, the Company must make the election on an annual basis. Through taxable year 2019, the Company has consistently
elected, for tax purposes, to measure its earnings in U.S. dollars.
g.
Income from continuing and discontinued operations before income taxes is comprised of the following:
Domestic (Israel)
Foreign (North America, the Cayman Islands, Ireland and the U.K.)
Income from continuing and discontinued operations before taxes
$
$
99,182
198,853
298,035
$
$
184,410
172,444
356,854
$
$
91,485
200,548
292,033
Year ended March 31,
2019
2020
2018
F-38
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
h.
Taxes on income are comprised of the following:
Current taxes
Prior years' benefits
Deferred income taxes
Domestic (Israel)
Foreign (North America)
TARO PHARMACEUTICAL INDUSTRIES LTD.
Year ended March 31,
2019
2020
2018
55,895
$
(9,995)
7,585
53,485
$
4,177
49,308
53,485
$
$
60,203
$
(2,980)
17,509
74,732
$
33,183
41,549
74,732
$
$
27,687
(1,830)
56,097
81,954
17,373
64,581
81,954
$
$
$
$
Included within current and deferred income tax expense are benefits relating to research and development tax credits at Taro Canada of
$664, $867 and $1,091 for the years ended March 31, 2020, 2019 and 2018, respectively. Taro Canada uses the “flow-through” method and
therefore records the benefits in earnings in the period the tax credits are utilized.
On December 22, 2017, the U.S. enacted the Tax Cuts and Jobs Act (the “Tax Act”), which among other provisions, reduced the U.S.
corporate tax rate from 35% to 21%, effective January 1, 2018. Fiscal year filers, such as Taro U.S.A., recognize a partial reduction in the
U.S. corporate tax rate for their year ending after January 1, 2018, and thereafter recognize the full reduction in the U.S. corporate tax
rate. For the year ending March 31, 2018, Taro U.S.A. was subject to a 31.5% federal tax rate and for subsequent years Taro U.S.A. is
subject to a 21% federal tax rate.
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%.
i.
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:
Tax benefits from reduced tax rates under benefit programs and
other
Utilization of net operating losses
Different tax rates applicable to non-Israeli subsidiaries
Uncertain tax positions, net
FX on tax payments
Taxes from prior years
Net operating loss carryback (1)
Change in Federal corporate income tax rate
Effective consolidated tax rate
Year ended March 31,
2019
23.0%
2018
24.0%
2020
23.0%
(4.1%)
—
1.3%
(0.6%)
0.4%
(0.8%)
(1.3%)
—
17.9%
(6.2%)
(0.4%)
0.8%
3.4%
(0.3%)
0.6%
—
—
20.9%
(7.8%)
(2.5%)
(2.3%)
(3.3%)
—
5.7%
—
14.2%
28.0%
(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%.
F-39
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
j.
Current taxes are calculated at the following combined federal and local rates:
TARO PHARMACEUTICAL INDUSTRIES LTD.
On Israeli operations (not including “Approved Enterprise”)
On U.S. operations *
On Canadian operations *
On U.K. discontinued operations *
On Ireland discontinued operations *
Year ended March 31,
2019
23.0%
21.2%
25.0%
*
*
2018
24.0%
31.7%
25.0%
20.0%
12.5%
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. Since the U.K. and Ireland operations are classified as discontinued operations, there is no current tax.
k.
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.
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
Other, net
Total deferred tax liabilities
Net deferred tax assets
Domestic
Foreign
F-40
March 31,
2020
2019
$
$
$
$
548 $
17,749
24,765
1,440
36,612
45,756
583
792
262
8,506
137,013
(23,338)
113,675
(10,178)
—
(199)
(10,377)
$
103,298
4,224 $
99,074
103,298
$
4,383
18,301
19,726
1,440
41,420
50,742
83
84
—
7,448
143,627
(24,652)
118,975
(8,803)
(1,924)
(259)
(10,986)
107,989
5,684
102,305
107,989
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
The deferred income taxes are presented on the Consolidated Balance Sheets as follows:
TARO PHARMACEUTICAL INDUSTRIES LTD.
Among non-current assets
Among long-term liabilities
l.
Carryforward tax losses:
1.
The Company:
March 31,
2020
2019
$
$
106,693 $
(3,395)
$
103,298
110,974
(2,985)
107,989
As of March 31, 2020, the Company has $77,169 carryforward capital losses. Please refer to Note 13.c. and Note 15.p. for
additional information relating to Israel’s carryforward capital losses.
2.
Canadian subsidiary:
As of March 31, 2020, this subsidiary has no carryforward losses.
3.
U.S. subsidiary
As of March 31, 2020, this subsidiary has deferred losses of $28,473. This subsidiary intends to carry the entire loss back to
previous years.
The Company’s Board of Directors has determined that its U.S. subsidiary will not pay any dividends as long as such payment will result in
any tax expense for the Company.
At March 31, 2020, deferred income taxes were not provided for on a cumulative total of $1,587,378 of the undistributed earnings of Taro
Canada, which are not taxable provided earnings remain undistributed. Taro Canada may not pay any dividend as long as such dividend will
result in the current 25% tax expense for the Company.
Foreign withholding taxes have been accrued as necessary by the Company and its subsidiaries.
Federal tax assessments:
m.
n.
o.
p.
The Company completed its tax assessments with the Israeli tax authorities for years through 2014. In February 2017, after consulting with
its tax advisors, the Company filed an appeal pursuant to Section 153 of the Income Tax Ordinance (New Version), 1961 in the Haifa District
Court. The appeal challenged the ITA’s tax assessment for the period of January 1, 2010 through March 31, 2014 in the amount of $40,782
(before interest, linkage and penalties), and denial of an unutilized capital loss in an amount of $74,551 that had been claimed by the
Company. The Company is under examination by the Israeli tax authorities for the years 2015 through 2017. The Company may be subject
to examination by the Israeli tax authorities for the years 2015 and onward. The Company believes that its tax provision is adequate to
satisfy any assessments resulting from examination to the years.
In March 2018, the Company reached a settlement with the Israel Tax authority (“ITA”), under which the Company is obligated to pay a
reduced tax assessment of $15,000, and the Company was permitted to record the unutilized capital loss, transfer intellectual property from
TNA to Taro Israel and Taro Canada and reorganize assets held by our subsidiaries without triggering an Israeli tax event (the “Settlement”).
The Settlement finalized all tax disputes between the parties for the tax years 2010 through 2014 as well as related tax issues with respect to
the tax years 2015 through 2016, which years were not subject to the controversy.
Taro U.S.A. completed its tax assessments with the U.S. tax authorities for the years through March 31, 2015. The period in which Taro
U.S.A.’s tax return for the year ending March 31, 2016 may be examined has expired and this year is no longer subject to federal audit.
F-41
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
Taro Canada completed its tax assessments with the Canadian tax authorities for the years through 2011. The Company’s tax provision was
materially adequate to satisfy these assessments. The Company is under examination by the Canada tax authorities for the year ended March
31, 2015 through the short period ended March 15, 2017. 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.
q.
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,
2019
2020
2018
$
$
28,188 $
382
(7,913)
4,601
$
25,258
16,810 $
1,689
(128)
9,817
$
28,188
23,457
—
(15,506)
8,859
16,810
The total amount of interest and linkage to Consumer Price Index recognized on the Consolidated Statement of Operations for the three years
ended March 31, 2020, 2019 and 2018, were $1,224, $323, and $427 respectively. The total amount of interest and linkage to Consumer
Price Index recognized on the Consolidated Balance Sheets at March 31, 2020 and 2019 were $2,548 and $1,324, respectively.
The total amount of unrecognized tax benefits, which would impact the effective tax rate if recognized, was $25,258 and $28,188 at
March 31, 2020 and 2019, respectively.
NOTE 16: — SELECTED STATEMENTS OF INCOME DATA
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 gains
F-42
Year ended March 31,
2019
2020
2018
$
644,769
$
669,893
$
661,913
$
$
$
$
$
31,754
4,902
56,757
—
93,413
2,382
$
$
$
$
39,495
6,527
43,949
(3,678)
$
86,293
144
$
725
$
(11,714)
(22,655)
(14,838)
(48,482) $
256
$
(14,107)
(19,691)
(25,309)
(58,851) $
33,724
9,913
44,559
1,884
90,080
(124)
304
(13,367)
(6,871)
32,465
12,531
TARO PHARMACEUTICAL INDUSTRIES LTD.
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
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, 2020 and as of
March 31, 2020:
Sales *
Long-lived assets **
Year ended March 31, 2019 and as of
March 31, 2019:
Sales *
Long-lived assets **
Year ended March 31, 2018 and as of
March 31, 2018:
Sales *
Long-lived assets **
$
$
$
$
$
$
42,817 $
123,679 $
97,997 $
63,506 $
495,673 $
38,379 $
8,282 $
— $
644,769
225,564
40,050 $
123,698 $
83,970 $
59,108 $
537,111 $
39,479 $
8,762 $
— $
669,893
222,285
38,223 $
114,145 $
67,226 $
56,629 $
549,174 $
37,246 $
7,290 $
— $
661,913
208,020
*
**
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, 2020, the Company had net sales to two different U.S. customers of 13.0% and 11.5% of consolidated net
sales. For the year ended March 31, 2019, the Company had net sales to two different customers of 12.1% and 11.0% of consolidated net
sales. For the year ended March 31, 2018, the Company had net sales to three different customers of 15.3%, 11.5% and 11.4% of
consolidated net sales.
c.
Sales by therapeutic category, as a percentage of total net sales for the years ended March 31, 2020, 2019 and 2018, were as follows:
Category
Dermatological and topical
Neuropsychiatric
Cardiovascular
Anti-inflammatory
Other
Total
Year ended March 31,
2019
2020
2018
63%
17%
6%
3%
11%
100%
61%
18%
7%
3%
11%
100%
65%
17%
6%
4%
8%
100%
F-43
TARO PHARMACEUTICAL INDUSTRIES LTD.
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
NOTE 18: — DISCONTINUED OPERATIONS
a.
During 2010, the Company’s management decided to sell its Irish facility, which was sold in July 2017 for $946. The results of operations of
the Irish facility were classified as discontinued operations in the Consolidated Statements of Operations. The subsidiary was dissolved as of
January 2018.
b.
The following is the detail of discontinued operations:
Sales, net
Cost of sales
Gross loss
Operating expenses:
2020
$
Research and development
Selling, marketing, general and administrative
Operating loss
Financial income, net
Other loss, net
Loss before income taxes
Net loss from discontinued operations
$
Year ended March 31,
2019
2018
$
—
—
—
—
—
—
—
—
—
— $
$
—
—
—
—
—
—
—
—
—
— $
—
(103)
(103)
(30)
(169)
(302)
113
(146)
(335)
(335)
NOTE 19: — RELATED PARTY TRANSACTIONS
In addition to Sun controlling 84.7% of the voting power in the Company as of March 31, 2020, 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, 2019, 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 in the following areas: Human Resources, Information Technology, Legal (including intellectual property matters), OTC,
Management, Procurement, certain aspects of Commercial and Customer Service, Finance (Accounts Receivable, Accounts Payable,
Government Pricing, Gross-to-Net and Tax Compliance), Regulatory Affairs (Canada only), Supply Chain, Travel Related Services, and
Generic Rx (chargeback and rebate maintenance) (each a “Service Area”).
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 the approved allocation methodologies for each Service
Area. 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.
F-44
Notes to consolidated financial statements
U.S. dollars in thousands (except share and per share data)
TARO PHARMACEUTICAL INDUSTRIES LTD.
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 April 2017, the Board of Directors approved for Taro to negotiate an agreement with Sun whereby Taro's U.S. branded products team
advertised and promoted a combined portfolio of Taro and Sun corticosteroid products. The agreement between Taro U.S.A., and Sun went
into effect on May 1, 2017. Under this agreement, Sun sold its products to customers and paid Taro a percentage of the net sales for Taro's
promotional services. Taro discontinued the promotion of its U.S. branded products effective March 31, 2019, and terminated the
corticosteroid agreement.
In May 2018, Taro Canada signed an agreement with Sun’s affiliate Ranbaxy Pharmaceuticals Canada Inc., 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; additionally, Sun and Ranbaxy Inc. pay Taro Canada a sales and distribution fee.
NOTE 20: — SUBSEQUENT EVENTS
Subsequent to March 31, 2020, the Company received final approvals from the FDA for four additional ANDAs:
Clocortolone Pivalate Cream USP, 0.1% and Mupirocin Cream USP, 2% in April 2020; Ivermectin Lotion, 0.5% in May 2020; and
Betamethasone Dipropionate Spray, 0.05% in June 2020. The Company currently has a total of twenty-one ANDAs awaiting FDA approval,
including five tentative approvals.
In June 2020, the Company along with an additional pharmaceutical manufacturer were named as part of a proceeding in Israel seeking
approval for a proposed class action relating to the alleged sale of opioid products in Israel.
In June 2020, Taro U.S.A. and former members of its commercial team were named as defendants in a lawsuit brought by U.S. State
Attorney Generals. The lawsuit alleges Taro U.S.A. and the concerned individuals conspired with competitors in violation of antitrust laws
with respect to Taro U.S.A. products and engaged in an industry-wide conspiracy. In addition, in June 2020, Taro U.S.A. and Taro
Pharmaceuticals Inc. were named as defendants in a proposed class action in Canada. The lawsuit alleges that the Taro entities conspired
with competitors in violation of antitrust laws with respect to the Taro entities’ products.
End of consolidated financial statements.
F-45
SCHEDULE II: — VALUATION AND QUALIFYING ACCOUNTS
Schedules have been omitted as the required information is provided elsewhere in these financial statements.
S-1
Description of Taro Pharmaceutical Industries Ltd. Ordinary Shares Registered Under Section 12 of the Exchange Act
As of March 31, 2020, 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 June 1, 2020, 2,600 founders’ shares and 38,258,077 ordinary shares were issued and outstanding.
Exhibit 2.2
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.
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” includes 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).
The 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 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.
-2-
A person shall be qualified to serve as a statutory external director only if he or she possesses accounting and financial expertise or professional
competence, as defined in the regulations promulgated under the Companies Law. At least one statutory external director must possess accounting and
financial expertise.
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.
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. “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 only by the shareholders, 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.
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.
A statutory external director is entitled to compensation determined by the board within the scope provided in regulations adopted under the
Companies Law.
-3-
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.
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.
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;
-4-
●
●
●
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 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 fulfill one of the following requirements:
●
●
at least a majority of the shares held by all shareholders who do not have a personal interest in the transaction and who are present and
voting at the meeting approves the transaction, excluding abstentions; or
the shares voted against the transaction by shareholders who have no personal interest in the transaction and who are present and voting at
the meeting do not exceed 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;
-5-
(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 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); and
(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
-6-
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 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
Pursuant to the Companies Law and our articles, our board of directors possesses the power to borrow money for company purposes.
Changes in Capital
-7-
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.
-8-
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: June 19, 2020
/s/ Uday Baldota
Name:
Title:
Uday Baldota
Chief Executive Officer and Director
I, Daphne Huang, 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: June 19, 2020
/s/ Daphne Huang
Name:
Title:
Daphne Huang
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, 2020 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 Daphne Huang, 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: June 19, 2020
By: /s/ Uday Baldota
Uday Baldota
Chief Executive Officer and Director
By: /s/ Daphne Huang
Daphne Huang
Vice President, Chief Financial Officer and Chief
Accounting Officer