REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES
EXCHANGE ACT OF 1934
OR
x
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2003
OR
o
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition
period from
to
Commission file number 0-22286
TARO PHARMACEUTICAL INDUSTRIES LTD.
(Exact name of Registrant as specified in its charter)
Israel
(Jurisdiction of incorporation or organization)
Italy House, Euro Park, Yakum 60972, Israel
(Address of principal executive offices)
Securities registered or to be registered pursuant to Section 12(b) of the Act:
Title of each class
Name of each exchange on which registered
None
None
Securities registered or to be registered pursuant to Section 12(g) of the Act:
Ordinary Shares, NIS 0.0001 nominal (par) value per share
(Title of Class)
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:
None
(Title of Class)
Indicate the number of outstanding shares of each of the issuers classes of
capital or common stock as of the close of the period covered by the annual
report:
28,969,218 Ordinary Shares, NIS 0.0001 nominal (par) value per share
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.
x
Yes
o
No
Indicate by check mark which financial statement item the registrant has
elected to follow.
We develop, manufacture and market prescription and over-the-counter, or
OTC, pharmaceutical products, as well as active pharmaceutical ingredients, or
APIs, primarily in the United States, Canada and Israel. 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. In
October 2001, we sold 3,950,000 of our ordinary shares, and selling
shareholders sold 1,800,000 of our ordinary shares, in a public offering. Our
ordinary shares are currently traded on the Nasdaq National Market under the
symbol TARO.
In July 2001, we completed a split of our ordinary shares by distributing
a dividend of one ordinary share for every ordinary share then outstanding and
one ordinary share for every ten founders shares then outstanding. All
ordinary share and per share numbers contained in this annual report have been
adjusted to give effect to this dividend.
Except for the historical information contained in this annual report, the
statements contained herein are forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995 with respect to our
business, financial condition and results of operations. 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 3 Key
Information-Risk Factors and elsewhere in this annual report.
We urge you to consider that statements which use the terms
believe,
expect, plan, intend, estimate, anticipate, should, will, may
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.
Our consolidated financial statements appearing in this annual report are
prepared in U.S. dollars and in accordance with U.S. generally accepted
accounting principles, or U.S. GAAP. All references in this annual report to
dollars, or $, are to U.S. dollars and all references in this annual report
to NIS are to New Israeli Shekels. The published representative exchange
rate between the NIS and the dollar for March 31, 2004 was NIS 4.53 per $1.00.
The published representative exchange rate between the Canadian dollar and the
dollar for March 31, 2004 was $1.31 Canadian dollar per $1.00.
As
used in this annual report, the terms
we, us, our
and the
Company
mean Taro Pharmaceutical Industries Ltd. and its subsidiaries, unless
otherwise indicated.
ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS
Not applicable.
ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE
Not applicable.
ITEM 3. KEY INFORMATION
A. SELECTED FINANCIAL DATA
We have derived the following selected consolidated financial data as of
December 31, 2003 and 2002 and for each of the years ended December 31, 2003,
2002 and 2001 from our consolidated financial statements set forth elsewhere in
this annual report that have been prepared in accordance with U.S. GAAP. We
have derived the consolidated selected financial data as of December 31, 2001,
2000 and 1999 and for each of the years ended December 31, 2000 and 1999 from
our audited consolidated financial statements not included in this annual
report. In July 2001, we completed a split of our ordinary shares, NIS 0.0001
nominal (par) value per share, by distributing as a dividend one ordinary share
for every ordinary share then outstanding and one ordinary share for every ten
founders shares then outstanding. All ordinary share and per share numbers
contained in this annual report have been adjusted to give effect to this stock
split.
You should read the selected consolidated financial data together with
Item 5 - Operating and Financial Review and Prospects and our consolidated
financial statements included elsewhere in this annual report.
Our business, operating results and financial condition could be seriously
harmed due to any of the following risks, among others. If we do not
successfully address the risks to which we are subject, we could experience a
material adverse effect on 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 may
charge for our products, the market share of our products and our revenues 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, revenues and profitability. Depending upon how we respond to this
competition, its effect may be materially adverse to us. We compete with:
the original manufacturers of the brand-name equivalents of
our generic products;
other drug manufacturers (including brand-name companies that
also manufacture generic drugs); 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 in
respect of which patents have expired. None of these products benefits from
patent protection and are therefore more subject to the risk of competition
than patented products. In addition, because many of our competitors have
substantially greater financial, production, 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.
Brand-name companies frequently take actions to prevent or discourage the use
of generic drug products such as ours.
Brand-name companies frequently take actions to prevent or discourage the
use of generic equivalents to their products, including generic products that
we manufacture or market. Because most of the products that we sell are generic
versions of brand-name drugs, we are particularly subject to the risk that the
manufacturers and sellers of the brand-name equivalents of our products may
take the following actions, among others:
filing new patents on products whose original patent
protection is about to expire;
developing patented controlled-release products or other
product improvements;
developing and marketing branded products as over-the-counter
products;
increasing marketing initiatives, regulatory activities and
litigation relating to our products or proposed products; and
introducing authorized generics to the marketplace.
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 name at discounted prices are known as authorized generics.
This facilitates the sale by brand-name manufacturers of generic equivalents of
their 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 those 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
like ours that may obtain the first ANDA approval for a particular product, be
the first-to-market and/or the only generic alternative offered to the market
and thus diminish the economic benefit associated with this position.
New developments by others could make our products or technologies
non-competitive or obsolete.
The markets in which we compete and intend to compete are undergoing, and are
expected to continue to undergo, rapid and significant technological change. We
expect competition to intensify as technological advances are made. New
developments by others may render our products or technologies non-competitive
or obsolete. For example, AstraZeneca Pharmaceuticals have filed New Drug
Applications for a novel oral direct thrombin inhibitor, Exanta®
(ximelagatran). If approved by regulatory authorities, the launch of Exanta®
may have an adverse effect on our sales of
Coumadin® in Israel and warfarin in the United States and Canada. A reduction
in the sales and profitability of warfarin may have an adverse effect on the
results of our operations and financial condition.
Our ability to market products successfully depends, in part, upon the
acceptance of the 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 and
other retailers) as well as patients. In addition, unanticipated side effects
or unfavorable publicity concerning any of our products could have an adverse
effect on our ability to achieve acceptance by prescribing physicians, managed
care providers, pharmacies and other retailers, customers and patients.
Our ongoing profitability depends upon our ability to introduce new generic or
innovative products on a timely basis.
Our ongoing 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.
Our revenues and profits from individual generic pharmaceutical products are
likely to decline as our competitors introduce their own generic equivalents.
Revenues 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 will decline. For example, in May 2001, we began to
market the first generic equivalent of Schering-Ploughs Lotrisone® cream to be
sold to the public in the United States. Competitors have introduced their own
generic equivalents of Lotrisone® cream and additional competitors can be
expected to enter the market. The introduction of additional generic
equivalents or price reductions of existing generic products may have an
adverse effect on revenues from our products, including our generic equivalent
of Lotrisone® cream.
We are subject to extensive government regulation that increases our costs and
could 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 the approval,
testing, manufacture, labeling, marketing and sale of pharmaceutical products.
For example, approval by the United States Food and Drug Administration, or
FDA, is generally required before any new drug or the generic equivalent to any
previously approved drug may be marketed in the United States. The process for
obtaining FDA and other approvals is lengthy, costly and subject to the risk,
among others, that approval will not be obtained. In addition, the labeling
claims and marketing statements that we can make are limited by regulations
and, in most cases, by the labeling claims made in brand-name packaging.
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 United States Controlled Substances Act and its equivalents
in Israel and Canada, as well as the regulations promulgated thereunder in each
country. These regulations include stringent requirements for manufacturing
controls, importation, 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.
Furthermore, most of the products that we manufacture and distribute are
manufactured outside the United States and must be shipped into the United
States. The FDA and the U.S. Drug Enforcement Administration, in conjunction
with the U.S. Customs Service, can exercise greater legal authority over goods
that we seek to import into the United States than they can over products that
are manufactured in the United States.
Although we devote significant time, effort and expense to 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 fines, unanticipated compliance expenditures,
interruptions of our production and/or sale, prohibition of importation,
seizures and recalls of our products, criminal prosecution and debarment of us
and our employees from the generic drug approval process.
Reimbursement policies of third parties, cost containment measures and
healthcare reform 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 reimbursement
levels for them and related treatment established by healthcare providers
(including government authorities), private health insurers and other
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 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 governmental
authorities enact additional legislation or adopt regulations which affect
third party coverage and 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;
legislative proposals to reform healthcare and government
insurance programs; and
price controls and reimbursement policies relating to new and
expensive medicines.
These factors could result in lower prices and a reduced demand for our
products.
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 and 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.
The manufacture and storage of pharmaceutical products are subject to 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 incurring liability for damages caused by or during the storage or
refinement of both the chemical ingredients and the finished pharmaceutical
products. Although we have never incurred any material liability for damages of
that 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 manufacture and storage of pharmaceutical and chemical products are subject
to environmental regulation and risk.
Because of the chemical ingredients of pharmaceutical products and the
nature of their manufacturing process, the pharmaceutical industry is subject
to extensive environmental regulation and the risk of incurring liability for
damages or the costs of remedying environmental problems. 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
remedy environmental problems and comply with applicable regulations.
If we fail to comply with environmental regulations to use, discharge or
dispose of hazardous materials appropriately or otherwise to comply with the
conditions attached to 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 of the products being tested to 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 third parties. We have little
or no control over any of these factors.
Risks Relating to Our Company
We derive most of our revenues and profits from a small group of product lines.
In 2003, 2002 and 2001, seven product lines accounted for 54%, 53% and 57%
of our consolidated sales, respectively. In 2003, 2002 and 2001, one product
line accounted for approximately 11%, 16% and 19% of our consolidated sales,
respectively. A significant decline in revenues or profitability of any one of
these product lines may adversely affect the results of our operations and
financial condition.
In 2003, three U.S. major wholesale customers accounted for approximately 46%
of our consolidated sales. Any substantial decline in our sales to these
customers, for any reason, would have an adverse effect on our revenues and
profitability.
In 2003, AmerisourceBergen Corporation, McKesson Corporation and Cardinal
Health, Inc., collectively accounted for approximately 46% of our consolidated
sales. We have no long-term agreement with these wholesalers and thus they may
reduce or cease
their purchases from us at any time in the future. Furthermore, any change
in their buying pattern or changes in their policies and practices in relation
to their working capital and inventory management may result in a reduction of
purchases of our products. Any cessation or reduction of purchases from us
would likely have a material adverse effect on the results of our operations
and financial condition.
The nature of our business requires us to estimate future charges against
wholesaler accounts receivable. If these estimates are not accurate, the
results of our 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 goods to wholesalers and
the wholesalers sell to third parties at times and in quantities needed by the
third parties. Typically, we have a contract price with a third party that may
be different from the price at which we sold to the wholesaler. At the time the
third party purchases from the wholesaler, the wholesaler charges us back for
any price differential. At the time of any individual sale to a wholesaler, we
do not know under which contracts the wholesaler will sell goods to third
parties. Therefore, at the time of each sale, we make a reasonable estimate of
chargebacks and other credits associated with the sale and we reduce our
revenue accounts accordingly. From time to time, the transactions reported by
a wholesaler are different from our estimates. Actual transactions that differ
materially from our estimates may result in a reduction in the value of our
accounts receivable. The ultimate reconciliation of our accounts with those of
the wholesalers may delay the collection of our accounts receivable.
Our inventories are dated and may become obsolete.
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. The growth of our sales in
the past few years has resulted in higher levels of inventory in anticipation
of additional business for new products and from new customers, the exact
timing of which cannot be accurately determined. However, anticipated growth
in sales of any individual product or of all products may not materialize. In
this circumstance, inventories prepared for these anticipated sales may become
obsolete and have to be written off. These write-offs, if any, could have an
adverse affect on the results of our operations and financial condition.
Our future success depends on our ability to develop, manufacture and sell new
products.
Our future success is largely dependent upon our ability to develop,
manufacture and market new commercially viable pharmaceutical products and
generic equivalents of proprietary pharmaceutical products whose patents and
other exclusivity periods have expired. Delays in the development, manufacture
and marketing of new products will negatively impact our results of operations.
Each of the steps in the development, marketing and manufacture of our products
involves significant time and expense. We are, therefore, subject to the risks,
among others, that:
any products presently 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 of these new products cannot be successfully and
profitably produced and marketed; or
brand name companies can 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.
If we are unable to obtain raw materials, our operations could be seriously
impaired.
We currently obtain some raw materials for our products from either a
single supplier or a limited number of suppliers. 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 materials or products. While for some raw materials we do have
long-term supply agreements, for most raw materials we do not have any
long-term supply agreements and we are therefore subject to the risk that our
suppliers of raw materials may not continue to supply us with raw materials 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 as a consequence 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.
We are increasing our efforts to develop new proprietary pharmaceutical
products, but these efforts may not be commercially successful.
Our principal business in North America has traditionally been the
development, manufacture and marketing of generic equivalents of pharmaceutical
products first
introduced by other companies. However, we have recently increased our
efforts to develop new proprietary products, including T-2000 and T2001 (our
patented non-sedating barbiturate compounds) and the Elixsure® line of products
utilizing NonSpil (our patented spill-resistant liquid drug delivery system.)
Expanding our focus beyond generic products and broadening our pipeline to
include proprietary product candidates 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 product candidates 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 proprietary product candidates.
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, only a small minority of all new proprietary research and development
programs ultimately results in commercially successful drugs. A program
(including any program of ours) cannot be deemed successful until it actually
produces a drug that is commercially marketed for a significant period of time.
In order to obtain regulatory approvals for the commercial sale of our
proprietary product candidates, we are required to complete extensive clinical
trials in humans to demonstrate the safety and efficacy of the products. We
have limited experience in conducting clinical trials in these new product
areas.
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 product candidate to demonstrate safety and efficacy;
the development of serious (including life threatening)
adverse events (including, for example, side effects caused by or
connected with exposure to the product candidate); or
the failure of clinical investigators, trial monitors and
other consultants or trial subjects to comply with the trial plan or
protocol.
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, even if launched commercially, 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 adversely affect the results of
our operations and financial condition.
We may not be able to successfully identify, consummate and integrate
recent and/or future acquisitions.
We plan to pursue additional acquisitions of product lines and/or
companies and seek to integrate them into our operations. The recent and
future acquisitions of additional product lines and companies involve risks
that could adversely affect our future revenues and results of operations. For
example:
we may not be able to identify suitable acquisition targets
or to acquire companies on favorable terms;
we compete with other companies that may have stronger
financial positions to acquire product lines and companies. We
believe that this competition will increase and may result in
decreased availability or increased prices for suitable acquisition
targets;
we may not be able to obtain the necessary financing, on
favorable terms or at all, to finance any of our potential
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
acquisitions;
we may ultimately fail to complete an acquisition after we
announce that we plan to acquire a product line or a company;
we may fail to integrate successfully our acquisitions in
accordance with our business strategy;
we may choose to acquire a business that is not profitable at
the time of acquisition;
potential acquisitions may require significant management
resources and divert attention away from our daily operations,
result 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 operate the
businesses we may 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; or
we may purchase a company that has contingent liabilities
that include, among others, known or unknown patent or product
liability claims.
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.
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
and consultants. These agreements may be breached and there may not be 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 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 certain of our products.
There has been substantial litigation in the pharmaceutical industry with
respect to the manufacture, use and sale of new products. These lawsuits relate
to the validity and infringement of patents or proprietary rights of third
parties. We may be required to commence or defend against charges relating to
the infringement of patent or proprietary rights. Any such litigation could:
require us to incur substantial expense, 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; and
require us to pay substantial monetary damages or royalties
in order to license proprietary rights from third parties.
Although patent and intellectual property disputes within the
pharmaceutical industry have often been settled through licensing or similar
arrangements, costs associated with these arrangements may be substantial and
could include the long-term payment of royalties. These arrangements may be
investigated by U.S. regulatory agencies and, if improper, may be invalidated.
Furthermore, the required licenses may not be made available to us on
acceptable terms. Accordingly, an adverse determination in a
judicial or administrative proceeding or a failure to obtain necessary
licenses could prevent us from manufacturing and selling some of our products
or increase our costs to market these products.
From time to time, we seek to market products before the patents for them
expire. In order to do so in the United States, we must challenge the patent
under the procedures set forth in the Waxman-Hatch Act of 1984. To the extent
that we engage in patent challenge procedures, we are involved and expect to be
involved in patent litigation regarding the validity or infringement of the
originators patent. Patent challenges are complex, costly and can take a
significant time to complete.
In addition, when seeking regulatory approval for some of our products, we
are required to certify to regulatory authorities, including the FDA, that such
products do not infringe upon third party patent rights. Filing a certification
against a patent gives the patent holder the right to bring a patent
infringement lawsuit against us. Any lawsuit would delay regulatory approval by
the FDA until the earlier of the resolution of such claim or 30 months from the
patent holders receipt of notice of certification. A claim of infringement and
the resulting delay could result in substantial expenses and even prevent us
from manufacturing and selling certain of our products.
Our launch of a product prior to a final court decision 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
equal to three times their loss of income. If we are found to infringe a patent
held by a third party and become subject to such treble damages, these damages
could have a material adverse effect on the results of our operations and
financial condition.
Volatility of the market price of our ordinary shares could adversely affect us
and our shareholders.
The market price of our ordinary shares may be volatile, and could 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 and enhanced products;
market conditions or trends in the pharmaceutical industry;
developments or disputes concerning proprietary rights;
introduction of technologies or product enhancements by
others that reduce the need for our products;
changes in financial estimates by securities analysts;
general economic and political conditions;
departures of key personnel;
changes in the market valuations of our competitors;
Four of our directors, and members of their immediate families, currently
control 49.5% of the voting power in our company.
Dr. Barrie Levitt, Aaron Levitt, Dr. Daniel Moros, Tal Levitt and members
of their immediate families currently control, through their beneficial
ownership of outstanding ordinary shares and founders shares, approximately
49.5% of the voting power in our company. Dr. Levitt and Mr. Levitt are
brothers. Dr. Moros is their cousin and Ms. Levitt is Dr. Levitts daughter. By
reason of their shareholdings, the Levitt and Moros families should be able to
control the outcome of most actions that require majority shareholder approval,
including the election of directors, the appointment of management, the
entering into of mergers, sales of substantially all of our assets and other
extraordinary transactions. The companys board of directors has the
authority, subject to the terms and limitations of our debt agreements, to
issue additional shares, implement share repurchase programs, declare interim
dividends and make other decisions about our shares. For information
concerning a prospective change in the shareholdings of the persons
referred to in this paragraph, please see Note (3) to the table
set forth under the heading E. SHARE OWNERSHIP in
ITEM 6 below.
50% of the voting power in our subsidiary Taro Pharmaceuticals U.S.A., Inc., or
Taro U.S.A., is held by a corporation which is jointly controlled by the
Chairman of our Board of Directors and by our President.
The share capital of Taro U.S.A. is divided into two classes. We own 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, or 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. Dr. Levitt and Mr. Levitt are able to vote an aggregate of
54.7% of the outstanding voting shares of TDC and thereby control 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 we 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 our preference, TDC could prevent us 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 us from
consolidating Taro U.S.A. into our financial statements. Taro U.S.A. accounted
for approximately 90% of our consolidated sales in 2003. For information
concerning a prospective change in the ownership of TDC, please see Note (3) to the table
set forth under the heading E. SHARE OWNERSHIP in
ITEM 6 below.
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,
or 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 U.S. persons from seeking to acquire, or from accumulating, 15% or
more of our ordinary shares (which, due to the voting power of the founders
shares, would represent 10% or more of the voting power of our company).
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 and
receivables denominated in a foreign currency are greater or less than our
liabilities denominated in a foreign currency, we have foreign exchange
exposure.
Our business requires us to move goods across international borders. Any
events that interfere with, or increase the costs of, the transfer of goods
across international borders could have a material adverse effect on our
business.
We transport most of our goods across international borders, primarily
those of the United States, Canada and Israel. Since the terrorist attacks
that occurred in the United States on September 11, 2001, there has been more
intense scrutiny of goods that are transported across international borders.
As a result, we may face delays, and increases in costs due to such delays, in
delivering goods to our customers. Any events that interfere with, or increase
the costs of the transfer of goods across international borders could have a
material adverse effect on our business.
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 our principal offices and a
significant component of our manufacturing and research and development
facilities are located in Israel. Political, economic and military conditions
in Israel 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. Since the establishment of the State of Israel
in 1948, a number of armed conflicts have taken place between Israel and its
Arab
neighbors and a state of hostility, varying in degree and intensity, has
led to security and economic problems for Israel. Since October 2000, there
has been a marked increase in hostilities between Israel and the Palestinians,
which has continued with varying levels of severity and which has adversely
affected the peace process and negatively influenced Israels relationship with
several Arab countries and international organizations. Furthermore, certain
parties with whom we do business have declined to travel to Israel during this
period, forcing us to make alternative arrangements where necessary, and the
United States Department of State has issued an advisory regarding travel to
Israel, impeding the ability of travelers to attain travel insurance. As a
result of the State Departments advisory, 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. Also, although it has not yet occurred,
the political and security situation in Israel may result in certain parties
with whom we have contracts claiming that they are not obligated to perform
their commitments pursuant to force majeure provisions of those contracts.
In addition, since a significant component of our manufacturing and
research and development facilities are located in Israel, we could experience
disruption of our manufacturing and research and development due to terrorist
attacks. 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 incurred by
us could have a material adverse effect on our business.
Some neighboring countries, as well as certain companies and
organizations, continue to participate in a boycott of Israeli firms and others
doing business with Israel or with Israeli companies. We are also precluded
from marketing our products to certain of these countries due to U.S. and
Israeli regulatory restrictions. Because none of our revenue is currently
derived from sales to these countries, we believe that the boycott has not had
a material adverse effect on our current operations. However, continuation or
extension of the boycott and the implementation of additional restrictive laws,
policies or practices directed towards Israel or Israeli businesses could have
an adverse impact on the expansion of our business.
Finally, all male adult citizens and permanent residents of Israel under
the age of 50 generally are obligated to perform up to 45 days of military
reserve duty annually. Additionally, these residents are subject to being
called to active duty at any time under emergency circumstances. Certain of
our employees are currently obligated to perform annual reserve duty.
Recently, there has been a significant call-up of military reservists, and it
is possible that there will be additional call-ups in the future. While we
believe that we have operated relatively efficiently given these requirements,
both since we began operations and during the period of the increase in
hostilities with the Palestinians since October 2000, we cannot predict the
effect on our business operations if the conflict with the Palestinians
continues to escalate or intensify. 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 would
harm our business.
We may be adversely affected if the rate of inflation in Israel exceeds the
rate of devaluation of the New Israeli Shekel, or NIS, against the U.S. dollar.
A substantial portion of our expenses, primarily labor and occupancy
expenses in Israel, is incurred in NIS. As a result, the cost of our operations
in Israel, as measured in U.S. dollars, is subject to the risk that the rate of
inflation in Israel will exceed the rate of devaluation of the NIS in relation
to the U.S. dollar or that the timing of any devaluation will lag behind
inflation in Israel. If the U.S. dollar cost of our operations in Israel
increases, our U.S. dollar-measured results of operations will be adversely
affected.
Government price control policies can materially impede our ability to set
prices for our products.
All pharmaceutical products sold in Israel are subject to price controls.
Permitted price increases 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 currently benefit from government programs and tax benefits, both or either
of which may be discontinued or reduced.
We currently receive grants and substantial tax benefits under Government
of Israel programs, including the Approved Enterprise program and programs of
the Office of the Chief Scientist of the State of Israel. In order to maintain
our eligibility for these programs and benefits, we must continue to 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 restrict our ability to manufacture particular
products or 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 taxes. In recent years, the Government of
Israel has reduced the benefits available under these programs, and these
programs and tax benefits may be discontinued or curtailed in the future. If
the Government of Israel ends these programs and tax benefits, our business,
financial condition and results of operations could be materially adversely
affected.
Provisions of Israeli law may delay, prevent or make a merger or acquisition of
us difficult, which 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 a merger or acquisition of us more difficult.
The Israeli Companies Law, or the Companies Law, generally requires that a
merger be approved by a companys board of directors and by a shareholder vote
at a shareholders meeting that
has been called on at least 21 days advance notice. Any creditor of a
merger party may seek a court order blocking a merger if there is a reasonable
concern that the surviving company will not be able to satisfy all of the
obligations of any party to the merger. Moreover, a merger may not be completed
until at least 70 days have passed from the time that the merger proposal has
been filed with the Israeli Registrar of Companies.
Other potential means of acquiring a public Israeli company such as ours
might involve additional obstacles. In addition, a body of case law has not yet
developed with respect to the Companies Law. Until this happens, uncertainties
will exist regarding its interpretation.
Finally, Israeli tax law treats some acquisitions, such as stock-for-stock
exchanges between an Israeli company and a foreign company, less favorably than
do U.S. tax laws. The provisions of Israeli corporate and tax law and the
uncertainties surrounding such laws may have the effect of delaying, preventing
or making a merger or acquisition of us more difficult. This could prevent a
change of control of us and depress the market price of our ordinary shares
which otherwise might rise as a result of such a change of control.
It may be difficult to effect service of process and enforce judgments against
directors, officers and experts named in this annual report.
We are incorporated in Israel. A majority of our executive officers and
directors and some of the experts named in this annual report are nonresidents
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 U.S. federal securities
laws in original actions instituted in Israel.
Risks Relating to Our Location in Canada
Government price control policies can materially impede our ability to set
prices for our products.
The Canadian Government Patented Medicine Prices Review Board, or PMPRB,
monitors and controls prices of patented drug products marketed in Canada by
persons holding, or licensed under, one or more patents. The PMPRB will approve
an introductory price (based on a comparative analysis) and will require that
the price not be increased each year thereafter by more than 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
industrys ability to set pricing. The inability to control the prices of our
products may adversely affect our operations.
Sales of our products in Canada depend, in part, upon their being eligible for
reimbursement from drug benefit formularies.
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.
There is not complete uniformity among provinces. However, provincial
governments generally will reimburse the lowest available price of the generic
equivalents of any drug listed on the formulary list of the province. The
formularies can also provide for 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. The potential lack of reimbursement represents a
significant threat to our business. Additionally, the substitution effect may
adversely affect our ability to profitably market our products.
We may be adversely affected if the rate of inflation in Canada exceeds the
rate of devaluation of the Canadian dollar against the U.S. dollar.
A substantial portion of our expenses, primarily labor and occupancy
expenses in Canada, is incurred in Canadian dollars. As a result, the cost of
our operations in Canada, as measured in U.S. dollars, is subject to the risk
that the rate of inflation in Canada will exceed the rate of devaluation of the
Canadian dollar in relation to the U.S. dollar or that the timing of any
devaluation will lag behind inflation in Canada. If the U.S. dollar cost of our
operations in Canada increases, our U.S. dollar-measured results of operations
will be adversely affected.
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. In 1961, we completed the initial public
offering of our ordinary shares, which are currently traded on the Nasdaq
National Market under the symbol TARO. In that year, we also acquired 97% of
the outstanding stock of an Israeli corporation, then known as Taro
Pharmaceutical Industries Ltd., or 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 split of our
ordinary shares by distributing a dividend of 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 selling shareholders sold 1,800,000 of our ordinary shares, in a
public offering.
In May 2002, we purchased substantially all of the assets of Thames
Pharmacal Company, Inc., or Thames, a manufacturer of prescription and OTC
pharmaceuticals, through a newly-created subsidiary of Taro U.S.A. The
purchase price was approximately $6.4 million, all of which was paid in cash.
The assets acquired included
the right to all of Thames generic prescription and OTC products, as
well as Thames laboratories and manufacturing operations. We also added to
our operations all of Thames approximately 60 employees and acquired the
leases for its facilities, which include laboratories, manufacturing and
warehousing operations, located in Ronkonkoma, New York.
On January 14, 2003, Taro Pharmaceuticals North America Inc., or TNA,
entered into a license and option agreement with Medicis Pharmaceutical
Corporation, or Medicis. According to the agreement, TNA, on June 1, 2004,
exercised its option and purchased from Medicis four branded prescription
product lines for sale in the United States and Puerto Rico for an aggregate
purchase price of $23.8 million. Approximately $11.7 million was for the
licensing period and was payable over five consecutive quarters. The balance of
$12.1 million was due upon the exercise of the purchase option. Two of these
products are used in dermatology and the other two are used in pediatrics.
On March 21, 2003, our Irish subsidiary, Taro Pharmaceuticals Ireland
Ltd., acquired, for 5.55 million Euros paid in cash, a multi-purpose
pharmaceutical manufacturing and research facility in Ireland. The facility was
purchased out of liquidation proceedings under the Official Liquidator
appointed by the High Court of Ireland.
The facility consists of 124,000 square feet of manufacturing, laboratory,
office and warehouse space located on a 14-acre campus in central Ireland. The
facility, which was operating until the end of 2002, has been licensed and
approved by the Irish Medicines Board to manufacture and distribute
pharmaceutical products in Ireland and the European Union.
In December 2003, our Canadian subsidiary expanded its distribution
capacity with the purchase of a 108,797 square foot distribution facility
located on 6.7 acres in Brampton, Ontario in close proximity to the existing
facilities.
In January 2004, our U.S. subsidiary expanded its distribution capacity
with the purchase of a 315,000 square foot distribution center on 25 acres of
land in South Brunswick, New Jersey. The U.S. subsidiary acquired the facility
for approximately $18 million. In conjunction with the purchase, we expect that
the U.S. subsidiary will receive some financial incentives from the New Jersey
Economic Development Authority.
Our registered office in Israel is located at 14 Hakitor Street, Haifa
Bay, Israel, 26100. Our principal executive offices are located at Italy
House, Euro Park, Yakum 60972, Israel, and our telephone number there is
972-9-971-1800.
Capital Expenditures
During the past three years, our capital expenditures amounted to
approximately $156.9 million. The focus of our capital expenditure program has
been the expansion and upgrade of our manufacturing facilities and information
technology systems in order to enable us to increase operational efficiencies,
remain in compliance with current Good
Manufacturing Practices, or cGMP, accommodate increasing demand for our
products, and maintain a competitive position in the marketplace.
The major projects undertaken during the past three years, as part of our
capital expenditure program, include:
the expansion of our production and distribution facilities in Canada and
Israel;
the construction of new research and development and plant operations
facilities in Canada and Israel;
the acquisition of additional production and packaging equipment;
the upgrade of our information technology systems;
acquisition of additional land in Haifa Bay, Israel for expansion of our
facilities;
acquisition of a facility (previously rented by us) in Canada;
acquisition of Thames;
acquisition of a 32% interest in a 123,713 square feet building adjacent to the
offices of Taro U.S.A. for the construction of research laboratory and
administrative offices;
acquisition of a multi-purpose pharmaceutical manufacturing and research
facility in Ireland;
acquisition of a distribution center facility in New Jersey; and
acquisition of a distribution facility in Ontario, Canada.
In addition, in anticipation of an increase in sales and the overall
growth of our operations, we have purchased, leased or contracted to purchase
additional properties and ordered new equipment for our construction of new
multi-purpose pharmaceutical and chemical plants in Haifa Bay, Israel. (For a
detailed presentation of our property, plant and equipment, please see Note 5
to our consolidated financial statements included elsewhere in this report.)
B. BUSINESS OVERVIEW
We are a multinational, science-based pharmaceutical company. We develop,
manufacture and market prescription and OTC pharmaceutical products, as well as
active pharmaceutical ingredients, or APIs, primarily in the United States,
Canada and Israel. Our primary areas of focus include topical creams and
ointments, liquids, capsules and tablets mainly in the dermatological,
cardiovascular and central nervous system therapeutic categories. We operate
principally through three entities: Taro Pharmaceutical Industries Ltd., or
Taro Israel, and two of its subsidiaries, Taro Pharmaceuticals Inc., or
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
Manufactures more than 60
finished dosage form pharmaceutical
products for sale in Israel and for
export
Dermatology: Prescription and
OTC semi-solid products (creams,
ointments, gels and liquids)
Produces, for its own use and for
sale to third parties, APIs used in
the manufacture of finished dosage
form pharmaceutical products
Cardiology and Neurology: Prescription
oral dosage products
Oral Analgesics: Prescription
and OTC
Markets both proprietary and
generic products in the local Israeli
market
OTC Nasal Sprays and Nutritional
Supplements
Performs research and development
independently and through Taro
Research Institute Ltd., a Taro
subsidiary
Oral, Opthalmic and OTC
preparations
Taro Canada
Manufactures more than 45
finished dosage form pharmaceutical
products for sale in Canada and for
export
Dermatology: Prescription and
OTC semi-solid products (creams,
ointments, gels and liquids)
Markets both proprietary and
generic products in the local Canadian market
Cardiology and Neurology:
Prescription oral dosage products
Performs research and development
independently and through Taro
Research Institute
Taro U.S.A.
Manufactures more than 10
finished dosage form pharmaceutical
products for sale in the United
States and for export
Dermatology: Prescription and
OTC semi-solid products (creams,
ointments, gels and liquids)
Markets both proprietary and generic products in the local U.S.
market
Cardiology and Neurology:
Prescription oral dosage products
Performs research and development
independently and through Taro
Research Institute
OTC products
In May 2001, we received approval from the FDA to market the first generic
equivalent of Schering-Ploughs Lotrisone® cream, which we began to sell at the
end of that month. According to industry sources, within a few weeks we had
become the
leading supplier of the generic equivalent of Lotrisone® cream in the
United States, a position which we maintained throughout the remainder of 2001,
2002 and 2003. Our generic equivalent of Lotrisone® cream was our largest
selling product and comprised approximately 11%, 16% and 19% of our
consolidated sales in 2003, 2002 and 2001, respectively.
As of April 29, 2004 31 of our ANDAs and one NDA are being reviewed by the
FDA. In addition, there are multiple 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 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
submitted by our competitors prior to 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.
Generic pharmaceutical products must meet the same quality standards as
branded pharmaceutical products although they are 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 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
dramatically. We believe that this growth has been driven by the following
factors, among others:
efforts by governments, employers, third-party payors 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.
Products
Currently, we
market more than
180 pharmaceutical
products in over 20
countries. The
following table
represents some of
our key product
groups and the
major markets in
which they are sold:
Topical corticosteroids are used in the treatment of some dermatologic
conditions (including psoriasis, eczema and various types of skin rashes).
Antifungals are used in the treatment of some infections (including athletes
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 antiarrhythmics. Anticoagulants are blood thinners used in the treatment of
heart disease and stroke associated with heart disease.
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.
The following is a breakdown of our sales by geographic region, including
the percentage of our total consolidated sales for each period:
2003
2002
2001
In
% of our
In
% of our
In
% of our
thousands
total sales
thousands
total sales
thousands
total sales
U.S.A.
$
283,197
90
%
$
183,857
87
%
$
123,762
83
%
Canada
15,603
5
%
12,819
6
%
8,968
6
%
Israel
13,468
4
%
11,809
5
%
13,690
9
%
Other
3,190
1
%
3,096
2
%
2,810
2
%
Total
$
315,458
100
%
$
211,581
100
%
$
149,230
100
%
In 2003, sales in the United States accounted for approximately 90% of our
total consolidated sales. In addition to marketing prescription drugs, Taro
U.S.A. markets its OTC products primarily as store brands under its customers
labels to wholesalers, drug chains, food chains and mass merchandisers. During
2003, we sold to approximately 250 customers in the United States. The
following table represents sales to our three largest wholesale customers as a
percent of consolidated sales during the last three years:
The following table sets forth the contributions to sales by each type of
customer of Taro U.S.A. in 2003:
Percentage of
Customer Type
Consolidated Sales
Drug wholesalers
52
%
Drug store chains
15
%
Mass merchandisers food and retail chains
11
%
Generic drug distributors
8
%
Managed care organizations
4
%
In 2003, sales in Israel accounted for approximately 4% of our total
consolidated sales. The marketing sales and distribution of prescription
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 organization in the United States, as well as
private pharmacies. Most of our marketing efforts in Israel focus on selling
directly to these groups. In 2003, sales to other international markets
accounted for approximately 1% of our consolidated sales.
All pharmaceutical products sold in Israel are subject to price controls.
Permitted price increases are enacted by the Israeli government as part of a
formal review process. In addition, recently enacted parallel import
regulations are expected to further increase pressure within the industry to
lower prices on prescription products. 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 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 Klalit or Kupat
Holim (the largest health fund in Israel), the Israel Ministry of Health and
other health insurance groups.
The following table sets forth the contributions to sales by each type of
customer of Taro Israel and other international markets in 2003:
Percentage of
Customer Type
Consolidated Sales
Institutional market
3
%
Private market
1
%
Other international markets
1
%
In 2003, sales in Canada accounted for approximately 5% of our total
consolidated sales. Taro Canada has approximately 4,000 customers, which
consist primarily of independent pharmacies.
The following table sets forth the contributions to sales by each type of
customer of Taro Canada in 2003:
Percentage of
Customer Type
Consolidated Sales
Drug wholesalers
4
%
Drug chains, independent pharmacies and others
1
%
As a result of our sales growth during the past five years, especially in
North America, we have expanded the production capacity of our Israel, U.S. and
Canadian operations. In addition, we utilize contract manufacturing for
certain products to satisfy customer demand in a timely manner. In 2001, 2002
and 2003, our production capacity increased significantly as a result of our
investment in facilities, capital equipment and an increase in the number of
our manufacturing personnel. As a result, in each of 2001, 2002 and 2003,
backorders generally represented less than one percent (1%) of our annualized
consolidated 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), 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.
Historically, brand-name drug companies have 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 generic equivalents of brand-name drug products other than their
own.
In the United States, we compete with such brand-name manufacturers as
Novartis, Schering-Plough, Medicis Pharmaceutical, GlaxoSmithKline and
Bristol-Myers Squibb, as well as with generic companies such as Alpharma,
Altana, Atrix, Barr Laboratories, Clay Park Labs, Geneva Pharmaceuticals, Mylan
Laboratories, Teva Pharmaceuticals U.S.A. and Warrick Pharmaceuticals. In the
market for proprietary drugs, our ElixSure® products compete with products of
Johnson & Johnson, Novartis and Wyeth among others. These companies have more
resources, market and name recognition and better access to customers than we
have. Therefore, there can be no assurance of the success of any of our
products, including but not limited to our ElixSure® products.
We compete in the Canadian market with Hoffmann-La Roche, Schering Canada,
Novartis, GlaxoSmithKline, Medicis Canada, Bayer and Bristol-Myers Squibb
Canada, as well as with other manufacturers of generic products, such as
Apotex, Novopharm Limited (Teva), Ratiopharm, GenPharm and Pharmascience.
Pricing in Canada is established in part by competitive factors and in
part by Canadian formulary price lists published by the Canadian provinces.
In Israel, we compete with Teva Pharmaceutical Industries Ltd., Agis
Industries (1983) Ltd., Dexon and Rafa, among others. In addition, many leading
multinational companies, including Bayer, Eli Lilly, Merck and Pfizer, market
their products in Israel.
In Israel, the government establishes the prices for pharmaceutical
products as part of a formal review process. In addition, recently enacted
parallel import regulations are expected to further increase pressure within
the industry to lower prices. 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 the United States, Canada and Israel and
active pharmaceutical ingredients at our facilities in Israel. Due to the
continued growth of sales of our products, we have been expanding these
facilities, our related research and development and warehousing facilities and
we are continuing to do so.
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. 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 or Canada pending approval of one or more alternate sources of raw
materials.
We synthesize the active pharmaceutical ingredient used in some of our key
products, including our warfarin sodium tablets, our carbamazepine products and
our clorazepate dipotassium tablets. We plan to continue the strategic
selection of active pharmaceutical ingredients for synthesis in order to
maximize the advantages from this scientific capability.
Industry Practices Relating to Working Capital Items
Certain customary industry selling practices affect our supply of 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 at the expense of competing products.
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. The growth of our sales in
the past few years has resulted in higher levels of inventory in anticipation
of additional business for new products and from new customers, the exact
timing of which cannot be accurately determined.
Government Regulation
We are subject to extensive pharmaceutical industry regulation 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, 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 approval of
manufacturing facilities, including adherence to good manufacturing practices
during the production and storage of
pharmaceutical products. As a result, we have had periodic inspections of
our facilities and records. For example, Taro Canada was inspected by the FDA
in 1995, 1996, 1998 and 2001 and our facilities in Haifa Bay, Israel were
inspected by the FDA in 1996, 1997, 1999 and 2002.
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. Inability or delay
in obtaining approvals for our products could adversely affect our product
introduction plans and our results of operations.
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 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.
We generally receive approval for generic products by submitting an ANDA
to the FDA. When processing an ANDA, the FDA waives the requirement of
conducting complete clinical studies, although it may require bioavailability
and/or bioequivalence studies. 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 of absorption and levels of concentration
of a generic drug in the body or on the skin are substantially equivalent to
the previously approved brand-name reference drug. An ANDA may be submitted
for a drug on the basis that it is bioequivalent to a previously listed drug,
contains the same active ingredient, has the same route of administration,
dosage form, and strength as the listed drug, and otherwise complies with legal
and regulatory requirements. There can be no assurance that approval for ANDAs
can be obtained in a timely manner, or at all. 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 therapeutically
equivalent or bioequivalent to the brand-name reference 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 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. Approval of an ANDA, if granted, generally takes more than one
year from the submission of the application.
Products resulting from our proprietary drug program may require us to
submit an NDA to the FDA. When processing an NDA, the FDA generally requires,
in addition to the ANDA requirements (except for bioequivalence), complete
pharmacological and toxicological studies in animals and humans to establish
the safety and efficacy of the drug. However, 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. Approval of an NDA, if granted, generally takes at least one year from
the submission of the application to the FDA.
Among the requirements for drug approval by the FDA is that manufacturing
procedures and operations conform to cGMP, as defined in the U.S. Code of
Federal Regulations. The cGMP regulations must be followed at all times during
the manufacture of pharmaceutical products. In complying with the standards set
forth in the cGMP regulations, a manufacturer must expend time, money and
effort in the areas of production and quality control to ensure full
compliance.
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 or imposes
monetary fines. We believe that we are currently in substantial compliance with
cGMP.
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 United States Controlled Substances Act and its equivalents
in Israel and Canada, as well as the regulations promulgated thereunder in each
country. These regulations include stringent requirements for manufacturing
controls, receipt and handling procedures and security to prevent diversion of,
or the unauthorized access to, the controlled substances in each stage of the
production and distribution process.
In May 1992, the Generic Drug Enforcement Act of 1992, or 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.
Lastly, the Generic Act 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.
The review process in Canada and Israel is substantively similar to the
review process in the United States.
Environmental Compliance
We believe that we are currently in compliance with all applicable
environmental laws and regulations in Canada,the United States and Ireland. In
Israel, in light of the continued expansion of our Haifa Bay facility and an
enhanced general enforcement program instituted by the Israeli Ministry of the
Environment, we have taken steps to improve our waste water treatment facility
and plan to further upgrade our facility in accordance with a plan submitted to
the Ministry. The cost of this program is not anticipated to have a material
adverse effect on our business or operations. However, environmental laws and
regulations may become more stringent and therefore require us to commit
substantial resources which are beyond our current plan.
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 principal subsidiaries and countries of
incorporation:
See Note 2c to our consolidated financial statements included elsewhere in this
annual report for information regarding the ownership of our subsidiaries.
D. PROPERTY, PLANTS AND EQUIPMENT
The following is a list of our facilities as of April 1, 2004:
Pharmaceutical manufacturing,
production laboratories and
warehousing
Lease
Budapest, Hungary
1,250
Administrative offices
Lease
Roscrea, Ireland
124,000
Pharmaceutical manufacturing,
research laboratories and
warehousing
Own
Mumbai, India
9,000
Pharmaceutical research
laboratories and
administrative offices
Lease
Our plant, research and office facilities in Haifa Bay, Israel are located
in a complex of buildings with an aggregate area of approximately 322,000
square feet. We lease much of the land underlying these facilities from the
Israel Land Authority pursuant to long-term ground leases that expire between
2009 and 2049. We have the option to renew each lease for an additional 49
years. We also lease approximately 15,000 square feet of adjacent space in
Haifa Bay pursuant to two separate leases. The first is for ten years, which
commenced in January 2001, with an option to purchase this property at the
termination of the lease. The second was for an initial term of five years,
commencing in September 1997, and has subsequently been renewed for two
additional one-year terms. For additional information, please refer to Note 6
to our consolidated financial statements included elsewhere in this annual
report.
Since December 2000, we have purchased approximately 570,000 square feet
of land adjacent to the Haifa Bay plant for expansion of our manufacturing and
warehouse facilities. We lease approximately 15,000 square feet of space in a
facility located in Yakum, Israel, which is used for administrative and
marketing offices.
In February 2002, Taro Canada purchased 74,000 square feet of space that
we had leased since March 1997 adjacent to the main 68,000 square foot
manufacturing facility, which we own, in Brampton, Canada. In September 2000,
Taro Canada leased an additional 75,400 square feet of office and warehouse
space, adjacent to the other two facilities, for a period of five years, with
renewal options, which can extend the lease period for an additional twenty
years. In December 2003, Taro Canada purchased for $3.6 million a 108,797
square foot building in close proximity to its existing facilities. This
building is used for warehousing and distribution.
In August 2002, Taro U.S.A. purchased a 32% interest in a 123,713 square
foot building in which it located its U.S. research operations for
approximately $4.4 million. The U.S. subsidiary has two options exercisable at
two different times to purchase the remainder of the building, approximately
86,000 square feet, for an additional amount of $9.3 million.
In January 2004, Taro U.S.A. purchased a 315,000 square foot distribution
facility in South Brunswick, New Jersey for approximately $18 million.
In addition, Taro U.S.A. leases approximately 130,000 square feet of
office and warehouse space in Hawthorne, New York pursuant to two leases. One
lease, for approximately 100,000 square feet, expires in July 2007 and the
other lease, for approximately 30,000 square feet expired on April 30, 2004 and
was not renewed.
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 three years ended
December 31, 2003, which are included elsewhere in this annual report.
Overview
We are a multinational, science-based pharmaceutical company. We develop,
manufacture and market prescription and OTC pharmaceutical products, as well as
active pharmaceutical ingredients, primarily in Israel, Canada and the United
States. 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.
We generate most of our revenues from the sales of prescription 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. During the past three
years, three major drug wholesalers in the United States accounted for the
following proportion of our total consolidated sales in millions:
2003
2002
2001
Customer
Amount
Percent
Amount
Percent
Amount
Percent
AmerisourceBergen
Corporation
$
62.7
20
%
$
46.5
22
%
$
19.4
13
%
McKesson Corporation
$
53.0
17
%
$
25.4
12
%
$
22.3
15
%
Cardinal Health,
Inc.
$
28.4
9
%
$
19.0
9
%
$
13.4
9
%
We also sell active pharmaceutical ingredients to unaffiliated customers
around the world. Sales of active pharmaceutical ingredients to third parties
have historically represented
less than 1% of consolidated revenues. Our primary reason for manufacturing
active pharmaceutical ingredients is to support our pharmaceutical
manufacturing operations.
Due to increased competition from other generic pharmaceutical
manufacturers as they gain regulatory approvals to manufacture 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, the
operating results are dependent on the impact of pricing pressures on existing
products. These pricing pressures are inherent in the generic pharmaceutical
industry.
In 2003 and 2002, sales of seven product lines contributed approximately
54% and 53% of our consolidated sales, respectively. These seven product lines
include four topical product families and three oral product families.
Clotrimazole and betamethasone dipropionate cream, our generic equivalent of
Lotrisone® cream, which we introduced into the market in May 2001, contributed
approximately 10% and 16% to our consolidated sales during 2003 and 2002,
respectively.
Our sales of these and other product lines 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 revenues of these seven
product lines 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 and direct labor identified
with a specific product. Allocated costs are costs not associated with a
specific product. Since the allocation of various elements of overhead to
individual products or product lines is to some extent arbitrary, it is not
practical to determine the specific amount or percentage of our profits that
may be attributed to any individual product or product line, including our
generic equivalent of Lotrisone® cream.
Certain customary industry selling practices affect our supply of 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 at the expense of competing products.
For example, the payment terms that we typically provide to our U.S.
customers vary from 30 to more than 90 days, with the longer terms typically
allowed to customers purchasing higher volumes of a product. Similarly, the
cash discounts that we offer may range from two to more than ten percent, with
the higher discounts offered in connection with larger sales.
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 inventories. Increased demand for existing
products and preparation for new product
launches, the exact timing of which cannot be determined accurately, has
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.
Critical Accounting Policies
Our significant accounting policies are described in Note 2 to our
Consolidated Financial Statements, which we have prepared in accordance with
accounting principles generally accepted in the United States. The preparation
of these financial statements requires us to make estimates and judgements 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, 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:
Revenue Recognition.
Revenue is recognized when delivery to our customers
has occurred. When we recognize and record revenue from the sale of our
pharmaceutical products, we simultaneously record an estimate of various future
costs related to the sale. This has the effect of reducing the amount of
reported product sales. These costs include our estimates of product returns,
rebates, chargebacks and other sales allowances. In addition, we may record
allowances for shelf-stock adjustments when appropriate. We base our estimates
for these sales allowances on a variety of factors, including actual return
experience of products returned, rebate agreements for each product and
estimated sales by our wholesale customers to other third parties who have
contracts with us. Actual experience associated with any of these items may
differ materially from our estimates. We conduct a review of the factors that
influence our estimates periodically. When we find that actual product returns,
credits and other allowances differ from our established reserves we make the
necessary adjustments. In addition, it is customary in the generic industry to
grant customers shelf-stock adjustments based on customers existing levels of
inventory and the decrease in market price of the related product. When market
prices for our product decline, we may elect to provide shelf-stock adjustments
and thereby allow customers with existing inventories to compete at the lower
product price. These shelf-stock adjustments are intended to support our market
position and to promote customers loyalty.
Functional and Reporting Currency.
A majority of our revenues is
generated, and a substantial portion of our expenses is incurred, in U.S.
dollars. Hence, the U.S. dollar is our functional and reporting currency.
Monetary accounts that are maintained in other currencies are re-measured into
dollars in accordance with Statement No. 52 of the Financial Accounting
Standards Board.
Product Rights.
Our rights in licensed or acquired products are stated at
cost, less accumulated amortization. Product rights are amortized using the
straight-line method over their estimated useful lives ranging from five to
twenty years. We determine amortization periods for product rights based on our
assessment of various factors impacting estimated useful lives and cash flows
generated by the acquired products. These factors include a products position
in its life cycle, the existence of like products in the marketplace, various
other competitive and regulatory issues, and contractual terms. Significant
changes to any of these factors may result in a reduction in a product rights
useful life and acceleration of related amortization expense which could cause
our operating income, net income and earnings per share to decline.
Deferred Taxes
. In 2001, we conducted a public offering of our ordinary
shares. In connection with the offering, we recorded, as of December 31, 2003,
approximately $9.5 million of deferred tax assets due to the exercise of stock
options by the selling shareholders. In the event that it appears that the
amount of these deferred tax assets is, at any time, greater than the amount
that we are likely to realize, we will reduce the amount at which we carry the
deferred tax assets accordingly. Any such reduction would result in a charge to
income, in the amount of the reduction, for the period in which the reduction
was made. For additional analysis of tax issues, please refer to Note 14 of our
consolidated financial statements included elsewhere in this annual report.
Results of Operations
The following table sets forth, for the periods indicated, selected items from
our consolidated statement of income as a percentage of total sales:
Year Ended December 31, 2003 compared with Year Ended December 31, 2002
Sales.
During 2003, our sales increased $103.9 million, or 49%, from the
amount of sales we reported in 2002. Of this increase, $27.7 million, or 27%,
was attributable to the sale of products that we introduced in 2003. The
balance of this increase was attributable to increased sales of products which
were sold in both 2002 and 2003, including clotrimazole and betamethasone
dipropionate cream, our generic version of Lotrisone®, which we began to sell
in May 2001. Sales in the United States during 2003 increased $99.3 million, or
54%, from the amount we reported in 2002. Sales in Canada increased by $2.8
million, or 22%, and sales in Israel and other international markets increased
$1.8 million, or 12%, from 2002. The products introduced during the year in the
United States included bethametasone dipropionate (augmented) cream, ammonium
lactate cream and etodolac XR tablets in three strengths, 400, 500 and 600 mg.
In the United States, we also introduced our ElixSure® line of products and the
four branded products we acquired earlier in the year from Medicis
Pharmaceutical Corporation.
Cost of Sales.
Cost of sales increased by 29%, in 2003, as a result of the
49% increase in sales described above.
Gross Profit.
Gross profit margin increased from 62% in 2002 to 68% in
2003. The increase reflects a higher level of branded product sales and a
favorable competitive environment for the generic products.
Research and Development.
Net R&D expenses increased $14.2 million, or
54%, in 2003. R&D expenses equaled 13% and 12% of sales in 2003 and 2002,
respectively. The increase in R&D expenses during 2003 was the result of
expanding our research facilities, recruiting additional scientists and
pursuing more projects.
Selling, General and Administrative.
In 2003, SG&A increased $45.2
million, or 86%, from the amount we recorded in 2002. Our SG&A expenses as a
percentage of sales increased from 25% in 2002 to 31% in 2003. Selling and
marketing expenses increased $32.4 million, or 162%, primarily due to the
recruitment of medical representatives and promotional campaigns, including
media advertising, aimed at supporting our branded initiatives in the United
States. General and administrative expenses increased $12.8 million, or 39%,
primarily due to investments in personnel, facilities and infrastructure
necessary to accommodate continued growth and expansion in the United States
and other markets.
Operating Income.
Operating income increased $21.4 million, or 40% in
2003. The increase was primarily the result of increased sales and improved
gross profit margins.
Financial Expenses.
Financial expenses consist of interest expense and
income, and the impact of currency fluctuations. Net financial expenses
increased $1.5 million, or 962%, in 2003. The increase is primarily the result
of a higher level of interest expenses as we increased our level of borrowing
during 2003. The increase in interest expenses was partially offset by interest
income that we earned on our cash balances and from foreign currency hedging
transactions.
Taxes on Income.
Due to a higher level of pre-tax income, our tax expense
increased $3.1 million, or 36%, in 2003. Our effective tax rate was 16% in both
2002 and 2003.
Net Income.
Our net income increased $16.6 million from $44.6 million in
2002 to $61.2 million in 2003, an increase of 37%, based on the factors cited
above.
Year Ended December 31, 2002 compared with Year Ended December 31, 2001
Sales.
During 2002, sales increased $62.0 million, or 42%, from the amount
we recorded in 2001. Of this increase, $7.6 million, or 4%, was attributable to
the sale of products that we introduced in 2002. The balance of the increase
was attributable to increased sales of products that were sold in both 2001 and
2002, including clotrimazole and betamethasone dipropionate cream, our generic
version of Lotrisone®, which we began to sell in May 2001. Sales in the United
States increased $60.1 million, or 49%, in 2002. Sales in Canada increased by
$3.8 million, or 44%, in 2002. Sales in Israel and other international markets
decreased $1.6 million, or 10%, in 2002. The products introduced during the
year in the United States were amcinonide cream, ketoconazole cream and
econazole nitrate cream.
Cost of Sales.
Cost of sales increased $24.8 million, or 45% in 2002, as a
result of the 42% increase in sales described above.
Gross Profit.
Gross profit increased $37.6 million, or 40% in 2002 but
gross profit margins declined from 63% in 2001 to 62% in 2002. The decrease
reflects a higher level of OTC product sales and a competitive environment for
some products, which was partially offset by an increased volume of sales for
other products.
Research and Development.
Net R&D expenses increased $6.8 million, or 35%
in 2002. R&D expenses equaled 12% and 13% of sales in 2002 and 2001,
respectively. The increase in R&D expenses during 2002 was the result of
expanding our research facilities, recruiting additional scientists and
pursuing more projects.
Selling, General and Administrative.
SG&A increased $10.4 million, or 25%
in 2002. Our SG&A expenses as a percentage of sales declined from 28% in 2001
to 25% in 2002. Selling and marketing expenses increased $0.8 million, or 4% in
2002. General and administrative expenses increased $9.7 million, or 43% in
2002, primarily due to investments
in personnel, facilities and infrastructure necessary to accommodate continued
growth and expansion in both the United States and international markets.
Operating Income.
Operating income increased $20.5 million, or 62% in
2002. The increase was primarily the result of increased sales and improved
SG&A margin.
Financial Expenses.
Net financial expenses decreased $2.4 million, or 92%
in 2002 primarily as a result of interest income realized from the high cash
balance maintained during 2002. This income nearly offset most of the Companys
cost of borrowing.
Taxes on Income.
Due to a higher level of pre-tax income, our tax expense
increased $4.0 million, or 91% in 2002, with our effective tax rate increasing
from 14% in 2001 to 16% in 2002.
Net Income.
Our net income increased $18.6 million from $26.0 million in
2001 to $44.6 million in 2002, an increase of 71%, based on the factors cited
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 inflation, the
devaluation (appreciation) rate of the NIS and the Canadian dollar against the
U.S. dollar and the exchange rates between the U.S. dollar and each of the NIS
and the Canadian dollar at the end of the year indicated:
Sources: (1) Bank of Israel. (2) Statistics Canada. (3) Bank of Canada.
B. LIQUIDITY AND CAPITAL RESOURCES
Liquidity
Cash and cash equivalents increased by $28.4 million to $159.1 million at
December 31, 2003. During 2003, we completed two private placements of bonds to
institutional investors in Israel in the aggregate amount of $110 million,
primarily to fund our capital expansion programs. Our increase in sales caused
trade accounts receivable to increase by 75%, to $120.5 million at December 31,
2003. Inventory levels increased 99% from December 31, 2002 to December 31,
2003, primarily due to strategic API acquisitions and to support increased
level of sales. Shareholders equity increased from $269.1 million at December
31, 2002 to $347.4 million at December 31, 2003, principally due to net income
contribution to retained earnings and tax benefits related to the exercise of
stock options.
We generated cash from operations amounting to $5.2 million for the year
ended December 31, 2003 as compared to $29.6 million in the prior year. The
decrease in cash from operations is the result of increases in trade
receivables and inventory, which were partially offset by higher amortization
and depreciation, higher net income and other working capital items.
Our long-term debt outstanding as of December 31, 2003 was approximately
$181.4 million, including current maturities of $24.4 million, and was
comprised of the following:
bonds payable of $130.4 million;
obligations of $29.7 million under a bank credit agreement; and
mortgage payable, capital leases and other obligations of $21.3 million.
Our bond obligations consist of the following, in millions:
Amount
Linkage
Rate
Maturity
$15.8
Israel CPI
8.25%
2004-2010
$48.0
Israel CPI
5.8%
2004-2014
$2.1
Dollar
Libor + 2-3%
2004-2010
$64.5
Dollar
6%
2004-2010
We have a contract to hedge our exposure to CPI fluctuations in Israel.
Under the bond agreements, our debt to equity ratio may not be greater than 2:1
and our current ratio may not be lower than 1:1. In addition the bonds that we
issued during the year require that we maintain an interest coverage ratio of
2:1. The interest coverage ratio is defined as earnings before interest, taxes,
depreciation and amortization expenses, or EBITDA, divided by net interest
expenses plus the current principal repayment. We are currently in compliance
with these covenants.
We anticipate that our operating cash flow, together with available
borrowings under our credit facilities and cash balances, will be sufficient to
meet all of our working capital, capital expenditure and interest requirements
for both the short-term and the foreseeable future. As for commitments for
future capital expenditures please see Note 5(d) to our consolidated financial
statements included elsewhere in this annual report.
Capital Expenditures
We invested $94.4 million in capital equipment and facilities during the
year ended December 31, 2003 and $43.2 million during the year ended December
31, 2002. These investments are principally related to expanding and upgrading
our research and development laboratories and our pharmaceutical and chemical
manufacturing facilities in Israel, Canada, Ireland and the United States and
maintaining compliance with cGMPs, while increasing manufacturing capacity. In
addition to facility-related investments, we acquired certain 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 5 to our
consolidated financial statements included elsewhere in this annual report for
an analysis of property, plant and equipment activity in 2003.
Tax Matters
Tax Loss Carryforward and Effective Tax Rates
As of December 31, 2003, on an unconsolidated basis, we had an available
tax loss carryforward of $1.3 million in Israel, $3.9 million in the United
Kingdom and $37.5 million in the United States. The loss carryforward in the
United States principally resulted from the
exercise by employees of stock options during 2001. Our consolidated effective
tax rates were 16%, 16% and 14% in 2003, 2002 and 2001, respectively.
Approved Enterprise Status in Israel
Israeli companies are generally subject to tax at the rate of 36% of
taxable income. However, our facilities in Israel have received Approved
Enterprise status from the Israel Investment Center, which entitles us to
receive specified tax benefits. We have received three approvals granting us a
package of benefits, subject to compliance with applicable requirements. Under
the first approval, our undistributed income derived from one Approved
Enterprise will be exempt from corporate tax for a period of four years from
2001, and we will be eligible for a reduced tax rate of between 10% to 25% for
an additional two years. Under the second approval, our undistributed income
derived from another Approved Enterprise was exempt from corporate tax for a
period of two years from 2001 and we will be eligible for a reduced tax rate of
10% to 25% for an additional eight years. Under the third approval (benefit
period starting 2003), our undistributed income will be exempt from corporate
tax for a period of two years following implementation of the plan. We will be
eligible for a reduced tax rate of between 10% to 25% for an additional
thirteen years thereafter. All of these programs are subject to time limits
imposed by the Law for Encouragement of Capital Investments, 1959 and based
upon the level of foreign ownership in our company in each tax year. To retain
the most favorable rates we must maintain a foreign shareholders level of at
least 90%. Currently, we exceed this level. As a result of these programs, a
substantial portion of the profits derived from products manufactured in Israel
may benefit from a reduced Israeli tax rate. Additionally, in October 2003, we
submitted an application for a fourth approval for capital investments that
will be implemented by the end of 2005.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk for changes in interest rates and foreign
currency rates relates mainly to our long-term debt obtained to purchase fixed
assets. Our interest expenses are sensitive to the LIBOR and CPI, as most of
our long-term debt bears a LIBOR or CPI-linked interest rate. As of December
31, 2003, $181.4 million of our outstanding debt bears an average interest rate
of 5.3%. Consequently, each 0.25% increase in interest rates will reduce pretax
income by approximately $0.5 million.
Our functional currency and that of our U.S. subsidiary is the U.S.
dollar. The functional currency of our European and Canadian subsidiaries, is
the local currency in their respective countries.
In 2003, over 90% of our revenues were generated in U.S. dollars. However,
the remainder of our sales were denominated in the local currencies of the
countries in which they occurred. As such, our reported profits and cash flows
are exposed to changing exchange rates. If the U.S. dollar weakens relative to
the foreign currencies, the earnings generated in these foreign currencies
will, in effect, increase 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 relative low level of
non-U.S. dollar revenues, the effects of currency fluctuations on consolidated
net revenues and operating income were not significant in 2003.
OFF-BALANCE SHEET ARRANGEMENTS
The Company does not have any material off-balance sheet arrangements.
CONTRACTUAL OBLIGATIONS
As of December 31, 2003, we have contractual obligations in connection
with the construction and installation of new pharmaceutical facilities in the
amount of $17.2 million. In addition we have contractual obligations under
several operating leases in relation to facilities and equipment which we lease
from third parties.
The following table describes the payment schedules of our contractual
obligations, in millions:
Payments due by period
Less
than 1
1-3
3-5
Over 5
Contractual Obligation
Total
year
years
years
years
Operating lease
obligation
$
16.5
$
4.7
$
7.6
$
2.9
$
1.3
Purchase obligations
$
17.2
$
17.2
C. RESEARCH AND DEVELOPMENT, PATENTS, TRADE MARKS AND LICENSES
Most of our sales are derived from products that are the result of our own
research and development. 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.
In 1991, we formed the Taro Research Institute Ltd., or the Institute, for
the purpose of consolidating our pharmaceutical and chemical research
activities. The Institute coordinates all of our research and development
activities on a global basis.
Recruiting talented scientists is essential to the success of our research
and development programs. Approximately 20% of our employees work in our
worldwide
research and development programs.
More than 80 of our scientists hold either M.D. or Ph.D. degrees.
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, capsules, injectables, suspensions, solutions,
creams and ointments) that are equivalent to numerous brand-name
products whose patents and FDA exclusivity periods have expired;
proprietary pharmaceuticals and delivery systems, in which we are
developing T-2000 and products utilizing the NonSpil delivery system;
and
organic and steroid chemistry, where our programs have enabled us to
synthesize the active ingredients used in many of our products.
Generic Pharmaceuticals
In 2003, we received multiple product approvals in Canada, Israel and the
United States. The following table sets forth the approvals in the United
States by the FDA during 2003 and through April 29, 2004:
Etodolac extended release tablets, 400, 500 and 600 mg
Lodine® XL
Fluconazole tablets 50, 100, 150 and 200 mg
1
Diflucan®
Fluorouracil topical solution, 2% and 5%
Efudex®
Hydrocortisone butyrate topical solution, 0.1%
3
Locoid®
Ibuprofen oral suspension, 100mg/5mL
2,3
ElixSure® IB
Phenytoin oral suspension USP, 125 mg/5mL
3
Dilantin-125®
Terconazole vaginal cream, 0.8%
3
Terazol®
(1)
Tentative approval (2) NDA approval (3) Approval received in 2004
As of April 29, 2004, 33 of our ANDAs and one NDA 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 submitted by our competitors.
We are currently conducting Phase II studies on T-2000, our non-sedating
barbiturate compound. This product is currently intended for the treatment of
epilepsy and essential tremor, but may have other indications. It is intended
to be a long-acting, non-sedating barbiturate compound that permits increased
patient compliance and reduced side effects.
T-2000 must complete Phase II testing, successfully undergo Phase III
studies and obtain regulatory approval in order to reach the market. There can
be no assurance of the successful completion of Phase II or Phase III testing,
the approval by the FDA of the drug or the commercial success of the drug.
NonSpil
We also continue to work on our NonSpil liquid drug delivery system,
which allows liquid medications to pour, but not spill, thereby increasing the
accuracy of dosage and ease of use.
NonSpil development activities include improving product formulations,
refining taste and texture, scaling up from laboratory sized manufacturing to
commercial sized manufacturing and preparing the marketing program for this new
delivery system. While there can be no assurance of regulatory approvals or
commercial success, we hope to introduce more NonSpil formulations in
commercial markets where they can contribute to both pediatric and geriatric
healthcare.
In 2003, we launched the ElixSure® line of childrens medicines for
fever/pain, cough and congestion. ElixSure is the first line of products to
use our NonSpil liquid drug delivery system. The commercial success of the
ElixSure® line will depend upon consumer acceptance of this new delivery
system. Furthermore, competition from other products for the same clinical
indications may prevent successful commercialization of these products. Thus,
there can be no assurance of the success of the ElixSure® product line.
Patents, Trademarks and Licenses
We have filed and received patents in the United States in a variety of
areas including for:
a class of anticonvulsant, tranquilizer and muscle relaxant drugs;
a class of antiarrhythmic drugs;
novel oral delivery for pharmaceutical and related products; and
the synthesis and formulation of some of our products.
We have registered trademarks in the United States and in Canada.
Moreover, we have recently acquired the rights to use the A/T/S®, Kerasal®,
Ovide®, Primsol® and Topicort®
trademarks in the United States. Taro U.S.A. typically does not use trademarks
in the sale and marketing of its generic products. We do not believe that any
single patent or license is of material importance to us in relation to our
current commercial activities.
From time to time, we seek to develop products for sale prior to patent
expiration in various countries. In the United States, in order to obtain a
final approval for a generic product prior to expiration of certain of the
innovators patents, we must, under the terms of the Drug Price Competition and
Patent Term Restoration Act of 1984 (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 a New Drug Application that we
believe that the patents listed in the Approved Drug Products with Therapeutic
Equivalence Evaluations (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 patent(s) 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 innovators or third partys process
patents. We may also become involved in patent litigation in other
jurisdictions where we conduct business, including Israel, Canada and Europe.
On November 14, 2003, Godecke Aktiengesellschaft, Pfizer and
Warner-Lambert (collectively, Warner Lambert), responding to our filing of an
ANDA requesting approval for gabapentin capsules prior to the expiration of
certain listed patents, filed a complaint against us and our U.S. subsidiary,
Taro Pharmaceuticals U.S.A., Inc. (collectively, Taro) in the district court
in New Jersey alleging that, under the provisions of the Hatch-Waxman Act,
Taros ANDA infringed certain Warner-Lambert patents.
D. TREND INFORMATION
Please see Item 4 Information on the Company and Item 5 Operating and
Financial Review and Prospect for trend information.
ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A. DIRECTORS AND SENIOR MANAGEMENT
The following table lists our current directors and executive officers as
of April 1, 2004:
(1)Statutory independent director elected in accordance with the Israeli
Companies Law
Certain Familial Relationships
Dr. Levitt and Aaron Levitt are brothers. Tal Levitt is the daughter of
Dr. Levitt and niece of Aaron Levitt. Dr. Moros is a first cousin of each of
Dr. Levitt and Aaron Levitt.
Business Experience
Barrie Levitt, M.D.
became Chairman of our board of directors in 1991.
Dr. Levitt has been a director since 1963. Dr. Levitt, a pharmacologist (basic
as well as clinical), has been involved in pharmacologic research and clinical
cardiology since 1963. From 1974 to 1977, he was Professor of Medicine and
Pharmacology and Director of Cardiology and Clinical Pharmacology at New York
Medical College. From 1977 to 1985, he was Clinical Professor of Medicine and
Visiting Professor of Pharmacology at the Albert Einstein College of Medicine
in New York. From 1982 to 2000, he was Chairman of the Committee on Clinical
Investigations at that institution. Dr. Levitt is a Fellow of the American
College of
Cardiology and of the American College of Clinical Pharmacology. He
is a member of the American Society for Pharmacology and Experimental
Therapeutics. In addition, Dr. Levitt
served as a consultant for the FDA from 1971 through March 1991, when he
resigned in order to increase his involvement in our company.
Aaron Levitt
was elected to our board of directors in 1981 and became
President of our company in 1982. Mr. Levitt joined our company in 1980 as
Director of Marketing for our Israel operations after serving as regional sales
manager for the Coty Division of Pfizer Inc. from 1970 to 1976 and later as
regional sales manager for the Ultima Division of Revlon Group Inc. from 1976
to 1979. He has been on a paid leave of absence from his employment
by Taro U.S.A. since February 2004.
Daniel Moros, M.D.
was elected to our board of directors in 1988 and is
currently Vice Chairman. He is instrumental in overseeing our clinical research
program, including the design and conduct of clinical trials. Dr. Moros has
been Associate Professor of Neurology at the Mount Sinai School of Medicine of
the City University of New York since 1991, and currently is Associate Clinical
Professor at such institution.
Myron Strober, C.P.A.
was elected to our board of directors in 2002 and
serves as the chairman of our audit committee. A Certified Public Accountant in
the United States, Mr. Strober was an audit partner of Ernst & Young, New York,
from 1969 to 1990. Since his retirement in 1990, Mr. Strober has been actively
involved as a financial consultant to a number of organizations. He was a
financial consultant to our company from 1993 to 2002 and served on our
advisory board.
Heather Douglas, Esq
. was elected to our board of directors in 1998. Ms.
Douglas is a partner with the Canadian law firm of Borden Ladner Gervais LLP.
Micha Friedman, Ph.D.
was elected to our board of directors in 2002 and is
currently a Professor in the Department of Pharmacy at the Hebrew University of
Jerusalem in Israel. He has published numerous articles both in Israel and
internationally and is a member of many professional pharmaceutical societies.
Eric Johnston, Esq.
was elected to our board of directors in 1984. Mr.
Johnston is currently an attorney with the Canadian law firm of
Perley-Robertson, Hill and McDougall LLP. From 1974 to 2000, Mr. Johnston
served as a Deputy Regional Solicitor of The Regional Municipality of
Ottawa-Carleton, Ontario, Canada.
Gad Keren, M.D.
served on our board of directors from 1991 to 2000 and was
reelected in 2001. Dr. Keren is currently Chairman of the Cardiology
Department at the Tel Aviv Medical Center, where he was named Professor of
Cardiology in 1995, and he has been secretary of the Israel Cardiology Society
since 1991. Dr. Keren was a research fellow at the National Institute of
Health in 1989 and 1990. Dr. Keren also acts as a research consultant to the
Taro Research Institute.
Tal Levitt, Esq.
was elected to our board of directors in 1998. Ms. Levitt
joined our company in 1995 as Associate Counsel and currently serves as Senior
Vice President, Corporate Affairs and Treasurer of Taro U.S.A. Ms. Levitt is
responsible for corporate communications, including investor and media
relations, and is also involved with legal
affairs. She previously worked as a
corporate attorney at the New York law firm of Jenkens Gilchrist Parker &
Chapin, LLP from 1994 to 1995.
Ben Zion Hod, C.P.A.
was elected to our board of directors in 2003 as an
independent director. Mr. Hod is a certified public accountant in Israel and
for the past 11
years, has served as company comptroller for Zim Israel Navigation
Company. Prior to joining Zim, Mr. Hod was a senior manager at Kesselman &
Kesselman, a member of PricewaterhouseCoopers International Ltd. Mr. Hod
previously served as a public director of the Company from 1993 to 1998.
Haim Fainaro, C.P.A.
is a certified public accountant in Israel, managing
a private accounting practice in Tel Aviv since 1969. Mr. Fainaro, has
previously served as the Companys internal auditor in Israel and as public
director from 1988 to 1993
Samuel Rubinstein
joined our company in 1990 and currently serves as
Senior Vice President and General Manager. From 1986 to 1989, Mr. Rubinstein
served as President of Laminated Plastics, Inc., a joint venture of two Israeli
corporations operating in the United States. From 1974 until 1986, Mr.
Rubinstein managed several different Israeli companies.
Kevin Connelly, C.P.A.
joined our company in 1993 and has served as our
Senior Vice President and Chief Financial Officer since 1994. A Certified
Public Accountant in the United States, Mr. Connelly has a background in
financial management. From 1990 to 1993, he served as a Vice President and
Controller of BT-Financial Services and Information Systems, a subsidiary of
Bankers Trust Co. Prior to 1990, he held the position of Vice President and
Divisional Controller with First American Bank of New York.
Avraham Yacobi, Ph.D.
joined our company in 1994 as President of the
Institute and was appointed our Senior Vice President, Research and Development
in 1998. Dr. Yacobi directs our pharmaceutical, scientific and regulatory
initiatives. Prior to joining our company, he was the Director of
Pharmacodynamics Research for the Medical Research Division of American
Cyanamid Company from 1982 to 1994. From 1976 to 1982, Dr. Yacobi served as
Section Head of Clinical Pharmacology and Drug Metabolism of American Critical
Care. He has extensive experience in drug development, with over 120
publications in the field.
Zahava Rafalowicz
joined our company in 1997 as Marketing Manager of our
Israeli operations. Ms. Rafalowicz presently serves as Group Vice President,
Sales and Marketing, and Deputy General Manager in Israel. She is responsible
for our Israeli and European sales and marketing operations and planning. Prior
to joining us, Ms. Rafalowicz was the Deputy Managing Director of the
Pharmaceutical Division of Teva Pharmaceutical Industries Ltd. She also spent
several years at IMS Health Global Services, or IMS, where she established IMS
in the Eastern European Bloc.
Mariana Bacalu
joined our company in 1984 as Senior Analyst in the Quality
Control Laboratory. As Vice President, Pharmaceutical Production, she is
currently responsible for pharmaceutical production at the Haifa Bay facility.
Prior to joining us, Ms. Bacalu served as a production manager for Polymer
Industry in Romania.
Hannah Bayer, C.P.A.
joined our company in 2001 as Vice President and
Chief Accounting Officer. Ms. Bayer is a Certified Public Accountant in Israel.
From 1999 to 2000, she served as Chief Financial Officer of Omrix
Biopharmaceuticals, Ltd. From 1990 to 1999, Ms. Bayer held several financial
positions in Teva Pharmaceutical Industries Ltd., including chief accountant
and manager of global business reporting.
Ilan Ben Cnaan
joined our company in 1999 and currently serves as Vice
President, Operations, Israel. He is responsible for our chemical manufacturing
operations in Israel. From 1979 to 1999, Mr. Ben Cnaan served as a pilot plant
manager, production manager and
operations manager for Teva Pharmaceutical Industries Ltd. in both the
chemical and veterinary divisions.
Marc Coles, Esq.
joined our company in 1992 as in-house legal counsel in
Israel and currently serves as our General Counsel responsible for legal
affairs in Israel. Before joining our company, Mr. Coles was the Director of
Regulatory Affairs for Biodan Medical Systems, Rehovot, Israel.
Puah Dekel
joined our company in 1987 in our Human Resources Department.
She served as the Director of Human Resources for the company from 1990 until
2003. Mrs. Dekel currently serves as Vice President of Administration. Prior
to joining the company, she worked in the field of human resources for various
companies, including Bank Leumi.
Yohanan Dichter
joined our company in 1986 in the research department and
since 1988 has served as the Vice President, Pharmacist in Charge of the Haifa
Bay pharmaceutical manufacturing plant. He is responsible for the review and
release of all pharmaceutical products manufactured or sold in Israel. Prior to
joining us, Mr. Dichter served in the Medical Corps of the Israel Defense
Forces, Kupat Holim Clalit (Israels largest healthcare fund) and worked in a
private pharmacy.
Roman Kaplan, Ph.D.
joined our company in 1991 and currently serves as
Vice President, Technical Operations, Pharmaceuticals. He is responsible for
process and product formulation improvements. Dr. Kaplan served from 1982 to
1987 as project manager of the biochemical laboratory of Abic Chemical and
Pharmaceutical Industries and from 1987 to 1991 as head of its solid dosage
forms development group.
Iftach Katz
joined our company in 1995 and is now the head of the
companys Pharmaceutical Technical Services Group in Israel. Mr. Katz has over
17 years of experience in the industry and has held several key positions in
the areas of product improvement and production.
Alon Korb
joined our company in 2002 and is currently serving as Vice
President, Engineering and Projects. Prior to joining our company, Mr. Korb
was the Facilities Manager for Tower Semiconductor Ltd. in Israel, responsible
for engineering, maintenance and the management of large-scale projects. He
has extensive experience in engineering, industrial plant operations and
project management.
Sigalit Portnoy, Ph.D.
joined our company in 1997 as Head of Sterile
Production. Thereafter, she was promoted to the position of Pharmaceutical
Production Manager and
presently serves as Vice President, Training and
Planning. From 1990 to 1997, she taught at the Technion Institute, Israel.
Sabar Sasson, Ph.D.
joined our company in 1991 and currently serves as
Vice President, Strategic Planning, Chemicals. He is responsible for scientific
strategy with respect to our chemical synthesis program. From 1976 to 1991, Dr.
Sasson served as manager of chemical process development for Abic Chemical and
Pharmaceutical Industries.
Tzvi Tal
joined our company in 1996 and currently serves as our Vice
President, Information Technology in Israel. He is responsible for all
information technology programs at our facilities in Israel. From 1977 to 1996,
Mr. Tal was Head of Information Technology for the Vargus Group and Plant
Manager for Egmo Industries.
B. COMPENSATION
Our directors, other than the independent directors, are paid $6,000 per
year for their service as directors. Directors who are not executive officers
are also paid $500 for each meeting of our board of directors that they attend.
Because of the increased responsibilities imposed by the Sarbanes-Oxley Act,
the Chairman of our Audit Committee will receive additional compensation of
$6,000 per year. Our independent directors, as defined under Israeli law, may
not be compensated in connection with their services as independent directors
in excess of the amounts set forth in the Companies Law and regulations
promulgated thereunder. Each of our independent directors receives $390 as a
participation fee for each board meeting that they attend and $6,400 as an
annual fee.
Cash Compensation of Executive Officers
We paid an aggregate of $7,512,808 to all our directors and officers (26
persons) for services rendered to us in all capacities during the year ended
December 31, 2003. This amount does not include certain additional benefits
which, as to all directors and officers as a group, aggregated approximately
$100,000.
C. BOARD PRACTICES
We are subject to the provisions of the Israeli Companies Law, which
became effective on February 1, 2000.
Board of Directors
According to the Companies Law and our Articles of Association, the
management of our business is vested in our board of directors. The board of
directors may exercise all powers and may take all actions that are not
specifically granted to our shareholders. As part of its powers, our board of
directors 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 thinks fit, including the
grant of security interests on all or any part of our property.
Our board of directors currently consists of eleven directors (including
our two independent directors). According to our Articles of Association (as
amended in 2002), our board of directors may neither consist of fewer than five
directors nor more than 25 directors.
Our directors, other than our independent directors, are elected at annual
general meetings of our shareholders to hold office until the next annual
general meeting of shareholders, which is required to be held at least once
during every calendar year and not more than fifteen months after the last
preceding meeting. Directors may also be appointed, whether to fill vacancies
or as additional members of the board of directors, by a resolution passed at
an extraordinary general meeting of our shareholders. Likewise, in the event of
a vacancy, the board of directors is empowered to appoint a director to fill
such vacancy. A director holds office until the next annual general meeting,
unless he is earlier removed from office by an ordinary resolution passed at an
extraordinary general meeting of our shareholders.
Independent Directors
Qualifications of Independent Directors
Under the Companies Law, companies incorporated under the laws of Israel
whose shares are listed for trading on a stock exchange or have been offered to
the public by a prospectus, and are held by the public, in or outside of Israel
are required to elect two independent directors. The Companies Law provides
that a person may not be elected as an independent director if the person or
the persons relative, partner, employer or any entity under the persons
control has, as of the date of the persons election to serve as an independent
director, or had, during the two years preceding that date, any affiliation
with:
our company;
any entity controlling our company; or
any entity controlled by our company or under common control
with our company.
The term affiliation includes an employment relationship, a business or
professional relationship maintained on a regular basis, control of the
company, and service as an office holder.
The Companies Law defines the term office holder as a director, general
manager, chief business manager, deputy general manager, vice general manager,
any other person assuming the responsibilities of any of the forgoing positions
without regard to such persons title, or any manager that reports directly to
the general manager. The Companies Law further provides that no person can
serve as an independent director if the persons other positions or other
business creates, or may create, a conflict of interest with the persons
responsibilities as an independent director or may otherwise interfere with the
persons ability to serve as an independent director. Until the lapse of two
years from termination of office, a company may not engage an independent
director to serve as an office holder and cannot employ or receive services
from that person, either directly or indirectly, including through a
corporation controlled by that person.
Independent directors generally are to be elected by a majority vote at a
shareholders meeting, provided that either:
the majority include at least one-third of the shares of
non-controlling shareholders (as defined in the Companies Law) or
their representatives voted at the meeting in favor of the election;
or
the total number of shares voted against the election of the
independent director by the non-controlling shareholders, does not
exceed one percent of the aggregate voting rights in the company.
The initial term of an independent director is three years and may be
extended for three additional years. Independent directors may be removed from
office only by the same percentage of shareholders as is required for their
election or by a court, if the independent directors cease to meet the
statutory qualifications for their appointment or if they violate their duty of
loyalty to the company. Each committee of a companys board of directors is
required to include at least one independent director, except for the audit
committee which is required to include all the independent directors.
Our independent directors, Ben Zion Hod and Haim Fainaro, were elected by
our shareholders in 2003, pursuant to the provisions of the Companies Law for
an initial three year term, which will end on July 31, 2006 and August 28,
2006, respectively.
Alternate Directors
Pursuant to our Articles of Association and the Companies Law, any
director may appoint, by written notice to us, any person (other than a
director, an alternate director and a person who is not qualified to serve as a
director) to serve as an alternate director and may remove such alternate
director. An alternate director possesses all the rights and obligations of the
director who appointed him except that the alternate, in his capacity as such,
has no standing at any meeting if the appointing director is present. Unless
the appointing director limits the time or scope of the appointment, it shall
be effective for all purposes until the appointing director ceases to be a
director or terminates the appointment. The appointment of an alternate
director does not diminish the responsibility of the appointing director as a
director.
Committees
Subject to the provisions of the Companies Law, our board of directors may
delegate its powers to certain committees comprised of board members. Pursuant
to the Companies Law, any committee of the board of directors that is
authorized to exercise any function of the board must include at least one
independent director. Our board of directors has formed Audit, Executive,
Finance, Compensation and Stock Option committees.
Under the Companies Law, our board of directors is required to appoint an
audit committee, comprised of at least three directors including both
independent directors, but excluding:
the chairman of the board of directors; and
a controlling shareholder or a relative of a controlling
shareholder and any director employed by our company or who provides
services to us on a regular basis.
As of December 31, 2003, our audit committee consisted of the following
directors: Mr. Myron Strober, C.P.A., Chairman, Mr. Eric Johnston, Esq., Ms.
Heather Douglas, Esq., Ben Zion Hod, C.P.A. and Haim Fainaro, C.P.A., none of
whom are our employees.
The role of the audit committee is, among other things, to examine flaws
in our business management, in consultation with the internal auditor and the
independent accountants and to propose remedial measures to the board.
Audit Committee Report
The audit committee has reviewed and discussed with management the
Companys audited consolidated financial statements as of and for the year
ended December 31, 2003.
The audit committee has also discussed with Kost, Forer, Gabbay &
Kasierer, a member of Ernst & Young Global, the matters required to be
discussed by the Statement on
Auditing Standards No. 61, Communication with Audit Committees, as
amended, issued by the Auditing Standards Board of the American Institute of
Certified Public Accountants.
Based on the reviews and discussions referred to above, the audit
committee has recommended to the board of directors of the Company that the
audited consolidated financial statements referred to above be included in this
Form 20-F for the year ended December 31, 2003.
Approval of Interested Party Transactions
The approval of the audit committee is required to effect specified
actions and transactions with office holders, controlling shareholders and
entities in which they have a personal interest. An audit committee may not
approve an action or a transaction with controlling shareholders or with its
office holders unless at the time of approval the two independent directors are
serving as members of the audit committee and at least one of our independent
directors serving as members of our audit committee was present at the meeting
in which such approval was granted. A controlling shareholder is defined in the
Companies Law for this purpose as a person with the ability to direct the
actions of a company, or a person who holds 25% or more of the voting rights in
a public company if no other shareholder owns more than 50% of the voting
rights in the company, provided that two or more persons holding voting rights
in the company who each have a personal interest in the approval of the same
transaction shall be deemed to be one holder.
Audit committee approval is also required to approve the grant of an
exemption from the responsibility for a breach of the duty of care towards the
company, or for the provision of insurance or an undertaking to indemnify any
office holder who is not a director of the company. In addition, the audit
committee must approve contracts between the company and any of its directors
relating to the service or employment of a director.
Internal Auditor
Under the Companies Law, the board of directors is required to appoint an
internal auditor proposed by the audit committee. The internal auditor may not
be an interested party, an office holder, or a relative of any of the
foregoing, nor may the internal auditor be our independent accountant or its
representative. The Companies Law defines the term interested party to
include a person who holds 5% or more of our outstanding share capital or
voting rights, a person who has the right to appoint one or more directors or
the general manager, or any person who serves as a director or as the general
manager. The role of the internal auditor is to examine, among other things,
whether our actions comply with the law and orderly business procedure. Mr.
Elisha Saar, C.P.A., an independent public accountant, currently serves as our
internal auditor. 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 participate in all audit committee meetings.
D. EMPLOYEES
The following table sets forth the number of our employees as of December
31, 2003:
Israel
Canada
U.S.A.
Ireland
Other
Total
Sales and Marketing
35
39
168
1
3
246
Administration
51
36
137
9
6
239
Research and Development
135
81
36
14
266
Production and Quality
Control
363
253
53
26
695
Total
584
409
394
50
9
1,446
In general, our relationship with our employees is satisfactory. We have
no collective bargaining agreements with any of our employees. However,
certain provisions of the collective bargaining agreements between the
Histadrut (General Federation of Labor in Israel) and the Israeli Coordination
Bureau of Economic Organizations (including the Industrialists Association)
apply to all of our employees in Israel by order of the Israeli Ministry of
Labor. These provisions concern principally the length of the workday, minimum
daily wages for professional workers, insurance for work-related accidents,
procedures for dismissing employees, determination of severance pay, and other
conditions of employment. We generally provide our employees with benefits and
working conditions beyond the required minimums.
Israeli law generally requires severance pay upon the retirement or death
of an employee or termination of employment without cause. We currently fund
our ongoing severance obligations by contributing on behalf of our senior
employees to a fund known as
the Managers Insurance. This fund provides a
combination of savings plan, life insurance and severance pay benefits to our
employees, and each employee receives a lump sum payment upon retirement and
severance pay, if the employee is legally entitled to it, upon termination of
employment. We decide whether each employee is entitled to participate in the
plan, and each employee who agrees to participate contributes an amount equal
to 5% of his or her salary and we contribute an additional sum of between 13.3%
and 15.8% of the employees salary. In addition, 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 14.5% of an
employees wages (up to a specified amount), of which the employee contributes
approximately 66% and we contribute approximately 34%.
E. SHARE OWNERSHIP
The following table sets forth certain information regarding the ownership
of our ordinary shares by our directors and officers as of May 17, 2004. The
percentage of outstanding shares is based on 29,298,577 ordinary shares
outstanding as of May 17, 2004. Ordinary shares subject to options currently
exercisable, or exercisable within 60 days of May 17, 2004, are deemed
outstanding for computing the percentage ownership of the person holding such
options, but are not deemed outstanding for computing the percentage ownership
of any other person.
Total for all directors and
officers (28 persons) listed
above, as a group
3,928,661
13.3
%
(1) Of the ordinary shares beneficially owned by Dr. Levitt, (1) 297,066
ordinary shares are owned individually by Dr. Levitt, (2) 585,780 ordinary
shares are held by Dr. Levitt as trustee for trusts established by Dr. Levitt,
(3) 12,934 ordinary shares are owned by Dr. Levitt and his wife as joint
tenants, (4) 780 ordinary shares are owned by Morley and Company, Inc., or
Morley, which is controlled by Dr. Levitt, (5) 198,032 ordinary shares are
owned by Orenova Corporation, which is wholly-owned by Dr. Levitt and members
of his immediate family, (6) 35,200 ordinary shares, which are not currently
outstanding, are subject to incentive options granted to Dr. Levitt that are
presently exercisable, (7) 65,440 ordinary shares are owned by Taro Research
Foundation, Inc., or the Research Foundation, a charitable foundation
controlled by Dr. Levitt and Aaron Levitt, and (8) 751,852 ordinary shares are
owned by the R and J Levitt Corporation, or the R&J Corporation, which is owned
50% by Dr. Levitt and members of his immediate family and 50% by Aaron Levitt
and members of his immediate family. In addition, Dr. Levitt is the beneficial
owner of all 2,600 of our outstanding founders shares, whose holders are
entitled to exercise one-third of the total voting power in our company
regardless of the number of ordinary shares then outstanding.
(2) Of the ordinary shares beneficially owned by Aaron Levitt, (1) 22,600
ordinary shares are individually owned by Mr. Levitt, (2) 175,412 ordinary
shares are owned by Mr. Levitt and his wife as joint tenants, (3) 17,600
ordinary shares, which are not currently outstanding, are subject to incentive
options granted to Mr. Levitt that are presently exercisable, (4) 5,275 are
owned by his wife, (5) 65,440 ordinary shares are owned by the Research
Foundation, which is controlled by Mr. Levitt and Dr. Levitt, and (6) 751,852
ordinary shares are owned by the R&J Corporation, which is owned 50% by Mr.
Levitt and members of his immediate family and 50% by Dr. Levitt and members of
his immediate family.
(3) Aaron
Levitt, together with his wife and two sons, has commenced litigation
in the Supreme Court of the State of New York against Barrie Levitt,
Tal Levitt, Daniel Moros, TDC and R&J Corporation, seeking, among
other relief, to cause the ordinary shares of our company held by TDC
and R&J Corporation to be distributed by those corporations to
their respective shareholders. An agreement-in-principle to settle
the litigation has been reached by the parties to the litigation. The
agreement-in-principle contemplates that Aaron Levitt and members of
his family would exchange a portion of the outstanding shares of TDC
which they currently own for all of the outstanding shares of R&J
Corporation which they do not currently own. In addition, the
agreement-in-principle contemplates that TDC would sell approximately
510,000 of the ordinary shares of our company that it currently owns
and pay the net after-tax proceeds of the sales to Aaron Levitt and
members of his family in exchange for the balance of their
shareholdings in TDC. The sales are to be conducted by TDC at such
time or times, prior to July 31, 2005, as Aaron Levitt may
direct and in accordance with Rule 144 under the Securities Act
of 1933. Upon consummation of the transactions contemplated by the
agreement-in-principle, (i) Aaron Levitt and members of his
family would cease to own any shares of TDC and would become the sole
shareholders of R&J Corporation and (ii) the shareholdings
of TDC in our company would be reduced by approximately
510,000 shares. The agreement-in-principle does not impose any
restrictions upon the sale by R&J Corporation of its shares in
our company, except for a requirement that any such sale be made in
compliance with applicable law. It is anticipated that the
agreement-in-principle will be executed and delivered by each of the
parties to the pending litigation, and the resulting changes in the
ownership of TDC and R&J Corporation contemplated thereby will
take place, during the summer of 2004. There is, however, no
assurance that the agreement-in-principle will become a binding
agreement or that the transactions contemplated thereby will be
consummated. We are unable to predict what might happen in the event
that the litigation referred to above is not settled or is settled
upon terms other than those contemplated by the
agreement-in-principle.
(4) Of the ordinary shares owned by Dr. Moros, (1) 353,217 ordinary shares
are owned individually by Dr. Moros, (2) 229,960 ordinary shares are held by
Dr. Moros as co-trustee of the Nathan Moros
Trust, (3) 337,074 ordinary shares are held by Dr. Moros as trustee for
trusts established by Isabel Moros, and (4) 17,600 ordinary shares, which are
not currently outstanding, are subject to incentive options granted to Dr.
Moros that are presently exercisable. Each of Dr. Moross two minor daughters
owns 100 ordinary shares.
*
Less than 1%
As of April 1, 2004, the directors and executive officers listed above, as
a group, held options to purchase 630,700 of our ordinary shares at a weighted
average exercise price of $21.53, expiring between July 2005 and January 2014.
General.
From time to time, we have granted options to purchase our
ordinary shares. As of December 31, 2003, there were outstanding 1,300,372
options to acquire our ordinary shares.
Compensation Pursuant to Plans
1991 Stock Incentive Plan
Our 1991 Stock Incentive Plan was unanimously adopted by our board of
directors on November 19, 1991 and approved by our shareholders on April 10,
1992. The purpose of the 1991 Stock Incentive Plan is to attract, retain and
provide incentives to key employees, including directors and officers who are
key employees, and to consultants and directors who are not our employees by
enabling them to participate in our long-term growth. Dr. Levitt, Mr. Levitt
and Dr. Moros were not eligible to participate in the 1991 Stock Incentive
Plan.
The 1991 Stock Incentive Plan permits the grant of options and stock
appreciation rights, or SARs. Options may either be incentive stock options, or
ISOs, or nonqualified stock options, or NQSOs. The total number of our ordinary
shares with respect to which options and SARs may be granted under the 1991
Plan may not exceed 1,000,000, subject to appropriate adjustment in the event
of stock dividends, stock splits and similar transactions.
All key employees of, and consultants to us, and our directors, including
officers and directors who are key employees, other than the Optionees, and
members of our stock option committee, as defined in the 1991 Stock Incentive
Plan, were eligible to participate in the 1991 Stock Incentive Plan. However,
ISOs may only be granted to employees, including officers and directors who are
also employees. Under the plan, directors, excluding Identified Public
Directors who are not employees of our company or Outside Directors, both as
defined in the 1991 Stock Incentive Plan, are granted, on the date that such
individual is initially elected a director, a one-time nonqualified option to
purchase 4,000 ordinary shares, or the Initial Outside Director Award.
The 1991 Stock Incentive Plan is administered by our board of directors
(as required by the Companies Law) and by a Plan Committee, composed of not
less than two members, each of whom must be disinterested persons as defined
by the Securities and Exchange Commission (as required by U.S. law). Within the
limits of the 1991 Stock Incentive Plan, the Board of Directors and Plan
Committee are authorized to determine, among other things, to whom and the time
or times at which options and SARs are to be granted, the types of options and
SARs to be granted, the number of shares which will be subject to any option or
SAR, the term of each option and SAR, the exercise price of each option and
base price of each SAR,
and the time or times and conditions under which options and SARs may be
exercised. The Board of Directors and the Plan Committee may, with the consent
of the holder of the option or SAR, cancel or modify an option or SAR or grant
an option or SAR in substitution for any canceled option or SAR, provided that
any substituted option or SAR and any modified option or SAR is permitted to be
granted on such date under the terms of the 1991 Stock Incentive Plan and the
Code. In such case, the Board of Directors and the Plan Committee may give
credit toward any required vesting period for the substituted option or SAR for
the period during which the employee held the canceled option or SAR.
The exercise price of an option or base price of a SAR granted under the
1991 Stock Incentive Plan, other than the Initial Outside Director Award, shall
be determined by the Board of Directors and the Plan Committee, but may not be
less than 100% of the fair market value of the ordinary shares on the date of
grant or 110% of such fair market value in the case of an ISO granted to an
optionee who owns or is deemed to own stock possessing more than 10% of the
combined voting power of all classes of our stock. The exercise price of an
Initial Outside Director Award shall equal the fair market value of the
ordinary shares subject to such option on the date of grant.
Upon exercise of a SAR, subject to applicable law, the holder is entitled
to receive an amount, in cash, ordinary shares or a combination of the two, as
determined by the Board of Directors and the Plan Committee, equal to the
excess of the fair market value of the shares with respect to which the SAR is,
exercised calculated as of the exercise date, over the base price.
The term of each option and SAR other than an Initial Outside Director
Award will be for such period, and such option or SAR may be exercised at such
times during such period and on such terms and conditions, as the Board of
Directors and the Plan Committee may determine, consistent with the terms of
the 1991 Stock Incentive Plan. The term of an Initial Outside Director Award
will be five years. Each Initial Outside Director Award will become exercisable
in each of the four years commencing one year after the date of grant to the
extent of one-fourth of the number of our ordinary shares originally subject to
the option granted therein. Ordinary Shares not purchased pursuant to an
Initial Outside Director Award in any one exercise period may be purchased in
any subsequent exercise period prior to the termination of the award. The term
of any option or SAR may not exceed ten years, or five years with respect to
ISOs granted to optionees who own or are deemed to own stock representing more
than 10% of the combined voting power of all classes of our shares.
There is no limit on the number of shares for which options or SARs may be
granted or awarded to any eligible employee, consultant or director. However,
the aggregate fair market value (determined as of the date of grant) of
ordinary shares with respect to which ISOs granted to any employee may be first
exercisable in any calendar year under all of our incentive stock option plans
may not exceed $100,000. To the extent such limit is exceeded, the excess will
be treated as a separate NQSO.
As of April 1, 2004, 251,869 ordinary shares were subject to outstanding
options. Of such options, 126,250 (at an average exercise price of $2.74 per
share) were held by executive officers; 52,000 (at an average exercise price of
$3.40 per share) were held by directors who are not executive officers; and
73,619 (at an average exercise price of $3.34 per share) were held by other
persons. None of such options were SARs.
1999 Stock Incentive Plan
Our 1999 Stock Incentive Plan was unanimously adopted by our board of
directors on March 10, 1999, and was approved at the annual meeting held on
July 29, 1999. The purpose of the 1999 Stock Incentive Plan is to attract,
retain and provide incentives to key employees (including directors and
officers who are key employees) and to consultants and directors who
are not
our employees by enabling them to participate in our long-term growth. The
total number of ordinary shares with respect to which options and SARs may be
granted under the 1999 Plan may not exceed 2,100,000 subject to appropriate
adjustment in the event of stock dividends, stock splits and similar
transactions.
The 1999 Stock Incentive Plan permits the grant of options and SARs.
Options may either be ISOs or NQSOs. SARs may be granted either alone or in
tandem with ISOs or NQSOs, and may be granted before, simultaneously with or
subsequent to the grant of an option. Any option granted in tandem with a SAR
would no longer be exercisable to the extent the SAR is exercised and the
exercise of the related option would cancel the SAR to the extent of such
exercise.
All key employees and directors of, and consultants to us, (as defined in
the 1999 Stock Incentive Plan), are eligible to participate in the 1999 Stock
Incentive Plan. However, ISOs may only be granted to employees (including
officers and directors who are also employees). Each Outside Director,
excluding Identified Public Directors, as defined in the 1999 Stock Incentive
Plan, shall be granted, on the date initially elected a director, a one-time
nonqualified option to purchase the Initial Outside Director Award.
The 1999 Stock Incentive Plan is administered by our board of directors
(as required by the Companies Law), and, by a committee of our board of
directors, which shall contain at least the minimum number of and type of
directors (the Administrators) that may be required in order for options
granted under the Plan to be entitled to benefits under Section 162(m) of the
Code. Within the limits of the 1999 Stock Incentive Plan, the Administrators
are authorized to determine, among other things, to whom and the time or times
at which, options and SARs are to be granted, the types of options and SARs to
be granted, the number of shares which will be subject to any option or SAR,
the term of each option and SAR, the exercise price of each option and base
price of each SAR, and the time or times and conditions under which options and
SARs may be exercised. The Administrators may (with the consent of the holder
of the option or SAR) cancel or modify an option or SAR, or grant an option
and/or SAR in substitution for any canceled option or SAR, provided that any
substituted option or SAR and any modified option or SAR is permitted to be
granted on such date under the terms of the 1999 Stock Incentive Plan and the
Code. In such case, the Administrators may give credit toward any required
vesting period for the substituted option or SAR for the period during which
the employee held the canceled option or SAR.
The exercise price of an option or base price of a SAR granted under the
1999 Stock Incentive Plan shall be determined by the Administrators, but may
not be less than 100% of the fair market value of the ordinary shares on the
date of grant (110% of such fair market value in the case of an ISO granted to
an optionee who owns or is deemed to own stock possessing more than 10% of the
combined voting power of all classes of our stock). The exercise price of an
Initial Outside Director Award shall equal the fair market value of the
ordinary shares subject to such option on the date of grant.
Upon exercise of a SAR, the holder is entitled to receive an amount in
cash, ordinary shares or a combination of the two, as determined by the
Administrators, equal to the excess
of the fair market value of the shares with
respect to which the SAR is exercised (calculated as of the exercise date) over
the base price.
The term of each option and SAR, subject to applicable law, other than an
Initial Outside Director Award will be for such period, and such option or SAR
may be exercised at such times during such period and on such terms and
conditions, as the Administrators may determine, consistent with the terms of
the 1999 Stock Incentive Plan. The term of an Initial Outside Director Award
will be five years. Each Initial Outside Director Award will become exercisable
in each of the four years commencing one year after the date of grant to the
extent of one-fourth of the number of ordinary shares originally subject to the
option granted therein.
Ordinary shares not purchased pursuant to an Initial Outside Director
Award in any one exercise period may be purchased in any subsequent exercise
period prior to the termination of the award. The term of any ISO may not
exceed ten years (five years with respect to ISOs granted to optionees who own
or are deemed to own stock representing more than 10% of the combined voting
power of all classes of our shares).
The maximum number of shares for which options may be granted or awarded
in any calendar year to any eligible employee is 1,000,000. There is no limit
on the number of shares for which options may be granted or awarded to any
consultant or director, or for which SARs may be granted or awarded to any
eligible employee, consultant or director. However, the aggregate fair market
value (determined as of the date of grant) of ordinary shares in respect of
which ISOs granted to any employee may be first exercisable in any calendar
year under all incentive stock option plans of our company may not exceed
$100,000. To the extent such limit is exceeded, the excess will be treated as a
separate NQSO.
As of April 1, 2004, 1,124,057 ordinary shares were subject to outstanding
options. Of such options, 355,250 (at an average exercise price of $26.95 per
share) were held by executive officers; 97,200 (at an average exercise price of
$35.85 per share) were held by directors who are not executive officers; and
671,607 (at an average exercise price of $32.96 per share) were held by other
persons. None of such options were SARs.
2000 Employee Stock Purchase Plan
Our 2000 Employee Stock Purchase Plan was adopted by our board of
directors on May 3, 2000, and was approved at an extraordinary general meeting
of shareholders held on May 2, 2001. The purpose of the 2000 Employee Stock
Purchase Plan is to provide our employees and those of certain of our
subsidiaries designated by our board of directors with an opportunity to
purchase our ordinary shares. Dr. Levitt, Mr. Levitt, Ms. Levitt and Dr. Moros
are not eligible to participate in the 2000 Employee Stock Purchase Plan.
The 2000 Employee Stock Purchase Plan is administered by our board of
directors (as required by the Companies Law) and by a committee named by our
board of directors, which, subject to applicable law, has the power to adopt,
amend and rescind any rules deemed desirable and appropriate for the
administration of the 2000 Employee Stock Purchase Plan and not inconsistent
with the 2000 Employee Stock Purchase Plan, to construe and interpret the 2000
Employee Stock Purchase Plan, and to make all other determinations necessary or
advisable for the 2000 Employee Stock Purchase Plan. The composition of the
committee shall be in accordance with the requirements to obtain or retain any
available exemption from
the operation of Section 16(b) of the Securities and Exchange Act of 1934
pursuant to Rule 16b-3 promulgated thereunder.
Under the terms of the 2000 Employee Stock Purchase Plan, participating
employees accrue funds in an account through payroll deductions during
six-month offering periods. The funds in this account are applied at the end
of such offering periods to purchase our ordinary shares at a 15% discount from
the closing price of the ordinary shares on (i) the first business day of the
offering period or (ii) the last business day of the offering period, whichever
closing price shall be less.
The maximum number of shares issuable under the 2000 Employee Stock
Purchase Plan is 500,000 ordinary shares, subject to adjustment. To be eligible
to participate in the 2000 Employee Stock Purchase Plan, an individual must be
employed by us or one of our subsidiaries designated by the board of directors
on the first day of the applicable plan period. Notwithstanding the foregoing,
anyone who is both a highly compensated employee within the meaning of the
Code and is designated by the board of directors as ineligible to participate
in the 2000 Employee Stock Purchase Plan shall not be entitled to participate
in the 2000 Employee Stock Purchase Plan.
In addition, no employee will be granted a right under the 2000 Employee
Stock Purchase Plan if (i) immediately after the grant, such employee would own
stock and/or hold outstanding options to purchase stock constituting 5% or more
of the total combined voting power or value of our stock or any of our
subsidiaries or (ii) such grant would result in such employees rights to
purchase stock under all of our employee stock purchase plans or of our
subsidiaries to accrue at a rate that exceeds $25,000 of the fair market value
of such stock (determined as of the last business day of the preceding
semi-annual period) for each calendar year.
As of December 31, 2003, approximately 88,000 ordinary shares had been
purchased through the 2000 Employee Stock Purchase Plan at a weighted average
exercise price of $29.70.
ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A. MAJOR SHAREHOLDERS
The following table sets forth certain information, as of May 17, 2004,
with respect to the ownership of our ordinary shares by all persons who are
known to us to beneficially own more than 5% of our outstanding ordinary
shares, and by all of our directors and officers as a group. Except as
indicated, each such shareholder has sole voting and investment power with
respect to the ordinary shares beneficially owned by such shareholder.
Beneficial ownership is determined in accordance with rules of the United
States Securities and Exchange Commission and generally includes voting and
investment power with respect to our ordinary shares. Ordinary shares subject
to options currently exercisable, or exercisable within 60 days of May 17,
2004, are deemed outstanding for computing the percentage ownership of the
person holding such options, but are not deemed outstanding for computing the
percentage ownership of any other person. For information concerning prospective changes in the ownership of TDC and The R&J Corporation
and the shareholding of these two companies in our Company, please
see Note (3) to the table set forth under the heading E.
SHARE OWNERSHIP in ITEM 6 above.
Ordinary Shares
Percent of Ordinary
Name
Beneficially Owned
Shares Outstanding
Barrie Levitt, M.D. (1)(4)
1,947,084
6.6
%
Aaron Levitt (2)(4)
1,038,179
3.5
%
Daniel Moros, M.D. (3)
929,051
3.2
%
Taro Development Corporation (4)
2,921,896
10.0
%
(1) Of the ordinary shares beneficially owned by Dr. Levitt, (1) 297,066
ordinary shares are owned individually by Dr. Levitt, (2) 585,780 ordinary
shares are held by Dr. Levitt as trustee for trusts established by Dr. Levitt,
(3) 12,934 ordinary shares are owned by Dr. Levitt and his wife as joint
tenants, (4) 780 ordinary shares are owned by Morley and Company, Inc., or
Morley, which is controlled by Dr. Levitt, (5) 198,032 ordinary shares are
owned by Orenova Corporation, which is wholly-owned by Dr. Levitt and members
of his immediate family, (6) 35,200 ordinary shares, which are not currently
outstanding, are subject to incentive options granted to Dr. Levitt that are
presently exercisable, (7) 65,440 ordinary shares are owned by Taro Research
Foundation, Inc., or the Research Foundation, a charitable foundation
controlled by Dr. Levitt and Aaron Levitt, and (8) 751,852 ordinary shares are
owned by the R and J Levitt Corporation, or the R&J Corporation, which is owned
50% by Dr. Levitt and members of his immediate family and 50% by Aaron Levitt
and members of his immediate family. In addition, Dr. Levitt is the beneficial
owner of all 2,600 of our outstanding founders shares, whose holders are
entitled to exercise one-third of the total voting power in our company
regardless of the number of ordinary shares then outstanding.
(2) Of the ordinary shares beneficially owned by Aaron Levitt, (1) 22,600
ordinary shares are individually owned by Mr. Levitt, (2) 175,412 ordinary
shares are owned by Mr. Levitt and his wife as joint tenants, (3) 17,600
ordinary shares, which are not currently outstanding, are subject to incentive
options granted to Mr. Levitt that are presently exercisable, (4) 5,275 are
owned by his wife, (5) 65,440 ordinary shares are owned by the Research
Foundation, which is controlled by Mr. Levitt and Dr. Levitt, and (6) 751,852
ordinary shares are owned by the R&J Corporation, which is owned 50% by Mr.
Levitt and members of his immediate family and 50% by Dr. Levitt and members of
his immediate family.
(3) Of the ordinary shares owned by Dr. Moros, (1) 353,217 ordinary shares
are owned individually by Dr. Moros, (2) 229,960 ordinary shares are held by
Dr. Moros as co-trustee of the Nathan Moros Trust, (3) 337,074 ordinary shares
are held by Dr. Moros as trustee for trusts established by Isabel Moros, and
(4) 17,600 ordinary shares, which are not currently outstanding, are subject to
incentive options granted to Dr. Moros that are presently exercisable. Each of
Dr. Moross two minor daughters owns 100 ordinary shares.
(4) As a result of the TDC Shareholders Agreement and the familial
relationship of Dr. Levitt and Aaron Levitt, Dr. Levitt and Aaron Levitt may be
deemed to share beneficial ownership of the ordinary shares owned by TDC by
virtue of their ownership in TDC.
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. Morley and
Company owns all of the 2,600 outstanding Founders shares. Holders of
Morleys class A shares are entitled to elect one director of Morley and
holders of Morleys class B shares are entitled to elect two directors of
Morley.
As the holder of all of Morleys class B Shares, Dr. Levitt may cause the
election of two of the three directors and, therefore, may be deemed to
control the voting and disposition of the Founders shares.
Voting Power
As of May 17, 2004, Dr. Levitt, Aaron Levitt, Dr. Moros, Tal Levitt and
members of their respective immediate families, in the aggregate, control 49.5%
of the voting power in our company by reason of their (i) direct ownership of
an aggregate of 14.2% of our ordinary shares, (ii) their majority ownership of
TDC, which owns 10.0% of our ordinary shares, and (iii) Dr. Levitts control of
Morley, which, through its ownership of the Founders shares, has one-third of
the voting power of our shares.
As of April 1, 2004, 29,010,977 of our ordinary shares were outstanding.
They were held of record by 363 persons.
B. RELATED PARTY TRANSACTIONS
Not applicable.
C. INTERESTS OF EXPERTS AND COUNSEL
Not applicable.
ITEM 8. FINANCIAL INFORMATION
A. CONSOLIDATED STATEMENTS AND OTHER FINANCIAL INFORMATION
The Financial Statements required by this item are found at the end of
this annual report, beginning on page F-1.
Other Financial Information
We manufacture products and chemicals in our facilities in Israel and
Canada. A substantial amount of these products and chemicals 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 4 Information on the
Company-Business Overview-Sales and Marketing.
Legal Proceedings
We are not currently a party to any material litigation. We are, from
time to time, a party to routine litigation incidental to our business, none of
which, individually or in the aggregate, is expected to have a material adverse
effect on our financial position. A claim for compensation in the approximate
amount of $550,000 was filed by a customer in a previous year. Based on a
legal opinion and our insurance coverage, we believe that the ultimate
resolution of this matter will not result in a material adverse effect on our
financial position.
As mentioned above in Item 5, section C, on November 14, 2003, Godecke
Aktiengesellschaft, Pfizer and Warner-Lambert, responding to our filing of an
abbreviated new drug application requesting approval for gabapentin capsules
prior to the expiration of certain listed patents, filed a complaint against us
and our U.S. subsidiary, Taro Pharmaceuticals U.S.A., Inc. in the district
court in New Jersey alleging that under the provisions of the Hatch-Waxman Act
that Taros ANDA infringed certain Warner-Lambert patents.
We confirm that a private legal action involving Taro Development
Corporation and R&J Levitt Corporation is currently pending. Both corporations
are shareholders in our company, but neither our company nor any of our
subsidiaries is a party to the litigation or underlying dispute. Thus, neither
the litigation nor the dispute is expected to have any material effect on our
company or any of our subsidiaries.
Dividend Policy
We may declare a dividend in U.S. dollars out of our retained earnings.
Under the most restrictive debt covenants, any dividend distribution and any
cash dividend distribution requires prior approval of certain banks.
We have never paid cash dividends on either our ordinary shares or the
Founders shares and we do not anticipate paying any 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.
The following table sets forth the high and low closing sale prices of our
ordinary shares as quoted on the Nasdaq National Market during the last five
years:
High
Low
1999
$
9.50
$
2.44
2000
$
17.47
$
3.66
2001
$
48.50
$
13.44
2002
$
39.26
$
21.60
2003
$
72.11
$
30.14
The following table sets forth the high and low closing sale prices of our
ordinary shares as quoted on the Nasdaq National Market during each fiscal
quarter of the last two years and any subsequent period:
High
Low
First Quarter 2002
$
38.34
$
28.35
Second Quarter 2002
$
30.46
$
21.60
Third Quarter 2002
$
34.90
$
22.56
Fourth Quarter 2002
$
39.26
$
32.13
First Quarter 2003
$
38.92
$
30.14
Second Quarter 2003
$
57.77
$
39.43
Third Quarter 2003
$
58.71
$
48.85
Fourth Quarter 2003
$
72.11
$
57.34
First Quarter 2004
$
66.53
$
57.40
The following table sets forth the high and low closing sale prices of our
ordinary shares as quoted on the Nasdaq National Market during the last six
months:
Our ordinary shares have been traded in the over-the-counter market in the
United States since 1961. Our ordinary shares have been quoted on the Nasdaq
National Market since 1993 under the symbol TARO. In May 2001, the Chicago
Option Exchange started to quote options on our ordinary shares under the
symbol QTT. There is no non-United States trading market for our ordinary
shares.
D. SELLING SHAREHOLDERS
Not applicable.
E. DILUTION
Not applicable.
F. EXPENSES OF THE ISSUE
Not applicable.
ITEM 10. ADDITIONAL INFORMATION
A. SHARE CAPITAL
Not applicable.
B. MEMORANDUM AND ARTICLES OF ASSOCIATION
Our registration number at the Israeli Registrar of Companies is
52-002290-6.
Objects and Purposes
Our Memorandum of Association provides that our main objects and purposes
include any business connected with the developing, manufacturing, processing,
supplying, marketing and distributing of prescription, over-the-counter medical
and other health care products. These products include active pharmaceutical
ingredients and final dosage form products.
In February 2000, the Companys Ordinance (New Version 1983) was
replaced with the Companies Law. Since our Articles were approved before the
enactment of the Companies Law, they are not always consistent with the
provisions of the new law. In all instances in which the Companies Law changes
or amends provisions in the Companies Ordinance, and as a result our Articles
are not consistent with the Companies Law, the provisions of the Companies Law
apply unless specifically stated otherwise in the Companies Law. Similarly, in
all places where our Articles refer to a section of the Companies Ordinance
that has been replaced by the Companies Law, the Articles are understood to
refer to the relevant section of the Companies Law.
Approval of Specified Related Party Transactions Under Israeli Law
The Companies Law imposes fiduciary duties that office holders owe to a
company. An office holders 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 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 his approval or performed by him by virtue of his position and all
other important information pertaining to these actions.
The duty of loyalty generally requires an office holder to act in good
faith and for the good of the company. Specifically, an office holder must
avoid any conflict of interest between the office holders position in a
company and his or her other positions or personal affairs. In addition, an
office holder must avoid competing against the company or exploiting any
business opportunity of a company to receive a personal gain for himself or
others. An office holder must also disclose to a company any information or
documents relating to that companys affairs that the office holder has
received due to his or her position in a company.
Under the Companies Law, all arrangements as to compensation of public
companies directors require the approval of the audit committee, the board of
directors and shareholder approval, in that order.
Disclosure of Personal Interest of an Office Holder
The Companies Law requires that an office holder promptly disclose to the
company any personal interest that he or she may have, and all related material
information known to him or her, in connection with any existing or proposed
transaction by the company. A personal interest of an office holder includes
an interest of a company in which the office holder is, directly or indirectly,
a 5% or greater shareholder, holder of 5% or more of the voting power, director
or general manager or in which he or she has the right to appoint at least one
director or the general manager. In the case of an extraordinary transaction,
the office holders duty to disclose applies also to a personal interest of the
office holders spouse, siblings, parents, grandparents, descendants, spouses
descendants and the spouses of any of these people. An extraordinary
transaction is a transaction executed 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 the companys profitability, assets or liabilities.
Under the Companies Law, once the office holder complies 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 companys articles of association
provide otherwise. A transaction that is adverse to the companys interest may
not be approved. If the transaction is an extraordinary transaction, then it
also must be approved by the companys audit committee and board of directors,
and, under certain circumstances, by the shareholders of the company, in that
order.
A director who has a personal interest in a matter that is considered at a
meeting of the board of directors or the audit committee may not be present at
this meeting or vote on this
matter, unless a majority of the members of the board of directors or the
audit committee, as the case may be, has a personal interest in the matter. If
a majority of members of the board of directors have a personal interest
therein, shareholder approval is also required.
Disclosure of Personal Interests of a Controlling Shareholder
Under the Companies Law, the disclosure requirements that apply to an
office holder also apply to a controlling shareholder of a public company. A
controlling shareholder is a shareholder who has the ability to direct the
activities of a company, including a shareholder that owns 25% or more of the
voting rights if no other shareholder owns more than 50% of the voting rights,
but excluding a shareholder whose power derives solely from his or her position
on the board of directors or any other position with the company.
Extraordinary transactions with a controlling shareholder or in which a
controlling shareholder has a personal interest, and the engagement of a
controlling shareholder 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 shareholder approval must be by a majority of the
shares voted on the matter, provided that either:
such majority includes at least one-third of the shares of shareholders who
have no personal interest in the transaction and who vote on the matter vote in
favor thereof; or
the shareholders who have no personal interest in the transaction who vote
against the transaction do not represent more than one percent of the voting
rights in the company.
Shareholders generally have the right to examine documents in the
companys possession pertaining to any matter that requires shareholder
approval.
Voting, Rights Attached to Shares, Shareholders Meetings and Resolutions
Under the Companies Law, we are required to hold an annual meeting of
shareholders at least once every calendar year and not more than fifteen months
after the previous annual meeting. In addition, special meetings may be
conducted as required by certain events and circumstances.
Our share capital is divided into Founders shares and ordinary shares.
Holders of paid-up ordinary shares 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. In
addition, ordinary shares entitle their holders to two-thirds of the voting
power of our company. The Founders shares entitle their holders to one-third
of the voting power of our company.
Dividends on our ordinary shares may be paid only out of profits and other
surplus, as defined in the Companies Law, as of the end of the most recent
fiscal year or as accrued over a period of two years, whichever is higher. Our
board of directors is authorized to declare interim dividends, whereas our
shareholders are authorized to declare final dividends in accordance with our
board of directors recommendation, provided that there is no reasonable
concern that the dividend will prevent us from satisfying our existing and
foreseeable obligations as they become due.
Under the 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 shares 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 shares 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 said rights. 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 shares 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. At such reconvened meeting the required quorum
consists of any two members present in person or by proxy.
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 U.S. persons from
seeking to acquire, or from accumulating, 15% or more of our ordinary shares
(which, due to the voting power of the founders shares, would represent 10% or
more of the voting power of our company.)
Duties of Shareholders
Under the Companies Law, each and every shareholder has a duty to act in
good faith and in an acceptable manner in exercising his or her rights and
fulfilling his or her obligations towards us and other shareholders and to
refrain from abusing his power, such as in voting in the general meeting of
shareholders on the following matters:
any amendment to the articles of association;
an increase of our authorized share capital;
a merger; or
approval of certain actions and transactions that require shareholder approval.
In addition, each and every shareholder has the general duty to refrain
from depriving other shareholders of their rights.
Furthermore, any controlling shareholder, any shareholder who knows that
it 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 is under a duty to act in fairness
towards us. The Companies Law does not describe the substance of this duty of
fairness. These various shareholder duties may restrict the ability of a
shareholder to act in what the shareholder perceives to be its own best
interests.
Mergers and Acquisitions under Israeli Law
The Companies Law includes provisions that allow a merger transaction and
requires that each company that is a party to a merger have the transaction
approved by its board of directors and a vote of the majority of the voting
power of its shares at a shareholders meeting called on at least 21 days
prior notice. For purposes of the shareholder vote, unless a court rules
otherwise, the merger will not be deemed approved if a majority of the voting
power held by parties other than the other party to the merger, or by any
person who holds 25% or more of the shares or the right to appoint 25% or more
of the directors of the other party, vote against the merger. 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 70 days have passed from the time that a proposal
of the merger has been filed with the Israeli Registrar of Companies.
The Companies Law also provides that an acquisition of shares of a public
company must be made by means of a tender offer if as a result of the
acquisition the purchaser would become a 25% shareholder of the company and
there is no existing 25% or greater shareholder in the company. If there is no
existing 50% or greater shareholder in the company, the Companies Law provides
that an acquisition of shares of a public company must be made by means of a
tender offer if as a result of the acquisition the purchaser would become a 45%
shareholder of the Company. This rule does not apply if someone else is
already a majority shareholder in the company. If following any acquisition of
shares, the acquirer will hold 90% or more of the companys shares, the
acquisition may not be made other than through a tender offer to acquire all of
the shares of such class. If more than 95% of the outstanding shares are
tendered in the tender offer, all the shares that the acquirer offered to
purchase will be transferred to it. However, the remaining minority
shareholders may seek to alter the consideration by court order. Recent
promulgated regulations provide an exemption to the above tender offer
requirement, in the event that the acquisition of the control of the company,
in any degree, is subject to limitations of applicable non-Israeli law.
Finally, Israeli tax law treats stock-for-stock acquisitions between an
Israeli company and a foreign company less favorably than does U.S. tax law.
For example, unless the stock-for stock transaction is considered a
tax-deferred merger, Israeli tax law subjects a shareholder who exchanges his
ordinary shares for shares in another corporation to taxation on half the
shareholders shares two years following the exchange and on the balance four
years thereafter even if the shareholder has not yet sold the new shares.
Subject to the provisions of the Companies Law, our Articles of
Association provide that we may enter into an insurance contract that would
provide coverage for any monetary liability incurred by any of our office holders with respect to an act
performed in the capacity of an office holder for:
a breach of the office holders duty of care to us or to another person;
a breach of the office holders duty of loyalty to us, provided that the office
holder acted in good faith and had reasonable cause to assume that his or her
act would not harm us; 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 Companies Law, our Articles of
Association provide that we shall indemnify any of our office holders against
the following obligations and expenses imposed on the office holder with
respect to an act performed in the capacity of an office holder:
a financial obligation imposed on him or her in favor of another person by a
court judgment, including a compromise judgment or an arbitrators award
approved by the court; 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.
Limitations on Exculpation, Insurance and Indemnification
The Companies Law provides that a company may not exculpate or indemnify
an office holder, or enter into an insurance contract that would provide
coverage for any monetary liability