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