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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K
(Mark One)
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT
OF 1934
For the fiscal year ended June 30, 2000 or
[ ] 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 1-9860
BARR LABORATORIES, INC.
(Exact name of Registrant as specified in its charter)
NEW YORK 22-1927534
(State or Other Jurisdiction of (I.R.S. - Employer
Incorporation or Organization) Identification No.)
TWO QUAKER ROAD, P. O. BOX 2900, POMONA, NEW YORK 10970-0519
(Address of principal executive offices)
914-362-1100
(Registrant's telephone number)
Securities registered pursuant to Section 12(b) of Name of each exchange on
the Act: which registered:
Title of each class
Common Stock, Par Value $0.01 New York Stock Exchange
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
Yes X No
--- ---
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405
of Regulation S-K is not contained herein, and will not be contained, to the
best of Registrant's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K. [X]
The aggregate market value of the voting stock of the Registrant held by
nonaffiliates was approximately $870,972,748 as of June 30, 2000 (assuming
solely for purposes of this calculation that all Directors and Officers of the
Registrant are "affiliates").
Number of shares of Common Stock, Par Value $.01, outstanding as of June 30,
2000: 34,827,937
DOCUMENTS INCORPORATED BY REFERENCE
PORTIONS OF THE REGISTRANT'S 2000 ANNUAL REPORT TO SHAREHOLDERS ARE INCORPORATED
BY REFERENCE IN PART II AND PART IV HEREOF.
PORTIONS OF THE REGISTRANT'S 2000 PROXY STATEMENT ARE INCORPORATED BY REFERENCE
IN PART III HEREOF.
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PART I
ITEM 1. BUSINESS
Barr Laboratories, Inc. ("Barr" or the "Company") is an established specialty
pharmaceutical company engaged in the development, manufacture and marketing of
generic and proprietary prescription pharmaceuticals.
SAFE HARBOR STATEMENT
To the extent that any statements made in this report contain information that
is not historical, these statements are essentially forward-looking. These
statements are subject to risks and uncertainties that cannot be predicted or
quantified and, consequently, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such risks and
uncertainties include: the timing and outcome of legal proceedings; the
difficulty of predicting the timing of U.S. Food and Drug Administration ("FDA")
approvals; the difficulty in predicting the timing and outcome of FDA decisions
on patent challenges; market and customer acceptance and demand for new
pharmaceutical products; ability to market proprietary products; the impact of
competitive products and pricing; timing and success of product development and
launch; availability of raw materials; the regulatory environment; fluctuations
in operating results; and, other risks detailed from time-to-time in the
Company's filings with the Securities and Exchange Commission.
The Company wishes to caution each reader of this report to consider carefully
these factors as well as specific factors that may be discussed with each
forward-looking statement in this report or disclosed in the Company's filings
with the SEC as such factors, in some cases, could affect the ability of the
Company to implement its business strategy and may cause actual results to
differ materially from those contemplated by the statements expressed herein.
OVERVIEW
Barr was founded in 1970 and commenced active business in 1972 as a manufacturer
of generic drug products. Barr is listed on the New York Stock Exchange
(NYSE-BRL). The Company currently markets approximately 80 pharmaceutical
products, representing various dosage strengths and product forms of
approximately 30 chemical entities. The Company's product line is principally
focused on the development and marketing of generic and proprietary products in
the oncology, female healthcare (including hormone replacement and oral
contraceptives) and cardiovascular therapeutic categories. In addition, the
Company also maintains active development and marketing efforts in a second tier
of therapeutic categories including anti-infectives, pain management and
psychotherapeutic agents.
The Company's business strategy has three core components: (i) developing and
marketing generic pharmaceuticals that have one or more barriers to entry, (ii)
developing the generic version and then challenging patents protecting select
brand pharmaceuticals where the Company believes that such patents are either
invalid, unenforceable or not infringed by the Company's product, and (iii)
developing and marketing proprietary pharmaceuticals.
Generic Products
The majority of the Company's currently marketed products represent generic
forms of brand pharmaceutical products. These products are part of an industry
with annual sales of approximately
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$10 billion. The Company attempts to limit its pursuit of products where it
expects that a significant number of its competitors will successfully develop a
generic product. Instead, the Company principally pursues the development and
marketing of generic pharmaceuticals that have one or more barriers to entry.
The Company believes products with such barriers will face limited competition
and, therefore, provide longer product life cycles and/or higher profitability
than commodity generic products.
Among the Company's key generic products are:
ONCOLOGY: Tamoxifen Citrate, Hydroxyurea, Methotrexate, Megestrol
Acetate
CARDIOVASCULAR: Warfarin Sodium, Dipyridamole
FEMALE HEALTH CARE: Medroxyprogesterone Acetate, Danazol, Estradiol,
Estropipate
OTHER: Naltrexone, Meperidine, Oxy-APAP, Diazepam, Trazodone
The Company's largest selling product is Tamoxifen Citrate ("Tamoxifen"), the
generic version of Nolvadex(R). The Company distributes Tamoxifen under a
distribution agreement with the innovator. Tamoxifen is used to treat advanced
breast cancer, impede the recurrence of tumors following surgery, and in October
1998, was approved by the FDA to reduce the incidence of breast cancer in women
at high risk for developing this disease. In calendar 1999, Tamoxifen had
combined brand and generic sales in the U.S. of approximately $370 million.
Tamoxifen accounted for approximately 68%, 66% and 68% of the Company's product
sales during fiscal 2000, 1999 and 1998, respectively.
Warfarin Sodium is the generic equivalent of DuPont Pharmaceuticals Company's
("DuPont") Coumadin(R), an anti-coagulant. In calendar 1999, Warfarin Sodium had
combined brand and generic sales in the U.S. of approximately $535 million.
Since launch in July 1997, nearly 11 million prescriptions for Barr's generic
product have been dispensed. At the end of fiscal 2000, Barr's generic product
had captured approximately 27% of all prescriptions written for the product,
including nearly 80% of those filled with generic versions. Warfarin Sodium
accounted for approximately 14%, 15% and 11% of the Company's product sales
during fiscal 2000, 1999 and 1998, respectively.
Patent Challenges
The second part of Barr's generic product strategy is its patent challenge
strategy. As part of this strategy, the Company identifies patent-protected
brand products where it believes the patents are either invalid or will not be
infringed by the Company's product. Then, the Company either alone or with
selected partners, undertakes the development and filing with the FDA of its
generic version of the product, and engages in the litigation necessary to
resolve the patent issues.
Patent challenges are a complex, costly and lengthy process that can take 3-6
years to complete and require an investment of $8-10 million per challenge. As a
result, the Company has in the past and may elect in the future to have partners
on select patent challenges. These agreements typically provide for a sharing of
the costs and risks, and generally provide for a sharing of the benefits of a
successful outcome.
As of the close of fiscal 2000, the Company has engaged in six patent
challenges, three of which have been resolved and three are currently pending.
In 1993, as a result of a settlement of a patent challenge against the innovator
of Tamoxifen, Barr entered into a non-exclusive supply and distribution
agreement. As a result of this agreement, breast cancer patients have had access
to Barr's more affordable version of Tamoxifen nine years earlier
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than they might otherwise have. The Company also has a tentatively approved
Abbreviated New Drug Application ("ANDA") to manufacture Tamoxifen. At the time
of patent expiration in August 2002 (or should another company's patent
challenge succeed), Barr will be permitted to begin the direct manufacture of
Tamoxifen.
In January 1997, Barr and Bayer AG ("Bayer") settled the pending litigation
regarding Bayer's patents protecting Cipro(R) ("Ciprofloxacin"). Under terms of
the settlement, Barr and a partner in the case received a one-time payment and
entered into a contingent, non-exclusive supply agreement. Under this agreement,
Bayer has the option to make payments to Barr and its partner or to provide Barr
and its partner with quantities of Ciprofloxacin to market pursuant to a license
from Bayer. Also as part of the settlement, Barr and its partner have the
unconditional right to begin selling Ciprofloxacin no later than six months
prior to the expiration of the patent. As a result of this agreement, the
Company believes that consumers will receive a substantial benefit by having
access to a more affordable generic product in advance of the date when the
product would otherwise have been available for competition.
On August 9, 2000, the U.S. Court of Appeals, Federal Circuit in Washington,
D.C. ruled in favor of Barr's challenge of the patents protecting Eli Lilly's
Prozac(R) ("Fluoxetine"). The Court unanimously upheld Barr's "double-patenting"
claims and struck down the patent that would have protected Prozac from generic
competition until after December 2003. The ruling, when final, is expected to
permit Barr and its partners to introduce a more affordable generic Prozac
product in late fiscal 2001 or early fiscal 2002, pending FDA consideration of
issues related to exclusivity for use with pediatric patients. As the first to
file a Paragraph IV Certification that successfully challenged a listed patent,
the Company believes it is entitled to the 180-day exclusivity granted under the
Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman
Act") and intends, if necessary, to vigorously defend its rights. However, there
can be no assurances that the Company's position on the implementation of the
FDA's exclusivity rules will prevail. If the Company does not enjoy the full
exclusivity period it expects, the value of the favorable ruling could be
substantially diminished.
The Company is currently challenging the patents protecting Ortho-McNeil
Pharmaceutical Corporation's ("Ortho") Ortho-Novum 7/7/7(R) oral contraceptive
and Ortho's Ortho Tri-Cyclen(R) oral contraceptive. The Company continues to
invest heavily in research and development and the legal costs necessary to
identify future patent challenge opportunities.
In August 1999, the FDA published a proposed 180-Day Generic Drug Exclusivity
rule. This proposed rule is designed to clarify the FDA's interpretation of the
180-day generic drug exclusivity provision of the Hatch-Waxman Act, in response
to numerous court challenges and citizens petitions. The Company, as well as
other members of the generic industry, have submitted comments on the proposed
rule. While still reviewing the comments related to the proposed rule, the FDA
issued industry Guidance in March 2000. The Agency's implementation of the final
regulations and the Guidance may be delayed for a significant period and will
likely be the subject of additional court challenges and citizens petitions. As
such, it is impossible for the Company to provide a general conclusion as to the
effect the proposed rule and the Guidance would have on the exclusivity status
of its patent cases, but rather, believes that the exclusivity status for all
patent cases, past and future, must be evaluated on a case by case basis.
The patent challenge process is a fundamental component of the Hatch-Waxman Act
that is designed to encourage generic companies to develop versions of brand
products and challenge suspect patents years ahead of patent expiry. The Company
believes that its successful challenges provide more affordable medicine for
consumers who otherwise would have paid higher brand prices for these
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products through patent expiry. During 1999, the U.S. Department of Justice
("DOJ") and the Federal Trade Commission ("FTC") began an examination of the
settlement of several patent challenges in the industry, including Barr's
Tamoxifen and Ciprofloxacin challenges (See Item 3, Legal Proceedings). The
Company believes the patent challenge provisions under the Hatch-Waxman Act
provide a significant consumer benefit by allowing the introduction of more
affordable generic products earlier than might otherwise be possible. Further,
the Company believes that as the consumer benefits of this process become more
apparent to the DOJ and FTC, any concerns will be resolved.
Proprietary Products
The third component of Barr's business strategy is developing and marketing
proprietary products. On August 1, 2000, Barr assumed responsibility for
marketing and distribution of DuPont's VIASPAN(R) Belzer UW, Organ Storage
Solution product in the U.S. and Canada. Marketing this product gives Barr
immediate access to the brand pharmaceutical marketing arena, adding skills that
will be transferable to marketing our future proprietary products.
Introduced in the late 1980s, VIASPAN is a cold storage solution that can be
used to preserve intra-abdominal organs, including the kidneys, liver and
pancreas prior to transplantation. VIASPAN, which had revenues in calendar 1999
of approximately $14 million, is the most widely used organ transplant solution
in the United States.
Barr/DuPont Pharmaceuticals Company Strategic Alliance
In March 2000, the Company signed definitive agreements to establish a strategic
relationship with DuPont to develop, market and promote several proprietary
products and to terminate all litigation between the two companies. In the first
agreement, DuPont may invest up to $45 million over three years to support the
ongoing development of three proprietary products: CyPat(TM) prostate cancer
therapy; SEASONALE(TM) oral contraceptive; and a third product which has not yet
been disclosed. Upon approval of these products Barr will be responsible for
marketing the products, although Barr may elect to allow DuPont to play a role
in product promotion, and DuPont may receive royalties based on product sales.
In the second agreement, DuPont will assume sales and marketing support for an
undisclosed proprietary product developed internally by Barr. This product is
expected to be launched during the second half of fiscal 2001.
Under the terms of the third agreement, Barr becomes the sole distributor in the
U.S. and Canada of DuPont's VIASPAN organ transplant preservation agent.
Under the fourth agreement, DuPont was granted warrants to purchase 1.5 million
shares of Barr's common stock: 750,000 shares at $31.33 per share and 750,000
shares at $38.00 per share. The warrants are immediately exercisable and
terminate in four years.
PRODUCT DEVELOPMENT
The Company's product development efforts are focused in two principal product
areas: unique generic products and a portfolio of proprietary products.
During fiscal 2000, the Company filed 15 applications with the FDA and as of
June 30, 2000 had 17
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ANDAs pending. Of the 15 applications filed during fiscal 2000, three ANDAs
represent products where Barr is challenging the patents protecting the brand
version of the product, two are ANDAs which will support proprietary products
and two are Investigational New Drug ("IND") applications supporting proprietary
products.
The Company has historically developed generic products internally, although the
Company currently has one generic product in development with a third party. The
Company also continues to explore and evaluate other in-licensing opportunities
for generic as well as proprietary products.
For the fiscal years ended June 30, 2000, 1999 and 1998, total research and
development expenditures were approximately $40 million, $23 million and $19
million, respectively. The 79% increase in R&D investment during fiscal 2000
funded an enhanced commitment to both generic and proprietary product
development activities. The Company anticipates that research and development
expenditures will increase 20-25% during fiscal 2001, due to continued
investment in new generic drug development, continued progress on proprietary
product development, and clinical studies related to two IND applications.
Generic Product Development
The Company continues to focus generic drug development on unique products that
offer barriers to entry that limit competition, as well as products that
capitalize on the Company's expertise in formulation, development, manufacturing
and marketing.
The Company filed 11 generic product applications during fiscal 2000. Among the
applications pending or being prepared for filing are a line of oral
contraceptive products, as well as additional oncology, cardiovascular and other
therapies. The Company believes that it will file approximately 15-18 generic
product applications during fiscal 2001.
As part of Barr's commitment to bringing new female health care products to
American consumers, several of the pending ANDAs represent generic versions of
oral contraceptive products. Creating a franchise of oral contraceptive products
builds upon the Company's expertise in the area of developing and efficiently
manufacturing hormonal therapies. Of the total oral contraceptive market, valued
at approximately $1.8 billion a year, Barr has products in development that will
compete in nearly $1.5 billion of that total. The first generic oral
contraceptive product could enter the market in the first half of fiscal 2001.
Proprietary Development
The Company's proprietary product development strategy is focused on pursuing a
portfolio of products that will result in the introduction in the United States
of innovative dosage forms of existing chemical entities, commercialization of
therapies available outside of the U.S. market, as well as the development of
novel chemical entities that are not currently available. This strategy will
result in the introduction of products in the near-, mid- and long-term that
have varying periods of market exclusivity.
Barr is developing proprietary products under the IND development process, as
well as commercialization of proprietary medicines that result from ANDAs which
are normally associated with generic products.
Barr's decision to develop proprietary products was initiated in 1997, and the
Company currently has
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an active proprietary development portfolio in such therapeutic categories as
oncology, female health care, oral contraception, and anti-virals. Projects in
development are expected to compete in therapeutic categories that have total
current annual sales of approximately $4 billion. The Company is continually
evaluating new proprietary product candidates for inclusion in the pipeline.
INDs were filed with the FDA for two proprietary products during fiscal 2000:
the CyPat prostate cancer therapy and the SEASONALE oral contraceptive.
An IND describes where and by whom the clinical studies will be conducted, the
chemical structure of the compound and how it works in the body; any toxic
effects; and how the compound is manufactured. Phase III clinical studies for
both products will seek to confirm the effectiveness of the products and
identify any adverse reactions and will involve 1,000 or more patients in
clinics and hospitals.
Barr submitted its IND application with the FDA for its CyPat prostate cancer
therapy in July 1999. A tablet dosage form product, CyPat is indicated for the
treatment of hot flashes following the surgical or chemical castration that is
often used to treat prostate cancer. Of the more than 2.4 million patients in
the United States who have been diagnosed with prostate cancer, CyPat may prove
suitable for treating approximately 100,000 of those patients. The CyPat Phase
III clinical studies are expected to include approximately 1,000 patients at
more than 70 sites across the country. Pending success with the FDA, CyPat could
reach consumers as early as the end of fiscal 2003.
The Company submitted its IND for the SEASONALE oral contraceptive in May 2000.
Recruitment for the Phase III clinical study began in fiscal 2000. SEASONALE is
a patent-protected oral contraceptive product being developed through an
agreement with the Medical College of Hampton Roads, Eastern Virginia Medical
School (EVMS). Under the proposed SEASONALE regimen, women would take the
product for up to 84 consecutive days, and then would have a seven-day pill-free
interval. By contrast, the majority of oral contraceptive products currently
available in the United States are based on a regimen of 21 treatment days and
then seven pill-free days. The Company anticipates that 1,350 women at
approximately 50 sites across the country will be involved in the year-long
study. SEASONALE is an innovative oral contraceptive product designed to give
women the option of reducing the number of menses from 13 to 4 each year.
The Company also filed two ANDAs supporting near-term proprietary products. Both
products represent dosage-form changes of existing therapies, and are expected
to have some period of market exclusivity. The Company expects approval of the
first product during the first half of fiscal 2001, with approval of the second
product anticipated in the second half of fiscal 2001. Developed under the ANDA
approach, details of the products are being withheld until launch.
In early fiscal 2001, the Company announced that it was developing a vaccine
product to address Japanese encephalitis. Working in conjunction with a partner,
the Company anticipates that Phase III clinical studies to support approval of
the product will begin during fiscal 2001.
MARKETING AND CUSTOMERS
The Company markets its generic products to customers in the United States and
Puerto Rico through an integrated sales and marketing force that includes a five
person national sales force. The activities of the sales force are supplemented
by two customer service representatives who inform the Company's customers of
new products, process orders and advise of order status and current pricing. All
marketing activities are developed, implemented and coordinated by a product
marketing function
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consisting of three employees.
The Company's generic product customer base includes drug store chains, food
chains, mass merchandisers, wholesalers, distributors, managed care
organizations, mail order accounts, government/military and repackagers.
The Company's products are primarily sold under the Barr label.
The Company's generic business has approximately 140 direct purchasing customers
and 105 indirect customers that purchase the Company's products via wholesalers.
In fiscal 2000, 1999 and 1998, McKesson Drug Company, the nation's largest
wholesaler, accounted for approximately 16%, 14% and 12%, respectively, of
product sales. No other customer accounted for greater than 10% of product sales
in any of the last three fiscal years.
During the past three years the Company's customer base has undergone continued
consolidation, particularly in the chain drug store, food store, distributor and
wholesaler trade classes. In addition, customers continue to promote
single-source programs that limit the number of generic suppliers that provide
products to that customer. This continued consolidation and changes in customer
buying patterns have resulted in heightened competition among generic drug
marketers. Adding to these market pressures, managed care organizations have, in
some cases, limited the number of authorized vendors. In addition, mail-order
prescription services, which typically source product from a limited number of
suppliers, have continued to grow. While the Company believes that it has
excellent relationships with its key customers, there can be no assurance that
continued consolidation will not impact the Company's business, or that such
impact might not be significant.
Several of the Company's proprietary products are expected to require a sales
force to detail products directly to physicians and healthcare providers. During
fiscal 2001, Barr assumed responsibility for marketing the VIASPAN organ
transplant preservation agent in the U.S. and Canada, hiring an employee
dedicated to this direct marketing effort. In addition, DuPont is assuming
responsibility for marketing a proprietary product being developed by Barr that
could receive FDA approval in the second half of fiscal 2001. The Company is
also evaluating the marketing requirements for another near-term proprietary
product that could receive approval during the first half of fiscal 2001. The
Company continues to evaluate different options for implementing the sales and
marketing capabilities necessary to sell certain of its proprietary products.
Such options include partnerships, joint ventures or strategic acquisitions.
COMPETITION
The Company competes in varying degrees with numerous other manufacturers of
pharmaceutical products (both branded and generic). These competitors include
the generic divisions of proprietary pharmaceutical companies (either marketing
units or other generic manufacturers), large independent generic
manufacturers/distributors that seek to provide "one stop shopping" by offering
a full line of products, generic manufacturers that have targeted select
therapeutic categories and market niches, and proprietary pharmaceutical
companies whose patent protected therapies compete with both generic and
proprietary products marketed by the Company.
Many of the Company's competitors have greater financial and other resources,
and are therefore able to devote more resources than the Company in such areas
as marketing support and product development. In order to ensure its ability to
compete effectively, the Company has:
- focused its proprietary and generic product development in
areas of historical strength or
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competitive advantage;
- targeted generic products for development that offer
significant barriers to entry for competitors, including:
difficulty in sourcing raw materials; difficulty in
formulation or establishing bioequivalence; manufacturing that
requires unique facilities, processes or expertise; and
- invested in plant and equipment to give it a competitive edge
in manufacturing.
These factors, when combined with the Company's investment in new product
development and its focus on select therapeutic categories, provide the basis
for its belief that it will continue to remain a leading independent specialty
pharmaceutical company.
RAW MATERIALS
The active chemical raw materials, essential to the Company's business, are bulk
pharmaceutical chemicals, which are purchased from numerous manufacturers in the
U.S. and throughout the world. All purchases are made in United States dollars,
and while currency fluctuations do not have an immediate impact on prices the
Company pays, such fluctuations may, over time, have an effect on prices to the
Company. Certain products that have historically accounted for a significant
portion of Barr's revenues are currently available only from sole or limited
suppliers. Arrangements with foreign suppliers are subject to certain additional
risks, including the availability of governmental clearances, export duties,
political instability, currency fluctuations and restrictions on the transfer of
funds. Any inability to obtain raw materials on a timely basis, or any
significant price increases that cannot be passed on to customers, could have a
material adverse effect on the Company. Because prior FDA approval of raw
material suppliers is required, if raw materials from an approved supplier were
to become unavailable, the required FDA approval of a new supplier could cause a
significant delay in the manufacture of the drug product affected.
In addition, recent and pending regulatory actions may make it more difficult
for the Company and other generic pharmaceutical manufacturers to obtain
commitments from foreign suppliers prior to the expiration of patents on branded
products. The unavailability of such raw materials could also impede the Company
in its efforts to develop and obtain FDA approval to manufacture and market new
generic pharmaceutical products, including patent challenge candidates.
To date, the Company has not experienced any significant delays from lack of raw
material availability. However, there can be no assurance that significant
delays will not occur in the future.
EMPLOYEES
As of June 30, 2000, the Company had approximately 606 full-time employees
including 129 in research and development and 386 in production and quality
assurance/control. Approximately 85 are represented by a union that has a
collective bargaining agreement with the Company. The Company's current
collective bargaining agreement with its employees, who are represented by Local
2-149 of the Paper, Allied, Chemical and Energy (PACE) Union International,
expires on April 1, 2001.
GOVERNMENT REGULATION
All pharmaceutical manufacturers, including the Company, are subject to
extensive regulation by the federal government, principally by the FDA, and, to
a lesser extent, by the U.S. Drug Enforcement Administration ("DEA") and state
governments. The Federal Food, Drug and Cosmetic Act, the Controlled Substances
Act and other federal statutes and regulations govern or influence the testing,
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manufacturing, safety, labeling, storage, record keeping, approval, pricing,
advertising and promotion of the Company's products. Non-compliance with
applicable requirements can result in fines, recalls and seizure of products.
Under certain circumstances, the FDA also has the authority to revoke drug
approvals previously granted.
ANDA Process
FDA approval is required before a generic equivalent to a previously approved
drug or a new dosage form of an existing drug can be marketed. The Company
usually receives approval for such 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" indicates 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 are
substantially equivalent to the previously approved drug. An ANDA may be
submitted for a drug on the basis that it is the equivalent to a previously
approved drug or, in the case of a new dosage form, is suitable for use for the
indications specified.
NDA Process
FDA approval is required before any new drug can be marketed. A New Drug
Application ("NDA") is a filing submitted to the FDA to obtain approval of a
drug not eligible for an ANDA and must contain complete pre-clinical and
clinical safety and efficacy data or a right of reference to such data. Before
dosing a new drug in healthy human subjects or in patients, stringent government
requirements for pre-clinical data must be satisfied. The pre-clinical data must
provide an adequate basis for evaluating both the safety and the scientific
rationale for the initiation of clinical trials.
Clinical trials are typically conducted in three sequential phases, although the
phases may overlap. Data from pre-clinical testing and clinical trials are
submitted to the FDA as a NDA for marketing approval and to other health
authorities as a marketing authorization application. The process of completing
clinical trials for a new drug may take several years and requires the
expenditure of substantial resources. Preparing a NDA or marketing authorization
application involves considerable data collection, verification, analysis and
expense, and there can be no assurance that approval from the FDA or any other
health authority will be granted on a timely basis, if at all. The approval
process is affected by a number of factors, primarily the risks and benefits
demonstrated in clinical trials as well as the severity of the disease and the
availability of alternative treatments. The FDA or other health authorities may
deny a NDA or marketing authorization application if the regulatory criteria are
not satisfied, or such authorities may require additional testing or
information.
Even after initial FDA or other health authority approval has been obtained,
further studies may be required to provide additional data on safety and will be
required to gain approval for the use of a product as a treatment for clinical
indications other than those for which the product was initially tested.
Additionally, the FDA regulates post-approval promotional labeling and
advertising activities to assure that such activities are being conducted in
conformity with statutory and regulatory requirements.
cGMP Regulations
Among the requirements for drug approval by the FDA is that the Company's
manufacturing procedures and operations conform to current Good Manufacturing
Practices ("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
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regulations, the Company must continue to expend time, money and effort in the
areas of production and quality control to ensure full technical compliance.
If the FDA believes a company is not in compliance with cGMP, certain sanctions
are imposed upon that company including: (i) withholding from the company new
drug approvals as well as approvals for supplemental changes to existing
applications; (ii) preventing the company from receiving the necessary export
licenses to export its products; and (iii) classifying the company as an
"unacceptable supplier" and thereby disqualifying the company from selling
products to federal agencies. The Company believes it is currently in compliance
with cGMP.
In May of 1992, the Generic Drug Enforcement Act of 1992 (the "Act") was
enacted. The Act, a result of the 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 Act requires the
FDA to debar (i.e., not accept or review ANDAs for a period of time) 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 Act allows for civil penalties and withdrawal of previously
approved applications. Neither the Company nor any of its employees have ever
been subject to debarment.
DEA
Because the Company markets some and intends to introduce or reintroduce a wide
range of controlled substances in its analgesic and psychotherapeutic product
lines, it must meet the requirements of the Controlled Substances Act and the
regulations issued thereunder and administered by the DEA. These regulations
include stringent requirements for manufacturing controls and security to
prevent diversion of or unauthorized access to the drugs in each stage of the
production and distribution process. The DEA monitors allocation to the Company
of raw materials used in the production of controlled substances based on
historical sales data. The Company believes it is currently in compliance with
all applicable DEA requirements.
GOVERNMENT RELATIONS ACTIVITIES
As a record number of branded pharmaceutical products are scheduled to go off
patent over the next several years, the branded pharmaceutical industry has
increased efforts to utilize state and federal legislative and regulatory arenas
to delay generic competition, or limit the severe market erosion they can
experience once monopoly protection is lost for the branded product. Efforts to
achieve these goals include, but are not limited to, filing additional patents
in the Orangebook in an attempt to increase the period of patent protection for
products, directly petitioning the FDA to request amendments to FDA standards
through the Citizen Petition process, seeking changes in United States
Pharmacopeia standards and attempting to extend patents by attaching amendments
to important federal legislation. Federal legislation designed to extend the
patents an additional three years on several drugs, due to perceived delays in
the FDA approval process, has been introduced. State by state initiatives to
enact legislation opposing the substitution of equivalent generic drugs is an
additional anti-generic defense strategy.
Some companies have expressed interest over the last several years in reopening
the Hatch-Waxman Act and renegotiating some of the compromises reached between
the brand and generic pharmaceutical industries that resulted in the creation of
the modern generic pharmaceutical industry. Reopening the act could disturb the
delicate balance achieved in 1984 but may also offer the generic
11
<PAGE> 12
industry the opportunity to expand the Hatch-Waxman Act to include drug products
not currently covered under the Act.
Because a balanced and fair legislative and regulatory arena is critical to the
generic pharmaceutical industry, the Company has and will continue to put a
major emphasis in terms of management time and financial resources on government
affairs activities. During fiscal 2000, the Company opened an office and staffed
a full-time government affairs department in Washington, D.C., that assumed
responsibility for coordinating state and federal legislative activities and
coordination with generic industry trade associations.
MEDICAID/MEDICARE
In November 1990, a law regarding reimbursement for prescribed Medicaid drugs
was passed as part of the Congressional Omnibus Budget Reconciliation Act of
1990. This law basically required drug manufacturers to enter into a rebate
contract with the Federal Government. All generic pharmaceutical manufacturers,
whose products are covered by the Medicaid program, are required to rebate to
each state a percentage (currently 11% in the case of products manufactured by
the Company and 15% for Tamoxifen sold by the Company) of their average net
sales price for the products in question. The Company provides an accrual for
future estimated rebates in its consolidated financial statements.
Over the last year, the extension of prescription drug coverage to all Medicare
recipients has gained support in the Federal legislature. The generic
pharmaceutical industry trade associations are actively involved in discussions
regarding the structure and scope of any proposed Medicare prescription drug
benefit plans. The Company, as an active member in Generic Pharmaceutical
Association ("GPhA"), the leading trade association representing the generic
pharmaceutical industry, supports the development of an industry wide position
on Medicare.
The Company believes that federal and/or state governments may continue to enact
measures in the future aimed at reducing the costs of drugs to the public. The
Company cannot predict the nature of such measures or their impact on the
Company's profitability.
OTHER
The Company is also governed by federal, state and local laws of general
applicability, such as laws regulating intellectual property, including patents
and trademarks; working conditions; equal employment opportunity; and
environmental protection.
12
<PAGE> 13
ITEM 2. PROPERTIES
Barr has facilities and operations in Pomona and Blauvelt, New York; Northvale,
New Jersey; Forest, Virginia; and Washington, D.C. The following table presents
the facilities owned or leased by the Company and indicates the location and
type of each of these facilities.
<TABLE>
<CAPTION>
SQUARE
LOCATION FOOTAGE STATUS DESCRIPTION
-------- ------- ------ -----------
<S> <C> <C> <C>
NEW JERSEY
Northvale 27,500 Owned Manufacturing
NEW YORK
Blauvelt 48,000 Leased Corporate Administration
Pomona 1 34,000 Owned R&D, Laboratories, Manufacturing
Pomona 2 90,000 Owned Laboratories, Administrative Offices,
Manufacturing, Warehouse
VIRGINIA
Forest 165,500 Owned Administrative Offices, Manufacturing,
Warehouse, Packaging, Distribution
WASHINGTON, D.C. 1,800 Leased Corporate Administration
</TABLE>
Over the past three fiscal years, the Company has spent approximately $45
million in capital expenditures primarily to expand manufacturing capacity,
extend research and development activities and strengthen certain competitive
advantages.
ITEM 3. LEGAL PROCEEDINGS
PATENT CHALLENGES
In February 1996, Barr filed an ANDA seeking approval from the FDA to market
fluoxetine hydrochloride ("Fluoxetine"), the generic equivalent of Eli Lilly
Company's ("Lilly") Prozac. The Company notified Lilly pursuant to the
provisions of the Hatch-Waxman Act, and on April 19, 1996, Lilly filed a patent
infringement action in the United States District Court for the Southern
District of Indiana - Indianapolis Division seeking to prevent Barr from
marketing Fluoxetine until certain U.S. patents expire in 2003.
In rulings on pretrial motions on January 12, 1999, the U.S. District Court,
Southern District of Indiana, dismissed several of the claims that the Company
was to present at the trial. Prior to the trial beginning, Barr, two
co-defendants and Lilly reached an agreement pursuant to which Barr and Lilly
agreed to drop all the remaining claims in the litigation. In addition to
dropping their remaining claims, Lilly made a one-time payment of $4 million to
be shared between Barr and its co-defendants.
On August 9, 2000, the U.S. Court of Appeals, Federal Circuit in Washington D.C.
affirmed the decision of the lower court rejecting the Company's arguments with
respect to "best mode" claims against the patent expiring February 2001.
However, the court struck down the Lilly patent which was to have run until
December 2003 upon the Company's claim of "double patenting". Lilly is
13
<PAGE> 14
expected to seek a rehearing in the Appellate Court and a review by the Supreme
Court.
In October 1998, Barr filed an ANDA seeking approval from the FDA to market the
three different tablet combinations of norethindrone and ethinyl estradiol, the
generic equivalent of Ortho-McNeil Pharmaceutical Inc.'s ("Ortho") Ortho-Novum
7/7/7 oral contraceptive regimen. The Company notified Ortho pursuant to the
provisions of the Hatch-Waxman Act and on January 15, 1999, Ortho filed a patent
infringement action in the United States District Court for the District of New
Jersey - Trenton Division, seeking to prevent Barr from marketing the three
different tablet combinations of norethindrone and ethinyl estradiol until
certain U.S. patents expire in 2003. The case is currently in the discovery
stage.
In February 2000, Barr filed an ANDA seeking approval from the FDA to market
three different tablet combinations of norgestimate and ethinyl estradiol, the
generic equivalent of Ortho's Tri-Cyclen(R). The Company notified Ortho pursuant
to the provisions of the Hatch-Waxman Act and on June 9, 2000, Ortho filed a
patent infringement action in the United States District Court for the District
of New Jersey - Trenton Division, seeking to prevent Barr from marketing the
three different tablet combinations of norgestimate and ethinyl estradiol until
U.S. patents expire in 2003. The case is currently in the discovery stage.
CLASS ACTION LAWSUITS
On July 14, 2000, Louisiana Wholesale Drug Co. filed a class action complaint in
the United States District Court for the Southern District of New York against
Bayer Corporation, the Rugby Group and the Company. The complaint alleges that
the Company and the Rugby Group agreed with Bayer Corporation not to compete
with a generic version of Ciprofloxacin ("Cipro") pursuant to an agreement
between the defendants. The plaintiff purports to bring claims on behalf of all
direct purchasers of Cipro from 1997 to present. On August 1, 2000, Maria
Locurto filed a similar class action complaint in the United States District
Court for the Eastern Division of New York. On August 4, 2000, Ann Stuart et al
filed a class action complaint in the Superior Court of New Jersey, Law
Division, Camden County. This complaint alleges violations of New Jersey
statutes relating to the Cipro agreement.
The Company believes that its agreement with Bayer Corporation is a valid
settlement to a patent dispute and cannot form the basis of an antitrust claim.
Although it is not possible to forecast the outcome of these matters, the
Company intends to vigorously defend itself. It is anticipated that these
matters may take several years to be resolved but an adverse judgment could
have a material adverse impact on the Company's financial statements.
OTHER LEGAL MATTERS
In February 1998, Invamed, Inc., which has since been acquired by Geneva
Pharmaceuticals, Inc., a division of Novartis AG ("Invamed"), named the Company
and several others as defendants in a lawsuit filed in the United States
District Court for the Southern District of New York, charging that the Company
unlawfully blocked access to the raw material source for Warfarin Sodium. In May
1999, Apothecon, Inc., a division of Bristol-Meyers Squibb, Inc. ("Apothecon"),
filed a similar lawsuit. The two actions have been consolidated.
The Company believes that the suits filed against it by Invamed and Apothecon
are without merit and intends to defend its position vigorously. These actions
are currently in the discovery stage. It is anticipated that this matter may
take several years to be resolved but an adverse judgment could have
14
<PAGE> 15
a material adverse impact on the Company's consolidated financial statements.
In 1998 and 1999, the Company was contacted by the Department of Justice ("DOJ")
regarding the March 1993 settlement of the Tamoxifen patent litigation. Barr
continues to cooperate with the DOJ in this ongoing examination, and believes
that the DOJ will ultimately determine that the settlement was appropriate and a
benefit to consumers. The DOJ has not contacted the Company about this matter in
over a year.
On June 30, 1999, the Company received a civil investigative demand from the
Federal Trade Commission ("FTC") for interrogatories and a subpoena for
documents relating to the January 1997 settlement of the Hatch-Waxman Act patent
litigation relating to Ciprofloxacin which had been pending in the U.S. District
Court for the Southern District of New York. The FTC is investigating whether
the parties have engaged or are engaging in unfair methods of competition or
affecting commerce in violation of Section 5 of the Federal Trade Commission
Act.
The Company believes that the patent challenge process under the Hatch-Waxman
Act represents a pro-consumer and pro-competitive alternative to bringing
generic products to market more rapidly than might otherwise be possible. The
Company believes that once all the facts are considered, and the benefits to
consumers are assessed, that the DOJ and FTC investigations described above will
be resolved. However, consideration of these matters could take considerable
time, and while unlikely, any adverse judgment in either matter could have a
material adverse impact on the Company's consolidated financial statements.
As of June 30, 2000, the Company was involved, as plaintiff and defendant, in
other lawsuits incidental to its business. Management of the Company, based on
the advice of legal counsel, believes that the disposition of such litigation
will not have any significant adverse effect on the Company's consolidated
financial statements.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None.
15
<PAGE> 16
PART II
ITEM 5. MARKET FOR THE REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER
MATTERS
The information required by Item 5 is included on page 45 of the 2000 Annual
Report to Shareholders ("Annual Report") and is incorporated herein by
reference.
ITEM 6. SELECTED FINANCIAL DATA
The information required by Item 6 is included on page 48 of the Annual Report
and is incorporated herein by reference.
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
The information required by Item 7 is included on pages 25 through 28 of the
Annual Report and is incorporated herein by reference.
ITEM 7a. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The Company's exposure to market risk for a change in interest rates relates
primarily to the Company's investment portfolio of approximately $156 million
and debt instruments of approximately $30 million. The Company does not use
derivative financial instruments.
The Company's investment portfolio consists of cash and cash equivalents and
marketable securities classified as "available for sale." The primary objective
of the Company's investment activities is to preserve principal while at the
same time maximizing yields without significantly increasing risk. To achieve
this objective, the Company maintains its portfolio in a variety of high credit
quality securities, including U.S. government and corporate obligations,
certificates of deposit and money market funds. Approximately 99.9% of the
Company's portfolio matures in less than three months and the remaining .1%
matures in less than one year. The carrying value of the investment portfolio
approximates the market value at June 30, 2000. Because the Company's
investments are diversified and are of relatively short maturity, a hypothetical
10% change in interest rates would not have a material effect on the Company's
consolidated financial statements.
Approximately 90% of the Company's debt instruments at June 30, 2000, are
subject to fixed interest rates and principal payments. The related note
purchase agreements permit the Company to prepay these notes prior to their
scheduled maturity, but may require the Company to pay a prepayment fee based on
market rates at the time of prepayment and the note rates. The remaining 10% of
debt instruments are primarily subject to variable interest rates based on LIBOR
and have fixed principal payments. The fair value of all debt instruments is
approximately $30 million at June 30, 2000. Management does not believe that any
risk inherent in the variable-rate nature of these instruments is likely to have
a material effect on the Company's consolidated financial statements.
The Company's $20 million Unsecured Revolving Credit Facility ("Revolver") has
an interest rate based on the prime rate or LIBOR plus 0.75%, at the Company's
option. The Company currently maintains a zero balance on the Revolver. If the
Company were to draw down on the line prior to its expiration in December 2001,
and an unpredicted increase in both alternate rates occurred, it would not be
likely to have a material effect on the Company's consolidated financial
statements.
16
<PAGE> 17
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The information required by Item 8 is included on pages 29 through 47 of the
Annual Report and is incorporated herein by reference.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURES
None.
17
<PAGE> 18
PART III
ITEM 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANT
The Company's executive officers are as follows:
<TABLE>
<CAPTION>
NAME AGE POSITION
---- --- --------
<S> <C> <C>
Bruce L. Downey 52 Chairman of the Board and Chief Executive Officer
Paul M. Bisaro 39 President, Chief Operating Officer and Secretary
Timothy P. Catlett 45 Senior Vice President, Sales and Marketing
William T. McKee 39 Senior Vice President, Chief Financial Officer and Treasurer
Mary E. Petit 51 Senior Vice President, Proprietary Product Development
Martin Zeiger 63 Senior Vice President, Strategic Business Development and
General Counsel
Salah U. Ahmed 46 Vice President, Product Development
Ezzeldin A. Hamza 49 Vice President, Scientific Affairs
Catherine F. Higgins 48 Vice President, Human Resources
</TABLE>
BRUCE L. DOWNEY was elected Chairman of the Board and Chief Executive
Officer in February 1994. Prior to assuming these positions, from 1981 to 1993,
Mr. Downey was a partner in the law firm of Winston & Strawn and a predecessor
firm of Bishop, Cook, Purcell and Reynolds. Mr. Downey is also a director of
Warner Chilcott, plc.
PAUL M. BISARO was elected to the position of President and Chief
Operating Officer in December 1999. In September 1996, Mr. Bisaro was elected to
the position of Senior Vice President, Strategic Business Development. Mr.
Bisaro is the Secretary of the Company and in June 1998, was elected to the
Company's Board of Directors. Prior to September 1996, Mr. Bisaro held various
positions of increasing responsibility including General Counsel and Chief
Financial Officer. Prior to assuming these positions with the Company, he was
associated with the law firm of Winston & Strawn and a predecessor firm, Bishop,
Cook, Purcell and Reynolds.
TIMOTHY P. CATLETT was elected to Senior Vice President, Sales and
Marketing in September 1997. From February 1995 to August 1997, Mr. Catlett
served as Vice President, Sales and Marketing.
WILLIAM T. MCKEE was elected to the position of Senior Vice President,
Chief Financial Officer in December 1998. From December 1997 to November 1998,
Mr.
18
<PAGE> 19
McKee served as Vice President, Chief Financial Officer. From September 1996 to
November 1997, Mr. McKee served as Chief Financial Officer. Prior to this Mr.
McKee served as Director of Finance. Mr. McKee is the Treasurer of the Company
and is a C.P.A.
MARY E. PETIT was elected to the position of Senior Vice President,
Proprietary Product Development in December 1999. From September 1996 to
November 1999, Dr. Petit held the position of Senior Vice President, Operations.
Prior to this Dr. Petit held the position of Vice President, Quality.
MARTIN ZEIGER was employed by the Company in December 1999 as Senior
Vice President, Strategic Business Development and General Counsel. Mr. Zeiger
joined Barr from Hoechst Marion Roussel, where he served as a Vice President
since the 1995 acquisition by Hoechst of Marion Merrill Dow.
SALAH U. AHMED was elected Vice President, Product Development in
September 1996. Dr. Ahmed joined the Company as Director of Research and
Development in 1993.
EZZELDIN A. HAMZA was elected Vice President in 1993. Prior to this
position Mr. Hamza held positions of increasing responsibility including
Director of Quality Control, Director of Scientific Affairs and Vice President,
Technical Affairs.
CATHERINE F. HIGGINS was employed by the Company in January 1992 as
Vice President, Human Resources and was elected an officer in September 1992.
The Company's directors and executive officers are elected annually to serve
until the next annual meeting or until their successors have been elected and
qualified. The directors of the Company and their business experience are set
forth in the section headed "Information on Nominees" of the Company's Notice of
Annual Meeting of Shareholders, dated September 25, 2000 (the "Proxy Statement")
and are incorporated herein by reference.
ITEM 11. EXECUTIVE COMPENSATION
A description of the compensation of the Company's executive officers is set
forth in the sections headed "Executive Compensation", "Option Grants", "Option
Exercises and Option Values" and "Executive Agreements" of the Proxy Statement
and is incorporated herein by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
A description of the security ownership of certain beneficial owners and
management is set forth in the sections headed "Ownership of Securities" of the
Proxy Statement and is incorporated herein by reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
A description of certain relationships and related transactions is set forth in
the section headed "Certain Relationships and Related Transactions" of the Proxy
Statement and is incorporated herein by reference.
19
<PAGE> 20
PART IV
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES AND REPORTS ON FORM 8-K
(a) Financial Statement Schedules:
The consolidated balance sheets as of June 30, 2000 and 1999, and the
related consolidated statements of operations, shareholders' equity and
cash flows for each of the three years in the period ended June 30,
2000 and the related notes to the consolidated financial statements,
together with the Independent Auditors' Report, are incorporated herein
by reference. With the exception of the aforementioned information and
the information incorporated by reference in Items 5 through 8, the
Annual Report is not deemed filed as part of this report. The following
additional financial data should be read in conjunction with the
financial statements in the Annual Report. All other schedules are
omitted because they are not applicable or the required information is
shown in the consolidated financial statements or notes.
<TABLE>
<CAPTION>
Page
----
<S> <C>
Independent Auditors' Report 24
Schedule II - Valuation and Qualifying Accounts 25
</TABLE>
Exhibits
3.1 Composite Restated Certificate of Incorporation of the Registrant (2)
3.2 Amended and Restated By-Laws of the Registrant (2)
4.1 Loan and Security Agreement dated April 12, 1996 (9)
4.2 Amended and Restated Loan Agreement dated November 18, 1997 (9)
4.3 Note Purchase Agreements dated November 18, 1997 (1)
10.1 Stock Option Plan (3)
10.2 Savings and Retirement Plan (8)
10.6 Collective Bargaining Agreement, effective April 1, 1996 (12)
10.7 Agreement with Bruce L. Downey (4)
10.8 Agreement with Ezzeldin A. Hamza (4)
10.9 Distribution and Supply Agreement for Tamoxifen Citrate dated March 8,
1993 (4)
10.10 1993 Stock Incentive Plan (5)
10.11 1993 Employee Stock Purchase Plan (6)
20
<PAGE> 21
10.12 1993 Stock Option Plan for Non-Employee Directors (7)
10.13 Agreement with Edwin A. Cohen and Amendment thereto (8)
10.14 Distribution and Supply Agreement for Ciprofloxacin Hydrochloride dated
January 1997 (10)
10.15 Proprietary Drug Development and Marketing Agreement dated March 20,
2000 (portions of this exhibit have been omitted pursuant to a request
for confidential treatment) (13)
10.16 Description of Excess Savings and Retirement Plan
10.17 Agreement with Paul M. Bisaro
13.0 2000 Annual Report to Shareholders
21.0 Subsidiaries of the Company (11)
23.0 Consent of Deloitte & Touche LLP
27.0 Financial Data Schedule
----------
(1) Previously filed with the Securities and Exchange Commission as an
Exhibit to the Registrant's Quarterly Report on Form 10-Q for the
quarter ended December 31, 1997 and incorporated herein by reference.
(2) Previously filed with the Securities and Exchange Commission as an
Exhibit to the Registrant's Annual Report on Form 10-K for the year
ended June 30, 1999 and incorporated herein by reference.
(3) Previously filed with the Securities and Exchange Commission as an
Exhibit to the Registrant's Registration Statement on Form S-1 No.
33-13472 and incorporated herein by reference.
(4) Previously filed with the Securities and Exchange Commission as an
Exhibit to the Registrant's Annual Report on Form 10-K for the year
ended June 30, 1993 and incorporated herein by reference.
(5) Previously filed with the Securities and Exchange Commission as an
Exhibit to the Registrant's Registration Statement on Form S-8 Nos.
33-73696 and 333-17349 and incorporated herein by reference.
(6) Previously filed with the Securities and Exchange Commission as an
Exhibit to the Registrant's Registration Statement on Form S-8 No.
33-73700 and incorporated herein by reference.
21
<PAGE> 22
(7) Previously filed with the Securities and Exchange Commission as an
Exhibit to the Registrant's Registration Statement on Form S-8 Nos.
33-73698 and 333-17351 incorporated herein by reference.
(8) Previously filed with the Securities and Exchange Commission as an
Exhibit to the Registrant's Annual Report on Form 10-K for the year
ended June 30, 1995 and incorporated herein by reference.
(9) The Registrant agrees to furnish to the Securities and Exchange
Commission, upon request, a copy of any instrument defining the rights
of the holders of its long-term debt wherein the total amount of
securities authorized thereunder does not exceed 10% of the total
assets of the Registrant and its subsidiaries on a consolidated basis.
(10) Previously filed with the Securities and Exchange Commission as an
Exhibit to the Registrant's Quarterly Report on Form 10-Q for the
quarter ended March 31, 1997 and incorporated herein by reference.
(11) Previously filed with the Securities and Exchange Commission as an
Exhibit to the Registrant's Annual Report on Form 10-K for the year
ended June 30, 1988 and incorporated herein by reference.
(12) Previously filed with the Securities and Exchange Commission as an
Exhibit to the Registrant's Annual Report on Form 10-K for the year
ended June 30, 1996 and incorporated herein by reference.
(13) Previously filed with the Securities and Exchange Commission as an
Exhibit to the Registrant's Quarterly Report on Form 10-Q for the
quarter ended March 31, 2000 and incorporated herein by reference.
(b) Reports on Form 8-K
None.
22
<PAGE> 23
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities
Exchange Act of 1934, the Registrant has duly caused this report to be signed on
its behalf by the undersigned thereunto duly authorized.
BARR LABORATORIES, INC.
<TABLE>
<CAPTION>
Signature Title Date
--------- ----- ----
<S> <C> <C>
BY BRUCE L. DOWNEY Chairman of the Board & Chief August 9, 2000
---------------- Executive Officer
(Bruce L. Downey)
BY WILLIAM T. MCKEE Senior Vice President, Chief August 9, 2000
---------------- Financial Officer & Treasurer
(William T. McKee)
</TABLE>
Pursuant to the requirements of the Securities Exchange Act of 1934,
this report has been signed by the following persons on behalf of the Registrant
and in the capacities and on the dates indicated.
<TABLE>
<CAPTION>
Signature Title Date
--------- ----- ----
<S> <C> <C>
BRUCE L. DOWNEY Chairman of the Board August 9, 2000
---------------------
(Bruce L. Downey)
EDWIN A. COHEN Vice Chairman of the Board August 9, 2000
---------------------
(Edwin A. Cohen)
PAUL M. BISARO Director August 9, 2000
---------------------
(Paul M. Bisaro)
ROBERT J. BOLGER Director August 9, 2000
---------------------
(Robert J. Bolger)
MICHAEL F. FLORENCE Director August 9, 2000
---------------------
(Michael F. Florence)
JACOB M. KAY Director August 9, 2000
---------------------
(Jacob M. Kay)
BERNARD C. SHERMAN Director August 9, 2000
---------------------
(Bernard C. Sherman)
GEORGE P. STEPHAN Director August 9, 2000
---------------------
(George P. Stephan)
</TABLE>
23
<PAGE> 24
INDEPENDENT AUDITORS' REPORT
To the Board of Directors and Shareholders of
Barr Laboratories, Inc.:
We have audited the accompanying consolidated balance sheets of Barr
Laboratories, Inc. and subsidiaries (the "Company") as of June 30, 2000 and
1999, and the related consolidated statements of operations, shareholders'
equity, and cash flows for each of the three years in the period ended June 30,
2000. Our audits also included the financial statement schedule listed in the
Index at Item 14. These financial statements and financial statement schedule
are the responsibility of the Company's management. Our responsibility is to
express an opinion on the financial statements and financial statement schedule
based on our audits.
We conducted our audits in accordance with auditing standards generally accepted
in the United States of America. Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, such consolidated financial statements present fairly, in all
material respects, the financial position of Barr Laboratories, Inc. and
subsidiaries at June 30, 2000 and 1999, and the results of their operations and
their cash flows for each of the three years in the period ended June 30, 2000
in conformity with accounting principles generally accepted in the United States
of America. Also, in our opinion, such financial statement schedule, when
considered in relation to the basic consolidated financial statements taken as a
whole, presents fairly in all material respects the information set forth
therein.
DELOITTE & TOUCHE LLP
Parsippany, New Jersey
August 7, 2000
24
<PAGE> 25
SCHEDULE II
BARR LABORATORIES, INC.
VALUATION AND QUALIFYING ACCOUNTS
YEARS ENDED JUNE 30, 2000, 1999 AND 1998
(IN THOUSANDS OF DOLLARS)
<TABLE>
<CAPTION>
BALANCE AT ADDITIONS, RECOVERY
BEGINNING OF COSTS AND AGAINST DEDUCTIONS, BALANCE AT
YEAR EXPENSE WRITE-OFFS WRITE-OFFS END OF YEAR
-----------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C> <C>
Allowance for doubtful accounts:
Year ended June 30, 1998 $ 270 $ 180 $ 1 $ 189 $ 262
Year ended June 30, 1999 262 180 1 44 399
Year ended June 30, 2000 399 155 4 221 337
Reserve for returns and allowances:
Year ended June 30, 1998 1,350 5,003 - 3,877 2,476
Year ended June 30, 1999 2,476 7,640 - 7,845 2,271
Year ended June 30, 2000 2,271 9,895 - 8,363 3,803
Inventory reserves:
Year ended June 30, 1998 3,635 8,043 - 6,103 5,575
Year ended June 30, 1999 5,575 5,398 - 4,420 6,553
Year ended June 30, 2000 6,553 4,317 - 5,300 5,570
</TABLE>
25
