SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-K
Annual Report pursuant to Section 13 or 15(d)of the Securities Exchange Act
of 1934For the fiscal year ended March 31, 2000 Commission File No.
1-9114
MYLAN LABORATORIES INC. (Exact name of registrant as specified in its charter)
Pennsylvania 25-1211621
(State or other jurisdiction of incorporation or organization) (IRS Employer
Identification No.)
1030 Century Building
130 Seventh Street
Pittsburgh, Pennsylvania 15222
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: 412-232-0100
Securities registered pursuant to Section 12(b) of the Act:
Name of Each Exchange
Title of Each Class on Which Registered
------------------- ---------------------
Common Stock, par value $.50 per share New York Stock Exchange
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by checkmark 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 checkmark 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.[ ]
The aggregate market value of voting stock held by non-affiliates of
the registrant, computed by reference to the closing price of such stock as of
June 20, 2000:
$2,137,112,992
The number of shares of Common Stock of the registrant outstanding
as of June 20, 2000:
126,721,906
Documents incorporated by reference into this Report are:
Annual Report to Shareholders for year ended
March 31, 2000... Part I, Item 1
Part II, Items 5-8
Proxy Statement for 2000 Annual Meeting of
Shareholders... Part III, Items 10-13
PART I
Item 1. Business
Mylan Laboratories Inc., a Pennsylvania corporation incorporated in 1970,
and its subsidiaries (herein referred to collectively as "the Company") are
engaged in developing, licensing, manufacturing, marketing and distributing
generic and branded pharmaceutical products. References herein to fiscal 2000,
1999 and 1998 shall mean the fiscal years ended March 31, 2000, 1999 and 1998,
respectively.
The Company conducts business through its generic and branded
pharmaceutical operating segments. For fiscal 2000, the generic segment
represented approximately 85% of revenues and the branded segment represented
approximately 15% of revenues. The financial information for operating segments
required by Item 1 is hereby incorporated by reference to Note R of the Notes to
Consolidated Financial Statements in the accompanying Annual Report to
Shareholders for the year ended March 31, 2000.
Generic Segment
Through its subsidiaries, Mylan Pharmaceuticals Inc. and UDL Laboratories
Inc., acquired in fiscal 1996, the Company is recognized as a leader in the
generic pharmaceutical industry. Generic drugs are bioequivalent to their brand
name counterparts and are generally sold at prices significantly less than
branded products. Accordingly, generics provide a safe, effective and cost
efficient alternative to users of these branded products.
The Company attained its leadership position in the generic industry
through its ability to obtain Abbreviated New Drug Application ("ANDA")
approvals, uncompromising quality control and devotion to customer service. To
build on this position the Company has expanded beyond its traditional solid
oral dose products and now offers unit dose, suspensions, liquids, transdermal
and extended release products. The investment in research and development and
facilities to manufacture products in a variety of delivery systems is one of
the many reasons the Company is a leader in the generic industry.
The Company has entered into strategic alliances with several
pharmaceutical companies through distribution and licensing agreements which
provide the Company with additional products to broaden the Company's product
line. In addition, the Company has entered into product development and
licensing agreements, under which the Company has obtained rights to manufacture
and distribute other pharmaceutical products in exchange for funding of drug
development activities.
Due to the non-exclusive nature of generic products, the generic industry
is comprised of numerous competitors including manufacturers that market their
products under their own names, distributors that market products manufactured
by others, and brand name companies that market their products under both the
brand name and as a generic substitute. The non-exclusive nature thus allows for
significant price competition within the generic pharmaceutical industry.
Branded Segment
Pharmaceutical products initially sold on an exclusive basis are known in
the industry as proprietary or branded products. These products generally are
patent protected when introduced in the marketplace.
The Company operates its branded segment principally through its Bertek
Pharmaceutical Inc. ("Bertek") subsidiary. Bertek's three therapeutic areas of
concentration include cardiology, neurology and dermatology. The cardiology
focus is built upon Maxzide(R), Digitek(R) and Nitrek(R). The Maxzide(R)
products, originally developed and manufactured by the Company, were reacquired
from American Home Products Corp. in fiscal 1997.
The Company continues to expand its branded business through internally
developed products as well as through product acquisitions. To expand its
presence in dermatology, on October 2, 1998, the Company acquired 100% of the
outstanding stock of Penederm Inc. Bertek, through this acquisition, now
develops patented topical prescription products at its research and development
facilities in Foster City, California. The current product portfolio primarily
consists of Avita(R), Mentax(R), and Acticin(R).
New Product Approvals
The Company is required to secure and maintain the U.S. Food and Drug
Administration's ("FDA") approval for the products it intends to manufacture and
market. The FDA grants such approval by approving Company submitted ANDAs for
generic drug products and New Drug Applications ("NDAs") for branded drug
products.
During fiscal 2000, the Company received 20 final approvals: Verapamil
HCl ER Capsules, Estradiol Tablets, Prednisolone Syrup, Clozapine Tablets,
Diclofenac Potassium Tablets, Estropipate Tablets, Dicyclomine HCl Tablets,
Dicyclomine HCl Capsules, Carbidopa and Levodopa ER Tablets, Ticlopidine HCl
Tablets, Nitroglycerin Delivery System (0.1mg/hr, 0.2mg/hr, 0.4mg/hr, 0.6mg/hr),
Nifedipine ER Tablets, Ketoconazole Tablets, Hydrochlorothiazide Capsules,
Terazosin HCl Anhydrous Capsules, and Estradiol Transdermal System (0.05mg/day
and 0.1mg/day). Additionally, in fiscal 2000, the Company received two
supplements for additional strengths: Atenolol 25mg Tablets and Glyburide 6mg
Tablets.
Currently, the Company has before the FDA 25 ANDAs pending final
approval and seven Investigational New Drug ("IND") applications filed with the
FDA for new innovator compounds. An IND is the result of a successful
preclinical development program and becomes part of the final NDA.
Products
The information on the Company's product line set forth on pages8-12 of the
accompanying Annual Report to Shareholders for the year ended March 31, 2000, is
incorporated herein by reference. For fiscal 2000, sales of the Company's
antianxiety product group accounted for approximately 16% of net sales.
During fiscal 2000, 1999 and 1998, the Company expensed $49,121,000,
$61,843,000, and $46,278,000, for research and development. The Company's
research and development efforts are conducted primarily to qualify the Company
to manufacture ethical pharmaceuticals under FDA standards and approval.
Typically research expenses related to the development of innovative compounds
and the filing of NDAs are significantly higher than those associated with
ANDAs. As the Company continues to develop these products, research expenses
related to their development may increase.
Customers and Marketing
The Company sells its products to proprietary and ethical pharmaceutical
wholesalers and distributors, drug store chains, drug manufacturers and public
and governmental agencies. Four of the Company's customers accounted for
approximately 15%, 15%, 11%, and 10% of net sales in fiscal 2000. Three
customers accounted for approximately 15%, 14%, and 11% of net sales in fiscal
1999 and 13%, 12%, and 11% of net sales in fiscal 1998.
Generic pharmaceutical products are marketed directly to traditional drug
store chains, mass merchandising chains, and food and drug chains. In addition,
product is distributed through wholesalers and distributors servicing
non-warehousing chains, independent pharmacies, and institutional customers on a
contractual basis. Due to the buying patterns of certain customers, in
conjunction with incentive programs, a disproportionate amount of sales may be
recognized in the latter part of a period. Generic products involve limited
public promotion. Approximately 70 employees are engaged in selling and
servicing generic customers.
Branded pharmaceutical products are marketed directly to health care
professionals. Approximately 260 employees are engaged in marketing, selling and
servicing branded customers.
Competition
With respect to each of the generic products it sells, the Company believes
it is usually subject to active competition from numerous companies. The four
primary means of competition are service, product quality, FDA approval and
price. The competition experienced by the Company varies among the markets and
classes of customers. The Company has experienced additional competition from
brand-name competitors that have entered the generic pharmaceutical industry by
creating generic subsidiaries, purchasing generic companies or licensing their
products prior to or as their patents expire.
In addition to the increase in the number of competitors, the consolidation
of the Company's customers through mergers and acquisitions, along with the
emergence of large buying groups representing independent pharmacies and health
maintenance organizations, have contributed to severe price deterioration for
many of the Company's generic products. While the Company has increased unit
volume of its generic products through specialized marketing programs, this has
not fully offset the price declines the Company has experienced.
In response to the price declines for generic products, the Company
raised prices on 29 products beginning in fiscal 1998 and continuing through
fiscal 1999. While these price increases had a favorable impact on net earnings,
such impact, if any in the future, will be affected by many factors including
customer acceptance and the response by both existing and potential competitors
as well as by both existing and potential suppliers. The Company intends to
evaluate its pricing practices and make adjustments to the price of its products
when appropriate. The Company continues to work closely with its customers and
suppliers to ensure that its full line of generic products is available as a
cost effective alternative to the innovator products (See Part II, Item 7 of
this report for a discussion relating to the impact of the Company's pricing
policies).
In the branded segment, the Company faces competition from other branded
pharmaceutical companies that offer products which, while having different
properties, are intended to provide similar benefits to the consumers. These
competitors tend to have more products, a longer history in the industry,
additional marketing and sales representatives and significantly more financial
resources. Each of these factors or others could prevent the Company from
achieving profitable results in the branded industry.
Product Liability
Product liability suits by consumers represent a continuing risk to firms
in the pharmaceutical industry. The Company strives to minimize such risks by
adherence to stringent quality control procedures. Although the Company carries
insurance, it believes that no reasonable amount of insurance can fully protect
it against all such risks because of the potential liability inherent in the
business of producing pharmaceuticals for human consumption.
Raw Materials
The active chemical ingredients and other materials and supplies used in
the Company's pharmaceutical manufacturing operations are generally available
and purchased from many different foreign and domestic suppliers. However, in
some cases, the raw materials needed by the Company to manufacture
pharmaceutical products are available from a single FDA-approved supplier. Even
when more than one supplier exists, the Company may elect to list, and in some
cases has only listed, one supplier in its applications with the FDA. New
suppliers of the active ingredients in drugs must be approved by the FDA.
Accordingly, in the event of an interruption, any change in a supplier not
previously approved may take several months.
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 for raw materials 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.
Regulation
The Company's operations are subject to regulation under the Federal Food,
Drug and Cosmetic Act, pursuant to which government standards as to "good
manufacturing practice", product content, purity, labeling, effectiveness and
record keeping (among other things) must be observed. In this regard, the FDA
has extensive regulatory powers over the activities of pharmaceutical
manufacturers including the power to seize and prohibit the sale of noncomplying
products and to halt operations of noncomplying manufacturers.
In addition to the extensive regulation the Company faces under the Federal
Food, Drug and Cosmetic Act, other regulations have also affected the generic
approval process. In June 1995, the Uruguay Round Agreements Act ("URAA") took
effect which extended patent terms pursuant to the General Agreements on Tariffs
and Trade. The extension of patent terms has delayed the introduction of generic
products by the Company.
While URAA has already extended patent terms, the brand companies have
further delayed the approval of new generic products by filing patent
infringement suits under the Hatch-Waxman Act. The Company upon filing an ANDA
with the FDA must make one of five certifications with respect to innovator
patents. If the company certifies that its generic product is not infringing a
patent or that a patent is invalid, the patentee can file suit. Brand companies
use this certification process to prevent generic companies from introducing
competing generic products by bringing suit for alleged patent infringement.
Once a suit is filed, the FDA is prohibited from approving the ANDA for thirty
months or until the suit is litigated or settled.
Along with delaying the approval of generic products, the cost of
bringing a new generic product to market has risen substantially as the number
of these suits and the cost of defending them continues to increase. All such
suits settled to date have been on terms favorable to the Company. However,
until the laws are changed, the Company expects this type of suit will continue
since it has proven a very effective way for brand companies to delay generic
competition.
The Company is subject to inspection and regulation under other federal and
state legislation relating to drugs, narcotics and alcohol. Many of its
suppliers and customers, as well as the drug industry in general, are subject to
the same or similar governmental regulations. The Company also is subject to
various federal, state, and local environmental protection laws and regulations.
Compliance with current environmental protection laws and regulations has not
had a material effect on the earnings, cash flow or competitive position of the
Company.
It is impossible for the Company to predict the extent to which its
operations will be affected under the regulations discussed above or any new
regulations which may be adopted by regulatory agencies.
Employees
The Company employs approximately 2,300 persons, approximately 1,200 of
whom serve in clerical, sales and management capacities. The remaining are
engaged in production and maintenance activities.
The production and maintenance employees at the Company's manufacturing
facilities in Morgantown, West Virginia, are represented by the Oil, Chemical
and Atomic Workers International Union (AFL-CIO) and its Local Union 8-957 under
a contract which expires April 5, 2002.
Backlog
At March 31, 2000, the uncompleted portion of the Company's backlog of
orders was approximately $28,226,000 as compared to approximately $7,388,000 at
March 31, 1999, and $19,899,000 at March 31, 1998. Because of the relatively
short lead time required in filling orders for its products, the Company does
not believe these backlog amounts bear a significant relationship to sales or
income for any full twelve-month period.
Item 2. Properties
The Company operates from various facilities in the United States and
Puerto Rico which have an aggregate of approximately 1,305,000 square feet.
Mylan Pharmaceuticals Inc. owns production, warehouse, laboratory and
office facilities in three buildings in Morgantown, West Virginia containing
484,000 square feet. Mylan Pharmaceuticals operates two distribution centers: a
166,000 square foot center in Greensboro, North Carolina which it owns and a
38,000 square foot center in Reno, Nevada which it operates under a lease
expiring in 2002. A new sales and administration facility containing
approximately 65,000 square feet is currently under construction in Morgantown,
West Virginia.
Mylan Inc. owns a production and office facility in Caguas, Puerto Rico
containing 115,000 square feet and a production facility in Cidra, Puerto Rico
containing 32,000 square feet.
Bertek Pharmaceuticals, Inc. owns production, warehouse and office
facilities in two buildings in Sugar Land, Texas containing 70,000 square feet
and research and development facilities in two buildings in Foster City,
California containing 27,000 square feet under leases expiring in 2003.
Mylan Technologies Inc. owns production, warehouse, laboratory, and office
facilities in three buildings in Swanton and St. Albans, Vermont containing
118,000 square feet. Mylan Technologies Inc. also operates a coating and
extrusion facility in St. Albans containing 71,000 square feet under a lease
expiring in 2015.
UDL Laboratories Inc. owns production, laboratory, warehouse, and office
facilities in three buildings in Rockford, Illinois and Largo, Florida
containing 136,000 square feet. UDL also leases a warehouse facility in Rockford
containing 41,000 square feet under a lease expiring in 2005.
The Company's production equipment includes that equipment necessary to
produce and package tablet, capsule, aerosol, liquid, transdermal and powder
dosage forms. The Company maintains seven analytical testing laboratories for
quality control.
The Company's production facilities are operated primarily on a two-shift
basis. Properties and equipment are well maintained and adequate for present
operations.
The Company's corporate offices, approximately 7,000 square feet, are
located at 1030 Century Building, 130 Seventh Street, Pittsburgh, Pennsylvania,
and are occupied under a lease expiring in 2003.
Item 3. Legal Proceedings
In March 1999, a subsidiary of the Company entered into binding
arbitration related to a dispute with KaiGai Pharmaceutical, Co., Ltd.
("KaiGai"). The dispute arose out of a license and supply agreement for
nitroglycerin transdermal patches that both companies claim was breached by the
other party. KaiGai sought damages in excess of $20,000,000. In November 1999,
the arbitration panel denied KaiGai's request for damages. KaiGai filed an
appeal and the Company has filed a motion to dismiss the appeal due to the
appeal not being filed within the time period permitted.
In June 1998, the Company filed suit in Los Angeles Superior Court
against American Bioscience, Inc. ("ABI"), American Pharmaceutical Partners,
Inc. ("APP") and certain of their directors and officers. The Company's suit
seeks various legal and equitable remedies. The Los Angeles Superior Court
issued a preliminary injunction order which, among other things, prohibits the
defendants from transferring or disposing of funds, assets, technology or
property without the Company's consent or commingling assets, property,
technology or personnel with those of another company. In June 1999, the
defendants filed an answer to and cross-complaint against the Company. The
cross-complaint alleges violations of California state laws, interference with
contractual relations and prospective economic advantage, fraud, slander, libel
and other allegations. The cross-complaint seeks unspecified compensatory and
punitive damages. The Company believes the cross-complaint is without merit and
intends to vigorously defend its position.
In May 1998, Genpharm Inc. filed in the general division of Ontario
Court, Canada, a statement of claim against Novopharm Limited and Granutec, Inc.
("Novopharm"). The claim was filed to resolve contract interpretation issues and
collect additional funds due relating to an agreement between the parties for
the sale of ranitidine. In July 1998, Novopharm filed a counterclaim against
Genpharm and the Company seeking damages of up to $60,000,000. The Company was
named in the counterclaim due to its agreement with Genpharm in which it shared
in profits derived from the product ranitidine. The Company believes the
counterclaim is without merit and intends to vigorously to defend its position.
On December 22, 1998, the Federal Trade Commission ("FTC") filed suit in
U.S. District Court for the District of Columbia (the "Court") against the
Company. The FTC's complaint alleges the Company engaged in restraint of trade,
monopolization, attempted monopolization and conspiracy to monopolize, arising
out of certain agreements involving the supply of raw materials used to
manufacture two drugs. The FTC also sued in the same case the foreign supplier
of the raw materials, the supplier's parent company and its United States
distributor. Under the terms of the agreements related to these raw materials,
the Company has agreed to indemnify these parties.
The Company is a party to other suits involving the Attorneys General from
33 states and more than 25 putative class actions that allege the same conduct
alleged in the FTC suit as well as alleged violations of state consumer
protection laws. A qui tam action was commenced by a private party in the U.S.
District Court for the District of South Carolina purportedly on behalf of the
United States alleging violations of the False Claims Act and other statutes.
The relief sought by the FTC includes an injunction barring the Company
from engaging in the challenged conduct, recision of certain agreements and
disgorgement in excess of $120,000,000. The states and private parties seek
similar relief, treble damages and attorneys' fees. The Company's motions to
dismiss several of the private actions were granted.
A class action suit was filed alleging violations of federal securities
laws by the Company and certain directors and officers of the Company. Without
specifying a dollar amount, the suit sought compensatory damages. The Company's
motion to dismiss the federal securities case was granted on December 22, 1999.
An appeal is pending.
The Company had filed motions to dismiss the FTC complaint and significant
portions of the State Attorneys General complaint. In July 1999, the Court
denied the Company's motion to dismiss the FTC complaint. The Company filed a
motion requesting the Court to certify its ruling with respect to the
jurisdictional issue for expedited appeal to the U.S. Court of Appeals for the
District of Columbia. This motion was denied. The Court granted in part and
denied in part the Company's motion to dismiss portions of the State Attorneys
General complaint. In so doing, the Court limited certain theories of recovery
asserted by the states. Some States filed a motion with the Court requesting
that it reconsider certain claims that were dismissed, and, in December 1999,
the Court reinstated certain claims.
The Company believes that it has meritorious defenses to the claims in all
FTC and related suits and intends to vigorously defend them. Although the
Company believes it has meritorious defenses to the claims, an adverse result in
these suits could have a material adverse effect on the Company's financial
position and results of its operations.
The Company is involved in various other legal proceedings that are
considered normal to its business. While it is not feasible to predict the
ultimate outcome of such proceedings, it is the opinion of management that the
outcome of these suits will not have a material adverse effect on the Company's
operations, financial position, or liquidity.
Item 4. Submission of Matters to a Vote of Security Holders
Not applicable.
EXECUTIVE OFFICERS OF THE REGISTRANT
The names, ages and positions of the Company's executive officers are as
follows:
Milan Puskar 65 Chairman and Chief Executive Officer
Richard F. Moldin 52 President and Chief Operating Officer
Dana G. Barnett 59 Executive Vice President
Louis J. DeBone 54 Senior Vice President
Roger L. Foster 53 Vice President and General Counsel
Roderick P. Jackson 60 Senior Vice President
Donald C. Schilling 50 Vice President-Finance and Chief
Financial Officer
Patricia A. Sunseri 60 Vice President-Investor and
Public Relations
Robert W. Smiley 78 Secretary
Mr. Puskar was employed by the Company from 1961 to 1972 and served in
various positions, including Secretary-Treasurer, Executive Vice President and a
member of the Board of Directors. From 1972 to 1975, Mr. Puskar served as Vice
President and General Manager of the Cincinnati division of ICN Pharmaceuticals
Inc. In addition, he has served as a partner of several pharmaceutical firms in
foreign countries. Currently, Mr. Puskar is a director of West Virginia
University Foundation, Morgantown, West Virginia, and Duquesne University,
Pittsburgh, Pennsylvania. Mr. Puskar served as President of the Company from
1976 to March 2000 and as Vice Chairman of the Board from 1980. He was elected
Chairman of the Board and Chief Executive Officer in November 1993.
Mr. Moldin was employed by the Company in April 2000. Prior to assuming his
position as President and Chief Operating Officer of the Company, he was
President and Chief Executive Officer of Faulding Inc. from 1995 to 2000. Mr.
Moldin served in various executive and management positions for Wellcome plc. in
England, Australia and the United States from 1979 to 1995.
Mr. Barnett was employed by the Company in 1966. His responsibilities have
covered production, quality control and product development. Mr. Barnett became
Vice President in 1974, Senior Vice President in 1978 and Executive Vice
President in 1987. He was elected President and Chief Executive Officer of
Somerset Pharmaceuticals, Inc. in June 1991, and in August 1995, he was elevated
to Chairman and Chief Executive Officer.
Mr. DeBone has been employed by the Company since September 1987. Prior to
assuming his present position in May 1999, he served as Vice
President-Operations and Vice President-Quality Control. He was previously
employed with the Company from March 1976 until June 1986 as Director of
Manufacturing.
Mr. Foster has been employed by the Company since May 1984. Prior to
assuming his present position in June 1995 as Vice President and General Counsel
he served as Director of Legal Services and as Director of Governmental Affairs.
Mr. Jackson has been employed by the Company since March 1986. Prior to
assuming his present position in October 1992 as Senior Vice President, he
served as Vice President-Marketing and Sales.
Mr. Schilling has been employed by the Company since October
1997. Prior to assuming his present position as Vice President-Finance, he was
Vice President of Finance & Administration for Plastics Manufacturing Inc. in
Harrisburg, NC from 1991 to 1997.
Mrs. Sunseri has served as a Director of the Company since April 1997, as
Vice President-Investor and Public Relations of the Company since 1989 and as
Director of Investor Relations of the Company from 1984 to 1989.
Mr. Smiley has been the Secretary of the Company since 1976. He previously
served on the Company's Board of Directors. In October 1992, he joined the law
firm of Doepken Keevican & Weiss Professional, which provided legal services to
the Company in fiscal 2000. Previously, he was a partner of Smiley, McGinty &
Steger for more than five years.
No family relationships exist between any of the above executive
officers. Officers of the Company serve at the pleasure of the Board of
Directors.
PART II
Item 5. Market for Registrant's Common Equity and
Related Stockholder Matters
The information required by Item 5 is hereby incorporated by reference to
pp. 14 and 41 of the accompanying Annual Report to Shareholders for the year
ended March 31, 2000.
Item 6. Selected Financial Data
The information required by Item 6 is hereby incorporated by reference to
p. 14 of the accompanying Annual Report to Shareholders for the year ended March
31, 2000.
Item 7. Management's Discussion and Analysis of Financial Condition and
Results of Operations
The information required by Item 7 is hereby incorporated by reference to
pp. 15-21 of the accompanying Annual Report to Shareholders for the year ended
March 31, 2000.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk The
information required by Item 7A is hereby incorporated by reference to p. 20 of
the accompanying Annual Report to Shareholders for the year ended March 31,
2000.
Item 8. Financial Statements and Supplementary Data The information required by
Item 8 is hereby incorporated by reference to pp. 22-41 of the accompanying
Annual Report to Shareholders for the year ended March 31, 2000.
Item 9. Changes in and Disagreements with
Accountants on Accounting and Financial Disclosure
Not applicable.
PART III
Item 10. Directors and Executive Officers of the Registrant
The information as to directors required by Item 10 is hereby incorporated
by reference to pp. 2 and 3 of the Company's 2000 Proxy Statement. Information
concerning executive officers is provided in PART I of this report under the
caption "Executive Officers of the Registrant".
Item 11. Executive Compensation
The information required by Item 11 is hereby incorporated by reference to
pp. 8-9 of the Company's 2000 Proxy Statement.
Item 12. Security Ownership of Certain Beneficial Owners and Management The
information required by Item 12 is hereby incorporated by reference to pp. 10
and 11 of the Company's 2000 Proxy Statement.
Item 13. Certain Relationships and Related Transactions
The information required by Item 13 is hereby incorporated by reference to
p. 3 of the Company's 2000 Proxy Statement and Part I of this report.
PART IV
Item 14. Exhibits, Financial Statement Schedules, and Reports on Form 8-K
(a) 1. List of Financial Statements
Annual Report
Page
Number
INCLUDED IN ANNUAL REPORT TO SHAREHOLDERS:
Consolidated Balance Sheets.............................. 22-23
Consolidated Statements of Earnings...................... 24
Consolidated Statements of Shareholders' Equity ......... 25
Consolidated Statements of Cash Flows.................... 26-27
Notes to Consolidated Financial Statements............... 28-39
Independent Auditors' Report............................. 40
2. Financial Statement Schedules
The information required by this Item is incorporated herein
by reference to Exhibit 99. All other schedules have been
omitted because they are not required or the information can
be derived from the Consolidated Financial Statements
included in the accompanying Annual Report to Shareholders
for the year ended March 31, 2000.
3. Exhibits
(3)(a) Amended and Restated Articles of Incorporation of
the registrant, filed as Exhibit 4.2 to the Form
S-8 on December 23, 1997 (registration number
333-43081) and incorporated herein by reference.
(b) By-laws of the registrant, as amended to date,
filed as Exhibit 4.3 to the Form S-8 on December
23, 1997 (registration number 333-43081) and
incorporated herein by reference.
(4)(a) Rights Agreement, as amended to date, between the
Company and American Stock Transfer & Trust Co.,
filed as Exhibit 4.1 to Form 8-K dated August 30,
1996 and incorporated herein by reference.
Amendment is incorporated herein by reference to
Exhibit 1 to Form 8-A/A dated March 31, 2000.
(10)(a) Mylan Laboratories Inc. 1986 Incentive Stock
Option Plan, as amended to date, filed as
Exhibit 10(b) to Form 10-K for fiscal year ended
March 31, 1993 and incorporated herein by
reference.
(b) "Salary Continuation Plan" with Milan Puskar, Dana
G. Barnett and C.B. Todd each dated January 27,
1995 and filed as Exhibit 10(b) to Form 10-K for
fiscal year ended March 31, 1995 and incorporated
herein by reference.
(c) "Salary Continuation Plan" with Louis J. DeBone
dated March 14, 1995 filed as Exhibit 10(c) to
Form 10-K for fiscal year ended March 31, 1995 and
incorporated herein by reference.
(d) Employment contract with Milan Puskar dated April
28, 1983, as amended to date, filed as Exhibit
10(e) to Form 10-K for fiscal year ended March 31,
1993 and incorporated herein by reference.
(e) Split Dollar Life Insurance Arrangement with
McKnight Irrevocable Trust filed as Exhibit 10(g)
to Form 10-K for fiscal year ended March 31, 1994
and incorporated herein by reference.
(f) "Service Benefit Agreement" with Laurence S. DeLynn,
John C. Gaisford, M.D., and Robert W. Smiley, Esq. each
dated January 27, 1995 and filed as Exhibit 10(g) to
Form 10-K for fiscal year ended March 31, 1995 and
incorporated herein by reference.
(g) Split Dollar Life Insurance Arrangement with Milan Puskar
Irrevocable Trust filed as Exhibit 10(h) to Form 10-K
for the fiscal year ended March 31, 1996 and
incorporated herein by reference.
(h) Split Dollar Life Insurance Arrangement with the
Todd Family Irrevocable Trust filed as Exhibit
10(i) to Form 10-K for the fiscal year ended March
31, 1997 and incorporated herein by reference.
(i) Split Dollar Life Insurance Arrangement with the
Dana G. Barnett Irrevocable Family Trust filed as
Exhibit 10(j) to Form 10-K for the fiscal year
ended March 31, 1997 and incorporated herein by
reference.
(j) "Salary Continuation Plan" with Patricia Sunseri
dated March 14, 1995 filed as Exhibit 10(k) to
Form 10-K for the fiscal year ended March 31, 1997
and incorporated herein by reference.
(k) Mylan Laboratories Inc. 1997 Incentive Stock Option
Plan, as amended to date, filed herewith.
(l) Mylan Laboratories Inc. 1992 Nonemployee Director
Stock Option Plan, as amended to date, filed as
Exhibit 10(l) to Form 10-K for the fiscal year
ended March 31, 1998 and incorporated herein
by reference.
(m) "Salary Continuation Plan" with Roderick P.
Jackson dated March 14, 1995, as amended to date,
filed as Exhibit 10(m) to Form 10-K for fiscal
year ended March 31, 1999 and incorporated herein
by reference.
(13) Fiscal 2000 Annual Report to Shareholders which, except
for those portions incorporated by reference, is
furnished solely for the information of the Securities
and Exchange Commission and is not deemed to be
"filed".
(21) Subsidiaries of the registrant, filed herewith.
(23) Consents of Independent Auditors, filed herewith.
(27) Financial Data Schedule, filed herewith.
(99) Consolidated financial statements of Somerset
Pharmaceuticals, Inc. for years ended December 31, 1999,
1998, and 1997, filed herewith.
(b) Reports on Form 8-K
The Company was not required to file a report on Form 8-K during
the quarter ended March 31, 2000.
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.
Date: June 22, 2000
by /S/ MILAN PUSKAR
Milan Puskar
Chairman and Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934,
this Report has been signed below by the following persons on behalf of the
registrant and in the capacities and on the dates indicated.
/S/ MILAN PUSKAR June 22, 2000 /S/ DANA G. BARNETT June 22, 2000
Milan Puskar Dana G. Barnett
Chairman and Chief Executive Officer Executive Vice President and Director
(Principal executive officer)
/S/ LAURENCE S. DELYNN June 22, 2000 /S/ DOUGLAS J. LEECH June 22, 2000
Laurence S. DeLynn Douglas J. Leech
Director Director
/S/PATRICIA A. SUNSERI June 22, 2000 /S/JOHN C. GAISFORD,M.D.June 22, 2000
Patricia A. Sunseri John C. Gaisford,M.D.
Vice President and Director Director
/S/ C.B. TODD June 22, 2000 /S/ DONALD C. SCHILLING June 22, 2000
C.B. Todd Donald C. Schilling
Director Vice President-Finance and Chief
Financial Officer
(Principal financial officer
and principal accounting officer)
