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<SEC-DOCUMENT>0000730469-96-000001.txt : 19960325
<SEC-HEADER>0000730469-96-000001.hdr.sgml : 19960325
ACCESSION NUMBER: 0000730469-96-000001
CONFORMED SUBMISSION TYPE: 10-K
PUBLIC DOCUMENT COUNT: 9
CONFORMED PERIOD OF REPORT: 19951231
FILED AS OF DATE: 19960322
SROS: NYSE
FILER:
COMPANY DATA:
COMPANY CONFORMED NAME: A L PHARMA INC
CENTRAL INDEX KEY: 0000730469
STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834]
IRS NUMBER: 222095212
STATE OF INCORPORATION: DE
FISCAL YEAR END: 1231
FILING VALUES:
FORM TYPE: 10-K
SEC ACT: 1934 Act
SEC FILE NUMBER: 001-08593
FILM NUMBER: 96537584
BUSINESS ADDRESS:
STREET 1: ONE EXECUTIVE DR
STREET 2: P O BOX 1399
CITY: FORT LEE
STATE: NJ
ZIP: 07024
BUSINESS PHONE: 2019477774
FORMER COMPANY:
FORMER CONFORMED NAME: A L LABORATORIES INC
DATE OF NAME CHANGE: 19920703
</SEC-HEADER>
<DOCUMENT>
<TYPE>10-K
<SEQUENCE>1
<TEXT>
SECURITIES AND EXCHANGE
COMMISSION WASHINGTON, D.C.
20549
FORM 10 - K
Annual Report Pursuant to Section 13 or 15 (d) of the
Securities Exchange Act of 1934
For the fiscal year ended Commission File No.1-8593
December 31, 1995
ALPHARMA INC.
(Exact name of registrant as specified in its charter)
Delaware 22-2095212
(State of Incorporation) (I.R.S. Employer Identification No.)
One Executive Drive, Fort Lee, New Jersey 07024
(Address of principal executive offices) zip code
(201) 947-7774
(Registrant's Telephone Number Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
Name of each Exchange on
Title of each Class which Registered
Class A Common Stock, New York Stock Exchange
$.20 par value
Warrants to Purchase Shares New York Stock Exchange
of Class A Common Stock
Securities registered pursuant to Section 12 (g) of the Act: None
Indicate by check mark whether the Registrant (1) has filed
all reports to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding twelve 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. ( )
The aggregate market value of the voting stock of the
Registrant (Class A Common Stock, $.20 par value) as of March
1, 1996 was $348,257,000.
The number of shares outstanding of each of the Registrant's
classes of common stock as of March 15, 1996 was:
Class A Common Stock, $.20 par value - 13,466,568 shares;
Class B Common Stock, $.20 par value - 8,226,562 shares.
DOCUMENTS INCORPORATED BY REFERENCE:
Portions of the Proxy Statement relating to the Annual Meeting
of Shareholders to be held on May 30, 1996 are incorporated by
reference into Part III of this report. Other documents
incorporated by reference are listed in the Exhibit index.
PART I
Item 1. Business
General
ALPHARMA INC., formerly called A. L. Pharma, Inc.,
(the "Company") is a multinational pharmaceutical company
engaged in developing, manufacturing and marketing specialty
generic and proprietary human pharmaceuticals and animal
health products. The Company maintains dual corporate
headquarters in Fort Lee, New Jersey and Oslo, Norway.
The Company was originally organized in 1975 as a
whollyowned subsidiary of Apothekernes Laboratorium A.S, a Norwegian
health care company established in 1903. In February 1984,
the Company's Class A Common Stock was initially listed
on the American Stock Exchange through a public offering and
such stock is currently listed on the New York Stock Exchange.
On October 3, 1994, the Company completed a transaction
(the "Combination Transaction") in which the Company
acquired the pharmaceutical, bulk antibiotic, animal health
and aquatic animal health businesses of Apothekernes
Laboratorium A.S (the "Related Norwegian Businesses").
Immediately following the closing, the Company changed its
trading symbol on the New York Stock Exchange to "ALO".
In order to accomplish the Combination
Transaction, Apothekernes Laboratorium A.S changed its name to
A.L. Industrier AS ("A.L. Industrier") and demerged the
Related Norwegian Businesses into a new Norwegian corporation
called Apothekernes Laboratorium AS (which changed its name
in January 1996 to ALPHARMA AS, hereinafter referred to
as "A.L. Oslo"). The Company then acquired the shares of
A.L. Oslo through a tender offer for $23.6 million plus warrants
to purchase 3,600,000 shares of the Company's Class A Common Stock,
par value $0.20 per share. The warrants have an exercise price of
$21.945, and expire on January 3, 1999. Warrants to purchase
2,450,246 shares of Class A common stock (out of the
3,600,000 total) became exercisable after October 3, 1995
with the remainder to become exercisable after
October 3, 1997. The Company filed a
registration statement with the Securities and
Exchange Commission ("SEC"), which became effective on
September 28, 1995, concerning the warrants and warrant shares
exercisable in 1995. In addition, the Company listed the
aforementioned warrants and warrant shares for trading and
quotation on the New York Stock Exchange as of October 9,
1995.
A.L. Industrier is the beneficial owner of 100% of
the outstanding shares of the Company's Class B Common Stock
and is able to control the Company through its ability to
elect more than a majority of the Board of Directors and to
cast a majority of the votes in any vote of the Company's
stockholders. A.L. Industrier's holdings of the Company's
Class B Common Stock account for approximately 38.0% of
the Company's total common stock outstanding at December 31,
1995.
Subsequent to the Combination Transaction, the Company
was reorganized into five operating divisions included in
two business segments, Human Pharmaceuticals and Animal Health.
The Human Pharmaceuticals segment consists of three operating
divisions: U.S. Pharmaceuticals("USPD"), International
Pharmaceuticals("IPD") and Fine Chemicals ("FCD"). The
Animal Health segment consists of two operating divisions,
Animal Health ("AHD") and Aquatic Animal Health("AAHD").
After the closing of the Combination Transaction,
each division was required to evaluate its business to
determine actions necessary to maximize the division's and
the Company's competitive position. As a result, in December
1994, the Board of Directors approved a plan and the
Company announced postcombination management actions which
included exiting certain businesses and product lines which
did not fit into the Company's new strategic direction,
severing certain employees employed in the businesses or
product lines to be exited or whose positions had become
redundant as a result of the acquisition and the sale or
exiting of certain support facilities which also became
redundant as a result of the acquisition (the "Post
Combination Actions"). A summary of the charges resulting from
these actions is included in Note 3 of the Notes to the
Consolidated Financial Statements included in Item 8 of this
report.
In the third quarter of 1995, the Company
announced additional post-combination management actions
which continued the process begun in December 1994. The
actions occurred in the third and fourth quarters of 1995
and included severance of certain employees company-wide,
further efforts toward consolidation of operations in the
USPD, the utilization of substantial consulting resources
focused primarily on accelerating the realization of certain
combination benefits in the IPD and the sale in September of
its minority equity position and certain other product rights
in an R & D company.
In 1996, the IPD has continued to take and
consider additional actions which are designed to further
strengthen the competitive nature of the division by lowering
costs. In the first quarter of 1996, the IPD severed 30
sales and marketing personnel (primarily in the Nordic
countries) and will incur termination related costs of
approximately $1.5 million. The Company also announced
that a preliminary study of production rationalization
alternatives between the IPD's Copenhagen, Denmark and
Lier, Norway manufacturing facilities has identified potential
benefits. Based on these findings, a detailed study is being
initiated which is expected to be completed in the second
quarter of 1996. The Company expects that the detailed
study will result in a formal rationalization proposal which
may result in charges for severance, write downs of fixed
assets, and other exit costs. Any such plan will require
approval by the Board of Directors.
In 1992, the Company's wholly owned Danish subsidiary,
Dumex Ltd, completed the sale of all its former Human
Nutrition businesses. Accordingly, financial information for
1992 and 1991 has been presented to reflect the Human
Nutrition segment as a discontinued operation.
Human Pharmaceuticals
U.S. Pharmaceuticals Division (the "USPD")
The USPD develops, manufactures and markets
specialty generic human pharmaceuticals in the U.S. The
division is managed by a single senior management team and
is comprised of four wholly-owned subsidiaries: Barre-
National, Inc. ("Barre"), NMC Laboratories, Inc. ("NMC"),
Able Laboratories, Inc. ("Able") and ParMed Pharmaceuticals,
Inc. ("ParMed"). Barre, acquired in October 1987, is the
leading U.S. manufacturer of liquid generic pharmaceutical
products. NMC, acquired in August 1990, is a specialized
pharmaceutical manufacturer and marketer of creams
and ointments for topical use, primarily prescription
products. Able, acquired in October 1992, is a manufacturer and
marketer of specialized prescription and over the counter
pharmaceuticals with an emphasis on suppositories and tablets.
ParMed, acquired in May, 1986, has its products manufactured by
drug manufacturers and sells primarily to independent retail
pharmacies utilizing advanced telemarketing techniques.
In March 1993, Barre acquired a pharmaceutical
manufacturing facility in Lincolnton, North Carolina
("Lincolnton"), including inventories, approved Abbreviated New
Drug Applications ("ANDA") and other related assets.
The facility is designed to
manufacture oral liquids and topical ointments and creams.
In addition, a multi-year supply agreement was signed which
provides for the sale of pharmaceutical products from the
USPD to the previous owner of Lincolnton, a major generic
drug distributor. The facility was expanded in 1994 and the
USPD expects future production capacity increases and the
realignment of production capacity to relocate the
manufacture of certain products to Lincolnton. The
USPD has announced that NMC cream, lotion and
ointment products and Able suppository products will
ultimately be moved to Lincolnton. The move, which requires
FDA approval for each ANDA transferred, is expected to take
18 to 24 months. In 1994 the Company announced its intention
to sell or close its Able tablet business. During 1995
divestiture negotiations were held with several potential
buyers and did not result in a sale. However, the Company
intends to continue to try to sell the tablet business in
1996 and if unsuccessful, may have to terminate tablet
operations.
During the formation and organization of the USPD in
late 1993 and 1994, management took a number of consolidating
actions. Sales and marketing functions of all the manufacturing
subsidiaries comprising the division were combined to
provide pharmaceutical purchasers greater access to a larger
portfolio of products. Research and development activities
were centralized in a modern facility at the Bayview
campus of Johns Hopkins
University in Baltimore, Maryland. In addition, the
USPD consolidated distribution from its four manufacturing
sites into one 165,000 square foot facility in Maryland to
better serve customers and improve inventory management.
International Pharmaceuticals Division (the "IPD")
The IPD develops, manufactures and markets a broad range
of generic and specialty dosage-form human pharmaceuticals,
oral health care products, adhesive bandages and surgical tapes
under proprietary brands primarily in the Nordic and other
Western European countries and Indonesia. The division is
managed by a single senior management team and business is
primarily conducted through two wholly-owned subsidiaries,
DUMEX-ALPHARMA A/S of Copenhagen, Denmark ("Dumex") and A.L.
Oslo and their respective subsidiaries. As indicated in the
general section, the IPD has in process and is considering
a further reorganization of its selling and marketing and
manufacturing operations.
Fine Chemicals Division (the "FCD")
The FCD develops, manufactures and markets
bulk pharmaceutical antibiotics to the pharmaceutical
industry worldwide. The products of the FCD constitute
the active substances in a large number of finished
pharmaceuticals. The division is managed by a single senior
management team and business is conducted through the Company
and its A.L.Oslo and Dumex subsidiaries.
Animal Health
Animal Health Division (the "AHD")
The AHD develops, manufactures and markets feed
additives and animal health products for animals raised for
commercial food production worldwide. The division's principal
feed additive is the antibiotic bacitracin methylene
disalicylate sold under the BMD trademark ("BMD"), which is
used to promote growth and feed efficiency and to prevent or
treat diseases in poultry and swine. In addition, as a result
of the Combination Transaction, the AHD also manufactures a
zinc bacitracin based feed additive sold under the
Albac trademark ("Albac"). Sales of the division's
products are made principally to commercial feed
manufacturers and swine and poultry producers through a staff
of scientifically trained sales and technical service
personnel. The division is managed by a single senior
management team and business is primarily conducted through
the Company, A.L. Oslo and certain other subsidiaries.
In August, 1995 the AHD acquired a company whose
principal asset was a New Animal Drug Application ("NADA") for a feed
additive used in the treatment and prevention of
respiratory diseases in swine.
In July 1994 the AHD acquired the Wade Jones Company,
Inc. ("Wade Jones"). Wade Jones is the major poultry animal
health products distributor in the U.S. and is also actively
involved in the development, manufacture and sale of its own
line of products including animal health pharmaceuticals and
feed additives.
In July 1991 the AHD acquired, in two
unrelated transactions, trademarks, New Animal Drug
Applications, other intangibles and inventory associated with
two product lines of growth promotants and disease
preventatives, the principal components of which are
commonly used in combination or sequentially with BMD.
Aquatic Animal Health Division (the "AAHD")
The AAHD develops, manufactures and markets vaccines for
use in immunizing farmed fish against disease. The AAHD
was the leading supplier of fish vaccines to the Norwegian
fish farming industry in 1995. The division is managed by a
single senior management team and business is conducted
through two whollyowned
subsidiaries, A.L. Oslo and ALPHARMA NW INC.
("NW")(formerly called Biomed, Inc.) of Bellevue,
Washington, which was acquired in July 1989.
As part of the Post Combination Actions, AAHD
has discontinued manufacture and marketing of one aquatic
animal health antibiotic product and will close a current
production facility in Tromso, Norway during 1996.
Financial Information About Industry Segments
The Company's two business segments are (1)
Human Pharmaceuticals and (2) Animal Health. The Company's
segments and their operating
divisions contributed the following percentages
of revenues.
1995 1994 1993
USPD 33% 37% 35%
IPD 28% 26% 28%
FCD 8% 7% 8%
Human Pharmaceuticals 69% 70% 71%
Animal Health * 31% 30% 29%
Total Revenues 100% 100% 100%
* Predominantly sales of AHD.
For additional financial information concerning
the Company's business segments see Note 19 of the Notes to
the Consolidated Financial Statements included in Item 8 of
this Report.
Narrative Description of Business
Human Pharmaceuticals
The human pharmaceuticals segment is comprised of three
of the five operating divisions of the Company, namely the
USPD, IPD and FCD.
U.S. Pharmaceuticals Division
The USPD develops, manufactures and markets
specialty generic human pharmaceuticals in the U.S. The
USPD is not dependent on a single customer or a few
customers. Generic pharmaceuticals are chemical equivalents
of drugs that are sold under established brands and that may
have been subject to patent protection.
Although typically less expensive, generic drugs
must meet the same regulatory standards for good
manufacturing practices, efficacy and safety as the
corresponding branded products.
The generic pharmaceutical industry is highly
competitive, with competition from companies specializing in
generic products as well as the branded and generic product
operations of the major
international pharmaceutical companies. Consequently,
profit margins on generic drug products tend to be reduced
as more competitors obtain the necessary approvals to
manufacture and sell such products from the U.S. Food and Drug
Administration (the "FDA").
In recent years generic pharmaceuticals have increased
their market share in the U.S. relative to branded
drugs. This increase is due to several factors including:
(i) state laws permitting and/or mandating substitution
of generics by pharmacists; (ii) pressure from managed
care and third party payors to encourage cost containment by
health care providers and consumers; and (iii) increased
acceptance of generic drugs by physicians, pharmacists and
consumers.
Since 1989 the U.S. pharmaceutical industry has been,
and continues to be, subject to an intense level of scrutiny
by the FDA and by members of Congress. As a result of actions
taken by the Company to respond to the progressively
more demanding regulatory environment in which it operates,
the operating income of the USPD's operations has been
negatively affected.
The Company has spent, and will continue to spend, significant
funds and management time on FDA compliance matters. In
1992 Barre concluded a binding agreement in the form of a
consent decree with the FDA which clarified Barre's
regulatory obligations (the "Consent Decree"). The Consent
Decree defines the standards Barre
must achieve in meeting Current Good Manufacturing
Practices ("CGMP"). In addition, USPD's Able operation is
also a party to an amended consent decree with the FDA
governing manufacturing operations in accordance with
CGMP. In this regard, Able has engaged in extensive
regulatory compliance
activities which have included discontinuing certain
products and making capital expenditures and increasing
operating expenditures for quality assurance and control.
As described above, the cost of actions, both direct
and indirect, taken by the Company with respect to meeting
regulatory requirements has negatively affected gross profit
and operating income. See "Management's Discussion and
Analysis of Financial Condition and Results of Operations"
included in Item 7 of this report. Certain of these
higher costs will continue to be incurred.
The Company has been impacted in previous years by delays
in the receipt of approvals for new products and
supplemental approvals for certain existing products from
the FDA. The Company cannot predict whether future legislative or
regulatory developments might have an adverse effect on the
Company.
In July 1994, the USPD, in accordance with an industry
wide FDA directive discontinued marketing products to treat
respiratory congestion containing iodinated glycerol.
In 1994, sales of iodinated glycerol products
were approximately 2% of the Company's sales and the loss of
iodinated glycerol products negatively impacted the Company's
operations in 1995.
The USPD markets approximately 165 products, primarily
in liquid, cream, ointment and suppository dosage forms.
Each product represents a different formulation or chemical
entity. Products are sold in over 300 product presentations
and are marketed nationwide to pharmaceutical distributors,
merchandising chains and wholesalers under the "Barre" or
"NMC" labels and private labels. Prescription products are
sold by a divisional sales force. Over-the-counter products
are sold by the divisional sales force as well as by certain independent
sales representatives.
Liquid Pharmaceuticals: Through its Barre operation,
the USPD is the leading manufacturer of generic
pharmaceutical products in liquid form with
approximately 110 products. Most of the division's
liquid products are manufactured in its 255,000 square
foot facility in Baltimore, Maryland. The experience and
technical know-how of the USPD enables it to formulate
therapeutic equivalent drugs in liquid forms and to
refine product characteristics such as taste, texture,
appearance and fragrance.
Because of the importance to the USPD of cough and
cold remedies, this business is seasonal in nature. A
higher percentage of sales are made in the winter months and
are affected, from year to year, by the incidence of
colds, respiratory diseases and influenza in its
geographical market.
As with its other products, the USPD must obtain
FDA approval for new generic drugs it is developing.
In late 1995, the USPD received approval from the FDA
to manufacture and market Albuterol Sulfate Syrup
and Chlorhexidine Gluconate Oral Rinse 0.12%. In addition,
the USPD co-developed and received approval for
Albuterol Inhalation Solution 0.083%.
Creams, Lotions and Ointments: The USPD manufactures
approximately 50 cream, lotion and ointment products
for topical use. Most of these creams, lotions and
ointments are prescription products and include antibacterial,
antiinflammatory and combination products. The USPD
presently manufactures many of these creams, lotions
and ointments through its NMC operation in Glendale, New
York. Consistent with the other manufacturing
facilities of USPD, the NMC facility has been affected
by increased regulatory costs in its ongoing efforts to
comply with the FDA's interpretation of CGMP. As
previously mentioned herein, over the next 18 to 24
months, the company will transfer all of its creams,
lotion and ointment manufacturing to Lincolnton and
will close its NMC facility.
The creams, lotions and ointments market is
highly competitive and includes a number of
companies with significant market share. This market is
expected to grow significantly and a number of important
products will come off patent in the next few years.
In 1995, the USPD received approval from the FDA
to manufacture and market Betamethasone Dipropionate
Ointment USP (Augmented) 0.05%, Clobetasol Propionate
Topical Scalp Application Solution 0.05%, and
Fluocinonide Emulsified Cream 0.05%. In addition, the
FDA approved supplements to the existing approvals for
Gentamicin Cream and Ointment 0.1% and to Triple Sulfa
Vaginal Cream.
Suppositories and Other Specialty Generic Products:
During 1995, the USPD suppositories and other products
consisted of 5 products. In addition, the USPD also
manufactures and/or markets certain other specialty
generic products, including Epinephrine Mist and a Home
Pregnancy Test Kit.
In late February 1995, the USPD received FDA approval
to manufacture and market three strengths of
Acetaminophen Suppositories USP, 120 mg., 325 mg.
and 650 mg.
In addition, USPD also began commercial sale of
Miconazole Nitrate Vaginal Suppositories 200 mg. in
January 1995.
Through its ParMed operation, the USPD distributes a line
of over 1800 generic prescription and over-the-
counter pharmaceutical product presentations and offers certain
custom marketing services (such as telemarketing, order
processing and distribution) to the pharmaceutical industry.
The largest part of ParMed's sales are made to U.S.
independent retail pharmacies. A substantial majority of
ParMed's sales are made through a 45 person telemarketing
sales force. ParMed's products are manufactured by drug
manufacturers who package and label products for ParMed.
ParMed also markets USPD products bearing the
"Barre", and "NMC" labels. In addition, a special group
of telemarketers is dedicated to marketing USPD products
to retailers and institutional pharmacies (such as those in
nursing homes). Due to the fact that ParMed does not
manufacture its products, ParMed may be affected from time to time due to
recalls of products by its suppliers.
International Pharmaceuticals Division
The IPD develops, manufactures and markets a broad range
of generic and specialty dosage-form human pharmaceuticals,
oral health care products, adhesive bandages and surgical tapes
under proprietary brands primarily in the Nordic and other
Western European countries, Indonesia and the Middle East.
The IPD conducts its business primarily in Scandinavian and
U.S. Dollar denominated currencies (or currencies which
generally fluctuate with the U.S. Dollar).
Dosage-Form Pharmaceuticals: Substantially all of the
dosage form pharmaceutical products sold by the IPD in the Nordic
Countries, Western Europe and the Middle East are
manufactured at its facilities in Lier, Norway and
Copenhagen, Denmark. The IPD is presently preparing a
detailed study of production rationalization alternatives
between the Copenhagen, Denmark and Lier, Norway
manufacturing facilities. Products sold in Indonesia are
manufactured at its facility in Jakarta, Indonesia. The
facility at Lier, Norway was designed with a view towards
meeting the FDA's CGMP standard. However, given that the
facility's current production is not exported to the U.S.,
the Company has not initiated the process to cause the
facility to be in compliance with the FDA's interpretation
of CGMP.
The IPD has a broad range of dosage-forms, including tablets,
ointments, creams, and liquid and injectable preparations for
many different therapies with a concentration on prescription
drug antibiotics, analgesics/antirheumatics and psychotropics,
over-the-counter skin care, gastrointestinal and analgesic
products.
The principal geographical markets for the IPD's dosage-form
pharmaceutical products are the Nordic and other Western
European countries as well as Indonesia and certain Middle
Eastern countries. The IPD employs a specialized sales
force which markets and promotes dosage-form products to
doctors, hospitals, pharmacies and consumers. In each of
its markets, the IPD uses wholesalers to distribute its
pharmaceutical products.
The pharmaceutical business is highly competitive, and many
of IPD's competitors are substantially larger and have
greater financial, technical and marketing resources than
the IPD. Most of the IPD's pharmaceutical products compete
with one or more products of other companies which contain
the same active ingredient.
The development, manufacture and marketing of IPD
pharmaceutical products is subject to comprehensive
government regulation both in Norway, Denmark and in other
countries where the products are manufactured and marketed.
Government regulation includes detailed inspection of and
controls over manufacturing and quality control practices
and procedures, requires approvals to market products and
can result in the recall of products and the suspension of
production. Such government regulation substantially
increases the cost of producing pharmaceutical products.
Regulatory approvals are required before any new
prescription or over-the-counter drug can be marketed.
In Denmark and Norway, the IPD's pharmaceutical products are
beginning to encounter price pressures from parallel imports
(i.e. imports of competing products from neighboring
countries). The IPD believes that it is likely that
parallel imports may be a developing trend in other markets
in which the IPD sells its dosage-form pharmaceuticals.
Such parallel imports could lead to lower volume growth and
downward pressure on prices in certain product and market
areas.
In the Nordic countries in recent years, there has been an
increase in volume of sales of generic pharmaceuticals
relative to original pharmaceuticals. This increase in
market share is primarily a result of government initiatives
to reduce pharmaceutical expenses through new regulations
which promoted generic pharmaceuticals in lieu of original
formulations. However, the increased focus on the
regulation of pharmaceutical prices may lead to increased
competition and price pressure for suppliers of all types of
pharmaceuticals.
The pharmaceutical business of the IPD also includes oral
health care products. The two primary oral health care
products are Elyzol Dental Gel for the treatment of
periodontal disease and Flux sodium fluoride tablets.
In 1995 significant expenses continued to be incurred for an
administrative, selling and marketing infrastructure to
promote Elyzol Dental Gel and for continuing research and
development work, including the preparation of a New Drug
Application to be submitted for Elyzol Dental Gel in the
United States. IPD management is continuing to study
alternative marketing arrangements for the product which
include obtaining marketing partners in some geographical
areas. The Company considers the Elyzol Dental Gel product
to be in the developmental phase and expects to continue to
incur expenses in excess of revenues during 1996.
Adhesive Bandages and Surgical Tapes: The IPD manufactures
adhesive bandages, surgical tapes and non-medical tapes
under its proprietary Norgesplaster brand, and is the only
manufacturer of adhesive bandages and surgical tapes in the
Nordic countries. Its most significant market is Norway,
where it is the leading supplier in the industry. These
products are sold to consumers and hospitals through
pharmacies and other retail outlets. The IPD's production
facility is located at Vennesla, Norway, which is 320 km
southwest of Oslo.
Fine Chemicals Division
The FCD develops, manufactures and markets bulk
pharmaceutical antibiotics to the pharmaceutical industry
worldwide. The products of the FCD constitute the active
substances in a large number of finished pharmaceuticals,
including finished pharmaceuticals for the treatment of certain
skin, throat, intestinal and systemic infections. Bacitracin,
Zinc Bacitracin and Polymyxin are the most significant products
for the FCD, which believes it is the world's largest
manufacturer and supplier of such products. The division also
manufactures other antibiotics such as Vancomycin, Amphotericin B
and Colistin for use systemically and in specialized topical and
surgical human applications. In addition, the FCD markets other
well-established bulk antibiotics, such as Gramicidin and
Tyrothricin, which are contract manufactured for the division by
a Danish company.
The FCD manufactures its products in its plants in Oslo,
Norway and Copenhagen, Denmark. Both plants include
fermentation, specialized recovery and purification equipment.
Both facilities have been approved as a manufacturer of sterile
and non-sterile bulk antibiotics by the FDA and by the health
authorities of European countries. The manufacturing methods,
quality control procedures and quality assurance systems for the
production of such antibiotics are subject to periodic
inspections by regulatory agencies.
Animal Health
Since the completion of the Combination Transaction on
October 3, 1994, the Animal Health segment is comprised of two
of the operating divisions of the Company, namely the AHD and the
AAHD.
Animal Health Division
The AHD develops, manufactures and markets feed additives
and animal health products for animals raised for commercial food
production worldwide. The AHD's principal animal health product
is BMD, a feed additive, which is used to promote growth and feed
efficiency and prevent or treat diseases in poultry and swine.
In addition, the AHD also manufactures and markets a feed
additive for poultry, swine and calves sold under the Albac
trademark. Albac is produced in granulated, powder and
lactodispersible forms and contains a special grade of zinc
bacitracin as its active ingredient.
In 1991, the Company purchased two animal health lines which
are commonly used in combination or sequentially with BMD. These
products include 3-Nitro, Histostat, Zoamix, Mycostatin, and
chlortetracycline ("CTC"), a feed grade antibiotic. The AHD also
manufactures and sells Vitamin D3; and other feed additives which
are used for poultry and swine.
The AHD presently sells a major portion of its volume in the
U.S. However, with the recent opening of sales offices in
Canada, Latin America, and the Far East, coupled with the
international scope of the animal health business acquired in the
Combination Transaction, the AHD has increased its manufacturing
and marketing capabilities outside the U.S. and expects
international sales to increase in the future.
Historically, the principal market for BMD has been the
poultry segment of the feed additives business in which it is one
of the leading products. The AHD continues to increase its
marketing efforts with respect to the swine segment of the
market, which is more fragmented than the poultry market.
Effective August 1994, the AHD completed a distribution
arrangement with Merck AgVet, a division of Merck & Co., Inc.
whereby the AHD assumed all sales, marketing and distribution
functions for Merck AgVet's poultry products line in the U.S.
However, Merck AgVet recently notified the AHD that it intends to
sell its poultry products line to a third party and it is unclear
at this time as to whether this agreement will continue with the
new purchaser of such business.
Sales of the AHD's products in the U.S., Canada and Mexico
are made principally to commercial feed manufacturers and
integrated swine and poultry producers through a staff of
technically trained sales and technical service personnel located
throughout the country. Sales of the AHD's products outside
North America are made primarily through the use of distributors
and sales companies.
The AHD produces BMD at its Chicago Heights, Illinois
facility, which includes a modern fermentation and recovery
plant. During recent years, the Chicago Heights facility's
capacity has increased and it has operated at or near capacity.
In the Combination Transaction the Company acquired the
technology to manufacture BMD which it previously licensed from
A.L. Industrier.
The Albac product is manufactured at the division's Skoyen
facility in Oslo, Norway. The 3-Nitro product line is
manufactured in accordance with a ten year agreement using AHD
technology at an unrelated company's facility in Charles City,
Iowa. The contract requires the AHD to purchase minimum yearly
quantities on a cost plus basis. CTC is purchased primarily from
foreign suppliers and blended domestically.
In August 1995, the AHD acquired a company whose principal
asset was a NADA for a feed additive used in the treatment and
prevention of respiratory diseases in swine.
In July 1994, the AHD acquired Wade Jones Company, Inc.
Wade Jones is the major poultry animal health products
distributor in the U.S. and is also actively involved in the
development, manufacture and sales of its own line of products
including animal health pharmaceuticals and feed additives.
Approximately ninety percent (90%) of all products sold by the
AHD in the U.S. in 1995 to the poultry industry were distributed
by Wade Jones.
The animal health industry is highly competitive and
includes a large number of companies with greater financial,
technical and marketing resources than the Company. These
companies offer a wide range of products with various therapeutic
and growth stimulating qualities. Competition is also affected
by the issuance of regulatory approvals for similar or competing
products (particularly in the U.S.) and the availability of
generic versions of certain products. The Company believes that
its competitive position in the animal health business has been
enhanced because BMD and Albac are not absorbed into animal
tissues. The FDA does not require BMD and Albac to be withdrawn
from feed prior to the marketing of the food animals. Certain
tests have also shown that BMD and Albac do not tend to produce
resistance in bacteria which is a characteristic of some
competitive products.
Aquatic Animal Health Division
The AAHD develops, manufactures and markets vaccines for use
in immunizing farmed fish against disease. The Company
originally entered the aquaculture business with the purchase of
NW in 1989. This base business was expanded after the
Combination Transaction with the acquisition of A.L. Oslo's fish
health business. Presently, the AAHD is the leading supplier of
vaccines for farm raised salmon in Norway, which is the largest
market for the farming of salmon and other cold water species of
fish. In 1995, approximately 75% of the revenues of the AAHD
were generated from the Norwegian market. The Company believes
that the share of sales from markets outside Norway will increase
in the future as the division continues to expand its sales
efforts internationally.
The AAHD maintains two manufacturing locations, Bellevue,
Washington and Overhalla, Norway. The Overhalla facility was
purchased by the AAHD in November 1994 and presently manufactures
ringworm vaccines for cattle and listeriosis vaccines for sheep
and goats. The AAHD is currently involved in a major capital
investment to enable the Overhalla facility to manufacture
aquaculture products using state of the art technology. Such
project is expected to be completed in the second half of 1996.
Competition in the aquatic animal health industry is
characterized by relatively few competitors. However, the
industry is subject to rapid technological change. As a result,
new techniques and products developed by competitors could cause
the AAHD products to become obsolete if the division was unable
to match technological improvements.
Research, Product Development and Technical Activities
Scientific development is important to each of the Company's
business segments. The Company's research, product development
and technical activities in the Human Pharmaceuticals segment
within the U.S., Norway and Denmark concentrate on the
development of generic equivalents of established branded
products as well as discovering creative uses of existing drugs
for new treatments and on compiling the necessary data to obtain
government approvals. The Company's research, product
development and technical activities also focus on developing
proprietary drug delivery systems and on improving existing
delivery systems and packaging and manufacturing techniques. In
view of the substantial funds which are generally required to
develop new chemical drug entities the Company has not emphasized
such activities. The Company's technical development activities
for the Animal Health segment involve extensive product
development and testing for the primary purpose of establishing
clinical support for new products and additional uses for or
variations of existing products and seeking related FDA and
analogous governmental approvals.
Generally, research and development are conducted on a
divisional basis. The Company conducts its technical product
development activities at its facilities in Copenhagen, Denmark,
Oslo, Norway, Baltimore, Maryland, Bellevue, Washington and
Chicago Heights, Illinois, as well as through independent
research facilities in the U.S.
Significant research and development projects in progress
include: A project to conduct clinical trials as part of the new
drug approval process in the U.S. for Elyzol Dental Gel (a
product for the treatment of the gum disease periodontitis), a
project to obtain FDA approval for Albuterol metered dose
inhalant products, and a project to obtain FDA approval for a
gram negative antibiotic which will be used as an injectable
treatment for respiratory and systemic diseases in broilers and
cattle.
Research and development expenses were approximately
$ 32.8 million, $32.5 million and $24.0 million in 1995, 1994 and
1993, respectively.
Financial Information About Foreign and Domestic Operations and
Export Sales
The Company derives a substantial portion of its revenues
and operating income from its foreign operations. Revenues from
foreign operations accounted for over 40% of the Company's
revenues in 1995. For certain financial information concerning
foreign and domestic operations see Note 19 of the Notes to the
Consolidated Financial Statements included in Item 8 of this
Report. Export sales from domestic operations were not
significant.
The Company's foreign operations are subject to various
risks which are not present in domestic operations, including, in
certain countries, currency exchange fluctuations and
restrictions, restrictions on imports, government price controls,
restrictions on the level of remittance of dividends, interest,
royalties and other payments, the need for governmental approval
of new operations, the continuation of existing operations and
other corporate actions, political instability, the possibility
of expropriation and uncertainty as to the enforceability of
commercial rights, trademarks and other proprietary rights.
Regulation; Proprietary Rights
The development, manufacturing and marketing of the
Company's products are subject to comprehensive government
regulation in the U.S., Norway, Denmark and other countries.
Government regulation includes detailed inspection of and
controls over manufacturing practices and procedures, requires
approvals to market products and can result in the recall of
products and suspension of production. Such government
regulation substantially increases the cost of producing human
pharmaceutical and animal health products. FDA approval is
required before any new prescription or over-the-counter drug
products or any animal health drug can be marketed in the U.S.
Analogous governmental and agency approvals are similarly
required before such products are marketed in other countries.
These government approvals are therefore very important to both
the Human Pharmaceuticals and Animal Health segments.
Continuing studies of the proper utilization, safety, and
efficacy of pharmaceuticals and other health care products are
being conducted by industry, government agencies and others.
Such studies, which increasingly employ sophisticated methods and
techniques, can call into question the utilization, safety and
efficacy of previously marketed products and in some cases have
resulted, and may in the future result, in the discontinuance of
their marketing and, in certain countries, give rise to claims
for damages from persons who believe they have been injured as a
result of their use.
The Company's manufacturing operations are required to
comply with CGMP as interpreted by the FDA and, in countries
outside the U.S., with similar regulations. This concept
encompasses all aspects of the production process, including
validation and record keeping, and involves changing and evolving
standards. Consequently, continuing compliance with CGMP is a
particularly difficult and expensive part of regulatory
compliance.
The evolving and complex nature of regulatory requirements,
the broad authority and discretion of the FDA and analogous
foreign agencies, and the generally increased level of regulatory
oversight have resulted in a higher possibility that from time to
time the Company will be adversely affected by regulatory actions
despite its ongoing efforts and commitment to achieve and
maintain full compliance with all regulatory requirements.
In many countries in which the Company does business,
including some of the Scandinavian countries, the initial prices
of pharmaceutical preparations for human use are dependent upon
governmental approval or clearance under governmental
reimbursement schemes usually based on costs or prices of
comparable products and subsequent price increases may also be
regulated. In the past three years, as part of overall programs
to lower health care costs, certain European governments have not
allowed price increases and have introduced various systems to
lower prices. As a result, cost increases and/or lower revenues
due to exchange rate fluctuations have not been recovered.
Environmental Matters
The Company believes that it is substantially in compliance
with all presently applicable federal, state and local provisions
regulating the discharge of materials into the environment, or
otherwise relating to the protection of the environment. During
1995, the Company's Barre subsidiary received and responded to a
Notice of Potential Liability and Request for Information on a
site owned by Ramp Industries, an unaffiliated third party.
Barre historically made one small shipment to the site and no
material expenditures are expected to be made in conjunction with
this matter. Although many major capital projects typically
include a component for environmental control, including the
Company's current expansion projects, no material expenditures
specifically for environmental control are expected to be made in
1996.
Employees
As of December 31, 1995, the Company had approximately 2,788
employees, including 1,373 in the U.S. and 1,415 outside of the
United States.
Item 1A. Executive Officers of the Registrant
The following is a list of the names and ages of all of the
Company's corporate officers and certain officers of each of the
Company's principal operating units, indicating all positions and
offices with the Registrant held by each such person and each
such person's principal occupations or employment during the past
five years.
Each of the Company's corporate officers has been elected to
the indicated office or offices of the Registrant, to serve as