-
Notifications
You must be signed in to change notification settings - Fork 1
/
Copy path74.txt
executable file
·5499 lines (4477 loc) · 259 KB
/
74.txt
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100
101
102
103
104
105
106
107
108
109
110
111
112
113
114
115
116
117
118
119
120
121
122
123
124
125
126
127
128
129
130
131
132
133
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
149
150
151
152
153
154
155
156
157
158
159
160
161
162
163
164
165
166
167
168
169
170
171
172
173
174
175
176
177
178
179
180
181
182
183
184
185
186
187
188
189
190
191
192
193
194
195
196
197
198
199
200
201
202
203
204
205
206
207
208
209
210
211
212
213
214
215
216
217
218
219
220
221
222
223
224
225
226
227
228
229
230
231
232
233
234
235
236
237
238
239
240
241
242
243
244
245
246
247
248
249
250
251
252
253
254
255
256
257
258
259
260
261
262
263
264
265
266
267
268
269
270
271
272
273
274
275
276
277
278
279
280
281
282
283
284
285
286
287
288
289
290
291
292
293
294
295
296
297
298
299
300
301
302
303
304
305
306
307
308
309
310
311
312
313
314
315
316
317
318
319
320
321
322
323
324
325
326
327
328
329
330
331
332
333
334
335
336
337
338
339
340
341
342
343
344
345
346
347
348
349
350
351
352
353
354
355
356
357
358
359
360
361
362
363
364
365
366
367
368
369
370
371
372
373
374
375
376
377
378
379
380
381
382
383
384
385
386
387
388
389
390
391
392
393
394
395
396
397
398
399
400
401
402
403
404
405
406
407
408
409
410
411
412
413
414
415
416
417
418
419
420
421
422
423
424
425
426
427
428
429
430
431
432
433
434
435
436
437
438
439
440
441
442
443
444
445
446
447
448
449
450
451
452
453
454
455
456
457
458
459
460
461
462
463
464
465
466
467
468
469
470
471
472
473
474
475
476
477
478
479
480
481
482
483
484
485
486
487
488
489
490
491
492
493
494
495
496
497
498
499
500
501
502
503
504
505
506
507
508
509
510
511
512
513
514
515
516
517
518
519
520
521
522
523
524
525
526
527
528
529
530
531
532
533
534
535
536
537
538
539
540
541
542
543
544
545
546
547
548
549
550
551
552
553
554
555
556
557
558
559
560
561
562
563
564
565
566
567
568
569
570
571
572
573
574
575
576
577
578
579
580
581
582
583
584
585
586
587
588
589
590
591
592
593
594
595
596
597
598
599
600
601
602
603
604
605
606
607
608
609
610
611
612
613
614
615
616
617
618
619
620
621
622
623
624
625
626
627
628
629
630
631
632
633
634
635
636
637
638
639
640
641
642
643
644
645
646
647
648
649
650
651
652
653
654
655
656
657
658
659
660
661
662
663
664
665
666
667
668
669
670
671
672
673
674
675
676
677
678
679
680
681
682
683
684
685
686
687
688
689
690
691
692
693
694
695
696
697
698
699
700
701
702
703
704
705
706
707
708
709
710
711
712
713
714
715
716
717
718
719
720
721
722
723
724
725
726
727
728
729
730
731
732
733
734
735
736
737
738
739
740
741
742
743
744
745
746
747
748
749
750
751
752
753
754
755
756
757
758
759
760
761
762
763
764
765
766
767
768
769
770
771
772
773
774
775
776
777
778
779
780
781
782
783
784
785
786
787
788
789
790
791
792
793
794
795
796
797
798
799
800
801
802
803
804
805
806
807
808
809
810
811
812
813
814
815
816
817
818
819
820
821
822
823
824
825
826
827
828
829
830
831
832
833
834
835
836
837
838
839
840
841
842
843
844
845
846
847
848
849
850
851
852
853
854
855
856
857
858
859
860
861
862
863
864
865
866
867
868
869
870
871
872
873
874
875
876
877
878
879
880
881
882
883
884
885
886
887
888
889
890
891
892
893
894
895
896
897
898
899
900
901
902
903
904
905
906
907
908
909
910
911
912
913
914
915
916
917
918
919
920
921
922
923
924
925
926
927
928
929
930
931
932
933
934
935
936
937
938
939
940
941
942
943
944
945
946
947
948
949
950
951
952
953
954
955
956
957
958
959
960
961
962
963
964
965
966
967
968
969
970
971
972
973
974
975
976
977
978
979
980
981
982
983
984
985
986
987
988
989
990
991
992
993
994
995
996
997
998
999
1000
-----BEGIN PRIVACY-ENHANCED MESSAGE-----
Proc-Type: 2001,MIC-CLEAR
Originator-Name: [email protected]
Originator-Key-Asymmetric:
MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen
TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB
MIC-Info: RSA-MD5,RSA,
JJC/LW1j0SqRqxuWQmz4y2ACmkJYqTS0zTME4VdWX2oHKuf/N9g6Yeg1a2ouUhtb
GllNmAnQlI4RqU8uaU1jlw==
<SEC-DOCUMENT>0000730469-97-000002.txt : 19970325
<SEC-HEADER>0000730469-97-000002.hdr.sgml : 19970325
ACCESSION NUMBER: 0000730469-97-000002
CONFORMED SUBMISSION TYPE: 10-K
PUBLIC DOCUMENT COUNT: 8
CONFORMED PERIOD OF REPORT: 19961231
FILED AS OF DATE: 19970324
SROS: NYSE
FILER:
COMPANY DATA:
COMPANY CONFORMED NAME: ALPHARMA 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: 97561642
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 PHARMA
DATE OF NAME CHANGE: 19960513
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, 1996
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, 1997 was
$182,777,000.
The number of shares outstanding of each of the Registrant's
classes of common stock as of March 1, 1997 was:
Class A Common Stock, $.20 par value - 13,539,060 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 28, 1997 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
Overview
Alpharma Inc. (the "Company") is a multinational
pharmaceutical company which develops, manufactures and markets
specialty generic and proprietary human pharmaceutical and animal
health products.
The Company was originally organized in 1975 as a wholly-
owned 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 under the
trading symbol "ALO".
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 reorganized its business 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").
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 "Alpharma Oslo"). The
Company then acquired the shares of Alpharma 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"). The Warrants have an exercise
price of $21.945 (subject to change as set forth below), 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 such 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 37.8% of the Company's total common
stock outstanding at December 31, 1996.
On February 10, 1997, the Company entered into a
subscription agreement with A.L. Industrier, under which A.L.
Industrier irrevocably committed to purchase 1,273,438 newly
issued shares of the Company's Class B Common Stock at $16.34 per
share. The Board of Directors of the Company also approved a
distribution to its Class A Common shareholders of special rights
(the "Rights") to purchase for $16.34 per share approximately one
share of Class A Common Stock for every six shares of Class A
Common Stock held by such holders. The distribution of the Rights
will be made with a prospectus (subject to registration of the
rights with the SEC). Although the details of the Rights have not
been finalized, the Rights will be transferable and will have a
term expiring no later than November 30, 1997. A.L. Industrier's
purchase of the Class B Common Stock will occur upon termination
of the Rights. Assuming the Rights are fully exercised, the new
equity issued pursuant to these events will maintain the current
ownership percentages between the Class A and Class B
Shareholders.
Upon issuance of the Rights, the exercise price of the
outstanding Warrants will be adjusted downward and amount of
shares purchasable thereunder will be adjusted upward pursuant to
the governing warrant agreement.
Statements in this Report on Form 10-K which are not
historical facts, so-called "forward looking statements" are made
pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Investors are cautioned that all
forward-looking statements involve risks and uncertainties,
including those detailed in the narrative description of the
Company's business set forth below and in "Item 7. Management's
Discussion and Analysis of Financial Condition and Results of
Operations".
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.
1996 1995 1994
USPD 31% 33% 37%
IPD 29% 28% 26%
FCD 7% 8% 7%
Human Pharmaceuticals 67% 69% 70%
Animal Health * 33% 31% 30%
Total Revenues 100% 100% 100%
* Predominantly sales of AHD.
For additional financial information concerning the
Company's business segments see Note 20 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")
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
three wholly-owned subsidiaries: Alpharma USPD Inc. ("AUI";
formerly called Barre-National, Inc.), NMC Laboratories, Inc.
("NMC") and ParMed Pharmaceuticals, Inc. ("ParMed"). In August
1996, the USPD sold the tablet business of its Able Laboratories,
Inc. ("Able") subsidiary (including its leased manufacturing
facility in South Plainfield, New Jersey) to an unrelated third
party and moved production of Able's line of suppository products
to its facility in Lincolnton, North Carolina.
AUI, acquired in October 1987, is the leading U.S.
manufacturer of liquid generic pharmaceutical and over-the-
counter ("OTC") products. NMC, acquired in August 1990, is a
specialized manufacturer of pharmaceutical creams and ointments
for topical use. ParMed, acquired in May, 1986, distributes a
line of over 1,600 generic prescription and OTC pharmaceutical
product presentations (including those manufactured by USPD as
well as those of third parties) primarily to U.S. independent
retail pharmacies. They also provide, under the "Impact
Marketing" name, certain custom marketing services (such as
telemarketing, order processing and distribution) to the
pharmaceutical and certain other industries.
In March 1993, AUI acquired a pharmaceutical manufacturing
facility in Lincolnton, North Carolina ("Lincolnton") including
inventories, Abbreviated New Drug Applications ("ANDA") and other
related assets. The facility is designed to manufacture topical
creams and ointments and suppositories. The facility was
expanded in 1994 and the USPD expects this facility to grow and
become more efficient as it realigns production capacity in
accordance with the accelerated production consolidation plan
announced in May 1996. Such plan includes the discontinuation of
all activities in its facilities in Glendale, New York and South
Plainfield, New Jersey and the transfer of production to
Lincolnton. The move is expected to be complete by mid-1997 and
requires FDA approval for each ANDA transferred.
Generic pharmaceuticals are the chemical and therapeutic
equivalents of brand-name drugs. Although typically less
expensive, they are required to meet the same governmental
standards as brand-name drugs and must receive approval from the
U.S. Food and Drug Administration ("FDA") prior to manufacture
and sale. Generic pharmaceuticals may be manufactured and
marketed only if relevant patents (and any additional government-
mandated market exclusivity periods) have expired. Generic
pharmaceutical sales have increased in recent years, due in part
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; (iii)
increased acceptance of generic drugs by physicians, pharmacists
and consumers; and (iv) the increasing number of formerly
patented drugs which have become available to off-patent
competition.
The USPD (excluding its ParMed operation) manufactures
and/or markets approximately 175 generic 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 under the
"Alpharma", "Barre" or "NMC" labels and private labels.
Prescription products are sold by a divisional sales force. OTC
products are sold by the divisional sales force as well as by
certain independent sales representatives.
Liquid Pharmaceuticals: The USPD is the leading U.S.
manufacturer of generic pharmaceutical products in liquid
form with approximately 110 products. Most of the
division's liquid products are manufactured in its 268,000
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.
In 1996, the USPD received approval from the FDA to
manufacture and market Minoxidil Topical Solution 2%.
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, anti-
inflammatory and combination products. As previously
mentioned herein, the USPD is in the process of transferring
all cream, lotion and ointment manufacturing to Lincolnton
and will close its NMC facility in Glendale, New York in the
first quarter of 1997.
In 1996, the USPD received approval from the FDA to
manufacture and market Miconazole Nitrate Vaginal Cream 2%.
Suppositories and Other Specialty Generic Products: The USPD
also manufactures five suppository products and markets
certain other specialty generic products, including
Epinephrine Mist and a Home Pregnancy Test Kit.
The generic pharmaceutical industry is highly competitive,
with competition from companies specializing in generic products
as well as generic divisions of major international innovator
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 FDA. In
addition, brand-name competitors often try to prevent or
discourage the use of generic equivalents through marketing and
regulatory activities and litigation. Some brand-name
competitors also have introduced generic versions of their own
branded products prior to expiration of the patents for such
drugs, which may result in a greater market share for these
companies following expiration of the applicable patents.
The USPD has historically sold its products to
pharmaceutical wholesalers, distributors, mass merchandising and
retail chains, grocery stores, and to a lesser extent, hospitals
and managed care providers. However, in 1996, the U.S. generic
pharmaceutical industry experienced a fundamental shift in
distribution, purchasing and stocking patterns which resulted in
accelerated price erosion and significant volume swings as
inventories were adjusted. Programs initiated by U.S. national
wholesalers fueled the trend of lower prices as they reduced the
market share of private label pharmaceutical distributors, which
were an important (but declining) part of the USPD customer base.
The overall trend of aggressive trade inventory reductions
continued and resulted in lower levels of stocking in advance of
the cough and cold season. As a direct result of these industry
trends, the USPD experienced lower sales volume and lower pricing
compared to 1995. The Company cannot predict when pricing will
stabilize or when the negative effects of this shift may cease.
In addition to the decline in market share of pharmaceutical
distributors as set forth above, there is a general trend of
consolidation within the customer base for pharmaceutical
products in the U.S. At present, the USPD is not dependent on
any one customer. However, if consolidation continues, the
division could become more dependent on individual customers as
certain customers increase their size and market share.
USPD's principal focus in its product development strategy
is to obtain FDA approval to market equivalent formulations of
drugs through the ANDA process. The Company has been impacted
from time to time 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.
International Pharmaceuticals Division ("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, Indonesia and the Middle East. 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 Alpharma Oslo
and their respective subsidiaries. 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: The IPD manufactures and
markets 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 IPD's dosage form
pharmaceutical products are the Nordic and other Western
European countries as well as Indonesia and the Middle East.
IPD manufactures such products at its facilities in Lier,
Norway, Copenhagen, Denmark and Jakarta, Indonesia.
In May 1996, the Company's Board of Directors approved a
production rationalization plan which includes the transfer
of all tablet, ointment and liquid production from
Copenhagen to Lier and transfer of all sterile production to
the Copenhagen facility. The full transfer will be
completed in 1998. The facility at Lier 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 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 Norway and Denmark, the IPD's pharmaceutical products are
beginning to encounter price pressures from parallel imports
(i.e. imports of identical products from lower priced
markets under the European Union free trade clause). 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 1996 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 work done with regard to the
Company's project to conduct clinical trials as part of the
new drug approval process in the U.S. for Elyzol Dental Gel.
At present, the Company is in the process of clarifying the
FDA's current guidelines for the next phase of clinical
trials for such product. Additionally, IPD management is
continuing to explore alternative marketing arrangements for
the product which may include licensing and/or obtaining
marketing partners in certain geographical areas. The
Company considers the Elyzol Dental Gel product to be in the
developmental phase.
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 ("FCD")
The FCD develops, manufactures and markets bulk antibiotics
to the pharmaceutical industry worldwide and is managed by a
single senior management team. Business is conducted through the
Company and its Alpharma Oslo and Dumex subsidiaries.
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
operating divisions of the Company, namely the AHD and the AAHD.
Animal Health Division ("AHD")
The AHD develops, manufactures and markets feed additives
and animal health products for animals raised for commercial food
production worldwide and is managed by a single senior management
team. Business is primarily conducted through the Company,
Alpharma Oslo and Wade Jones Company, Inc., a major U.S. poultry
health products distributor acquired in July 1994. The AHD
restructured its operations in 1996 to better align its services
with customer needs. The restructuring resulted in a reduction
of approximately 10% of its workforce. The AHD believes its
streamlined organization will be better able to adapt to the ever-
changing animal health market place.
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. The AHD also
manufactures and markets a feed additive for poultry, swine and
calves under the Albac trademark. 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.
Commencing in 1994, the AHD also marketed and sold Merck AgVet's
(a division of Merck & Co., Inc.) line of poultry products in the
U.S. However, the AHD and Merck mutually agreed to terminate
this relationship effective June 30, 1996 as Merck sold its
poultry products line to an unrelated third party.
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 Norway. The 3-Nitro product line is manufactured in
accordance with a ten year agreement using AHD technology at an
unrelated company's facility. 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.
The AHD presently sells a major portion of its volume in the
U.S. However, with the 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.
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. Although the AHD is not dependent on any one
customer, the customer base for animal health products is in a
consolidation phase. Therefore, as consolidation continues, the
AHD could become more dependent on certain individual customers
as such customers increase their size and market share.
Because most of AHD's products are feed additives, the
division's sales of such products may be affected by the price of
feed grain. In 1996, the Company's results were negatively
impacted by record increases in U.S. grain (corn and wheat)
prices. These high prices resulted in a reduction in the use of
feed additives in general and intense price competition.
Although prices have decreased from their 1996 peak levels, the
Company cannot predict whether future feed grain price
developments might have an adverse effect on the Company.
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 ("AAHD")
The AAHD develops, manufactures and markets vaccines for use
in immunizing farmed fish against disease. The division is
managed by a single senior management team and business is
conducted through two wholly-owned subsidiaries, Alpharma Oslo
and Alpharma NW Inc. ("NW") which was acquired in July 1989.
Presently, the AAHD is the leading supplier of vaccines for farm
raised salmon in Norway, which is the largest market in the world
for the farming of salmon. In 1996, approximately 55% of the
revenues of the AAHD were generated from the Norwegian market.
The AAHD maintains two manufacturing locations, Bellevue,
Washington and Overhalla, Norway. The Overhalla facility was
purchased by the AAHD in November 1994 and a new production unit
within such facility was completed in 1996 so that it is capable
of manufacturing aquaculture products using state of the art
technology. The facility is also used to manufacture ringworm
vaccines for cattle and listeriosis vaccines for sheep and goats.
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, fermentation technology 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.
Research and development expenses were approximately $34.3
million, $32.8 million, and $32.5 million in 1996, 1995 and 1994,
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 45% of the Company's
revenues in 1996. For certain financial information concerning
foreign and domestic operations see Note 20 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 research, development, manufacturing and marketing of
the Company's products are subject to comprehensive government
regulation by the FDA in the U.S., and by comparable authorities
in Norway, Denmark, Indonesia and other countries. Government
regulation includes detailed inspection of and controls over
testing, manufacturing, safety, labeling, storage, recordkeeping,
approval, advertising, promotion, sale and distribution of
pharmaceutical products. Noncompliance with applicable
requirements can result in fines, recall or seizure of products,
total or partial suspension of production and/or distribution,
refusal of the government to approve new products and criminal
prosecution. 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. All applications for FDA approval must
contain data relating to bioequivalency, product formulation, raw
material suppliers, stability, manufacturing, packaging, labeling
and quality control. Validation of manufacturing processes are
also required before a company can market new products and the
FDA conducts pre-and post-approval reviews and facility
inspections to implement these rules. Supplemental filings for
approval to transfer products from one manufacturing site to
another also require review. Analogous governmental and agency
approvals are similarly required in other countries where the
Company conducts business. These government approvals are
therefore very important to both the Human Pharmaceuticals and
Animal Health segments.
The Company's manufacturing operations (in the U.S. as well
as two of the Company's European facilities that manufacture
products for export to the U.S.) are required to comply with
Current Good Manufacturing Practices ("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, especially since the FDA
and certain other analogous governmental agencies have increased
the number of regular inspections to determine compliance. 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
particularly affected as the Company has spent, and will continue
to spend, significant funds and management time on FDA compliance
matters. In this regard, in 1992, AUI concluded a binding
agreement in the form of a consent decree with the FDA which
clarified AUI's regulatory obligations (the "Consent Decree").
The Consent Decree defines the standards AUI must achieve in
meeting CGMP. USPD's Able operation also signed an amended
consent decree with FDA governing manufacturing operations in
accordance with CGMP. Additionally, the Company is currently
responding to a Warning Letter issued by the FDA regarding FDA's
latest inspection of bulk antibiotic production at its Skoyen,
Norway plant.
The evolving and complex nature of regulatory requirements,
the broad authority and discretion of the FDA and analogous
foreign agencies, and the generally high level of regulatory
oversight results in a continuing 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.
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 Waxman-Hatch Act of 1984 ("WH Act") extended the
abbreviated application procedure for obtaining FDA approval for
generic forms of brand-name pharmaceuticals originally marketed
before 1962 which are off-patent or whose market exclusivity has
expired. The WH Act also provides market exclusivity provisions
which could preclude the submission or delay the approval of a
competing ANDA. One such provision allows a five year market
exclusivity period for New Drug Applications ("NDA") involving
new chemical compounds and a three year market exclusivity period
for NDA's containing new clinical investigations essential to the
approval of such application. The market exclusivity provisions
apply equally to patented and non-patented drug products.
Another provision may extend patents for up to five years as
compensation for reduction of the effective life of the patent as
a result of time spent by the FDA reviewing an application for a
drug. Patents may also be extended pursuant to the terms of the
Uruguay Round Agreements Act ("URAA"). Therefore, the Company
cannot predict the extent to which the WH Act or URAA could
postpone launch of some of its new products.
The Generic Drug Enforcement Act of 1992 establishes
penalties for wrongdoing in connection with the development or
submission of an ANDA by authorizing the FDA to permanently or
temporarily debar companies or individuals from submitting or
assisting in the submission of an ANDA, and to temporarily deny
approval and suspend applications to market generic drugs. The
FDA may also suspend the distribution of all drugs approved or
developed in connection with certain wrongful conduct and/or
withdraw approval of an ANDA and seek civil penalties. The FDA
can also significantly delay the approval of any pending ANDA
under the "Fraud, Untrue Statements of Material Facts, Bribery
and Illegal Gratuities Policy".
The methods of reimbursement and fixing of reimbursement
levels under Medicare, Medicaid and other reimbursement programs
are under active review by state and federal government as well
as by private third party payors. In addition, Medicaid
legislation requires that all pharmaceutical manufactures rebate
to individual states a percentage of their revenues arising from
Medicaid-reimbursed pharmaceutical sales. The required rebate
for generic manufacturers is currently 11%. The Company believes
that the federal and/or state governments may continue to review
and assess alternative payment methodologies and reform measures
aimed at reducing the cost of drugs to the public. Due to the
uncertainties regarding the ultimate features of such reform
initiatives, the Company cannot predict which, if any, of such
measures will be adopted, when they will be adopted or what
impact they may have on the Company.
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 past 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 AUI 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. AUI
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 1997.
Employees
As of December 31, 1996, the Company had approximately 2,550
employees, including 1,100 in the U.S. and 1,450 outside of the
U.S.
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
such until the next annual election of officers of the Registrant
(expected to occur May 28, 1997) and until his successor is
elected, or until his earlier death, resignation or removal.
Name and Position Principal Business Experience
with the Company Age During the Past Five Years
E.W. Sissener 68 Chief Executive Officer since
Chairman, Director and June 1994. Member of the
Chief Executive Officer Office of the Chief Executive
of the Company July 1991-- May
1994. Chairman of the Company
since 1975. President,
Alpharma AS since October
1994. President of A.L.
Industrier AS 1972--1994.
Chairman of A.L. Industrier AS
since November 1994.
Jeffrey E. Smith 49 Chief Financial Officer and
Vice President, Finance Vice President since May 1994.
and Chief Financial Executive Vice President and
Officer Member of the Office of the
Chief Executive July 1991--
May 1994. Vice President,
Finance of the Company from
November 1984--July 1991.
Diane M. Cady 42 Vice President, Investor
Vice President, Relations since November 1996.
Investor Relations Vice President, Investor
Relations for Ply Gem
Industries, Inc. 1987--October
1996.
Phil Corke 43 Vice President, Human
Vice President, Human Resources since April 1996.
Resources Director of Training,
Development and International
Compensation, Textron
Corporation 1994--March 1996.
Director, Human Resources--
Europe, Bristol-Myers Squibb
Company 1990--1993.
Beth P. Hecht 33 Corporate Counsel of the
Secretary and Corporate Company since June 1993.
Counsel Secretary of the Company since
November 1993. Attorney with
the law firm of Kirkland &
Ellis 1990--1993.
Albert N. Marchio, II 44 Treasurer of the Company since
Treasurer May 1992. Treasurer of Laura
Ashley, Inc. 1990--1992.
John S. Towler 48 Controller of the Company
Controller since March 1989.
Thomas L. Anderson 48 President of the Company's
Vice President and U.S. Pharmaceuticals Division
President, U.S. since January 1997; President
Pharmaceuticals and Chief Operating Officer of
Division FoxMeyer Health Corporation
May 1993--February 1996;
Executive Vice President and
Chief Operating Officer of
FoxMeyer Health Corporation
July 1991--April 1993.
David E. Cohen 42 President of the Company's
Vice President and Animal Health Division since
President, Animal October 1994; President,
Health Division Animal Health Division of
A. L. Laboratories, Inc.
September 1988--October 1994.
Thor Kristiansen 53 President of the Company's
Vice President and Fine Chemicals Division since
President, Fine October 1994; President,
Chemicals Division Biotechnical Division of
Apothekernes Laboratorium A.S
1986--1994.
Knut Moksnes 46 President of the Company's
Vice President and Aquatic Animal Health Division
President, Aquatic since October 1994; Managing
Animal Health Division Director, Fish Health Division
of Apothekernes Laboratorium