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1
+ ITEM 1.
2
+ BUSINESS
3
+ Overview
4
+ Meridian is a fully-integrated life science company whose principal businesses
5
+ are (i) the development, manufacture, sale and distribution of diagnostic test
6
+ kits, primarily for certain respiratory, gastrointestinal, viral and parasitic
7
+ infectious diseases, (ii) the manufacture and distribution of bulk antigens and
8
+ reagents used by researchers and other diagnostic manufacturers and (iii) the
9
+ contract manufacture of proteins and other biologicals for use by
10
+ biopharmaceutical and biotechnology companies engaged in research for new drugs
11
+ and vaccines. By exploiting revenue opportunities across research, clinical
12
+ diagnostics and therapeutic areas for key biologicals, Meridian can maximize
13
+ revenues, efficiently invest in research and development and increase
14
+ profitability of manufacturing operations.
15
+ Operating Segments
16
+ As a result of changes that occurred in February 2003 in the organization and
17
+ management of Meridian’s businesses, effective with the quarter beginning
18
+ January 1, 2003, Meridian changed its reportable operating segments to US
19
+ Diagnostics (formerly referred to as Meridian Bioscience, Inc. or MBI),
20
+ European Diagnostics (formerly referred to as Meridian Bioscience Europe or
21
+ MBE) and Life Science. While the scientific foundation of these three segments
22
+ is essentially the same, the market dynamics, competitive trends, regulatory
23
+ requirements and sales and marketing approach vary substantially. The US
24
+ Diagnostics operating segment consists of research and development and
25
+ manufacturing operations in Cincinnati, Ohio, and the sale and distribution of
26
+ diagnostic test kits in the US and countries outside of Europe, Africa and the
27
+ Middle East. The European Diagnostics operating segment consists of the sale
28
+ and distribution of diagnostic test kits in Europe, Africa and the Middle East.
29
+ The Life Science operating segment consists of research and development and
30
+ manufacturing operations in Memphis, Tennessee and Saco, Maine, and the sale
31
+ and distribution of bulk antigens, antibodies and bioresearch reagents
32
+ domestically and abroad. Manufacturing operations for the Life Science
33
+ operating segment include a protein production laboratory for the contract
34
+ manufacture of proteins and other biologicals used by biopharmaceutical and
35
+ biotechnology companies in research for new drugs and vaccines. Financial
36
+ information for Meridian’s operating segments is included in Note 10 to the
37
+ consolidated financial statements contained herein.
38
+ Meridian’s primary source of revenues continues to be its core diagnostic
39
+ products. Meridian’s diagnostic products provide accuracy, simplicity and
40
+ speed, and enable early diagnosis and treatment of common, acute medical
41
+ conditions, and provide for better patient outcomes at reduced costs. Meridian
42
+ targets diagnostics for disease states that (i) are acute conditions where
43
+ rapid diagnosis impacts patient outcomes, (ii) have favorable
44
+ - 2 -
45
+ Table of Contents
46
+ demographic and disease profiles, (iii) are underserved by current diagnostic
47
+ products and (iv) have difficult sample handling requirements. This approach
48
+ has allowed Meridian to establish significant market share in its target
49
+ disease states.
50
+ Meridian expects that its Life Science operating segment will serve as a key
51
+ platform for sourcing biologicals and technologies, by acquisition or license,
52
+ for development of new products for all of Meridian’s operating segments. One
53
+ of Meridian’s specific strategies in this area is to target biologicals that
54
+ have commercial product applications across multiple markets, such as human
55
+ diagnostics, veterinary diagnostics and therapeutics. This strategy is
56
+ expected to leverage research and development resources as products can be
57
+ developed with all three markets in mind, rather than on a market-by-market
58
+ basis.
59
+ Meridian’s website is www.meridianbioscience.com. Meridian makes available its
60
+ Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on
61
+ Form 8-K and any amendments thereto, free of charge, as soon as reasonably
62
+ practicable after such material has been electronically filed with the
63
+ Securities and Exchange Commission.
64
+ US Diagnostics Operating Segment
65
+ Overview
66
+ The US Diagnostics operating segment’s business focuses on the development,
67
+ manufacture, sale and distribution of diagnostic test kits, primarily for
68
+ certain respiratory, gastrointestinal, viral and parasitic infectious diseases.
69
+ In addition to diagnostic test kits, products also include transport media
70
+ that store and preserve specimen samples from patient collection to laboratory
71
+ testing. Third-party sales for this operating segment were $39,906,000,
72
+ $34,171,000 and $32,557,000 for fiscal 2003, 2002 and 2001, respectively. As
73
+ of September 30, 2003, the US Diagnostics operating segment had 240 employees.
74
+ Meridian’s diagnostic test kits utilize immunodiagnostic technologies, which
75
+ test samples of blood, urine, stool and other body fluids or tissue for the
76
+ presence of antigens and antibodies of specific infectious diseases. Specific
77
+ immunodiagnostic technologies used in Meridian’s diagnostic test kits include
78
+ enzyme immunoassay, immunofluorescence, particle agglutination/aggregation,
79
+ immunodiffusion, complement fixation and chemical stains. The enzyme
80
+ immunoassay technology is used in multiple test formats; the Premier™ products
81
+ for large volume users and the ImmunoCard® products for single test, low volume
82
+ users.
83
+ Meridian’s diagnostic products are used principally in the detection of
84
+ respiratory diseases, such as pneumonia, valley fever, flu and RSV;
85
+ gastrointestinal diseases, such as stomach ulcers (H. pylori), antibiotic
86
+ associated diarrhea (C. difficile) and pediatric diarrhea (Rotavirus and
87
+ Adenovirus); viral diseases, such as mononucleosis, Herpes Simplex, chicken pox
88
+ and shingles (Varicella-Zoster) and Cytomegolovirus (organ transplant
89
+ infections);
90
+ - 3 -
91
+ Table of Contents
92
+ and parasitic diseases, such as Giardiasis, Cryptosporidiosis and Lyme. The
93
+ primary markets and customers for these products are reference laboratories,
94
+ hospitals and physicians’ offices.
95
+ Market Trends
96
+ The global market for infectious disease tests continues to expand as new
97
+ disease states are identified, new therapies become available and worldwide
98
+ standards of living and access to health care improve. More importantly,
99
+ within this market there is a continuing shift from conventional testing, which
100
+ requires highly trained personnel and lengthy turnaround times for test
101
+ results, to more technologically advanced testing which can be performed by
102
+ less highly trained personnel and completed in minutes or hours. These
103
+ technological advances permit accurate testing to occur outside the traditional
104
+ hospital or laboratory.
105
+ The increasing pressures to contain total health care costs have accelerated
106
+ the increased use of diagnostic testing and the market shift to alternate
107
+ sites. With rapid and accurate diagnoses of infectious diseases, physicians
108
+ can pinpoint appropriate therapies quickly, leading to faster recovery, shorter
109
+ hospital stays and less treatment expense. In addition, these pressures have
110
+ led to a major consolidation among reference laboratories and the formation of
111
+ multi-hospital alliances that have reduced the number of institutional
112
+ customers for diagnostic products and resulted in changes in buying practices.
113
+ Specifically, multi-year exclusive or primary source marketing or distribution
114
+ contracts with institutional customers have become more common, replacing less
115
+ formal distribution arrangements of shorter duration and involving lower
116
+ product volumes.
117
+ Sales and Marketing
118
+ The US Diagnostics operating segment’s sales and distribution network consists
119
+ of a direct sales force in the US and independent distributors in the US and
120
+ abroad. The direct sales force consists of three regional sales managers, one
121
+ corporate health systems manager, 21 technical sales representatives and two
122
+ inside sales representatives. Meridian utilizes two primary independent
123
+ distributors in the US, who accounted for 39% of the US Diagnostics operating
124
+ segment’s third-party sales in fiscal 2003. Meridian participates in the
125
+ selling effort for key customers where these independent distributors are
126
+ utilized. Therefore, Meridian believes that the loss of either of these
127
+ independent distributors would not have a material adverse effect on it.
128
+ Consolidation of the US healthcare industry is expected to continue and
129
+ potentially affect Meridian’s customers. Industry consolidation puts pressure
130
+ on pricing and aggregates buying power. In response, in the last four years,
131
+ Meridian has entered into, extended or renewed several exclusive multiple-year
132
+ contracts with consolidated healthcare providers and supply agreements with
133
+ major reference laboratories.
134
+ - 4 -
135
+ Table of Contents
136
+ Products and Markets
137
+ Meridian has expertise in the development and manufacture of products based on
138
+ multiple core diagnostic technologies, each of which enables the visualization
139
+ and identification of antigen/antibody reactions for specific pathogens. As a
140
+ result, Meridian is able to develop and manufacture diagnostic tests in a
141
+ variety of formats that satisfy customer needs and preferences, whether in a
142
+ hospital, commercial or reference laboratory or alternate site location.
143
+ Meridian’s product offering consists of over 200 medical diagnostic products.
144
+ Meridian’s products generally range in list price from $1 per test to $33 per
145
+ test.
146
+ Meridian’s product technologies include enzyme immunoassay, immunofluorescence,
147
+ particle agglutination/aggregation, immunodiffusion, complement fixation and
148
+ chemical stains.
149
+ Enzyme Immunoassay (EIA) – Products incorporating the EIA technology achieve
150
+ extremely high levels of accuracy in detecting disease-related antigens or
151
+ antibodies through the use of special color-based enzyme-substrate reactions.
152
+ Meridian utilizes this technology in its multiple test format, the Premier™
153
+ product for large volume users, and in its single test formats, the
154
+ Immuno Card®, Immuno Card STAT!® and Monolert® products, for lower volume users.
155
+ Immunofluorescence – When the microscopic visualization of an antigen/antibody
156
+ reaction is necessary or desired, immunofluorescence technology is frequently
157
+ utilized. Fluorescing immunochemicals, in the presence of the target antigen
158
+ or antibody, can be viewed via a fluorescent microscope. Meridian utilizes
159
+ this technology in its Merifluor® products.
160
+ Particle Agglutination/Aggregation – This technology utilizes microparticles
161
+ (e.g., latex, red blood cells) coated with specific antigens or antibodies that
162
+ form visible aggregates in the presence of a specimen containing the
163
+ complementary antigen or antibody. This technology is rapid and economical and
164
+ is used in Meridian’s Meritec™, MeriStar® and MonoSpot® products.
165
+ Other Technologies – Meridian utilizes other technologies that include
166
+ immunodiffusion, complement fixation and chemical stains. Meridian also
167
+ manufactures and markets specimen collection, transportation, preservation and
168
+ concentration products, such as Para-Pak®, Macro-CON® and Spin-CON.
169
+ Research and Development
170
+ The US Diagnostics operating segment’s research and development organization
171
+ consists of 13 research scientists with expertise in biochemistry, immunology,
172
+ mycology, bacteriology, virology and parasitology. Research and development
173
+ expenses for the US Diagnostics operating segment for fiscal 2003, 2002 and
174
+ 2001 were $2,527,000, $1,730,000 and $2,147,000, respectively. This research
175
+ and development organization focuses
176
+ - 5 -
177
+ Table of Contents
178
+ its activities on new applications for Meridian’s existing technologies,
179
+ improvements to existing products and development of new technologies.
180
+ Research and development efforts may occur in-house or with collaborative
181
+ partners. Meridian believes that internally developed products are a key
182
+ source for sustaining revenue growth. Meridian’s internally developed products
183
+ include Premier™ Platinum HpSA and Premier™ Toxins A & B, which accounted for
184
+ 25% of the US Diagnostics operating segment’s third-party sales during fiscal
185
+ 2003.
186
+ Manufacturing
187
+ Meridian’s immunodiagnostic products require the production of highly specific
188
+ and sensitive antigens and antibodies. Meridian produces substantially all of
189
+ its own requirements including monoclonal antibodies and polyclonal antibodies,
190
+ plus a variety of fungal, bacterial and viral antigens. Meridian believes it
191
+ has sufficient manufacturing capacity for anticipated growth.
192
+ Intellectual Property, Patents and Licenses
193
+ Meridian owns or licenses US and foreign patents for approximately 25 products
194
+ manufactured by the US Diagnostics operating segment, including Premier™
195
+ Platinum HpSA. In the absence of patent protection, Meridian may be vulnerable
196
+ to competitors who successfully replicate Meridian’s production and
197
+ manufacturing technologies and processes. Meridian’s employees are required to
198
+ execute confidentiality and non-disclosure agreements designed to protect
199
+ Meridian’s proprietary products. Meridian believes that its products and
200
+ technologies do not infringe the proprietary rights of any third parties.
201
+ Government Regulation
202
+ Meridian’s diagnostic products are regulated by the Food & Drug Administration
203
+ as “devices” pursuant to the Federal Food, Drug and Cosmetic Act (FDCA). Under
204
+ the FDCA, medical devices are classified into one of three classes (i.e., Class
205
+ I, II or III). Class I and II devices are not expressly approved by the FDA,
206
+ but, instead, are “cleared” for marketing. Class III devices generally must
207
+ receive “pre-market approval” from the FDA as to safety and effectiveness.
208
+ A 510(k) clearance will be granted if the submitted data establishes that the
209
+ proposed device is “substantially equivalent” to an existing Class I or Class
210
+ II medical device or to a Class III medical device for which the FDA has not
211
+ required pre-market approval. The 510(k) clearance process for “substantially
212
+ equivalent” devices allows product sales to be made after the filing of an
213
+ application and upon acknowledgment by the FDA, typically within 90 to 120 days
214
+ after submission. If the FDA requests additional information, the product
215
+ cannot be sold in the US until the application has been supplemented and upon
216
+ acknowledgment by the FDA within 90 to 120 days of the supplemental
217
+ application. In practice, the FDA has been granting clearance in about 90 days
218
+ following submission of the supplemental information. If there are no existing
219
+ FDA-approved products or
220
+ - 6 -
221
+ Table of Contents
222
+ processes comparable to a diagnostic product or process, approval by the FDA
223
+ involves the more lengthy pre-market approval procedures.
224
+ Each of the diagnostic products currently marketed by Meridian in the United
225
+ States has been cleared by the FDA pursuant to the 510(k) clearance process or
226
+ is exempt from such requirements. Meridian believes that most, but not all,
227
+ products under development will be classified as Class I or II medical devices
228
+ and, in the case of Class II devices, will be eligible for 510(k) clearance.
229
+ Sales of Meridian’s diagnostic products in foreign countries are subject to
230
+ foreign government regulation, the requirements of which vary substantially
231
+ from country to country. The time required to obtain approval by a foreign
232
+ country may be longer or shorter than that required for FDA approval and the
233
+ requirements may differ.
234
+ European Diagnostics Operating Segment
235
+ The European Diagnostics operating segment’s business focuses on the sale and
236
+ distribution of diagnostic test kits, those manufactured by the US Diagnostics
237
+ operating segment and others manufactured by third-party vendors.
238
+ Approximately 65% of third-party sales for fiscal 2003 were products
239
+ manufactured by the US Diagnostics operating segment. Third-party sales for
240
+ this operating segment were $13,756,000, $11,920,000 and $12,421,000 for fiscal
241
+ 2003, 2002 and 2001, respectively. As of September 30, 2003, the European
242
+ Diagnostics operating segment had 38 employees, including 13 employees in the
243
+ direct sales force. The European Diagnostics operating segment’s sales and
244
+ distribution network consists of direct sales forces in Belgium, France,
245
+ Holland and Italy, and independent distributors in other European countries,
246
+ Africa and the Middle East. The European Diagnostics operating segment
247
+ maintains distribution centers in Nivelle, Belgium and Milan, Italy. The
248
+ primary markets and customers for this operating segment are hospitals and
249
+ reference laboratories. Sales to customers in Italy are mainly to hospitals
250
+ and laboratories that are funded by the Italian government.
251
+ During the last three years, competitive factors and government reimbursement
252
+ policies have slowed growth in European markets. In response to these market
253
+ conditions, Meridian restructured its European distribution operations in
254
+ fiscal 2001 and 2000 by moving the export business from Germany to Belgium, and
255
+ moving the German in-country business to an independent distributor. This
256
+ restructuring has improved overall operating results for the European
257
+ Diagnostics operating segment by lowering its cost structure. Based on
258
+ operating results for fiscal 2003 and expectations for fiscal 2004, Meridian
259
+ believes that sales levels in local currency have stabilized, and in fact,
260
+ believes that market conditions have begun to improve and will yield modest
261
+ growth.
262
+ The European Diagnostics operating segment’s functional currency is the Euro.
263
+ The translation of Euros into US dollars is subject to exchange rate risk.
264
+ - 7 -
265
+ Table of Contents
266
+ Life Science Operating Segment
267
+ Overview
268
+ The Life Science operating segment’s business currently focuses on the
269
+ development, manufacture, sale and distribution of bulk antigens and reagents
270
+ used by researchers and other diagnostic companies, as well as the contract
271
+ manufacturing of proteins and other biologicals used by biopharmaceutical and
272
+ biotechnology companies engaged in research for new drugs and vaccines.
273
+ Third-party sales for this operating segment were $12,202,000, $13,013,000 and
274
+ $11,549,000 for fiscal 2003, 2002 and 2001, respectively. The Life Science
275
+ operating segment consists of Meridian’s Viral Antigens and BIODESIGN
276
+ subsidiaries. As of September 30, 2003, the Life Science operating segment
277
+ had 78 employees.
278
+ Revenue sources for the Life Science operating segment currently come from the
279
+ manufacture, sale and distribution of bulk antigens and reagents used by
280
+ researchers and other diagnostic companies. During fiscal 2003, 28% of
281
+ third-party sales were to one customer, a substantial portion of which is under
282
+ exclusive supply agreements that expire in fiscal 2007. Meridian has a
283
+ long-standing relationship with this customer, and although there can be no
284
+ assurances, Meridian intends to renew these supply agreements in the normal
285
+ course of business.
286
+ This customer is currently experiencing delays in taking delivery of certain
287
+ bulk antigen from Meridian. These delays are not related to the quality of
288
+ Meridian’s product. As a result of these delays, the Life Science operating
289
+ segment may generate an operating loss for the first quarter of fiscal 2004
290
+ that would be recouped during the second quarter, upon commencement of
291
+ shipments to this customer. Although, there can be no assurances that
292
+ shipments will commence during the second quarter. This matter is not expected
293
+ to have a material adverse effect on Meridian’s consolidated results of
294
+ operations for the fiscal year ended September 30, 2004.
295
+ Growth Strategies
296
+ Growth strategies for the Life Science operating segment include (i) developing
297
+ new product applications from existing technologies and (ii) acquisition or
298
+ licensing of biologicals and technologies for development of new products.
299
+ Contract manufacturing of proteins and other biologicals for biopharmaceutical
300
+ and biotechnology companies engaged in research for new drugs and vaccines is
301
+ an example of a significant new product application built from Meridian’s
302
+ existing expertise in manufacturing bulk antigens and reagents using cell
303
+ culture techniques. This business will focus on contract manufacturing of
304
+ materials that will be used in Phase I and II clinical trials. During March
305
+ 2003, Meridian opened its protein production laboratory for commercial
306
+ business. During the first quarter of fiscal 2004, Meridian began work in
307
+ manufacturing a recombinant protein that will be used by the
308
+ - 8 -
309
+ Table of Contents
310
+ National Institutes of Health in the development of a vaccine for parvovirus.
311
+ This contract is expected to be completed in the fourth quarter of fiscal 2004.
312
+ The proteins that will be produced are intended to be used as “injectibles”.
313
+ As such, they will be produced under cGMP Regulations for Biologics and Human
314
+ Drugs under the auspices of the FDA. Approval and licensing, following
315
+ clinical trials, of these products will be the responsibility of the applicant,
316
+ who owns the right to each protein. Meridian may or may not be the applicant
317
+ depending on specific circumstances with particular customers.
318
+ The protein production laboratory will provide a new class of customers, and in
319
+ some cases, have longer production cycles than historical bulk manufacturing of
320
+ antigens and reagents. Longer production cycles can affect timing of revenue
321
+ recognition, as revenue is recognized either upon shipment of product or final
322
+ lot acceptance depending on contract terms.
323
+ Meridian expects that its Life Science operating segment will serve as a key
324
+ platform for sourcing biologicals and technologies, by acquisition or license,
325
+ for development of new products for all of Meridian’s operating segments. One
326
+ of Meridian’s specific strategies in this area is to target biologicals that
327
+ have commercial product applications across multiple markets, such as human
328
+ diagnostics, veterinary diagnostics and therapeutics. This strategy is
329
+ expected to leverage research and development resources as products can be
330
+ developed with all three markets in mind, rather than on a market-by-market
331
+ basis.
332
+ Markets
333
+ The Life Science operating segment has targeted three primary market segments
334
+ for its products and services: bulk biomedical reagents, drug and vaccine
335
+ discovery, and drug and vaccine development. The customer base for bulk
336
+ biomedical reagents is large and fragmented, and includes other diagnostic
337
+ manufacturers as well as researchers in academia and the pharmaceutical and
338
+ biotechnology industries. The market segments for drug and vaccine discovery
339
+ and development are intended to be served via contract manufacturing in the
340
+ protein production laboratory discussed above.
341
+ Sales and Marketing
342
+ The Life Science operating segment applies sales and marketing efforts in two
343
+ different manners that are designed to complement one another. An internal
344
+ sales and marketing staff, as well as a website, have been built to market bulk
345
+ biomedical reagents directly to a large and fragmented customer base. The
346
+ website provides detailed technical information and capability to submit
347
+ purchase orders. For major bulk biomedical reagent customers, scientific
348
+ resources have been dedicated to establish sole-source supply arrangements.
349
+ Similarly for the protein production laboratory, scientific resources are
350
+ dedicated to each potential customer.
351
+ - 9 -
352
+ Table of Contents
353
+ Research and Development
354
+ The Life Science operating segment’s research and development organization
355
+ consists of 5 research scientists. Research and development expenses for the
356
+ Life Science operating segment for fiscal 2003, 2002 and 2001 were $1,348,000,
357
+ $1,158,000 and $1,216,000, respectively. This research and development
358
+ organization focuses its activities on the protein production laboratory,
359
+ developing new biomedical reagents, and working with the US Diagnostics
360
+ operating segment in the development of products that have commercial
361
+ application across multiple markets, such as human diagnostics, veterinary
362
+ diagnostics and therapeutics.
363
+ Manufacturing and Government Regulation
364
+ The proteins that will be produced in VAI’s cGMP protein production laboratory
365
+ are intended to be used as “injectibles”. As such they will be produced under
366
+ cGMP Regulations for Biologics and Human Drugs under the auspices of the FDA.
367
+ Approval and licensing, following clinical trials, of these products will be
368
+ the responsibility of the applicant, who owns the rights to each protein. VAI
369
+ may or may not be the applicant depending on specific circumstances with
370
+ particular customers.
371
+ Competition
372
+ Diagnostics
373
+ The market for diagnostic tests is a multi-billion dollar international
374
+ industry, which is highly competitive. Many of Meridian’s competitors are
375
+ larger with greater financial, research, manufacturing and marketing resources.
376
+ Important competitive factors of Meridian’s products include product quality,
377
+ price, ease of use, customer service, and reputation. In a broader sense,
378
+ industry competition is based upon scientific and technological capability,
379
+ proprietary know-how, access to adequate capital, the ability to develop and
380
+ market products and processes, the ability to attract and retain qualified
381
+ personnel and the availability of patent protection. To the extent that
382
+ Meridian’s product lines do not reflect technological advances, Meridian’s
383
+ ability to compete in those product lines could be adversely affected.
384
+ Companies competing in the diagnostic test industry generally focus on a
385
+ limited number of tests or limited segments of the market. As a result, the
386
+ diagnostic test industry is highly fragmented and segmented. Hundreds of
387
+ companies in the United States alone supply immunodiagnostic tests. These
388
+ companies range from multi-national health care companies, for which
389
+ immunodiagnostics is one line of business, to small start-up companies. Of
390
+ central importance in the industry are mid-sized medical diagnostic specialty
391
+ companies, like Meridian, that offer multiple, broad product lines and have the
392
+ ability to deliver new, high value products quickly to the marketplace. Among
393
+ the companies with which Meridian competes in the marketing of one or
394
+ - 10 -
395
+ Table of Contents
396
+ more of its products are Abbott Laboratories Inc., Becton, Dickinson and
397
+ Company, Diagnostic Products Corporation, Quidel Corporation and Inverness
398
+ Medical.
399
+ Life Science
400
+ The market for bulk biomedical reagents is highly competitive. Important
401
+ competitive factors include product quality, price, customer service and
402
+ reputation. Where sole-source supply arrangements do not exist, Meridian faces
403
+ competitors, many of which have greater financial, research and development,
404
+ sales and marketing, and manufacturing resources. From time to time, customers
405
+ may choose to manufacture their biomedical reagents in-house rather than
406
+ purchase from outside vendors such as Meridian.
407
+ The market for contract manufacturing in a validated cGMP facility such as the
408
+ protein production laboratory is also competitive. Important competitive
409
+ factors include reputation, customer service and price. Although the product
410
+ application for this facility was built from Meridian’s existing expertise in
411
+ manufacturing bulk antigens and reagents using cell culture techniques,
412
+ Meridian faces competitors with greater experience in contract manufacturing in
413
+ a cGMP environment.
414
+ Acquisitions
415
+ Acquisitions have played an important role in the historical growth of
416
+ Meridian’s businesses. Meridian’s acquisition objectives are to, among other
417
+ things, (i) enhance product offerings, (ii) improve product distribution
418
+ capabilities, (iii) provide access to new markets, and/or (iv) provide access
419
+ to key biologicals that lead to new products. Recent examples of this include
420
+ the acquisition of Gull Laboratories in fiscal 1999 and Viral Antigens in
421
+ fiscal 2000. The Gull acquisition enhanced product offerings, expanded sales
422
+ and distribution capabilities in Europe and provided the initial access into
423
+ the Life Science market for Meridian (through the BIODESIGN subsidiary). The
424
+ Viral Antigens acquisition, coupled with the opening of the protein production
425
+ laboratory, solidified Meridian’s entry into the Life Science market. Although
426
+ Meridian cannot provide any assurance that it will consummate any acquisitions
427
+ in the future, Meridian expects that acquisitions will continue to serve as a
428
+ source of new revenues and growth in the future.
429
+ International Markets
430
+ International markets are an important source of revenue for Meridian’s
431
+ operating segments. For all operating segments combined, international sales
432
+ were $23,220,000 or 35% of total sales, $17,993,000 or 30% of total sales and
433
+ $18,123,000 or 32% of total sales in fiscal 2003, 2002 and 2001, respectively.
434
+ Domestic exports for the US Diagnostics and Life Science operating segments
435
+ were $9,464,000, $6,073,000 and $5,702,000 in fiscal 2003, 2002 and 2001,
436
+ respectively. Meridian expects to continue to look to international markets as
437
+ a source of new revenues and growth in the future.
438
+ - 11 -
439
+ Table of Contents
440
+ Environmental
441
+ Meridian is a conditionally exempt small quantity generator of hazardous waste
442
+ and has a US EPA identification number. All hazardous material is manifested
443
+ and disposed of properly. Meridian is in compliance with applicable portions
444
+ of the federal and state hazardous waste regulations and has never been a party
445
+ to any environmental proceeding.
raw/filings/0000794172/2003/0000950152-03-010438/item13.txt ADDED
@@ -0,0 +1,3 @@
 
 
 
 
1
+ Item 13
2
+ Certain Relationships and Related Transactions
3
+ 57
raw/filings/0000794172/2003/0000950152-03-010438/item9a.txt ADDED
@@ -0,0 +1,431 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ ITEM 9A.
2
+ CONTROLS AND PROCEDURES
3
+ As of September 30, 2003, an evaluation was completed under the supervision and
4
+ with the participation of Meridian’s management, including Meridian’s Chief
5
+ Executive Officer and Chief Financial Officer, of the effectiveness of the
6
+ design and operation of Meridian’s disclosure controls and procedures pursuant
7
+ to Rule 13a-15(b) and 15(d)-15(b) promulgated under the Securities Exchange Act
8
+ of 1934, as amended. Based on that
9
+ -56-
10
+ Table of Contents
11
+ evaluation, Meridian’s management, including the CEO and CFO, concluded that
12
+ Meridian’s disclosure controls and procedures were effective as of September
13
+ 30, 2003. There have been no changes in Meridian’s internal controls over
14
+ financial reporting identified in connection with the evaluation of internal
15
+ controls that occurred during the last fiscal quarter that has materially
16
+ affected, or is reasonably likely to affect, Meridian’s internal controls over
17
+ financial reporting, or in other factors that could significantly affect
18
+ internal controls subsequent to September 30, 2003.
19
+ PART III
20
+ The information required by Items 10., 11., 12., and 13., of Part III are
21
+ incorporated by reference from the Registrant’s Proxy Statement for its 2004
22
+ Annual Shareholders’ Meeting to be filed with the Commission pursuant to
23
+ Regulation 14A. The equity compensation plan chart required by Regulation S-K
24
+ Item 201(d) appears in and is hereby incorporated by reference from Item 5 of
25
+ this Form 10-K. Because Meridian’s fiscal year ended prior to December 15,
26
+ 2003, no disclosure is being provided with respect to Item 14.
27
+ -57-
28
+ Table of Contents
29
+ ITEM 15.
30
+ EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K
31
+ (a)
32
+ (1) and (2) FINANCIAL STATEMENTS AND SCHEDULES.
33
+ All financial statements and schedules required to be filed by Item 8 of this
34
+ Form and included in this report have been listed previously under Item 8. No
35
+ additional financial statements or schedules are being filed since the
36
+ requirements of paragraph (d) under Item 15 are not applicable to Meridian.
37
+ (a)
38
+ (3) EXHIBITS.
39
+ Exhibit Number
40
+ Description of Exhibit
41
+ Filing Status
42
+ 3.1
43
+ Articles of Incorporation, including amendments
44
+ not related to Company name change
45
+ A
46
+ 3.2
47
+ Code of Regulations
48
+ B
49
+ 4.1
50
+ Indenture between Meridian and Star Bank, National
51
+ Association, as Trustee, relating to Meridian’s 7%
52
+ Convertible Subordinated Debentures due 2006
53
+ C
54
+ 4.2
55
+ Indenture between Meridian and LaSalle Bank
56
+ National Association, as Trustee, relating to
57
+ Meridian’s 5% Convertible Subordinated Debentures
58
+ due 2013
59
+ D
60
+ 10.3
61
+ License Agreement dated October 6, 1983 with
62
+ Marion Laboratories, Inc.
63
+ B
64
+ 10.5
65
+ Sublicense Agreement dated June 17, 1993 among
66
+ Johnson & Johnson, the Scripps Research Institute
67
+ and Meridian Concerning certain Patent Rights
68
+ E
69
+ 10.6
70
+ Assignment dated June 17, 1993 from Ortho
71
+ Diagnostic Systems Inc. to Meridian concerning
72
+ certain Patent Rights
73
+ E
74
+ 10.7
75
+ Agreement dated January 24, 1994 between Meridian
76
+ Diagnostics, Inc. and Immulok, Inc.
77
+ F
78
+ 10.8
79
+ Asset Purchase Agreement dated June 24, 1996
80
+ between Cambridge Biotech Corporation and Meridian
81
+ Diagnostics, Inc.
82
+ G
83
+ 10.9
84
+ Merger Agreement among Gull Laboratories, Inc.,
85
+ Meridian Diagnostics, Inc. Fresenius AG and
86
+ Meridian Acquisition Co. dated as of September 15,
87
+ 1998
88
+ H
89
+ 10.10*
90
+ Savings and Investment Plan Prototype Adoption
91
+ Agreement
92
+ Filed herewith
93
+ 10.12*
94
+ 1986 Stock Option Plan
95
+ I
96
+ 10.14*
97
+ 1994 Directors’ Stock Option Plan
98
+ J
99
+ 10.15*
100
+ 1996 Stock Option Plan
101
+ K
102
+ 10.16*
103
+ Salary Continuation Agreement for John A. Kraeutler
104
+ L
105
+ 10.17
106
+ First Amendment to Merger Agreement Among Gull
107
+ Laboratories, Inc., Meridian Diagnostics, Inc.
108
+ Fresenius AG and Meridian Acquisition Co.
109
+ M
110
+ -58-
111
+ Table of Contents
112
+ Exhibit Number
113
+ Description of Exhibit
114
+ Filing Status
115
+ 10.18*
116
+ 1999 Directors’ Stock Option Plan
117
+ N
118
+ 10.20
119
+ Dividend Reinvestment Plan
120
+ P
121
+ 10.21
122
+ Merger Agreement dated September 13, 2000 among
123
+ Meridian and the Shareholders of Viral
124
+ Antigens, Inc.
125
+ O
126
+ 10.22
127
+ Loan and Security Agreement among Meridian,
128
+ certain of its subsidiaries and Fifth Third
129
+ Bank Dated as of September 20, 2001
130
+ R
131
+ 10.23*
132
+ Employment Agreement Dated February 15, 2001
133
+ between Meridian and John A. Kraeutler,
134
+ including the Addendum to Employment Agreement
135
+ dated April 24, 2001 between Meridian and John
136
+ A. Kraeutler
137
+ R
138
+ 10.24*
139
+ Sample Option Agreement Dated October 1, 2001
140
+ R
141
+ 10.25*
142
+ Sample Option Agreement Dated October 1, 2001
143
+ R
144
+ 10.26*
145
+ 1996 Stock Option Plan as Amended and Restated
146
+ Effective January 23, 2001
147
+ Q
148
+ 10.27
149
+ Sample Option Agreement Dated November 19, 2002
150
+ Filed herewith
151
+ 10.28
152
+ Agreement Concerning Disability and Death dated
153
+ September 10, 2003, between Meridian and
154
+ William J. Motto
155
+ Filed herewith
156
+ 10.29
157
+ Professional Services Agreement dated October
158
+ 1, 2002 between Meridian and Antonio Interno
159
+ Filed herewith
160
+ 13
161
+ 2003 Annual Report to Shareholders
162
+ (1)
163
+ 14
164
+ Code of Ethics
165
+ Filed herewith
166
+ 21
167
+ Subsidiaries of the Registrant
168
+ Filed herewith
169
+ 23
170
+ Consent of Independent Accountants
171
+ Filed herewith
172
+ 31.1
173
+ Certification of Principal Executive Officer
174
+ required by Rule 13a-14(a)
175
+ Filed herewith
176
+ 31.2
177
+ Certification of Principal Financial Officer
178
+ required by Rule 13a-14(a)
179
+ Filed herewith
180
+ 32
181
+ Section 1350 Certification of Chief Executive
182
+ Officer and Chief Financial Officer
183
+ Filed herewith
184
+ (1) Only portions of the 2003 Annual Report to Shareholders specifically are
185
+ incorporated by reference in this Form 10-K as filed herewith. A supplemental
186
+ paper copy of the 2003 Annual Report to Shareholders has been provided to the
187
+ Securities and Exchange Commission for informational purposes only.
188
+ -59-
189
+ Table of Contents
190
+ *Management Compensatory Contracts
191
+ Incorporated by reference to:
192
+ A.
193
+ Registration Statement No. 333-02613 on Form S-3 filed with the
194
+ Securities and Exchange Commission on April 18, 1996.
195
+ B.
196
+ Registration Statement No. 33-6052 filed under the Securities Act of
197
+ 1933.
198
+ C.
199
+ Registration Statement No. 333-11077 on Form S-3 filed with the
200
+ Securities and Exchange Commission on August 29, 1996.
201
+ D.
202
+ Meridian’s Schedule T-O filed with the Securities and Exchange Commission on
203
+ October 24, 2003.
204
+ E.
205
+ Meridian’s Form 8-K filed with the Securities and Exchange Commission on
206
+ June 17, 1993.
207
+ F.
208
+ Meridian’s Forms 8-K filed with the Securities and Exchange Commission on
209
+ February 8, 1994 and April 6, 1994.
210
+ G.
211
+ Meridian’s Form 8-K filed with the Securities and Exchange Commission on
212
+ July 2, 1996.
213
+ H.
214
+ Meridian’s Form 8-K filed with the Securities and Exchange Commission on
215
+ September 17, 1998.
216
+ I.
217
+ Registration Statement No. 33-89214 on Form S-8 filed with the Securities
218
+ and Exchange Commission on April 5, 1995.
219
+ J.
220
+ Registration Statement No. 33-78868 on Form S-8 filed with the Securities
221
+ and Exchange Commission on May 12, 1994.
222
+ K.
223
+ Meridian’s Annual Report on Form 10-K for the Fiscal Year Ended September
224
+ 30, 1996.
225
+ L.
226
+ Meridian’s Annual Report on Form 10-K for the Fiscal Year Ended September
227
+ 30, 1995.
228
+ M.
229
+ Company’s Report on Form 8-K filed with the Securities and Exchange
230
+ Commission filed on November 13, 1998.
231
+ N.
232
+ Meridian’s Proxy Statement filed with the Securities and Exchange
233
+ Commission on December 21, 1998.
234
+ O.
235
+ Meridian’s Current Report on Form 8-K dated September 29, 2000.
236
+ P.
237
+ Meridian’s Annual Report on Form 10-K for the Fiscal Year Ended September
238
+ 30, 1999.
239
+ Q.
240
+ Registration Statement No. 333-75312 on Form S-8 filed with the
241
+ Securities and Exchange Commission on December 17, 2001
242
+ R.
243
+ Meridian’s Annual Report on Form 10-K for the Fiscal Year Ended September
244
+ 30, 2001.
245
+ (b)
246
+ REPORTS ON FORM 8-K.
247
+ Report on Form 8-K dated September 25, 2003, Item 5, reports change in
248
+ operating segments
249
+ •
250
+ Annual Report on Form 10-K for the year ended September
251
+ 30, 2002, Part II, Item 8, Financial Statements and Supplementary
252
+ Data
253
+ •
254
+ Quarterly Report on Form 10-Q for the quarter ended
255
+ December 31, 2002, Part I, Item 1, Financial Statements
256
+ -60-
257
+ Table of Contents
258
+ SIGNATURES
259
+ Pursuant to the requirements of Section 13 of the Securities Exchange Act of
260
+ 1934, the Registrant has duly caused this report to be signed on its behalf by
261
+ the undersigned, thereunto duly authorized.
262
+ MERIDIAN BIOSCIENCE, INC.
263
+ By:
264
+ /s/ William J. Motto
265
+ Date: December 22, 2003
266
+ William J. Motto
267
+ Chairman of the Board
268
+ and Chief Executive Officer
269
+ -61-
270
+ Table of Contents
271
+ Pursuant to the requirements of the Securities Exchange Act of 1934, this
272
+ report has been signed by the following persons on behalf of the Registrant and
273
+ in the capacities and on the dates indicated.
274
+ Signature
275
+ Capacity
276
+ Date
277
+ /s/ William J. Motto
278
+ William J. Motto
279
+ Chairman of the Board of Directors and
280
+ Chief
281
+ Executive Officer (Principal
282
+ Executive Officer)
283
+ December 22, 2003
284
+ /s/ John A. Kraeutler
285
+ John A. Kraeutler
286
+ President and Chief Operating
287
+ Officer, Director
288
+ December 22, 2003
289
+ /s/ Melissa Lueke
290
+ Melissa Lueke
291
+ Vice President and Chief Financial Officer
292
+ December 22, 2003
293
+ /s/ James A. Buzard
294
+ James A. Buzard
295
+ Director
296
+ December 22, 2003
297
+ /s/ Gary P. Kreider
298
+ Gary P. Kreider
299
+ Director
300
+ December 22, 2003
301
+ /s/ David C. Phillips
302
+ David C. Phillips
303
+ Director
304
+ December 22, 2003
305
+ /s/ Robert J. Ready
306
+ Robert J. Ready
307
+ Director
308
+ December 22, 2003
309
+ -62-
310
+ Table of Contents
311
+ SCHEDULE II
312
+ Meridian Bioscience, Inc.
313
+ and Subsidiaries
314
+ Valuation and Qualifying Accounts
315
+ (Amounts in Thousands)
316
+ Years Ended September 30, 2003, 2002 and 2001
317
+ Charged
318
+ Balance at
319
+ to Costs
320
+ Charged
321
+ Balance
322
+ Beginning
323
+ and
324
+ to Other
325
+ at End of
326
+ Description
327
+ of Period
328
+ Expenses
329
+ Accounts
330
+ Deductions
331
+ Other (a)
332
+ Period
333
+ Year Ended September 30, 2003:
334
+ Allowance for doubtful accounts
335
+ $
336
+ 987
337
+ $
338
+ (268
339
+ )
340
+ $
341
+ —
342
+ $
343
+ (360
344
+ )
345
+ $
346
+ 112
347
+ $
348
+ 471
349
+ Inventory realizability reserves
350
+ 730
351
+ 289
352
+ —
353
+ (439
354
+ )
355
+ 5
356
+ 585
357
+ European restructuring reserves
358
+ 83
359
+ 98
360
+ —
361
+ (94
362
+ )
363
+ 16
364
+ 103
365
+ Year Ended September 30, 2002:
366
+ Allowance for doubtful accounts
367
+ $
368
+ 889
369
+ $
370
+ 94
371
+ $
372
+ —
373
+ $
374
+ (46
375
+ )
376
+ $
377
+ 50
378
+ $
379
+ 987
380
+ Inventory realizability reserves
381
+ 774
382
+ 1,399
383
+ —
384
+ (1,443
385
+ )
386
+ —
387
+ 730
388
+ European restructuring reserves
389
+ 119
390
+ 78
391
+ —
392
+ (119
393
+ )
394
+ 5
395
+ 83
396
+ Year Ended September 30, 2001:
397
+ Allowance for doubtful accounts
398
+ $
399
+ 438
400
+ $
401
+ 528
402
+ $
403
+ —
404
+ $
405
+ (109
406
+ )
407
+ $
408
+ 32
409
+ $
410
+ 889
411
+ Inventory realizability reserves
412
+ 685
413
+ 4,486
414
+ —
415
+ (4,498
416
+ )
417
+ 101
418
+ 774
419
+ European restructuring reserves
420
+ 800
421
+ 1,321
422
+ —
423
+ (2,002
424
+ )
425
+ —
426
+ 119
427
+ (a)
428
+ Balances reflect the effects of currency translation (fiscal years
429
+ 2001-2003) and acquired valuation accounts related to the Viral Antigens
430
+ acquisition (fiscal year 2001).
431
+ -63-
raw/filings/0000794172/2003/0000950152-03-010438/rp_note.txt ADDED
File without changes
raw/filings/0000794172/2003/0000950152-03-010438/rpt_disclosure.txt ADDED
File without changes
raw/filings/0000794172/2004/0000950152-04-008932/filing.txt ADDED
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raw/filings/0000794172/2004/0000950152-04-008932/filing_metadata.csv ADDED
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1
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1
+ ITEM 1.
2
+ BUSINESS
3
+ Overview
4
+ Meridian is a fully-integrated life science company whose principal businesses
5
+ are (i) the development, manufacture, sale and distribution of diagnostic test
6
+ kits, primarily for certain respiratory, gastrointestinal, viral and parasitic
7
+ infectious diseases, (ii) the manufacture and distribution of bulk antigens and
8
+ reagents used by researchers and other diagnostic manufacturers and (iii) the
9
+ contract manufacture of proteins and other biologicals for use by
10
+ biopharmaceutical and biotechnology companies engaged in research for new drugs
11
+ and vaccines. By exploiting revenue opportunities across research, clinical
12
+ diagnostics, and therapeutic areas for key biologicals, Meridian can maximize
13
+ revenues, efficiently invest in research and development, and increase
14
+ profitability of manufacturing operations.
15
+ Operating Segments
16
+ As a result of changes that occurred in February 2003 in the organization and
17
+ management of Meridian’s businesses, effective with the quarter beginning
18
+ January 1, 2003, Meridian changed its reportable operating segments to US
19
+ Diagnostics, European Diagnostics, and Life Science. While the scientific
20
+ foundation of these three segments is essentially the same, the market
21
+ dynamics, competitive trends, regulatory requirements, and sales and marketing
22
+ approach vary substantially. The US Diagnostics operating segment consists of
23
+ research and development and manufacturing operations in Cincinnati, Ohio, and
24
+ the sale and distribution of diagnostic test kits in the US and countries
25
+ outside of Europe, Africa and the Middle East. The European Diagnostics
26
+ operating segment consists of the sale and distribution of diagnostic test kits
27
+ in Europe, Africa, and the Middle East. The Life Science operating segment
28
+ consists of research and development and manufacturing operations in Memphis,
29
+ Tennessee and Saco, Maine, and the sale and distribution of bulk antigens,
30
+ antibodies and bioresearch reagents domestically and abroad. Manufacturing
31
+ operations for the Life Science operating segment include a protein production
32
+ laboratory for the contract manufacture of proteins and other biologicals used
33
+ by biopharmaceutical and biotechnology companies in research for new drugs and
34
+ vaccines. Financial information for Meridian’s operating segments is included
35
+ in Note 7 to the consolidated financial statements contained herein.
36
+ Meridian’s primary source of domestic and international revenues continues to
37
+ be its core diagnostic products. Meridian’s diagnostic products provide
38
+ accuracy, simplicity, and speed, enable early diagnosis and treatment of
39
+ common, acute medical conditions, and provide for better patient outcomes at
40
+ reduced costs. Meridian targets diagnostics for disease states that (i) are
41
+ acute conditions where rapid diagnosis impacts patient outcomes, (ii) have
42
+ favorable demographic and disease profiles, (iii) are underserved by current
43
+ diagnostic
44
+ -2-
45
+ Table of Contents
46
+ products and (iv) have difficult sample handling requirements. This approach
47
+ has allowed Meridian to establish significant market share in its target
48
+ disease states.
49
+ Meridian expects that its Life Science operating segment will serve as a key
50
+ platform for sourcing biologicals and technologies, by acquisition or license,
51
+ for development of new products for all of Meridian’s operating segments. One
52
+ of Meridian’s specific strategies in this area is to target biologicals that
53
+ have commercial product applications across multiple markets, such as human
54
+ diagnostics, veterinary diagnostics, and therapeutics. This strategy is
55
+ expected to leverage research and development resources as products can be
56
+ developed with all three markets in mind, rather than on a market-by-market
57
+ basis.
58
+ Meridian’s website is www.meridianbioscience.com. Meridian makes available its
59
+ Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on
60
+ Form 8-K and any amendments thereto, free of charge through this website, as
61
+ soon as reasonably practicable after such material has been electronically
62
+ filed with the Securities and Exchange Commission.
63
+ US Diagnostics Operating Segment
64
+ Overview
65
+ The US Diagnostics operating segment’s business focuses on the development,
66
+ manufacture, sale and distribution of diagnostic test kits, primarily for
67
+ certain respiratory, gastrointestinal, viral and parasitic infectious diseases.
68
+ In addition to diagnostic test kits, products also include transport media
69
+ that store and preserve specimen samples from patient collection to laboratory
70
+ testing. Third-party sales for this operating segment were $48,153,000,
71
+ $39,906,000 and $34,171,000 for fiscal 2004, 2003 and 2002, respectively. As
72
+ of September 30, 2004, the US Diagnostics operating segment had 246 employees.
73
+ Meridian’s diagnostic test kits utilize immunodiagnostic technologies, which
74
+ test samples of blood, urine, stool and other body fluids or tissue for the
75
+ presence of antigens and antibodies of specific infectious diseases. Specific
76
+ immunodiagnostic technologies used in Meridian’s diagnostic test kits include
77
+ enzyme immunoassay, immunofluorescence, particle agglutination/aggregation,
78
+ immunodiffusion, complement fixation, and chemical stains. The enzyme
79
+ immunoassay technology is used in multiple test formats; the Premier™ products
80
+ for large volume users and the ImmunoCard® products for single test, low volume
81
+ users.
82
+ Meridian’s diagnostic products are used principally in the detection of
83
+ respiratory diseases, such as pneumonia, valley fever, flu and RSV;
84
+ gastrointestinal diseases, such as stomach ulcers (H. pylori), antibiotic
85
+ associated diarrhea (C. difficile) and pediatric diarrhea (Rotavirus and
86
+ Adenovirus); viral diseases, such as mononucleosis, Herpes Simplex, chicken pox
87
+ and shingles (Varicella-Zoster) and Cytomegalovirus (organ
88
+ -3-
89
+ Table of Contents
90
+ transplant infections); and parasitic diseases, such as Giardiasis,
91
+ Cryptosporidiosis and Lyme. The primary markets and customers for these
92
+ products are reference laboratories, hospitals, and physicians’ offices.
93
+ Market Trends
94
+ The global market for infectious disease tests continues to expand as new
95
+ disease states are identified, new therapies become available, and worldwide
96
+ standards of living and access to health care improve. More importantly,
97
+ within this market there is a continuing shift from conventional testing, which
98
+ requires highly trained personnel and lengthy turnaround times for test
99
+ results, to more technologically advanced testing which can be performed by
100
+ less highly trained personnel and completed in minutes or hours. These
101
+ technological advances permit accurate testing to occur outside the traditional
102
+ hospital or laboratory.
103
+ The increasing pressures to contain total health care costs have accelerated
104
+ the increased use of diagnostic testing and the market shift to alternate
105
+ sites. With rapid and accurate diagnoses of infectious diseases, physicians
106
+ can pinpoint appropriate therapies quickly, leading to faster recovery, shorter
107
+ hospital stays and less treatment expense. In addition, these pressures have
108
+ led to a major consolidation among reference laboratories and the formation of
109
+ multi-hospital alliances that have reduced the number of institutional
110
+ customers for diagnostic products and resulted in changes in buying practices.
111
+ Specifically, multi-year exclusive or primary source marketing or distribution
112
+ contracts with institutional customers have become more common, replacing less
113
+ formal distribution arrangements of shorter duration and involving lower
114
+ product volumes.
115
+ Sales and Marketing
116
+ The US Diagnostics operating segment’s sales and distribution network consists
117
+ of a direct sales force in the US and independent distributors in the US and
118
+ abroad. The direct sales force consists of one director of sales, three
119
+ regional sales managers, one director of corporate health systems, 21 technical
120
+ sales representatives, two inside sales representatives, and six physician
121
+ marketing representatives. Meridian utilizes two primary independent
122
+ distributors in the US, who accounted for 42% of the US Diagnostics operating
123
+ segment’s third-party sales in fiscal 2004. Meridian participates in the
124
+ selling effort for key customers where these independent distributors are
125
+ utilized. Therefore, Meridian believes that the loss of either of these
126
+ independent distributors would not have a material adverse effect on the
127
+ Company.
128
+ Consolidation of the US healthcare industry is expected to continue and
129
+ potentially affect Meridian’s customers. Industry consolidation puts pressure
130
+ on pricing and aggregates buying power. In response, in the last five years,
131
+ Meridian has entered into, extended, or renewed several exclusive multiple-year
132
+ contracts with consolidated healthcare providers and supply agreements with
133
+ major reference laboratories.
134
+ -4-
135
+ Table of Contents
136
+ Products and Markets
137
+ Meridian has expertise in the development and manufacture of products based on
138
+ multiple core diagnostic technologies, each of which enables the visualization
139
+ and identification of antigen/antibody reactions for specific pathogens. As a
140
+ result, Meridian is able to develop and manufacture diagnostic tests in a
141
+ variety of formats that satisfy customer needs and preferences, whether in a
142
+ hospital, commercial or reference laboratory or alternate site location.
143
+ Meridian’s product offering consists of over 200 medical diagnostic products.
144
+ Meridian’s products generally range in list price from $1 per test to $33 per
145
+ test.
146
+ Meridian’s product technologies include enzyme immunoassay, immunofluorescence,
147
+ particle agglutination/aggregation, immunodiffusion, complement fixation and
148
+ chemical stains.
149
+ Enzyme Immunoassay (EIA) — Products incorporating the EIA technology achieve
150
+ extremely high levels of accuracy in detecting disease-related antigens or
151
+ antibodies through the use of special color-based enzyme-substrate reactions.
152
+ Meridian utilizes this technology in its multiple test format, the Premier™
153
+ product for large volume users, and in its single test formats, the
154
+ Immuno Card®, Immuno Card STAT!® and Monolert® products, for lower volume users.
155
+ Immunofluorescence — When the microscopic visualization of an antigen/antibody
156
+ reaction is necessary or desired, immunofluorescence technology is frequently
157
+ utilized. Fluorescing immunochemicals, in the presence of the target antigen
158
+ or antibody, can be viewed via a fluorescent microscope. Meridian utilizes
159
+ this technology in its Merifluor® products.
160
+ Particle Agglutination/Aggregation — This technology utilizes microparticles
161
+ (e.g., latex, red blood cells) coated with specific antigens or antibodies that
162
+ form visible aggregates in the presence of a specimen containing the
163
+ complementary antigen or antibody. This technology is rapid and economical and
164
+ is used in Meridian’s Meritec™, MeriStar® and MonoSpot® products.
165
+ Other Technologies — Meridian utilizes other technologies that include
166
+ immunodiffusion, complement fixation, and chemical stains. Meridian also
167
+ manufactures and markets specimen collection, transportation, preservation and
168
+ concentration products, such as Para-Pak®, Macro-CON® and Spin-CON.
169
+ Research and Development
170
+ The US Diagnostics operating segment’s research and development organization
171
+ consists of 13 research scientists with expertise in biochemistry, immunology,
172
+ mycology, bacteriology, virology, and parasitology. Research and development
173
+ expenses for the US Diagnostics operating segment for fiscal 2004, 2003 and
174
+ 2002 were $3,131,000, $2,527,000 and $1,730,000, respectively. This research
175
+ and development organization
176
+ -5-
177
+ Table of Contents
178
+ focuses its activities on new applications for Meridian’s existing
179
+ technologies, improvements to existing products and development of new
180
+ technologies. Research and development efforts may occur in-house or with
181
+ collaborative partners. Meridian believes that internally developed products
182
+ are a key source for sustaining revenue growth. Meridian’s internally
183
+ developed products include Premier™ Platinum HpSA and Premier™ Toxins A & B,
184
+ which accounted for 27% of the US Diagnostics operating segment’s third-party
185
+ sales during fiscal 2004.
186
+ Manufacturing
187
+ Meridian’s immunodiagnostic products require the production of highly specific
188
+ and sensitive antigens and antibodies. Meridian produces substantially all of
189
+ its own requirements including monoclonal antibodies and polyclonal antibodies,
190
+ plus a variety of fungal, bacterial, and viral antigens. Meridian believes it
191
+ has sufficient manufacturing capacity for anticipated growth.
192
+ Intellectual Property, Patents, and Licenses
193
+ Meridian owns or licenses US and foreign patents for approximately 25 products
194
+ manufactured by the US Diagnostics operating segment, including Premier™
195
+ Platinum HpSA. In the absence of patent protection, Meridian may be vulnerable
196
+ to competitors who successfully replicate Meridian’s production and
197
+ manufacturing technologies and processes. Meridian’s employees are required to
198
+ execute confidentiality and non-disclosure agreements designed to protect
199
+ Meridian’s proprietary products. Meridian believes that its products and
200
+ technologies do not infringe the proprietary rights of any third parties.
201
+ Government Regulation
202
+ Meridian’s diagnostic products are regulated by the Food & Drug Administration
203
+ (FDA) as “devices” pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA).
204
+ Under the FDCA, medical devices are classified into one of three classes
205
+ (i.e., Class I, II or III). Class I and II devices are not expressly approved
206
+ by the FDA, but, instead, are “cleared” for marketing. Class III devices
207
+ generally must receive “pre-market approval” from the FDA as to safety and
208
+ effectiveness.
209
+ A 510(k) clearance will be granted if the submitted data establishes that the
210
+ proposed device is “substantially equivalent” to an existing Class I or Class
211
+ II medical device or to a Class III medical device for which the FDA has not
212
+ required pre-market approval. The 510(k) clearance process for “substantially
213
+ equivalent” devices allows product sales to be made after the filing of an
214
+ application and upon acknowledgment by the FDA, typically within 90 to 120 days
215
+ after submission. If the FDA requests additional information, the product
216
+ cannot be sold in the US until the application has been supplemented and upon
217
+ acknowledgment by the FDA within 90 to 120 days of the supplemental
218
+ application. In practice, the FDA has been granting clearance in
219
+ -6-
220
+ Table of Contents
221
+ about 90 days following submission of the supplemental information. If there
222
+ are no existing FDA-approved products or processes comparable to a diagnostic
223
+ product or process, approval by the FDA involves the more lengthy pre-market
224
+ approval procedures.
225
+ Each of the diagnostic products currently marketed by Meridian in the United
226
+ States has been cleared by the FDA pursuant to the 510(k) clearance process or
227
+ is exempt from such requirements. Meridian believes that most, but not all,
228
+ products under development will be classified as Class I or II medical devices
229
+ and, in the case of Class II devices, will be eligible for 510(k) clearance.
230
+ Sales of Meridian’s diagnostic products in foreign countries are subject to
231
+ foreign government regulation, the requirements of which vary substantially
232
+ from country to country. The time required to obtain approval by a foreign
233
+ country may be longer or shorter than that required for FDA approval and the
234
+ requirements may differ.
235
+ European Diagnostics Operating Segment
236
+ The European Diagnostics operating segment’s business focuses on the sale and
237
+ distribution of diagnostic test kits, those manufactured by the US Diagnostics
238
+ operating segment and others manufactured by third-party vendors.
239
+ Approximately 71% of third-party sales for fiscal 2004 were products
240
+ manufactured by the US Diagnostics operating segment. Third-party sales for
241
+ this operating segment were $15,412,000, $13,756,000 and $11,920,000 for fiscal
242
+ 2004, 2003 and 2002, respectively. As of September 30, 2004, the European
243
+ Diagnostics operating segment had 40 employees, including 16 employees in the
244
+ direct sales force. The European Diagnostics operating segment’s sales and
245
+ distribution network consists of direct sales forces in Belgium, France,
246
+ Holland, and Italy, and independent distributors in other European countries,
247
+ Africa and the Middle East. The European Diagnostics operating segment
248
+ maintains distribution centers in Nivelle, Belgium and Milan, Italy. The
249
+ primary markets and customers for this operating segment are hospitals and
250
+ reference laboratories. Sales to customers in Italy are mainly to hospitals
251
+ and laboratories that are funded by the Italian government.
252
+ During the last several years, competitive factors and government reimbursement
253
+ policies have slowed growth in European markets. Based on operating results
254
+ for fiscal 2003 and fiscal 2004, Meridian believes that sales levels in local
255
+ currency have stabilized, and in fact, believes that market conditions have
256
+ begun to improve and will yield modest growth. Sales in local currency, the
257
+ Euro, increased 7% during the last six months of fiscal 2004 compared to fiscal
258
+ 2003.
259
+ The European Diagnostics operating segment’s functional currency is the Euro.
260
+ The translation of Euros into US dollars is subject to exchange rate changes.
261
+ -7-
262
+ Table of Contents
263
+ Life Science Operating Segment
264
+ Overview
265
+ The Life Science operating segment’s business focuses on the development,
266
+ manufacture, sale and distribution of bulk antigens and reagents used by
267
+ researchers and other diagnostic companies, as well as the contract
268
+ manufacturing of proteins and other biologicals used by biopharmaceutical and
269
+ biotechnology companies engaged in research for new drugs and vaccines.
270
+ Third-party sales for this operating segment were $16,041,000, $12,202,000 and
271
+ $13,013,000 for fiscal 2004, 2003 and 2002, respectively. The Life Science
272
+ operating segment consists of Meridian’s Viral Antigens and BIODESIGN
273
+ subsidiaries. As of September 30, 2004, the Life Science operating segment had
274
+ 77 employees.
275
+ Most of the revenue for the Life Science operating segment currently comes from
276
+ the manufacture, sale and distribution of bulk antigens and reagents used by
277
+ researchers and other diagnostic companies. During fiscal 2004, 34% of
278
+ third-party sales were to one customer, a substantial portion of which is under
279
+ exclusive supply agreements that expire in fiscal 2007. Meridian has a
280
+ long-standing relationship with this customer, and although there can be no
281
+ assurances, Meridian intends to renew these supply agreements in the normal
282
+ course of business.
283
+ During fiscal 2004, Meridian completed its first contract manufacturing project
284
+ in its protein production facility. Meridian delivered recombinant proteins to
285
+ the National Institutes of Health to be used in a vaccine for parvovirus
286
+ (“fifth disease”) in Phase I clinical trials. Revenue related to this project
287
+ was $1,528,000. During fiscal 2005, Meridian expects to deliver additional
288
+ material for Phase II clinical trials and begin contract manufacturing for
289
+ other customers.
290
+ Growth Strategies
291
+ Growth strategies for the Life Science operating segment include (i) developing
292
+ new product applications from existing technologies and (ii) acquisition or
293
+ licensing of biologicals and technologies for development of new products.
294
+ Contract manufacturing of proteins and other biologicals for biopharmaceutical
295
+ and biotechnology companies engaged in research for new drugs and vaccines is
296
+ an example of a significant new product application built from Meridian’s
297
+ existing expertise in manufacturing bulk antigens and reagents using cell
298
+ culture techniques. This business will focus on contract manufacturing of
299
+ protein materials that will be used in Phase I and II clinical trials.
300
+ -8-
301
+ Table of Contents
302
+ The protein production laboratory provides a new class of customers that, in
303
+ some cases, have longer production cycles than historical bulk manufacturing of
304
+ antigens and reagents. Longer production cycles can affect timing of revenue
305
+ recognition, as revenue may be recognized either upon shipment of product or
306
+ final lot acceptance depending on contract terms.
307
+ Meridian expects that its Life Science operating segment will serve as a key
308
+ platform for sourcing biologicals and technologies, by acquisition or license,
309
+ for development of new products for all of Meridian’s operating segments. One
310
+ of Meridian’s specific strategies in this area is to target biologicals that
311
+ have commercial product applications across multiple markets, such as human
312
+ diagnostics, veterinary diagnostics, and therapeutics. This strategy is
313
+ expected to leverage research and development resources as products can be
314
+ developed with all three markets in mind, rather than on a market-by-market
315
+ basis.
316
+ Markets
317
+ The Life Science operating segment has targeted three primary market segments
318
+ for its products and services: bulk biomedical reagents, drug and vaccine
319
+ discovery, and drug and vaccine development. The customer base for bulk
320
+ biomedical reagents is large and fragmented, and includes other diagnostic
321
+ manufacturers as well as researchers in academia and the pharmaceutical and
322
+ biotechnology industries. The market segments for drug and vaccine discovery
323
+ and development are intended to be served via contract manufacturing in the
324
+ protein production laboratory discussed above.
325
+ Sales and Marketing
326
+ The Life Science operating segment applies sales and marketing efforts in two
327
+ different manners that are designed to complement one another. An internal
328
+ sales and marketing staff, as well as a website, have been built to market bulk
329
+ biomedical reagents directly to a large and fragmented customer base. The
330
+ website provides detailed technical information and capability to submit
331
+ purchase orders. For major bulk biomedical reagent customers, scientific
332
+ resources have been dedicated to establish sole-source supply arrangements.
333
+ Similarly, for the protein production laboratory, scientific resources are
334
+ dedicated to each potential customer.
335
+ Research and Development
336
+ The Life Science operating segment’s research and development organization
337
+ consists of six research scientists. Research and development expenses for the
338
+ Life Science operating segment for fiscal 2004, 2003 and 2002 were $1,226,000,
339
+ $1,348,000 and $1,158,000, respectively. This research and development
340
+ organization focuses its activities on the protein production laboratory,
341
+ developing new biomedical reagents, and working with the US Diagnostics
342
+ operating segment in the development of products that have commercial
343
+ application across multiple markets, such as human diagnostics, veterinary
344
+ diagnostics, and therapeutics.
345
+ -9-
346
+ Table of Contents
347
+ Manufacturing and Government Regulation
348
+ The proteins that will be produced in VAI’s cGMP protein production laboratory
349
+ are intended to be used as “injectibles”. As such, they will be produced under
350
+ cGMP Regulations for Biologics and Human Drugs under the auspices of the FDA.
351
+ Approval and licensing, following clinical trials, of these products will be
352
+ the responsibility of the applicant, who owns the rights to each protein. VAI
353
+ may or may not be the applicant depending on specific circumstances with
354
+ particular customers.
355
+ Competition
356
+ Diagnostics
357
+ The market for diagnostic tests is a multi-billion dollar international
358
+ industry, which is highly competitive. Many of Meridian’s competitors are
359
+ larger with greater financial, research, manufacturing and marketing resources.
360
+ Important competitive factors of Meridian’s products include product quality,
361
+ price, ease of use, customer service, and reputation. In a broader sense,
362
+ industry competition is based upon scientific and technological capability,
363
+ proprietary know-how, access to adequate capital, the ability to develop and
364
+ market products and processes, the ability to attract and retain qualified
365
+ personnel and the availability of patent protection. To the extent that
366
+ Meridian’s product lines do not reflect technological advances, Meridian’s
367
+ ability to compete in those product lines could be adversely affected.
368
+ Companies competing in the diagnostic test industry generally focus on a
369
+ limited number of tests or limited segments of the market. As a result, the
370
+ diagnostic test industry is highly fragmented and segmented. Hundreds of
371
+ companies in the United States alone supply immunodiagnostic tests. These
372
+ companies range from multi-national health care companies, for which
373
+ immunodiagnostics is one line of business, to small start-up companies. Of
374
+ central importance in the industry are mid-sized medical diagnostic specialty
375
+ companies, like Meridian, that offer multiple, broad product lines and have the
376
+ ability to deliver new, high value products quickly to the marketplace. Among
377
+ the companies with which Meridian competes in the marketing of one or more of
378
+ its products are Abbott Laboratories Inc., Becton, Dickinson and Company,
379
+ Diagnostic Products Corporation, Quidel Corporation, and Inverness Medical.
380
+ Life Science
381
+ The market for bulk biomedical reagents is highly competitive. Important
382
+ competitive factors include product quality, price, customer service, and
383
+ reputation. Where sole-source supply arrangements do not exist, Meridian faces
384
+ competitors, many of which have greater financial, research and development,
385
+ sales and
386
+ -10-
387
+ Table of Contents
388
+ marketing, and manufacturing resources. From time to time, customers may
389
+ choose to manufacture their biomedical reagents in-house rather than purchase
390
+ from outside vendors such as Meridian.
391
+ The market for contract manufacturing in a validated cGMP facility such as the
392
+ protein production laboratory is also competitive. Important competitive
393
+ factors include reputation, customer service, and price. Although the product
394
+ application for this facility was built from Meridian’s existing expertise in
395
+ manufacturing bulk antigens and reagents using cell culture techniques,
396
+ Meridian faces competitors with greater experience in contract manufacturing in
397
+ a cGMP environment.
398
+ Acquisitions
399
+ Acquisitions have played an important role in the historical growth of
400
+ Meridian’s businesses. Meridian’s acquisition objectives are to, among other
401
+ things, (i) enhance product offerings, (ii) improve product distribution
402
+ capabilities, (iii) provide access to new markets, and/or (iv) provide access
403
+ to key biologicals that lead to new products.
404
+ During November 2004, Meridian executed a letter of intent to purchase all the
405
+ outstanding capital stock of OEM Concepts, a manufacturer and distributor of
406
+ bulk antibodies to the diagnostic, pharmaceutical, and research markets. This
407
+ pending acquisition, which is subject to due diligence review and execution of
408
+ a definitive agreement, will add large-volume monoclonal antibody manufacturing
409
+ capabilities to Meridian’s Life Science operating segment and will complement
410
+ the Viral Antigens and BIODESIGN subsidiaries. It will also decrease
411
+ Meridian’s reliance on third parties for monoclonal and polyclonal antibodies.
412
+ Recent examples of completed acquisitions include Gull Laboratories in fiscal
413
+ 1999 and Viral Antigens in fiscal 2000. The Gull acquisition enhanced product
414
+ offerings, expanded sales and distribution capabilities in Europe, and provided
415
+ the initial access into the Life Science market for Meridian (through the
416
+ BIODESIGN subsidiary). The Viral Antigens acquisition, coupled with the
417
+ opening of the protein production laboratory, solidified Meridian’s entry into
418
+ the Life Science market.
419
+ Although Meridian cannot provide any assurance that it will consummate any
420
+ acquisitions in the future, Meridian expects that acquisitions will continue to
421
+ serve as a source of new revenues and growth in the future.
422
+ International Markets
423
+ International markets are an important source of revenue for Meridian’s
424
+ operating segments. For all operating segments combined, international sales
425
+ were $24,916,000 or 31% of total sales, $23,220,000 or 35% of total sales and
426
+ $17,993,000 or 30% of total sales in fiscal 2004, 2003 and 2002, respectively.
427
+ Domestic exports for the US Diagnostics and Life Science operating segments
428
+ were $9,504,000, $9,464,000 and $6,073,000 in fiscal
429
+ -11-
430
+ Table of Contents
431
+ 2004, 2003 and 2002, respectively. Meridian expects to continue to look to
432
+ international markets as a source of new revenues and growth in the future.
433
+ Environmental
434
+ Meridian is a conditionally exempt small quantity generator of hazardous waste
435
+ and has a US EPA identification number. All hazardous material is manifested
436
+ and disposed of properly. Meridian is in compliance with applicable portions
437
+ of the federal and state hazardous waste regulations and has never been a party
438
+ to any environmental proceeding.
raw/filings/0000794172/2004/0000950152-04-008932/item13.txt ADDED
@@ -0,0 +1,3 @@
 
 
 
 
1
+ Item 13
2
+ Certain Relationships and Related Transactions
3
+ 54
raw/filings/0000794172/2004/0000950152-04-008932/item9a.txt ADDED
@@ -0,0 +1,16 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ ITEM 9A.
2
+ CONTROLS AND PROCEDURES
3
+ As of September 30, 2004, an evaluation was completed under the supervision and
4
+ with the participation of Meridian’s management, including Meridian’s Chief
5
+ Executive Officer and Chief Financial Officer, of the effectiveness of the
6
+ design and operation of Meridian’s disclosure controls and procedures pursuant
7
+ to Rule 13a-15(b) and 15d-15(b) promulgated under the Securities Exchange Act
8
+ of 1934, as amended. Based on that evaluation, Meridian’s management,
9
+ including the CEO and CFO, concluded that Meridian’s disclosure controls and
10
+ procedures were effective as of September 30, 2004. There have been no changes
11
+ in Meridian’s internal controls over financial reporting identified in
12
+ connection with the evaluation of internal controls that occurred during the
13
+ last fiscal quarter that has materially affected, or is reasonably likely to
14
+ affect, Meridian’s internal controls over financial reporting, or in other
15
+ factors that could significantly affect internal controls subsequent to
16
+ September 30, 2004.
raw/filings/0000794172/2004/0000950152-04-008932/rp_note.txt ADDED
File without changes
raw/filings/0000794172/2004/0000950152-04-008932/rpt_disclosure.txt ADDED
File without changes
raw/filings/0000794172/2005/0000950152-05-009857/filing.txt ADDED
The diff for this file is too large to render. See raw diff
 
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1
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2
+ 0000794172,VIVO,MERIDIAN BIOSCIENCE INC,10-K,2005-12-09,2005-09-30,2005-12-09T20:06:00.000Z,0000950152-05-009857,l17079ae10vk.htm,"MERIDIAN BIOSCIENCE, INC. 10-K/FYE 9-30-05",704975,0,0,https://www.sec.gov/Archives/edgar/data/794172/000095015205009857/l17079ae10vk.htm,https://www.sec.gov/Archives/edgar/data/794172/000095015205009857/,2005,2005,1
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1
+ ITEM 1.
2
+ BUSINESS
3
+ Overview
4
+ Meridian is a fully-integrated life science company whose principal businesses are (i) the
5
+ development, manufacture, sale and distribution of diagnostic test kits, primarily for certain
6
+ respiratory, gastrointestinal, viral and parasitic infectious diseases, (ii) the manufacture and
7
+ distribution of bulk antigens, antibodies, and reagents used by researchers and other diagnostic
8
+ manufacturers and (iii) the contract manufacture of proteins and other biologicals for use by
9
+ biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines. By
10
+ exploiting revenue opportunities across research, clinical diagnostics, and therapeutic areas for
11
+ key biologicals, Meridian can maximize revenues, efficiently invest in research and development,
12
+ and increase profitability of manufacturing operations.
13
+ Operating Segments
14
+ Meridian’s reportable operating segments are US Diagnostics, European Diagnostics, and Life
15
+ Science. While the scientific foundation of these segments is essentially the same, the market
16
+ dynamics, competitive trends, regulatory requirements, and sales and marketing approach vary
17
+ substantially. The US Diagnostics operating segment consists of research and development and
18
+ manufacturing operations in Cincinnati, Ohio, and the sale and distribution of diagnostic test kits
19
+ in the US and countries outside of Europe, Africa and the Middle East. The European Diagnostics
20
+ operating segment consists of the sale and distribution of diagnostic test kits in Europe, Africa,
21
+ and the Middle East. The Life Science operating segment consists of manufacturing operations in
22
+ Memphis, Tennessee; Saco, Maine; and Boca Raton, Florida; the sale and distribution of bulk
23
+ antigens, antibodies and bioresearch reagents domestically and abroad; and contract research and
24
+ development and manufacturing services. The Life Science operating segment consists of the Viral
25
+ Antigens, BIODESIGN, and OEM Concepts businesses. Financial information for Meridian’s operating
26
+ segments is included in Note 8 to the consolidated financial statements contained herein.
27
+ Meridian’s primary source of domestic and international revenues continues to be its core
28
+ diagnostic products, which represented 77% of consolidated net sales for fiscal 2005. Meridian’s
29
+ diagnostic products provide accuracy, simplicity, and speed, enable early diagnosis and treatment
30
+ of common, acute medical conditions, and provide for better patient outcomes at reduced costs.
31
+ Meridian targets diagnostics for disease states that (i) are acute conditions where rapid diagnosis
32
+ impacts patient outcomes, (ii) have favorable demographic and disease profiles, (iii) are
33
+ underserved by current diagnostic products, and (iv) have difficult sample handling
34
+ -4-
35
+ Table of Contents
36
+ requirements. This approach has allowed Meridian to establish significant market share in its
37
+ target disease states.
38
+ Meridian expects that its Life Science operating segment will serve as a key platform for sourcing
39
+ biologicals and technologies, by acquisition or license, for development of new products for all of
40
+ Meridian’s operating segments. One of Meridian’s specific strategies in this area is to target
41
+ biologicals that have commercial product applications across multiple markets, such as human
42
+ diagnostics, veterinary diagnostics, and therapeutics. This strategy is expected to leverage
43
+ research and development resources as products can be developed with all three markets in mind,
44
+ rather than on a market-by-market basis.
45
+ Meridian’s
46
+ website is www.meridianbioscience.com. Meridian makes available its Annual Reports on
47
+ Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and any amendments thereto,
48
+ free of charge through this website, as soon as reasonably practicable after such material has been
49
+ electronically filed with or furnished to the Securities and Exchange Commission. These reports
50
+ may also be read and copied at the SEC’s public reference room at 100 F Street, N.E., Room 1580,
51
+ Washington, DC 20549, phone 1-800-732-0330. The SEC maintains an internet site containing these
52
+ filings and other information regarding Meridian at http://www.sec.gov.
53
+ US Diagnostics Operating Segment
54
+ Overview
55
+ The US Diagnostics operating segment’s business focuses on the development, manufacture, sale and
56
+ distribution of diagnostic test kits, primarily for certain respiratory, gastrointestinal, viral
57
+ and parasitic infectious diseases. In addition to diagnostic test kits, products also include
58
+ transport media that store and preserve specimen samples from patient collection to laboratory
59
+ testing. Third-party sales for this operating segment were $53,485,000, $48,153,000 and
60
+ $39,906,000 for fiscal 2005, 2004 and 2003, respectively, reflecting a compound annual growth rate
61
+ of 16%. As of September 30, 2005, the US Diagnostics operating segment had 245 employees.
62
+ Meridian’s diagnostic test kits utilize immunodiagnostic technologies, which test samples of blood,
63
+ urine, stool, and other body fluids or tissue for the presence of antigens and antibodies of
64
+ specific infectious diseases. Specific immunodiagnostic technologies used in Meridian’s diagnostic
65
+ test kits include enzyme immunoassay, immunofluorescence, particle agglutination/aggregation,
66
+ immunodiffusion, complement fixation, and chemical stains. The enzyme immunoassay technology is
67
+ used in multiple test formats; the Premier ä products for large volume users and the
68
+ ImmunoCard â products for single test, low volume users.
69
+ -5-
70
+ Table of Contents
71
+ Meridian’s diagnostic products are used principally in the detection of respiratory diseases, such
72
+ as pneumonia, valley fever, influenza, and Respiratory Syncytial Virus (RSV); gastrointestinal
73
+ diseases, such as stomach ulcers (H. pylori ), antibiotic associated diarrhea (C. difficile ) and
74
+ pediatric diarrhea (Rotavirus and Adenovirus); viral diseases, such as Mononucleosis, Herpes
75
+ Simplex, Chicken Pox and Shingles (Varicella-Zoster) and Cytomegalovirus (organ transplant
76
+ infections); and parasitic diseases, such as Giardiasis, Cryptosporidiosis and Lyme. The primary
77
+ markets and customers for these products are reference laboratories, hospitals, and physicians’
78
+ offices.
79
+ Market Trends
80
+ The global market for infectious disease tests continues to expand as new disease states are
81
+ identified, new therapies become available, and worldwide standards of living and access to health
82
+ care improve. More importantly, within this market there is a continuing shift from conventional
83
+ testing, which requires highly trained personnel and lengthy turnaround times for test results, to
84
+ more technologically advanced testing which can be performed by less highly trained personnel and
85
+ completed in minutes or hours. These technological advances permit accurate testing to occur
86
+ outside the traditional hospital or laboratory.
87
+ The increasing pressures to contain total health care costs have accelerated the increased use of
88
+ diagnostic testing and the market shift to alternate sites. With rapid and accurate diagnoses of
89
+ infectious diseases, physicians can pinpoint appropriate therapies quickly, leading to faster
90
+ recovery, shorter hospital stays and lower treatment expense. In addition, these pressures have
91
+ led to a major consolidation among reference laboratories and the formation of multi-hospital
92
+ alliances that have reduced the number of institutional customers for diagnostic products and
93
+ resulted in changes in buying practices. Specifically, multi-year exclusive or primary source
94
+ marketing or distribution contracts with institutional customers have become more common, replacing
95
+ less formal distribution arrangements of shorter duration and involving lower product volumes.
96
+ Sales and Marketing
97
+ The US Diagnostics operating segment’s sales and distribution network consists of a direct sales
98
+ force in the US and independent distributors in the US and abroad. The direct sales force consists
99
+ of one director of sales, three regional sales managers, one director of corporate health systems,
100
+ one director of managed health care, 24 technical sales representatives, and three inside sales
101
+ representatives. Meridian utilizes two primary independent distributors in the US, who accounted
102
+ for 44% of the US Diagnostics operating segment’s third-party sales in fiscal 2005. Meridian
103
+ participates in the selling effort for key customers where these independent distributors are
104
+ utilized. Therefore, Meridian believes that the loss of either of these independent distributors
105
+ would not have a material adverse effect on the Company.
106
+ -6-
107
+ Table of Contents
108
+ Consolidation of the US healthcare industry is expected to continue and potentially affect
109
+ Meridian’s customers. Industry consolidation puts pressure on pricing and aggregates buying power.
110
+ In response, in the last five years, Meridian has entered into, extended, or renewed several
111
+ exclusive multiple-year contracts with consolidated healthcare providers and supply agreements with
112
+ major reference laboratories.
113
+ Products and Markets
114
+ Meridian has expertise in the development and manufacture of products based on multiple core
115
+ diagnostic technologies, each of which enables the visualization and identification of
116
+ antigen/antibody reactions for specific pathogens. As a result, Meridian is able to develop and
117
+ manufacture diagnostic tests in a variety of formats that satisfy customer needs and preferences,
118
+ whether in a hospital, commercial or reference laboratory or alternate site location. Meridian’s
119
+ product offering consists of over 200 medical diagnostic products. Meridian’s products generally
120
+ range in list price from $1 per test to $33 per test.
121
+ Meridian’s product technologies include enzyme immunoassay, immunofluorescence, particle
122
+ agglutination/aggregation, immunodiffusion, complement fixation and chemical stains.
123
+ Enzyme Immunoassay (EIA) - Products incorporating the EIA technology achieve extremely high
124
+ levels of accuracy in detecting disease-related antigens or antibodies through the use of special
125
+ color-based enzyme-substrate reactions. Meridian utilizes this technology in its multiple test
126
+ format, the Premier Ô product for large volume users, and in its single test formats, the
127
+ Immuno Card ® , Immuno Card STAT! ® and MONOLERT ® products, for lower
128
+ volume users.
129
+ Immunofluorescence - When the microscopic visualization of an antigen/antibody reaction is
130
+ necessary or desired, immunofluorescence technology is frequently utilized. Fluorescing
131
+ immunochemicals, in the presence of the target antigen or antibody, can be viewed via a fluorescent
132
+ microscope. Meridian utilizes this technology in its MERIFLUOR ® products.
133
+ Particle Agglutination/Aggregation - This technology utilizes microparticles (e.g., latex,
134
+ red blood cells) coated with specific antigens or antibodies that form visible aggregates in the
135
+ presence of a specimen containing the complementary antigen or antibody. This technology is rapid
136
+ and economical and is used in Meridian’s MERITEC ® , MeriStar ® and
137
+ MONOSPOT ® products.
138
+ Other Technologies - Meridian utilizes other technologies that include immunodiffusion,
139
+ complement fixation, and chemical stains. Meridian also manufactures and markets specimen
140
+ collection, transportation, preservation and concentration products, such as Para-Pak ® ,
141
+ Macro-CON ® and Spin-Con ® .
142
+ Research and Development
143
+ -7-
144
+ Table of Contents
145
+ The US Diagnostics operating segment’s research and development organization consists of 11
146
+ research scientists with expertise in biochemistry, immunology, mycology, bacteriology, virology,
147
+ and parasitology. Research and development expenses for the US Diagnostics operating segment for
148
+ fiscal 2005, 2004 and 2003 were $2,998,000, $3,131,000 and $2,527,000, respectively. This research
149
+ and development organization focuses its activities on new applications for Meridian’s existing
150
+ technologies, improvements to existing products and development of new technologies. Research and
151
+ development efforts may occur in-house or with collaborative partners. Meridian believes that
152
+ internally developed products are a key source for sustaining revenue growth. Meridian’s
153
+ internally developed products include Premier ä Platinum HpSA, Premier ä Toxins A & B,
154
+ and Immuno Card Ò C. difficile Toxins A & B, which together accounted for 30% of the US
155
+ Diagnostics operating segment’s third-party sales during fiscal 2005.
156
+ Manufacturing
157
+ Meridian’s immunodiagnostic products require the production of highly specific and sensitive
158
+ antigens and antibodies. Meridian produces substantially all of its own requirements including
159
+ monoclonal antibodies and polyclonal antibodies, plus a variety of fungal, bacterial, and viral
160
+ antigens. Meridian believes it has sufficient manufacturing capacity for anticipated growth.
161
+ Intellectual Property, Patents, and Licenses
162
+ Meridian owns or licenses US and foreign patents for approximately 25 products manufactured by the
163
+ US Diagnostics operating segment, including Premier ä Platinum HpSA. In the absence of patent
164
+ protection, Meridian may be vulnerable to competitors who successfully replicate Meridian’s
165
+ production and manufacturing technologies and processes. Meridian’s employees are required to
166
+ execute confidentiality and non-disclosure agreements designed to protect Meridian’s proprietary
167
+ products. Meridian believes that its products and technologies do not infringe the proprietary
168
+ rights of any third parties.
169
+ Government Regulation
170
+ Meridian’s diagnostic products are regulated by the Food & Drug Administration (FDA) as “devices”
171
+ pursuant to the Federal Food, Drug, and Cosmetic Act (FDCA). Under the FDCA, medical devices are
172
+ classified into one of three classes (i.e., Class I, II or III). Class I and II devices are not
173
+ expressly approved by the FDA, but, instead, are “cleared” for marketing. Class III devices
174
+ generally must receive “pre-market approval” from the FDA as to safety and effectiveness.
175
+ Each of the diagnostic products currently marketed by Meridian in the United States has been
176
+ cleared by the FDA pursuant to the 510(k) clearance process or is exempt from such requirements.
177
+ Meridian believes that
178
+ -8-
179
+ Table of Contents
180
+ most, but not all, products under development will be classified as Class I or II medical devices
181
+ and, in the case of Class II devices, will be eligible for 510(k) clearance.
182
+ A 510(k) clearance will be granted if the submitted data establishes that the proposed device is
183
+ “substantially equivalent” to an existing Class I or Class II medical device or to a Class III
184
+ medical device for which the FDA has not required pre-market approval. The 510(k) clearance
185
+ process for “substantially equivalent” devices allows product sales to be made after the filing of
186
+ an application and upon acknowledgment by the FDA, typically within 90 to 120 days after
187
+ submission. If the FDA requests additional information, the product cannot be sold in the US until
188
+ the application has been supplemented and upon acknowledgment by the FDA within 90 to 120 days of
189
+ the supplemental application. In practice, the FDA has been granting clearance in about 90 days
190
+ following submission of the supplemental information. If there are no existing FDA-approved
191
+ products or processes comparable to a diagnostic product or process, approval by the FDA involves
192
+ the more lengthy pre-market approval procedures.
193
+ Sales of Meridian’s diagnostic products in foreign countries are subject to foreign government
194
+ regulation, the requirements of which vary substantially from country to country. The time
195
+ required to obtain approval by a foreign country may be longer or shorter than that required for
196
+ FDA approval and the requirements may differ.
197
+ European Diagnostics Operating Segment
198
+ The European Diagnostics operating segment’s business focuses on the sale and distribution of
199
+ diagnostic test kits, those manufactured by the US Diagnostics operating segment and others
200
+ manufactured by third-party vendors. Approximately 67% of third-party sales for fiscal 2005 were
201
+ products purchased from the US Diagnostics operating segment. Third-party sales for this operating
202
+ segment were $17,818,000, $15,412,000 and $13,756,000 for fiscal 2005, 2004 and 2003, respectively,
203
+ reflecting a compound annual growth rate of 14%. As of September 30, 2005, the European
204
+ Diagnostics operating segment had 37 employees, including 15 employees in the direct sales force.
205
+ The European Diagnostics operating segment’s sales and distribution network consists of direct
206
+ sales forces in Belgium, France, Holland, and Italy, and independent distributors in other European
207
+ countries, Africa and the Middle East. The European Diagnostics operating segment maintains a
208
+ distribution center in Milan, Italy. The primary markets and customers for this operating segment
209
+ are hospitals and reference laboratories.
210
+ During the last two years, market conditions have begun to improve in European markets. Due to the
211
+ introduction of new products and improvements in general market conditions, sales in local
212
+ currency, the Euro, increased 11% in fiscal 2005, compared to fiscal 2004, and increased 7% during
213
+ the last six months of fiscal 2004, compared to the last six months of fiscal 2003.
214
+ -9-
215
+ Table of Contents
216
+ The European Diagnostics operating segment’s functional currency is the Euro. The translation of
217
+ Euros into US dollars is subject to exchange rate fluctuations.
218
+ Life Science Operating Segment
219
+ Overview
220
+ The Life Science operating segment’s business focuses on the development, manufacture, sale, and
221
+ distribution of bulk antigens, antibodies, and reagents used by researchers and other diagnostic
222
+ companies, as well as the contract manufacturing of proteins and other biologicals used by
223
+ biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines.
224
+ Third-party sales for this operating segment were $21,662,000, $16,041,000 and $12,202,000 for
225
+ fiscal 2005, 2004 and 2003, respectively, reflecting a compound annual growth rate of 19%,
226
+ including the OEM Concepts acquisition discussed below. The Life Science operating segment
227
+ consists of Meridian’s Viral Antigens, BIODESIGN and OEM Concepts businesses. As of September 30,
228
+ 2005, the Life Science operating segment had 108 employees.
229
+ Most of the revenue for the Life Science operating segment currently comes from the manufacture,
230
+ sale and distribution of bulk antigens, antibodies, and reagents used by researchers and other
231
+ diagnostic companies. During fiscal 2005, 23% of third-party sales for this segment were to one
232
+ customer, a substantial portion of which is under exclusive supply agreements that expire in fiscal
233
+ 2007. Meridian has a long-standing relationship with this customer, and although there can be no
234
+ assurances, Meridian intends to renew these supply agreements in the normal course of business.
235
+ On January 31, 2005, Meridian completed its acquisition of OEM Concepts, Inc., a large-volume
236
+ manufacturer of monoclonal antibodies that are critical components of commercial diagnostic
237
+ products used in the diagnosis of infectious diseases and in the monitoring of human protein levels
238
+ in metabolic disorders, pregnancy, and cardiac disease. OEM Concepts adds custom ascites
239
+ manufacturing capabilities and also diversifies Meridian’s customer base of major diagnostic
240
+ companies. OEM Concepts contributed revenues of $3,087,000 for eight months during fiscal 2005.
241
+ Viral Antigens’ protein production facility serves as an enabling technology for process
242
+ development and large-scale manufacturing for biologicals used in new drugs and vaccines. The size
243
+ of the facility is intended to accommodate manufacturing requirements for Phase I and Phase II
244
+ clinical trials. The customer base for this aspect of the Life Science business includes
245
+ biopharmaceutical and biotechnology companies, as well as government agencies, such as the National
246
+ Institutes of Health. Production cycles, in some cases, are longer than historical bulk
247
+ manufacturing of antigens, antibodies, and reagents. See Note 1(i) to the Consolidated Financial
248
+ Statements herein for revenue recognition policies. Meridian’s revenues for contract research and
249
+ -10-
250
+ Table of Contents
251
+ development services and contract manufacturing services increased to $3,053,000 in fiscal 2005
252
+ from $1,528,000 in fiscal 2004.
253
+ Growth Strategies
254
+ Growth strategies for the Life Science operating segment include (i) developing new product
255
+ applications from existing technologies and (ii) acquisition or licensing of biologicals and
256
+ technologies for development of new products.
257
+ Contract manufacturing of proteins and other biologicals used in research for new drugs and
258
+ vaccines is an example of a significant new product application built from Meridian’s existing
259
+ expertise in manufacturing bulk antigens and reagents using cell culture techniques.
260
+ Meridian expects that its Life Science operating segment will serve as a key platform for sourcing
261
+ biologicals and technologies, by acquisition or license, for development of new products for all of
262
+ Meridian’s operating segments. One of Meridian’s specific strategies in this area is to target
263
+ biologicals that have commercial product applications across multiple markets, such as human
264
+ diagnostics, veterinary diagnostics, and therapeutics. This strategy is expected to leverage
265
+ research and development resources as products can be developed with all three markets in mind,
266
+ rather than on a market-by-market basis.
267
+ Markets
268
+ The Life Science operating segment has targeted three primary market segments for its products and
269
+ services: bulk biomedical reagents, drug and vaccine discovery, and drug and vaccine development.
270
+ The customer base for bulk biomedical reagents is large and fragmented, and includes other
271
+ diagnostic manufacturers as well as researchers in academia and the pharmaceutical and
272
+ biotechnology industries. The market segments for drug and vaccine discovery and development are
273
+ intended to be served via contract manufacturing in the protein production laboratory discussed
274
+ above.
275
+ Sales and Marketing
276
+ The Life Science operating segment applies sales and marketing efforts in two different manners
277
+ that are designed to complement one another. An internal sales and marketing staff, as well as a
278
+ website, have been built to market bulk biomedical reagents directly to a large and fragmented
279
+ customer base. The website provides detailed technical information and capability to submit
280
+ purchase orders. For major bulk biomedical reagent customers, scientific resources have been
281
+ dedicated to establish sole-source supply arrangements. For drug and vaccine discovery and
282
+ development, management and scientific resources are dedicated to each potential customer.
283
+ -11-
284
+ Table of Contents
285
+ Research and Development
286
+ The Life Science operating segment’s research and development organization consists of five
287
+ research scientists. Research and development expenses for the Life Science operating segment for
288
+ fiscal 2005, 2004 and 2003 were $823,000, $1,226,000 and $1,348,000, respectively. This research
289
+ and development organization focuses its activities on the protein production laboratory,
290
+ developing new biomedical reagents, and working with the US Diagnostics operating segment in the
291
+ development of products that have commercial application across multiple markets, such as human
292
+ diagnostics, veterinary diagnostics, and therapeutics.
293
+ Manufacturing and Government Regulation
294
+ The proteins that are produced in Viral Antigens’ protein production facility are intended to be
295
+ used as “injectibles”. As such, they are produced under cGMP Regulations for Biologics and Human
296
+ Drugs under the auspices of the FDA. Approval and licensing, following clinical trials, of these
297
+ products is the responsibility of the applicant, who owns the rights to each protein. Viral
298
+ Antigens may or may not be the applicant depending on specific circumstances with particular
299
+ customers.
300
+ Competition
301
+ Diagnostics
302
+ The market for diagnostic tests is a multi-billion dollar international industry, which is highly
303
+ competitive. Many of Meridian’s competitors are larger with greater financial, research,
304
+ manufacturing and marketing resources. Important competitive factors of Meridian’s products
305
+ include product quality, price, ease of use, customer service, and reputation. In a broader sense,
306
+ industry competition is based upon scientific and technological capability, proprietary know-how,
307
+ access to adequate capital, the ability to develop and market products and processes, the ability
308
+ to attract and retain qualified personnel and the availability of patent protection. To the extent
309
+ that Meridian’s product lines do not reflect technological advances, Meridian’s ability to compete
310
+ in those product lines could be adversely affected.
311
+ Companies competing in the diagnostic test industry generally focus on a limited number of tests or
312
+ limited segments of the market. As a result, the diagnostic test industry is highly fragmented and
313
+ segmented. Hundreds of companies in the United States alone supply immunodiagnostic tests. These
314
+ companies range from multi-national health care companies, for which immunodiagnostics is one line
315
+ of business, to small start-up companies. Of central importance in the industry are mid-sized
316
+ medical diagnostic specialty companies, like Meridian, that offer multiple, broad product lines and
317
+ have the ability to deliver new, high value products quickly to the marketplace. Among the
318
+ companies with which Meridian competes in the marketing of one or
319
+ -12-
320
+ Table of Contents
321
+ more of its products are Abbott Laboratories Inc., Becton, Dickinson and Company, Diagnostic
322
+ Products Corporation, Quidel Corporation, and Inverness Medical.
323
+ Life Science
324
+ The market for bulk biomedical reagents is highly competitive. Important competitive factors
325
+ include product quality, price, customer service, and reputation. Where sole-source supply
326
+ arrangements do not exist, Meridian faces competitors, many of which have greater financial,
327
+ research and development, sales and marketing, and manufacturing resources. From time to time,
328
+ customers may choose to manufacture their biomedical reagents in-house rather than purchase from
329
+ outside vendors such as Meridian.
330
+ The market for contract manufacturing in a validated cGMP facility such as Meridian’s protein
331
+ production laboratory at its Viral Antigens facility is also competitive. Important competitive
332
+ factors include reputation, customer service, and price. Although the product application for this
333
+ facility was built from Meridian’s existing expertise in cell culture manufacturing techniques,
334
+ Meridian faces competitors with greater experience in contract manufacturing in a cGMP environment.
335
+ Acquisitions
336
+ Acquisitions have played an important role in the historical growth of Meridian’s businesses.
337
+ Meridian’s acquisition objectives are to, among other things, (i) enhance product offerings, (ii)
338
+ improve product distribution capabilities, (iii) provide access to new markets, and/or (iv) provide
339
+ access to key biologicals that lead to new products.
340
+ Recent examples of completed acquisitions include Gull Laboratories in fiscal 1999, Viral Antigens
341
+ in fiscal 2000, and OEM Concepts in fiscal 2005. The Gull acquisition enhanced product offerings,
342
+ expanded sales and distribution capabilities in Europe, and provided the initial access into the
343
+ Life Science market for Meridian (through the BIODESIGN business). The Viral Antigens acquisition,
344
+ coupled with the opening of the protein production facility, solidified Meridian’s entry into the
345
+ Life Science market. The OEM Concepts acquisition strengthened Meridian’s Life Science business by
346
+ adding custom ascites manufacturing capabilities and diversifying Meridian’s customer base of major
347
+ diagnostic manufacturing companies.
348
+ During September 2005, Meridian completed an offering of 1,800,000 common shares, raising net
349
+ proceeds of $29,580,000. These proceeds are intended, in part, to fund future acquisitions.
350
+ Although Meridian cannot provide any assurance that it will consummate any acquisitions in the
351
+ future, Meridian expects that acquisitions will continue to serve as a source of new revenues and
352
+ earnings growth in the future.
353
+ -13-
354
+ Table of Contents
355
+ International Markets
356
+ International markets are an important source of revenue for Meridian’s operating segments. For
357
+ all operating segments combined, international sales were $30,232,000 or 33% of total fiscal 2005
358
+ sales, $24,916,000 or 31% of total fiscal 2004 sales and $23,220,000 or 35% of total fiscal 2003
359
+ sales. Domestic exports for the US Diagnostics and Life Science operating segments were
360
+ $12,414,000, $9,504,000 and $9,464,000 in fiscal 2005, 2004 and 2003, respectively. Meridian
361
+ expects to continue to look to international markets as a source of new revenues and growth in the
362
+ future.
363
+ Environmental
364
+ Meridian is a conditionally exempt small quantity generator of hazardous waste and has a US EPA
365
+ identification number. All hazardous material is manifested and disposed of properly. Meridian is
366
+ in compliance with applicable portions of the federal and state hazardous waste regulations and has
367
+ never been a party to any environmental proceeding.
raw/filings/0000794172/2005/0000950152-05-009857/item13.txt ADDED
@@ -0,0 +1,3 @@
 
 
 
 
1
+ Item 13
2
+ Certain Relationships and Related Transactions
3
+ 65
raw/filings/0000794172/2005/0000950152-05-009857/item9a.txt ADDED
@@ -0,0 +1,15 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ ITEM 9A.
2
+ CONTROLS AND PROCEDURES
3
+ As of September 30, 2005, an evaluation was completed under the supervision and with the
4
+ participation of Meridian’s management, including Meridian’s Chief Executive Officer and Chief
5
+ Financial Officer, of the effectiveness of the design and operation of Meridian’s disclosure
6
+ controls and procedures pursuant to Rule 13a-15(b) and 15d-15(b) promulgated under the Securities
7
+ Exchange Act of 1934, as amended. Based on that evaluation, Meridian’s management, including the
8
+ CEO and CFO, concluded that Meridian’s disclosure controls and procedures were effective as of
9
+ September 30, 2005. There have been no changes in Meridian’s internal control over financial
10
+ reporting identified in connection with the evaluation of internal control that occurred during the
11
+ fourth fiscal quarter that has materially affected, or is reasonably likely to affect, Meridian’s
12
+ internal control over financial reporting, or in other factors that could significantly affect
13
+ internal control subsequent to September 30, 2005.
14
+ The Company’s internal control report is included in this Annual Report on Form 10-K after Item 8,
15
+ under the caption “Management’s Report on Internal Control over Financial Reporting”.
raw/filings/0000794172/2005/0000950152-05-009857/rp_note.txt ADDED
File without changes
raw/filings/0000794172/2005/0000950152-05-009857/rpt_disclosure.txt ADDED
File without changes
raw/filings/0000794172/2007/0000950152-07-009366/filing.txt ADDED
The diff for this file is too large to render. See raw diff
 
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2
+ 0000794172,VIVO,MERIDIAN BIOSCIENCE INC,10-K,2007-11-30,2007-09-30,2007-11-30T19:37:02.000Z,0000950152-07-009366,l28988ae10vk.htm,"MERIDIAN BIOSCIENCE, INC. 10-K",903996,0,0,https://www.sec.gov/Archives/edgar/data/794172/000095015207009366/l28988ae10vk.htm,https://www.sec.gov/Archives/edgar/data/794172/000095015207009366/,2007,2007,1
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1
+ ITEM 1.
2
+ BUSINESS
3
+ Overview
4
+ Meridian is a fully-integrated life science company whose principal businesses are (i) the
5
+ development, manufacture, sale and distribution of diagnostic test kits, primarily for certain
6
+ respiratory, gastrointestinal, viral and parasitic infectious diseases, (ii) the manufacture and
7
+ distribution of bulk antigens, antibodies, and reagents used by researchers and other diagnostic
8
+ manufacturers and (iii) the contract development and manufacture of proteins and other biologicals
9
+ for use by biopharmaceutical and biotechnology companies engaged in research for new drugs and
10
+ vaccines. By exploiting revenue opportunities across research, clinical diagnostics, and
11
+ therapeutics, we strive to maximize revenues, efficiently invest in research and development, and
12
+ increase profitability of our manufacturing operations.
13
+ Operating Segments
14
+ Our reportable operating segments are US Diagnostics, European Diagnostics, and Life Science. The
15
+ US Diagnostics operating segment consists of manufacturing operations in Cincinnati, Ohio, and the
16
+ sale and distribution of diagnostics test kits in the US and countries outside of Europe, Africa
17
+ and the Middle East. The European Diagnostics operating segment consists of the sale and
18
+ distribution of diagnostics test kits in Europe, Africa and the Middle East. The Life Science
19
+ operating segment consists of manufacturing operations in Memphis, Tennessee, Saco, Maine, and Boca
20
+ Raton, Florida, and the sale and distribution of bulk antigens, antibodies, and bioresearch
21
+ reagents domestically and abroad. The Life Science operating segment also includes the contract
22
+ development and manufacture of proteins and other biologicals for use by biopharmaceutical and
23
+ biotechnology companies engaged in research for new drugs and vaccines. Financial
24
+ -3-
25
+ Table of Contents
26
+ information for Meridian’s operating segments is included in Note 9 to the consolidated financial
27
+ statements contained herein.
28
+ Our primary source of domestic and international revenues continues to be core diagnostic products,
29
+ which represented 80% of consolidated net sales for fiscal 2007. Our diagnostic products provide
30
+ accuracy, simplicity, and speed, enable early diagnosis and treatment of common, acute medical
31
+ conditions, and provide for better patient outcomes at reduced costs. We target diagnostics for
32
+ disease states that (i) are acute conditions where rapid diagnosis impacts patient outcomes, (ii)
33
+ have opportunistic demographic and disease profiles, (iii) are underserved by current diagnostic
34
+ products, and (iv) have difficult sample handling requirements. This approach has allowed us to
35
+ establish significant market share in our target disease states.
36
+ Our website is www.meridianbioscience.com . We make available our Annual Reports on Form 10-K,
37
+ Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and any amendments thereto, free of
38
+ charge through this website, as soon as reasonably practicable after such material has been
39
+ electronically filed with or furnished to the Securities and Exchange Commission. These reports
40
+ may also be read and copied at the SEC’s public reference room at 100 F Street, N.E., Room 1580,
41
+ Washington, DC 20549, phone 1-800-732-0330. The SEC maintains an internet site containing these
42
+ filings and other information regarding Meridian at http://www.sec.gov .
43
+ US Diagnostics Operating Segment
44
+ Overview
45
+ Our US Diagnostics operating segment’s business focuses on the development, manufacture, sale and
46
+ distribution of diagnostic test kits, primarily for certain respiratory, gastrointestinal, viral
47
+ and parasitic infectious diseases. In addition to diagnostic test kits, products also include
48
+ transport media that store and preserve specimen samples from patient collection to laboratory
49
+ testing. Third-party sales for this operating segment were $74,845,000, $65,721,000 and
50
+ $53,485,000 for fiscal 2007, 2006 and 2005, respectively, reflecting a three-year compound annual
51
+ growth rate of 16%. As of September 30, 2007, our US Diagnostics operating segment had 250
52
+ employees.
53
+ Our diagnostic test kits utilize immunodiagnostic technologies, which test samples of blood, urine,
54
+ stool, and other body fluids or tissue for the presence of antigens and antibodies of specific
55
+ infectious diseases. Specific immunodiagnostic technologies used in our diagnostic test kits
56
+ include enzyme immunoassay, immunofluorescence, particle agglutination/aggregation,
57
+ immunodiffusion, complement fixation, and chemical stains.
58
+ -4-
59
+ Table of Contents
60
+ Our diagnostic products are used principally in the detection of respiratory diseases, such as
61
+ pneumonia, valley fever, influenza, and Respiratory Syncytial Virus (RSV); gastrointestinal
62
+ diseases, such as stomach ulcers ( H. pylori ), antibiotic-associated diarrhea (C. difficile ) and
63
+ pediatric diarrhea (Rotavirus and Adenovirus); viral diseases, such as Mononucleosis, Herpes
64
+ Simplex, Chicken Pox and Shingles (Varicella-Zoster) and Cytomegalovirus (organ transplant
65
+ infections); and parasitic diseases, such as Giardiasis, Cryptosporidiosis and Lyme. The primary
66
+ markets and customers for these products are reference laboratories, hospitals, and physicians’
67
+ offices.
68
+ Market Trends
69
+ The global market for infectious disease tests continues to expand as new disease states are
70
+ identified, new therapies become available, and worldwide standards of living and access to health
71
+ care improve. More importantly, within this market there is a continuing shift from conventional
72
+ testing, which requires highly trained personnel and lengthy turnaround times for test results, to
73
+ more technologically advanced testing which can be performed by less highly trained personnel and
74
+ completed in minutes or hours.
75
+ The increasing pressures to contain total health care costs have accelerated the increased use of
76
+ diagnostic testing. With rapid and accurate diagnoses of infectious diseases, physicians can
77
+ pinpoint appropriate therapies quickly, leading to faster recovery, shorter hospital stays and
78
+ lower treatment expense. In addition, these pressures have led to a major consolidation among
79
+ reference laboratories and the formation of multi-hospital alliances that have reduced the number
80
+ of institutional customers for diagnostic products and resulted in changes in buying practices.
81
+ Specifically, multi-year exclusive or primary source marketing or distribution contracts with
82
+ institutional customers have become more common, replacing less formal distribution arrangements of
83
+ shorter duration and involving lower product volumes.
84
+ Sales and Marketing
85
+ Our US Diagnostics operating segment’s sales and distribution network consists of a direct sales
86
+ force in the US and independent distributors in the US and abroad. The direct sales force consists
87
+ of one senior director of sales, three regional sales managers, one director of corporate health
88
+ systems, one manager of corporate health systems, one director of health plan and payer markets,
89
+ one international distribution manager, 25 technical sales representatives, and three inside sales
90
+ representatives. We utilize two primary independent distributors in the US, who accounted for 51%
91
+ of the US Diagnostics operating segment’s third-party sales in fiscal 2007. We manage the selling
92
+ effort for key customers where these independent distributors are utilized.
93
+ Consolidation of the US healthcare industry is expected to continue and potentially affect our
94
+ customers. Industry consolidation puts pressure on pricing and aggregates buying power. In
95
+ response, we have looked to
96
+ -5-
97
+ Table of Contents
98
+ multi-year supply agreements with consolidated healthcare providers and major reference
99
+ laboratories to stabilize pricing.
100
+ Products and Markets
101
+ We have expertise in the development and manufacture of products based on multiple core diagnostic
102
+ technologies, each of which enables the visualization and identification of antigen/antibody
103
+ reactions for specific pathogens. Our product technologies include enzyme immunoassay,
104
+ immunofluorescence, particle agglutination/aggregation, immunodiffusion, complement fixation and
105
+ chemical stains. As a result, we are able to develop and manufacture diagnostic tests in a variety
106
+ of formats that satisfy customer needs and preferences, whether in a hospital, commercial or
107
+ reference laboratory or alternate site location. Our product offering consists of approximately
108
+ 140 medical diagnostic products. Our products generally range in list price from $1 per test to
109
+ $33 per test.
110
+ Research and Development
111
+ Our US Diagnostics operating segment’s research and development organization consists of 14
112
+ research scientists with expertise in biochemistry, immunology, mycology, bacteriology, virology,
113
+ and parasitology. Research and development expenses for the US Diagnostics operating segment for
114
+ fiscal 2007, 2006 and 2005 were $4,571,000, $3,342,000 and $3,043,000, respectively. This research
115
+ and development organization focuses its activities on new applications for our existing
116
+ technologies, improvements to existing products and development of new technologies. Research and
117
+ development efforts may occur in-house or with collaborative partners. We believe that new product
118
+ development is a key source for sustaining revenue growth. Our internally developed products
119
+ include Premier ä Platinum HpSA PLUS, Premier ä Toxins A & B, and
120
+ Immuno Card Ò Toxins A & B, which together accounted for 39% of our US Diagnostics
121
+ operating segment’s third-party sales during fiscal 2007.
122
+ We believe that the use of collaborative partners in the development of new products will
123
+ complement our internal research and development staff in a manner that allows us to bring products
124
+ to market more quickly than if development were to occur solely on an internal basis. During
125
+ August 2006, we entered into a partnership agreement with the Performance & Life Science Chemicals
126
+ Division of Merck KGaA, Darmstadt, Germany for the development of new clinical assays. Our first
127
+ product under this agreement, Immuno Card STAT! ® EHEC, was launched during the second
128
+ quarter of fiscal 2007.
129
+ Over the last 15 months, we have begun exploring and developing a molecular-based diagnostic
130
+ testing technology to complement our existing antigen/antibody-based testing technologies. This
131
+ first look at molecular-based testing started in October 2006, when we executed a license agreement
132
+ with Eiken Chemical Co., Ltd. that provides rights to Eiken’s loop-mediated isothermal
133
+ amplification technology. This license
134
+ -6-
135
+ Table of Contents
136
+ provides us with rights for infectious disease testing in the United States and 18 other geographic
137
+ markets. We currently have one product in active development using this molecular technology.
138
+ Several other infectious diseases have been identified for future development using this
139
+ technology.
140
+ Manufacturing
141
+ Our immunodiagnostic products require the production of highly specific and sensitive antigens and
142
+ antibodies. Meridian produces substantially all of its own requirements including monoclonal
143
+ antibodies and polyclonal antibodies, plus a variety of fungal, bacterial, and viral antigens. We
144
+ believe that we have sufficient manufacturing capacity for anticipated growth in the near term.
145
+ Intellectual Property, Patents, and Licenses
146
+ We own or license US and foreign patents for approximately 25 products manufactured by our US
147
+ Diagnostics operating segment, including Premier ä Platinum HpSA and Premier ä Platinum
148
+ HpSA Plus. In the absence of patent protection, we may be vulnerable to competitors who
149
+ successfully replicate our production and manufacturing technologies and processes. Our employees
150
+ are required to execute confidentiality and non-disclosure agreements designed to protect our
151
+ proprietary products.
152
+ Government Regulation
153
+ Our diagnostic products are regulated by the Food & Drug Administration (FDA) as “devices” pursuant
154
+ to the Federal Food, Drug, and Cosmetic Act (FDCA). Under the FDCA, medical devices are classified
155
+ into one of three classes (i.e., Class I, II or III). Class I and II devices are not expressly
156
+ approved by the FDA, but, instead, are “cleared” for marketing. Class III devices generally must
157
+ receive “pre-market approval” from the FDA as to safety and effectiveness.
158
+ Each of the diagnostic products currently marketed by us in the United States has been cleared by
159
+ the FDA pursuant to the 510(k) clearance process or is exempt from such requirements. We believe
160
+ that most, but not all, products under development will be classified as Class I or II medical
161
+ devices and, in the case of Class II devices, will be eligible for 510(k) clearance.
162
+ Sales of our diagnostic products in foreign countries are subject to foreign government regulation,
163
+ the requirements of which vary substantially from country to country. The time required to obtain
164
+ approval by a foreign country may be longer or shorter than that required for FDA approval and the
165
+ requirements may differ.
166
+ -7-
167
+ Table of Contents
168
+ European Diagnostics Operating Segment
169
+ Our European Diagnostics operating segment’s business focuses on the sale and distribution of
170
+ diagnostic test kits, manufactured both by our US Diagnostics operating segment and by third-party
171
+ vendors. Approximately 70% of third-party sales for fiscal 2007 for this operating segment were
172
+ products purchased from our US Diagnostics operating segment. Third-party sales for this operating
173
+ segment were $23,563,000, $19,828,000 and $17,818,000 for fiscal 2007, 2006 and 2005, respectively,
174
+ reflecting a three-year compound annual growth rate of 15%. As of September 30, 2007, the European
175
+ Diagnostics operating segment had 40 employees, including 17 employees in the direct sales force.
176
+ Our European Diagnostics operating segment’s sales and distribution network consists of direct
177
+ sales forces in Belgium, France, Holland, and Italy, and independent distributors in other European
178
+ countries, Africa and the Middle East. The European Diagnostics operating segment maintains a
179
+ distribution center in Milan, Italy. The primary markets and customers for this operating segment
180
+ are hospitals and reference laboratories.
181
+ The European Diagnostics operating segment’s functional currency is the Euro. The translation of
182
+ Euros into US dollars is subject to exchange rate fluctuations.
183
+ Life Science Operating Segment
184
+ Overview
185
+ Our Life Science operating segment’s business focuses on the development, manufacture, sale, and
186
+ distribution of bulk antigens, antibodies, and reagents used by researchers and other diagnostic
187
+ companies, as well as contract development and manufacturing services under clinical cGMP
188
+ conditions. Third-party sales for this operating segment were $24,555,000, $22,864,000 and
189
+ $21,662,000 for fiscal 2007, 2006 and 2005, respectively, reflecting a three-year compound annual
190
+ growth rate of 15%. As of September 30, 2007, our Life Science operating segment had 106
191
+ employees.
192
+ Most of the revenue for our Life Science operating segment currently comes from the manufacture,
193
+ sale and distribution of bulk antigens, antibodies, and reagents used by researchers and other
194
+ diagnostic companies. During fiscal 2007, 27% of third-party sales for this segment were to one
195
+ customer, a substantial portion of which is under exclusive supply agreements that have annual
196
+ automatic renewal provisions. We have a long-standing relationship with this customer, and
197
+ although there can be no assurances, we intend to renew these supply agreements in the normal
198
+ course of business.
199
+ Our clinical cGMP protein production facility in Memphis, Tennessee serves as an enabling
200
+ technology for process development and large-scale manufacturing for biologicals used in new drugs
201
+ and vaccines. The size of the facility is intended to accommodate manufacturing requirements for
202
+ Phase I and Phase II clinical trials.
203
+ -8-
204
+ Table of Contents
205
+ The customer base for this aspect of our Life Science business includes biopharmaceutical and
206
+ biotechnology companies, as well as government agencies, such as the National Institutes of Health.
207
+ Revenues for our Life Science operating segment, in the normal course of business, may be affected
208
+ from quarter to quarter by the timing and nature of arrangements for contract services work, which
209
+ may have longer production cycles than bioresearch reagents and bulk antigens and antibodies, as
210
+ well as buying patterns of major customers. See Note 1(j) to the Consolidated Financial Statements
211
+ herein for revenue recognition policies. Our revenues for contract services were $765,000,
212
+ $2,537,000, and $3,053,000 in fiscal 2007, 2006, and 2005, respectively.
213
+ Products, Markets and Growth Strategies
214
+ Our Life Science operating segment’s businesses have been assembled via acquisitions (BIODESIGN
215
+ International in fiscal 1999, Viral Antigens in fiscal 2000, and most recently, OEM Concepts in
216
+ fiscal 2005). Historically, these businesses were run autonomously. Over the last 18 months,
217
+ growth strategies have been developed around sales and marketing integration, new product
218
+ development integration, and four product brands. Our Life Science operating segment’s four
219
+ product brands can be described as follows:
220
+ •
221
+ BIODESIGN – Antibodies, antigens and assay development reagents
222
+ •
223
+ Viral Antigens – Custom infectious disease antigens
224
+ •
225
+ OEM Concepts – Custom antibody development and manufacturing, in vivo or in vitro
226
+ •
227
+ Meridian Biologics – Development and manufacturing of cGMP clinical grade biologicals
228
+ We believe that the business and growth prospects for all four product brands are favorable.
229
+ Products from the BIODESIGN, OEM Concepts, and Viral Antigens brands are marketed primarily to
230
+ diagnostic manufacturing customers as a source of raw materials for their products, or as an
231
+ outsourced step in their manufacturing processes. These markets are highly fragmented; however, we
232
+ believe we can be successful through product and marketing integration and customer penetration
233
+ across these three brands. These three brand names were aligned with the predecessor company
234
+ names, prior to acquisition, as we believe that there is value in the names of these long-standing
235
+ businesses. Sales efforts are focused on multi-year supply agreements in order to provide
236
+ stability in volumes and pricing. We believe this benefits both us and our customers.
237
+ With respect to our Meridian Biologics brand and contract services, we believe that the business
238
+ prospects are also favorable despite our recent revenue trends for this brand. In August 2007, we
239
+ were awarded a five-year contract (base year plus four option years) having a sales value of up to
240
+ $12,200,000 for the manufacturing of experimental clinical vaccines for the National Institutes of
241
+ Allergy and Infectious Diseases of the National Institutes of Health. This contract provides an
242
+ opportunity for steady production work over a five-year period.
243
+ -9-
244
+ Table of Contents
245
+ Research and Development
246
+ Our Life Science operating segment’s research and development organization consists of 5 research
247
+ scientists. Research and development expenses for our Life Science operating segment for fiscal
248
+ 2007, 2006 and 2005 were $1,514,000, $1,457,000 and $823,000, respectively. This research and
249
+ development organization has integrated its activities around the four product brands previously
250
+ discussed.
251
+ Manufacturing and Government Regulation
252
+ The cGMP clinical grade proteins that are produced in our Memphis facility are intended to be used
253
+ as “injectables”. As such, they are produced under cGMP Regulations for Biologics and Human Drugs
254
+ under the auspices of the FDA. Approval and licensing, following clinical trials, of these
255
+ products is the responsibility of the applicant, who owns the rights to each protein. Typically,
256
+ the customer is the applicant, not Meridian Life Science.
257
+ All of the Meridian Life Science facilities are ISO 9001:2000 certified and EC 1774:2002 approved.
258
+ Competition
259
+ Diagnostics
260
+ The market for diagnostic tests is a multi-billion dollar international industry, which is highly
261
+ competitive. Many of our competitors are larger with greater financial, research, manufacturing
262
+ and marketing resources. Important competitive factors of Meridian��s products include product
263
+ quality, price, ease of use, customer service, and reputation. In a broader sense, industry
264
+ competition is based upon scientific and technological capability, proprietary know-how, access to
265
+ adequate capital, the ability to develop and market products and processes, the ability to attract
266
+ and retain qualified personnel and the availability of patent protection. To the extent that our
267
+ product lines do not reflect technological advances, our ability to compete in those product lines
268
+ could be adversely affected.
269
+ The diagnostic test industry is highly fragmented and segmented. Of importance in the industry are
270
+ mid-sized medical diagnostic specialty companies, like Meridian, that offer multiple, broad product
271
+ lines and have the ability to deliver new, high value products quickly to the marketplace. Among
272
+ the companies with which we compete in the marketing of one or more of our products are Abbott
273
+ Laboratories Inc., Becton, Dickinson and Company, Diagnostic Products Corporation (acquired by
274
+ Siemens in 2006), Quidel Corporation, Inverness Medical, and Remel (owned by Thermo Fisher).
275
+ -10-
276
+ Table of Contents
277
+ Life Science
278
+ The market for bulk biomedical reagents is highly competitive. Important competitive factors
279
+ include product quality, price, customer service, and reputation. We face competitors, many of
280
+ which have greater financial, research and development, sales and marketing, and manufacturing
281
+ resources where sole-source supply arrangements do not exist. From time to time, customers may
282
+ choose to manufacture their biomedical reagents in-house rather than purchase from outside vendors
283
+ such as Meridian.
284
+ The market for contract manufacturing in a validated cGMP facility such as our Memphis facility is
285
+ also competitive. Important competitive factors include reputation, customer service, and price.
286
+ Although the product application for this facility was built from our existing expertise in cell
287
+ culture manufacturing techniques, we face competitors with greater experience in contract
288
+ manufacturing in a clinical cGMP environment.
289
+ Acquisitions
290
+ Acquisitions have played an important role in the historical growth of our businesses. Our
291
+ acquisition objectives include, among other things, (i) enhancing product offerings, (ii) improving
292
+ product distribution capabilities, (iii) providing access to new markets, and/or (iv) providing
293
+ access to key biologicals or new technologies that lead to new products. Although we cannot
294
+ provide any assurance that we will consummate any acquisitions in the future, we expect that the
295
+ potential for acquisitions will continue to serve as an opportunity for new revenues and earnings
296
+ growth in the future.
297
+ International Markets
298
+ International markets are an important source of revenue and future growth opportunities for all of
299
+ our operating segments. For all operating segments combined, international sales were $38,691,000
300
+ or 31% of total fiscal 2007 sales, $34,557,000 or 32% of total fiscal 2006 sales and $30,232,000 or
301
+ 33% of total fiscal 2005 sales. Domestic exports for our US Diagnostics and Life Science operating
302
+ segments were $15,128,000, $14,728,000 and $12,414,000 in fiscal 2007, 2006 and 2005, respectively.
303
+ We expect to continue to look to international markets as a source of new revenues and growth in
304
+ the future.
305
+ Environmental
306
+ We are a conditionally exempt small quantity generator of hazardous waste and have a US EPA
307
+ identification number. All hazardous material is manifested and disposed of properly. We are in
308
+ compliance with applicable portions of the federal and state hazardous waste regulations and have
309
+ never been a party to any environmental proceeding.
310
+ -11-
311
+ Table of Contents
raw/filings/0000794172/2007/0000950152-07-009366/item13.txt ADDED
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1
+ Item 13 Certain Relationships and Related Transactions
2
+ 73
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1
+ ITEM 9A.
2
+ CONTROLS AND PROCEDURES
3
+ As of September 30, 2007, an evaluation was completed under the supervision and with the
4
+ participation of our management, including our Chief Executive Officer and Chief Financial Officer,
5
+ of the effectiveness of the design and operation of our disclosure controls and procedures pursuant
6
+ to Rule 13a-15(b) and 15d-15(b) promulgated under the Securities Exchange Act of 1934, as amended.
7
+ Based on that evaluation, our management, including the CEO and CFO, concluded that our disclosure
8
+ controls and procedures were effective as of September 30, 2007. There have been no changes in our
9
+ internal control over financial reporting identified in connection with the evaluation of internal
10
+ control that occurred during the fourth fiscal quarter that has materially affected, or is
11
+ reasonably likely to affect, our internal control over financial reporting, or in other factors
12
+ that could significantly affect internal control subsequent to September 30, 2007, other than we
13
+ implemented, as planned, new enterprise resource planning and general ledger and financial
14
+ reporting systems for our Life Science facilities during the first quarter of fiscal 2008. These
15
+ new system implementations provide the appropriate foundation to support future growth in our Life
16
+ Science operating segment.
17
+ Our internal control report is included in this Annual Report on Form 10-K after Item 8, under the
18
+ caption “Management’s Report on Internal Control over Financial Reporting”.
19
+ -72-
20
+ Table of Contents
raw/filings/0000794172/2007/0000950152-07-009366/rp_note.txt ADDED
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raw/filings/0000794172/2007/0000950152-07-009366/rpt_disclosure.txt ADDED
@@ -0,0 +1,7 @@
 
 
 
 
 
 
 
 
1
+ CERTAIN RELATED PERSON TRANSACTIONS
2
+ Todd Motto, the adult son of William J. Motto, is Vice President, Sales and Marketing. Todd Motto received $343,311 in compensation for fiscal 2007. This compensation consisted of base salary of $168,273, bonus of $131,254 under the Officers’ Performance Compensation
3
+ 21
4
+ Plan, $8,834 of auto and professional allowances, $11,972 of retirement plan contributions, and $22,978 related to stock option awards.
5
+ Nasdaq rules require the Company to conduct an appropriate review of related party transactions required to be disclosed by the Company pursuant to SEC Regulation S-K Item 404 for potential conflict of interest situations on an ongoing basis and that all such transactions must be approved by the Audit Committee or another committee comprised of independent directors. As a result, the Audit Committee annually reviews all such related party transactions and approves each related party transaction if it determines that it is in the best interests of the Company. Additionally, the Audit Committee’s Charter provides it the authority to review, approve and monitor transactions involving the Company and “related persons” (directors and executive officers or their immediate family members, or shareholders owning five percent or greater of the Company’s outstanding stock). This also covers
6
+ any related person transaction that meets the minimum threshold for disclosure in the proxy statement under the relevant SEC rules (generally, transactions involving amounts exceeding $120,000 in which a related person has a direct or indirect material interest). In considering the transaction, the Audit Committee may consider all relevant factors, including, as applicable, (i) the Company’s business rationale for entering into the transaction; (ii) the alternatives to entering into a related person transaction; (iii) whether the transaction is on terms comparable to those available to third parties, or in the case of employment relationships, to employees generally; (iv) the potential for the transaction to lead to an actual or apparent conflict of interest and any safeguards imposed to prevent such actual or apparent conflicts; and (vi) the overall fairness of the transaction to the Company. While the Company adheres to this policy for potential related person transactions, the
7
+ policy, except as described above, is not in written form and approval of such related person transactions are evidenced by internal Company resolutions where applicable and/or our practice of approving transactions in this manner.
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+ 0000794172,VIVO,MERIDIAN BIOSCIENCE INC,10-K,2012-11-29,2012-09-30,2012-11-29T17:45:13.000Z,0001193125-12-485192,d413125d10k.htm,FORM 10-K,8130018,1,0,https://www.sec.gov/Archives/edgar/data/794172/000119312512485192/d413125d10k.htm,https://www.sec.gov/Archives/edgar/data/794172/000119312512485192/,2012,2012,1
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1
+ ITEM 1.
2
+ BUSINESS
3
+ Overview
4
+ Meridian is a fully-integrated
5
+ life science company with principal businesses in (i) the development, manufacture, sale and distribution of clinical diagnostic test kits, primarily for certain gastrointestinal, viral, respiratory and parasitic infectious diseases;
6
+ (ii) the manufacture and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents used by researchers and other diagnostic manufacturers; and (iii) the contract development and
7
+ manufacture of proteins and other biologicals under cGMP conditions for use by biopharmaceutical and biotechnology companies engaged in research for new drugs and vaccines. The company was incorporated in Ohio in 1976. Our principal corporate
8
+ offices are located in Cincinnati, Ohio, USA.
9
+ Our website is www.meridianbioscience.com . We make available our Annual Reports on Form
10
+ 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and any amendments thereto, free of charge through this website, as soon as reasonably practicable after such material has been electronically filed with or furnished to the
11
+ Securities and Exchange Commission (SEC). These reports may also be read and copied at the SEC’s public reference room at 100 F Street, N.E., Washington, DC 20549, phone number 1-800-732-0330. The SEC maintains an internet site containing these
12
+ filings and other information regarding Meridian at www.sec.gov . The information on our website is not and should not be considered part of this Annual Report on Form 10-K.
13
+ - 3 -
14
+ Table of Contents
15
+ Reportable Segments
16
+ Our reportable segments are U.S. Diagnostics, European Diagnostics and Life Science. The U.S. Diagnostics segment consists of manufacturing operations in Cincinnati, Ohio, and the sale and distribution of
17
+ diagnostic test kits in the U.S. and countries outside of Australia, Europe, Africa and the Middle East. The European Diagnostics segment consists of the sale and distribution of diagnostic test kits in Australia, Europe, Africa and the Middle East.
18
+ The Life Science segment consists of manufacturing operations in Memphis, Tennessee; Boca Raton, Florida; London, England; Luckenwalde, Germany; and Sydney, Australia, and the sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents,
19
+ nucleotides, competent cells and bioresearch reagents domestically and abroad. The Life Science segment also includes the contract development and manufacture of cGMP clinical grade proteins and other biologicals for use by biopharmaceutical and
20
+ biotechnology companies engaged in research for new drugs and vaccines. Financial information for Meridian’s segments is included in Note 8 to the consolidated financial statements.
21
+ Our primary source of revenues continues to be diagnostic products, with our Diagnostics segments providing 75% of consolidated net sales for fiscal 2012. Our diagnostic products provide accuracy,
22
+ simplicity and speed, enable early diagnosis and treatment of common, acute medical conditions, and provide for better patient outcomes at reduced costs. We target diagnostics for disease states that (i) are acute conditions where rapid
23
+ diagnosis impacts patient outcomes; (ii) have opportunistic demographic and disease profiles; (iii) are underserved by current diagnostic products; and (iv) have difficult sample handling requirements. This approach has allowed us to
24
+ establish significant market share in our target disease states. The acquisition of the Bioline group of companies (collectively the “Bioline Group”) in July 2010 dramatically increased the revenue base for our Life Science segment;
25
+ revenues for our Life Science segment represented 25% of consolidated net sales for fiscal 2012.
26
+ Products and Markets
27
+ We have expertise in the development and manufacture of products based on multiple core diagnostic technologies. Our product technologies include DNA
28
+ amplification, enzyme immunoassay, immunofluorescence, particle agglutination/aggregation, immunodiffusion, complement fixation and chemical stains. As a result, we are able to develop and manufacture diagnostic tests in a variety of formats that
29
+ satisfy customer needs and preferences, whether in a hospital, commercial or reference laboratory, or alternate site location. Our product offering consists of approximately 140 clinical diagnostic products.
30
+ Sales within our focus product families – C. difficile, foodborne and H. pylori – accounted for 62%, 58% and 51% of our U.S.
31
+ Diagnostics segment’s third-party sales during fiscal 2012, 2011 and 2010, respectively. These same product families accounted for 47%, 44% and 43% of consolidated net sales in fiscal 2012, 2011 and 2010, respectively.
32
+ - 4 -
33
+ Table of Contents
34
+ U.S. Diagnostics Segment
35
+ Overview
36
+ Our U.S. Diagnostics segment’s business focuses on the development,
37
+ manufacture, sale and distribution of diagnostic test kits, primarily for certain gastrointestinal, viral, respiratory and parasitic infectious diseases. In addition to diagnostic test kits, products also include transport media that store and
38
+ preserve specimen samples from patient collection to laboratory testing. Third-party sales for this segment were $108,000, $97,000 and $92,000 for fiscal 2012, 2011 and 2010, respectively, reflecting a three-year compound annual growth rate of 3%.
39
+ Excluding influenza-related sales, the three-year compound annual growth rate was 8%. The higher rate reflects the impact of influenza-related sales in 2009 in connection with the H1N1 influenza pandemic. As of September 30, 2012, our U.S.
40
+ Diagnostics segment had approximately 290 employees.
41
+ Our diagnostic test kits utilize immunodiagnostic and molecular
42
+ technologies, which test samples of stool, blood, urine and other body fluids or tissue for the presence of specific infectious diseases. Specific immunodiagnostic technologies used in our diagnostic test kits include enzyme immunoassay,
43
+ immunofluorescence, particle agglutination/aggregation, immunodiffusion, complement fixation and chemical stains. During fiscal 2010 we commercialized our molecular amplification diagnostic testing platform, illumi gene ® , and introduced our first assay, C. difficile . The illumi gene ® C. difficile assay detects the presence of the toxin producing region from the C. difficile DNA, and
44
+ provides highly accurate results in under an hour. Throughout fiscal 2011 and fiscal 2012, we continued with the development of additional tests for the illumi gene ® molecular platform, receiving FDA clearance for our second and third molecular tests for the platform – illumi gene ® Group B Streptococcus (Group B Strep or GBS) in December 2011 and illumi gene ® Group A Streptococcus (Group A Strep) in September 2012. A test for Mycoplasma pneumoniae (Walking
45
+ Pneumonia) was recently submitted to the FDA for marketing clearance and is expected to be available for sale in the U.S. during the second quarter of fiscal 2013. Our fifth test on the illumi gene ® platform is for Bordetella pertussis (Whooping Cough), which is expected to be available for sale
46
+ in the U.S. during the third or fourth quarter of fiscal 2013. Our development pipeline for
47
+ illumi gene ® also includes two sexually-transmitted disease assays, expected to be available
48
+ for sale in the U.S. during the first half of fiscal 2014.
49
+ Our diagnostic products are used principally in the detection of gastrointestinal
50
+ diseases, such as antibiotic-associated diarrhea ( C. difficile ), pediatric diarrhea (Rotavirus and Adenovirus) and stomach ulcers ( H. pylori ); foodborne diseases such as Enterohemorrhagic E. coli infection (EHEC) and
51
+ Campylobacter jejuni (Campy); Streptococcus bacterial infections (both Group A and Group B Strep); viral diseases, such as Mononucleosis, Herpes Simplex, Chicken Pox and Shingles (Varicella-Zoster) and Cytomegalovirus (organ transplant
52
+ infections); parasitic diseases, such as Giardiasis, Cryptosporidiosis and Lyme; and respiratory diseases, such as Pneumonia, Valley Fever, Influenza and Respiratory Syncytial Virus (RSV). The primary markets and customers for these products are
53
+ reference laboratories and hospitals.
54
+ - 5 -
55
+ Table of Contents
56
+ In particular, the three tests we currently offer on our illumi gene ® platform – C. difficile , Group A Strep and Group B Strep – are expected to drive the majority
57
+ of growth in fiscal 2013.
58
+ C. difficile
59
+ Clostridium difficile ( C. difficile ) is a bacteria found in the gut that can cause serious damage to the colon
60
+ and even death, primarily in hospital patients using antibiotics. It is the most common infection acquired by patients while they are in the hospital. Annually in the U.S., an estimated 8 million C. difficile tests are performed. This
61
+ hospital acquired infection occurs when antibiotics disrupt other bacteria that normally prevent the colonization of C. difficile . Rapid, accurate diagnosis, followed by appropriate treatment is essential to improving patient outcomes
62
+ and reducing the overall cost of care. Our strong line of C. difficile tests, including our illumi gene ® C. difficile molecular test, provide the most comprehensive and accurate testing options for this serious and life threatening infection.
63
+ Group A Strep
64
+ Group A Streptococcus is the bacterium commonly found in the throat which causes strep throat (acute pharyngitis). Pharyngitis is diagnosed in approximately 11 million patients in the U.S.
65
+ each year. Our illumi gene ® Group A Strep test, the only FDA-cleared molecular Strep A test
66
+ in the U.S. market, provides results in less than one hour, detects more positives than culture methods and is ideal for early diagnosis and proper patient management of the common, sometimes serious disease. In addition to front line testing in
67
+ hospital and clinical settings, rapid strep throat tests performed in physician offices in the U.S. that are negative are routinely sent on to hospital and reference labs for confirmation testing, usually by culture methods that take up to 48 hours
68
+ to run. With results in less than one hour and a 53% increase in the detection of positives,
69
+ illumi gene ® Group A Strep provides improved patient care over culture methods.
70
+ Group B Strep
71
+ Each year in the U.S. there are over 4 million babies born. Appropriately testing women in the late stages of pregnancy for the presence of Group B Streptococcus is critical to the health of
72
+ the baby. Without proper treatment during labor, GBS infection can lead to sepsis, pneumonia and even meningitis, and lead to hearing and vision loss. Testing with our illumi gene ® GBS improves accuracy by up to 29% over traditional culture methods, increasing the likelihood of improved outcomes and a healthy baby.
73
+ Market Trends
74
+ The global market
75
+ for infectious disease tests continues to expand as new disease states are identified, new therapies become available, and worldwide standards of living and access to health care improve. More importantly, within this market there is a continuing
76
+ shift from conventional testing, which requires highly trained personnel and lengthy turnaround times for test results, to more technologically advanced testing, which can be performed by less highly trained personnel and completed in minutes or
77
+ hours.
78
+ - 6 -
79
+ Table of Contents
80
+ The increasing pressures to contain total health care costs have accelerated the increased use of diagnostic
81
+ testing. With rapid and accurate diagnoses of infectious diseases, physicians can pinpoint appropriate therapies quickly, leading to faster recovery, shorter hospital stays and lower overall treatment expense. In addition, these pressures have led
82
+ to a major consolidation among reference laboratories and the formation of multi-hospital group purchasing organizations and integrated delivery networks that have reduced the number of institutional customers for diagnostic products and resulted in
83
+ changes in buying practices. Specifically, multi-year exclusive or primary source marketing or distribution contracts with institutional customers have become more common, replacing less formal distribution arrangements.
84
+ Sales and Marketing
85
+ Our U.S.
86
+ Diagnostics segment’s sales and distribution network in the U.S. consists of a direct sales force complemented by independent distributors. The use of independent distributors in the U.S. allows our products to reach any bed-size healthcare
87
+ facility and also provides our customers the option to purchase our products direct or through distribution along with other supplies. For our export markets in Asia, Canada and South America, we use independent distributors. Two independent
88
+ distributors in the U.S. accounted for 10% or more of consolidated net sales in fiscal 2012, 2011 and 2010: Cardinal Healthcare Corporation and Fisher Scientific. Our sales to Cardinal were approximately $33,000, $30,000 and $34,000 during fiscal
89
+ 2012, 2011 and 2010, respectively. Our sales to Fisher were approximately $20,000, $18,000 and $18,000 during fiscal 2012, 2011 and 2010, respectively.
90
+ Consolidation of the U.S. healthcare industry is expected to continue and potentially affect our customers. Industry consolidation puts pressure on pricing and aggregates buying power. In response, we
91
+ have looked to multi-year supply agreements with group purchasing organizations, integrated delivery networks and major reference laboratories to stabilize pricing.
92
+ Clostridium difficile
93
+ C. difficile , a serious hospital
94
+ acquired bacterial infection, is our largest product family, generating approximately $36,000 in global sales for fiscal 2012, or 21% growth from fiscal 2011. This product family has experienced significant competition over the last three years from
95
+ new technologies, including molecular testing platforms. Our illumi gene ® molecular C.
96
+ difficile product has now been available in markets around the world for over two years. Sales of this product were approximately $22,000, $9,000 and $500 in fiscal 2012, 2011 and 2010, respectively. Approximately 950 clinical laboratories are
97
+ current customers using our illumi gene ® platform, which now includes three tests (see below
98
+ for a discussion of our second and third tests for Group B and Group A Strep). While the majority of these customers have adopted the C. difficile assay, a growing number of customers are purchasing multiple assays for the platform. Our
99
+ illumi gene ® molecular C. difficile product has restored the C. difficile
100
+ product family to positive sales growth, 21% and 10% during each of the last two fiscal years.
101
+ - 7 -
102
+ Table of Contents
103
+ Our major competitors in this product family are Cepheid and Becton Dickinson (molecular) and Alere
104
+ (immunoassay). We believe that we have two principal advantages versus our competition. First, our molecular instrumentation package has a smaller footprint and significantly lower cost than either Cepheid or Becton Dickinson. We believe that this
105
+ advantage allows our product to fit into virtually any size hospital or reference laboratory. We believe that our second principal advantage is the breadth of our C. difficile product offerings. With the launch of our molecular product and
106
+ FDA clearance of our common antigen C. difficile products – Premier C. difficile GDH received FDA clearance in May 2011, and Immuno Card C. difficile GDH received FDA clearance in December 2011 – we believe we are in a
107
+ unique position to offer a full line of testing solutions to our clinical laboratory customers around the world to counter the competitive pressures surrounding this market. Additionally, we hold the only FDA-approved claim for C. difficile
108
+ testing in the pediatric population. These advantages, along with the performance features of the products in our C. difficile portfolio, give us a compelling product offering for any hospital testing method preference.
109
+ During fiscal 2012, we received FDA clearance for our second and third molecular tests for the illumi gene ® molecular platform – illumi gene ® GBS (Group B Streptococcus ) in December 2011 and illumi gene ® Group A Strep (Group A Streptococcus ) in September 2012. As alluded to above, over 100 customers are now purchasing two assays for the
110
+ illumi gene ® platform – the majority being C. difficile and GBS – with
111
+ revenue generated by our GBS test approximating $1,100 during fiscal 2012. In addition, with the recent introduction of the Group A Strep test, there are a growing number of customers adopting all three of our molecular-platform assays. A test for
112
+ Mycoplasma pneumoniae was recently submitted to the FDA for marketing clearance and is expected to be available for sale in the U.S. during the second quarter of fiscal 2013. Our fifth test on the illumi gene ® platform is for Bordetella pertussis , which is expected to be available for sale in the U.S. during the
113
+ third or fourth quarter of fiscal 2013. Our development pipeline for illumi gene ® also
114
+ includes two sexually-transmitted disease assays, expected to be available for sale in the U.S. during the first half of fiscal 2014.
115
+ In
116
+ addition to Cepheid, Becton Dickinson and Alere, other competitors have begun to enter the C. difficile market. During fiscal 2012, Quest Diagnostics and Great Basin received FDA clearance for a molecular C. difficile test and Quidel
117
+ received CE marking approval for a molecular C. difficile test for sale within the European Union. Although we believe that the breadth of our C. difficile product offerings and our low cost molecular platform provide key advantages to
118
+ the offerings of our competitors, selling prices may come under pressure as more competitors enter the market.
119
+ - 8 -
120
+ Table of Contents
121
+ Foodborne
122
+ Our foodborne product family achieved approximately $21,000 in global sales for fiscal 2012, or growth of 13%, with over 95% of such sales occurring in the U.S. Our foodborne products include tests for
123
+ Enterohemorrhagic E. coli (EHEC) and Campylobacter jejuni (Campy). In the U.S. market, we believe that there are potentially 20 million annual stool cultures that are tested for foodborne illnesses. At present, we believe that we
124
+ have less than a 20% market share for EHEC and less than a 5% market share for Campy.
125
+ While historically the primary competition for our
126
+ foodborne products has been laboratory culture methods, one of our competitors, Alere, has recently cleared through the FDA a shiga toxin test that will compete with our EHEC test. We believe that our products have two principal advantages versus
127
+ culture methods. The first principal advantage is test accuracy. Independent evaluations have shown our products to have higher sensitivity than culture methods. The second principal advantage is improved work flow of the testing process, resulting
128
+ in significantly shortened time to test result. Our single-use rapid products provide a test result in approximately 20 minutes, whereas culture results can take up to 24-48 hours. Time to test result can be a critical factor in the physician’s
129
+ choice of therapies, as the mortality rate for EHEC is estimated to be 5% to 10%.
130
+ Helicobacter pylori
131
+ H. pylori , a bacterium found in the stomach, is a major cause of peptic ulcers and is linked to duodenal ulcers and stomach cancer. H.
132
+ pylori represents our second largest product family, generating approximately $24,000 in global sales for 2012, or 7% growth. We offer both antibody and direct antigen tests in alternative formats (single-use and high volume batch). Our major
133
+ competition in this product family are test-method alternatives, serology and urea breath, and the prescription of symptom-relieving medications. In the U.S., our strategy has been to partner with managed care companies to promote the health and
134
+ economic benefits of a test and treat strategy, and to move physician behavior away from serology-based testing toward direct antigen testing. In the U.S. market, we believe that there are potentially 30 million people suffering from peptic
135
+ ulcers and we believe that we currently have a 5% market share.
136
+ In European markets, we face a greater number of competitive products for
137
+ this product family. As a result, pricing pressures have led to 3% sales growth for fiscal 2012 for our European Diagnostics segment, excluding the effect of currency translation.
138
+ - 9 -
139
+ Table of Contents
140
+ Research and Development
141
+ Our U.S. Diagnostics segment’s research and development organization has expertise in biochemistry, immunology, mycology, bacteriology, virology, parasitology and molecular biology. Research and
142
+ development expenses for the U.S. Diagnostics segment for fiscal 2012, 2011 and 2010 were approximately $8,000, $7,000 and $6,000, respectively. This research and development organization focuses its activities on new applications for our existing
143
+ technologies, improvements to existing products and development of new technologies. Research and development efforts may occur in-house or with collaborative partners. We believe that new product development is a key source for sustaining revenue
144
+ growth. The products within our C. difficile , foodborne, and H. pylori product families were either developed solely in-house, or via collaboration with outside partners.
145
+ The introduction of our molecular amplification diagnostic testing platform, illumi gene ® , introduced in markets around the world over two years ago, followed nearly four years of exploration and
146
+ development of a molecular-based diagnostic testing technology to complement our existing antigen/antibody-based testing technologies. Our illumi gene ® C. difficile assay, the initial assay introduced for the illumi gene ® platform, detects the presence of a key toxin producing region from the C. difficile DNA, and provides highly accurate results in under an hour. We believe
147
+ this molecular assay uniquely positions us in the market to provide a full line of testing solutions that will meet the needs of both our domestic and international customers and, as a result, throughout fiscal 2011 and fiscal 2012, we continued
148
+ with the development of additional tests for the illumi gene ® molecular platform, receiving
149
+ FDA clearance for our second and third molecular tests for the platform – illumi gene ®
150
+ GBS (Group B Streptococcus ) in December 2011 and illumi gene ® Group A Strep (Group A
151
+ Streptococcus ) in September 2012. A test for Mycoplasma pneumoniae (Walking Pneumonia) was recently submitted to the FDA for marketing clearance and is expected to be available for sale in the U.S. during the second quarter of fiscal
152
+ 2013. Our fifth test on the illumi gene ® platform is for Bordetella pertussis
153
+ (Whooping Cough), which is expected to be available for sale in the U.S. during the third or fourth quarter of fiscal 2013. Our development pipeline for illumi gene ® also includes two sexually-transmitted disease assays, expected to be available for sale in the U.S. during the first half of fiscal 2014. We currently hold
154
+ registrations to sell illumi gene ® in 37 countries, including the U.S., with registrations
155
+ pending in 5 additional countries.
156
+ During fiscal 2008, we launched our first products under our patented TRU rapid test
157
+ technology. The design of this technology enhances laboratory safety by containing the specimen in a closed system during testing as recommended by CDC guidelines. TRU tests also use less space than other immunoassay technologies, which is an
158
+ advantage in space-constrained clinical laboratories. Products using this technology include TRU FLU ® , TRU RSV ® , TRU EBV-M ® and TRU EBV-G ® . TRU
159
+ LEGIONELLA TM and TRU HSV 1 and 2 IgG TM the latest additions to the TRU line of products. Legionella was
160
+ launched in foreign markets during the fourth quarter of fiscal 2011, and became available in the U.S. market during the second quarter of fiscal 2012, while TRU HSV 1 and 2 IgG TM were registered for sale in Europe during September 2012.
161
+ - 10 -
162
+ Table of Contents
163
+ Manufacturing
164
+ Our immunodiagnostic and molecular products require the production of highly specific and sensitive antigens, antibodies, primers and enzymes. While we produce substantially all of our own requirements
165
+ including monoclonal antibodies and polyclonal antibodies, plus a variety of fungal, bacterial and viral antigens, currently a number of the raw materials used in our products, including our illumi gene ® molecular products, are purchased from outside vendors. We believe that we have sufficient manufacturing and
166
+ sourcing capacity for anticipated growth in the near term.
167
+ Intellectual Property, Patents and Licenses
168
+ We own or license U.S. and foreign patents, most of which are for products manufactured by our U.S. Diagnostics segment. Sales of these products are as
169
+ follows:
170
+ Product/Technology Family
171
+ Number of
172
+ products
173
+ % of consolidated sales
174
+ 2012
175
+ 2011
176
+ illumigene ®
177
+ 3
178
+ 13
179
+ %
180
+ 6
181
+ %
182
+ H. pylori
183
+ 2
184
+ 13
185
+ %
186
+ 13
187
+ %
188
+ Respiratory
189
+ 3
190
+ 2
191
+ %
192
+ 2
193
+ %
194
+ Other
195
+ 6
196
+ 1
197
+ %
198
+ 1
199
+ %
200
+ Total patented products
201
+ 14
202
+ 29
203
+ %
204
+ 22
205
+ %
206
+ The patents for the illumi gene ® products expire between 2020 and 2022; the patents for the two H. pylori products expire between 2016 and 2017; and the patents for the three respiratory
207
+ products expire in 2022 (two products) and 2027. The remaining six patented products for which we own or license patents are spread over three product families.
208
+ In the absence of patent protection, we may be vulnerable to competitors who successfully replicate our production and manufacturing technologies and processes. Our employees are required to execute
209
+ confidentiality and non-disclosure agreements designed to protect our proprietary products.
210
+ Government Regulation
211
+ Our diagnostic products are regulated by the Food & Drug Administration (FDA) as “devices” pursuant to the Federal Food, Drug, and
212
+ Cosmetic Act (FDCA). Under the FDCA, medical devices are classified into one of three classes (i.e., Class I, II or III). Class I and II devices are not expressly approved by the FDA, but, instead, are “cleared” for marketing. Class III
213
+ devices generally must receive “pre-market approval” from the FDA as to safety and effectiveness.
214
+ - 11 -
215
+ Table of Contents
216
+ Each of the diagnostic products currently marketed by us in the United States has been cleared by the FDA
217
+ pursuant to the 510(k) clearance process or is exempt from such requirements. We believe that most, but not all, products under development will be classified as Class I or II medical devices and, in the case of Class II devices, will be eligible
218
+ for 510(k) clearance; however, we can make no assurances in this regard.
219
+ Sales of our diagnostic products in foreign countries are subject to
220
+ foreign government regulation, the requirements of which vary substantially from country to country. The time required to obtain approval by a foreign country may be longer or shorter than that required for FDA approval and the requirements may
221
+ differ.
222
+ Meridian’s Cincinnati manufacturing facility is certified to ISO 13485:2003.
223
+ Medical Device Tax
224
+ Included
225
+ within the U.S. government’s comprehensive healthcare reform legislation, enacted during 2010, was the establishment of a 2.3% excise tax on the sales of medical devices beginning in calendar 2013. We currently anticipate that this legislation
226
+ will result in an excise tax for our company of approximately $2,000 in fiscal 2013. At the present time it is believed that little, if any, of this cost can be passed on to customers.
227
+ Seasonal Factors and Sporadic Outbreaks
228
+ Our principal business is the sale of a
229
+ broad range of diagnostic test kits for common gastrointestinal, viral, upper respiratory and parasitic infectious diseases. Certain infectious diseases may be seasonal in nature, while others may be associated with sporadic outbreaks, such as
230
+ foodborne illnesses, or pandemics such as the H1N1 influenza outbreak during fiscal 2009. While we believe that the breadth of our diagnostic product lines reduces the risk that infections subject to seasonality and sporadic outbreaks will cause
231
+ significant variability in diagnostic revenues, we can make no assurance that revenues will not be impacted period over period by such factors.
232
+ European Diagnostics Segment
233
+ Our
234
+ European Diagnostics segment’s business focuses on the sale and distribution of diagnostic test kits, manufactured both by our U.S. Diagnostics segment and by third-party vendors. Approximately 85% of third-party sales for fiscal 2012 for this
235
+ segment were products purchased from our U.S. Diagnostics segment. Third-party sales for this segment were approximately $23,000, $24,000 and $24,000 for fiscal 2012, 2011 and 2010, respectively. As of September 30, 2012, the European
236
+ Diagnostics segment had approximately 40 employees. Our European Diagnostics segment’s sales and distribution network consists of direct sales forces in Australia, Belgium, France, Holland and Italy, and independent distributors in other
237
+ European countries, Africa and the Middle East. The European Diagnostics segment maintains a distribution center near Milan, Italy. The primary markets and customers for this segment are hospitals and reference laboratories.
238
+ - 12 -
239
+ Table of Contents
240
+ The European Diagnostics segment’s functional currency is the Euro. The translation of Euros into U.S.
241
+ dollars is subject to exchange rate fluctuations.
242
+ Life Science Segment
243
+ Overview
244
+ Our Life Science segment’s business focuses on the development,
245
+ manufacture, sale and distribution of bulk antigens, antibodies, PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents used by researchers and other diagnostic companies, as well as contract development and manufacturing services
246
+ under clinical cGMP conditions. Third-party sales for this segment were approximately $43,000, $38,000 and $27,000 for fiscal 2012, 2011 and 2010, respectively. As of September 30, 2012, our Life Science segment had approximately 180 employees.
247
+ Most of the revenue for our Life Science segment currently comes from the manufacture, sale and distribution of bulk antigens, antibodies,
248
+ PCR/qPCR reagents, nucleotides, competent cells and bioresearch reagents used by researchers and other diagnostic companies. During fiscal 2012, 19% of third-party sales for this segment were to two diagnostic manufacturing customers. For one of
249
+ these two customers, we have exclusive supply agreements that have annual, automatic renewal provisions. We have a long-standing relationship with this customer; and although there can be no assurances, we intend to renew these supply agreements in
250
+ the normal course of business.
251
+ In July 2010, we acquired the Bioline Group and in so doing added important technologies and capabilities to
252
+ our Life Science business and complemented our expanding life science product lines sold into the research, pharmaceutical and commercial diagnostic markets. In addition to technological capabilities, Bioline also added proprietary know-how in the
253
+ production of high-volume nucleotides and PCR enzymes, as well as a growing portfolio of intellectual property in the form of patents and licenses. The Bioline Group contributed approximately $17,000 and $15,000 in sales for fiscal 2012 and 2011,
254
+ respectively.
255
+ Our clinical cGMP protein production facility in Memphis, Tennessee serves as an enabling technology for process development
256
+ and large-scale manufacturing for biologicals used in new drugs and vaccines. The size of the facility is intended to accommodate manufacturing requirements for Phase I and Phase II clinical trials. The customer base for this aspect of our Life
257
+ Science business includes biopharmaceutical and biotechnology companies, as well as government agencies. Revenues for our Life Science segment, in the normal course of business, may be affected from quarter to quarter by the timing and nature of
258
+ arrangements for contract services work, which may have longer production cycles than our immunodiagnostic and molecular biology products, as well as buying patterns of major customers. See Note 1 (i) to the Consolidated Financial Statements
259
+ herein for revenue recognition policies. Our revenues for contract services were approximately $2,000, $3,000 and $2,000 in fiscal 2012, 2011 and 2010, respectively.
260
+ - 13 -
261
+ Table of Contents
262
+ As a result of the order volume trends in bulk antigens, antibodies and reagents, during the fourth quarter
263
+ of fiscal 2011, we announced the closure of our Saco, Maine facility, and completed the consolidation of manufacturing operations into our Memphis, Tennessee facility during the third fiscal quarter of 2012. Total costs to complete the consolidation
264
+ of facilities approximated $2,100, consisting of fixed asset impairments, inventory impairments, stay bonuses and moving costs, among other similar items. During the fourth quarter of 2011, we recognized approximately $1,100 of these costs, and
265
+ recognized the remaining $1,000 during the first three quarters of fiscal 2012.
266
+ Products, Markets and Growth Strategies
267
+ Our Life Science segment’s businesses have been assembled via acquisitions (BIODESIGN International in fiscal 1999, Viral
268
+ Antigens in fiscal 2000, OEM Concepts in fiscal 2005, and the Bioline Group in July 2010). Historically, these businesses were run autonomously. In recent years, growth strategies have been developed around sales and marketing integration, new
269
+ product development integration, and the acquisition of complementary product lines.
270
+ Immunodiagnostic products such as antibodies, antigens
271
+ and reagents are marketed primarily to diagnostic manufacturing customers as a source of raw materials for their products, or as an outsourced step in their manufacturing processes. These products are typically sold in bulk quantities, and may also
272
+ be custom-designed for a particular manufacturer’s requirements. Sales efforts are focused on multi-year supply agreements in order to provide stability in volumes and pricing. We believe this benefits both us and our customers.
273
+ Molecular biology products such as PCR/qPCR reagents, nucleotides and competent cells are marketed primarily to research customers. These products are
274
+ typically sold in small quantities.
275
+ Research and Development
276
+ Research and development expenses for our Life Science segment for fiscal 2012, 2011 and 2010 were approximately $2,000, $3,000 and $2,000, respectively. This research and development organization is
277
+ heavily involved in vaccine development and production activities for our cGMP facility and development of new molecular components.
278
+ Manufacturing and Government Regulation
279
+ The cGMP clinical grade proteins that are produced in our Memphis facility are intended to be used as “injectibles,” and, as such, they are produced under cGMP Regulations for Biologics and
280
+ Human Drugs under the auspices of the FDA. Approval and licensing, following clinical trials, of these products is the responsibility of the applicant, who owns the rights to each protein. Typically, the customer is the applicant, not Meridian Life
281
+ Science.
282
+ - 14 -
283
+ Table of Contents
284
+ The Meridian Life Science facilities are ISO 9001:2000 certified and EC 1069:2009 approved, where
285
+ appropriate and as required.
286
+ Competition
287
+ Diagnostics
288
+ The market for diagnostic tests is a multi-billion dollar international
289
+ industry, which is highly competitive. Many of our competitors are larger than we are with greater financial, research, manufacturing and marketing resources. Important competitive factors for Meridian’s products include product quality, price,
290
+ ease of use, customer service and reputation. In a broader sense, industry competition is based upon scientific and technological capability, proprietary know-how, access to adequate capital, the ability to develop and market products and processes,
291
+ the ability to attract and retain qualified personnel, and the availability of patent protection. To the extent that our product lines do not reflect technological advances, our ability to compete in those product lines could be adversely affected.
292
+ The diagnostic test industry is highly fragmented and segmented. Of importance in the industry are mid-sized medical diagnostic specialty
293
+ companies, like Meridian, that offer multiple, broad product lines and have the ability to deliver new, high value products quickly to the marketplace. Among the companies with which we compete in the marketing of one or more of our products are the
294
+ diagnostic product divisions of Abbott Laboratories Inc., Becton, Dickinson and Company, Thermo Fisher and Siemens. We also compete with smaller companies such as Cepheid, Quidel Corporation and Alere, Inc.
295
+ Life Science
296
+ The market for bulk
297
+ biomedical reagents is highly competitive. Important competitive factors include product quality, price, customer service, and reputation. We face competitors, many of which have greater financial, research and development, sales and marketing, and
298
+ manufacturing resources, and where sole-source supply arrangements do not exist. From time to time, customers may choose to manufacture their biomedical reagents in-house rather than purchase from outside vendors such as Meridian.
299
+ The market for contract manufacturing in a validated cGMP facility, such as our Memphis facility, is also competitive. Important competitive factors
300
+ include reputation, customer service and price. Although the product application for this facility was built from our existing expertise in cell culture manufacturing techniques, we face competitors with greater experience in contract manufacturing
301
+ in a clinical cGMP environment.
302
+ Acquisitions
303
+ Acquisitions have played an important role in the growth of our businesses. Our acquisition objectives include, among other things, (i) enhancing product offerings; (ii) improving product
304
+ distribution capabilities; (iii) providing access to new markets; and/or (iv) providing access to key biologicals or new technologies that lead to new products. Although we cannot provide any assurance that we will consummate any
305
+ additional acquisitions in the future, nor can we provide any assurance that any acquisitions will accomplish these objectives, we expect that the potential for acquisitions will continue to provide opportunities for revenues and earnings growth in
306
+ the future.
307
+ - 15 -
308
+ Table of Contents
309
+ International Markets
310
+ International markets are an important source of revenue and future growth opportunities for all of our segments. For all segments combined, international sales were approximately $54,000 or 31% of
311
+ consolidated fiscal 2012 sales, $53,000 or 33% of consolidated fiscal 2011 sales and $43,000 or 30% of consolidated fiscal 2010 sales. We expect to continue to look to international markets as a source of new revenues and growth in the future. See
312
+ Notes 6 and 8 to the Consolidated Financial Statements for information concerning sales, long-lived assets and deferred tax assets by country.
313
+ Environmental
314
+ We are a conditionally
315
+ exempt, small quantity generator of hazardous waste and have a U.S. EPA identification number. We are in compliance with applicable portions of the federal and state hazardous waste regulations and have never been a party to any environmental
316
+ proceeding.
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@@ -0,0 +1,2 @@
 
 
 
1
+ Item 13 Certain Relationships and Related Transactions, and Director Independence
2
+ 75
raw/filings/0000794172/2012/0001193125-12-485192/item9a.txt ADDED
@@ -0,0 +1,9 @@
 
 
 
 
 
 
 
 
 
 
1
+ ITEM 9A.
2
+ CONTROLS AND PROCEDURES
3
+ As of September 30, 2012, an evaluation was completed under the supervision and with the participation of our management, including our Chief
4
+ Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures pursuant to Rule 13a-15(b) and 15d-15(b) promulgated under the Securities Exchange Act of 1934, as amended.
5
+ Based on that evaluation, our management, including the CEO and CFO, concluded that our disclosure controls and procedures were effective as of September 30, 2012. There have been no changes in our internal control over financial reporting
6
+ identified in connection with the evaluation of internal control that occurred during the fourth fiscal quarter that has materially affected, or is reasonably likely to affect, our internal control over financial reporting, or in other factors that
7
+ could significantly affect internal control subsequent to September 30, 2012.
8
+ Our internal control report is included in this Annual
9
+ Report on Form 10-K after Item 8, under the caption “Management’s Report on Internal Control over Financial Reporting.”
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raw/filings/0000794172/2012/0001193125-12-485192/rpt_disclosure.txt ADDED
@@ -0,0 +1,13 @@
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1
+ TRANSACTIONS WITH RELATED PERSONS
2
+ During fiscal 2012, the Company leased certain office space from an entity controlled by Marco G. Calzavara, President and Managing Director, Meridian
3
+ Bioscience Europe. Payments made under such arrangements during fiscal 2012 totaled approximately $190,000.
4
+ Nasdaq rules require the
5
+ Company to conduct an appropriate review of related party transactions required to be disclosed by the Company pursuant to SEC Regulation S-K Item 404 for potential conflict of interest situations on an ongoing basis and that all such
6
+ transactions must be approved by the Audit Committee or another Committee comprised of independent Directors. As a result, the Audit Committee annually reviews all such related party transactions and approves each related party transaction if it
7
+ determines that it is in the best interests of the Company. Additionally, the Audit Committee’s Charter provides it the authority to review, approve and monitor transactions involving the Company and “related persons” (Directors and
8
+ Executive Officers or their immediate family members, or shareholders owning five percent or greater of the Company’s outstanding stock). This also covers any related person transaction that meets the minimum threshold for disclosure in the
9
+ proxy statement under the relevant SEC rules (generally, transactions involving amounts exceeding $120,000 in which a related person has a direct or indirect material interest). In considering the transaction, the Audit Committee may consider all
10
+ relevant factors, including, as applicable, (i) the Company’s business rationale for entering into the transaction; (ii) the alternatives to entering into a related person transaction; (iii) whether the transaction is on terms
11
+ comparable to those available to third parties, or in the case of employment relationships, to employees generally; (iv) the potential for the transaction to lead to an actual or apparent conflict of interest and any safeguards imposed to
12
+ prevent such actual or apparent conflicts; and (v) the overall fairness of the transaction to the Company. This policy is included in the Company’s Employee Handbook. The approval of such related person transactions are evidenced by
13
+ internal Company resolutions or memoranda.
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1
+ ITEM 1. BUSINESS
2
+ GENERAL
3
+ The Company builds niche products into global lifestyle brands by designing
4
+ and marketing innovative, functional and fashion-oriented footwear, developed
5
+ for both high performance outdoor activities and everyday casual lifestyle use.
6
+ Currently, the Company offers three primary product lines under the following
7
+ recognized brand names: Teva(R) -- high-performance sports sandals and rugged
8
+ outdoor and casual footwear; Simple(R) -- innovative shoes that combine the
9
+ comfort elements of athletic footwear with casual styling; and Ugg(R) --
10
+ authentic sheepskin boots and other footwear. Teva is a registered trademark of
11
+ Mark Thatcher, the inventor and licensor of Teva Sport Sandals. Simple and Ugg
12
+ are registered trademarks of the Company and its subsidiaries. All of the
13
+ Company's footwear possess the common features of high quality with a primary
14
+ focus on functionality and comfort. In 2000, the Company sold approximately
15
+ 4,265,000 pairs of footwear. Revenues from sales (domestic and international) of
16
+ Teva products have been $79,732,000, $80,963,000 and $68,870,000 during 2000,
17
+ 1999 and 1998, representing 70.1%, 72.9% and 66.5% of net sales, respectively.
18
+ For financial information regarding the Company's industry segments, see note 9
19
+ to the accompanying consolidated financial statements.
20
+ MARKET OVERVIEW
21
+ The casual, outdoor and athletic footwear market is comprised of footwear
22
+ worn for casual everyday use and for outdoor and athletic activities such as
23
+ hiking, boating, basketball, tennis, fitness and jogging. The market for such
24
+ footwear has grown significantly during the last decade. The Company believes
25
+ that the principal reasons for the growth in sales of such footwear have been
26
+ the growing acceptance of athletic footwear as casual wear and the growing
27
+ acceptance of casual wear, in general, including the increasing casualization of
28
+ the workplace, increasingly active consumer lifestyles and the growing emphasis
29
+ on comfort.
30
+ Over the last few years the overall footwear market has seen significant
31
+ growth of the outdoor segment as well as the growing emphasis on comfort.
32
+ Outdoor footwear includes shoes, boots and sandals for outdoor recreational
33
+ activities such as hiking, river rafting, camping and casual wear. Companies
34
+ engaged in the outdoor footwear market include Nike, Adidas, Timberland,
35
+ Columbia and Salomon. The Company believes that the growth in outdoor footwear
36
+ is driven by several factors including a general shift in consumer preferences
37
+ and lifestyles to include more outdoor, sports and recreational activities such
38
+ as hiking and camping. In addition, the increasing popularity of extreme sports,
39
+ including skateboarding, snowboarding, kayaking and river rafting, among others,
40
+ has created an additional emphasis and awareness of outdoor activities and
41
+ lifestyles. As consumers engage in outdoor activities, they typically desire
42
+ footwear specifically designed for these purposes, yet they demand the same
43
+ level of quality and high performance that they have come to expect from
44
+ traditional athletic footwear. In addition, more consumers are turning to an
45
+ emphasis on casual and comfortable footwear and apparel, including the trend
46
+ toward casual workplaces. The Company believes that its products have benefited
47
+ from this growing trend and that its footwear addresses consumers' demands for
48
+ highly functional footwear that is durable as well as comfortable and
49
+ fashionable.
50
+ The casual, outdoor and athletic footwear markets are generally
51
+ characterized by a high level of recognition of brand names, logos and
52
+ trademarks. Unique and identifying features create brand awareness among
53
+ consumers and allow a favorable reputation to be transferred to new products.
54
+ The manufacture of casual, outdoor and athletic footwear is typically conducted
55
+ overseas through independent manufacturers. Casual and athletic footwear is
56
+ distributed through athletic footwear stores, department stores and specialty
57
+ retailers. Outdoor footwear is generally distributed through these channels as
58
+ well but is to a large extent distributed through outdoor specialty retailers.
59
+ Retailers may purchase footwear on a "futures" basis (orders placed at a
60
+ discount in advance of a season) or an "at once" basis (orders placed and filled
61
+ immediately). Futures orders allow the Company to more accurately predict its
62
+ manufacturing and sourcing needs. By placing futures orders, retailers are also
63
+ able to reduce the risk that the Company will be unable to meet their
64
+ 3
65
+ 4
66
+ delivery requirements. Retailers are generally encouraged to purchase goods on a
67
+ futures basis by receiving discounts or special payment terms not otherwise
68
+ available.
69
+ RISK FACTORS
70
+ This Annual Report on Form 10-K contains a variety of forward-looking
71
+ statements within the meaning of the Private Securities Litigation Reform Act of
72
+ 1995 including forward-looking statements in this "Risk Factors" section, the
73
+ "Outlook" section, the last paragraph under "Liquidity and Capital Resources",
74
+ the discussion under "Seasonality" and other statements in this Annual Report.
75
+ These forward-looking statements relate to expectations regarding sales and
76
+ earnings per share, expectations regarding the Company's liquidity, the
77
+ potential impact of a non-renewal of the Teva license due to the Company's
78
+ potential failure to meet required sales minimums in 2004 or 2008, the potential
79
+ impact of certain litigation, the potential impact of economic factors and
80
+ conditions, the potential impact of the Company's dependence on foreign
81
+ manufacturers, the potential impact of competition, the potential impact of the
82
+ Company's dependence upon key personnel, the potential impact of weather
83
+ conditions, the potential impact of the possible acquisition of Teva and the
84
+ impact of seasonality on the Company's operations. These forward-looking
85
+ statements are based on the Company's expectations as of March 2001. No one
86
+ should assume that any forward-looking statement made by the Company will remain
87
+ consistent with the Company's expectations after the date the forward-looking
88
+ statement is made. The Company disclaims any obligation to update any such
89
+ factors or to publicly announce the results of any revisions to any of the
90
+ forward-looking statements contained in this Annual Report on Form 10-K. These
91
+ forward-looking statements involve known and unknown risks, uncertainties and
92
+ other factors which may cause the actual results, performance or achievement of
93
+ the Company, or industry results, to differ materially from any future results,
94
+ performance or achievements expressed or implied by such forward-looking
95
+ statements. The factors listed below represent certain important factors the
96
+ Company believes could cause such results to differ. These factors are not
97
+ intended to represent a complete list of the general or specific risks that may
98
+ affect the Company. Other risks may be significant, presently or in the future,
99
+ and the risks set forth below may affect the Company to a greater extent than
100
+ indicated.
101
+ Teva License Agreement
102
+ The Company has been selling its Teva line of sport sandals and other
103
+ footwear since 1985 pursuant to various exclusive licensing arrangements with
104
+ Mark Thatcher, the inventor of the Teva sport sandal and owner of the Teva
105
+ patents and trademark. In June 1999, the Company signed a new exclusive footwear
106
+ license agreement with Mr. Thatcher. The agreement became effective January 1,
107
+ 2000 and continues through December 31, 2004. If minimum annual sales levels are
108
+ achieved in 2004, the license automatically renews for an additional four years,
109
+ through December 31, 2008. If minimum annual sales levels are achieved in 2008,
110
+ the license automatically renews again through December 31, 2011. However, if
111
+ the minimum annual sales levels are not achieved in 2004 or 2008, the license
112
+ expires and the Company will no longer be able to sell Teva footwear. These
113
+ required minimum annual sales levels exceed the annual sales levels achieved by
114
+ the Company to date. Also, Mr. Thatcher may terminate the licensing agreement if
115
+ the Company breaches its obligations under the agreement. Sales of Teva footwear
116
+ and apparel accounted for approximately 70.1%, 72.9% and 66.5% of the Company's
117
+ net sales for fiscal years 2000, 1999 and 1998, respectively. The termination of
118
+ the license would have a material adverse effect on the Company's results of
119
+ operations.
120
+ Brand Strength; Changes in Fashion Trends
121
+ The Company's success is largely dependent on the continued strength of the
122
+ Teva, Simple and Ugg brands (collectively, "Deckers Brands") and on its ability
123
+ to anticipate the rapidly changing fashion tastes of footwear customers and to
124
+ provide merchandise that appeals to their preferences in a timely manner. There
125
+ can be no assurance that consumers will continue to prefer the Deckers Brands or
126
+ that the Company will respond in a timely manner to changes in consumer
127
+ preferences or that the Company will successfully introduce new models and
128
+ styles of footwear. Achieving market acceptance for new products will also
129
+ likely require substantial marketing and product development efforts and the
130
+ expenditure of significant funds to
131
+ 4
132
+ 5
133
+ create consumer demand. Decisions with respect to product designs often need to
134
+ be made many months in advance of the time when consumer acceptance can be
135
+ determined. As a result, the Company's failure to anticipate, identify or react
136
+ appropriately to changes in styles and features could lead to, among other
137
+ things, excess inventories and higher markdowns and lower gross margins due to
138
+ the necessity of providing discounts to retailers. Conversely, failure by the
139
+ Company to anticipate consumer demand could result in inventory shortages, which
140
+ can adversely affect the timing of shipments to customers, negatively impacting
141
+ retailer and distributor relationships and diminishing brand loyalty. The
142
+ failure to introduce new products that gain market acceptance would have a
143
+ material adverse effect on the Company's business, financial condition and
144
+ results of operations, and could adversely affect the image of the Deckers
145
+ Brands.
146
+ Inventory Risk
147
+ The footwear industry has relatively long lead times for design and
148
+ production of product and, thus, the Company must commit to production tooling
149
+ and to production in advance of orders. In addition, the industry is highly
150
+ subject to fashion risks and changes in consumer preferences. If the Company
151
+ fails to accurately forecast consumer demand, or if there are changes in
152
+ consumer preference or market demand after the Company has made such production
153
+ commitments, the Company may encounter difficulty in filling customer orders or
154
+ in liquidating excess inventory, which may have an adverse effect on the
155
+ Company's sales, margins and brand image.
156
+ Quality and Performance
157
+ In response to consumer demand, the Company also uses certain specialized
158
+ materials in its footwear. The failure of products using such materials to
159
+ perform to the Company's specifications or customer satisfaction could result in
160
+ a higher rate of customer returns and could adversely affect the image of the
161
+ Deckers Brands, which could have a material adverse effect on the Company's
162
+ business, financial condition and results of operations.
163
+ Economic Cyclicality and Footwear Retailing
164
+ The footwear industry historically has been subject to cyclical variation
165
+ and can be negatively impacted by decreased consumer spending or softness in the
166
+ retail market. This cyclicality could adversely affect the Company's business.
167
+ In addition, various retailers, including some of the Company's customers, have
168
+ experienced financial difficulties during the past several years, thereby
169
+ increasing the risk that such retailers may not pay for the Company's products
170
+ in a timely manner. No assurance can be given that the Company's bad debt
171
+ expense will not increase relative to net sales in the future. Any significant
172
+ increase in the Company's bad debt expense relative to net sales would adversely
173
+ impact the Company's net earnings and cash flow and could affect the Company's
174
+ ability to pay its obligations as they become due.
175
+ Dependence on Foreign Manufacturers
176
+ Virtually all of the Deckers footwear products are manufactured by third
177
+ party suppliers in the Far East, Australia and New Zealand, with the vast
178
+ majority of production occurring in China. There can be no assurance that the
179
+ Company will not experience difficulties with such manufacturers, including
180
+ reduction in the availability of production capacity, errors in complying with
181
+ product specifications, inability to obtain sufficient raw materials,
182
+ insufficient quality control, failure to meet production and delivery deadlines
183
+ or increases in manufacturing costs. In addition, if the Company's relationship
184
+ with any of its manufacturers were to be interrupted or terminated, alternative
185
+ manufacturing sources will have to be located. The establishment of new
186
+ manufacturing relationships involves numerous uncertainties, and there can be no
187
+ assurance that the Company would be able to obtain alternative manufacturing
188
+ sources on terms satisfactory to it. If a change in its suppliers becomes
189
+ necessary, the Company would likely experience increased costs, as well as
190
+ substantial disruption and a resulting loss of sales.
191
+ Foreign manufacturing is subject to a number of risks, including work
192
+ stoppage, transportation delays and interruptions, political instability,
193
+ foreign currency fluctuations, changing economic conditions, expropriation,
194
+ 5
195
+ 6
196
+ nationalization, imposition of tariffs, import and export controls and other
197
+ non-tariff barriers (including quotas), restrictions on the transfer of funds,
198
+ environmental regulation and other changes in governmental policies. The Company
199
+ may also experience general risks associated with managing operations
200
+ effectively and efficiently from a far distance and understanding and complying
201
+ with local laws, regulations and customs. There can be no assurance that such
202
+ factors will not materially adversely affect the Company's business, financial
203
+ condition and results of operations.
204
+ Products manufactured overseas and imported into the United States and
205
+ other countries are subject to duties collected by the Customs Service in the
206
+ applicable country. Customs information submitted by the Company is subject to
207
+ review by the Customs Service. The Company is unable to predict whether
208
+ additional customs duties, quotas or restrictions may be imposed on the
209
+ importation of its products in the future. The enactment of any such duties,
210
+ quotas or restrictions could result in increases in the cost of such products
211
+ generally and might adversely affect the sales or profitability of the Company.
212
+ In 1997, the European Commission enacted anti-dumping duties of 49.2% on
213
+ certain types of footwear imported into Europe from China and Indonesia. Dutch
214
+ Customs has issued an opinion to the Company that certain popular Teva styles
215
+ are covered by this anti-dumping duty legislation. The Company has been
216
+ contesting the opinion and is working with Dutch Customs to resolve the
217
+ situation. The Company has since obtained, and is using, alternative sourcing
218
+ for the potentially impacted products from sources outside of China in an effort
219
+ to reduce the potential risk in the future. In the event that Dutch Customs
220
+ makes a final determination that the anti-dumping provisions are applicable, the
221
+ Company would have an exposure for prior unpaid anti-dumping duties during 1997
222
+ of approximately $400,000. Recently, the European Commission added an
223
+ explanatory note to the anti-dumping legislation which effectively strengthened
224
+ its position. As a result of this recent development, the Company recorded a
225
+ $400,000 charge to selling, general and administration expenses to accrue for
226
+ the potential loss on this matter during the year ended December 31, 2000.
227
+ Competition and Infringing Products
228
+ The outdoor and footwear industries are both highly competitive, and the
229
+ recent growth in the markets for sports sandals and casual footwear has
230
+ encouraged the entry of many new competitors into the marketplace as well as
231
+ increased competition from established companies. Many of the Company's
232
+ competitors have substantially greater financial, distribution and marketing
233
+ resources, as well as greater brand awareness in the footwear market, than the
234
+ Company. In addition, the general availability of offshore manufacturing
235
+ capacity allows rapid expansion by competitors and new market entrants. The
236
+ Company believes that it has been able to compete successfully because of the
237
+ brand recognition, quality and selective distribution of its products. From time
238
+ to time, the Company also discovers products in the marketplace that infringe
239
+ upon patent and trademark rights held by or licensed to the Company. Under the
240
+ Company's licensing arrangement with the licensor of the Teva products, Mark
241
+ Thatcher, Mr. Thatcher initially may bring proceedings to halt infringement of
242
+ the Teva patents and trademark. If Mr. Thatcher elects not to bring such
243
+ proceedings, the Company may initiate such proceedings, with the prior written
244
+ consent of Mr. Thatcher. To date, Mr. Thatcher has vigorously pursued
245
+ infringements following discovery. To the extent permitted in its agreement with
246
+ Mr. Thatcher, the Company will vigorously pursue infringements in the event Mr.
247
+ Thatcher elects not to do so. However, if Mr. Thatcher or the Company is
248
+ unsuccessful in challenging a third party's products on the basis of patent and
249
+ trademark infringement, continued sales of such competing products by third
250
+ parties could adversely impact the Company's business, financial condition and
251
+ results of operations. See "Business -- Competition" and "Business -- Legal
252
+ Proceedings."
253
+ Dependence on Key Personnel
254
+ The Company's continued success will depend upon its ability to retain
255
+ Douglas B. Otto, its Chairman of the Board and Chief Executive Officer, Peter
256
+ Benjamin, its President and Chief Operating Officer and a core group of key
257
+ executive officers and employees. Mr. Otto and Mr. Benjamin have employment
258
+ agreements with the Company through 2001 and 2002, respectively. Mr. Otto's
259
+ agreement prohibits him from competing with the Company for one year following
260
+ termination. However, none of the other executive officers is subject to
261
+ 6
262
+ 7
263
+ agreements that restrict his or her ability to compete with the Company
264
+ following termination of employment. The Company believes that its future
265
+ success will depend in large part on its ability to attract and retain highly
266
+ skilled personnel. Competition for such personnel is intense, and there can be
267
+ no assurance that the Company will be successful in attracting and retaining
268
+ such personnel. The loss of certain key employees or the Company's inability to
269
+ attract and retain other qualified employees could have an adverse impact on the
270
+ Company's business.
271
+ Intellectual Property
272
+ The Company believes that its trademarks, technologies and designs are of
273
+ great value. From time to time, the Company may be the subject of litigation
274
+ challenging its ownership of certain intellectual property. Loss of the
275
+ Company's Simple or Ugg trademark rights or the ability to use the licensed Teva
276
+ trademarks could have a serious impact on the Company's business. Because of the
277
+ importance of such intellectual property rights, the Company's business is
278
+ subject to the risk of counterfeiting, parallel trade or intellectual property
279
+ infringement.
280
+ Economic Factors
281
+ The Company's business is subject to economic conditions in the Company's
282
+ major markets, including, without limitation, recession, inflation, general
283
+ weakness in retail markets and changes in consumer purchasing power and
284
+ preferences. Adverse changes in such economic factors could have a negative
285
+ effect on the Company's business.
286
+ Weather Conditions
287
+ Sales of the Company's products, particularly those under the Teva and Ugg
288
+ lines, are very sensitive to weather conditions. Extended periods of unusually
289
+ cold weather during the spring and summer could adversely impact demand for the
290
+ Company's Teva line. Likewise, unseasonably warm weather during the fall and
291
+ winter months could adversely impact demand for the Company's Ugg product line.
292
+ Substantial Ownership of the Company
293
+ At December 31, 2000, Douglas B. Otto and all executive officers and
294
+ directors of the Company, as a group, owned approximately 35.9% and 46.7%,
295
+ respectively, of the outstanding shares of the Company's Common Stock. Due to
296
+ such ownership position, Mr. Otto, whether acting alone or together with one or
297
+ more of the other executive officers of the Company, would likely be able to
298
+ control the affairs and policies of the Company and would likely be able to
299
+ elect a sufficient number of directors to control the Company's Board of
300
+ Directors and to approve or disapprove any matter submitted to a vote of the
301
+ stockholders. The ownership positions of Mr. Otto and the executive officers of
302
+ the Company, as a group, together with the anti-takeover effects of certain
303
+ provisions in the Delaware General Corporation Law (the "DGCL"), in the
304
+ Company's Certificate of Incorporation and Bylaws, and in the Company's
305
+ shareholder rights plan would likely have the effect of delaying, deferring or
306
+ preventing a change in control of the Company. Such factors could have a
307
+ negative effect on the market price of the Company's Common Stock.
308
+ The Company adopted a shareholder rights plan in 1998 pursuant to a
309
+ shareholder rights agreement (the Rights Agreement) to protect stockholders
310
+ against unsolicited attempts to acquire control of the Company that do not offer
311
+ what the Company believes to be an adequate price to all stockholders. As part
312
+ of the plan, the Board of Directors of the Company declared a dividend of one
313
+ preferred share purchase right (a Right) for each outstanding share of common
314
+ stock of the Company (the Common Shares).
315
+ The dividend was payable to stockholders of record on December 1, 1998 (the
316
+ Record Date). In addition, one Right shall be issued with each Common Share that
317
+ becomes outstanding (i) between the Record Date and the earliest of the
318
+ Distribution Date, the Redemption Date and the Final Expiration Date (as such
319
+ terms are defined in the Rights Agreement) or (ii) following the Distribution
320
+ Date and prior to the Redemption Date or Final Expiration Date, pursuant to the
321
+ exercise of stock options or under any employee plan or arrangement or upon the
322
+ exercise, conversion or exchange of other securities of the Company, which
323
+ options
324
+ 7
325
+ 8
326
+ or securities were outstanding prior to the Distribution Date, in each case upon
327
+ the issuance of the Company's common stock in connection with any of the
328
+ foregoing. Each Right entitles the registered holder to purchase from the
329
+ Company one one-hundredth of a share of Series B Junior Participating Preferred
330
+ Stock, par value $0.01 per share (the Preferred Shares), of the Company, at a
331
+ price of $50.00, subject to adjustment.
332
+ The rights have no voting power and expire on November 11, 2008. The rights
333
+ may be redeemed by the Company for $.01 per right until the right becomes
334
+ exercisable.
335
+ BUSINESS STRATEGY
336
+ Management's mission is to build niche products into global brands and its
337
+ business strategy is to offer diverse lines of footwear that emphasize
338
+ functionality, quality, comfort and technical performance tailored to a variety
339
+ of activities and demographic groups. Specifically, the Company's business
340
+ strategy emphasizes the following elements:
341
+ Introduce New Products under Existing Brands. The Company intends to
342
+ leverage consumer recognition of its existing brands by developing and
343
+ introducing additional innovative footwear products that satisfy the Company's
344
+ high standards of practicality, comfort and quality. The Company believes the
345
+ introduction of additional products at a variety of price points, such as the
346
+ range of new models in its Teva, Simple and Ugg lines which were offered in the
347
+ Company's 2000 product offerings, have broadened the Company's customer base,
348
+ further diversified the Company's product lines, and helped reduce the effects
349
+ of seasonality on the Company's sales. See "Management's Discussion and Analysis
350
+ of Financial Condition and Results of Operations -- Seasonality." In Spring
351
+ 2000, the Company successfully launched the Trail Wraptor and Wraptor Technology
352
+ into the running market and then in the fall of 2000 entered the hiking market
353
+ with the Summit series consisting of the Challenger, North Rim, and Quest models
354
+ which utilize the new Teva Wraptor Technology. The Quest quickly gained momentum
355
+ in the hiking market at key retail points for the Company. Expanding on the
356
+ acceptance of the Trail Wraptor running sandal and the Quest, the Company
357
+ launched the Road Wraptor, Women's Wraptor (runner) and Women's Quest hiker in
358
+ 2001. The Company will also make a commitment to the women's market by expanding
359
+ its line of women's fitness walking sandals with the Kinetic Circuit, the
360
+ improved Pretty Rugged Nylon and expanded Leather Casual category. Also, the
361
+ Company is expanding its offering of water sport specific products in the XPD
362
+ Hydro category with the newly organized Team Teva, an elite squad of the world's
363
+ best male and female whitewater athletes. The Company will use Team Teva's
364
+ knowledge to expand its technical offerings in this category. As the Company
365
+ moves to the future, the Company plans to strengthen existing categories and
366
+ expand into new channels of distribution. The 2000 and 2001 Simple product lines
367
+ target consumers in the sixteen to twenty-five year old youth market. The line
368
+ focuses on lifestyle comfort based products such as clogs, sandals, casuals and
369
+ non-performance sneakers that are priced affordably. In 2000, the Company
370
+ expanded its Ugg product line beyond its heritage boots and slippers by adding a
371
+ variety of new, more streetwise and fashion-oriented products including clogs,
372
+ chukka boots, and apres ski boots, as well as cold weather-resistant boots with
373
+ water resistant leathers.
374
+ Pursue Additional Market Opportunities. Management intends to continue to
375
+ consider new markets for its existing line of products. For the years ended
376
+ December 31, 2000, 1999 and 1998 international net sales totaled $31,135,000,
377
+ $28,859,000 and $24,254,000, representing 27.4%, 26.0% and 23.4% of net sales,
378
+ respectively. Management believes that significant opportunities exist to market
379
+ its products abroad and intends to selectively expand its distribution
380
+ worldwide. To bolster these efforts, the Company has opened a Netherlands office
381
+ to service the European market and an office in Japan to service the Asian
382
+ market.
383
+ Acquire or Develop New Brands. The Company intends to continue to focus on
384
+ identifying and building new brands for growth. The Company has been successful
385
+ in the past in taking the concepts of entrepreneurs for innovative, fashionable
386
+ footwear targeted at niche markets and building the products into viable brands
387
+ and intends to continue to identify concepts for potential future niche products
388
+ which have the potential of developing into successful brands or product lines.
389
+ 8
390
+ 9
391
+ PRODUCTS
392
+ The Company currently offers three primary product lines: (1) Teva sport
393
+ sandals and footwear; (2) Simple casual footwear; and (3) Ugg sheepskin
394
+ footwear. Each of these lines, as well as individual models within these lines,
395
+ is designed to appeal to various demographic groups. The Company's footwear
396
+ products emphasize function, comfort and technical performance, and are suitable
397
+ for a variety of demanding outdoor and athletic activities, as well as casual
398
+ and everyday use. The Company's products are designed and marketed to promote a
399
+ high level of brand name recognition and consumer appeal by combining functional
400
+ and creative designs with quality materials and construction. The Teva footwear
401
+ and the Simple footwear lines are generally previewed twice per year, once in
402
+ the summer for deliveries that commence in the fall and once in the winter for
403
+ the following back to school and fall season. The Ugg line of sheepskin footwear
404
+ is generally previewed in the winter with most deliveries occurring in the
405
+ following fall and winter. The following sets forth a summary description of
406
+ each of the Company's primary product lines:
407
+ Teva Sport Sandals and Footwear. The Teva sport sandal is one of the first
408
+ sport sandals to be developed and is popular among outdoor enthusiasts and the
409
+ general public. The Company licenses the Teva patents and trademark from Mark
410
+ Thatcher, a professional river guide who invented the Teva sport sandal. The
411
+ terms of such licenses run through 2011, subject to achieving certain minimum
412
+ sales levels beginning in 2004. Certain styles of the Teva sport sandal
413
+ incorporate a proprietary strapping configuration ideally suited for outdoor
414
+ activities such as hiking, boating and river rafting. This strapping system
415
+ consists of high-quality nylon webbing or leather, is fully adjustable, and
416
+ holds the foot firmly to the sandal's durable, cellular rubber, molded EVA,
417
+ polyurethane or leather footbed. Teva sport sandals are extremely durable and
418
+ many of the styles are water resistant. The Spring 2001 line includes more than
419
+ 100 different models designed for a variety of uses. The Wilderness Series, a
420
+ category of sandals built for high performance and rugged outdoor use, includes
421
+ 16 models of men's and women's sandals. The Utility Series which includes
422
+ several of the most popular styles, has 11 styles that combine elements of sport
423
+ performance with casual everyday comfort. The Surf Series includes 11 styles of
424
+ slides and thongs offered in a variety of materials including leather, nylon,
425
+ suede and airmesh. The Spring 2001 line includes an expanded variety of
426
+ Precision sport sandals and footwear, including the newly-introduced Trail
427
+ Wraptor and Road Wraptor performance running sandals, a collection of Circuit
428
+ walking sandals, the Marine collection of boating and deck footwear, the Hydro
429
+ collection of water shoes and booties, and the newly introduced Summit
430
+ collection of hikers incorporating the Wraptor technology. Continuing on the
431
+ success of recent years, the Spring 2001 line includes 25 styles of men's and
432
+ women's leather casuals, including a variety of sandals, slides and clogs. The
433
+ Spring 2001 Children's category has been expanded to include 15 different styles
434
+ of nylon and leather sandals. The domestic manufacturer's suggested retail
435
+ prices for adult sizes of Spring 2001 Teva footwear products range from $19.95
436
+ to $129.95.
437
+ Simple Casual Footwear. The Simple line consists of casual shoes that
438
+ combine the comfort and function of athletic footwear construction with the
439
+ simple, understated styling of "back-to-basics," casual lifestyle footwear. The
440
+ Simple product line includes a variety of comfortable, fashionable, basic shoes
441
+ for men and women including sneakers, sandals, slides, clogs and leather
442
+ casuals. The Spring 2001 collection reflects the Company's emphasis on a younger
443
+ target consumer in the sixteen to twenty-four year old age group. For Spring
444
+ 2001, Simple is offering a total of 69 models including 32 styles for men and 37
445
+ for women. The Spring 2001 line includes 21 styles of sneakers with leather and
446
+ suede uppers, 20 styles of sandals and thongs and 28 styles of leather casual
447
+ and clogs in a variety of colors. The domestic manufacturer's suggested retail
448
+ prices for adult sizes for the Spring 2001 line range from $29.99 to $99.99.
449
+ Ugg Sheepskin Footwear. Ugg is a line of authentic sheepskin footwear,
450
+ popularized in Australia in the 1960's and 1970's. These sheepskin boots,
451
+ slippers and other footwear styles have high-grade fleece linings which act as a
452
+ natural insulator, keeping feet warm and comfortable. The 2001 Ugg line offers a
453
+ range of 52 models of casual, fashionable and streetwise styles in various
454
+ colors, including several new styles of shoes and boots for men and women. The
455
+ 2001 line includes several styles with new innovative fashionable uppers and
456
+ several styles with water resistant leather treatments to address more inclement
457
+ and cold weather conditions. The 2001 line also includes products designed for
458
+ more fashionable and functional everyday use in both warm and cold climates,
459
+ including several new styles in its successful Ultra, Birch, Solvang,
460
+ Adirondack,
461
+ 9
462
+ 10
463
+ Fluff and Slipper collections. The domestic manufacturer's suggested retail
464
+ prices for adult sizes for the Ugg line range from $50.00 to $275.00.
465
+ MARKETING AND DISTRIBUTION
466
+ The Company's products are currently distributed throughout the United
467
+ States by a network of approximately 41 independent sales representatives,
468
+ organized geographically, who make sales, visit retail stores to train personnel
469
+ and review sales of the Company's footwear on a periodic basis. Beginning in
470
+ 2000, the Company added a separate dedicated independent sales force for the
471
+ Simple and Ugg brands as these products are sold through different distribution
472
+ channels and are targeted toward a different consumer than the Company's Teva
473
+ brand. The Company's sales managers for each brand manage their networks of
474
+ representatives, recruit experienced sales representatives in the industry and
475
+ coordinate sales to national accounts. The Company currently sells its products
476
+ internationally through independent distributors. The Company's goal is to
477
+ promote retail sales of its products at attractive profit margins for its
478
+ accounts through selective distribution and marketing, targeted toward distinct
479
+ groups of consumers. As a result of this approach, the Company's accounts have a
480
+ strong incentive to devote greater selling space to the Company's products, and
481
+ the Company is better able to assess consumer preferences, the future ordering
482
+ needs of its customers and inventory requirements.
483
+ The Company's principal domestic customers include specialty retailers,
484
+ upscale department stores, outdoor retailers and athletic footwear stores which
485
+ market products consistent with the Company's standards and, in the case of
486
+ Teva, have been approved by the Company's licensor. The Company's five largest
487
+ customers accounted for approximately 20.4% of the Company's net sales for the
488
+ year ended December 31, 2000, compared to 18.1% for the year ended December 31,
489
+ 1999. No single customer accounted for more than 10% of the Company's net sales
490
+ for the years ended December 31, 2000 or 1999.
491
+ In order to encourage accounts to place orders early in the season the
492
+ Company has continued with a preseason discount program under which accounts are
493
+ offered discounts on preseason orders placed. The Company's strategy is to
494
+ emphasize this "futures" program, as compared to "at once" sales, in order to
495
+ stabilize its supply arrangements, reduce the risk of customer cancellations and
496
+ to benefit from the significant positive impact of the program on the Company's
497
+ inventory costs, sourcing schedule and allocation of marketing resources.
498
+ Consistent with prior years, the Company offered an early delivery program for
499
+ the spring 2001 season to be delivered the fourth quarter of 2000. This early
500
+ delivery program allows the Company to reduce the impact of peak warehouse
501
+ inventory levels during the spring and provides retailers the opportunity to
502
+ have earlier sell through, lengthening the retail selling season and increasing
503
+ the potential for inventory turns at retail.
504
+ Domestic deliveries generally originate from the Company's 126,000 square
505
+ foot warehouse facility in Ventura County, California. European deliveries
506
+ originate from a distribution center in the Netherlands, while all other
507
+ international deliveries originate from offshore factories.
508
+ ADVERTISING AND PROMOTION
509
+ The Company attempts to maximize the impact of its advertising, public
510
+ relations and promotional expenditures by utilizing media that provide high
511
+ visibility within targeted market segments. The Company's brand names are
512
+ generally advertised and promoted through a variety of consumer print
513
+ advertising campaigns in addition to highly visible editorial coverage in both
514
+ consumer and trade publications. Retail presence and "point of purchase"
515
+ materials along with production packaging provide additional visible brand
516
+ support. The Company's in-house marketing departments for each brand work
517
+ closely with targeted accounts in many aspects of these activities.
518
+ The Company continues to advertise its Teva brand through a national print
519
+ advertising campaign targeted at various different demographic groups. For its
520
+ core outdoor market, Teva advertises in several outdoor-related magazines,
521
+ including Backpacker, Outside, Kayak, Elevation, Paddler, and Climbing, among
522
+ others. In addition, to promote its newly introduced Wraptor running sandal,
523
+ Teva is advertising in Runner's World, Sports Network, and Walking Magazine,
524
+ among other publications. With the broadened appeal of the
525
+ 10
526
+ 11
527
+ Teva offerings, including the leather casual models, the Company has also
528
+ focused its print advertising toward more mainstream print publications,
529
+ including Shape, Maxim and Sailing, among others.
530
+ In order to maintain the Company's historically high visibility among core
531
+ outdoor enthusiasts such as professional river rafters, kayakers, mountain
532
+ bikers and rock climbers, Teva products are given or sold at professional
533
+ discounts to members of this group. In order to further bolster the loyalty of
534
+ these individuals, the Company offers a category called the "Wilderness Series,"
535
+ incorporating the latest technological developments and highest quality
536
+ materials. The Company actively sponsors several of the world's best male and
537
+ female whitewater athletes. By outfitting and sponsoring these highly visible
538
+ athletes, the Company creates awareness among targeted consumers at relatively
539
+ low cost. In addition, the Company has traveling promotional and technical
540
+ representatives who represent the Teva brand at a wide variety of festivals,
541
+ outdoor sporting events and competitions. Teva is sponsoring over twenty events
542
+ in 2001, including the Teva Whitewater Series, a series of whitewater rafting
543
+ and kayaking events held between April and August at locations in California,
544
+ Oregon, Washington and Colorado, as well as France and Switzerland. Teva
545
+ sponsors and promotes these events in order to increase the Company's visibility
546
+ for its core outdoor consumer, in addition to the significant marketing
547
+ available to the more mainstream public with the increasing popularity of
548
+ viewing these extreme sports. In addition to the Teva Whitewater Series, the
549
+ Teva promotional team attends and sponsors other events including the Santa Cruz
550
+ Surf Kayak Festival in Santa Cruz, California, Grandma's Marathon in Duluth,
551
+ Minnesota, The Telluride Bluegrass Festival in Telluride, Colorado, and Reggae
552
+ on the River in Garberville, California, among others.
553
+ The Teva mobile promotions team attends the events in dedicated promotional
554
+ vehicles where they showcase Teva products and provide consumers with the
555
+ opportunity to see and try on the latest styles.
556
+ With respect to the Simple product line, the Company has continued its
557
+ national print advertising campaign. Simple print advertisements will appear in
558
+ alternative and youth focused consumer magazines such as Jane, Nylon and Lucky.
559
+ In addition, the marketing effort focuses around grass roots advertising
560
+ including advertising on billboards, website advertising and "Go Cards". A
561
+ rigorous public relations campaign will focus on obtaining magazine editorial
562
+ placement in addition to newspaper and television coverage. Recent public
563
+ relations coverage has appeared in Footwear News, Teen People, Nylon Magazine,
564
+ YM Magazine, Footwear Plus, Shape Magazine, Code Magazine and Surfing Girl.
565
+ These public relations efforts have also resulted in Simple products appearing
566
+ on television shows such as Friends, Ally McBeal, Dawson's Creek, Tucker and
567
+ MTV.
568
+ Simple's marketing efforts are performed internally by an in-house Simple
569
+ marketing team which works to promote the Simple brand positioning of being
570
+ "simple" and "down to earth".
571
+ In 2001, the Company plans to continue to build on the success of the Ugg
572
+ 1999 and 2000 national print advertising campaigns. The Company continues to
573
+ target a luxury consumer who seeks high quality, luxurious and fashionable
574
+ products for cold weather. The Company expects to advertise Fall 2001 Ugg
575
+ products in upscale publications such as Vogue and O Magazine.
576
+ In November 2000, Ugg's were featured on the Oprah Winfrey Show as her
577
+ choice of one of ten gift-giving ideas for the holiday season and each member of
578
+ the studio audience received a free pair of Ugg boots on the air. The show aired
579
+ several times from the week before Thanksgiving through Christmas, providing the
580
+ Ugg brand with nationwide exposure.
581
+ In addition to this national advertising campaign, the Ugg brand is being
582
+ supported by national public relations and product placement efforts. In-house
583
+ marketing personnel work closely with a public relations firm and a product
584
+ placement agency to gain brand visibility in popular magazines, television shows
585
+ and feature films. Recent editorial coverage includes articles in magazines such
586
+ as Harper's Bazaar, In Style, Cosmopolitan, Marie Claire, Maxim, Jane, YM
587
+ Magazine, Shape, Self, O Magazine and Real Simple. Television coverage of Ugg
588
+ product includes shows such as Dharma and Greg, Once and Again, Dawson's Creek,
589
+ E.R., King of Queens, Will and Grace, Ally McBeal, 7th Heaven, Everybody Loves
590
+ Raymond, Two Guys and a Girl and Providence. These public relations efforts have
591
+ also resulted in Ugg product appearances in the following feature films: Hanging
592
+ Up, starring Meg Ryan, Lisa Kudrow and Diane Keaton; The Kid,
593
+ 11
594
+ 12
595
+ starring Bruce Willis and Lily Tomlin; Mission Impossible II, starring Tom
596
+ Cruise and Thandie Newton; Panic, starring William H. Macy and Neve Campbell;
597
+ Snow Day, starring Chevy Chase; and Dragonfly, starring Kevin Costner and Kathy
598
+ Bates.
599
+ In 2000, 1999 and 1998, the Company incurred $7,108,000, $5,602,000 and
600
+ $5,847,000 respectively, for advertising, marketing and promotional expenses. In
601
+ addition to these expenditures, the Company's 31 international distributors
602
+ spend additional amounts for marketing the Company's brands within their
603
+ respective territories. The Company is required under its Teva License Agreement
604
+ to spend a minimum amount for advertising and promoting Teva products, based on
605
+ a percentage of sales. In addition to the minimum contractual marketing
606
+ expenditures, the Company and the licensor have agreed to each contribute
607
+ annually a certain percentage of sales toward the promotion of the Teva brand
608
+ and trademark, with or without particular reference to individual Teva styles.
609
+ DESIGN AND PRODUCT DEVELOPMENT
610
+ The design and product development staff for each of the Company's brands
611
+ creates and introduces new innovative footwear products that are consistent with
612
+ the Company's standards of high quality, combined with comfort and
613
+ functionality. The Company was restructured in 1999 from a company organized by
614
+ functions to a company aligned by brand, with each brand as a separate profit
615
+ center. As part of this reorganization, the previously existing design
616
+ department was disbanded and reassigned to the Company's various brands. In
617
+ addition, much of the design is currently provided by independent design firms
618
+ which perform the design function on an outsourced basis. In doing so, the
619
+ Company was able to eliminate certain positions, obtain efficiencies and reduce
620
+ design and development costs considerably. As a result, research and development
621
+ costs aggregated $1,076,000, $1,607,000 and $2,393,000 in 2000, 1999 and 1998,
622
+ respectively, reflecting the operational efficiencies gained under this new
623
+ approach.
624
+ With respect to Teva, in order to ensure that the Company's high
625
+ performance technical products continue to satisfy the requirements of its
626
+ historical customer base of performance-oriented "core enthusiasts," the
627
+ Company's design staff solicits comments and feedback from its licensor and
628
+ professional outdoorsmen, as well as several of its retailers, including REI and
629
+ L.L. Bean. Certain models are modified and technical innovations are developed
630
+ in response to such comments and feedback. The Company adds new innovations,
631
+ components and styles to its product line continually. For example, the Company
632
+ recently designed and introduced its new Wraptor technology, a two-part system
633
+ with a continuous strap which travels under the arch and then crosses over the
634
+ instep to provide a snug, solid fit. This technology has been incorporated in
635
+ these Trail Wraptor and Road Wraptor running sandals, as well as the newly
636
+ introduced line of hikers. In addition, for added traction and durability, the
637
+ Company has incorporated Spider Rubber(TM) into several styles, including its
638
+ high performance Wilderness Series.
639
+ While Teva continues to develop high performance sport sandals by
640
+ continually updating and designing new styles for this category, the Company
641
+ also continues to increase its focus on the casual footwear market through its
642
+ Teva, Simple and Ugg brands. The Company continues to introduce and offer new
643
+ styles of leather and other casual footwear for men and women and has expanded
644
+ its offerings under its collection of Teva children's sandals for Spring 2001.
645
+ The Company has also added several new styles of clogs, sandals, sneakers and
646
+ leather casuals to its offerings under the Simple line for 2001. By monitoring
647
+ changes in consumer lifestyles and preferences and then focusing first on
648
+ function and practicality, the Company develops footwear designed to appeal to
649
+ quality-minded consumers seeking comfortable casual footwear.
650
+ In recent years, the Company has taken steps to update the Ugg products in
651
+ order to make them more functional for use in cold and wet climates. For
652
+ example, the popular Ultra styles of men's and women's boots have been updated
653
+ with new lug outsoles to improve traction. In addition, the 2001 Ugg line
654
+ includes several styles of its rugged Adirondack collection of foul weather
655
+ boots. New Ugg additions for 2001 include several new styles in its popular
656
+ Ultra collection and high-end Fluff collection, as well as new slippers and
657
+ shoes for everyday casual use. More fashionable and unique upper styles help to
658
+ differentiate Ugg from the low cost imitation brands.
659
+ 12
660
+ 13
661
+ Integral factors in the design and product development process include an
662
+ evaluation of the availability and cost of raw materials, the capabilities of
663
+ the factories that will manufacture products and the target retail cost of new
664
+ models and lines. The design and development staff works closely with brand
665
+ management to develop new styles of footwear and components for their various
666
+ product lines. Drawings and prototypes are utilized to produce samples of
667
+ proposed new concepts. Throughout the development process, members of the design
668
+ staff coordinate closely with each other and with the Company's product
669
+ development, manufacturing and sourcing personnel toward a common goal of
670
+ developing and sourcing a high-quality product that will be delivered on a
671
+ timely basis. The Company endeavors to minimize the risk of changing fashion
672
+ trends by offering a diverse line of functional products and closely monitoring
673
+ sales to its accounts after introduction.
674
+ PRODUCT SOURCING
675
+ The Company currently sources all of its Teva and Simple footwear and a
676
+ portion of its Ugg footwear from independent contract manufacturers in the Far
677
+ East. The Company imports the remainder of its Ugg footwear from independent
678
+ contract manufacturers in Australia and New Zealand.
679
+ In 1997 and 1998, the Company closed its California and Mexican
680
+ manufacturing facilities. As a result of the closure of these facilities, the
681
+ Company is no longer involved in the direct manufacture of footwear, but rather
682
+ sources completed footwear entirely from independent contractors. As the Company
683
+ continues to grow, it expects to continue to rely heavily on its independent
684
+ contractors for its sourcing needs.
685
+ The manufacturing of footwear by the Company's independent contractors is
686
+ performed in accordance with detailed specifications provided by the Company and
687
+ is subject to quality control standards. In efforts to ensure the production of
688
+ high quality products, many of the materials and components used in production
689
+ are purchased from independent suppliers designated by the Company. The Company
690
+ believes that its completed footwear as well as the various raw materials and
691
+ components used in the manufacture of the footwear, including rubber, leather,
692
+ nylon webbing and sheepskin, are generally available from multiple sources at
693
+ competitive prices.
694
+ The Company generally does not have any long-term agreements with the
695
+ manufacturers or suppliers of its products, but does business based on
696
+ individual purchase orders.
697
+ QUALITY CONTROL
698
+ The Company has instituted inspections and other procedures to satisfy the
699
+ high quality demanded by users of the Company's products. The Company's quality
700
+ assurance program includes inspection procedures at the factory level as well as
701
+ a final inspection upon arrival of product at the Company's distribution center.
702
+ The Company uses on-site inspectors at its independent suppliers who oversee the
703
+ production process and perform quality assurance inspections. In addition, the
704
+ products undergo further inspection procedures prior to being accepted at the
705
+ Company's distribution center.
706
+ LICENSES
707
+ Teva License. The Company has been selling its Teva line of sport sandals
708
+ and other footwear since 1985 pursuant to various license arrangements with Mark
709
+ Thatcher, the inventor of the Teva sport sandal and the owner of the Teva
710
+ patents and trademark. Mr. Thatcher owns seven United States patents on designs
711
+ used in Teva sport sandals and has a United States trademark registration for
712
+ the Teva mark.
713
+ On June 7, 1999, the Company signed a new license agreement (the "License
714
+ Agreement") for Teva, which became effective January 1, 2000. Under the License
715
+ Agreement, the Company has the exclusive worldwide rights for the manufacture
716
+ and distribution of Teva footwear through 2004. Apparel and other non-footwear
717
+ products are not covered by the License Agreement. The License Agreement is
718
+ automatically renewable through 2008 and through 2011 under two renewal options,
719
+ provided that minimum required sales levels are achieved. These minimum annual
720
+ sales levels are established at amounts which are in excess of the annual sales
721
+ levels which have been achieved to date.
722
+ 13
723
+ 14
724
+ As with the previous arrangement, the License Agreement provides for a
725
+ sliding scale of royalty rates, depending on sales levels, and includes
726
+ guaranteed minimum annual royalty amounts. Additionally, the License Agreement
727
+ provides for an increase in the required amount of marketing expenditures,
728
+ depending on sales levels and varying by territory. In addition to the minimum
729
+ contractual marketing expenditures, the Company and the licensor have agreed to
730
+ each contribute annually a certain percentage of sales toward the promotion of
731
+ the Teva brand and trademark, with or without particular reference to individual
732
+ Teva styles.
733
+ As additional consideration, the Company paid the licensor a licensing fee
734
+ of $1,000,000 and issued the licensor 428,743 shares of its previously unissued
735
+ common stock valued at $1,608,000. The Company has recorded the license as an
736
+ intangible asset equal to the cash and market value of the stock issued on the
737
+ date of the License Agreement. These shares are subject to various contractual
738
+ and other holding period requirements. In addition, the Company has agreed to
739
+ grant the licensor not less than 50,000 stock options on the Company's common
740
+ stock annually, at the market value on the date of grant.
741
+ The licensor retains the rights to approve the quality of the licensed
742
+ products produced, all marketing, advertising and promotional plans and
743
+ materials, and the distribution channels and customers to whom the Company can
744
+ sell the licensed products. In addition, the License Agreement provides for
745
+ minimum annual research and development spending levels for the Company with
746
+ respect to the Teva products and restricts the volume of closeouts and seconds
747
+ which the Company is able to sell each year.
748
+ The License Agreement provides that the licensor, in his sole discretion,
749
+ may take any action against parties believed to be infringing upon the
750
+ licensor's trademark, patents and other intellectual property. The licensor is
751
+ fully responsible for any legal and other costs incurred in such actions and is
752
+ entitled to any recovery resulting from the actions. The Company may not
753
+ participate in any such action or in any other action regarding the infringement
754
+ of the Teva intellectual property without the licensor's prior written consent.
755
+ In the event that the license term is automatically renewed beyond 2004,
756
+ the Company must achieve minimum annual sales levels for the years 2005 through
757
+ 2011. These minimum annual sales levels are based upon certain percentages of
758
+ net sales in the preceding calendar year. If the Company is not able to achieve
759
+ the minimum annual sales levels for two years during a renewal term, the License
760
+ Agreement can be terminated at the option of the licensor.
761
+ During the term of the License Agreement, including the renewal terms, the
762
+ Company is prohibited from manufacturing, marketing, selling and distributing
763
+ any sandals other than Teva sandals. In addition, for the two years following
764
+ the termination of the License Agreement, the Company is prohibited from
765
+ manufacturing, marketing, selling and distributing sandals, in general. However,
766
+ the Company may continue to manufacture, market, sell and distribute all styles
767
+ and models of sandals offered under its Simple product line which existed as of
768
+ the date of the License Agreement as well as all styles subsequently approved by
769
+ the licensor.
770
+ The License Agreement can be terminated under several circumstances, if
771
+ they remain uncured for specific periods of time. These circumstances include
772
+ the following, among others: if either party becomes insolvent or bankrupt; if
773
+ the Company offers sandals which compete with the Teva products or otherwise
774
+ engages in activities which compete with the Teva products; if the Company
775
+ transfers substantially all of its property or stock to other parties; if the
776
+ Company sells unapproved merchandise in violation of the License Agreement; or
777
+ if the Company or the licensor otherwise violate or breach the terms of the
778
+ License Agreement.
779
+ In connection with the execution of the License Agreement in 1999, the
780
+ Company received an option to buy Teva and virtually all of its assets,
781
+ including all worldwide rights to all Teva products. The Company's original
782
+ option was exercisable during the period from January 1, 2000 to December 31,
783
+ 2001 or during the period from January 1, 2006 to December 31, 2008. On January
784
+ 22, 2001, the option agreement was amended, extending the first option window
785
+ for two additional years. As a result, the first option window is January 1,
786
+ 2000 through December 31, 2003. The Company paid Mr. Thatcher $1.6 million as
787
+ consideration for this extension. The option price is based on formulas tied to
788
+ net sales of Teva products and varies depending on when the option is exercised.
789
+ For the first option period, the option price is for an amount equal to the
790
+ greater of (i) $61.6 million or (ii) 75% of the largest calendar year revenues
791
+ since January 1, 2000 for the Teva brand,
792
+ 14
793
+ 15
794
+ plus $1.6 million. In addition, the Company would issue to Mr. Thatcher 100,000
795
+ shares of common stock and options to purchase 100,000 shares of common stock.
796
+ The purchase price for the second option period, January 1, 2006 to December 31,
797
+ 2008, is equal to 110% of the average of the aggregate sales for all Teva
798
+ products for the two calendar years since January 1, 2000 with the highest
799
+ aggregate net sales. If the Company does not exercise its option to acquire
800
+ Teva, the licensor has the option to acquire the Teva distribution rights from
801
+ the Company for the period from January 1, 2010 to December 31, 2011, the end of
802
+ the license term, and the option price is based on a formula tied to the
803
+ Company's earnings before interest, taxes, depreciation and amortization. The
804
+ Company is currently evaluating the possibility of exercising the option in the
805
+ January 1, 2000 to December 31, 2003 period. The payment of the purchase price
806
+ must be completed within 90 days of the exercise of the purchase option. If the
807
+ Company exercises its purchase option, but subsequently fails to complete the
808
+ purchase within the 90 day payment period, the purchase option and the Option
809
+ Agreement will automatically be terminated.
810
+ HEIRLOOMS, INC. AGREEMENT
811
+ Since 1993, the Company and Bob Eason, the designer and founder of Picante
812
+ clothing, were parties to an agreement pursuant to which the Company owned 50%
813
+ of Heirlooms, Inc. ("Heirlooms"), the manufacturer and distributor of Picante
814
+ clothing. In January 2001, the Company sold its 50% interest in Heirlooms back
815
+ to Mr. Eason for cash of approximately $1,200,000 and a note receivable of
816
+ approximately $420,000, which is secured by a secondary security interest in the
817
+ assets of Heirlooms. The selling price was for an amount that approximated the
818
+ net carrying value of the underlying assets and, accordingly, the resulting gain
819
+ on the sale is not expected to be significant.
820
+ PATENTS AND TRADEMARKS
821
+ Mr. Thatcher holds seven United States patents and one patent in each of
822
+ Australia, New Zealand, Korea, Germany, France, China, Japan and the United
823
+ Kingdom for Teva footwear. As a result of the expiration of the applicable
824
+ period during which foreign patent applications were required to have been
825
+ filed, Mr. Thatcher does not and cannot hold such patent rights in other
826
+ countries. Mr. Thatcher also currently holds Teva trademark rights in the United
827
+ States and in several other countries, including, among others, France, Germany,
828
+ the United Kingdom, Japan and Australia. Mr. Thatcher's patent and trademark
829
+ rights are licensed to the Company under the License Agreement discussed
830
+ previously. Both the Company and Mr. Thatcher regard such proprietary rights as
831
+ valuable assets, and the Company cooperates with Mr. Thatcher in vigorously
832
+ protecting such rights against infringement by third parties. To date, Mr.
833
+ Thatcher has successfully enforced his patent and trademark rights in all 20
834
+ concluded lawsuits brought against such third parties. Under certain
835
+ circumstances, if Mr. Thatcher declines to challenge a potential infringement,
836
+ the Company may bring an infringement action at its own cost, with Mr.
837
+ Thatcher's prior written consent. See "Licenses -- Teva License."
838
+ The Company owns the Simple and Ugg trademarks and has applied for or
839
+ received registrations for them in the United States and in many foreign
840
+ countries. The Company has selectively registered style category names and
841
+ marketing slogans. In addition, the Company holds two design patents for its
842
+ footwear products.
843
+ The Company has acquired the patent and trademarks for Alp(R)sport sandals
844
+ and has registered the Deckers trademark.
845
+ BACKLOG
846
+ Historically, the Company has encouraged and has received a significant
847
+ portion of its orders as preseason orders, which are generally placed by
848
+ customers approximately four to eight months prior to shipment date. The Company
849
+ has emphasized this "futures" business, as compared to "at once" sales, as it
850
+ allows the Company to better forecast its inventory requirements and assists
851
+ with the Company's sourcing schedule. As a result, the Company provides its
852
+ customers with incentives to participate in such preseason programs. Unfilled
853
+ customer orders ("backlog"), as of any date, represent orders scheduled to be
854
+ shipped at a future date and do
855
+ 15
856
+ 16
857
+ not represent firm sales. The mix of future and immediate delivery orders can
858
+ vary significantly from quarter to quarter and year to year. The backlog as of a
859
+ particular date is affected by a number of factors, including seasonality and
860
+ the scheduling of manufacture and shipment of products as well as variations in
861
+ the quarter to quarter and year to year preseason incentive programs. As a
862
+ result, comparisons of backlog from period to period are not meaningful and the
863
+ Company's backlog at any given time is generally not indicative of sales levels
864
+ expected to be achieved in the future.
865
+ COMPETITION
866
+ The casual, outdoor and athletic footwear markets are highly competitive.
867
+ The Company believes that currently its largest competitors of the Teva line are
868
+ Nike, Adidas, Timberland, Columbia and Salomon. The principal competitors of
869
+ Simple's casual line include Steve Madden, Nine West, Doc Marten, Camper, and
870
+ Kenneth Cole and of Simple's sneaker/sandal line include Skechers, Diesel, Steve
871
+ Madden and Guess. Ugg's competitors include Acorn, Aussie Dogs, LB Evans and
872
+ Timberland, as well as retailers' private label footwear.
873
+ Competition in the Company's footwear is primarily based on brand
874
+ awareness, product quality, design, price points, fashion appeal, marketing,
875
+ distribution, performance and brand positioning. The Company's Teva line of
876
+ footwear competes primarily on the basis of its authenticity as a recognized
877
+ brand in the outdoor market, its consumer brand recognition as one of the first
878
+ sandals of its kind, as well as its high performance nature and its diversity of
879
+ styles offered. In addition, several of the most popular styles employ a
880
+ distinctive patented strapping system, which contributes to performance and the
881
+ brand's consumer recognition. The Company competes through its Simple line as an
882
+ alternative brand offering a diversity of simple, back-to-basics styles designed
883
+ for a variety of recreational and leisure activities. Ugg competes primarily on
884
+ the basis of its authenticity as well as its brand name recognition,
885
+ identifiable with the United States sheepskin footwear market. The Company
886
+ believes its business strategy has resulted in increased awareness for its
887
+ brands. However, no assurance can be given that in the future the Company will
888
+ be able to maintain or further increase its brand awareness, maintain or
889
+ increase its market share or respond to changing consumer preferences.
890
+ RISKS OF FOREIGN OPERATIONS/RESTRICTIONS ON IMPORTS
891
+ The Company's operations are subject to the customary risks of doing
892
+ business abroad, including, but not limited to, currency fluctuations, customs
893
+ duties and related fees, various import controls and other non-tariff barriers
894
+ (e.g., quotas), the cost of transportation, restrictions on the transfer of
895
+ funds, labor unrest and strikes, and in certain parts of the world, political
896
+ instability. Countries where the Company's products are manufactured and sold
897
+ may, from time to time, seek to increase customs duties or impose other
898
+ non-tariff barriers (e.g., quotas), all of which have the potential to affect
899
+ the Company's operations and its ability to maintain or increase the current
900
+ level of importation of the Company's products. The Company is unable to predict
901
+ the likelihood or frequency of the occurrence of any of these events.
902
+ The products imported by the Company into the United States are subject to
903
+ various duty rates which are established by law. At the present time these
904
+ duties range between 8.5% and 12.5% of the entered value of footwear with uppers
905
+ made principally of leather or sheepskin, and 6.0% and 37.5%, plus $.90 per
906
+ pair, of the entered value of footwear with uppers made principally of synthetic
907
+ textiles or plastic. Certain products imported by the Company are exempt from
908
+ duties pursuant to laws pertaining to products manufactured in certain
909
+ beneficiary countries. "Entered value" means the value taken into account for
910
+ purposes of determining the amount of any customs duties or any other duties
911
+ which may be imposed on the importation of any property. In general, the entered
912
+ value is normally based on the price paid or payable by the Company to the
913
+ seller of the imported merchandise.
914
+ From time to time, the Company may be subject to claims for additional
915
+ duties arising as a result of the United States Customs Service, or similar
916
+ agencies of foreign countries, disagreeing with the classification and/or
917
+ valuation used by the Company to enter various styles of footwear.
918
+ 16
919
+ 17
920
+ The United States Trade Representative ("USTR") is required by the Trade
921
+ Act of 1974, as amended by the Trade and Tariff Act of 1984, the Omnibus Trade
922
+ and Competitiveness Act of 1988 and the 1994 Uruguay Round Agreements Act to
923
+ submit an annual National Trade Estimates Report on Foreign Trade Barriers (the
924
+ "NTE Report") identifying significant restrictions or barriers on United States
925
+ access to foreign markets. In January 1999, the President reinstated, by
926
+ Executive Order, the "Super 301" Provisions of the Trade Act. Relying on the NTE
927
+ Report, the USTR is required to report to Congress any trade barriers, trade
928
+ distorting practices and particular countries identified as priorities for trade
929
+ liberalization.
930
+ On April 30, 1997, the USTR designated China for monitoring under Section
931
+ 306 of the 1974 Trade Act. This provision focuses on compliance with bilateral
932
+ trade agreements and allows the U.S. government to impose a variety of sanctions
933
+ if a party fails to comply with the terms of a bilateral agreement. On April 28,
934
+ 2000, USTR again designated Paraguay and China for "Section 306 monitoring" to
935
+ ensure both countries comply with the commitments made to the United States
936
+ under bilateral intellectual property agreements. This means that USTR will be
937
+ in a position to move directly to trade sanctions if there is slippage in either
938
+ country's enforcement of bilateral IPR agreements.
939
+ In June 2000, President Clinton extended non-discriminating "normal trade
940
+ relations" ("NTR," formerly "most favored nation") trading status with China
941
+ through June 2001. While NTR status has been extended for another year, this
942
+ topic has traditionally been the subject of vigorous debate, and the Company is
943
+ unable to predict if the United States will revoke China's NTR status at some
944
+ point in the future. If a revocation of NTR status were to occur, it would
945
+ result in significantly higher duties on imports from China. It is noted that
946
+ bilateral agreements negotiated with China concerning that country's accession
947
+ to the World Trade Organization require that the United States grant permanent
948
+ NTR to China and in its report of May 1, 2000, USTR announced that the granting
949
+ of permanent NTR was its top trade expansion priority.
950
+ On April 28, 2000, the USTR announced that 39 countries had been placed on
951
+ the "special 301" watch list and 16 countries on the priority watch list because
952
+ of intellectual property protection concerns. Watch list countries include among
953
+ others: Australia, Canada, Denmark, Costa Rica, and Korea. The Company is unable
954
+ to predict whether or not additional countries will be added to the priority
955
+ watch list, or if any other actions will be imposed by the United States and if
956
+ such actions were taken, whether such actions would include footwear imports or
957
+ otherwise result in increased costs for the Company's products or restrict the
958
+ supply of footwear, generally, or of the Company's footwear in particular.
959
+ In 1997, the European Commission enacted anti-dumping duties of 49.2% on
960
+ certain types of footwear imported into Europe from China and Indonesia. Dutch
961
+ Customs has issued an opinion to the Company that certain popular Teva styles
962
+ are covered by this anti-dumping duty legislation. The Company has been
963
+ contesting the opinion and is working with Dutch Customs to resolve the
964
+ situation. The Company has since obtained, and is using, alternative sourcing
965
+ for the potentially impacted products from sources outside of China in an effort
966
+ to reduce the potential risk in the future. In the event that Dutch Customs
967
+ makes a final determination that the anti-dumping provisions are applicable, the
968
+ Company would have an exposure for prior unpaid anti-dumping duties during 1997
969
+ of approximately $400,000. Recently, the European Commission added an
970
+ explanatory note to the anti-dumping legislation which effectively strengthened
971
+ its position. As a result of this recent development, the Company recorded a
972
+ $400,000 charge to selling, general and administration expenses during the year
973
+ ended December 31, 2000 to accrue for the potential loss on this matter.
974
+ The European communities also impose quantitative limits on imports from
975
+ China of certain leather upper and textile upper footwear. The Company is unable
976
+ to predict how long the anti-dumping duty and import quota restrictions will
977
+ remain in effect or changes in the scope or severity of such restrictions.
978
+ EMPLOYEES
979
+ At December 31, 2000, the Company employed approximately 105 full-time
980
+ employees in its U.S. facilities, 7 at its European subsidiary and 28 at its
981
+ Hong Kong subsidiaries, none of whom is represented by a union. The Company
982
+ believes its relationship with its employees is good.
983
+ 17
984
+ 18
raw/filings/0000910521/2000/0000950148-01-000493/item13.txt ADDED
@@ -0,0 +1,9 @@
 
 
 
 
 
 
 
 
 
 
1
+ ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
2
+ Information relating to Certain Relationships and Related Transactions is
3
+ set forth in the Company's definitive proxy statement relating to the
4
+ Registrant's 2001 annual meeting of shareholders, which will be filed pursuant
5
+ to Regulation 14A within 120 days after the end of the Company's fiscal year
6
+ ended December 31, 2000, and such information is incorporated herein by
7
+ reference.
8
+ 48
9
+ 49
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+ 0000910521,DECK,DECKERS OUTDOOR CORP,10-K,2002-03-29,2001-12-31,2002-03-29T05:00:00.000Z,0000950148-02-000814,v79832e10-k.htm,"DECKERS FORM 10-K FOR DECEMBER 31, 2001",840316,0,0,https://www.sec.gov/Archives/edgar/data/910521/000095014802000814/v79832e10-k.htm,https://www.sec.gov/Archives/edgar/data/910521/000095014802000814/,2001,2001,1
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1
+ Item 1. Business
2
+ General
3
+ The Company builds niche products into global
4
+ lifestyle brands by designing and marketing innovative,
5
+ functional and fashion-oriented footwear, developed for both
6
+ high performance outdoor activities and everyday casual
7
+ lifestyle use. Currently, the Company offers three primary
8
+ product lines under the following recognized brand names:
9
+ Teva® — high-performance sports sandals and
10
+ rugged outdoor footwear; Simple® — innovative
11
+ shoes that combine the comfort elements of athletic footwear
12
+ with casual styling; and Ugg® — authentic
13
+ sheepskin boots and other footwear. Teva is a registered
14
+ trademark of Mark Thatcher, the inventor and licensor of Teva
15
+ Sport Sandals. Simple and Ugg are registered trademarks of the
16
+ Company and its subsidiaries. All of the Company’s footwear
17
+ possess the common features of high quality with a primary focus
18
+ on functionality and comfort. In 2001, the Company sold
19
+ approximately 3,705,000 pairs of footwear. Revenues from sales
20
+ (domestic and international) of Teva products have been
21
+ $61,221,000, $79,732,000 and $80,963,000 during 2001, 2000 and
22
+ 1999, representing 66.9%, 70.1% and 72.9% of net sales,
23
+ respectively. For financial information regarding the
24
+ Company’s industry segments, see note 10 to the
25
+ accompanying consolidated financial statements.
26
+ Market Overview
27
+ The casual, outdoor and athletic footwear market
28
+ is comprised of footwear worn for casual everyday use and for
29
+ outdoor and athletic activities such as hiking, boating,
30
+ basketball, tennis, fitness and jogging. The market for such
31
+ footwear has grown significantly during the last decade. The
32
+ Company believes that the principal reasons for the growth in
33
+ sales of such footwear have been the growing acceptance of
34
+ athletic footwear as casual wear and the growing acceptance of
35
+ casual wear, in general, including the trend toward casual dress
36
+ in the workplace, increasingly active consumer lifestyles and
37
+ the growing emphasis on comfort.
38
+ Over the last few years the overall footwear
39
+ market has seen significant growth of the outdoor segment as
40
+ well as the growing emphasis on comfort. Outdoor footwear
41
+ includes shoes, boots and sandals for outdoor recreational
42
+ activities such as hiking, river rafting, camping and casual
43
+ wear. Companies engaged in the outdoor footwear market include
44
+ Nike, Adidas, Timberland, Columbia and Salomon. The Company
45
+ believes that the growth in outdoor footwear is driven by
46
+ several factors including a general shift in consumer
47
+ preferences and lifestyles to include more outdoor, sports and
48
+ recreational activities such as hiking and camping. In addition,
49
+ the increasing popularity of extreme sports, including
50
+ skateboarding, snowboarding, kayaking and river rafting, among
51
+ others, has created an additional emphasis and awareness of
52
+ outdoor activities and lifestyles. As consumers engage in
53
+ outdoor activities, they typically desire footwear specifically
54
+ designed for these purposes, yet they demand the same level of
55
+ quality and high performance that they have come to expect from
56
+ traditional athletic footwear. In addition, more consumers are
57
+ turning to an emphasis on casual and comfortable footwear and
58
+ apparel, as evidenced by the trend toward casual workplaces in
59
+ recent years. The Company believes that its products have
60
+ benefited from this growing trend and that its footwear
61
+ addresses consumers’ demands for highly functional footwear
62
+ that is durable as well as comfortable and fashionable.
63
+ The casual, outdoor and athletic footwear markets
64
+ are generally characterized by a high level of recognition of
65
+ brand names, logos and trademarks. Unique and identifying
66
+ features create brand awareness among consumers and allow a
67
+ favorable reputation to be transferred to new products. The
68
+ manufacture of casual, outdoor and athletic footwear is
69
+ typically conducted overseas through independent manufacturers.
70
+ Casual and athletic footwear is distributed through athletic
71
+ footwear stores, department stores and specialty retailers.
72
+ Outdoor footwear is generally distributed through these channels
73
+ as well but is to a large extent distributed through outdoor
74
+ specialty retailers. Retailers may purchase footwear on a
75
+ “futures” basis (orders placed at a discount in
76
+ advance of a season) or an “at once” basis (orders
77
+ placed and filled immediately). Futures orders allow the Company
78
+ to more accurately predict its manufacturing and sourcing needs.
79
+ By placing futures orders, retailers are also able to reduce the
80
+ risk that the Company will be unable to meet their
81
+ 3
82
+ Table of Contents
83
+ delivery requirements. Retailers are generally
84
+ encouraged to purchase goods on a futures basis by receiving
85
+ discounts or special payment terms not otherwise available.
86
+ Risk Factors
87
+ This Annual Report on Form 10-K contains a
88
+ variety of forward-looking statements within the meaning of the
89
+ Private Securities Litigation Reform Act of 1995 including
90
+ forward-looking statements in this “Risk Factors”
91
+ section, the “Outlook” section, the last paragraph
92
+ under “Liquidity and Capital Resources”, the
93
+ discussion under “Seasonality” and other statements in
94
+ this Annual Report. Forward-looking statements relating to
95
+ sales, earnings per share, and the Company’s liquidity may
96
+ be significantly impacted by future developments such as the
97
+ possible non-renewal of the Teva license due to the
98
+ Company’s potential failure to meet required sales minimums
99
+ in 2004 or 2008, certain litigation, economic factors and world
100
+ events, the Company’s dependence on foreign manufacturers,
101
+ competition, the Company’s dependence upon key personnel,
102
+ weather conditions, the possible acquisition of Teva and the
103
+ impact of seasonality on the Company’s operations, among
104
+ others. These forward-looking statements are based on the
105
+ Company’s expectations as of March 2002. No one should
106
+ assume that any forward-looking statement made by the Company
107
+ will remain consistent with the Company’s expectations
108
+ after the date the forward-looking statement is made. The
109
+ Company disclaims any obligation to update any such factors or
110
+ to publicly announce the results of any revisions to any of the
111
+ forward-looking statements contained in this Annual Report on
112
+ Form 10-K. These forward-looking statements involve known and
113
+ unknown risks, uncertainties and other factors which may cause
114
+ the actual results, performance or achievement of the Company,
115
+ or industry results, to differ materially from any future
116
+ results, performance or achievements expressed or implied by
117
+ such forward-looking statements. The factors listed below
118
+ represent certain important factors the Company believes could
119
+ cause such results to differ. These factors are not intended to
120
+ represent a complete list of the general or specific risks that
121
+ may affect the Company. Other risks may be significant,
122
+ presently or in the future, and the risks set forth below may
123
+ affect the Company to a greater extent than indicated.
124
+ Teva License Agreement
125
+ The Company has been selling its Teva line of
126
+ sports sandals and other footwear since 1985 pursuant to various
127
+ exclusive licensing arrangements with Mark Thatcher, the
128
+ inventor of the Teva sport sandal and owner of the Teva patents
129
+ and trademark. In June 1999, the Company signed a new exclusive
130
+ footwear license agreement with Mr. Thatcher. The agreement
131
+ became effective January 1, 2000 and continues through
132
+ December 31, 2004. If minimum annual sales levels are
133
+ achieved in 2004, the license automatically renews for an
134
+ additional four years, through December 31, 2008. If
135
+ minimum annual sales levels are achieved in 2008, the license
136
+ automatically renews again through December 31, 2011.
137
+ However, if the minimum annual sales levels are not achieved in
138
+ 2004 or 2008, the license expires and the Company will no longer
139
+ be able to sell Teva footwear. These required minimum annual
140
+ sales levels are $107.9 million in 2004 and
141
+ $137.3 million in 2008, both of which are significantly
142
+ greater than the annual sales of $61.2 million achieved by
143
+ the Company in 2001. Also, Mr. Thatcher may terminate the
144
+ licensing agreement if the Company breaches certain of its other
145
+ obligations under the agreement. The Company believes it is
146
+ unlikely to achieve the contractual minimum for 2004 and has
147
+ begun discussions with the licensor to address this issue.
148
+ However, the Company can provide no assurances that it will be
149
+ successful in its efforts to reach an acceptable resolution.
150
+ Sales of Teva footwear and apparel accounted for approximately
151
+ 66.9%, 70.1% and 72.9% of the Company’s net sales for
152
+ fiscal years 2001, 2000 and 1999, respectively. The termination
153
+ of the license would have a material adverse effect on the
154
+ Company’s results of operations.
155
+ Brand Strength; Changes in Fashion
156
+ Trends
157
+ The Company’s success is largely dependent
158
+ on the continued strength of the Teva, Simple and Ugg brands
159
+ (collectively, “Deckers Brands”) and on its ability to
160
+ anticipate the rapidly changing fashion tastes of footwear
161
+ customers and to provide merchandise that appeals to their
162
+ preferences in a timely manner. There can be no assurance that
163
+ consumers will continue to prefer the Deckers Brands or that the
164
+ Company will respond in a timely manner to changes in consumer
165
+ preferences or that the Company will successfully
166
+ 4
167
+ Table of Contents
168
+ introduce new models and styles of footwear.
169
+ Achieving market acceptance for new products will also likely
170
+ require substantial marketing and product development efforts
171
+ and the expenditure of significant funds to create consumer
172
+ demand. Decisions with respect to product designs often need to
173
+ be made many months in advance of the time when consumer
174
+ acceptance can be determined. As a result, the Company’s
175
+ failure to anticipate, identify or react appropriately to
176
+ changes in styles and features could lead to, among other
177
+ things, excess inventories and higher markdowns and lower gross
178
+ margins due to the necessity of providing discounts to
179
+ retailers. Conversely, failure by the Company to anticipate
180
+ consumer demand could result in inventory shortages, which can
181
+ adversely affect the timing of shipments to customers,
182
+ negatively impacting retailer and distributor relationships and
183
+ diminishing brand loyalty. The failure to introduce new products
184
+ that gain market acceptance would have a material adverse effect
185
+ on the Company’s business, financial condition and results
186
+ of operations, and could adversely affect the image of the
187
+ Deckers Brands.
188
+ Inventory Risk
189
+ The footwear industry has relatively long lead
190
+ times for design and production of product and, thus, the
191
+ Company must commit to production tooling and to production in
192
+ advance of orders. In addition, the industry is highly subject
193
+ to fashion risks and changes in consumer preferences. This risk
194
+ is exacerbated by the large number of models, colors and sizes
195
+ in the Company’s three product lines. If the Company fails
196
+ to accurately forecast consumer demand, or if there are changes
197
+ in consumer preference or market demand after the Company has
198
+ made such production commitments, the Company may encounter
199
+ difficulty in filling customer orders or in liquidating excess
200
+ inventory, which may have an adverse effect on the
201
+ Company’s sales, margins and brand image.
202
+ Quality and Performance
203
+ In response to consumer demand, the Company also
204
+ uses certain specialized materials in its footwear. The failure
205
+ of products using such materials to perform to the
206
+ Company’s specifications or customer satisfaction could
207
+ result in a higher rate of customer returns and could adversely
208
+ affect the image of the Deckers Brands, which could have a
209
+ material adverse effect on the Company’s business,
210
+ financial condition and results of operations.
211
+ Economic Cyclicality and Footwear
212
+ Retailing
213
+ The footwear industry historically has been
214
+ subject to cyclical variation and can be negatively impacted by
215
+ decreased consumer spending or softness in the retail market.
216
+ This cyclicality could adversely affect the Company’s
217
+ business. In addition, various retailers, including some of the
218
+ Company’s customers, have experienced financial
219
+ difficulties during the past several years, thereby increasing
220
+ the risk that such retailers may not be able to pay for the
221
+ Company’s products in a timely manner. No assurance can be
222
+ given that the Company’s bad debt expense will not increase
223
+ relative to net sales in the future. Any significant increase in
224
+ the Company’s bad debt expense relative to net sales would
225
+ adversely impact the Company’s net earnings and cash flow
226
+ and could affect the Company’s ability to pay its
227
+ obligations as they become due.
228
+ Dependence on Foreign
229
+ Manufacturers
230
+ Virtually all of the Deckers footwear products
231
+ are manufactured by third party suppliers in the Far East,
232
+ Australia and New Zealand, with the vast majority of production
233
+ occurring in China. There can be no assurance that the Company
234
+ will not experience difficulties with such manufacturers,
235
+ including reduction in the availability of production capacity,
236
+ errors in complying with product specifications, inability to
237
+ obtain sufficient raw materials, insufficient quality control,
238
+ failure to meet production and delivery deadlines or increases
239
+ in manufacturing costs. In addition, if the Company’s
240
+ relationship with any of its manufacturers were to be
241
+ interrupted or terminated, alternative manufacturing sources
242
+ will have to be located. The establishment of new manufacturing
243
+ relationships involves numerous uncertainties, and there can be
244
+ no assurance that the Company would be able to obtain
245
+ alternative manufacturing sources on terms satisfactory to it.
246
+ If a change in its suppliers becomes necessary, the Company
247
+ would likely experience increased costs, as well as substantial
248
+ disruption and a resulting loss of sales.
249
+ 5
250
+ Table of Contents
251
+ Foreign manufacturing is subject to a number of
252
+ risks, including work stoppage, transportation delays and
253
+ interruptions, political instability, foreign currency
254
+ fluctuations, changing economic conditions, expropriation,
255
+ nationalization, imposition of tariffs, import and export
256
+ controls and other non-tariff barriers (including quotas),
257
+ restrictions on the transfer of funds, environmental regulation
258
+ and other changes in governmental policies. The Company may also
259
+ experience general risks associated with managing operations
260
+ effectively and efficiently from a far distance and
261
+ understanding and complying with local laws, regulations and
262
+ customs. There can be no assurance that such factors will not
263
+ materially adversely affect the Company’s business,
264
+ financial condition and results of operations.
265
+ Products manufactured overseas and imported into
266
+ the United States and other countries are subject to duties
267
+ collected by the Customs Service in the applicable country.
268
+ Customs information submitted by the Company is subject to
269
+ review by the Customs Service. The Company is unable to predict
270
+ whether additional customs duties, quotas or restrictions may be
271
+ imposed on the importation of its products in the future. The
272
+ enactment of any such duties, quotas or restrictions could
273
+ result in increases in the cost of such products generally and
274
+ might adversely affect the sales or profitability of the Company.
275
+ In 1997, the European Commission enacted
276
+ anti-dumping duties of 49.2% on certain types of footwear
277
+ imported into Europe from China and Indonesia. Dutch Customs has
278
+ issued an opinion to the Company that certain popular Teva
279
+ styles are covered by this anti-dumping duty legislation. The
280
+ Company has been contesting the opinion and is working with
281
+ Dutch Customs to resolve the situation. The Company has since
282
+ obtained, and is using, alternative sourcing for the potentially
283
+ impacted products from sources outside of China in an effort to
284
+ reduce the potential risk in the future. In the event that Dutch
285
+ Customs makes a final determination that the anti-dumping
286
+ provisions are applicable, the Company would have an exposure
287
+ for prior unpaid anti-dumping duties during 1997 of
288
+ approximately $500,000, which has been fully accrued as of
289
+ December 31, 2001.
290
+ Competition and Infringing
291
+ Products
292
+ The outdoor and footwear industries are both
293
+ highly competitive, and the recent growth in the markets for
294
+ sports sandals and casual footwear has encouraged the entry of
295
+ many new competitors into the marketplace as well as increased
296
+ competition from established companies. Many of the
297
+ Company’s competitors have substantially greater financial,
298
+ distribution and marketing resources, as well as greater brand
299
+ awareness in the footwear market, than the Company. In addition,
300
+ the general availability of offshore manufacturing capacity
301
+ allows rapid expansion by competitors and new market entrants.
302
+ The Company believes that it has been able to compete
303
+ successfully because of the brand recognition, quality and
304
+ selective distribution of its products. From time to time, the
305
+ Company also discovers products in the marketplace that infringe
306
+ upon patent and trademark rights held by or licensed to the
307
+ Company. Under the Company’s licensing arrangement with the
308
+ licensor of the Teva products, Mark Thatcher, Mr. Thatcher
309
+ initially may bring proceedings to halt infringement of the Teva
310
+ patents and trademark. If Mr. Thatcher elects not to bring
311
+ such proceedings, the Company may initiate such proceedings,
312
+ with the prior written consent of Mr. Thatcher. To date,
313
+ Mr. Thatcher has vigorously pursued infringements following
314
+ discovery. To the extent permitted in its agreement with
315
+ Mr. Thatcher and to the extent considered necessary, the
316
+ Company will vigorously pursue infringements in the event
317
+ Mr. Thatcher elects not to do so. However, if
318
+ Mr. Thatcher or the Company is unsuccessful in challenging
319
+ a third party’s products on the basis of patent and
320
+ trademark infringement, continued sales of such competing
321
+ products by third parties could adversely impact the
322
+ Company’s business, financial condition and results of
323
+ operations. See “Business — Competition” and
324
+ “Business — Legal Proceedings.”
325
+ Dependence on Key
326
+ Personnel
327
+ The Company’s continued success will depend
328
+ substantially upon its ability to retain Douglas B. Otto, its
329
+ Chairman of the Board and Chief Executive Officer, Peter
330
+ Benjamin, its President and Chief Operating Officer and a core
331
+ group of key executive officers and employees. The Company
332
+ believes that its future success will depend in large part on
333
+ its ability to attract and retain highly skilled personnel.
334
+ Competition for such personnel is intense, and there can be no
335
+ assurance that the Company will be successful in attracting and
336
+ 6
337
+ Table of Contents
338
+ retaining such personnel. The loss of certain key
339
+ employees or the Company’s inability to attract and retain
340
+ other qualified employees could have an adverse impact on the
341
+ Company’s business.
342
+ Intellectual Property
343
+ The Company believes that its trademarks,
344
+ technologies and designs are of great value. From time to time,
345
+ the Company may be the subject of litigation challenging its
346
+ ownership of certain intellectual property. Loss of the
347
+ Company’s Simple or Ugg trademark rights or the ability to
348
+ use the licensed Teva trademarks could have a serious impact on
349
+ the Company’s business. Because of the importance of such
350
+ intellectual property rights, the Company’s business is
351
+ subject to the risk of counterfeiting, parallel trade or
352
+ intellectual property infringement.
353
+ Economic Factors and World
354
+ Events
355
+ The Company’s business is subject to
356
+ economic conditions in its major markets, including, without
357
+ limitation, recession, inflation, general weakness in retail
358
+ markets and changes in consumer purchasing power and
359
+ preferences. Adverse changes in such economic factors could have
360
+ a negative effect on the Company’s business.
361
+ In addition, the Company’s results, and the
362
+ domestic and international economies in general, may be further
363
+ negatively impacted by the terrorist activities of
364
+ September 11, 2001 and any subsequent terrorist acts, as
365
+ well as the impact of the United States’ war efforts. The
366
+ overall negative impact of these activities, including the
367
+ effect on the economy and commerce in general, cannot currently
368
+ be determined.
369
+ Weather Conditions
370
+ Sales of the Company’s products,
371
+ particularly those under the Teva and Ugg lines, are very
372
+ sensitive to weather conditions. Extended periods of unusually
373
+ cold weather during the spring and summer could adversely impact
374
+ demand for the Company’s Teva line. Likewise, unseasonably
375
+ warm weather during the fall and winter months could adversely
376
+ impact demand for the Company’s Ugg product line.
377
+ Substantial Ownership of the
378
+ Company and Shareholder Rights Agreement
379
+ At December 31, 2001, Douglas B. Otto
380
+ and all executive officers and directors of the Company, as a
381
+ group, owned approximately 33.7% and 42.2%, respectively, of the
382
+ outstanding shares of the Company’s Common Stock. Due to
383
+ such ownership position, Mr. Otto, whether acting alone or
384
+ together with one or more of the other executive officers of the
385
+ Company, would likely be able to control the affairs and
386
+ policies of the Company and would likely be able to elect a
387
+ sufficient number of directors to control the Company’s
388
+ Board of Directors and to approve or disapprove any matter
389
+ submitted to a vote of the stockholders.
390
+ The Company adopted a shareholder rights plan in
391
+ 1998 pursuant to a shareholder rights agreement (the
392
+ “Rights Agreement”) to protect stockholders against
393
+ unsolicited attempts to acquire control of the Company that do
394
+ not offer what the Board of Directors of the Company believes to
395
+ be an adequate price to all stockholders. As part of the plan,
396
+ the Board of Directors of the Company declared a dividend so
397
+ that one preferred share purchase right was and will be issued
398
+ for each outstanding share of Common Stock of the Company until
399
+ the expiration date of the Rights Agreement.
400
+ The ownership positions of Mr. Otto and the
401
+ executive officers of the Company, as a group, together with the
402
+ anti-takeover effects of certain provisions in the Delaware
403
+ General Corporation Law (the “DGCL”), in the
404
+ Company’s Certificate of Incorporation and Bylaws and in
405
+ the Company’s shareholder rights plan would likely have the
406
+ effect of delaying, deferring or preventing a change in control
407
+ of the Company and could have a negative effect on the market
408
+ price of the Company’s Common Stock.
409
+ Other Factors
410
+ The Company’s offices and distribution
411
+ center are located in the state of California, which has
412
+ experienced rolling electrical power outages in 2001. Depending
413
+ on the occurrence, timing, length and
414
+ 7
415
+ Table of Contents
416
+ frequency of the any future outages, the Company
417
+ may be unable to ship products in a timely manner, which could
418
+ negatively impact the Company’s net sales.
419
+ Also, during the year ended December 31,
420
+ 2001, the Company implemented a new Enterprise Resource Planning
421
+ (“ERP”) computer system to replace its legacy system.
422
+ In connection with this conversion, the Company initially
423
+ encountered various difficulties. The effectiveness of the
424
+ system’s operation can impact the Company’s ability to
425
+ receive and accept orders, monitor its inventory levels, and
426
+ coordinate the shipment of products to customers, among other
427
+ activities. In the event that significant difficulties are
428
+ encountered in the future, the Company may experience lower
429
+ sales and increased expenses, which would negatively impact the
430
+ Company’s results of operations and cash flows.
431
+ The Company’s results of operations,
432
+ financial condition and cash flows are also subject to risks and
433
+ uncertainties with respect to the Company’s ability to
434
+ secure and maintain adequate financing, to forecast its future
435
+ sales, inventory needs and cash flows and to subsequently
436
+ achieve those forecasts.
437
+ Business Strategy
438
+ Management’s mission is to build niche
439
+ products into global brands and its business strategy is to
440
+ offer diverse lines of footwear that emphasize functionality,
441
+ quality, comfort and technical performance tailored to a variety
442
+ of activities and demographic groups. Specifically, the
443
+ Company’s business strategy emphasizes the following
444
+ elements:
445
+ Introduce New Categories and Styles under
446
+ Existing Brands. The Company intends
447
+ to leverage consumer recognition of its existing brands by
448
+ developing and introducing additional innovative footwear
449
+ products that satisfy the Company’s high standards of
450
+ practicality, comfort and quality. The Company believes the
451
+ introduction of additional products at a variety of price
452
+ points, such as the range of new models in its Teva, Simple and
453
+ Ugg lines being offered in the Company’s 2002 product
454
+ offerings, have broadened the Company’s customer base,
455
+ further diversified the Company’s product lines, and helped
456
+ reduce the effects of seasonality on the Company’s sales.
457
+ See “Management’s Discussion and Analysis of Financial
458
+ Condition and Results of Operations —
459
+ Seasonality.” Over the last several years, the Teva product
460
+ offering has been greatly expanded to include a variety of new
461
+ sport sandal styles at a variety of price points and
462
+ incorporating a range of new uppers and technologies. In
463
+ addition, the Company has begun to leverage the success of the
464
+ Teva brand in the outdoor markets by launching into several new
465
+ categories of footwear, including amphibious footwear, hikers,
466
+ trailrunners, cold-weather boots, and other rugged outdoor
467
+ footwear. The Spring 2002 and Fall 2002 Teva product lines
468
+ include a significant redesign and the introduction of several
469
+ new styles and categories. One of the features prevalent in the
470
+ Spring 2002 line is the use of the Wraptor technology, a
471
+ patent-pending 360 degree continuous strapping system that
472
+ simultaneously secures the instep and arch shank to the foot.
473
+ Following on the success of this feature in the Company’s
474
+ running sandals, the Company has also designed a line of hikers
475
+ around this technology and has added it to certain styles of the
476
+ Company’s high performance Guide offering for professional
477
+ paddlers and adventurers. In addition, the Company continues to
478
+ expand into the hiking, trailrunning and rugged outdoor arenas,
479
+ where the aggregate market size is considerably greater than the
480
+ market for sport sandals, the area in which the Teva brand was
481
+ initially founded. By launching into these new areas of closed
482
+ footwear, the Company hopes to increase sales while at the same
483
+ time reducing the impact of seasonality on the Company’s
484
+ business. In addition to its historically strong outdoor
485
+ orientation, the 2002 line also includes athletically inspired
486
+ styles aimed directly at the athletic distribution channels,
487
+ another significant area where the Company hopes to gain
488
+ distribution. In addition to these new categories for the brand,
489
+ Teva has also re-designed its core sport sandal offering by
490
+ adding many new features and styles, incorporating the latest
491
+ technologies and innovations. The Company continues to use the
492
+ knowledge and experience of Team Teva, an elite group of the
493
+ world’s best male and female whitewater athletes, to
494
+ enhance the development of future technical offerings in this
495
+ category. As the Company moves to the future, it plans to
496
+ strengthen existing categories and further expand into new
497
+ channels of distribution.
498
+ The 2002 Simple product line includes a
499
+ re-emphasis on the men’s footwear business, an area where
500
+ the brand had been very successful several years ago, as well as
501
+ a focus on athletically inspired designs. The 2002 Simple line
502
+ also includes a collection of women’s casual styles
503
+ featuring low profiles and sleek outsoles. The
504
+ 8
505
+ Table of Contents
506
+ Simple line continues to target consumers in the
507
+ sixteen to twenty-five year old youth market. The line focuses
508
+ on lifestyle comfort based products such as clogs, sandals,
509
+ casuals and non-performance sneakers that are priced affordably.
510
+ In 2002, the Company’s Ugg product offering continued to
511
+ include its heritage boots and slippers, as well as an improved
512
+ women’s Town Collection of casual, fashionable boots and
513
+ clogs and a new Aspen Collection of rugged cold-weather footwear
514
+ featuring seam sealed lugged outsoles and waterproof leathers
515
+ combined with sheepskin linings.
516
+ Pursue Licensing of Brands.
517
+ Given the strength of the
518
+ Company’s brands, the Company is also pursuing the
519
+ licensing of its brand names to other ancillary products, beyond
520
+ the Company’s existing core footwear products. Through this
521
+ type of brand extension, the Company hopes to generate
522
+ additional revenues in the form of royalty income; to further
523
+ increase awareness for the Company’s brands and their
524
+ related products, and thereby increase sales of its footwear;
525
+ and to build the long-term value of the brands. The
526
+ Company’s business strategy currently includes the pursuit
527
+ of brand extension through licensing for both the Ugg and Simple
528
+ brands. The sublicensing of the Teva brand is not currently
529
+ available under the existing Teva license agreement; however, in
530
+ the event that the Company subsequently exercises its purchase
531
+ option to acquire Teva, the licensing of the Teva trademarks to
532
+ other products would be considered as part of the long-term
533
+ strategy for the brand (See “Management’s Discussion
534
+ and Analysis of Financial Condition and Results of
535
+ Operations — Liquidity and Capital Resources”).
536
+ As part of this approach, the Company has recently signed agency
537
+ agreements with BHPC Marketing, Inc. to assist in
538
+ identifying candidates and coordinating the efforts for the
539
+ licensing of the Ugg and Simple trademarks on various products
540
+ ranging from sportswear and outerwear to housewares and
541
+ accessories. Because the Company is currently in the early
542
+ stages of pursuing licensing opportunities for its brands it
543
+ cannot yet provide any assurances regarding how successful its
544
+ efforts will be or how significant the market size will be.
545
+ Pursue Additional Market
546
+ Opportunities. Management intends to
547
+ continue to consider new markets for its existing line of
548
+ products. For the years ended December 31, 2001, 2000 and
549
+ 1999 international net sales totaled $21,096,000, $31,135,000
550
+ and $28,859,000, representing 23.1%, 27.4% and 26.0% of net
551
+ sales, respectively. Management believes that significant
552
+ opportunities exist to market its products abroad and intends to
553
+ selectively expand its distribution worldwide. To bolster these
554
+ efforts, the Company has entered into an agency arrangement,
555
+ effective January 1, 2002, with a firm in the United
556
+ Kingdom for the coordination of the sales, distribution,
557
+ marketing and advertising efforts in the European markets. In
558
+ addition, the Company has an office in Japan that facilitates
559
+ the servicing of the Asian market.
560
+ The Company believes significant opportunities
561
+ exist to expand distribution domestically too. For example, the
562
+ Company’s Teva brand has had its roots in the outdoor
563
+ market where it has successfully distributed its products for
564
+ many years. The Company sees the potential for expansion into
565
+ the athletic retail distribution channel as a significant
566
+ opportunity for the Teva brand in future years. The Company
567
+ intends to pursue this channel of distribution going forward and
568
+ has recently designed product targeted at this market and has
569
+ added sales personnel with significant experience in this
570
+ market. In addition, the Ugg brand has historically been popular
571
+ in California for many years. The Company believes that
572
+ significant opportunities exist to expand distribution for this
573
+ brand throughout the United States, especially in light of its
574
+ suitability to a variety of climates. In recent years, the
575
+ Company has been successful in expanding outside of California
576
+ and expects to continue to pursue this expansion in the future.
577
+ Acquire or Develop New
578
+ Brands. The Company intends to
579
+ continue to focus on identifying and building new brands for
580
+ growth. The Company has been successful in the past in taking
581
+ the concepts of entrepreneurs for innovative, fashionable
582
+ footwear targeted at niche markets and building the products
583
+ into viable brands and intends to continue to identify concepts
584
+ for potential future niche products which have the potential of
585
+ developing into successful brands or product lines.
586
+ Products
587
+ The Company currently offers three primary
588
+ product lines: (1) Teva sport sandals and footwear;
589
+ (2) Simple casual footwear; and (3) Ugg sheepskin
590
+ footwear. Each of these lines, as well as individual models
591
+ within these lines, is designed to appeal to various demographic
592
+ groups. The Company’s footwear products
593
+ 9
594
+ Table of Contents
595
+ emphasize function, comfort and technical
596
+ performance and are suitable for a variety of demanding outdoor
597
+ and athletic activities, as well as casual and everyday use. The
598
+ Company’s products are designed and marketed to promote a
599
+ high level of brand name recognition and consumer appeal by
600
+ combining functional and creative designs with quality materials
601
+ and construction. The Teva footwear and the Simple footwear
602
+ lines are generally previewed twice per year, once in the summer
603
+ for deliveries that commence in the fall and once in the winter
604
+ for the following back to school and fall season. The Ugg line
605
+ of sheepskin footwear is generally previewed in the winter with
606
+ most deliveries occurring in the following fall and winter. The
607
+ following sets forth a summary description of each of the
608
+ Company’s primary product lines:
609
+ Teva Sport Sandals and Footwear.
610
+ The Teva sport sandal was one of the
611
+ first sport sandals to be developed and remains popular among
612
+ outdoor enthusiasts and the general public. The Company licenses
613
+ the Teva patents and trademark from Mark Thatcher, a
614
+ professional river guide who invented the Teva sport sandal. The
615
+ terms of such licenses run through 2011, subject to achieving
616
+ certain minimum sales levels beginning in 2004. Certain styles
617
+ of the Teva sport sandal incorporate a variety of proprietary
618
+ strapping configurations ideally suited for outdoor activities
619
+ such as hiking, boating and river rafting. These strapping
620
+ systems generally consist of high-quality nylon webbing or
621
+ leather, are fully adjustable, and hold the foot firmly to the
622
+ sandal’s durable, cellular rubber, molded EVA, polyurethane
623
+ or leather footbed. Teva sport sandals are extremely durable,
624
+ with many styles designed specifically for performance in and
625
+ around the water. In addition, the Company has recently
626
+ leveraged the brand’s success in the outdoor markets by
627
+ launching into various natural progressions for the brand
628
+ including hiking boots, trailrunning shoes, amphibious footwear
629
+ and other rugged outdoor footwear styles. For Spring 2002, the
630
+ Teva line has been redesigned to include numerous new styles,
631
+ categories and features and now includes 86 different models
632
+ spread across various categories and designed for a variety of
633
+ uses. The Hydro Series, a category of sandals and other
634
+ amphibious footwear built for high performance and rugged
635
+ outdoor use, includes 14 models of men’s and
636
+ women’s styles of sport sandals, neoprene and quick
637
+ draining monofilament mesh watershoes and other outdoor footwear
638
+ ideal for professional outdoorsmen and adventurers. The Terra
639
+ Series, a line of 17 styles of sandals and hiking boots
640
+ primarily designed for use on land, includes performance walking
641
+ sandals and convertible sandals with removable heel straps that
642
+ allow the sandal to be worn as a slide, as well as hiking boots
643
+ and running sandals incorporating the patent-pending Wraptor
644
+ technology, an upper which encircles the instep and continually
645
+ adjusts to the movement of the foot to provide a consistently
646
+ secure fit. The Originals Series has 16 styles of sandals
647
+ and thongs that combine the elements of performance with casual
648
+ everyday use and includes several of the most popular styles as
649
+ well as new models with retro-1970’s inspired colors and
650
+ stylings. Continuing on the success of recent years, the Spring
651
+ 2002 line includes 15 styles of men’s and women’s
652
+ leather casuals under the Nomad Series, including a variety of
653
+ sandals, slides and clogs. The Sun and Moon Series includes
654
+ 11 styles of slides and thongs offered in a variety of
655
+ materials including waterproof leather, nylon, suede and
656
+ airmesh. The Spring 2002 Children’s category is a
657
+ collection of 13 styles at various price points and
658
+ includes an assortment of sandals incorporating a variety of
659
+ materials including leather, waterproof suede, nylon, neoprene
660
+ and mesh as well as slip-on watershoes, hikers and other styles
661
+ of amphibious footwear. In addition, for the Fall 2002
662
+ season, the Company has significantly expanded its Fall product
663
+ offering with a variety of different types of closed footwear,
664
+ including hiking boots, cold weather boots, trailrunners and an
665
+ assortment of other rugged outdoor styles. The domestic
666
+ manufacturer’s suggested retail prices for adult sizes of
667
+ Spring 2002 Teva footwear products range from $20.00
668
+ to $130.00.
669
+ Simple Casual
670
+ Footwear. The Simple line consists of
671
+ casual shoes that combine the comfort and function of athletic
672
+ footwear construction with the simple, understated styling of
673
+ “back-to-basics,” casual lifestyle footwear. The
674
+ Simple product line includes a variety of comfortable,
675
+ fashionable, basic shoes for men and women including sneakers,
676
+ sandals, slides, clogs and leather casuals. The Spring 2002
677
+ collection reflects the Company’s emphasis on a target
678
+ consumer in the sixteen to twenty-five year old age group. For
679
+ the 2002 line, the Company has added several new styles of
680
+ clogs, sandals, sneakers and leather casuals to its offerings
681
+ including several athletically inspired styles for men and women
682
+ as well as a re-emphasis on the men’s footwear business, an
683
+ area where the Company had considerable success in the past. The
684
+ 2002 Simple line also includes a series of new, innovative
685
+ styles of women’s footwear featuring models with low
686
+ profiles and sleek lines. For Spring 2002, Simple is
687
+ offering a total of 86 models including 46 styles for men
688
+ and 40 for women. The Spring 2002 line includes
689
+ 32 styles of sneakers with leather and suede uppers,
690
+ 29 styles of sandals
691
+ 10
692
+ Table of Contents
693
+ and thongs and 25 styles of leather casuals
694
+ and clogs in a variety of colors. The domestic
695
+ manufacturer’s suggested retail prices for adult sizes for
696
+ the Spring 2002 line range from $40.00 to $95.00.
697
+ Ugg Sheepskin
698
+ Footwear. Ugg is a line of authentic
699
+ sheepskin footwear, popularized in Australia in the 1960’s
700
+ and 1970’s. These sheepskin boots, slippers and other
701
+ footwear styles have high-grade fleece linings which act as a
702
+ natural insulator, keeping feet warm and comfortable. The
703
+ 2002 Ugg line offers a range of 52 models of casual,
704
+ fashionable and streetwise styles in various colors, including
705
+ several new styles of shoes and boots for men and women. The
706
+ 2002 line includes several styles with new innovative
707
+ fashionable uppers and several styles with water resistant
708
+ leather treatments to address more inclement and cold weather
709
+ conditions. The 2002 line continues the tradition of the
710
+ highly successful Classic and Ultra boots, as well as the Home/
711
+ Spa Collection of slippers and other comfort footwear. In
712
+ addition, for 2002, the line includes an expanded Town
713
+ collection of men’s and women’s casual footwear,
714
+ including the men’s Birch styles, the women’s Solvang
715
+ styles, and the women’s Brooks styles featuring lug bottoms
716
+ for traction combined with sleek profiles. The 2002 line
717
+ also includes a new Aspen Collection of rugged cold-weather
718
+ footwear featuring seam sealed lugged outsoles and waterproof
719
+ leathers combined with sheepskin linings to prevent water from
720
+ coming in and to prevent warmth from escaping. The domestic
721
+ manufacturer’s suggested retail prices for adult sizes for
722
+ the Ugg line range from $50.00 to $275.00.
723
+ Marketing and Distribution
724
+ The Company’s products are currently
725
+ distributed throughout the United States by a network of
726
+ approximately 32 independent sales representatives,
727
+ organized geographically, who make sales, visit retail stores to
728
+ train personnel and review sales of the Company’s footwear
729
+ on a periodic basis. Beginning in 2000, the Company added a
730
+ separate dedicated independent sales force for the Simple and
731
+ Ugg brands as these products are sold through different
732
+ distribution channels and are targeted toward a different
733
+ consumer than the Company’s Teva brand. The Company’s
734
+ sales managers for each brand manage their networks of
735
+ representatives, recruit experienced sales representatives in
736
+ the industry and coordinate sales to national accounts. The
737
+ Company currently sells its products internationally through
738
+ independent distributors. The Company’s goal is to promote
739
+ retail sales of its products at attractive profit margins for
740
+ its accounts through selective distribution and marketing,
741
+ targeted toward distinct groups of consumers. As a result of
742
+ this approach, the Company’s accounts have a strong
743
+ incentive to devote greater selling space to the Company’s
744
+ products, and the Company is better able to assess consumer
745
+ preferences, the future ordering needs of its customers and
746
+ inventory requirements.
747
+ The Company’s principal domestic customers
748
+ include specialty retailers, upscale department stores, outdoor
749
+ retailers and athletic footwear stores which market products
750
+ consistent with the Company’s standards and, in the case of
751
+ Teva, have been approved by the Company’s licensor. The
752
+ Company’s five largest customers accounted for
753
+ approximately 20.6% of the Company’s net sales for the year
754
+ ended December 31, 2001, compared to 20.4% for the year
755
+ ended December 31, 2000. No single customer accounted for
756
+ more than 10% of the Company’s net sales for the years
757
+ ended December 31, 2001 or 2000.
758
+ In order to encourage accounts to place orders
759
+ early in the season the Company has continued with a preseason
760
+ discount program under which accounts are offered discounts on
761
+ preseason orders placed. The Company’s strategy is to
762
+ emphasize this “futures” program, as compared to
763
+ “at once” sales, in order to stabilize its supply
764
+ arrangements, reduce the risk of customer cancellations and to
765
+ benefit from the significant positive impact of the program on
766
+ the Company’s inventory costs, sourcing schedule and
767
+ allocation of marketing resources. Consistent with prior years,
768
+ the Company offered an early delivery program for the
769
+ spring 2002 season which was delivered the fourth quarter
770
+ of 2001. This early delivery program allows the Company to
771
+ reduce the impact of peak warehouse inventory levels during the
772
+ spring and provides retailers the opportunity to have earlier
773
+ sell through, lengthening the retail selling season and
774
+ increasing the potential for inventory turns at retail.
775
+ Domestic deliveries generally originate from the
776
+ Company’s 126,000 square foot warehouse facility in
777
+ Ventura County, California. European deliveries originate from a
778
+ distribution center in the Netherlands, while all other
779
+ international deliveries originate from offshore factories.
780
+ 11
781
+ Table of Contents
782
+ Advertising and Promotion
783
+ The Company attempts to maximize the impact of
784
+ its advertising, public relations and promotional expenditures
785
+ by utilizing media that provide high visibility within targeted
786
+ market segments. The Company’s brand names are generally
787
+ advertised and promoted through a variety of consumer print
788
+ advertising campaigns in addition to highly visible editorial
789
+ coverage in both consumer and trade publications. Retail
790
+ presence and “point of purchase” materials along with
791
+ production packaging provide additional visible brand support.
792
+ The Company’s in-house marketing departments for each brand
793
+ work closely with targeted accounts in many aspects of these
794
+ activities.
795
+ The Company continues to advertise its Teva brand
796
+ through a national print advertising campaign targeted at
797
+ various different demographic groups. For its core outdoor
798
+ market, Teva advertises in several outdoor-related magazines,
799
+ including Backpacker, Outside, National Geographic
800
+ Adventurer, Paddler, and Sports Illustrated Women,
801
+ among others. In addition, to promote its newly introduced Elden
802
+ Trail trailrunner, Teva is advertising in Trail Runner
803
+ and The Running Network, among other publications. With
804
+ the broadened appeal of the Teva offerings, including the
805
+ leather casual models, the Company has also focused its print
806
+ advertising toward more mainstream print publications, including
807
+ Shape and National Geographic Traveler. Teva will
808
+ also target the alternative, youth market with advertisements in
809
+ Stuff and Adrenaline. In addition, with the
810
+ introduction of Teva’s first full Fall line in 2002, Teva
811
+ will increase its advertising in the fall and winter months.
812
+ In order to maintain the Company’s
813
+ historically high visibility among core outdoor enthusiasts such
814
+ as professional river rafters, kayakers, mountain bikers and
815
+ rock climbers, Teva products are given or sold at professional
816
+ discounts to members of this group. In order to further bolster
817
+ the loyalty of these individuals, the Company offers categories
818
+ called “Hydro” and “Terra,” incorporating
819
+ the latest technological developments and highest quality
820
+ materials. The Company actively sponsors a group of the
821
+ world’s best male and female whitewater athletes called
822
+ Team Teva. Teva also sponsors teams from other outdoor
823
+ disciplines including the Teva US Mountain Running Team and
824
+ the SOBE Headshok Mountain Bike Team. By outfitting and
825
+ sponsoring these highly visible athletes and teams, the Company
826
+ creates awareness among targeted consumers at relatively low
827
+ cost. In addition, the Company has traveling promotional and
828
+ technical representatives who represent the Teva brand at a wide
829
+ variety of festivals, outdoor sporting events and competitions.
830
+ Teva is sponsoring over fifty events in 2002, including the Teva
831
+ Tour, a series of whitewater rafting and kayaking events held
832
+ between April and October at fourteen rivers across America.
833
+ Internationally, the Company is also the title sponsor for
834
+ events in Japan, Canada, Switzerland and Italy. Teva sponsors
835
+ and promotes these events in order to increase the
836
+ Company’s visibility for its core outdoor consumer, in
837
+ addition to the significant marketing available to the more
838
+ mainstream public with the increasing popularity of viewing
839
+ these extreme sports. In addition to the Teva Tour, the Teva
840
+ promotional team attends and sponsors other events including the
841
+ Teva Mountain Games at Vail, Teva Mountain Running Series, Teva
842
+ Liquid Lifestyles Film US Tour, Santa Cruz Surf Kayak
843
+ Festival in Santa Cruz, California, Grandma’s Marathon in
844
+ Duluth, Minnesota, The Telluride Bluegrass Festival in
845
+ Telluride, Colorado, and Reggae on the River in Garberville,
846
+ California, among others.
847
+ The Teva mobile promotions team attends the
848
+ events in dedicated state of the art promotional vehicles where
849
+ they showcase Teva products and provide consumers with the
850
+ opportunity to see and try on the latest styles. The Teva brand
851
+ has also recently initiated a partnership with Land Rover. Land
852
+ Rover is now the official vehicle of Team Teva, outfitting the
853
+ Team Teva athletes and the Teva Technical Representatives in
854
+ Teva branded Land Rovers throughout the United States.
855
+ With respect to the Simple product line, the
856
+ Company has continued its national print advertising campaign.
857
+ Simple print advertisements will appear in niche art, music and
858
+ style-related youth-focused consumer magazines such as Paper,
859
+ URB, Surfer and FHM . In addition, the marketing
860
+ effort focuses around grass roots advertising including wild
861
+ postering, flyering, and “Go Cards.” As an extension
862
+ of its grass roots efforts, Simple will launch a national road
863
+ tour in March 2002 as part of its grass roots marketing
864
+ campaign, The Stream of Consciousness. A Simple journalist will
865
+ drive an Airstream trailer across America, visit and sponsor
866
+ art-related events at universities and create a film documentary
867
+ of his experiences on the road. A
868
+ 12
869
+ Table of Contents
870
+ rigorous public relations campaign will focus on
871
+ obtaining magazine editorial placement in addition to newspaper
872
+ and television coverage. Recent public relations coverage has
873
+ appeared in Footwear News, Teen People, Nylon, YM, Footwear
874
+ Plus, W Magazine, Lucky, Shuz, Shape, and Surfing
875
+ Girl. These public relations efforts have also resulted in
876
+ Simple products appearing on television shows such as
877
+ Friends, Ally McBeal, Dawson’s Creek, and MTV.
878
+ Simple’s marketing efforts are performed
879
+ internally by an in-house Simple marketing team which works to
880
+ promote the Simple brand positioning of being “simple”
881
+ and “down to earth”.
882
+ In 2002, the Company plans to continue to build
883
+ on the success of the Ugg 2000 and 2001 national print
884
+ advertising campaigns. The Company continues to target its Ugg
885
+ products toward luxury consumers who seek high quality,
886
+ luxurious and fashionable products for cold weather. The Company
887
+ expects to advertise Fall 2002 Ugg products in upscale
888
+ publications such as Vogue, In Style and
889
+ O Magazine. In February 2002, Ugg’s were
890
+ featured in the Opening and Closing Ceremonies of the 2002
891
+ Winter Olympic Games. 1,000 Ugg boots were used to outfit
892
+ both the children in the Children of Light performances and the
893
+ individuals presenting medals to athletes at all the events.
894
+ Both the children and adults were outfitted in Ultra Short Ugg
895
+ boots. Ugg also received Olympic exposure on the Today Show with
896
+ Katie Couric the day after the opening ceremonies.
897
+ In addition to this national advertising
898
+ campaign, the Ugg brand is being supported by national public
899
+ relations and product placement efforts. In-house marketing
900
+ personnel work closely with a public relations firm and a
901
+ product placement agency to gain brand visibility in popular
902
+ magazines, television shows and feature films. Recent editorial
903
+ coverage includes articles in magazines such as Glamour, In
904
+ Style, Cosmopolitan, Marie Claire, Maxim, Shape, Self,
905
+ O Magazine and Real Simple. Television coverage
906
+ of Ugg product includes shows such as Friends, Once and
907
+ Again, Dawson’s Creek, E.R., Will and Grace, Ally McBeal,
908
+ My Wife and Kids, Judging Amy, Alias, 7th Heaven and
909
+ Everybody Loves Raymond. These public relations efforts
910
+ have also resulted in Ugg product appearances in the following
911
+ recent feature films: America’s Sweethearts,
912
+ starring Julia Roberts, Snow Dogs, starring Cuba Gooding
913
+ Jr., American Pie II, starring Sean William
914
+ Scott, Dinner with Friends, starring Andie McDowell,
915
+ Josie and the Pussycats, starring Tara Reid and Life
916
+ as a House, starring Kevin Kline.
917
+ In 2001, 2000 and 1999, the Company incurred
918
+ $6,087,000, $7,108,000 and $5,602,000 respectively, for
919
+ advertising, marketing and promotional expenses. In addition to
920
+ these expenditures, the Company’s 29 international
921
+ distributors spend additional amounts for marketing the
922
+ Company’s brands within their respective territories. The
923
+ Company is required under its Teva License Agreement to spend a
924
+ minimum amount for advertising and promoting Teva products,
925
+ based on a percentage of sales. In addition to the minimum
926
+ contractual marketing expenditures, the Company and the licensor
927
+ have agreed to each contribute annually a certain percentage of
928
+ sales toward the promotion of the Teva brand and trademark, with
929
+ or without particular reference to individual Teva styles.
930
+ Design and Product Development
931
+ The design and product development staff for each
932
+ of the Company’s brands creates and introduces new
933
+ innovative footwear products that are consistent with the
934
+ Company’s standards of high quality, combined with comfort
935
+ and functionality. In addition to its internal design and
936
+ development staff, the Company has begun to rely more heavily in
937
+ recent years on outside design firms for a significant portion
938
+ of the design function. By transitioning much of the design
939
+ function to independent design firms, the Company has been able
940
+ to eliminate certain positions, obtain efficiencies and reduce
941
+ design and development costs considerably in recent years. As a
942
+ result, research and development costs aggregated $1,034,000,
943
+ $1,076,000 and $1,607,000 in 2001, 2000 and 1999, respectively,
944
+ reflecting the operational efficiencies gained under this new
945
+ approach.
946
+ With respect to Teva, in order to ensure that the
947
+ Company’s high performance technical products continue to
948
+ satisfy the requirements of its historical customer base of
949
+ performance-oriented “core enthusiasts,” the
950
+ Company’s design staff solicits comments and feedback from
951
+ its licensor, its Team Teva whitewater athletes and other
952
+ professional outdoorsmen, as well as several of its retailers,
953
+ including REI, EMS, Galyans and L.L. Bean. Certain models
954
+ are modified and technical innovations are developed in response
955
+ to such comments and feedback. The Company adds new innovations,
956
+ components and styles to its product line
957
+ 13
958
+ Table of Contents
959
+ continually. For example, the Company recently
960
+ designed and introduced a new line of trailrunners incorporating
961
+ the patented Liquid Frame technology and has incorporated its
962
+ newly developed Wraptor technology into performance running
963
+ sandals, an assortment of hikers and certain styles of its high
964
+ performance Guide sport sandals specifically targeted at
965
+ professional outdoorsmen and adventurers. In addition, for added
966
+ traction and durability, the Company has recently incorporated
967
+ various materials in its sandals, including Spider
968
+ Rubber®— a sticky, non-slip rubber outsole material
969
+ for use across wet and dry terrain, Traction
970
+ Rubber TM — a highly durable and abrasion
971
+ resistant material designed specifically for the extra rigors of
972
+ land use, and River Rubber® — a non-slip material
973
+ designed to offer superior grip on smooth wet surfaces such as
974
+ rocks, fiberglass and raft rubber.
975
+ While Teva continues to develop high performance
976
+ sport sandals and other rugged outdoor footwear by continually
977
+ updating and designing new styles for these categories, the
978
+ Company also continues to increase its focus on the casual
979
+ footwear market through its Teva, Simple and Ugg brands. The
980
+ Company continues to introduce and offer new styles of leather
981
+ and other casual footwear for men and women and has added
982
+ several new styles of hikers, sport sandals, slip-ons and other
983
+ shoes to its Teva children’s offering for Spring 2002. The
984
+ Company has also added several new styles of clogs, sandals,
985
+ sneakers and leather casuals to its offerings under the Simple
986
+ line for 2002 including several athletically inspired styles for
987
+ men and women as well as a re-emphasis on the men’s
988
+ footwear business, an area where the Company had considerable
989
+ success in the past. The 2002 Simple line also includes a series
990
+ of new, innovative styles of womens’ footwear featuring
991
+ models with low profiles and sleek lines. By monitoring changes
992
+ in consumer lifestyles and preferences and then focusing first
993
+ on function and practicality, the Company develops footwear
994
+ designed to appeal to quality-minded consumers seeking
995
+ comfortable casual footwear.
996
+ In recent years, the Company has taken steps to
997
+ take Ugg’s longtime success in the Southern California
998
+ market and duplicate that success across the United States. In
999
+ support of this effort, the Company has taken steps in recent
1000
+ years to update the Ugg products in order to make them more
1001
+ functional for use in cold and wet climates. For example, the
1002
+ 2002 line includes a new Aspen Collection of cold weather
1003
+ boots, shoes and clogs featuring seam sealed lugged outsoles and
1004
+ waterproof leathers combined with sheepskin linings for high
1005
+ functionality and comfort. In addition, the Company has added a
1006
+ new Brooks Series to its women’s Town Collection, featuring
1007
+ styles with a new lugged outsole, contemporary styling and wool
1008
+ fleece linings which are designed to keep feet dry and
1009
+ comfortable in both warm and cold climates. The Ugg brand
1010
+ continues to design and offer more fashionable and unique upper
1011
+ styles to help differentiate Ugg from the low cost imitation
1012
+ brands.
1013
+ Integral factors in the design and product
1014
+ development process include an evaluation of the availability
1015
+ and cost of raw materials, the capabilities of the factories
1016
+ that will manufacture products and the target retail price of
1017
+ new models and lines. The design and development staff works
1018
+ closely with brand management to develop new styles of footwear
1019
+ and components for their various product lines. Drawings and
1020
+ prototypes are utilized to produce samples of proposed new
1021
+ concepts. Throughout the development process, members of the
1022
+ design staff coordinate closely with each other and with the
1023
+ Company’s product development, manufacturing and sourcing
1024
+ personnel toward a common goal of developing and sourcing a
1025
+ high-quality product that will be delivered on a timely basis.
1026
+ The Company endeavors to minimize the risk of changing fashion
1027
+ trends by offering a diverse line of functional products and
1028
+ closely monitoring sales to its accounts after introduction.
1029
+ Product Sourcing
1030
+ The Company currently sources all of its Teva and
1031
+ Simple footwear and a portion of its Ugg footwear from
1032
+ independent contract manufacturers in the Far East. The Company
1033
+ imports the remainder of its Ugg footwear from independent
1034
+ contract manufacturers in Australia and New Zealand. The Company
1035
+ is not involved in the direct manufacture of footwear, but
1036
+ rather sources completed footwear, produced to required
1037
+ specifications, directly from these independent contractors. As
1038
+ the Company continues to grow, it expects to continue to rely
1039
+ heavily on its independent contractors for its sourcing needs.
1040
+ The manufacturing of footwear by the
1041
+ Company’s independent contractors is performed in
1042
+ accordance with detailed specifications provided by the Company
1043
+ and is subject to quality control standards. In efforts to
1044
+ 14
1045
+ Table of Contents
1046
+ ensure the production of high quality products,
1047
+ many of the materials and components used in production are
1048
+ purchased from independent suppliers designated by the Company.
1049
+ The Company believes that its completed footwear as well as the
1050
+ various raw materials and components used in the manufacture of
1051
+ the footwear, including rubber, leather, nylon webbing and
1052
+ sheepskin, are generally available from multiple sources at
1053
+ competitive prices.
1054
+ The Company generally does not have any long-term
1055
+ agreements with the manufacturers or suppliers of its products,
1056
+ but does business based on individual purchase orders.
1057
+ Quality Control
1058
+ The Company has instituted inspections and other
1059
+ procedures to satisfy the high quality demanded by users of the
1060
+ Company’s products. The Company’s quality assurance
1061
+ program includes inspection procedures at the factory level as
1062
+ well as a final inspection upon arrival of product at the
1063
+ Company’s distribution center. The Company uses on-site
1064
+ inspectors at its independent suppliers who oversee the
1065
+ production process and perform quality assurance inspections. In
1066
+ addition, the products undergo further inspection procedures
1067
+ prior to being accepted at the Company’s domestic
1068
+ distribution center.
1069
+ Licenses
1070
+ Teva License. The
1071
+ Company has been selling its Teva line of sport sandals and
1072
+ other footwear since 1985 pursuant to various license
1073
+ arrangements with Mark Thatcher, the inventor of the Teva sport
1074
+ sandal and the owner of the Teva patents and trademark.
1075
+ Mr. Thatcher owns seven United States patents on designs
1076
+ used in Teva footwear and has a United States trademark
1077
+ registration for the Teva mark.
1078
+ On June 7, 1999, the Company signed a new
1079
+ license agreement (the “License Agreement”) for Teva,
1080
+ which became effective January 1, 2000. Under the License
1081
+ Agreement, the Company has the exclusive worldwide rights for
1082
+ the manufacture and distribution of Teva footwear through 2004.
1083
+ Apparel and other non-footwear products are not covered by the
1084
+ License Agreement. The License Agreement is automatically
1085
+ renewable through 2008 and through 2011 under two renewal
1086
+ options, provided that minimum required sales levels are
1087
+ achieved. These required minimum annual sales levels are
1088
+ $107.9 million in 2004 and $137.3 million in 2008,
1089
+ both of which are significantly greater than the annual sales of
1090
+ $61.2 million achieved by the Company in 2001. The Company
1091
+ believes it is unlikely to achieve the contractual minimum for
1092
+ 2004 and has begun discussions with the licensor to address this
1093
+ issue. However, the Company can provide no assurances that it
1094
+ will be successful in its efforts to reach an acceptable
1095
+ resolution.
1096
+ As with the previous arrangement, the License
1097
+ Agreement provides for a sliding scale of royalty rates,
1098
+ depending on sales levels, and includes guaranteed minimum
1099
+ annual royalty amounts. Additionally, the License Agreement
1100
+ provides for an increase in the required amount of marketing
1101
+ expenditures, depending on sales levels and varying by
1102
+ territory. In addition to the minimum contractual marketing
1103
+ expenditures, the Company and the licensor have agreed to each
1104
+ contribute annually a certain percentage of sales toward the
1105
+ promotion of the Teva brand and trademark, with or without
1106
+ particular reference to individual Teva styles.
1107
+ As additional consideration, the Company paid the
1108
+ licensor a licensing fee of $1,000,000 in 1999 and issued the
1109
+ licensor 428,743 shares of its previously unissued common stock
1110
+ valued at $1,608,000. The Company has recorded the license as an
1111
+ intangible asset equal to the cash and market value of the stock
1112
+ issued on the date of the License Agreement. These shares are
1113
+ subject to various contractual and other holding period
1114
+ requirements. In addition, the Company has agreed to grant the
1115
+ licensor not less than 50,000 stock options on the
1116
+ Company’s common stock annually, at an exercise price equal
1117
+ to the market value on the date of grant.
1118
+ The licensor retains the rights to approve the
1119
+ quality of the licensed products produced, all marketing,
1120
+ advertising and promotional plans and materials, and the
1121
+ distribution channels and customers to whom the Company can sell
1122
+ the licensed products. In addition, the License Agreement
1123
+ provides for minimum annual research and development spending
1124
+ levels for the Company with respect to the Teva products and
1125
+ restricts the volume of closeouts and seconds which the Company
1126
+ is able to sell each year.
1127
+ 15
1128
+ Table of Contents
1129
+ The License Agreement provides that the licensor,
1130
+ in his sole discretion, may take any action against parties
1131
+ believed to be infringing upon the licensor’s trademark,
1132
+ patents and other intellectual property. The licensor is fully
1133
+ responsible for any legal and other costs incurred in such
1134
+ actions and is entitled to any recovery resulting from the
1135
+ actions. The Company may not participate in any such action or
1136
+ in any other action regarding the infringement of the Teva
1137
+ intellectual property without the licensor’s prior written
1138
+ consent.
1139
+ In the event that the license term is
1140
+ automatically renewed beyond 2004, the Company must achieve
1141
+ minimum annual sales levels for the years 2005 through 2011.
1142
+ These minimum annual sales levels are based upon certain
1143
+ percentages of net sales in the preceding calendar year. If the
1144
+ Company is not able to achieve the minimum annual sales levels
1145
+ for two years during a renewal term, the License Agreement can
1146
+ be terminated at the option of the licensor. Currently, annual
1147
+ sales of Teva products are substantially below the required
1148
+ minimums.
1149
+ During the term of the License Agreement,
1150
+ including the renewal terms, the Company is prohibited from
1151
+ manufacturing, marketing, selling and distributing any sandals
1152
+ other than Teva sandals. In addition, for the two years
1153
+ following the termination of the License Agreement, the Company
1154
+ is prohibited from manufacturing, marketing, selling and
1155
+ distributing sandals, in general. However, the Company may
1156
+ continue to manufacture, market, sell and distribute all styles
1157
+ and models of sandals offered under its Simple product line
1158
+ which existed as of the date of the License Agreement as well as
1159
+ all styles subsequently approved by the licensor.
1160
+ The License Agreement can be terminated under
1161
+ several circumstances, if they remain uncured for specific
1162
+ periods of time. These circumstances include the following,
1163
+ among others: if either party becomes insolvent or bankrupt; if
1164
+ the Company offers sandals which compete with the Teva products
1165
+ or otherwise engages in activities which compete with the Teva
1166
+ products; if the Company transfers substantially all of its
1167
+ property or stock to other parties; if the Company sells
1168
+ unapproved merchandise in violation of the License Agreement; or
1169
+ if the Company or the licensor otherwise violate or breach the
1170
+ terms of the License Agreement.
1171
+ In connection with the execution of the most
1172
+ recent license agreement with Mark Thatcher, the Company
1173
+ received an option to buy Teva and virtually all of its assets,
1174
+ including all worldwide rights to Teva. The option price is
1175
+ based on formulas tied to net sales of Teva products and varies
1176
+ depending on when the option is exercised. For the first option
1177
+ period, January 1, 2000 through December 31, 2003, the
1178
+ option price is for an amount equal to the greater of
1179
+ (i) $61.6 million or (ii) 75% of the largest
1180
+ calendar year revenues since January 1, 2000 for the Teva
1181
+ brand, plus $1.6 million. In addition, the Company would
1182
+ issue to Mr. Thatcher 100,000 shares of common stock and
1183
+ options to purchase 100,000 shares of common stock. The purchase
1184
+ price for the second option period, January 1, 2006 to
1185
+ December 31, 2008, is equal to 110% of the average of the
1186
+ aggregate sales for all Teva products for the two calendar years
1187
+ since January 1, 2000 with the highest aggregate net sales.
1188
+ If the Company does not exercise its option to acquire Teva, the
1189
+ licensor has the option to acquire the Teva distribution rights
1190
+ from the Company for the period from January 1, 2010 to
1191
+ December 31, 2011, the end of the license term, and the
1192
+ option price is based on a formula tied to the Company’s
1193
+ earnings before interest, taxes, depreciation and amortization.
1194
+ The Company is currently evaluating the possibility of
1195
+ exercising the option in the January 1, 2000 to
1196
+ December 31, 2003 option period. The payment of the
1197
+ purchase price must be completed within 90 days of the
1198
+ exercise of the purchase option. If the Company exercises its
1199
+ purchase option, but subsequently fails to complete the purchase
1200
+ within the 90 day payment period, the purchase option and the
1201
+ Option Agreement will automatically be terminated.
1202
+ Sale of Heirlooms, Inc.
1203
+ The Company and Bob Eason, the designer and
1204
+ founder of Picante clothing, were parties to an agreement
1205
+ pursuant to which the Company owned 50% of Heirlooms, Inc.
1206
+ (“Heirlooms”), the manufacturer and distributor of
1207
+ Picante clothing. In January 2001, the Company sold its 50%
1208
+ interest in Heirlooms back to Mr. Eason for cash of
1209
+ approximately $1,200,000 and a note receivable of approximately
1210
+ $420,000, which was secured by a secondary security interest in
1211
+ the assets of Heirlooms. The selling price was for an amount
1212
+ that approximated the net carrying value of the underlying
1213
+ assets and, accordingly, the resulting gain on the sale was not
1214
+ significant.
1215
+ 16
1216
+ Table of Contents
1217
+ Patents and Trademarks
1218
+ Mr. Thatcher holds seven United States
1219
+ patents and one patent in each of Australia, New Zealand, Korea,
1220
+ Germany, France, China, Japan and the United Kingdom for Teva
1221
+ footwear. As a result of the expiration of the applicable period
1222
+ during which foreign patent applications were required to have
1223
+ been filed, Mr. Thatcher does not and cannot hold such
1224
+ patent rights in other countries. Mr. Thatcher also
1225
+ currently holds Teva trademark rights in the United States and
1226
+ in several other countries, including, among others, France,
1227
+ Germany, the United Kingdom, Japan and Australia.
1228
+ Mr. Thatcher’s patent and trademark rights are
1229
+ licensed to the Company under the License Agreement discussed
1230
+ previously. Both the Company and Mr. Thatcher regard such
1231
+ proprietary rights as valuable assets, and the Company
1232
+ cooperates with Mr. Thatcher in vigorously protecting such
1233
+ rights against infringement by third parties. To date,
1234
+ Mr. Thatcher has successfully enforced his patent and
1235
+ trademark rights in all 20 concluded lawsuits brought
1236
+ against such third parties. Under certain circumstances, if
1237
+ Mr. Thatcher declines to challenge a potential
1238
+ infringement, the Company may bring an infringement action at
1239
+ its own cost, with Mr. Thatcher’s prior written
1240
+ consent. See “Licenses — Teva License.”
1241
+ The Company owns the Simple and Ugg trademarks
1242
+ and has applied for or received registrations for them in the
1243
+ United States and in many foreign countries. The Company has
1244
+ selectively registered style category names and marketing
1245
+ slogans. In addition, the Company holds two design patents for
1246
+ its footwear products.
1247
+ The Company has acquired the patent and
1248
+ trademarks for Alp®sport sandals and has registered the
1249
+ Deckers trademark.
1250
+ Backlog
1251
+ Historically, the Company has encouraged and has
1252
+ received a significant portion of its orders as preseason
1253
+ orders, which are generally placed by customers approximately
1254
+ four to eight months prior to shipment date. As discussed above,
1255
+ the Company has emphasized this “futures” business, as
1256
+ compared to “at once” sales, as it allows the Company
1257
+ to better forecast its inventory requirements and assists with
1258
+ the Company’s sourcing schedule. As a result, the Company
1259
+ provides its customers with incentives to participate in such
1260
+ preseason programs. Unfilled customer orders
1261
+ (“backlog”), as of any date, represent orders
1262
+ scheduled to be shipped at a future date and do not represent
1263
+ firm sales. The mix of future and immediate delivery orders can
1264
+ vary significantly from quarter to quarter and year to year. The
1265
+ backlog as of a particular date is affected by a number of
1266
+ factors, including seasonality and the scheduling of manufacture
1267
+ and shipment of products as well as variations in the quarter to
1268
+ quarter and year to year preseason incentive programs. As a
1269
+ result, comparisons of backlog from period to period are not
1270
+ meaningful and the Company’s backlog at any given time is
1271
+ generally not indicative of sales levels expected to be achieved
1272
+ in the future.
1273
+ Competition
1274
+ The casual, outdoor and athletic footwear markets
1275
+ are highly competitive. The Company believes that currently its
1276
+ largest competitors of the Teva line are Nike, Adidas,
1277
+ Timberland, Merrell, Columbia and Salomon. The principal
1278
+ competitors of Simple’s casual line include Steve Madden,
1279
+ Dr. Marten, Camper, and Kenneth Cole and of Simple’s
1280
+ sneaker/sandal line include Skechers, Diesel, Steve Madden,
1281
+ Puma, NM70 and Guess. Ugg’s competitors include Merrell,
1282
+ Rocket Dog, Acorn, Aussie Dogs, LB Evans and Timberland, as well
1283
+ as retailers’ private label footwear.
1284
+ Competition in the Company’s footwear is
1285
+ primarily based on brand awareness, product quality, design,
1286
+ price points, fashion appeal, marketing, distribution,
1287
+ performance and brand positioning. The Company’s Teva line
1288
+ of footwear competes primarily on the basis of its authenticity
1289
+ as a recognized brand in the outdoor market, its consumer brand
1290
+ recognition as one of the first sandals of its kind, as well as
1291
+ its high performance nature and its diversity of styles offered.
1292
+ In addition, several of the most popular styles employ a
1293
+ distinctive patented strapping system, which contributes to
1294
+ performance and the brand’s consumer recognition. The
1295
+ Company competes through its Simple line as an alternative brand
1296
+ offering a diversity of simple, back-to-basics styles designed
1297
+ for a variety of recreational and leisure activities. Ugg
1298
+ competes primarily on the basis of
1299
+ 17
1300
+ Table of Contents
1301
+ its authenticity as well as its brand name
1302
+ recognition as a high quality premium luxury brand, identifiable
1303
+ with the United States sheepskin footwear market. The Company
1304
+ believes its business strategy has resulted in increased
1305
+ awareness for its brands. However, no assurance can be given
1306
+ that in the future the Company will be able to maintain or
1307
+ further increase its brand awareness, maintain or increase its
1308
+ market share or respond to changing consumer preferences.
1309
+ Risks of Foreign Operations/ Restrictions on
1310
+ Imports
1311
+ The Company’s operations are subject to the
1312
+ customary risks of doing business abroad, including, but not
1313
+ limited to, currency fluctuations, customs duties and related
1314
+ fees, various import controls and other non-tariff barriers
1315
+ (e.g., quotas), the cost of transportation, restrictions on the
1316
+ transfer of funds, labor unrest and strikes, and in certain
1317
+ parts of the world, political instability. Countries where the
1318
+ Company’s products are manufactured and sold may, from time
1319
+ to time, seek to increase customs duties or impose quotas, all
1320
+ of which have the potential to affect the Company’s
1321
+ operations and its ability to maintain or increase the current
1322
+ level of importation of the Company’s products. The Company
1323
+ is unable to predict the likelihood or frequency of the
1324
+ occurrence of any of these events.
1325
+ The products imported by the Company into the
1326
+ United States are subject to various duty rates which are
1327
+ established by law. At the present time these duties range
1328
+ between 8.5% and 12.5% of the entered value of footwear with
1329
+ uppers made principally of leather or sheepskin, and 6.0% and
1330
+ 37.5%, plus $.90 per pair, of the entered value of footwear with
1331
+ uppers made principally of synthetic textiles or plastic.
1332
+ Certain products imported by the Company are exempt from duties
1333
+ pursuant to laws pertaining to products manufactured in certain
1334
+ beneficiary countries. “Entered value” means the value
1335
+ taken into account for purposes of determining the amount of any
1336
+ customs duties or any other duties which may be imposed on the
1337
+ importation of any property. In general, the entered value is
1338
+ normally based on the price paid or payable by the Company to
1339
+ the seller of the imported merchandise.
1340
+ From time to time, the Company may be subject to
1341
+ claims for additional duties arising as a result of the United
1342
+ States Customs Service, or similar agencies of foreign
1343
+ countries, disagreeing with the classification and/or valuation
1344
+ used by the Company to enter various styles of footwear.
1345
+ In 1997, the European Commission enacted
1346
+ anti-dumping duties of 49.2% on certain types of footwear
1347
+ imported into Europe from China and Indonesia. Dutch Customs has
1348
+ issued an opinion to the Company that certain popular Teva
1349
+ styles are covered by this anti-dumping duty legislation. The
1350
+ Company has been contesting the opinion and is working with
1351
+ Dutch Customs to resolve the situation. The Company has since
1352
+ obtained, and is using, alternative sourcing for the potentially
1353
+ impacted products from sources outside of China in an effort to
1354
+ reduce the potential risk in the future. In the event that Dutch
1355
+ Customs makes a final determination that the anti-dumping
1356
+ provisions are applicable, the Company would have an exposure
1357
+ for prior unpaid anti-dumping duties during 1997 of
1358
+ approximately $500,000, which has been fully accrued as of
1359
+ December 31, 2001.
1360
+ The European communities also impose quantitative
1361
+ limits on imports from China of certain leather upper and
1362
+ textile upper footwear. The Company is unable to predict how
1363
+ long the anti-dumping duty and import quota restrictions will
1364
+ remain in effect or changes in the scope or severity of such
1365
+ restrictions.
1366
+ Employees
1367
+ At December 31, 2001, the Company employed
1368
+ approximately 98 full-time employees in its U.S.
1369
+ facilities, 4 at its European subsidiary and 28 at its Hong Kong
1370
+ subsidiaries, none of whom is represented by a union. The
1371
+ Company believes its relationship with its employees is good.
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1
+ Item 13. Certain Relationships and
2
+ Related Transactions
3
+ Information relating to Certain Relationships and
4
+ Related Transactions is set forth in the Company’s
5
+ definitive proxy statement relating to the Registrant’s
6
+ 2002 annual meeting of shareholders, which will be filed
7
+ pursuant to Regulation 14A within 120 days after the
8
+ end of the Company’s fiscal year ended December 31,
9
+ 2001, and such information is incorporated herein by reference.
10
+ 53
11
+ Table of Contents
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