PART I
Item 1. Business
Except as otherwise indicated, all references in this Form 10-K to “we”, “us”, “our” or “Chattem” refer to Chattem, Inc. and our subsidiaries. In addition, in this Form 10-K, our fiscal years ended November 30, 2003, November 30, 2004 and November 30, 2005 are referred to as fiscal 2003, fiscal 2004 and fiscal 2005, respectively, and our fiscal year ending on November 30, 2006 is referred to as fiscal 2006. Brand names that are italicized in this Form 10-K refer to trademarks that we own or license.
General
We are a leading marketer and manufacturer of a broad portfolio of branded over-the-counter (“OTC”) healthcare products, toiletries and dietary supplements, including such categories as topical analgesics, medicated skin care products, medicated dandruff shampoos and conditioner, dietary supplements and other OTC and toiletry products. Our portfolio of products includes well-recognized brands such as:
| • | Topical analgesics such as Icy Hot and Aspercreme; |
| • | Medicated skin care products such as Gold Bond medicated skin care powder, cream, lotion, first aid and foot care products |
| • | Selsun Blue medicated dandruff shampoos and conditioner; |
| • | Dietary supplements including Dexatrim, Garlique and New Phase; and |
| • | Other OTC and toiletry products such as Pamprin, a menstrual analgesic; Herpecin-L, a lip care product; Benzodent, a dental analgesic cream; and toiletries such as Bullfrog, a line of sunblocks; UltraSwim, a chlorine-removing shampoo; and Sun-In, a hair lightener. |
Our products target niche markets that are often outside the core product areas of larger companies where we believe we can achieve and sustain significant market penetration through innovation and strong advertising and promotion support. Many of our products are among the U.S. market leaders in their respective categories. For example, our portfolio of topical analgesic brands and our Gold Bond medicated body powders have the leading U.S. market share in these categories. We support our brands through extensive and cost-effective advertising and promotion, the expenditures for which represented approximately 28% of our total revenues in fiscal 2005. We sell our products nationally through mass merchandiser, drug and food channels, principally utilizing our own sales force.
Our experienced management team has grown our business by developing product line extensions, increasing market penetration of our existing products and acquiring brands. Recent product line extensions include Gold Bond Ultimate Healing Skin Therapy Lotion and the Icy Hot Medicated Sleeve. In March 2002, we acquired the Selsun Blue line of medicated dandruff shampoos, expanding our brand portfolio into another attractive niche category. We will continue to seek opportunities to acquire attractive brands in niche markets such as Selsun Blue. We intend to drive growth through strong marketing and promotional programs, new product development and acquisitions of new brands.
Competitive Strengths
We believe that the following key competitive strengths are critical to our continuing success:
Diverse and broad portfolio of well-recognized branded products. We currently market a diverse and broad portfolio of 22 brands in a variety of different product categories, including topical analgesics, medicated dandruff shampoos and conditioner, medicated skin care products, toiletries and dietary supplements. Our products are marketed under well-recognized brand names, such as our portfolio of topical analgesic brands lcy Hot, Aspercreme, Flexall, Sportscreme, Capzasin and Arthritis Hot, as well as Gold Bond, Selsun Blue, Dexatrim and Garlique. Our presence in diverse product categories allows us to reduce our exposure to changing consumer demand or weakness in any single category.
Significant presence in niche markets. We acquire and develop brands that compete in niche markets where we believe we can achieve significant market presence and build brand equity. Our products often face less competitive pressures, because we focus on niche markets that are frequently outside the core product areas of larger consumer products and
pharmaceutical companies. Our focus on niche markets provides us with the opportunity to develop strong brand equity, identify and respond to consumer trends in these markets and leverage our strong selling and distribution capabilities.
High margins and efficient operating structure. We are able to achieve high gross margins as a result of our ability to build and maintain brand equity, our significant market presence in niche markets and efficiencies in purchasing, manufacturing and distribution. In addition, we seek to tightly control our expenses, which strengthens our operating margins. Our high margins and resulting strong cash flow allow us to weather temporary fluctuations in our product markets that could otherwise more adversely affect our business.
Proven advertising and promotion strategy. We aggressively seek to build brand awareness and usage of our larger brands through extensive and cost-effective advertising strategies that emphasize the competitive strengths of our products. We rely principally on television and radio advertising and, to a lesser extent, print advertising and promotional programs. We strive to achieve cost efficiencies in our advertising by being opportunistic in our purchase of media and controlling our production costs. We also maintain the flexibility to allocate purchased media time among our key brands to respond quickly to changing consumer trends and to support our growing brands. We believe our well-developed advertising and promotion platform allows us to quickly and efficiently launch and support newly acquired brands and product line extensions, as well as increase market penetration of existing brands. Advertising and promotion expenditures represented approximately 28% of our total revenues in fiscal 2005. Given the importance of our products’ brand equity, we expect to maintain a significant level of spending on advertising and promotion.
Established national sales and distribution network. We have an established national sales and distribution network that sells to mass merchandiser, drug and food retailers such as Wal-Mart Stores, Inc., Walgreen Co. and The Kroger Co. In fiscal 2005, sales to our top ten customers constituted approximately 70% of our total sales, which allows us to target our selling efforts to our key customers and tailor specific programs to meet their needs. Our fiscal 2005 sales to Wal-Mart Stores, Inc. accounted for approximately 36% of our total revenues. Through targeted sales and by utilizing our established network, including our approximately 45 person sales force, we believe we can effectively sell and distribute newly acquired brands and product line extensions while maintaining tight controls over our selling expenses.
Focused new product development. We strive to increase the value of our base brands while obtaining an increased market presence through product line extensions. In fiscal 2005, our product development expenditures were $3.6 million. During the past several years, we have expanded our product development staff and completed a new 10,000 square foot research and development facility. We rely on internal market research as well as consultants to identify new product formulations and line extensions that we believe appeal to the needs of consumers. Recent examples of successful product line extensions include Gold Bond Ultimate Healing Skin Therapy Lotion and the Icy Hot Medicated Sleeve. In fiscal 2005, we introduced seven new product line extensions and have six new product launches scheduled for fiscal 2006.
Enhanced financial position. We have strengthened our balance sheet as a significant portion of our cash flows have been used to reduce our debt. For example, since the acquisition of Selsun Blue in March 2002, we have reduced outstanding debt by approximately $67.2 million as of November 30, 2005. In addition, we completed a debt refinancing transaction in February 2004 that generated a reduction of annual interest expense of approximately $5.5 million in fiscal 2004. Our total debt outstanding as of November 30, 2005 was $182.5 million. On November 29, 2005, we amended our Senior Secured Revolving Credit Facility (the “Amended Revolving Credit Facility”) with a syndicate of commercial banks led by Bank of America, N.A., as agent, that, among other things, increased our borrowing capacity under the facility from $50.0 million to $100.0 million, increased our flexibility to repurchase shares of our stock and improved our borrowing rate under the facility. On November 30, 2005, we called our $75.0 million of Floating Rate Senior Notes for full redemption on December 30, 2005. The $75.0 million of Floating Rate Senior Notes were fully redeemed on December 30, 2005 at a purchase price of 102% of the principal amount of the notes plus accrued interest. We utilized borrowings of $38.0 million under our Amended Revolving Credit Facility and $38.9 million of our cash on hand to fund the redemption of the Floating Rate Senior Notes. Our total debt outstanding as of February 17, 2006 was $145.5 million.
Business Strategy
Our strategy to achieve future growth is to generate new sales through strong marketing and promotional programs, new product development and acquisitions of new brands.
Brand management and growth. We will seek to increase market share for our major brands through focused marketing of our existing products and product line extensions while maintaining market share for our smaller brands. Our marketing strategy is to position our products to meet consumer preferences identified through extensive use of market and consumer research. We intend to channel advertising and promotion resources to those brands that we feel exhibit the most potential for
growth. We also intend to increase our new product line extension activities as evidenced by our increased research and development spending, the expansion of our product development staff and our research and product development facility constructed in 2003. In addition, we continually evaluate the profit potential of and markets for our brands and, in instances where our objectives are not realized, will dispose of under-performing brands and redeploy the resulting cash assets. For example, in fiscal 2000, we sold the Ban® (a registered trademark of Kao Corporation) product line of antiperspirants and deodorants in response to major shifts in the competitive environment in this product category and the resulting prospect of declining sales, and in fiscal 2005, we sold the pHisoderm line of skin care products, a brand that was no longer consistent with our brand strategy.
Strategic acquisitions. We intend to identify and acquire brands in niche markets where we believe we can achieve a significant market presence through our established advertising and promotion platform, sales and distribution network and research and development capabilities. We target brands with sales that are highly responsive to increased advertising support, provide an opportunity for product line extensions through our research and development efforts and have the potential to meet our high gross margin goals. We will continue to seek opportunities to acquire attractive brands in niche markets.
Developments During Fiscal 2005
Fiscal 2005 was highlighted by the development and marketing of new product line extensions; the refinancing of our indebtedness; the class action settlement of claims relating to Dexatrim containing phenylpropanolamine (“PPA”); and our sale of the pHisoderm line of skin care products.
In the first quarter of fiscal 2005, we introduced the following product line extensions: Aspercreme Odor-Free Therapy Back and Body Patch, Gold Bond Ultimate Comfort Powder, New Phase Extra Strength, Dexatrim Max and Bullfrog Kids UV Defender. Selsun Salon was introduced in the fourth quarter of fiscal 2005.
During the second quarter of fiscal 2005, we repurchased $17.5 million of our 7.0% Senior Subordinated Notes due March 1, 2014 (“7.0% Subordinated Notes”) in the open market at an average premium of 1.6% over the principal amount of the notes. The repurchases resulted in a loss on early extinguishment of debt of $0.7 million in the second quarter of fiscal 2005. The outstanding balance of the remaining 7.0% Subordinated Notes was reduced to $107.5 million.
On November 29, 2005, we entered into the Amended Revolving Credit Facility that, among other things, increased our borrowing capacity under the facility from $50.0 million to $100.0 million, increased our flexibility to repurchase shares of our common stock and improved our borrowing rate under the facility.
On November 30, 2005, we called our $75.0 million of Floating Rate Senior Notes for full redemption on December 30, 2005. The terms of the indenture for the Floating Rate Senior Notes required the payment of a price of 102% of the principal amount of the notes plus accrued interest. The $75.0 million of Floating Rate Senior Notes were fully redeemed on December 30, 2005. We utilized borrowings of $38.0 million under our Amended Revolving Credit Facility and $38.9 million of our cash on hand to fund the redemption of the Floating Rate Senior Notes. As a result of the redemption, a loss on early extinguishment of debt of $2.9 million will be recorded in the first quarter of fiscal 2006.
During fiscal 2005, we resolved substantially all of the claims submitted in the Dexatrim PPA settlement and now estimate that the total cost of the Dexatrim settlement will be approximately $56.0 million. A total of $70.9 million has been funded into a settlement trust by our insurers and the product manufacturer and is available to pay claims in the settlement. Any funds remaining in the settlement trust after all claims and expenses of the trust have been paid will be distributed as approved by the court in accordance with the class action settlement agreement and our settlement agreements with each of Kemper Indemnity Insurance Company and the product manufacturer. We currently expect that after all claims and expenses of the settlement trust have been paid, we could recover up to approximately $8.5 million from the settlement trust. If realized, this potential recovery is estimated to occur in the first half of fiscal 2006. We currently do not expect to record any additional charges relative to the settlement of the PPA litigation, except for legal expenses that will be recorded in the period incurred. During the fourth quarter of fiscal 2005, we incurred and recorded $0.3 million of legal expenses related to the Dexatrim litigation.
During the third quarter of fiscal 2005, we entered into a settlement agreement with the DELACO Company (“DELACO”), successor by merger to the Thompson Medical Company, Inc., which owned the Dexatrim brand prior to December 21, 1998 (the “DELACO Agreement”). Pursuant to the DELACO Agreement, we will assume responsibility for all claims against DELACO and its predecessor, Thompson Medical Company, Inc., or us relating to Dexatrim products involving an injury date after December 21, 1998 and will hold the DELACO bankruptcy estate harmless from any such claims. In exchange, a settlement trust to be established under DELACO’s bankruptcy plan will pay us $8.75 million and will assume responsibility for all claims
related to Dexatrim products alleging injury dates on or before December 21, 1998. The DELACO Agreement was approved by the bankruptcy court in the DELACO bankruptcy on July 28, 2005. The DELACO Agreement and our receipt of $8.75 million from the DELACO settlement trust is conditioned upon final confirmation and approval of the DELACO bankruptcy plan and funding of the DELACO settlement trust by the insurance companies and other parties obligated to fund the trust. At the confirmation hearing on February 15, 2006, the bankruptcy court indicated that it would enter an order confirming the DELACO bankruptcy plan. Absent any appeals being filed, the order confirming the plan would become final ten days after the bankruptcy court enters the order. Substantial funding of the DELACO settlement trust is due to occur on or before March 13, 2006. Counsel for DELACO announced at the confirmation hearing that the effective date of the plan is anticipated to be March 13, 2006. On the effective date, we will be released from all liability from holders of Dexatrim claims with injury dates prior to December 21, 1998, and if the settlement trust is funded as anticipated, we expect to receive a payment of $8.75 million before the end of March 2006.
In the first quarter of fiscal 2005, we sold our Selsun business in certain countries in Africa and Asia to The Mentholatum Co., Inc. We maintain our rights to Selsun elsewhere in the world (except India). The divested territory was not compatible with our strategic goals for the remainder of our international Selsun operations and contributed only $1.3 million in net sales in fiscal 2004.
On November 30, 2005, we sold the pHisoderm line of skin care products to The Mentholatum Co., Inc. for a purchase price of $8.5 million plus inventories of approximately $1.1 million. Of the $2.9 million initially held in escrow subject to certain post-closing conditions, only $0.3 million remained in escrow as of February 17, 2006. The transaction allowed us to divest a brand that was no longer consistent with our brand strategy and enables us to focus our financial and management resources on our leading brands. pHisoderm generated a total of $10.5 million of net sales in fiscal 2005. As a result of this transaction, we recorded a loss on product divestures of $8.7 million in the fourth quarter of fiscal 2005.
Products
We currently market a diverse and broad portfolio of branded OTC healthcare products, toiletries and dietary supplements in such categories as topical analgesics, medicated skin care products, medicated dandruff shampoos, dietary supplements and other OTC and toiletry products. Our branded products by category consist of:
Category and Brands | Product Description |
Topical Analgesics | |
Icy Hot | Dual action muscular and arthritis pain reliever |
Aspercreme | Odor-free arthritis pain reliever |
Flexall | Aloe-vera based pain reliever |
Capzasin | Deep penetrating, odor-free arthritis pain reliever |
Sportscreme | Odor-free muscular pain reliever |
Arthritis Hot | Value-priced arthritis pain reliever |
Medicated Skin Care Products | |
Gold Bond | Medicated powder, cream, lotion, first aid and foot care products |
| |
Medicated Dandruff Shampoos | |
Selsun Blue | Medicated dandruff shampoos and conditioner |
Selsun Salon | Medicated dandruff shampoos with enhanced moisturizers and nutrients |
Dietary Supplements | |
Dexatrim | Diet pills |
Garlique | Cholesterol health supplement |
Melatonex | Sleep aid |
New Phase | Menopausal supplement |
Omnigest EZ | Digestive aid |
Other OTC and Toiletry Products | |
Internal Analgesics | |
Pamprin | Menstrual pain reliever |
Prēmsyn PMS | Premenstrual pain reliever |
Seasonal | |
Bullfrog | Waterproof sunblocks |
Sun-In | Spray-on hair lightener |
UltraSwim | Chlorine-removing shampoo and conditioner |
Oral Care | |
Herpecin-L | Cold sore lip treatment |
Benzodent | Denture pain relief cream |
Other | |
Mudd | Facial Masque |
Topical Analgesics
Our topical analgesic portfolio features six distinctly positioned brands. Our flagship brand, Icy Hot, is a leader in the external analgesic category and receives heavy media support and strong advertising featuring NBA super-star Shaquille O'Neal. In the first quarter of fiscal 2006, we will extend the Icy Hot brand into the elastics support category with Icy Hot Pro-Therapy, a new product line which combines strong knee or back support with therapeutic pain relieving inserts. Icy Hot Pro-Therapy began shipping to the retail trade in late January, 2006. The new product line will be supported with advertising featuring Shaquille O'Neal and Olympic Gold Medalist and World Cup soccer champion Mia Hamm.
Aspercreme provides odor-free pain relief for sufferers of arthritis and other joint and muscle pain. Capzasin is an arthritis pain reliever that contains capsaicin, the active ingredient that doctors and pharmacists recommend most for arthritis sufferers. In the first quarter of 2006, we will launch a new back and body patch under our Capzasin brand. Sportscreme is targeted at serious athletes as well as “weekend warriors”. Flexall is marketed toward those who seek a menthol and aloe vera based pain reliever for conditions such as chronic back pain or muscle strain. Arthritis Hot rounds out the portfolio and is positioned against private label products at a value price.
We support our topical analgesic brands with extensive national television and radio advertising as well as targeted consumer promotions.
Medicated Skin Care Products
The Gold Bond brand competes in numerous product categories with specially formulated products for both adults and babies, including body powder, therapeutic hand and body lotions, foot care and first aid. Gold Bond has long been the number one selling brand of medicated body powder domestically, and its strong brand equity among consumers has allowed us to successfully launch new line extensions, most recently under the Gold Bond Ultimate line.
Initially launched in fiscal 2003, Gold Bond Ultimate Healing Skin Therapy Lotion helps to heal and nurture extremely dry, cracked and irritated skin with seven intensive moisturizers plus vitamins A, C and E. The Gold Bond Ultimate line expanded into the everyday bath powder category with the introduction of Gold Bond Ultimate Comfort Body Powder during the first quarter of fiscal 2005. Gold Bond Ultimate Comfort Body Powder is a talc-free powder that provides freshness, odor protection and moisture control and features the signature Ultimate fragrance. In fiscal 2005, we continued efforts to expand our presence in the foot care category through advertising and promotional support of our foot powder, foot spray and foot cream business.
The Gold Bond product line is heavily supported by national television, print and radio advertising throughout most of the year as well as with consumer promotions such as sampling and coupons to further drive awareness and trial. We believe Gold Bond continues to represent a solid opportunity for growth both through our existing medicated product lines and the introduction of line extensions under the Ultimate line.
Medicated Dandruff Shampoos
Domestic net sales of our medicated dandruff shampoos have continued to grow significantly following our acquisition of the Selsun Blue brand in 2002. We attribute the resurgence and continuing strength of this 50+ year old medicated shampoo brand to the development and implementation of an effective advertising campaign, expansion of the brand’s appeal to a broader consumer base, increased media and promotional support and expanded distribution. Virtually all aspects of the brand image have been enhanced since 2002, including the product, packaging, advertising, media and retail distribution.
Selsun Blue offers four domestic shampoo formulations: medicated, with a unique cooling clean feel; moisturizing, with aloe and moisturizers; 2-in-1, with a patented conditioning system; and pH balanced for color treated hair. Each formula blends
the active medication (selenium sulfide) with extra hair care properties to provide alternative formulas for individuals who need a medicated dandruff shampoo.
In the fourth quarter of fiscal 2005, we began shipping Selsun Salon, a maximum dandruff control shampoo with enhanced moisturizers and nutrients. All Selsun Salon products are formulated with a unique blend of salon quality moisturizers, vitamins and nutrients to provide great looking hair and the proven dandruff ingredient pyrithione zinc 1% for effective dandruff control. Selsun Salon is available in four formulas to accommodate varying hair types of the dandruff shampoo consumer: Classic - for normal hair; 2-in-1 - for dry or damaged hair; Volumizing - for thinning or fine hair; and Moisturizing - for hair that needs extra conditioning.
We believe that growth opportunities remain for both Selsun Blue and new Selsun Salon and we will continue to support both segments of our business with extensive national television and radio advertising as well as targeted consumer promotions.
Dietary Supplements
Dexatrim is a leading brand in the diet pill category. Dexatrim diet pills are available in two forms: Dexatrim Natural, and, new to the brand in 2005, Dexatrim MAX. Dexatrim Natural, a drug-free, all-natural dietary supplement, is available in green tea, caffeine-free and extra energy versions. The newly launched Dexatrim Max has been a strong positive addition to the line and contains Vitamin B Complex, Ginseng, Chromium and EGCG from Green Tea. Dexatrim Max was introduced to consumers through television advertising and Sunday newspaper coupons. The initial success of Dexatrim Max has provided a platform for a unique new diet product, Dexatrim Max2O, which we plan to launch in the second quarter of fiscal 2006.
We compete in the dietary supplements category with our Sunsource line of products. We focus the marketing of our Sunsource dietary supplements in two key areas: cardiovascular and menopausal health. Known for its support of cardiovascular health, Garlique leads the garlic supplement category and is positioned as an odor-free, one-per-day supplement that will help maintain cholesterol levels within a healthy range. In fiscal 2006, we intend to introduce a new cardiovascular health supplement called Garlique CardioAssist. Garlique CardioAssist is a clinically tested, odor-free dietary supplement containing an ingredient clinically proven to help lower total and LDL cholesterol. The proprietary formula also helps support normal levels of HDL cholesterol, triglycerides and homosysteines for more complete heart health. New Phase is a menopausal supplement that helps relieve the common discomforts of menopause, as well as providing support for strong bones and a healthy heart. All Sunsource products are specially formulated to provide consumers with an all-natural, drug-free way to support their specific health care goals.
Other OTC and Toiletry Products
Internal Analgesics
We compete in the menstrual analgesic category with two brands, Pamprin and Prēmsyn PMS. Pamprin, featuring three distinct formulas, seeks to provide complete relief of a woman’s menstrual symptoms, while Prēmsyn PMS has one formula designed to address specific symptoms of premenstrual syndrome. The target consumers for our menstrual analgesic business are women aged 18 to 49, and secondarily teen girls as they first enter the category. Pamprin is available in three formulas: Multi-Symptom, Cramp and All Day. In fiscal 2006, we plan to add Pamprin Max to the line. Pamprin Max is formulated with three active ingredients to provide maximum relief from menstrual symptoms. Awareness of the Pamprin brand is driven by network, cable and spot television advertising.
Seasonal
The majority of sales of our seasonal brands, Bullfrog, Sun-In and UltraSwim, typically occur during the first three quarters of our fiscal year. Bullfrog is a line of high quality, high SPF waterproof sunblocks. In fiscal 2005, Bullfrog enhanced its product offering for children with the introduction of Bullfrog Kids UV Defender which is available in three product forms: Fastblast Spray Gel, Lotion Spray and Surfer Gel. All three Kids UV Defender formulas remain true to Bullfrog’s waterproof and high SPF heritage. This launch was supported with print and radio advertising targeted towards mothers of children age 4 to 12. The base Bullfrog business was supported with local and national radio advertising as well as through event sponsorships and targeted sampling programs. In the first quarter of fiscal 2006, we will launch Bullfrog Mosquito Coast. This new product combines SPF 30 sunblock with a DEET-free insect repellent in a convenient spray form. Bullfrog Mosquito Coast provides sun protection and mosquito repellency for up to 8 hours. We will seek to establish awareness of Bullfrog Mosquito Coast among active adults through a comprehensive advertising campaign including magazines, television, radio and the internet.
Sun-In, a hair lightener, is available in two varieties of spray-on and a highlighting gel. Sun-In is supported by print advertising in teen magazines, an interactive web site and promotional prepacks. UltraSwim is our niche line of swimmers’ shampoos and conditioner. In addition to promotional prepacks, we support this brand through print advertising targeted at competitive and fitness swimmers to communicate that UltraSwim removes more chlorine from hair than ordinary shampoos.
Oral Care
Our oral care brands include Herpecin-L, a lip care product that treats cold sores and protects lips from the harmful rays of the sun, and Benzodent, a dental analgesic cream for pain related to dentures. We support Herpecin-L with national television advertising.
Other
Other brands include Mudd, a line of specialty masque products, and a variety of other smaller brands.
International Business
Our international business, which represented approximately 10% of our total revenues in fiscal 2005, has been concentrated in Canada, an export market driven from our operations in Ireland and the U.K. and in international countries in which Selsun and certain of our other products are sold.
Selsun International
We plan to focus our efforts on expanding Selsun’s international presence in existing key markets, such as Canada, Mexico, Brazil, the U.K. and Australia. In certain international markets, we sell Selsun through a distributor and receive a royalty based on a percentage of distributor sales. We have entered into distributor agreements with third party distributors for Selsun in various international markets other than Canada and the U.K., in which we engage national brokers.
Europe
Our European business is conducted through Chattem Global Consumer Products Limited (“Chattem Global”), our Irish subsidiary, located in Limerick, Ireland, and Chattem (U.K.) Limited (“Chattem (U.K.)”), a wholly-owned subsidiary located in Basingstoke, Hampshire, England. This unit also services distributors in various other worldwide locations. Packaging and distribution operations are conducted principally in Ireland with certain products sourced from our U.S. operations. Chattem uses a national broker in the U.K., while distributors are used to market and sell our products on the European continent and elsewhere. Our products sold in Europe include Selsun, Sun-In, Mudd and UltraSwim. Cornsilk® is sold by Chattem (U.K.) under a licensing arrangement with the owner of its registered trademark, Del Laboratories, Inc. Spray Blond Spray-In Hair lightener is marketed only on the European continent. Certain of our OTC health care products are sold by Chattem Global to customers in parts of Central Europe and the Middle East.
Canada
Chattem Canada, a wholly-owned subsidiary based in Mississauga, Ontario, Canada, markets and distributes certain of our consumer products throughout Canada. The manufacturing of these products is principally done in our facilities in Chattanooga, Tennessee, while some packaging is done in Mississauga. Chattem Canada utilizes a national broker for its sales efforts. Brands marketed and sold in Canada include Icy Hot, Selsun, Gold Bond, Pamprin, Sun-In, UltraSwim and Aspercreme.
United States Export
Our United States export division services various distributors primarily located in the Caribbean and Latin America. We distribute Selsun, Gold Bond, Dexatrim and certain of our topical analgesic products into these markets.
Marketing, Sales and Distribution
Advertising and Promotion
We aggressively seek to build brand awareness and product usage through extensive and cost effective advertising strategies that emphasize the strengths of our products. We allocate a significant portion of our revenues to the advertising and promotion of our products. Expenditures for these purposes were approximately 28% of total revenues in fiscal 2005.
We will seek to increase market share for our major brands through focused marketing of our existing products and product line extensions while maintaining market share for our smaller brands. Our marketing strategy is to position our products to meet consumer preferences identified through extensive use of market and consumer research. We intend to channel advertising and promotion resources to those brands that we feel exhibit the most potential for growth. We rely principally on television and radio advertising and to a lesser extent print advertising and promotional programs. We strive to achieve cost efficiencies in our advertising by being opportunistic in our purchase of media and controlling our production costs. We also maintain the flexibility to allocate purchased media time among our key brands to respond quickly to changing consumer trends and to support our growing brands. We believe our well-developed advertising and promotion platform allows us quickly and efficiently to launch and support new brands and product line extensions as well as increase market penetration of existing brands.
We work directly with retailers to develop promotional calendars and campaigns for each brand, customizing the promotion to the particular requirements of the individual retailer. These programs, which include cooperative advertising, temporary price reductions, in-store displays and special events, are designed to obtain or enhance distribution at the retail level and to reach the ultimate consumers of the product. We also utilize consumer promotions such as coupons, samples and trial sizes to increase the trial and consumption of the products.
Customers
Our customers consist of mass merchandisers such as Wal-Mart Stores, Inc., drug retailers such as Walgreens Co. and CVS Corp. and food retailers such as The Kroger Co. In fiscal 2005, our ten largest customers represented approximately 70% of total revenues, and our 20 largest customers represented approximately 81% of total revenues, which allows us to target our selling efforts to our key customers and customize programs to meet their needs. Our fiscal 2005 sales to Wal-Mart Stores, Inc. accounted for approximately 36% of total revenues. No other customer accounts for more than 10% of our total revenues. Shoppers Drug Mart, a Canadian retailer, accounted for more than 10% of our international revenues in fiscal 2005. Consistent with industry practice, we do not operate under a long-term written supply contract with any of our customers.
Sales and Distribution
We have an established national sales and distribution sales organization that sells to mass merchandiser, drug and food retailers. We utilize our national sales network, consisting primarily of our own sales force, to sell and distribute newly acquired brands and product line extensions while maintaining tight controls over our selling expenses. Our experienced sales force of approximately 45 people serves all direct buying accounts on an individual basis. Our internal sales force accounts for more than 95% of domestic sales. For the more fragmented food channel and for the smaller individual stores, we rely on a national network of regional brokers to provide retail support. In excess of 90% of our domestic orders are received electronically through our electronic data interchange, or EDI, system, and accuracy for our order fulfillment has been consistently high. Our sales department performs significant analysis helping both our sales personnel and customers understand sales patterns and create appropriate promotions and merchandising aids for our products. Although not contractually obligated to do so, in certain circumstances, we allow our customers to return unsold merchandise, and for seasonal products, we provide extended payment terms to our customers.
Internationally, our products are sold by national brokers in Canada and the U.K. and by distributors in Europe and Latin America. We have entered into distribution agreements with third party distributors for Selsun in various international markets except Canada and the U.K.
Most of our products, including those manufactured by third party manufacturers, are currently shipped from a leased warehouse located in Chattanooga, Tennessee. We also use a third party logistics service located in California to warehouse and distribute our products to the west coast area of the United States. We use outside carriers to transport our products. We do
not generally experience wide variances in the amount of inventory we maintain. At present, we have no significant backlog of customer orders and are promptly meeting customer requirements.
Manufacturing and Quality Control
We currently manufacture approximately 60% of the sales volume of our products at our two Chattanooga, Tennessee, facilities. The balance of our products are manufactured by third party contract manufacturers including our Gold Bond medicated powders and first aid wipes, Icy Hot patches and sleeves, Herpecin-L, and our dietary supplements, including Dexatrim products. Newly acquired products that are similar to our currently manufactured products generally can be manufactured by us with the adaptation of existing equipment and facilities or the addition of new equipment at relatively small cost. We contract with third party manufacturers to manufacture products that are not compatible with our existing manufacturing facilities or which can be more cost-effectively manufactured by others. In many cases, third party manufacturers are not obligated under contracts that fix the term of their commitment. We believe we have adequate capacity to meet anticipated demand for our products through our own manufacturing facilities and third party manufacturers.
We currently are manufacturing all of our North American Selsun Blue products at our Chattanooga, Tennessee, facilities. We have entered into third party manufacturing agreements to source the international markets in which Selsun is sold.
To monitor the quality of our products, we maintain an internal quality control system supported by onsite microbiology and analytical laboratories. We have trained quality control technicians who test our products and processes and guide the products through the manufacturing cycle. Consultants also are employed from time to time to test our quality control procedures and the compliance of our manufacturing operations with the United States Food and Drug Administration (“FDA”) regulations. We audit our third party manufacturers to monitor compliance with applicable current good manufacturing practices (“GMPs”) as defined by FDA regulations.
We purchase raw materials and packaging materials from a number of third party suppliers primarily on a purchase order basis. Except for pamabrom, pyrilamine maleate and compap, active ingredients used in our Pamprin and Prēmsyn PMS products, we are not limited to a single source of supply for the ingredients used in the manufacture of our products. Sales of our Pamprin and Prēmsyn PMS products represented approximately 3% of our consolidated total revenues in fiscal 2005. In addition, we have a limited source of supply for selenium sulfide, the active ingredient in Selsun Blue. As a result of the limited supply and increase in worldwide demand for selenium metal, a major component in the manufacture of selenium sulfide, prices have been and are expected to be volatile. We believe that our current and potential alternative sources of supply will be adequate to meet future product demands.
Product Development
We strive to increase the value of our base brands and obtain an increased market presence through product line extensions. We rely on internal market research as well as consultants to identify new product formulations and line extensions that we believe appeal to the needs of consumers. Our growth strategy includes an increased emphasis on new product development as evidenced by our increased research and development spending, the expansion of our product development staff and our completion of a new 10,000 square foot research and product development facility in fiscal 2003. We currently employ approximately 24 persons in our research and development department and also engage consultants from time to time to provide expertise or research in a particular product area. Our product development expenditures were $3.6 million in fiscal 2005, $3.1 million in fiscal 2004 and $2.7 million in fiscal 2003.
Competition
We compete in the OTC health care, toiletries and dietary supplements markets. These markets are highly competitive and are characterized by the frequent introduction of new products, including the migration of prescription drugs to the OTC market, often accompanied by major advertising and promotional support. Our competitors include large pharmaceutical companies such as Pfizer, Inc. and Johnson & Johnson, consumer products companies such as Procter & Gamble Co. and dietary supplements companies such as Nature’s Bounty, Inc. and Pharmaton Natural Health Products, many of which have considerably greater financial and other resources and are not as highly leveraged. Our competitors may be better positioned to spend more on research and development, employ more aggressive pricing strategies, utilize greater purchasing power, build stronger vendor relationships and develop broader distribution channels than us. In addition, our competitors have often been willing to use aggressive spending on trade promotions and advertising as a strategy for building market share at the expense of their competitors including us. The private label or generic category has also become increasingly more competitive in certain of our product markets. Our products continue to compete for shelf space among retailers who are increasingly consolidating.
Trademarks and Patents
Our trademarks are of material importance to our business and among our most important assets. We own all of our trademarks associated with brands that we currently market. In fiscal 2005, substantially all of our total revenues were from products bearing proprietary or licensed brand names. Accordingly, our future success may depend in part upon the goodwill associated with our brand names, particularly Gold Bond, Selsun Blue, Icy Hot and Aspercreme.
Our principal brand names are registered trademarks in the United States and certain foreign countries. We maintain or have applied for patent and copyright protection in the United States relating to certain of our existing and proposed products and processes. We also license from third parties other intellectual property that is used in certain of our products. The sale of these products relies on our ability to maintain and extend our supply and licensing agreements with these third parties.
Government Regulation
The manufacturing, distribution, processing, formulation, packaging, labeling and advertising of our products are subject to regulation by federal agencies, including, but not limited to:
• the Food & Drug Administration (the “FDA”);
• the Federal Trade Commission (the “FTC”);
• the Drug Enforcement Administration (the “DEA”);
• the Consumer Product Safety Commission (the “CPSC”);
• the United States Postal Service;
• the Environmental Protection Agency (“EPA”); and
• the Occupational Safety and Health Administration (“OSHA”).
These activities are also regulated by various agencies of the states, localities and foreign countries in which our products are sold. In particular, the FDA regulates the safety, manufacturing, labeling and distribution of dietary supplements including vitamins, minerals and herbs, as well as food additives, OTC and prescription drugs, medical devices and cosmetics. In addition, the FTC has primary jurisdiction to regulate the advertising of OTC drugs, medical devices, dietary supplements, functional toiletries and skin care products.
Under the Federal Food, Drug, and Cosmetic Act (“FDC Act”) all “new drugs”, including OTC products, are subject to pre-market approval by the FDA under the new drug application (“NDA”) process. The FDC Act defines a “new drug” as a drug that is not generally recognized among scientifically qualified experts as safe and effective for use under the conditions stated in its labeling. A drug might also be considered new if it has not been used, outside of clinical investigations, to a material extent or for a material time under conditions described for a product. A drug that is generally regarded as safe and effective is not a “new drug” and therefore does not require pre-market approval.
The FDA has adopted an administrative process, the OTC Drug Review, to determine which active ingredients and indications are safe and effective for use in OTC products. With the aid of independent expert advisory review panels, the FDA develops rules, referred to as “monographs”, that define categories of safe and effective OTC drugs. These monographs group drug ingredients into therapeutic classes such as OTC external analgesics. Products that comply with monograph conditions do not require pre-market approval from the FDA.
The FDA has finalized monographs for certain categories of OTC drugs such as drug products for the control of dandruff. If a product is marketed beyond the scope of a particular final monograph and without an approved NDA, such as if the manufacturer makes a label claim not covered by the monograph, the FDA will consider the product to be unapproved and misbranded and can take enforcement action against the drug company and product including, but not limited to, issuing a warning letter or initiating a product seizure. In order to market a product whose active ingredients are not permitted by a final monograph, a company must submit an NDA to the FDA.
There are several categories of OTC drugs, such as external analgesics, for which the FDA has not completed its review. In such cases, the FDA has established tentative final monographs. These tentative final monographs are similar to final
monographs in that they establish conditions under which OTC drugs can be marketed for certain uses without FDA pre-marketing approval. The FDA generally does not take enforcement action against an OTC drug subject to a tentative final monograph unless there is a safety problem or a substantial effectiveness question.
All of our OTC drug products are regulated pursuant to the FDA monograph system with the exception of Pamprin All Day, the subject of an abbreviated NDA held by The Perrigo Company. Many of our products are sold according to tentative final monographs. Therefore, we face the risk that the FDA could take action if there is a safety or efficacy issue with respect to one of our products or finalize these monographs with revised conditions as to which of our products do not comply. If any of our products were found not to be in compliance with the final monograph, we may be forced to reformulate or relabel such products, if possible, or submit an abbreviated NDA or an abbreviated NDA to continue to market our existing formulation. The submission of a marketing application may require the preparation and submission of clinical tests, which would be time consuming and expensive. We may not receive FDA approval of any application in a timely manner or at all. If we were not able to reformulate or relabel our product or obtain FDA approval of an NDA, we would be required to discontinue selling the affected product. Changes in monographs could also require us to change our product formulation or dosage form, revise our labeling, modify our production process or provide additional scientific data, any of which would involve additional costs and may be prohibitive. For our OTC drug products that are sold according to final monographs, we cannot deviate from the conditions described in the final monograph, such as changes in approved active levels or labeling claims, unless we obtain pre-marketing approval from the FDA. In 2004, we launched Pamprin All Day containing the menstrual pain reliever naproxen sodium. The Perrigo Company manufactures this product for us under its existing abbreviated NDA. Failure to comply with the conditions in a final monograph or NDA, where applicable, could result in an FDA enforcement action.
We have responded to certain questions received from the FDA with respect to efficacy of pyrilamine maleate, one of the active ingredients used in certain of the Pamprin Menstrual Pain Relief and Prēmsyn PMS products. While we addressed all of the FDA questions in detail, the final monograph for menstrual drug products, which has not yet been issued, will determine if the FDA considers pyrilamine maleate safe and effective for menstrual relief products. If pyrilamine maleate is not included in the final monograph, we would be required to reformulate the products to continue to provide the consumer with multi-symptom relief benefits. We have been actively monitoring the process and do not believe that either Pamprin Menstrual Pain Relief or Prēmsyn PMS will be materially adversely affected by the FDA review. We believe that any adverse finding by the FDA would likewise affect our principal competitors in the menstrual product category and that finalization of the menstrual products monograph is not imminent. Moreover, the company has formulated alternative Pamprin products that fully comply with both the internal analgesic and menstrual product monographs. Sales of our Pamprin Menstrual Pain Relief and Prēmsyn PMS products represented approximately 3% of our consolidated total revenues in fiscal 2005.
In early 2005, infrequent, but serious, adverse cardiovascular events were reported to the FDA associated with patients who were prescribed a subclass of COX-2 inhibitor non-steroidal anti-inflammatory drugs (“NSAID’s”) for long periods to relieve pain of chronic diseases such as arthritis. These products include Vioxx®, Bextra® and Celebrex®. In February 2005, the FDA held a joint advisory committee meeting to seek external counsel on the extent to which manufacturers might further warn patients of these cardiovascular risks on prescription product labeling, or prohibit sale of these prescription products. As part of its response on this issue, the FDA has recommended labeling changes for both the prescription and OTC NSAID’s. Well-known OTC NSAID’s such as ibuprofen and naproxen, which have been sold in vast quantities since the 1970s were affected by this regulatory action. Manufacturers of OTC NSAID’s were asked to revise their labeling to provide more specific information about the potential cardiovascular and gastrointestinal risks recognizing the limited dose and duration of treatment of these products. Our Pamprin All Day product, which contains naproxen sodium, is subject to these new labeling requirements. Pamprin All Day is manufactured for us by The Perrigo Company (“Perrigo”), holder of an abbreviated NDA for naproxen sodium. As holder of the abbreviated NDA, Perrigo has made the mandated labeling changes within the time frame required by the FDA. Product with revised labeling compliant with new FDA regulations is being shipped in February, 2006.
We are also aware of the FDA's concern about the potential toxicity due to concomitant use of OTC and prescription products that contain the analgesic ingredient acetaminophen, an ingredient also found in Pamprin and Prēmsyn PMS. We are participating in an industry-wide effort to reassure the FDA that the current recommended dosing regimen is safe and effective and that proper labeling and public education by both OTC and prescription drug companies are the best policies to abate the FDA's concern. The FDA will address this issue in its effort to finalize the monograph on internal analgesic products. We believe the FDA may issue revised labeling requirements within the next year, perhaps prior to monograph closure, that will cause the industry to relabel its analgesic products to better inform consumers of concomitant use.
We were notified in October 2000 that the FDA denied a citizen petition submitted by Thompson Medical Company, Inc., the previous owner of Sportscreme and Aspercreme. The petition sought a determination that 10% trolamine salicylate, the active ingredient in Sportscreme and Aspercreme, was clinically proven to be an effective active ingredient in external analgesic
OTC drug products and should be included in the FDA’s yet-to-be finalized monograph for external analgesics. We have met with the FDA and submitted a proposed protocol study to evaluate the efficacy of 10% trolamine salicylate as an active ingredient in OTC external analgesic drug products. We are working to develop alternate formulations for Sportscreme and Aspercreme in the event that the FDA does not consider the available clinical data to conclusively demonstrate the efficacy of trolamine salicylate when the OTC external analgesic monograph is finalized. If 10% trolamine salicylate is not included in the final monograph, we would likely be required to discontinue these products as currently formulated and remove them from the market after expiration of an anticipated grace period. If this occurred, we believe we could market related products as homeopathic products and could also reformulate them using ingredients included in the FDA monograph. We are uncertain as to when the monograph is likely to become final. Sales of our Sportscreme and Aspercreme products represented approximately 7% of our consolidated total revenues in fiscal 2005.
Certain of our topical analgesic products are currently marketed under an FDA tentative final monograph. The FDA has recently proposed that the final monograph exclude external analgesic products in patch, plaster or poultice form, unless the FDA receives additional data supporting the safety and efficacy of these products. On October 14, 2003, we submitted to the FDA information regarding the safety of our Icy Hot patches and arguments to support our product’s inclusion in the final monograph. We have also participated in an industry-wide effort coordinated by Consumer Healthcare Products Association (“CHPA”) to establish with the FDA a protocol of additional research that will allow the patches to be marketed under the final monograph even if the final monograph does not explicitly allow them. The CHPA submission to the FDA was made on October 15, 2003. Thereafter, in April 2004, we launched the Icy Hot Sleeve, a flexible, non-occlusive fabric patch with 16% menthol. In February, 2006 we launched the Icy Hot Pro-Therapy Medicated Foam Pad with Knee Wrap containing 5% menthol, and the Capzasin Back & Body Patch containing 0.025% capsaicin. All of these drug products contain levels of active ingredients consistent with the levels permitted in the OTC monograph. If additional research is required either as a preliminary to final FDA monograph approval and/or as a requirement of future individual product sale, we may need to invest in a considerable amount of expensive testing and data analysis. Any preliminary cost may be shared with other patch manufacturers. Because the submissions made into the FDA docket have been forwarded from its OTC Division to its Dermatological Division within the Center for Drug Evaluation and Research (“CDER”), we believe that the monograph is unlikely to become final and take effect before mid-2007 and perhaps thereafter. If neither action described above is successful and the final monograph summarily excludes such products, we will have to file an NDA in order to continue to market the Icy Hot and Aspercreme patches, Icy Hot Sleeve, Icy Hot Pro-Therapy Medicated Pad with Knee Wrap, Capzasin Back & Body Patch, and/or similar delivery systems under our other topical analgesic brands. In such case, we would have to remove the existing products from the market likely one year from the effective date of the final monograph, or pending FDA review and approval of an NDA. The preparation of an NDA would likely take us six to 18 months and would be expensive. It typically takes the FDA at least 12 months to rule on an NDA once it is submitted. Sales of our Icy Hot and Aspercreme patches and Icy Hot Sleeve products represented approximately 13% of our consolidated total revenues in fiscal 2005.
During the finalization of the monograph on sunscreen products the FDA chose to hold in abeyance specific requirements relating to the characterization of a product’s ability to reduce UVA radiation. A final ruling on this matter would be expected to result in new UVA testing requirements and subsequent labeling changes related to sun protection factor, or SPF, ratings, and other labeling claims. We expect that the FDA may take action on this matter within the next six months. If implemented, the final rules would likely result in new testing requirements and revised labeling of our Bullfrog product line, and all of our competitors’ products in the suncare category, within one year after issuance of the final rules.
The FDA also regulates the research, testing, manufacturing, safety, labeling, storage, recordkeeping, pre-market clearance or approval, promotion, distribution and production of medical devices in the United States to ensure that medical products distributed domestically are safe and effective for their intended uses. Under the FDC Act, medical devices are classified into one of three classes (Class I, Class II or Class III) depending on the degree of risk associated with each medical device and the extent of control needed to ensure safety and effectiveness. Our Icy Hot Pro-Therapy Knee and Back Brace and the Icy Hot Pro-Therapy Disposable Cold and Hot Packs are Class I devices.
Class I devices are subject to the lowest level of regulatory scrutiny because they are considered low risk devices. FDA requires Class I devices to comply with its General Controls, which include compliance with the applicable portions of the FDA’s Quality System Regulation, or QSR, facility registration and product listing, reporting of adverse medical events, and use of appropriate truthful and non-misleading labeling, advertising, and promotional materials. Most Class I devices are not required to submit 510(k) pre-market notifications (so-called “Class I Exempt”), but all are subject to FDA’s general misbranding and adulteration prohibitions. Both the Icy Hot Pro-Therapy Back and Knee Brace and the Icy Hot Pro-Therapy Disposable Cold and Hot Packs are subject to regulations which exempt them from the 510(k) pre-market notification requirements.
The FDA may disagree with our conclusion that clearances or approvals for such devices were not required or may require clearance or approval for future modifications of these or other devices. Such submissions may be time consuming and costly and may not ultimately be cleared or approved by FDA. If the FDA determines that we have failed to comply with applicable regulatory requirements, it can impose a variety of enforcement actions which could include public warning letters, fines, injunctions, consent decrees, civil penalties, suspension or delayed issuance of approvals or seizure or recall of our products. The FDA could also require us to repair, replace, or refund the cost of devices that we manufactured or distributed.
The Dietary Supplement Health and Education Act of 1994 (“DSHEA”) was enacted on October 25, 1994. DSHEA amends the FDC Act by defining dietary supplements, which include vitamins, minerals, amino acids, nutritional supplements, herbs and botanicals, as a new category of food separate from conventional food. DSHEA provides a regulatory framework to ensure safe, quality dietary supplements and to foster the dissemination of accurate information about such products. Under DSHEA, the FDA is generally prohibited from regulating dietary supplements as food additives or as drugs unless product claims, such as claims that a product may diagnose, mitigate, cure or prevent an illness, disease or malady, permit the FDA to attach drug status to a product. In such case, the FDA could require pre-market approval to sell the product. Manufacturers are not required to obtain prior FDA approval before producing or selling a dietary supplement unless the ingredient is considered “new” or was not on the market as of October 15, 1994.
Dietary supplement products may include truthful, non-misleading and substantiated statements of nutritional support. Examples of such claims are statements describing general well-being resulting from consumption of a dietary ingredient or the role of a nutrient or dietary ingredient in affecting or maintaining a structure or function of the body. These claims are also known as "structure/function" claims. FDA requires companies which include structure/function claims on their labeling to notify the agency of the claim within 30 days of first marketing the dietary supplement with the identified claims. FDA does not typically respond to these notifications, but could issue a "courtesy letter" should the agency question some aspect of the submission. A dietary supplement that includes a structure/function claim on its labeling is also required to include a disclaimer stating that the FDA has not evaluated the claim. FDA distinguishes between structure/function claims which do not require FDA pre-approval and disease-related health claims which require FDA prior approval or the issuance of an authorizing regulation.
A product marketed as a dietary supplement and subsequently approved for use as a drug or biologic may continue to be sold and regulated as a dietary supplement unless the FDA specifically finds that it is unsafe for use as a dietary supplement. A substance that has not been marketed as a dietary supplement prior to its approval as a drug or biologic, or prior to initiation of substantial clinical investigations for such uses, may be sold as a dietary supplement only pursuant to an FDA regulation authorizing its use as a dietary supplement.
The FDA may take enforcement action against a dietary supplement if the FDA believes the supplement presents a significant or unreasonable risk of illness or injury under conditions of use suggested in the labeling or under ordinary conditions of use. Under DSHEA, the FDA bears the burden of proof to show that a dietary supplement presents a significant or unreasonable risk of illness or injury. The FDA may also take enforcement action for unlawful promotion of a dietary supplement.
The FDA has finalized some of its regulations to implement DSHEA including those relating to nutritional labeling requirements and nutritional support claims. The FDA also has under development additional regulations and guidelines to implement DSHEA. Newly adopted and future regulations may require expanded or different labeling for our dietary supplements. We cannot determine what effect these regulations, when fully implemented, will have on our business in the future. These regulations could require the reformulation or discontinuance of certain products, additional recordkeeping, warnings, notification procedures and expanded documentation of the properties of certain products and scientific substantiation regarding ingredients, product claims and safety. Failure to comply with applicable FDA requirements can result in sanctions being imposed on us or the manufacture of our products including, but not limited to, warning letters, product recalls and seizures, injunctions or criminal prosecution.
The FDA has promulgated regulations relating to the manufacturing process for drugs, which are known as current GMP’s. We anticipate that the FDA will promulgate GMP’s, which are specific to dietary supplements and require at least some of the quality control provisions contained in the GMP’s for drugs, which are more rigorous than the GMP’s for foods. We source all of our dietary supplement products from outside suppliers, including Dexatrim, New Phase, Garlique, Melatonex, CardioAssist, and Omnigest. As part of its regulatory authority, the FDA may periodically conduct audits of the physical facilities, machinery, processes and procedures that we, or our suppliers, use to manufacture products. The FDA may perform these audits at any time without advanced notice. As a result of these audits, the FDA may order us, or our suppliers, to make certain changes in manufacturing facilities and processes. We may be required to make additional expenditures to comply with these
orders or new GMP requirements, or possibly discontinue selling certain products until we, or our suppliers, comply with these orders and requirements. As a result, our business could be adversely affected.
In 1994, the Nonprescription Drug Manufacturers Association (now CHPA) initiated a large scale study in conjunction with the Yale University School of Medicine to investigate a possible association, if any, of stroke in women aged 18 to 49 using PPA, formerly the active ingredient in certain of our Dexatrim products (the “Yale Study”). PPA is also used in other OTC medications, which were also part of the study. In May 2000, the results of the Yale Study were filed with the FDA. The investigators concluded that the results of the Yale Study suggest that PPA increases the risk of hemorrhagic stroke. The FDA indicated at that time that no immediate action was required and scheduled an FDA advisory panel to meet in October 2000 to discuss the results of this study.
In October 2000, a Nonprescription Drugs Advisory Committee commissioned by the FDA to review the safety of PPA, determined that there is an association between PPA and hemorrhagic stroke and recommended that PPA not be considered generally recognized as safe for OTC use as a nasal decongestant or for weight control. In response to a request from the FDA to voluntarily cease marketing Dexatrim with PPA, we announced on November 7, 2000 our decision to immediately cease shipping Dexatrim with PPA and to accept product returns from any retailers who decide to discontinue marketing Dexatrim with PPA. We have been subject to a number of lawsuits arising from our Dexatrim with PPA product most of which are being resolved through the class action settlement of all Dexatrim PPA claims described below. See “Legal Proceedings”.
In 1997, the FDA published a proposed rule on the use of dietary supplements containing ephedrine alkaloids. In June 2002, the United States Department of Health and Human Services (“HHS”) proposed an expanded scientific evaluation of Ephedra which led to the issuance of a report by the RAND-based Southern California Evidence-Based Practice Center (the “RAND Report”). The RAND Report concluded that ephedrine, ephedrine plus caffeine and Ephedra-containing dietary supplements with or without herbs containing caffeine all promote modest amounts of weight loss over the short term and use of Ephedra, or ephedrine plus caffeine, is associated with an increased risk of gastrointestinal, psychiatric and autonomic symptoms. The adverse event reports contained a smaller number of more serious adverse events. Given the small number of such events, the RAND Report concluded that further study would be necessary to determine whether consumption of Ephedra, or ephedrine, may be causally related to these serious adverse events. In connection with the RAND Report, HHS sought public comment on whether additional measures are required concerning the sale and distribution of dietary supplements containing ephedrine alkaloids.
On December 30, 2003, the FDA issued a consumer alert on the safety of dietary supplements containing ephedrine alkaloids and on February 6, 2004 published a final rule with respect to these products. The final rule prohibits the sale of dietary supplements containing ephedrine alkaloids because such supplements present an unreasonable risk of illness or injury. The final rule became effective on April 11, 2004. Although we discontinued the manufacturing and shipment of Dexatrim containing ephedrine in September 2002, the FDA’s final rule may result in lawsuits in addition to those we currently have being filed against us alleging damages related to the use or purchase of Dexatrim containing ephedrine. See “Legal Proceedings”. In April 2005, a Utah federal court called into question the 2004 final rule. The court decision is being appealed and may have an effect on FDA’s enforcement of the ephedrine alkaloid final rule.
The FDA also regulates some of our products as cosmetics or drug-cosmetics. There are fewer regulatory requirements for cosmetics than for drugs or dietary supplements. Cosmetics marketed in the United States must comply with the FDC Act, the Fair Packaging and Labeling Act and the FDA’s implementing regulations. Cosmetics must also comply with quality and labeling requirements proscribed by the FDA. In addition, several of our products are subject to product packaging regulation by the CPSC and the FDA.
Combination products can be regulated via a memorandum of understanding between federal agencies. In February 2006, we launched Bullfrog Mosquito Coast, a combination of sunscreen and insect repellent. The sunscreen labeling is regulated by FDA in its sunscreen monograph but the insect repellent, IR-3535, and its labeling, require pre-market safety and efficacy testing and approval by the EPA and all 50 states (and US Territories). Bullfrog Mosquito Coast received approval from all states and the EPA prior to launch. Further, the FDA has announced its intention in its November, 2005 Unified Agenda to regulate, under the monograph system, the combination of sunscreens and insect repellents in a notice of proposed rulemaking yet to be published. Any final rule making is years in the future and FDA might grandfather existing products or otherwise allow time for their compliance.
Our business is also regulated by the California Safe Drinking Water and Toxic Enforcement Act of 1986, known as Proposition 65. Proposition 65 prohibits businesses from exposing consumers to chemicals that the state has determined cause
cancer or reproduction toxicity without first giving fair and reasonable warning unless the level of exposure to the carcinogen or reproductive toxicant falls below prescribed levels. From time to time, one or more ingredients in our products could become subject to an inquiry under Proposition 65. If an ingredient is on the state’s list as a carcinogen, it is possible that a claim could be brought, in which case we would be required to demonstrate that exposure is below a “no significant risk” level for consumers. Any such claims may cause us to incur significant expense, and we may face monetary penalties or injunctive relief, or both, or be required to reformulate our product to acceptable levels. The State of California under Proposition 65 is also considering the inclusion of titanium dioxide on the state’s list of suspected carcinogens. Titanium dioxide has a long history of widespread use as an excipient in prescription and OTC pharmaceuticals, cosmetics, dietary supplements and skin care products and is an active ingredient in our Bullfrog Superblock products. We have participated in an industry-wide submission to the State of California, facilitated through CHPA, presenting evidence that titanium dioxide presents “no significant risk” to consumers. Sales of our Bullfrog Superblock products represented approximately 1% of our consolidated total revenues in fiscal 2005.
Finally, the FDA regulates the quality of all finished drug, medical device, and food products under GMP’s. As part of its regulatory authority, the FDA may periodically conduct audits of the physical facilities, machinery, processes and procedures that we, or our suppliers, use to manufacture products. The FDA may perform these audits at any time without advanced notice. In February, 2006 the company registered as a medical device manufacturer with FDA. It might be expected that we could be audited as a new device manufacturer under medical device GMP’s. Working with consultants we have instituted medical device GMP’s pursuant to applicable portions of the medical device Quality System Regulation, or QSR. As a result of any audits, the FDA may order us, or our suppliers, to make certain changes in manufacturing facilities and processes. We may be required to make additional expenditures to comply with these orders, or possibly discontinue selling certain products until we, or our suppliers, comply with these orders. As a result, our business could be adversely affected. In the future, manufacturers of dietary supplements may be mandated by the FDA to comply with more rigorous GMPs as well as post-marketing responsibilities similar to those applied to OTC drugs or medical devices. Such regulations may include mandatory adverse event reporting requirements as part of new GMP’s regulations.
The FDA has broad regulatory and enforcement powers. If the FDA determines that we have failed to comply with applicable regulatory requirements, it can impose a variety of enforcement actions from public warning letters, fines, injunctions, consent decrees and civil penalties to suspension or delayed issuance of approvals, seizure or recall of our products, total or partial shutdown of production, withdrawal of approvals or clearances already granted, and criminal prosecution. The FDA can also require us to repair, replace or refund the cost of devices that we manufactured or distributed. If any of these events were to occur, it could materially adversely affect us.
Environmental Matters
We continually assess the compliance of our operations with applicable federal, state and local environmental laws and regulations. Our policy is to record liabilities for environmental matters when loss amounts are probable and reasonably determinable. Our manufacturing site utilizes chemicals and other potentially hazardous materials and generates both hazardous and non-hazardous waste, the transportation, treatment, storage and disposal of which are regulated by various governmental agencies. We have engaged environmental consultants on a regular basis to assist with our compliance efforts. We believe we are currently in compliance with all applicable environmental permits and are aware of our responsibilities under applicable environmental laws. Any expenditure necessitated by changes in law and permitting requirements cannot be predicted at this time, although such costs are not expected to be material to our financial position, results of operations or cash flows.
In late 2005 we began the manufacture of Bullfrog Mosquito Coast at our Chattanooga, Tennessee plant. Bullfrog Mosquito Coast is a combination of sunscreen and insect repellent. The handling, disposal, and environmental exposure of the insect repellent, IR-3535, is strictly regulated by EPA under the Clean Waters Act. We intend to make a capital investment in waste treatment of IR-3535 in July, 2006, while in the interim carefully controlling and monitoring effluent levels. Any failure to comply with the regulations with respect to the use of IR-3535 might result in EPA action against us, including fines or injunctive action.
Legal Proceedings
We were named as a defendant in a number of lawsuits alleging that the plaintiffs were injured as a result of ingestion of products containing phenylpropanolamine (“PPA”), which was an active ingredient in most of our Dexatrim products until November 2000. The lawsuits filed in federal court were transferred to the United States District Court for the Western District of Washington before United States District Judge Barbara Jacobs Rothstein (In Re Phenylpropanolamine (“PPA”) Products Liability Litigation, MDL No. 1407). The remaining lawsuits were filed in state court in a number of different states.
On April 13, 2004, we entered into a class action settlement agreement with representatives of the plaintiffs’ settlement class, which provided for a national class action settlement of all Dexatrim PPA claims. On November 12, 2004, Judge Barbara J. Rothstein of the United States District Court for the Western District of Washington entered a final order and judgment certifying the class and granting approval of the Dexatrim PPA settlement. After the final judgment was entered, two parties who had objected to the settlement filed appeals challenging and seeking to set aside the final judgment. Both of these appeals have now been dismissed.
The Dexatrim PPA settlement includes claims against us involving alleged injuries by Dexatrim products containing PPA in which the alleged injury occurred after December 21, 1998, the date we acquired the Dexatrim brand. In accordance with the terms of the class action settlement agreement, we previously published notice of the settlement and details as to the manner in which claims could be submitted. The deadline for submission of claims was July 7, 2004. A total of 391 claims were certified by the court as timely submitted. Of these 391 claims, 173 alleged stroke as an injury and 218 alleged other non-stroke injuries. Of the 391 total claims, only 371 claimants actually had alleged injuries that occurred after December 21, 1998 and continued to pursue their claims in the settlement. The remaining claimants have either withdrawn their claims or cannot be located. A total of 14 claimants with alleged injuries that occurred after December 21, 1998 elected to opt out of the class settlement. Subsequently, we have settled nine of the opt out claims. The five remaining opt out claimants may pursue claims for damages against us in separate lawsuits. As of February 17, 2006, two of the five remaining opt out claimants have filed lawsuits against us that we are continuing to defend.
We previously reached an agreement with Kemper Indemnity Insurance Company ("Kemper") to settle its lawsuit that sought to rescind our policy for $50.0 million of excess coverage for product liability claims. After giving effect to the settlement with Kemper, we have available for the claims against us related to the PPA litigation, through our first three layers of insurance coverage, approximately $60.9 million of the $77.0 million of product liability coverage provided by these insurance policies. The $60.9 million of available coverage consists of $37.5 million of insurance under the Kemper policy and approximately $23.4 million under policies with two other insurance companies. In accordance with the terms of the class action settlement agreement, this $60.9 million of coverage has been funded into a settlement trust. In addition, on July 14, 2004, we entered into a settlement agreement with Sidmak Laboratories, Inc. (“Sidmak”), the manufacturer of Dexatrim products containing PPA, pursuant to which Sidmak has contributed $10.0 million into the settlement trust. We have also entered into a settlement agreement with Interstate Fire & Casualty Company (“Interstate”) with regard to its $25.0 million of coverage in excess of the insurance funds available in the settlement trust.
During fiscal 2005, we resolved substantially all of the claims submitted in the Dexatrim PPA settlement and now estimate that the total cost of the Dexatrim settlement will be approximately $56.0 million. As indicated above, a total of $70.9 million has been funded into a settlement trust by our insurers and Sidmak and is available to pay claims in the settlement. Any funds remaining in the settlement trust after all claims and expenses of the trust have been paid will be distributed as approved by the court in accordance with the class action settlement agreement and our settlement agreements with each of Kemper and Sidmak. We currently expect that after all claims and expenses of the settlement trust have been paid, we could recover up to approximately $8.5 million from the settlement trust. If realized, this potential recovery is estimated to occur in the first half of fiscal 2006. We currently do not expect to record any additional charges relative to the settlement of the PPA litigation, except for legal expenses that will be recorded in the period incurred. During the fourth quarter of fiscal 2005, we incurred and recorded $0.3 million of legal expenses related to the Dexatrim litigation.
We are also named as a defendant in approximately 206 lawsuits relating to Dexatrim containing PPA which involve alleged injuries by Dexatrim products containing PPA manufactured and sold prior to our acquisition of Dexatrim on December 21, 1998. In these lawsuits, we are being defended on the basis of indemnification obligations assumed by The DELACO Company (“DELACO”), successor by merger to the Thompson Medical Company, Inc., which owned the brand prior to December 21, 1998. On February 12, 2004, DELACO filed a Chapter 11 bankruptcy petition in the United States Bankruptcy Court for the Southern District of New York. Accordingly, it is uncertain whether DELACO will be able to indemnify us for claims arising from products manufactured and sold prior to our acquisition of Dexatrim on December 21, 1998. However, DELACO is seeking to resolve all Dexatrim cases with injury dates prior to December 21, 1998 as part of a liquidating Chapter 11 bankruptcy plan. We understand that DELACO’s product liability insurance carriers and other sources are expected to fund this plan. We have filed a claim in DELACO’s bankruptcy case in order to preserve our claims for indemnification against DELACO.
In order to resolve DELACO’s indemnity obligations to us, we have entered into a settlement agreement with DELACO dated June 30, 2005 (“the DELACO Agreement”). Pursuant to the DELACO Agreement, we will assume responsibility for all claims against DELACO and its predecessor, Thompson Medical Company, Inc., or us relating to Dexatrim products involving an injury date after December 21, 1998, and will hold the DELACO bankruptcy estate harmless from any such claims. In exchange, a settlement trust to be established under DELACO’s bankruptcy plan will pay us $8.75 million and will assume responsibility for
all claims related to Dexatrim products alleging injury dates on or before December 21, 1998. Upon the effective date of the bankruptcy plan, we expect that the plan will release us from all liability from holders of Dexatrim claims with injury dates prior to December 21, 1998, whether brought by an injured party or a co-defendant to a Dexatrim products liability case. We expect all claims with injury dates prior to December 21, 1998 to be channeled to the DELACO settlement trust, which we expect to come into existence and be funded prior to the effective date of the DELACO bankruptcy plan. This payment and the channeling injunction and release described above will conclusively compromise and settle our previously filed claim in the DELACO bankruptcy case. The DELACO Agreement was approved by the bankruptcy court in the DELACO bankruptcy on July 28, 2005. The DELACO Agreement and our receipt of $8.75 million from the DELACO settlement trust is conditioned upon final confirmation and approval of the DELACO bankruptcy plan, and funding of the DELACO settlement trust by the insurance companies and other parties obligated to fund the trust. At the confirmation hearing on February 15, 2006, the bankruptcy court indicated that it would enter an order confirming the DELACO bankruptcy plan. Absent any appeals being filed, the order confirming the plan would become final ten days after the bankruptcy court enters the order. Substantial funding of the DELACO settlement trust is due to occur on or before March 13, 2006. Counsel for DELACO announced at the confirmation hearing that the effective date of the plan is anticipated to be March 13, 2006. On the effective date, we will be released from all liability from holders of Dexatrim claims with injury dates prior to December 21, 1998, and if the settlement trust is funded as anticipated, we expect to receive a payment of $8.75 million before the end of March 2006.
Our product liability insurance, as described above, would not apply to claims arising from products manufactured and sold prior to our acquisition of Dexatrim. If the DELACO bankruptcy plan does not resolve these cases as we expect, we will also seek to defend ourselves in these lawsuits on the basis that we did not manufacture and sell products containing PPA prior to December 21, 1998. In the approximately 206 cases that have been filed against us for products manufactured and sold prior to December 21, 1998, approximately half of the plaintiffs are in cases filed in states that we believe do not under current law impose liability upon a successor. The remaining plaintiffs are in cases filed in states that may in some circumstances permit liability against a successor. Even in these cases, although there can be no assurances, we do not believe that successor liability would be imposed against us. The reasons for our belief, among others, are that we did not purchase all of DELACO’s assets and DELACO continued to operate its remaining business after December 21, 1998; we did not cause DELACO’s bankruptcy; and many plaintiffs included in cases filed in states that in some circumstances impose successor liability are actually residents of other states. If the DELACO bankruptcy plan is confirmed with the terms required by the DELACO Agreement, we will be released from potential liability in these cases.
We maintain a significantly lower level of insurance coverage for all other potential product liability claims relating to our products, including Dexatrim products containing ephedrine. Our existing product liability insurance coverage for all of our other products, including Dexatrim products containing ephedrine, consists of $20.0 million of coverage through our captive insurance subsidiary, of which approximately $5.5 million is funded as of February 17, 2006, and a total of $30.0 million of excess coverage through third party insurers. We are currently defending two lawsuits related to Dexatrim containing ephedrine.
On December 30, 2003, the United States Food and Drug Administration ("FDA") issued a consumer alert on the safety of dietary supplements containing ephedrine alkaloids and on February 6, 2004 published a final rule with respect to these products. The final rule prohibits the sale of dietary supplements containing ephedrine alkaloids because such supplements present an unreasonable risk of illness or injury. The final rule became effective on April 11, 2004. Although we discontinued the manufacturing and shipment of Dexatrim containing ephedrine in September 2002, the FDA's final rule may result in additional lawsuits being filed against us alleging damages related to the use or purchase of Dexatrim containing ephedrine.
We have been named as a defendant in a putative class action suit filed in the Superior Court of the State of California for the County of Los Angeles on February 11, 2004. The lawsuit seeks certification of classes consisting of residents of the United States, or residents of the State of California, who have purchased our Bullfrog sun care products during the past four years. The lawsuit seeks injunctive relief and compensatory damages under the California Business and Professions Code against us arising out of alleged deceptive, untrue or misleading advertising, and breach of warranty, in connection with the manufacturing, labeling, advertising, promotion and sale of Bullfrog products. The plaintiff has stipulated that the amount in controversy with respect to plaintiff’s individual claim and each member of the proposed class does not exceed $75,000. We filed an answer on June 28, 2004 and are vigorously defending the lawsuit.
We have been named as a defendant in a putative class action suit filed in the Superior Court of the State of California, County of Los Angeles, on January 13, 2005. The lawsuit seeks injunctive relief, compensatory damages and attorney fees against us under the California Business and Professions Code, arising out of alleged deceptive, untrue or misleading advertising and breach of express warranty in connection with the manufacturing, labeling, advertising, promotion and sale of certain Dexatrim Natural products. The lawsuit seeks certification of a class consisting of all persons who purchased Dexatrim Natural in California during the four year period prior to the filing of the lawsuit up to the date of any judgment obtained. The
plaintiff has stipulated that the amount in controversy with respect to each individual claim and each member of the proposed class in the action does not exceed $75,000. We filed an answer on March 1, 2005 and are vigorously defending the lawsuit.
Other claims, suits and complaints arise in the ordinary course of our business involving such matters as patents and trademarks, product liability, environmental matters, employment law issues and other alleged injuries or damage. The outcome of such litigation cannot be predicted, but, in the opinion of management, based in part upon assessments from counsel, all such other pending matters are without merit or are of such kind or involve such other amounts as would not have a material adverse effect on our financial position, results of operations or cash flows if disposed of unfavorably.
Product Liability and Insurance
Our product liability insurance for claims asserted in the Dexatrim PPA litigation is provided by third party insurers. We previously reached an agreement with Kemper to settle Kemper’s lawsuit that sought to rescind our policy for $50.0 million of excess coverage for product liability claims. After giving effect to the settlement with Kemper, we have available through our first three layers of insurance coverage, approximately $60.9 million of the $77.0 million of product liability coverage provided by these policies. These $60.9 million of available funds consist of $37.5 million of insurance under the Kemper policy and approximately $23.4 million under policies with two other insurance companies. As noted above, this $60.9 million of coverage has been funded into a settlement trust in accordance with the terms of the class action settlement agreement. We have also entered into a settlement agreement with Interstate with regard to its $25.0 million of coverage in excess of the insurance funds available in the settlement trust.
Currently, we maintain a significantly lower level of insurance coverage for all other potential product liability claims relating to our products, including Dexatrim products containing ephedrine, which consists of $20.0 million of coverage through our captive insurance subsidiary, of which approximately $5.5 million is funded as of February 17, 2006, and a total of $30.0 million of excess coverage through third party insurers.
All of our insurance policies are subject to certain limitations that are generally customary for policies of this type, such as deductibles and exclusions for exemplary and punitive damages. Since plaintiffs in product liability claims may seek exemplary and punitive damages, if these damages were awarded, some of our insurance coverage would not cover these amounts, and we may not have sufficient resources to pay these damages. Any amounts paid by our insurance to satisfy product liabilities would decrease product liability insurance coverage available for any other claims. If our liability for product liability claims is significant, our existing insurance is likely to be insufficient to cover these claims, and we may not have sufficient resources to pay the liabilities in excess of our insurance coverage. Furthermore, our product liability insurance provided by third parties will expire at the end of each annual policy period, currently in May of each year. We may incur significant additional costs to obtain insurance coverage upon the expiration of our current policies and may not be able to obtain coverage in the future in amounts equal to that which we currently have or in amounts sufficient to satisfy future claims.
Employees
We employ approximately 414 persons on a full-time basis and 9 persons on a part-time basis in the United States. In addition, we employ approximately 26 persons at our foreign subsidiaries’ offices. Our employees are not represented by any organized labor union, and we consider our labor relations to be good.
Financial Information on Products and Geographical Areas
For financial information on our product categories and geographical areas, see note 12 to our consolidated financial statements.
Additional Information
Our internet website address is www.chattem.com. We make available free of charge on or through our website our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, reports filed pursuant to Section 16, and all amendments to those reports as soon as reasonably practicable after such material is electronically filed with or furnished to the Securities and Exchange Commission.
Item 1A. Risk Factors
Our business is subject to a number of risks. Some of the risks associated with our operations are described in the “Competition,”“Government Regulation,”“Environmental,” and “Manufacturing and Quality Control” portions of this Form 10-K. In addition to the other information contained in this Form 10-K, the following risk factors should be carefully considered.
We may face additional lawsuits alleging injury from the use of Dexatrim products containing ephedrine, which we discontinued manufacturing and shipping in September 2002, or from other products that we currently produce or may produce in the future.
We are currently named as a defendant in two lawsuits alleging that the plaintiffs were injured as a result of the ingestion of Dexatrim containing ephedrine. On December 30, 2003, the FDA issued a consumer alert on the safety of dietary supplements containing ephedrine alkaloids and on February 6, 2004 published a final rule with respect to these products. The final rule prohibits the sale of dietary supplements containing ephedrine alkaloids because such supplements present an unreasonable risk of illness or injury. The final rule became effective on April 11, 2004. Although we discontinued the manufacturing and shipment of Dexatrim containing ephedrine in September 2002, the FDA’s final rule may result in additional lawsuits being filed against us alleging damages related to the use or purchase of Dexatrim containing ephedrine.
Our available product liability coverage for the defense of lawsuits alleging injury from the use of Dexatrim products containing ephedrine, or from other products that we currently produce or may produce in the future, consists of $20.0 million of coverage through our captive insurance subsidiary, of which approximately $5.5 million is funded as of February 17, 2006, and an additional $30.0 million of excess coverage through third party insurers. In the future, if we face significant liabilities relating to the Dexatrim products which included ephedrine, our product liability insurance may be insufficient, and we may not have sufficient resources to satisfy these liabilities in excess of our insurance coverage.
An inherent risk of our business is exposure to product liability claims by users of our products. We may also experience significant product liability exposure related to our other products in the future.
Our product liability insurance coverage may be insufficient to cover existing or future product liability claims.
Our business inherently makes us the potential target of product liability claims. We have product liability insurance through our captive insurance subsidiary and third party insurers that provides coverage for product liability claims. Our product liability insurance coverage for all of our products, including Dexatrim products containing ephedrine, consists of $20.0 million of coverage through our captive insurance subsidiary, of which approximately $5.5 million is funded as of February 17, 2006, and an additional $30.0 million of excess coverage through third party insurers.
All of our insurance policies are subject to certain limitations that are generally customary for policies of this type such as deductibles and exclusions for exemplary and punitive damages. Since plaintiffs in product liability claims may seek exemplary and punitive damages, if these damages were awarded, some of our insurance coverage would not cover these amounts, and we may not have sufficient resources to pay these damages. Any amounts paid by our insurance to satisfy product liabilities would decrease product liability insurance coverage available for any other claims. If our liability for product liability claims is significant, our existing insurance is likely to be insufficient to cover these claims, and we may not have sufficient resources to pay the liabilities in excess of our insurance coverage. Furthermore, our product liability insurance provided by third parties will expire at the end of each annual policy period, currently in May of each year. We may incur significant additional costs to obtain insurance coverage upon the expiration of our current policies and may not be able to obtain coverage in the future in amounts equal to that which we currently have or in amounts sufficient to satisfy future claims.
Our acquisition strategy is subject to risk and may not be successful.
A component of our growth strategy depends on our ability to successfully execute acquisitions, which involves numerous risks including:
• not accurately identifying suitable products or brands for acquisition;
• difficulties in integrating the operations, technologies and manufacturing processes of the acquired products;
• the diversion of management’s attention from other business concerns; and
• incurring substantial additional indebtedness.
Any future acquisitions, or potential acquisitions, may result in substantial costs, disrupt our operations or materially adversely affect our operating results.
We face significant competition in the OTC health care, toiletries and dietary supplements markets.
The OTC health care, toiletries and dietary supplements markets are highly competitive and are characterized by the frequent introduction of new products, including the migration of prescription drugs to the OTC market, often accompanied by major advertising and promotional support. These introductions may adversely affect our business especially because we compete in categories in which product sales are highly influenced by advertising and promotions. Our competitors include large pharmaceutical companies such as Pfizer, Inc. and Johnson & Johnson, consumer products companies such as Procter & Gamble Co. and dietary supplements companies such as Nature’s Bounty, Inc. and Pharmaton Natural Health Products, many of which have considerably greater financial and other resources than we do and are not as highly leveraged as we are. These competitors are thus better positioned to spend more on research and development, employ more aggressive pricing strategies, utilize greater purchasing power, build stronger vendor relationships and develop broader distribution channels than us. In addition, our competitors have often been willing to use aggressive spending on trade promotions and advertising as a strategy for building market share at the expense of their competitors including us. The private label or generic category has also become increasingly more competitive in certain of our product markets. If we are unable to continue to introduce new and innovative products that are attractive to consumers or are unable to allocate sufficient resources to effectively advertise and promote our products so that they achieve wide spread market acceptance, we may not be able to compete effectively, and our operating results and financial condition may be adversely affected.
Our business is regulated by numerous federal, state and foreign governmental authorities, which subjects us to elevated compliance costs and risks of non-compliance.
The manufacturing, distributing, processing, formulating, packaging and advertising of our products are subject to numerous and complicated federal, state and foreign governmental regulations. Compliance with these regulations is difficult and expensive. In particular, the FDA regulates the safety, manufacturing, labeling and distributing of our OTC products, medical devices, and dietary supplements. In addition, the FTC may regulate the promotion and advertising of our drug products, particularly OTC versions and dietary supplements. The EPA regulates our Bullfrog Mosquito Coast insect repellent products. We are also regulated by various state statutes, including the California Safe Drinking Water and Toxic Enforcement Act of 1986. If we fail to adhere to the standards required by these federal and state regulations, or are alleged to have failed to adhere such regulations, our operating results and financial condition may be adversely affected.
Our success depends on our ability to anticipate and respond in a timely manner to changing consumer demands.
Our success depends on our products’ appeal to a broad range of consumers whose preferences cannot be predicted with certainty and are subject to change. If our current products do not meet consumer demands, our sales may decline. In addition, our growth depends upon our ability to develop new products through product line extensions and product modifications, which involve numerous risks. We may not be able to accurately identify consumer preferences and translate our knowledge into customer-accepted products or successfully integrate these products with our existing product platform or operations. We may also experience increased expenses incurred in connection with product development, marketing and advertising that are not subsequently supported by a sufficient level of sales, which would negatively affect our margins. Furthermore, product development may divert management’s attention from other business concerns, which could cause sales of our existing products to suffer. We cannot assure you that newly developed products will contribute favorably to our operating results.
We rely on a few large customers, particularly Wal-Mart Stores, Inc., for a significant portion of our sales.
In fiscal 2005, Wal-Mart Stores, Inc. represented approximately 36% of our total revenues, our ten largest customers represented approximately 70% of our total revenues and our 20 largest customers represented approximately 81% of our total revenues. Consistent with industry practice, we do not operate under a long-term written supply contract with Wal-Mart Stores, Inc. or any of our other customers. Our business would materially suffer if we lost Wal-Mart Stores, Inc. as a continuing major customer or if our business with Wal-Mart Stores, Inc. significantly decreases. The loss of sales to any other large customer could also materially and adversely affect our financial results.
We may be adversely affected by fluctuations in buying decisions of mass merchandiser, drug and food trade buyers and the trend toward retail trade consolidation.
We sell our products to mass merchandiser and food and drug retailers in the United States. Consequently, our total revenues are affected by fluctuations in the buying patterns of these customers. These fluctuations may result from wholesale buying decisions, economic conditions and other factors. In addition, with the growing trend towards retail consolidation, we are increasingly dependent upon a few leading retailers, such as Wal-Mart Stores, Inc., whose bargaining strength continues to grow due to their size. Such retailers have demanded, and may continue to demand, increased service and order accommodations as well as price and incremental promotional investment concessions. As a result, we may face downward pressure on our prices and increased promotional expenses to meet these demands, which would reduce our margins. We also may be negatively affected by changes in the policies of our retail trade customers such as inventory destocking, limitations on access to shelf space and other conditions.
We rely on third party manufacturers for a portion of our product portfolio including products under our Gold Bond, Icy Hot, Selsun and Dexatrim brands.
We use third party manufacturers to make products representing approximately 40% of our fiscal 2005 sales volume, including our Gold Bond medicated powders and foot spray, the Icy Hot patches and sleeves, Herpecin-L, and our line of dietary supplements including Dexatrim Max and, internationally, our line of Selsun medicated dandruff shampoos. We will also rely on third party manufacturers to manufacture our Icy Hot Pro-Therapy line of products. In many cases, third party manufacturers are not obligated under contracts that fix the term of their commitments, and they may discontinue production upon little or no advance notice. Manufacturers also may experience problems with product quality or timeliness of product delivery. We rely on these manufacturers to comply with applicable current GMPs. The loss of a contract manufacturer may force us to shift production to in-house facilities and possibly cause manufacturing delays, disrupt our ability to fill orders or require us to suspend production until we find another third party manufacturer. We are not able to control the manufacturing efforts of these third party manufacturers as closely as we control our business. Should any of these manufacturers fail to meet our standards, we may face regulatory sanctions, additional product liability claims or customer complaints, any of which could harm our reputation and our business.
Our dietary supplement business could suffer as a result of injuries caused by dietary supplements in general, unfavorable scientific studies or negative press.
Our dietary supplements consist of Dexatrim and our Sunsource product line. We are highly dependent upon consumers’ perceptions of the benefit and integrity of the dietary supplements business as well as the safety and quality of products in that industry. Injuries caused by dietary supplements or unfavorable scientific studies or news relating to products in this category, such as the December 30, 2003 consumer alert on the safety of dietary supplements containing ephedrine alkaloids issued by the FDA and the subsequent FDA rule banning the sale of supplements containing ephedrine alkaloids that became effective on April 11, 2004, may negatively affect consumers’ overall perceptions of products in this category, including our products, which could harm the goodwill of these brands and cause our sales to decline.
Our business could be adversely affected if we are unable to successfully protect our intellectual property.
Our trademarks are of material importance to our business and are among our most important assets. In fiscal 2005, substantially all of our total revenues were from products bearing proprietary or licensed brand names. Accordingly, our future success may depend in part upon the goodwill associated with our brand names, particularly Gold Bond, Selsun Blue, Icy Hot and Aspercreme. Although our principal brand names are registered trademarks in the United States and certain foreign countries, we cannot assure you that the steps we take to protect our proprietary rights in our brand names will be adequate to prevent the misappropriation of these registered brand names in the United States or abroad. In addition, the laws of some foreign countries do not protect proprietary rights in brand names to the same extent as do the laws of the United States. We cannot assure you that we will be able to successfully protect our trademarks from infringement or otherwise. The loss or infringement of our trademarks could impair the goodwill associated with our brands, harm our reputation and materially adversely affect our financial results.
We license additional intellectual property from third parties that is used in certain of our products, and we cannot assure you that these third parties can successfully maintain their intellectual property rights. In addition, the sale of these products relies on our ability to maintain and extend our licensing agreements with third parties, and we cannot assure you that we will be successful in maintaining these licensing agreements. Any significant impairment of the intellectual property covered by these licenses, or in our rights to use this intellectual property, may cause our sales to decline.
In addition, our product line extensions are often based on new or unique delivery methods for those products like our Icy Hot patches and sleeves. These delivery methods may not be protected by intellectual property rights that we own or license on
an exclusive basis or by exclusive manufacturing agreements. As a result, we may be unable to prevent any competitor or customer from duplicating our delivery methods to compete directly with these product line extensions, which could cause sales to suffer.
We may face litigation in the future, either to protect our intellectual property rights or to defend against claims that we have infringed the intellectual property rights of others. Intellectual property litigation can be extremely expensive, and such expense could materially adversely affect our business.
Because most of our operations are located in Chattanooga, Tennessee, we are subject to regional and local risks.
Approximately 60% of our sales volume in fiscal 2005 was from products manufactured in two plants located in Chattanooga, Tennessee. We store the raw materials used in our manufacturing activities in two warehouses that are also located in Chattanooga. We package and ship most of our products from Chattanooga. Additionally, our corporate headquarters are also located in Chattanooga, and most of our employees live in the area. Because of this, we are subject to regional and local risks, such as:
• changes in state and local government regulations;
• severe weather conditions, such as floods, ice storms and tornadoes;
• natural disasters, such as fires and earthquakes;
• power outages;
• nuclear facility incidents;
• spread of infectious diseases;
• hazardous material incidents; or
• any other catastrophic events in our area.
If our region, city or facilities were to suffer a significant disaster, our operations are likely to be disrupted and our business would suffer.
We depend on sole source suppliers for three active ingredients used in our Pamprin and Prēmsyn PMS products and a limited source of supply for selenium sulfide, the active ingredient in Selsun Blue, and if we are unable to buy these ingredients, we will not be able to manufacture these products.
Pamabrom, pyrilamine maleate and compap, active ingredients used in our Pamprin and Prēmsyn PMS products, are purchased from single sources of supply. Pamabrom is sold only by Chattem Chemicals, Inc. (an unrelated company), pyrilamine maleate is produced only in India and sold only by Lonza, Inc. and compap is sold only by Mallinckrodt, Inc. In addition, we have a limited source of supply for selenium sulfide, the active ingredient in Selsun Blue. Financial, regulatory or other difficulties faced by these source suppliers or significant changes in demand for these active ingredients could limit the availability and increase the price of these active ingredients. We may not be able to obtain necessary supplies in a timely manner, and we may be required to pay higher than expected prices for these active ingredients, which could adversely affect our gross margin from these products. Any interruption or significant delay in the supply of these active ingredients would impede our ability to manufacture these products, which would cause our sales to decline. We would not be able to find an alternative supplier and would either need to reformulate these products or discontinue their production. While we do not currently know of any facts or circumstances that would adversely affect the supply of pamabrom, pyrilamine maleate, compap, or selenium sulfide, we cannot assure you that we will be able to continue to purchase adequate quantities of these active ingredients at acceptable prices in the future.
We are subject to the risk of doing business internationally.
In fiscal 2005, approximately 10% of our total revenues were attributable to our international business. Our acquisition of Selsun Blue in 2002 has greatly expanded our international business. We operate in regions and countries where we have little or no experience, and we may not be able to market our products in, or develop new products successfully for, these markets. We may also encounter other risks of doing business internationally including:
• unexpected changes in, or impositions of, legislative or regulatory requirements;
• fluctuations in foreign exchange rates, which could cause fluctuations in the price of our products in foreign markets or cause fluctuations in the cost of certain raw materials purchased by us;
• delays resulting from difficulty in obtaining export licenses, tariffs and other barriers and restrictions, potentially longer payment cycles, greater difficulty in accounts receivable collection and potentially adverse tax treatment;
• potential trade restrictions and exchange controls;
• differences in protection of our intellectual property rights; and
• the burden of complying with a variety of foreign laws.
In addition, we will be increasingly subject to general geopolitical risks in foreign countries where we operate such as political and economic instability and changes in diplomatic and trade relationships, which could affect, among other things, customers’ inventory levels and consumer purchasing, which could cause our results to fluctuate and our sales to decline. It has not been our practice to engage in foreign exchange hedging transactions to manage the risk of fluctuations in foreign exchange rates because of the limited nature of our past international operations. Due to the significant expansion of our international operations as a result of the Selsun Blue acquisition, our exposure to fluctuations in foreign exchange rates has increased.
We have a significant amount of debt that could adversely affect our business and growth prospects.
As of November 30, 2005, our total long-term debt was $182.5 million. In the future we may incur significant additional debt. Our debt could have significant adverse effects on our business including:
• requiring us to dedicate a substantial portion of our available cash for interest payments and the repayment of principal;
• limiting our ability to capitalize on significant business opportunities;
• making us more vulnerable to economic downturns;
• limiting our ability to withstand competitive pressures; and
• making it more difficult for us to obtain additional financing on favorable terms.
If we are unable to generate sufficient cash flow from operations in the future, we may not be able to service our debt and may have to refinance all or a portion of our debt, obtain additional financing or sell assets to repay such debt. We cannot assure you that we will be able to obtain such refinancing, additional financing or asset sale on favorable terms or at all.
The terms of our outstanding debt obligations limit certain of our activities.
The terms of the indenture under which our 7.0% Subordinated Notes are issued and our Amended Revolving Credit Facility impose operating and financial restrictions on us including restrictions on:
• incurrence of additional indebtedness;
• dividends and restricted payments;
• investments;
• loans and guarantees;
• creation of liens;
• transactions with affiliates;
• use of proceeds from sales of assets and subsidiary stock; and
• certain mergers, consolidations and transfers of assets.
The terms of our Amended Revolving Credit Facility also require us to comply with financial maintenance covenants. In the future, we may have other indebtedness with similar or even more restrictive covenants. These restrictions may impair our ability to respond to changing business and economic conditions or to grow our business. In the event that we fail to comply with these covenants, there could be an event of default under the applicable debt instrument, which in turn could cause a cross default to other debt instruments. As a result, all amounts outstanding under our various debt instruments may become immediately due and payable.
Our operations are subject to significant environmental laws and regulations.
Our manufacturing sites use chemicals and other potentially hazardous materials and generate both hazardous and non-hazardous waste, the transportation, treatment, storage and disposal of which are regulated by various governmental agencies and federal, state and local laws. Under these laws, we are exposed to liability primarily as an owner or operator of real property, and as such, we may be responsible for the clean-up or other remediation of contaminated property. Environmental laws and regulations can change rapidly, and we may become subject to more stringent environmental laws and regulations in the future, which may be retroactively applied to earlier events. Product line extensions, such as Bullfrog Mosquito Coast, or acquisitions of new products may also subject our business to new or additional environmental laws and regulations. In addition, compliance with new or more stringent environmental laws and regulations could involve significant costs.
We are dependent on certain key executives, the loss of whom could have a material adverse effect on our business.
Our future performance depends significantly upon the efforts and abilities of certain members of senior management, in particular those of Zan Guerry, our chairman and chief executive officer, and Robert E. Bosworth, our president and chief operating officer. If we were to lose any key senior executive, our business could be materially adversely affected.
Our shareholder rights plan and restated charter contain provisions that may delay or prevent a merger, tender offer or other change of control of us.
Provisions of our shareholder rights plan and our restated charter, as well as certain provisions of Tennessee corporation law, may deter unfriendly offers or other efforts to obtain control over us and could deprive shareholders of their ability to receive a premium on their common stock.
Generally, if any person attempts to acquire 15% or more of our common stock then outstanding without the approval of our independent directors, pursuant to our shareholder rights plan, our shareholders may purchase a significant amount of additional shares of our common stock at 50% of the then applicable market price. This threat of substantial dilution will discourage takeover attempts not approved by our board despite significant potential benefits to our shareholders.
Our restated charter contains the following additional provisions, which may have the effect of discouraging takeover attempts:
| • | our directors are divided into three classes, with only one class of directors elected at each annual meeting for a term of three years, making it difficult for new shareholders to quickly gain control of our board of directors; |
| • | directors may be removed only for cause prior to the expiration of their terms; and |
| • | we are prohibited from engaging in certain business combination transactions with any interested shareholder unless such transaction is approved by the affirmative vote of at least 80% of the outstanding shares of our common stock held by disinterested shareholders, unless disinterested members of our board of directors approve the transaction or certain fairness conditions are satisfied, in which case such transaction may be approved by either the affirmative vote of the holders of not less than 75% of our outstanding shares of common stock and the affirmative vote of the |
| | holders of not less than 66% of the outstanding shares of our common stock which are not owned by the interested shareholder, or by a majority of disinterested members of our board of directors, provided that certain quorum requirements are met. |
The Tennessee Business Combination Act prevents an interested shareholder, which is defined generally as a person owning 10% or more of our voting stock, from engaging in a business combination with us for five years following the date such person became an interested shareholder unless before such person became an interested shareholder, our board of directors approved the transaction in which the interested shareholder became an interested shareholder or approved the business combination, and the proposed business combination satisfied any additional applicable requirements imposed by law and by our restated charter or bylaws. If the requisite approval for the business combination or share acquisition has not been obtained, any business combination is prohibited until the expiration of five years following the date such person became an interested shareholder.
The trading price of our common stock may be volatile.
The trading price of our common stock could be subject to significant fluctuations in response to several factors, some of which are beyond our control, including variations in our quarterly operating results, our leveraged financial position, potential sales of additional shares of our common stock, general trends in the consumer products industry, changes by securities analysts in their estimates or investment ratings, the relative illiquidity of our common stock, news regarding PPA-related product liability litigation and other potential product liability litigation and stock market conditions generally.
We have no current intention of paying dividends to holders of our common stock.
We presently intend to retain our earnings, if any, for use in our operations, to repurchase our common stock and to repay our outstanding indebtedness and have no current intention of paying dividends to holders of our common stock.
Market Data
We use market and industry data throughout this Annual Report on Form 10-K and the documents incorporated by reference herein, which we have obtained from market research, publicly available information and industry publications. These sources generally state that the information that they provide has been obtained from sources believed to be reliable, but that the accuracy and completeness of such information are not guaranteed. The market and industry data is often based on industry surveys and the preparers’ experience in the industry. Similarly, although we believe that the surveys and market research that others have performed are reliable, we have not independently verified this information. In particular, market share information has been coordinated and prepared for us by A.C. Nielsen at our request based on market segments that we defined and for which we have paid customary fees. Therefore, such data, including the market category delineations that form the basis for such data, are not necessarily representative of results that would have been obtained from an independent source.
Item 2. Properties
Our headquarters and administrative offices are located at 1715 West 38th Street, Chattanooga, Tennessee. Our primary production facilities are in close proximity to our headquarters on land owned by us. We lease our primary warehouse and distribution centers in Chattanooga, Tennessee for our domestic consumer products. The following table describes in detail the principal properties owned and leased by us:
| Total Area (Acres) | | Total Buildings (Square Feet) | | Use | | Square Feet | |
Owned Properties: | | | | | | | | |
Chattanooga, Tennessee | 12.0 | | 117,600 | | Manufacturing Office & Administration | | 77,000 40,600 | |
Chattanooga, Tennessee | 8.3 | | 78,500 | | Manufacturing & Warehousing Office Product Development Center | | 58,300 10,200 10,000 | |
Leased Properties: | | | | | | | | |
Chattanooga, Tennessee (1) | 5.1 | | 139,000 | | Warehousing Warehousing & Manufacturing | | 103,800 35,200 | |
Chattanooga, Tennessee (2) | 5.0 | | 50,000 | | Warehousing Office | | 49,300 700 | |
Mississauga, Ontario, Canada (3) | 0.3 | | 15,069 | | Warehousing Office & Administration Packaging | | 10,569 3,000 1,500 | |
Basingstoke, Hampshire, England (4) | 0.5 | | 12,332 | | Warehousing Office & Administration | | 9,332 3,000 | |
Limerick, Ireland (5) | — | | 2,100 | | Office & Administration | | 2,100 | |
NOTES:
(1) | Leased on a month-to-month basis for a monthly rental of approximately $38,000. A twelve month termination notice is required. |
(2) | Leased on a month-to-month basis for a monthly rental of approximately $13,000. |
(3) | Leased on a month-to-month basis for a monthly rental of approximately $9,400. |
(4) | Leased under a lease ending in 2014 for a monthly rental of approximately $14,000. |
(5) | Leased under a lease ending in 2009 for a monthly rental of approximately $3,000. |
We are currently operating our manufacturing facilities at approximately 70% of total capacity. These manufacturing facilities are FDA registered and are capable of further utilization through the use of a full-time second shift and the addition of a third shift.
Item 3. Legal Proceedings
See “Legal Proceedings” in Item 1 of this Form 10-K and note 13 of notes to consolidated financial statements included in Item 8 “Financial Statements and Supplementary Data”.
Item 4. Submission of Matters to a Vote of Security Holders
None
Part II
Item 5. Market for the Registrant’s Common Equity, Related Shareholder Matters and Issuer Purchases of Equity Securities
Market Information
Our common stock is quoted on the Nasdaq National Market under the symbol “CHTT”. The table below sets forth the high and low closing sales prices of our common stock as reported on the Nasdaq National Market for the periods indicated.
Fiscal 2005: | | High | | Low | |
First Quarter | | $ | 38.08 | | $ | 32.01 | |
Second Quarter | | | 45.65 | | | 36.30 | |
Third Quarter | | | 46.08 | | | 38.05 | |
Fourth Quarter | | | 39.68 | | | 31.77 | |
| | | | | | | |
| | | | | | | |
Fiscal 2004: | | | | | | | |
First Quarter | | $ | 23.33 | | $ | 15.40 | |
Second Quarter | | | 28.65 | | | 23.71 | |
Third Quarter | | | 30.65 | | | 26.08 | |
Fourth Quarter | | | 36.22 | | | 30.31 | |
Holders
As of February 17, 2006, there were approximately 253 holders of record of our common stock. The number of record holders does not include beneficial owners whose shares are held in the names of banks, brokers, nominees or other fiduciaries.
Dividends
We have not paid dividends on our common stock during the past two fiscal years. We are restricted from paying dividends by the terms of the indenture under which our Floating Rate Senior Notes were issued and by the terms of our Amended Revolving Credit Facility. (See note 5 of notes to consolidated financial statements in Item 8 “Financial Statements and Supplementary Data”.)
Purchases of Equity Securities by the Issuer and Affiliated Purchasers
Period | | | Total Number of Shares Purchased | | Average Price Paid Per Share (1) | | Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs (2) | | Maximum Dollar Value of Shares that may yet be Purchased under the Plans or Programs (2) | |
9/1/05-9/30/05 | | | | 335,201 | | $ | 37.05 | | | 335,201 | | $ | 10,579,277 | |
10/1/05-10/31/05 | | | | — | | | | | | | | | 10,579,277 | |
11/1/05-11/30/05 | | | | | | | | | | | | | 30,000,000 | |
Total Fourth Quarter | | | | 335,201 | | $ | 37.05 | | | 355,201 | | | 30,000,000 | |
(1) | Average price paid per share includes broker commissions. |
(2) | In January 2005, our board of directors increased the total authorization to repurchase our common stock under our stock buyback program to $30.0 million. A total of $17.3 million remained available under the stock buyback authority prior to July 29, 2005, when our board of directors increased the total buyback authorization back to $30.0 million. Subsequent to share purchases made in the fourth quarter of fiscal 2005, our board of directors again increased the total buyback authorization back to $30.0 million, effective November 29, 2005. There is no expiration date specified for our stock buyback program. |
Item 6. Selected Financial Data
This selected financial data should be read in conjunction with Management’s Discussion and Analysis of Financial Condition and Results of Operations and our consolidated financial statements and notes thereto included elsewhere in this Annual Report on Form 10-K. The following data for fiscal 2001 has been restated to give effect to the adoption of the provisions of Statement of Financial Accounting Standards (“SFAS”) No. 145, “Rescission of FASB Statements No. 4, 44, and 64, amendment of FASB Statement No. 13, and Technical Corrections” (“SFAS 145”) on December 1, 2002 and Emerging Issues Task Force (“EITF”) Issue Nos. 00-14 and 00-25 (codified by EITF Issue No. 01-9) on December 1, 2001.
| | Year Ended November 30, | |
| | 2005 | | 2004 | | 2003 | | 2002 | | 2001 | |
| | | | as adjusted(1) | | as adjusted(1) | | as adjusted(1) (2) | | as adjusted(1) (2) | |
| | (dollars in thousands, except per share amounts) | |
INCOME STATEMENT DATA: | | | | | | | | | | | |
Total revenues | | $ | 279,318 | | $ | 258,155 | | $ | 233,749 | | $ | 223,116 | | $ | 181,166 | |
Operating costs and expenses | | | 212,830 | | | 228,292 | | | 177,849 | | | 171,540 | | | 147,937 | |
Income from operations | | | 66,488 | | | 29,863 | | | 55,900 | | | 51,576 | | | 33,229 | |
Other expense, net | | | (13,478 | ) | | (27,709 | ) | | (20,307 | ) | | (21,406 | ) | | (8,221 | ) |
Income before income taxes and change in accounting principle | | | 53,010 | | | 2,154 | | | 35,593 | | | 30,170 | | | 25,008 | |
Provision for (benefit from) income taxes | | | 16,963 | | | 703 | | | 12,246 | | | 11,470 | | | 9,632 | |
Income before change in accounting principle | | | 36,047 | | | 1,451 | | | 23,347 | | | 18,700 | | | 15,376 | |
Cumulative effect of change in accounting principle, net of income tax benefit (3) | | | — | | | — | | | — | | | (8,877 | ) | | — | |
Net income | | $ | 36,047 | | $ | 1,451 | | $ | 23,347 | | $ | 9,823 | | $ | 15,376 | |
PER SHARE DATA: | | | | | | | | | | | | | | | | |
Income per diluted share before change in accounting principle | | $ | 1.77 | | $ | .07 | | $ | 1.19 | | $ | .97 | | $ | .85 | |
Change in accounting principle | | | — | | | — | | | — | | | (.46 | ) | | — | |
Total diluted | | $ | 1.77 | | $ | .07 | | $ | 1.19 | | $ | .51 | | $ | .85 | |
BALANCE SHEET DATA: (At end of year) | | | | | | | | | | | | | | | | |
Total assets | | $ | 368,293 | | $ | 372,642 | | $ | 364,466 | | $ | 354,574 | | $ | 300,978 | |
Long-term debt, less current maturities | | $ | 145,500 | | $ | 200,000 | | $ | 204,676 | | $ | 217,458 | | $ | 204,740 | |
(1) | The selected financial data has been adjusted to reflect retroactively the change in method of valuing our domestic inventory from the last-in, first-out (“LIFO”) method to the first-in, first-out (“FIFO”) method adopted in fiscal 2005. |
(2) | Share amounts reflect the two-for-one split of our common stock on November 29, 2002. |
(3) | Upon adoption of SFAS 142, we obtained independent appraisals to determine the fair value of our indefinite lived intangible assets and recorded a write-down of $8.9 million in fiscal 2002, as a cumulative effect of change in accounting principle, net of income tax benefit. |
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. The actual results may differ materially from those anticipated in these forward-looking statements as a result of a number of factors, including, but not limited to, those described in our filings with the Securities and Exchange Commission.
Overview
We are a leading marketer and manufacturer of a broad portfolio of branded OTC healthcare products, toiletries and dietary supplements including such categories as topical analgesics, medicated skin care products, medicated dandruff shampoos and conditioner, dietary supplements, and other OTC and toiletry products. Our portfolio of products includes well-recognized brands such as:
| • | Topical analgesics such as Icy Hot and Aspercreme; |
| • | Medicated skin care products such as Gold Bond medicated skin care powder, cream, lotion, first aid, and foot care products; |
| • | Selsun Blue medicated dandruff shampoos and conditioner; |
| • | Dietary supplements including Dexatrim, Garlique and New Phase; and |
| • | Other OTC and toiletry products such as Pamprin, a menstrual analgesic; Herpecin-L, a lip care product; Benzodent, a dental analgesic cream; and toiletries such as Bullfrog, a line of sunblocks; UltraSwim, chlorine-removing shampoo; and Sun-In, a hair lightener. |
Our products typically target niche markets that are often outside the core product areas of larger companies where we believe we can achieve and sustain significant market penetration through innovation and strong advertising and promotion support. Many of our products are among the U.S. market leaders in their respective categories. For example, our portfolio of topical analgesic brands and our Gold Bond medicated body powders have the leading U.S. market share in these categories. We support our brands through extensive and cost-effective advertising and promotion, the expenditures for which represented approximately 28% of our total revenues in fiscal 2005. We sell our products nationally through mass merchandiser, drug and food channels principally utilizing our own sales force.
Developments During Fiscal 2005
Products
In the first quarter of fiscal 2005, we introduced the following product line extensions: Aspercreme Odor-Free Therapy Back and Body Patch, Gold Bond Ultimate Comfort Powder, New Phase Extra Strength, Dexatrim Max and Bullfrog Kids UV Defender. Selsun Salon was introduced in the fourth quarter of fiscal 2005.
Product Divestures
In the first quarter of fiscal 2005, we sold our Selsun business in certain countries in Africa and Asia to The Mentholatum Co., Inc. We maintain our rights to Selsun elsewhere in the world (except India). The divested territory was not compatible with our strategic goals for the remainder of our international Selsun operations and contributed only $1.3 million in net sales in fiscal 2004.
On November 30, 2005, we sold the pHisoderm line of skin care products to The Mentholatum Co., Inc. for a purchase price of $8.5 million plus inventories of approximately $1.1 million. Of the $2.9 million initially held in escrow subject to certain post-closing conditions, only $0.3 million remained in escrow as of February 17, 2006. The transaction allowed us to divest a brand that was no longer consistent with our brand strategy and enables us to focus our financial and management resources on our leading brands. pHisoderm generated a total of $10.5 million of net sales in fiscal 2005. As a result of this transaction, we recorded a loss on product divestures of $8.7 million in the fourth quarter of fiscal 2005.
Debt
During the second quarter of fiscal 2005, we repurchased $17.5 million of our 7.0% Senior Subordinated Notes due March 1, 2014 in the open market at an average premium of 1.6% over the principal amount of the notes. The repurchases resulted in a loss on early extinguishment of debt of $0.7 million in the second quarter of fiscal 2005. The outstanding balance of the remaining 7.0% Subordinated Notes was reduced to $107.5 million.
On November 29, 2005, we entered into the Amended Revolving Credit Facility that, among other things, increased our borrowing capacity under the facility from $50.0 million to $100.0 million, increased our flexibility to repurchase shares of our stock and improved our borrowing rate under the facility.
On November 30, 2005, we called our $75.0 million of Floating Rate Senior Notes for full redemption on December 30, 2005. The terms of the indenture for the Floating Rate Senior Notes required the payment of a price of 102% of the principal amount of the notes plus accrued interest. The $75.0 million of Floating Rate Senior Notes were fully redeemed on December 30, 2005. We utilized borrowings of $38.0 million under our Amended Revolving Credit Facility and $38.9 million of our cash on hand to fund the redemption of the Floating Rate Senior Notes. As a result of the redemption, a loss on early extinguishment of debt of $2.9 million will be recorded in the first quarter of fiscal 2006.
During fiscal 2005, we resolved substantially all of the claims submitted in the Dexatrim PPA settlement and now estimate that the total cost of the Dexatrim settlement will be approximately $56.0 million. A total of $70.9 million has been funded into a settlement trust by our insurers and the product manufacturer and is available to pay claims in the settlement. Any funds remaining in the settlement trust after all claims and expenses of the trust have been paid will be distributed as approved by the court in accordance with the class action settlement agreement and our settlement agreements with each of Kemper Indemnity Insurance Company and the product manufacturer. We currently expect that after all claims and expenses of the settlement trust have been paid, we could recover up to approximately $8.5 million from the settlement trust. If realized, this potential recovery is estimated to occur in the first half of fiscal 2006. We currently do not expect to record any additional charges relative to the settlement of the PPA litigation, except for legal expenses that will be recorded in the period incurred. During the fourth quarter of fiscal 2005, we incurred and recorded $0.3 million of legal expenses related to the Dexatrim litigation.
During the third quarter of fiscal 2005, we entered into a settlement agreement with the DELACO Company (“DELACO”), successor by merger to the Thompson Medical Company, Inc., which owned the Dexatrim brand prior to December 21, 1998 (the “DELACO Agreement”). Pursuant to the DELACO Agreement, we will assume responsibility for all claims against DELACO and its predecessor, Thompson Medical Company, Inc., or us relating to Dexatrim products involving an injury date after December 21, 1998 and will hold the DELACO bankruptcy estate harmless from any such claims. In exchange, a settlement trust to be established under DELACO’s bankruptcy plan will pay us $8.75 million and will assume responsibility for all claims related to Dexatrim products alleging injury dates on or before December 21, 1998. The DELACO Agreement was approved by the bankruptcy court on July 28, 2005. The DELACO Agreement and our receipt of $8.75 million from the DELACO settlement trust is conditioned upon final confirmation and approval of the DELACO bankruptcy plan and funding of the DELACO settlement trust by the insurance companies and other parties obligated to fund the trust. At the confirmation hearing on February 15, 2006, the bankruptcy court indicated that it would enter an order confirming the DELACO bankruptcy plan. Absent any appeals being filed, the order confirming the plan would become final ten days after the bankruptcy court enters the order. Substantial funding of the DELACO settlement trust is due to occur on or before March 13, 2006. Counsel for DELACO announced at the confirmation hearing that the effective date of the plan is anticipated to be March 13, 2006. On the effective date, we will be released from all liability from holders of Dexatrim claims with injury dates prior to December 21, 1998, and if the settlement trust is funded as anticipated, we expect to receive a payment of $8.75 million before the end of March 2006.
Management
During the third quarter of fiscal 2005, we entered into a separation agreement with our former president and chief operating officer. In connection with the separation agreement, we incurred a $2.3 million executive severance charge consisting of a $0.9 million lump-sum cash payment and a $1.4 million non-cash charge as a result of accelerating the vesting of restricted stock. Robert E. Bosworth was named our president and chief operating officer effective September 19, 2005.
On November 16, 2005, Richard D. Moss resigned from his position as vice president and chief financial officer of Chattem. Robert E. Bosworth, our president and chief operating officer, who formerly served as our chief financial officer from 1985 to 1998, will serve as our principal financial officer on an interim basis.
Results of Operations
The following table sets forth for the periods indicated, certain items from our consolidated statements of income expressed as a percentage of total revenues:
| | | Year Ended November 30, | |
| | | 2005 | | | 2004 | | | 2003 | |
| | | | | | as adjusted (1) | | | as adjusted(1) | |
TOTAL REVENUES | | | 100.0 | % | | 100.0 | % | | 100.0 | % |
COSTS AND EXPENSES: | | | | | | | | | | |
Cost of sales | | | 28.6 | | | 28.4 | | | 28.4 | |
Advertising and promotion | | | 27.5 | | | 29.0 | | | 30.2 | |
Selling, general and administrative | | | 16.9 | | | 17.1 | | | 17.5 | |
Executive severance charges | | | 0.8 | | | — | | | — | |
Impairment of indefinite-lived intangible assets | | | — | | | 7.8 | | | — | |
Loss on product divestures | | | 3.1 | | | — | | | — | |
Litigation settlement | | | (0.7 | ) | | 6.1 | | | — | |
Total costs and expenses | | | 76.2 | | | 88.4 | | | 76.1 | |
INCOME FROM OPERATIONS | | | 23.8 | | | 11.6 | | | 23.9 | |
OTHER INCOME (EXPENSE): | | | | | | | | | | |
Interest expense | | | (4.9 | ) | | (5.9 | ) | | (8.8 | ) |
Investment and other income (expense), net | | | 0.4 | | | 0.1 | | | 0.1 | |
Loss on early extinguishment of debt | | | (0.3 | ) | | (5.0 | ) | | — | |
Total other income (expense) | | | (4.8 | ) | | (10.8 | ) | | (8.7 | ) |
INCOME BEFORE INCOME TAXES | | | 19.0 | | | 0.8 | | | 15.2 | |
PROVISION FOR INCOME TAXES | | | 6.1 | | | 0.2 | | | 5.2 | |
NET INCOME | | | 12.9 | % | | 0.6 | % | | 10.0 | % |
(1) | The fiscal 2004 and 2003 consolidated statements of income have been adjusted to reflect retroactively the change in method of valuing our domestic inventory from the LIFO to the FIFO method adopted in fiscal 2005. |
Our net income margin (net income/total revenues) was 12.9%, 0.6% and 10.0% for fiscal 2005 and 2004, respectively. Our adjusted net income (excluding debt extinguishment, impairment, loss on product divestures, litigation settlement and executive severance charges) margin (adjusted net income/total revenues) was 15.2% and 13.2% for fiscal 2005 and 2004, respectively. Adjusted net income (net income excluding debt extinguishment, impairment, loss on product divestures, litigation settlement and executive severance charges) margin is a non-GAAP financial measure. We believe that disclosure of adjusted net income margin provides investors with useful information regarding our financial performance and allows for easier comparison with net income margin without the effect of the charges in prior periods. We use this non-GAAP financial measure to analyze our performance compared to forecasted and prior period results. In addition, the fiscal 2004 consolidated statement of income has been adjusted to reflect retroactively the change in method of valuing our domestic inventory from the LIFO to the FIFO method adopted in fiscal 2005. A reconciliation of adjusted net income to net income for fiscal 2005 and 2004 is presented in the following table:
| | For the Year November 30, | |
| | (dollars in thousands) | |
| | 2005 | | 2004 | |
| | | | | as adjusted | |
Net income | | $ | 36,047 | | $ | 1,451 | |
Add: | | | | | | | |
Loss on early extinguishment of debt | | | 750 | | | 12,958 | |
Impairment of indefinite-lived assets | | | — | | | 20,000 | |
Loss on product divestures | | | 8,678 | | | | |
Litigation settlement | | | (2,086 | ) | | 15,836 | |
Executive severance | | | 2,269 | | | | |
Provision for income taxes | | | (3,076 | ) | | (16,102 | ) |
Net income (excluding debt extinguishment, impairment, loss on product divestures, litigation settlement and executive severance charges) | | $ | 42,582 | | $ | 34,143 | |
Net income (excluding debt extinguishment, impairment, loss on product divestures, litigation settlement and executive severance charges) per common share (diluted) | | $ | 2.09 | | $ | 1.69 | |
Net income (excluding debt extinguishment, impairment, loss on product divestures, litigation settlement and executive severance charges) margin | | | 15.2 | % | | 13.2 | % |
EBITDA, earnings before interest, taxes, depreciation and amortization, is a key non-GAAP financial measure used by us to measure operating performance but may not be comparable to similarly titled measures reported by other companies. The most directly comparable U.S. generally accepted accounting principles (“GAAP”) financial measure is net income. EBITDA and adjusted EBITDA (excluding impairment, loss on product divestures, litigation settlement charges and executive severance charges) are used by us to supplement net income as an indicator of operating performance and not as an alternative to measures defined and required by GAAP. We consider EBITDA and adjusted EBITDA as well as EBITDA margin and adjusted EBITDA margin as important indicators of our operational strength and performance, including our ability to pay interest, service debt and fund capital expenditures. We believe that presenting EBITDA and EBITDA margin, both adjusted to exclude litigation settlement and executive severance charges, provides investors with a useful measure of our ongoing operating performance. Further, EBITDA adjusted to exclude litigation settlement charges is one measure used in the calculation of certain ratios to determine our compliance with the terms of our Amended Revolving Credit Facility. Our presentation of EBITDA and EBITDA margin, as we have adjusted such measures, should not be construed as an inference that our future results will be unaffected by items similar to those excluded from the calculation of EBITDA and EBITDA margin, as we have adjusted such measures. EBITDA and adjusted EBITDA are not measurements of financial performance and liquidity under GAAP and should not be considered as alternatives to operating income, net income and other measures of financial performance reported in accordance with GAAP or as alternatives to cash flows provided by operating, investing or financing activities.
A reconciliation of EBITDA and EBITDA (excluding impairment, loss on product divestures, litigation settlement charges and executive severance charges) to net income is presented in the following table:
| | For the Year Ended November 30, | |
| | | | | | | | | | | Increase (Decrease) | |
| | | | | | | | | | | Amount | | Percentage | |
| | 2005 | | 2004 | | 2003 | | | | 2004 vs. 2003 | | 2005 vs. 2004 | | 2004 vs. 2003 | |
| | | | | | as adjusted (2) | | | as adjusted (2) | | | | | | as adjusted (2) | | | | | | as adjusted (2) | |
| | (dollars in thousands) | |
Net income | | $ | 36,047 | | $ | 1,451 | | $ | 23,347 | | $ | 34,596 | | $ | (21,896 | ) | | 2384.3 | % | | (93.8 | )% |
Add: | | | | | | | | | | | | | | | | | | | | | | |
Provision for income taxes | | | 16,963 | | | 703 | | | 12,246 | | | 16,260 | | | (11,543 | ) | | 2312.9 | | | (94.3 | ) |
Interest expense, net (1) | | | 13,478 | | | 27,709 | | | 20,307 | | | (14,231 | ) | | 7,402 | | | (51.4 | ) | | 36.5 | |
Depreciation and amortization less amounts included in interest | | | 5,388 | | | 5,293 | | | 4,969 | | | 95 | | | 324 | | | 1.8 | | | 6.5 | |
EBITDA | | $ | 71,876 | | $ | 35,156 | | $ | 60,869 | | $ | 36,720 | | $ | (25,713 | ) | | 104.4 | | | (42.2 | ) |
Impairment of indefinite-lived intangible assets | | | — | | | 20,000 | | | — | | | (20,000 | ) | | 20,000 | | | nm | | | nm | |
Loss on product divestures | | | 8,678 | | | — | | | — | | | 8,678 | | | — | | | nm | | | nm | |
Litigation settlement charges | | | (2,086 | ) | | 15,836 | | | — | | | (17,922 | ) | | 15,836 | | | (113.2 | ) | | nm | |
Executive severance charges | | | 2,269 | | | — | | | — | | | 2,269 | | | — | | | nm | | | nm | |
EBITDA (excluding impairment and litigation settlement charges) | | $ | 80,737 | | $ | 70,992 | | $ | 60,869 | | $ | 9,745 | | $ | 10,123 | | | 13.7 | | | 16.6 | |
EBITDA margin (EBITDA/total revenues) | | | 25.7 | % | | 13.6 | % | | 26.0 | % | | | | | | | | | | | | |
EBITDA (excluding impairment loss on product divestures, litigation settlement and executive settlement charges) margin (EBITDA (excluding impairment, loss on product divestures, litigation settlement and executive settlement charges)/total revenues) | | | 28.9 | % | | 27.5 | % | | 26.0 | % | | | | | | | | | | |
(1) | Fiscal 2005 and 2004 results include losses on early extinguishment of debt of $0.8 million and $13.0 million, respectively. |
(2) | The fiscal 2004 and 2003 consolidated statements of income have been adjusted to reflect retroactively the change in method of valuing our domestic inventory from the LIFO to the FIFO method adopted in fiscal 2005. |
Critical Accounting Policies
The preparation of financial statements in accordance with U.S. generally accepted accounting principles requires management to use estimates. Several different estimates or methods can be used by management that might yield different results. The following are the significant estimates used by management in the preparation of the November 30, 2005 consolidated financial statements:
Allowance for Doubtful Accounts
As of November 30, 2005, an estimate was made of the collectibility of the outstanding accounts receivable balances. This estimate requires the utilization of outside credit services, knowledge about the customer and the customer’s industry, new developments in the customer’s industry and operating results of the customer as well as general economic conditions and historical trends. When all these facts are compiled, a judgment as to the collectibility of the individual account is made. Many factors can impact this estimate, including those noted in this paragraph. The adequacy of the estimated allowance may be impacted by the deterioration in the financial condition of a large customer, weakness in the economic environment resulting in a higher level of customer bankruptcy filings or delinquencies and the competitive environment in which the customer operates. During the year ended November 30, 2005, we performed a detailed assessment of the collectibility of trade accounts receivable and reduced our estimate of allowance for doubtful accounts by approximately $0.5 million, which resulted in a decrease to
selling, general and administrative expense in our consolidated financial statements. The balance of allowance for doubtful accounts was $0.3 million and $0.8 million at November 30, 2005 and 2004, respectively.
Revenue Recognition
Revenue is recognized when our products are shipped to our customers. It is generally our policy across all classes of customers that all sales are final. As is common in the consumer products industry, customers return products for a variety of reasons including products damaged in transit, discontinuance of a particular size or form of product and shipping errors. As sales are recorded, we accrue an estimated amount for product returns, as a reduction of these sales, based upon our historical experience and any known specific events that affect the accrual. We charge the allowance account resulting from this accrual with any authorized deduction from remittance by the customer or product returns upon receipt of the product.
In accordance with industry practice, we allow our customers to return unsold sun care products (i.e. Bullfrog and Sun In lines of products) at the end of the sun care season. We record the sales at the time the products are shipped and title transfers. At the time of shipment, we also record a reduction in sales and an allowance on our balance sheet for anticipated returns based upon an estimated return level. The level of returns may fluctuate from our estimates due to several factors including weather conditions, customer inventory levels and competitive conditions. Each percentage point change in our return rate would impact our net sales by approximately $0.2 million. During fiscal 2005, we reduced our estimate of seasonal returns by approximately $0.2 million, to a balance of $0.2 million, which resulted in an increase to net sales in our consolidated financial statements in fiscal 2005, as compared to an approximately $0.9 million reduction in our estimate in fiscal 2004 and an approximately $0.3 million increase in our estimate in fiscal 2003, which resulted in an increase and decrease to net sales in our consolidated financial statements in fiscal 2004 and 2003, respectively. During fiscal 2005, as a result of our estimate of customer inventory levels and based on historical non-seasonal product returns, we increased our estimate of non-seasonal returns by approximately $0.6 million, to a balance of $0.6 million, which resulted in a decrease to net sales in our consolidated financial statements in fiscal 2005. During fiscal 2004 and 2003, we reduced our estimate of non-seasonal returns by approximately $0.8 million and $0.7 million, respectively, which resulted in an increase in net sales in our consolidated financial statements in fiscal 2004 and 2003, respectively. At November 30, 2005 we recorded an allowance for returns of pHisoderm of $0.7 million as a result of the sale of pHisoderm.
We routinely enter into agreements with our customers to participate in promotional programs. These programs generally take the form of coupons, temporary price reductions, scan downs, display activity and participations in advertising vehicles provided uniquely by the customer. The ultimate cost of these programs is often variable based on the number of units actually sold. Estimated unit sales of a product under a promotional program are used to estimate the total cost of the program, which is recorded as a reduction of sales. Actual results can differ from the original estimate. In addition, increases and decreases in total program commitments each year impact the accrual. We also consider customer delays in requesting promotional program payments when evaluating the required accrual. Some customers audit programs significantly after the date of performance to determine the actual amount due and make a claim for reimbursement at that time. As a result, changes in the unit sales trends under promotional programs as well as the timing of payments could result in changes in the accrual. During fiscal 2005, 2004 and 2003, we reduced our estimate of promotional accruals by approximately $1.6 million, $1.6 million and $2.3 million, respectively, which resulted in an increase to net sales or a decrease in advertising and promotion expense in our consolidated financial statements.
Income Taxes
We account for income taxes using the asset and liability approach as prescribed by SFAS No. 109, “Accounting for Income Taxes”. This approach requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the consolidated financial statements or tax returns. Using the enacted tax rates in effect for the year in which the differences are expected to reverse, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax basis of an asset or liability. We record income tax expense in our consolidated financial statements based on an estimated annual effective income tax rate. We revised our annual estimated annual effective income tax rate during fiscal 2005 to 32%, as compared to 33% in fiscal 2004 and 34% in fiscal 2003, as a result of the implementation of a number of foreign and state tax planning initiatives.
For additional information regarding our significant accounting policies, see note 2 of notes to consolidated financial statements.
Fiscal 2005 Compared to Fiscal 2004
To facilitate discussion of our operating results for the years ended November 30, 2005 and 2004, we have included the following selected data from our consolidated statements of income:
| | For the Year Ended November 30, | |
| | | | | | | | Increase (Decrease) | |
| | 2005 | | 2004 | | Amount | | Percentage | |
| | | | | as adjusted (1) | | | | | | | |
| | (dollars in thousands) | |
Domestic net sales | | $ | 252,436 | | $ | 234,003 | | $ | 18,433 | | | 7.9 | % |
International revenues (including royalties) | | | 26,882 | | | 24,152 | | | 2,730 | | | 11.3 | |
Total revenues | | | 279,318 | | | 258,155 | | | 21,163 | | | 8.2 | |
Cost of sales | | | 79,884 | | | 73,358 | | | 6,526 | | | 8.9 | |
Advertising and promotion expense | | | 76,763 | | | 74,929 | | | 1,834 | | | 2.4 | |
Selling, general and administrative expense | | | 47,322 | | | 44,169 | | | 3,153 | | | 7.1 | |
Executive severance charges | | | 2,269 | | | | | | 2,269 | | | 100.0 | |
Impairment of indefinite-lived intangible assets | | | | | | 20,000 | | | (20,000 | ) | | (100.0 | ) |
Loss on product divestures | | | 8,678 | | | | | | 8,678 | | | 100.0 | |
Litigation settlement charges | | | (2,086 | ) | | 15,836 | | | (17,922 | ) | | (113.2 | ) |
Interest expense | | | 13,814 | | | 15,049 | | | (1,235 | ) | | (8.2 | ) |
Loss on early extinguishment of debt | | | 750 | | | 12,958 | | | (12,208 | ) | | (94.2 | ) |
Net income | | | 36,047 | | | 1,451 | | | 34,596 | | | 2,384.3 | |
(1) | The fiscal 2004 selected financial data has been adjusted to reflect retroactively the change in method of valuing our domestic inventory from the LIFO to the FIFO method adopted in fiscal 2005. |
Domestic Net Sales
Domestic net sales for fiscal 2005 increased $18.4 million, or 7.9%, to $252.4 million from $234.0 million in fiscal 2004. For a description of each brand included in the following categories, see “Products” in Item 1 of this Form 10-K. A comparison of domestic net sales for the categories of products included in our portfolio of OTC healthcare products is as follows:
| | For the Year Ended November 30, | |
| | | | | | | | Increase ( Decrease) | |
| | 2005 | | 2004 | | Amount | | Percentage | |
| | (dollars in thousands) | |
Topical analgesics | | $ | 89,539 | | $ | 76,300 | | $ | 13,239 | | | 17.4 | % |
Medicated skin care products | | | 62,458 | | | 60,495 | | | 1,963 | | | 3.2 | |
Dietary supplements | | | 33,828 | | | 33,011 | | | 817 | | | 2.5 | |
Medicated dandruff shampoos and conditioner | | | 34,880 | | | 31,309 | | | 3,571 | | | 11.4 | |
Other OTC and toiletry products | | | 31,731 | | | 32,888 | | | (1,157 | ) | | (3.5 | ) |
Total | | $ | 252,436 | | $ | 234,003 | | $ | 18,433 | | | 7.9 | |
Net sales growth in the topical analgesics category was led by 38% and 15% increases in sales of Aspercreme and Icy Hot, respectively. Aspercreme’s sales increase was driven by the launch of the Odor-Free Therapy Back and Body Patch. Icy Hot continued to benefit from the strength of the Icy Hot Back Patch and a full year of sales from the Medicated Sleeve. Net sales growth in this category also resulted from 15%, 9% and 2% sales increases in Capzasin, Sportscreme and Flexall, respectively. The overall sales growth in this category was partially offset by decreased sales of Arthritis Hot.
Net sales growth in the medicated skin care products category resulted from an 8% increase in the Gold Bond franchise. Gold Bond sales growth was attributable to 26%, 7%, 6% and 2% increases from the lotion, powder, foot care and cream lines, respectively, and was partially offset by lost sales from our discontinued first aid and antifungal foot swab products. The increase in sales from the Gold Bond lotion line of products was attributable to continued sales increases of Gold Bond Ultimate Healing Lotion. The increase in net sales of Gold Bond powder was driven by the launch of Gold Bond Ultimate Comfort Body Powder, and the sales increase of Gold Bond foot care products resulted from increased distribution. Although pHisoderm benefited from the launch of the new pH2O line, this line extension was more than offset by weakness in sales and
lost distribution from its acne and base skin care business. The pHisoderm brand and related inventories were sold on November 30, 2005 to The Mentholatum Co., Inc.
Net sales for the dietary supplements category improved primarily due to 15% and 8% increases in New Phase and Garlique, respectively. Net sales of New Phase increased due to the introduction of New Phase Extra Strength, and Garlique sales benefited from an effective new advertising campaign. Dexatrim diet pill sales increased 30% due to the successful launch of Dexatrim Max, but were offset in part by declining sales of the Dexatrim All in One bar.
Domestic net sales of our medicated dandruff shampoos increased 11%, reflecting continued sales growth of Selsun Blue resulting from an effective advertising campaign and the launch of Selsun Salon in the fourth quarter of fiscal 2005.
The decrease in net sales for the other OTC and toiletry products category was due primarily to sales decreases of Pamprin, Bullfrog and Prēmsyn. The decreases in sales of Pamprin and Prēmsyn were primarily attributable to lost distribution with a major retailer. The 3% decrease in sales of Bullfrog was primarily attributable to unfavorable weather principally at the beginning of the suncare season and the timing and magnitude of returns in the fourth quarter of fiscal 2005. The decrease in sales was partially offset by sales growth of Sun-In, UltraSwim, Herpecin-L and Benzodent.
Domestic sales variances were principally the result of changes in unit sales volumes with the exception of certain selected products, for which we implemented a unit sales price increase.
International Revenues
For fiscal 2005, international revenues increased $2.7 million, or 11.3%, to $26.9 million from $24.1 million in fiscal 2004. The increase was primarily due to the introduction of Icy Hot in Canada and strengthening distributor sales in certain European and Middle Eastern countries offset in part by sales declines in the U.K. market.
Cost of Sales
Cost of sales in fiscal 2005 increased $6.5 million, or 8.9%, to $79.9 million from $73.4 million in fiscal 2004 due primarily to an increase in sales volume. Cost of sales as a percentage of total revenues was 28.6% for fiscal 2005 as compared to 28.4% for fiscal 2004. The increase in cost of sales as a percentage of total revenues was primarily due to increases in raw materials and transportation costs, offset in part by price increases for several products. It is anticipated that costs of sales may increase as a percentage of sales in fiscal 2006 as a result of the introduction of Icy Hot Pro-Therapy and Selsun Salon.
Advertising and Promotion Expense
Advertising and promotion expenses in fiscal 2005 increased $1.8 million, or 2.4%, to $76.8 million from $74.9 million in fiscal 2004 and were 27.5% of total revenues for 2005 compared to 29.0% for the comparable period of fiscal 2004. Support for new product introductions resulted in an increase in advertising and promotion expenditures in fiscal 2005 for Dexatrim, Aspercreme, Gold Bond powder, Bullfrog, New Phase and pHisoderm. The decrease in advertising and promotion expense as a percentage of total revenues was attributable to a more cost-effective use of advertising expenditures and higher sales.
Selling, General and Administrative Expense
Selling, general and administrative expenses increased $3.2 million, or 7.1%, to $47.3 million from $44.2 million in fiscal 2004. Selling, general and administrative expenses were 16.9% and 17.1% of total revenues for fiscal 2005 and 2004, respectively. An increase in sales was primarily responsible for higher selling expenses. In addition, freight expenses increased due to higher fuel costs. The increase in general and administrative expenses was largely a result of higher levels of product development expenses, compensation expense and insurance expense during fiscal 2005.
Executive Severance Charges
During the third quarter of fiscal 2005, we entered into a separation agreement with our former president and chief operating officer. In connection with the separation agreement, we incurred a $2.3 million executive severance charge consisting of a $0.9 million lump-sum cash payment and a $1.4 million non-cash charge as a result of accelerating the removal of restrictions on restricted stock.
Impairment of Indefinite-Lived Assets
As a result of a decline in sales and reforecasted expected future cash flows in the fourth quarter of fiscal 2004, we performed the impairment test as prescribed by SFAS 142 and determined that a revaluation was required for our Dexatrim product line at November 30, 2004. We obtained an independent appraisal to determine the fair value of the indefinite-lived intangible asset related to this product line. As a result, we incurred an impairment charge of $20.0 million in the fourth quarter of fiscal 2004. No corresponding charge was incurred in fiscal 2005.
Loss on Product Divestures
During the fourth quarter of fiscal 2005, we sold the pHisoderm line of skin care products for a purchase price of $8.5 million plus inventories of approximately $1.1 million. As a result of this transaction, we recorded a loss on product divestures of $8.7 million in the fourth quarter of fiscal 2005.
Litigation Settlement Charges
Litigation settlement items decreased $17.9 million in fiscal 2005 to a gain of $2.1 million from an expense of $15.8 million in fiscal 2004. The change was principally due to a $6.0 million reversal of previously estimated costs related to the Dexatrim litigation, net of legal expenses, recorded in the second quarter of fiscal 2005 and reduced Dexatrim legal and administrative costs in fiscal 2005 compared to fiscal 2004.
Interest Expense
Interest expense decreased $1.2 million, or 8.2%, in fiscal 2005 to $13.8 million from $15.0 million in fiscal 2004. The decrease was largely the result of reductions in outstanding debt as a result of our repurchase of $17.5 million of our 7.0% Senior Subordinated Notes completed in the second quarter of fiscal 2005 and the remaining benefit from the debt refinancing completed during the first quarter of fiscal 2004. Until our indebtedness is reduced substantially, interest expense will continue to represent a significant percentage of our total revenues.
Loss on Early Extinguishment of Debt
During the second quarter of fiscal 2005, we repurchased $17.5 million of our 7.0% Senior Subordinated Notes, which resulted in a loss on early extinguishment of debt of $0.7 million. During the fourth quarter of fiscal 2005, we called our $75.0 million Floating Rate Senior Notes for full redemption on December 30, 2005. The $75 million of Floating Rate Senior Notes were fully redeemed on December 30, 2005. As a result of the redemption, a loss on early extinguishment of debt of $2.9 million will be recorded in the first quarter of fiscal 2006.
Fiscal 2004 Compared to Fiscal 2003
To facilitate discussion of our operating results for the years ended November 30, 2004 and 2003, we have included the following selected data from our Consolidated Statements of Income:
| | For the Year Ended November 30, | |
| | | | | | | | Increase ( Decrease) | |
| | 2004 | | 2003 | | Amount | | Percentage | |
| | as adjusted (1) | | as adjusted (1) | | | | | |
| | (dollars in thousands) | |
Domestic net sales | | $ | 234,003 | | $ | 209,874 | | $ | 24,129 | | | 11.5 | % |
International revenues (including royalties) | | | 24,152 | | | 23,875 | | | 277 | | | 1.2 | |
Total revenues | | | 258,155 | | | 233,749 | | | 24,406 | | | 10.4 | |
Cost of sales | | | 73,358 | | | 66,424 | | | 6,934 | | | 10.4 | |
Advertising and promotion expense | | | 74,929 | | | 70,622 | | | 4,307 | | | 6.1 | |
Selling, general and administrative expense | | | 44,169 | | | 40,803 | | | 3,366 | | | 8.2 | |
Impairment of indefinite-lived intangible assets | | | 20,000 | | | | | | 20,000 | | | nm | |
Litigation settlement charges | | | 15,836 | | | | | | 15,836 | | | nm | |
Interest expense | | | 15,049 | | | 20,431 | | | (5,382 | ) | | (26.3 | ) |
Loss on early extinguishment of debt | | | 12,958 | | | | | | 12,958 | | | nm | |
Net income | | | 1, 451 | | | 23,347 | | | (21,896 | ) | | (93.8 | ) |
(1) | The selected financial data has been adjusted to reflect retroactively the change in method of valuing our domestic inventory from the LIFO to the FIFO method adopted in fiscal 2005. |
Domestic Net Sales
Domestic net sales for fiscal 2004 increased $24.1 million, or 11.5%, to $234.0 million from $209.9 million in fiscal 2003. For a description of each brand included in the following categories, see “Products” in Item 1 of this Form 10-K. A comparison of domestic net sales for the categories of products included in our portfolio of OTC healthcare products is as follows:
| | For the Year Ended November 30, | |
| | | | | | | | Increase (Decrease) | |
| | 2004 | | 2003 | | Amount | | Percentage | |
| | (dollars in thousands) | |
Topical analgesics | | $ | 76,300 | | $ | 58,594 | | $ | 17,706 | | | 30.2 | % |
Medicated skin care products | | | 60,495 | | | 56,528 | | | 3,967 | | | 7.0 | |
Dietary supplements | | | 33,011 | | | 37,420 | | | (4,409 | ) | | (11.8 | ) |
Medicated dandruff shampoos and conditioner | | | 31,309 | | | 28,351 | | | 2,958 | | | 10.4 | |
Other OTC and toiletry products | | | 32,888 | | | 28,981 | | | 3,907 | | | 13.5 | |
Total | | $ | 234,003 | | $ | 209,874 | | $ | 24,129 | | | 11.5 | |
Net sales growth in the topical analgesics category was led by a 57% increase in sales of Icy Hot, which was primarily driven by the continued strength of the Icy Hot Back Patch and the newly introduced Icy Hot Medicated Sleeve. Net sales growth in this category also resulted from 34% and 12% sales increases in Capzasin and Aspercreme, respectively. The overall sales growth in this category was partially offset by a decline in sales of Flexall as competition from inside and outside the category increased and media support was curtailed.
Net sales growth in the medicated skin care products category resulted from a 14% increase in the Gold Bond franchise. Gold Bond sales growth was attributable to 46%, 27% and 24% increases from the lotion, foot care and cream lines, respectively, and was partially offset by declines in the first aid portion of the business. The increase in sales from the Gold Bond lotion line of products was attributable to the successful launch of Gold Bond Ultimate Healing Skin Therapy Lotion in the third quarter of fiscal 2003. Sales growth in the medicated skin care products category was also offset by a 15% decrease in pHisoderm sales due to increased competition.
Net sales for the dietary supplements category declined primarily due to a 47% decrease in Dexatrim diet pill sales. Sales of Dexatrim were impacted by the overall decline in the diet pill market resulting in part from negative ephedrine publicity and the impact of low carbohydrate diet products. The decline in net sales of Dexatrim diet pills was partially offset by sales of the Dexatrim All in One bar, which was introduced in the first quarter of fiscal 2004. The Dexatrim All in One bar sales were lower than expected for fiscal 2004, as the category has proved to be more promotional and seasonal than we expected.
Domestic net sales of Selsun Blue medicated dandruff shampoo increased due to an effective advertising campaign and sales of Selsun Blue conditioner, which was launched in the first quarter of fiscal 2004.
The increase in net sales for the other OTC and toiletry products category was due primarily to sales increases of Pamprin and Bullfrog. The increase in sales of Pamprin was primarily attributable to the introduction of Pamprin All Day in the first quarter of fiscal 2004. The increase in sales of Bullfrog was primarily attributable to expanded distribution and increased sales of pre-pack displays.
Domestic sales variances were principally the result of changes in unit sales volumes with the exception of Pamprin, Prēmsyn PMS, pHisoderm, Flexall, Aspercreme, Capzasin and Sportscreme, for which we implemented a unit sales price increase.
International Revenues
For fiscal 2004, international revenues increased $0.3 million, or 1.2%, to $24.2 million from $23.9 million in fiscal 2003 due principally to an increase in Selsun sales in Canada, Europe and Latin America and favorable foreign currency translation. International sales variances were principally the result of changes in unit sales volumes.
Cost of Sales
Cost of sales in fiscal 2004 increased $6.9 million, or 10.4%, to $73.4 million from $66.4 million in fiscal 2003 due primarily to sales of the Dexatrim All in One bar, the Icy Hot Back Patch and the Icy Hot Medicated Sleeve, all of which have lower profit margins than many of our other products. Cost of sales as a percentage of total revenues was 28.4% for both fiscal 2004 and fiscal 2003.
Advertising and Promotion Expense
Advertising and promotion expenses in fiscal 2004 increased $4.3 million, or 6.1%, to $74.9 million from $70.6 million in fiscal 2003 and were 29.0% of total revenues for 2004 compared to 30.2% for fiscal 2003. Support for new product introductions resulted in an increase in advertising and promotion expenditures for fiscal 2004 for Icy Hot, Pamprin, the Dexatrim All in One bar, Selsun Blue and the Gold Bond lotion and foot care lines.
Selling, General and Administrative Expense
Selling, general and administrative expenses increased $3.4 million, or 8.2%, to $44.2 million from $40.8 million in fiscal 2003. Selling, general and administrative expenses were 17.1% and 17.5% of total revenues for fiscal 2004 and 2003, respectively. An increase in sales was primarily responsible for the higher selling expenses. In addition, freight expenses increased due to the higher fuel costs. The increase in general and administrative expenses was largely a result of increased incentive compensation and new product development expenses as well as expenses related to compliance with the Sarbanes-Oxley Act of 2002.
Impairment of Indefinite-Lived Intangible Assets
As a result of a decline in sales and reforecasted expected future cash flows in the fourth quarter, we performed the impairment test as prescribed by SFAS 142 and determined that a revaluation was required for our Dexatrim product line at November 30, 2004. We obtained an independent appraisal to determine the fair value of the indefinite-lived intangible asset related to this product line. As a result, we incurred an impairment charge of $20.0 million in the fourth quarter of fiscal 2004. No corresponding charge was incurred in fiscal 2003.
Litigation Settlement Charges
Litigation settlement charges were $15.8 million in fiscal 2004. This expense was attributable to legal, administrative and estimated settlement costs related to our Dexatrim litigation.
Interest Expense
Interest expense decreased $5.4 million, or 26.3%, in fiscal 2004 to $15.0 million from $20.4 million in fiscal 2003. The decrease was largely the result of lower interest rates and a reduction in outstanding debt as a result of our debt refinancing completed during the first quarter of fiscal 2004. Until our indebtedness is reduced substantially, interest expense will continue to represent a significant percentage of our total revenues.
Loss on Early Extinguishment of Debt
During fiscal 2004, we retired $204.5 million principal amount of our 8.875% senior subordinated notes and the remaining outstanding balance of our $60.0 million senior secured credit facility, which resulted in a loss on early extinguishment of debt of $13.0 million. No corresponding charge was incurred in fiscal 2003.
Liquidity and Capital Resources
We have historically funded our operations with a combination of internally generated funds and borrowings. Our principal uses of cash are for operating expenses, servicing long-term debt, acquisitions, working capital, repurchases of our common stock, payment of income taxes and capital expenditures.
Cash of $55.0 million and $44.7 million was provided by operations in fiscal 2005 and 2004, respectively. The increase in cash provided by operating activities was due to the loss on early extinguishment of debt of $13.0 million incurred in fiscal
2004 year compared to $0.8 million incurred in fiscal 2005. Increased net income, refundable income taxes and deferred income taxes also contributed to the increase in cash flow from operations. These increases were partially offset by decreases in the tax benefit realized from stock option exercises, prepaid expenses and accounts payable and accrued liabilities.
Investing activities used cash of $0.7 million and $5.5 million in fiscal 2005 and 2004, respectively. The decrease in the usage of cash was primarily due to proceeds received from the sale of our Selsun business in certain countries in Africa and Asia in fiscal 2005.
Financing activities used cash of $46.5 million and $26.2 million in fiscal 2005 and 2004, respectively. The increase in cash used primarily was attributable to the $34.1 million repurchase of common stock in fiscal 2005 as compared to $5.0 million of common stock repurchased in fiscal 2004.
As of November 30, 2005, our total debt was $182.5 million, consisting of our Floating Rate Senior Notes of $75.0 million and 7.0% Subordinated Notes of $107.5 million. As of November 30, 2005, we had no borrowings outstanding under our Amended Revolving Credit Facility with available borrowings up to $100.0 million. As of February 17, 2006, our total debt was $145.5 million, consisting of borrowings outstanding under our Amended Revolving Credit Facility totaling $38.0 million and $107.5 million of our 7.0% Subordinated Notes. Borrowings under our Amended Revolving Credit Facility bear interest at LIBOR plus applicable percentages of 1.00% to 2.00% or a base rate (the higher of the federal funds rate plus 0.5% or the prime rate) plus applicable percentages of 0.0% to 0.5% (7.00% as of November 30, 2005). The applicable percentages are calculated based on our leverage ratio. The Floating Rate Senior Notes bear interest at a three-month LIBOR plus 3.00% per year (6.87% as of November 30, 2005). On March 8, 2004, we entered into an interest rate cap agreement effective June 1, 2004 with decreasing annual notional principal amounts of $15.0 million beginning March 1, 2006 and cap rates ranging from 4.0% to 5.0% over the life of the agreement. We paid a $1.4 million premium to enter into the interest rate cap agreement, which will be amortized over the life of the agreement. The current portion of the premium on the interest rate cap agreement of $0.4 million is included in prepaid expenses and other current assets, and the long-term portion of $0.7 million is included in other non-current assets. During fiscal 2005, the amortized value of the premium on the interest rate cap was compared to the fair value of the interest rate cap and the change in the market value of the premium of $0.2 million, net of tax, was recorded to other comprehensive income. Also as of November 30, 2005, a portion of the interest rate cap was deemed to be an ineffective cash flow hedge due to the reduction of variable rate debt upon the subsequent redemption of the Floating Rate Senior Notes, resulting in a loss of $0.1 million, net of tax, reflected in the income statement as interest expense. The balance of the cash flow hedge was deemed to be effective as of November 30, 2005. The interest rate cap agreement terminates on March 1, 2010.
In October 2005, our board of directors increased the total authorization to repurchase our common stock under our stock buyback program to $30.0 million, which became effective on November 29, 2005 upon consummation of the Amended Revolving Credit Facility. During fiscal 2005, we repurchased 882,267 shares of our common stock for $34.1 million. We are limited in our ability to repurchase shares due to restrictions under the terms of our Amended Revolving Credit Facility and the indenture pursuant to which the 7.0% Subordinated Notes were issued.
We believe that cash provided by operating activities, our cash and cash equivalents balance and funds available under our Amended Revolving Credit Facility will be sufficient to fund our capital expenditures, debt service and working capital requirements for the foreseeable future as our business is currently conducted. It is likely that any acquisitions we make in the future will require us to obtain additional financing.
Contractual Obligations
The following data summarizes our contractual obligations as of November 30, 2005. We had no commercial obligations as of November 30, 2005:
| | Payments due by | |
Contractual Obligations: | | Total | | Within 1 year | | 2-3 years | | 4-5 years | | After 5 years | |
| | (dollars in thousands) | |
Long-term debt | | $ | 182,500 | | $ | 37,000 | | $ | — | | $ | | | $ | 145,500 | |
Operating leases | | | 3,796 | | | 1,470 | | | 1,190 | | | 588 | | | 548 | |
Purchase commitments | | | 3,979 | | | 1,495 | | | 2,484 | | | | | | | |
Endorsements | | | 5,525 | | | 1,500 | | | 3,225 | | | 800 | | | | |
Total | | $ | 195,800 | | $ | 41,465 | | $ | 6,899 | | $ | 1,388 | | $ | 146,048 | |
Purchase orders or contracts for the purchase of inventory and other goods and services are not included in the table above. We are not able to determine the aggregate amount of such purchase orders that represent contractual obligations, as purchase orders may represent authorizations to purchase rather than binding agreements. Our purchase orders are based on our current distribution needs and are fulfilled by our vendors within short time horizons. We do not have significant agreements for the purchase of inventory or other goods specifying minimum quantities or set prices that exceed our expected requirements for three months.
Foreign Operations
Historically, our primary foreign operations have been conducted through our Canadian and United Kingdom (“U.K.”) subsidiaries. Since November 1, 2004, our European business has been conducted through Chattem Global Consumer Products Limited, a wholly-owned subsidiary located in Limerick, Ireland. The functional currencies of these subsidiaries are Canadian dollars, British pounds and Euros, respectively. Fluctuations in exchange rates can impact operating results, including total revenues and expenses, when translations of the subsidiary financial statements are made in accordance with SFAS No. 52, “Foreign Currency Translation”. For fiscal 2005 and 2004, these subsidiaries accounted for 8% and 7% of total revenues, respectively, and 4% of total assets, respectively. It has not been our practice to hedge our assets and liabilities in Canada, the U.K. and Ireland or our intercompany transactions due to the inherent risks associated with foreign currency hedging transactions and the timing of payments between us and our foreign subsidiaries. Following our acquisition of Selsun Blue, which is sold in approximately 70 foreign countries, our international business operations have expanded significantly, which has increased our exposure to fluctuations in foreign exchange rates. During fiscal 2005, a portion of these foreign sales was reflected as royalties, which have been paid to us in U.S. dollars. In addition, until July 2005 Abbott Laboratories (“Abbott”), from whom we acquired Selsun Blue, continued to supply a portion of our international supply of Selsun and billed us in U.S. dollars in certain instances. Beginning April 1, 2004, a portion of our international supply of Selsun was billed to us in local currencies. Historically, gains or losses from foreign currency transactions have not had a material impact on our operating results. Gains of $0.2 million and $0.2 million for the years ended November 30, 2005 and 2004, respectively, resulted from foreign currency transactions and are included in selling, general and administrative expenses in the consolidated statements of income.
Recent Accounting Pronouncements
In December 2003, the Financial Accounting Standards Board (“FASB”) issued Interpretation No. 46R, “Consolidation of Variable Interest Entities” (“FIN 46R”), which supersedes Interpretation No. 46, “Consolidation of Variable Interest Entities” issued in January 2003. FIN 46R requires a company to consolidate a variable interest entity (“VIE”), as defined, when the company will absorb a majority of the VIE’s expected losses, receives a majority of the VIE’s expected residual returns or both. FIN 46R also requires consolidation of existing, non-controlled affiliates if the VIE is unable to finance its operations without investor support, or where the other investors do not have exposure to the significant risks and rewards of ownership. FIN 46R applies immediately to a VIE created or acquired after January 31, 2003. For a VIE created before February 1, 2003, FIN 46R applies in the first fiscal year or interim period beginning after March 15, 2004, our third fiscal quarter beginning June 1, 2004. Application of FIN 46R is also required in financial statements that have interests in structures that are commonly referred to as special-purpose entities for periods ending after December 15, 2003. The adoption of FIN 46R did not have a material impact on our financial position, results of operations or cash flows.
In November 2004, the FASB issued Statement of Financial Accounting Standards (“SFAS”) No. 151, “Inventory Costs” (“SFAS 151”). SFAS 151 amends the guidance in Accounting Research Bulletin No. 43, Chapter 4, “Inventory Pricing”, to clarify that abnormal amounts of idle facility expense, freight, handling costs and wasted materials (spoilage) should be recognized as current-period charges and requires the allocation of fixed production overheads to inventory based on normal capacity of the production facilities. This statement is effective for inventory costs incurred during fiscal years beginning after June 15, 2005. The adoption of SFAS 151 is not expected to have an impact on our financial position, results of operations or cash flows.
In November 2004, the Emerging Issues Task Force (“EITF”) reached a consensus on Issue No. 03-13, “Applying the Conditions in Paragraph 42 of FASB Statement No. 144, “Accounting for the Impairment or Disposal of Long-Lived Assets” in Determining Whether to Report Discontinued Operations” (“EITF 03-13”). Under the consensus, the approach for assessing whether cash flows of the component have been eliminated from the ongoing operations of the entity focuses on whether continuing cash flows are direct or indirect cash flows. Cash flows of the component would not be eliminated if the continuing cash flows to the entity are considered direct cash flows. The consensus should be applied to a component of an enterprise that is either disposed of or classified as held for sale in fiscal periods beginning after December 15, 2004. The adoption of EITF 03-13 did not have an impact on our financial position, results of operations or cash flows.
In December 2004, the FASB issued SFAS No. 123 (revised 2004), “Share-Based Payment” (“SFAS 123R”), which is a revision of SFAS No. 123, “Accounting for Stock-Based Compensation”. SFAS 123R supersedes APB Opinion No. 25, “Accounting for Stock Issued to Employees” and amends SFAS No. 95, “Statement of Cash Flows”. SFAS 123R focuses primarily on accounting for transactions in which an entity obtains employee services in share-based payment transactions and requires all share-based payments to employees, including grants of employee stock options, to be recognized in the income statement based on their fair values. Accordingly, the adoption of SFAS 123R’s fair value method will have a significant impact on our results of operations, although it will have no impact on our overall financial position. We are currently evaluating the impact of this standard, but we estimate the impact of applying the various provisions of SFAS 123R will result in an expense, net of tax, of approximately $2.1 million during fiscal 2006 if all current unvested stock options vest on the scheduled dates and the assumptions in the Black-Scholes model remain the same. Had we adopted SFAS 123R in prior periods, the impact of that standard would have approximated the impact of SFAS 123 as described in the disclosure of proforma net income and earnings per share in note 2, stock-based compensation, of notes to consolidated financial statements. SFAS 123R also requires the benefits of tax deductions in excess of recognized compensation costs to be reported as a financing cash flow, rather than as an operating cash flow as required under current literature. This requirement will reduce net operating cash flows and increase net financing cash flows in periods after adoption. While we cannot estimate what those amounts will be in the future (because they depend on, among other things, when employees exercise stock options), the amount of operating cash flows recognized in prior periods for such excess tax deductions were not material to our consolidated financial position or results of operations. This statement is effective for our fiscal year that begins December 1, 2005.
In December 2004, the FASB issued SFAS 153, “Exchanges of Nonmonetary Assets” (“SFAS 153”). SFAS 153 amends the guidance in APB Opinion No. 29, “Accounting for Nonmonetary Transactions” to eliminate certain exceptions to the principle that exchanges of nonmonetary assets be measured based on the fair value of the assets exchanged. SFAS 153 eliminates the exception for nonmonetary exchanges of similar productive assets and replaces it with a general exception for exchanges of nonmonetary assets that do not have commercial substance. This statement is effective for nonmonetary asset exchanges in fiscal years beginning after June 15, 2005. The adoption of SFAS 153 is not expected to have an impact on our financial position, results of operations or cash flows.
The American Jobs Creation Act of 2004 (the “AJCA”) was enacted on October 22, 2004. The AJCA repeals an export incentive, creates a new deduction for qualified domestic manufacturing activities and includes a special one-time deduction of 85% of certain foreign earnings repatriated to the U.S.
In December 2004, the FASB issued FASB Staff Position No. 109-1, “Application of FASB Statement No. 109 (SFAS 109), Accounting for Income Taxes, to the Tax Deduction on Qualified Production Activities Provided by the American Jobs Creation Act of 2004” (FSP 109-1). FSP 109-1 clarifies that the manufacturer’s deduction provided for under the American Jobs Creation Act of 2004 (AJCA) should be accounted for as a special deduction in accordance with SFAS 109 and not as a tax rate reduction. We have not completed the process of evaluating the impact that will result from adopting this statement and are therefore unable to disclose the impact that adopting FSP 109-1 will have on our financial position and results of operations.
The FASB also issued FASB Staff Position No. 109-2, Accounting and Disclosure Guidance for the Foreign Earnings Repatriation Provision within the American Jobs Creation Act of 2004 (FSP 109-2). The AJCA introduces a special one-time dividends received deduction on the repatriation of certain foreign earnings to a U.S. taxpayer (repatriation provision), provided certain criteria are met. FSP 109-2 provides accounting and disclosure guidance for the repatriation provision. We have described the impact of FSP 109-2 on our financial statements in note 7, Income Taxes.
In May 2005, the FASB issued SFAS No. 154, “Accounting Changes and Error Corrections,” (“SFAS 154”). SFAS No. 154 replaces APB No. 20, “Accounting Changes” and SFAS No. 3, “Reporting Accounting Changes in Interim Financial Statements” and establishes retrospective application as the required method for reporting a change in accounting principle. The reporting of a correction of an error by restating previously issued financial statements is also addressed. SFAS No. 154 is effective for accounting changes and corrections of errors made in fiscal years beginning after December 15, 2005. We do not believe that the adoption of SFAS No. 154 will have a material effect on our results of operations or consolidated financial position.
In October 2005, the FASB issued FASB Staff Position (“FSP”) 123R-2, “Practical Accommodation to the Application of Grant Date as Defined in FASB Statement No. 123(R) (“FSP 123R-2”)”. FSP 123R-2 provides companies with a “practical accommodation” when determining the grant date of an award that is subject to the accounting provisions in SFAS 123R. Specifically, assuming a company meets all of the other criteria in the definition of grant date in SFAS 123R, a mutual understanding (between the company and the recipient) of the key terms and conditions of an award is presumed to exist at the date the award is approved (in accordance with the company’s normal corporate governance policy) if (1) the award is unilateral grant meaning that the recipient does not have the ability to negotiate the key terms and conditions of the award, and (2) the key
terms and conditions of the award are expected to be communicated to the recipient within a relatively short period of time (as defined in the FSP 123R-2) after the grant was approved. This FSP is effective upon initial adoption of SFAS 123-R on December 1, 2005.
In November 2005, the FASB issued FSP 123R-3, “Transition Election Related to Accounting for the Tax Effects of Share-Based Payment Awards” (“FSP 123R-3”). FSP 123R-3 provides a practical exception when a company transitions to the accounting requirements in SFAS 123R. SFAS 123R requires a company to calculate the pool of excess tax benefits available to absorb tax deficiencies recognized subsequent to adopting SFAS 123R (“APIC Pool”), assuming the company had been following the recognition provisions prescribed by SFAS 123. The FASB learned that several companies do not have the necessary historical information to calculate the APIC pool as envisioned by SFAS 123R and accordingly, the FASB decided to allow a practical exception as documented in FSP 123R-3. This FSP is effective immediately.
Forward Looking Statements
We may from time to time make written and oral forward-looking statements. Written forward-looking statements may appear in documents filed with the Securities and Exchange Commission, in press releases and in reports to shareholders or be made orally in publicly accessible conferences or conference calls. The Private Securities Litigation Reform Act of 1995 contains a safe harbor for forward-looking statements. We rely on this safe harbor in making such disclosures. The forward-looking statements are based on management’s current beliefs and assumptions about expectations, estimates, strategies and projections. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed or forecasted in such forward-looking statements. We undertake no obligation to update publicly any forward-looking statements whether as a result of new information, future events or otherwise. The risks, uncertainties and assumptions of the forward-looking statements include, but are not limited to, the lack of availability, limits of coverage and expense related to product liability insurance, the reduction of available insurance coverage as proceeds are used to fund any product liability settlements or awards; the possibility of other product liability claims, including claims relating to the prior existence of ephedrine in Dexatrim products or arising from the FDA’s rule banning the sale of dietary supplements containing ephedrine; our ability to fund liabilities from product liability claims greater than our insurance coverage or outside the scope of insurance coverage; the possible effect of the negative public perception resulting from product liability claims on sales of Dexatrim products without PPA or ephedrine; the impact of brand acquisitions and divestures; the impact of gains or losses resulting from product acquisitions or divestures; product demand and market acceptance risks; product development risks, such as delays or difficulties in developing, producing and marketing new products or line extensions; the impact of competitive products, pricing and advertising; our ability to sell and market Selsun internationally where we have only limited experience and infrastructure; constraints resulting from our financial condition, including the degree to which we are leveraged, debt service requirements and restrictions under indentures and loan agreements; government regulations; risks of loss of material customers; public perception regarding our products; dependence on third party manufacturers; environmental matters; and other risks described in our Securities and Exchange Commission filings.
Item 7A. Quantitative and Qualitative Disclosures about Market Risk
We are exposed to market risk from changes in interest rates and foreign currency exchange rates, which may adversely affect our results of operations and financial condition. We seek to minimize the risks from these interest rates and foreign currency exchange rate fluctuations through our regular operating and financing activities.
Our exposure to interest rate risk currently consists of our Floating Rate Senior Notes, which were redeemed on December 30, 2005, and our Amended Revolving Credit Facility. The aggregate balance outstanding under the Floating Rate Senior Notes as of November 30, 2005 was $75.0 million. The Floating Rate Senior Notes bear interest at a three-month LIBOR plus 3.00% per year (6.87% as of November 30, 2005). Loans under our Amended Revolving Credit Facility bear interest at LIBOR plus applicable percentages of 1.00% to 2.00% or a base rate (the higher of the federal funds rate plus 0.5% or the prime rate) plus applicable percentages of 0.0% to 0.5%. The applicable percentages are calculated based on our leverage ratio. As of November 30, 2005, no amounts had been borrowed under the Amended Revolving Credit Facility, and the variable rate on the Amended Revolving Credit Facility was 7.0%. The Floating Rate Senior Notes were fully redeemed on December 30, 2005 utilizing $38.9 million of cash on hand plus $38.0 million drawn from the Amended Revolving Credit Facility. The 7.0% Subordinated Notes are fixed interest rate obligations. On March 8, 2004, we entered into an interest rate cap agreement effective June 1, 2004 with decreasing annual notional principal amounts of $15.0 million beginning March 1, 2006 and cap rates ranging from 4.0% to 5.0% over the life of the agreement. The amortized value of the premium on the interest rate cap was compared to its fair value as of November 30, 2005, and a charge of $0.1 million, net of tax, was recorded to other comprehensive income. The interest rate cap agreement terminates on March 1, 2010. The impact on our results of operations
of a one-point rate change on the February 17, 2006 outstanding balance of our Amended Revolving Credit Facility for the next twelve months would be approximately $0.3 million, net of tax.
We are subject to risk from changes in the foreign exchange rates relating to our Canadian, U.K. and Irish subsidiaries. Assets and liabilities of these subsidiaries are translated to U.S. dollars at year-end exchange rates. Income and expense items are translated at average rates of exchange prevailing during the year. Translation adjustments are accumulated as a separate component of shareholders' equity. Gains and losses, which result from foreign currency transactions, are included in the consolidated statements of income. Until July 2005, Abbott continued to supply us with a portion of our international supply of Selsun and billed us in U.S. dollars in certain instances. Beginning April 1, 2004, a portion of our international supply of Selsun was billed to us in local currencies. The potential loss resulting from a hypothetical 10.0% adverse change in the quoted foreign currency exchange rate amounts to approximately $1.0 million as of November 30, 2005.
This market risk discussion contains forward-looking statements. Actual results may differ materially from this discussion based upon general market conditions and changes in financial markets.