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| WST > SEC Filings for WST > Form 10-Q on 6-Nov-2008 | All Recent SEC Filings |
6-Nov-2008
Quarterly Report
The following discussion should be read in conjunction with the Management's Discussion and Analysis and consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2007.
COMPANY OVERVIEW
Our mission is to develop and apply proprietary technologies that improve the safety and effectiveness of therapeutic and diagnostic healthcare delivery systems. We have manufacturing locations in North and South America, Europe and Asia, with affiliates in Mexico and Japan. Our business is conducted through two segments: "Pharmaceutical Systems" and "Tech Group." Our Pharmaceutical Systems segment focuses on primary packaging components and systems for injectable drug delivery, including stoppers and seals for vials, and closures and disposable components used in syringe, intravenous and blood collection systems. The Tech Group operating segment offers custom contract-manufacturing solutions using plastic injection molding and manual and automated assembly processes targeted to the healthcare and consumer products industries. Our customer base includes the leading global manufacturers of pharmaceuticals, biologics and medical devices.
Recent Trends and Developments - Pharmaceutical Systems Segment
In our Pharmaceutical Systems segment, 2008 sales growth continues to be limited by regulatory and insurance reimbursement issues affecting the demand for certain biotechnology customer products, our decision to cease production of a lower-margin disposable medical product component, and the impact of customer inventory management programs in response to the recent global economic turmoil. Despite these issues, we have been successful in maintaining existing business and participating in growth across the markets we serve. We currently expect full year sales growth of approximately 3% to 5% for the Pharmaceutical Systems segment in 2008, excluding the benefit of foreign currency exchange rates. We also expect that our full year 2008 sales and operating profit at actual foreign exchange rates will reflect a benefit from the effects of foreign currency exchange rates, despite a recent reversal in trends for certain currencies significant to the Company.
We continue to carefully monitor the impact of higher hydrocarbon prices on raw materials and utilities used to operate our production facilities and in the distribution of our products. Many of our Pharmaceutical Systems segment products are made from synthetic elastomers, which are derived from the petroleum refining process. Elastomer prices are subject to short-term impacts of shifts in demand of petroleum products, as well as shortages of supply due to unexpected events such as those recently caused by hurricane activity in the U.S. gulf coast. We expect that market conditions for petroleum-based products will remain volatile for the remainder of the year. Some of our more significant raw material supply contracts contain petroleum-indexed price escalators and provide for incremental surcharges that have been enacted during the current year. As the price adjustors in our key supplier contracts are derived from historical prices, there is typically a lag of three or more months before we realize the effects of changes in the spot market for commodities. As a result, we do not expect to experience a fourth quarter benefit of the recent decline in the market price of crude oil.
Our sales contracts and pricing agreements with our customers are generally indexed to producer price and other inflation indices, which allow us to increase our sales prices in-line with related commodity or other production cost increases. Selling prices for customers under long-term contracts are typically revised once per year to reflect these indices. Due to the greater lag time inherent in our sales contracts, our selling price adjustments may trail the actual effect of significant changes in cost structure on a short-term basis. During periods of increasing manufacturing costs, we generally incur incremental costs that are not immediately recoverable from our customers.
To offset some of the financial impact, we have implemented cost-reduction efforts throughout the organization, imposed a petroleum-based raw material surcharge on non-contractual customers, and accelerated our lean manufacturing initiatives. We expect a negative impact on our fourth quarter 2008 results of $1.0 million to $2.0 million, representing the net impact of raw material and other cost increases in excess of sales price increases that are expected to go into effect during this period. On a longer-term basis, we expect to fully recover material, labor and other increases through price increases and company-wide cost reduction initiatives.
We remain optimistic about the demand for our products and continue to be committed to expanding our manufacturing capacity and the geographic scope of our operations. Several of our production facilities are operating at very high levels of output and are near full capacity. As a result, we are currently expanding capacity at the following plants: Eschweiler, Germany; Kovin, Serbia; Le Nouvion, France; Singapore; Clearwater, Florida and Kinston, North Carolina. A portion of the additional manufacturing capacity from the Eschweiler, Kovin, Singapore and Kinston projects will become available toward the end of 2008, with full completion of these projects expected by the end of 2009. The construction of our new production facility in China, which will manufacture plastic components for intravenous systems, is progressing and we are in the process of finalizing the detailed design work for the building itself. We anticipate completion of construction and customer product validation activities for the China plastics plant by the end of 2009, and we continue to evaluate opportunities for constructing rubber manufacturing facilities in China and India.
Recent Trends and Developments - Tech Group Segment
Our Tech Group segment continues to respond to the loss of revenues from the production of the Exubera® inhalation device, which our customer and its licensing partner discontinued marketing at the end of 2007, as well as decreased demand for certain other customer products following 2007 product launch activities. At the same time, we have experienced stronger than expected demand for several products, including components used in intravenous ("IV") and blood filter products, auto-injection insulin pens and intra-nasal systems used in the delivery of allergy medications. We expect 2008 net sales in our Tech Group segment to be between 8% and 10% lower than in 2007 on a constant currency basis, as the improvement in sales of other products only partially offset the lost 2007 Exubera® device sales of $33 million.
As part of a plan to reduce Tech Group operating costs, we initiated a series of restructuring initiatives in 2007 to reduce production, engineering and administrative operations and consolidate our tool shops into one location. We now expect to incur restructuring costs totaling between $3 million and $4 million in 2008 and the first half of 2009 as we complete these programs, realizing $3 million of cost savings within 2008 and annual operating savings in future years of approximately $7 million. The Tech Group segment is also affected by higher raw material and energy costs, but, the majority of our contractual arrangements in this business allow us to pass these costs on to our customers. We believe that the combination of the leaner cost structure made possible by our restructuring initiatives, the increased utilization of Tech Group production facilities, and an improved outlook for several products, will more than offset the operating profit impact from the loss of the Exubera® inhalation device sales and other revenue-related constraints in 2008. On a longer-term basis, we believe that the Tech Group segment will benefit from our innovation initiatives in developing proprietary products incorporating new technologies. With the construction of our Grand Rapids, Michigan plant now completed, the majority of our current capital spending within the Tech Group is focused on routine facility and equipment upgrades.
Research and Development Activities
We expect consolidated research and development spending in 2008 to reach $21 million, 30% more than what was incurred in 2007. A major focus of our innovation team is the development of pre-fillable syringe systems, a passive needle safety device and an advanced injection system using auto-injector technology. We anticipate that the majority of these developmental injectable packaging and delivery systems will be manufactured by our Tech Group segment and marketed by our Pharmaceutical Systems segment. We believe that our commitment to develop and apply proprietary technologies that improve the quality, safety and effectiveness of therapeutic and diagnostic healthcare delivery systems will result in continued long-term growth for our company.
RESULTS OF OPERATONS
NET SALES
The following table summarizes net sales by reportable segment:
Three Months Ended Nine Months Ended
Net sales: September 30, September 30,
($ in millions) 2008 2007 2008 2007
Pharmaceutical Systems $ 190.5 $ 173.8 $ 610.6 $ 554.5
Tech Group 68.3 71.4 204.3 218.1
Intersegment sales (2.6 ) (2.5 ) (8.6 ) (8.6 )
Total net sales $ 256.2 $ 242.7 $ 806.3 $ 764.0
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Consolidated third quarter 2008 net sales increased by $13.5 million, or 5.6%, over those achieved in the third quarter of 2007. Foreign currency translation accounted for $9.4 million, or 3.9 percentage points, of the sales growth. Excluding foreign currency translation, third quarter 2008 net sales increased $4.1 million or 1.7% as compared to the prior year quarter. Sales price increases contributed approximately 2.4 percentage points to consolidated sales growth in the comparison of the 2008 to 2007 third quarter results. Price increases and raw material surcharges were implemented in response to the rising cost of raw materials, plant utilities and transportation costs.
Consolidated net sales for the nine months ended September 30, 2008 increased by $42.3 million, or 5.5%, compared to the first nine months of 2007. The favorable effect of foreign currency translation accounted for $43.6 million, or 5.7 percentage points, of the sales growth. Excluding foreign currency translation effects, consolidated 2008 year-to-date net sales decreased $1.3 million, or 0.2%, from the prior year. Sales price increases and surcharges in 2008 contributed approximately 1.8 percentage points to consolidated sales growth.
Pharmaceutical Systems Segment
In the Pharmaceutical Systems segment, third quarter 2008 net sales were $16.7 million, or 9.6%, favorable to those achieved in the prior year quarter. The favorable impact of foreign currency translation accounted for $8.2 million, or 4.7 percentage points, of the increase. Excluding the foreign currency translation effect, third quarter 2008 net sales in the Pharmaceutical Systems segment were $182.3 million, or 4.9%, above those achieved in the third quarter of 2007. Sales growth in the Pharmaceutical Systems segment continues to be limited by the impact of regulatory and insurance reimbursement issues affecting the demand for certain customer products designed to treat anemia in cancer and other patients, resulting in a $3.6 million decrease in third quarter 2008 versus 2007 sales of components used in the packaging of these products. These sales decreases were more than offset by a $7.1 million increase in sales of stoppers used in vial packaging for a variety of customer products, many of which incorporate our advanced coating treatments and our Westar® Ready-to-Sterilize process. In addition, we experienced increased sales of safety and administration systems products and Flip-off® seals used in flu vaccine packaging. Sales of other medical device components were $2.4 million higher, offsetting a majority of the $3.2 million in lower sales resulting from our decision to cease production of low-margin components used in blood collection systems.
Pharmaceutical Systems segment sales for the nine month period ended September 30, 2008 were $56.1 million, or 10.1%, higher than in the corresponding prior year period, including $38.9 million resulting from the favorable effect of foreign currency translation. Excluding the effect of foreign currency translation, Pharmaceutical Systems net sales were $17.2 million, or 3.1%, above prior year levels. Sales growth continued to be constrained by a reduction of $17.7 million and $11.0 million, respectively, in sales resulting from the impacts of the issues affecting the demand for our customers' anemia products and our decision to discontinue production of the components used in blood collection systems.
These sales declines were more than offset by an overall increase in sales of pharmaceutical packaging and processing components, led by a significant increase in sales to generic pharmaceutical and contract manufacturing operations. Sales also benefited from continuing demand for our drug reconstitution and delivery products and increased sales of components used in pre-filled syringes.
Tech Group Segment
Tech Group segment third quarter 2008 net sales were $68.3 million, or 4.4%, below those reported in the third quarter of 2007. The effect of foreign currency translation was favorable by $1.2 million, or 1.8 percentage points, to the prior year quarter. Excluding foreign currency translation effects, third quarter 2008 net sales in the Tech Group segment were $67.1 million, or 6.2%, below those achieved in the third quarter of 2007. The majority of the decline in Tech Group segment sales was due to the absence of 2008 sales of the Exubera® inhalation device following an October 2007 decision by our customer's licensing partner to discontinue marketing the product. Net sales of the Exubera® device were $7.3 million in the third quarter of 2007. In addition, the Tech Group segment experienced a $3.7 million decrease in sales of packaging for a customer's weight loss product launched in June of 2007, for which we have no sales in 2008. On the positive side, sales of IV and blood filter products were $3.8 million above third quarter 2007 levels, and sales of self-injection pens used for the delivery of insulin were $3.3 million higher due primarily to increases in volume. We also continued to see strong sales increases of an intra-nasal delivery system used in a customer's allergic rhinitis treatment, and increased sales of a juice and dairy product packaging system, which more than offset sales declines in containers for personal care products.
Tech Group segment year-to-date net sales were $13.8 million below prior year levels. Foreign currency translation effects for that period were $4.7 million favorable to 2007. Excluding the effect of foreign currency translation, 2008 year-to-date Tech Group segment sales were $18.5 million, or 8.5%, unfavorable to those achieved in 2007. The loss of sales resulting from the discontinuation of the Exubera® inhalation device accounts for $27.4 million of lower sales. Sales for the first nine months of 2007 also benefited from $10.6 million of revenue derived from packaging for the customer's weight loss product discussed above. These sales declines were partially offset by increased revenues from IV filter components, together with strong demand for self-injection insulin pens, intra-nasal drug delivery systems and our juice and dairy closure product.
GROSS PROFIT
The following table summarizes our gross profit and related gross margins by
reportable segment:
Three Months Ended Nine Months Ended
Gross profit: September 30, September 30,
($ in millions) 2008 2007 2008 2007
Pharmaceutical Systems Segment
Gross Profit $ 56.2 $ 55.2 $ 204.3 $ 194.1
Gross Margin 29.5 % 31.8 % 33.5 % 35.0 %
Tech Group Segment
Gross Profit $ 9.8 $ 9.1 $ 28.7 $ 27.2
Gross Margin 14.4 % 12.7 % 14.1 % 12.5 %
Consolidated Gross Profit $ 66.0 $ 64.3 $ 233.0 $ 221.3
Consolidated Gross Margin 25.7 % 26.5 % 28.9 % 29.0 %
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Third quarter 2008 consolidated gross profit increased by $1.7 million over the 2007 third quarter, consisting of a $1.0 million increase in Pharmaceutical Systems segment gross profit and a $0.7 million increase in Tech Group segment gross profit. The effect of foreign currency translation was $2.3 million favorable to 2008 gross profit, but unfavorable to the gross margin percentage as the relative impact on costs was greater than the benefit to sales.
In the Pharmaceutical Systems segment, our third quarter 2008 gross margin declined by 2.3 percentage points from that achieved in the third quarter of 2007. The majority of the decrease was due to higher plant overhead costs related to increased staffing for quality support and other plant management positions in North America, project management costs associated with the plastics plant currently being constructed in China, higher plant maintenance costs in Europe, and the impact of lower volume and unfavorable mix due to the drop-off in sales of components used in customer products designed to treat anemia in patients. The positive benefit of sales price increases offset a majority of the impact from increased costs of raw materials, wage increases and utilities used to operate our production facilities. The effect of foreign currency exchange rates contributed 0.3 percentage points to the decline in gross margin.
In the Tech Group segment, gross margins improved by 1.7 percentage points by comparison to third quarter 2007 results. The improved gross margin performance was largely due to a net decrease in direct labor and plant overhead costs in North America resulting from our restructuring efforts and efficiencies from the completion of start-up activities at our new production facility in Michigan. Reduced overhead costs more than offset the negative impact on margins due to lower sales, primarily related to the loss of the Exubera® inhalation device and the weight loss product packaging activity that benefited 2007 results. During the quarter, the vast majority of raw material cost increases were passed on to customers in the form of increased selling prices.
For the nine-month period ended September 30, 2008, consolidated gross profit was $11.7 million above that reported in the same period of 2007. The effect of foreign currency translation was $13.2 million favorable in the comparison of the nine month periods, mostly benefiting the Pharmaceutical Systems segment. Gross margins in the Pharmaceutical Systems segment declined by 1.5 percentage points in the comparison of the nine month results largely due to increased staffing of manufacturing initiatives, production support positions, and higher depreciation expense. Tech Group margins improved by 1.6 percentage points from last year's nine month results, with lower overhead costs resulting from restructuring initiatives and the completion of our Michigan plant relocation and start-up activities. These savings more than offset the negative impact of the lost sales volume described above. For both Pharmaceutical Systems and the Tech Group, sales price increases during the year-to-date period offset a majority of the negative impact from higher raw material costs, wage increases and plant utility costs.
RESEARCH AND DEVELOPMENT ("R&D") COSTS
Three Months Ended Nine Months Ended
Research and development (R&D): September 30, September 30,
($ in millions) 2008 2007 2008 2007
Pharmaceutical Systems segment $ 4.2 $ 3.6 $ 13.6 $ 9.9
Tech Group segment 0.4 0.5 1.2 1.6
Total R&D expense $ 4.6 $ 4.1 $ 14.8 $ 11.5
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R&D costs for the three and nine month periods ended September 30, 2008 were $0.5 million and $3.3 million, respectively, above those incurred in the corresponding periods of 2007, mostly due to three ongoing development projects in the Pharmaceutical Systems segment. The first is our development of pre-fillable syringe systems that will use Daikyo's Crystal Zenith® resin, a unique, transparent polymer that can be used to produce vials and syringe barrels. Daikyo Seiko, Ltd., our 25% owned affiliate in Japan, is also our partner in a long-standing marketing and technology transfer agreement that enables West and Daikyo to develop products that help customers mitigate drug product development risks and enhance patient safety. The other projects are an advanced injection system using auto-injector technology, which was acquired in the first quarter of 2007, and a passive needle safety device.
SELLING, GENERAL AND ADMINISTRATIVE ("SG&A") COSTS
The following table summarizes SG&A costs by reportable segment including
corporate and unallocated costs:
Three Months Ended Nine Months Ended
Selling, general and administrative
costs (SG&A): September 30, September 30,
($ in millions) 2008 2007 2008 2007
Pharmaceutical Systems SG&A costs $ 28.7 $ 25.0 $ 83.6 $ 72.7
Pharmaceutical Systems SG&A as a % of
segment net sales 15.1 % 14.4 % 13.7 % 13.1 %
Tech Group SG&A costs $ 4.4 $ 5.4 $ 13.6 $ 16.5
Tech Group SG&A as a % of segment net
sales 6.5 % 7.6 % 6.7 % 7.6 %
Corporate costs:
General corporate costs 3.8 4.9 13.7 15.7
Stock-based compensation expense 3.1 1.0 7.1 3.4
U.S. pension and other retirement
benefits 1.5 1.4 4.5 4.5
Total Selling, General & Administrative
costs $ 41.5 $ 37.7 $ 122.5 $ 112.8
Total SG&A as a % of total net sales 16.2 % 15.5 % 15.2 % 14.8 %
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Consolidated SG&A expenses for the three and nine month periods ended September 30, 2008 were $3.8 million and $9.7 million, respectively, above those recorded in the corresponding periods of 2007. Foreign currency translation accounted for $1.2 million and $4.8 million of the increase in the three and nine month period comparisons, respectively.
In the Pharmaceutical Systems segment, third quarter and year-to-date 2008 SG&A expenses increased by $3.7 million and $10.9 million, respectively, over the corresponding prior year periods. Foreign currency translation accounted for $1.2 million and $4.6 million, respectively, of the increase in SG&A costs in the comparison of the three and nine month results of 2008 versus 2007. Compensation costs were $1.2 million and $3.3 million, respectively, above those incurred in the 2007 third quarter and nine month periods due to the impact of annual pay increases, increased staffing of information technology support functions and post-employment benefit costs in Brazil. Depreciation costs, primarily associated with the first phase of a new information systems implementation, accounted for $0.7 million and $0.5 million, respectively, of the increase during the three and nine month periods. Consulting costs for the preliminary design of new information systems resulted in increased spending of $0.6 million during the nine-month period when compared to the prior year. Various other increases including facilities costs and utilities contributed to the remaining increase in SG&A spending in both the three and nine month period comparisons.
Third-quarter and year-to-date 2008 SG&A costs in the Tech Group segment were $1.0 million and $2.9 million, respectively, below the corresponding prior year periods. A net reduction in headcount associated with our restructuring efforts accounted for a majority of the reduction in SG&A. The remainder of the reduction was attributable to lower amortization expense of intangible assets, a reduction in various consulting services, as well as the positive effect of bad debt recoveries.
General corporate SG&A costs include executive compensation, director compensation, legal, compliance, finance, communications and other administrative expenses. These costs were $1.1 million and $2.0 million below those incurred in the three and nine month periods of 2007, respectively. The majority of this 2008 decrease in both the three and nine month periods relates to a reduction in accrued liabilities for our annual management incentive plan bonus, which is adjusted periodically based upon progress toward attainment of certain financial and other performance criteria.
Stock-based compensation costs for the third quarter and year-to-date period ended September 30, 2008 were $2.1 million and $3.7 million, respectively, above those incurred in 2007, almost entirely due to the impact of changes in our stock price on our stock-price indexed deferred compensation plans. Our stock price increased $8.23 per share during the first nine months of 2008, closing at $48.82 per share on September 30, 2008. During the first nine months of 2007, our stock price decreased $9.57 per share, closing at $41.66 per share on September 30, 2007. Likewise, our stock price increased during the third quarter 2008 and decreased during the third quarter of 2007. The resulting change in the fair value of our deferred stock unit liabilities accounts for substantially all of the comparative increase in stock-based compensation costs.
U.S. pension plan expenses in the three and nine month periods ended September 30, 2008 were relatively consistent with the comparable 2007 periods. We anticipate full-year 2008 U.S. pension and other retirement benefits costs of approximately $6.0 million, essentially equal to those incurred during 2007. The costs of non-U.S. pension and other retirement benefits programs are reflected in the operating profit of the respective segment.
RESTRUCTURING AND OTHER ITEMS Other income and expense items, consisting of gains, losses or impairments of segment assets, foreign exchange transaction items and miscellaneous royalties and sundry transactions are generally recorded within the respective segment. . . . |
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