- Annual Report (10-K)
18 Fevereiro 2010 - 11:16AM
Edgar (US Regulatory)
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2009
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
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Commission File Number: 1-31946
HOSPIRA, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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20-0504497
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(State or other jurisdiction
of incorporation or organization)
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(I.R.S. Employer
Identification No.)
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275 North Field Drive
Lake Forest, Illinois 60045
(Address of principal executive offices, including zip code)
(224) 212-2000
(Registrant's telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
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Title of Class
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Name of Exchange on which each class is registered
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Common Stock, par value $0.01 per share
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New York Stock Exchange
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Preferred Stock Purchase Rights
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New York Stock Exchange
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Securities
registered pursuant to Section 12(g) of the Act: Common Stock:
None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes
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No
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Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes
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No
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Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act
of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the
past 90 days. Yes
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No
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Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§229.405 of this chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files). Yes
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No
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Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be
contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to
this Form 10-K.
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Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting
company. See definitions of "large accelerated filer," "accelerated filer," "non-accelerated filer," and "smaller reporting company" in Rule 12b-2 of the Exchange Act.
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Large accelerated filer
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Accelerated filer
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Non-accelerated filer
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(Do not check if a smaller reporting company)
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Smaller reporting company
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes
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No
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The aggregate market value of registrant's common stock held by non-affiliates of the registrant on June 30, 2009 (the last business day of the
registrant's most recently completed second fiscal quarter), was approximately $6,201.4 million.
Registrant
had 163,850,606 shares of common stock outstanding as of February 5, 2010.
INCORPORATION OF DOCUMENTS BY REFERENCE
Certain sections of the registrant's Proxy Statement to be filed in connection with the 2010 Annual Meeting of Shareholders are incorporated by reference into
Part III of this Form 10-K where indicated. The 2010 Proxy Statement will be filed on or about March 26, 2010.
Table of Contents
HOSPIRA, INC.
ANNUAL REPORT ON FORM 10-K
TABLE OF CONTENTS
Table of Contents
FORWARD-LOOKING STATEMENTS
This annual report contains forward-looking statements within the meaning of the federal securities laws. Hospira intends that these
forward-looking statements be covered by the safe harbor provisions for forward-looking statements in the federal securities laws. In some cases, these statements can be identified by the use of
forward-looking words such as "may," "will," "should," "anticipate," "estimate," "expect," "plan," "believe," "predict," "potential," "project," "intend," "could" or similar expressions. In
particular, statements regarding Hospira's plans, strategies, prospects and expectations regarding its business and industry are forward-looking statements. You should be aware that these statements
and any other forward-looking statements in this document only reflect Hospira's expectations and are not guarantees of performance. These statements involve risks, uncertainties and assumptions. Many
of these risks, uncertainties and assumptions are beyond Hospira's control, and may cause actual results and performance to differ materially from its expectations. Important factors that could cause
Hospira's actual results to be materially different from its expectations include (i) the risks and uncertainties described in "Item 1A. Risk Factors" and (ii) the factors
described in "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations." Accordingly, you should not place undue reliance on the forward-looking statements
contained in this annual report. These forward-looking statements speak only as of the date on which the statements were made. Hospira undertakes no obligation to update or revise publicly any
forward-looking statements, whether as a result of new information, future events or otherwise.
PART I
Item 1. Business
Overview
Hospira, Inc. ("Hospira") is a global specialty pharmaceutical and medication delivery company that develops, manufactures and
markets products that help improve the safety, cost and productivity of patient care. Hospira's portfolio includes generic acute-care and oncology injectables, as well as integrated
infusion therapy and medication management systems. Hospira's portfolio of products is used by hospitals and alternate site providers, such as clinics, home healthcare providers and
long-term care facilities.
Hospira
conducts operations worldwide and is managed in three reportable segments: Americas; Europe, Middle East and Africa ("EMEA"); and Asia Pacific ("APAC"). The Americas segment
includes the United States ("U.S."), Canada and Latin America; the EMEA segment includes Europe, the Middle East and Africa; and the APAC segment includes Asia, Japan, Australia and New Zealand. In
all segments, Hospira sells a broad line of products, including specialty injectable and other pharmaceuticals and medication management systems and other devices. For financial information relating
to Hospira's segments and the geographic areas, see Note 12 to the consolidated financial statements included in Item 8 of this document, which is incorporated herein by reference.
Unless the context requires otherwise, the disclosures in Items 1 and 1A relate to all three reportable segments.
General Development of Business
Hospira was incorporated in Delaware on September 16, 2003, as a wholly owned subsidiary of Abbott Laboratories ("Abbott").
Hospira's business first began operation as part of Abbott in the 1930s. As part of a plan to spin off its core hospital products business ("spin-off"), Abbott transferred the assets and
liabilities relating to Hospira's business to Hospira and, on April 30, 2004, distributed Hospira's common stock to Abbott's shareholders. On that date, Hospira began operating as an
independent company, and on May 3, 2004, Hospira's common stock began trading on the New York Stock Exchange under the symbol "HSP."
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In
February 2007, Hospira acquired Mayne Pharma Limited ("Mayne Pharma"), an Australia-based specialty injectable pharmaceutical company listed on the Australian Stock Exchange, for
$2,055.0 million in cash. Hospira's financial statements included in this report do not include the financial results of Mayne Pharma for any of the periods or at any of the dates presented
prior to February 2007. Hospira has completed integrating Mayne Pharma into its operations.
In
March 2009, Hospira announced details of a restructuring and optimization plan ("Project Fuel"), which would occur over the next 2 years from the date of announcement. Project
Fuel includes the following activities: optimizing the product portfolio, evaluating non-strategic assets and streamlining the organizational structure. For further information related to
Project Fuel, including the financial impact of the project, see the section captioned Project Fuel in "Item 7. Management's Discussion and Analysis of Financial Condition and Results of
Operations," which is incorporated herein by reference.
In
December 2009, Hospira announced an agreement to acquire a certain business of Orchid Chemicals & Pharmaceuticals Ltd. ("Orchid Pharma"), an Indian pharmaceutical
company for approximately $400 million. The acquisition includes U.S. Food and Drug Administration ("FDA") approved facilities and equipment used for the manufacture of beta-lactam
antibiotics, the site's pharmaceutical research and development facility, the generic injectable product portfolio and pipeline and the employees associated with the operation. The transaction is
expected to close in the first quarter of 2010.
Products
Hospira offers the following types of products and services:
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Product Line
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Description
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Specialty Injectable Pharmaceuticals
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Approximately 200 injectable generic drugs
in multiple dosages and formulations
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Proprietary specialty injectables,
including Precedex
TM
(dexmedetomidine HCl), a proprietary drug for sedation
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Retacrit
TM
(erythropoietin
zeta), a biogeneric version of erythropoietin, used primarily in the treatment of anemia in dialysis and in certain oncology applications
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Other Pharmaceuticals
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Large volume intravenous ("I.V.")
solutions and nutritional products
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Contract manufacturing
services
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Medication Management Systems
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Infusion pumps and administration sets
for the infusion pumps
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Hospira MedNet
TM
safety
software system and related services
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Software applications and devices that
support point of care medication administration
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Other Devices
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Gravity administration sets
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Other device products
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Specialty Injectable Pharmaceuticals
Hospira's specialty injectable pharmaceutical products primarily consist of generic injectable pharmaceuticals, which provide customers
with a lower-cost alternative to branded products that are no longer patent protected. These drugs' therapeutic areas include analgesia, anesthesia, anti-infectives,
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cardiovascular,
oncology, and other areas. All of Hospira's generic injectable pharmaceuticals in the U.S. include unit-of-use bar-code labels that can be used to
support safer medication delivery. Hospira primarily procures the active pharmaceutical ingredients in these products from third-party suppliers.
During
2009, Hospira broadened its global portfolio with the introduction into new markets of more than 23 drugs that the company had previously launched in other markets. In addition,
Hospira launched several new generic injectable pharmaceutical products in the U.S. including oxaliplatin and azithromycin, both for injection, and expanded its offering of heparin to include
high-dose flip-top vials. Hospira has launched its first biogeneric, Retacrit
TM
, in 16 EMEA countries. Biogeneric products, also called biosimilars, are large
complex molecules derived from cells that are demonstrated to be similar to an approved biologic product.
Hospira
believes that novel drug delivery formulations and formats are key points of product differentiation for generic injectable pharmaceuticals. Hospira offers a wide variety of drug
delivery options, and believes that its products assist its customers' efforts to enhance safety, increase productivity and reduce waste. Hospira's drug delivery formats include standard offerings in
ampoules and flip-top vials, which clinicians can use with standard syringes. Hospira's proprietary drug delivery options include Carpuject
TM
and iSecure
TM
prefilled syringes, Ansyr
TM
prefilled needleless emergency syringe systems, First Choice
TM
ready-to-use premixed formulations and the
ADD-Vantage
TM
system for preparing drug solutions from prepackaged drug powders or concentrates.
Hospira's
specialty injectable pharmaceutical product portfolio also includes Precedex
TM
(dexmedetomidine HCl), a proprietary sedative. Precedex
TM
is licensed
to Hospira in the Americas and APAC segments, and in the Middle East and Africa. Hospira sells and markets Precedex
TM
for use in non-intubated patients requiring sedation, as
well as intubated and mechanically ventilated patients.
Other Pharmaceuticals
Hospira's other pharmaceuticals primarily consist of large volume I.V. solutions, nutritionals and contract manufacturing services.
Hospira
offers infusion therapy solutions and related supplies that include I.V. solutions for general use, I.V. nutrition products, and solutions for the washing and cleansing of wounds
or surgical sites. All of Hospira's injectable I.V. solutions in the U.S. include unit-of-use bar-code labels that can be used to support medication
management efforts. Hospira also offers infusion therapy solutions in its VisIV
TM
next-generation non-PVC, non- DEHP I.V. container, an I.V. bag with
advanced safety and environmentally friendly features.
Hospira's
One2One
TM
services group provides formulation development, filling and finishing of injectable and oral drugs worldwide. Hospira works with its proprietary
pharmaceutical and biotechnology customers to develop stable injectable forms of their drugs, and Hospira fills and finishes those and other drugs into containers and packaging selected by the
customer. The customer then sells the finished products under its own label. Hospira's One2One
TM
manufacturing services group does not generally manufacture active pharmaceutical
ingredients, but offers a wide range of filling and finishing services in a variety of delivery systems. As part of Project Fuel, in 2009 and early 2010, Hospira sold its facilities in Salisbury,
Australia and Wasserburg, Germany which primarily performed contract manufacturing.
Medication Management Systems
Medication management systems include electronic drug delivery pumps, safety software and disposable administration sets dedicated to
Hospira pumps. These sets are used to deliver I.V. fluids and medications. Hospira also offers software maintenance agreements and other service offerings. Hospira estimates that approximately 550,000
of its electronic drug delivery pumps were in use on a
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global
basis as of December 31, 2009. Hospira's electronic drug delivery pumps include Hospira's general infusion system, Symbiq
TM
; the Plum A+
TM
line of infusion
pumps; Hospira's patient-controlled analgesia device, LifeCare PCA
TM
; GemStar
TM
ambulatory infusion pump; and Plum
TM
XLD infusion pump.
Hospira
believes that electronic drug delivery pumps with enhanced systems capabilities have become a key contributor in efforts to improve medication management programs and reduce the
incidence of medication errors. Some of Hospira's pumps use bar coding to read drug labels that are compatible with other Hospira products, reducing the opportunity for drug infusion errors. Hospira
offers the Hospira MedNet
TM
safety software system, which has been designed to enable hospitals to customize intravenous drug dosage limits and track drug delivery to prevent medication
errors. Through its drug library and programmable drug dosage limits, the system can help ensure that medication is infused within hospital-defined dose guidelines and best practices. The wireless
network version of the Hospira MedNet
TM
system establishes real-time send-and-receive capability and can interface with select hospital and pharmacy
information systems. Hospira continues to work with hospital information technology companies to integrate the Hospira MedNet
TM
system with other systems.
The
Hospira MedNet
TM
system is standard in the Symbiq
TM
infusion system, and is also available as an additional feature for the Plum A+
TM
line
of infusion pumps, and LifeCare PCA
TM
patient-controlled analgesia device, which, when aggregated represent the majority of Hospira's line of electronic drug delivery pumps. Hospira also
offers safety software with its GemStar
TM
ambulatory infusion pump.
Medication
management systems also include the VeriScan
TM
Rx Medication Administration System, a software application that supports bar code medication administration at
the point of care and the EndoTool
TM
glucose management system, a software system that helps establish and maintain patient glycemic control in acute, critical care and operating room
settings. Hospira has submitted a 510k application on the integration of its Symbiq
TM
pump with the EndoTool
TM
glucose management software system, while still offering
EndoTool
TM
on a stand-alone basis. In 2009, Hospira acquired TheraDoc, Inc. and its Infection Control Assistant
TM
and Antibiotic Assistant
TM
products,
software applications that automate hospital-wide surveillance for infection-related events and optimize the utilization of antimicrobials.
Other Devices
The other devices product line includes gravity administration sets and other devices products. Other devices also included the
critical care product line until August 2009. As part of Project Fuel's evaluation of non-strategic assets, in August 2009, Hospira sold the commercial rights and the physical assets of
its critical care product line to ICU Medical, Inc. ("ICU Medical").
The
devices products include needlestick safety products and programs to support Hospira's customers' needlestick prevention initiatives. LifeShield
TM
,
CLAVE
TM
and MicroCLAVE
TM
connectors are one-piece valves that directly connect syringes filled with medications to a patient's I.V. line without the use of
needles. ICU Medical's CLAVE
TM
connectors are a component of administration sets sold by Hospira to its customers in the U.S. and select markets outside the U.S.
Sales, Customers and Distribution
Sales.
Net sales (gross sales less reductions for wholesaler chargebacks, rebates, returns and other allowances) in the Americas
segment accounted
for approximately 79% of Hospira's 2009 net sales. Net sales in the EMEA and APAC segments comprised approximately 14% and 7%, respectively, of 2009 net sales. Hospira's sales organizations include
sales professionals who sell across its major product lines, as well as product specialists who detail and promote its medication management systems, or who market and sell Precedex
TM
and select other products. Hospira also has extensive experience
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contracting
with, marketing to and servicing members of the major group purchasing organizations ("GPOs") in the U.S.
Customers.
Hospira's primary customers in the Americas segment include hospitals, wholesalers,
integrated delivery networks ("IDN") and alternate site facilities. In the U.S., a substantial portion of Hospira's product is sold to GPO member hospitals and through wholesalers and
distributors. Net sales through the largest four wholesalers that supply products to many end-users accounted for approximately 42% of global net sales during 2009. As
end-users have multiple ways to access Hospira's products, including through more than one wholesaler or distributor, and, in some cases, from Hospira directly, Hospira believes that it is
not dependent on any single wholesaler or distributor for distribution of its products. Hospira has no single end-use customer that accounts for more than 10% of net sales. Hospira has
pricing agreements for specified products with the major GPOs in the United States, including Amerinet, Inc.; Broadlane Inc.; HealthTrust Purchasing Group LP;
MedAssets, Inc.; Novation, LLC; PACT, LLC; and Premier Purchasing Partners, LP. The scope of products included in these agreements varies by GPO.
Hospira's
primary customers in the EMEA and APAC segments are hospitals and wholesalers that Hospira serves through its own sales force and its distributors. The majority of Hospira's
business in the EMEA and APAC segments is conducted through contracting with individual hospitals or through regional or national tenders whereby Hospira submits bids to sell its products.
Distribution.
In the America segment, Hospira's products are primarily distributed in the U.S. through a network of company-operated
distribution
facilities and public warehouses, as well as through external distributors. The U.S. distribution facilities Hospira operates are located in Atlanta, Georgia; Dallas, Texas; King of Prussia,
Pennsylvania; Los Angeles, California; and Pleasant Prairie, Wisconsin. For the remainder of the Americas segment outside the U.S., Hospira utilizes third-party logistics providers, including
operations in Toronto, Canada, and several smaller warehouses in Canada and Latin America.
In
the EMEA and APAC segments, Hospira manages its distribution operations mainly through third-party logistics providers. Hospira's regional headquarters are located in Royal Leamington
Spa, United Kingdom, for EMEA and Melbourne, Australia, for APAC. Hospira has direct commercial infrastructure in some countries and operates through distributors in others.
Seasonal Aspects, Backlog and Renegotiation
There are no significant seasonal aspects to Hospira's consolidated net sales. Hospira believes that backlogged orders do not represent
a material portion of its sales or provide a meaningful indication of future sales. No material portion of Hospira's business is subject to renegotiation of profits or termination of contracts at the
election of the government.
Product Development and Manufacturing
Hospira's product development programs are concentrated in the areas of specialty injectable pharmaceuticals and medication management
systems. Hospira also maintains an active development program to support its injectable pharmaceutical contract manufacturing relationships. Hospira engages in programs to bring new products to market
that are unique or that enhance the effectiveness, ease of use, productivity, safety or reliability of existing product lines. Hospira also engages in programs to expand the use of products in new
markets or new applications. Hospira operates significant product development facilities in Lake Forest, Illinois; McPherson, Kansas; San Diego, California; Mulgrave, Victoria, Australia; and
Adelaide, South Australia, Australia.
In
Hospira's specialty injectable pharmaceuticals product line, Hospira is actively working to develop small molecule compounds. For certain of these compounds, Hospira is actively
pursuing a
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strategy
of challenging the intellectual property of proprietary pharmaceutical companies in an effort to be the first generic company to the market. Hospira is also actively working to develop and
commercialize biosimilars products. In addition to the launch of Retacrit
TM
in the European Union in 2008, Hospira has also accomplished other significant milestones with biogenerics,
including the submission of a dossier for marketing authorization to the European Union for filgrastim and the initiation of a Phase 1 study for pegfilgrastim, the long-acting
version of filgrastim. Filgrastim and pegfilgrastim are used primarily in the treatment of neutropenia (low white blood cells) in patients who have received a chemotherapeutic agent. In 2009, Hospira
acquired worldwide rights to the biogeneric version of filgrastim and a biologic manufacturing facility from PLIVA Hrvatska d.o.o. This is in alignment with Hospira's biogenerics strategy, which is to
expand its biogenerics portfolio and capabilities with measured investment and risk. In 2008, Hospira entered into a process development and bulk drug manufacturing relationship with Human Genome
Sciences ("HGS") for biogeneric products for the U.S. market. In the fourth quarter of 2009, Hospira entered into an agreement with Celltrion, Inc. and Celltrion Healthcare, Inc. to
develop and market eight biogeneric molecules, five of which are new to Hospira's biogeneric portfolio. With the addition of the five incremental Celltrion biogenerics, Hospira's biogeneric pipeline
has been expanded to eleven biogeneric products.
Hospira
continues to invest in Precedex
TM
for expansion of clinical use and is seeking opportunities to selectively invest in various other proprietary systems and
molecules that align with its business strategy. In 2009, Hospira and ChemGenex Pharmaceuticals Limited ("ChemGenex") entered into a collaborative agreement to develop, license, and commercialize a
ChemGenex proprietary oncology product candidate in EMEA.
Hospira's
key programs in the area of medication management systems include the development of advanced infusion platforms and systems, including its Hospira MedNet
TM
safety software system, and systems that emphasize ease of use for clinicians, including its Symbiq
TM
infusion pump. Hospira has
entered into alliances with several leading information technology companies to develop interfaces that enable the Hospira MedNet
TM
system to be used with a variety of hospital
information systems and to improve cost efficiencies in patient management. Hospira expects to continue entering into strategic alliances as part of its "open architecture system" strategy for the
Hospira MedNet
TM
system. Hospira also has submitted a 510k application on the integration of its Symbiq
TM
pump with the EndoTool
TM
glucose management software
system, while still offering the EndoTool
TM
on a stand alone basis. In addition, in 2009, Hospira acquired TheraDoc, Inc. and its Infection Control Assistant
TM
and
Antibiotic Assistant
TM
products, software applications that automate hospital-wide surveillance for infection-related events and optimize the utilization of antimicrobials.
Hospira's
research and development expenses were $240.5 million in 2009, $211.9 million in 2008 and $201.2 million in 2007.
As
of December 31, 2009, Hospira operated 13 manufacturing facilities globally. Hospira's principal manufacturing facilities are identified in Item 2 of this report.
Hospira's largest facilities, located in Rocky Mount, North Carolina; Austin, Texas; LaAurora, Costa Rica; McPherson, Kansas; and Mulgrave, Victoria, Australia, account for a significant portion of
Hospira's manufacturing output. While Hospira has not experienced a significant interruption of manufacturing at those facilities, such an interruption could materially and adversely affect Hospira's
ability to manufacture and sell its products.
Raw Materials and Components
While Hospira produces some raw materials, components and active pharmaceutical ingredients at its manufacturing sites, the majority
are sourced on a global basis from third-party suppliers.
Although
many of the raw materials and components Hospira uses to produce its products are readily available from multiple suppliers, Hospira relies on supply from a single source for
many raw
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materials
and components. For example, Hospira relies on certain proprietary components available exclusively from ICU Medical. ICU Medical's CLAVE
TM
and MicroCLAVE
TM
connector products are components of administration sets that represented approximately 15% of Hospira's 2009 U.S. net sales. In addition, Hospira purchases some of its other raw materials and
components from single suppliers for reasons of quality assurance, sole-source availability, cost effectiveness or constraints resulting from regulatory requirements.
To
manage risk, Hospira continually evaluates alternate-source suppliers, although it does not typically pursue regulatory qualification of alternative sources due to the strength of its
existing supplier relationships, the reliability of its current supplier base, and the time and expense associated with the regulatory process. Although a change in suppliers could require significant
effort or investment by Hospira in circumstances where the items supplied are integral to the performance of its products or incorporate unique technology, Hospira does not believe that the loss of
any existing supply arrangement (other than its CLAVE
TM
supply arrangement with ICU Medical, which continues through 2014) would have a material adverse effect on its business.
Quality Assurance
Hospira has developed and implemented quality systems and concepts throughout its organization. Hospira is actively involved in setting
quality policies and managing internal and external quality performance. Its quality assurance department provides quality leadership and supervises its quality systems. An active audit program,
utilizing both internal and external auditors, monitors compliance with applicable regulations, standards and internal policies. In addition, Hospira's facilities are subject to periodic inspection by
the FDA and other regulatory authorities. Hospira has received notices from regulatory authorities alleging violations of applicable regulations and standards, and Hospira has developed definitive
action plans, implemented remedial programs and modified its practices to address these issues. During 2009, Hospira received a warning letter from the FDA related to Hospira's corrective action plans
with respect to the failure of certain AC power cords manufactured by a third party. The affected power cords are used on certain infusion pumps and related products. Hospira initiated a voluntary
recall of the affected power cords in August 2009. Hospira has responded to the warning letter and is working closely with the FDA to conclude this matter. Hospira initiated other voluntary recalls of
certain other products and initiated field corrections and other remedial actions with respect to those products. Hospira continues to have an ongoing dialogue with the FDA. These matters have not
materially impacted Hospira's ability to market and sell its products.
Competition
Hospira's industry is highly competitive. Hospira believes that the most effective competitors in its industry are those focused on
product quality and performance, breadth of product offering, and manufacturing efficiency as well as the ability to develop and deliver cost-effective products that help hospitals improve
the safety of patient care, reduce medication errors and provide high quality care. These are increasingly important factors in a healthcare environment that requires increasing levels of efficiency
and productivity.
Hospira's
most significant competitors in specialty injectable pharmaceuticals include Baxter International Inc. ("Baxter"), Bedford Laboratories (a division of Boehringer
Ingelheim), Fresenius Medical Care AG, Sandoz, Teva Pharmaceuticals ("Teva"), as well as divisions of several multinational pharmaceutical companies. Local manufacturers of specialty injectable
pharmaceuticals also compete with Hospira on a country-by-country basis. Hospira's most significant competitors in medication management systems include Baxter, B. Braun
Melsungen AG, CareFusion and Fresenius Medical Care AG.
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Hospira
believes that it is one of the leading competitors, in terms of U.S. market share, in each of its major product lines, and believes that its size, scale, customer relationships
and breadth of product line are significant contributors to its market positions. Hospira believes that to further its competitive position it must continue to invest significantly in, and
successfully execute, its research and product development activities, and optimize its manufacturing efficiency and productivity. Particularly, within its specialty injectable product line, Hospira
seeks to maximize its opportunity to establish a "first-to-market" position for its generic injectable drugs and, within its medication management systems product line, Hospira
seeks to differentiate its products through technological innovation and an integrated approach to drug delivery. These efforts will depend heavily on the success of Hospira's research and development
programs.
In
the EMEA segment, the use of generic pharmaceuticals is subject to variations in the structure of health care systems (including purchasing practices) and government policies
regarding the use of generic products and pricing, which all lead to differing levels of customer acceptance. There are different policies and levels of generic penetration in each country in EMEA,
causing the competition for generic pharmaceuticals to differ widely. In EMEA, competitors tend to vary by country and are often smaller in scale than those in the U.S., although some consolidation
and geographic expansion is now occurring. Teva is the largest company that competes with Hospira in the generic oncology market across Europe. Hospira's other key competitors vary from country to
country.
The
use of generic pharmaceuticals in the APAC segment is subject to variations in government policies and public perception. In Australia, generic penetration is moderate and growing
primarily due to changes in government support. Competitors include Sandoz and Teva, a number of smaller competitors and the innovator companies. In Asia, Hospira sells its products primarily to
public and private hospitals. Hospira's competition in Asia tends to be with the innovator companies and multinational companies such as Teva. In Japan, the market share of generic pharmaceutical
products traditionally has been low because of quality perceptions, product format and other regulatory differences in comparison to other markets. The Japanese government is actively pursuing a
program to double generic usage within the next three years. Laws in Japan have been introduced to allow for easier substitution of generics for branded pharmaceuticals and to change financial
incentives for hospitals and clinics to use generics, in a government sponsored effort to reduce costs, which is believed to have resulted in an increased acceptance of generic pharmaceutical
products.
Patents, Trademarks and Other Intellectual Property
When possible, Hospira seeks patent and trademark protection for its products. Hospira owns, or has licenses under, a substantial
number of patents, patent applications, trademarks and trademark applications. Hospira is in patent litigation concerning its proprietary product, Precedex
TM
. The patents at issue in
that litigation are detailed in Item 3 "Legal Proceedings."
Employees
As of December 31, 2009, Hospira had approximately 13,500 employees. Approximately 7,400 employees were in the U.S. Hospira
believes that it generally has a good relationship with its employees and the works councils and unions that represent certain employees.
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Governmental Regulation and Other Matters
Hospira's operations and business activities are subject to extensive legal and regulatory requirements that are enforced by numerous
governmental agencies in the countries in which it does business. If it were determined that Hospira was not in compliance with these laws and regulations, Hospira could be subject to criminal and/or
civil liability and other material adverse effects. Hospira has compliance programs in place to ensure compliance with these laws and believes that it is in compliance in all material respects with
applicable laws and regulations, including those described below.
Drug and Medical Device Laws
Most of Hospira's products and facilities and those of Hospira's suppliers are subject to drug and medical device laws and regulations
promulgated by the FDA and national and supranational regulatory authorities outside the U.S., including Health Canada's Health Products and Foods Branch, the U.K.'s Medicines and Healthcare Products
Regulatory Agency, the European
Medicines Agency for the Evaluation of Medicinal Products for Human Use and Australia's Therapeutics Goods Agency. These authorities regulate a range of activities including, among other matters,
manufacturing, post-marketing studies in humans, advertising and promotion, product labeling, post-marketing surveillance and reporting of adverse events.
All
aspects of Hospira's manufacturing and distribution of regulated products and those of Hospira's suppliers are subject to substantial governmental oversight. Facilities used for the
production, packaging, labeling, storage and distribution of drugs and medical devices must be registered with the FDA and other regulatory authorities. All manufacturing activities for these products
must be conducted in compliance with current good manufacturing practices. Hospira's manufacturing facilities and those of Hospira's suppliers are subject to periodic, routine and
for-cause inspections to verify compliance with current good manufacturing practices. New manufacturing facilities or the expansion of existing facilities require inspection and approval
by the FDA and other regulatory authorities before products produced at that site can enter commercial distribution. If, upon inspection, the FDA or another regulatory agency finds that a manufacturer
has failed to comply with current good manufacturing practices, it may take various enforcement actions, including, but not limited to, issuing a warning letter or similar correspondence, mandating a
product recall, seizing violative product, imposing civil penalties, and referring the matter to a law enforcement authority for criminal prosecution. These actions could result in, among other
things, substantial modifications to Hospira's business practices and operations; a total or partial shutdown of production in one or more of Hospira's facilities while Hospira or Hospira's suppliers
remedy the alleged violation; the inability to obtain future pre-market clearances or approvals; and withdrawals or suspensions of current products from the market. Any of these events
could disrupt Hospira's business and have a material adverse effect on Hospira's revenues, profitability and financial condition. For information related to the 2009 warning letter received by Hospira
and other voluntary recalls and corrective actions in 2009, see the section captioned "Quality Assurance."
Hospira
continues to make improvements to our products to further reduce patient safety issues. Based upon our consultations with the FDA and other regulatory authorities, these
improvements may require Hospira to initiate recalls or corrective actions if the improvement reduces the health risk posed by the product and not making the improvements to the on-market
product is deemed a patient safety issue.
Hospira's
sales and marketing activities for its products, particularly its prescription drugs and medical devices, are also highly regulated. Regulatory authorities have the power to
mandate the discontinuation of promotional materials, practices and programs that include information beyond the
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scope
of the indications in the approved or cleared labeling or that are not in compliance with specific regulatory requirements.
Some
of Hospira's drug products are considered controlled substances and are subject to additional regulation by the U.S. Drug Enforcement Administration ("DEA") and various state and
international authorities. These drugs, which have varying degrees of potential for abuse, require specialized controls for production, storage and distribution to prevent theft and diversion.
Hospira
has begun investing in the development of generic and/or similar versions of currently marketed biopharmaceuticals. In November 2005, the European Medicines Agency implemented
guidelines which provided a pathway for the approval of certain biogenerics in the European Union. In the U.S., there is no specific regulatory pathway for abbreviated approval of the majority of
biogenerics. The U.S. Congress and the FDA are considering legislation and regulatory proposals that would allow the FDA to approve and companies to market these products in the U.S. If adopted, the
specific legislative or regulatory provisions could have a material impact on Hospira's business.
Healthcare Fraud and Abuse Laws
As a manufacturer and distributor of prescription drugs and medical products to hospitals and other healthcare providers, Hospira and
its customers are subject to laws which apply to Medicare, Medicaid, and other federal and state healthcare programs in the U.S. One such law, the Anti-kickback Statute, prohibits the
solicitation, offer, payment or receipt of remuneration in return for referral or purchase, or in return for the recommending or arranging for the referral or purchase, of products covered by the
programs. The Anti-kickback Statute provides a number of exceptions or "safe harbors" for particular types of transactions. While Hospira generally does not file claims for reimbursement
from government payors, the U.S. federal government has asserted theories of liability against manufacturers under the Federal False Claims Act, which prohibits the submission of false claims to
Medicare, Medicaid, and other state and federal programs. Many states have similar fraud and abuse laws which apply to Hospira.
Anti-bribery Laws
Hospira's global activities are subject to the U.S. Foreign Corrupt Practices Act and other countries' anti-bribery laws
that have been enacted in support of the Organization for Economic Cooperation and Development's Anti-bribery Convention. These laws prohibit companies and individuals from offering or
providing anything of value to government officials with the intent of inappropriately gaining a business advantage. They also require companies to maintain accurate books and records and internal
financial controls. The enforcement of such laws in the U.S. and elsewhere has increased dramatically in the past few years. Hospira has a compliance program in place to ensure compliance with these
laws.
Environmental Laws
Hospira's manufacturing operations are subject to many requirements under environmental laws. In the U.S., the Environmental Protection
Agency and similar state agencies administer laws which restrict the emission of pollutants into the air, the discharge of pollutants into bodies of water and the disposal of hazardous substances. The
failure to obtain a permit for certain activities may be a violation of environmental laws. Most environmental agencies also have the power to shut down an operation if it is operating in violation of
environmental laws. U.S. laws also allow citizens to bring private enforcement actions in some situations. Outside the U.S., the environmental laws and their enforcement vary, and can be more
burdensome. For example, in some European countries, there are environmental taxes and laws requiring manufacturers to take back used products at the end of their useful life. This does not currently
have a significant impact on Hospira's products, but such laws are
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expanding
rapidly in Europe. Hospira has management systems in place that are intended to minimize the potential for violation of these laws.
Other
environmental laws address the contamination of land and groundwater, and require the clean-up of such contamination. Hospira has been involved with a number of sites
at which clean-up has been required, some as the sole owner and responsible party, and some as a contributor in conjunction with other parties. Hospira believes that environmental
compliance has not had, and will not have, a material adverse effect on our operations, results or competitive position.
Safety and Health Laws
In the U.S., the Occupational Safety and Health Act sets forth requirements for conditions of the workplace. Hospira's operations are
subject to many of these requirements, particularly in connection with Hospira's employees' use of equipment and chemicals at manufacturing sites that pose a potential health or safety hazard.
Transportation Laws
Hospira's operations include transporting materials defined as "hazardous" over land, sea and through the air. All of these activities
are regulated under laws administered by the U.S. Department of Transportation and similar agencies outside the U.S. They include complex requirements for packing, labeling and recordkeeping.
Customs, Export and Anti-boycott Laws
The import and export of products, technology, equipment and other business materials across national borders are subject to regulation
by U.S. agencies, including the U.S. Customs and Border Protection, the Bureau of Industry and Security, Department of Commerce and the Office of Foreign Assets ControlTreasury
Department, as well as other national and supranational regulatory authorities. As the importer and exporter of products and technologies, Hospira must comply with all applicable customs, export and
anti-boycott laws and regulations and must pay fees and duties on certain shipments.
State Laws
There are numerous legal and regulatory requirements imposed by individual states in the U.S. on pharmaceutical and medical device
companies doing business in those states. For example, several states either require the tracking and reporting of specific types of interactions which pharmaceutical and medical device companies have
with healthcare professionals or restrict such interactions.
California
has enacted Senate Bill ("SB") 1307, which provides for major changes to the California e-Pedigree laws. SB 1307 requires that drug manufacturers, like Hospira,
implement unit serialization and e-pedigree processes by 2015 that provide track and trace technology for drugs dispensed to patients in the state of California. Some of Hospira's drug
products, such as the I.V. solutions, are exempted from California's e-Pedigree requirements. Failure to comply could result in pharmacies and wholesalers not being allowed to distribute,
dispense, or accept any non-pedigreed drugs for sale in California.
Other Laws
Hospira is also subject to a variety of other laws, directives and regulations in and outside of the U.S., including income, value
added and excise taxes. Hospira stays abreast of, and plans for, proposed legislation that could significantly affect our operations. For example, Hospira tracks laws that may impact Hospira's
employees, like the U.S. Employee Free Choice Act, or laws that may impact our business and customers, such as the two U.S. healthcare reform bills: "The Affordable Health Care for
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America
Act" in the House of Representatives and the "Patient Protection and Affordable Care Act" amendment in the Senate. In the U.S., Hospira could see material changes in certain areas such as
medical device excise taxes, the 340B drug discount program, Medicaid drug rebates, medical device registry, reporting requirements for physician payments and reporting requirements for drug Average
Manufacturer Price (AMP). Tax legislation being considered around the world could also have a significant impact on our financial results.
Internet Information
Copies of Hospira's Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports
on Form 8-K, and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, are available free of charge
through the Investor Relations section of Hospira's Web site (
www.hospira.com
) as soon as Hospira electronically files the material with, or furnishes
them to, the Securities and Exchange Commission ("SEC").
Hospira's
corporate governance guidelines, code of business conduct and the charters of its audit, compensation, governance and public policy, and science and technology committees are
all available in the Investor Relations section of Hospira's Web site (
www.hospira.com
) or by sending a request to: Corporate Governance Materials
Request, Hospira General Counsel and Secretary, Hospira, Inc., 275 North Field Drive, Dept. NLEG, Bldg. H1, Lake Forest, Illinois 60045.
Hospira
also routinely posts important information for investors on its Web site (
www.hospira.com
) in its Investor Relations section.
Hospira may use this Web site as a means of disclosing material, non-public information and for complying with its disclosure obligations under SEC Regulation FD. Accordingly,
investors should monitor the Investor Relations portion of Hospira's Web
site, in addition to following Hospira's press releases, SEC filings, and public conference calls and webcasts.
Item 1A. Risk Factors
Hospira's business, financial condition, results of operations and cash flows are subject to various risks and uncertainties, including
those described below. These risks and uncertainties may cause (1) Hospira's sales and results of operations to fluctuate significantly; (2) Hospira's past performance to not be
indicative of future performance; and (3) Hospira's actual performance to differ materially from Hospira's expectations or projections. The risks described below may not be the only risks
Hospira faces. Additional risks that Hospira does not yet know of or that Hospira currently thinks are immaterial may also impair its business operations. This Form 10-K also
contains forward-looking statements that involve risks and uncertainties. Hospira's results could materially differ from those anticipated in these forward-looking statements as a result of certain
factors, including the risks described below. See the section captioned "Forward-Looking Statements."
Hospira faces significant competition and may not be able to compete effectively.
The healthcare industry is highly competitive. Hospira competes with many companies that range from small, highly focused companies to
large diversified healthcare manufacturers that have access to greater financial, marketing, technical and other resources. There has been consolidation by Hospira's competitors and customer base,
which has resulted in pricing and sales pressures, causing competition to become more intense. Hospira's present or future products could be rendered obsolete or uneconomical by technological advances
by competitors or by the introduction of competing products by one or more of its competitors. To remain competitive and bolster its competitive position, Hospira believes that it must successfully
execute various strategic plans, including expanding its research and development initiatives, and lowering its operating costs. These initiatives may result in significant expenditures and ultimately
may not be successful. Hospira's failure to compete effectively could cause it to lose market share to its competitors and have a material adverse effect on its sales and profitability.
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If Hospira does not successfully introduce new products in a timely manner, its sales and operating results may decline.
A key component to Hospira's strategy is effective execution of its research and development activities. Without the timely
introduction of new products and enhancements, Hospira's products may become obsolete over time, causing its sales and operating results to suffer. If Hospira does not continue to develop generic
injectable pharmaceuticals in a timely manner, its competitors may develop products that are more competitive than Hospira's, and Hospira could find it more difficult to renew or expand GPO pricing
agreements or to obtain new agreements. The ability to launch a generic pharmaceutical product at or before generic market formation is important to that product's profitability. Prices for generic
products typically decline, sometimes dramatically, following market formation, as additional companies receive approvals to market that product and competition intensifies. If a company can be "first
to market," such that the branded drug is the only other competition for a period of time, higher levels of sales and profitability can be achieved. With increasing competition in the generic product
market, the timeliness with which Hospira can market new generic products will increase in importance. If Hospira is unable to bring its generic products to market on a timely basis, and secure "first
to market" positions, its sales and profitability could be adversely impacted.
Hospira
is also actively working to develop and commercialize biogeneric products. Hospira has entered into several agreements described under "Product Development and Manufacturing"
related to expanding its biogenerics portfolio and capabilities. The success of our biogenerics activities depends on several factors, including among other factors, the adoption of certain
legislation and regulatory provisions, failure to obtain regulatory approvals, and the success of the arrangements with third parties.
Hospira
faces similar risks if it does not introduce new versions or upgrades to its medication management systems portfolio. Innovations generally require a substantial investment in
product development before Hospira can determine their commercial viability, and Hospira may not have the financial resources necessary to fund these innovations. Even if Hospira succeeds in creating
new product candidates from these innovations, such innovations may still fail to result in commercially successful products.
The
success of new product offerings will depend on several factors, including Hospira's ability to properly anticipate customer needs, obtain timely regulatory approvals, and
manufacture products in an economic and timely manner. Even if Hospira is able to successfully develop new products or enhancements, they may not produce sales equal to or greater than the costs of
development or may not avoid infringing the proprietary rights of third parties. They may be quickly rendered obsolete by changing customer preferences or the introduction by competitors of products
embodying new technologies or features. Moreover, innovations may not become successful because of difficulties encountered in achieving positive clinical outcomes, meeting safety, efficacy or other
regulatory requirements of government agencies, or obtaining favorable pricing on such products. Finally, innovations may not be accepted quickly in the marketplace because of, among other things,
entrenched patterns of clinical practice, and uncertainty over third-party reimbursement.
Failure to effectively manage efforts under product collaboration agreements may harm Hospira's business and profitability.
Hospira collaborates with other companies for the development, regulatory approval, manufacturing and marketing of new products in both
the specialty injectable pharmaceutical and medication management systems product lines. Hospira has entered into collaboration agreements relating to the long-term development and
commercialization of biogeneric products, which Hospira views as an important long-term opportunity for its specialty injectable pharmaceutical product line.
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Hospira's
ability to benefit from these arrangements will depend on its ability to successfully manage these arrangements and the performance of the other parties to these arrangements. Hospira and
the other parties to these arrangements may not efficiently work together, leading to higher-than-anticipated costs and delays in important activities under the
arrangements. The other parties to these arrangements may not devote the resources that are required for the arrangement to be successful. These arrangements are often governed by complex agreements
that may be subject to differing interpretations by the parties, which may result in disputes. These factors are often beyond the control of Hospira, and could harm Hospira's sales, product
development efforts and profitability.
The Company is increasingly dependent on its outsourcing and third-party provider arrangements.
Hospira is becoming more dependent on its outsourcing arrangements, and if problems were to develop with respect to these arrangements,
Hospira's business could be negatively impacted. Hospira is increasing its dependence on third-party providers for certain services, some of which include processes provided off-shore, including
certain information technology, research and development, third party manufacturing, and finance and accounting outsourcing arrangements. The failure of these service providers to meet their
obligations or the development of significant disagreements or other factors may materially disrupt Hospira's ongoing relationship with these providers or the services they provide could negatively
affect operations.
Hospira is subject to the cost-containment efforts of wholesalers, distributors, third-party payors and government organizations.
Hospira relies on drug wholesalers to assist in the distribution of its generic injectable pharmaceutical products. In general, drug
wholesalers have been attempting to implement a fee-for-service model for the distribution of such products. While Hospira has business arrangements in place with its major
drug wholesalers, if Hospira is required to pay fees not contemplated by its existing arrangements, Hospira will incur additional costs to distribute its products, which may harm Hospira's
profitability.
Hospira's
products and services are sold to hospitals and alternate site providers, such as clinics, home healthcare providers and long-term care facilities which receive
reimbursement for the healthcare services provided to their patients from third-party payors, such as government programs, private insurance plans and managed-care programs. These
third-party payors are increasingly attempting to contain healthcare costs by limiting both coverage and the level of reimbursement for medical products and services. Levels of reimbursement, if any,
may be decreased in the future, and future healthcare reform legislation, regulations or changes to reimbursement policies of third-party payors may otherwise adversely affect the demand for and price
levels of Hospira's products, which could have a material adverse effect on Hospira's sales and profitability.
In
markets outside the U.S., Hospira's business has experienced downward pressure on product pricing as a result of the concentrated buying power of governments as principal customers
and the use of bid-and-tender sales methods whereby Hospira is required to submit a bid for the sale of its products. Hospira's failure to offer acceptable prices to these
customers could have a material adverse effect on its sales and profitability in these markets.
If Hospira is unable to obtain or maintain its GPO and IDN pricing agreements, sales of its products could decline.
Many existing and potential customers for Hospira's products have combined to form GPOs, and IDNs in an effort to lower costs. A small
number of GPOs influence a majority of sales to Hospira's hospital customers in the U.S. GPOs and IDNs negotiate pricing arrangements with medical supply manufacturers and distributors, and these
negotiated prices are made available to a GPO's or an IDN's
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affiliated
hospitals and other members. Failure to negotiate advantageous pricing and purchasing arrangements could cause Hospira to lose market share to its competitors and have a material adverse
effect on its sales and profitability.
Hospira
has pricing agreements covering certain products with the major GPOs in the U.S., including Amerinet, Inc.; Broadlane Inc.; HealthTrust Purchasing Group LP; MedAssets,
Inc.; Novation, LLC; PACT, LLC; and Premier Purchasing Partners, LP. It is important for Hospira to continue to maintain pricing arrangements with major GPOs. In order to maintain these relationships,
Hospira must offer a reliable supply of high-quality, regulatory-compliant products. Hospira also needs to maintain a broad product line and be price-competitive. Several GPO contracts are
up for renewal or extension each year. Moreover, some of the agreements may be terminated on 60 or 90 days' notice, while others may not be terminated without breach until the end of their
contracted term. If Hospira is unable to renew or extend one or more of those contracts, or one or more of the contracts are terminated, and Hospira cannot replace lost business, Hospira's sales and
profitability will decline. There has been consolidation among major GPOs, and further consolidation may occur. The effect of consolidation is uncertain, and consolidation may impair Hospira's ability
to contract with GPOs in the future.
The
GPOs also have a variety of business relationships with Hospira's competitors and may decide to enter into pricing agreements for, or otherwise prefer, products other than Hospira's.
While GPOs negotiate incentives for members to purchase specified products from a given manufacturer or distributor, GPO pricing agreements allow customers to choose between the products covered by
the arrangement and another manufacturer's products, whether or not purchased under a negotiated pricing agreement. As a result, Hospira may face competition for its products even within the context
of its GPO pricing agreements.
Changes in the buying patterns of Hospira's customers could adversely affect Hospira's operating results.
During 2009, sales through the four largest wholesalers that supply products to many end-users accounted for approximately
42% of Hospira's global net sales. Hospira's profitability may be impacted by changes in the buying patterns of these wholesalers, or any other major distributor, or wholesale customer. Their buying
patterns may change as a result of end-use buyer purchasing decisions, end-use customer demand, pricing, or other factors, which could adversely affect Hospira's results of
operations.
Hospira and its suppliers and customers are subject to various governmental regulations, and it could be costly to comply with these regulations and to develop compliant
products and processes. In addition, failure to comply with these regulations could subject us to sanctions which could adversely affect our business, results of operations and financial condition.
Hospira's products are subject to rigorous regulation by the FDA, and numerous other national, supranational, federal and state
governmental authorities. The process of obtaining regulatory approvals to market a drug or medical device, particularly from the FDA and governmental authorities outside the U.S., can be costly and
time-consuming, and approvals might not be granted for future products on a timely basis, if at all. To ensure ongoing customer safety, regulatory agencies such as the FDA may
re-evaluate their current approval processes and may impose additional requirements. In addition, the FDA and others may impose increased or enhanced regulatory inspections for domestic or
foreign plants.
The
FDA, along with other regulatory agencies around the world, has been experiencing a backlog of generic drug and medical device applications, which has delayed approvals of new
products. Those delays have become longer, and may continue to increase in the future. These delays can result in higher levels of unapproved inventory and increased costs due to excess and
obsolescence exposures.
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Existing
regulations may also delay or prevent generic drug producers such as Hospira from offering certain products, such as biogeneric products in key territories, which could harm
Hospira's ability to
grow its business. If a clear regulatory pathway for the approval of biogeneric products is not fully developed in the U.S. and other jurisdictions, Hospira may not be able to generate future sales of
such products in those jurisdictions and may not realize the anticipated benefits of its investments in the development, manufacture and sale of such products. Delays in receipt of, or failure to
obtain, approvals for product candidates could result in delayed realization of product revenues and in substantial additional costs.
Hospira
and Hospira's suppliers may not be able to remain in compliance with applicable FDA and other material regulatory requirements once it has obtained clearance or approval for a
product. These requirements include, among other things, regulations regarding manufacturing practices, product labeling, advertising and postmarketing reporting, including adverse event reports and
field alerts, some of which are related to manufacturing quality concerns. Hospira may be required by regulatory authorities, or determine on its own, to temporarily cease production and sale of
certain products to resolve manufacturing and product quality concerns, which would harm Hospira's sales, margins and profitability in the affected periods and may have a material adverse effect on
Hospira's business. For information related to the 2009 warning letter received by Hospira and other voluntary recalls and corrective actions in 2009, see the section captioned "Quality Assurance."
Hospira
is also subject to various federal, state, and foreign laws pertaining to foreign corrupt practices and healthcare fraud and abuse, including anti-kickback and false
claims laws. Violations of these laws are punishable by criminal and/or civil sanctions, including, in some instances, substantial fines, imprisonment and exclusion from participation in national,
federal and state healthcare programs, including Medicare, Medicaid, and Veterans' Administration health programs and health programs outside the U.S. These laws and regulations are broad in scope and
are subject to evolving interpretations, which could require Hospira to alter one or more of its sales or marketing practices. In addition, violations of these laws, or allegations of such violations,
could disrupt Hospira's business and result in a material adverse effect on Hospira's sales, profitability and financial condition.
For
a more detailed listing of the laws and regulations that significantly affect Hospira's business and operations, see the section captioned "Governmental Regulation and Other
Matters." Any adverse regulatory action, or action taken by Hospira to maintain appropriate regulatory compliance, with respect to these laws and regulations could disrupt Hospira's business and have
a material adverse effect on its sales, profitability and financial condition. Furthermore, an adverse regulatory action with respect to any Hospira product, operating procedure or manufacturing
facility could materially harm Hospira's reputation in the marketplace.
Hospira may continue to acquire other businesses and assets, license rights to technologies or products from third parties, form alliances, or dispose of businesses and
assets, and any of these actions may not be completed in a timely or cost-effective manner, or at all.
As part of Hospira's business strategy, Hospira may continue to acquire other businesses and assets, license rights to technologies or
products from third parties, form alliances,
or dispose of businesses and assets, and any of these actions may not be completed in a timely or cost-effective manner, or at all. Hospira also may pursue strategic alliances to expand
its product offerings and geographic presence. Hospira may not identify or complete these transactions in a timely manner, on a cost-effective basis, or at all, and may not realize the
expected benefits of any acquisition, license arrangement, strategic alliance, or disposition. Other companies, including those with substantially greater resources, may compete with Hospira for
opportunities. If Hospira is successful in securing certain opportunities, the products and technologies that Hospira acquires may not be successful or may require significantly greater resources and
investments than originally anticipated. Hospira may not be able to integrate acquisitions successfully into its existing business.
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To
finance acquisitions, Hospira has incurred, and may continue to incur or assume significant debt. This significant indebtedness may require Hospira to dedicate a substantial portion
of its cash flow from operations to servicing its debt, thereby reducing the availability of cash flow to fund capital expenditures, to pursue other acquisitions or investments in new technologies,
and for general corporate purposes. In addition, this significant indebtedness may increase Hospira's vulnerability to general adverse economic conditions, including increases in interest rates. In
addition, this may limit Hospira's flexibility in planning for, or reacting to, changes in or challenges relating to its business and industry. Hospira may incur greater than expected costs in
connection with these transactions if it encounters difficulties or issues not known to it at the time of entering into the transaction. In addition, Hospira may enter markets in which it has no or
limited prior experience. Hospira could experience negative effects on its reported results of operations from acquisition or disposition-related charges. Any of these negative effects could cause a
downgrade of Hospira's credit rating, which would affect Hospira's ability to obtain new financing and negatively impact Hospira's cost of financing and credit.
Current economic conditions could adversely affect our operations.
The securities and credit markets have been experiencing volatility, and in some cases, have exerted negative pressure on the
availability of liquidity and credit capacity for certain companies. Hospira's ability to access the credit and capital markets, and the related cost of borrowings, will depend on a variety of
factors, including market conditions, the availability of credit and the strength of Hospira's credit rating. In addition, lending institutions, including those associated with Hospira's
$700 million revolving credit facility which expires in 2012, may suffer losses due to their lending and other financial relationships, especially because of the general weakening of the global
economy and increased financial instability of many borrowers. As a result, lenders may become insolvent, which could affect the actual availability of credit under Hospira's revolving credit
facility, or Hospira's ability to obtain other financing on equally favorable terms. Moreover, insurance companies and other financial institutions may suffer losses, which could affect the cost and
availability of insurance coverage. If one or more of these events occurred, Hospira's sources of liquidity may prove
to be insufficient, cost of borrowing may increase and Hospira's financial condition or results of operations could be adversely affected.
In
addition, demand for Hospira's products may decrease due to these adverse economic conditions, resulting in the loss of jobs or healthcare coverage, thereby affecting an individual's
ability to pay for elective healthcare. Interest rate fluctuations, changes in capital market conditions and adverse economic conditions may increase Hospira's customers' cost-containment
efforts, and affect Hospira's customers' ability to obtain credit to finance their purchases of Hospira's products, which could reduce Hospira's revenue and cause a decrease in Hospira's
profitability.
Acquisitions have increased Hospira's investment balances, intangible assets and goodwill balances, and a decline in the value of assets may adversely affect Hospira's
financial position or results of operation.
As a result of Hospira's acquisitions, intangible assets and goodwill have become significant. The values for these assets can be
affected by factors, such as increased competition, changes in business strategies and the impact of restructurings, disposition transactions, and business combinations. As a result of these factors
or other events, Hospira may have to impair these assets or change estimated useful lives, which may have a material adverse effect on Hospira's financial position or results of operations.
In
addition, Hospira regularly reviews its investments, including equity and cost-based investments, to determine when a significant event or change in circumstance has
occurred that may have an adverse effect on the fair value of each investment. Hospira considers numerous factors, including factors affecting the investee, factors affecting the industry of the
investee, and general equity market trends. Hospira also considers the length of time an investment's market value has been below carrying value
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and
the near-term prospects for recovery to carrying value. The recent volatility in the global equity markets and other factors could adversely impact the fair value of Hospira's
investments and, as a consequence, could result in a charge for an other than temporary decline in value, which could have an adverse effect on Hospira's financial position and results of operations.
The manufacture of Hospira's products is highly exacting and complex, and if Hospira or its suppliers encounter problems manufacturing, storing or distributing products,
Hospira's business could suffer.
The manufacture of Hospira's products and products Hospira produces for third parties is highly exacting and complex, due in part to
strict regulatory requirements governing the manufacture of drugs and medical devices. Problems may arise during manufacturing, storage or distribution of Hospira's products and products Hospira
manufactures for third parties for a variety of reasons, including equipment malfunction, failure to follow specific protocols and procedures, manufacturing quality concerns, or problems with raw
materials, electromechanical, software and other components, supplier issues, and natural disaster related events or other environmental factors. If problems arise during the production, storage or
distribution of a batch of product, that batch of product may have to be discarded. This could, among other things, lead to increased costs, lost sales, damage to customer relations, time and expense
spent investigating the cause and, depending on the cause, similar losses with respect to other batches or products. If problems are not discovered before the product is released to the market,
voluntary recalls, corrective actions or product liability related costs may also be incurred. Problems with respect to the manufacture, storage or distribution of its products could materially
disrupt Hospira's business and harm its sales and profitability.
Hospira can experience higher costs to produce its products as a result of rising oil and gas prices.
Hospira uses resins and other petroleum-based materials as raw materials in many of its products. Prices of oil, fuel, and other gases
also significantly affect Hospira's costs for freight and utilities. Oil, fuel, and other gas prices are volatile. If costs increase and Hospira is unable to fully recover these costs through price
increases or offset these increases through other cost reductions, Hospira could experience lower margins and profitability.
Hospira depends on third parties to supply raw materials, electromechanical and other components, and third party finished goods. Hospira may not be able to obtain
sufficient quantities of these materials, which could limit Hospira's ability to manufacture or sell products on a timely basis and could harm its profitability.
The manufacture of Hospira's products requires raw materials and electromechanical and other components that must meet stringent FDA
and other regulatory requirements. Some of these raw materials and other components are currently available from a limited number of suppliers. For example, the LifeShield
TM
,
CLAVE
TM
and MicroCLAVE
TM
connector products, which are components of administration sets that represented approximately 15% of Hospira's 2009
U.S. net sales, rely on proprietary components that are available exclusively from ICU Medical. CLAVE
TM
and MicroCLAVE
TM
are registered trademarks of ICU Medical. In
addition, Hospira purchases from single sources certain compounding material, polyvinyl-chloride resin and laminate film components for Hospira's production of certain flexible bags that it uses with
its I.V. and pre-mixed solutions, as well as rubber components that it uses with some of its injectable pharmaceuticals. Hospira also obtains from single sources certain active
pharmaceutical ingredients and finished products. Identifying alternative suppliers and obtaining approval to change or substitute a raw material or component, or the supplier of a finished product,
raw material or component, can be time-consuming and expensive, as testing, validation and regulatory approval are necessary.
In
the past, Hospira's business has experienced shortages in some of the raw materials and components of its products. Continuous supply of petroleum-based products is especially risky
due to
18
Table of Contents
the
limited number of capable suppliers, limited production capacity and the effect of natural disasters. If suppliers are unable to deliver sufficient quantities of these materials on a timely basis
or if supply is otherwise disrupted, including by suppliers exiting the market, the manufacture and sale of Hospira's products may be disrupted, and its sales and profitability could be adversely
affected.
Hospira's cost-reduction and optimization activities have resulted, and may continue to result, in significant charges and cash expenditures. These activities
may disrupt Hospira's business and may not result in the intended cost savings.
Hospira's strategy, in part, relies on the establishment of a low-cost operating infrastructure to improve margins and cash
flow to drive sustained growth. In addition to the several initiatives under Project Fuel, Hospira has taken various other actions to dispose of, or close, certain manufacturing, research and
development, and other facilities. These actions have resulted in, and are expected to continue to result in, significant charges to Hospira's results of operations and cash expenditures.
Cost-reduction and optimization activities are complex, and if Hospira does not successfully manage these activities, its operations and business could be disrupted and Hospira may incur
more costs than anticipated. In connection with these activities, the company's failure to hire or retain personnel with the right expertise and experience in operations that are critical to its
business functions could adversely impact the execution of its business strategy. Future cost reduction and optimization activities, if taken, may result in additional charges and cash expenditures,
which may be material. If Hospira does not realize the expected savings from its cost-reduction and optimization efforts, its profitability may be adversely affected.
Hospira's manufacturing capacity could limit its ability to expand its business without significant capital investment.
Although Hospira believes that it has adequate manufacturing capacity for its primary products, it may need to invest substantial
capital resources to expand its manufacturing capacity if Hospira introduces new products, demand increases significantly for its products, or if it is successful in obtaining significant additional
customers for its injectable pharmaceuticals contract manufacturing services business. Hospira may not be able to complete any such expansion projects in a timely manner or on a
cost-effective basis, and may not realize the desired benefits of any such expansion.
As
a result of cost-reduction efforts, Hospira has announced the planned closing of, or has sold, certain of its facilities. While Hospira believes it will have available
manufacturing capacity to absorb, or the ability to outsource, the production at these facilities, there may be less available capacity at Hospira's facilities. If Hospira experiences an interruption
in manufacturing at any of its primary manufacturing facilities, it may not be able to produce sufficient products for its customers. As a result, Hospira's sales, margins and profitability may be
adversely impacted.
Hospira relies on the performance of its information technology systems, the failure of which could have an adverse effect on Hospira's business and performance.
Hospira operates in a highly regulated industry that requires the continued operation of sophisticated information technology systems
and network infrastructure. These systems are vulnerable to interruption by fire, power loss, system malfunction and other such events, which are beyond Hospira's control. Systems interruptions could
reduce Hospira's ability to manufacture its products, and could have a material adverse effect on Hospira's operations and financial performance. The level of Hospira's protection and
disaster-recovery capability varies from site to site, and there can be no guarantee that any such plans, to the extent they are in place, will be totally effective.
19
Table of Contents
Hospira conducts sales activity outside of the U.S. and is subject to additional business risks, including fluctuations in foreign currency exchange rates, that may cause
its sales and profitability to decline.
Sales in markets outside the U.S. comprised approximately 29% of 2009 net sales. The additional risks associated with Hospira's
operations outside the United States include: (i) fluctuations in foreign currency exchange rates; (ii) multiple regulatory requirements that are subject to change, which may delay or
deter Hospira's international product commercialization efforts; (iii) differing local product preferences and product requirements; (iv) trade protection measures and import or export
licensing requirements; (v) difficulty in establishing, staffing and managing operations outside the U.S.; (vi) differing labor regulations or work stoppages or strikes at Hospira's
union facilities; (vii) complying with U.S. regulations that apply to international operations, including trade laws, the Foreign Corrupt Practices Act and anti-boycott laws;
(viii) potentially negative consequences from changes in tax laws; (ix) political and economic instability; (x) natural disasters; and (xi) diminished protection of
intellectual property in some countries outside of the U.S.
In
addition, Hospira operates in many countries outside the U.S. through distributors. Its success will depend on the efforts and performance of such distributors, which are beyond
Hospira's control. These risks could have an adverse effect on Hospira's ability to distribute and sell its products in markets outside the U.S. and could adversely affect Hospira's profitability.
Hospira is involved in various lawsuits and proceedings that could negatively affect its business.
Hospira is involved in various claims and legal proceedings, as well as product liability claims and proceedings related to Hospira's
business, including in some instances when Hospira operated as part of Abbott. In some instances, these claims and proceedings could preclude the continued sale and marketing of Hospira's products or
otherwise adversely affect operations, profitability or liquidity. These claims and proceedings include those described in Item 3 "Legal Proceedings." There can be no assurance that these
matters would not have an adverse effect on Hospira's business, profitability or financial condition. In addition, there can be no assurance that there will not be an increase in scope of these
matters or that there will not be additional lawsuits, claims, proceedings or investigations in the future.
In
the past, Hospira has been involved in investigations related to improper marketing and pricing practices with respect to certain Medicare and Medicaid reimbursable products. Hospira
could be subject to these investigations or lawsuits again in the future, and there can be no assurance that these matters would not have an adverse impact on Hospira.
Income taxes can have an unpredictable effect on Hospira's results of operations and result in greater-than-anticipated liabilities.
Hospira is subject to income taxes in a variety of jurisdictions, and its tax structure is subject to review by both domestic and
foreign taxation authorities. Because Hospira's income tax expense for any period depends heavily on the mix of income derived from the various taxing jurisdictions during that period, which is
inherently uncertain, its income tax expense and reported net income may fluctuate significantly, and may be materially different than forecasted. Moreover, changes in or interpretations of tax laws
and regulations (including laws related to the remittance of foreign earnings), changes in investments in foreign countries with favorable tax rates, and settlements of federal, state and foreign tax
audits, may affect Hospira's profitability and financial condition.
Hospira
is the beneficiary of tax exemptions in certain jurisdictions outside the U.S., where a portion of its income is earned. These tax exemptions have a significant impact on
reducing Hospira's overall effective tax rate. If Hospira is unable to maintain these tax exemptions, Hospira's future profitability may be reduced. Changes in laws or governmental policies can affect
the availability of these exemptions.
20
Table of Contents
Significant
judgment is required in determining the provision for income taxes and in evaluating tax positions that are subject to audits and adjustments. Liabilities for unrecognized
tax benefits are established when, despite Hospira's belief that the tax return positions are fully supportable, positions taken by Hospira are likely to be challenged based on the applicable tax
authority's determination of the positions. Although Hospira believes its tax provisions and related liability balances are reasonable, the ultimate tax outcome may differ from the amounts recorded in
its financial statements and may materially affect its financial results in the period or periods for which such determination is made.
Hospira may incur product liability losses and insurance coverage could be inadequate or unavailable to cover these losses.
Hospira's business is subject to potential product liability risks that are inherent in the design, development, manufacture and
marketing of drugs and medical devices and
products. In the ordinary course of business, Hospira is the subject of product liability claims and lawsuits, including those described in Item 3 "Legal Proceedings," alleging that its
products have resulted or could result in an unsafe condition or injury to patients. Product liability claims and lawsuits, safety alerts, voluntary recalls or corrective actions, regardless of their
ultimate outcome, could have a material adverse effect on Hospira's business and reputation and on its ability to attract and retain customers.
Hospira
is responsible for all liabilities, including liabilities for claims and lawsuits, related to its business, whether they arose before or after the spin-off, other
than certain liabilities relating to allegations that it engaged in improper marketing and pricing practices in connection with federal, state or private reimbursement for its products. As part of
Hospira's risk management policy, Hospira carries third-party product liability insurance coverage, which includes a substantial retention or deductible which provides that Hospira will not receive
insurance proceeds until the losses incurred exceed the amount of that retention or deductible. To the extent that any losses are within these retentions or deductibles, Hospira will be responsible
for the administration and payment of these losses. Product liability claims in excess of applicable insurance could have a material adverse effect on Hospira's profitability and financial condition.
If Hospira is unable to protect its intellectual property rights, its business and prospects could be harmed.
Hospira relies on trade secrets, confidentiality agreements, continuing technological innovation and, in some cases, patent, trademark
and service mark protection to preserve its competitive position. A failure to protect Hospira's intellectual property could harm its business and prospects, and its efforts to protect its proprietary
rights may not be adequate.
Most
of Hospira's products are not protected by patents or other proprietary rights, and have limited or no market exclusivity. Patent filings by third parties could render Hospira's
intellectual property less valuable. In addition, intellectual property rights may be unavailable or limited in certain countries outside the U.S., which could make it easier for competitors to
capture market position. Competitors may also harm sales of Hospira's products by designing products that mirror the capabilities of those products or technology without infringing Hospira's
intellectual property rights. If Hospira does not obtain sufficient international protection for its intellectual property, Hospira's competitiveness in international markets could be impaired, which
could limit its growth and future sales.
If Hospira infringes the intellectual property rights of third parties, Hospira may face legal action, increased costs and delays in marketing new products.
Hospira seeks to launch generic pharmaceutical products either where patent protection of equivalent branded products has expired,
where patents have been declared invalid or where products do not infringe the patents of others. To achieve a "first-to-market" position for generic pharmaceutical
21
Table of Contents
products,
Hospira may take action, such as litigation, to seek to assert that its products do not infringe patents of existing products or that those patents are invalid or unenforceable. Hospira may
also launch a product prior to the termination of the underlying litigation. These actions may result in increased litigation, which could be costly and time consuming, and may not be successful.
Hospira has made abbreviated new drug applications and certifications (known as "Paragraph IV certifications" in the U.S.) that the relevant patents for existing products would not be infringed
by a Hospira product, or were invalid or unenforceable, in the U.S. and equivalent filings in Canada. Claims filed by innovators challenging these Paragraph IV certifications may delay or
prevent the launch of the relevant products and result in additional costs.
Third
parties may claim that Hospira's products are infringing their intellectual property rights. Claims of intellectual property infringement could be costly and
time-consuming and might require Hospira to enter into costly royalty or license agreements, if Hospira is able to obtain royalty or license agreements on acceptable terms or at all.
Hospira also may be subject to significant damages, which may be based on the lost profits from the sale of the branded product or an injunction preventing it from manufacturing, selling or using some
of its products in the event of a successful claim of patent or other intellectual property infringement. Any of these adverse consequences could have a material adverse effect on Hospira's
profitability and financial condition.
Changes in the funded status or costs of Hospira's pension or post-retirement benefit plans could adversely affect Hospira's financial position and results of
operations.
The funded status of Hospira's pension and post-retirement benefit plans is subject to developments and changes in
actuarial and other related assumptions. Decreases in the valuation of plan assets, particularly with respect to equity securities, and a change in the actual rate of return on plan assets can result
in significant changes to the expected return on plan assets in the following year and, as a consequence, could result in higher funding requirements and net periodic benefit costs. In addition,
changes in assumptions, such as discount rates, mortality rates, retirement rates, healthcare cost trend rates and other factors, may lead
to significant increases in the value of the respective obligations. Assumption changes could affect the reported funded status of Hospira's plans and, as a result, could result in higher funding
requirements and net periodic benefit costs. All of these factors could have an adverse effect on Hospira's financial position and results of operations.
The stock market can be volatile and fluctuations in Hospira's operating results, as well as other factors, could cause its stock price to decline.
During the past few years, the stock market has experienced fluctuations, which has significantly impacted the market prices of
securities issued by many companies for reasons unrelated to their operating performance. Further, market fluctuations could adversely affect Hospira's stock price. Moreover, Hospira's sales and
operating results may vary from quarter to quarter due to the risk factors set forth herein. Hospira's stock price could fluctuate significantly in response to its quarterly results and the impact of
these risk factors on Hospira's operating results or financial position.
Item 1B. Unresolved Staff Comments
None.
22
Table of Contents
Item 2. Properties
Hospira's corporate headquarters and the locations and uses of Hospira's principal manufacturing and research and development ("R&D")
properties as of December 31, 2009, are as follows:
|
|
|
|
|
Location*
|
|
Use
|
|
Owned/Leased
|
Adelaide, South Australia, Australia
|
|
R&D
|
|
Owned
|
Austin, Texas
|
|
Manufacturing
|
|
Owned
|
Buffalo, New York
|
|
Manufacturing
|
|
Owned
|
Boulder, Colorado
|
|
R&D and Manufacturing
|
|
Leased (expires 2011)
|
Clayton, North Carolina
|
|
R&D and Manufacturing
|
|
Owned
|
Finisklin, Sligo, Ireland
|
|
Manufacturing
|
|
Leased (expires 2013)
|
La Aurora, Costa Rica
|
|
Manufacturing
|
|
Owned
|
Lake Forest, Illinois**
|
|
Corporate Headquarters and R&D
|
|
Owned/Leased (expires 2016)
|
Liscate, Italy
|
|
Manufacturing
|
|
Owned
|
McPherson, Kansas
|
|
R&D and Manufacturing
|
|
Owned
|
Morgan Hill, California
|
|
Manufacturing
|
|
Owned
|
Mulgrave, Victoria, Australia
|
|
R&D and Manufacturing
|
|
Owned
|
Rocky Mount, North Carolina
|
|
Manufacturing
|
|
Owned
|
San Cristobal, Dominican Republic
|
|
Manufacturing
|
|
Owned
|
San Diego, California
|
|
R&D
|
|
Leased (expires 2019)
|
Wasserburg, Germany***
|
|
Manufacturing
|
|
Owned
|
-
*
-
The
locations listed above are generally used by all of Hospira's segments.
-
**
-
The
Lake Forest facilities consist of four buildings, three of which are owned and one of which is leased.
-
***
-
In
January 2010, Hospira completed the sale of the contract manufacturing facility in Wasserburg, Germany.
Hospira
phased out production at the North Chicago, Illinois manufacturing facility during the first half of 2009. Hospira is exiting manufacturing operations at its Morgan Hill,
California plant and the transfer of product manufacturing will continue throughout 2010, but could extend into 2011. Production of the primary products at these facilities is moving to other Hospira
facilities or is being outsourced to third-party suppliers. In 2008, Hospira began an expansion of manufacturing capacity at the LaAurora, Costa Rica facility, in part to accommodate some of the
production being transferred from other Hospira facilities. The facility has not been completed, but has begun producing some limited incremental products in the currently existing space. For further
details regarding the financial impact of these activities, see Note 4, to the consolidated financial statements included in Item 8.
Hospira
believes that its facilities and equipment are in good operating condition and are well maintained. Hospira believes that it has adequate capacity to meet its current business
needs.
As
a result of the acquisition of Mayne Pharma, Hospira has a joint venture with Cadila Healthcare Limited, a pharmaceutical company located in India. The joint venture has been approved
to begin manufacturing and commercial sales of injectable cytotoxic drugs for Europe, and has been inspected by the FDA. The FDA issued an approval letter in December 2009 related to these
manufacturing facilities.
23
Table of Contents
Item 3. Legal Proceedings
Hospira is involved in various claims and legal proceedings, as well as product liability claims and proceedings related to Hospira's
business, including in some instances when Hospira operated as part of Abbott.
Hospira
has been named as a defendant in a lawsuit alleging generally that the spin-off of Hospira from Abbott resulted in a mass termination of employees so as to interfere
with the future attainment of benefits in violation of the Employee Retirement Income Security Act of 1974 ("ERISA"). The lawsuit was filed on November 8, 2004 in the U.S. District Court for
the Northern
District of Illinois, and is captioned:
Myla Nauman, Jane Roller and Michael Loughery v. Abbott Laboratories and Hospira, Inc.
Plaintiffs generally seek
reinstatement in Abbott benefit plans, disgorgement of profits and attorneys fees. On November 18, 2005, the complaint was amended to assert an additional claim against Abbott and Hospira for
breach of fiduciary duty under ERISA. Hospira has been dismissed as a defendant with respect to the fiduciary duty claim. By Order dated December 30, 2005, the Court granted class action status
to the lawsuit. As to the sole claim against Hospira, the court certified a class defined as: "all employees of Abbott who were participants in the Abbott Benefit Plans and whose employment with
Abbott was terminated between August 22, 2003 and April 30, 2004, as a result of the spin-off of the HPD [Hospital Products Division] /creation of
Hospira announced by Abbott on August 22, 2003, and who were eligible for retirement under the Abbott Benefit Plans on the date of their terminations." Hospira denies all material allegations
asserted against it in the complaint. The trial of this matter has concluded, but the court has not rendered a decision. In 2008, Hospira received notice from Abbott requesting that Hospira indemnify
Abbott for all liabilities that Abbott may incur in connection with this litigation. Hospira denies any obligation to indemnify Abbott for the claims asserted against Abbott in this litigation.
On
August 12, 2005, Retractable Technologies, Inc. ("RTI") filed a lawsuit against Abbott alleging breach of contract and fraud in connection with a National Marketing and
Distribution Agreement ("Agreement") between Abbott and RTI signed in May 2000.
Retractable Technologies, Inc. v. Abbott Laboratories, Inc.
, Case
No. 505CV157 is pending in the U.S. District Court for the Eastern District of Texas. RTI purported to terminate the contract for breach in 2003. The lawsuit alleges that Abbott misled RTI and
breached the Agreement in connection with Abbott's marketing efforts. RTI is seeking monetary damages which are alleged to be in excess of $300 million as well as punitive damages. Hospira has
conditionally agreed to defend and indemnify Abbott in connection with this lawsuit, which involves a contract carried out by Abbott's former Hospital Products Division. Abbott denies all material
allegations in the complaint. Abbott has brought counterclaims against RTI for breach of the Agreement, including failure to pay marketing fees owed to Abbott. Hospira is entitled, pursuant to its
agreements with Abbott, to any amounts recovered due to RTI's breach of the Agreement. The case is proceeding in the U.S. District Court for the Eastern District of Texas.
Hospira
is involved in patent litigation in the U.S. and elsewhere concerning Hospira's attempts to market the generic oncology drug oxaliplatin. In the U.S., litigation is pending in
the U.S. District Court for the District of New Jersey:
Sanofi-Aventis, U.S., LLC, et al. v. Sandoz, Inc., et al.
(D. N.J. 2007). In the lawsuit,
plaintiffs allege that various generic oxaliplatin products infringe one or more patents held by plaintiffs. Hospira is currently marketing and selling its oxaliplatin products, and alleges that the
single patent plaintiffs have asserted against Hospira is not valid and not infringed by Hospira's products. In June 2009, the District Court entered summary judgment of non-infringement
in favor of Hospira. Plaintiffs appealed that decision and, in September 2009, the U.S. Court of Appeals for the Federal Circuit vacated the District Court's ruling. Trial is expected in 2010. Hospira
denies all material allegations asserted against it in the complaint. The plaintiffs seek damages, injunctive relief and costs. If Hospira were required to pay damages in this case, the amount of
damages would generally be based on a reasonable royalty or the plaintiffs' lost profits based on the sale of the branded product. Plaintiffs are also pursuing proceedings against the FDA in a
separate legal action
24
Table of Contents
aimed
at removing Hospira's products from the market and prohibiting future sales in advance of the trial.
Hospira
and Abbott are defendants in a number of lawsuits brought by individual plaintiffs alleging that plaintiffs developed Post-arthroscopic Glenohumeral Chondrolysis
("PAGCL") from the use of certain continuous infusion pain pumps to deliver local anesthetic into the intra-articular joint space following shoulder surgeries. In each case, Hospira
and/or Abbott is alleged, singularly or with other anesthetic medication defendants, to have provided the medication delivered by continuous infusion pain pumps manufactured by other
(non-Hospira/non-Abbott) defendants. The analgesic medications at issue include Marcaine
TM
(bupivacaine) and lidocaine. As of December 31, 2009, there are
a total of 123 cases, involving 313 plaintiffs, in which Hospira is a party. 62 cases are pending in federal court and 61 cases are pending in state court. Pursuant to its separation agreement with
Abbott, Hospira is defending those lawsuits which relate to sales of products prior to Hospira's spin-off from Abbott. Hospira denies all material allegations asserted against it in the
complaint. Generally, plaintiffs seek compensatory damages and, in some cases, punitive damages and costs.
On
September 4, 2009, Hospira brought suit against Sandoz International GmbH and Sandoz, Inc. for patent infringement. The lawsuit, which alleges infringement of U.S.
Patents 4,910,214 (expires July 15, 2013) and 6,716,867 (expires March 31, 2019), is in the U.S. District Court for the District of New Jersey:
Hospira, Inc. and
Orion Corp. v. Sandoz International GmbH and Sandoz, Inc.
(D. N.J. 2009). The lawsuit is based on Sandoz's "Paragraph IV" notice indicating that Sandoz has filed
an abbreviated new drug application ("ANDA") with the FDA for a generic version of Hospira's Precedex
TM
(dexmedetomidine hydrochloride). Hospira seeks a judgment of infringement,
injunctive relief and costs.
Hospira's
litigation exposure, including product liability claims, is evaluated each reporting period. Hospira's reserves, which are not significant at December 31, 2009 and 2008,
are the best estimate of
loss, as defined by ASC Topic 450, "Contingencies." Based upon information that is currently available, management believes that the likelihood of a material loss in excess of recorded amounts
is remote.
Additional
legal proceedings may occur that may result in a change in the estimated reserves recorded by Hospira. It is not feasible to predict the outcome of such proceedings with
certainty and there can be no assurance that their ultimate disposition will not have a material adverse effect on Hospira's financial position, cash flows, or results of operations.
Item 4. Submission of Matters to a Vote of Security Holders
None.
Executive Officers of Hospira
The executive officers of Hospira are set forth below. Their ages as of February 18, 2010, and the positions and offices held by
them in the past are also indicated. There are no family relationships between any corporate officers or directors.
Christopher B. Begley
, age 57, is Hospira's Chairman of the Board and Chief Executive Officer. He has served as Chief Executive Officer
and as a director since the spin-off in April 2004 and as the Chairman of the Board since May 2007. Mr. Begley provided 18 years of service to Abbott, a global broad-based
healthcare company, and served as Senior Vice President and President, Hospital Products, from 2000 to April 2004. Prior to his appointment as Senior Vice President and President, Hospital Products,
Mr. Begley served as Senior Vice President and President, Chemical and Agricultural Products from 1999 to 2000, Vice President, Abbott Health Systems, from 1998 to 1999, and Vice President,
MediSense Operations, in 1998. Mr. Begley is a director of Sara Lee Corporation, AdvaMed and the National Center for Healthcare Leadership.
25
Table of Contents
Terrence C. Kearney
, age 55, is Hospira's Chief Operating Officer. He has served in such position since April 2006. From April 2004 to
April 2006, he served as Hospira's Senior Vice President, Finance, and Chief Financial Officer, and he served as Acting Chief Financial Officer through August 2006. Mr. Kearney served as Vice
President and Treasurer of Abbott from 2001 to April 2004. From 1996 to 2001, Mr. Kearney was Divisional Vice President and Controller for Abbott's International Division. Mr. Kearney
provided 24 years of service to Abbott.
Daphne E. Jones,
age 52, is Hospira's Senior Vice President and Chief Information Officer. Ms. Jones has served in that position
since November 2009. Ms. Jones served as the worldwide Vice President of information technology ("IT") and Chief Information Officer for Johnson & Johnson's Ortho-Clinical Diagnostics,
Inc. from 2007 to 2009. Previously, from 1997 to 2006, she served in other IT global leadership roles at Johnson & Johnson.
Kenneth F. Meyers
, age 48, is Hospira's Senior Vice President, Organizational Transformation and People Development. Mr. Meyers has
served in that position since November 2008. Mr. Meyers served as a partner of Oliver-WymanDelta Executive Learning Center (a global management consulting firm) from 2004 to 2008.
From 2002 to 2004, Mr. Meyers served as Senior Vice President, Human Resources, Starbucks Coffee International (a subsidiary of Starbucks Coffee Company). From 2000 to 2002, he founded and
acted as managing director of KFM Consulting (a human resources consultancy).
Sumant Ramachandra, M.D., Ph.D.,
age 41, is Hospira's Senior Vice President and Chief Scientific Officer. Dr. Ramachandra has
served in that position since July 2008. Dr. Ramachandra served as Vice President and Senior Project Leader, Global Development, at Schering-Plough, a global healthcare company, from 2005 to
2008. From 2003 to 2005, he served as Group Leader in the U.S. Medical Oncology Therapeutic Area at Pfizer Inc., a global pharmaceuticals company.
Brian J. Smith
, age 58, is Hospira's Senior Vice President, General Counsel and Secretary. He has served in such position since the
spin-off in April 2004. Mr. Smith served as Divisional Vice President, Domestic Legal Operations of Abbott from 1995 to April 2004 and served with Abbott for 25 years.
Ron Squarer
, age 43, is Hospira's Senior Vice President, Global Marketing and Corporate Development. Mr. Squarer has served in that
position since January 2009. Mr. Squarer served as Hospira's Corporate Vice President, Global Strategy and Business Development from 2007 to 2008, and as Senior Vice President, Global Corporate
and Business Development at Mayne Pharma, Ltd. (an Australia-based specialty injectable pharmaceutical company) from 2006 to 2007. From 2004 to 2006, he served as the Oncology Therapy Area
Commercial Development Leader at Pfizer Inc., a global pharmaceuticals company. Prior to 2004, Mr. Squarer supported other therapeutic areas at Pfizer and held various commercial and business
development positions at SmithKline Beecham in the United States and Europe.
Thomas E. Werner
, age 52, is Hospira's Senior Vice President, Finance and Chief Financial Officer. He has served in such position since
August 2006. Mr. Werner served as Senior Vice President, Finance and Chief Financial Officer of Böwe Bell + Howell, a service, manufacturing and software company
that provides document processing and postal solutions. Prior to joining Böwe Bell + Howell in late 2001, he served as Chief Financial Officer for Xpedior Incorporated (a
software developer and integrator), for uBid, Inc., (an e-commerce company), and as Corporate Controller for Gateway, Inc. (a seller of personal computers and related products and
services).
Richard J. Hoffman
, age 43, is Hospira's Corporate Vice President, Controller and Chief Accounting Officer. He has served in such position
since August 2009. From August 2007 to August 2009, he served as Hospira's Vice President, Corporate Controller and Chief Accounting Officer. From 2000 until his appointment by Hospira,
Mr. Hoffman was employed by CNH Global N.V. (Case New Hollanda global agricultural and construction equipment manufacturer with a captive financial services company). His
last position was Vice President, Corporate Controller and Chief Accounting Officer, which he held since July 2004. Prior to that time, he served as Assistant Corporate Controller and Chief Accounting
Officer and in various other finance and reporting roles at Case New Holland.
26
Table of Contents
PART II
Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
Market for Common Stock
Hospira's common stock is listed and traded on the New York Stock Exchange ("NYSE") under the symbol "HSP." The following table sets
forth the high and low closing prices for Hospira's common stock on the NYSE for each period indicated.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Market Price Per Share
|
|
|
|
2009
|
|
2008
|
|
For the quarter ended:
|
|
High
|
|
Low
|
|
High
|
|
Low
|
|
March 31
|
|
$
|
30.86
|
|
$
|
21.38
|
|
$
|
43.80
|
|
$
|
39.90
|
|
June 30
|
|
$
|
38.82
|
|
$
|
30.44
|
|
$
|
43.56
|
|
$
|
39.32
|
|
September 30
|
|
$
|
44.87
|
|
$
|
36.12
|
|
$
|
40.36
|
|
$
|
36.96
|
|
December 31
|
|
$
|
51.11
|
|
$
|
43.25
|
|
$
|
38.34
|
|
$
|
25.36
|
|
As
of January 31, 2010, Hospira had approximately 38,671 shareholders of record. Hospira has not paid any dividends on its common stock.
Issuer Purchases of Equity Securities
The following table gives information on a monthly basis regarding purchases made by Hospira of its common stock during the fourth
quarter of 2009.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period
|
|
Total Number of
Shares Purchased
(1)
|
|
Average
Price Paid
per Share
|
|
Total
Number of
Shares
Purchased as
Part of
Publicly
Announced
Plans or
Programs
|
|
Maximum Number
(or Approximate Dollar
Value) of Shares that
May Yet be Purchased
Under the Plans or
Programs
(2)
|
|
October 1-October 31, 2009
|
|
|
72,206
|
|
$
|
46.38
|
|
|
|
|
$
|
100,233,606
|
|
November 1-November 30, 2009
|
|
|
16,526
|
|
|
47.22
|
|
|
|
|
|
100,233,606
|
|
December 1-December 31, 2009
|
|
|
4,354
|
|
|
50.58
|
|
|
|
|
|
100,233,606
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
93,086
|
|
$
|
46.66
|
|
|
|
|
$
|
100,233,606
|
|
-
(1)
-
These
shares represent the shares deemed surrendered to Hospira to pay the exercise price and to satisfy minimum statutory tax withholding obligations in
connection with the exercise of employee stock options. For further details regarding employee stock options, see Note 15, to the consolidated financial statements included in Items 8.
These shares include the shares purchased on the open market for the benefit of participants in the Hospira Healthcare Corporation Stock Purchase Plan1,000 in October, 900 in November,
and 1,500 in December.
-
(2)
-
In
February 2006, Hospira's board of directors authorized the repurchase of up to $400.0 million of Hospira's common stock in accordance with
Rule 10b-18 under the Securities Exchange Act of 1934. The repurchase of shares commenced in early March 2006. As of December 31, 2009, Hospira had purchased
7.6 million shares for $299.8 million in aggregate under the 2006 board authorization, all of which were purchased during 2006.
27
Table of Contents
Performance Graph
The following graph compares the performance of Hospira common stock for the periods indicated with the performance of the
S&P 500 Stock Index and the S&P Health Care Index.
Comparison of Cumulative Total Return
Assumes
$100 was invested on December 31, 2004 in Hospira common stock and each index. Values are as of the close of the U.S. stock markets on December 31, 2005, 2006,
2007, 2008 and 2009, and assume dividends are reinvested. No cash dividends have been declared or paid on Hospira common stock. Returns over the indicated period may not be indicative of future
returns.
28
Table of Contents
Item 6. Selected Financial Data
The following table sets forth Hospira's selected financial information derived from its audited consolidated financial statements as
of, and for the years ended, December 31, 2009, 2008, 2007, 2006 and 2005.
The
selected financial information should be read in conjunction with "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" and Hospira's
audited financial statements included in Item 8.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Years Ended December 31,
|
|
(dollars in millions, except per share amounts)
|
|
2009
|
|
2008
|
|
2007
|
|
2006
|
|
2005
|
|
Statements of Income Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales
(1)
|
|
$
|
3,879.3
|
|
$
|
3,629.5
|
|
$
|
3,436.2
|
|
$
|
2,688.5
|
|
$
|
2,626.7
|
|
Gross profit
(2)
|
|
|
1,456.4
|
|
|
1,342.7
|
|
|
1,195.7
|
|
|
974.9
|
|
|
873.1
|
|
Income from operations
(1)
|
|
|
502.9
|
|
|
517.8
|
|
|
302.6
|
|
|
339.6
|
|
|
336.6
|
|
Income before income taxes
|
|
|
384.8
|
|
|
407.5
|
|
|
187.8
|
|
|
324.7
|
|
|
322.1
|
|
Net income
|
|
$
|
403.9
|
|
$
|
320.9
|
|
$
|
136.8
|
|
$
|
237.7
|
|
$
|
235.6
|
|
Earnings per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
2.51
|
|
$
|
2.02
|
|
$
|
0.87
|
|
$
|
1.51
|
|
$
|
1.48
|
|
|
Diluted
|
|
$
|
2.47
|
|
$
|
1.99
|
|
$
|
0.85
|
|
$
|
1.48
|
|
$
|
1.46
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
161.0
|
|
|
159.2
|
|
|
156.9
|
|
|
157.4
|
|
|
159.3
|
|
|
Diluted
|
|
|
163.2
|
|
|
161.3
|
|
|
160.2
|
|
|
160.4
|
|
|
161.6
|
|
-
(1)
-
As
Mayne Pharma was acquired in February 2007, there are no Mayne Pharma net sales in 2006 and 2005. Income from operations includes acquired in-process
research and development charge of $0.5 million, $88.0 million and $10.0 million in 2008, 2007 and 2006, respectively.
-
(2)
-
Gross
profit is defined as Net sales less Cost of products sold.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
(dollars in millions)
|
|
2009
|
|
2008
|
|
2007
|
|
2006
|
|
2005
|
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
5,502.9
|
|
$
|
5,074.1
|
|
$
|
5,084.7
|
|
$
|
2,847.6
|
|
$
|
2,789.2
|
|
Long-term debt
|
|
$
|
1,707.3
|
|
$
|
1,834.0
|
|
$
|
2,184.4
|
|
$
|
702.0
|
|
$
|
695.3
|
|
29
Table of Contents
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations
Overview
Hospira is a global specialty pharmaceutical and medication delivery company that develops, manufactures and markets products that help
improve the safety, cost and productivity of patient care. Hospira's portfolio includes generic acute-care and oncology injectables, as well as integrated infusion therapy and medication
management systems. Hospira's portfolio of products is used by hospitals and alternate site providers, such as clinics, home healthcare providers and long-term care facilities. In February
2007, Hospira acquired Mayne Pharma to increase its global presence in specialty generic injectable pharmaceuticals.
In
2009, Hospira reclassified costs that were previously reported in Cost of products sold and Research and development to Restructuring and impairment, a separate operating costs and
expenses line item. The reclassifications did not affect net income or shareholders' equity.
Cost-Reduction and Optimization Activities
As part of its strategy to improve margins and cash flows, Hospira has taken a number of actions to reduce operating costs and optimize
operations. The costs related to these actions consist primarily of severance pay and other employee benefits, accelerated depreciation resulting from the decreased useful lives of buildings and
certain equipment, impairments, relocation of production, process optimization implementation, other asset charges and exit costs. Hospira will transfer related operations and production of the
primary products from some facilities to other Hospira facilities, outsource certain product components to third-party suppliers or cease activities entirely. For further details regarding the
financial impact of these cost-reduction activities, see Note 4 to the consolidated financial statements included in Item 8.
2009 Actions.
In March 2009, Hospira announced details of Project Fuel which will occur over the next two years from the date of
announcement.
Project Fuel includes the following activities: optimizing the product portfolio, evaluating non-strategic assets and streamlining the organizational structure. Hospira expects to incur
aggregate charges related to these actions in the range of $140 million to $160 million on a pre-tax basis, of which approximately $100 million to $110 million
are expected to be reported as restructuring costs and other asset charges. During 2009, Hospira incurred aggregate charges of $83.7 million with $50.6 million recorded as restructuring
and other asset charges.
As
part of Project Fuel initiatives, Hospira committed to dispose of certain non-strategic businesses and the underlying assets. As a result of these decisions and
measurement of the fair value of these businesses, Hospira recognized non-cash, pre-tax impairment charges of $52.8 million in 2009. Hospira received cash of
$46.6 million upon completion of the disposals of the critical care business and oral pharmaceutical contract manufacturing facility in Salisbury, Australia. In 2010, a disposal was completed
for an estimated sales price of approximately $68 million
related to the remaining assets and related liabilities held for sale associated with the facility in Wasserburg, Germany which primarily performed contract manufacturing. These disposals will reduce
net sales in the Other Pharma and Other Devices product lines in periods subsequent to the disposals. As Hospira continues to consider each Project Fuel initiative, the amount, timing and recognition
of charges will be affected by the occurrence of commitments and triggering events as defined under accounting principles generally accepted in the United States ("GAAP"), among other factors.
30
Table of Contents
2008 Actions.
In April 2008, Hospira announced plans to exit manufacturing operations at its Morgan Hill, California, plant over the
next two to
three years. Hospira expects to incur aggregate charges through 2011 related to these actions in the range of $29 million to $35 million on a pre-tax basis, of which
approximately $20 million to $24 million are expected to be reported as restructuring charges. During 2009 and 2008, Hospira incurred charges of $15.7 million and
$8.8 million, respectively.
2006 Actions.
In February 2006, Hospira announced plans to close plants in Ashland, Ohio, Montreal, Canada, and North Chicago, Illinois
and completed
these plans in 2007, 2008, and 2009, respectively. During 2009, 2008 and 2007, Hospira incurred charges of $12.7 million, $26.6 million and $37.6 million, respectively.
2007 Actions.
In late 2007, Hospira made the decision to limit future research and development investments related to a non-strategic
device product and recognized an intangible asset impairment charge of $7.5 million.
Restructuring,
impairment and optimization charges incurred for these cost reduction and optimization actions collectively were reported in the consolidated statements of income line
items included in Item 8 as follows:
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31 (dollars in millions)
|
|
2009
|
|
2008
|
|
2007
|
|
Cost of products sold
|
|
$
|
40.7
|
|
$
|
12.4
|
|
$
|
23.3
|
|
Restructuring and impairment
|
|
|
94.2
|
|
|
22.4
|
|
|
21.8
|
|
Research and development
|
|
|
3.3
|
|
|
0.6
|
|
|
|
|
Selling, general and administrative
|
|
|
26.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total pre-tax Project Fuel, Facilities Optimization and Other Actions charges
|
|
$
|
164.9
|
|
$
|
35.4
|
|
$
|
45.1
|
|
|
|
|
|
|
|
|
|
Hospira
aims to achieve a culture of continuous improvement that will enhance its efficiency, effectiveness and competitiveness and substantially improve its cost base.
Cost-reduction and optimization activities involve risks and uncertainties. Hospira may incur more charges and cash expenditures than estimated and may not realize the expected cost
savings on its planned time frame or at all. See "Item 1A. Risk FactorsHospira's cost-reduction and optimization activities have resulted, and may continue to result,
in significant charges and cash expenditures. These activities may disrupt Hospira's business and may not result in the intended cost savings."
Acquisitions
In December 2009, Hospira announced an agreement to acquire a certain business of Orchid Chemicals & Pharmaceuticals Ltd.
("Orchid Pharma") for approximately $400 million. While Hospira has taken actions and incurred costs associated with the pending transaction that are reflected in Hospira's financial
statements, the pending acquisition of Orchid Pharma will not be reflected in the financial statements until the transaction closes. The transaction has been unanimously approved by Hospira's and
Orchid Pharma's boards of directors and Orchid Pharma's shareholders. The acquisition is subject to customary closing conditions. The transaction is expected to be completed in the first quarter of
2010.
31
Table of Contents
In December 2009, Hospira acquired TheraDoc, Inc. ("TheraDoc") and its Infection Control Assistant
TM
and Antibiotic
Assistant
TM
products, software applications that automate hospital-wide surveillance for infection-related events and optimize the utilization of antimicrobials for cash of
$63.3 million, net of cash acquired. The impact of this acquisition was not material to Hospira's results of operations in 2009.
On February 2, 2007, Hospira completed its acquisition of Mayne Pharma for $2,055.0 million. The acquisition broadened
Hospira's specialty injectable pharmaceuticals product line. As Mayne Pharma had strong market positions in Europe and Australia and a significant commercial infrastructure outside the United States,
the acquisition has also substantially increased Hospira's international presence. The results of operations of Mayne Pharma are included in Hospira's results for periods on and after
February 2, 2007, which has affected comparability of the financial statements for the periods presented in this report. For further details, see Note 2 to the consolidated financial
statements included in Item 8.
Intangible
assets amortization, inventory step-up, acquired in-process research and development and integration charges incurred for the Mayne Pharma acquisition
were reported in the consolidated statements of income line items included in Item 8 as follows:
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31 (dollars in millions)
|
|
2009
|
|
2008
|
|
2007
|
|
Cost of products sold
|
|
$
|
54.2
|
|
$
|
71.4
|
|
$
|
107.7
|
|
Restructuring and impairment
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
|
1.0
|
|
|
1.6
|
|
Acquired in-process research and development
|
|
|
|
|
|
0.5
|
|
|
88.0
|
|
Selling, general and administrative
|
|
|
|
|
|
21.0
|
|
|
36.2
|
|
|
|
|
|
|
|
|
|
Total pre-tax Mayne Pharma related charges
|
|
$
|
54.2
|
|
$
|
93.9
|
|
$
|
233.5
|
|
|
|
|
|
|
|
|
|
Acquisitions
and related transactions are subject to various risks and uncertainties, including risks relating to the integration and risks relating to incurring substantial indebtedness
in connection with an acquisition. Please see "Item 1A. Risk FactorsHospira may continue to acquire other
businesses and assets, license rights to technologies or products from third parties, form alliances or dispose of businesses and assets, and any of these actions may not be completed in a timely or
cost-effective manner, or at all."
32
Table of Contents
Results of Operations
Net Sales
A comparison of product line sales is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage Change at
Actual Currency Rates
|
|
Percentage Change at
Constant Currency Rates
(1)
|
|
Years Ended December 31
(dollars in millions)
|
|
2009
|
|
2008
|
|
2007
|
|
2009
|
|
2008
|
|
2009
|
|
2008
|
|
Americas
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceuticals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Injectables
|
|
$
|
1,589.9
|
|
$
|
1,328.9
|
|
$
|
1,240.9
|
|
|
19.6
|
%
|
|
7.1
|
%
|
|
20.3
|
%
|
|
7.1
|
%
|
|
Other Pharma
|
|
|
556.4
|
|
|
522.0
|
|
|
549.2
|
|
|
6.6
|
%
|
|
(5.0
|
)%
|
|
7.8
|
%
|
|
(4.7
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,146.3
|
|
|
1,850.9
|
|
|
1,790.1
|
|
|
16.0
|
%
|
|
3.4
|
%
|
|
16.7
|
%
|
|
3.5
|
%
|
Devices
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medication Management Systems
|
|
|
559.7
|
|
|
558.9
|
|
|
501.3
|
|
|
0.1
|
%
|
|
11.5
|
%
|
|
1.2
|
%
|
|
11.4
|
%
|
|
Other Devices
|
|
|
357.3
|
|
|
368.5
|
|
|
367.5
|
|
|
(3.0
|
)%
|
|
0.3
|
%
|
|
(2.3
|
)%
|
|
0.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
917.0
|
|
|
927.4
|
|
|
868.8
|
|
|
(1.1
|
)%
|
|
6.7
|
%
|
|
(0.2
|
)%
|
|
6.6
|
%
|
Total Americas
|
|
|
3,063.3
|
|
|
2,778.3
|
|
|
2,658.9
|
|
|
10.3
|
%
|
|
4.5
|
%
|
|
11.1
|
%
|
|
4.5
|
%
|
EMEA
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceuticals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Injectables
|
|
|
272.0
|
|
|
287.4
|
|
|
255.4
|
|
|
(5.4
|
)%
|
|
12.5
|
%
|
|
2.1
|
%
|
|
8.0
|
%
|
|
Other Pharma
|
|
|
128.4
|
|
|
152.1
|
|
|
162.3
|
|
|
(15.6
|
)%
|
|
(6.3
|
)%
|
|
(8.8
|
)%
|
|
(8.1
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
400.4
|
|
|
439.5
|
|
|
417.7
|
|
|
(8.9
|
)%
|
|
5.2
|
%
|
|
(1.7
|
)%
|
|
1.8
|
%
|
Devices
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medication Management Systems
|
|
|
77.8
|
|
|
75.9
|
|
|
66.4
|
|
|
2.5
|
%
|
|
14.3
|
%
|
|
8.6
|
%
|
|
7.6
|
%
|
|
Other Devices
|
|
|
64.6
|
|
|
68.4
|
|
|
68.0
|
|
|
(5.6
|
)%
|
|
0.6
|
%
|
|
0.9
|
%
|
|
(4.6
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
142.4
|
|
|
144.3
|
|
|
134.4
|
|
|
(1.3
|
)%
|
|
7.4
|
%
|
|
4.9
|
%
|
|
1.4
|
%
|
Total EMEA
|
|
|
542.8
|
|
|
583.8
|
|
|
552.1
|
|
|
(7.0
|
)%
|
|
5.7
|
%
|
|
(0.1
|
)%
|
|
1.6
|
%
|
APAC
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharmaceuticals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Injectables
|
|
|
211.4
|
|
|
205.4
|
|
|
168.9
|
|
|
2.9
|
%
|
|
21.6
|
%
|
|
7.2
|
%
|
|
19.6
|
%
|
|
Other Pharma
|
|
|
16.4
|
|
|
15.2
|
|
|
14.1
|
|
|
7.9
|
%
|
|
7.8
|
%
|
|
17.8
|
%
|
|
4.8
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
227.8
|
|
|
220.6
|
|
|
183.0
|
|
|
3.3
|
%
|
|
20.5
|
%
|
|
7.9
|
%
|
|
18.4
|
%
|
Devices
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medication Management Systems
|
|
|
21.2
|
|
|
19.9
|
|
|
16.7
|
|
|
6.5
|
%
|
|
19.2
|
%
|
|
11.1
|
%
|
|
15.5
|
%
|
|
Other Devices
|
|
|
24.2
|
|
|
26.9
|
|
|
25.5
|
|
|
(10.0
|
)%
|
|
5.5
|
%
|
|
(8.9
|
)%
|
|
(0.7
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
45.4
|
|
|
46.8
|
|
|
42.2
|
|
|
(3.0
|
)%
|
|
10.9
|
%
|
|
(0.4
|
)%
|
|
5.7
|
%
|
Total APAC
|
|
|
273.2
|
|
|
267.4
|
|
|
225.2
|
|
|
2.2
|
%
|
|
18.7
|
%
|
|
6.5
|
%
|
|
16.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Sales
|
|
$
|
3,879.3
|
|
$
|
3,629.5
|
|
$
|
3,436.2
|
|
|
6.9
|
%
|
|
5.6
|
%
|
|
9.0
|
%
|
|
4.8
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty
Injectables include generic injectables and proprietary specialty injectables. Other Pharmaceuticals include large volume I.V. solutions, nutritionals and contract manufacturing services.
Medication Management Systems include infusion pumps, related software, services and administration sets. Other Devices include gravity administration sets, critical care products (through August
2009) and other device products.
33
Table of Contents
-
(1)
-
The
comparisons at constant currency rates reflect comparative local currency balances at prior periods' foreign exchange rates. We have calculated these
percentages by taking years ended net sales for the three years presented less the respective prior years ended reported net sales, divided by the respective prior years ended reported net sales, all
at the respective prior years' foreign exchange rates. This measure provides information on the change in net sales assuming that foreign currency exchange rates have not changed between the prior and
the current period. Management believes the use of this measure aids in the understanding of our change in net sales without the impact of foreign currency and provides greater transparency into
Hospira's results of operations. Management uses these measures internally to monitor business unit performance and in evaluating management performance. These measures are intended to supplement the
applicable GAAP measures and should not be considered in isolation from or a replacement for, financial measures prepared in accordance with GAAP.
Net
sales for 2007 include eleven months of Mayne Pharma net sales.
2009
compared to 2008:
Net
sales increased 6.9%, or 9.0% excluding the impact of changes in foreign exchange rates. The decrease in Other Devices in all segments is due to the disposal of the critical care
business in August 2009. The following discussion, except as noted, reflects changes from the prior period excluding the impact of changes in foreign exchange rates.
Net
sales in the Americas segment increased 10.3%, or 11.1% excluding the impact of changes in foreign exchange rates. Net sales of Specialty Injectable Pharmaceuticals increased
primarily due to the product launch of generic oxaliplatin in the U.S. Despite the strong generic substitution rates achieved by oxaliplatin since the launch, the sales trend for this product is not
expected to continue at this level as sales during a generic launch period have a higher degree of end customer price movement due to competitive market factors and reflect wholesalers' common
practice of purchasing quantities of product at launch to assure adequate supply for end customer use. In addition, Specialty Injectable Pharmaceuticals net sales were higher due to other new product
introductions and increased volume for Hospira's proprietary sedation drug Precedex
TM
, partially offset by lower anti-infectives volume due to temporary capacity constraints.
Other Pharma net sales increased due to higher demand from certain contract manufacturing customers and increased large volume I.V. solutions sales due to additional GPO contract awards. Net sales in
Medication Management Systems were slightly higher with increased volumes in ambulatory and large volume infusion systems, primarily Plum A+
TM
, and dedicated administration sets.
Net
sales in the EMEA segment decreased (7.0)%, or (0.1)% excluding the impact of changes in foreign exchange rates. Specialty Injectable Pharmaceuticals net sales were slightly higher
with increases from new product introductions, including a biogeneric, offset by lower price and volume declines on certain existing oncology products. Net sales of Other Pharma were lower due to a
decline in demand from certain contract manufacturing customers and a decline in certain low margin compounding products. Net sales in Medication Management Systems increased due to higher sales
volume of large volume infusion systems, primarily Plum A+
TM
and GemStar
TM
and dedicated administration sets.
Net
sales in the APAC segment increased 2.2%, or 6.5% excluding the impact of changes in foreign exchange rates. Specialty Injectable Pharmaceuticals net sales increased due to higher
volume in Hospira's proprietary sedation drug Precedex
TM
, cardiovascular-related products, a new oncology product launch and higher proprietary and differentiated product sales in
Australia. Net sales in
34
Table of Contents
Medication
Management Systems increased due to higher sales volume of ambulatory infusion systems and dedicated administration sets.
2008
compared to 2007:
Net
sales increased 5.6%, or 4.8% excluding the impact of changes in foreign exchange rates.
Net
sales in the Americas segment increased 4.5%. The growth in net sales of Specialty Injectable Pharmaceuticals was due to increased volumes from GPO contract awards, new product
introductions, increased volume for Precedex
TM
and the impact of competitor supply issues. Other Pharma net sales decreased due to lower demand from certain contract manufacturing
customers, partially offset by increased large volume I.V. solutions sales due to GPO contract awards. Net sales in Medication Management Systems increased due to strong demand, particularly for
Symbiq
TM
. Other Devices net sales increased due to volume growth in gravity administration sets.
Net
sales in the EMEA segment increased 5.7%, or 1.6% excluding the impact of changes in foreign exchange rates. Specialty Injectable Pharmaceuticals net sales increased primarily due to
an additional month of Mayne Pharma net sales in 2008 and sales of the newly launched biogeneric Retacrit
TM
, partially offset by expected price decreases in oncology products. Net sales
of Other Pharma were lower due to declines in demand from certain contract manufacturing customers. Net sales in Medication Management Systems increased due to higher sales volume of ambulatory and
large volume infusion systems.
Net
sales in the APAC segment increased 18.7%, or 16.1% excluding the impact of changes in foreign exchange rates. The increase was primarily due to volume growth in Specialty
Injectables anti-infectives and certain oncology products and an additional month of Mayne Pharma net sales in 2008. The remaining increase was due to higher volume growth in Medication
Management Systems, Other Pharma and Devices.
Gross Profit (Net sales less Cost of products sold)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percent change
|
|
Years ended December 31 (dollars in millions)
|
|
2009
|
|
2008
|
|
2007
|
|
2009
|
|
2008
|
|
|
|
Gross profit
|
|
$
|
1,456.4
|
|
$
|
1,342.7
|
|
$
|
1,195.7
|
|
|
8.5
|
%
|
|
12.3
|
%
|
As a percent of net sales
|
|
|
37.5
|
%
|
|
37.0
|
%
|
|
34.8
|
%
|
|
|
|
|
|
|
|
|
2009
compared to 2008:
Gross
profit increased $113.7 million, or 8.5%, in 2009, compared to 2008.
The
gross profit increase is primarily the result of higher sales volume and favorable product mix including the impact of the U.S. product launch of generic oxaliplatin and higher
anesthesia-related product sales, primarily Precedex
TM
. In addition, higher production volume and cost reductions associated with Project Fuel and Facilities Optimization initiatives
contributed to manufacturing efficiency gains. These increases were partially offset by the impact of changes in foreign exchange rates, costs associated with certain product corrective actions and
inventory charges including those related with the Project Fuel product line complexity reduction initiative.
35
Table of Contents
2008
compared to 2007:
Gross
profit increased $147.0 million, or 12.3%, in 2008 compared to 2007.
The
gross profit increase is primarily the result of higher sales volume, including an additional month of Mayne Pharma related gross profit in 2008, the impact of changes in foreign
exchange rates, improved manufacturing performance and favorable product mix driven by Medication Management Systems. These increases were partially offset by higher freight and distribution expenses.
A portion of the increase in gross profit results from the absence in 2008 of purchase accounting charges for Mayne Pharma, which in the prior year included inventory step-up charges of
$53.1 million.
Restructuring and Impairment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percent change
|
|
Years ended December 31 (dollars in millions)
|
|
2009
|
|
2008
|
|
2007
|
|
2009
|
|
2008
|
|
|
|
Restructuring and impairment
|
|
$
|
94.2
|
|
$
|
22.4
|
|
$
|
21.8
|
|
|
320.5
|
%
|
|
2.8
|
%
|
As a percent of net sales
|
|
|
2.4
|
%
|
|
0.6
|
%
|
|
0.6
|
%
|
|
|
|
|
|
|
|
|
2009
compared to 2008:
Restructuring
and impairment charges were $94.2 million in 2009, compared with $22.4 million in 2008. The increase in Restructuring and impairment was due to
non-cash, pre-tax impairment charges of $52.8 million related to property and equipment, allocated goodwill and intangible asset impairments associated with
non-strategic businesses and related assets associated with Project Fuel initiatives. In addition to the impairment charges in 2009, restructuring charges of $41.4 million,
primarily severance costs, relate to Project Fuel and Facilities Optimization. Restructuring incurred in 2008 was related to Facilities Optimization initiatives.
2008
compared to 2007:
Restructuring
and impairment charges were $22.4 million in 2008, compared with $21.8 million in 2007, primarily relating to severance costs associated with Facilities
Optimization initiatives and in 2007 included an impairment of an intangible asset related to a non-strategic device product.
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percent change
|
|
Years ended December 31 (dollars in millions)
|
|
2009
|
|
2008
|
|
2007
|
|
2009
|
|
2008
|
|
|
|
Research and development expense
|
|
$
|
240.5
|
|
$
|
211.9
|
|
$
|
201.2
|
|
|
13.5
|
%
|
|
5.3
|
%
|
As a percent of net sales
|
|
|
6.2
|
%
|
|
5.8
|
%
|
|
5.9
|
%
|
|
|
|
|
|
|
|
|
2009
compared to 2008:
Research
and development ("R&D") expenses increased $28.6 million, or 13.5%, in 2009, compared to 2008. The increase was primarily related to investments in various new product
development programs, including biogenerics, and charges related to a third party agreement and corresponding milestone reached for development of an oncology product that has not yet reached
regulatory approval. These increases were partially offset by the impact of changes in foreign exchange rates and productivity improvements associated with Project Fuel initiatives.
2008
compared to 2007:
R&D
expenses increased $10.7 million, or 5.3%, in 2008, compared to 2007. The increase was primarily related to higher spending on product development associated with new
compounds in
36
Table of Contents
Hospira's
generic injectable drug pipeline, including biogenerics, and device pipeline, partially offset by lower proprietary clinical trial spending.
Acquired In-Process Research and Development
In 2007, as part of the Mayne Pharma acquisition, Hospira allocated and expensed $84.8 million to acquired
in-process research and development related to Mayne Pharma's pipeline products. Additionally in late 2007, Hospira purchased certain clinical studies related to a compound that will be
used to file for expanded medical indications. The cost for these clinical studies was $3.2 million and was recorded as acquired in-process research and development expense in 2007
as the studies have no alternative future uses.
Selling, General and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percent change
|
|
Years ended December 31 (dollars in millions)
|
|
2009
|
|
2008
|
|
2007
|
|
2009
|
|
2008
|
|
|
|
Selling, general and administrative expense
|
|
$
|
618.8
|
|
$
|
590.1
|
|
$
|
582.1
|
|
|
4.9
|
%
|
|
1.4
|
%
|
As a percent of net sales
|
|
|
16.0
|
%
|
|
16.3
|
%
|
|
16.9
|
%
|
|
|
|
|
|
|
|
|
2009
compared to 2008:
Selling,
general and administrative ("SG&A") expenses increased $28.7 million, or 4.9%, in 2009, compared to 2008. The increase was primarily due to higher sales force and annual
incentive compensation provisions and costs associated with Project Fuel initiatives offset by the impact of changes in foreign exchange rates. In 2008, SG&A includes costs related to Mayne Pharma
integration.
2008
compared to 2007:
SG&A
expenses increased $8.0 million, or 1.4%, in 2008, compared to 2007. The increase was primarily due to sales and marketing support within the Americas and support costs for
new product launches in the EMEA and APAC segments, partially offset by lower costs related to the integration of Mayne Pharma in 2008 compared to 2007.
Interest Expense
Hospira incurred interest expense of $106.3 million in 2009, $116.2 million in 2008 and $134.5 million in 2007.
The decrease in 2009 compared to 2008 was primarily due to lower debt outstanding in 2009 and lower interest rates on floating rate notes, including the impact of interest rate swaps on fixed rate
notes. The decrease in 2008 compared to 2007 was primarily due to lower debt outstanding in 2008, the 2007 write-off of costs associated with the issuance of debt incurred related to the
Mayne Pharma acquisition, and lower interest rates on floating rate notes. Refer to the Liquidity and Capital Resources section below, as well as Note 11 to the consolidated financial
statements included in Item 8, for further information regarding Hospira's debt and credit facilities.
Other Expense (Income), Net
Other expense (income) for 2009, 2008 and 2007 primarily includes amounts relating to foreign currency transaction gains and losses,
interest income, and other items. Interest (income) for 2009, 2008 and 2007 was $(7.6) million, $(9.3) million and $(15.1) million, respectively. The decrease in 2009 compared to
2008 was primarily due to lower interest rates. In 2009, Hospira recognized an other-than-temporary impairment charge of $16.6 million on marketable equity securities.
In 2007, Hospira also had net realized gains on the sale of investments of $(5.0) million.
37
Table of Contents
Income Tax (Benefit) Expense
The effective tax rate was a benefit of 5.0% in 2009, compared to an expense of 21.3% in 2008 and 27.2% in 2007. In 2009, the Internal
Revenue Service ("IRS") audit of Hospira's 2004 and 2005 tax returns was completed and the years were effectively settled. The outcome of the IRS audit settlement resulted in a $91.9 million
discrete income tax benefit. Excluding the effect of the IRS audit settlement, the 2009 effective tax rate was an expense of 18.9%. The effective tax rate for 2007 included the impact of expensing
non-deductible acquired in-process research and development of $84.8 million. Excluding the effect of this item, the 2007 effective tax rate was 18.7%. The effective tax
rates for all three years include certain items such as purchase accounting, integration and restructuring charges and interest expense generating benefits in higher tax rate jurisdictions. The
effective tax rates are less than the statutory U.S. federal income tax rate principally due to the benefit of tax exemptions, of varying durations, in certain jurisdictions outside the U.S.
Additionally in 2009, the effective tax rate was impacted by income tax benefits recognized upon the expiration of statutes of limitation on certain unrecognized tax benefits and lower unrecognized
tax benefit accruals. These benefits were partially offset by the establishment of a valuation allowance on certain deferred tax assets associated with the disposal of certain
non-strategic assets, the impairment of non-deductible goodwill, as well as the impairment of marketable equity securities without the availability of a statutory tax benefit.
Liquidity and Capital Resources
Net cash provided by operating activities continues to be Hospira's primary source of funds to finance operating needs, capital
expenditures and repay debt. Other capital resources include cash on hand, borrowing availability under a revolving credit facility and access to the capital markets. Hospira believes that its current
capital resources will be sufficient to finance its operations, including debt service obligations, capital expenditures, acquisitions, product development and investments in cost reduction and
optimization activities for the foreseeable future. Specific to acquisitions, these capital resources will be used for the announced transaction to purchase Orchid Pharma in 2010.
Summary
of Sources and (Uses) of Cash
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31 (dollars in millions)
|
|
2009
|
|
2008
|
|
2007
|
|
|
|
Operating activities
|
|
$
|
944.9
|
|
$
|
584.1
|
|
$
|
551.1
|
|
Investing activities
|
|
|
(211.1
|
)
|
|
(264.9
|
)
|
|
(2,228.0
|
)
|
Financing activities
|
|
|
(308.6
|
)
|
|
(60.1
|
)
|
|
1,580.2
|
|
|
|
Operating Activities
In 2009, Net Cash Provided by Operating Activities of $944.9 million was driven by net income of $403.9 million, adjusted
for non-cash impairments and inventory charges of $95.8 million. Non-cash depreciation, amortization and stock-based compensation expense and tax-related
adjustment totaled $204.3 million. Net cash provided by operating assets and liabilities and Other, net of $240.9 million was primarily associated with the timing of receipt and payments
related to 2009 sales of oxaliplatin and lower inventories. Hospira also made a contribution of $30.0 million to the Hospira Annuity Retirement Plan.
In
2008, Net Cash Provided by Operating Activities of $584.1 million was driven by net income of $320.9 million. Non-cash adjustments to net income primarily
consisted of depreciation, amortization, the write-off of acquired in-process research and development, stock-based compensation expense and tax-related adjustments
and the net gains on sales of assets and totaled $334.9 million. Net cash used in operating assets and liabilities and Other, net of $(71.7) million was driven by higher trade
receivables and higher inventories for planned product launches and increased GPO contract awards, partially offset by higher trade payables.
38
Table of Contents
In
2007, Net Cash Provided by Operating Activities of $551.1 million was driven by net income of $136.8 million. Non-cash adjustments to net income primarily
consisted of depreciation, amortization, the write-off of acquired in-process research and development, the step-up value of acquired inventories sold, and
stock-based compensation expense and totaled $415.0 million. Net cash used in operating assets and liabilities and Other, net of $(0.7) million consist primarily of payments made on
acquired Mayne Pharma current liabilities, including merger advisory fees, and higher trade receivables due to increased net sales, partially offset by lower inventory and higher trade payables.
Investing Activities
In 2009, Net Cash Used in Investing Activities of $211.1 million includes capital expenditures of $159.4 million and
$86.6 million of payments for acquisitions, contingent consideration on prior acquisitions and other investments, offset by $49.2 million of proceeds from dispositions of businesses and
related assets.
In
2008, Net Cash Used in Investing Activities of $264.9 million includes capital expenditures of $164.3 million and $50.8 million of payments for certain intangible
assets including product rights, primarily acquired in 2007 but paid in 2008, and other investments. Hospira paid $26.1 million for acquisitions and deferred consideration related to
acquisitions made by Mayne Pharma in prior years. Also, Hospira purchased $24.5 million of marketable equity securities.
In
2007, Net Cash Used in Investing Activities of $2,228.0 million includes principally payments related to the acquisition of Mayne Pharma including the purchase price of
$1,961.3 million, net of cash acquired. In addition, capital expenditures of $210.5 million were partially offset by proceeds from dispositions of certain product rights for
$13.8 million and proceeds from the sales of marketable securities of $10.4 million.
Financing Activities
Net Cash Used in Financing Activities totaled $308.6 million in 2009. During 2009, Hospira paid $300.0 million on the
maturity of the notes due June 2009 and paid $375.0 million on the notes due in March 2010. Financing activities also include proceeds from the issuance of $250.0 million aggregate
principal amount notes and employee stock option exercises and related tax benefits of $123.3 million.
Net
Cash Used in Financing Activities totaled $60.1 million in 2008. During 2008, Hospira prepaid $70.7 million in principal amount of the term loan, in addition to the
revised required $24.3 million in principal, for a total of $95.0 million. Financing activities also include proceeds from employee stock option exercises and related tax benefits of
$28.8 million.
Net
Cash Provided by Financing Activities totaled $1,580.2 million in 2007. Hospira incurred $1,925.0 million of bank debt to finance the Mayne Pharma acquisition. The
bridge loan facility was completely refinanced in March through the issuance of long-term debt securities of varying maturities. During 2007, Hospira prepaid $400.0 million in
principal amount of the term loan. In addition, financing activities include proceeds from employee stock option exercises and related tax benefits of $75.4 million.
Summary of Financial Position
|
|
|
|
|
|
|
|
As of Years ended December 31 (dollars in millions)
|
|
2009
|
|
2008
|
|
|
|
Cash and cash equivalents
|
|
$
|
946.0
|
|
$
|
483.8
|
|
Working capital
|
|
|
1,644.3
|
|
|
1,101.8
|
|
Short-term borrowings and long-term debt
|
|
|
1,730.9
|
|
|
2,172.3
|
|
|
|
39
Table of Contents
Working Capital
The increase in working capital in 2009 was primarily due to an increase in cash and cash equivalents and decrease in
short-term borrowings due to the payment of $300.0 million on the maturity of the notes due June 2009 and payment of $375.0 million on the notes due in March 2010. Higher
collections of gross trade receivables were associated with the launch of generic oxaliplatin while related chargeback and rebate liabilities increased due to timing of end-use customer
and claim submissions from wholesalers. In addition, lower inventory in 2009 was due to product portfolio optimization initiatives, higher volume throughput, and planned facility shutdowns in
December. Assets held for sales, net and cash received to date also increased working capital in 2009 related to Hospira's commitment to dispose of non-strategic businesses and related
assets.
The
increase in working capital in 2008 was primarily due to an increase in cash and cash equivalents offset by the reclassification of the $300.0 million principal notes due June
2009, to short term borrowings. In addition, trade receivables increased due to higher sales, inventories increased due to planned product launches and increased GPO contract awards, partially offset
by increases in trade payables.
Debt and Capital
Senior Notes.
Hospira has $1,700.0 million aggregate principal amount of senior unsecured notes outstanding, including
$500.0 million
principal amount of 5.55% notes due in March 2012, $400.0 million principal amount of 5.90% notes due in June 2014, $250.0 million principal amount of 6.40% notes due May 2015 and
$550.0 million principal amount of 6.05% notes due in March 2017. In June 2009, Hospira repaid in full the $300.0 million aggregate principal amount of 4.95% notes upon maturity. In
December 2009, the $375.0 million aggregate principal amount due in March 2010 plus accrued interest was fully paid.
In
2009, Hospira entered into interest rate swap contracts whereby $200.0 million of the $400.0 million principal amount of 5.90% notes due June 2014 and
$100.0 million of the $250.0 million principal amount of 6.40% notes due May 2015 were effectively converted from fixed to floating rate debt. In 2008, $300.0 million of the
$400.0 million principal amount of 5.90% notes due in June 2014 were effectively converted to floating rate notes through interest rate swaps with various counterparties for approximately four
months. Upon termination of these interest rate swaps in 2008, the senior unsecured notes were effectively converted back to the applicable fixed rate. As a result of the interest rate swap contract
terminations, Hospira received $9.2 million in cash, excluding accrued interest. The corresponding gains related to the basis adjustment of the debt associated with the terminated swap
contracts were deferred and are being amortized as a reduction of interest expense over the remaining term of the notes.
The
senior notes contain customary covenants that limit Hospira's ability to incur secured indebtedness and liens and merge or consolidate with other companies.
Other Borrowings.
In connection with acquisitions, facility expansions, international capital structure optimization and equipment
lease
requirements, Hospira enters into other borrowings including mortgages, lease arrangements and promissory notes. These borrowings bear a weighted average interest rate of approximately 7.3%, with
principle and interest due in various intervals, and are primarily unsecured. As of December 31, 2009 and 2008, Hospira had $26.5 million and $37.7 million, respectively, of other
borrowings outstanding, of which $22.6 million and $32.4 million, respectively, were classified as short-term.
Revolving Credit Facility.
In 2009, Hospira entered into a new $700.0 million unsecured revolving credit facility (the "Revolver")
maturing in
October 2012. The Revolver replaced Hospira's prior revolving credit agreement that was scheduled to expire in December 2010. The Revolver is available
40
Table of Contents
for
general corporate purposes. Borrowings under the Revolver bear interest at LIBOR or a base rate plus, in each case, a margin. Hospira also pays a facility fee on the aggregate amount of the
commitments under the Revolver. The annual percentage rates for the LIBOR margin, the base rate margin and the facility fee are 2.5%, 1.5% and 0.5%, respectively, and are subject to increase or
decrease if there is a change in Hospira's credit ratings. The amount of available borrowings may be increased to a maximum of $825.0 million, under certain circumstances. As of
December 31, 2009, Hospira has not borrowed any amounts under the Revolver.
Debt Covenants.
The Revolver has financial covenants that require Hospira to maintain (i) a maximum leverage ratio (consolidated
total debt to
consolidated net earnings before financing expense, taxes and depreciation, amortization, adjusted for certain non-cash items and agreed-upon restructuring charges ("Adjusted
EBITDA")) of not more than 3.25 to 1.0 and (ii) a minimum interest coverage ratio (Adjusted EDITDA to consolidated financing expense) of not less than 5.0 and 1.0. As of December 31,
2009, Hospira was in compliance with all applicable covenants.
Credit Ratings.
During 2009, Hospira's credit rating and outlook were upgraded from BBB to BBB+ by Standard and Poor's Rating Services,
and from Baa3
negative to Baa3 stable by Moody's Investor Service. Hospira's credit rating had been downgraded in 2007 from stable to negative by Moody's as a result of the increased debt associated with the Mayne
Pharma acquisition.
Share Repurchase.
In February 2006, Hospira's board of directors authorized the repurchase of $400.0 million of Hospira's common
stock. The
program authorizes Hospira to repurchase common shares from time to time through the open market in compliance with securities regulations and other legal requirements. The size and timing of any
purchases are at the discretion of company management, based on factors such as alternative uses of cash and business and market conditions. The repurchase of shares commenced in early March 2006. As
of December 31, 2009, Hospira repurchased 7.6 million shares for $299.8 million in the aggregate under the 2006 board authorization, all of which were purchased during 2006.
Hospira does not expect to repurchase any shares in 2010.
Contractual Obligations and Off-Balance Sheet Arrangements
The following table summarizes Hospira's estimated contractual obligations as of December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment Due by Period
|
|
(dollars in millions)
|
|
Total
|
|
2010
|
|
2011-2012
|
|
2013-2014
|
|
2015 and
Thereafter
|
|
Debt and interest payments
|
|
$
|
2,225.1
|
|
$
|
113.7
|
|
$
|
691.7
|
|
$
|
534.5
|
|
$
|
885.2
|
|
Lease obligations
|
|
|
98.5
|
|
|
22.1
|
|
|
33.4
|
|
|
20.0
|
|
|
23.0
|
|
Purchase commitments
(1)
|
|
|
1,374.3
|
|
|
746.3
|
|
|
389.8
|
|
|
238.2
|
|
|
|
|
Other long-term liabilities reflected on the consolidated balance sheet
(2)
|
|
|
101.9
|
|
|
4.3
|
|
|
72.5
|
|
|
25.1
|
|
|
|
|
Pension funding requirements
(3)
|
|
|
84.0
|
|
|
|
|
|
37.0
|
|
|
29.0
|
|
|
18.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
3,883.8
|
|
$
|
886.4
|
|
$
|
1,224.4
|
|
$
|
846.8
|
|
$
|
926.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
(1)
-
Purchase
obligations for purchases made in the normal course of business to meet operational and capital requirements. Hospira has committed to make
potential future "milestone" payments to third parties as part of in-licensing and development agreements. Payments under these agreements are contingent upon achievement of certain
developmental, regulatory and/or commercial milestones and are not included in the table above. For further details regarding the collaborative arrangements, see Note 5 to the consolidated
financial statements included in Item 8.
41
Table of Contents
-
(2)
-
Includes
liability of $73.6 million relating to unrecognized tax benefits, penalties and interest; excludes approximately $170.8 million of
other long-term liabilities related primarily to pension and post-retirement benefit obligations.
-
(3)
-
While
Hospira's funding policy requires contributions to Hospira's defined benefit plans equal to the amounts necessary to, at a minimum, satisfy the
funding requirements as prescribed by the laws and regulations of each country, Hospira does make discretionary contributions when management determines it is prudent to do so.
Hospira's
other commercial commitments as of December 31, 2009, representing commitments not recorded on the balance sheet but potentially triggered by future events, primarily
consist of non-debt letters of credit to provide credit support for certain transactions as requested by third parties. In the normal course of business, Hospira provides indemnification
for guarantees it arranges in the form of bonds guaranteeing the payment of value added taxes, performance bonds, custom bonds and bid bonds. As of December 31, 2009, Hospira had
$29.8 million of these commitments, with a majority expiring in 2010. No amounts have been drawn on these letters of credit or bonds.
Hospira
has no material exposures to off-balance sheet arrangements, no special purpose entities and no activities that include non-exchange-traded contracts
accounted for at fair value.
Critical Accounting Policies
Critical accounting policies are those policies that require management to make the most difficult, subjective or complex judgments,
often because they must estimate the effects of matters that are inherently uncertain and may change in subsequent periods. Critical accounting policies involve judgments and uncertainties that are
sufficiently sensitive to result in materially different results under different assumptions and conditions. Hospira believes its most critical accounting policies are those described below. For a
detailed discussion of these and other accounting policies, see Note 1 to the consolidated financial statements included in Item 8.
Revenue Recognition
Hospira recognizes revenues from product sales when persuasive evidence of an arrangement exists, delivery has occurred (or
services have been rendered), the price is fixed or determinable and collectibility is reasonably assured. For other than certain drug delivery pumps and contract manufacturing, product revenue is
recognized when products are delivered to customers and title passes. In certain circumstances, Hospira enters into arrangements in which it commits to provide multiple elements (deliverables) to its
customers. In these cases, total revenue is divided among the separate deliverables based on their relative fair value and is recognized for each deliverable in accordance with the applicable revenue
recognition criteria.
For
drug delivery pumps, revenue is typically derived under one of three types of arrangements: outright sales of the drug delivery pump; placements under lease arrangements; and
placements under contracts that include associated disposable set purchases. For outright sales of the drug delivery pump and for related sales of disposable products (sets) revenue is recognized as
the products are delivered, in accordance with the provisions of Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") Topic 605, "Revenue Recognition,"
including revenue recognition when right of return exists. Other arrangements (leases and contracts that included associated disposable set purchases) are assessed in accordance with the provisions of
ASC Topic 840, "Leases," including determining whether an arrangement contains a lease and drug delivery pump revenue is recorded as a sales-type lease or operating lease. For
arrangements that qualify as sales-type leases, the discounted sales value of the drug delivery pump is recorded as revenue upon delivery to the customer. For arrangements that qualify as
operating leases, Hospira recognizes revenue over the lease term, and the related asset is depreciated over its estimated useful life on a straight-line basis.
42
Table of Contents
Hospira markets a server-based suite of software applications designed to exchange data from a hospital's drug information library database to drug delivery pumps
throughout the hospital. The arrangements related to such applications typically include a perpetual or subscription software license, software maintenance and implementation services, in addition to
the drug delivery pump. Hospira recognizes revenue related to these arrangements in accordance with the provisions of ASC Topic 985, "Software." Drug delivery pump, perpetual software license
and implementation service revenue are generally recognized as obligations are completed or upon customer acceptance. Software subscription license revenue and software maintenance revenue is
recognized ratably over the contract period.
Contract
manufacturing involves filling customers' active pharmaceutical ingredients ("API") into delivery systems. Under these arrangements, customers' API is often consigned to Hospira
and revenue is recorded for the materials and labor provided by Hospira, plus a profit, upon shipment to the customer.
Upon
recognizing revenue from a sale, Hospira records an estimate for certain items that reduce gross sales in arriving at its reported net sales for each period. These items include
chargebacks, rebates and other items (such as cash discounts and returns). Provisions for chargebacks and rebates represent the most significant and complex of these estimates.
Chargebacks
Hospira sells a significant portion of its specialty injectable pharmaceutical products through wholesalers, which maintain inventories of
Hospira products and later sell those products to end customers. In connection with its sales and marketing efforts, Hospira negotiates prices with end customers for certain products under pricing
agreements (including, for example, group purchasing organization contracts). Consistent with industry practice, the negotiated end customer prices are typically lower than the prices charged to the
wholesalers. When an end customer purchases a Hospira product that is covered by a pricing agreement from a wholesaler, the end customer pays the wholesaler the price determined under the pricing
agreement. The wholesaler is then entitled to charge Hospira back for the difference between the price the wholesaler paid Hospira and the contract price paid by the end customer (a "chargeback").
Hospira
records the initial sale to a wholesaler at the price invoiced to the wholesaler and at the same time, records a provision equal to the estimated amount the wholesaler will later
charge back to Hospira, reducing gross sales and trade receivables. This provision must be estimated because the actual end customer and applicable pricing terms may vary at the time of the sale to
the wholesaler. Accordingly, the most significant estimates inherent in the initial chargeback provision relate to the volume of sales to the wholesalers that will be subject to chargeback and the
ultimate end customer contract price. These estimates are based primarily on an analysis of Hospira's product sales and most recent historical average chargeback credits by product, estimated
wholesaler inventory levels, current contract pricing, anticipated future contract pricing changes and claims processing lag time. Hospira estimates the levels of inventory at the wholesalers through
analysis of wholesaler purchases and inventory data obtained directly from certain of the wholesalers. Hospira regularly monitors the provision for chargebacks and makes adjustments when it believes
the actual chargebacks may differ from earlier estimates. The methodology used to estimate and provide for chargebacks was consistent across all periods presented.
Settlement
of chargebacks, excluding generic oxaliplatin sales, generally occurs between 25 and 35 days after the sale to wholesalers. A one percent decrease in end customer
contract prices for sales pending chargeback, excluding generic oxaliplatin sales, at December 31, 2009, would decrease net sales and income before income taxes by approximately
$1.4 million. A one percent increase in wholesale units sold subject to chargebacks, excluding generic oxaliplatin sales, at December 31, 2009, would decrease net sales and income before
income taxes by approximately $0.6 million.
Hospira's
generic oxaliplatin sales, launched in the U.S. in 2009, contributed to the increase in the chargebacks accrual from $60.2 million at December 31, 2008, to
$177.0 million at December 31, 2009.
43
Table of Contents
Generally,
sales during a generic launch period experience more rapid end customer price declines due to competitive market factors and reflect wholesalers' common practice of purchasing quantities of
product at launch to assure adequate supply for end customer use. Due to these factors, settlement of chargebacks generally occur over a longer duration and at a higher per unit rate than with other
Hospira products.
The
most significant variables that could affect Oxaliplatin chargeback related accruals are the rate of end customer price decline and the rate of end customer demand experienced by the
wholesalers. A five percent decline in end customer prices would decrease net sales and income before income taxes by approximately $2.5 million. A five percent decrease in monthly end customer
demand experienced by wholesalers would decrease net sales and income before income taxes by approximately $0.8 million.
Rebates
Hospira primarily offers rebates to direct customers, customers who purchase from certain wholesalers at end customer contract prices and
government agencies, which administer various programs such as Medicaid. Direct rebates are generally rebates paid to direct purchasing customers based on a contracted discount applied to the direct
customer's purchases. Indirect rebates are rebates paid to "indirect customers" that have purchased Hospira products from a wholesaler under a pricing agreement with Hospira. Governmental agency
rebates are amounts owed based on legal requirements with public sector benefit providers (such as Medicaid), after the final dispensing of the product by a pharmacy to a benefit plan participant.
Rebate amounts are usually based upon the volume of purchases. Hospira estimates the amount of the rebate due at the time of sale, and records the liability and a reduction of gross sales at the same
time the product sale is recorded. Settlement of the rebate generally occurs from one to fifteen months after sale.
In
determining provisions for rebates to direct customers, Hospira considers the volume of eligible purchases by these customers and the rebate terms. In determining rebates on sales
through wholesalers, Hospira considers the volume of eligible contract purchases, the rebate terms and the estimated level of inventory at the wholesalers that would be subject to a rebate, which is
estimated as described above under "Chargebacks." Upon receipt of a chargeback, due to the availability of product and customer specific information, Hospira can then establish a specific provision
for fees or rebates based on the specific terms of each agreement. Rebates under governmental programs are based on the estimated volume of products sold subject to these programs. Each period the
estimates are reviewed and revised, if necessary, in conjunction with a review of contract volumes within the period. Adjustments related to prior period sales have not been material in any period.
Hospira
regularly analyzes the historical rebate trends and makes adjustments to recorded reserves for changes in trends and terms of rebate programs. At December 31, 2009 and
2008, accrued rebates of $156.0 million and $107.4 million, respectively, are included in other accrued liabilities on the consolidated balance sheet. Hospira's generic oxaliplatin
sales, launched in the U.S. in 2009, contributed to the increase in the rebate accrual. The methodology used to estimate and provide for rebates was consistent across all periods presented.
44
Table of Contents
The
following table is an analysis of chargebacks and rebates for years ended 2009 and 2008. In each year, the provisions for chargebacks and rebates relating to prior period sales were
not material.
|
|
|
|
|
|
|
|
(dollars in millions)
|
|
Chargebacks
|
|
Rebates
|
|
Balance at January 1, 2008
|
|
$
|
73.6
|
|
$
|
106.5
|
|
Provisions
|
|
|
727.0
|
|
|
222.8
|
|
Payments
|
|
|
(740.4
|
)
|
|
(221.9
|
)
|
|
|
|
|
|
|
Balance at December 31, 2008
|
|
|
60.2
|
|
|
107.4
|
|
|
|
|
|
|
|
Provisions
|
|
|
1,041.1
|
|
|
269.2
|
|
Payments
|
|
|
(924.3
|
)
|
|
(220.6
|
)
|
|
|
|
|
|
|
Balance at December 31, 2009
|
|
$
|
177.0
|
|
$
|
156.0
|
|
|
|
|
|
|
|
Returns
Provisions for returns are provided for at the time the related sales are recognized, and are reflected as a reduction of sales. The estimate
of the provision for returns is primarily based on historical experience of actual returns. Additionally, Hospira considers other factors such as levels of inventory in the distribution channel,
product dating and expiration period, whether products have been discontinued and entrance in the market of additional competition. This estimate is reviewed periodically and, if necessary, revised,
with any revisions recognized immediately as adjustments to net sales.
Inventories
Inventories are stated at the lower of cost (first-in, first-out basis) or market. Hospira monitors inventories
for exposures related to obsolescence, excess and date expiration, non-conformance, corrective actions and loss and damage, and recognizes a charge to cost of products sold for the amount
required to reduce the carrying value of inventory to estimated net realizable value. If conditions are less favorable than estimated, additional charges may be required. Such reserves were
$110.7 million and $67.8 million at December 31, 2009 and 2008, respectively. The increase to the provision is primarily associated with product portfolio optimization charges and
product corrective action related charges.
Stock-Based Compensation
In accordance with the provisions of ASC Topic 718, "CompensationStock Compensation," ("ASC 718"), share-based
payment transactions are recognized as compensation cost over the vesting period based on the fair value of the instrument on the date of grant. Hospira uses the Black-Scholes option valuation model
and the Monte Carlo simulation model to determine the fair value of stock options and performance share awards, respectively. The fair value models include various assumptions, including the expected
volatility and expected life of the awards. These assumptions reflect Hospira's best estimates, but they involve inherent uncertainties based on market conditions generally outside of Hospira's
control. As a result, if other assumptions had been used, stock-based compensation expense, as calculated could have been materially impacted. Furthermore, if Hospira uses different assumptions in
future periods, stock-based compensation expense could be materially impacted in future periods. See Note 15 to the consolidated financial statements included in Item 8 for additional
information regarding stock-based compensation.
Pension and Post-Retirement Benefits
Hospira provides pension and post-retirement medical and dental benefits to certain of
its active and retired employees based both in and outside of the U.S. For financial reporting purposes, Hospira develops assumptions, the most significant of which are the discount rate, the expected
rate of return on plan assets and healthcare cost trend rate. For these assumptions, management consults with actuaries, monitors plan provisions and demographics and reviews public market data and
general economic information. These assumptions reflect Hospira's best estimates, but they involve inherent uncertainties based on market conditions generally outside of Hospira's control. Assumption
changes could affect the reported funded status of Hospira's plans and, as a result, could result in higher funding requirements and net periodic benefit costs.
45
Table of Contents
The
U.S. discount rate estimates were developed with the assistance of yield curves developed by third-party actuaries. For non-U.S. plans, benchmark yield data for
high-quality fixed income investments for which the timing and amounts of payments match the timing and amounts of projected benefit payments is used to derive discount rate assumptions.
The
expected return on assets for the pension plan represents the average rate of return to be earned on plan assets over the period the benefits are expected to be paid. The expected
return on assets is developed from the expected future return of each asset class, weighted by the expected allocation of pension assets to that asset class. Hospira considers historical performance
for the types of assets in which the plans invest, independent market forecasts and economic and capital market conditions.
Sensitivity
analysis for U.S. plans which represent the primary portion of obligations is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
2009 Net Benefit Cost
(Income)/Expense
|
|
As of December 31, 2009
Benefit Obligation
Increase/(Decrease)
|
|
(dollars in millions)
|
|
One
Percentage-
Point
Increase
|
|
One
Percentage-
Point
Decrease
|
|
One
Percentage-
Point
Increase
|
|
One
Percentage-
Point
Decrease
|
|
Pension PlansU.S.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discount rate
|
|
$
|
(3.0
|
)
|
$
|
3.5
|
|
$
|
(49.9
|
)
|
$
|
60.9
|
|
Expected long-term return on assets
|
|
|
(3.5
|
)
|
|
3.5
|
|
|
|
|
|
|
|
Medical and Dental PlanU.S.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discount rate
|
|
|
(0.1
|
)
|
|
0.2
|
|
|
(5.5
|
)
|
|
6.8
|
|
Expected health care cost trend rate (initial and ultimate)
|
|
|
0.6
|
|
|
(0.5
|
)
|
|
6.4
|
|
|
(5.3
|
)
|
One
provision of ASC Topic 715, "CompensationRetirement Benefits" ("ASC 715") requires full recognition of the funded status of Hospira's defined benefit and
post-retirement plans. Another provision of ASC 715 requires the measurement of Hospira's defined benefit plan's assets and its obligations to determine the funded status as of the end of
the fiscal year. The incremental effect of the application of these provisions in 2008 is provided in Note 8 of the consolidated financial statements included in Item 8.
Impairment of Long-Lived and Other Assets
In accordance with provision of ASC Subtopic 360-10, "Property, Plant, and
Equipment: Overall" and ASC Topic 350, "IntangiblesGoodwill and Other," the carrying value of long-lived assets, including amortizable intangible assets and property and
equipment, are reviewed whenever events or changes in circumstances indicate that the related carrying amounts may not be recoverable. Impairment is generally determined by comparing projected
undiscounted cash flows to be generated by the asset, or appropriate grouping of assets, to its carrying value. If an impairment is identified, a loss is recorded equal to the excess of the asset's
net book value over its fair value, and the cost basis is adjusted. Determining the extent of an impairment, if any, typically requires various estimates and assumptions including using management's
judgment, cash flows directly attributable to the asset, the useful life of the asset and residual value, if any. When necessary, Hospira uses internal cash flow estimates, quoted market prices and
appraisals as appropriate to determine fair value. Actual results could vary from these estimates. In addition, the remaining useful life of the impaired asset is revised, if necessary. Hospira
reports assets and related liabilities held for sale at the lower of its carrying value or its estimated net realizable value.
Hospira
regularly reviews its investments to determine whether an other-than-temporary decline in market value exists. Hospira considers factors affecting the
investee, factors affecting the industry the investee operates in, and general equity market trends. Hospira considers the length of time an
46
Table of Contents
investment's
market value has been below carrying value and the prospects for recovery to carrying value. When Hospira determines that an other-than-temporary decline has
occurred, the carrying basis of the investment is written down to fair value and the amount of the write-down is included in Other expense (income), net.
Goodwill
is not amortized but tested for impairment at least annually, or more frequently if an event occurs or circumstances change that would reduce the fair value of a reporting unit
below its carrying value. Hospira's reporting units are U.S., Canada, Latin America, EMEA and APAC. The evaluation is based upon the estimated fair value of Hospira's reporting units compared to the
net carrying value of assets and liabilities. Hospira uses internal discounted cash flow estimates and market value comparisons to determine estimated fair value. The annual assessment occurs in the
third quarter of each year.
Loss Contingencies
In accordance with the provisions of ASC Topic 450, "Contingencies," loss contingency provisions are recorded for probable losses
at management's best estimate of a loss, or when a best estimate cannot be made, a minimum loss contingency amount is recorded. These estimates are often initially developed substantially earlier than
the ultimate loss is known, and the estimates are refined each accounting period, as additional information is known. Accordingly, if Hospira is initially unable to develop a best estimate of loss,
the minimum amount, which could be zero, is recorded.
Income Taxes
Hospira's provision for income taxes is based on taxable income at statutory tax rates in effect in the various jurisdictions in which
Hospira operates. Significant judgment is required in determining the provision for income taxes and in evaluating tax positions that are subject to audits and adjustments. Liabilities for
unrecognized tax benefits are established when, despite Hospira's belief that the tax return positions are fully supportable, certain positions are likely to be challenged based on the applicable tax
authority's determination of the positions. Such liabilities are based on management's judgment, utilizing internal and external tax advisors and represent management's best estimate as to the likely
outcome of tax audits. The provision for income taxes includes the impact of changes to unrecognized tax benefits. Each quarter, Hospira reviews the anticipated mix of income derived from the various
taxing jurisdictions and its associated liabilities in accordance with the provisions of ASC Topic 740, "Income Taxes," ("ASC 740"), including the provisions of Accounting for Uncertainty in Income
Taxes. ASC 740 prescribes a recognition threshold and measurement attribute for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return.
Deferred income taxes are provided for the tax effect of temporary differences between the tax basis of assets and liabilities and their reported amounts in the financial statements at the enacted
statutory rate expected to be in effect when the taxes are paid. Provision for income taxes and foreign withholding taxes are not provided for on undistributed earnings for certain foreign
subsidiaries when Hospira intends to reinvest these earnings indefinitely to fund foreign acquisitions or meet working capital and plant and equipment acquisition needs.
Recently Issued and Adoption of New Accounting Standards
The disclosure provided in Note 1 to the consolidated financial statements included in Part II Item 8 hereof is
incorporated herein by reference.
Certain Regulatory Matters
On August 13, 2009, Hospira received a Warning Letter, dated August 12, 2009, from the FDA related to Hospira's
corrective action plans with respect to the failure of certain AC power cords manufactured by a third party. The affected power cords are used on certain infusion pumps and related products. Hospira
initiated a voluntary recall of the affected power cords in August 2009. Hospira has responded to the Warning Letter and is working closely with the FDA to conclude this
47
Table of Contents
matter.
Hospira cannot, however, give any assurances as to the expected date of resolution of the matters included in the Warning Letter.
Hospira
recognized costs related to the voluntary recall of the AC power cords and certain other products during 2009. Hospira has initiated field corrections and other remediation
activities with respect to the impacted products. It is possible that additional costs related to these items may be required in future periods, based on modifications to the current remediation plans
and changes in estimates as a result of ongoing dialogue with the FDA. While Hospira continues to work to resolve the remaining matters described above, there can be no assurance that additional costs
or penalties will not be incurred, and that additional regulatory actions with respect to Hospira will not occur.
Private Securities Litigation Reform Act of 1995A Caution Concerning Forward-Looking Statements
Under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, Hospira cautions investors that any
forward-looking statements or projections made by Hospira, including those made in this document, are subject to risks and uncertainties that may cause actual results to differ materially from those
projected. Economic, competitive, governmental, legal, technological and other factors that may affect Hospira's operations are discussed in Item 1A. Risk Factors, to this Annual Report on
Form 10-K.
Item 7A. Qualitative and Quantitative Disclosures About Market Risk
Financial Instrument and Risk Management
Hospira operates globally, and earnings and cash flows are exposed to market risk from changes in currency exchange rates and interest
rates. Upon consideration of management objectives, costs and opportunities, Hospira uses derivative instruments, including foreign currency forward exchange contracts and interest rate swaps to
manage these risks. Hospira enters into derivative instrument contracts with a diversified group of major financial institutions to limit the amount of credit exposure to nonperformance by any one
institution. Hospira does not utilize derivative instruments for trading or speculative purposes.
Foreign Currency Sensitive Financial Instruments
Hospira's operations are exposed to currency exchange-rate risk, which is mitigated by Hospira's use of foreign currency
forward exchange contracts ("forward contracts"). The objective is to reduce volatility of earnings and cash flows associated with foreign currency exchange-rate changes. Currency
exposures primarily in Euros, Australian dollars, and British pounds include foreign currency denominated assets and liabilities, commitments and anticipated foreign currency revenue and expenses,
including inter-company payables, receivables and loans. These forward contracts are not designated as hedges in accordance with the provisions of ASC Topic 815, "Derivatives and Hedging", and,
therefore, changes in the fair value are recognized in earnings in Other expense (income), net, during the term of the forward contract. As of December 31, 2009, Hospira has
$32.2 million net notional value of forward contracts primarily dominated in Euros, Australian dollars, and British pounds that mature within one to six months. Net forward contract (income)
expense for the years ended December 31, 2009, 2008 and 2007 was $(5.6) million, $(1.8) million and $3.4 million, respectively. The carrying value and fair value of forward contracts was
a net receivable of $3.9 million and a net payable of $12.7 million as of December 31, 2009 and 2008, respectively.
Interest Rate Sensitive Financial Instruments
Hospira's primary interest rate exposures relate to cash and cash equivalents, and fixed and variable rate debt. The objective in
managing exposure to changes in interest rates is to reduce volatility on earnings and cash flows associated with these changes. Hospira utilizes a mix of debt
48
Table of Contents
maturities
along with both fixed-rate and variable-rate debt to manage changes in interest rates. Hospira may use interest rate swap contracts on certain borrowing transactions
to manage its net exposure to interest rate changes and to reduce its overall cost of borrowing. In 2009, Hospira entered into $300.0 million notional amount interest rate swap contracts
whereby $200.0 million of the $400.0 million senior unsecured notes due June 2014 and $100.0 million of the $250.0 million senior unsecured notes due May 2015 were
effectively converted from fixed to floating rate debt. For these fair value hedges, changes in the fair value of the interest rate swaps offset changes in the fair value of the fixed-rate debt due to
changes in market interest rates. Interest rate swap contract gains and losses are included in Interest expense.
Hospira's
investment portfolio of $995.3 million at December 31, 2009, consists of cash and cash equivalents, equity investments in affiliated companies and fair value and
cost investments. Fair value investments consist of marketable securities classified as available-for-sale. Any gains or losses on available-for-sale investments will not be recognized in Hospira's
consolidated statements of income until the investment is sold or if there is a reduction in fair value that is determined to be an other-than-temporary impairment. In 2009,
Hospira assessed the decline in the market value of marketable equity securities to be other-than-temporary, primarily due to the duration and severity of the investment's
decline in market value and the near-term prospects for recovery to the original invested value. Accordingly, Hospira recognized a non-cash, impairment charge of
$16.6 million in Other expense (income), net. The carrying value of the investment portfolio approximates fair market value at December 31, 2009, and the value at maturity, as the
majority of investments consist of securities with maturities of less than three months. Because Hospira's investments consist principally of cash and cash equivalents, a hypothetical one percentage
point increase/(decrease) in interest rates, based on average cash and cash equivalents during the year, would increase/(decrease) interest income by approximately $7.2 million.
Hospira
has a Revolver that allows borrowings up to $700.0 million for general corporate purposes at variable interest rates. The amount of available borrowings under the Revolver
may be increased to a maximum of $825.0 million, under certain circumstances. As of December 31, 2009, Hospira has not borrowed any amounts under the Revolver.
Refer
to the Liquidity and Capital Resources section above, as well as Notes 3, 6, 7 and 11 to the consolidated financial statements included in this Annual Report on
Form 10-K, for further information.
49
Table of Contents
Item 8. Financial Statements and Supplementary Data
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS AND SCHEDULE
50
Table of Contents
MANAGEMENT REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING
The management of Hospira, Inc. (the "Company") is responsible for establishing and maintaining adequate internal control over
financial reporting. The Company's internal control system was designed to provide reasonable assurance to the Company's management and board of directors regarding the preparation and fair
presentation of published financial statements.
All
internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with
respect to financial statement preparation and presentation.
Company
management assessed the effectiveness of its internal control over financial reporting as of December 31, 2009. In making this assessment, it used the criteria established
in
Internal ControlIntegrated Framework
issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on our
assessment, we believe that, as of December 31, 2009, the Company's internal control over financial reporting was effective based on those criteria.
The
Company's independent registered public accounting firm has issued an audit report on their assessment of the Company's internal control over financial reporting as of
December 31, 2009, which is included herein.
|
|
|
/s/ CHRISTOPHER B. BEGLEY
Chairman of the Board and
Chief Executive Officer
February 18, 2010
|
|
/s/ THOMAS E. WERNER
Senior Vice President, Finance, and
Chief Financial Officer
February 18, 2010
|
51
Table of Contents
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Board of Directors and Shareholders of Hospira, Inc.
Lake Forest, Illinois
We
have audited the accompanying consolidated balance sheets of Hospira, Inc. and subsidiaries (the "Company") as of December 31, 2009 and 2008, and the related
consolidated statements of income and comprehensive income (loss), changes in shareholders' equity, and cash flows for each of the three years in the period ended December 31, 2009. Our audits
also included the financial statement schedule listed in the Index at Item 15. These financial statements and financial statement schedule are the responsibility of the Company's management.
Our responsibility is to express an opinion on the financial statements and financial statement schedule based on our audits.
We
conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis for our opinion.
In
our opinion, such consolidated financial statements present fairly, in all material respects, the financial position of Hospira, Inc. and subsidiaries as of December 31,
2009 and 2008, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2009, in conformity with accounting principles generally
accepted in the United States of America. Also, in our opinion, such financial statement schedule, when considered in relation to the basic consolidated financial statements taken as a whole, presents
fairly, in all material respects, the information set forth therein.
We
have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the Company's internal control over financial reporting as of
December 31, 2009, based on the criteria established in
Internal ControlIntegrated Framework
issued by the Committee of Sponsoring
Organizations of the Treadway Commission and our report dated February 18, 2010 expressed an unqualified opinion on the Company's internal control over financial reporting.
/s/
DELOITTE & TOUCHE LLP
Chicago,
Illinois
February 18, 2010
52
Table of Contents
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Board of Directors and Shareholders of Hospira, Inc.
Lake Forest, Illinois
We
have audited the internal control over financial reporting of Hospira, Inc. and subsidiaries (the "Company") as of December 31, 2009, based on criteria established in
Internal ControlIntegrated
Framework
issued by the Committee of Sponsoring Organizations of the Treadway Commission. The Company's
management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting, included in the
accompanying Management Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company's internal control over financial reporting based on our audit.
We
conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control
over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and
performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
A
company's internal control over financial reporting is a process designed by, or under the supervision of, the company's principal executive and principal financial officers, or
persons performing similar functions, and effected by the company's board of directors, management, and other personnel to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company's internal control over financial reporting includes those
policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;
(2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that
receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding
prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on the financial statements.
Because
of the inherent limitations of internal control over financial reporting, including the possibility of collusion or improper management override of controls, material
misstatements due to error or fraud may not be prevented or detected on a timely basis. Also, projections of any evaluation of the effectiveness of the internal control over financial reporting to
future periods are subject to the risk that the controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
In
our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2009, based on the criteria established in
Internal ControlIntegrated
Framework
issued by the Committee of Sponsoring Organizations of the Treadway Commission.
We
have also audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated financial statements and financial statement
schedule as of and for the year ended December 31, 2009 of the Company and our report dated February 18, 2010 expressed an unqualified opinion on those financial statements and financial
statement schedule.
/s/
DELOITTE & TOUCHE LLP
Chicago,
Illinois
February 18, 2010
53
Table of Contents
Hospira, Inc.
Consolidated Statements of Income and Comprehensive Income (Loss)
(dollars and shares in millions, except for per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
2009
|
|
2008
|
|
2007
|
|
Net sales
|
|
$
|
3,879.3
|
|
$
|
3,629.5
|
|
$
|
3,436.2
|
|
|
|
|
|
|
|
|
|
Cost of products sold
|
|
|
2,422.9
|
|
|
2,286.8
|
|
|
2,240.5
|
|
Restructuring and impairment
|
|
|
94.2
|
|
|
22.4
|
|
|
21.8
|
|
Research and development
|
|
|
240.5
|
|
|
211.9
|
|
|
201.2
|
|
Acquired in-process research and development
|
|
|
|
|
|
0.5
|
|
|
88.0
|
|
Selling, general and administrative
|
|
|
618.8
|
|
|
590.1
|
|
|
582.1
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses
|
|
|
3,376.4
|
|
|
3,111.7
|
|
|
3,133.6
|
|
|
|
|
|
|
|
|
|
|
|
Income From Operations
|
|
|
502.9
|
|
|
517.8
|
|
|
302.6
|
|
Interest expense
|
|
|
106.3
|
|
|
116.2
|
|
|
134.5
|
|
Other expense (income), net
|
|
|
11.8
|
|
|
(5.9
|
)
|
|
(19.7
|
)
|
|
|
|
|
|
|
|
|
|
|
Income Before Income Taxes
|
|
|
384.8
|
|
|
407.5
|
|
|
187.8
|
|
Income tax (benefit) expense
|
|
|
(19.1
|
)
|
|
86.6
|
|
|
51.0
|
|
|
|
|
|
|
|
|
|
|
|
Net Income
|
|
$
|
403.9
|
|
$
|
320.9
|
|
$
|
136.8
|
|
|
|
|
|
|
|
|
|
Earnings Per Common Share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
2.51
|
|
$
|
2.02
|
|
$
|
0.87
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
$
|
2.47
|
|
$
|
1.99
|
|
$
|
0.85
|
|
|
|
|
|
|
|
|
|
Weighted Average Common Shares Outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
161.0
|
|
|
159.2
|
|
|
156.9
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
|
163.2
|
|
|
161.3
|
|
|
160.2
|
|
|
|
|
|
|
|
|
|
Comprehensive Income (Loss):
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments, net of taxes of $0.0
|
|
$
|
249.3
|
|
$
|
(307.6
|
)
|
$
|
116.8
|
|
Pension liability adjustments, net of taxes of $1.4, $25.3 and $(5.6), respectively
|
|
|
(5.4
|
)
|
|
(40.1
|
)
|
|
8.8
|
|
Unrealized gains (losses) on marketable equity securities, net of taxes of $0.0, $0.0 and $3.2, respectively
|
|
|
6.6
|
|
|
(16.5
|
)
|
|
(5.4
|
)
|
Reclassification of other-than-temporary impairment charge included in net income
|
|
|
16.6
|
|
|
|
|
|
|
|
Reclassification of losses on terminated cash flow hedges, net of taxes of $(0.6), $(0.4) and $1.1, respectively
|
|
|
1.0
|
|
|
0.7
|
|
|
(1.8
|
)
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss)
|
|
|
268.1
|
|
|
(363.5
|
)
|
|
118.4
|
|
Net Income
|
|
|
403.9
|
|
|
320.9
|
|
|
136.8
|
|
|
|
|
|
|
|
|
|
Comprehensive Income (Loss)
|
|
$
|
672.0
|
|
$
|
(42.6
|
)
|
$
|
255.2
|
|
|
|
|
|
|
|
|
|
The
accompanying notes are an integral part of these consolidated financial statements.
54
Table of Contents
Hospira, Inc.
Consolidated Statements of Cash Flows
(dollars in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
2009
|
|
2008
|
|
2007
|
|
Cash Flow From Operating Activities:
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
403.9
|
|
$
|
320.9
|
|
$
|
136.8
|
|
|
Adjustments to reconcile net income to net cash from operating activities-
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
168.6
|
|
|
183.2
|
|
|
183.0
|
|
|
|
Amortization of intangible assets
|
|
|
61.5
|
|
|
68.7
|
|
|
52.1
|
|
|
|
Write-off of acquired in-process research and development
|
|
|
|
|
|
0.5
|
|
|
88.0
|
|
|
|
Step-up value of acquired inventories sold
|
|
|
|
|
|
|
|
|
53.1
|
|
|
|
Stock-based compensation expense
|
|
|
40.5
|
|
|
42.0
|
|
|
39.4
|
|
|
|
Deferred income tax and other tax adjustments
|
|
|
(66.3
|
)
|
|
43.5
|
|
|
(3.1
|
)
|
|
|
Impairment and other asset charges
|
|
|
95.8
|
|
|
|
|
|
7.5
|
|
|
|
Net gains on sales of assets
|
|
|
|
|
|
(3.0
|
)
|
|
(5.0
|
)
|
|
Changes in assets and liabilities-
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade receivables
|
|
|
97.2
|
|
|
(55.4
|
)
|
|
(47.6
|
)
|
|
|
Inventories
|
|
|
54.4
|
|
|
(117.9
|
)
|
|
34.4
|
|
|
|
Prepaid expenses and other assets
|
|
|
8.2
|
|
|
12.9
|
|
|
17.7
|
|
|
|
Trade accounts payable
|
|
|
(4.2
|
)
|
|
49.5
|
|
|
11.5
|
|
|
|
Other liabilities
|
|
|
107.5
|
|
|
15.8
|
|
|
(40.3
|
)
|
|
Other, net
|
|
|
(22.2
|
)
|
|
23.4
|
|
|
23.6
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash Provided by Operating Activities
|
|
|
944.9
|
|
|
584.1
|
|
|
551.1
|
|
|
|
|
|
|
|
|
|
Cash Flow From Investing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures (including instruments placed with or leased to customers of $23.0, $30.5 and $36.7 in 2009, 2008 and 2007, respectively)
|
|
|
(159.4
|
)
|
|
(164.3
|
)
|
|
(210.5
|
)
|
|
Acquisitions, net of cash acquired, and payments for contingent consideration
|
|
|
(86.6
|
)
|
|
(26.1
|
)
|
|
(1,980.5
|
)
|
|
Purchases of intangibles and other investments
|
|
|
(14.3
|
)
|
|
(50.8
|
)
|
|
(5.5
|
)
|
|
(Purchases) sales of marketable securities
|
|
|
|
|
|
(24.5
|
)
|
|
10.4
|
|
|
Settlements of foreign currency contracts
|
|
|
|
|
|
|
|
|
(55.7
|
)
|
|
Proceeds from disposition of businesses and assets
|
|
|
49.2
|
|
|
0.8
|
|
|
13.8
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash Used in Investing Activities
|
|
|
(211.1
|
)
|
|
(264.9
|
)
|
|
(2,228.0
|
)
|
|
|
|
|
|
|
|
|
Cash Flow From Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of long-term debt, net of fees paid
|
|
|
246.7
|
|
|
|
|
|
3,336.2
|
|
|
Repayment of long-term debt
|
|
|
(681.2
|
)
|
|
(95.2
|
)
|
|
(1,825.2
|
)
|
|
Other borrowings, net
|
|
|
2.6
|
|
|
6.3
|
|
|
(6.2
|
)
|
|
Excess tax benefit from stock-based compensation arrangements
|
|
|
0.8
|
|
|
1.0
|
|
|
2.3
|
|
|
Proceeds from stock options exercised
|
|
|
122.5
|
|
|
27.8
|
|
|
73.1
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash (Used in) Provided by Financing Activities
|
|
|
(308.6
|
)
|
|
(60.1
|
)
|
|
1,580.2
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents
|
|
|
37.0
|
|
|
(16.4
|
)
|
|
15.8
|
|
|
|
|
|
|
|
|
|
Net change in cash and cash equivalents
|
|
|
462.2
|
|
|
242.7
|
|
|
(80.9
|
)
|
Cash and cash equivalents at beginning of year
|
|
|
483.8
|
|
|
241.1
|
|
|
322.0
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year
|
|
$
|
946.0
|
|
$
|
483.8
|
|
$
|
241.1
|
|
|
|
|
|
|
|
|
|
Supplemental Cash Flow Information:
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the year-
|
|
|
|
|
|
|
|
|
|
|
|
Interest
|
|
$
|
108.7
|
|
$
|
120.8
|
|
$
|
127.4
|
|
|
Income taxes, net of refunds
|
|
$
|
28.4
|
|
$
|
14.9
|
|
$
|
72.4
|
|
The accompanying notes are an integral part of these consolidated financial statements.
55
Table of Contents
Hospira, Inc.
Consolidated Balance Sheets
(dollars in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2009
|
|
2008
|
|
Assets
|
|
|
|
|
|
|
|
Current Assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
946.0
|
|
$
|
483.8
|
|
|
|
Trade receivables, less allowances of $6.2 in 2009 and $6.7 in 2008
|
|
|
498.1
|
|
|
583.4
|
|
|
|
Inventories
|
|
|
755.4
|
|
|
830.5
|
|
|
|
Deferred income taxes
|
|
|
185.9
|
|
|
172.2
|
|
|
|
Prepaid expenses
|
|
|
34.3
|
|
|
35.7
|
|
|
|
Other receivables
|
|
|
41.5
|
|
|
43.7
|
|
|
|
Assets held for sale
|
|
|
65.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Current Assets
|
|
|
2,526.2
|
|
|
2,149.3
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
1,147.8
|
|
|
1,192.1
|
|
Intangible assets, net
|
|
|
406.5
|
|
|
404.4
|
|
Goodwill
|
|
|
1,243.4
|
|
|
1,167.4
|
|
Deferred income taxes
|
|
|
54.5
|
|
|
70.1
|
|
Investments
|
|
|
49.3
|
|
|
37.6
|
|
Other assets
|
|
|
75.2
|
|
|
53.2
|
|
|
|
|
|
|
|
|
|
|
Total Assets
|
|
$
|
5,502.9
|
|
$
|
5,074.1
|
|
|
|
|
|
|
|
Liabilities and Shareholders' Equity
|
|
|
|
|
|
|
|
Current Liabilities:
|
|
|
|
|
|
|
|
|
|
Short-term borrowings
|
|
$
|
23.6
|
|
$
|
338.3
|
|
|
|
Trade accounts payable
|
|
|
229.5
|
|
|
231.5
|
|
|
|
Salaries, wages and commissions
|
|
|
176.5
|
|
|
144.7
|
|
|
|
Deferred income taxes
|
|
|
0.1
|
|
|
1.5
|
|
|
|
Other accrued liabilities
|
|
|
438.3
|
|
|
331.5
|
|
|
|
Liabilities related to assets held for sale
|
|
|
13.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Current Liabilities
|
|
|
881.9
|
|
|
1,047.5
|
|
|
|
|
|
|
|
Long-term debt
|
|
|
1,707.3
|
|
|
1,834.0
|
|
Deferred income taxes
|
|
|
18.6
|
|
|
25.2
|
|
Post-retirement obligations and other long-term liabilities
|
|
|
271.4
|
|
|
391.0
|
|
Commitments and Contingencies
|
|
|
|
|
|
|
|
Shareholders' Equity:
|
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
1.7
|
|
|
1.7
|
|
|
|
Preferred stock
|
|
|
|
|
|
|
|
|
|
Treasury stock, at cost
|
|
|
(299.8
|
)
|
|
(299.8
|
)
|
|
|
Additional paid-in capital
|
|
|
1,409.5
|
|
|
1,234.2
|
|
|
|
Retained earnings
|
|
|
1,540.1
|
|
|
1,136.2
|
|
|
|
Accumulated other comprehensive loss
|
|
|
(27.8
|
)
|
|
(295.9
|
)
|
|
|
|
|
|
|
Total Shareholders' Equity
|
|
|
2,623.7
|
|
|
1,776.4
|
|
|
|
|
|
|
|
Total Liabilities and Shareholders' Equity
|
|
$
|
5,502.9
|
|
$
|
5,074.1
|
|
|
|
|
|
|
|
The
accompanying notes are an integral part of these consolidated financial statements.
56
Table of Contents
Hospira, Inc.
Consolidated Statements of Changes in Shareholders' Equity
(dollars and shares in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
|
|
|
|
|
|
Accumulated
Other
Comprehensive
(Loss) Income
|
|
|
|
|
|
Treasury
Stock, at cost
|
|
Additional
Paid-in
Capital
|
|
Retained
Earnings
|
|
|
|
|
|
Shares
|
|
Amount
|
|
Total
|
|
Balances at January 1, 2007
|
|
|
155.9
|
|
$
|
1.7
|
|
$
|
(299.8
|
)
|
$
|
1,033.3
|
|
$
|
676.6
|
|
$
|
(50.8
|
)
|
$
|
1,361.0
|
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
136.8
|
|
|
|
|
|
136.8
|
|
Other comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
118.4
|
|
|
118.4
|
|
Adoption of the provisions of ASC Topic 740, "Income Taxes"
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2.1
|
|
|
|
|
|
2.1
|
|
Changes in shareholders' equity related to incentive stock programs
|
|
|
2.7
|
|
|
|
|
|
|
|
|
126.9
|
|
|
|
|
|
|
|
|
126.9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at December 31, 2007
|
|
|
158.6
|
|
|
1.7
|
|
|
(299.8
|
)
|
|
1,160.2
|
|
|
815.5
|
|
|
67.6
|
|
|
1,745.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
320.9
|
|
|
|
|
|
320.9
|
|
Other comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(363.5
|
)
|
|
(363.5
|
)
|
ASC Topic 718, "CompensationRetirement Benefits" transition amount, net of tax of $0.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(0.2
|
)
|
|
|
|
|
(0.2
|
)
|
Changes in shareholders' equity related to incentive stock programs
|
|
|
1.0
|
|
|
|
|
|
|
|
|
74.0
|
|
|
|
|
|
|
|
|
74.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at December 31, 2008
|
|
|
159.6
|
|
|
1.7
|
|
|
(299.8
|
)
|
|
1,234.2
|
|
|
1,136.2
|
|
|
(295.9
|
)
|
|
1,776.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
403.9
|
|
|
|
|
|
403.9
|
|
Other comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
268.1
|
|
|
268.1
|
|
Changes in shareholders' equity related to incentive stock programs
|
|
|
3.9
|
|
|
|
|
|
|
|
|
175.3
|
|
|
|
|
|
|
|
|
175.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at December 31, 2009
|
|
|
163.5
|
|
$
|
1.7
|
|
$
|
(299.8
|
)
|
$
|
1,409.5
|
|
$
|
1,540.1
|
|
$
|
(27.8
|
)
|
$
|
2,623.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
57
Table of Contents
Hospira, Inc.
Notes to Consolidated Financial Statements
Note 1Summary of Significant Accounting Policies
Description of Business
Hospira, Inc. ("Hospira") is a global specialty pharmaceutical and medication delivery company that develops, manufactures and
markets products that help improve the safety, cost and productivity of patient care. Hospira's portfolio includes generic acute-care and oncology injectables, as well as integrated
infusion therapy and medication management systems. Hospira's portfolio of products is used by hospitals and alternate site providers, such as clinics, home healthcare providers and
long-term care facilities.
Basis of Presentation
The consolidated financial statements, prepared in conformity with United States ("U.S.") generally accepted accounting principles
("GAAP"), include the accounts of Hospira and all of its controlled majority-owned subsidiaries. All intercompany balances and transactions have been eliminated. Subsequent events that occurred after
December 31, 2009, up until the filing with the Securities and Exchange Commission ("SEC") were considered in the preparation of these consolidated financial statements.
Reclassifications
For comparative purposes, Hospira made certain reclassifications to prior year amounts. Hospira reclassified costs that were previously
reported in Cost of products sold and Research and development to Restructuring and impairment, a separate operating costs and expenses line item. Hospira also reclassified deferred tax adjustments
previously reported in Other liabilities and Other, net to Deferred income tax and other tax adjustments, a separate cash flow line item. The reclassifications did not affect net income, net cash
provided by operating activities or shareholders' equity.
In
2008, Hospira re-aligned its segment presentation to reflect how the business is managed. Hospira has three reportable segments: Americas; Europe, Middle East and Africa
("EMEA") and Asia Pacific ("APAC"). The 2007 segment disclosure has been reclassified to conform to the 2008 and 2009 presentation.
Use of Estimates
The financial statements include amounts based on estimates and assumptions by management. Actual results could differ from those
amounts. Significant estimates include, but are not limited to, provisions for chargebacks and rebates, inventory exposure reserves, income tax liabilities, pension and other
post-retirement benefits liabilities and loss contingencies.
Revenue Recognition
Hospira recognizes revenues from product sales when persuasive evidence of an arrangement exists, delivery has occurred (or services
have been rendered), the price is fixed or determinable and collectibility is reasonably assured. For other than certain drug delivery pumps and contract manufacturing, product revenue is recognized
when products are delivered to customers and title passes. In certain circumstances, Hospira enters into arrangements in which it commits to provide multiple elements (deliverables) to its customers.
In these cases, total revenue is divided among the separate deliverables based on their relative fair value and is recognized for each deliverable in accordance with the applicable revenue recognition
criteria.
58
Table of Contents
For
drug delivery pumps, revenue is typically derived under one of three types of arrangements: outright sales of the drug delivery pump; placements under lease arrangements; and
placements under contracts that include associated disposable set purchases. For outright sales of the drug delivery pump and for related sales of disposable products (sets) revenue is recognized as
the products are delivered, in accordance with the provisions of Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC") Topic 605, "Revenue Recognition," including
revenue recognition when right of return exists. Other arrangements (leases and contracts that included associated disposable set purchases) are assessed in accordance with the provisions of ASC Topic
840, "Leases," including determining whether an arrangement contains a lease and drug delivery pump revenue is recorded as a sales-type or operating lease. For arrangements that qualify as
sales-type leases, the discounted sales value of the drug delivery pump is recorded as revenue upon delivery to the customer. For arrangements that qualify as operating leases, Hospira
recognizes revenue over the lease term, and the related asset is depreciated over its estimated useful life on a straight-line basis.
Hospira
markets a server-based suite of software applications designed to exchange data from a hospital's drug information library database to drug delivery pumps throughout the
hospital. The arrangements related to such applications typically include a perpetual or subscription software license, software maintenance and implementation services, in addition to the drug
delivery pump. Hospira recognizes revenue related to these arrangements in accordance with the provisions of ASC Topic 985, "Software." Drug delivery pump, perpetual software license revenue and
implementation service revenue are generally recognized as obligations are completed or upon customer acceptance. Software subscription license and software maintenance revenue is recognized ratably
over the contract period.
Contract
manufacturing involves filling customers' active pharmaceutical ingredients ("API") into delivery systems. Under these arrangements, customers' API is often consigned to Hospira
and revenue is recorded for the materials and labor provided by Hospira, plus a profit, upon shipment to the customer.
Upon
recognizing revenue from a sale, Hospira records an estimate for certain items that reduce gross sales in arriving at its reported net sales for each period. These items include
chargebacks, rebates and other items (such as cash discounts and returns). Provisions for chargebacks and rebates represent the most significant and complex of these estimates.
Chargebacks
Hospira sells a significant portion of its specialty injectable pharmaceutical products through wholesalers, which
maintain inventories of Hospira products and later sell those products to end customers. In connection with its sales and marketing efforts, Hospira negotiates prices with end customers for certain
products under pricing agreements (including, for example, group purchasing organization contracts). Consistent with industry practice, the negotiated end customer prices are typically lower than the
prices charged to the wholesalers. When an end customer purchases a Hospira product that is covered by a pricing agreement from a wholesaler, the end customer pays the wholesaler the price determined
under the pricing agreement. The wholesaler is then entitled to charge Hospira back for the difference between the price the wholesaler paid Hospira and the contract price paid by the end customer (a
"chargeback").
Hospira
records the initial sale to a wholesaler at the price invoiced to the wholesaler and at the same time, records a provision equal to the estimated amount the wholesaler will later
charge back to Hospira, reducing gross sales and trade receivables. This provision must be estimated because the actual end customer and applicable pricing terms may vary at the time of the sale to
the wholesaler. Accordingly, the most significant estimates inherent in the initial chargeback provision relate to the volume of sales to the wholesalers that will be subject to chargeback and the
ultimate end customer contract price. These estimates are based primarily on an analysis of Hospira's product sales and most recent historical average chargeback credits by product, estimated
wholesaler inventory levels, current contract pricing, anticipated future contract pricing changes and claims processing lag time. Hospira
59
Table of Contents
estimates
the levels of inventory at the wholesalers through analysis of wholesaler purchases and inventory data obtained directly from certain of the wholesalers. Hospira regularly monitors the
provision for chargebacks and makes adjustments when it believes the actual chargebacks may differ from earlier estimates. The methodology used to estimate and provide for chargebacks was consistent
across all periods presented.
Settlement
of chargebacks, excluding generic oxaliplatin sales, generally occurs between 25 and 35 days after the sale to wholesalers. A one percent decrease in end customer
contract prices for sales pending chargeback, excluding generic oxaliplatin sales, at December 31, 2009, would decrease net sales and income before income taxes by approximately
$1.4 million. A one percent increase in wholesale units sold subject to chargebacks, excluding generic oxaliplatin sales, at December 31, 2009, would decrease net sales and income before
income taxes by approximately $0.6 million.
Hospira's
generic oxaliplatin sales, launched in the U.S. in 2009, contributed to the increase in the chargebacks accrual from $60.2 million at December 31, 2008, to
$177.0 million at December 31, 2009. Generally, sales during a generic launch period experience more rapid end customer price declines due to competitive market factors and reflect
wholesalers' common practice of purchasing quantities of product at launch to assure adequate supply for end customer use. Due to these factors, settlement of chargebacks generally occurs over a
longer duration and at a higher per unit rate than with other Hospira products.
The
most significant variables that could affect Oxaliplatin chargeback related accruals are the rate of end customer price decline and the rate of end customer demand experienced by the
wholesalers. A five percent decline in end customer prices would decrease net sales and income before income taxes by approximately $2.5 million. A five percent decrease in monthly end customer
demand experienced by wholesalers would decrease net sales and income before income taxes by approximately $0.8 million.
Rebates
Hospira primarily offers rebates to direct customers, customers who purchase from certain wholesalers at end customer
contract prices and government agencies, which administer various programs such as Medicaid. Direct rebates are generally rebates paid to direct purchasing customers based on a contracted discount
applied to the direct customer's purchases. Indirect rebates are rebates paid to "indirect customers" that have purchased Hospira products from a wholesaler under a pricing agreement with Hospira.
Governmental agency rebates are amounts owed based on legal requirements with public sector benefit providers (such as Medicaid), after the final dispensing of the product by a pharmacy to a benefit
plan participant. Rebate amounts are usually based upon the volume of purchases. Hospira estimates the amount of the rebate due at the time of sale, and records the liability and a reduction of gross
sales at the same time the product sale is recorded. Settlement of the rebate generally occurs from one to fifteen months after sale.
In
determining provisions for rebates to direct customers, Hospira considers the volume of eligible purchases by these customers and the rebate terms. In determining rebates on sales
through wholesalers, Hospira considers the volume of eligible contract purchases, the rebate terms and the estimated level of inventory at the wholesalers that would be subject to a rebate, which is
estimated as described above under "Chargebacks." Upon receipt of a chargeback, due to the availability of product and customer specific information, Hospira can then establish a specific provision
for fees or rebates based on the specific terms of each agreement. Rebates under governmental programs are based on the
estimated volume of products sold subject to these programs. Each period the estimates are reviewed and revised, if necessary, in conjunction with a review of contract volumes within the period.
Adjustments related to prior period sales have not been material in any period.
Hospira
regularly analyzes the historical rebate trends and makes adjustments to recorded reserves for changes in trends and terms of rebate programs. At December 31, 2009 and
2008, accrued rebates of $156.0 million and $107.4 million, respectively, are included in other accrued liabilities on the consolidated balance sheet. Hospira's generic oxaliplatin
sales, launched in the U.S. in 2009,
60
Table of Contents
contributed
to the increase in the rebate accrual. The methodology used to estimate and provide for rebates was consistent across all periods presented.
Returns
Provisions for returns are provided for at the time the related net sales are recognized, and are reflected as a
reduction of sales. The estimate of the provision for returns is primarily based on historical experience of actual returns. Additionally, Hospira considers other factors such as levels of inventory
in the distribution channel, product dating and expiration period, whether products have been discontinued, and entrance in the market of additional competition. This estimate is reviewed periodically
and, if necessary, revised, with any revisions recognized immediately as adjustments to net sales. Returns reserves were $18.5 million and $19.5 million as of December 31, 2009
and 2008, respectively, and included in other accrued liabilities on the consolidated balance sheet.
Concentration of Risk
Financial instruments that are subject to concentrations of credit risk consist primarily of cash and cash equivalents, marketable
securities and trade receivables. Hospira holds cash and invests in cash equivalents and marketable securities with a diversified group of major financial institutions to limit the amount of credit
exposure to non-performance by any one institution.
In
2009, 2008 and 2007, no end use customer accounted for more than 10% of net sales (gross sales less reductions for wholesaler chargebacks, rebates, returns and other allowances). For
2009 and 2008, the largest four wholesalers accounted for approximately 40% and 30%, respectively, of net trade receivables. Net sales through the same four wholesalers noted above accounted for
approximately 42%, 38% and 37% of global net sales in 2009, 2008 and 2007, respectively. Global net sales related to group purchasing organizations ("GPO") contracts amounted to
$1,705.1 million in 2009, $1,564.7 million in 2008 and $1,380.2 million in 2007.
Loss Contingencies
In accordance with the provisions of ASC Topic 450, "Contingencies" ("ASC 450"), loss contingency provisions are recorded for probable
losses at management's best estimate of a loss, or when a best estimate cannot be made, a minimum loss contingency amount is recorded. These estimates are often initially developed substantially
earlier than the ultimate loss is known, and the estimates are refined each accounting period, as additional information is known. Accordingly, if Hospira is initially unable to develop a best
estimate of loss, the minimum amount, which could be zero, is recorded.
Income Taxes
Hospira's provision for income taxes is based on taxable income at statutory tax rates in effect in the various jurisdictions in which
Hospira operates. Significant judgment is required in determining the provision for income taxes and in evaluating tax positions that are subject to audits and adjustments. Liabilities for
unrecognized tax benefits are established when, despite Hospira's belief that the tax return positions are fully supportable, certain positions are likely to be challenged based on the applicable tax
authority's determination of the positions. Such liabilities are based on management's judgment, utilizing internal and external tax advisors and represent management's best estimate as to the likely
outcome of tax audits. The provision for income taxes includes the impact of changes to unrecognized tax benefits. Each quarter, Hospira reviews the anticipated mix of income derived from the various
taxing jurisdictions and its associated liabilities in accordance with the provisions of ASC Topic 740, "Income Taxes," ("ASC 740"), including the provisions of Accounting for Uncertainty in Income
Taxes. ASC 740 prescribes a recognition threshold and measurement attribute for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return.
Deferred income taxes are provided for the tax effect of temporary differences between the tax basis of
61
Table of Contents
assets
and liabilities and their reported amounts in the financial statements at the enacted statutory rate expected to be in effect when the taxes are paid. Provision for income taxes and foreign
withholding taxes are not provided for on undistributed earnings for certain foreign subsidiaries when Hospira intends to reinvest these earnings indefinitely to fund foreign investments or meet
working capital and plant and equipment acquisition needs.
Cash and Cash Equivalents
Hospira considers all cash investments purchased with an original maturity of three months or less to be cash equivalents.
Inventories
Inventories are stated at the lower of cost (first-in, first-out basis) or market. Hospira monitors inventories
for exposures related to obsolescence, excess and date expiration, non-conformance, corrective actions and loss and damage, and recognizes a charge to cost of products sold for the amount
required to reduce the carrying value of inventory to estimated net realizable value. If conditions are less favorable than estimated, additional charges may be required. Such reserves were
$110.7 million and $67.8 million at December 31, 2009 and 2008, respectively. The increase to the provision is primarily associated with product portfolio optimization charges and
product corrective action related charges. Inventory cost includes material and conversion costs.
Goodwill and Intangible Assets, Net
The following summarizes goodwill and intangible assets, net activity:
|
|
|
|
|
|
|
|
|
(dollars in millions)
|
|
Goodwill
|
|
Intangible
Assets, Net
|
|
Balances at January 1, 2008
|
|
$
|
1,240.9
|
|
$
|
554.0
|
|
|
Acquisitions
|
|
|
23.3
|
|
|
11.9
|
|
|
Amortization
|
|
|
|
|
|
(68.7
|
)
|
|
Currency translation effect and other
|
|
|
(96.8
|
)
|
|
(92.8
|
)
|
|
|
|
|
|
|
Balances at December 31, 2008
|
|
|
1,167.4
|
|
|
404.4
|
|
|
Acquisitions
|
|
|
47.9
|
|
|
22.1
|
|
|
Amortization
|
|
|
|
|
|
(61.5
|
)
|
|
Impairments
|
|
|
(7.6
|
)
|
|
(22.5
|
)
|
|
Re-classified as held for sale
|
|
|
(17.9
|
)
|
|
|
|
|
Currency translation effect and other
|
|
|
53.6
|
|
|
64.0
|
|
|
|
|
|
|
|
Balances at December 31, 2009
|
|
$
|
1,243.4
|
|
$
|
406.5
|
|
|
|
|
|
|
|
2009 Activity.
The impairments are related to the disposal of certain non-strategic businesses and the underlying assets. See
Note 4 for more information on the circumstances leading to the impairments. The additions to goodwill and intangible assets, net are primarily related to the acquisition in the Americas
segment. See Note 2 for more details.
2008 Activity.
The additions to goodwill and intangible assets, net are primarily related to the acquisitions in the Americas segment. See
Note 2 for more details. Currency translation effect and other includes a $35.3 million reduction in goodwill in the APAC segment related to Mayne Pharma deferred tax liabilities for
pre-acquisition tax return settlements and the adjusted tax basis of certain acquired Mayne Pharma assets. There were no reductions from goodwill or intangible assets, net relating to
impairments or disposal of all or a portion of a business in 2008.
62
Table of Contents
In
accordance with the provisions of ASC Topic 350, "IntangiblesGoodwill and Other" ("ASC 350"), goodwill is not amortized but is tested for impairment at least annually, or
more frequently if an event occurs or circumstances change that would reduce the fair value of a reporting unit below its carrying value. Hospira's reporting units are the U.S., Canada, Latin America,
EMEA and APAC. The evaluation is based upon the estimated fair value of Hospira's reporting units compared to the net carrying value of assets and liabilities. Hospira uses internal discounted cash
flow estimates and market value comparisons to determine estimated fair value. The annual assessment occurs in the third quarter of each year. As of the latest assessment, no additional impairment was
indicated.
Additionally,
intangible assets, net as of December 31, consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009
|
|
2008
|
|
(dollars in millions)
|
|
Gross
Carrying
Amount
|
|
Accumulated
Amortization
|
|
Net
Intangible
Assets
|
|
Gross
Carrying
Amount
|
|
Accumulated
Amortization
|
|
Net
Intangible
Assets
|
|
Product rights
|
|
$
|
524.6
|
|
$
|
(159.0
|
)
|
$
|
365.6
|
|
$
|
464.3
|
|
$
|
(92.0
|
)
|
$
|
372.3
|
|
Customer relationships
|
|
|
27.6
|
|
|
(7.1
|
)
|
|
20.5
|
|
|
28.1
|
|
|
(7.5
|
)
|
|
20.6
|
|
Technology
|
|
|
26.7
|
|
|
(6.3
|
)
|
|
20.4
|
|
|
15.1
|
|
|
(3.6
|
)
|
|
11.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
578.9
|
|
$
|
(172.4
|
)
|
$
|
406.5
|
|
$
|
507.5
|
|
$
|
(103.1
|
)
|
$
|
404.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible
assets have definite lives and are amortized on a straight-line basis over their estimated useful lives (1 to 16 years, weighted average 10 years).
Intangible asset amortization expense was $61.5 million, $68.7 million and $52.1 million in 2009, 2008 and 2007, respectively. Intangible asset amortization for each of the five
succeeding fiscal years is estimated at $70 million for 2010, $62 million for 2011, $51 million for 2012, $50 million for 2013, and $48 million for 2014.
Investments
Investments in companies in which Hospira has significant influence, but less than a majority-owned controlling interest, are accounted
for using the equity method. Significant influence is generally deemed to exist if Hospira has an ownership interest in the voting stock of the investee of between 20% and 50%, although other factors,
such as representations on the investee's Board of Directors, are considered in determining whether the equity method of accounting is appropriate.
Investments
in companies in which Hospira does not have a controlling interest or is unable to exert significant influence are accounted for at market value if the investments have
readily determinable fair values ("available-for-sale investments") or using the cost method if not practicable to estimate the fair value of the investment. Unrealized gains
and losses on available-for-sale investments accounted for at market value are reported, net-of-tax, in accumulated other comprehensive income (loss)
until the investment is sold or considered other-than-temporarily impaired, at which time the realized gain or loss is charged to Other expense (income), net.
Hospira
regularly reviews its investments to determine whether an other-than-temporary decline in market value exists. Hospira considers factors affecting the
investee, factors affecting the industry the investee operates in and general equity market trends. Hospira considers the length of time an investment's market value has been below carrying value and
the prospects for recovery to carrying value. When Hospira determines that an other-than-temporary decline has occurred, the carrying basis of the investment is written down to
fair value and the amount of the write-down is included in Other expense (income), net. See Note 3 for more details.
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Table of Contents
Property and Equipment
Depreciation is provided on a straight-line basis over the estimated useful lives of the assets.
Property
and equipment at cost as of December 31, consists of the following:
|
|
|
|
|
|
|
|
|
Classification (dollars in millions)
|
|
2009
|
|
2008
|
|
Estimated Useful Life
|
Land
|
|
$
|
44.2
|
|
$
|
51.3
|
|
N/A
|
Buildings
|
|
|
490.5
|
|
|
498.1
|
|
10 to 50 years (weighted average 29 years)
|
Equipment
|
|
|
1,557.1
|
|
|
1,593.5
|
|
3 to 20 years (weighted average 8 years)
|
Construction in progress
|
|
|
117.2
|
|
|
106.7
|
|
N/A
|
Instruments placed with customers
|
|
|
256.2
|
|
|
290.9
|
|
3 to 7 years (weighted average 5 years)
|
|
|
|
|
|
|
|
Property and equipment at cost
|
|
|
2,465.2
|
|
|
2,540.5
|
|
|
Less: accumulated depreciation
|
|
|
(1,317.4
|
)
|
|
(1,348.4
|
)
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
$
|
1,147.8
|
|
$
|
1,192.1
|
|
|
|
|
|
|
|
|
|
Instruments
placed with customers are drug delivery systems placed with or leased to customers under operating leases.
Impairment of Long-Lived Assets
In accordance with provision of ASC Subtopic 360-10, "Property, Plant, and Equipment: Overall" and ASC 350, the carrying
value of long-lived assets, including amortizable intangible assets and property and equipment, are reviewed whenever events or changes in circumstances indicate that the related carrying
amounts may not be recoverable. Impairment is generally determined by comparing projected undiscounted cash flows to be generated by the asset, or appropriate grouping of assets, to its carrying
value. If an impairment is identified, a loss is recorded equal to the excess of the asset's net book value over its fair value, and the cost basis is adjusted. Determining the extent of an
impairment, if any, typically requires various estimates and assumptions including using management's judgment, cash flows directly attributable to the asset, the useful life of the asset and residual
value, if any. When necessary, Hospira uses internal cash flow estimates, quoted market prices and appraisals as appropriate to determine fair value. Actual results could vary from these estimates. In
addition, the remaining useful life of the impaired asset is revised, if necessary. Hospira reports assets and related liabilities held for sale at the lower of its carrying value or its estimated net
realizable value.
Capitalized Software Costs
Costs incurred during the application development stage of software projects that are developed or obtained for internal use are
capitalized. At December 31, 2009 and 2008, unamortized capitalized software costs totaled $78.1 million and $87.6 million, respectively. Such capitalized amounts will be
amortized ratably over the expected useful lives of the projects when they become operational, not to exceed 10 years. Amortization was $19.4 million, $16.1 million and
$15.5 million for the years ended 2009, 2008 and 2007, respectively, and is included in Depreciation in the consolidated statements of cash flows.
Capitalized Interest
Hospira follows the provisions of ASC Subtopic 835-20, "Interest: Capitalization of Interest," to determine the interest to
be capitalized during the construction period for projects under construction. Hospira recorded capitalized interest of $5.8 million, $8.0 million and $11.1 million in 2009, 2008
and 2007, respectively.
64
Table of Contents
Collaborative Arrangements
Hospira enters into collaborative arrangements with third parties for product development and commercialization of products. These
arrangements typically involve two (or more) parties who are active participants in the collaboration and are exposed to significant risks and rewards dependent on the commercial success of the
activities. Hospira's rights and obligations under these collaborative arrangements vary. These collaborations usually involve various activities including research and development, marketing and
selling, and distribution.
In
general, the income statement presentation for these collaborations is as follows:
|
|
|
Nature / Type of Collaboration
|
|
Consolidated Statement of
Income Presentation
|
Third party sale of product
|
|
Net sales
|
Royalties / milestones paid to collaborative partner (post-regulatory approval)
(1)
|
|
Cost of products sold
|
Royalties received from collaborative partner
|
|
Net sales
|
Upfront payments and milestones paid to collaborative partner (pre-regulatory approval)
|
|
Research and development
|
Refundable upfront payments paid to collaborative partner (pre-regulatory approval)
(2)
|
|
Research and development or Cost of products sold
|
Research and development payments to collaborative partner
|
|
Research and development
|
Research and development payments received from collaborative partner
|
|
Reduction of Research and development
|
-
(1)
-
Milestones
are capitalized as intangible assets and amortized to Cost of products sold over the useful life.
-
(2)
-
Refundable
payments for which the contingency is resolved prior to regulatory approval are expensed to Research and development as the contingency becomes
probable of being resolved. For refundable payments for which the contingency is regulatory approval, payments are capitalized as intangible assets and amortized to Cost of products sold over the
useful life upon receiving regulatory approval.
Each
arrangement tends to be unique in nature and Hospira's most significant arrangements are discussed in Note 5.
Research and Development Costs
Internal research and development costs are expensed as incurred. Clinical trial costs incurred by third parties are expensed as the
contracted work is performed. Services provided to third parties for research and development is recorded upon completion of all obligations under the contract in Research and development for products
in development. Revenue from third-party research and development is not significant.
Translation Adjustments
For foreign operations in highly inflationary economies, translation gains and losses are included in net foreign exchange (gain) loss.
For remaining foreign operations, translation adjustments are included as a component of accumulated other comprehensive (loss) income.
65
Table of Contents
Stock-Based Compensation
In accordance with the provisions of ASC Topic 718, "CompensationStock Compensation," ("ASC 718"), share-based payment
transactions are recognized as compensation cost over the vesting period based on the fair value of the instrument on the date of grant. Hospira uses the Black-Scholes option valuation model and the
Monte Carlo simulation model to determine the fair value of stock options and performance share awards, respectively. The fair value models include various assumptions, including the expected
volatility and expected life of the awards. These assumptions reflect Hospira's best estimates, but they involve inherent uncertainties based on market conditions generally outside of Hospira's
control. As a result, if other assumptions had been used, stock-based compensation expense, as calculated could have been materially impacted. Furthermore, if Hospira uses different assumptions in
future periods, stock-based compensation expense could be materially impacted in future periods.
Pension and Post-Retirement Benefits
Hospira develops assumptions, the most significant of which are the discount rate, the expected return on plan assets and healthcare
cost trend rate. For these assumptions, management consults with actuaries, monitors plan provisions and demographics and reviews public market data and general economic information.
The
U.S. discount rate estimates were developed with the assistance of yield curves developed by third-party actuaries. For non-U.S. plans, benchmark yield data for
high-quality fixed income investments for which the timing and amounts of payments match the timing and amounts of projected benefit payments is used to derive discount rate assumptions.
The
expected return on assets for the pension plan represents the average rate of return to be earned on plan assets over the period the benefits are expected to be paid. The expected
return on assets is developed from the expected future return of each asset class, weighted by the expected allocation of pension assets to that asset class. Hospira considers historical performance
for the types of assets in which the plans invest, independent market forecasts and economic and capital market conditions.
Recently Issued Accounting Standards
In October 2009, the FASB codified and issued Accounting Standards Updated ("ASU") No. 2009-13, Revenue Recognition
(Topic 605), "Multiple-Deliverable Revenue Arrangements" ("ASU No. 2009-13"). ASU No. 2009-13 amends the guidance that in the absence of vendor-specific objective
and third-party evidence for deliverables in multiple-deliverable arrangements, companies will be required to develop a best estimate of the selling price to separate deliverables and allocate
arrangements consideration using the relative selling price method. ASU No. 2009-13 expands the disclosure requirements for multiple-deliverable revenue arrangements. The guidance
will be effective for financial statements issued for fiscal years beginning after June 15, 2010. Early adoption is permitted. Hospira plans to early adopt the guidance on March 31,
2010, with retrospective application to the beginning of the fiscal year. Hospira is currently evaluating the potential impact of ASU 2009-13 on the financial statements and related
disclosures.
In
October 2009, the FASB codified and issued ASU No. 2009-14, Software (Topic 985), "Certain Revenue Arrangements That Include Software Elements" ("ASU
No. 2009-14"). ASU No. 2009-14 amends the guidance to exclude from the scope of software revenue accounting requirements tangible products if the product contains
both software and non-software components that function together to deliver a product's essential functionality and factors to consider in determining whether a product is within the scope
of the guidance. The guidance will be effective for financial statements issued for fiscal years beginning after June 15, 2010. Early adoption is permitted. Hospira plans to early adopt the
guidance on March 31, 2010, with retrospective application to the beginning of the fiscal year. Hospira
66
Table of Contents
is
currently evaluating the potential impact of ASU No. 2009-14 on the financial statements and related disclosures.
Adoption of New Accounting Standards
Hospira adopted the provisions of FASB ASU No. 2009-05, "Measuring Liabilities at Fair Value" ("ASU
No. 2009-05"), for interim periods ending after August 28, 2009. ASU No. 2009-05 provides guidance on measuring liabilities at fair value when a quoted
price in an active market for the identical liability is not available. There was no impact to Hospira's consolidated financial position, results of operations or cash flows upon initial adoption of
this guidance.
Effective
July 1, 2009, the FASB issued Statement of Financial Accounting Standards ("SFAS") No. 168, "The FASB Accounting Standards Codification
TM
and the
Hierarchy of Generally Accepted Accounting Principlesa replacement of FASB Statement No. 162" ("SFAS No. 168"). SFAS No. 168 reduces the U.S. GAAP hierarchy to
two levels, one that is authoritative and one that is not. Hospira began to use the new guidance and reflect the new accounting guidance references when referring to GAAP for the quarterly period
ended September 30, 2009, and all subsequent periods. As the guidance was not intended to change or alter existing GAAP, adoption of this pronouncement did not have an effect on Hospira's
consolidated financial statements.
Hospira
adopted the provisions of ASC Topic 855, "Subsequent Events," for the interim periods ending after June 15, 2009. ASC Topic 855 establishes general standards of accounting
for and disclosures of events that occur after the balance sheet date but before financial statements are issued or available to be issued. There was no impact to Hospira's consolidated financial
position, results of operations or cash flows upon adoption of this guidance.
Hospira
adopted the provisions of ASC 825-10-65-1 for the interim periods ending after March 15, 2009. ASC
825-10-65-1 expands the fair value disclosures required for all financial instruments within the scope of ASC 825-10-65-1 to
include interim periods. There was no impact to Hospira's consolidated financial position, results of operations or cash flows upon adoption of this guidance.
Hospira
adopted the provisions of ASC 715-20-65-2 on January 1, 2009. ASC 715-20-65-2 requires more
detailed disclosures about Hospira's plan assets, including investment strategies, major categories of plan assets, concentrations of risk within plan assets and valuation techniques used to measure
the fair value of plan assets. Additional disclosures are required beginning with the year-end 2009 consolidated financial statements. There was no impact to Hospira's consolidated
financial position, results of operations or cash flow upon adoption of this guidance.
Hospira
adopted the provisions of ASC 350-30-55-1C on January 1, 2009. ASC 350-30-55-1C amends the factors
that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset under ASC Topic 350. This guidance was applied prospectively
to intangible assets acquired on or after January 1, 2009. There was no impact to Hospira's consolidated financial position, results of operations or cash flows upon adoption of this guidance.
Hospira
adopted the provisions of ASC 815-10-65-1 on January 1, 2009. ASC 815-10-65-1 expands the
disclosure requirements for derivative instruments and hedging activities. There was no impact to Hospira's consolidated financial position, results of operations or cash flows upon adoption of this
guidance.
Hospira
adopted the provisions of ASC 808-10-10-1 on January 1, 2009. ASC 808-10-10-1 provides guidance on
how to determine whether an arrangement constitutes a collaborative arrangement, how costs incurred and revenue generated on sales to third parties should be reported by the participants in a
collaborative arrangement, how payments made between participants in a collaborative arrangement should be characterized and what participants should disclose in the notes to the financial statements
67
Table of Contents
about
a collaborative arrangement. There was no impact to Hospira's consolidated financial position, results of operations or cash flows upon adoption of this guidance.
Hospira
adopted the provisions of ASC 805-10-65-1 on January 1, 2009. ASC 805-10-65-1 establishes
principles and requirements for the reporting entity in a business combination, including recognition and measurement in the financial statements of the identifiable assets acquired, the liabilities
assumed and any noncontrolling interest in the acquiree. This statement also establishes disclosure requirements to enable financial statement users to evaluate the nature and financial effects of the
business combination. ASC 805-10-65-1 is effective for business combinations that close in years beginning on or after December 15, 2008. There was no impact
to Hospira's consolidated financial position, results of operations or cash flows upon adoption of this guidance.
Hospira
adopted the provisions of ASC 805-20-25-18A on April 1, 2009. ASC 805-20-25-18A amends the
provision for the initial recognition and measurement, subsequent measurement and accounting, and disclosures for assets and liabilities arising from contingencies in business combinations. ASC
805-20-25-18A is effective for contingent assets or contingent liabilities acquired in business combinations for which the acquisition date is on or after the
beginning of the first annual reporting period beginning on or after December 15, 2008. There was no impact to Hospira's consolidated financial position, results of operations or cash flows
upon adoption of this guidance.
Note 2Business Acquisitions
In December 2009, Hospira acquired TheraDoc, Inc. and its Infection Control Assistant
TM
and Antibiotic
Assistant
TM
products, software applications that automate hospital-wide surveillance for infection-related events and optimize the utilization of antimicrobials. The purchase
price was $63.3 million, net of cash acquired. The purchase price was allocated to the Americas segment as follows: intangible assets of $17.1 million, mostly technology based, that will
be amortized over their estimated useful lives (5 to 8 years, weighted average 6 years); non-tax deductible goodwill of $47.9 million; and other assets, net of
$5.1 million. The impact of this acquisition was not material to Hospira's results of operations in 2009.
In
2009, Hospira announced an agreement to acquire a certain business of Orchid Chemicals & Pharmaceuticals Ltd. ("Orchid Pharma") for approximately $400 million.
While Hospira has taken actions and incurred costs associated with the pending transaction that are reflected in Hospira's financial statements, the pending acquisition of Orchid Pharma will not be
reflected in the financial statements until the closing of the transaction. The transaction has been unanimously approved by Hospira's and Orchid Pharma's Boards of Directors and approved by Orchid
Pharma's shareholders. The acquisition is subject to customary closing conditions. The transaction is expected to be completed in the first quarter of 2010.
Hospira acquired Sculptor Developmental Technologies and its VeriScan
TM
Rx product, a software application that supports
bar code medication administration at the point of care. Additionally, Hospira acquired the EndoTool
TM
glucose management system, a software system that helps establish and maintain
patient glycemic control in acute, critical care and operating room settings. The purchase price for the acquisitions combined was allocated to the Americas segment as follows: intangible assets of
$10.4 million, mostly technology based, that will be amortized over their estimated useful lives (3 to 7 years, weighted average 5 years); acquired in-process research
and development of $0.5 million that was expensed at the date of acquisition; non-tax deductible goodwill of $23.3 million; and other assets and (liabilities), net of $(1.7)
million. Approximately $15.0 million of deferred consideration related to
68
Table of Contents
one
of the 2008 acquisitions was paid in 2009. The impact of these acquisitions was not material to Hospira's results of operations in 2008.
On February 2, 2007, Hospira acquired all the outstanding ordinary shares of Mayne Pharma (including those shares issuable
pursuant to stock options) for $2,055.0 million. The $2,055.0 million purchase price includes the cash purchase price and direct acquisition costs. Mayne Pharma primarily manufactures
and sells specialty injectable pharmaceuticals. The results of operations of Mayne Pharma are included in Hospira's results for periods on and after February 2, 2007.
The
following allocation of the purchase price, which was finalized as of December 31, 2007, has been allocated to the tangible and intangible assets acquired and liabilities
assumed on the basis of their respective estimated fair values on the acquisition date. The allocation is as follows:
|
|
|
|
|
|
(dollars in millions)
|
|
|
|
Current assets
|
|
$
|
468.8
|
|
Property and equipment
|
|
|
192.7
|
|
Intangible assets
|
|
|
603.0
|
|
Goodwill
|
|
|
1,083.6
|
|
Deferred income taxes
|
|
|
30.1
|
|
Other assets
|
|
|
6.6
|
|
Current liabilities
|
|
|
(233.6
|
)
|
Long-term debt
|
|
|
(4.5
|
)
|
Post-retirement obligations, deferred income taxes and other long-term liabilities
|
|
|
(91.7
|
)
|
|
|
|
|
|
Total allocation of purchase price
|
|
$
|
2,055.0
|
|
|
|
|
|
Of
the $603.0 million of acquired intangible assets, $84.8 million relates to acquired in-process research and development that was expensed at the date of
acquisition. Of the remaining $518.2 million, $486.6 million relates to developed product rights that will be amortized over their estimated useful lives (9 to 12 years, weighted
average 11 years), including $13.8 million of product rights disposed of as a result of the acquisition, and $31.6 million relates to customer relationships that will be amortized
over their estimated useful lives (4 to 12 years, weighted average 10 years). Of the $1,083.6 million of goodwill, approximately $659.8 million was assigned to the
Americas, $228.7 million was assigned to the EMEA, and approximately $195.1 million was assigned to the APAC. Goodwill is not expected to be deductible for tax purposes.
As
Hospira took certain actions in connection with the integration that give rise to restructuring charges, such as termination of employees and exiting certain activities and
facilities, certain of those charges were recorded as goodwill as part of the purchase price allocation. The overall impact to goodwill associated with restructuring charges for these activities is
$14.5 million, net of taxes, and is included in current liabilities in the table above.
The
total purchase price of $2,055.0 million was comprised of $2,042.3 million of cash purchase price and $12.7 million of direct acquisition costs. On
February 1, 2007, Hospira incurred $1,925.0 million of bank debt to finance the Mayne Pharma acquisition. The remainder of the purchase price was funded with cash on hand. The bank
facilities included a $500.0 million, three-year term loan facility and a $1,425.0 million one-year bridge loan facility. The bridge loan facility was completely
refinanced on March 23, 2007, through the issuance of long-term debt securities. See Note 11 for more details. In connection with the acquisition, Hospira entered into
certain foreign currency forward exchange contracts to limit its exposure from currency movements of the Australian dollar. Forward
69
Table of Contents
contract
gains and losses of this exposure substantially offset the remeasurement of the related asset and both are included in Other expense (income), net. During 2007, Hospira paid
$55.7 million upon the settlements relating to these foreign currency contracts.
Supplemental
information on an unaudited pro forma basis for the 12 months ended December 31, 2007, as if the Mayne Pharma acquisition had taken place on January 1,
2007, is as follows:
|
|
|
|
|
(dollars in millions)
|
|
Twelve Months Ended
December 31, 2007
|
|
Net sales
|
|
$
|
3,487.5
|
|
|
|
|
|
Net income
|
|
$
|
127.3
|
|
|
|
|
|
Diluted earnings per share
|
|
$
|
0.79
|
|
|
|
|
|
Unaudited
pro forma supplemental information is based on accounting estimates and judgments, which Hospira believes are reasonable. The unaudited pro forma supplemental information also
includes purchase accounting adjustments (including inventories step-up charges, adjustments to depreciation on acquired property and equipment, and a charge for in-process
research and development), amortization charges from acquired intangible assets, adjustments to interest expense and related tax effects. The unaudited pro forma supplemental information is not
necessarily indicative of the results of operations in future periods or the results that actually would have been realized had Hospira and Mayne Pharma been combined at the beginning of the period
presented.
Note 3Investments
Investments as of December 31, consist of the following:
|
|
|
|
|
|
|
|
(dollars in millions)
|
|
2009
|
|
2008
|
|
Investments, at cost
(1)
|
|
$
|
19.2
|
|
$
|
16.1
|
|
Investments, at fair value
(2)
|
|
|
12.7
|
|
|
6.1
|
|
Investments, at equity
(3)
|
|
|
17.4
|
|
|
15.4
|
|
|
|
|
|
|
|
|
|
$
|
49.3
|
|
$
|
37.6
|
|
|
|
|
|
|
|
-
(1)
-
Cost
investments consist of investments in companies over which Hospira does not have significant influence or ownership of more than 20%.
-
(2)
-
Fair
value investments consist of marketable securities classified as available-for-sale.
-
(3)
-
Equity
investments consist of investments in affiliated companies over which Hospira has significant influence but not the majority of the equity or risks
and rewards. As a result of the Mayne Pharma acquisition, Hospira has a joint venture with Cadila Healthcare Limited, a pharmaceutical company located in India, which began commercial manufacturing of
injectable cytotoxic drugs in the first half of 2009. Hospira's share of (earnings) or losses of the investees included in Other expense (income), net was $(1.9) million, $4.7 million, and
$1.2 million for 2009, 2008 and 2007, respectively.
In
2009, Hospira assessed the decline in the market value of marketable equity securities to be other-than-temporary, primarily due to the duration and severity
of the investment's decline in market value and the near-term prospects for recovery to the original invested value. Accordingly, Hospira recognized a non-cash, impairment
charge of $16.6 million in Other expense (income), net. The changes in market value are reported, net-of-tax, in accumulated other comprehensive income (loss) until the
investment is sold or considered other-than-temporarily impaired in periods subsequent to the
70
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2009
impairment. The fair value of the investment may continue to be impacted by the volatility in the global equity markets, Hospira's ability and intent to remain invested among other factors.
In
2007, Hospira recorded an impairment loss of $1.4 million on a portion of the portfolio of marketable equity securities classified as available-for-sale
and realized a gain of $6.4 million as most of these investments were sold.
Note 4Restructuring Actions and Asset Impairments
As part of its strategy to improve margins and cash flows, Hospira has taken a number of actions to reduce operating costs and optimize
operations. The costs related to these actions consist primarily of severance and other employee benefits, accelerated depreciation resulting from the decreased useful lives of the buildings and
certain equipment, impairments, other asset charges and other exit costs.
2009 Actions.
In 2009, Hospira announced details of a restructuring and optimization
plan, ("Project Fuel,"), which will occur over the next two years from the date of the announcement. Project Fuel includes the following activities: optimizing the product portfolio, evaluating
non-strategic assets and streamlining the organizational structure. Hospira expects to incur aggregate restructuring costs and other asset charges related to these actions in the range of
$100 million to $110 million on a pre-tax basis. During 2009, Hospira incurred in the Americas, EMEA and APAC segment pre-tax restructuring costs of
$22.7 million, $1.8 million and $2.8 million, respectively; $27.3 million, pre-tax, in aggregate to date. During 2009, inventory charges of $18.7 million
and $4.6 million related to product portfolio optimization, impacting the Americas and EMEA segments, respectively, are included in Cost of products sold.
As
part of the Project Fuel initiatives, Hospira committed to dispose of certain non-strategic businesses and the underlying assets over the next succeeding twelve months
from the date of commitment. In some instances, the range of proceeds received from these disposals was less than the historical carrying value. As a result of these commitments, non-cash,
pre-tax impairment charges of $52.8 million were recognized in Restructuring and impairment during 2009. Hospira incurred $42.9 million, $7.6 million and
$2.3 million of impairment charges in the Americas, EMEA and APAC segment, respectively. Additionally, pre-tax inventory charges of $3.1 million were recognized in Cost of
products sold. The impairment charges recognized during 2009 reduced property and equipment, net for these businesses by $22.7 million, allocated goodwill by $7.6 million and intangible
assets by $22.5 million. Hospira received cash of $46.6 million upon completion of the disposal of the critical care business and the oral pharmaceutical contract manufacturing facility
in Salisbury, Australia ("Salisbury"), and will provide certain limited transition services related to critical care products through 2010. Subsequent to the Salisbury transaction close, Hospira will
receive contingent consideration based on sales for each of the next six years.
As
of December 31, 2009, the remaining assets held for sale included $26.2 million of property and equipment, $17.9 million of goodwill and $20.9 million of
other assets, net and liabilities related to assets held for sale included $7.1 million of post-retirement obligations and $6.8 million of other liabilities. These assets
held for sale, net related to a facility in Wasserburg, Germany ("Wasserburg") which primarily performed contract manufacturing in the EMEA segment. In 2010, the Wasserburg disposal was completed for
an estimated sales price of approximately $68 million.
71
Table of Contents
The
following summarizes the Project Fuel restructuring and asset impairment activity for the year ended December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(dollars in millions)
|
|
Employee-Related
Benefit Costs
|
|
Accelerated
Depreciation
|
|
Impairment
Charges
|
|
Other
|
|
Total
|
|
Balance at January 1, 2009
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
$
|
|
|
Costs incurred
|
|
|
21.1
|
|
|
2.3
|
|
|
52.8
|
|
|
3.9
|
|
|
80.1
|
|
Payments
|
|
|
(12.0
|
)
|
|
|
|
|
|
|
|
|
|
|
(12.0
|
)
|
Non cash items
|
|
|
|
|
|
(2.3
|
)
|
|
(52.8
|
)
|
|
|
|
|
(55.1
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009
|
|
$
|
9.1
|
|
$
|
|
|
$
|
|
|
$
|
3.9
|
|
$
|
13.0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 Actions.
In April 2008, Hospira announced a plan to exit manufacturing operations at its Morgan Hill, California, plant over the next
two to three years. Hospira expects to incur aggregate restructuring charges through 2011 related to these actions in the range of $20 million to $24 million on a pre-tax
basis. Hospira is in the process of transferring related operations and production of the primary products to other Hospira facilities, or outsourcing certain product components to third-party
suppliers, or ceasing activities entirely. Hospira has incurred $20.4 million, pre-tax, to date for restructuring costs, primarily employee-related, associated with this action.
During 2009 and 2008, Hospira incurred in the Americas segment pre-tax Restructuring costs of $11.6 million and $8.8 million, respectively.
2006 Actions.
In February 2006, Hospira announced plans to close plants in Ashland, Ohio, Montreal, Canada and North Chicago, Illinois,
and completed these plans in 2007, 2008, and in 2009, respectively. Hospira incurred $51.5 million, pre-tax, in aggregate for restructuring costs associated with these actions.
During 2009, 2008 and 2007, Hospira incurred in the Americas segment pre-tax Restructuring costs of $2.5 million, $13.6 million and $13.6 million, respectively.
The
following summarizes the Facilities Optimization (Morgan Hill, California; Ashland, Ohio; Montreal, Canada; North Chicago, Illinois) restructuring activity for the years ended
December 31:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(dollars in millions)
|
|
Employee-Related
Benefit Costs
|
|
Accelerated
Depreciation
|
|
Other
|
|
Total
|
|
Balance at January 1, 2007
|
|
$
|
16.5
|
|
$
|
|
|
$
|
1.3
|
|
$
|
17.8
|
|
Costs incurred
|
|
|
4.8
|
|
|
5.9
|
|
|
3.6
|
|
|
14.3
|
|
Payments
|
|
|
(10.3
|
)
|
|
|
|
|
(4.3
|
)
|
|
(14.6
|
)
|
Non cash items
|
|
|
6.8
|
|
|
(5.9
|
)
|
|
|
|
|
0.9
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007
|
|
|
17.8
|
|
|
|
|
|
0.6
|
|
|
18.4
|
|
Costs incurred
|
|
|
15.2
|
|
|
4.2
|
|
|
3.0
|
|
|
22.4
|
|
Payments
|
|
|
(13.9
|
)
|
|
|
|
|
(5.1
|
)
|
|
(19.0
|
)
|
Non cash items
|
|
|
(1.7
|
)
|
|
(4.2
|
)
|
|
2.5
|
|
|
(3.4
|
)
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008
|
|
|
17.4
|
|
|
|
|
|
1.0
|
|
|
18.4
|
|
Costs incurred
|
|
|
11.8
|
|
|
2.3
|
|
|
|
|
|
14.1
|
|
Payments
|
|
|
(15.3
|
)
|
|
|
|
|
(0.1
|
)
|
|
(15.4
|
)
|
Non cash items
|
|
|
|
|
|
(2.3
|
)
|
|
(0.4
|
)
|
|
(2.7
|
)
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009
|
|
$
|
13.9
|
|
$
|
|
|
$
|
0.5
|
|
$
|
14.4
|
|
|
|
|
|
|
|
|
|
|
|
72
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