- Annual Report (10-K)
16 Fevereiro 2011 - 2:02PM
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, 2010
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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," 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, 2010 (the last business day of the
registrant's most recently completed second fiscal quarter), was approximately $9,593.7 million.
Registrant
had 166,646,244 shares of common stock outstanding as of February 9, 2011.
DOCUMENTS INCORPORATED BY REFERENCE
Certain sections of the registrant's definitive Proxy Statement to be filed in connection with the 2011 Annual Meeting of Shareholders are incorporated by
reference into Part III of this Form 10-K where indicated. The definitive 2011 Proxy Statement will be filed on or about March 25, 2011.
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 "Part II, 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 products. Hospira products are 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 products. For financial information relating to Hospira's
segments and principal product lines and other geographic information, see Note 23 to the consolidated financial statements included in Part II, 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
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independent
company, and on May 3, 2004, Hospira's common stock began trading on the New York Stock Exchange under the symbol "HSP."
In
March 2009, Hospira announced details of a restructuring and optimization plan ("Project Fuel"), which has been ongoing over the last two years. Project Fuel has included 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 addition to Project Fuel, Hospira is actively working to maintain a culture of continuous improvement as part of its strategy to improve margins and cash flows,
reduce operating costs and optimize operations.
In
March 2010, Hospira completed its acquisition of the generic injectable pharmaceuticals business of Orchid Chemicals & Pharmaceuticals Ltd. ("Orchid Pharma") for
$381.0 million, which was purchased by and operates under the name Hospira Healthcare India Private Limited ("Hospira India"), a wholly-owned subsidiary of Hospira. The acquisition included a
beta-lactam antibiotic formulations manufacturing complex and pharmaceutical research and development facility, as well as a generic injectable dosage-form product portfolio
and pipeline. Hospira also acquired some of Orchid Pharma's long-term land leases in India, which were held by Orchid Pharma for their anticipated future expansion. To ensure Hospira's
manufacturing capacity aligns with expected future commercial growth and demand, Hospira may be taking steps in India over the next few years to prepare for the expansion of Hospira's global
manufacturing footprint.
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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Biosimilars, including
Retacrit
TM
(erythropoietin zeta), a biosimilar erythropoietin, used primarily in the treatment of anemia in dialysis and in certain oncology applications, and Nivestim
TM
, a biosimilar filgrastim used for the treatment of low
white blood cells in patients who have received a chemotherapeutic agent
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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
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Infusion pumps and dedicated
administration sets
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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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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. These products provide
customers with a lower-cost alternative to branded products, when the patent protection has expired, when patents have been declared invalid, or when the products do not infringe the
patents of others. These drugs' therapeutic areas include analgesia, anesthesia, anti-infectives, 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.
Beginning
in 2009 and for the first half of 2010, Hospira's specialty injectable pharmaceutical products included oxaliplatin, a major oncolytic drug used in the treatment of colon
cancer. Hospira exited the U.S. oxaliplatin market on June 30, 2010, pursuant to a settlement agreement related to ongoing patent
litigation. Hospira intends to re-launch its oxaliplatin products pursuant to a royalty-free license on August 9, 2012. Also during 2010, Hospira continued to broaden
its global portfolio with the introduction into new markets of 11 drugs that the company had previously launched in other markets. Hospira launched several new generic injectable pharmaceutical
products in the U.S. including a 2 gram freeze-dried powder presentation of gemcitabine (an oncolytic drug used to treat a variety of cancers) and piperacillin/tazobactam for injection (an antibiotic
used to treat patients with moderate to severe infections). In the U.S., Hospira also launched meropenem for injection, a beta-lactam anti-infective and the first product to
launch in the U.S. that was manufactured by Hospira India. In EMEA, Hospira launched the oncolytic drug, docetaxel, and in APAC, Hospira launched two oncolytic drugs, gemcitabine and irinotecan in
certain markets.
Hospira's
specialty injectable pharmaceuticals also include biosimilar products, which are large complex molecules derived from cells that are demonstrated to be similar to an approved
biologic product. Hospira's first biosimilar, Retacrit
TM
, was originally launched in 2008 and is currently available in 19 EMEA countries. In 2010, Hospira announced the start of
a U.S. Phase I clinical trial for Retacrit
TM
in patients with renal dysfunction who have anemia. Also, Hospira launched its second biosimilar, Nivestim
TM
, in Europe
in mid-2010. In 2010, Nivestim
TM
received approval for the Australian market by the Australian Therapeutic Goods Administration.
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 products also include 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. During 2010, Hospira received approval for the long-term use of Precedex
TM
in Japan.
During
2010, Hospira completed its acquisition of Javelin Pharmaceuticals Inc. ("Javelin Pharma"). The acquisition will enable Hospira to take advantage of synergies between
Hospira's Precedex
TM
and Javelin Pharma's main product candidate, Dyloject
TM
, a post-operative pain management drug currently awaiting U.S. Food and Drug
Administration ("FDA") approval. In October 2010, Hospira received a
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complete
response letter from the FDA regarding Dyloject
TM
and Hospira is working to respond to the letter. Hospira and its third party manufacturer continue to work closely with FDA to
address any items raised as part of the regulatory process and the timing of resolution is uncertain.
During
2010, Hospira also entered into two collaborative agreements. Hospira entered into a licensing agreement with DURECT Corporation to develop and market DURECT's
POSIDUR
TM
, a long-acting version of the anesthetic bupivacaine currently in Phase III clinical trials. Hospira will co-develop the drug and will have
exclusive marketing rights in the U.S. and Canada following regulatory approval. Hospira and Kiadis Pharma B.V. ("Kiadis") entered into a collaborative agreement to develop, license, and
commercialize Kiadis' ATIR
TM
drug candidate. ATIR
TM
is a personalized hematology product designed for blood cancer patients in need of allogeneic bone marrow
transplantation who cannot locate a matched donor. The product is designed to enable any family member to act as a donor and is being developed to reduce transplant related mortality caused by
infections and graft-versus-host disease. Hospira was granted exclusive marketing rights to ATIR
TM
for Europe, the Middle East, Africa, Australia, Japan and parts of Asia.
Hospira will be responsible for regulatory approval and sales and marketing of the product.
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 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 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, respectively, which primarily
performed contract manufacturing.
Medication Management
Medication management includes 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 575,000 of its
electronic drug delivery pumps were in use on a global basis as of December 31, 2010. 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
; the GemStar
TM
ambulatory infusion pump; and the
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
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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,
and LifeCare PCA
TM
devices, which, when aggregated represent the majority of Hospira's line of electronic drug delivery pumps. Hospira also offers safety software with its
GemStar
TM
pump.
Medication
management includes TheraDoc, Inc. and its Infection Control Assistant
TM
and Antibiotic Assistant
TM
products, which are software
applications that automate hospital-wide surveillance for infection-related events and optimize the utilization of antimicrobials. In 2010, Hospira introduced the Anticoagulation
Assistant
TM
knowledge module, which helps reduce the risk of adverse events associated with anticoagulation therapy.
Medication
management also includes gravity administration sets and other device products, including 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 80% of Hospira's 2010 net sales. Net sales in the EMEA and APAC segments comprised approximately 12% and 8%, respectively, of 2010 net sales. Hospira's sales organizations include
sales professionals who sell across its major product lines, as well as product specialists who promote its medication management products, or who market and sell Precedex
TM
and select
other products. Hospira also has extensive experience 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 40% of global net sales during 2010. 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 U.S.,
including Amerinet, 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.
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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 Americas 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. During 2010, Hospira experienced an increase in backlogs due to supply constraints which decreased by
year-end. 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.
Hospira's research and development expenses were $300.5 million in 2010, $240.5 million in 2009, and $211.9 million in 2008. 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; Adelaide, South Australia, Australia; and Irungattukottai, India.
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 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. For a discussion of Hospira's developments in 2010 related to biosimilars, see the discussion of Hospira's products under "Item 1. Business." In 2009,
Hospira acquired worldwide rights to the biosimilar version of filgrastim and a biologic manufacturing facility from PLIVA Hrvatska d.o.o. This is in alignment with Hospira's biosimilars strategy,
which is to expand its biosimilars 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 biosimilar products for the U.S. market. In 2009, Hospira entered into an agreement with Celltrion, Inc. and Celltrion Healthcare, Inc. to develop and market
eight biosimilar molecules, five of
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which
are new to Hospira's biosimilar portfolio. Hospira's biosimilar pipeline has 11 biosimilar products.
Hospira
continues to invest in Precedex
TM
for expansion of clinical use and has selectively invested 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. In 2010, Hospira acquired Javelin Pharma and entered into a licensing agreement with DURECT Corporation to develop and market DURECT's POSIDUR
TM
. For further
information related to those developments, see the discussion of Hospira's products under "Item 1. Business."
Hospira's
key programs in the area of medication management products 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.
As
of December 31, 2010, Hospira operated 12 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. Hospira's manufacturing facility in Irungattukottai, India and its joint venture manufacturing facility near Ahmedabad, India may also be significant manufacturing
facilities for Hospira in 2011. During 2010, Hospira temporarily shut down certain of its production lines to respond to certain quality issues cited in a 2010 warning letter as described in "Quality
Assurance" in Item 1. If Hospira experiences any further significant interruption of manufacturing at any of the foregoing facilities, such an interruption could materially and adversely affect
Hospira's ability to manufacture and sell its products.
Hospira
has a joint venture with Cadila Healthcare Limited, an Indian domestic pharmaceutical company located in Ahmedabad, India. The joint venture, Zydus Hospira Oncology
Pvt. Ltd. ("ZHOPL"), operates a manufacturing facility in a special economic zone outside of Ahmedabad, India, that has been inspected and approved by the United Kingdom's
Medicines and Healthcare Products Regulatory Agency and the FDA. Since 2009, the facility has been manufacturing a number of cytotoxic drugs for sale by both Cadila and Hospira in their respective
exclusive territories in the United States, Europe and other countries. In addition, in 2010 and 2011, Hospira has entered into separate and independent contract manufacturing agreements with ZHOPL
for the production of numerous other cytotoxic drugs that Hospira will sell under its own label throughout the world.
Raw Materials and Components
While Hospira produces some 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 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 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 2010 U.S. net sales. In addition, Hospira purchases some of its other raw materials, components
and active pharmaceutical ingredients
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from
single suppliers for reasons of quality assurance, sole-source availability, cost effectiveness or constraints resulting from regulatory requirements.
To
manage risk, Hospira works closely with its suppliers to ensure continuity of supply. In addition, Hospira attempts to diversify its sources of materials and continually evaluates
alternate-source suppliers. In certain circumstances, it may pursue regulatory qualification of alternative sources, depending upon the strength of its existing supplier relationships, the reliability
of its current supplier base, and the time and expense associated with the regulatory process. 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. The loss of certain supply arrangements, including certain arrangements for active pharmaceutical
ingredients, certain commodities, and the 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 recall was limited to device power cords with a certain prong design that could crack and fail at/or inside the plug. In October 2010, the FDA notified Hospira that it appeared that Hospira
had addressed the warning letter deficiencies and that future FDA inspections would further assess the adequacy and
sustainability of these corrections. In December 2010, the FDA notified Hospira that the AC power cord recall activities were completed and the FDA considered the recall terminated.
During
2010, Hospira received a warning letter from the FDA in connection with the FDA's inspection of Hospira's pharmaceutical and device manufacturing facilities located in Rocky
Mount, North Carolina, and Clayton, North Carolina (the "2010 warning letter"). In the warning letter, the FDA cites current good manufacturing practice deficiencies related to particulate in certain
emulsion products at the Clayton facility and the failure to adequately validate the processes used to manufacture products at the Rocky Mount facility. The warning letter also asserts other
inadequacies, including procedures related to the Quality Control unit, investigations, and medical reporting obligations. The warning letter asserts that some of the deficiencies were repeat
observations from a prior inspection conducted in April 2009, and include a similar violation cited in the August 2009 warning letter related to the AC power cords. The FDA did not believe that
Hospira had identified the root cause(s) of the problems and had adequately resolved them. The warning letter also questioned whether Hospira's interim plans ensured the quality of products that were
manufactured at the facilities while implementing the corrective actions and validation activities. Hospira has made significant progress on completing a comprehensive review of its manufacturing
operations to ensure compliance with applicable regulations. In January 2011, the FDA completed an inspection of the Clayton facility with no observations noted by the inspector.
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Nothing
in either the October or December 2010 letters precludes any future regulatory action by the FDA should violations be observed in subsequent inspections or through other means,
and these letters do not relieve Hospira from the responsibility to assure compliance with the Food, Drug and Cosmetic Act in the future. The FDA's warning letters are publicly available on the FDA's
Web site. Hospira has responded to the 2010 warning letter and is working closely with the FDA to conclude this matter.
In
April 2010, Hospira placed a voluntary hold on all shipments to new customers of Symbiq
TM
, a large volume infusion device. Hospira initiated this hold after it received
an unexplained increase in customer complaints related to the failure of the Symbiq
TM
to alarm at the end of infusion therapy under certain use conditions. In June 2010, Hospira notified
customers on interim steps to be taken by customers to mitigate this issue and to avoid the use conditions that can lead to the failure of the Symbiq
TM
to alarm at the end of infusion
therapy. In August 2010, Hospira initiated a set recall related to the issue. Additionally, Hospira notified customers of reports of unrestricted flow when the Symbiq
TM
infusion set
cassette is improperly removed from the pump before the pump's cassette door is fully opened. Hospira cautioned customers to allow the pump's cassette door to fully open before removing the infusion
set as the pump may not alarm when the infusion set is improperly removed. The FDA has classified each of these actions as a Class I recall and Hospira is working closely with the FDA to
conclude these matters. Further, Hospira is developing a solution to improve the performance of the pump and the issues therewith. Hospira has not asked customers to return or cease using their
Symbiq
TM
pumps.
In
December 2010, Hospira informed the FDA that Hospira had received a small number of customer reports associated with the Plum
TM
pumps regarding failure of the pump's
audible alarm under certain conditions. Hospira has provided notice to customers notifying them of the corrective action plan. For the Plum A+
TM
pumps, the alarm failures are associated
with the alarm assembly which will need to be replaced. For the Plum XL
TM
pumps, the alarm failure is associated with fluid ingress and physical damage to the alarm assembly over time.
Plum XL
TM
customers are being asked to follow the proper cleaning procedure and inspect the alarm assembly for physical damage during routine maintenance. This action is classified as a
field recall and FDA is not requiring Hospira to remove Plum
TM
pumps from the market or halt production.
For
further discussion of these other remedial actions, Hospira's responses to the warning letters, and the resulting financial impact, see the section captioned "Certain Quality and
Product Related Matters" in "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations."
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 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 pharmaceuticals also compete with Hospira on a
country-by-country basis. Hospira's most significant competitors in medication management include Baxter, B. Braun Melsungen AG, CareFusion and Fresenius Medical Care AG.
Hospira believes that it is one of the
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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, for its pharmaceutical products, Hospira seeks to maximize its opportunity to establish a
"first-to-market" position for its generic injectable drugs, and for its medication management products, 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, competitors include Teva, Sandoz, Actavis, Fresenius Kabi, Mylan Inc., Stada Arzneimittel AG, and Baxter. 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
hospitals. Hospira's competition in Asia tends to be with the originator companies and multinational companies such as Teva and Actavis. 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. 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. Principal products and their related trademarks are discussed in "Item 1. General Development of Business."
Hospira believes that no single patent, trademark, or related group of patents or trademarks are material in relation to Hospira's business as a whole. 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." While this drug is not material to Hospira's business as a
whole or its segments, it is significant to Hospira's specialty injectable pharmaceutical product line. Precedex
TM
is licensed to Hospira in the Americas and APAC segments, and in the
Middle East and Africa.
Employees
As of December 31, 2010, Hospira had approximately 14,000 employees. 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 Therapeutic 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 and 2010 warning letters received
by Hospira and other voluntary recalls and corrective actions in 2009 and 2010, see the sections captioned "Quality Assurance" above, and "Certain Quality and Product Related Matters" in
"Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations."
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. See discussion regarding corrective actions to Hospira's pumps under the section captioned "Certain Quality and Product Related Matters" in "Item 7.
Management's Discussion and Analysis of Financial Condition and Results of Operations."
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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
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
continues investing in the development of generic and/or similar versions of currently marketed biopharmaceuticals. Since 2005, the European Medicines Agency has implemented
guidelines which provided a pathway for the approval of certain biosimilars in the European Union. In 2010, the "Patient Protection and Affordable Care Act" ("PPACA") was passed and signed into law in
the U.S. This legislation includes new authorization for the FDA to approve companies to market these products in the U.S. In addition, other provisions, such as the medical device excise tax of the
PPACA, will also have an impact on Hospira in the future.
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 ("U.S. FCPA") 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. A new anti-bribery law that will become effective in April 2011 is the U.K. Bribery Act of 2010. In addition to prohibitions similar to the U.S. FCPA, this law also prohibits
commercial bribery and makes it a crime for a company to fail to prevent bribery. Companies have the burden of proving that they have adequate procedures in place to prevent bribery. The enforcement
of such laws in the U.S. and elsewhere has increased dramatically in the past few years, and authorities have indicated that the pharmaceutical and medical device industry will be a significant focus
for enforcement efforts. Hospira has a compliance program in place to ensure compliance with these laws by its employees and agents and to communicate its expectations of compliance to third parties,
including its distributors.
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
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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 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 and the District of Columbia 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. A similar requirement arose under the PPACA to track spending on physicians and teaching institutions,
beginning on January 1, 2012. The
2012 data will be reportable to an agency of the federal government in 2013. This reporting requirement is expected to preempt some but not all of the state disclosure requirements.
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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.
Available 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 reasonably practicable after Hospira electronically files or
furnishes such material 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, technology and quality
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.
Information
contained on Hospira's Web site shall not be deemed incorporated into, or to be a part of, this Annual Report on Form 10-K.
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 productivity, lowering its operating costs, and improving its business processes. 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 biosimilar products. Hospira has entered into several agreements described under "Product Development and Manufacturing"
related to expanding its biosimilars portfolio and capabilities. The success of our biosimilars activities depends on several factors, including among other factors, the adoption of certain laws and
regulations, ability to obtain regulatory approvals, and the success of the arrangements with third parties. These activities will require a substantial investment of the company's resources, which
may not result in commercially successful products.
In
2010, the Patient Protection Affordable Care Act was passed and signed into law in the U.S. This legislation includes new authorization to the FDA to approve companies to market
biosimilar products in the U.S. The regulations under this law have not been developed yet. Those regulations may delay or prevent generic drug producers such as Hospira from offering certain
products, such as biosimilar products in key territories, which could harm Hospira's ability to grow its business. Hospira may not be able to generate future sales of such products in certain
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
faces similar risks if it does not introduce new versions or upgrades to its medication management 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 quality 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.
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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 or to realize the benefits 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 product lines. Hospira has entered into collaboration agreements relating to the long-term development and
commercialization of proprietary and biosimilar products, which Hospira views as an important long-term opportunity for its specialty injectable pharmaceutical product line. 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.
The
development of proprietary and biosimilar products may require substantial investment by Hospira. Hospira may not be able to realize the expected benefits of such investment. These
factors are often beyond the control of Hospira, and could harm Hospira's sales, product development efforts and profitability.
Hospira is subject to the cost-containment efforts of wholesalers, distributors, third-party payors and government organizations, which could have a material
adverse effect on our sales and profitability.
Hospira relies on drug wholesalers to assist in the distribution of its generic injectable pharmaceutical 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
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manufacturers
and distributors, and these negotiated prices are made available to a GPO's or an IDN's 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 for certain products with the major GPOs in the U.S., including Amerinet, 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 2010, sales through the four largest wholesalers that supply products to many end-users accounted for approximately
40% 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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Hospira's
collaborative partners and 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, and adverse event
reports and field alerts. In addition, manufacturing flaws, component failures, design defects, off-label uses or inadequate disclosure of product related information could result in an
unsafe condition or the injury or death of a patient. Hospira may be required by regulatory authorities, or determine on its own, to issue a safety alert, recall or temporarily cease production and
sale of certain products to resolve manufacturing and product quality concerns. All of these events could 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 and 2010 FDA warning letters received by Hospira and other voluntary recalls and corrective actions, including those related to Hospira's pumps , see
the section captioned "Quality Assurance" under Item 1 above and "Management's Discussion and Analysis of Financial Condition and Results of Operation" in Part II, Item 7. In
response to certain quality issues, Hospira placed a voluntary hold on all shipments to new customers of Symbiq
TM
. Also during 2010, Hospira temporarily shut down certain of its
production lines to respond to the quality issues cited in the 2010 warning letter. Hospira has also been working with third-party consultants in connection with the 2010 warning letter, who have been
overseeing Hospira's activities to ensure it is developing compliant processes and procedures. These activities have increased the time to get product to market. If the FDA is not satisfied with
Hospira's progress, this could result in longer delays to market or additional production line shut-downs. The FDA could find additional violations in subsequent inspections or through
other means. In some circumstances, adverse events arising from or associated with the design, manufacture or marketing of our products could result in the suspension or delay of regulatory reviews of
our applications for new product approvals or clearances. Any of the foregoing could disrupt our business and harm our reputation, resulting in an adverse effect on our results of operations and
financial condition.
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 in Item 1. "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.
Proposed changes in FDA regulations or actions related to infusion pumps and medical devices may lead to increased costs and delays, which could negatively impact Hospira's
business.
In April 2010, the FDA issued a draft guidance document entitled "Total Product Life Cycle: Infusion Pump-Premarket
Notification [510(k)] Submissions." Through this new draft guidance, the FDA has established additional pre-market requirements for infusion pumps. The proposed
guidance is subject to further revisions by the FDA, but the FDA's expectation is that the guidelines should be
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followed
in the interim. At the same time, the FDA is also enhancing its pre-market requirements for medical devices generally. Although Hospira cannot predict with certainty the future
impact of these initiatives, it appears that the process for obtaining regulatory approvals to market infusion pumps and medical devices will become more costly and time consuming. In addition, the
new requirements could result in longer delays for the approval of new products as well as remediation of existing products in the market. Future delays in the receipt of, or failure to obtain,
approvals could result in delayed or no realization of product revenues.
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, as recently evidenced by Hospira's expanding its manufacturing presence in India. 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.
To
finance acquisitions or other investments, 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,
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.
The Company is increasingly dependent on its outsourcing and third-party provider arrangements.
Hospira is increasing its dependence on third-party providers for certain services, 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.
Challenging economic conditions could adversely affect our operations.
The securities and credit markets have experienced volatility in the past, and in some cases, 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
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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. 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 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 adverse economic conditions, resulting in the loss of jobs or healthcare coverage, thereby affecting an individual's
ability to pay for elective healthcare. In addition, adverse economic conditions may increase Hospira's customers' cost-containment efforts, and affect Hospira's customers' solvency or
their 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. These economic conditions may
also adversely affect certain of our suppliers, which could cause a disruption in our ability to produce our products.
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, development discontinuation, delay in regulatory approval, product quality, 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 and the near-term prospects for recovery to
carrying value. 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. Problems could also lead to increased costs, lost sales, damage to customer relations, failure to supply penalties,
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
20
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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, active pharmaceutical ingredient and electromechanical and other
components that must meet stringent FDA and other regulatory requirements. While efforts are made to diversify our sources of materials and components, some of these raw materials and other components
are currently available from a limited number of suppliers. For example, Hospira relies on certain proprietary components available exclusively from ICU Medical. For a description of that
relationship, see the section captioned "Raw Materials and Components" in Item 1.
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.
While
we work closely with our suppliers to ensure the continuity of supply, we cannot guarantee that these efforts will be successful. 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 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
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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.
From time to time, Hospira 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. These efforts may not be completed in a timely or cost-effective manner, and Hospira may not realize the desired benefits of these efforts. To ensure Hospira's manufacturing
capacity aligns with expected future commercial growth and demand, Hospira may be taking steps in India over the next few years to prepare for the expansion of Hospira's global footprint.
As
a result of cost-reduction efforts, Hospira has announced the closing of, or has sold, certain of its facilities. While Hospira believes it has available manufacturing
capacity to absorb, or has had the ability to outsource, the production at these closed or sold 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.
Hospira conducts operations outside of the U.S. and is subject to additional 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 28% of 2010 net sales. Hospira anticipates that sales from outside the U.S.
will continue to represent a significant portion of net sales. The additional risks associated with Hospira's operations outside the United States include:
-
(i)
-
fluctuations
in foreign currency exchange rates (for a discussion of the ways and extent to which Hospira attempts to mitigate such risk, see
Part II, Item 7A. "Quantitative and Qualitative Disclosures About Market Risk.");
-
(ii)
-
multiple
regulatory requirements that are subject to change, which may delay or deter Hospira's international product commercialization efforts;
-
(iii)
-
differing
local medical practices, product preferences and product requirements;
-
(iv)
-
trade
protection measures and import or export licensing requirements or other controls or restrictions;
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-
(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 U.S. FCPA and anti-boycott laws;
-
(viii)
-
loss
of business through government tenders that are held annually in many cases;
-
(ix)
-
potentially
negative consequences from changes in tax laws, including legislative changes in the U.S. and international taxation of income earned outside
of the U.S.;
-
(x)
-
political
and economic instability;
-
(xi)
-
disruption
or destruction of operations in a significant geographic area, due to the location of manufacturing facilities, distribution facilities or
customers, caused by natural or man-made disasters or other causes; and
-
(xii)
-
diminished
or insufficient 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. If certain of those distributor relationships are unsuccessful, the costs to terminate such distributor relationship and/or to re-establish a customer base could
adversely affect Hospira's profitability in certain regions. 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." These matters could have an adverse effect
on Hospira's business, profitability or financial condition. In addition, there could be an increase in scope of these matters and there could 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 these matters could have an adverse impact on Hospira.
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, 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
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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 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 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. These actions and
litigation 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.
Hospira
is currently involved in patent-related disputes with companies with branded products over Hospira's attempts to market generic pharmaceutical products. Once Hospira has final
approval of the related generic pharmaceuticals in the U.S., Hospira may decide to commercially market these products while the ultimate disposition of legal proceedings has not concluded. If
Hospira's products are ultimately found to infringe the patent rights of another company, Hospira may be subject to significant damages, which may be based on the lost profits from the sale of the
branded product and/or an injunction preventing Hospira from further sales.
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. Hospira also
may be subject to significant damages 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.
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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.
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.
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.
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. 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.
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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, 2010, 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**
|
|
Manufacturing and R&D
|
|
Owned/Leased (expires 2011)
|
Clayton, North Carolina
|
|
Manufacturing and R&D
|
|
Owned
|
Finisklin, Sligo, Ireland
|
|
Manufacturing
|
|
Leased (expires 2013)
|
Irungattukottai, India
|
|
Manufacturing and R&D
|
|
Owned/Leased (expires 2102)
|
La Aurora, Costa Rica
|
|
Manufacturing
|
|
Owned
|
Lake Forest, Illinois***
|
|
Corporate Headquarters and R&D
|
|
Owned/Leased (expires 2016)
|
Liscate, Italy
|
|
Manufacturing
|
|
Owned
|
McPherson, Kansas
|
|
Manufacturing and R&D
|
|
Owned
|
Mulgrave, Victoria, Australia
|
|
Manufacturing and R&D
|
|
Owned
|
Rocky Mount, North Carolina
|
|
Manufacturing
|
|
Owned
|
San Cristobal, Dominican Republic
|
|
Manufacturing
|
|
Owned
|
San Diego, California
|
|
R&D
|
|
Leased (expires 2019)
|
-
*
-
The
locations listed above generally support all of Hospira's segments.
-
**
-
The
Boulder facilities consist of nine buildings, one of which is owned and eight of which are leased.
-
***
-
The
Lake Forest facilities consist of four buildings, three of which are owned and one of which is leased.
Hospira ceased manufacturing operations at its Morgan Hill, California plant and the transfer of product manufacturing was completed in 2010.
Production of the primary products at this facility has been moved to other Hospira facilities or has been outsourced to third-party suppliers. For further details regarding the financial impact of
these activities, see Note 3, to the consolidated financial statements included in Part II, Item 8.
Hospira
has a joint venture with Cadila Healthcare Limited, a pharmaceutical company located in Ahmedabad, Gujarat State, India. The joint venture, ZHOPL operates a manufacturing
facility in a
special economic zone outside of Ahmedabad, India, that has been inspected and approved by the Medicines and Healthcare Products Regulatory Agency and the FDA. The facility is now manufacturing a
number of cytotoxic drugs for sale by both Cadila and Hospira in their respective exclusive territories in the United States and Europe.
In
addition, Hospira acquired some of Orchid Pharma's long-term land leases in India, which were held by Orchid Pharma for their anticipated future expansion. To ensure
Hospira's manufacturing capacity aligns with expected future commercial growth and demand, Hospira may be taking steps in India over the next few years to prepare for the expansion of Hospira's global
manufacturing footprint.
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.
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.
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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. Trial of this matter has concluded. On April 22, 2010, the court issued a ruling in favor of Hospira and Abbott on
all counts. Plaintiffs have appealed that verdict. 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.
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, 2010, there are
a total of 11 cases, involving 11 plaintiffs, in which Hospira is a party. 5 cases are pending in federal court and 6 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 and Abbott deny all material allegations asserted against
them in the complaints. Generally, plaintiffs seek compensatory damages and, in some cases, punitive damages and costs. Hospira has successfully achieved dismissals in hundreds of these lawsuits.
Given the few lawsuits that remain and absent a significant change in this litigation, Hospira no longer believes this litigation is material and no longer intends to report on this litigation.
Hospira
is involved in two patent lawsuits concerning Precedex
TM
(dexmedetomidine hydrochloride), a proprietary sedation agent. 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 pending 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 Precedex
TM
. Hospira seeks a judgment of infringement, injunctive relief and costs. On November 12, 2010,
Hospira brought suit against Caraco Pharmaceutical Laboratories, Ltd. for patent infringement. The lawsuit, which alleges infringement of U.S. Patent No. 6,716,867 (referred to above) is
pending in the U.S. District Court for the Eastern District of Michigan:
Hospira, Inc. and Orion Corporation v. Caraco Pharmaceutical
Laboratories, Ltd.,
No. 10-cv-14514 (E.D. Mich. 2010). The lawsuit is based on Caraco's "Paragraph IV" notice indicating that
Caraco has filed an abbreviated new drug application ("ANDA") with the FDA for a generic version of Precedex
TM
. Hospira seeks a judgment of infringement, injunctive relief and costs.
27
Table of Contents
Hospira's
litigation exposure, including product liability claims, is evaluated each reporting period. Hospira's reserves, which are not significant at December 31, 2010 and 2009,
are the best estimate of loss, as defined by Accounting Standards Codification ("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.
Executive Officers of Hospira
The executive officers of Hospira are set forth below. Their ages as of February 16, 2011, 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 58, 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 had previously provided 18 years of service to Abbott, a global
broad-based healthcare company. In August 2010, Mr. Begley announced his intention to retire as CEO once a successor had been named. At that time, he would remain an employee of Hospira as
Executive Chairman of the Board. Mr. Begley is a director of Sara Lee Corporation and AdvaMed.
Francois (Frans) L. Dubois
, age 57, is Hospira's Senior Vice President, Quality. Mr. Dubois has served in that position since
January 2011. Mr. Dubois served as the Vice President of Quality for Tengion, Inc. (a regenerative medicine company) from 2009 to 2010. From 2008 to 2009, Mr. Dubois was Vice
President of Global External Manufacturing and Supplier Quality Operations at Global Pharmaceutical Supply Group (a fully owned subsidiary of Johnson & Johnson, a global pharmaceutical, medical
device and consumer packaged goods manufacturer). From 2006 to 2008, Mr. Dubois was Vice President, Worldwide Quality at Global Biologics Supply Chain (a fully owned subsidiary of
Johnson & Johnson).
James H. Hardy, Jr.,
age 51, is Hospira's Senior Vice President, Operations. Mr. Hardy has served in that position since January
2011. Mr. Hardy was Hospira's Corporate Vice President, Supply Chain, from 2009 to 2010. From 2007 to 2009, Mr. Hardy served as the Senior Vice President, Supply Chain, at Dial
Corporation (a maker of personal care and household cleaning products). Prior to that, he served as the Executive Vice President, Product Supply (2006-2007) and as the Senior Vice
President, Manufacturing (2006) at ConAgra Foods, Inc. (a packaged foods company).
Daphne E. Jones,
age 53, 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. During 2006, she served in other IT roles at Johnson & Johnson (a global pharmaceutical, medical device and consumer packaged goods manufacturer).
Kenneth F. Meyers
, age 49, is Hospira's Senior Vice President, Organizational Transformation and People Development. Mr. Meyers has
served in that position since November 2008. From 2006 to 2008, Mr. Meyers served as a partner of Oliver-Wyman-Delta Executive Learning Center (a global management consulting firm).
Sumant Ramachandra, M.D., Ph.D.,
age 42, 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
28
Table of Contents
President
and Senior Project Leader, Global Development, at Schering-Plough, a global healthcare company, from 2006 to 2008.
Brian J. Smith
, age 59, is Hospira's Senior Vice President, General Counsel and Secretary. He has served in such position since the
spin-off in April 2004.
Ron Squarer
, age 44, is Hospira's Senior Vice President, Chief Commercial Officer. He has served in such position since February 2010.
From 2009 to 2010, Mr. Squarer served as Senior Vice President, Global Marketing and Corporate Development. 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.
Thomas E. Werner
, age 53, is Hospira's Senior Vice President, Finance and Chief Financial Officer. He has served in such position since
August 2006. Prior to joining Hospira, 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.
Richard J. Hoffman
, age 44, 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 2006
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).
29
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
|
|
|
|
2010
|
|
2009
|
|
For the quarter ended:
|
|
High
|
|
Low
|
|
High
|
|
Low
|
|
March 31
|
|
$
|
57.38
|
|
$
|
48.56
|
|
$
|
30.86
|
|
$
|
21.38
|
|
June 30
|
|
$
|
57.97
|
|
$
|
50.11
|
|
$
|
38.82
|
|
$
|
30.44
|
|
September 30
|
|
$
|
59.75
|
|
$
|
50.26
|
|
$
|
44.87
|
|
$
|
36.12
|
|
December 31
|
|
$
|
59.65
|
|
$
|
54.83
|
|
$
|
51.11
|
|
$
|
43.25
|
|
As
of February 9, 2011, Hospira had approximately 35,678 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 2010.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period
|
|
Total Number of
Shares Purchased
(1)(2)
|
|
Average
Price Paid
per Share
|
|
Total
Number of
Shares
Purchased as
Part of
Publicly
Announced
Plans or
Programs
(2)
|
|
Maximum Number
(or Approximate Dollar
Value) of Shares that
May Yet be Purchased
Under the Plans or
Programs
(2)
|
|
October 1 - October 31, 2010
|
|
|
51,603
|
|
$
|
57.00
|
|
|
|
|
$
|
50,233,606
|
|
November 1 - November 30, 2010
|
|
|
190,749
|
|
|
58.55
|
|
|
169,344
|
|
|
50,233,606
|
|
December 1 - December 31, 2010
|
|
|
684,645
|
|
|
56.92
|
|
|
680,704
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
926,997
|
|
$
|
57.26
|
|
|
850,048
|
|
$
|
|
|
-
(1)
-
In
addition to the shares purchased as part of the publicly announced Plan, 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 21, to the consolidated financial statements included in Item 8. These shares include the shares purchased on the open market for the benefit of participants in the Hospira
Healthcare Corporation ("Hospira Canada") Stock Purchase Plan1,150 in October, 1,000 in November, and 1,800 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. As of December 31, 2010, Hospira has repurchased 9.2 million shares for $400.0 million in
the aggregate under the 2006 board authorization. In August 2010, Hospira entered into an accelerated share repurchase ("ASR") contract with a third party financial institution to repurchase
$50.0 million of Hospira's common stock. Under the ASR, Hospira received 0.9 million shares. In December 2010, Hospira entered into a second ASR contract with a third party financial
30
Table of Contents
institution
to repurchase $50.0 million of Hospira's common stock. Under the second ASR, Hospira received 0.7 million shares based on seventy-five percent of the
$50.0 million repurchased on the trade date, with the remaining shares to be delivered over the next three months subject to adjustment based on the average stock price during the period. The
second ASR was completed and Hospira received an incremental 0.2 million shares on February 7, 2011.
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, 2005 in Hospira common stock and each index. Values are as of the close of the U.S. stock markets on December 31, 2006, 2007,
2008, 2009 and 2010, 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.
31
Table of Contents
Item 6. Selected Financial Data
The following tables set forth Hospira's selected financial information derived from its audited consolidated financial statements as
of, and for the years ended, December 31, 2010, 2009, 2008, 2007 and 2006.
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)
|
|
2010
|
|
2009
|
|
2008
|
|
2007
|
|
2006
|
|
Statements of Income Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net sales
(1)
|
|
$
|
3,917.2
|
|
$
|
3,879.3
|
|
$
|
3,629.5
|
|
$
|
3,436.2
|
|
$
|
2,688.5
|
|
Gross profit
(2)
|
|
|
1,514.4
|
|
|
1,456.4
|
|
|
1,342.7
|
|
|
1,195.7
|
|
|
974.9
|
|
Income from operations
(1)
|
|
|
519.2
|
|
|
502.9
|
|
|
517.8
|
|
|
302.6
|
|
|
339.6
|
|
Income before income taxes
|
|
|
391.5
|
|
|
384.8
|
|
|
407.5
|
|
|
187.8
|
|
|
324.7
|
|
Net income
|
|
$
|
357.2
|
|
$
|
403.9
|
|
$
|
320.9
|
|
$
|
136.8
|
|
$
|
237.7
|
|
Earnings per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
2.15
|
|
$
|
2.51
|
|
$
|
2.02
|
|
$
|
0.87
|
|
$
|
1.51
|
|
|
Diluted
|
|
$
|
2.11
|
|
$
|
2.47
|
|
$
|
1.99
|
|
$
|
0.85
|
|
$
|
1.48
|
|
Weighted average common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
166.0
|
|
|
161.0
|
|
|
159.2
|
|
|
156.9
|
|
|
157.4
|
|
|
Diluted
|
|
|
169.5
|
|
|
163.2
|
|
|
161.3
|
|
|
160.2
|
|
|
160.4
|
|
-
(1)
-
As
Mayne Pharma was acquired in February 2007, there are no Mayne Pharma net sales in 2006. 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)
|
|
2010
|
|
2009
|
|
2008
|
|
2007
|
|
2006
|
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
6,046.3
|
|
$
|
5,502.9
|
|
$
|
5,074.1
|
|
$
|
5,084.7
|
|
$
|
2,847.6
|
|
Long-term debt
|
|
$
|
1,714.4
|
|
$
|
1,707.3
|
|
$
|
1,834.0
|
|
$
|
2,184.4
|
|
$
|
702.0
|
|
32
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 products. Hospira's portfolio of products is used by hospitals and alternate site providers, such as clinics, home healthcare providers and long-term care facilities.
Acquisitions
In July 2010, Hospira completed the acquisition of Javelin Pharmaceuticals, Inc. ("Javelin Pharma") for a purchase price of
$161.9 million. The purchase price was comprised of $145.2 million, in cash, paid on July 2, 2010 for the outstanding shares of Javelin Pharma and additional consideration
provided to Javelin Pharma of $16.7 million in the quarter ended June 30, 2010 in connection with various pre-close operating costs and other liabilities incurred by Javelin
Pharma. The acquisition will enable Hospira to take advantage of synergies between Hospira's Precedex
TM
and Javelin Pharma's main product candidate, Dyloject
TM
, a
post-operative pain management drug currently awaiting U.S. Food and Drug Administration ("FDA") approval. In October 2010, Hospira received a complete response letter from the FDA
regarding Dyloject
TM
and Hospira is working to respond to the letter. Hospira and its third party manufacturer continue to work closely with FDA to address any items raised as part of
the regulatory process and timing of resolution is uncertain. The future impact of Dyloject
TM
on Hospira depends on the various product development and commercialization efforts, and the
timing of resolution of the regulatory process in connection therewith.
In March 2010, Hospira completed its acquisition of the generic injectable pharmaceutical business of Orchid Chemicals &
Pharmaceuticals Ltd. ("Orchid Pharma") for $381.0 million which was purchased by and operates under the name Hospira Healthcare India Private Limited ("Hospira India"), a wholly owned
subsidiary of Hospira. The acquisition included a beta-lactam antibiotic formulations manufacturing complex and pharmaceutical research and development facility, as well as a generic
injectable dosage-form product portfolio and pipeline. Hospira also acquired some of Orchid Pharma's long-term land leases in India, which were held by Orchid Pharma for their
anticipated future expansion.
Acquisition
related pre-tax charges were recognized, the majority of which was in Selling, general and administrative, during the year ended December 31, 2010 of
approximately $20.2 million related to the Javelin Pharma and Hospira India acquisitions. The impact of these acquisitions was not material to Hospira's results of operations for the year ended
December 31, 2010,
exclusive of the acquisition related charges. For further details, see Note 2 to the consolidated financial statements included in Item 8.
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 Part I, "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."
33
Table of Contents
Governmental Regulation
Hospira's operations and business activities are subject to extensive legal and regulatory requirements. The enactment of the "Patient
Protection and Affordable Care Act" on March 23, 2010 and the "Health Care and Education Affordability Reconciliation Act of 2010" on March 30, 2010 (collectively the "Acts") is expected
to affect Hospira's business. The Acts increase access to healthcare and establish a United States ("U.S.") pathway for biosimilars. Hospira does not expect a material impact to our business from the
proprietary pharmaceutical fee or the closure of the "doughnut hole" components of the Acts. The medical device excise tax will not impact Hospira until 2013. As enacted, Hospira expects the medical
device excise tax to have an overall, after-tax impact of approximately $0.10 per share annually. The Acts eliminated the future tax deduction for prescription drug costs associated with
Hospira's post-retirement medical and dental plans for which Hospira receives Medicare Part D subsidies. The impact to Hospira was not material. Hospira will continue to evaluate
any change to our post-retirement liabilities if new interpretations or final regulations are published.
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, exit costs and gain on disposal of
assets. For further details regarding the financial impact of these cost-reduction activities, see Note 3 to the consolidated financial statements included in Item 8.
2009 Actions.
In March 2009, Hospira announced details of Project Fuel which has been ongoing over the last two years. Project Fuel has
included 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 now approximately $60 million to $70 million are expected to be reported
as restructuring costs and other asset charges. The range for restructuring costs and other asset charges was reduced from the originally announced range of $100 million to $110 million,
primarily related to reduced inventory write-offs and a decrease in employee-benefit costs. These decreases are off-set by an expected increase in process optimization costs
resulting in no change to the aggregate charges related to Project Fuel. During 2010 and 2009, Hospira incurred charges of $39.2 million and $83.7 million with $12.9 million and
$50.6 million reported as restructuring and other asset charges, respectively.
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, non-cash, pre-tax impairment charges of $52.8 million were recognized in Restructuring, impairment and (gain) on
disposition of assets, net 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 February 2010, Hospira completed the disposal of a facility in Wasserburg, Germany for $69.3 million, which primarily performed contract manufacturing in the EMEA
segment. This was comprised of cash proceeds of $62.6 million and an additional $6.7 million due in twelve months from the close of the transaction. Hospira recognized a gain of
$11.4 million included in Restructuring, impairment and (gain) on disposition of assets, net.
As
Hospira continues to consider each cost reduction and optimization initiative, the amount, timing and recognition of charges will be affected by the occurrence of commitments and
triggering
34
Table of Contents
events
as defined under accounting principles generally accepted in the United States ("GAAP"), among other factors.
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 from the date of announcement. During 2010, 2009 and 2008, Hospira incurred charges of $16.9 million, $15.7 million and $8.8 million, respectively. Hospira now expects
to incur aggregate charges through 2011 related to this action in the range of $42 million to $45 million on a pre-tax basis, of which approximately $28 million to
$30 million are expected to be reported as restructuring charges. The range for this action was increased from the originally announced range of $29 million to $35 million,
primarily related to an increase in accelerated depreciation on the facility due to the deterioration in real estate market value. Hospira has completed the process of transferring related operations
and production of products to other Hospira facilities or outsourcing certain product components to third-party suppliers.
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 and 2008, Hospira incurred charges of $12.7 million and $26.6 million, respectively.
Restructuring,
impairment, optimization costs and gain on disposition of assets incurred for Project Fuel and Facilities Optimization collectively were reported in the consolidated
statements of income line items included in Item 8 as follows:
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31 (dollars in millions)
|
|
2010
|
|
2009
|
|
2008
|
|
Cost of products sold
|
|
$
|
26.4
|
|
$
|
40.7
|
|
$
|
12.4
|
|
Restructuring, impairment, and (gain) on diposition of assets, net
|
|
|
7.0
|
|
|
94.2
|
|
|
22.4
|
|
Research and development
|
|
|
0.1
|
|
|
3.3
|
|
|
0.6
|
|
Selling, general and administrative
|
|
|
11.2
|
|
|
26.7
|
|
|
|
|
|
|
|
|
|
|
|
|
Total pre-tax Project Fuel and Facilities Optimization
|
|
$
|
44.7
|
|
$
|
164.9
|
|
$
|
35.4
|
|
|
|
|
|
|
|
|
|
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 "Part 1, 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."
Certain Quality and Product Related Matters
Warning Letter (August 2009)
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. Hospira had recognized charges in 2009 in Cost of products sold for quality assessment and testing, materials, labor and freight to remediate this
matter, which were not significant to date to Hospira. The recall was limited to device power cords with a certain prong design that could crack and fail at/or inside the plug. In October 2010, the
FDA notified Hospira that it appeared that Hospira had addressed the warning letter deficiencies and that future FDA inspections would further assess the adequacy and sustainability of these
corrections. In December 2010, the FDA notified Hospira that the AC power cord recall activities were completed and the FDA considered the recall terminated. Nothing
35
Table of Contents
in
either the October or December 2010 letters precludes any future regulatory action by the FDA should violations be observed in subsequent inspections, and these letters do not relieve Hospira from
the responsibility to assure compliance with the Food, Drug and Cosmetic Act in the future.
Warning Letter (April 2010)
In April 2010, Hospira received a Warning Letter from the FDA in connection with the FDA's inspection of Hospira's pharmaceutical and
device manufacturing facilities located in Rocky Mount, North Carolina and Clayton, North Carolina. In the Warning Letter, the FDA cites Current Good Manufacturing Practice deficiencies related to
particulate in certain emulsion products at the Clayton facility and the failure to adequately validate the processes used to manufacture products at the Rocky Mount facility. The Warning Letter also
asserts other inadequacies, including procedures related to the Quality Control unit, investigations, and medical reporting obligations. The Warning Letter asserts that some of the deficiencies were
repeat observations from a prior inspection conducted in April 2009, and include a similar violation cited in the August 2009 Warning Letter related to the AC power cords. The FDA did not believe that
Hospira had identified the root cause(s) of the problems and had adequately resolved them. The Warning Letter also
questioned whether Hospira's interim plans ensured the quality of products that were manufactured at the facilities while implementing the corrective actions and validation activities. Hospira has
made significant progress on completing a comprehensive review of its manufacturing operations to ensure compliance with applicable regulations.
Hospira
has responded to the April 2010 Warning Letter and is working closely with the FDA to conclude these matters. As part of Hospira's response, Hospira took immediate actions to
address the FDA's concerns, including recalling the propofol and liposyn products manufactured at the Clayton facility and the fosphenytoin sodium injection products manufactured at the Rocky Mount
facility. Hospira is also working with several third party experts to assist with the ongoing activities at both facilities. Hospira has implemented certain interim controls, including third party
oversight, to ensure products manufactured at both facilities meet their specifications prior to release. The Warning Letter does not restrict production or shipment of Hospira's products from these
facilities but Hospira is holding shipment of certain products pending its further investigation and discussions with the FDA. Hospira resumed shipment of certain products placed on voluntary shipping
hold, but cannot predict when all products on voluntary hold will be reintroduced to the market.
During
2010, Hospira recognized pre-tax charges, in Cost of products sold, of $54.3 million for third party oversight and consulting, idle facility costs and penalties
for failure to supply product to certain customers under various contracts, all directly associated with Hospira's response to the FDA's Warning Letter received in April 2010. These costs include
activities associated with the matters cited above for the Rocky Mount and Clayton facilities as well as Hospira's assessment of the status of its quality operations on a holistic basis throughout its
global manufacturing facilities.
Symbiq
TM
Pumps
In April 2010, Hospira placed a voluntary hold on all shipments to new customers of Symbiq
TM
, a large volume infusion
device. Hospira initiated this hold after it received an unexplained increase in customer complaints related to the failure of the Symbiq
TM
to alarm at the end of infusion therapy under
certain use conditions. In June 2010, Hospira notified customers on interim steps to be taken by customers to mitigate this issue and to avoid the use conditions that can lead to the failure of the
Symbiq
TM
to alarm at the end of infusion therapy. In August 2010, Hospira initiated a set recall related to the issue. Additionally, Hospira notified customers of reports of unrestricted
flow when the Symbiq
TM
infusion set cassette is improperly removed from the pump before the pump's cassette door is fully opened. Hospira cautioned customers to allow the pump's cassette
door to fully open before removing the infusion set as the pump may not alarm when the infusion set is improperly removed. The FDA has classified each of these actions as a Class I recall and
Hospira is working closely with the
36
Table of Contents
FDA
to conclude these matters. Hospira has not asked customers to return or cease using their Symbiq
TM
pumps. Hospira has recognized charges in Cost of products sold for quality
assessment and testing, materials, and labor to remediate these matters, which have not been significant to date to Hospira.
Additionally,
Hospira is working to address the failure to alarm issue with a software upgrade package. The software upgrade package submission will be one of the first to follow the
guidelines of the new 510K process of the FDA, thus approval timing remains uncertain. New pump placements for Symbiq
TM
will remain on voluntary hold until we receive FDA approval of our
510K submission. Further, costs for long-term solutions and product improvements will depend on various product development efforts and corresponding regulatory outcomes in connection
therewith.
Plum
TM
Pumps
In December 2010, Hospira informed the FDA that we had received a small number of customer reports associated with the
Plum
TM
pumps regarding failure of the pump's audible alarm under certain conditions. Hospira has provided notice to customers notifying them of the corrective action plan. For the Plum
A+
TM
pumps, the alarm failures are associated with the alarm assembly which will need to be replaced. For the Plum XL
TM
pumps, the alarm failure is associated with fluid
ingress and physical damage to the alarm assembly over time. Plum XL
TM
customers are being asked to follow the proper cleaning procedure and inspect the alarm assembly for physical
damage during routine maintenance. This action is classified as a field recall and FDA is not requiring Hospira to remove Plum
TM
pumps from the market or halt production. Hospira will
service the pumps in the field,
for which Hospira recognized a charge of $25.0 million for the estimate of the field recall as of December 31, 2010.
Regulatory Environment and Related Impact
These quality matters have impacted, and may impact further, Hospira's ability to market and sell certain products including Hospira's
pumps and certain emulsion products primarily in the Americas segment. Additionally, these quality matters have resulted in, and may further result in, higher customer backlog orders and penalties for
failure to supply products, which historically have not been material.
The
FDA's Warning Letters are publicly available on the FDA's website. Hospira takes all of these matters seriously and responds fully, and in a timely manner, to the FDA's Warning
Letters. Hospira cannot, however, give any assurances as to the expected date of resolution of the matters related to pumps or the matters included in the Warning Letters. 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. Until the violations and other product matters are corrected, Hospira may be subject to additional regulatory actions by the FDA, including the withholding of approval of new drug
applications, product seizure, injunction, and/or civil monetary penalties. Changes in and stricter enforcement of the laws and regulations impacting Hospira's industry may result in changes to
customer buying patterns, increased investment in quality systems and personnel and additional on-market remediation activities being classified as recalls, including improvement related
activities that are deemed by the FDA to reduce the risk to health posed by the products. Any such additional FDA actions, or further adverse developments related to pumps, could significantly disrupt
our ongoing business and operations and have a material adverse impact on our financial position and operating results. There can be no assurance that the FDA or customers will be satisfied with
Hospira's response and corrective actions.
37
Table of Contents
Patent Related Product Matters
Hospira is involved in patent-related disputes with companies with branded products over our attempts to market generic pharmaceutical
products. In April 2010, Hospira reached an agreement to settle the U.S. litigation related to oxaliplatin. Pursuant to the settlement, Hospira exited the U.S. market with its oxaliplatin products on
June 30, 2010 and is expected to re-launch its products pursuant to a royalty-free license on August 9, 2012.
Hospira
is currently awaiting final approvals for an oncolytic drug docetaxel (a generic version of Sanofi-Aventis's Taxotere®) in the U.S. that is the subject of ongoing
patent litigation. Once Hospira has final approval for its generic pharmaceuticals in the U.S., we may decide to commercially market these products while the ultimate disposition of legal proceedings
has not concluded. Additionally, Hospira received final approval in the U.S. and launched in November 2010 a 2 gram freeze dried powder presentation of gemcitabine (a generic version of Eli Lilly's
Gemzar®), that is subject to ongoing patent litigation. If Hospira's products are ultimately found to infringe the patent rights of another company, Hospira may be subject to significant
damages, which may be based on the lost profits from the sale of the branded product and/or an injunction preventing Hospira from further sales.
Results of Operations
Net Sales
A comparison of product line net sales is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage
Change at
Actual
Currency Rates
|
|
Percentage
Change at
Constant
Currency Rates
(1)
|
|
Years Ended December 31
(dollars in millions)
|
|
2010
|
|
2009
|
|
2008
|
|
2010
|
|
2009
|
|
2010
|
|
2009
|
|
Americas
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Injectable Pharmaceuticals
|
|
$
|
1,829.0
|
|
$
|
1,589.9
|
|
$
|
1,328.9
|
|
|
15.0
|
%
|
|
19.6
|
%
|
|
14.0
|
%
|
|
20.3
|
%
|
|
Medication Management
|
|
|
827.5
|
|
|
917.0
|
|
|
927.4
|
|
|
(9.8
|
)%
|
|
(1.1
|
)%
|
|
(10.8
|
)%
|
|
(0.2
|
)%
|
|
Other Pharma
|
|
|
481.4
|
|
|
556.4
|
|
|
522.0
|
|
|
(13.5
|
)%
|
|
6.6
|
%
|
|
(13.7
|
)%
|
|
7.8
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Americas
|
|
|
3,137.9
|
|
|
3,063.3
|
|
|
2,778.3
|
|
|
2.4
|
%
|
|
10.3
|
%
|
|
1.5
|
%
|
|
11.1
|
%
|
Europe, Middle East & Africa ("EMEA")
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Injectable Pharmaceuticals
|
|
|
283.2
|
|
|
272.0
|
|
|
287.4
|
|
|
4.1
|
%
|
|
(5.4
|
)%
|
|
7.6
|
%
|
|
2.1
|
%
|
|
Medication Management
|
|
|
126.6
|
|
|
142.4
|
|
|
144.3
|
|
|
(11.1
|
)%
|
|
(1.3
|
)%
|
|
(7.0
|
)%
|
|
4.9
|
%
|
|
Other Pharma
|
|
|
78.7
|
|
|
128.4
|
|
|
152.1
|
|
|
(38.7
|
)%
|
|
(15.6
|
)%
|
|
(37.0
|
)%
|
|
(8.8
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total EMEA
|
|
|
488.5
|
|
|
542.8
|
|
|
583.8
|
|
|
(10.0
|
)%
|
|
(7.0
|
)%
|
|
(6.8
|
)%
|
|
(0.1
|
)%
|
Asia Pacific ("APAC")
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty Injectable Pharmaceuticals
|
|
|
237.3
|
|
|
211.4
|
|
|
205.4
|
|
|
12.3
|
%
|
|
2.9
|
%
|
|
0.7
|
%
|
|
7.2
|
%
|
|
Medication Management
|
|
|
45.0
|
|
|
45.4
|
|
|
46.8
|
|
|
(0.9
|
)%
|
|
(3.0
|
)%
|
|
(9.0
|
)%
|
|
(0.4
|
)%
|
|
Other Pharma
|
|
|
8.5
|
|
|
16.4
|
|
|
15.2
|
|
|
(48.2
|
)%
|
|
7.9
|
%
|
|
(54.9
|
)%
|
|
17.8
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total APAC
|
|
|
290.8
|
|
|
273.2
|
|
|
267.4
|
|
|
6.4
|
%
|
|
2.2
|
%
|
|
(4.3
|
)%
|
|
6.5
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Sales
|
|
$
|
3,917.2
|
|
$
|
3,879.3
|
|
$
|
3,629.5
|
|
|
1.0
|
%
|
|
6.9
|
%
|
|
|
%
|
|
9.0
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
-
Specialty
Injectable Pharmaceuticals include generic injectables and proprietary specialty injectables. As part of Project Fuel, Hospira
disposed of the non-strategic critical care business, during 2009. As a result, the former Other Devices product line is now included in a single device product line, Medication
Management. Medication Management includes infusion pumps, related
38
Table of Contents
software
and services, dedicated administration sets, gravity administration sets, critical care products (through August 2009) and other device products. Other Pharma includes large volume I.V.
solutions, nutritionals and contract manufacturing services.
-
(1)
-
The
comparisons at constant currency rates reflect comparative local currency balances at prior years' 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.
2010
compared to 2009:
Net
sales increased 1.0%, or were flat compared to 2009 excluding the impact of changes in foreign exchange rates.
Net
sales were impacted by various disposals of non-strategic businesses and underlying assets. These disposals were part of Hospira's commitment to dispose of certain
non-strategic businesses and underlying assets as part of Project Fuel and affected the Other Pharma and Medication Management product lines. Other Pharma net sales in all segments
decreased due to the disposal of the contract manufacturing facilities in Salisbury, Australia in October
2009 and Wasserburg, Germany in February 2010. Medication Management net sales in all segments decreased 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 2.4%, or 1.5% excluding the impact of changes in foreign exchange rates. Net sales of Specialty Injectable Pharmaceuticals ("SIP") increased
primarily due to increased volume for Precedex
TM
, the launch of generic meropenem and gemcitabine and high-dose heparin introduced in late 2009. The increase was partially
offset by a decrease in volume due to a voluntary hold on shipments of certain emulsion products. Other Pharma net sales decreased primarily due to the dispositions noted above and lower volumes in
nutritional products. Net sales in Medication Management were lower driven by decreased volumes related to the voluntary hold on shipments of Symbiq
TM
to new customers, decreased sales
of Plum
TM
and the disposal of the critical care business, partly offset by increased sales of dedicated administration sets.
Net
sales in the EMEA segment decreased (10.0)%, or (6.8)% excluding the impact of changes in foreign exchange rates. SIP net sales increased with the introduction of generic docetaxel
in a number of European countries during 2010, as well as other oncology product introductions, and continued growth of a biosimilar product, Retacrit
TM
. The increase was partially
offset by a decrease in volume and prices for certain oncology products. Other Pharma net sales decreased primarily due to the dispositions noted above. Medication Management net sales decreased due
to the disposal of the critical care business and lower volumes of large volume infusion and ambulatory systems partly offset by increased sales in dedicated administration sets.
39
Table of Contents
Net
sales in the APAC segment increased 6.4%, but decreased (4.3)% excluding the impact of changes in foreign exchange rates. SIP net sales slightly increased due to higher volumes in
Hospira's proprietary sedation drug, Precedex
TM
, offset by decreased volume in anti-infective
products and decreased prices in oncology products. Other Pharma net sales decreased primarily due to the dispositions noted above. Medication Management net sales decreased due to the disposal of the
critical care business, partly offset by higher volumes in dedicated administration sets.
2009
compared to 2008:
Net
sales increased 6.9%, or 9.0% excluding the impact of changes in foreign exchange rates. 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 SIP increased primarily due to the product launch of
generic oxaliplatin in the U.S. In addition, SIP 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 Group Purchasing Organization ("GPO") contract awards. Net sales in Medication Management were essentially flat with increased volumes
in ambulatory and large volume infusion systems, primarily Plum A+
TM
, and dedicated administration sets, offset by the impact of the disposal of the non-strategic critical
care business.
Net
sales in the EMEA segment decreased (7.0)%, or (0.1)% excluding the impact of changes in foreign exchange rates. SIP net sales were slightly higher with increases from new product
introductions, including Retacrit
TM
, 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 increased due to higher sales volume of large volume infusion
systems, primarily Plum A+
TM
and GemStar
TM
, and dedicated administration sets, offset by the impact of the disposal of the non-strategic critical care business.
Net
sales in the APAC segment increased 2.2%, or 6.5% excluding the impact of changes in foreign exchange rates. SIP 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 other proprietary
and differentiated product sales in Australia. Net sales in Medication Management were essentially flat due to higher sales volume of ambulatory infusion systems and dedicated administration sets,
offset by the impact of the disposal of the non-strategic critical care business.
Gross Profit (Net sales less Cost of products sold)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percent
change
|
|
Years ended December 31 (dollars in millions)
|
|
2010
|
|
2009
|
|
2008
|
|
2010
|
|
2009
|
|
|
|
Gross profit
|
|
$
|
1,514.4
|
|
$
|
1,456.4
|
|
$
|
1,342.7
|
|
|
4.0
|
%
|
|
8.5
|
%
|
As a percent of net sales
|
|
|
38.7
|
%
|
|
37.5
|
%
|
|
37.0
|
%
|
|
|
|
|
|
|
|
|
40
Table of Contents
2010
compared to 2009:
Gross
profit increased $58.0 million, or 4.0%, in 2010, compared to 2009.
The
gross profit increase was the result of higher sales volume primarily driven by growth in Precedex
TM
and new product launches. In addition, cost reductions associated
with Project Fuel initiatives and the
impact of changes in foreign exchange rates contributed to the increase. These were partly offset by activities and related charges directly associated with the 2010 Warning Letter received from the
FDA and voluntary shipment holds on certain products as well as penalties for failure to supply customers and increased product correction charges on these and other products.
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.
Restructuring, impairment and (gain) on disposition of assets, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percent
change
|
|
Years ended December 31 (dollars in millions)
|
|
2010
|
|
2009
|
|
2008
|
|
2010
|
|
2009
|
|
|
|
Restructuring, impairment and (gain) on disposition of assets, net
|
|
$
|
19.7
|
|
$
|
94.2
|
|
$
|
22.4
|
|
|
(79.1
|
)%
|
|
320.5
|
%
|
As a percent of net sales
|
|
|
0.5
|
%
|
|
2.4
|
%
|
|
0.6
|
%
|
|
|
|
|
|
|
|
|
2010
compared to 2009:
Restructuring,
impairment and (gain) on disposition of assets, net were $19.7 million in 2010, compared with $94.2 million in 2009. In February 2010, Hospira completed the
disposal of a facility in Wasserburg, Germany, and recognized a gain of $11.4 million. Excluding the gain on the disposal of Wasserburg, restructuring charges were $18.4 million in 2010.
In addition, Hospira incurred a charge of $12.7 million in 2010 for the impairment of an anti-infective product right intangible asset. In 2009, Hospira incurred higher impairment
charges due to Hospira's commitment to dispose of certain non-strategic businesses and underlying assets. In addition, restructuring charges, primarily severance costs, were higher in 2009
related to Project Fuel and Facilities Optimization.
2009
compared to 2008:
Restructuring,
impairment and (gain) on disposition of assets, net 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.
41
Table of Contents
Research and Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percent
change
|
|
Years ended December 31 (dollars in millions)
|
|
2010
|
|
2009
|
|
2008
|
|
2010
|
|
2009
|
|
|
|
Research and development
|
|
$
|
300.5
|
|
$
|
240.5
|
|
$
|
212.4
|
|
|
24.9
|
%
|
|
13.2
|
%
|
As a percent of net sales
|
|
|
7.7
|
%
|
|
6.2
|
%
|
|
5.9
|
%
|
|
|
|
|
|
|
|
|
2010
compared to 2009:
Research
and development ("R&D") expenses increased $60.0 million, or 24.9%, in 2010, compared to 2009. The increase was primarily related to initial milestone payments for
collaborative agreements for research and development of $27.5 million for an anesthetic product and $21.3 million for a hematology product, that have not yet reached regulatory
approval. In addition, investments in various new product development programs, including biosimilars and clinical trials, contributed to the increase.
2009
compared to 2008:
R&D
expenses increased $28.1 million, or 13.2%, in 2009, compared to 2008. The increase was primarily related to investments in various new product development programs, including
biosimilars,
and charges of $16.0 million 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.
Selling, General and Administrative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percent
change
|
|
Years ended December 31 (dollars in millions)
|
|
2010
|
|
2009
|
|
2008
|
|
2010
|
|
2009
|
|
|
|
Selling, general and administrative
|
|
$
|
675.0
|
|
$
|
618.8
|
|
$
|
590.1
|
|
|
9.1
|
%
|
|
4.9
|
%
|
As a percent of net sales
|
|
|
17.2
|
%
|
|
16.0
|
%
|
|
16.3
|
%
|
|
|
|
|
|
|
|
|
2010
compared to 2009:
Selling,
general and administrative ("SG&A") expenses increased $56.2 million, or 9.1%, in 2010, compared to 2009. The increase was primarily due to acquisition and integration
charges associated with the Orchid Pharma and Javelin Pharma acquisitions, higher legal costs, and the RTI litigation settlement and related charges. Higher costs associated with certain sales and
promotional expenses, also contributed to the increase, offset by decreased annual incentive compensation provisions.
2009
compared to 2008:
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.
Interest Expense
Hospira incurred interest expense of $101.1 million in 2010, $106.3 million in 2009 and $116.2 million in 2008.
The decreases in 2010 compared to 2009 and 2009 compared to 2008 were primarily due to lower average outstanding debt and the impact of variable interest rate swaps on fixed rate notes. Refer to the
Liquidity and Capital Resources section below, as well as Note 16 to the
42
Table of Contents
consolidated
financial statements included in Item 8, for further information regarding Hospira's debt and credit facilities.
Other Expense (Income), Net
Other expense (income), net was $26.6 million in 2010, $11.8 million in 2009 and $(5.9) million in 2008. Other expense
(income), net primarily includes amounts relating to foreign currency transaction gains and losses, interest income, equity (income) loss and other items. The increase in 2010 from 2009 was primarily
due to the $36.8 million charge incurred for the early extinguishment of 5.55% notes due in 2012 and $8.8 million of impairment charges for certain cost-method investments.
The increase of expense in 2009 from 2008 was primarily due to an other-than-temporary impairment charge of $16.6 million. Interest (income) for 2010, 2009 and 2008 was
$(9.9) million, $(7.6) million and $(9.3) million, respectively.
Income Tax Expense (Benefit)
The effective tax rate was an expense of 8.8% in 2010, compared to a benefit of (5.0)% in 2009 and an expense of 21.3% in 2008. In
2010, a favorable mix of income in lower tax jurisdictions and substantial increase of expenditures in higher tax jurisdictions resulted in a lower effective tax rate. 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 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. as well as lower statutory tax rates in substantially all non-U.S. jurisdictions in which Hospira operates.
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.
On December 17, 2010, U.S. tax legislation was enacted that provided an extension for the 2010 and 2011 tax years of certain expired business tax provisions affecting Hospira which generated a
favorable impact in our fourth quarter and full year 2010 U.S. tax expense of $28.0 million.
Liquidity and Capital Resources
Net cash provided by operating activities continues to be Hospira's primary source of funds to finance operating needs, certain
acquisitions, 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.
Further,
Hospira has reviewed its needs in the U.S. for possible repatriation of foreign subsidiary earnings, and continues to indefinitely invest all earnings outside of the U.S. of all
foreign subsidiaries to fund foreign investments or meet foreign working capital and plant, property and equipment acquisition needs. Future changes in U.S. tax legislation may require Hospira to
reevaluate the need for possible repatriation of foreign subsidiary earnings.
Hospira
has incurred and may incur further charges related to certain quality and product related matters that will require cash outflows in the future. These matters are further
discussed under the
43
Table of Contents
section
"Certain Quality and Product Related Matters" in Item 7. Hospira currently believes current capital resources will be sufficient to fund development costs and charges associated
therewith.
Summary
of Sources and (Uses) of Cash
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31 (dollars in millions)
|
|
2010
|
|
2009
|
|
2008
|
|
|
|
Operating activities
|
|
$
|
314.9
|
|
$
|
944.9
|
|
$
|
584.1
|
|
Investing activities
|
|
|
(705.4
|
)
|
|
(211.1
|
)
|
|
(264.9
|
)
|
Financing activities
|
|
|
35.1
|
|
|
(308.6
|
)
|
|
(60.1
|
)
|
|
|
Operating Activities
In 2010, Net Cash Provided by Operating Activities was $314.9 million. The decrease from 2009 is primarily due to the timing of
payments of chargebacks and rebates related to 2009 sales of oxaliplatin, increased inventory associated with new product launches and strategic opportunities, and higher income tax payments.
Additionally, quality initiatives and employee related payments contributed to the decrease, partially offset by higher trade payables in 2010. Hospira also made a discretionary contribution of
$92.0 million to the Hospira Annuity Retirement Plan, the frozen U.S. pension plan, resulting in fully funded status under regulatory guidelines.
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
discretionary 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, 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.
Investing Activities
In 2010, Net Cash Used in Investing Activities of $705.4 million, an increase from 2009 primarily due to payments of
$540.8 million for acquisitions, in addition to higher capital expenditures. Hospira received proceeds of $62.6 million on the disposal of a facility in Wasserburg, Germany in 2010.
In
2009, Net Cash Used in Investing Activities of $211.1 million included 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 included 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.
Financing Activities
Net Cash Provided by Financing Activities totaled $35.1 million in 2010, an increase from 2009 primarily due to proceeds
received from stock options exercised including the related excess tax benefit
44
Table of Contents
of
$174.6 million, partially offset by payments of $100.0 million related to the repurchase of common stock and $36.8 million for the early extinguishment of 5.55% notes due in
2012.
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.
Summary of Financial Position
|
|
|
|
|
|
|
|
Years ended December 31 (dollars in millions)
|
|
2010
|
|
2009
|
|
|
|
Cash and cash equivalents
|
|
$
|
604.3
|
|
$
|
946.0
|
|
Working capital
|
|
|
1,545.9
|
|
|
1,644.3
|
|
Short-term borrowings and long-term debt
|
|
|
1,747.9
|
|
|
1,730.9
|
|
|
|
Working Capital
The decrease in working capital in 2010 was primarily due to decrease in cash and cash equivalents and an increase in trade account
payables, offset by a decrease in chargeback and rebate liabilities associated with generic oxaliplatin due to timing of 2009 claim submissions from wholesalers and the temporary exit from the U.S.
market mid-year 2010 pursuant to the litigation settlement. Higher inventory in 2010 was due to inventory build for new product launches and future strategic opportunities. Assets held for
sale, net also decreased working capital in 2010 related to Hospira's disposal of a facility in Wasserburg, Germany in 2010.
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 sale, 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.
Debt and Capital
Senior Notes.
Hospira has $1,700.0 million aggregate principal amount of senior unsecured notes outstanding, including
$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, $550.0 million principal amount of 6.05% notes due in March 2017, and
$500.0 million principal amount of 5.60% notes due in September 2040.
In
September 2010, Hospira issued in a registered public offering $500.0 million principal amount of 5.60% notes due on September 15, 2040 in a registered public offering.
The net proceeds of the notes, after deducting approximately $2.6 million of bond discounts and underwriting fees of $4.4 million, plus cash on-hand were used to extinguish
$500.0 million principal amount of 5.55% notes originally due March 2012 and accrued interest in October 2010. Hospira incurred $36.8 million in charges associated with the early
extinguishment of the notes. In December 2009, the $375.0 million aggregate principal amount due in March 2010 plus accrued interest was fully paid. In June 2009, Hospira repaid in full the
$300.0 million aggregate principal amount of 4.95% notes upon maturity.
45
Table of Contents
In
December 2010, Hospira entered into interest rate swaps contracts whereby $250.0 million of the $400.0 million principal amount of 5.90% note due in June 2014 and
$150.0 million of the $250.0 million principal amount of 6.40% note due in May 2015 were effectively converted from fixed to floating rate debt. In addition, in June 2010, Hospira
terminated interest rate swap contracts originally entered into in 2009 with a total notional amount of $300.0 million, which had effectively converted from fixed to variable rate debt
$200.0 million of the $400.0 million principal amount notes due in June 2014 and $100.0 million of the $250.0 million principal amount notes due in May 2015. As a result of
the swap terminations, Hospira received $15.4 million in cash, including accrued interest. The corresponding gains related to the basis adjustment of the debt associated with the terminated
swap contracts is deferred and amortized as a reduction of interest expense over the remaining term of the related notes. The cash flows from these contracts are reported as operating activities in
the Consolidated Statements of Cash Flows. There were no penalties associated with the termination of the interest rate swap agreements.
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. Additionally, Hospira enters into uncommitted lines of credits in certain international
countries, available for general entity purposes in their respective countries that are subject to banks' approval. These borrowings bore a weighted average interest rate of approximately 8.3% in
2010, with principal and interest due in various intervals, and are primarily unsecured. As of December 31, 2010 and 2009, Hospira had $33.5 million and $26.5 million,
respectively, of other borrowings outstanding, of which $29.0 million and $22.6 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 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, 2010, 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 EBITDA to consolidated financing expense) of not less than 5.0 to 1.0. As of December 31,
2010, Hospira was in compliance with all applicable covenants.
46
Table of Contents
Short-Term Borrowings.
Hospira entered into short-term borrowings including the Revolver and current portion of Other
borrowings as described above. The following table is a summary of additional information related to Hospira's short-term borrowings:
|
|
|
|
|
|
|
|
(dollars in millions)
|
|
Revolver
(1)
|
|
Other
Borrowings
|
|
|
|
Year ended December 31, 2010,
|
|
|
|
|
|
|
|
Outstanding balance at year-end
|
|
$
|
|
|
$
|
29.0
|
|
Weighted average interest rate at year-end
|
|
|
|
|
|
10.9
|
%
|
Average monthly balance during the year-end
|
|
$
|
|
|
$
|
25.7
|
|
Weighted average interest rate during the year-end
|
|
|
|
|
|
8.3
|
%
|
Maximum month-end balance during the year-end
|
|
$
|
|
|
$
|
38.6
|
|
Three months ended December 31, 2010,
|
|
|
|
|
|
|
|
Outstanding balance at period end
|
|
$
|
|
|
$
|
29.0
|
|
Weighted average interest rate at period end
|
|
|
|
|
|
10.9
|
%
|
Average monthly balance during the period end
|
|
$
|
|
|
$
|
35.3
|
|
Weighted average interest rate during the period end
|
|
|
|
|
|
8.7
|
%
|
Maximum month-end balance during the period end
|
|
$
|
|
|
$
|
38.6
|
|
|
|
-
(1)
-
During
the year ended and three months ended December 31, 2010, Hospira has not borrowed any amounts under the Revolver.
Share Repurchase.
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. As of December 31, 2010, Hospira has repurchased 9.2 million shares for approximately
$400.0 million in the aggregate under the 2006 board authorization. In August 2010, Hospira entered into an accelerated share repurchase ("ASR") contract with a third party financial
institution to repurchase $50.0 million of Hospira's common stock. Under the ASR, Hospira received 0.9 million shares. In December 2010, Hospira entered into a second ASR contract with a
third party financial institution to repurchase $50.0 million of Hospira's common stock. Under the second ASR, Hospira received 0.7 million shares based on seventy-five
percent of the $50.0 million repurchased on the trade date, with the remaining shares to be delivered over the next three months subject to adjustment based on the average stock price during
the period. The second ASR was completed and Hospira received an incremental 0.2 million shares on February 7, 2011.
Contractual Obligations and Off-Balance Sheet Arrangements
The following table summarizes Hospira's estimated contractual obligations as of December 31, 2010:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment Due by Period
|
|
(dollars in millions)
|
|
Total
|
|
2011
|
|
2012-2013
|
|
2014-2015
|
|
2016 and
Thereafter
|
|
Debt and interest payments
|
|
$
|
2,951.6
|
|
$
|
130.3
|
|
$
|
204.8
|
|
$
|
822.3
|
|
$
|
1,794.2
|
|
Lease obligations
|
|
|
154.7
|
|
|
34.3
|
|
|
54.7
|
|
|
36.1
|
|
|
29.6
|
|
Purchase commitments
(1)
|
|
|
568.0
|
|
|
537.9
|
|
|
30.1
|
|
|
|
|
|
|
|
Other long-term liabilities reflected on the consolidated balance sheet
(2)
|
|
|
128.3
|
|
|
|
|
|
101.2
|
|
|
27.1
|
|
|
|
|
Pension funding requirements
(3)
|
|
|
1.6
|
|
|
1.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
3,804.2
|
|
$
|
704.1
|
|
$
|
390.8
|
|
$
|
885.5
|
|
$
|
1,823.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-
(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
47
Table of Contents
commercial
milestones and are not included in the table above. For further details regarding the collaborative arrangements, see Note 4 to the consolidated financial statements included in
Item 8.
-
(2)
-
Includes
liability of $83.4 million relating to unrecognized tax benefits, penalties and interest; excludes approximately
$84.7 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. As of
December 31, 2010, the frozen U.S. pension plan is in fully funded status under regulatory guidelines.
Hospira's
other commercial commitments as of December 31, 2010, 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, 2010, Hospira
had $34.8 million of these commitments, with a majority expiring in 2011. 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.
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.
Arrangements with Certain Multiple Deliverables
Hospira accounts for sales of drug delivery pumps (pumps) and server-based suite of software
applications (software), inclusive of certain software related services, under multi-element arrangements, depending on the functionality of the software associated with the pump, as one or two units
of accounting.
48
Table of Contents
Hospira allocates revenue to arrangements with multiple deliverables based on their relative selling prices. In such circumstances, Hospira applies a hierarchy to
determine the selling price to be used for allocating revenue to deliverables as follows: (i) vendor-specific objective evidence ("VSOE") of fair value, (ii) third-party evidence of
selling price ("TPE"), and (iii) best estimate of the selling price ("ESP"). VSOE generally exists only when Hospira sells the deliverable separately and is the price actually charged by
Hospira for that deliverable. Where VSOE and TPE are not available, Hospira's process for determining ESP includes multiple factors that may vary depending upon the unique facts and circumstances
related to each deliverable. Key factors considered in developing the ESP for pumps, software and software related services include prices charged by Hospira for similar offerings, historical pricing
practices, the market and nature of the deliverable and the relative ESP of certain deliverables compared to the total selling price of the arrangement.
For
certain arrangements where the software is not essential to the functionality of the pump, Hospira has identified three primary deliverables. The first deliverable is the pump which
is recognized as delivered, the second deliverable is the related sale of disposable products (sets) which are recognized as the products are delivered and the third deliverable is the software and
software related services. Revenue recognition for the third deliverable is further described below in the Software section. The allocation of revenue for the first and second deliverable is based on
VSOE and for the third deliverable is based on Hospira's ESP.
For
other arrangements where the software is essential to the functionality of the pump, Hospira has also identified three primary deliverables. The first deliverable is the pump and
software essential to
the functionality of the pump which is delivered and recognized at the time of installation. The second deliverable is the related sale of sets which are recognized as the products are delivered and
the third deliverable is software related services. Revenue recognition for the third deliverable is further described below in the Software section. The allocation of revenue for the first
deliverable is based on Hospira's ESP. The allocation of revenue for the second deliverable is based on VSOE and for the third deliverable is based on Hospira's ESP.
Software
Hospira accounts for the server-based suite of software applications not essential to the functionality of a pump and related maintenance and
implementation services in accordance with industry specific accounting guidance for software and software-related transactions. For such transactions, revenue on arrangements that include multiple
elements is allocated to each element based on the relative fair value of each element, and fair value is generally determined by VSOE. If Hospira cannot objectively determine the fair value of any
undelivered element included in such multiple-element arrangements, Hospira defers revenue until all elements are delivered and services have been performed. Perpetual software license revenue and
implementation service revenue are generally recognized as obligations are completed. Software subscription license and software maintenance revenue is recognized ratably over the applicable contract
period.
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
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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 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.
Hospira's
total chargeback accrual for all products was $129.7 million and $177.0 million at December 31, 2010 and 2009, respectively, and included in Trade
receivables. Settlement of chargebacks 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
at December 31, 2010, would decrease net sales and income before income taxes by approximately $1.8 million. A one percent increase in units sold subject to chargebacks held by
wholesalers at December 31, 2010, would decrease net sales and income before income taxes by approximately $1.1 million.
Rebates
Hospira 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 1 to 15 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.
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, 2010 and
2009, accrued rebates of $137.0 million and $156.0 million, respectively, are included in Other accrued liabilities on the consolidated balance sheet. The methodology used to estimate
and provide for rebates was consistent across all periods presented.
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The
following table is an analysis of chargebacks and rebates for years ended 2010 and 2009:
|
|
|
|
|
|
|
|
(dollars in millions)
|
|
Chargebacks
|
|
Rebates
|
|
Balance at January 1, 2009
|
|
$
|
60.2
|
|
$
|
107.4
|
|
Provisions
|
|
|
1,041.1
|
|
|
269.2
|
|
Payments
|
|
|
(924.3
|
)
|
|
(220.6
|
)
|
|
|
|
|
|
|
Balance at December 31, 2009
(1)
|
|
|
177.0
|
|
|
156.0
|
|
|
|
|
|
|
|
Provisions
|
|
|
934.5
|
|
|
273.0
|
|
Payments and releases
(2)
|
|
|
(981.8
|
)
|
|
(292.0
|
)
|
|
|
|
|
|
|
Balance at December 31, 2010
(1)
|
|
$
|
129.7
|
|
$
|
137.0
|
|
|
|
|
|
|
|
-
(1)
-
Hospira's
generic oxaliplatin sales, launched in the U.S. in 2009 and temporarily exited the market in June 2010, contributed to the increase
and subsequent decrease in the chargebacks and rebate accrual.
-
(2)
-
Hospira
released $33.8 million for a portion of the chargeback accrual relating to 2009 in 2010 for oxaliplatin sales as the expected
rate of price decrease was less than estimated and typically experienced in generic product launches. Adjustments for rebates related to prior period sales have not been material in any period.
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. Inventory cost includes
material and conversion costs. Hospira monitors inventories for exposures related to obsolescence, excess and date expiration, non-conformance, product recalls 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 $100.0 million and $110.7 million at December 31, 2010 and 2009, respectively.
Stock-Based Compensation
In accordance with the provisions of Accounting Standards Codification ("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
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expense
could be materially impacted in future periods. See Note 21 to the consolidated financial statements included in Item 8 for additional information regarding stock-based
compensation.
Pension and Other Post-Retirement Benefits
Hospira provides pension and other post-retirement medical and dental benefits to certain of its active and retired employees based
both in and outside of the U.S. 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.
The
U.S. discount rate estimates were developed with the assistance of actuarially developed yield curves. 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,
2010 Net Benefit Cost
(Income)/Expense
|
|
As of December 31, 2010
Benefit Obligation
Increase/(Decrease)
|
|
(dollars in millions)
|
|
One
Percentage-
Point
Increase
|
|
One
Percentage-
Point
Decrease
|
|
One
Percentage-
Point
Increase
|
|
One
Percentage-
Point
Decrease
|
|
Pension PlanU.S.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discount rate
|
|
$
|
(3.1
|
)
|
$
|
3.6
|
|
$
|
(55.2
|
)
|
$
|
67.5
|
|
Expected long-term return on assets
|
|
|
(3.7
|
)
|
|
3.7
|
|
|
|
|
|
|
|
Medical and Dental PlanU.S.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discount rate
|
|
|
(0.2
|
)
|
|
0.2
|
|
|
(4.6
|
)
|
|
5.5
|
|
Expected health care cost trend rate (initial and ultimate)
|
|
|
0.7
|
|
|
(0.6
|
)
|
|
5.1
|
|
|
(4.4
|
)
|
Impairment of Long-Lived and Other Assets
Property and Equipment and Intangible Assets, Net
In accordance with provision of ASC Subtopic 360-10, "Property, Plant, and
Equipment: Overall" and ASC Subtopic 350-30, "IntangiblesGoodwill and Other: General Intangibles Other than Goodwill", 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 of assets with definite-lives is generally determined by comparing projected undiscounted cash flows to be generated by the asset, or appropriate grouping of assets, to its carrying value.
Indefinite-lived intangible asset are tested for impairment at least annually, or more frequently if an event occurs or circumstances change that would reduce the fair value below its carrying value.
If an
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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.
Goodwill
In accordance with the provisions of ASC Subtopic 350-20, "IntangiblesGoodwill and Other: Goodwill" 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 impairment was indicated.
Investments
Hospira regularly reviews its investments to determine whether an
impairment or 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 impairment or
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 5 for more details.
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
53
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withholding
taxes are not provided for 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 Item 8 hereof is incorporated
herein by reference.
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, regulatory, technological and other factors that may affect Hospira's operations are discussed in Part I, Item 1A. Risk Factors, to this Annual Report on
Form 10-K.
Item 7A. Quantitative and Qualitative 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, Canadian 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, 2010, Hospira had
$31.0 million net notional value of forward contracts purchased primarily dominated in Euros, Australian dollars, Canadian dollars and British pounds that mature within one to six months. Net
forward contract income for the years ended December 31, 2010, 2009 and 2008 was $15.3 million, $5.6 million and $1.8 million, respectively. The carrying value and fair
value of forward contracts was a
net payable of $0.1 million and net receivable of $3.9 million as of December 31, 2010 and 2009, respectively.
As
part of its risk management program, Hospira performs a sensitivity analysis of changes in the fair value of foreign currency forward exchange contracts outstanding at
December 31, 2010 and, while not predictive in nature, indicated that if the U.S. dollar uniformly fluctuates unfavorably by 10% against all currencies, the net liability balance of
$(0.1) million would increase by $(0.8) million.
The
sensitivity analysis recalculates the fair value of the foreign currency forward exchange contracts outstanding at December 31, 2010 by replacing the actual exchange rates at
December 31,
54
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2010
with exchange rates that are 10% unfavorable to the actual exchange rates for each applicable currency. All other factors are held constant. The sensitivity analysis disregards the possibility
that currency exchange rates can move in opposite directions and that gains from one currency may or may not be offset by losses from another currency. The analysis also disregards the offsetting
change in value of the underlying hedged transactions and balances.
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 maturities along with both fixed-rate
and variable-rate debt to manage changes in interest rates. In 2010, Hospira entered into interest rate swap contracts whereby $200.0 million of the $400.0 million principal amount of
5.90% note due June 2014 and $200.0 million of the $250.0 million principal amount of 6.40% note due in May 2015 were effectively converted from fixed to floating-rate debt.
As
part of its risk management program, Hospira performs sensitivity analyses to assess potential gains and losses in earnings relating to hypothetical movements in interest rates
associated with outstanding interest rates swap contracts. A 10 basis-point change in interest rates affecting Hospira's interest rate swap contracts, would have an immaterial effect on the
annual earnings over the term of the related instruments.
Hospira's
investment portfolio of $669.0 million at December 31, 2010, consists of cash and cash equivalents, equity investments in affiliated companies and marketable and
cost-method investments.
Marketable investments consist of marketable securities classified as available-for-sale. The carrying value of the investment portfolio approximates fair market value at December 31, 2010, 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
$7.8 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, 2010, Hospira has not borrowed any amounts under the Revolver.
Refer
to the Liquidity and Capital Resources section above, as well as Notes 5, 6, 7 and 16 to the consolidated financial statements included in this Annual Report on
Form 10-K in Item 8, for further information.
55
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Item 8. Financial Statements and Supplementary Data
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS AND SCHEDULE
56
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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, 2010. 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, 2010, 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, 2010, which is included herein.
|
|
|
/s/ CHRISTOPHER B. BEGLEY
Chairman of the Board and
Chief Executive Officer
February 16, 2011
|
|
/s/ THOMAS E. WERNER
Senior Vice President, Finance, and
Chief Financial Officer
February 16, 2011
|
57
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, 2010 and 2009, 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, 2010. 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,
2010 and 2009, and the results of their operations and their cash flows for each of the three years in the period ended December 31, 2010, 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, 2010, 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 16, 2011 expressed an unqualified opinion on the Company's internal control over financial reporting.
/s/
DELOITTE & TOUCHE LLP
Chicago,
Illinois
February 16, 2011
58
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, 2010, 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, 2010, 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, 2010 of the Company and our report dated February 16, 2011 expressed an unqualified opinion on those financial statements and financial
statement schedule.
/s/
DELOITTE & TOUCHE LLP
Chicago,
Illinois
February 16, 2011
59
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,
|
|
|
|
2010
|
|
2009
|
|
2008
|
|
Net sales
|
|
$
|
3,917.2
|
|
$
|
3,879.3
|
|
$
|
3,629.5
|
|
|
|
|
|
|
|
|
|
Cost of products sold
|
|
|
2,402.8
|
|
|
2,422.9
|
|
|
2,286.8
|
|
Restructuring, impairment and (gain) on disposition of assets, net
|
|
|
19.7
|
|
|
94.2
|
|
|
22.4
|
|
Research and development
|
|
|
300.5
|
|
|
240.5
|
|
|
212.4
|
|
Selling, general and administrative
|
|
|
675.0
|
|
|
618.8
|
|
|
590.1
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses
|
|
|
3,398.0
|
|
|
3,376.4
|
|
|
3,111.7
|
|
|
|
|
|
|
|
|
|
|
|
Income From Operations
|
|
|
519.2
|
|
|
502.9
|
|
|
517.8
|
|
Interest expense
|
|
|
101.1
|
|
|
106.3
|
|
|
116.2
|
|
Other expense (income), net
|
|
|
26.6
|
|
|
11.8
|
|
|
(5.9
|
)
|
|
|
|
|
|
|
|
|
|
|
Income Before Income Taxes
|
|
|
391.5
|
|
|
384.8
|
|
|
407.5
|
|
Income tax expense (benefit)
|
|
|
34.3
|
|
|
(19.1
|
)
|
|
86.6
|
|
|
|
|
|
|
|
|
|
|
|
Net Income
|
|
$
|
357.2
|
|
$
|
403.9
|
|
$
|
320.9
|
|
|
|
|
|
|
|
|
|
Earnings Per Common Share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
2.15
|
|
$
|
2.51
|
|
$
|
2.02
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
$
|
2.11
|
|
$
|
2.47
|
|
$
|
1.99
|
|
|
|
|
|
|
|
|
|
Weighted Average Common Shares Outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
166.0
|
|
|
161.0
|
|
|
159.2
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
|
169.5
|
|
|
163.2
|
|
|
161.3
|
|
|
|
|
|
|
|
|
|
Comprehensive Income (Loss):
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments, net of taxes of $0.0
|
|
$
|
64.5
|
|
$
|
249.3
|
|
$
|
(307.6
|
)
|
Retirement plans liability adjustments, net of taxes of $2.2, $1.4 and $25.3, respectively
|
|
|
(3.4
|
)
|
|
(5.4
|
)
|
|
(40.1
|
)
|
Unrealized gains (losses) on marketable equity securities, net of taxes of $0.0
|
|
|
8.6
|
|
|
6.6
|
|
|
(16.5
|
)
|
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 $(0.3), $(0.6) and $(0.4), respectively
|
|
|
0.4
|
|
|
1.0
|
|
|
0.7
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss)
|
|
|
70.1
|
|
|
268.1
|
|
|
(363.5
|
)
|
Net Income
|
|
|
357.2
|
|
|
403.9
|
|
|
320.9
|
|
|
|
|
|
|
|
|
|
Comprehensive Income (Loss)
|
|
$
|
427.3
|
|
$
|
672.0
|
|
$
|
(42.6
|
)
|
|
|
|
|
|
|
|
|
The
accompanying notes are an integral part of these consolidated financial statements.
60
Table of Contents
Hospira, Inc.
Consolidated Statements of Cash Flows
(dollars in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31,
|
|
|
|
2010
|
|
2009
|
|
2008
|
|
Cash Flow From Operating Activities:
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$
|
357.2
|
|
$
|
403.9
|
|
$
|
320.9
|
|
|
Adjustments to reconcile net income to net cash from operating activities
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
164.3
|
|
|
168.6
|
|
|
183.2
|
|
|
|
Amortization of intangible assets
|
|
|
81.6
|
|
|
61.5
|
|
|
68.7
|
|
|
|
Loss on early debt extinguishment
|
|
|
36.8
|
|
|
|
|
|
|
|
|
|
Stock-based compensation expense
|
|
|
47.5
|
|
|
40.5
|
|
|
42.0
|
|
|
|
Deferred income tax and other tax adjustments
|
|
|
(14.0
|
)
|
|
(66.3
|
)
|
|
43.5
|
|
|
|
Impairment and other asset charges
|
|
|
25.1
|
|
|
95.8
|
|
|
|
|
|
|
Net gains on disposition of assets
|
|
|
(11.4
|
)
|
|
|
|
|
(3.0
|
)
|
|
Changes in assets and liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
Trade receivables
|
|
|
(94.5
|
)
|
|
97.2
|
|
|
(55.4
|
)
|
|
|
Inventories
|
|
|
(201.8
|
)
|
|
54.4
|
|
|
(117.9
|
)
|
|
|
Prepaid expenses and other assets
|
|
|
(18.5
|
)
|
|
8.2
|
|
|
12.9
|
|
|
|
Trade accounts payable
|
|
|
84.6
|
|
|
(4.2
|
)
|
|
49.5
|
|
|
|
Other liabilities
|
|
|
(76.0
|
)
|
|
107.5
|
|
|
15.8
|
|
|
Other, net
|
|
|
(66.0
|
)
|
|
(22.2
|
)
|
|
23.9
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash Provided by Operating Activities
|
|
|
314.9
|
|
|
944.9
|
|
|
584.1
|
|
|
|
|
|
|
|
|
|
Cash Flow From Investing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures (including instruments placed with or leased to customers of $25.0, $23.0 and $30.5 in 2010, 2009 and 2008, respectively)
|
|
|
(208.5
|
)
|
|
(159.4
|
)
|
|
(164.3
|
)
|
|
Acquisitions, net of cash acquired, and payments for contingent consideration
|
|
|
(540.8
|
)
|
|
(86.6
|
)
|
|
(26.1
|
)
|
|
Purchases of intangibles and other investments
|
|
|
(18.7
|
)
|
|
(14.3
|
)
|
|
(50.8
|
)
|
|
Purchases of marketable securities
|
|
|
|
|
|
|
|
|
(24.5
|
)
|
|
Proceeds from disposition of businesses and assets
|
|
|
62.6
|
|
|
49.2
|
|
|
0.8
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash Used in Investing Activities
|
|
|
(705.4
|
)
|
|
(211.1
|
)
|
|
(264.9
|
)
|
|
|
|
|
|
|
|
|
Cash Flow From Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of long-term debt, net of fees paid
|
|
|
492.5
|
|
|
246.7
|
|
|
|
|
|
Repayment of long-term debt
|
|
|
(500.3
|
)
|
|
(681.2
|
)
|
|
(95.2
|
)
|
|
Payment on early debt extinguishment
|
|
|
(36.8
|
)
|
|
|
|
|
|
|
|
Other borrowings, net
|
|
|
5.1
|
|
|
2.6
|
|
|
6.3
|
|
|
Common stock repurchased
|
|
|
(100.0
|
)
|
|
|
|
|
|
|
|
Excess tax benefit from stock-based compensation arrangements
|
|
|
21.3
|
|
|
0.8
|
|
|
1.0
|
|
|
Proceeds from stock options exercised
|
|
|
153.3
|
|
|
122.5
|
|
|
27.8
|
|
|
|
|
|
|
|
|
|
|
|
Net Cash Provided by (Used in) Financing Activities
|
|
|
35.1
|
|
|
(308.6
|
)
|
|
(60.1
|
)
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents
|
|
|
13.7
|
|
|
37.0
|
|
|
(16.4
|
)
|
|
|
|
|
|
|
|
|
Net change in cash and cash equivalents
|
|
|
(341.7
|
)
|
|
462.2
|
|
|
242.7
|
|
Cash and cash equivalents at beginning of year
|
|
|
946.0
|
|
|
483.8
|
|
|
241.1
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year
|
|
$
|
604.3
|
|
$
|
946.0
|
|
$
|
483.8
|
|
|
|
|
|
|
|
|
|
Supplemental Cash Flow Information:
|
|
|
|
|
|
|
|
|
|
|
Cash paid during the year
|
|
|
|
|
|
|
|
|
|
|
|
Interest
|
|
$
|
101.8
|
|
$
|
108.7
|
|
$
|
120.8
|
|
|
Income taxes, net of refunds
|
|
$
|
78.8
|
|
$
|
28.4
|
|
$
|
14.9
|
|
The accompanying notes are an integral part of these consolidated financial statements.
61
Table of Contents
Hospira, Inc.
Consolidated Balance Sheets
(dollars in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2010
|
|
2009
|
|
Assets
|
|
|
|
|
|
|
|
Current Assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
604.3
|
|
$
|
946.0
|
|
|
|
Trade receivables, less allowances of $8.2 in 2010 and $6.2 in 2009
|
|
|
605.0
|
|
|
498.1
|
|
|
|
Inventories
|
|
|
955.5
|
|
|
755.4
|
|
|
|
Deferred income taxes
|
|
|
165.2
|
|
|
185.9
|
|
|
|
Prepaid expenses
|
|
|
43.6
|
|
|
34.3
|
|
|
|
Other receivables
|
|
|
103.9
|
|
|
41.5
|
|
|
|
Assets held for sale
|
|
|
|
|
|
65.0
|
|
|
|
|
|
|
|
|
|
|
Total Current Assets
|
|
|
2,477.5
|
|
|
2,526.2
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
1,279.2
|
|
|
1,147.8
|
|
Intangible assets, net
|
|
|
527.7
|
|
|
406.5
|
|
Goodwill
|
|
|
1,471.2
|
|
|
1,243.4
|
|
Deferred income taxes
|
|
|
161.0
|
|
|
54.5
|
|
Investments
|
|
|
64.7
|
|
|
49.3
|
|
Other assets
|
|
|
65.0
|
|
|
75.2
|
|
|
|
|
|
|
|
|
|
|
Total Assets
|
|
$
|
6,046.3
|
|
$
|
5,502.9
|
|
|
|
|
|
|
|
Liabilities and Shareholders' Equity
|
|
|
|
|
|
|
|
Current Liabilities:
|
|
|
|
|
|
|
|
|
|
Short-term borrowings
|
|
$
|
33.5
|
|
$
|
23.6
|
|
|
|
Trade accounts payable
|
|
|
320.7
|
|
|
229.5
|
|
|
|
Salaries, wages and commissions
|
|
|
136.0
|
|
|
176.5
|
|
|
|
Deferred income taxes
|
|
|
0.1
|
|
|
0.1
|
|
|
|
Other accrued liabilities
|
|
|
441.3
|
|
|
438.3
|
|
|
|
Liabilities related to assets held for sale
|
|
|
|
|
|
13.9
|
|
|
|
|
|
|
|
|
|
|
Total Current Liabilities
|
|
|
931.6
|
|
|
881.9
|
|
|
|
|
|
|
|
Long-term debt
|
|
|
1,714.4
|
|
|
1,707.3
|
|
Deferred income taxes
|
|
|
4.4
|
|
|
18.6
|
|
Post-retirement obligations and other long-term liabilities
|
|
|
212.4
|
|
|
271.4
|
|
Commitments and Contingencies
|
|
|
|
|
|
|
|
Shareholders' Equity:
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
1.8
|
|
|
1.7
|
|
|
Preferred stock
|
|
|
|
|
|
|
|
|
Treasury stock, at cost
|
|
|
(399.8
|
)
|
|
(299.8
|
)
|
|
Additional paid-in capital
|
|
|
1,641.9
|
|
|
1,409.5
|
|
|
Retained earnings
|
|
|
1,897.3
|
|
|
1,540.1
|
|
|
Accumulated other comprehensive income (loss)
|
|
|
42.3
|
|
|
(27.8
|
)
|
|
|
|
|
|
|
Total Shareholders' Equity
|
|
|
3,183.5
|
|
|
2,623.7
|
|
|
|
|
|
|
|
Total Liabilities and Shareholders' Equity
|
|
$
|
6,046.3
|
|
$
|
5,502.9
|
|
|
|
|
|
|
|
The
accompanying notes are an integral part of these consolidated financial statements.
62
Table of Contents
Hospira, Inc.
Consolidated Statements of Changes in Shareholders' Equity
(dollars and shares in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
|
|
|
|
|
|
Accumulated
Other
Comprehensive
Income (Loss)
|
|
|
|
|
|
Treasury
Stock, at cost
|
|
Additional
Paid-in
Capital
|
|
Retained
Earnings
|
|
|
|
|
|
Shares
|
|
Amount
|
|
Total
|
|
Balances at January 1, 2008
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
357.2
|
|
|
|
|
|
357.2
|
|
Other comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
70.1
|
|
|
70.1
|
|
Common stock repurchased
|
|
|
(1.6
|
)
|
|
|
|
|
(100.0
|
)
|
|
|
|
|
|
|
|
|
|
|
(100.0
|
)
|
Changes in shareholders' equity related to incentive stock programs
|
|
|
4.8
|
|
|
0.1
|
|
|
|
|
|
232.4
|
|
|
|
|
|
|
|
|
232.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balances at December 31, 2010
|
|
|
166.7
|
|
$
|
1.8
|
|
$
|
(399.8
|
)
|
$
|
1,641.9
|
|
$
|
1,897.3
|
|
$
|
42.3
|
|
$
|
3,183.5
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
63
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 products. 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.
Reclassifications
For comparative purposes, Hospira made certain reclassifications to prior year amounts. In 2010, Hospira reclassified costs that
were previously reported in Acquired in-process research and development to Research and development, a separate operating expense line item. Hospira also reclassified amounts previously
reported in Write-off of acquired in-process research and development to Other, net, a separate cash flow line item. The reclassifications did not affect net income, net cash
provided by operating activities or shareholders' equity.
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 benefit liabilities and loss contingencies and other costs.
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.
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.
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Table of Contents
Arrangements with Certain Multiple Deliverables
Hospira accounts for sales of drug delivery pumps (pumps) and server-based suite of software
applications (software), inclusive of certain software related services, under multi-element arrangements, depending on the functionality of the software associated with the pump, as one or two units
of accounting.
Hospira
allocates revenue to arrangements with multiple deliverables based on their relative selling prices. In such circumstances, Hospira applies a hierarchy to determine the selling
price to be used for allocating revenue to deliverables as follows: (i) vendor-specific objective evidence ("VSOE") of fair value, (ii) third-party evidence of selling price ("TPE"), and
(iii) best estimate of the selling price ("ESP"). VSOE generally exists only when Hospira sells the deliverable separately and is the price actually charged by Hospira for that deliverable.
Where VSOE and TPE are not available, Hospira's process for determining ESP includes multiple factors that may vary depending upon the unique facts and circumstances related to each deliverable. Key
factors considered in developing the ESP for pumps, software and software related services include prices charged by Hospira for similar offerings, historical pricing practices, the market and nature
of the deliverable and the relative ESP of certain deliverables compared to the total selling price of the arrangement.
For
certain arrangements where the software is not essential to the functionality of the pump, Hospira has identified three primary deliverables. The first deliverable is the pump which
is recognized as delivered, the second deliverable is the related sale of disposable products (sets) which are recognized as the products are delivered and the third deliverable is the software and
software related services. Revenue recognition for the third deliverable is further described below in the Software section of this Note 1. The allocation of revenue for the first and second
deliverable is based on VSOE and for the third deliverable is based on Hospira's ESP.
For
other arrangements where the software is essential to the functionality of the pump, Hospira has also identified three primary deliverables. The first deliverable is the pump and
software essential to the functionality of the pump which is delivered and recognized at the time of installation. The second deliverable is the related sale of sets which are recognized as the
products are delivered and the third deliverable is software related services. Revenue recognition for the third deliverable is further described below in the Software section of this Note 1.
The allocation of revenue for the first deliverable is based on Hospira's ESP. The allocation of revenue for the second deliverable is based on VSOE and for the third deliverable is based on Hospira's
ESP.
Software
Hospira accounts for the server-based suite of software applications not essential to the functionality of a pump and related maintenance and
implementation services in accordance with industry specific accounting guidance for software and software-related transactions. For such transactions, revenue on arrangements that include multiple
elements is allocated to each element based on the relative fair value of each element, and fair value is generally determined by VSOE. If Hospira cannot objectively determine the fair value of any
undelivered element included in such multiple-element arrangements, Hospira defers revenue until all elements are delivered and services have been performed. Perpetual software license revenue and
implementation service revenue are generally recognized as obligations are completed. Software subscription license and software maintenance revenue is recognized ratably over the applicable contract
period.
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
65
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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 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.
Hospira's
total chargeback accrual for all products was $129.7 million and $177.0 million at December 31, 2010 and 2009, respectively, and included in trade
receivables. Settlement of chargebacks 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
at December 31, 2010, would decrease net sales and income before income taxes by approximately $1.8 million. A one percent increase in units sold subject to chargebacks held by
wholesalers at December 31, 2010, would decrease net sales and income before income taxes by approximately $1.1 million.
Rebates
Hospira 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 as a reduction of gross sales at the same time the product sale is recorded. Settlement of the
rebate generally occurs from 1 to 15 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.
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, 2010
and 2009, accrued rebates of $137.0 million and $156.0 million, respectively, are included in Other accrued liabilities on the consolidated balance sheet. The methodology used to
estimate and provide for rebates was consistent across all periods presented.
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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 $20.6 million and $18.5 million as of December 31, 2010 and 2009,
respectively, and included in Other accrued liabilities on the consolidated balance sheet.
Warranties and other costs
Hospira offers warranties on certain products and generally determines the warranty liability by applying historical claims rate
experience and the cost to replace or repair products under warranty. Product warranty reserves were not material at December 31, 2010 and 2009. In addition to product warranties,
Hospira accrues for costs of product recalls, corrective actions, and other related costs based on management's best estimates when it is probable a liability has been incurred, management commits to
a plan, and/or regulatory requirement dictates the need for corrective action and the amount of loss can be reasonably estimated. Reserves for various product recalls, corrective actions, and other
related costs were $38.7 million and $20.4 million as of December 31, 2010 and 2009, respectively, and are 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 2010,
2009 and 2008, 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 2010 and 2009, the largest four wholesalers accounted for approximately 38% and 40%, respectively, of net trade receivables. Net sales through the same four
wholesalers noted above accounted for approximately 40%, 42% and 38% of global net sales in 2010, 2009 and 2008, respectively. Global net sales related to group purchasing
organizations ("GPO") contracts amounted to $1,732.5 million in 2010, $1,705.1 million in 2009 and $1,564.7 million in 2008.
Loss Contingencies
In accordance with the provisions of Accounting Standards Codification ("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 becomes known. Accordingly, if Hospira is initially unable to develop a best estimate of loss, the minimum amount, which could be zero, is recorded.
Collaborative Arrangements
Hospira enters into collaborative arrangements with third parties for product development and commercialization. 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
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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
|
-
(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 4.
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.
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
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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. Inventory cost includes
material and conversion costs. Hospira monitors inventories for exposures related to obsolescence, excess and date expiration, non-conformance, product recalls 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 $100.0 million and $110.7 million at December 31, 2010 and 2009, respectively.
Property and Equipment
Property and equipment are stated at cost and depreciation is provided on a straight-line basis over the estimated useful
lives or lease term of the assets. Instruments placed with customers are drug delivery systems placed with or leased to customers under operating leases. See Note 10 for more details.
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 $8.4 million, $5.8 million and $8.0 million in 2010, 2009 and 2008, respectively.
Goodwill and Intangible Assets, Net
Goodwill represents the excess of the purchase price of an acquired business over the amounts assigned to assets and liabilities
assumed in the business combination. Goodwill is not amortized. Acquired-in-process research and development ("IPR&D") is accounted for as an indefinite-lived intangible asset
until completion, regulatory approval or discontinuation. Upon successful completion or regulatory approval of each project, Hospira will make a determination as to the useful life of the intangible
asset and begin amortization. Intangible assets with definite lives are amortized on a straight-line basis over their estimated useful lives.
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, 2010 and 2009, un-depreciated capitalized software costs totaled $85.2 million and $78.1 million, respectively. Such capitalized amounts
will be depreciated ratably over the expected useful lives of the projects when they become operational, not to exceed 10 years. Depreciation was $14.5 million, $19.4 million and
$16.1 million for the years ended 2010, 2009 and 2008, respectively, and is included in Depreciation in the consolidated statements of cash flows.
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Costs incurred during the application development stage for software held for sale are capitalized once a project has reached the point of technological
feasibility. Completed projects are amortized after reaching the point of general availability using the straight-line method based on an estimated useful life. Hospira monitors the net
realizable value of capitalized software held for sale to ensure that the investment will be recovered through future sales. Unamortized capitalized software cost held for sale was not material at
December 31, 2010 and 2009.
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.
Impairment of Long-Lived Assets and Other Assets
Property and Equipment and Intangible Assets, Net
In accordance with provision of ASC Subtopic 360-10, "Property, Plant, and
Equipment: Overall" and ASC Subtopic 350-30, "IntangiblesGoodwill and Other: General Intangibles Other than Goodwill", 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 of assets with definite-lives is generally determined by comparing projected undiscounted cash flows to be generated by the asset, or appropriate grouping of assets, to its carrying value.
Indefinite-lived intangible asset are tested for impairment at least annually, or more frequently if an event occurs or circumstances change that would reduce the fair value below 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.
Goodwill
In accordance with the provisions of ASC Subtopic 350-20, "IntangiblesGoodwill and Other: Goodwill" 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 impairment was indicated.
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Investments
Hospira regularly reviews its investments to determine whether an impairment or 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 impairment or 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 5 for
more details.
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. These assumptions
involve inherent uncertainties based on market conditions generally outside of Hospira's control.
The
U.S. discount rate estimates were developed with the assistance of actuarially developed yield curves. 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.
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 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.
Translation Adjustments
For foreign operations in highly inflationary economies, translation gains and losses are included in foreign exchange loss (gain),
net. For remaining foreign operations, translation adjustments are included as a component of accumulated other comprehensive income (loss).
Recently Issued Accounting Standards
In December 2010, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU")
No. 2010-29, Business Combinations (Topic 805), "Disclosure of Supplementary Pro Forma Information for Business Combinations" ("ASU No. 2010-29"). ASU
No. 2010-29 requires revenues and earnings of the combined entity be disclosed as if the business
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combination
occurred as of the beginning of the comparable prior annual reporting period. The ASU also requires additional disclosures about adjustments included in the reported pro forma revenues and
earnings. ASU No. 2010-29 is effective prospectively for business combinations for which the acquisition date is on or after fiscal years beginning on or after December 15,
2010. Early adoption
is permitted. Hospira is currently evaluating the potential impact of ASU No. 2010-29 on the financial statements disclosures.
In
December 2010, the FASB issued ASU No. 2010-27, Other Expenses (Topic 720), "Fees Paid to the Federal Government by Pharmaceutical Manufacturers"
("ASU No. 2010-27"). ASU No. 2010-27 specifies the accounting for annual fees imposed on the pharmaceutical manufacturing industry by the Patient Protection and
Affordable Care Acts as amended by the Health Care and Education Reconciliation Act (collectively, the "Acts"). The ASU specify that a liability for the fee should be estimated and recorded in full
upon the first qualifying sale with deferred costs amortized to expense on a straight-line basis, unless another method of allocation is more appropriate. ASU
No. 2010-27 is effective for calendar years beginning after December 31, 2010. Hospira is currently evaluating the potential impact of ASU No. 2010-27 on
the financial statements and related disclosures but does not anticipate a material impact to Hospira.
Adoption of New Accounting Standards
In December 2010, Hospira adopted the provisions of the FASB ASU No. 2010-20, Receivables (Topic 310),
"Disclosures about the Credit Quality of Financing Receivables and the Allowance for Credit Losses" ("ASU No. 2010-20"). ASU No. 2010-20 requires disclosures
about financing receivables and related credit risk on a disaggregated basis, excluding short-term trade accounts receivables. There was no material impact to Hospira's consolidated
financial position, results of operations or cash flows upon adoption of this guidance.
In
April 2010, the FASB issued ASU No. 2010-17, Revenue Recognition (Topic 605), "Milestone Method of Revenue Recognition" ("ASU
No. 2010-17"). ASU No. 2010-17 establishes a revenue recognition method for contingent consideration that is payable upon the achievement of an uncertain future
event, referred to as a milestone. The scope of ASU No. 2010-17 is limited to research and development agreements and is applicable to milestones in multiple-deliverable
arrangements involving research and development transactions. The guidance does not preclude the application of any other applicable revenue guidance. The new ASU permits prospective or retrospective
adoption, and Hospira elected prospective adoption during the third quarter of 2010. Prospective adoption required Hospira to apply the new ASU to milestones achieved beginning January 1, 2010.
There was no material impact to Hospira's consolidated financial position, results of operations or cash flows upon adoption of this guidance.
In
March 2010, Hospira adopted the provisions of ASU No. 2010-12, Income Taxes (Topic 740), "Accounting for Certain Tax Effects of the 2010 Health Care
Reform Acts" ("ASU No. 2010-12"). On March 30, 2010, the President of the U.S. signed the Health Care and Education Reconciliation Act of 2010, which is a
reconciliation bill that amends the Patient Protection and Affordable Act that was signed on March 23, 2010 (collectively, the "Acts"). ASU
No. 2010-12 allows entities to consider the two Acts together for accounting purposes. The Acts' elimination of the future tax deduction for prescription drug costs associated with
Hospira's post-retirement medical and dental plans for which Hospira receives a Medicare Part D drug subsidy was not material to Hospira's consolidated financial position, results
of operations or cash flows upon adoption of this guidance.
In
February 2010, Hospira adopted the provisions of ASU No. 2010-09, Subsequent Events (Topic 855), "Amendments to Certain Recognition and Disclosure
Requirements" ("ASU No. 2010-09"). ASU No. 2010-09 removes the requirement for an SEC filer to disclose the date through which
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subsequent
events have been evaluated. There was no material impact to Hospira's consolidated financial position, results of operations or cash flows upon adoption of this guidance.
In
January 2010, the FASB issued ASU No. 2010-06, Fair Value Measurements and Disclosures (Topic 820), "Improving Disclosures about Fair Value
Measurements" ("ASU No. 2010-06"). ASU No. 2010-06 requires new disclosures about significant transfers in and out of Level 1 and Level 2 fair value
measurements and the reasons for such transfers and in the reconciliation for Level 3 fair value measurements to disclose separately information about purchases, sales, issuances and
settlements. Hospira adopted the provisions of ASU No. 2010-06 on January 1, 2010, except for disclosures about purchases, sales, issuances and settlements in the
reconciliation for Level 3 fair value measurements. Those disclosures will be effective for financial statements issued for fiscal years beginning after December 15, 2010. There was no
material impact to Hospira's consolidated financial position, results of operations or cash flows upon adoption of this guidance.
In
October 2009, the FASB issued ASU No. 2009-14, Software (Topic 985), "Certain Revenue Arrangements That Include Software Elements" and
No. 2009-13, Revenue Recognition (Topic 605), "Multiple-Deliverable Revenue Arrangements" related to revenue recognition for arrangements with multiple deliverables and
arrangements that include software elements. The new ASUs permit prospective or retrospective adoption, and Hospira elected prospective adoption during the first quarter of 2010. Prospective
adoption required Hospira to apply the new ASUs to revenue arrangements entered into or materially modified beginning January 1, 2010. Upon adoption of this guidance, the timing of revenue
recognition has not significantly changed and the impact to Hospira's consolidated financial position, results of operations or cash flows was not material.
Note 2Business Acquisitions
In July 2010, Hospira completed the acquisition of Javelin Pharmaceuticals, Inc. ("Javelin Pharma") for a purchase price
of $161.9 million. The purchase price was comprised of $145.2 million, in cash, paid on July 2, 2010 for the outstanding shares of Javelin Pharma and additional consideration
provided to Javelin Pharma of $16.7 million in the quarter ended June 30, 2010 in connection with various pre-close operating costs and other liabilities incurred by Javelin
Pharma. The acquisition will enable Hospira to take advantage of synergies between Hospira's Precedex
TM
and Javelin Pharma's main product candidate, Dyloject
TM
, a
post-operative pain management drug currently awaiting U.S. Food and Drug Administration ("FDA") approval. The impact of this acquisition was not material to Hospira's results of
operations in 2010, exclusive of the acquisition charges. During the year ended December 31, 2010, $7.9 million of acquisition related pre-tax charges were recognized
in Selling, general and administrative. In October 2010, Hospira received a complete response letter from the FDA regarding Dyloject
TM
and Hospira is working to respond to the
letter. Hospira and its third party manufacturer continue to work closely with FDA to address any items, including visual inspection methods and a product particulate matter identified at the
acquisition date, raised as part of the regulatory process. Timing of resolution and expected launch of the product is uncertain.
The
allocation of the purchase price is preliminary, based on the initial accounting of the assets acquired and liabilities assumed at their respective estimated fair values on the
acquisition date of July 2, 2010. In December 2010, Hospira adjusted the preliminary values assigned to certain assets for a product matter which existed as of the acquisition date,
based on additional information, obtained since July 2, 2010. The opening balance sheet has been adjusted to reflect these changes, which included an increase to goodwill of
$43.2 million, an increase to deferred income taxes, net of $25.9 million, a decrease to IPR&D of $67.7 million and a decrease to intangible assets of $1.4 million. The
allocation of the purchase price for intangible assets and IPR&D is pending finalization of the valuation and allocation of goodwill among reporting units. The final allocation of the purchase price
may result in
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adjustments
to the recognized amounts of assets and liabilities, which could be significant. Hospira expects to finalize the preliminary allocation as soon as possible. The preliminary allocation
based on management's best estimate is as follows:
|
|
|
|
|
|
(dollars in millions)
|
|
|
|
Intangible assets
|
|
$
|
5.4
|
|
IPR&D
|
|
|
53.8
|
|
Goodwill
|
|
|
68.2
|
|
Deferred income taxes, net
|
|
|
39.3
|
|
Other liabilities, net
|
|
|
(4.8
|
)
|
|
|
|
|
|
Total allocation of purchase price
|
|
$
|
161.9
|
|
|
|
|
|
The
$5.4 million of acquired intangible assets includes $4.6 million of developed product rights and $0.8 million of trademarks that will be amortized over their
estimated useful lives (10 years). The amount allocated to IPR&D is being accounted for as an indefinite-lived intangible asset until completion, regulatory approval or discontinuation. Upon
successful completion or regulatory approval of the project, Hospira will make a determination as to the useful life of the intangible asset and begin amortization. The majority of goodwill,
$68.2 million, was assigned to the U.S., Canada, and Latin America ("Americas") segment. Goodwill recorded as part of the acquisition includes the expected synergies and other benefits that
Hospira believes will result from the combined operations. Goodwill is not expected to be deductible for tax purposes.
On
March 30, 2010, Hospira completed its acquisition of the generic injectable pharmaceutical business of Orchid Chemicals & Pharmaceuticals Ltd. ("Orchid Pharma")
for $381.0 million which was purchased by and operates under the name Hospira Healthcare India Private Limited ("Hospira India"), a wholly owned subsidiary of Hospira. The acquisition included
a beta-lactam antibiotic formulations manufacturing complex and pharmaceutical research and development facility, as well as a generic injectable dosage-form product portfolio
and pipeline. Primarily acquisition related pre-tax charges of $12.3 million were recognized, majority of which was in Selling, general and administrative, during 2010. The impact
of this acquisition was not material to Hospira's results of operations in 2010, exclusive of the acquisition related charges.
During
the second quarter of 2010, Hospira finalized the allocation of the purchase price for the acquisition by Hospira India based on the assets acquired and liabilities assumed at
their respective fair values on the acquisition date of March 30, 2010. The allocation of the purchase price is as follows:
|
|
|
|
|
|
(dollars in millions)
|
|
|
|
Current assets, net
|
|
$
|
13.3
|
|
Property and equipment
|
|
|
88.0
|
|
Intangible assets
|
|
|
88.1
|
|
IPR&D
|
|
|
13.3
|
|
Goodwill
|
|
|
171.1
|
|
Deferred income taxes, net
|
|
|
7.2
|
|
|
|
|
|
|
Total allocation of purchase price
|
|
$
|
381.0
|
|
|
|
|
|
The
$88.1 million of acquired intangible assets includes $83.4 million of developed product rights and $4.7 million of customer relationships that will be amortized
over their estimated useful lives (5 to 9 years, weighted average 8 years). The amount allocated to IPR&D is being accounted for as an indefinite-lived intangible asset until completion,
regulatory approval or discontinuation. Upon successful completion or regulatory approval of each project, Hospira will make a determination as to the useful life of the intangible asset and begin
amortization. Of the $171.1 million of goodwill,
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$121.5 million
was assigned to the Americas segment, $18.4 million was assigned to the EMEA segment, and $31.2 million was assigned to the APAC segment. Goodwill recorded as part
of the acquisition includes the expected synergies and other benefits that Hospira believes will result from the combined operations. Goodwill is not expected to be deductible for tax purposes.
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.
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); IPR&D of $0.5 million that was
expensed at the date of acquisition; non-tax deductible goodwill of $23.3 million; and other (liabilities), net of $(1.7) million. Approximately $15.0 million of
deferred consideration related to 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.
Note 3Restructuring 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, exit costs and gain on disposal of assets.
In March 2009, Hospira announced details of a restructuring and optimization plan, ("Project Fuel,"), which has been ongoing
over the last two years. Project Fuel has included the following activities: optimizing the product portfolio, evaluating non-strategic assets and streamlining the organizational
structure. Hospira now expects to incur aggregate restructuring costs and other asset charges related to these actions in the range of $60 million to $70 million on a pre-tax
basis, a reduction from the originally announced range of $100 million to $110 million, primarily related to reduced inventory write-offs and a decrease in employee-related
benefit costs. These decreases are off-set by an increase in process optimization costs, non-restructuring and other asset charges, resulting in no change to the projected
aggregate charges related to Project Fuel.
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The following summarizes the Project Fuel pre-tax restructuring costs and inventory charges (included in Cost of products sold) for the years ended
December 31:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring costs
|
|
Inventory charges
|
|
(dollars in millions)
|
|
Aggregrate
to date
|
|
2010
|
|
2009
|
|
Aggregrate
to date
|
|
2010
|
|
2009
|
|
Americas
|
|
$
|
27.4
|
|
$
|
4.7
|
|
$
|
22.7
|
|
$
|
14.3
|
|
$
|
(4.4
|
)
|
$
|
18.7
|
|
EMEA
|
|
|
6.7
|
|
|
4.9
|
|
|
1.8
|
|
|
6.0
|
|
|
1.4
|
|
|
4.6
|
|
APAC
|
|
|
4.5
|
|
|
1.7
|
|
|
2.8
|
|
|
4.6
|
|
|
4.6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
38.6
|
|
$
|
11.3
|
|
$
|
27.3
|
|
$
|
24.9
|
|
$
|
1.6
|
|
$
|
23.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As
part of the Project Fuel initiatives, Hospira committed to dispose of certain non-strategic businesses and the underlying assets. As a result of these commitments,
non-cash, pre-tax impairment charges of $52.8 million were recognized in Restructuring, impairment and (gain) on disposition of assets, net during 2009. Additionally,
pre-tax inventory charges of $3.1 million were recognized in Cost of products sold. 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 provided 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. In 2010, Hospira completed the disposal of a
facility in Wasserburg, Germany for $69.3 million, which primarily performed contract manufacturing in the EMEA segment. This was comprised of cash proceeds of $62.6 million and an
additional $6.7 million due in twelve months from the close of the transaction. Hospira recognized a gain of $11.4 million included in Restructuring, impairment and (gain) on disposition
of assets, net. As of December 31, 2009, assets held for sale, net related to this facility were as follows:
|
|
|
|
|
|
(dollars in millions)
|
|
|
|
Property and equipment, net
|
|
$
|
26.2
|
|
Goodwill
|
|
|
17.9
|
|
Other assets, net
|
|
|
20.9
|
|
|
|
|
|
|
Total assets held for sale
|
|
$
|
65.0
|
|
|
|
|
|
Post-retirement obligations
|
|
|
7.1
|
|
Other liabilities
|
|
|
6.8
|
|
|
|
|
|
|
Total liabilities related to assets held for sale
|
|
$
|
13.9
|
|
|
|
|
|
The
following summarizes the Project Fuel asset impairment activity related to the disposal of certain non-strategic businesses and the underlying assets for the year ended
December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
(dollars in millions)
|
|
By Segment:
|
|
|
|
By Asset:
|
|
Americas
|
|
$
|
42.9
|
|
Property and equipment, net
|
|
$
|
22.7
|
|
EMEA
|
|
|
7.6
|
|
Goodwill
|
|
|
7.6
|
|
APAC
|
|
|
2.3
|
|
Intangible asset
|
|
|
22.5
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
52.8
|
|
Total
|
|
$
|
52.8
|
|
|
|
|
|
|
|
|
|
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