Table of Contents
UNITED STATES SECURITIES AND EXCHANGE
COMMISSION
WASHINGTON, D. C. 20549
FORM 10-Q
x
QUARTERLY REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2010
OR
o
TRANSITION REPORT PURSUANT TO
SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from
to
Commission File No. 1-31946
HOSPIRA, INC.
(Exact
name of registrant as specified in its charter)
Delaware
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20-0504497
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(State
or other jurisdiction
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(I.R.S.
Employer
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of
incorporation or organization)
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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
(Registrants
telephone number, including area code)
Indicate by check mark
whether the registrant: (l) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of l934 during the
preceding l2 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
x
No
o
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 (§ 232.405 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
x
No
o
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.
Large
accelerated filer
x
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Accelerated
filer
o
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|
Non-accelerated
filer
o
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Smaller
reporting company
o
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(Do
not check if a 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
Exchange Act). Yes
o
No
x
As of July 22, 2010,
Registrant had outstanding 167,310,057 shares of common stock, par value $0.01
per share.
Table of Contents
PART I. FINANCIAL INFORMATION
Item
1. Financial Statements
Hospira, Inc.
Condensed Consolidated Statements of Income
(Unaudited)
(dollars and shares in millions, except for
per share amounts)
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Three Months Ended June 30,
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Six Months Ended June 30,
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2010
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2009
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2010
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2009
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Net
sales
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$
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968.2
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$
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956.9
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$
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1,975.8
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$
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1,816.6
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Cost
of products sold
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599.0
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610.7
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1,176.3
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1,150.8
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Restructuring,
impairment and (gain) on disposition of assets, net
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2.6
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55.9
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(5.0
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)
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65.3
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Research
and development
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80.4
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52.9
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132.1
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102.9
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Selling,
general and administrative
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169.9
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146.3
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348.5
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291.8
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|
Total
operating costs and expenses
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851.9
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|
865.8
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|
1,651.9
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1,610.8
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|
Income
From Operations
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116.3
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91.1
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323.9
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205.8
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|
|
|
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|
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Interest
expense
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24.2
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28.2
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47.6
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55.1
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|
Other
(income) expense, net
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(0.8
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)
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14.5
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(2.5
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)
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14.2
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Income
Before Income Taxes
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92.9
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|
48.4
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278.8
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136.5
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|
|
|
|
|
|
|
|
|
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Income
tax expense (benefit)
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9.4
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22.9
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53.6
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(54.5
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)
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Net
Income
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$
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83.5
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$
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25.5
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$
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225.2
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$
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191.0
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Earnings
Per Common Share:
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Basic
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$
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0.50
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$
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0.16
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$
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1.36
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$
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1.19
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Diluted
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$
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0.49
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$
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0.16
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$
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1.34
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$
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1.18
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Weighted
Average Common Shares Outstanding:
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Basic
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165.8
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160.5
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165.0
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160.0
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Diluted
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169.1
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162.4
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168.5
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161.5
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The
accompanying notes are an integral part of these condensed consolidated
financial statements.
3
Table of Contents
Hospira, Inc.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(dollars in millions)
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Six Months Ended June 30,
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2010
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2009
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Cash
Flow From Operating Activities:
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Net
income
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$
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225.2
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$
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191.0
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Adjustments
to reconcile net income to net cash from operating activities-
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Depreciation
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79.9
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83.2
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Amortization
of intangible assets
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40.2
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30.7
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|
Stock-based
compensation expense
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27.8
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22.7
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Deferred
income tax and other tax adjustments
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12.1
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(98.3
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)
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Impairment
and other asset (benefits) charges
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(5.9
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)
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69.7
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Gain
on disposition of assets
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(11.4
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)
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Changes
in assets and liabilities-
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Trade
receivables
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(126.7
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)
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(2.8
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)
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Inventories
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(41.9
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)
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(6.3
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)
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Prepaid
expenses and other assets
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(12.6
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)
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(11.4
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)
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Trade
accounts payable
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34.0
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(32.8
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)
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Other
liabilities
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(94.7
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)
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(18.2
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)
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Other,
net
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17.8
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8.5
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Net
Cash Provided by Operating Activities
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143.8
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236.0
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Cash
Flow From Investing Activities:
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Capital
expenditures (including instruments placed with or leased to customers)
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(79.4
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)
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(77.8
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)
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Acquisitions,
net of cash acquired, and payments for contingent consideration
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(397.7
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)
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(14.2
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)
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Purchases
of intangibles and other investments
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(11.2
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)
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(3.2
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)
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Proceeds
on disposition of assets
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62.6
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Net
Cash Used in Investing Activities
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(425.7
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)
|
(95.2
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)
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Cash
Flow From Financing Activities:
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Issuance
of long-term debt, net of fees paid
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246.7
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Repayment
of long-term debt
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(306.1
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)
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Other
borrowings, net
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(3.5
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)
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0.7
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Excess
tax benefit from stock-based compensation arrangements
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16.3
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0.2
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Proceeds
from stock options exercised
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112.4
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35.4
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|
Net
Cash Provided by (Used In) Financing Activities
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125.2
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(23.1
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)
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Effect
of exchange rate changes on cash and cash equivalents
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(6.0
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)
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7.0
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Net
change in cash and cash equivalents
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(162.7
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)
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124.7
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Cash
and cash equivalents at beginning of period
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946.0
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483.8
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|
Cash
and cash equivalents at end of period
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$
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783.3
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$
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608.5
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Supplemental
Cash Flow Information:
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Cash
paid during the period-
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Interest
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$
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50.3
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$
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54.8
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|
Income
taxes, net of refunds
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$
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70.9
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$
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18.7
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|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
4
Table of Contents
Hospira, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(dollars in millions)
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June 30,
2010
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December 31,
2009
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Assets
|
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Current
Assets:
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Cash
and cash equivalents
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$
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783.3
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$
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946.0
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Trade
receivables, less allowances of $9.1 in 2010 and $6.2 in 2009
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613.0
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498.1
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|
Inventories
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794.2
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755.4
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|
Deferred
income taxes
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171.2
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185.9
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|
Prepaid
expenses
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44.4
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34.3
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Other
receivables
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105.0
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41.5
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Assets
held for sale
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65.0
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Total
Current Assets
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2,511.1
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2,526.2
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Property
and equipment, net
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1,211.5
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1,147.8
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Intangible
assets, net
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469.8
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406.5
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Goodwill
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1,366.1
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1,243.4
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Deferred
income taxes
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56.2
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|
54.5
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Investments
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50.5
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49.3
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|
Other
assets
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65.9
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|
75.2
|
|
Total
Assets
|
|
$
|
5,731.1
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|
$
|
5,502.9
|
|
Liabilities and Shareholders
Equity
|
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|
Current
Liabilities:
|
|
|
|
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|
Short-term
borrowings
|
|
$
|
23.8
|
|
$
|
23.6
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|
Trade
accounts payable
|
|
253.0
|
|
229.5
|
|
Salaries,
wages and commissions
|
|
115.6
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|
176.5
|
|
Other
accrued liabilities
|
|
447.2
|
|
438.4
|
|
Liabilities
related to assets held for sale
|
|
|
|
13.9
|
|
Total
Current Liabilities
|
|
839.6
|
|
881.9
|
|
Long-term
debt
|
|
1,717.4
|
|
1,707.3
|
|
Deferred
income taxes
|
|
16.3
|
|
18.6
|
|
Post-retirement
obligations and other long-term liabilities
|
|
277.2
|
|
271.4
|
|
Commitments
and Contingencies
|
|
|
|
|
|
Total
Shareholders Equity
|
|
2,880.6
|
|
2,623.7
|
|
Total
Liabilities and Shareholders Equity
|
|
$
|
5,731.1
|
|
$
|
5,502.9
|
|
|
|
|
|
|
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
5
Table of Contents
Hospira, Inc.
Condensed Consolidated Statement of Changes in
Shareholders Equity
(Unaudited)
(dollars and shares in millions)
|
|
Common Stock
|
|
Treasury
|
|
Additional
Paid-in
|
|
Retained
|
|
Accumulated
Other
Comprehensive
|
|
|
|
|
|
Shares
|
|
Amount
|
|
Stock
|
|
Capital
|
|
Earnings
|
|
Loss
|
|
Total
|
|
Balances at January 1, 2010
|
|
163.5
|
|
$
|
1.7
|
|
$
|
(299.8
|
)
|
$
|
1,409.5
|
|
$
|
1,540.1
|
|
$
|
(27.8
|
)
|
$
|
2,623.7
|
|
Net
income
|
|
|
|
|
|
|
|
|
|
225.2
|
|
|
|
225.2
|
|
Other
comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
(133.0
|
)
|
(133.0
|
)
|
Changes
in shareholders equity related to incentive stock programs
|
|
3.5
|
|
|
|
|
|
164.7
|
|
|
|
|
|
164.7
|
|
Balances at June 30, 2010
|
|
167.0
|
|
$
|
1.7
|
|
$
|
(299.8
|
)
|
$
|
1,574.2
|
|
$
|
1,765.3
|
|
$
|
(160.8
|
)
|
$
|
2,880.6
|
|
The
accompanying notes are an integral part of these condensed consolidated
financial statements.
6
Table of Contents
Hospira, Inc.
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Note 1
Basis of Presentation and Significant Accounting Policies
The accompanying unaudited
condensed consolidated financial statements have been prepared pursuant to the
rules and regulations of the Securities and Exchange Commission (SEC)
for interim reporting and, therefore, do not include all information and
footnote disclosures normally included in audited financial statements in
conformity with accounting principles generally accepted in the United States (GAAP).
However, in the opinion of management, all adjustments, consisting of normal
recurring adjustments, unless otherwise noted herein, necessary to present
fairly the results of operations, financial position and cash flows have been
made. These condensed consolidated financial statements should be read in
conjunction with the consolidated financial statements and notes thereto
included in the Hospira, Inc. (Hospira) Annual Report on Form 10-K
for the year ended December 31, 2009. The results of operations for any
interim period are not necessarily indicative of the results of operations to
be expected for the full year.
Recently Issued and Adoption of New Accounting Standards
In October 2009, the
Financial Accounting Standards Board (FASB) issued Accounting Standards
Updates (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 Hospiras condensed
consolidated financial position, results of operations or cash flows was not
material.
In July 2010, the FASB
issued 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 new disclosures about
financing receivables and related credit risk on a disaggregated basis,
excluding short-term trade accounts receivables. The disclosures will be
effective for financial statements issued for fiscal years ending on or after
December 15, 2010. Hospira is currently evaluating the potential impact of
ASU No. 2010-20 on the financial statements.
In April 2010, the FASB
issued FASB 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 the milestone method 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
guidance will be effective for financial statements issued for fiscal years
beginning after June 15, 2010. Early adoption is permitted. Hospira is
currently evaluating the potential impact of ASU No. 2010-17 on the
financial statements.
Hospira adopted the
provisions of the FASB 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 United States
(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 Hospiras post-retirement medical and dental plans for which Hospira
receives a Medicare Part D drug subsidy was not material to Hospiras
condensed consolidated financial position, results of operations or cash flows
upon adoption of this guidance. Hospira
continues to evaluate the potential impact of other sections of this
legislation on the post-retirement medical and dental and current medical
plans, but does not anticipate a material impact to Hospira.
Hospira adopted the
provisions of the FASB 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 subsequent events have been evaluated. There was no impact
to Hospiras condensed 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
7
Table of Contents
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 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 impact to Hospiras condensed consolidated
financial position, results of operations or cash flows upon adoption of this
guidance.
Significant Accounting Policies - Revenue Recognition
Hospiras accounting policy
for revenue recognition is included in Note 1 Summary of Significant
Accounting Policies in the Hospira Annual Report on Form 10-K for the year
ended December 31, 2009.
Arrangements
with Certain Multiple Deliverables
Under the historical
accounting principles, Hospira accounted 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 as one
unit of accounting. Hospira allocated revenue to this unit based on
vendor-specific objective evidence. The new accounting principles, depending on
the functionality of the software associated with the pump, generally require
Hospira to account for sales of pumps and software as one or two units of
accounting and allow multiple methods of determining the selling price for the
purpose of allocating revenue.
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 of fair value (VSOE),
(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, Hospiras 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 ESPs 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
Hospiras 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 Hospiras ESP.
The allocation of revenue for the second deliverable is based on VSOE and for
the third deliverable is based on Hospiras 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
Hospiras accounting policy
for revenue recognition including a description of chargebacks (estimated
reimbursements to wholesalers for honoring contracted prices to end customers)
is included in Note 1 Summary of Significant Accounting Policies in the
Hospira Annual Report on Form 10-K for the year ended December 31,
2009. Hospira regularly monitors the provision for chargebacks and makes
adjustments when it believes the actual chargeback may differ from
estimates. The methodology used to estimate and provide for chargebacks
was consistent across all periods presented.
8
Table of Contents
Hospiras generic
oxaliplatin sales in the U.S. are subject to chargebacks and contributed to the
increase in the chargeback accrual beginning in the third quarter of 2009.
Generally, generic product launch sales have a higher degree of end customer
price movement, often greater than 80% from the end customer price prior to
generic introduction, as additional competitors enter the market. Further, the
oxaliplatin litigation discussed in Note 15 has impacted the quantities and
types of generic oxaliplatin product available in the market thereby affecting
the rate of end customer price movement. The oxaliplatin sales contributed to
Hospiras total chargeback accrual at December 31, 2009 of $177.0 million
and $146.2 million at June 30, 2010. During the six months ended June 30,
2010, Hospira accrued chargebacks of $544.8 million related to current period
sales and paid $522.8 million. Hospira released $33.8 million and $19.0 million
which was a portion of the chargeback accrual relating to prior year and first
quarter 2010 oxaliplatin product sales, respectively, as the expected rate of
price movement was less than estimated. A five percent decrease in the end
customer contract prices for generic oxaliplatin sales subject to chargebacks
at June 30, 2010 could decrease net sales and income before income taxes
by approximately $4 million.
Note 2
Acquisitions
In July 2010, Hospira
completed the acquisition of Javelin Pharmaceuticals, Inc. (Javelin
Pharma) for a purchase price of approximately $161.7 million. The
purchase price was comprised of approximately $145 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 Javelin Pharmas main
product candidate, Dyloject
TM
, a post-operative pain management drug currently awaiting U.S. Food
and Drug Administration (FDA) approval, and Hospiras Precedex
TM
. Due to the timing of the
acquisition, Hospira has not yet completed the initial purchase accounting for
the business combination which will be finalized when the valuation is
completed. A substantial portion of the fair value of the acquisition will be
allocated to acquired in-process research and development (IPR&D) that
will be accounted for as an indefinite-lived intangible asset until regulatory
approval or discontinuation. The impact of Javelin Pharmas operations on
Hospira in 2010 will depend on the various product development and
commercialization efforts, and the corresponding regulatory outcomes in
connection therewith. During the three months ended June 30, 2010, $0.9
million of acquisition related pre-tax charges were recognized in Selling,
general and administrative.
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 $11.3 million were recognized,
majority of which was in Selling, general and administrative, during the six
months ended June 30, 2010. The
impact of this acquisition was not material to Hospiras results of operations
for the three and six months ended June 30, 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
|
|
Goodwill
|
|
171.1
|
|
Deferred
income taxes
|
|
7.2
|
|
IPR&D
|
|
13.3
|
|
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, $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.
9
Table of Contents
Note 3
Restructuring 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.
Project
Fuel
2009
Actions.
In March 2009, Hospira announced details
of a restructuring and optimization plan (Project Fuel), which will occur
over the next two years from the date of the announcement. Project Fuel
includes the following activities: optimizing the product portfolio, evaluating
non-strategic assets, and streamlining the organizational structure. Hospira
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 an
expected 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. Hospira has, in aggregate to date, incurred
restructuring charges related to these actions in the U.S., Canada, and Latin
America (Americas), Europe Middle East and Africa (EMEA) and Asia Pacific (APAC)
segments of $25.9 million, $2.9 million and $3.5 million, respectively. During
the three months ended June 30, 2010 and 2009, Hospira incurred, primarily
in the Americas segment, pre-tax Restructuring charges of $2.2 million and $4.4
million, respectively. During the six months ended June 30, 2010 and 2009,
Hospira incurred, primarily in the Americas segment, pre-tax Restructuring
charges of $5.0 million and $9.1 million, respectively. During the three and six
months ended June 30, 2010, Hospira released $3.3 million and $5.9
million, respectively, of the inventory reserve related to product portfolio
optimization. Hospira has recognized inventory charges in Cost of products sold
of $12.8 million and $4.6 million, in aggregate to date, related to the
Americas and EMEA segments, respectively. Inventory charges of $1.7 million
related to product portfolio optimization, primarily impacting the Americas
segment, are included in Cost of products sold during the three and six months
ended June 30, 2009.
The following summarizes the
Project Fuel restructuring activity for 2010:
(dollars
in millions)
|
|
Balance at
December 31, 2009
|
|
Costs
Incurred
|
|
Payments
|
|
Non cash
Items
|
|
Balance at
June 30, 2010
|
|
Employee-related
benefit costs
|
|
$
|
9.1
|
|
$
|
4.5
|
|
$
|
(10.0
|
)
|
$
|
|
|
$
|
3.6
|
|
Accelerated
depreciation
|
|
|
|
0.3
|
|
|
|
(0.3
|
)
|
|
|
Other
|
|
3.9
|
|
0.2
|
|
(1.2
|
)
|
(0.2
|
)
|
2.7
|
|
|
|
$
|
13.0
|
|
$
|
5.0
|
|
$
|
(11.2
|
)
|
$
|
(0.5
|
)
|
$
|
6.3
|
|
In February 2010,
Hospira completed the disposal of a facility in Wasserburg, Germany which
primarily performed contract manufacturing in the EMEA segment for $69.3
million, 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.
Facilities
Optimization
2008
Actions.
In April 2008, Hospira announced a plan
to exit manufacturing operations at its Morgan Hill, California plant over the
next two to three years from the date of announcement. Recent market
opportunities for Hospiras pumps may extend the exit date beyond the original
announced time frame. Hospira expects to incur aggregate restructuring charges
through 2011 related to this action in the range of $20 million to $24 million
on a pre-tax basis. Hospira is in the process of transferring related
operations and production of the primary products to other Hospira facilities,
or outsourcing certain product components to third-party suppliers, or ceasing
activities entirely. Hospira has incurred $21.8 million, pre-tax, to date for
restructuring charges in the Americas segment, primarily employee related,
associated with this action. During the three months ended June 30, 2010
and 2009, Hospira incurred in the Americas segment pre-tax restructuring costs
of $0.4 million and $3.2 million, respectively. During the six months ended June 30,
2010 and 2009, Hospira incurred in the Americas segment pre-tax restructuring
costs of $1.4 million and $6.2 million, respectively.
10
Table of Contents
The following summarizes the
Facilities Optimization (Morgan Hill, California) restructuring activity for
2010:
(dollars
in millions)
|
|
Balance at
December 31, 2009
|
|
Costs
Incurred
|
|
Payments
|
|
Non cash
Items
|
|
Balance at
June 30, 2010
|
|
Employee-related
benefit costs
|
|
$
|
13.9
|
|
$
|
0.7
|
|
$
|
(4.3
|
)
|
$
|
(1.5
|
)
|
$
|
8.8
|
|
Accelerated
depreciation
|
|
|
|
0.7
|
|
|
|
(0.7
|
)
|
|
|
Other
|
|
0.5
|
|
|
|
|
|
(0.5
|
)
|
|
|
|
|
$
|
14.4
|
|
$
|
1.4
|
|
$
|
(4.3
|
)
|
$
|
(2.7
|
)
|
$
|
8.8
|
|
Note 4
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.
Hospiras rights and obligations under these collaborative arrangements vary.
These collaborations usually involve various activities including research and
development, marketing and selling, and distribution. Hospira has numerous
collaborative arrangements, none of which individually or in the aggregate have
had material changes or activity during the six months ended June 30,
2010, except for as noted below. For a more detailed description of Hospiras
collaborative arrangements see Note 5 Collaborative Arrangements in the
Hospiras Annual Report on Form 10-K for the year ended December 31,
2009.
Hospira and DURECT Corporation
entered into a collaborative agreement to develop, license, and market DURECTs
POSIDUR (SABER-bupivacaine) a long-acting version of the anesthetic
bupivacaine currently in Phase III clinical trials. Hospira will co-develop the
drug and has exclusive marketing rights in the U.S. and Canada following
regulatory approval. For the U.S. and Canada, the two companies will equally
fund the remaining development costs, while Hospira will have sole funding
responsibility for commercialization of the product. During the three months
ended June 30, 2010, Hospira recorded a charge of $27.5 million in
Research and development related to an initial milestone payment. Hospira may
be required to pay approximately $5 million for a pre-regulatory approval
milestone, approximately $30 million upon reaching regulatory approval and
up to approximately $150 million in milestones tied to achievement of
certain levels of commercial sales. Hospira will also make royalty payments
based upon commercial sales.
Note 5
Fair Value Measures
The following table
summarizes the basis used to measure certain assets and liabilities at fair
value in the balance sheet:
|
|
|
|
Fair Value Measurements at Reporting Date, Using:
|
|
Description
(dollars in millions)
|
|
June 30,
2010
|
|
Quoted Prices
in Active
Markets for
Identical Items
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
Financial
Assets:
|
|
|
|
|
|
|
|
|
|
Available-for-sale
marketable equity securities
|
|
$
|
11.5
|
|
$
|
11.5
|
|
$
|
|
|
$
|
|
|
Foreign
currency forward exchange contracts
|
|
0.8
|
|
|
|
0.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial
Liabilities:
|
|
|
|
|
|
|
|
|
|
Foreign
currency forward exchange contracts
|
|
$
|
3.5
|
|
$
|
|
|
$
|
3.5
|
|
$
|
|
|
11
Table of Contents
|
|
|
|
Fair Value Measurements at Reporting Date, Using:
|
|
Description
(dollars in millions)
|
|
December 31,
2009
|
|
Quoted Prices
in Active
Markets for
Identical Items
(Level 1)
|
|
Significant
Other
Observable
Inputs
(Level 2)
|
|
Significant
Unobservable
Inputs
(Level 3)
|
|
Financial
Assets:
|
|
|
|
|
|
|
|
|
|
Interest
rate swap contracts
|
|
$
|
2.5
|
|
$
|
|
|
$
|
2.5
|
|
$
|
|
|
Available-for-sale
marketable equity securities
|
|
12.7
|
|
12.7
|
|
|
|
|
|
Foreign
currency forward exchange contracts
|
|
5.4
|
|
|
|
5.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial
Liabilities:
|
|
|
|
|
|
|
|
|
|
Foreign
currency forward exchange contracts
|
|
$
|
1.4
|
|
$
|
|
|
$
|
1.4
|
|
$
|
|
|
The fair value of the Level
1 assets is based on quoted market prices of the identical underlying security
in an active market. The fair value of the Level 2 assets and liabilities is
primarily based on market observable inputs to quoted market prices, benchmark
yields and broker/dealer quotes. Level 3 inputs, as applicable, are
unobservable inputs which reflect assumptions developed by management to
measure assets and liabilities at fair value.
The carrying values of
certain financial instruments, including primarily cash and cash equivalents,
accounts receivable, accounts payable and short-term borrowings, approximate
their estimated fair values due to their short-term nature. The carrying value
and estimated aggregate fair value, based primarily on market prices (Level 1),
of the senior unsecured notes are as follows:
|
|
June 30, 2010
|
|
December 31, 2009
|
|
Description
(dollars in millions)
|
|
Carrying
Value
|
|
Fair Value
|
|
Carrying
Value
|
|
Fair Value
|
|
Senior
unsecured notes
|
|
$
|
1,700.0
|
|
$
|
1,875.9
|
|
$
|
1,700.0
|
|
$
|
1,838.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 6
Financial Instruments and Derivatives
Hospiras operations are
exposed to market risk primarily due to changes in currency exchange rates and
interest rates. The objective in managing these risks is to reduce volatility
on earnings and cash flows. To reduce the risk, Hospira enters into certain
derivative financial instruments, when available on a cost-effective basis, to
hedge its underlying economic exposure. For a more detailed description of
Hospiras financial instruments and derivatives see Note 7 Financial
Instruments and Derivatives in the Hospiras Annual Report on Form 10-K
for the year ended December 31, 2009.
In June 2010, Hospira
terminated all existing interest rate swap contracts with a total notional
amount of $300.0 million. For further details, see Note 14.
The following table
summarizes Hospiras fair value of outstanding derivatives:
(dollars
in millions)
|
|
Condensed Consolidated Balance
Sheet Presentation
|
|
June 30,
2010
|
|
December 31,
2009
|
|
Derivatives not designated as hedging instruments
|
|
|
|
|
|
|
|
Foreign
currency forward exchange contracts:
|
|
Other receivables
|
|
$
|
0.8
|
|
$
|
5.4
|
|
|
|
Other accrued liabilities
|
|
3.5
|
|
1.4
|
|
|
|
|
|
|
|
|
|
Derivatives designated as hedging instruments
|
|
|
|
|
|
|
|
Interest
rate swap contracts:
|
|
Other receivables
|
|
|
|
0.6
|
|
|
|
Other assets
|
|
|
|
1.9
|
|
|
|
|
|
|
|
|
|
|
|
12
Table of Contents
The impact on earnings from
derivatives activity was as follows for the three and six months ended June 30:
|
|
Presentation of Gain (Loss)
Recognized
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
(dollars
in millions)
|
|
on Derivatives
|
|
2010
|
|
2009
|
|
2010
|
|
2009
|
|
Derivatives not designated as hedging instruments
|
|
|
|
|
|
|
|
|
|
|
|
Foreign
currency forward exchange contracts
|
|
Other (income) expense,
net
|
|
$
|
(6.6
|
)
|
$
|
0.8
|
|
$
|
(0.3
|
)
|
$
|
6.7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivatives designated as hedging instruments
|
|
|
|
|
|
|
|
|
|
|
|
Interest
rate swap contracts
|
|
Interest expense
|
|
1.8
|
|
|
|
4.4
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Note 7
Stock-Based Compensation
Hospiras 2004 Long-Term
Stock Incentive Plan, as amended, provides for the grant of shares of stock
options, stock appreciation rights, stock awards (restricted stock, restricted
stock units, performance shares and performance units), and cash-based awards
to employees and non-employee directors. Stock-based compensation expense of
$10.5 million and $9.6 million was recognized for the three months ended June 30,
2010 and 2009, respectively. The related income tax benefit recognized was $3.6
million and $3.3 million for the three months ended June 30, 2010 and
2009, respectively. Stock-based compensation expense of $27.8 million and $22.7
million was recognized for the six months ended June 30, 2010 and 2009,
respectively. The related income tax benefit recognized was $9.4 million and
$7.9 million for the six months ended June 30, 2010 and 2009,
respectively.
In February 2010, 1.9
million options were granted to certain employees for the 2010 annual stock
option grant. For the six months ended June 30, 2010, an additional 0.3
million options were granted. These options were awarded at the fair market
value at the time of grant, generally vest over three years, and have a seven-year
term. For 2010, the expected life assumption of the options is based on
the expected amount of time that options granted are expected to be
outstanding, based on historical and forecasted exercise behavior of employees
post-vesting forfeitures and exercises. For 2009, the expected life assumption
of the options is based on the simplified method, which is the midpoint
between the vesting date and the end of the contractual term.
The weighted average fair
value using the Black-Scholes option-pricing model and the corresponding
weighted average assumptions for stock option grants for the three and six
months ended June 30, are as follows:
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
|
|
2010
|
|
2009
|
|
2010
|
|
2009
|
|
Volatility
|
|
30.2
|
%
|
30.2
|
%
|
30.2
|
%
|
30.2
|
%
|
Expected
life (years)
|
|
2.8
|
|
4.0
|
|
4.6
|
|
4.5
|
|
Risk-free
interest rate
|
|
1.3
|
%
|
2.0
|
%
|
2.1
|
%
|
1.8
|
%
|
Dividend
yield
|
|
0.0
|
%
|
0.0
|
%
|
0.0
|
%
|
0.0
|
%
|
Fair
value per stock option
|
|
$
|
11.31
|
|
$
|
9.84
|
|
$
|
14.40
|
|
$
|
6.35
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In February 2010,
228,292 performance share awards were granted to key members of management. The
performance share awards vest at the end of the three-year performance cycle.
The 2010 performance share award is based on a formula that measures
performance using relative total shareholder return over the three-year
performance cycle compared to an industry peer group. Based on the actual
performance at the end of the performance cycle the number of performance share
awards earned, which can range between 0% and 200% of the target awards granted,
will be satisfied with Hospira common stock.
The weighted average fair
value using the Monte Carlo simulation model and the corresponding weighted
average assumptions for the February 2010 and March 2009 performance
share award grants are as follows:
|
|
2010
|
|
2009
|
|
Volatility
|
|
36.2
|
%
|
37.2
|
%
|
Risk-free
interest rate
|
|
1.4
|
%
|
1.2
|
%
|
Dividend
yield
|
|
0.0
|
%
|
0.0
|
%
|
Fair
value per performance share
|
|
$
|
69.43
|
|
$
|
24.98
|
|
|
|
|
|
|
|
|
|
As of June 30, 2010,
there were $62.0 million of total unrecognized compensation costs related to
non-vested share-based compensation arrangements. This cost is expected to be
recognized over a weighted average period of 1.8 years.
13
Table of Contents
Note 8
Post-Retirement Benefits
Retirement plans consist of
defined benefit and legislated obligations such as employee severance indemnity
plans (pension plans), post-retirement medical and dental plans (medical and
dental plans) and defined contribution plans. Plans cover certain employees
both in and outside of the U.S.
Net cost recognized for the
pension plans and medical and dental plans for the three and six months ended June 30,
is as follows:
|
|
Pension Plans
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
(dollars
in millions)
|
|
2010
|
|
2009
|
|
2010
|
|
2009
|
|
Service
cost for benefits earned during the period
|
|
$
|
0.3
|
|
$
|
0.3
|
|
$
|
0.5
|
|
$
|
0.6
|
|
Interest
cost on projected benefit obligations
|
|
6.3
|
|
6.5
|
|
12.6
|
|
13.0
|
|
Expected
return on plans assets
|
|
(7.4
|
)
|
(6.9
|
)
|
(14.8
|
)
|
(13.9
|
)
|
Net
amortization
|
|
1.6
|
|
0.9
|
|
3.2
|
|
1.8
|
|
Net
cost
|
|
$
|
0.8
|
|
$
|
0.8
|
|
$
|
1.5
|
|
$
|
1.5
|
|
|
|
Medical and Dental Plans
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
(dollars
in millions)
|
|
2010
|
|
2009
|
|
2010
|
|
2009
|
|
Service
cost for benefits earned during the period
|
|
$
|
|
|
$
|
0.1
|
|
$
|
|
|
$
|
0.1
|
|
Interest
cost on projected benefit obligations
|
|
0.8
|
|
0.8
|
|
1.6
|
|
1.6
|
|
Net
amortization
|
|
0.2
|
|
0.1
|
|
0.4
|
|
0.3
|
|
Net
cost
|
|
$
|
1.0
|
|
$
|
1.0
|
|
$
|
2.0
|
|
$
|
2.0
|
|
Based on current Federal
laws and regulations, Hospira is not required to make any contributions to its
U.S. pension plans in 2010. While Hospiras funding policy requires
contributions to our defined benefit plans equal to the amounts necessary to,
at a minimum, satisfy the funding requirements as prescribed by Federal laws
and regulations, Hospira does make discretionary contributions when management
deems it is prudent to do so.
The Acts related to
healthcare reform eliminated the future tax deduction for prescription drug
costs associated with Hospiras post-retirement medical and dental plans for
which Hospira receives Medicare Part D subsidies, which was not material
to Hospira. Hospira continues to evaluate the potential impact of other
sections of this legislation on the post-retirement medical and dental and
current medical and dental plans, but does not anticipate a material impact.
Certain Hospira employees in
the U.S. and Puerto Rico participate in the Hospira 401(k) Retirement
Savings Plan. Hospiras expenses for this defined contribution plan for the
three months ended June 30, 2010 and 2009 were $8.4 million and $8.9
million, respectively. For the six months ended June 30, 2010 and 2009,
expenses were $16.8 million and $18.3 million, respectively.
Note 9
Income Taxes
Taxes on income reflect the
estimated annual effective rates, excluding the effect of significant unusual
items. 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 several non-U.S. taxing jurisdictions.
Hospira remains open to tax
examination for post-May 1, 2004 periods in the major tax-paying
jurisdictions of Australia, Ireland, and Italy, for years 2005 forward in
Canada, for years 2006 forward for the U.S., and for years 2007 forward for the
United Kingdom. The U.S. federal tax returns for Hospira for 2006 and 2007 are
currently under examination by the Internal Revenue Service (IRS). Hospira
expects the audit fieldwork and the issuance of the initial IRS audit report to
be completed within the next six months. However, ultimate resolution of the
IRS audit is dependent on a number of factors and procedures that cannot be
predicted at this time. In addition, other tax jurisdictions are in various
audit stages for certain Hospira subsidiaries and certain tax statutes are
expected to close within the next 12 months. Accordingly, it is reasonably
possible that a change in unrecognized tax benefits will occur within the next
12 months; however, quantification of a range cannot be made at this time.
14
Table of Contents
Note 10
Earnings per Share
Basic earnings per share are
computed by dividing net income by the number of weighted average common shares
outstanding during the reporting period. Diluted earnings per share are
calculated to give effect to all potentially dilutive common shares that were
outstanding during the reporting period. The following table shows the effect
of stock-based awards on the weighted average number of shares outstanding used
in calculating diluted earnings per share for the three and six months ended June 30:
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
(shares in
millions)
|
|
2010
|
|
2009
|
|
2010
|
|
2009
|
|
Weighted
average basic common shares outstanding
|
|
165.8
|
|
160.5
|
|
165.0
|
|
160.0
|
|
Incremental
shares outstanding related to stock-based awards
|
|
3.3
|
|
1.9
|
|
3.5
|
|
1.5
|
|
Weighted
average dilutive common shares outstanding
|
|
169.1
|
|
162.4
|
|
168.5
|
|
161.5
|
|
The number of outstanding
options and awards to purchase Hospira stock for which the exercise price of
the options exceeded the average stock price was 2.5 million and 0.7 million
for the three and six months ended June 30, 2010, respectively, and 6.8
million and 9.7 million for the three and six months ended June 30, 2009,
respectively. Accordingly, these options are excluded from the diluted earnings
per share calculation for these periods.
Note 11
Inventories
Inventories consist of the
following:
|
|
June 30,
|
|
December 31,
|
|
(dollars
in millions)
|
|
2010
|
|
2009
|
|
Finished
products
|
|
$
|
379.8
|
|
$
|
405.3
|
|
Work
in process
|
|
184.8
|
|
143.9
|
|
Materials
|
|
229.6
|
|
206.2
|
|
Total
inventories
|
|
$
|
794.2
|
|
$
|
755.4
|
|
Note 12
Property and equipment, net
Property and equipment, net
consists of the following:
|
|
June 30,
|
|
December 31,
|
|
(dollars
in millions)
|
|
2010
|
|
2009
|
|
Property
and equipment, at cost
|
|
$
|
2,555.2
|
|
$
|
2,465.2
|
|
Accumulated
depreciation
|
|
(1,343.7
|
)
|
(1,317.4
|
)
|
Total
property and equipment, net
|
|
$
|
1,211.5
|
|
$
|
1,147.8
|
|
Note 13
Goodwill and Intangible assets, net
The following summarizes
goodwill and intangible assets, net activity:
|
|
Balance at
|
|
|
|
|
|
Currency
|
|
Balance at
|
|
(dollars in millions)
|
|
December 31, 2009
|
|
Acquisitions
|
|
Amortization
|
|
Translation Effect
|
|
June 30, 2010
|
|
Goodwill
|
|
$
|
1,243.4
|
|
$
|
171.1
|
|
$
|
|
|
$
|
(48.4
|
)
|
$
|
1,366.1
|
|
Intangible
assets, net
|
|
406.5
|
|
123.8
|
|
(40.2
|
)
|
(20.3
|
)
|
469.8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See Note 2 for more
information related to acquisitions. Hospira also acquired other intangible
assets, primarily product rights for a cardiovascular product marketed in
Japan, during the first quarter of 2010.
Intangible assets with
definite lives are amortized on a straight-line basis over their estimated
useful lives (1 to 16 years, weighted average 9 years). Indefinite-lived
intangibles, principally IPR&D are not amortized until completion,
regulatory approval or discontinuation. Intangible asset amortization expense
was $18.7 million and $16.0 million for the three months ended June 30,
2010 and 2009, respectively. Intangible asset amortization expense was $40.2 million
and $30.7 million for the six months ended June 30, 2010 and 2009,
respectively. Intangible asset amortization is estimated at $37.8 million for
the remainder of 2010, $74.0 million for
15
Table of Contents
2011, $63.4 million for
2012, $61.8 million for 2013, and $60.5 million for 2014.
Additionally, intangible
assets, net consist of the following:
|
|
June 30, 2010
|
|
December 31, 2009
|
|
(dollars
in millions)
|
|
Gross
Carrying
Amount
|
|
Accumulated
Amortization
|
|
Net Intangible
Assets
|
|
Gross
Carrying
Amount
|
|
Accumulated
Amortization
|
|
Net Intangible
Assets
|
|
Product
rights and other
|
|
$
|
597.2
|
|
$
|
(186.6
|
)
|
$
|
410.6
|
|
$
|
524.6
|
|
$
|
(159.0
|
)
|
$
|
365.6
|
|
Customer
relationships
|
|
30.6
|
|
(8.4
|
)
|
22.2
|
|
27.6
|
|
(7.1
|
)
|
20.5
|
|
IPR&D
|
|
13.0
|
|
|
|
13.0
|
|
|
|
|
|
|
|
Technology
|
|
32.9
|
|
(8.9
|
)
|
24.0
|
|
26.7
|
|
(6.3
|
)
|
20.4
|
|
|
|
$
|
673.7
|
|
$
|
(203.9
|
)
|
$
|
469.8
|
|
$
|
578.9
|
|
$
|
(172.4
|
)
|
$
|
406.5
|
|
Note 14
Short-term Borrowings and Long-term Debt
Hospira has a three-year
$700.0 million unsecured revolving credit facility expiring in
October 2012 in which no amounts are outstanding as of June 30, 2010.
Certain borrowing agreements
contain covenants that require compliance with, among other restrictions, a
maximum leverage ratio and a minimum interest coverage ratio. As of June 30,
2010, Hospira was in compliance with all applicable covenants.
In June 2010, Hospira
terminated all existing interest rate swap contracts 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, 5.90% fixed-rate
senior unsecured notes due in June 2014 and $100.0 million of the $250.0
million, 6.40% fixed-rate senior unsecured 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 will be
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 Condensed Consolidated Statements of Cash Flows.
There were no penalties associated with the termination of the interest rate
swap agreements.
Note 15
Litigation
Hospira is involved in
various claims and legal proceedings, as well as product liability claims,
regulatory matters and proceedings related to Hospiras business, including in
some instances when Hospira operated as part of Abbott Laboratories (Abbott).
Hospira has been named as a
defendant in a lawsuit alleging generally that the spin-off of Hospira from
Abbott resulted in a mass termination of employees so as to interfere with the
future attainment of benefits in violation of the Employee Retirement Income
Security Act of 1974 (ERISA). The lawsuit was filed on November 8,
2004 in the U.S. District Court for the Northern District of Illinois, and is
captioned: Myla Nauman, Jane Roller and Michael Loughery v. Abbott
Laboratories and Hospira, Inc. Plaintiffs generally seek
reinstatement in Abbott benefit plans, disgorgement of profits and attorneys
fees. On November 18, 2005, the complaint was amended to assert an
additional claim against Abbott and Hospira for breach of fiduciary duty under
ERISA. Hospira has been dismissed as a defendant with respect to the
fiduciary duty claim. By Order dated December 30, 2005, the Court
granted class action status to the lawsuit. As to the sole claim against
Hospira, the court certified a class defined as: all employees of Abbott who
were participants in the Abbott Benefit Plans and whose employment with Abbott
was terminated between August 22, 2003, and April 30, 2004, as a
result of the spin-off of the HPD [Hospital Products Division]/creation of
Hospira announced by Abbott on August 22, 2003, and who were eligible for
retirement under the Abbott Benefit Plans on the date of their terminations. Hospira
denies all material allegations asserted against it in the complaint. 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.
On August 12, 2005,
Retractable Technologies, Inc. (RTI) filed a lawsuit against Abbott
alleging breach of contract and fraud in connection with a National Marketing
and Distribution Agreement (Agreement) between Abbott and RTI signed in
May 2000. Retractable Technologies, Inc. v. Abbott
Laboratories, Inc., Case No. 505CV157 was filed in U.S. District
Court for the Eastern District of Texas. RTI purported to terminate the
contract for breach in 2003. The lawsuit alleged that Abbott misled RTI and breached
the Agreement in connection with Abbotts marketing efforts. Hospira agreed to
defend and indemnify Abbott in connection with this lawsuit, which involved a
contract carried out by Abbotts former Hospital Products Division. Abbott
denied all material allegations in the complaint. Abbott brought counterclaims
against RTI for breach of the Agreement, including failure to pay
16
Table of Contents
marketing fees owed to
Abbott. During the second quarter of 2010, the court issued rulings dismissing
RTIs fraud claim and claim for punitive damages; limiting the damages RTI
would be permitted at trial; and entered judgment in favor of Abbott on a portion
of its breach of contract claim for approximately $1.2 million plus attorneys
fees. The lawsuit was settled in July 2010. Pursuant to the settlement,
Hospira will waive its judgment against RTI and pay RTI $6 million in August 2010.
In addition, Hospira has obtained an exclusive one year option to license
another of RTIs products, the Patient Safe
®
syringe, and
for the option will pay RTI four quarterly payments of $2 million each
commencing in October 2010. If Hospira exercises the option, any prospective
quarterly payments will be credited toward royalties otherwise owed to RTI
under the licensing agreement. Hospira recognized charges related to the
payments discussed above during the three months ended June 30, 2010 in
Selling, general and administrative.
Hospira was involved in
patent litigation in the U.S. and elsewhere concerning Hospiras attempts to
market the generic oncology drug oxaliplatin. The U.S., litigation was
pending in the U.S. District Court for the District of New Jersey: Sanofi-Aventis,
U.S., LLC, et al. v. Sandoz, Inc., et al. (D. N.J. 2007). In the
lawsuit, plaintiffs alleged that various generic oxaliplatin products infringed
one or more patents held by plaintiffs. Hospira alleged that the single
patent plaintiffs have asserted against Hospira was not valid and not infringed
by Hospiras product. In June 2009, the District Court entered
summary judgment of non-infringement in favor of Hospira. Plaintiffs
appealed that decision and, in September 2009, the U.S. Court of Appeals
for the Federal Circuit vacated the District Courts ruling. In April 2010,
Hospira settled the litigation. Pursuant to the settlement, Hospira exited the
U.S. market with its oxaliplatin products on June 30, 2010 and intends to
re-launch its products pursuant to a royalty-free license on August 9,
2012.
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 June 30, 2010, there are a total of 69 cases,
involving 87 plaintiffs, in which Hospira is a party. 28 cases are pending in
federal court and 41 cases are pending in state court. One case is being
pursued as a class action lawsuit. Pursuant to its separation agreement with
Abbott, Hospira is defending those lawsuits which relate to sales of products
prior to Hospiras spin-off from Abbott. Hospira denies all material
allegations asserted against it in the complaint. Generally, plaintiffs seek
compensatory damages and, in some cases, punitive damages and costs.
On September 4, 2009,
Hospira brought suit against Sandoz International GmbH and Sandoz, Inc.
for patent infringement. The lawsuit, which alleges infringement of U.S.
Patents 4,910,214 (expires July 15, 2013) and 6,716,867 (expires March 31,
2019), is 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 Sandozs Paragraph
IV notice indicating that Sandoz had filed an abbreviated new drug application
(ANDA) with the FDA for a generic version of Hospiras Precedex
TM
(dexmedetomidine
hydrochloride). Hospira seeks a judgment of infringement, injunctive relief and
costs.
Hospira is subject to
certain regulatory matters. Regulatory matters may lead to voluntary or
involuntary product recalls, injunctions to halt manufacture and distribution
of products, monetary sanctions and other restrictions on operations.
Hospiras litigation
exposures, including product liability claims and regulatory matters, are
evaluated each reporting period. Hospiras reserves, which are not significant
at June 30, 2010 and December 31, 2009, except for the RTI settlement
discussed above and are the best estimate of loss. 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 Hospiras financial position, cash flows,
or results of operations.
Note 16
Shareholders Equity
Common
Stock
Hospira is authorized to
issue 400.0 million shares of common stock, par value $0.01 per share, and
50.0 million shares of preferred stock, par value $0.01 per share. As of June 30,
2010 and December 31, 2009, 174.6 million and 171.1 million common shares
were issued and 167.0 million and 163.5 million common shares were outstanding,
respectively.
Treasury
Stock
In February 2006,
Hospiras board of directors authorized the repurchase of up to $400 million of
Hospiras common stock. Hospira
17
Table of Contents
has repurchased 7.6 million
shares for $299.8 million in the aggregate under the 2006 board authorization,
all of which were purchased during 2006. Hospira is considering repurchasing
all or some of the remaining authorized amount of $100.2 million.
Note 17 Comprehensive
(Loss) Income and Accumulated Other Comprehensive Loss
,
net of tax
Comprehensive (loss) income,
net of taxes, for the three and six months ended June 30, consists of the
following:
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
(dollars
in millions)
|
|
2010
|
|
2009
|
|
2010
|
|
2009
|
|
Foreign
currency translation adjustments, net of taxes of $0.0
|
|
$
|
(125.7
|
)
|
$
|
174.8
|
|
$
|
(134.3
|
)
|
$
|
147.5
|
|
Pension
liability adjustments, net of taxes $(0.7) million and $(0.4) million for the
three months ended June 30, 2010 and 2009, respectively, and $(1.2)
million and $(0.8) million for the six months ended June 30, 2010 and
2009, respectively
|
|
1.2
|
|
0.9
|
|
2.3
|
|
1.5
|
|
Unrealized
gains (losses) on marketable equity securities, net of taxes $0.0
|
|
0.4
|
|
0.2
|
|
(1.3
|
)
|
0.2
|
|
Reclassification
of other-than-temporary impairment charge included in net income
|
|
|
|
16.6
|
|
|
|
16.6
|
|
Reclassification
of losses on terminated cash flow hedges, net of taxes $(0.1) million and
$(0.1) million for the three months ended June 30, 2010 and 2009,
respectively, and $(0.2) million and $(0.3) million for the six months ended
June 30, 2010 and 2009, respectively
|
|
0.1
|
|
0.2
|
|
0.3
|
|
0.5
|
|
Other
comprehensive (loss) income
|
|
(124.0
|
)
|
192.7
|
|
(133.0
|
)
|
166.3
|
|
Net
Income
|
|
83.5
|
|
25.5
|
|
225.2
|
|
191.0
|
|
Comprehensive
(Loss) Income
|
|
$
|
(40.5
|
)
|
$
|
218.2
|
|
$
|
92.2
|
|
$
|
357.3
|
|
Accumulated other comprehensive
loss, net of taxes, consists of the following:
|
|
June 30,
|
|
December 31,
|
|
(dollars
in millions)
|
|
2010
|
|
2009
|
|
Cumulative
foreign currency translation adjustments, net of taxes of $0.0
|
|
$
|
(62.9
|
)
|
$
|
71.4
|
|
Cumulative
retirement plans unrealized losses, net of taxes $63.2 million and $65.3
million, respectively
|
|
(103.1
|
)
|
(105.4
|
)
|
Cumulative
unrealized gains on marketable equity securities, net of taxes of $0.0
|
|
5.1
|
|
6.4
|
|
Cumulative
gains (losses) on terminated cash flow hedges, net of taxes $(0.1) million
and $0.1 million, respectively
|
|
0.1
|
|
(0.2
|
)
|
Accumulated
Other Comprehensive Loss
|
|
$
|
(160.8
|
)
|
$
|
(27.8
|
)
|
Note 18
Segment Information
Hospira conducts operations
worldwide and is managed in three reportable segments: Americas, EMEA and APAC.
The Americas segment includes the aggregation of the U.S., Canada and Latin
America operating segments; the EMEA segment includes Europe, the Middle East
and Africa; and the APAC segment includes Asia, Japan and Australia. Hospira
has five operating segments: U.S., Canada, Latin America, EMEA and APAC. In all
segments, Hospira sells a broad line of products, including specialty
injectable pharmaceuticals, other pharmaceuticals, medication management
systems and other devices. Specialty Injectable Pharmaceuticals include generic
injectables and proprietary specialty injectables. Other Pharmaceuticals
include large volume intravenous solutions, nutritionals and contract
manufacturing services. Medication Management Systems include infusion pumps,
related software, services and administration sets. Other Devices include
gravity administration sets, critical care products (through August 2009)
and other device products.
Hospiras underlying
accounting records are maintained on a legal-entity basis for government and public
reporting requirements. Segment disclosures are on a performance basis
consistent with internal management reporting. For internal management
reporting, intersegment transfers of inventory are recorded at standard cost
and are not a measure of segment income from operations. The costs of certain
corporate functions, stock-based compensation, interest expense, and other
(income) expense, net that benefit the entire organization are not allocated.
The following segment information has been prepared in accordance with the
internal accounting policies of Hospira, as described above.
18
Table of Contents
Reportable segment information:
The table below presents
information about Hospiras reportable segments:
|
|
Three Months Ended June 30,
|
|
|
|
Net Sales
|
|
Income (Loss) from Operations
|
|
(dollars
in millions)
|
|
2010
|
|
2009
|
|
2010
|
|
2009
|
|
|
|
|
|
|
|
|
|
|
|
Americas
|
|
$
|
781.1
|
|
$
|
751.7
|
|
$
|
161.2
|
|
$
|
123.2
|
|
EMEA
|
|
120.8
|
|
138.4
|
|
(5.4
|
)
|
1.2
|
|
APAC
|
|
66.3
|
|
66.8
|
|
10.0
|
|
(2.8
|
)
|
|
|
|
|
|
|
|
|
|
|
Total
reportable segments
|
|
$
|
968.2
|
|
$
|
956.9
|
|
165.8
|
|
121.6
|
|
|
|
|
|
|
|
|
|
|
|
Corporate
functions
|
|
|
|
|
|
(39.0
|
)
|
(20.9
|
)
|
Stock-based
compensation
|
|
|
|
|
|
(10.5
|
)
|
(9.6
|
)
|
Income
from operations
|
|
|
|
|
|
116.3
|
|
91.1
|
|
Interest
expense and other (income) expense, net
|
|
|
|
|
|
(23.4
|
)
|
(42.7
|
)
|
|
|
|
|
|
|
|
|
|
|
Income
before income taxes
|
|
|
|
|
|
$
|
92.9
|
|
$
|
48.4
|
|
|
|
Six Months Ended June 30,
|
|
|
|
Net Sales
|
|
Income (Loss) from Operations
|
|
(dollars
in millions)
|
|
2010
|
|
2009
|
|
2010
|
|
2009
|
|
|
|
|
|
|
|
|
|
|
|
Americas
|
|
$
|
1,596.9
|
|
$
|
1,436.4
|
|
$
|
407.9
|
|
$
|
258.2
|
|
EMEA
|
|
243.3
|
|
259.6
|
|
7.8
|
|
11.3
|
|
APAC
|
|
135.6
|
|
120.6
|
|
6.9
|
|
0.4
|
|
|
|
|
|
|
|
|
|
|
|
Total
reportable segments
|
|
$
|
1,975.8
|
|
$
|
1,816.6
|
|
422.6
|
|
269.9
|
|
|
|
|
|
|
|
|
|
|
|
Corporate
functions
|
|
|
|
|
|
(70.9
|
)
|
(41.4
|
)
|
Stock-based
compensation
|
|
|
|
|
|
(27.8
|
)
|
(22.7
|
)
|
Income
from operations
|
|
|
|
|
|
323.9
|
|
205.8
|
|
Interest
expense and other (income) expense, net
|
|
|
|
|
|
(45.1
|
)
|
(69.3
|
)
|
|
|
|
|
|
|
|
|
|
|
Income
before income taxes
|
|
|
|
|
|
$
|
278.8
|
|
$
|
136.5
|
|
|
|
Goodwill
|
|
|
|
June 30,
|
|
December 31,
|
|
(dollars
in millions)
|
|
2010
|
|
2009
|
|
|
|
|
|
|
|
Americas
|
|
$
|
936.5
|
|
$
|
817.2
|
|
EMEA
|
|
212.8
|
|
228.8
|
|
APAC
|
|
216.8
|
|
197.4
|
|
|
|
|
|
|
|
Total
reportable segments
|
|
$
|
1,366.1
|
|
$
|
1,243.4
|
|
19
Table of Contents
Item 2. Managements
Discussion and Analysis of Financial Condition and Results of Operations
Forward-Looking
Statements
This 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 words such as may, will, should, anticipate,
estimate, expect, plan, believe, predict, potential, project, intend,
could, or similar expressions. In particular, statements regarding Hospiras
plans, strategies, prospects and expectations regarding its business and
industry are forward-looking statements. Investors should be aware that these
statements and any other forward-looking statements in this document only
reflect Hospiras expectations and are not guarantees of performance. These
statements involve risks, uncertainties and assumptions. Many of these risks,
uncertainties and assumptions are beyond Hospiras control, and may cause
actual results and performance to differ materially from expectations.
Important factors that could cause Hospiras actual results to be materially
different from its expectations include (i) the risks and uncertainties
described in Item 1A. Risk Factors in Hospiras Annual Report on
Form 10-K for the year ended December 31, 2009 (the 2009
Form 10-K) and (ii) the factors described in Item 7. Managements
Discussion and Analysis of Financial Condition and Results of Operations in
the 2009 Form 10-K, and the factors described in Item 2. Managements
Discussion and Analysis of Financial Condition and Results of Operations in
the report on Form 10-Q for the three month period ended March 31,
2010, as updated by this Item 2. Accordingly, you should not place undue
reliance on the forward-looking statements contained in this 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.
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. Hospiras portfolio includes generic acute-care
and oncology injectables, as well as integrated infusion therapy and medication
management systems. Hospiras broad portfolio of products is used by hospitals
and alternate site providers, such as clinics, home healthcare providers and
long-term care facilities.
The ability to maintain
group purchasing organization (GPO) contracts is an important factor for
Hospira to generate sales. During the second quarter of 2010, Hospira renewed
two five-year contracts with a GPO, Novation, for pharma and device products,
taking effect in October 2010.
Acquisitions
In July 2010, Hospira
completed the acquisition of Javelin Pharmaceuticals, Inc. (Javelin
Pharma) for a purchase price of approximately $161.7 million. The
purchase price was comprised of approximately $145 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 impact of Javelin
Pharmas operations on Hospira in 2010 will depend on the various product
development and commercialization efforts, and the corresponding regulatory
outcomes in connection therewith.
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. Approximately $11 million of primarily acquisition related pre-tax
charges were recognized, majority of which was in Selling, general and
administrative, during the six months ended June 30, 2010. The impact of
this acquisition was not material to Hospiras results of operations for the
three and six months ended June 30, 2010, exclusive of the acquisition
related charges. For further details, see Note 2 to the condensed
consolidated financial statements included in Part I Item 1.
Governmental
Regulation
Hospiras 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 Hospiras business. The Acts increase access to healthcare
and establish a United States (U.S.) pathway for biogenerics. 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 excess tax to have an overall,
after-tax impact of less than $0.10 per share annually. The Acts eliminated the
future tax deduction for prescription drug costs associated with Hospiras
post-retirement medical and dental plans for which Hospira receives Medicare
Part D subsidies. The impact to Hospira was not material. Hospira
continues to evaluate the potential impact of other sections of this
legislation on the post-retirement medical and dental and current medical and
dental plans, but does not anticipate a material impact to Hospira.
20
Table of Contents
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 the buildings and
certain equipment, impairments, relocation of production, process optimization
implementation, other asset charges, exit costs and gain on disposal of assets.
Project
Fuel
2009
Actions.
In March 2009, Hospira announced details
of a restructuring and optimization plan (Project Fuel), which will occur
over the next two years from the date of announcement. Project Fuel includes
the following activities: optimizing the product portfolio, evaluating
non-strategic assets and streamlining the organizational structure. Hospira now
expects to incur aggregate charges related to these actions in the range of
$140 million to $160 million on a pre-tax basis, of which
approximately $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 an expected decrease in employee-related 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.
Hospira incurred aggregate pre-tax charges through June 30, 2010 of $104.8
million with $49.7 reported as restructuring costs and other asset charges.
In February 2010,
Hospira completed the disposal of a facility in Wasserburg, Germany, which
primarily performed contract manufacturing in the EMEA segment for $69.3
million, 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.
Facilities
Optimization
2008 and
2006 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. Recent market
opportunities for Hospira pumps may extend the exit date beyond the original announced
time frame. Hospira expects to incur aggregate charges through 2011 related to
these actions in the range of $29 million to $35 million on a pre-tax basis, of
which approximately $20 million to $24 million are expected to be reported as
restructuring charges. Hospira is in the process of transferring related
operations and production of the primary products to other Hospira facilities,
or outsourcing certain product components to third-party suppliers, or ceasing
activities entirely. Hospira incurred aggregate pre-tax charges to date of
$30.0 million, with $21.8 million reported as restructuring. In
February 2006, Hospira announced plans to close manufacturing plants in
Ashland, Ohio; Montreal, Canada; and North Chicago, Illinois, and
completed these plans in 2007, 2008, and in March 2009, respectively.
Restructuring, impairment,
optimization costs and gain on disposition of assets incurred for Project Fuel
and Facilities Optimization collectively were reported in the condensed
consolidated statements of income line items included in Part I Item 1 as
follows:
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
(dollars
in millions)
|
|
2010
|
|
2009
|
|
2010
|
|
2009
|
|
Cost
of products sold
|
|
$
|
6.1
|
|
$
|
5.2
|
|
$
|
11.8
|
|
$
|
12.2
|
|
Restructuring,
impairment and (gain) on disposition of assets, net
|
|
2.6
|
|
55.9
|
|
(5.0
|
)
|
65.3
|
|
Research
and development
|
|
0.1
|
|
0.9
|
|
0.3
|
|
1.3
|
|
Selling,
general and administrative
|
|
4.8
|
|
9.2
|
|
8.1
|
|
14.6
|
|
Total
pre-tax Project Fuel and Facilities Optimization charges
|
|
$
|
13.6
|
|
$
|
71.2
|
|
$
|
15.2
|
|
$
|
93.4
|
|
As Hospira continues to
consider each Project Fuel and Facilities Optimization activity, the amount,
the timing and recognition of charges will be affected by the occurrence of
commitments and triggering events as defined under accounting principles
generally accepted in the United States (GAAP), among other factors. For
further details regarding the impact of these cost-reduction and optimization
activities, see Note 3 to the condensed consolidated financial statements
included in Part I Item 1.
21
Table of Contents
Certain
Quality and Product Related Matters
In August 2009, Hospira
received a Warning Letter from the U.S. Food and Drug Administration (FDA)
related to Hospiras corrective action plans with respect to the failure of
certain AC power cords manufactured by a third party. The affected power cords
are used on certain infusion pumps and related products. Hospira
initiated a voluntary recall of the affected power cords in August 2009.
The recall was limited to device power cords with a certain prong design that
could crack and fail at/or inside the plug. Although Hospira had not received
any reports of serious patient harm, Hospira had received customer reports of
sparking or charring on the plug of these power cords. The FDAs Warning Letter
cited deficiencies regarding Hospiras initial corrective action plans, and
that Hospira failed to identify the actions needed to correct and prevent the
recurrence of nonconforming product and other quality problems. More
specifically, Hospiras initial corrective action plans included the gradual
introduction of replacement power cords, but did not require the removal of the
affected power cords from the market.
Hospira has responded to the
August 2009 Warning Letter and is working closely with the FDA to conclude this
matter. Hospira has initiated and completed a substantial portion of the field
corrections and other remediation activities with respect to the recalled
products, which involved exchanging the affected power cords with replacement
power cords, for which the related costs had been reserved for during
2009. 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 had not been significant to date to Hospira. It is possible that
additional costs related to this recall may be required in future periods,
based on modifications to the current remediation plans and changes in
estimates as a result of the ongoing dialogue with the FDA.
In April 2010, Hospira
placed a voluntary hold on all shipments of Symbiq
TM
pumps, a large volume
infusion device, to new customers. Hospira initiated this hold after it
received an unexplained increase in customer complaints related to the failure
of the Symbiq
TM
pump 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
pump to alarm at the end of infusion therapy.
Hospira has not asked customers to return or cease using their Symbiq
TM
pumps. The FDA has
classified this voluntary action as a Class I recall and Hospira is
working with the FDA to finalize a comprehensive action plan to address this
issue. Hospira cannot predict when it
will lift this voluntary hold. Hospira has recognized charges in Cost of
products sold for quality assessment and testing, materials, and labor to
remediate this matter, which have not been significant to date to Hospira.
In April 2010, Hospira
received a Warning Letter from the FDA in connection with the FDAs inspection
of Hospiras 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 Hospiras
interim plans ensured the quality of products that were manufactured at the
facilities while implementing the corrective actions and validation activities.
Hospira has begun to undertake 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 Hospiras response, Hospira took immediate actions to
address the FDAs 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 Hospiras products from these facilities but Hospira
is holding shipment of certain products pending its further investigation and
discussions with the FDA. Hospira is working to resume shipment of these
products, but cannot predict when such shipments will commence.
During the three months
ended June 30, 2010, Hospira recognized pre-tax charges, in Cost of
products sold, of $25.8 million for third party oversight and consulting, and
penalties for failure to supply product to certain customers under various
contracts, all directly associated with Hospiras response to the FDAs 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 Hospiras assessment of the status of its quality operations on a holistic
basis throughout its global manufacturing facilities. Hospira expects to incur
an additional $10 million to $15 million per remaining quarter in 2010 related
to these activities.
22
Table of Contents
These quality matters have
impacted, and may impact further, Hospiras ability to market and sell certain
products including Symbiq
TM
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 FDAs Warning Letters
are publicly available on the FDAs website. Hospira takes all of these matters
seriously and intends to respond fully, and in a timely manner, to the FDAs
Warning Letters. Hospira cannot, however, give any assurances as to the expected
date of resolution of the matters related to the Symbiq
TM
pump 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 action
by the FDA, including the withholding of approval of new drug applications,
product seizure, injunction, and/or civil monetary penalties. Any such
additional FDA actions, or further adverse developments related to the Symbiq
TM
pump, 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 Hospiras response and corrective actions.
23
Table of Contents
Results of
operations for the three months ended June 30, 2010 compared to June 30,
2009
Net Sales
A comparison of product line
sales is as follows:
Hospira, Inc.
Net Sales by Product Line
(Unaudited)
(dollars in millions)
|
|
Three Months Ended June 30,
|
|
|
|
2010
|
|
2009
|
|
Percent Change
at Actual
Currency Rates
|
|
Percent Change
at Constant
Currency Rates
(1)
|
|
Americas
|
|
|
|
|
|
|
|
|
|
Pharmaceuticals
|
|
|
|
|
|
|
|
|
|
Specialty
Injectables
|
|
$
|
453.0
|
|
$
|
368.5
|
|
22.9
|
%
|
21.6
|
%
|
Other
Pharma
|
|
122.9
|
|
139.4
|
|
(11.8
|
)%
|
(12.3
|
)%
|
|
|
575.9
|
|
507.9
|
|
13.4
|
%
|
12.3
|
%
|
Devices
|
|
|
|
|
|
|
|
|
|
Medication
Management Systems
|
|
120.4
|
|
152.2
|
|
(20.9
|
)%
|
(21.9
|
)%
|
Other
Devices
|
|
84.8
|
|
91.6
|
|
(7.4
|
)%
|
(8.8
|
)%
|
|
|
205.2
|
|
243.8
|
|
(15.8
|
)%
|
(17.0
|
)%
|
Total
Americas
|
|
781.1
|
|
751.7
|
|
3.9
|
%
|
2.8
|
%
|
|
|
|
|
|
|
|
|
|
|
Europe,
Middle East & Africa (EMEA)
|
|
|
|
|
|
|
|
|
|
Pharmaceuticals
|
|
|
|
|
|
|
|
|
|
Specialty
Injectables
|
|
67.3
|
|
68.1
|
|
(1.2
|
)%
|
4.3
|
%
|
Other
Pharma
|
|
24.9
|
|
35.4
|
|
(29.7
|
)%
|
(27.1
|
)%
|
|
|
92.2
|
|
103.5
|
|
(10.9
|
)%
|
(6.5
|
)%
|
Devices
|
|
|
|
|
|
|
|
|
|
Medication
Management Systems
|
|
16.5
|
|
17.5
|
|
(5.7
|
)%
|
0.6
|
%
|
Other
Devices
|
|
12.1
|
|
17.4
|
|
(30.5
|
)%
|
(24.7
|
)%
|
|
|
28.6
|
|
34.9
|
|
(18.1
|
)%
|
(12.0
|
)%
|
Total
EMEA
|
|
120.8
|
|
138.4
|
|
(12.7
|
)%
|
(7.9
|
)%
|
|
|
|
|
|
|
|
|
|
|
Asia
Pacific (APAC)
|
|
|
|
|
|
|
|
|
|
Pharmaceuticals
|
|
|
|
|
|
|
|
|
|
Specialty
Injectables
|
|
54.1
|
|
53.0
|
|
2.1
|
%
|
(7.9
|
)%
|
Other
Pharma
|
|
1.8
|
|
2.7
|
|
(33.3
|
)%
|
(44.4
|
)%
|
|
|
55.9
|
|
55.7
|
|
0.4
|
%
|
(9.7
|
)%
|
Devices
|
|
|
|
|
|
|
|
|
|
Medication
Management Systems
|
|
5.5
|
|
4.9
|
|
12.2
|
%
|
4.1
|
%
|
Other
Devices
|
|
4.9
|
|
6.2
|
|
(21.0
|
)%
|
(27.4
|
)%
|
|
|
10.4
|
|
11.1
|
|
(6.3
|
)%
|
(13.5
|
)%
|
Total
APAC
|
|
66.3
|
|
66.8
|
|
(0.7
|
)%
|
(10.3
|
)%
|
|
|
|
|
|
|
|
|
|
|
Net
Sales
|
|
$
|
968.2
|
|
$
|
956.9
|
|
1.2
|
%
|
0.3
|
%
|
Specialty Injectables
include generic injectables and proprietary specialty injectables. Other Pharmaceuticals
include large volume I.V. solutions, nutritionals and contract manufacturing
services. Medication Management Systems include infusion pumps, related
software, services and administration sets. Other Devices include gravity
administration sets, critical care products (through August 2009) and
other device products.
24
Table of Contents
(1)
The comparisons
at constant currency rates reflect comparative local currency balances at prior
periods foreign exchange rates. We have calculated these percentages by taking
current period reported net sales less the respective prior period reported net
sales, divided by the prior period reported net sales, all at the respective
prior periods 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 Hospiras
results of operations. Management uses these measures internally to monitor business
unit performance and in evaluating management performance. These measures are
intended to supplement the applicable GAAP measures and should not be
considered in isolation from or a replacement for, financial measures prepared
in accordance with GAAP.
Net sales increased 1.2%, or
0.3% 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 Hospiras commitment to dispose of certain non-strategic
businesses and underlying assets as part of Project Fuel and affected the Other
Devices and Other Pharma 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. Other Devices 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.
Americas
Net sales in the Americas
segment increased 3.9%, or 2.8% excluding the impact of changes in foreign
exchange rates. Net sales of Specialty Injectable Pharmaceuticals increased
primarily due to the continued strong performance of oxaliplatin in the U.S.,
increased volume for Hospiras proprietary sedation drug, Precedex
TM
, and other new product
introductions. The increase was offset by a decrease in volume of certain
anti-infective products and a voluntary hold on shipments of certain emulsion
products. In April 2010, Hospira reached an agreement to settle the U.S.
litigation related to oxaliplatin, see Note 15 to the condensed consolidated
financial statements included in Part I Item 1. 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. The litigation has impacted the
quantities and types of generic oxaliplatin product available in the market
thereby affecting the rate of end customer price movements and contributed to
the release of a portion of the chargeback accrual relating to prior period
oxaliplatin product sales as the expected rate of price decrease was
significantly less than estimated and typically experienced in generic products
launches. Net sales in Medication Management Systems were lower driven by
decreased volumes related to the voluntary hold on shipments of Symbiq
TM
pumps and decreased Plum
TM
pumps volumes related to temporary supply
constraints.
EMEA
Net sales in the EMEA
segment decreased (12.7)%, or (7.9)% excluding the impact of changes in foreign
exchange rates. Specialty Injectable Pharmaceuticals net sales were higher with
continued growth of a biogeneric product, Retacrit
TM
, as well as other oncology products, offset by
price decreases due to competition in certain existing oncology products and
anti-infective products. Medication Management Systems net sales were
essentially flat with increased volumes in ambulatory dedicated administration
sets partly offset by decreased volume of large volume infusion systems.
APAC
Net sales in the APAC
segment decreased (0.7)%, or (10.3)% excluding the impact of changes in foreign
exchange rates. Specialty Injectable Pharmaceuticals net sales decreased,
primarily due to wholesaler buying patterns in the first half of the year.
Medication Management Systems net sales increased due to higher volumes in dedicated
administration sets.
25
Table of Contents
Gross
Profit (Net sales less Cost of product sold)
Three
months ended June 30 (dollars in millions)
|
|
2010
|
|
2009
|
|
Percent
change
|
|
Gross
profit
|
|
$
|
369.2
|
|
$
|
346.2
|
|
6.6
|
%
|
As
a percent of net sales
|
|
38.1
|
%
|
36.2
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit increased $23.0
million, or 6.6%, for the three months ended June 30, 2010, compared with
the same period in 2009.
The gross profit increase
was primarily the result of higher sales volume and favorable product mix
including the impact of the U.S. oxaliplatin sales and continued higher sales
of Precedex
TM
. In addition,
cost reductions associated with Project Fuel initiatives and the impact of
foreign exchange contributed to the increase, partly offset by activities
directly associated with the FDAs Warning Letter received in April 2010
and voluntary shipment holds on certain products, as previously described, as well
as penalties for failure to supply customers and increased warranty charges on
these and other products.
Restructuring, Impairment
and (gain) on disposition of assets, net
Three
months ended June 30 (dollars in millions)
|
|
2010
|
|
2009
|
|
Percent
change
|
|
Restructuring,
impairment and (gain) on disposition of assets, net
|
|
$
|
2.6
|
|
$
|
55.9
|
|
(95.3
|
)%
|
As
a percent of net sales
|
|
0.3
|
%
|
5.8
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring, impairment
and (gain) on disposition of assets, net were $2.6 million for the three months
ended June 30, 2010, and $55.9 million for the same period in 2009.
Restructuring, primarily severance costs, incurred for the three months ended June 30,
2010 were related to Project Fuel initiatives and actions taken at the
manufacturing plant in Morgan Hill, California. The restructuring and
impairment charges incurred for the three months ended June 30, 2009 were
primarily due to non-cash, pre-tax charges of $48.3 million related to the
impairment of property and equipment, allocated goodwill and intangible assets
associated with Project Fuel initiatives.
Research
and Development
Three
months ended June 30 (dollars in millions)
|
|
2010
|
|
2009
|
|
Percent
change
|
|
Research
and development
|
|
$
|
80.4
|
|
$
|
52.9
|
|
52.0
|
%
|
As
a percent of net sales
|
|
8.3
|
%
|
5.5
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
expenses increased $27.5 million, or 52.0%, for the three months ended June 30,
2010, compared with the same period in 2009. The increase is related to an
initial milestone payment of $27.5 million related to an agreement with DURECT
Corporation for research and development of an anesthetic product that has not
yet reached regulatory approval.
Selling,
General and Administrative
Three
months ended June 30 (dollars in millions)
|
|
2010
|
|
2009
|
|
Percent
change
|
|
Selling,
general and administrative
|
|
$
|
169.9
|
|
$
|
146.3
|
|
16.1
|
%
|
As
a percent of net sales
|
|
17.5
|
%
|
15.3
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative expenses increased $23.6 million, or 16.1%, for the three months
ended June 30, 2010, compared with the same period in 2009. The increase
was primarily due to higher legal costs, the RTI litigation settlement and
related charges and higher costs associated with Project Fuel initiatives,
including related information technology optimization.
Interest
Expense and Other (Income) Expense, Net
Hospira incurred interest
expense of $24.2 million for the three months ended June 30, 2010 and
$28.2 million in the same period in 2009. The decrease was primarily due to
lower average outstanding debt and the impact of variable interest rate swaps
on fixed rate notes. Other (income) expense, net was $(0.8) million income for
the three months ended June 30, 2010 compared to $14.5 million expense for
the three months ended June 30, 2009, primarily due to an
other-than-temporary impairment of marketable equity securities charge of $16.6
million.
26
Table of Contents
Income Tax
Expense
The effective tax rate
decreased to 10.1% for the three months ended June 30, 2010, compared to
47.3% for the same period in 2009.
During the three months ended June 30, 2010, Hospira experienced an
increase in deductible expenses in higher tax jurisdictions. During the three
months ended June 30, 2009, the effective tax rate was unfavorably
impacted by the establishment of a valuation allowance on certain deferred tax
assets associated with the impairment of certain non-strategic assets,
impairment of non-deductible goodwill, as well as the impairment of certain
marketable equity securities without the availability of a statutory tax
benefit. Excluding these impairment-related tax treatments, 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.
27
Table of Contents
Results of
operations for the six months ended June 30, 2010 compared to June 30,
2009
Net Sales
A comparison of product line
sales is as follows:
Hospira, Inc.
Net Sales by Product Line
(Unaudited)
(dollars in millions)
|
|
Six Months Ended June 30,
|
|
|
|
2010
|
|
2009
|
|
Percent Change
at Actual
Currency Rates
|
|
Percent Change
at Constant
Currency Rates
(1)
|
|
Americas
|
|
|
|
|
|
|
|
|
|
Pharmaceuticals
|
|
|
|
|
|
|
|
|
|
Specialty
Injectables
|
|
$
|
936.9
|
|
$
|
701.6
|
|
33.5
|
%
|
31.8
|
%
|
Other
Pharma
|
|
248.3
|
|
277.2
|
|
(10.4
|
)%
|
(10.9
|
)%
|
|
|
1,185.2
|
|
978.8
|
|
21.1
|
%
|
19.7
|
%
|
Devices
|
|
|
|
|
|
|
|
|
|
Medication
Management Systems
|
|
246.8
|
|
273.6
|
|
(9.8
|
)%
|
(11.5
|
)%
|
Other
Devices
|
|
164.9
|
|
184.0
|
|
(10.4
|
)%
|
(11.8
|
)%
|
|
|
411.7
|
|
457.6
|
|
(10.0
|
)%
|
(11.6
|
)%
|
Total
Americas
|
|
1,596.9
|
|
1,436.4
|
|
11.2
|
%
|
9.7
|
%
|
|
|
|
|
|
|
|
|
|
|
EMEA
|
|
|
|
|
|
|
|
|
|
Pharmaceuticals
|
|
|
|
|
|
|
|
|
|
Specialty
Injectables
|
|
137.2
|
|
125.7
|
|
9.1
|
%
|
8.3
|
%
|
Other
Pharma
|
|
43.5
|
|
63.1
|
|
(31.1
|
)%
|
(31.4
|
)%
|
|
|
180.7
|
|
188.8
|
|
(4.3
|
)%
|
(5.0
|
)%
|
Devices
|
|
|
|
|
|
|
|
|
|
Medication
Management Systems
|
|
35.6
|
|
36.6
|
|
(2.7
|
)%
|
(2.5
|
)%
|
Other
Devices
|
|
27.0
|
|
34.2
|
|
(21.1
|
)%
|
(21.3
|
)%
|
|
|
62.6
|
|
70.8
|
|
(11.6
|
)%
|
(11.6
|
)%
|
Total
EMEA
|
|
243.3
|
|
259.6
|
|
(6.3
|
)%
|
(6.8
|
)%
|
|
|
|
|
|
|
|
|
|
|
APAC
|
|
|
|
|
|
|
|
|
|
Pharmaceuticals
|
|
|
|
|
|
|
|
|
|
Specialty
Injectables
|
|
111.7
|
|
92.0
|
|
21.4
|
%
|
3.5
|
%
|
Other
Pharma
|
|
3.9
|
|
6.3
|
|
(38.1
|
)%
|
(49.2
|
)%
|
|
|
115.6
|
|
98.3
|
|
17.6
|
%
|
0.1
|
%
|
Devices
|
|
|
|
|
|
|
|
|
|
Medication
Management Systems
|
|
10.8
|
|
9.6
|
|
12.5
|
%
|
2.1
|
%
|
Other
Devices
|
|
9.2
|
|
12.7
|
|
(27.6
|
)%
|
(36.2
|
)%
|
|
|
20.0
|
|
22.3
|
|
(10.3
|
)%
|
(19.7
|
)%
|
Total
APAC
|
|
135.6
|
|
120.6
|
|
12.4
|
%
|
(3.6
|
)%
|
|
|
|
|
|
|
|
|
|
|
Net
Sales
|
|
$
|
1,975.8
|
|
$
|
1,816.6
|
|
8.8
|
%
|
6.5
|
%
|
Specialty Injectables
include generic injectables and proprietary specialty injectables. Other
Pharmaceuticals include large volume I.V. solutions, nutritionals and contract
manufacturing services. Medication Management Systems include infusion pumps,
related software, services and administration sets. Other Devices include
gravity administration sets, critical care products (through August 2009)
and other device products.
(1)
The comparisons at constant
currency rates reflect comparative local currency balances at prior periods
foreign exchange rates. We have calculated these percentages by taking current
period reported net sales less the respective prior period reported net sales,
divided by the prior period reported net sales, all at the respective prior
periods 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 Hospiras
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.
28
Table of Contents
Net sales increased 8.8%, or
6.5% 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 Hospiras commitment to dispose of certain non-strategic
businesses and underlying assets as part of Project Fuel and affected the Other
Devices and Other Pharma 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. Other Devices 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.
Americas
Net sales in the Americas
segment increased 11.2%, or 9.7% excluding the impact of changes in foreign
exchange rates. Net sales of Specialty Injectable Pharmaceuticals increased
primarily due to the continued strong performance of generic oxaliplatin in the
U.S., increased volume for Hospiras proprietary sedation drug, Precedex
TM
, and other new product
introductions, offset by a decrease in volume of certain anti-infective
products and a voluntary hold on shipments of certain emulsion products. Net
sales in Medication Management Systems were lower driven by decreased volumes
related to the voluntary hold on shipments of Symbiq
TM
pumps.
EMEA
Net sales in the EMEA segment decreased (6.3)%, or (6.8)% excluding the
impact of changes in foreign exchange rates. Specialty Injectable
Pharmaceuticals net sales were higher with continued growth of a biogeneric
product, Retacrit
TM
, as well as
oncology and anti-infectives product introductions, offset by price decreases
due to competition in certain existing oncology products. Medication Management
Systems net sales decreased due to lower volume of large volume infusion
systems partly offset by increased volumes in ambulatory dedicated
administration sets.
APAC
Net sales in the APAC segment increased 12.4%. Excluding the impact of
changes in foreign exchange rates net sales decreased (3.6)%. Specialty
Injectable Pharmaceuticals net sales increased primarily due to volume in
oncology and cardiovascular products. Medication Management Systems net sales
increased due to higher volumes in dedicated administration sets.
Gross Profit (Net sales less Cost of product sold)
Six months
ended June 30 (dollars in millions)
|
|
2010
|
|
2009
|
|
Percent
change
|
|
Gross
profit
|
|
$
|
799.5
|
|
$
|
665.8
|
|
20.1
|
%
|
As
a percent of net sales
|
|
40.5
|
%
|
36.7
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit increased
$133.7 million, or 20.1%, for the six months ended June 30, 2010, compared
with the same period in 2009.
The gross profit increase
was primarily the result of higher sales volume and favorable product mix
including the impact of the U.S. oxaliplatin sales and continued higher sales
of Precedex
TM
. In addition,
cost reductions associated with Project Fuel initiatives and the impact of
foreign exchange contributed to the increase, partly offset by activities
directly associated with the FDAs Warning Letter received in April 2010
and voluntary shipment holds on certain products, as previously described, as
well as penalties for failure to supply customers and increased warranty
charges on these and other products.
29
Table of Contents
Restructuring, Impairment and (gain) on disposition of
asset, net
Six months
ended June 30 (dollars in millions)
|
|
2010
|
|
2009
|
|
Percent
change
|
|
Restructuring,
impairment and (gain) on disposition of assets, net
|
|
$
|
(5.0
|
)
|
$
|
65.3
|
|
(107.7
|
)%
|
As
a percent of net sales
|
|
(0.3
|
)%
|
3.6
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring, impairment
and (gain) on disposition of assets, net were $(5.0) million for the six months
ended June 30, 2010, compared with $65.3 million expense for the same
period 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
$6.4 million for the six months ended June 30, 2010. The
restructuring and impairment charges incurred for the six months ended June 30,
2009 were primarily due to non-cash, pre-tax charges of $48.3 million related
to the impairment of property and equipment, allocated goodwill and intangible
assets associated with Project Fuel initiatives.
Research and Development
Six months
ended June 30 (dollars in millions)
|
|
2010
|
|
2009
|
|
Percent
change
|
|
Research
and development
|
|
$
|
132.1
|
|
$
|
102.9
|
|
28.4
|
%
|
As
a percent of net sales
|
|
6.7
|
%
|
5.7
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
expenses increased $29.2 million, or 28.4%, for the six months ended June 30,
2010, compared with the same period in 2009. The increase was primarily related
to an initial milestone payment of $27.5 million related to an agreement with
DURECT Corporation for research and development of an anesthetic product that
has not yet reached regulatory approval and investments in various new product
development programs.
Selling, General and Administrative
Six months
ended June 30 (dollars in millions)
|
|
2010
|
|
2009
|
|
Percent
change
|
|
Selling,
general and administrative
|
|
$
|
348.5
|
|
$
|
291.8
|
|
19.4
|
%
|
As
a percent of net sales
|
|
17.6
|
%
|
16.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative expenses increased $56.7 million, or 19.4%, for the six months
ended June 30, 2010, compared with the same period in 2009. The increase
was primarily due to acquisition and integration charges associated with the
Orchid Pharma acquisition and higher costs associated with Project Fuel
initiatives, including related information technology optimization. Higher
legal costs, the RTI litigation settlement and related charges and the impact
of changes in foreign exchange rates also contributed to the increase.
Interest
Expense and Other (Income) Expense, Net
Hospira incurred interest
expense of $47.6 million for the six months ended June 30, 2010 and $55.1
million in the same period in 2009. The decrease was primarily due to lower
average outstanding debt and the impact of variable interest rate swaps on
fixed rate notes. Other (income) expense, net was $(2.5) million income for the
six months ended June 30, 2010 compared to $14.2 million expense for the
six months ended June 30, 2009, primarily due to an other-than-temporary
impairment of marketable equity securities charge of $16.6 million.
Income Tax
Expense (Benefit)
The effective tax rate was
an expense of 19.2% for the six months ended June 30, 2010, compared to a
benefit of 39.9% for the same period in 2009. During the six months ended June 30,
2010, a higher proportion of deductible expenses in higher tax jurisdictions
resulted in a lower effective tax rate. During the six months ended June 30,
2009, the Internal Revenue Service (IRS) audit of Hospiras 2004 and 2005 tax
returns was completed and the years were effectively settled. Excluding the
effect of the audit settlement
30
Table of Contents
discrete income tax benefit,
the effective tax rate for the six months ended June 30, 2009 was an
expense of 27.4%. The 2009 effective tax rate was higher due to the
establishment of a valuation allowance on certain deferred tax assets
associated with the impairment of certain non-strategic assets, impairment of
non-deductible goodwill, as well as the impairment of certain marketable equity
securities without the availability of a statutory tax benefit. Excluding both
the impairment-related tax treatments and the audit settlement tax benefit, the
operating 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.
31
Table of Contents
Liquidity
and Capital Resources
Net cash provided by
operating activities continues to be Hospiras 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, certain
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 property and equipment acquisition needs.
Hospira has incurred and may
incur futher charges related to certain quality and product related matters
that will require cash outflows in the future. These matters are further
discussed under the section Certain Quality and Product Related Matters in
Part I Item 2. Hospira currently believes current capital resources will
be sufficient to fund charges associated therewith.
In February 2006,
Hospiras board of directors authorized the repurchase of up to $400.0 million
of Hospiras common stock. Hospira has repurchased 7.6 million shares for
$299.8 million in the aggregate under the 2006 board authorization, all of
which were purchased during 2006. Hospira is considering repurchasing all or
some of the remaining authorized amount of $100.2 million.
Summary of
Cash Flows
|
|
Six Months Ended June 30,
|
|
(dollars
in millions)
|
|
2010
|
|
2009
|
|
Cash
flow provided by (used in):
|
|
|
|
|
|
Operating
activities
|
|
$
|
143.8
|
|
$
|
236.0
|
|
Investing
activities
|
|
(425.7
|
)
|
(95.2
|
)
|
Financing
activities
|
|
125.2
|
|
(23.1
|
)
|
|
|
|
|
|
|
|
|
Cash flows from operating
activities decreased in the six months ended June 30, 2010, compared with
the same period in 2009. Although net income increased compared to 2009,
changes in operating assets and liabilities resulted in a decrease in cash
flows of $161.1 million primarily due to the to timing of payments of
chargebacks related to sales of oxaliplatin, increased inventory levels, and
increased income tax and employee related payments.
Cash flows used in investing
activities increased during the six months ended June 30, 2010, primarily
due to payments of $397.7 million for acquisitions. Hospira received proceeds
of $62.6 million on the disposal of a facility in Wasserburg, Germany in 2010.
Cash flows provided by
financing activities increased primarily due to the proceeds from stock options
exercised and related excess tax benefit received during the six months ended June 30,
2010, compared to the same period of 2009. In addition, in 2009 Hospira paid
$300.0 million on the maturity of the notes due in June 2009 offset by the
issuance of $250.0 million aggregate principal amount notes.
Debt and
Capital
Hospira has a three-year
$700.0 million unsecured revolving credit facility expiring in
October 2012 in which no amounts are outstanding as of June 30, 2010.
Certain borrowing agreements
contain covenants that require compliance with, among other restrictions, a
maximum leverage ratio and a minimum interest coverage ratio. As of June 30,
2010, Hospira was in compliance with all applicable covenants.
Contractual
Obligations
There have been no material
changes to the contractual obligations information provided in Hospiras Annual
Report on Form 10-K for the year ended December 31, 2009, except for
approximately $145 million for the acquisition of Javelin Pharma on July 2,
2010.
32
Table of Contents
Critical
Accounting Policies
The preparation of financial
statements in accordance with GAAP requires management to make estimates and
judgments that affect the reported amounts of assets, liabilities, revenues and
expenses. A summary of Hospiras significant accounting policies is included in
Note 1 Summary of Significant Accounting Policies to the companys
consolidated financial statements, which are included in Hospiras Annual
Report on Form 10-K for the year ended December 31, 2009. Certain of
Hospiras accounting policies are considered critical, as these policies
require significant, difficult or complex judgments by management, often
employing the use of estimates about the effects of matters that are inherently
uncertain. Such policies are summarized in Item 7. Managements Discussion and
Analysis of Financial Condition and Results of Operations (Item 7) in the
2009 Form 10-K.
The significant accounting
policies disclosure contained in Note 1 to the condensed consolidated financial
statements included in Part I Item 1 hereof is incorporated herein by
reference.
Recently
Issued and Adoption of New Accounting Standards
The disclosures contained in
Note 1 to the condensed consolidated financial statements included in
Part I Item 1 hereof is incorporated herein by reference.
Item 3. Quantitative
and Qualitative Disclosures About Market Risk
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 June 30,
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 $(2.7) million would increase by $(0.8) million.
The sensitivity analysis
model recalculates the fair value of the foreign currency forward exchange
contracts outstanding at June 30, 2010 by replacing the actual exchange
rates at June 30, 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.
In June 2010, Hospira
terminated all existing interest rate swap contracts with a total notional
amount of $300.0 million. For further details, see Note 14 to the condensed
consolidated financial statements included in Part I Item 1.
There have been no other
material changes to the information provided in Item 7A to Hospiras Annual
Report on Form 10-K for the year ended December 31, 2009.
Item 4. Controls
and Procedures
Evaluation
of disclosure controls and procedures.
The Chairman of the
Board and Chief Executive Officer, Christopher B. Begley, and Senior Vice
President, Finance and Chief Financial Officer, Thomas E. Werner, evaluated the
effectiveness of Hospiras disclosure controls and procedures (as defined in Rules 13a-15(e) or
15d-15(e) under the Securities Exchange Act of 1934) as of the end of the
period covered by this report, and concluded that Hospiras disclosure controls
and procedures were effective.
Changes in
internal controls.
During the second quarter of 2010, Hospira
continued to transition certain information technology processes off-shore
under various outsourcing arrangements, which include information technology
application and infrastructure processes. Internal controls over financial
reporting related to these areas have been added or modified accordingly. There
have been no other changes in internal control over financial reporting that
occurred during the second quarter of 2010 that have materially affected or are
reasonably likely to materially affect Hospiras internal control over
financial reporting.
33
Table of Contents
PART II. OTHER INFORMATION
Item 1. Legal
Proceedings
The disclosure contained in
Note 15 to the condensed consolidated financial statements included in
Part I Item 1 hereof is incorporated herein by reference.
Item 1A. Risk
Factors
Please refer to Item 1A in
Hospiras Annual Report on Form 10-K for the year ended December 31,
2009, for a discussion of risks to which Hospiras business, financial
condition, results of operations and cash flows are subject. There have been no
material changes in our Risk Factors as disclosed in Hospiras Form 10-K,
except for the following:
Proposed recent changes in FDA regulations or actions related to
infusion pumps and medical devices may lead to increased costs and delays,
which could negatively impact Hospiras 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 is moving to establish additional pre-market
requirements for infusion pumps. The proposed guidance is subject to further
revision by the FDA, but the FDAs expectation is that the guidelines should be
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.
Item 2. Unregistered
Sales of Equity Securities and Use of Proceeds
(c)
Issuer Purchases of Equity
Securities
The table below gives
information on a monthly basis regarding purchases made by Hospira of its
common stock.
Period
|
|
Total Number
of Shares
Purchased
(1)
|
|
Average Price
Paid per Share
|
|
Total Number
of Shares
Purchased as
Part of
Publicly
Announced
Plans or
Programs
|
|
Maximum Number
(or Approximate
Dollar Value) of
Shares that May
Yet be Purchased
Under the Plans or
Programs
(2)
|
|
April 1-April 30,
2010
|
|
83,857
|
|
$
|
55.61
|
|
|
|
$
|
100,233,606
|
|
May 1-May 31,
2010
|
|
25,099
|
|
$
|
51.43
|
|
|
|
$
|
100,233,606
|
|
June 1-June 30,
2010
|
|
6,031
|
|
$
|
56.06
|
|
|
|
$
|
100,233,606
|
|
Total
|
|
114,987
|
|
$
|
54.72
|
|
|
|
$
|
100,233,606
|
|
(1)
These shares
represent the shares deemed surrendered to Hospira to pay the exercise price
and satisfy minimum statutory tax withholding obligations in connection with
the exercise of employee stock options. For further details regarding employee
stock options, see Note 7 to the condensed consolidated financial statements
included in Part I Item 1. These shares include the shares purchased on
the open market for the benefit of participants in the Hospira Healthcare
Corporation (Hospira Canada) Stock Purchase Plan 1,500 in April, 1,700 in
May, and 1,000 in June.
(2)
In
February 2006, Hospiras board of directors authorized the repurchase of
up to $400.0 million of Hospiras common stock in accordance with
Rule 10b-18 under the Securities Exchange Act of 1934. The repurchase of
shares commenced in early March 2006. As of June 30, 2010, Hospira
had purchased 7.6 million shares for $299.8 million in the aggregate under the
2006 board authority, all of which were purchased during 2006. Hospira is
considering repurchasing all or some of the remaining authorized amount of
$100.2 million.
34
Table of Contents
Item 6. Exhibits
A list of exhibits
immediately precedes such exhibits and is incorporated herein by reference.
35
Table of Contents
SIGNATURE
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this
report to be signed on its behalf by the undersigned thereunto duly authorized.
|
HOSPIRA, INC.
|
|
|
|
|
By:
|
/s/ THOMAS E. WERNER
|
|
|
Thomas E. Werner,
Senior Vice President, Finance and
Chief Financial Officer
|
|
|
Date: July 28, 2010
|
36
Table of Contents
EXHIBIT INDEX
Exhibit No.
|
|
Exhibit
|
|
|
|
10.1
|
|
Hospira, Inc.
Non-Employee Directors Fee Plan, as amended.*
|
|
|
|
10.2
|
|
Hospira Corporate Offer
Severance Plan, as amended.*
|
|
|
|
12.1
|
|
Computation of Ratio of
Earnings to Fixed Charges.
|
|
|
|
31.1
|
|
Certificate of Chief
Executive Officer pursuant to Rule 13a-14(a).
|
|
|
|
31.2
|
|
Certificate of Chief
Financial Officer pursuant to Rule 13a-14(a).
|
|
|
|
32.1
|
|
Certificate of Chief
Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
32.2
|
|
Certificate of Chief
Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
|
|
101
|
|
The following financial
statements from the Hospira, Inc. Quarterly Report on Form 10-Q for
the quarter ended June 30, 2010, filed on July 28, 2010, formatted
in Extensive Business Reporting Language (XBRL): (i) condensed
consolidated statements of income, (ii) condensed consolidated
statements of cash flows, (iii) condensed consolidated balance sheets,
(iv) condensed consolidated statement of changes in shareholders
equity, and (v) the notes to the condensed consolidated financial
statements.
|
* Management compensatory plan or arrangement.
37
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