UNITED STATES SECURITIES AND EXCHANGE
COMMISSION
WASHINGTON, D. C. 20549
FORM 10-Q
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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For the quarterly period ended June 30, 2011 | |
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OR | |
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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 |
(State or other jurisdiction |
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(I.R.S. Employer |
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 |
(Do not check if a smaller reporting company) |
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 21, 2011, Registrant had outstanding 164,869,397 shares of common stock, par value $0.01 per share.
Hospira, Inc.
Quarterly Report on Form 10-Q
Hospira, Inc.
Condensed Consolidated Statements of Income and Comprehensive Income (Loss)
(Unaudited)
(dollars and shares in millions, except for per share amounts)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2011 |
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2010 |
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2011 |
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2010 |
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Net sales |
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$ |
1,064.1 |
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$ |
968.2 |
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$ |
2,066.4 |
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$ |
1,975.8 |
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Cost of products sold |
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650.7 |
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599.0 |
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1,253.9 |
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1,176.3 |
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Restructuring, impairment and (gain) on disposition of assets, net |
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1.5 |
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2.6 |
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14.7 |
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(5.0 |
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Research and development |
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65.8 |
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80.4 |
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122.7 |
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132.1 |
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Selling, general and administrative |
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155.6 |
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169.9 |
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320.8 |
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348.5 |
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Total operating costs and expenses |
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873.6 |
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851.9 |
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1,712.1 |
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1,651.9 |
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Income From Operations |
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190.5 |
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116.3 |
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354.3 |
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323.9 |
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Interest expense |
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23.9 |
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24.2 |
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47.3 |
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47.6 |
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Other income, net |
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(2.0 |
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(0.3 |
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(4.2 |
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(1.5 |
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Income Before Income Taxes |
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168.6 |
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92.4 |
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311.2 |
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277.8 |
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Income tax expense |
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36.7 |
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9.4 |
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46.6 |
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53.6 |
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Equity income from affiliates, net |
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(11.7 |
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(0.5 |
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(28.9 |
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(1.0 |
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Net Income |
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$ |
143.6 |
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$ |
83.5 |
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$ |
293.5 |
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$ |
225.2 |
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Earnings Per Common Share: |
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Basic |
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$ |
0.86 |
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$ |
0.50 |
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$ |
1.76 |
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$ |
1.36 |
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Diluted |
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$ |
0.85 |
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$ |
0.49 |
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$ |
1.73 |
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$ |
1.34 |
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Weighted Average Common Shares Outstanding: |
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Basic |
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166.1 |
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165.8 |
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166.5 |
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165.0 |
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Diluted |
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169.0 |
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169.1 |
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169.6 |
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168.5 |
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Comprehensive Income (Loss): |
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Foreign currency translation adjustments, net of taxes $0.0 million |
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$ |
52.2 |
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$ |
(125.7 |
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$ |
116.8 |
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$ |
(134.3 |
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Pension liability adjustments, net of taxes $(1.0) million and $(0.7) million for the three months ended June 30, 2011 and 2010, respectively, and $(2.0) million and $(1.2) million for the six months ended June 30, 2011 and 2010, respectively |
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1.3 |
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1.2 |
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5.7 |
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2.3 |
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Unrealized (losses) gains on marketable equity securities, net of taxes $0.0 million |
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(2.4 |
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0.4 |
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(2.7 |
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(1.3 |
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Reclassification of gains on terminated cash flow hedges, net of taxes $0.0 million and $(0.1) million for the three months ended June 30, 2011 and 2010, respectively, and $(0.1) million and $(0.2) million for the six months ended June 30, 2011 and 2010, respectively |
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0.1 |
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0.1 |
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0.3 |
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0.3 |
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Other comprehensive income (loss) |
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51.2 |
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(124.0 |
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120.1 |
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(133.0 |
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Net Income |
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143.6 |
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83.5 |
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293.5 |
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225.2 |
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Comprehensive Income (Loss) |
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$ |
194.8 |
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$ |
(40.5 |
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$ |
413.6 |
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$ |
92.2 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
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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2011 |
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2010 |
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Cash Flow From Operating Activities: |
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Net income |
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$ |
293.5 |
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$ |
225.2 |
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Adjustments to reconcile net income to net cash from operating activities- |
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Depreciation |
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81.7 |
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79.9 |
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Amortization of intangible assets |
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45.1 |
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40.2 |
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Stock-based compensation expense |
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23.0 |
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27.8 |
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Undistributed equity income from affiliates |
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(28.9 |
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(1.0 |
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Deferred income taxes and other tax adjustments |
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(24.6 |
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12.1 |
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Impairment and other asset charges (benefits) |
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8.3 |
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(5.9 |
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Gains on disposition of assets |
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(11.4 |
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Changes in assets and liabilities- |
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Trade receivables |
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29.1 |
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(126.7 |
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Inventories |
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(173.6 |
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(41.9 |
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Prepaid expenses and other assets |
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(2.7 |
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(12.6 |
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Trade accounts payable |
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(44.9 |
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34.0 |
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Other liabilities |
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43.9 |
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(94.7 |
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Other, net |
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3.1 |
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18.8 |
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Net Cash Provided by Operating Activities |
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253.0 |
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143.8 |
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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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(138.6 |
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(79.4 |
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Acquisitions, net of cash acquired |
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(397.7 |
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Purchases of intangibles and other investments |
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(4.2 |
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(11.2 |
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Proceeds from disposition of businesses and assets |
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13.3 |
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62.6 |
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Net Cash Used in Investing Activities |
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(129.5 |
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(425.7 |
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Cash Flow From Financing Activities: |
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Other borrowings, net |
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6.7 |
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(3.5 |
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Common stock repurchased |
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(200.0 |
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Excess tax benefit from stock-based compensation arrangements |
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6.8 |
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16.3 |
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Proceeds from stock options exercised |
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44.0 |
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112.4 |
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Net Cash (Used in) Provided by Financing Activities |
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(142.5 |
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125.2 |
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Effect of exchange rate changes on cash and cash equivalents |
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16.1 |
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(6.0 |
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Net change in cash and cash equivalents |
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(2.9 |
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(162.7 |
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Cash and cash equivalents at beginning of period |
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604.3 |
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946.0 |
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Cash and cash equivalents at end of period |
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$ |
601.4 |
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$ |
783.3 |
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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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$ |
50.8 |
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$ |
50.3 |
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Income taxes, net of refunds |
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$ |
31.2 |
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$ |
70.9 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
Hospira, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(dollars in millions)
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June 30, |
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December 31, |
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2011 |
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2010 |
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Assets |
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Current Assets: |
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Cash and cash equivalents |
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$ |
601.4 |
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$ |
604.3 |
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Trade receivables, less allowances of $10.8 in 2011 and $8.2 in 2010 |
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593.8 |
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605.0 |
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Inventories |
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1,141.6 |
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955.5 |
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Deferred income taxes |
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149.0 |
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165.2 |
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Prepaid expenses |
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57.1 |
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43.6 |
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Other receivables |
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60.3 |
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103.9 |
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Total Current Assets |
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2,603.2 |
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2,477.5 |
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Property and equipment, net |
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1,346.0 |
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1,279.2 |
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Intangible assets, net |
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448.8 |
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480.3 |
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Goodwill |
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1,531.7 |
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1,500.8 |
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Deferred income taxes |
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216.5 |
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178.8 |
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Investments |
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91.1 |
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64.7 |
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Other assets |
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74.4 |
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65.0 |
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Total Assets |
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$ |
6,311.7 |
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$ |
6,046.3 |
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Liabilities and Shareholders Equity |
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Current Liabilities: |
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Short-term borrowings |
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$ |
43.1 |
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$ |
33.5 |
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Trade accounts payable |
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280.3 |
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320.7 |
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Salaries, wages and commissions |
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128.1 |
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136.0 |
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Other accrued liabilities |
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476.6 |
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441.4 |
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Total Current Liabilities |
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928.1 |
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931.6 |
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Long-term debt |
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1,716.4 |
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1,714.4 |
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Deferred income taxes |
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4.5 |
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4.4 |
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Post-retirement obligations and other long-term liabilities |
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189.0 |
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212.4 |
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Commitments and Contingencies |
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Total Shareholders Equity |
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3,473.7 |
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3,183.5 |
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Total Liabilities and Shareholders Equity |
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$ |
6,311.7 |
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$ |
6,046.3 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
Hospira, Inc.
Condensed Consolidated Statement of Changes in Shareholders Equity
(Unaudited)
(dollars and shares in millions)
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Common Stock |
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Treasury |
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Additional |
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Retained |
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Accumulated |
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Shares |
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Amount |
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Stock |
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Capital |
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Earnings |
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Income |
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Total |
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Balances at January 1, 2011 |
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166.7 |
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$ |
1.8 |
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$ |
(399.8 |
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$ |
1,641.9 |
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$ |
1,897.3 |
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$ |
42.3 |
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$ |
3,183.5 |
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Net income |
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293.5 |
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293.5 |
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Other comprehensive income |
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120.1 |
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120.1 |
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Common stock repurchases |
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(3.4 |
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(200.0 |
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(200.0 |
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Changes in shareholders equity related to incentive stock programs |
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1.8 |
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76.6 |
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76.6 |
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Balances at June 30, 2011 |
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165.1 |
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$ |
1.8 |
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$ |
(599.8 |
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$ |
1,718.5 |
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$ |
2,190.8 |
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$ |
162.4 |
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$ |
3,473.7 |
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The accompanying notes are an integral part of these condensed consolidated financial statements.
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, 2010 (the 2010 Form 10-K). The results of operations for any interim period are not necessarily indicative of the results of operations to be expected for the full year.
Certain prior year amounts have been reclassified to conform to the current year presentation. During 2011, Hospira reclassified income that was previously reported in Other income, net to Equity income from affiliates, net line item on the Condensed Consolidated Statements of Income and Comprehensive Income (Loss). In addition, Hospira reclassified cash flows from operating activities that were previously reported in Other, net to Undistributed equity income from affiliates line item on the Condensed Consolidated Statements of Cash Flows. See Note 5 for additional details related to Equity income from affiliates. Further, Hospira reclassified Comprehensive Income (Loss) and Other comprehensive income (loss) and related components, previously disclosed in the Notes to Condensed Consolidated Financial Statements, to the Condensed Consolidated Statements of Comprehensive Income (Loss). Lastly, Hospira reclassified various line items on the Condensed Consolidated Balance Sheets, primarily Goodwill, Deferred income taxes and Intangible assets, net as of December 31, 2010. These reclassifications related to the measurement period adjustments for the finalized purchase price allocation. See Note 2 for additional details. The reclassifications did not affect net income, cash flows from operations or shareholders equity.
Recently Issued and Adoption of New Accounting Standards
In June 2011, Hospira adopted the provisions of the Financial Accounting Standards Board (FASB) Accounting Standards Update (ASU) No. 2011-05, Comprehensive Income (Topic 220), Presentation of Comprehensive Income in U.S. GAAP (ASU No. 2011-05). ASU No. 2011-05 requires that comprehensive income and the related components of net income and of other comprehensive income be presented in a single continuous statement of comprehensive income or in two separate but consecutive statements. The ASU also requires reclassification adjustments from other comprehensive income to net income be presented on the face of the financial statements. There was no impact to Hospiras condensed consolidated financial position, results of operations or cash flows upon adoption of this guidance.
In May 2011, the FASB issued ASU No. 2011-04, Fair Value Measurement (Topic 820), Amendments to Achieve Common Fair Value Measurements and Disclosure Requirements in U.S. GAAP and IFRS (ASU No. 2011-04). ASU No. 2011-04 amends the wording used to describe many of the requirements for measuring fair value to achieve the objective of developing common fair value measurement and disclosure requirements, as well as improving consistency and understandability. Some of the requirements clarify the FASBs intent about the application of existing fair value measurement requirements while other amendments change a particular principle or requirement for measuring fair value or for disclosing information about fair value measurements. ASU No. 2011-04 is effective for calendar years beginning after December 15, 2011. Early adoption is prohibited. Hospira is currently evaluating the potential impact of ASU No. 2011-04 on the financial statements and related disclosures but does not anticipate a material impact to Hospira.
In December 2010, the FASB issued ASU No. 2010-29, Business Combinations (Topic 805), Disclosure of Supplementary Pro Forma Information for Business Combinations (ASU No. 2010-29). ASU No. 2010-29 requires revenues and earnings of the combined entity be disclosed as if the business combination occurred as of the beginning of the comparable prior annual reporting period. The ASU also requires additional disclosures about adjustments included in the reported pro forma revenues and earnings. Hospira adopted the provisions of ASU No. 2010-29 prospectively for business combinations for which the acquisition date is on or after January 1, 2011. There was no impact to Hospiras condensed consolidated financial position, results of operations or cash flows upon adoption of this guidance.
In December 2010, the FASB issued ASU No. 2010-27, Other Expenses (Topic 720), Fees Paid to the Federal Government by Pharmaceutical Manufacturers (ASU No. 2010-27). ASU No. 2010-27 specifies the accounting for annual fees imposed on the
pharmaceutical manufacturing industry by the Patient Protection and Affordable Care Acts as amended by the Health Care and Education Reconciliation Act (collectively, the Acts). The ASU specifies that a liability for the fee should be estimated and recorded in full upon the first qualifying sale with deferred costs amortized to expense on a straight-line basis, unless another method of allocation is more appropriate. ASU No. 2010-27 is effective for calendar years beginning after December 31, 2010. Hospira adopted the provisions of ASU No. 2010-27 on January 1, 2011. There was no material impact to Hospiras condensed consolidated financial position, results of operations or cash flows upon adoption of this guidance.
Significant Accounting Policies - Revenue Recognition
Chargebacks
Hospiras accounting policy for revenue recognition including a description of chargebacks (estimated payments to wholesalers for honoring contracted prices to end customers) is included in Note 1 Summary of Significant Accounting Policies in Hospiras 2010 Form 10-K. 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.
Sales of Hospiras generic oncolytic product docetaxel, launched in the United States (U.S.) in March 2011, are subject to chargebacks and contributed to the increase of the chargeback accrual from December 31, 2010 to June 30, 2011. Generally, generic product launch sales have a higher degree of end customer price movement, which may be greater than 80% from the end customer price prior to generic introduction, as additional competitors enter the market. A five percent decrease in the end customer contract prices for docetaxel sales subject to chargebacks at June 30, 2011 could decrease net sales and income before income taxes by approximately $4 million.
The following table is a rollforward of Hospiras total chargeback accrual for all products, including docetaxel, for the six months ended June 30, 2011.
(dollars in millions) |
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Balances at January 1, 2011 |
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$ |
129.7 |
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Provisions |
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624.9 |
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Payments and releases (1) |
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(553.8 |
) | |
Balances at June 30, 2011 |
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$ |
200.8 |
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(1) During the quarter ended June 30, 2011 Hospira released $19.5 million for a portion of the chargeback accrual relating to the quarter ended March 31, 2011 for docetaxel product sales, as the expected rate of price decrease was less than estimated.
Note 2 Business Acquisition
In July 2010, Hospira completed the acquisition of Javelin Pharmaceuticals, Inc. (Javelin Pharma) for a purchase price of $161.9 million. The acquisition will enable Hospira to take advantage of operating synergies between Hospiras PrecedexTM and Javelin Pharmas main product candidate, DylojectTM, a post-operative pain management drug currently awaiting U.S. Food and Drug Administration (FDA) approval. The impact, except for the acquisition costs of $7.9 million in 2010, of this acquisition was not significant to Hospiras results of operations through June 30, 2011.
In October 2010, Hospira received a complete response letter from the FDA regarding DylojectTM. Hospira and its third party manufacturer continue to work closely with the FDA to address all items, including visual inspection methods and a product particulate issue identified at the acquisition date, raised as part of the regulatory process. Timing of resolution and expected launch of the product is uncertain.
During the second quarter of 2011, Hospira finalized the allocation of the purchase price based on the assets acquired and liabilities assumed at their respective fair values on the acquisition date of July 2, 2010. Upon finalization, Hospira adjusted the preliminary values assigned based on additional information primarily for a product particulate issue which existed at the acquisition date. The opening balance sheet has been adjusted to reflect these changes, inclusive of previous adjustments since the acquisition date. The aggregate adjustments included an increase to goodwill of $72.8 million, an increase to deferred income taxes, net of $43.7 million, a decrease to in-process research and development (IPR&D) of $114.2 million and a decrease to intangible assets of $2.3 million.
The final allocation of the purchase price is as follows:
(dollars in millions) |
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Intangible assets |
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$ |
4.5 |
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IPR&D |
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7.3 |
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Goodwill |
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97.8 |
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Deferred income taxes, net |
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57.1 |
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Other liabilities, net |
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(4.8 |
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Total allocation of purchase price |
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$ |
161.9 |
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The $4.5 million of acquired intangible assets includes developed product rights that will be amortized over their estimated useful lives (10 years). The $7.3 million of IPR&D is being accounted for as an indefinite-lived intangible asset until resolution of the particulate matter, regulatory approval or discontinuation. Upon successful resolution of the particulate matter and regulatory approval of the product, Hospira will make a determination as to the useful life of the IPR&D intangible asset and begin amortization. The majority of goodwill, $97.8 million, was assigned to the U.S., Canada, and Latin America (Americas) segment. Goodwill recorded as part of the acquisition includes the expected synergies and other benefits that Hospira believes will result from the combined operations. Goodwill is not expected to be deductible for tax purposes.
Note 3 Restructuring Actions
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 net charges 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, contract termination costs and gain on disposal of assets.
Project Fuel
In March 2009, Hospira announced details of a restructuring and optimization plan, (Project Fuel), which was completed in March 2011. Project Fuel included the following activities: optimizing the product portfolio, evaluating non-strategic assets and streamlining the organizational structure. Hospira incurred aggregate restructuring costs and other asset charges related to these actions of $72.0 million on a pre-tax basis.
The following summarizes the Project Fuel pre-tax restructuring costs and inventory charges (included in Cost of products sold):
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Restructuring costs |
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Aggregate |
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Three months ended June 30, |
|
Six months ended June 30, |
| |||||||||
(dollars in millions) |
|
to date |
|
2011 |
|
2010 |
|
2011 |
|
2010 |
| |||||
Americas |
|
$ |
29.1 |
|
$ |
|
|
$ |
1.3 |
|
$ |
1.7 |
|
$ |
3.2 |
|
Europe, Middle East & Africa (EMEA) |
|
7.8 |
|
|
|
0.5 |
|
1.1 |
|
1.1 |
| |||||
Asia Pacific (APAC) |
|
5.1 |
|
|
|
0.4 |
|
0.6 |
|
0.7 |
| |||||
Total |
|
$ |
42.0 |
|
$ |
|
|
$ |
2.2 |
|
$ |
3.4 |
|
$ |
5.0 |
|
|
|
Inventory charges |
| |||||||||||||
|
|
Aggregate |
|
Three months ended June 30, |
|
Six months ended June 30, |
| |||||||||
(dollars in millions) |
|
to date |
|
2011 |
|
2010 |
|
2011 |
|
2010 |
| |||||
Americas |
|
$ |
19.3 |
|
$ |
|
|
$ |
(3.3 |
) |
$ |
5.0 |
|
$ |
(5.9 |
) |
EMEA |
|
6.4 |
|
|
|
|
|
0.4 |
|
|
| |||||
APAC |
|
4.3 |
|
|
|
|
|
(0.3 |
) |
|
| |||||
Total |
|
$ |
30.0 |
|
$ |
|
|
$ |
(3.3 |
) |
$ |
5.1 |
|
$ |
(5.9 |
) |
As part of Project Fuel initiatives, Hospira committed to dispose of certain non-strategic businesses and the underlying assets. In February 2010, Hospira completed the disposal of a facility in Wasserburg, Germany for $69.3 million, comprised of initial cash proceeds of $62.6 million and an additional $6.7 million received in the first quarter of 2011. Hospira recognized a gain of $11.4 million on the disposal of the Wasserburg facility which is included in Restructuring, impairment and (gain) on disposition of assets, net in the first quarter of 2010.
The following summarizes the Project Fuel restructuring activity for 2011:
|
|
Employee-Related |
|
|
|
|
| |||
(dollars in millions) |
|
Benefit Costs |
|
Other |
|
Total |
| |||
Balance at January 1, 2011 |
|
$ |
1.8 |
|
$ |
3.4 |
|
$ |
5.2 |
|
Costs incurred |
|
3.0 |
|
0.4 |
|
3.4 |
| |||
Payments |
|
(3.2 |
) |
(1.0 |
) |
(4.2 |
) | |||
Non cash items |
|
|
|
(0.4 |
) |
(0.4 |
) | |||
Balance at June 30, 2011 |
|
$ |
1.6 |
|
$ |
2.4 |
|
$ |
4.0 |
|
Facilities Optimization
In April 2008, Hospira announced a plan to exit manufacturing operations at its Morgan Hill, California facility. In March 2011, Hospira completed the process of transferring related operations and production of products to other Hospira facilities or outsourcing certain product components to third-party suppliers. During the three months ended June 30, 2011 and 2010, Hospira incurred in the Americas segment pre-tax restructuring costs of $0.0 million and $0.4 million, respectively. During the six months ended June 30, 2011 and 2010, Hospira incurred in the Americas segment pre-tax restructuring costs of $0.3 million and $1.4 million, respectively. Hospira incurred aggregate restructuring charges related to these actions of $27.8 million in the Americas segment.
The following summarizes the Facilities Optimization for Morgan Hill, California restructuring activity for 2011:
|
|
Employee-Related |
| |
(dollars in millions) |
|
Benefit Costs |
| |
Balance at January 1, 2011 |
|
$ |
6.0 |
|
Costs incurred |
|
0.3 |
| |
Payments |
|
(4.7 |
) | |
Balance at June 30, 2011 |
|
$ |
1.6 |
|
Other Restructuring
In addition to the programs discussed above, from time to time Hospira incurs costs to implement restructuring actions for specific operations. During the three months ended March 31, 2011, Hospira incurred costs to terminate distributor contracts in the Americas segment of $7.8 million reported in Restructuring, impairment and (gain) on disposition of assets, net related to the restructuring of certain Latin America operations. No additional restructuring costs are expected to be incurred for these actions.
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, 2011. For a more detailed description of Hospiras collaborative arrangements see Note 4 to Hospiras consolidated financial statements included in Hospiras 2010 Form 10-K.
Note 5 Investments
Equity investments consist of investments in affiliated companies over which Hospira has significant influence but not the majority of the equity or risks and rewards. Hospira has a 50% ownership in a joint venture, Zydus Hospira Oncology Private Limited (ZHOPL), in addition to other equity investments. During the three and six months ended June 30, 2011, Equity income from affiliates, net, including the ZHOPL equity investment, was $11.7 million and $28.9 million, respectively, primarily due to the launch in 2011 of docetaxel, the majority of which was sourced from ZHOPL.
Note 6 Fair Value Measures
The following table summarizes the basis used to measure certain assets and liabilities at fair value on a recurring basis in the balance sheet:
|
|
|
|
Fair Value Measurements at Reporting Date, Using: |
| ||||||||
Description (dollars in millions) |
|
June 30, 2011 |
|
Quoted Prices |
|
Significant |
|
Significant |
| ||||
Financial Assets: |
|
|
|
|
|
|
|
|
| ||||
Foreign currency forward exchange contracts |
|
$ |
2.6 |
|
$ |
|
|
$ |
2.6 |
|
$ |
|
|
Interest rate swap contracts |
|
6.9 |
|
|
|
6.9 |
|
|
| ||||
Available-for-sale marketable equity securities |
|
19.6 |
|
19.6 |
|
|
|
|
| ||||
|
|
|
|
|
|
|
|
|
| ||||
Financial Liabilities: |
|
|
|
|
|
|
|
|
| ||||
Foreign currency forward exchange contracts |
|
2.1 |
|
|
|
2.1 |
|
|
| ||||
|
|
|
|
Fair Value Measurements at Reporting Date, Using: |
| ||||||||
Description (dollars in millions) |
|
December 31, |
|
Quoted Prices |
|
Significant |
|
Significant |
| ||||
Financial Assets: |
|
|
|
|
|
|
|
|
| ||||
Foreign currency forward exchange contracts |
|
$ |
2.4 |
|
$ |
|
|
$ |
2.4 |
|
$ |
|
|
Interest rate swap contracts |
|
1.5 |
|
|
|
1.5 |
|
|
| ||||
Available-for-sale marketable equity securities |
|
21.9 |
|
21.9 |
|
|
|
|
| ||||
|
|
|
|
|
|
|
|
|
| ||||
Financial Liabilities: |
|
|
|
|
|
|
|
|
| ||||
Foreign currency forward exchange contracts |
|
2.5 |
|
|
|
2.5 |
|
|
| ||||
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 cash and cash equivalents, which include money market fund instruments, approximate their carrying value due to their short-term nature, and are within Level 1 of the fair value hierarchy. 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 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, 2011 |
|
December 31, 2010 |
| ||||||||
Description (dollars in millions) |
|
Carrying |
|
Fair Value |
|
Carrying |
|
Fair Value |
| ||||
Senior unsecured notes (1) |
|
$ |
1,700.0 |
|
$ |
1,829.8 |
|
$ |
1,700.0 |
|
$ |
1,824.0 |
|
(1) The carrying value and fair value excludes the interest rate swaps fair value adjustments. See Note 7 for further details.
Note 7 Financial Instruments and Derivatives
Hospiras operations are exposed to market risk primarily due to changes in currency exchange 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 to Hospiras consolidated financial statements included in Hospiras 2010 Form 10-K.
The following table summarizes Hospiras fair value of outstanding derivatives:
(dollars in millions) |
|
Condensed Consolidated Balance |
|
June 30, |
|
December 31, |
| ||
Derivatives not designated as hedging instruments |
|
|
|
|
|
|
| ||
Foreign currency forward exchange contracts: |
|
Other receivables |
|
$ |
2.6 |
|
$ |
2.4 |
|
|
|
Other accrued liabilities |
|
2.1 |
|
2.5 |
| ||
|
|
|
|
|
|
|
| ||
Derivatives designated as hedging instruments |
|
|
|
|
|
|
| ||
Interest rate swap contracts: |
|
Other receivables |
|
0.7 |
|
0.2 |
| ||
|
|
Other assets |
|
6.2 |
|
1.3 |
| ||
The impact on earnings from derivatives activity was as follows:
|
|
Presentation of Gain (Loss) |
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
| ||||||||
(dollars in millions) |
|
on Derivatives |
|
2011 |
|
2010 |
|
2011 |
|
2010 |
| ||||
Derivatives not designated as hedging instruments |
|
|
|
|
|
|
|
|
|
|
| ||||
Foreign currency forward exchange contracts |
|
Other (income) expense, net |
|
$ |
4.4 |
|
$ |
(6.6 |
) |
$ |
2.4 |
|
$ |
(0.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Derivatives designated as hedging instruments |
|
|
|
|
|
|
|
|
|
|
| ||||
Interest rate swap contracts |
|
Interest expense |
|
1.4 |
|
1.8 |
|
3.0 |
|
4.4 |
| ||||
Note 8 Inventories
Inventories consist of the following:
|
|
June 30, |
|
December 31, |
| ||
(dollars in millions) |
|
2011 |
|
2010 |
| ||
Finished products |
|
$ |
560.6 |
|
$ |
495.1 |
|
Work in process |
|
277.9 |
|
194.3 |
| ||
Materials |
|
303.1 |
|
266.1 |
| ||
Total inventories |
|
$ |
1,141.6 |
|
$ |
955.5 |
|
Note 9 Property and equipment, net
Property and equipment, net consists of the following:
|
|
June 30, |
|
December 31, |
| ||
(dollars in millions) |
|
2011 |
|
2010 |
| ||
Property and equipment, at cost |
|
$ |
2,803.1 |
|
$ |
2,690.2 |
|
Accumulated depreciation |
|
(1,457.1 |
) |
(1,411.0 |
) | ||
Total property and equipment, net |
|
$ |
1,346.0 |
|
$ |
1,279.2 |
|
Note 10 Goodwill and Intangible assets, net
The following summarizes goodwill and intangible assets, net activity:
(dollars in millions) |
|
Goodwill |
|
Intangible |
| ||
Balance at December 31, 2010 |
|
$ |
1,500.8 |
|
480.3 |
| |
Acquisitions |
|
|
|
1.9 |
| ||
Amortization |
|
|
|
(45.1 |
) | ||
Impairments |
|
|
|
(3.2 |
) | ||
Currency translation effect and other |
|
30.9 |
|
14.9 |
| ||
Balance at June 30, 2011 |
|
$ |
1,531.7 |
|
$ |
448.8 |
|
During the six months ended June 30, 2011, Hospira recorded impairment charges of $3.2 million primarily in the Americas reporting segment, including $1.7 million related to IPR&D, due to delays in various product launch dates, and $1.5 million related to the discontinuation of a medication management product. The impairment charges were based on internal discounted cash flow analysis, a non-recurring Level 3 fair value measurement, and were included in Restructuring, impairment and (gain) on disposition of assets, net.
Intangible assets have definite lives and 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 and regulatory approval. Intangible asset amortization expense was $22.9 million and $18.7 million for the three months ended June 30, 2011 and 2010, respectively. Intangible asset amortization expense was $45.1 million and $40.2 million for the six months ended June 30, 2011 and 2010, respectively. Intangible asset amortization is estimated at $41.3 million for the remainder of 2011, $70.0 million for 2012, $68.5 million for 2013, $57.7 million for 2014, and $47.1 million for 2015.
Intangible assets, net consist of the following:
|
|
June 30, 2011 |
|
December 31, 2010 |
| ||||||||||||||
(dollars in millions) |
|
Gross |
|
Accumulated |
|
Net Intangible |
|
Gross |
|
Accumulated |
|
Net Intangible |
| ||||||
Product rights and other |
|
$ |
679.8 |
|
$ |
(291.3 |
) |
$ |
388.5 |
|
$ |
655.3 |
|
$ |
(240.4 |
) |
$ |
414.9 |
|
Customer relationships |
|
32.7 |
|
(13.4 |
) |
19.3 |
|
31.8 |
|
(11.0 |
) |
20.8 |
| ||||||
IPR&D |
|
20.4 |
|
|
|
20.4 |
|
22.1 |
|
|
|
22.1 |
| ||||||
Technology |
|
32.3 |
|
(11.7 |
) |
20.6 |
|
34.0 |
|
(11.5 |
) |
22.5 |
| ||||||
|
|
$ |
765.2 |
|
$ |
(316.4 |
) |
$ |
448.8 |
|
$ |
743.2 |
|
$ |
(262.9 |
) |
$ |
480.3 |
|
Note 11 Sales-Type Leases
The net investment in sales-type leases of certain medication management products consist of the following:
(dollars in millions) |
|
June 30, |
|
December 31, |
| ||
Minimum lease payments receivables |
|
$ |
18.5 |
|
$ |
23.4 |
|
Unearned interest income |
|
(2.3 |
) |
(3.0 |
) | ||
Net investment in sales-type leases |
|
16.2 |
|
20.4 |
| ||
Current portion (1) |
|
(6.3 |
) |
(7.6 |
) | ||
Net investment in sales-type leases, less current portion (1) |
|
$ |
9.9 |
|
$ |
12.8 |
|
(1) The current and long-term portions were recorded in Trade receivables and Other assets, respectively, in the condensed consolidated balance sheets.
Hospira monitors the credit quality of sales-type leases and recognizes an allowance for credit loss based on historical loss experience. As of June 30, 2011 and December 31, 2010, allowance for credit losses and amounts past due 90 days for sales-type leases were not material.
Note 12 Other Accrued Liabilities
Other accrued liabilities consist of the following:
|
|
June 30, |
|
December 31, |
| ||
(dollars in millions) |
|
2011 |
|
2010 |
| ||
Accrued rebates |
|
$ |
141.1 |
|
$ |
137.0 |
|
All other |
|
335.5 |
|
304.4 |
| ||
Total Other accrued liabilities |
|
$ |
476.6 |
|
$ |
441.4 |
|
Note 13 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 were as follows:
|
|
Pension Plans |
| ||||||||||
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
| ||||||||
(dollars in millions) |
|
2011 |
|
2010 |
|
2011 |
|
2010 |
| ||||
Service cost for benefits earned during the period |
|
$ |
0.3 |
|
$ |
0.3 |
|
$ |
0.6 |
|
$ |
0.5 |
|
Interest cost on projected benefit obligations |
|
6.4 |
|
6.3 |
|
12.8 |
|
12.6 |
| ||||
Expected return on plans assets |
|
(8.6 |
) |
(7.4 |
) |
(17.2 |
) |
(14.8 |
) | ||||
Net amortization |
|
2.6 |
|
1.6 |
|
5.2 |
|
3.2 |
| ||||
Net cost |
|
$ |
0.7 |
|
$ |
0.8 |
|
$ |
1.4 |
|
$ |
1.5 |
|
|
|
Medical and Dental Plans |
| ||||||||||
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
| ||||||||
(dollars in millions) |
|
2011 |
|
2010 |
|
2011 |
|
2010 |
| ||||
Service cost for benefits earned during the period |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
|
Interest cost on projected benefit obligations |
|
0.7 |
|
0.8 |
|
1.4 |
|
1.6 |
| ||||
Expected return on plans assets |
|
|
|
|
|
|
|
|
| ||||
Net amortization |
|
0.1 |
|
0.2 |
|
0.2 |
|
0.4 |
| ||||
Net cost |
|
$ |
0.8 |
|
$ |
1.0 |
|
$ |
1.6 |
|
$ |
2.0 |
|
Based on current Federal laws and regulations, Hospira is not required to make any contributions to its U.S. pension plans in 2011. 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.
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, 2011 and 2010 were $8.6 million and $8.4 million, respectively. For the six months ended June 30, 2011 and 2010, expenses were $16.6 million and $16.8 million, respectively.
Note 14 Short-term Borrowings and Long-term Debt
Hospira has a $700.0 million unsecured revolving credit facility expiring in October 2012 under which no amounts are outstanding as of June 30, 2011.
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, 2011, Hospira was in compliance with all applicable covenants.
In July 2011, Hospira terminated all existing interest rate swap contracts with a total notional amount of $400.0 million, which had effectively converted the debt from fixed to variable rate debt. As a result of the swap terminations, in July 2011, Hospira received $9.0 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 will be 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 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 certain non-U.S. taxing jurisdictions.
During the six months ended June 30, 2011, the Internal Revenue Service (IRS) audit of Hospiras 2006 and 2007 U.S. federal tax returns was concluded and the years were effectively settled. The outcome of the audit settlement is a reduction in the gross unrecognized tax benefits for both of the audit years settled, of which $19.7 million was recognized in the results for the six months ended June 30, 2011 as a discrete income tax benefit, inclusive of interest and state tax impacts. The IRS has commenced the audit of Hospiras 2008 and 2009 U.S. federal tax returns during the six months ended June 30, 2011.
Hospira remains open to tax examinations, which are in various stages, in the following major tax-paying jurisdictions: for years 2005 forward in Canada, for years 2006 forward for Italy, for years 2007 forward for Australia, and for years 2008 forward for the U.S. and United Kingdom. In addition, various tax statutes of limitation are expected to close within the next 12 months. Accordingly, a change in unrecognized tax benefits may occur for which an estimate of the range cannot be quantified at this time.
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, 2011 and December 31, 2010, 177.6 million and 175.9 million common shares were issued and 165.1 million and 166.7 million common shares were outstanding, respectively.
Treasury Stock
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. In December 2010, Hospira entered into an accelerated share repurchase (ASR) contract with a third party financial institution to repurchase $50.0 million of Hospiras common stock. Under the ASR, Hospira received 0.7 million shares in December 2010 based on seventy-five percent of the $50.0 million repurchased on the trade date, with the remaining 0.2 million shares delivered in February of 2011. In the aggregate, Hospira repurchased 9.4 million shares for approximately $400.0 million completing the 2006 board authorization.
In April 2011, Hospiras Board of Directors authorized the repurchase of up to $1.0 billion of Hospiras common stock in accordance with Rule 10b-18 under the Securities Exchange Act of 1934. In April and May 2011, Hospira entered into ASR contracts with a third party financial institution to repurchase $200.0 million in aggregate of Hospiras common stock. Under the ASR contracts, Hospira received 2.7 million shares based on seventy-five percent of the $200.0 million repurchased on the trade date, with the remaining shares to be delivered over the next three months subject to adjustment based on the average stock price during the period. The ASR contracts were completed in June and July, and Hospira received incremental 0.5 million and 0.5 million shares, respectively. Hospira from time to time may repurchase additional shares under this authorization which will depend on various factors such as cash generation from operations, current stock price and other factors.
Note 17 Accumulated Other Comprehensive Income, net of tax
Accumulated other comprehensive income, net of taxes, consists of the following:
|
|
June 30, |
|
December 31, |
| ||
(dollars in millions) |
|
2011 |
|
2010 |
| ||
Cumulative foreign currency translation adjustments, net of taxes $0.0 million |
|
$ |
252.7 |
|
$ |
135.9 |
|
Cumulative retirement plans unrealized losses, net of taxes $64.6 million and $66.6 million, respectively |
|
(103.1 |
) |
(108.8 |
) | ||
Cumulative unrealized gains on marketable equity securities, net of taxes $0.0 |
|
12.3 |
|
15.0 |
| ||
Cumulative gains on terminated cash flow hedges, net of taxes $(0.3) million and $(0.2) million, respectively |
|
0.5 |
|
0.2 |
| ||
Accumulated Other Comprehensive Income |
|
$ |
162.4 |
|
$ |
42.3 |
|
Note 18 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) |
|
2011 |
|
2010 |
|
2011 |
|
2010 |
|
Weighted average basic common shares outstanding |
|
166.1 |
|
165.8 |
|
166.5 |
|
165.0 |
|
Incremental shares outstanding related to stock-based awards |
|
2.9 |
|
3.3 |
|
3.1 |
|
3.5 |
|
Weighted average dilutive common shares outstanding |
|
169.0 |
|
169.1 |
|
169.6 |
|
168.5 |
|
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 2.0 million and 0.6 million for the three and six months ended June 30, 2011, respectively, and 2.5 million and 0.7 million for the three and six months ended June 30, 2010, respectively. Accordingly, these options are excluded from the diluted earnings per share calculation for these periods.
Note 19 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 $9.3 million and $10.5 million was recognized for the three months ended June 30, 2011 and 2010, respectively. The related income tax benefit recognized was $3.4 million and $3.6 million for the three months ended June 30, 2011 and 2010, respectively. Stock-based compensation expense of $23.0 million and $27.8 million was recognized for the six months ended June 30, 2011 and 2010, respectively. The related income tax benefit recognized was $8.1 million and $9.4 million for the six months ended June 30, 2011 and 2010, respectively. As of June 30, 2011, there was $69.2 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 2.0 years.
Stock Options
In February 2011, 1.4 million options were granted to certain employees for the 2011 annual stock option grant. For the six months ended June 30, 2011, an additional 0.2 million options were granted. These options were awarded at the fair market value at the time of grant, generally vest over three to four years, and have a seven-year term. The expected life assumption of the options was 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.
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, were as follows:
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
| ||||||||
|
|
2011 |
|
2010 |
|
2011 |
|
2010 |
| ||||
Volatility |
|
29.3 |
% |
30.2 |
% |
29.3 |
% |
30.2 |
% | ||||
Expected life (years) |
|
4.1 |
|
2.8 |
|
4.8 |
|
4.6 |
| ||||
Risk-free interest rate |
|
1.7 |
% |
1.3 |
% |
2.2 |
% |
2.1 |
% | ||||
Dividend yield |
|
0.0 |
% |
0.0 |
% |
0.0 |
% |
0.0 |
% | ||||
Fair value per stock option |
|
$ |
13.58 |
|
$ |
11.31 |
|
$ |
15.33 |
|
$ |
14.40 |
|
Performance Share Awards
During the first quarter of 2011, 250,985 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 2011 performance share awards were 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 performance share award grants, were as follows:
|
|
2011 |
|
2010 |
| ||
Volatility |
|
34.7 |
% |
36.2 |
% | ||
Risk-free interest rate |
|
1.2 |
% |
1.4 |
% | ||
Dividend yield |
|
0.0 |
% |
0.0 |
% | ||
Fair value per performance share |
|
$ |
61.64 |
|
$ |
69.43 |
|
Restricted Stock
During the first quarter of 2011, 109,308 restricted stock awards were granted to a key member of management. Hospira issues restricted stock with a vesting period ranging from one to three years. The weighted average grant date fair value of restricted stock granted during the first quarter of 2011 was $55.20 per grant.
Note 20 Commitments and Contingencies
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.
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. 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. On June 6, 2011 the appeal was argued before the United States Court of Appeals for the Seventh Circuit. We are awaiting a decision on the appeal. In 2008, Hospira received notice from Abbott requesting that Hospira indemnify Abbott for all liabilities that Abbott may incur in connection with this litigation. Hospira denies any obligation to indemnify Abbott for the claims asserted against Abbott in this litigation.
Hospira is involved in patent litigation in the U.S. and elsewhere concerning Hospiras attempts to market, and the marketing of, the generic oncology drug gemcitabine. In September 2006, in the United States, Mayne Pharma Limited (now Hospira Australia Pty Ltd.) and Mayne Pharma (USA) Inc. (now Hospira Boulder, Inc.) were sued for patent infringement in the United States District Court for the Southern District of Indiana: Eli Lilly and Co. v. Mayne Pharma Ltd. et al., No. 06-cv-1558 (S.D. Ind. 2006). A second suit was filed in January 2008: Eli Lilly and Co. v. Mayne Pharma Ltd. et al., No. 08-cv-0037 (S.D. Ind. 2008). In March 2010, a third case was filed: Eli Lilly and Co. v. Hospira, Inc., No. 10-cv-0346 (S.D. Ind. 2010). In each of the suits, plaintiffs alleged that Hospiras gemcitabine drug products, if marketed in the U.S., would infringe U.S. patents 4,808,614 and 5,464,826. Plaintiffs sought injunctive relief to prevent approval and marketing of Hospiras products.
On August 17, 2009, the United States District Court for the Eastern District of Michigan invalidated the 826 patent in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., No. 07-cv-15087 (E.D. Mich. Aug. 17, 2009). That decision was upheld on appeal in July 28, 2010 (Sun Pharms. Indus. Ltd. v. Eli Lilly & Co., No. 2010-1105 (Fed. Cir. July 28, 2010)), and the matter is now concluded. The 614 patent expired on May 15, 2010, and the additional six-month period of pediatric exclusivity ran out on November 15, 2010. Hospira launched its 2 gram gemcitabine drug product that day. On September 30, 2010, Hospira filed an action in the Northern District of Illinois against Eli Lilly and Company, seeking a judicial declaration that the process used to manufacture Hospiras gemcitabine drug products would not (and does not) infringe Lillys U.S. Patent No. 5,606,048. Lilly did not assert infringement counterclaims in the Illinois action. However, on January 20, 2011, Lilly filed a Complaint with the U.S. International Trade Commission under Section 227 of the Tariff Act of 1930, 19 U.S.C. § 1337, alleging that the importation into the United States, the sale for importation, or sale within the United States after importation of Hospiras gemcitabine drug product would infringe one or more claims of the 048 patent. The Complaint sought an order excluding Hospiras products from being imported into the United States. The Commission voted to open an investigation. The Notice of Investigation was published on March 23, 2011 (76 Fed. Reg. 16,445). The Commission has set the matter for trial in January 2012. Hospira denies that the process used to manufacture its gemcitabine drug products infringes the 048 patent, and it intends to vigorously defend the action pending in the Commission and to continue prosecuting its action for declaratory relief in Illinois. Hospira is currently marketing and selling gemcitabine. If Hospira is ultimately found to infringe the 048 patent, the Commission could issue an order of exclusion that would prevent Hospira from importing its gemcitabine drug product.
Hospira is involved in patent litigation in the U.S. and elsewhere concerning Hospiras attempts to market, and the marketing of, the generic oncolytic drug docetaxel. In the United States, Hospira was sued for patent infringement in the United States District Court for the District of Delaware: Aventis Pharma, S.A., et al. v. Hospira, Inc. (D. Del. 2008). The plaintiffs alleged that Hospiras docetaxel products, if marketed in the U.S., would infringe U.S. patents 5,714,512 and 5,750,561. Plaintiffs sought injunctive relief to prevent approval and marketing of Hospiras products. A trial was held in this matter and on September 27, 2010, the U.S. District Court issued its decision in favor of Hospira, finding that the asserted claims of the patents were both invalid and unenforceable. Plaintiffs have appealed that decision to the United States Court of Appeals for the Federal Circuit. Hospira is currently marketing and selling its docetaxel products. If the trial court decision is reversed and Hospira was ultimately found liable for patent infringement, the damages would generally be based on a reasonable royalty or the plaintiffs lost profits based on lost sales of the branded product. In
the event of a reversal, Hospira could also be enjoined from further sales of its docetaxel products until expiration of one or both of the patents if they are held valid and enforceable.
Hospira is involved in two patent lawsuits concerning Hospiras PrecedexTM (dexmedetomidine hydrochloride), a proprietary sedation agent. On September 4, 2009, Hospira brought suit against Sandoz International GmbH and Sandoz, Inc. for patent infringement. The lawsuit, which alleges infringement of U.S. Patents 4,910,214 (expires July 15, 2013) and 6,716,867 (expires March 31, 2019), is pending in the U.S. District Court for the District of New Jersey: Hospira, Inc. and Orion Corp. v. Sandoz International GmbH and Sandoz, Inc. (D. N.J. 2009). The lawsuit is based on Sandozs Paragraph IV notice indicating that Sandoz has filed an abbreviated new drug application (ANDA) with the FDA for a generic version of PrecedexTM. Hospira seeks a judgment of infringement, injunctive relief and costs. Sandozs ANDA has received tentative approval from the FDA. Pursuant to this litigation, a thirty-month stay of final approval is in place through January 28, 2012. The expiration of the stay does not prevent Hospira from seeking an injunction to block the launch of a generic product pending the resolution of the underlying litigation. On November 12, 2010, Hospira brought suit against Caraco Pharmaceutical Laboratories, Ltd. for patent infringement. The lawsuit, which alleges infringement of U.S. Patent No. 6,716,867 (referred to above) is pending in the U.S. District Court for the Eastern District of Michigan: Hospira, Inc. and Orion Corporation v. Caraco Pharmaceutical Laboratories, Ltd., No. 10-cv-14514 (E.D. Mich. 2010). The lawsuit is based on Caracos Paragraph IV notice indicating that Caraco has filed an ANDA with the FDA for a generic version of PrecedexTM. 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, delays in product approvals and other restrictions on operations.
Hospiras litigation exposure, including product liability claims, is evaluated each reporting period. Hospiras reserves, which are not significant at June 30, 2011 and December 31, 2010, are the best estimate of loss, as defined by ASC Topic 450, Contingencies (ASC 450). 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 21 Segment Information
Hospira conducts operations worldwide and is managed in three reportable segments: Americas, EMEA and APAC. The Americas segment includes the U.S., Canada and Latin America; 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. Hospira has aggregated U.S., Canada, and Latin America within the Americas reportable segment in accordance with the provisions of ASC Topic 280 Segment Reporting. In all segments, Hospira sells a broad line of products, including specialty injectable pharmaceuticals, medication management, and other pharmaceuticals. Specialty Injectable Pharmaceuticals include generic injectables and proprietary specialty injectables. Medication Management includes infusion pumps, related software and services, dedicated administration sets, gravity administration sets, and other device products. Other Pharmaceuticals include large volume intravenous solutions, nutritionals and contract manufacturing services.
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, 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.
Reportable segment information:
The table below presents information about Hospiras reportable segments for the three months ended June 30:
|
|
Three Months Ended June 30, |
| ||||||||||
|
|
Net Sales |
|
Income (Loss) from Operations |
| ||||||||
(dollars in millions) |
|
2011 |
|
2010 |
|
2011 |
|
2010 |
| ||||
|
|
|
|
|
|
|
|
|
| ||||
Americas |
|
$ |
843.1 |
|
$ |
781.1 |
|
$ |
213.2 |
|
$ |
161.2 |
|
EMEA |
|
134.6 |
|
120.8 |
|
(7.8 |
) |
(5.4 |
) | ||||
APAC |
|
86.4 |
|
66.3 |
|
9.9 |
|
10.0 |
| ||||
|
|
|
|
|
|
|
|
|
| ||||
Total reportable segments |
|
$ |
1,064.1 |
|
$ |
968.2 |
|
215.3 |
|
165.8 |
| ||
|
|
|
|
|
|
|
|
|
| ||||
Corporate functions |
|
|
|
|
|
(15.5 |
) |
(39.0 |
) | ||||
Stock-based compensation |
|
|
|
|
|
(9.3 |
) |
(10.5 |
) | ||||
Income from operations |
|
|
|
|
|
190.5 |
|
116.3 |
| ||||
Interest expense and other income, net |
|
|
|
|
|
(21.9 |
) |
(23.9 |
) | ||||
|
|
|
|
|
|
|
|
|
| ||||
Income before income taxes |
|
|
|
|
|
$ |
168.6 |
|
$ |
92.4 |
|
The table below presents information about Hospiras reportable segments for the six months ended June 30:
|
|
Six Months Ended June 30, |
| ||||||||||
|
|
Net Sales |
|
Income (Loss) from Operations |
| ||||||||
(dollars in millions) |
|
2011 |
|
2010 |
|
2011 |
|
2010 |
| ||||
|
|
|
|
|
|
|
|
|
| ||||
Americas |
|
$ |
1,652.0 |
|
$ |
1,596.9 |
|
$ |
418.5 |
|
$ |
407.9 |
|
EMEA |
|
254.6 |
|
243.3 |
|
(15.8 |
) |
7.8 |
| ||||
APAC |
|
159.8 |
|
135.6 |
|
13.9 |
|
6.9 |
| ||||
|
|
|
|
|
|
|
|
|
| ||||
Total reportable segments |
|
$ |
2,066.4 |
|
$ |
1,975.8 |
|
416.6 |
|
422.6 |
| ||
|
|
|
|
|
|
|
|
|
| ||||
Corporate functions |
|
|
|
|
|
(39.3 |
) |
(70.9 |
) | ||||
Stock-based compensation |
|
|
|
|
|
(23.0 |
) |
(27.8 |
) | ||||
Income from operations |
|
|
|
|
|
354.3 |
|
323.9 |
| ||||
Interest expense and other income, net |
|
|
|
|
|
(43.1 |
) |
(46.1 |
) | ||||
|
|
|
|
|
|
|
|
|
| ||||
Income before income taxes |
|
|
|
|
|
$ |
311.2 |
|
$ |
277.8 |
|
Entity wide disclosures:
Due to the acquisition in March 2010 of the generic injectable business of Orchid Chemicals and Pharmaceuticals Ltd. located in India and current year capacity expansion activities, long-lived assets in India were $163.8 million and $114.1 million as of June 30, 2011 and December 31, 2010, respectively.
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, 2010 (the 2010 Form 10-K) and (ii) the factors described in Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations (Item 7) in the 2010 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, 2011, 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 products. Hospiras broad portfolio of products is used by hospitals and alternate site providers, such as clinics, home healthcare providers and long-term care facilities.
Product Development
Hospiras product development programs are concentrated in the areas of specialty injectable pharmaceuticals and medication management. Hospira manages these product development programs and related costs through the following four categories: generic pharmaceuticals, biosimilars, proprietary pharmaceuticals and device products. For purposes of reporting the generic pharmaceutical and biosimilar pipelines, Hospira considers a new compound to be introduced in one or more countries to be a compound in the pipeline.
Generic Pharmaceutical Product Development. As of June 30, 2011, Hospiras generic pharmaceutical pipeline consisted of 45 compounds. In terms of therapeutic areas, more than half of the overall pipeline consisted of compounds related to oncology and anti-infectives, with the remainder focused on cardiovascular, anesthesia and other areas. Of the pipelines compounds, 20 have been submitted to one or more regulatory agencies for approval. The applicable regulatory process could delay or prevent Hospira from offering certain of these compounds, or could increase the cost of development.
Biosimilar Product Development. As of June 30, 2011, Hospiras biosimilar pipeline (including co-developed biosimilars) consisted of 11 compounds. While guidelines have existed for the approval of biosimilars in the European Union for some time, the regulatory requirements for biosimilars in the United States (U.S.) and other countries are evolving. To date, the U.S. Food and Drug Administration (FDA) and many other regulatory agencies have not issued specific biosimilar guidance. The costs of development and approval along with the probability of success for Hospiras biosimilar candidates will be impacted by any final regulations issued by these regulatory authorities. Hospira expects that the product development costs for each internally developed biosimilar candidate could be up to $100-$200 million per biosimilar over a 7 to 8 year period. Hospira has entered into agreements with other companies to share in the manufacturing and development of certain of these biosimilar candidates. This is in alignment with Hospiras biosimilar strategy to expand its portfolio and capabilities with measured investment and risk. However, the cost to develop each biosimilar candidate could vary significantly and is highly dependent on the specific compound, as well as any final guidance that is issued by the applicable regulatory authorities, which will dictate the amount and type of clinical trial work that will be necessary for regulatory approval. The final regulations could delay or prevent Hospira from offering certain of its proposed biosimilar candidates, or could increase the cost of developing such biosimilar candidates. There are no internally developed biosimilar candidates currently in Phase III development.
Proprietary Pharmaceutical Product Development. As of June 30, 2011, Hospira has in development/co-development the following proprietary pharmaceutical products:
· PrecedexTM is a proprietary sedative. Hospira is engaged in the following development programs to expand the clinical use of this product:
· in 2007, Hospira completed its clinical program for the long-term use of PrecedexTM (greater than 24 hour infusion), and is in the process of responding to additional requests from the FDA based on this data as well as additional long-term treatment data while it has achieved approval of this indication in certain markets outside the U.S.; and
· in 2009, Hospira began clinical trials in its Phase III development for the use of PrecedexTM in the pediatric setting.
· POSIDURTM is a long-acting version of the anesthetic bupivacaine. In 2010, Hospira entered into a licensing agreement with DURECT Corporation to develop and market DURECTs POSIDURTM, which was under Phase III development at the time Hospira entered into the agreement.
· ATIRTM is a personalized hematology product designed for blood cancer patients in need of allogeneic bone marrow transplantation who cannot locate a matched donor. In 2010, Hospira and Kiadis Pharma B.V. entered into a collaborative agreement to develop, license and commercialize ATIRTM, which was under Phase III development at the time Hospira entered into the agreement.
· Dyloject TM is a post-operative pain management drug currently awaiting FDA approval. In 2010, Hospira received a complete response letter from the FDA regarding Dyloject TM. Hospira and its third party manufacturer continue to work closely with the FDA to address all items raised as part of the regulatory process, but the timing of resolution is uncertain.
Device Product Development. Hospiras key device programs include the development of advanced infusion platforms and systems, program/software updates to those platforms and systems and developments in consumables. In March 2011, Hospira submitted a 510 (k) application with the FDA for modifications to its SymbiqTM infusion system. In May 2011, the FDA responded to the 510(k) application with clarifying questions, which are currently being reviewed by Hospira. Hospira believes this application is one of the first in the industry to be submitted under recent FDA draft guidance for 510(k) infusion pump clearances, which makes it difficult to project the timeline for FDA clearance of this SymbiqTM 510(k).
For information related to Hospiras patents, see the section captioned Patents, Trademarks and Other Intellectual Property in Hospiras 2010 Form 10-K. For further information related to certain of Hospiras development agreements for biosimilars and proprietary pharmaceuticals, see the section captioned Product Development and Manufacturing and Note 4 to the financial statements in Hospiras 2010 Form 10-K.
Research and development (R&D) spending includes costs identifiable to specific projects, general costs which are essential to all of Hospiras R&D operations, and one-time initial and development milestone payments associated with external collaborative arrangements. The costs identifiable to a specific project are not individually material to Hospiras Research and development expense line item for the three and six months ended June 30, 2011 and 2010, respectively.
From time to time, Hospira may enter into collaborative arrangements with third parties for the development, license or commercialization of certain products. The timing and terms of such collaborative arrangements are uncertain and unpredictable. Hospira plans to continue to manage its portfolio to achieve R&D spend in full-year 2011 in the range of approximately 6% to 7% of net sales, exclusive of any one-time initial and development milestone payments associated with collaborative arrangements.
Continuous Improvement Activities
Hospira aims to achieve a culture of continuous improvement that will enhance its efficiency, effectiveness and competitiveness and substantially improve its cost base. As part of its strategy, Hospira has taken a number of actions to reduce operating costs and optimize operations. The net charges 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, relocation of production, process optimization implementation, other asset charges, exit costs, contract termination costs and gain on disposal of assets.
Project Fuel
In March 2009, Hospira announced details of a restructuring and optimization plan, (Project Fuel), which was completed in March 2011. Project Fuel included the following activities: optimizing the product portfolio, evaluating non-strategic assets and streamlining the organizational structure. Hospira incurred aggregate charges related to these actions of $132.5 million on a pre-tax basis. These charges included aggregate restructuring costs and other asset charges of $72.0 million on a pre-tax basis.
As part of Project Fuel initiatives, Hospira committed to dispose of certain non-strategic businesses and the underlying assets. In February 2010, Hospira completed the disposal of a facility in Wasserburg, Germany for $69.3 million, comprised of initial cash proceeds of $62.6 million and an additional $6.7 million received in the first quarter of 2011. Hospira recognized a gain of $11.4 million on the disposal of the Wasserburg facility which is included in Restructuring, impairment and (gain) on disposition of assets, net in first quarter of 2010.
Hospiras March 2009 Project Fuel announcement included the expectation that these actions would deliver annual pre-tax savings of approximately $8 million to $10 million in 2009, approximately $70 million to $80 million in 2010, and approximately $110 million to $140 million on an annualized run-rate basis thereafter. To date, Hospira has achieved annual pre-tax savings within the stated ranges.
Facilities Optimization and Capacity Expansion
In April 2008, Hospira announced a plan to exit manufacturing operations at its Morgan Hill, California facility. In March 2011, Hospira completed the process of transferring related operations and production of products to other Hospira facilities or outsourcing certain product components to third-party suppliers. Hospira incurred aggregate charges related to this action of $42.5 million on a pre-tax basis. These charges included aggregate restructuring charges of $27.8 million on a pre-tax basis.
In 2011, to ensure Hospiras manufacturing capacity aligns with expected future commercial growth and demand, Hospira began expansion in India of specialty injectable manufacturing capacity utilizing the long-term land leases acquired in 2010. Capital expenditures and related start-up charges are anticipated for this multi-year project. Approximately $125 million of capital expenditures are expected in 2011.
Other restructuring
In addition to the programs discussed above, from time to time Hospira incurs costs to implement restructuring efforts for specific operations. During the three months ended March 31, 2011, Hospira incurred costs to terminate distributor contracts in the Americas segment of $7.8 million reported in Restructuring, impairment and (gain) on disposition of assets, net related to the restructuring of certain Latin America operations. No additional restructuring costs are expected to be incurred for these actions.
The net charges incurred for the above continuous improvement activities collectively were reported in the condensed consolidated statements of income and comprehensive income (loss) line items included in Item 1 as follows:
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
| ||||||||
(dollars in millions) |
|
2011 |
|
2010 |
|
2011 |
|
2010 |
| ||||
Cost of products sold |
|
$ |
|
|
$ |
6.1 |
|
$ |
5.8 |
|
$ |
11.8 |
|
Restructuring, impairment and (gain) on disposition of assets, net |
|
|
|
2.6 |
|
11.5 |
|
(5.0 |
) | ||||
Research and development |
|
|
|
0.1 |
|
|
|
0.3 |
| ||||
Selling, general and administrative |
|
|
|
4.8 |
|
1.2 |
|
8.1 |
| ||||
Total net charges |
|
$ |
|
|
$ |
13.6 |
|
$ |
18.5 |
|
$ |
15.2 |
|
As Hospira continues to consider each restructuring and continuous improvement 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 continuous improvement activities, see Note 3 to the condensed consolidated financial statements included in Item 1.
Acquisitions
Javelin Pharma
In July 2010, Hospira completed the acquisition of Javelin Pharmaceuticals, Inc. (Javelin Pharma) for a purchase price of $161.9 million. The acquisition will enable Hospira to take advantage of operating synergies between Hospiras PrecedexTM and Javelin Pharmas main product candidate, DylojectTM, a post-operative pain management drug currently awaiting U.S. FDA approval. In October 2010, Hospira received a complete response letter from the FDA regarding DylojectTM. Hospira and its third party manufacturer continue to work closely with the FDA to address all items raised as part of the regulatory process. Timing of resolution and expected launch of the product is uncertain. The impact, except for the acquisition costs of $7.9 million in 2010, of this acquisition was not significant to Hospiras results of operations through June 30, 2011. The future impact of DylojectTM on Hospira depends on the various product development and commercialization efforts, and the timing of resolution of the regulatory process in connection therewith.
Hospira India Acquisition
In March 2010, Hospira Healthcare India Private Limited (Hospira India), a wholly owned subsidiary of Hospira, completed its acquisition of the generic injectable pharmaceutical business of Orchid Chemicals & Pharmaceuticals Ltd. (Orchid Pharma) for $381 million. The acquisition included a beta-lactam antibiotic formulation manufacturing complex and pharmaceutical research and development facility, as well as a generic injectable dosage-form product portfolio and pipeline. Hospira incurred acquisition costs of $12.3 million in 2010.
Certain Quality and Product Related Matters
Warning Letter (April 2010)
In April 2010, Hospira received a Warning Letter from the FDA (the FDAs April 2010 Warning Letter is publicly available on the FDAs website) in connection with the FDAs inspection of Hospiras pharmaceutical and device manufacturing facilities located in Clayton, North Carolina and Rocky Mount, North Carolina. In the Warning Letter, the FDA cited 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. 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 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 certain products manufactured at the Clayton and Rocky Mount facilities. Hospira has worked with several third party experts to assist with the activities at both facilities. Hospira had implemented certain interim controls, including third party oversight, to ensure products manufactured at both facilities meet their specifications prior to release. Hospira has completed a comprehensive review of its manufacturing operations to ensure compliance with applicable regulations, and continues to ensure compliance with new regulations. 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 resumed shipment of certain products placed on voluntary shipping hold, but cannot predict when all products on voluntary hold will be reintroduced to the market.
In January 2011, the FDA conducted a follow-up inspection at the Clayton facility to evaluate Hospiras corrective actions in response to items raised in the April 2010 Warning Letter. The FDA did not issue an Inspectional Observation (Form 483) of any potentially objectionable conditions related to the Clayton inspection. The FDA conducted a follow-up inspection at the Rocky Mount facility in May 2011. The FDA issued a Form 483 for the Rocky Mount inspection listing their observations related to certain quality systems, facilities, and operating procedures. Hospira has submitted a response to the FDA, and continues to interact and work with the FDA to resolve the matters identified in the Form 483.
During 2010, Hospira incurred charges of $54.3 million related to the activities associated with the matters cited above for the Clayton and Rocky Mount facilities as well as Hospiras assessment of the status of its quality operations on a holistic basis throughout its global manufacturing facilities. During 2011, Hospira continued to invest in quality operations throughout its global manufacturing facilities including at the Clayton and Rocky Mount facilities. However, to remediate the specific matters cited above, charges incurred were not significant during the three and six months ended June 30, 2011.
SymbiqTM Infusion Pumps
In April 2010, Hospira placed a voluntary hold on all shipments to new customers of SymbiqTM, a large volume infusion device. Hospira initiated this hold after it received an unexplained increase in customer complaints related to the failure of the SymbiqTM 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 SymbiqTM to alarm at the end of infusion therapy. In August 2010, Hospira initiated a set recall related to the issue. Additionally, Hospira notified customers of reports of unrestricted flow when the SymbiqTM infusion set cassette is improperly removed from the pump before the pumps cassette door is fully opened. Hospira cautioned customers to allow the pumps cassette door to fully open before removing the infusion set as the pump may not alarm when the infusion set is improperly removed. The FDA has classified each of these actions as a Class I recall and Hospira is working closely with the FDA to conclude these matters. Hospira has not asked customers to return or cease using their SymbiqTM pumps. Hospira has recognized charges in Cost of products sold for quality assessment and testing, materials, and labor to remediate these matters, which have not been significant to date to Hospira.
Hospira has submitted the appropriate applications for modifications to its SymbiqTM infusion system to regulatory agencies in various countries. On March 31, 2011, Hospira submitted a 510(k) application with the FDA for these modifications. The 510(k) application included software updates to further enhance the reliability of the infusion system, and to correct the recall issues impacting the device. Hospira believes this application is one of the first in the industry to be submitted under recent FDA draft guidance for 510(k) infusion pump clearances, which makes it difficult to project the timeline for FDA clearance of this SymbiqTM update and Hospira is not able to predict the timeline for approval by the other regulatory agencies. In May 2011, the FDA responded to the 510(k) application with clarifying questions, which are currently being reviewed by Hospira. New customer pump placements for SymbiqTM will remain on voluntary hold until Hospira receives the clearance from the applicable regulatory agencies. Further, costs for long-term solutions and product improvements will depend on various product development efforts and corresponding regulatory outcomes in connection therewith.
PlumTM Infusion Pumps
In December 2010, Hospira informed the FDA that it had received a small number of customer reports associated with the Plum A+TM and XL family of infusion pumps regarding failure of the pumps audible alarm under certain conditions. Hospira has notified customers of the corrective action plan to address this issue. For the Plum A+TM pumps, the alarm failures are associated with the alarm assembly. For the Plum XLTM pumps, the alarm failure is associated with fluid ingress and physical damage to the alarm assembly over time. Plum XLTM customers are being asked to follow the proper cleaning procedure and inspect the alarm assembly for physical damage during routine maintenance. The Plum A+TM and Plum XL TM actions have been classified as a Class II field recall and the FDA is not requiring Hospira to remove any PlumTM pumps from the market or halt production. Hospira recognized a charge of $26 million for the estimated costs of the field recall during December 2010. Hospira is in the process of validating replacement components for the Plum A+TM as part of the overall remediation process and expects the remediation to extend through 2012.
Regulatory Environment and Related Impact
Hospira committed to the FDA that it would engage in a comprehensive product review for each of Hospiras device products. The product reviews are designed to confirm compliance with current regulatory requirements and document safety and performance of the products. The product reviews will include retrospective assessments of customer experiences with these products over the preceding two years. The product reviews will provide Hospira with important information for enhancing the reliability of these products and future products. The product reviews are ongoing, and certain remediation actions for Hospiras device products may be required upon finalization of the product reviews. While Hospira cannot predict the amount of costs that may be required to remediate its device products at this time, there can be no assurance that such costs would not be material to Hospiras results of operations for a particular period.
These quality matters have impacted, and may impact further, Hospiras ability to market and sell certain products including Hospiras pumps and certain other products in all segments. Additionally, these quality matters have resulted in, and may further result in, higher customer backlog orders and penalties for failure to supply products.
Hospira takes all of these matters seriously and responds fully, and in a timely manner, to the FDA. Hospira cannot, however, give any assurances as to the expected date of resolution of the matters related to pumps or the matters included in the Warning Letter. While Hospira continues to work to resolve the remaining matters described above, there can be no assurance that additional costs or penalties will not be incurred, and that additional regulatory actions with respect to Hospira will not occur. Until the violations and other product matters are corrected, Hospira may be subject to additional regulatory actions by the FDA, including the withholding of approval of new drug applications, product seizure, injunction, and/or civil monetary penalties.
Changes in and stricter enforcement of the laws and regulations impacting Hospiras industry may result in changes to customer buying patterns, increased investment in quality systems and personnel and additional on-market remediation activities being classified as recalls, including improvement related activities that are deemed by regulatory agencies to reduce the risk to health posed by the products. Any such additional actions, or further adverse developments, 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 regulatory agencies or customers will be satisfied with Hospiras response and corrective actions.
Patent-Related Product Matters
Hospira is involved in patent-related disputes with companies with branded products over our efforts to market generic pharmaceutical products. In March 2011, Hospira received final FDA approval in the U.S. and launched an oncolytic drug docetaxel (a generic version of Sanofi-Aventiss Taxotere®) that is the subject of ongoing patent litigation. Additionally, Hospira received final approval in the U.S. and launched in November 2010 a 2 gram freeze dried powder presentation of gemcitabine (a generic version of Eli Lillys Gemzar®), that is subject to ongoing patent litigation. If Hospiras products are ultimately found to infringe the patent rights of another company, Hospira may be subject to significant damages, which may be based on a reasonable royalty or on the lost profits from the sale of the branded product and/or an injunction preventing Hospira from further sales.
For further details regarding Hospiras PrecedexTM patents and related litigation, see Note 20 to the condensed consolidated financial statements included in Item 1.
Results of operations for the three months ended June 30, 2011 compared to June 30, 2010
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, |
| ||||||||
|
|
2011 |
|
2010 |
|
Percent Change |
|
Percent Change |
| ||
Americas |
|
|
|
|
|
|
|
|
| ||
Specialty Injectable Pharmaceuticals |
|
$ |
528.7 |
|
$ |
453.0 |
|
16.7 |
% |
15.9 |
% |
Medication Management |
|
200.5 |
|
205.2 |
|
(2.3 |
)% |
(4.4 |
)% | ||
Other Pharma |
|
113.9 |
|
122.9 |
|
(7.3 |
)% |
(5.7 |
)% | ||
Total Americas |
|
843.1 |
|
781.1 |
|
7.9 |
% |
7.2 |
% | ||
|
|
|
|
|
|
|
|
|
| ||
Europe, Middle East & Africa (EMEA) |
|
|
|
|
|
|
|
|
| ||
Specialty Injectable Pharmaceuticals |
|
76.1 |
|
67.3 |
|
13.1 |
% |
(0.4 |
)% | ||
Medication Management |
|
33.9 |
|
28.6 |
|
18.5 |
% |
4.5 |
% | ||
Other Pharma |
|
24.6 |
|
24.9 |
|
(1.2 |
)% |
(8.4 |
)% | ||
Total EMEA |
|
134.6 |
|
120.8 |
|
11.4 |
% |
(0.9 |
)% | ||
|
|
|
|
|
|
|
|
|
| ||
Asia Pacific (APAC) |
|
|
|
|
|
|
|
|
| ||
Specialty Injectable Pharmaceuticals |
|
70.4 |
|
54.1 |
|
30.1 |
% |
12.0 |
% | ||
Medication Management |
|
12.1 |
|
10.4 |
|
16.3 |
% |
2.9 |
% | ||
Other Pharma |
|
3.9 |
|
1.8 |
|
116.7 |
% |
116.7 |
% | ||
Total APAC |
|
86.4 |
|
66.3 |
|
30.3 |
% |
13.4 |
% | ||
|
|
|
|
|
|
|
|
|
| ||
Net Sales |
|
$ |
1,064.1 |
|
$ |
968.2 |
|
9.9 |
% |
6.6 |
% |
Specialty Injectable Pharmaceuticals include generic injectables and proprietary specialty injectables. Medication Management includes infusion pumps, related software, services, dedicated administration sets, gravity administration sets, and other device products. Other Pharma includes large volume I.V. solutions, nutritionals and contract manufacturing services.
(1) The comparisons at constant currency rates reflect comparative local currency balances at prior periods foreign exchange rates. Hospira 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 9.9%, or 6.6% excluding the impact of changes in foreign exchange rates.
Americas
Net sales in the Americas segment increased 7.9%, or 7.2% excluding the impact of changes in foreign exchange rates. Net sales of Specialty Injectable Pharmaceuticals increased primarily due to the continuing effects of the launch of docetaxel during the first quarter of 2011, the launches of meropenem, piperacillin and tazobactam, and gemcitabine in mid and late 2010, and continued volume growth of Hospiras proprietary sedation drug, PrecedexTM. The second quarter of 2010 included the net sales impact of oxaliplatin in the U.S. for which Hospira temporarily exited this market in mid-2010. Medication Management net sales were lower due to decreased sales volumes for PlumTM infusion pumps and administration sets. Net sales in Other Pharma decreased due to lower volumes for solution products.
EMEA
Net sales in the EMEA segment increased 11.4%, but decreased (0.9)% excluding the impact of changes in foreign exchange rates. Specialty Injectable Pharmaceuticals net sales decreased slightly due to expected price and volume decreases resulting from competition for certain existing oncology products. The decrease was offset by continued strong sales volume of the biosimilar, RetacritTM and heparin, and launch of meropenem. Medication Management net sales increased due primarily to increased volumes in PlumTM dedicated administration sets.
APAC
Net sales in the APAC segment increased 30.3%, or 13.4% excluding the impact of changes in foreign exchange rates. Specialty Injectable Pharmaceuticals net sales increased due to strong sales volume for PrecedexTM and the launch of docetaxel in Australia in 2011. Medication Management net sales increased due primarily to sales volume for PlumTM and GemStarTM dedicated administration sets.
Gross Profit (Net sales less Cost of product sold)
Three months ended June 30 (dollars in millions) |
|
2011 |
|
2010 |
|
Percent |
| ||
Gross profit |
|
$ |
413.4 |
|
$ |
369.2 |
|
12.0 |
% |
As a percent of net sales |
|
38.8 |
% |
38.1 |
% |
|
| ||
Gross profit increased $44.2 million, or 12.0%, for the three months ended June 30, 2011, compared with the same period in 2010.
Gross profit increased in the second quarter of 2011 partially due to new product launches including docetaxel in the U.S. in 2011 as well as other generic product launches in mid and late 2010. A portion of the increase was due to the reduction of costs for activities directly associated with the FDAs Warning Letter received in April 2010, and failure to supply penalties and warranty charges that were predominantly incurred in 2010. These increases were partially offset by the impact of oxaliplatin in the U.S. for which Hospira temporarily exited this market in mid-2010. In 2011, a portion of the profit generated by sales of docetaxel was recorded in Equity income from affiliates, net as the product is sourced from Hospiras joint venture.
Restructuring, Impairment and (gain) on disposition of assets, net
Three months ended June 30 (dollars in millions) |
|
2011 |
|
2010 |
|
Percent |
| ||
Restructuring, impairment and (gain) on disposition of assets, net |
|
$ |
1.5 |
|
$ |
2.6 |
|
(42.3 |
)% |
As a percent of net sales |
|
0.1 |
% |
0.3 |
% |
|
| ||
Restructuring, impairment and (gain) on disposition of assets, net was $1.5 million for the three months ended June 30, 2011, compared with $2.6 million for the same period in 2010. The impairment charge in 2011 was related to the discontinuation of a medication management product. The restructuring charges in 2010, primarily severance, were associated with Hospiras Project Fuel and Facilities optimization initiatives.
Research and Development
Three months ended June 30 (dollars in millions) |
|
2011 |
|
2010 |
|
Percent |
| ||
Research and development |
|
$ |
65.8 |
|
$ |
80.4 |
|
(18.2 |
)% |
As a percent of net sales |
|
6.2 |
% |
8.3 |
% |
|
| ||
R&D decreased $14.6 million, or (18.2)%, for the three months ended June 30, 2011, compared with the same period in 2010. R&D in 2010 included an initial milestone payment of $27.5 million for an agreement with DURECT Corporation for research and development of an anesthetic product that had not yet reached regulatory approval. Excluding the prior year initial milestone payment, there was higher spending in 2011 on certain clinical trials for biosimilar and proprietary pharmaceutical product development.
Selling, General and Administrative
Three months ended June 30 (dollars in millions) |
|
2011 |
|
2010 |
|
Percent |
| ||
Selling, general and administrative |
|
$ |
155.6 |
|
$ |
169.9 |
|
(8.4 |
)% |
As a percent of net sales |
|
14.6 |
% |
17.5 |
% |
|
| ||
Selling, general and administrative (SG&A) decreased $14.3 million, or (8.4)%, for the three months ended June 30, 2011, compared with the same period in 2010. SG&A in 2010 included costs incurred for the RTI litigation settlement and related charges, and for Project Fuel initiatives, which were completed in March 2011. Excluding the prior year charges, SG&A was higher in 2011 due primarily to the impact of foreign exchange.
Interest Expense and Other Income, Net
Hospira incurred interest expense of $23.9 million for the three months ended June 30, 2011 and $24.2 million in the same period in 2010. Other income, net was $2.0 million for the three months ended June 30, 2011 compared to $0.3 million for the three months ended June 30, 2010.
Income Tax Expense
The effective tax rate was 21.8% for the three months ended June 30, 2011, compared to 10.2% for the same period in 2010. During the three months ended June 30, 2010, the effective tax rate was lower as a result of certain charges in higher tax rate jurisdictions. The effective tax rates are less than the statutory U.S. federal income tax rate principally due to the benefit of tax exemptions of varying durations, in certain jurisdictions outside the U.S.
Equity Income From Affiliates, Net
Equity income from affiliates increased to $11.7 million during the three months ended June 30, 2011 compared to $0.5 million for the same period in 2010, primarily due to income from Hospiras joint venture associated with the continuing effect of the docetaxel launch in 2011.
Results of operations for the six months ended June 30, 2011 compared to June 30, 2010
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, |
| ||||||||
|
|
2011 |
|
2010 |
|
Percent Change |
|
Percent Change |
| ||
Americas |
|
|
|
|
|
|
|
|
| ||
Specialty Injectable Pharmaceuticals |
|
$ |
1,040.0 |
|
$ |
936.9 |
|
11.0 |
% |
10.4 |
% |
Medication Management |
|
396.5 |
|
411.7 |
|
(3.7 |
)% |
(5.2 |
)% | ||
Other Pharma |
|
215.5 |
|
248.3 |
|
(13.2 |
)% |
(12.4 |
)% | ||
Total Americas |
|
1,652.0 |
|
1,596.9 |
|
3.5 |
% |
2.8 |
% | ||
|
|
|
|
|
|
|
|
|
| ||
EMEA |
|
|
|
|
|
|
|
|
| ||
Specialty Injectable Pharmaceuticals |
|
144.6 |
|
137.2 |
|
5.4 |
% |
(1.5 |
)% | ||
Medication Management |
|
67.7 |
|
62.6 |
|
8.1 |
% |
2.1 |
% | ||
Other Pharma |
|
42.3 |
|
43.5 |
|
(2.8 |
)% |
(7.4 |
)% | ||
Total EMEA |
|
254.6 |
|
243.3 |
|
4.6 |
% |
(1.6 |
)% | ||
|
|
|
|
|
|
|
|
|
| ||
APAC |
|
|
|
|
|
|
|
|
| ||
Specialty Injectable Pharmaceuticals |
|
129.2 |
|
111.7 |
|
15.7 |
% |
3.0 |
% | ||
Medication Management |
|
22.5 |
|
20.0 |
|
12.5 |
% |
1.5 |
% | ||
Other Pharma |
|
8.1 |
|
3.9 |
|
107.7 |
% |
97.4 |
% | ||
Total APAC |
|
159.8 |
|
135.6 |
|
17.8 |
% |
5.5 |
% | ||
|
|
|
|
|
|
|
|
|
| ||
Net Sales |
|
$ |
2,066.4 |
|
$ |
1,975.8 |
|
4.6 |
% |
2.4 |
% |
Specialty Injectable Pharmaceuticals include generic injectables and proprietary specialty injectables. Medication Management includes infusion pumps, related software, services, dedicated administration sets, gravity administration sets, and other device products. Other Pharma includes large volume I.V. solutions, nutritionals and contract manufacturing services.
(1) The comparisons at constant currency rates reflect comparative local currency balances at prior periods foreign exchange rates. Hospira 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 4.6%, or 2.4% excluding the impact of changes in foreign exchange rates.
Americas
Net sales in the Americas segment increased 3.5%, or 2.8% excluding the impact of changes in foreign exchange rates. Net sales of Specialty Injectable Pharmaceuticals increased primarily due to the launch of docetaxel during the first quarter of 2011, the continuing effects of the launches of meropenem, piperacillin and tazobactam, and gemcitabine in mid and late 2010, and continued volume growth of Hospiras proprietary sedation drug, PrecedexTM. Net sales in 2010 included the impact of oxaliplatin in the U.S. for which Hospira temporarily exited this market in mid-2010. Medication Management net sales were lower due to decreased sales volumes for PlumTM infusion pumps, partially offset by increased volume of dedicated administration sets across all major infusion devices. Net sales in Other Pharma decreased due to lower volumes for solution and nutritional products.
EMEA
Net sales in the EMEA segment increased 4.6%, but decreased (1.6)% excluding the impact of changes in foreign exchange rates. Specialty Injectable Pharmaceuticals net sales decreased due to expected price and volume decreases resulting from competition for certain existing oncology products. The decrease was partly offset by continued strong sales volume of the biosimilar, RetacritTM and heparin, and launch of meropenem. Medication Management net sales increased slightly due primarily to volumes in PlumTM and related dedicated administration sets. Net Sales in Other Pharma decreased due to lower contract manufacturing volume.
APAC
Net sales in the APAC segment increased 17.8%, or 5.5% excluding the impact of changes in foreign exchange rates. Specialty Injectable Pharmaceuticals net sales increased due to strong sales volume for PrecedexTM and the launch of docetaxel in Australia in 2011. Medication Management net sales increased primarily due to sales volume for PlumTM and GemStarTM related dedicated administration sets.
Gross Profit (Net sales less Cost of product sold)
Six months ended June 30 (dollars in millions) |
|
2011 |
|
2010 |
|
Percent |
| ||
Gross profit |
|
$ |
812.5 |
|
$ |
799.5 |
|
1.6 |
% |
As a percent of net sales |
|
39.3 |
% |
40.5 |
% |
|
| ||
Gross profit increased $13.0 million, or 1.6%, for the six months ended June 30, 2011, compared with the same period in 2010.
Gross profit increased in the first six months of 2011 partially due to new product launches including docetaxel in the U.S. in 2011 as well as other generic product launches in mid and late 2010. Further, cost reductions associated with Project Fuel initiatives contributed to net manufacturing efficiency gains. A portion of the increase was due to the reduction of costs for activities directly associated with the FDAs Warning Letter received in April 2010, and failure to supply penalties and warranty charges that were predominantly incurred in 2010. These increases were partially offset by the impact of oxaliplatin in the U.S. for which Hospira temporarily exited this market in mid-2010. In 2011, a portion of the profit generated by sales of docetaxel was recorded in Equity income from affiliates, net as the product is sourced from Hospiras joint venture.
Restructuring, Impairment and (gain) on disposition of assets, net
Six months ended June 30 (dollars in millions) |
|
2011 |
|
2010 |
|
Percent |
| ||
Restructuring, impairment and (gain) on disposition of assets, net |
|
$ |
14.7 |
|
$ |
(5.0 |
) |
(394.0 |
)% |
As a percent of net sales |
|
0.7 |
% |
(0.3 |
)% |
|
| ||
Restructuring, impairment and (gain) on disposition of assets, net was an expense of $14.7 million for the six months ended June 30, 2011, compared to a gain of $5.0 million for the same period in 2010. The increase in 2011 is primarily due to distributor contract termination costs of $7.8 million incurred for restructuring of certain Latin America operations. 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.
Research and Development
Six months ended June 30 (dollars in millions) |
|
2011 |
|
2010 |
|
Percent |
| ||
Research and development |
|
$ |
122.7 |
|
$ |
132.1 |
|
(7.1 |
)% |
As a percent of net sales |
|
5.9 |
% |
6.7 |
% |
|
| ||
R&D decreased $9.4 million, or (7.1)%, for the six months ended June 30, 2011, compared with the same period in 2010. R&D in 2010 included an initial milestone payment of $27.5 million for an agreement with DURECT Corporation for research and development of an anesthetic product that had not yet reached regulatory approval. Excluding the prior year initial milestone payment, there was higher spending in 2011 on certain clinical trials for biosimilar and proprietary pharmaceutical product development.
Selling, General and Administrative
Six months ended June 30 (dollars in millions) |
|
2011 |
|
2010 |
|
Percent |
| ||
Selling, general and administrative |
|
$ |
320.8 |
|
$ |
348.5 |
|
(7.9 |
)% |
As a percent of net sales |
|
15.5 |
% |
17.6 |
% |
|
| ||
SG&A decreased $27.7 million, or (7.9)%, for the six months ended June 30, 2011, compared with the same period in 2010. SG&A in 2010 included costs incurred for the RTI litigation settlement and related charges, and for Project Fuel initiatives, which were completed in March 2011. Further, SG&A in 2010 included acquisition and integration charges associated with the acquisitions of Orchid Pharma and Javelin Pharma. Excluding the prior year charges, SG&A was higher in 2011 due primarily to the impact of foreign exchange.
Interest Expense and Other Income, Net
Hospira incurred interest expense of $47.3 million for the six months ended June 30, 2011 and $47.6 million in the same period in 2010. Other income, net was $4.2 million for the six months ended June 30, 2011 compared to $1.5 million for the six months ended June 30, 2010.
Income Tax Expense
The effective tax rate was 15.0% for the six months ended June 30, 2011, compared to 19.3% for the same period in 2010. During the six months ended June 30, 2011, the Internal Revenue Service (IRS) audit of Hospiras 2006 and 2007 U.S. federal tax returns was concluded and the years were effectively settled. The outcome of the audit settlement resulted in a $19.7 million discrete income tax benefit. Excluding the effect of the IRS audit settlement, the effective tax rate for the six months ended June 30, 2011 was 21.3%. For the six months ended June 30, 2010, the effective tax rate was lower as a result of certain charges in higher tax rate jurisdictions. The effective tax rates are less than the statutory U.S. federal income tax rate principally due to the benefit of tax exemptions of varying durations, in certain jurisdictions outside the U.S.
The IRS has commenced the audit of Hospiras 2008 and 2009 U.S. federal tax returns. In addition, Hospira remains open to tax audits in other jurisdictions and various tax statutes of limitation are expected to close within the next 12 months. Accordingly, a change in unrecognized tax benefits may occur for which an estimate of the range cannot be quantified at this time.
Equity Income From Affiliates, Net
Equity income from affiliates increased to $28.9 million during the six months ended June 30, 2011 compared to $1.0 million for the same period in 2010, primarily due to income from Hospiras joint venture associated with the docetaxel launch in 2011.
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, acquisitions, product development and investments in continuous improvement 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 foreign subsidiaries earnings outside of the U.S. to fund foreign investments or meet foreign working capital and plant, property and equipment acquisition needs. Future changes in U.S. tax legislation may require Hospira to reevaluate the need for possible repatriation of foreign subsidiary earnings.
Hospira has incurred and may incur further charges related to certain quality and product related matters that will require cash outflows in the future. These matters are further discussed under the section Certain Quality and Product Related Matters in Item 2. Hospira currently believes current capital resources will be sufficient to fund development costs and charges associated therewith.
In 2011, to ensure Hospiras manufacturing capacity aligns with expected future commercial growth and demand, Hospira began expansion in India of specialty injectable manufacturing capacity utilizing the long-term land leases acquired in 2010. Capital expenditures and related start-up charges are anticipated for this multi-year project. Approximately $125 million of capital expenditures are expected in 2011.
In April 2011, Hospiras Board of Directors authorized the repurchase of up to $1.0 billion of Hospiras common stock in accordance with Rule 10b-18 under the Securities Exchange Act of 1934. In April and May 2011, Hospira entered into accelerated share repurchase (ASR) contracts with a third party financial institution to repurchase $200.0 million in aggregate of Hospiras common stock. Under the ASR contracts, Hospira received 2.7 million shares based on seventy-five percent of the $200.0 million repurchased on the trade date, with the remaining shares to be delivered over the next three months subject to adjustment based on the average stock price during the period. The ASR contracts were completed in June and July, and Hospira received incremental 0.5 million and 0.5 million shares, respectively. Hospira from time to time may repurchase additional shares under this authorization which will depend on various economic factors such as cash generation from operations, current stock price and other financial considerations.
Summary of Cash Flows
|
|
Six Months Ended June 30, |
| ||||
(dollars in millions) |
|
2011 |
|
2010 |
| ||
Cash flow provided by (used in): |
|
|
|
|
| ||
Operating activities |
|
$ |
253.0 |
|
$ |
143.8 |
|
Investing activities |
|
(129.5 |
) |
(425.7 |
) | ||
Financing activities |
|
(142.5 |
) |
125.2 |
| ||
Cash flows from operating activities increased for the six months ended June 30, 2011, compared with the same period in 2010. Changes related to operating assets and liabilities were primarily due to account receivables, chargebacks, and sales rebates in 2011. Further, lower income tax payments in 2011 compared to 2010 and lower payments of employee related liabilities contributed to the increase in operating cash flows. These improvements were offset by higher inventory levels related to increased cycle times and new products launched with regulatory approval in 2010 and 2011.
Cash flows used in investing activities decreased during the six months ended June 30, 2011, primarily due to payments of $397.7 million for acquisitions during 2010. Capital expenditures increased $59.2 million compared to the prior period due to investments in capacity expansion and information technology initiatives. Further, proceeds from dispositions decreased from the prior period due to the disposal of a facility in Wasserburg, Germany during 2010.
Cash flows from financing activities decreased during the six months ended June 30, 2011, compared with the same period in 2010, due primarily to the repurchase of common stock during 2011, and lower proceeds from stock options exercised.
Debt and Capital
Hospira has a $700.0 million unsecured revolving credit facility (Revolver) expiring in October 2012 under which no amounts were outstanding as of June 30, 2011.
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, 2011, Hospira was in compliance with all applicable covenants.
Hospira has entered into short-term borrowings as described under the section Debt and Capital in Item 7 of Hospiras 2010 Form 10-K. There have been no material changes to the short-term borrowing information provided in Hospiras 2010 Form 10-K. The following table is a summary of information related to Hospiras short-term borrowings:
(dollars in millions) |
|
Revolver (1) |
|
Other |
| ||
Six months ended June 30, 2011 |
|
|
|
|
| ||
Outstanding balance at period end |
|
$ |
|
|
$ |
43.1 |
|
Weighted average interest rate at period end |
|
|
% |
13.1 |
% | ||
Average monthly balance during the period end |
|
$ |
|
|
$ |
36.3 |
|
Weighted average interest rate during the period end |
|
|
% |
11.7 |
% | ||
Maximum month-end balance during the period end |
|
$ |
|
|
$ |
43.1 |
|
|
|
|
|
|
| ||
Three months ended June 30, 2011 |
|
|
|
|
| ||
Outstanding balance at period end |
|
$ |
|
|
$ |
43.1 |
|
Weighted average interest rate at period end |
|
|
% |
13.1 |
% | ||
Average monthly balance during the period end |
|
$ |
|
|
$ |
39.5 |
|
Weighted average interest rate during the period end |
|
|
% |
12.4 |
% | ||
Maximum month-end balance during the period end |
|
$ |
|
|
$ |
43.1 |
|
(1) During the three and six months ended June 30, 2011, Hospira had not borrowed any amounts under the Revolver.
Contractual Obligations
There have been no material changes to the contractual obligations information provided in Hospiras 2010 Form 10-K, except that Hospira began expansion in India of specialty injectable manufacturing capacity utilizing the long-term land leases acquired in 2010. Capital expenditures and related start-up charges are anticipated for this multi-year project. Approximately $125 million of capital expenditures are expected in 2011.
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 to the companys consolidated financial statements, which are included in Hospiras 2010 Form 10-K. 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 in the 2010 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 sensitivity analyses of changes in the fair value of foreign currency forward exchange contracts outstanding at June 30, 2011 and, while not predictive in nature, indicated that if the U.S. dollar uniformly fluctuates unfavorably by 10% against all currencies the net assets balance of $0.5 million would decrease by ($0.3) million.
The sensitivity analyses recalculate the fair value of the foreign currency forward exchange contracts outstanding at June 30, 2011 by replacing the actual exchange rates at June 30, 2011 with exchange rates that are 10% unfavorable to the actual exchange rates for
each applicable currency. All other factors are held constant. These sensitivity analyses disregard 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 analyses also disregard the offsetting change in value of the underlying hedged transactions and balances.
As part of its risk management program, Hospira performs sensitivity analyses to assess potential gains and losses in earnings relating to hypothetical movements in interest rates associated with outstanding interest rates swap contracts. A 10 basis-point increase in benchmark interest rates affecting Hospiras $400.0 million notional interest rate swap contracts would have an immaterial effect on the annual earnings over the term of the related instruments.
In July 2011, Hospira terminated all existing interest rate swap contracts with a total notional amount of $400.0 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 2010 Form 10-K.
Item 4. Controls and Procedures
Evaluation of disclosure controls and procedures. Chief Executive Officer, F. Michael Ball, and Chief Financial Officer, Thomas E. Werner, evaluated the effectiveness of Hospiras disclosure controls and procedures (as defined in Rules 13a-15(e) and 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 2011, Hospira continued to transition certain finance processes under an outsourcing arrangement, which includes various general ledger, fixed assets, accounts payable, credit, collections and cash application 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 2011 that have materially affected or are reasonably likely to materially affect Hospiras internal control over financial reporting.
The disclosure contained in Note 20 to the condensed consolidated financial statements included in Part I Item 1 hereof is incorporated herein by reference.
Please refer to Item 1A in Hospiras Annual Report on Form 10-K for the year ended December 31, 2010 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.
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 |
|
Average Price |
|
Total Number |
|
Maximum Number |
| ||
April 1-April 30, 2011 |
|
1,323,052 |
|
$ |
56.73 |
|
1,322,052 |
|
$ |
900,000,000 |
|
May 1-May 31, 2011 |
|
1,373,835 |
|
$ |
54.99 |
|
1,364,035 |
|
$ |
800,000,000 |
|
June 1-June 30, 2011 |
|
511,945 |
|
$ |
54.75 |
|
504,562 |
|
$ |
800,000,000 |
|
Total |
|
3,208,832 |
|
$ |
56.67 |
|
3,190,649 |
|
$ |
800,000,000 |
|
(1) In addition to the shares purchased as part of Hospiras publicly announced program, 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: 0 in April, 8,800 in May, and 6,383 in June. For further details regarding employee stock options, see Note 19 to the condensed consolidated financial statements included in Part I Item 1. These shares also include the shares purchased on the open market for the benefit of participants in the Hospira Healthcare Corporation (Hospira Canada) Stock Purchase Plan 1,000 in April, 1,000 in May, and 1,000 in June.
(2) In April 2011, Hospiras Board of Directors authorized the repurchase of up to $1.0 billion of Hospiras common stock in accordance with Rule 10b-18 under the Securities Exchange Act of 1934. In April and May 2011, Hospira entered into accelerated share repurchase (ASR) contracts with a third party financial institution to repurchase $200.0 million in aggregate of Hospiras common stock. Under the ASR contracts, Hospira received 2.7 million shares based on seventy-five percent of the $200.0 million repurchased on the trade date, with the remaining shares to be delivered over the next three months subject to adjustment based on the average stock price during the period. The ASR contracts were completed in June and July, and Hospira received incremental 0.5 million and 0.5 million shares, respectively. Hospira from time to time may repurchase additional shares under this authorization which will depend on various factors such as cash generation from operations, current stock price and other factors.
A list of exhibits immediately precedes such exhibits and is incorporated herein by reference.
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, |
|
|
Date: July 27, 2011 |
EXHIBIT INDEX
Exhibit No. |
|
Exhibit |
|
|
|
3.1 |
|
Restated Certificate of Incorporation of Hospira, Inc. (filed as Exhibit 3.1 to the Hospira, Inc. Current Report on Form 8-K filed on May 12, 2011, and incorporated herein by reference). |
|
|
|
3.2 |
|
Amended and Restated Bylaws of Hospira, Inc. (filed as Exhibit 3.2 to the Hospira, Inc. Current Report on Form 8-K filed on May 12, 2011, and incorporated herein by reference). |
|
|
|
10.1 |
|
Hospira Corporate Officer 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, 2011, filed on July 27, 2011, formatted in Extensive Business Reporting Language (XBRL): (i) condensed consolidated statements of income and comprehensive income (loss), (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. |
Exhibit 10.1
Hospira Corporate Officer Severance Plan
(Effective September 1, 2007 and as amended through the Third Amendment effective May 10, 2011)
1. Purpose. The Hospira Corporate Officer Severance Plan (Plan) was established to provide Severance Pay and other benefits to terminated Corporate Officers of Hospira, Inc. (the Company) who satisfy the terms of the Plan. Severance Pay and benefits under the Plan shall be in lieu of any benefits available under the Hospira Transitional Pay Plan or any other severance plan or policy maintained by the Company or any of its subsidiaries and affiliates (each an Affiliate); and benefits will not be payable under the Plan if the relevant termination of employment results in the employee being eligible for equivalent (or greater) severance pay and benefits under an employment agreement between the Company or an Affiliate and the employee, or under the Hospira, Inc. Change in Control Severance Pay Plan or any Change in Control agreement between the Company or any Affiliate and the employee.
2. Administration. Except as specifically stated herein, the Plan is administered by the Companys Senior Vice President, Organizational Transformation and People Development or, if there is no person by such title, such other person acting as chief human resources officer of Hospira, Inc. (Administrator). The Administrator has the complete discretion and authority with respect to the Plan and its application. The Administrator reserves the right to interpret the Plan, prescribe, amend and rescind rules and regulations relating to it, determine the terms and provisions of Severance Pay and benefits and make all other determinations it deems necessary or advisable for the administration of the Plan. The determination of the Administrator in all matters regarding the Plan shall be conclusive and binding on all persons. The Administrator may delegate any of his or her duties under the Plan to one or more other persons.
3. Scope. The Plan will apply to all Corporate Officers (Participants). For purposes of the Plan, the term Corporate Officer means an individual elected a corporate officer of the Company by its Board of Directors or designated as a Plan participant by the Compensation Committee of the Board of Directors of the Company (Committee) and listed on the attached Exhibit A, but shall not include assistant officers.
4. Eligibility for Severance Pay. A Participant becomes entitled to receive severance pay (Severance Pay) only if he or she is terminated by the Company or an Affiliate for any of the following reasons, and the conditions described in Section 5 below are met:
(a) The Participants position is eliminated due to a reduction in force or other restructuring.
(b) For the Companys Chief Executive Officer (CEO), the Participants employment is terminated for other than Cause, defined as the willful engaging by the Participant in illegal conduct or gross misconduct which is demonstrably and materially injurious to the Company. For purposes of this Plan, no act, or
failure to act, on the Participants part shall be deemed willful unless done, or omitted to be done, by the Participant not in good faith and without reasonable belief that the Participants action or omission was in the best interest of the Company.
(c) For all other Participants other than the CEO, the Participants employment is otherwise terminated for reasons not related to performance, illegal activity, failure to abide by the Companys Code of Conduct, or other good cause as determined by the Administrator and is otherwise considered to be involuntary.
Section 4(b) shall apply only to a Participant who is the CEO. A Participants eligibility for Severance Pay shall not be affected by the Companys decision to accept his or her resignation or retirement following the occurrence of any of the conditions described in Sections 4(a), 4(b), and 4(c). The decision as to whether a Participant is eligible for Severance Pay and benefits under this Plan shall be made by the Administrator, not the Participant. If the Participant disagrees, the Participant must follow the procedures set forth in Section 14.
5. Conditions to Receipt of Severance Pay.
(a) Severance Pay is not available to a Participant otherwise eligible for Severance Pay who transfers to another position with the Company or any Affiliate.
(b) A Participant must sign an agreement in a form provided by the Administrator under which the Participant agrees to use all best efforts to protect the secrecy and confidentiality of information that is confidential and proprietary to Hospira or any of its Affiliates (Confidential Information) and under which the Participant agrees that, for a period of 2 years after his or her termination of employment the Participant will: (1) not engage, directly or indirectly, in any activity or employment, for the benefit of the Participant or others, in a manner that contributes to any research, discovery, development, manufacture, importation, marketing, promotion, sale or use of any competing Hospira product, process or service, which is related in any way to the Participants employment with the Company or any of its Affiliates; (2) not engage in any activity or employment in the performance of which any Confidential Information obtained, provided or otherwise acquired, directly or indirectly, during the term of employment with Hospira or any of its Affiliates is likely to be used or disclosed, notwithstanding the Participants undertaking to the contrary; (3) not solicit the customers of the Company or any of its Affiliates or entice any employee of the Company or any of its Affiliates to leave the employment of the Company or any of its Affiliates; and (4) inform the Company of other employment by contacting the Administrator within 5 days of accepting such other employment.
(c) A Participant must satisfy any other condition specified in Section 5 and Section 6. During the period in which a Participant is entitled to consider the execution of the waiver and release agreement described in Section 6, or during such other period as is otherwise agreed to by the Administrator and the Participant, he or
she may be required to complete unfinished business projects and be available for discussions regarding matters relative to the Participants duties with the Company or any of its Affiliates.
(d) A Participant must return all property and information of the Company or any of its Affiliates.
(e) A Participant must agree to pay all outstanding amounts owed to the Company or any Affiliate and authorize the Company or Affiliate to withhold any outstanding amounts from his or her final paycheck and/or Severance Pay.
6. Amount of Severance Pay. The amount of Severance Pay to which a Participant is entitled under the Plan is the sum of:
(a) 2 years of the Participants base salary at the rate in effect on the date of termination, plus
(b) for the year of termination: (1) if the Participant also participates in the Hospira Incentive Plan or a successor plan (HIP), the Participants pro rata annual incentive bonus award through the date of termination, with the determination of the amount of such award based on an assumption that the target level of performance has been achieved; or (2) if the Participant also participates in the Hospira, Inc. Performance Incentive Plan or a successor plan (PIP), the Participants pro rata annual incentive bonus award, if any, through the date of termination as determined under the PIP.
In addition to the pro-rata bonus provided under Section 6(b) above, if the Participants date of termination occurs after the end of a performance period applicable to an annual incentive bonus award in which the Participant participates, and prior to the payment of the award, if any, for the period, the Participant shall be entitled to a lump sum payment in cash with respect to such prior performance period, as determined under the terms of that incentive award arrangement.
A Participant who is receiving benefits under a short term disability plan maintained by the Company or any Affiliate will be entitled to Severance Pay at the end of the period of payment of short term disability if, and only if, (1) he or she is not then eligible for benefits under a long term disability plan maintained by the Company or an Affiliate, and (2) he or she is not offered employment with the Company or an Affiliate that, in the discretion of the Administrator, is comparable to that held by the Participant at the time the applicable period of short term disability commenced. A Participant will not be entitled to Severance Pay at the end of the period of long term disability.
Except as provided in the last sentence of this paragraph, Severance Pay will be paid to a Participant in one lump sum cash payment. Payment will be made as soon as practicable after the last to occur of (1) the date of the Participants termination of employment, (2) the effective date of the Participants executed waiver and release agreement in the form provided by the Administrator (i) which releases the Company and its Affiliates, and their respective officers, directors and employees, from any and all actions, suits, proceedings,
claims and demands relating to the Participants employment with the Company or any Affiliate and the termination thereof, (ii) which releases all rights and benefits required under any other severance policy or plan maintained by the Company or any Affiliate, and (iii) under which the Participant agrees to maintain and protect the reputation of the Company and its Affiliates and their businesses, products and personnel, and the Participant agrees further to not disparage the Company, any Affiliate, or any person representing the Company or any Affiliate, or engage in any similar activities which reasonably could be anticipated to affect negatively the reputation of the Company and any Affiliate and their businesses, products and personnel, and relationships with current or prospective customers, suppliers and employees and (3) the satisfaction of the conditions described in Sections 5(b), (c), (d) and (e). In any event, the payment shall be made no later than 2 ½ months after the end of the year in which the termination described in Section 4 occurs. Severance Pay shall be reduced by applicable amounts necessary to comply with federal, state and local income tax withholding requirements. Notwithstanding any provision contained herein, for a Participant who participates in the PIP, the payment described in Section 6(b)(2) shall be paid after the determination of such amount, but no later than 2 ½ months after the end of the year in which the termination described in Section 4 occurs. For all participants, the benefits described in this Plan shall be forfeited if the Participant fails to execute the agreement described in Section 5(b) and the waiver and release agreement described in this paragraph within 2 ½ months after the end of the year in which the termination described in Section 4 occurs.
7. Benefits.
(a) Welfare Benefits. A Participant entitled to Severance Pay shall receive, at the time of payment of Severance Pay, a lump sum payment equivalent to 130% of the cost of 72-weeks of COBRA (as defined in Section 4980B of the Internal Revenue Code of 1986, as amended (the Code), and Sections 601-609 of the Employee Retirement Income Security Act of 1974, as amended (ERISA), or any successor sections) continuation coverage premiums in lieu of any continued medical, dental, vision, and other welfare benefits offered by the Company or any Affiliate. Such period of COBRA continuation coverage shall be included as part of the period during which the Participant may elect continued group health coverage under COBRA.
(b) Outplacement Services. A Participant entitled to Severance Pay shall receive outplacement services, selected by the Company at its expense, for a period commencing on the date of termination of employment and continuing until the earlier to occur of the Participant accepting other employment or 12 months thereafter.
8. Death of Participant. No Severance Pay will be paid if a Participant dies before satisfying Section 4 and Section 5; provided, however, that if a Participant dies after becoming entitled to receive Severance Pay by satisfying Section 4 and Section 5 but prior to receiving Severance Pay pursuant to Section 4, payment of the Severance Pay determined under Section 4 will be made to the representative of his or her estate. Notwithstanding any provision of this Plan to the contrary, the Administrator and the
Participants estate may agree to alternative means for the satisfaction of the requirements in Sections 5 (b), (c), (d) and (e).
9. Effective Date of Plan. The Plan is effective as of September 1, 2007.
10. Amendment or Termination.
(a) Hospira reserves the right to amend or terminate the Plan at any time; provided, however, that no amendment or termination may adversely affect any Severance Pay and benefits of a Participant who has terminated employment and is entitled to Severance Pay and benefits by satisfying the requirements in Section 4 and Section 5. All amendments and any termination of the Plan will be adopted by resolution of the Committee.
(b) Severance Pay and benefits under the Plan are not intended to be a vested right.
11. Code Section 409A. Notwithstanding anything to the contrary in this Plan, the Committee may adopt such amendments to the Plan, or adopt policies or procedures, as may be necessary or appropriate to (a) exempt Severance Pay and benefits from Code Section 409A and/or to preserve the intended tax treatment thereof or (b) otherwise comply with the requirements of Code Section 409A and related regulations.
12. Governing Law. The terms of the Plan shall, to the extent not preempted by federal law, be governed by, and construed and enforced in accordance with, the laws of the State of Illinois, including all matters of construction, validity and performance.
13. Miscellaneous Provisions.
(a) Severance Pay and other benefits pursuant to the Plan shall not be subject in any manner to anticipation, alienation, sale, transfer, assignment, pledge, encumbrance or charge prior to actual receipt by a Participant, and any attempt to so anticipate, alienate, sell, transfer, assign, pledge, encumber or charge prior to such receipt shall be void and neither the Company nor any Affiliate shall be liable in any manner for, or subject to, the debts, contracts, liabilities, engagements or torts of any person entitled to any Severance Pay or other benefits under the Plan.
(b) Nothing contained in the Plan shall confer upon any individual the right to be retained in the service of the Company or any Affiliate, nor limit the right of the Company or Affiliate to discharge or otherwise deal with any individual without regard to the existence of the Plan.
(c) The Plan shall at all times be entirely unfunded. No provision shall at any time be made with respect to segregating assets of the Company or any Affiliate for payment of any Severance Pay or other benefits hereunder. No employee or any other person shall have any interest in any particular assets of the Company or any Affiliate by reason of the right to receive Severance Pay or other benefits under the Plan, and any such employee or any other person shall have only the rights of
a general unsecured creditor of the Company or an Affiliate with respect to any rights under the Plan.
14. Appeals Procedure. If a Participant feels he or she should be eligible for Severance Pay or benefits under the Plan, the Participant may file a written claim with the Administrator. If a written claim for Severance Pay or benefits under the Plan by a Participant or his or her beneficiary is denied, either in whole or in part, the Administrator will let the claimant know in writing within 90 days. If the claimant does not hear within 90 days, the claimant may treat the claim as if it had been denied. A notice of a denial of a claim will refer to a specific reason or reasons for the denial of the claim; will have specific references to the Plan provisions upon which the denial is based; will describe any additional material or information necessary for the claimant to perfect the claim and explain why such material information is necessary; and will have an explanation of the Plans review procedure.
The claimant will have 60 days after the date of the denial to request in writing for a review and a hearing. The claimant must file a written request with the CEO (Claims Administrator) for a review; provided, however, that, if the claimant is the CEO, the Claims Administrator for such purpose shall be the Companys Board of Directors. During this time the claimant may review pertinent documents and may submit issues and comments in writing. The Claims Administrator will have another 60 days in which to consider the claimants written request for review. If special circumstances require an extension of time for processing, the Claims Administrator may have an additional 60 days to answer the claimant. The claimant will receive a written notice if the extra days are needed. The claimant may submit in writing any document, issues and comments he or she may wish. The decision of the Claims Administrator will tell the claimant the specific reasons for his or her actions, and refer the claimant to the specific Plan provisions upon which its decision is based.
15. Rights Under ERISA. Each Participant in the Plan is entitled to certain rights and protection under ERISA, which provides that all Participants shall be entitled to:
(a) Examine, without charge, at the Companys office all Plan documents.
(b) Obtain copies of all Plan documents and other Plan information upon written request to the Administrator. The Administrator may make a reasonable charge for the copies.
In addition to creating rights for Participants, ERISA imposes duties upon the people who are responsible for the operation of an employee benefit plan. The people who operate the Plan, called fiduciaries of the Plan, have a duty to do so prudently and in the interest of the Participants and beneficiaries. No one, including the Company, any Affiliate or any other person, may fire a Participant or otherwise discriminate against a Participant in any way to prevent him or her from obtaining a benefit or exercising his or her rights under ERISA. If a Participants claim for a benefit is denied in whole or in part, he or she must receive a written explanation of the reason for the denial. A Participant has the
right to have the Claims Administrator review and reconsider his or her written claim. Under ERISA, there are steps a Participant can take to enforce the above rights. For instance, if a Participant requests materials from the Administrator and does not receive them within thirty (30) days, he or she may file suit in a federal court. In such a case the court may require the Company to provide the materials and pay the Participant up to $110 a day until the Participant receives the materials, unless the materials were not sent because of reasons beyond the control of the Company. If a Participant has a claim for benefits, which is denied or ignored, in whole or in part, he or she may file suit in a state or federal court. If a Participant is discriminated against for asserting his or her rights, he or she may ask assistance from the United States Department of Labor, or he or she may file suit in a federal court. The court will decide who should pay the court costs and legal fees. If the Participant is successful, the court may order the person he or she has sued to pay these costs and fees. If the Participant loses, the court may order him or her to pay these costs and fees, for example, if it finds his or her claim to be frivolous. If a Participant has questions about the Plan, he or she should contact the Administrator. If a Participant has any questions about this statement or about his or her rights under ERISA, he or she should contact the nearest Area Office of the United States Labor-Management Services Administration, Department of Labor.
16. Plan Facts:
Company: |
|
Hospira, Inc. |
Plan Name: |
|
Hospira Corporate Officer Severance Plan |
Type of Plan: |
|
Severance Plan-Welfare Benefits Plan |
Plan Year: |
|
Calendar year |
Employer Identification Number (EIN): |
|
20-0504497 |
Plan Administrator: |
|
Senior Vice President, Organizational Transformation and People Development |
Business Address: |
|
275 North Field Drive |
Agent for Service of Legal Process: |
|
Senior Vice President, Organizational Transformation and People Development |
Address |
|
275 North Field Drive |
Hospira Corporate Officer Severance Plan
Exhibit A
List of Plan Participants
Name |
|
Position |
|
|
|
Svend Andersen |
|
Corporate Vice President and President, Europe, Middle East and Africa |
|
|
|
F. Michael Ball |
|
Chief Executive Officer |
|
|
|
Anthony N. Cacich |
|
Corporate Vice President, One to One |
|
|
|
Anil DSouza |
|
Corporate Vice President, Global Marketing and Corporate Development |
|
|
|
Francois Dubois |
|
Senior Vice President, Quality |
|
|
|
Arthur J. Fiocco, Jr. |
|
Corporate Vice President, Pharmaceutical Operations |
|
|
|
James H. Hardy, Jr. |
|
Senior Vice President, Operations |
|
|
|
Richard J. Hoffman |
|
Corporate Vice President, Controller |
|
|
|
Daphne Jones |
|
Senior Vice President and Chief Information Officer |
|
|
|
Jim Mahoney |
|
Corporate Vice President, Global Manufacturing Operations |
|
|
|
Kenneth F. Meyers |
|
Senior Vice President, Organizational Transformation and People Development |
|
|
|
Thomas Moore |
|
Corporate Vice President and President, U.S. |
|
|
|
Timothy Oldham |
|
Corporate Vice President and President, Asia-Pacific |
|
|
|
Mary ONeill |
|
Corporate Vice President, Supply Chain and Device Operations |
|
|
|
Sumant Ramachandra |
|
Senior Vice President, Research and Development, Medical and Regulatory Affairs and Chief Scientific Officer |
|
|
|
Brian Smith |
|
Senior Vice President, General Counsel and Secretary |
|
|
|
Ron Squarer |
|
Senior Vice President, Chief Commercial Officer |
|
|
|
Thomas Werner |
|
Senior Vice President, Finance and Chief Financial Officer |
Exhibit A (as revised May 10, 2011)
Exhibit 12.1
Hospira, Inc.
Computation of Ratio of Earnings to Fixed Charges
(Unaudited)
(dollars in millions except ratios)
|
|
Six Months Ended |
| |
Income from Continuing Operations Before Taxes |
|
$ |
311.2 |
|
Add: |
|
|
| |
One-third of rents |
|
4.6 |
| |
Interest on long-term and short-term debt |
|
47.3 |
| |
Interest capitalized, net of amortization |
|
2.2 |
| |
|
|
|
| |
Earnings from Continuing Operations |
|
$ |
365.3 |
|
|
|
|
| |
Fixed charges: |
|
|
| |
One-third of rents |
|
$ |
4.6 |
|
Interest on long-term and short-term debt |
|
47.3 |
| |
Interest capitalized |
|
5.3 |
| |
|
|
|
| |
Fixed Charges from Continuing Operations |
|
$ |
57.2 |
|
|
|
|
| |
Ratio of Earnings to Fixed Charges from Continuing Operations |
|
6.4 |
|
For purposes of computing this ratio, earnings consist of income from continuing operations before taxes, one-third of rents (deemed by Hospira to be representative of the interest factor inherent in rents), interest expense and interest capitalized, net of amortization. Fixed charges consist of one-third of rents, interest expense and interest capitalized.
Exhibit 31.1
Certification of Chief Executive Officer
Required by Rule 13a-14(a) (17 CFR 240.13a-14(a))
I, F. Michael Ball, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Hospira, Inc. (the registrant);
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.
/s/ F. MICHAEL BALL |
|
F. Michael Ball, |
|
Chief Executive Officer |
|
|
|
Date: July 27, 2011 |
|
Exhibit 31.2
Certification of Chief Financial Officer
Required by Rule 13a-14(a) (17 CFR 240.13a-14(a))
I, Thomas E. Werner, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Hospira, Inc. (the registrant);
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrants disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrants ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal control over financial reporting.
/s/ THOMAS E. WERNER |
|
Thomas E. Werner, |
|
Senior Vice President, Finance and Chief Financial Officer |
|
|
|
Date: July 27, 2011 |
|
Exhibit 32.1
Certification Pursuant To
18 U.S.C. Section 1350
As Adopted Pursuant To
Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the Quarterly Report of Hospira, Inc. (the Company) on Form 10-Q for the period ended June 30, 2011 as filed with the Securities and Exchange Commission (the Report), I, F. Michael Ball, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
/s/ F. MICHAEL BALL |
|
F. Michael Ball |
|
Chief Executive Officer |
|
July 27, 2011 |
|
Exhibit 32.2
Certification Pursuant To
18 U.S.C. Section 1350
As Adopted Pursuant To
Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the Quarterly Report of Hospira, Inc. (the Company) on Form 10-Q for the period ended June 30, 2011 as filed with the Securities and Exchange Commission (the Report), I, Thomas E. Werner, Senior Vice President, Finance and Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
/s/ THOMAS E. WERNER |
|
Thomas E. Werner |
|
Senior Vice President, Finance and Chief Financial Officer |
|
July 27, 2011 |
|