Jersey (Channel Islands)
(State or other jurisdiction of incorporation or organization)
|
98-0601486
(I.R.S. Employer Identification No.)
|
5 Riverwalk, Citywest Business Campus, Dublin 24, Republic of Ireland
(Address of principal executive offices and zip code)
|
+353 1 429 7700
(Registrant’s telephone number, including area code)
|
Page
|
||
PART I |
FINANCIAL INFORMATION
|
|
ITEM 1. |
FINANCIAL STATEMENTS
|
|
Unaudited Consolidated Balance Sheets at March 31, 2012 and December 31, 2011
|
4
|
|
Unaudited Consolidated Statements of Income for the three months to March 31, 2012 and March 31, 2011
|
6
|
|
Unaudited Consolidated Statements of Comprehensive Income for the three months to March 31, 2012 and March 31, 2011
|
7
|
|
Unaudited Consolidated Statement of Changes in Equity for the three months to March 31, 2012
|
8
|
|
Unaudited Consolidated Statements of Cash Flows for the three months to March 31, 2012 and March 31, 2011
|
9
|
|
Notes to the Unaudited Consolidated Financial Statements
|
11
|
|
ITEM 2. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
31
|
ITEM 3. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
43
|
ITEM 4. |
CONTROLS AND PROCEDURES
|
43
|
PART II |
OTHER INFORMATION
|
|
ITEM 1. |
LEGAL PROCEEDINGS
|
43
|
ITEM 1A. |
RISK FACTORS
|
43
|
ITEM 2. |
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
43
|
ITEM 3. |
DEFAULTS UPON SENIOR SECURITIES
|
43
|
ITEM 4. |
MINE SAFETY DISCLOSURES
|
43
|
ITEM 5. |
OTHER INFORMATION
|
44
|
ITEM 6. |
EXHIBITS
|
44
|
March 31,
|
December 31,
|
|||||||||||
2012
|
2011
|
|||||||||||
Notes
|
$’M | $’M | ||||||||||
ASSETS
|
||||||||||||
Current assets:
|
||||||||||||
Cash and cash equivalents
|
879.4 | 620.0 | ||||||||||
Restricted cash
|
14.9 | 20.6 | ||||||||||
Accounts receivable, net
|
3 | 921.2 | 845.0 | |||||||||
Inventories
|
4 | 368.7 | 340.1 | |||||||||
Deferred tax asset
|
219.1 | 207.6 | ||||||||||
Prepaid expenses and other current assets
|
5 | 148.3 | 174.9 | |||||||||
Total current assets
|
2,551.6 | 2,208.2 | ||||||||||
Non-current assets:
|
||||||||||||
Investments
|
34.7 | 29.9 | ||||||||||
Property, plant and equipment, net
|
921.8 | 932.1 | ||||||||||
Goodwill
|
598.8 | 592.6 | ||||||||||
Other intangible assets, net
|
6 | 2,489.0 | 2,493.0 | |||||||||
Deferred tax asset
|
46.2 | 50.7 | ||||||||||
Other non-current assets
|
76.2 | 73.7 | ||||||||||
Total assets
|
6,718.3 | 6,380.2 | ||||||||||
LIABILITIES AND EQUITY
|
||||||||||||
Current liabilities:
|
||||||||||||
Accounts payable and accrued expenses
|
7 | 1,396.2 | 1,370.5 | |||||||||
Convertible bonds
|
9 | - | 1,100.0 | |||||||||
Other current liabilities
|
8 | 51.4 | 63.8 | |||||||||
Total current liabilities
|
1,447.6 | 2,534.3 | ||||||||||
Non-current liabilities:
|
||||||||||||
Convertible bonds
|
9 | 1,100.0 | - | |||||||||
Deferred tax liability
|
502.8 | 516.6 | ||||||||||
Other non-current liabilities
|
10 | 147.3 | 144.3 | |||||||||
Total liabilities
|
3,197.7 | 3,195.2 | ||||||||||
Commitments and contingencies
|
11 |
March 31,
|
December 31,
|
||||||||
2012
|
2011
|
||||||||
Notes
|
$’M | $’M | |||||||
Equity:
|
|||||||||
Common stock of 5p par value; 1,000 million shares authorized; and 562.5 million shares issued and outstanding (2011: 1,000 million shares authorized; and 562.5 million shares issued and outstanding)
|
55.7 | 55.7 | |||||||
Additional paid-in capital
|
2,910.2 | 2,853.3 | |||||||
Treasury stock: 6.2 million shares (2011: 11.8 million shares)
|
(159.8 | ) | (287.2 | ) | |||||
Accumulated other comprehensive income
|
99.8 | 60.3 | |||||||
Retained earnings
|
614.7 | 502.9 | |||||||
Total equity
|
3,520.6 | 3,185.0 | |||||||
Total liabilities and equity
|
6,718.3 | 6,380.2 |
3 months to March 31,
|
2012
|
2011
|
||||||||||
|
Notes
|
$’M | $’M | |||||||||
Revenues:
|
||||||||||||
Product sales
|
1,106.9 | 889.3 | ||||||||||
Royalties
|
56.3 | 73.6 | ||||||||||
Other revenues
|
8.6 | 9.3 | ||||||||||
Total revenues
|
1,171.8 | 972.2 | ||||||||||
Costs and expenses:
|
||||||||||||
Cost of product sales (1)
|
158.4 | 124.5 | ||||||||||
Research and development
|
220.3 | 177.9 | ||||||||||
Selling, general and administrative ("SG&A")(1)
|
500.0 | 402.9 | ||||||||||
(Gain)/loss on sale of product rights
|
(7.2 | ) | 1.3 | |||||||||
Reorganization costs
|
- | 5.5 | ||||||||||
Integration and acquisition costs
|
2 | 5.3 | (6.4 | ) | ||||||||
Total operating expenses
|
876.8 | 705.7 | ||||||||||
|
||||||||||||
Operating income
|
295.0 | 266.5 | ||||||||||
|
||||||||||||
Interest income
|
0.8 | 0.6 | ||||||||||
Interest expense
|
(10.2 | ) | (9.2 | ) | ||||||||
Other income, net
|
1.9 | 0.3 | ||||||||||
Total other expense, net
|
(7.5 | ) | (8.3 | ) | ||||||||
Income from continuing operations before income taxes and equity in earnings of equity method investees
|
287.5 | 258.2 | ||||||||||
Income taxes
|
(50.0 | ) | (48.1 | ) | ||||||||
Equity in earnings of equity method investees, net of taxes
|
0.9 | 1.2 | ||||||||||
Net income
|
238.4 | 211.3 |
Earnings per ordinary share - basic
|
43.1 | c | 38.5 | c | ||||||||
Earnings per ordinary share – diluted
|
41.4 | c | 37.0 | c | ||||||||
Weighted average number of shares (millions):
|
||||||||||||
Basic
|
15 | 553.5 | 549.5 | |||||||||
Diluted
|
15 | 595.6 | 593.6 |
|
(1)
|
Cost of product sales includes amortization of intangible assets relating to favorable manufacturing contracts of $0.2 million for the three months to March 31, 2012 (2011: $0.4 million). SG&A costs include amortization of intangible assets relating to intellectual property rights acquired of $45.6 million for the three months to March 31, 2012 (2011: $36.1 million).
|
3 months to March 31,
|
2012
|
2011
|
||||||
$'M
|
$'M
|
|||||||
Net income
|
238.4 | 211.3 | ||||||
Other comprehensive income:
|
||||||||
Foreign currency translation adjustments
|
36.6 | 70.6 | ||||||
Unrealized holding gain on available-for-sale securities (net of taxes of $nil and $2.3 million)
|
2.9 | 10.1 | ||||||
Other than temporary impairment of available-for-sale securities (net of taxes of $nil in all periods)
|
- | 2.4 | ||||||
Comprehensive income
|
277.9 | 294.4 |
March 31,
|
December 31,
|
|||||||
2012
|
2011
|
|||||||
$’M | $’M | |||||||
Foreign currency translation adjustments
|
98.0 | 61.4 | ||||||
Unrealized holding gain/(loss) on available-for-sale securities, net of taxes
|
1.8 | (1.1 | ) | |||||
Accumulated other comprehensive income
|
99.8 | 60.3 |
Shire plc shareholders' equity
|
|||||||||||||||
Common
stock
$'M
|
Common
stock
Number of shares
M's
|
Additional
paid-in
capital
$’M
|
Treasury
stock
$'M
|
Accumulated other comprehensive income
$'M
|
Retained earnings
$'M
|
Total equity
$'M
|
|||||||||
As at January 1, 2012
|
55.7
|
562.5
|
2,853.3
|
(287.2)
|
60.3
|
502.9
|
3,185.0
|
||||||||
Net income
|
-
|
-
|
-
|
-
|
-
|
238.4
|
238.4
|
||||||||
Foreign currency translation
|
-
|
-
|
-
|
-
|
36.6
|
-
|
36.6
|
||||||||
Options exercised
|
-
|
-
|
0.1
|
-
|
-
|
-
|
0.1
|
||||||||
Share-based compensation
|
-
|
-
|
22.0
|
-
|
-
|
-
|
22.0
|
||||||||
Tax benefit associated with exercise of stock options
|
-
|
-
|
34.8
|
-
|
-
|
-
|
34.8
|
|
|||||||
Shares released by Employee Benefit Trust ("EBT") to satisfy exercise of stock options
|
-
|
-
|
-
|
127.4
|
-
|
(126.6)
|
0.8
|
||||||||
Unrealized holding gain on available-for-sale securities, net of taxes
|
-
|
-
|
-
|
-
|
2.9
|
-
|
2.9
|
||||||||
As at March 31, 2012
|
55.7
|
562.5
|
2,910.2
|
(159.8)
|
99.8
|
614.7
|
3,520.6
|
3 months to March 31,
|
2012
|
2011
|
||||||
|
$’M | $’M | ||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net income
|
238.4 | 211.3 | ||||||
Adjustments to reconcile net income to net cash provided by operating activities:
|
||||||||
Depreciation and amortization
|
73.0 | 63.5 | ||||||
Share based compensation
|
22.0 | 15.7 | ||||||
Other
|
(5.9 | ) | (5.5 | ) | ||||
Movement in deferred taxes
|
(20.8 | ) | 42.2 | |||||
Equity in earnings of equity method investees
|
(0.9 | ) | (1.2 | ) | ||||
|
||||||||
Changes in operating assets and liabilities:
|
||||||||
Increase in accounts receivable
|
(65.2 | ) | (74.8 | ) | ||||
Increase in sales deduction accrual
|
54.5 | 31.2 | ||||||
Increase in inventory
|
(25.0 | ) | (12.7 | ) | ||||
Decrease in prepayments and other assets
|
17.2 | 5.0 | ||||||
Decrease in accounts and notes payable and other liabilities
|
(30.3 | ) | (72.8 | ) | ||||
Net cash provided by operating activities (A)
|
257.0 | 201.9 | ||||||
|
||||||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Movements in restricted cash
|
5.7 | (4.1 | ) | |||||
Purchases of non-current investments
|
(4.1 | ) | (2.5 | ) | ||||
Purchases of property, plant and equipment ("PP&E")
|
(31.7 | ) | (46.5 | ) | ||||
Purchases of intangible assets
|
(22.0 | ) | - | |||||
Proceeds received on sale of product rights
|
5.6 | - | ||||||
Proceeds from capital expenditure grants
|
8.4 | - | ||||||
Proceeds from disposal of non-current investments and PP&E
|
3.8 | 0.1 | ||||||
Returns from equity investments
|
0.1 | 1.1 | ||||||
Net cash used in investing activities (B)
|
(34.2 | ) | (51.9 | ) |
3 months to March 31,
|
2012
|
2011
|
||||||
|
$’M | $’M | ||||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Payment under building finance obligation
|
(0.3 | ) | (0.2 | ) | ||||
Proceeds from exercise of options
|
0.9 | 0.2 | ||||||
Excess tax benefit associated with exercise of stock options
|
34.8 | 9.0 | ||||||
Net cash provided by financing activities(C)
|
35.4 | 9.0 | ||||||
Effect of foreign exchange rate changes on cash and cash equivalents (D)
|
1.2 | 2.4 | ||||||
Net increase in cash and cash equivalents (A+B+C+D)
|
259.4 | 161.4 | ||||||
Cash and cash equivalents at beginning of period
|
620.0 | 550.6 | ||||||
Cash and cash equivalents at end of period
|
879.4 | 712.0 |
Supplemental information associated with continuing
|
||||||||
operations:
|
||||||||
3 months to March 31,
|
2012
|
2011
|
||||||
$’M | $’M | |||||||
Interest paid
|
(1.1 | ) | (0.5 | ) | ||||
Income taxes paid
|
(29.5 | ) | (6.4 | ) |
2012
|
2011
|
|||||||
$’M | $’M | |||||||
As at January 1,
|
31.1 | 23.4 | ||||||
Provision charged to operations
|
65.4 | 50.4 | ||||||
Provision utilization
|
(63.8 | ) | (54.3 | ) | ||||
As at March 31,
|
32.7 | 19.5 |
March 31,
|
December 31,
|
|||||||
2012
|
2011
|
|||||||
$’M | $’M | |||||||
Finished goods
|
99.5 | 99.9 | ||||||
Work-in-progress
|
185.8 | 162.6 | ||||||
Raw materials
|
83.4 | 77.6 | ||||||
368.7 | 340.1 |
March 31,
|
December 31,
|
|||||||
2012
|
2011
|
|||||||
$’M | $’M | |||||||
Prepaid expenses
|
49.4 | 46.9 | ||||||
Income tax receivable
|
25.3 | 48.1 | ||||||
Value added taxes receivable
|
17.3 | 18.9 | ||||||
Other current assets
|
56.3 | 61.0 | ||||||
148.3 | 174.9 |
March 31,
|
December 31,
|
|||||||
2012
|
2011
|
|||||||
$’M | $’M | |||||||
Amortized intangible assets
|
||||||||
Intellectual property rights acquired for currently marketed products
|
2,520.4 | 2,500.7 | ||||||
Acquired product technology
|
710.0 | 710.0 | ||||||
Other intangible assets
|
45.9 | 23.2 | ||||||
3,276.3 | 3,233.9 | |||||||
Unamortized intangible assets
|
||||||||
Intellectual property rights acquired for In-process R&D (“IPR&D”)
|
123.2 | 119.8 | ||||||
3,399.5 | 3,353.7 | |||||||
Less: Accumulated amortization
|
(910.5 | ) | (860.7 | ) | ||||
2,489.0 | 2,493.0 |
Other intangible assets
|
||||||||
2012
|
2011
|
|||||||
$’M | $’M | |||||||
As at January 1,
|
2,493.0 | 1,978.9 | ||||||
Acquisitions
|
22.0 | - | ||||||
Amortization charged
|
(45.8 | ) | (36.1 | ) | ||||
Foreign currency translation
|
19.8 | 43.0 | ||||||
As at March 31,
|
2,489.0 | 1,985.8 |
March 31,
|
December 31,
|
|||||||
2012
|
2011
|
|||||||
$’M | $’M | |||||||
Trade accounts payable and accrued purchases
|
197.9 | 259.6 | ||||||
Accrued rebates – Medicaid
|
442.1 | 409.8 | ||||||
Accrued rebates – Managed care
|
228.1 | 202.8 | ||||||
Sales return reserve
|
86.1 | 88.8 | ||||||
Accrued bonuses
|
56.3 | 103.0 | ||||||
Accrued employee compensation and benefits payable
|
95.2 | 59.3 | ||||||
R&D accruals
|
53.6 | 52.7 | ||||||
Marketing accruals
|
20.0 | 18.2 | ||||||
Other accrued expenses
|
216.9 | 176.3 | ||||||
1,396.2 | 1,370.5 |
March 31,
|
December 31,
|
|||||||
2012
|
2011
|
|||||||
$’M | $’M | |||||||
Income taxes payable
|
12.9 | 27.7 | ||||||
Value added taxes
|
16.0 | 13.3 | ||||||
Other current liabilities
|
22.5 | 22.8 | ||||||
51.4 | 63.8 |
March 31,
|
December 31,
|
|||||||
2012
|
2011
|
|||||||
$’M | $’M | |||||||
Income taxes payable
|
79.9 | 78.3 | ||||||
Deferred revenue
|
12.8 | 12.2 | ||||||
Deferred rent
|
14.1 | 14.0 | ||||||
Insurance provisions
|
14.2 | 14.5 | ||||||
Other non-current liabilities
|
26.3 | 25.3 | ||||||
147.3 | 144.3 |
Operating
|
||||
leases
|
||||
$’M | ||||
2012
|
29.6 | |||
2013
|
32.2 | |||
2014
|
29.4 | |||
2015
|
24.0 | |||
2016
|
16.3 | |||
2017
|
12.2 | |||
Thereafter
|
31.8 | |||
175.5 |
Foreign
currency
translation
adjustment
|
Un-realized
holding
gain/(loss)
on available
for sale
securities
|
Accumulated
other
Comprehensive
income
|
||||||||||
$M | $M | $M | ||||||||||
As at January 1, 2012
|
61.4 | (1.1 | ) | 60.3 | ||||||||
Current period change
|
36.6 | 2.9 | 39.5 | |||||||||
As at March 31, 2012
|
98.0 | 1.8 | 99.8 |
Fair value
|
Fair value
|
||||||||
March 31,
|
December 31,
|
||||||||
2012
|
2011
|
||||||||
$’M | $’M | ||||||||
Assets
|
Prepaid expenses and other current assets
|
2.6 | 3.4 | ||||||
Liabilities
|
Other current liabilities
|
1.9 | 0.4 |
Location of net loss recognized in income
|
Amount of net loss recognized in income
|
||||||||
Year to
|
March 31,
|
March 31,
|
|||||||
2012
|
2011
|
||||||||
$’M | $’M | ||||||||
Foreign exchange contracts
|
Other income, net
|
(0.8 | ) | (1.2 | ) |
|
Carrying
|
Fair value
|
||||||||||||||||||
|
value
|
|||||||||||||||||||
|
Total
|
Level 1
|
Level 2
|
Level 3
|
||||||||||||||||
At March 31, 2012
|
$'M
|
$'M
|
$'M
|
$'M
|
$'M
|
|||||||||||||||
Financial assets:
|
||||||||||||||||||||
Available-for-sale securities(1)
|
11.2 | 11.2 | 11.2 | - | - | |||||||||||||||
Contingent consideration receivable (2)
|
40.2 | 40.2 | - | - | 40.2 | |||||||||||||||
Foreign exchange contracts
|
2.6 | 2.6 | - | 2.6 | - | |||||||||||||||
|
||||||||||||||||||||
Financial liabilities:
|
||||||||||||||||||||
Foreign exchange contracts
|
1.9 | 1.9 | - | 1.9 | - | |||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
Total
|
Level 1
|
Level 2
|
Level 3
|
||||||||||||||||
At December 31, 2011
|
$'M
|
$'M
|
$'M
|
$'M
|
$'M
|
|||||||||||||||
Financial assets:
|
||||||||||||||||||||
Available-for-sale securities(1)
|
7.4 | 7.4 | 7.4 | - | - | |||||||||||||||
Contingent consideration receivable (2)
|
37.8 | 37.8 | - | - | 37.8 | |||||||||||||||
Foreign exchange contracts
|
3.4 | 3.4 | - | 3.4 | - | |||||||||||||||
|
||||||||||||||||||||
Financial liabilities:
|
||||||||||||||||||||
Foreign exchange contracts
|
0.4 | 0.4 | - | 0.4 | - |
(1)
|
Available-for-sale securities are included within Investments in the consolidated balance sheet.
|
(2)
|
Contingent consideration receivable is included within Prepaid expenses and other current assets and Other non-current assets in the consolidated balance sheet.
|
|
·
|
Available-for-sale securities – the fair values of available-for-sale securities are estimated based on quoted market prices for those investments.
|
|
·
|
Contingent consideration receivable – the fair value of the contingent consideration receivable has been estimated using the income approach (using a probability weighted discounted cash flow method).
|
|
·
|
Foreign exchange contracts – the fair values of the swap and forward foreign exchange contracts have been determined using an income approach based on current market expectations about the future cash flows.
|
|
Contingent consideration receivable
|
|||||||
|
2012
|
2011
|
||||||
|
$'M
|
$'M
|
||||||
|
||||||||
Balance at January 1,
|
37.8 | 61.0 | ||||||
Gain/(loss) recognized in the income statement due to change in fair value during the period
|
7.2 | (1.3 | ) | |||||
Reclassification of amounts to Other receivables within Other current assets
|
(5.6 | ) | (5.1 | ) | ||||
Foreign exchange translation recorded to other comprehensive income
|
0.8 | 3.4 | ||||||
Balance at March 31,
|
40.2 | 58.0 |
Fair Value at the Measurement Date
|
|||||||
|
|
|
|
||||
At March 31, 2012
|
Fair value
|
Valuation
Technique
|
Significant unobservable Inputs
|
Range
|
|||
$'M
|
|||||||
Contingent consideration receivable ("CCR")
|
40.2
|
Income approach
(probability weighted
discounted cash flow) |
• Probability weightings
applied to different
sales scenarios
• Future forecast
royalties receivable
at relevant contractual
royalty rates
• Assumed market
participant discount rate
|
• 10-35%
•$17 million to
$163 million
• 5.8 to 6.5%
|
March 31, 2012
|
December 31, 2011
|
|||||||||||||||
Carrying
|
Carrying
|
|||||||||||||||
amount
|
Fair value
|
amount
|
Fair value
|
|||||||||||||
$’M | $’M | $’M | $’M | |||||||||||||
Financial liabilities:
|
||||||||||||||||
Convertible bonds (Level 1)
|
1,100.0 | 1,314.2 | 1,100.0 | 1,309.7 | ||||||||||||
Building financing obligation (Level 3)
|
8.4 | 8.5 | 8.2 | 9.7 |
|
·
|
Convertible bonds – the fair value of Shire’s $1,100 million 2.75% convertible bonds due 2014 is determined by reference to the market price of the instrument as the convertible bonds are publicly traded.
|
|
·
|
Building finance obligations - the fair value of building finance obligations are estimated based on the present value of future cash flows, and an estimate of the residual value of the underlying property at the end of the lease term, associated with these obligations.
|
3 months to March 31,
|
2012
|
2011
|
||||||
|
$’M | $’M | ||||||
Numerator for basic earnings per share
|
238.4 | 211.3 | ||||||
|
||||||||
Interest on convertible bonds, net of tax
|
8.4 | 8.4 | ||||||
Numerator for diluted earnings per share
|
246.8 | 219.7 | ||||||
|
||||||||
|
||||||||
Weighted average number of shares:
|
||||||||
|
Millions
|
Millions
|
||||||
Basic 1
|
553.5 | 549.5 | ||||||
Effect of dilutive shares:
|
||||||||
Share based awards to employees 2
|
8.6 | 10.9 | ||||||
Convertible bonds 2.75% due 2014 3
|
33.5 | 33.2 | ||||||
Diluted
|
595.6 | 593.6 |
3 months to March 31,
|
2012
|
2011
|
||||||
|
No. of shares
|
No. of shares
|
||||||
|
Millions
|
Millions
|
||||||
Share based awards to employees1
|
6.1 | 7.5 |
|
SP
|
HGT
|
RM
|
All Other
|
Total
|
|||||||||||||||
3 months to March 31, 2012
|
$’M | $’M | $’M | $’M | $’M | |||||||||||||||
Product sales
|
706.7 | 351.4 | 48.8 | - | 1,106.9 | |||||||||||||||
Royalties
|
42.4 | - | - | 13.9 | 56.3 | |||||||||||||||
Other revenues
|
8.3 | 0.3 | - | - | 8.6 | |||||||||||||||
Total revenues
|
757.4 | 351.7 | 48.8 | 13.9 | 1,171.8 | |||||||||||||||
|
||||||||||||||||||||
Cost of product sales(1)
|
87.1 | 61.3 | 10.0 | - | 158.4 | |||||||||||||||
Research and development(1)
|
131.0 | 86.3 | 3.0 | - | 220.3 | |||||||||||||||
Selling, general and administrative(1)
|
300.1 | 104.4 | 41.7 | 53.8 | 500.0 | |||||||||||||||
Gain on sale of product rights
|
(7.2 | ) | - | - | - | (7.2 | ) | |||||||||||||
Integration and acquisition costs
|
1.6 | - | 3.7 | - | 5.3 | |||||||||||||||
Total operating expenses
|
512.6 | 252.0 | 58.4 | 53.8 | 876.8 | |||||||||||||||
Operating income/(loss)
|
244.8 | 99.7 | (9.6 | ) | (39.9 | ) | 295.0 | |||||||||||||
|
||||||||||||||||||||
Total assets
|
2,463.3 | 1,917.9 | 961.5 | 1,375.6 | 6,718.3 | |||||||||||||||
Long-lived assets(2)
|
126.3 | 712.1 | 23.2 | 61.7 | 923.3 | |||||||||||||||
Capital expenditure on long-lived assets(2)
|
2.1 | 13.0 | 0.1 | 2.3 | 17.5 |
(1)
|
Depreciation from manufacturing plants ($7.2 million) and amortization of favorable manufacturing contracts ($0.2 million) is included in Cost of product sales; depreciation of research and development assets ($6.4 million) in Research and development; and all other depreciation and amortization ($59.2 million) is included in Selling, general and administrative.
|
(2)
|
Long-lived assets comprise all non-current assets (excluding goodwill and other intangible assets, deferred contingent consideration assets, deferred tax assets, investments, income tax receivable and financial instruments).
|
|
SP
|
HGT
|
RM
|
All Other
|
Total
|
|||||||||||||||
3 months to March 31, 2011
|
$’M | $’M | $’M | $’M | $’M | |||||||||||||||
Product sales
|
616.1 | 273.2 | - | - | 889.3 | |||||||||||||||
Royalties
|
37.5 | - | - | 36.1 | 73.6 | |||||||||||||||
Other revenues
|
7.6 | 0.4 | - | 1.3 | 9.3 | |||||||||||||||
Total revenues
|
661.2 | 273.6 | - | 37.4 | 972.2 | |||||||||||||||
|
||||||||||||||||||||
Cost of product sales(1)
|
81.8 | 42.7 | - | - | 124.5 | |||||||||||||||
Research and development(1)
|
102.7 | 75.2 | - | - | 177.9 | |||||||||||||||
Selling, general and administrative(1)
|
266.6 | 80.1 | - | 56.2 | 402.9 | |||||||||||||||
Loss on sale of product rights
|
1.3 | - | - | - | 1.3 | |||||||||||||||
Reorganization costs
|
2.3 | - | - | 3.2 | 5.5 | |||||||||||||||
Integration and acquisition costs
|
(6.4 | ) | - | - | - | (6.4 | ) | |||||||||||||
Total operating expenses
|
448.3 | 198.0 | - | 59.4 | 705.7 | |||||||||||||||
Operating income/(loss)
|
212.9 | 75.6 | - | (22.0 | ) | 266.5 | ||||||||||||||
|
||||||||||||||||||||
Total assets
|
2,548.0 | 1,836.7 | - | 1,288.1 | 5,672.8 | |||||||||||||||
Long-lived assets(2)
|
150.2 | 678.8 | - | 44.7 | 873.7 | |||||||||||||||
Capital expenditure on long-lived assets(2)
|
4.8 | 36.3 | - | 2.8 | 43.9 |
(1)
|
Depreciation from manufacturing plants ($7.7 million) and amortization of favorable manufacturing contracts ($0.4 million) is included in Cost of product sales; depreciation of research and development assets ($4.7 million) is included in Research and development; and all other depreciation, amortization and impairment charges ($50.7 million) is included in Selling, general and administrative.
|
(2)
|
Long-lived assets comprise all non-current assets (excluding goodwill and other intangible assets, deferred contingent consideration assets, deferred tax assets, investments, income tax receivable and financial instruments).
|
·
|
On February 22, 2012 Shire announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use had approved the production of VPRIV in its new biologics manufacturing facility in Lexington, Massachusetts and this decision was adopted by the European Commission on March 26, 2012. Shire now has two EMA approved facilities – Alewife in Cambridge, Massachusetts, as well as the new Lexington facility – in which to manufacture VPRIV drug substance.
|
·
|
On March 6, 2012 Shire announced that it is initiating two Phase 4 clinical trials to compare VYVANSE Capsules to CONCERTA Extended-Release Tablets. These prospectively designed head-to-head clinical trials will provide important information for physicians, patients, caregivers, and payors to make informed choices, and have been designed to explore differences in efficacy between VYVANSE and CONCERTA in adolescents aged 13 to 17 with ADHD. Together the two trials will enroll approximately 1,000 patients, and results are expected in the second half of 2013.
|
·
|
On March 8, 2012 Shire announced that it has received approval through the European Decentralised Procedure for an oral powder formulation of FOSRENOL. The oral powder formulation was developed by Shire to give patients more choice in how they take their phosphate binder. Submissions for national marketing authorisations of FOSRENOL in oral powder form have been made to Sweden and the other 27 European markets, with the first national approvals anticipated in the second quarter of 2012.
|
·
|
On March 14, 2012 Shire announced that it had withdrawn its Biologics License Application (“BLA”) for REPLAGAL with the FDA. In 2009, and again in 2011, the FDA encouraged Shire to submit an application for the approval of REPLAGAL in the US. These discussions led Shire to file a BLA in November 2011 in anticipation of a quick review process and eventual approval. Recent interactions with the FDA in the first quarter of 2012 led Shire to believe that the FDA would require additional controlled trials for approval. No concerns over the product’s safety profile were raised by the FDA. Shire has concluded that the likely additional studies would cause a significant delay, and an approval of REPLAGAL for US patients would only be possible in the distant future. Shire therefore decided to withdraw its BLA. Patients currently treated with REPLAGAL in the US under treatment access programs will be transitioned off REPLAGAL therapy by June 30, 2012.
|
·
|
On March 30, 2012 Shire announced top-line results of the PREVENT2 trial, a Phase 3 investigational study of once-daily SPD476, MMX mesalamine in patients with a history of diverticulitis. The study did not meet the primary endpoint in reducing the rate of recurrence of diverticulitis over a two year treatment period. Shire will continue to analyze these data and those of the second study, PREVENT1, which was similar in design to PREVENT2 and will report later in the year. Although the results of the second trial are pending, the current intention is not to pursue a regulatory filing for this indication for MMX mesalamine.
|
·
|
On April 26 2012, Shire announced Phase 2 results from an efficacy and safety clinical study of LDX for the treatment of BED. In this study treatment of adults with 50 and 70 mg doses of LDX resulted in a statistically significant reduction in binge eating behavior compared to placebo, the pre-defined primary end-point. Additionally, treatment with 30, 50 and 70 mg doses of LDX resulted in a statistically significant increase in remission rates from binge eating compared to placebo. There is currently no approved pharmacologic treatment for patients struggling with BED, a serious and common eating disorder. The preliminary safety data suggests a profile generally consistent with the known profile of studies of VYVANSE in adults with ADHD.
|
·
|
On April 2, 2012 Shire completed the acquisition of FerroKin and with it SPD 602 (formally referred to as FBS0701), FerroKin’s iron chelator treatment in Phase 2 development. SPD 602 serves a chronic patient need for treatment of iron overload following numerous blood transfusions. Together with our collaboration with Sangamo, the acquisition of FerroKin represents a strategic step in building Shire’s hematology business, which already includes XAGRID and a growing development pipeline, including SPD 535. Cash consideration paid on closing amounted to $94.5 million. Further contingent cash consideration of up to $225 million may be payable by Shire in future periods, dependent upon the achievement of certain clinical development, regulatory and net sales milestones. For further details refer to Note 2 of PART I: ITEM 1 of this Form 10-Q.
|
·
|
On April 19, 2012 Shire acquired substantially all the assets and certain liabilities of Pervasis. This acquisition adds VASCUGEL to Shire’s Regenerative Medicine business. VASCUGEL is currently in Phase 2 development for acute vascular repair, focused on improving hemodialysis access for patients with end-stage renal disease. For further details refer to Note 2 of PART I: ITEM 1 of this Form 10-Q.
|
·
|
On January 10, 2012 Shire announced that it had acquired the rights to develop and market prucalopride (marketed in certain countries in Europe as RESOLOR) in the US in an agreement with Janssen Pharmaceutica N.V., part of the Johnson & Johnson Group.
|
·
|
On February 1, 2012 Shire announced it had entered a collaboration and license agreement with Sangamo to develop therapeutics for hemophilia and other monogenic diseases based on Sangamo’s zinc finger DNA-binding protein (“ZFP”) technology.
|
·
|
On February 3, 2012 Shire exercised its option to acquire a worldwide exclusive license from Heptares Therapeutics Ltd (“Heptares”) to certain novel adenosine A2a antagonist compounds. These compounds are currently in preclinical development and being considered as candidates for central nervous system (“CNS”) disorders.
|
·
|
On February 29, 2012 Shire entered into a collaboration agreement with arGEN-X B.V. to develop novel therapeutic antibody products for the treatment of rare diseases.
|
|
·
|
LIALDA/MEZAVANT for the treatment of diverticulitis
|
|
·
|
Product sales were up 24% to $1,107 million (2011: $889 million). The growth in product sales was driven particularly by VYVANSE (up 29% to $260 million), REPLAGAL (up 28% to $134 million), ELAPRASE (up 21% to $126 million), VPRIV (up 22% to $72 million), FIRAZYR (up 272% to $20 million) and INTUNIV (up 63% to $69 million). On a Non GAAP CER basis(1), product sales were up 26%.
|
|
·
|
Total revenues were up 21%, to $1,172 million (2011: $972 million), as the growth in product sales was partially offset, as expected, by a lower level of royalties and other revenues.
|
|
·
|
Operating income increased by 11% to $295 million (2011: $267 million). R&D expenditure in the first quarter of 2012 increased by 24%, and included the up-front payments to Sangamo and on acquisition of the US rights to prucalopride (marketed in certain countries in Europe as RESOLOR). SG&A expenditure increased by 24% compared to the first quarter of 2011, as the first quarter of 2012 included $42 million of ABH’s SG&A which was not incurred in the first quarter of 2011, and SG&A in the first quarter of 2011 was lower than the level experienced in subsequent quarters in 2011.
|
|
·
|
Diluted earnings per ordinary share were up 12% to $0.41 (2011: $0.37), due to higher operating income and a lower effective tax rate of 17% (2011: 19%).
|
1.
|
The Company’s management analyzes product sales and revenue growth for certain products sold in markets outside of the US on a constant exchange rate (“CER”) basis, so that product sales and revenue growth can be considered excluding movements in foreign exchange rates. Product sales and revenue growth on a CER basis is a Non-GAAP financial measure (“Non-GAAP CER”), computed by comparing 2012 product sales and revenues restated using 2011 average foreign exchange rates to 2011 actual product sales and revenues. Average exchange rates for the three months to March 31, 2012 were $1.57:£1.00 and $1.31:€1.00 (2011: $1.60:£1.00 and $1.37:€1.00).
|
3 months to
|
3 months to
|
|||||||||||
March 31,
|
March 31,
|
|||||||||||
2012
|
2011
|
change
|
||||||||||
$'M
|
$'M
|
%
|
||||||||||
Product sales
|
1,106.9 | 889.3 | +24 | |||||||||
Royalties
|
56.3 | 73.6 | -24 | |||||||||
Other revenues
|
8.6 | 9.3 | -8 | |||||||||
Total
|
1,171.8 | 972.2 | +21 |
3 months to
|
3 months to
|
|
|
|||||||||||||||||||||
March 31,
|
March 31,
|
Product sales
|
Non-GAAP CER
|
US prescription
|
Exit market
|
|||||||||||||||||||
2012
|
2011
|
growth
|
growth
|
growth1
|
share1
|
|||||||||||||||||||
$'M
|
$'M
|
%
|
%
|
%
|
%
|
|||||||||||||||||||
SP
|
|
|
||||||||||||||||||||||
ADHD
|
|
|
||||||||||||||||||||||
VYVANSE
|
260.0 | 202.3 | +29 | +29 | +23 | 17 | ||||||||||||||||||
ADDERALL XR
|
111.4 | 111.2 | - | - | +4 | 7 | ||||||||||||||||||
INTUNIV
|
68.5 | 41.9 | +63 | +63 | +54 | 4 | ||||||||||||||||||
EQUASYM
|
7.2 | 4.6 | +57 | +62 | n/a | n/a | 3 | |||||||||||||||||
Gastrointestinal ("GI")
|
||||||||||||||||||||||||
LIALDA / MEZAVANT
|
90.0 | 87.1 | +3 | +4 | +3 | 21 | ||||||||||||||||||
PENTASA
|
65.8 | 64.5 | +2 | +2 | -6 | 14 | ||||||||||||||||||
RESOLOR
|
2.4 | 0.9 | +167 | +168 | n/a | 3 | n/a | 3 | ||||||||||||||||
General Products
|
||||||||||||||||||||||||
FOSRENOL
|
45.5 | 41.2 | +10 | +12 | -23 | 5 | ||||||||||||||||||
XAGRID
|
23.2 | 22.7 | +2 | +6 | n/a | n/a | 2 | |||||||||||||||||
Other product sales
|
32.7 | 39.7 | -18 | -17 | n/a | n/a | ||||||||||||||||||
706.7 | 616.1 | +15 | ||||||||||||||||||||||
HGT
|
||||||||||||||||||||||||
REPLAGAL
|
134.4 | 105.4 | +28 | +31 | n/a | 3 | n/a | 3 | ||||||||||||||||
ELAPRASE
|
125.6 | 103.5 | +21 | +24 | n/a | 2 | n/a | 2 | ||||||||||||||||
VPRIV
|
71.7 | 59.0 | +22 | +23 | n/a | 2 | n/a | 2 | ||||||||||||||||
FIRAZYR
|
19.7 | 5.3 | +272 | +280 | n/a | 2 | n/a | 2 | ||||||||||||||||
351.4 | 273.2 | +29 | ||||||||||||||||||||||
RM
|
||||||||||||||||||||||||
DERMAGRAFT
|
48.8 | n/a | n/a | n/a | n/a | 2 | n/a | 2 | ||||||||||||||||
48.8 | - | n/a | ||||||||||||||||||||||
Total product sales
|
1,106.9 | 889.3 | +24 |
(1)
|
Data provided by IMS Health National Prescription Audit (“IMS NPA”). Exit market share represents the average monthly US market share in the month ended March 31, 2012.
|
(2)
|
IMS NPA Data not available.
|
(3)
|
Not sold in the US in the first quarter of 2012.
|
3 months to
|
3 months to
|
|||||||||||
March 31,
|
March 31,
|
|||||||||||
2012
|
2011
|
Change
|
||||||||||
$'M
|
$'M
|
%
|
||||||||||
ADDERALL XR
|
25.3 | 16.8 | +51 | |||||||||
3TC and ZEFFIX
|
13.6 | 35.5 | -62 | |||||||||
FOSRENOL
|
10.0 | 8.1 | +23 | |||||||||
Others
|
7.4 | 13.2 | -44 | |||||||||
Total
|
56.3 | 73.6 | -24 |
|
March 31,
|
December 31,
|
||||||
|
2012
|
2011
|
||||||
|
$’M | $’M | ||||||
Cash and cash equivalents1
|
879.4 | 620.0 | ||||||
Convertible debt
|
1,100.0 | 1,100.0 | ||||||
Building financing obligation
|
8.4 | 8.2 | ||||||
Total debt
|
1,108.4 | 1,108.2 | ||||||
Net debt
|
(229.0 | ) | (488.2 | ) |
2.01
|
Agreement and Plan of Merger by and among Shire Pharmaceuticals Group plc, Transkaryotic Therapies, Inc. and Sparta Acquisition Corporation, dated as of April 21, 2005.(1)
|
2.02
|
Agreement of Merger dated as of February 20, 2007 among Shire plc, Shuttle Corporation and New River Pharmaceuticals, Inc.(2)
|
2.03
|
Business Combination Agreement dated as of July 3, 2008 between Maia Elfte Vermögensverwaltungs GmbH and Jerini AG. (3)
|
2.04
|
Heads of Agreement by and among Shire plc and Movetis NV relating to a friendly tender offer, dated August 3, 2010. (4)
|
2.05
|
Agreement and Plan of Merger, dated as of May 17, 2011, by and among Shire Pharmaceuticals Inc., ABH Merger Sub Inc., Advanced Biohealing, Inc., and solely for the limited purposes set forth therein, Canaan VII L.P. and Shire plc. (5)
|
2.06
|
Agreement and Plan of Merger, dated as of March 14, 2012, by and among Shire Pharmaceuticals LLC, Pelegrina Corporation, FerroKin BioSciences, Inc. and Shareholder Representative Services LLC, solely for the limited purposes set forth therein. (6)
|
3.01
|
Form of Memorandum of Association of Shire plc as adopted by a special resolution passed on April 10, 2008 and amended by a special resolution passed on September 24, 2008. (7)
|
3.02
|
Form of Article of Association of Shire plc as amended by a special resolution passed on April 26, 2011 and adopted by a special resolution passed on April 26, 2011. (8)
|
4.01
|
Form of Assignment and Novation Agreement between Shire Limited, Shire plc, JPMorgan Chase Bank, N.A. dated April 16, 2008 relating to the Deposit Agreement among Shire plc, JPMorgan Chase Bank, N.A. as depositary and all holders from time to time of ADRs issued thereunder dated November 21, 2005.(9)
|
4.02
|
Form of Deposit Agreement among Shire plc, JPMorgan Chase Bank, N.A. as depositary and all holders from time to time of ADRs issued thereunder dated November 21, 2005. (10)
|
4.03
|
Form of Ordinary Share Certificate of Shire Limited. (11)
|
4.04
|
Form of American Depositary Receipt Certificate of Shire Limited. (12)
|
4.05
|
Trust Deed for the New Shire Income Access Trust, dated August 29, 2008. (13)
|
6.06
|
Form of Amended and Restated Deposit Agreement among Shire plc, Citibank, N.A. as successor depositary, and all holders from time to time of ADRs thereunder dated May 23, 2011 (14)
|
10.01
|
Tender and Support Agreement dated as of February 20, 2007 among Shire plc, Mr. Randal J. Kirk and the other parties named therein. (15)
|
10.02
|
Multicurrency Term and Revolving Facilities Agreement as of February 20, 2007 by and among Shire plc, ABN AMRO Bank N.V., Barclays Capital, Citigroup Global Markets Limited, The Royal Bank of Scotland plc, and Barclays Bank plc. (16)
|
10.03
|
Accession and Amendment Deed dated April 15, 2008 between Shire Limited, Shire plc, certain subsidiaries of Shire plc and Barclays Bank PLC as Facility Agent relating to a US $1,200,000,000 facility agreement dated February 20, 2007 (as amended by a syndication and amendment agreement dated July 19, 2007). (17)
|
10.04
|
Subscription Agreement dated May 2, 2007 relating to the 2.75% Convertible Bonds due 2014 between Shire plc and ABN AMRO Bank N.V. and NM Rothschild & Sons Limited (trading together as ABN AMRO Rothschild, an unincorporated equity capital markets joint venture) and Barclays Bank PLC and Citigroup Global Markets Limited and Goldman Sachs International and Morgan Stanley & Co. International plc and others. (18)
|
10.05
|
Amending Subscription Agreement dated May 8, 2007 relating to the 2.75% Convertible Bonds due 2014 between Shire plc and ABN AMRO Bank N.V. and NM Rothschild & Sons Limited (trading together as ABN AMRO Rothschild, an unincorporated equity capital markets joint venture) and Barclays Bank PLC and Citigroup
|
Global Markets Limited and Goldman Sachs International and Morgan Stanley & Co. International plc and others. (19)
|
10.06
|
Trust Deed dated May 9, 2007 relating to the 2.75% Convertible Bonds due 2014 between Shire plc and BNY Corporate Trustee Services Limited. (20)
|
10.07
|
Supplemental Trust Deed dated April 15, 2008 between Shire Limited, Shire plc and BNY Corporate Trustee Services Limited relating to a trust deed dated May 9, 2007 relating to US $1,100,000,000 2.75% Convertible Bonds due 2014. (21)
|
10.08
|
Accession and Amendment Agreement dated April 15, 2008 between Shire Limited, Shire plc, BNY Corporate Trustee Services Limited and The Bank of New York relating to a paying and conversion agency agreement dated May 9, 2007 relating to US $1,100,000,000 2.75% Convertible Bonds due 2014. (22)
|
10.09*
|
Revised and Restated Master License Agreement dated November 20, 1995 among Shire BioChem Inc (f/k/a BioChem Pharma Inc.), Glaxo Group Limited, Glaxo Wellcome Inc. (formerly Glaxo Canada Inc.), Glaxo Wellcome Inc. (formerly Glaxo Inc.), Tanaud Holdings (Barbados) Limited, Tanaud International B.V. and Tanaud LLC. (23)
|
10.10*
|
Settlement Agreement, dated August 14, 2006 by and between Shire Laboratories Inc. and Barr. (24)
|
10.11*
|
Product Development and License Agreement, dated August 14, 2006 by and between Shire LLC and Duramed Pharmaceuticals, Inc. (25)
|
10.12*
|
Product Acquisition and License Agreement, dated August 14, 2006 by and among Shire LLC, Shire plc and Duramed Pharmaceuticals, Inc. (26)
|
10.13
|
Service Agreement between Shire plc and Mr Angus Russell, dated March 10, 2004. (27)
|
10.14
|
Novation Agreement dated November 21, 2005 relating to the Employment Agreement of Angus Russell dated March 10, 2004. (28)
|
10.15
|
Novation Agreement dated April 11, 2008 relating to the Employment Agreement of Angus Russell dated March 10, 2004, as previously novated on November 21, 2005. (29)
|
10.16
|
Form of Amended and Restated Employment Agreement between Shire plc and Mr Matthew Emmens, dated March 12, 2004. (30)
|
10.17
|
Amendment Agreement dated November 21, 2005 relating to the Amended and Restated Employment Agreement of Matthew Emmens dated March 12, 2004. (31)
|
10.18
|
Ratification and Guaranty dated November 21, 2005 relating to the Amended and Restated Employment Agreement of Matthew Emmens dated March 12, 2004. (32)
|
10.19
|
Amendment Agreement dated May 20, 2008 relating to the Amended and Restated Employment Agreement of Matthew Emmens dated March 12, 2004, as amended on November 21, 2005. (33)
|
10.20
|
Ratification and Guaranty dated May 20, 2008 relating to the Amended and Restated Employment Agreement of Matthew Emmens dated March 12, 2004. (34)
|
10.21
|
Form of Indemnity Agreement for Directors of Shire Limited. (35)
|
10.22
|
Service Agreement between Shire Limited and Mr Angus Russell, dated July 2, 2008. (36)
|
10.23
|
Service Agreement between Shire Limited and Mr Graham Hetherington, dated July 2, 2008. (37)
|
10.24
|
Form of Settlement Agreement and Mutual Release in re: Transkaryotic Therapies, Inc., by and between Shire Human Genetic Therapies, Inc., Shire plc and the parties set forth therein. (38)
|
10.25
|
Amended Agreement dated February 24, 2009 relating to the Product Development and License Agreement dated August 14, 2006. (39)
|
10.26
|
Amendment of the Service Agreement of A.C Russell dated January 15, 2010. (40)
|
10.27
|
Amendment to the Shire Portfolio Share Plan as approved by the Annual General meeting held on April 27, 2010. (41)
|
10.28
|
Multicurrency revolving and swingline facilities agreement as at November 23, 2010 by and among Shire plc & with a number of financial institutions, for which Abbey National Treasury Services Plc (trading as Santander Global Banking and Markets), Bank of America Securities Limited, Barclays Capital, Citigroup Global Markets Limited, Lloyds TSB Bank plc and The Royal Bank of Scotland plc acted as mandated lead arrangers and bookrunners and Credit Suisse AG, London Branch, Deutsche Bank AG, London Branch, Goldman Sachs
|
|
International, Morgan Stanley Bank, N.A. and Sumitomo Mitsui Banking Corporation, Brussels Branch acted as arrangers. (42)
|
31.1
|
Certification of Angus Russell pursuant to Rule 13a - 14 under The Exchange Act.
|
31.2
|
Certification of Graham Hetherington pursuant to Rule 13a - 14 under The Exchange Act.
|
32.1
|
Certification of Angus Russell and Graham Hetherington pursuant to Section 906 of the Sarbanes - Oxley Act of 2002.
|
*
|
Certain portions of this exhibit have been omitted intentionally, subject to a confidential treatment request. A complete version of this agreement has been filed separately with the Securities and Exchange Commission.
|
(1)
|
Incorporated by reference to Exhibit 99.02 to Shire's Form 8-K filed on April 25, 2005.
|
(2)
|
Incorporated by reference to Exhibit 2.1 to Shire's Form 8-K filed on February 23, 2007.
|
(3)
|
Incorporated by reference to Exhibit 2.1 to Shire's Form 8-K filed on July 10, 2008.
|
(4)
|
Incorporated by reference to Exhibit 2.04 to Shire's Form 10-Q filed on November 5, 2010.
|
(5)
|
Incorporated by reference to Exhibit 2.1 to Shire's Form 8-K filed on June 30, 2011.
|
(6)
|
Filed herewith.
|
(7)
|
Incorporated by reference to Exhibit 99.02 to Shire's Form 8-K filed on October 1, 2008.
|
(8)
|
Incorporated by reference to Exhibit 99.02 to Shire's Form 8-K filed on April 29, 2011.
|
(9)
|
Incorporated by reference to Exhibit 4.01 to Shire's Form 8-K filed on May 23, 2008.
|
(10)
|
Incorporated by reference to Exhibit 4.02 to Shire's Form 8-K filed on May 23, 2008.
|
(11)
|
Incorporated by reference to Exhibit 4.03 to Shire's Form 8-K filed on May 23, 2008.
|
(12)
|
Incorporated by reference to Exhibit 4.04 to Shire's Form 8-K filed on May 23, 2008.
|
(13)
|
Incorporated by reference to Exhibit 4.05 to Shire's Form 10-K filed on February 27, 2009.
|
(14)
|
Incorporated by reference to Exhibit 4.06 to Shire's Form F-6 filed on April 27, 2011.
|
(15)
|
Incorporated by reference to Exhibit 99.1 to Shire's Form 8-K filed on February 23, 2007.
|
(16)
|
Incorporated by reference to Exhibit 10.2 to Shire's Form 10-Q filed on May 1, 2007.
|
(17)
|
Incorporated by reference to Exhibit 10.01 to Shire's Form 8-K filed on May 23, 2008.
|
(18)
|
Incorporated by reference to Exhibit 10.1 to Shire's Form 10-Q filed on August 2, 2007.
|
(19)
|
Incorporated by reference to Exhibit 10.2 to Shire's Form 10-Q filed on August 2, 2007.
|
(20)
|
Incorporated by reference to Exhibit 10.3 to Shire's Form 10-Q filed on August 2, 2007.
|
(21)
|
Incorporated by reference to Exhibit 10.02 to Shire's Form 8-K filed on May 23, 2008.
|
(22)
|
Incorporated by reference to Exhibit 10.03 to Shire's Form 8-K filed on May 23, 2008.
|
(23)
|
Incorporated by reference to Exhibit 10.09 to Shire's Form 10-K/A filed on May 30, 2008.
|
(24)
|
Incorporated by reference to Exhibit 10.1 to Shire's Form 10-Q filed on November 7, 2006.
|
(25)
|
Incorporated by reference to Exhibit 10.2 to Shire's Form 10-Q filed on November 7, 2006.
|
(26)
|
Incorporated by reference to Exhibit 10.3 to Shire's Form 10-Q filed on November 7, 2006.
|
(27)
|
Incorporated by reference to Exhibit 10.11 to Shire's Form 10-K filed on March 12, 2004.
|
(28)
|
Incorporated by reference to Exhibit 10.03 to Shire's Form 8-K filed on November 25, 2005.
|
(29)
|
Incorporated by reference to Exhibit 10.06 to Shire's Form 8-K filed on May 23, 2008.
|
(30)
|
Incorporated by reference to Exhibit 10.13 to Shire's Form 10-K filed on March 12, 2004.
|
(31)
|
Incorporated by reference to Exhibit 10.01 to Shire's Form 8-K filed on November 25, 2005.
|
(32)
|
Incorporated by reference to Exhibit 10.02 to Shire's Form 8-K filed on November 25, 2005.
|
(33)
|
Incorporated by reference to Exhibit 10.04 to Shire's Form 8-K filed on May 23, 2008.
|
(34)
|
Incorporated by reference to Exhibit 10.05 to Shire's Form 8-K filed on May 23, 2008.
|
(35)
|
Incorporated by reference to Exhibit 10.07 to Shire's Form 8-K filed on May 23, 2008.
|
(36)
|
Incorporated by reference to Exhibit 10.22 to Shire's Form 10-Q filed on November 10, 2008.
|
(37)
|
Incorporated by reference to Exhibit 10.23 to Shire's Form 10-Q filed on November 10, 2008.
|
(38)
|
Incorporated by reference to Exhibit 10.24 to Shire's Form 10-Q filed on November 10, 2008.
|
(39)
|
Incorporated by reference to Exhibit 10.25 to Shire's Form 10-Q filed on May 7, 2009.
|
(40)
|
Incorporated by reference to Exhibit 10.26 to Shire's Form 10-K filed on February 26, 2010.
|
(41)
|
Incorporated by reference to Exhibit 10.27 to Shire's Form 10-Q filed on May 6, 2010.
|
(42)
|
Incorporated by reference to Exhibit 10.28 to Shire's Form 10-K filed on February 23, 2011.
|
Date: May 9, 2012
|
/s/ Angus Russell
Angus Russell
Chief Executive Officer
|
Date: May 9, 2012
|
/s/ Graham Hetherington
Graham Hetherington
Chief Financial Officer
|
2.
|
Based on my knowledge, this quarterly 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 quarterly report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this quarterly 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 quarterly report;
|
4.
|
The registrant's other certifying officer 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 quarterly 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 registrant's disclosure controls and procedures and presented in this quarterly 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;
|
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's 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 registrant's 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 registrant's internal control over financial reporting.
|
/s/ Angus Russell
Angus Russell
Chief Executive Officer
|
2.
|
Based on my knowledge, this quarterly 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 quarterly report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this quarterly 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 quarterly report;
|
4.
|
The registrant's other certifying officer 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 quarterly 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 registrant's disclosure controls and procedures and presented in this quarterly 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;
|
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant's other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's 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 registrant's 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 registrant's internal control over financial reporting.
|
/s/ Graham Hetherington
Graham Hetherington
Chief Financial Officer
|
1.
|
the Report fully complies with the requirements of Section 13(a) or 15(d) of the Exchange Act; and
|
2.
|
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Shire plc.
|
/s/ Angus Russell
Angus Russell
Chief Executive Officer
/s/ Graham Hetherington
Graham Hetherington
Chief Financial Officer
|
Segmental Reporting (Tables)
|
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2012
|
Mar. 31, 2011
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Reporting [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Segment Reporting Information, by Segment |
|
|
Financial Instruments (Interest Rate and Credit Risks) (Details) (USD $)
In Millions, unless otherwise specified |
3 Months Ended | 12 Months Ended |
---|---|---|
Mar. 31, 2012
|
Dec. 31, 2011
|
|
Interest rate risk | ||
Average interest rate received on cash and liquid investments | less than 1% per annum | |
Debt Instrument [Line Items] | ||
Principal amount | $ 1,100 | |
Stated interest rate | 2.75% | |
Credit risk | ||
Percent of the Company's product sales accounted for by three major customers in the US | 49.00% | |
Shire 2.75% Convertible Bond due 2014
|
||
Debt Instrument [Line Items] | ||
Principal amount | $ 1,100 | |
Stated interest rate | 2.75% |
Long-term Debt (Other Long-term Debt) (Details) (USD $)
In Millions, unless otherwise specified |
3 Months Ended |
---|---|
Mar. 31, 2012
|
|
Long-term Debt, Unclassified [Abstract] | |
Debt issuance date | May 9, 2007 |
Principal amount | $ 1,100 |
Stated interest rate | 2.75% |
Final maturity date | May 09, 2014 |
Put Option Date | May 09, 2012 |
Financial Instruments (Foreign Exchange Risk and Its Classification on Balance Sheet) (Details) (USD $)
In Millions, unless otherwise specified |
Mar. 31, 2012
contract
|
Dec. 31, 2011
|
---|---|---|
Derivatives, Fair Value | ||
Assets | $ 2.6 | $ 3.4 |
Liabilities | 1.9 | 0.4 |
Net derivative fair value | $ 0.7 | |
Number of swap and forward foreign exchange contracts outstanding | 25 |
Accounts Payable and Accrued Expenses (Details) (USD $)
In Millions, unless otherwise specified |
Mar. 31, 2012
|
Dec. 31, 2011
|
---|---|---|
Accounts Payable and Accrued Liabilities, Current [Line Items] | ||
Trade accounts payable and accrued purchases | $ 197.9 | $ 259.6 |
Accrued rebate - Medicaid | 442.1 | 409.8 |
Accrued rebate - Managed care | 228.1 | 202.8 |
Sales return reserve | 86.1 | 88.8 |
Accrued bonuses | 56.3 | 103.0 |
Accrued employee compensation and benefits payable | 95.2 | 59.3 |
R&D accruals | 53.6 | 52.7 |
Marketing accruals | 20.0 | 18.2 |
Other accrued expenses | 216.9 | 176.3 |
Accounts payable and accrued expenses, total | $ 1,396.2 | $ 1,370.5 |
Other Non-current Liabilities (Tables)
|
3 Months Ended | ||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2012
|
|||||||||||||||||||||||||||||||||||||
Other Liabilities, Noncurrent [Abstract] | |||||||||||||||||||||||||||||||||||||
Schedule of Other Noncurrent Liabilities |
|
Segmental Reporting
|
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2012
|
Mar. 31, 2011
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Reporting [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Reporting Disclosure | 16. Segmental reporting
Shire's internal financial reporting is in line with its business unit and management reporting structure. The Company has three business units and three reportable segments: SP, HGT and RM. The SP, HGT and RM reportable segments represent the Company's revenues and costs for currently promoted and sold products, together with the costs of developing projects for future commercialization. 'All Other' has been included in the table below in order to reconcile the three segments to the total consolidated figures.
The Company evaluates performance based on revenue and operating income. The Company does not have inter-segment transactions. Assets that are directly attributable or allocable to the segments have been separately disclosed.
(1) Depreciation from manufacturing plants ($7.2 million) and amortization of favorable manufacturing contracts ($0.2 million) is included in Cost of product sales; depreciation of research and development assets ($6.4 million) in Research and development; and all other depreciation and amortization ($59.2 million) is included in Selling, general and administrative. (2) Long-lived assets comprise all non-current assets (excluding goodwill and other intangible assets, deferred contingent consideration assets, deferred tax assets, investments, income tax receivable and financial instruments). |
(1) Depreciation from manufacturing plants ($7.7 million) and amortization of favorable manufacturing contracts ($0.4 million) is included in Cost of product sales; depreciation of research and development assets ($4.7 million) is included in Research and development; and all other depreciation, amortization and impairment charges ($50.7 million) is included in Selling, general and administrative. (2) Long-lived assets comprise all non-current assets (excluding goodwill and other intangible assets, deferred contingent consideration assets, deferred tax assets, investments, income tax receivable and financial instruments).
|
Commitments and Contingencies (Leases, and LC and Guarantees ) (Details) (USD $)
In Millions, unless otherwise specified |
3 Months Ended | |
---|---|---|
Mar. 31, 2012
|
Mar. 31, 2011
|
|
Future Minimum Lease Payments under Operating Leases | ||
2012 | $ 29.6 | |
2013 | 32.2 | |
2014 | 29.4 | |
2015 | 24.0 | |
2016 | 16.3 | |
2017 | 12.2 | |
Thereafter | 31.8 | |
Future minimum lease payments, total | 175.5 | |
Operating Leases, Rent Expense | ||
Lease and rental expense | 12.8 | 8.7 |
Letters of credit and guarantees | ||
Irrevocable standby letters of credit and guarantees | 34.8 | |
Restricted cash required by letters of credit | $ 9.2 |
Inventories (Details) (USD $)
In Millions, unless otherwise specified |
Mar. 31, 2012
|
Dec. 31, 2011
|
---|---|---|
Schedule of Inventory | ||
Finished goods | $ 99.5 | $ 99.9 |
Work-in-progress | 185.8 | 162.6 |
Raw materials | 83.4 | 77.6 |
Total inventories | 368.7 | 340.1 |
Inventories awaiting regulatory approval | $ 7.2 | $ 22.7 |
Fair Value Measurement (Tables)
|
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2012
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Fair Value, Assets and Liabilities Measured on Recurring Basis |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assets Measured at Fair Value on a Recurring Basis Using Significant Unobervable Inputs (Level 3) |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Fair Value, Assets and Liabilities Not Measured at Fair Value on Recurring Basis |
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Fair Value Inputs Assets Quantitative Information |
|
Commitments and Contingencies (Commitments and Loss Contingency) (Details) (USD $)
In Millions, unless otherwise specified |
3 Months Ended | 12 Months Ended |
---|---|---|
Mar. 31, 2012
|
Dec. 31, 2011
|
|
Legal and other proceedings | ||
Provisions for litigation loss, insurance claims and other disputes | $ 76.5 | $ 36.9 |
Clinical Testing
|
||
Commitment [Line Items] | ||
Commitment amount | 399.7 | 358.6 |
Contract Manufacturing
|
||
Commitment [Line Items] | ||
Commitment amount | 101.3 | 86.4 |
Commitments expected to be paid in next year | 76.3 | |
Other Purchasing Commitment
|
||
Commitment [Line Items] | ||
Commitment amount | 225.9 | 190.1 |
Commitments expected to be paid in next year | 218.9 | |
Investment Commitment
|
||
Commitment [Line Items] | ||
Commitment amount | 7.3 | 9.4 |
Capital Commitment
|
||
Commitment [Line Items] | ||
Commitment amount | $ 14.1 | $ 25.4 |
Segmental Reporting (by Segment) (Details) (USD $)
In Millions, unless otherwise specified |
3 Months Ended | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2012
|
Mar. 31, 2011
|
Dec. 31, 2011
|
|||||||||||
Segment reporting, operating income/(loss) | |||||||||||||
Product sales | $ 1,106.9 | $ 889.3 | |||||||||||
Royalties | 56.3 | 73.6 | |||||||||||
Other revenues | 8.6 | 9.3 | |||||||||||
Total revenues | 1,171.8 | 972.2 | |||||||||||
Cost of product sales | 158.4 | 124.5 | [1] | ||||||||||
Research and development | 220.3 | 177.9 | |||||||||||
Selling, general and administrative ("SG&A") | 500.0 | 402.9 | [1] | ||||||||||
(Gain)/loss on sale of product rights | (7.2) | 1.3 | |||||||||||
Reorganization costs | 0 | 5.5 | |||||||||||
Integration and acquisition costs | 5.3 | (6.4) | |||||||||||
Total operating expenses | 876.8 | 705.7 | |||||||||||
Operating income/(loss) | 295.0 | 266.5 | |||||||||||
Assets | 6,718.3 | 5,672.8 | 6,380.2 | ||||||||||
Long-lived assets | 923.3 | [2] | 873.7 | [2] | |||||||||
Capital expenditure on long-lived assets | 17.5 | [2] | 43.9 | [2] | |||||||||
Specialty Pharmaceuticals
|
|||||||||||||
Segment reporting, operating income/(loss) | |||||||||||||
Product sales | 706.7 | 616.1 | |||||||||||
Royalties | 42.4 | 37.5 | |||||||||||
Other revenues | 8.3 | 7.6 | |||||||||||
Total revenues | 757.4 | 661.2 | |||||||||||
Cost of product sales | 87.1 | [3] | 81.8 | [4] | |||||||||
Research and development | 131.0 | [3] | 102.7 | [4] | |||||||||
Selling, general and administrative ("SG&A") | 300.1 | [3] | 266.6 | [4] | |||||||||
(Gain)/loss on sale of product rights | (7.2) | 1.3 | |||||||||||
Reorganization costs | 2.3 | ||||||||||||
Integration and acquisition costs | 1.6 | (6.4) | |||||||||||
Total operating expenses | 512.6 | 448.3 | |||||||||||
Operating income/(loss) | 244.8 | 212.9 | |||||||||||
Assets | 2,463.3 | 2,548.0 | |||||||||||
Long-lived assets | 126.3 | [2] | 150.2 | [2] | |||||||||
Capital expenditure on long-lived assets | 2.1 | [2] | 4.8 | [2] | |||||||||
Human Genetic Therapies
|
|||||||||||||
Segment reporting, operating income/(loss) | |||||||||||||
Product sales | 351.4 | 273.2 | |||||||||||
Royalties | 0 | 0 | |||||||||||
Other revenues | 0.3 | 0.4 | |||||||||||
Total revenues | 351.7 | 273.6 | |||||||||||
Cost of product sales | 61.3 | [3] | 42.7 | [4] | |||||||||
Research and development | 86.3 | [3] | 75.2 | [4] | |||||||||
Selling, general and administrative ("SG&A") | 104.4 | [3] | 80.1 | [4] | |||||||||
(Gain)/loss on sale of product rights | 0 | 0 | |||||||||||
Reorganization costs | 0 | ||||||||||||
Integration and acquisition costs | 0 | 0 | |||||||||||
Total operating expenses | 252.0 | 198.0 | |||||||||||
Operating income/(loss) | 99.7 | 75.6 | |||||||||||
Assets | 1,917.9 | 1,836.7 | |||||||||||
Long-lived assets | 712.1 | [2] | 678.8 | [2] | |||||||||
Capital expenditure on long-lived assets | 13.0 | [2] | 36.3 | [2] | |||||||||
Regenerative Medicine
|
|||||||||||||
Segment reporting, operating income/(loss) | |||||||||||||
Product sales | 48.8 | 0 | |||||||||||
Royalties | 0 | 0 | |||||||||||
Other revenues | 0 | 0 | |||||||||||
Total revenues | 48.8 | 0 | |||||||||||
Cost of product sales | 10.0 | [3] | 0 | [4] | |||||||||
Research and development | 3.0 | [3] | 0 | [4] | |||||||||
Selling, general and administrative ("SG&A") | 41.7 | [3] | 0 | [4] | |||||||||
(Gain)/loss on sale of product rights | 0 | 0 | |||||||||||
Reorganization costs | 0 | ||||||||||||
Integration and acquisition costs | 3.7 | 0 | |||||||||||
Total operating expenses | 58.4 | 0 | |||||||||||
Operating income/(loss) | (9.6) | 0 | |||||||||||
Assets | 961.5 | 0 | |||||||||||
Long-lived assets | 23.2 | [2] | 0 | [2] | |||||||||
Capital expenditure on long-lived assets | 0.1 | [2] | 0 | [2] | |||||||||
All Other Segment
|
|||||||||||||
Segment reporting, operating income/(loss) | |||||||||||||
Product sales | 0 | 0 | |||||||||||
Royalties | 13.9 | 36.1 | |||||||||||
Other revenues | 0 | 1.3 | |||||||||||
Total revenues | 13.9 | 37.4 | |||||||||||
Cost of product sales | [3] | 0 | [4] | ||||||||||
Research and development | 0 | [3] | 0 | [4] | |||||||||
Selling, general and administrative ("SG&A") | 53.8 | [3] | 56.2 | [4] | |||||||||
(Gain)/loss on sale of product rights | 0 | 0 | |||||||||||
Reorganization costs | 3.2 | ||||||||||||
Integration and acquisition costs | 0 | ||||||||||||
Total operating expenses | 53.8 | 59.4 | |||||||||||
Operating income/(loss) | (39.9) | (22.0) | |||||||||||
Assets | 1,375.6 | 1,288.1 | |||||||||||
Long-lived assets | 61.7 | [2] | 44.7 | [2] | |||||||||
Capital expenditure on long-lived assets | $ 2.3 | [2] | $ 2.8 | [2] | |||||||||
|
Other Current Liabilities (Details) (USD $)
In Millions, unless otherwise specified |
Mar. 31, 2012
|
Dec. 31, 2011
|
---|---|---|
Other Liabilities, Current [Abstract] | ||
Income taxes payable | $ 12.9 | $ 27.7 |
Value added taxes | 16.0 | 13.3 |
Other accrued liabilities | 22.5 | 22.8 |
Other current liabilities, total | $ 51.4 | $ 63.8 |