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 June 30, 2011 and December 31, 2010 |
4
|
||||
Unaudited Consolidated Statements of Income for the three months and six months to June 30, 2011 and June 30, 2010 |
6
|
||||
Unaudited Consolidated Statement of Changes in Equity for the six months to June 30, 2011 |
8
|
||||
Unaudited Consolidated Statements of Comprehensive Income for the three months and six months to June 30, 2011 and June 30, 2010 |
9
|
||||
Unaudited Consolidated Statements of Cash Flows for the six months to June 30, 2011 and June 30, 2010 |
10
|
||||
Notes to the Unaudited Consolidated Financial Statements |
12
|
||||
ITEM 2. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
35
|
|||
ITEM 3. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
53
|
|||
ITEM 4. |
CONTROLS AND PROCEDURES
|
53
|
|||
PART II |
OTHER INFORMATION
|
53
|
|||
ITEM 1. |
LEGAL PROCEEDINGS
|
53
|
|||
ITEM 1A. |
RISK FACTORS
|
53
|
|||
ITEM 2. |
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
|
53
|
|||
ITEM 3. |
DEFAULTS UPON SENIOR SECURITIES
|
53
|
|||
ITEM 4. |
RESERVED
|
53
|
|||
ITEM 5. |
OTHER INFORMATION
|
54
|
|||
ITEM 6. | EXHIBITS |
54
|
|
|
June 30,
|
December 31,
|
|||||||||
|
|
2011
|
2010
|
|||||||||
|
Notes
|
$’M | $’M | |||||||||
ASSETS
|
|
|||||||||||
Current assets:
|
|
|||||||||||
Cash and cash equivalents
|
|
144.6 | 550.6 | |||||||||
Restricted cash
|
|
21.9 | 26.8 | |||||||||
Accounts receivable, net
|
4 | 797.2 | 692.5 | |||||||||
Inventories
|
5 | 336.3 | 260.0 | |||||||||
Deferred tax asset
|
166.9 | 182.0 | ||||||||||
Prepaid expenses and other current assets
|
6 | 198.6 | 168.4 | |||||||||
Total current assets
|
1,665.5 | 1,880.3 | ||||||||||
|
||||||||||||
Non-current assets:
|
||||||||||||
Investments
|
125.7 | 101.6 | ||||||||||
Property, plant and equipment, net
|
905.8 | 853.4 | ||||||||||
Goodwill
|
7 | 612.9 | 402.5 | |||||||||
Other intangible assets, net
|
8 | 2,679.4 | 1,978.9 | |||||||||
Deferred tax asset
|
128.3 | 110.4 | ||||||||||
Other non-current assets
|
48.0 | 60.5 | ||||||||||
Total assets
|
6,165.6 | 5,387.6 | ||||||||||
LIABILITIES AND EQUITY
|
||||||||||||
Current liabilities:
|
||||||||||||
Accounts payable and accrued expenses
|
9 | 1,317.5 | 1,239.3 | |||||||||
Convertible bonds
|
10 | 1,100.0 | - | |||||||||
Deferred tax liability
|
4.4 | 4.4 | ||||||||||
Other current liabilities
|
11 | 75.5 | 49.6 | |||||||||
Total current liabilities
|
2,497.4 | 1,293.3 | ||||||||||
|
||||||||||||
Non-current liabilities
|
||||||||||||
Convertible bonds
|
- | 1,100.0 | ||||||||||
Deferred tax liability
|
579.0 | 352.1 | ||||||||||
Other non-current liabilities
|
12 | 173.6 | 190.8 | |||||||||
Total liabilities
|
3,250.0 | 2,936.2 | ||||||||||
Commitments and contingencies
|
13 |
|
|
|
|
||||||
|
|
June 30,
|
December 31,
|
||||||
|
|
2011
|
2010
|
||||||
|
Notes
|
$’M | $’M | ||||||
|
|
||||||||
Equity:
|
|
||||||||
Common stock of 5p par value; 1,000 million shares authorized; and 562.3 million shares issued and outstanding (2010: 1,000 million shares authorized; and 562.2 million shares issued and outstanding)
|
|
55.7 | 55.7 | ||||||
Additional paid-in capital
|
|
2,799.6 | 2,746.4 | ||||||
Treasury stock: 11.5 million shares (2010: 14.0 million shares)
|
|
(253.4 | ) | (276.1 | ) | ||||
Accumulated other comprehensive income
|
|
204.3 | 85.7 | ||||||
Retained earnings/(accumulated deficit)
|
|
109.4 | (160.3 | ) | |||||
Total equity
|
|
2,915.6 | 2,451.4 | ||||||
Total liabilities and equity
|
|
6,165.6 | 5,387.6 |
|
3 months to
|
3 months to
|
6 months to
|
6 months to
|
||||||||||||||||
|
June 30,
|
June 30,
|
June 30,
|
June 30,
|
||||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
||||||||||||||||
Notes
|
$’M | $’M | $’M | $’M | ||||||||||||||||
Revenues:
|
||||||||||||||||||||
Product sales
|
|
993.3 | 764.3 | 1,882.6 | 1,482.4 | |||||||||||||||
Royalties
|
|
63.4 | 82.7 | 137.0 | 178.0 | |||||||||||||||
Other revenues
|
|
6.2 | 2.4 | 15.5 | 5.1 | |||||||||||||||
Total revenues
|
|
1,062.9 | 849.4 | 2,035.1 | 1,665.5 | |||||||||||||||
Costs and expenses:
|
|
|||||||||||||||||||
Cost of product sales (1)
|
|
143.7 | 119.1 | 268.2 | 221.0 | |||||||||||||||
Research and development
|
|
176.9 | 147.0 | 354.8 | 278.0 | |||||||||||||||
Selling, general and administrative (1)
|
|
440.3 | 354.4 | 843.2 | 714.3 | |||||||||||||||
Loss/(gain) on sale of product rights
|
|
2.2 | (4.1 | ) | 3.5 | (4.1 | ) | |||||||||||||
Reorganization costs
|
3 | 7.5 | 8.6 | 13.0 | 13.6 | |||||||||||||||
Integration and acquisition costs
|
9.0 | - | 2.6 | 0.6 | ||||||||||||||||
Total operating expenses
|
779.6 | 625.0 | 1,485.3 | 1,223.4 | ||||||||||||||||
Operating income
|
283.3 | 224.4 | 549.8 | 442.1 | ||||||||||||||||
Interest income
|
0.6 | 0.5 | 1.2 | 0.8 | ||||||||||||||||
Interest expense
|
(9.9 | ) | (8.3 | ) | (19.1 | ) | (17.3 | ) | ||||||||||||
Other (expense)/income, net
|
- | (2.6 | ) | 0.3 | 8.2 | |||||||||||||||
Total other expense, net
|
(9.3 | ) | (10.4 | ) | (17.6 | ) | (8.3 | ) | ||||||||||||
Income before income taxes and equity in earnings of equity method investees
|
274.0 | 214.0 | 532.2 | 433.8 | ||||||||||||||||
Income taxes
|
(69.7 | ) | (54.5 | ) | (117.8 | ) | (108.1 | ) | ||||||||||||
Equity in earnings of equity method investees, net of taxes
|
1.2 | 1.0 | 2.4 | 0.5 | ||||||||||||||||
Net income
|
205.5 | 160.5 | 416.8 | 326.2 |
|
|
3 months to
|
3 months to
|
6 months to
|
6 months to
|
||||||||||||
|
|
June 30,
|
June 30,
|
June 30,
|
June 30,
|
||||||||||||
|
Notes
|
2011
|
2010
|
2011
|
2010
|
||||||||||||
Earning per ordinary share - basic
|
|
|
|
|
|
||||||||||||
|
|
|
|
|
|
||||||||||||
|
|
|
|
|
|
||||||||||||
Earnings per ordinary share - basic
|
|
37.2 | c | 29.4 | c | 75.7 | c | 59.8 | c | ||||||||
|
|
||||||||||||||||
Earnings per ordinary share - diluted
|
|
||||||||||||||||
|
|
||||||||||||||||
Earnings per ordinary share - diluted
|
|
35.9 | c | 28.6 | c | 72.9 | c | 58.2 | c | ||||||||
|
|
||||||||||||||||
Weighted average number of shares (millions):
|
|
||||||||||||||||
Basic
|
16
|
552.3 | 546.6 | 551.1 | 545.7 | ||||||||||||
Diluted
|
16
|
595.1 | 590.0 | 594.8 | 589.1 |
|
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/ (accumulated deficit)
$'M
|
Total equity
$'M
|
|||||||||||||||||||||
As at January 1, 2011
|
55.7 | 562.2 | 2,746.4 | (276.1 | ) | 85.7 | (160.3 | ) | 2,451.4 | |||||||||||||||||||
Net income
|
- | - | - | - | - | 416.8 | 416.8 | |||||||||||||||||||||
Foreign currency translation
|
- | - | - | - | 100.2 | - | 100.2 | |||||||||||||||||||||
Options exercised
|
- | 0.1 | 0.8 | - | - | - | 0.8 | |||||||||||||||||||||
Share-based compensation
|
- | - | 35.9 | - | - | - | 35.9 | |||||||||||||||||||||
|
||||||||||||||||||||||||||||
Excess tax benefit associated with exercise of stock options
|
- | - | 16.5 | - | - | - | 16.5 | |||||||||||||||||||||
Shares purchased by Employee Share Ownership Trust ("ESOT")
|
- | - | - | (63.9 | ) | - | - | (63.9 | ) | |||||||||||||||||||
|
||||||||||||||||||||||||||||
Shares released by ESOT to satisfy exercise of stock options
|
- | - | - | 86.6 | - | (86.6 | ) | - | ||||||||||||||||||||
|
||||||||||||||||||||||||||||
Unrealized holding gain on available-for-sale securities, net of taxes
|
- | - | - | - | 16.0 | - | 16.0 | |||||||||||||||||||||
Other than temporary impairment of available-for-sale securities
|
- | - | - | - | 2.4 | - | 2.4 | |||||||||||||||||||||
Dividends
|
- | - | - | - | - | (60.5 | ) | (60.5 | ) | |||||||||||||||||||
As at June 30, 2011
|
55.7 | 562.3 | 2,799.6 | (253.4 | ) | 204.3 | 109.4 | 2,915.6 |
|
3 months to
|
3 months to
|
6 months to
|
6 months to
|
||||||||||||
|
June 30,
|
June 30,
|
June 30,
|
June 30,
|
||||||||||||
|
2011
|
2010
|
2011
|
2010
|
||||||||||||
|
$'M
|
$'M
|
$'M
|
$'M
|
||||||||||||
|
|
|
|
|
||||||||||||
Net income
|
205.5 | 160.5 | 416.8 | 326.2 | ||||||||||||
Other comprehensive income:
|
||||||||||||||||
Foreign currency translation adjustments
|
29.6 | (47.1 | ) | 100.2 | (82.2 | ) | ||||||||||
Unrealized holding gain/(loss) on available-for-sale securities (net of taxes of $1.1 million, $1.6 million, $3.4 million and $2.6 million)
|
5.9 | (15.9 | ) | 16.0 | (22.6 | ) | ||||||||||
Other than temporary impairment of available-for-sale securities (net of taxes of $nil, $nil, $nil and $nil)
|
- | 1.5 | 2.4 | 1.5 | ||||||||||||
Comprehensive income
|
241.0 | 99.0 | 535.4 | 222.9 |
|
June 30,
|
December 31,
|
||||||
|
2011
|
2010
|
||||||
|
$’M | $’M | ||||||
Foreign currency translation adjustments
|
185.6 | 85.4 | ||||||
Unrealized holding gain on available-for-sale securities, net of taxes
|
18.7 | 0.3 | ||||||
Accumulated other comprehensive income
|
204.3 | 85.7 |
6 months to
|
6 months to
|
|||||||
June 30,
|
June 30,
|
|||||||
2011
|
2010
|
|||||||
$’M | $’M | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net income
|
416.8 | 326.2 | ||||||
Adjustments to reconcile net income to net cash provided by operating activities:
|
||||||||
Depreciation and amortization
|
132.3 | 129.1 | ||||||
Share based compensation
|
34.9 | 26.7 | ||||||
Gain on sale of non-current investments
|
- | (11.1 | ) | |||||
Loss/(gain) on sale of product rights
|
3.5 | (4.1 | ) | |||||
Other
|
(5.7 | ) | 11.0 | |||||
Movement in deferred taxes
|
17.7 | 58.8 | ||||||
Equity in earnings of equity method investees
|
(2.4 | ) | (0.5 | ) | ||||
Changes in operating assets and liabilities:
|
||||||||
Increase in accounts receivable
|
(56.2 | ) | (43.9 | ) | ||||
Increase in sales deduction accrual
|
66.1 | 154.3 | ||||||
Increase in inventory
|
(30.6 | ) | (50.1 | ) | ||||
Increase in prepayments and other assets
|
(13.8 | ) | (83.3 | ) | ||||
Decrease in accounts payable and other liabilities
|
(77.1 | ) | (43.2 | ) | ||||
Net cash provided by operating activities (A)
|
485.5 | 469.9 | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Movements in restricted cash
|
4.8 | 6.0 | ||||||
Purchases of subsidiary undertakings, net of cash acquired
|
(719.7 | ) | - | |||||
Purchases of non-current investments
|
(4.5 | ) | - | |||||
Purchases of property, plant and equipment ("PP&E")
|
(95.0 | ) | (208.1 | ) | ||||
Purchases of intangible assets
|
- | (2.7 | ) | |||||
Proceeds from disposal of non-current investments, PP&E and product rights
|
6.9 | 2.1 | ||||||
Returns of equity investments and proceeds from short term investments
|
1.6 | - | ||||||
Net cash used in investing activities (B)
|
(805.9 | ) | (202.7 | ) |
6 months to
|
6 months to
|
|||||||
June 30,
|
June 30,
|
|||||||
2011
|
2010
|
|||||||
$’M | $’M | |||||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Proceeds from drawings of revolving credit facility (“RCF”)
|
30.0 | - | ||||||
Repayment of debt acquired with ABH
|
(13.1 | ) | - | |||||
Payment under building finance obligation
|
(0.4 | ) | (1.3 | ) | ||||
Extinguishment of building finance obligation
|
- | (43.1 | ) | |||||
Tax benefit of stock based compensation
|
18.8 | 4.4 | ||||||
Proceeds from exercise of options
|
0.8 | 1.8 | ||||||
Payment of dividend
|
(60.5 | ) | (49.8 | ) | ||||
Payments to acquire shares by ESOT
|
(63.9 | ) | (1.7 | ) | ||||
Net cash used in financing activities(C)
|
(88.3 | ) | (89.7 | ) | ||||
Effect of foreign exchange rate changes on cash and cash equivalents (D)
|
2.7 | 6.1 | ||||||
Net (decrease)/increase in cash and cash equivalents (A+B+C+D)
|
(406.0 | ) | 183.6 | |||||
Cash and cash equivalents at beginning of period
|
550.6 | 498.9 | ||||||
Cash and cash equivalents at end of period
|
144.6 | 682.5 |
Supplemental information associated with continuing
|
|
|
||||||
operations:
|
|
|
||||||
|
|
|
||||||
|
6 months to
|
6 months to
|
||||||
|
June 30,
|
June 30,
|
||||||
|
2011
|
2010
|
||||||
|
$’M | $’M | ||||||
|
||||||||
Interest paid
|
(16.2 | ) | (13.0 | ) | ||||
Income taxes paid
|
(147.7 | ) | (205.0 | ) | ||||
|
||||||||
Non cash investing and financing activities:
|
||||||||
Equity in Vertex Pharmaceuticals, Inc. (“Vertex”) received as part consideration for disposal of non-current investment
|
- | 9.1 |
|
Preliminary
|
|||
|
Fair value
|
|||
|
$’M | |||
Identifiable assets acquired and liabilities assumed
|
||||
|
||||
ASSETS
|
||||
Current assets:
|
||||
Cash and cash equivalents
|
14.6 | |||
Accounts receivable
|
30.1 | |||
Inventories
|
31.8 | |||
Deferred tax assets
|
32.3 | |||
Other current assets
|
7.9 | |||
Total current assets
|
116.7 | |||
|
||||
Non-current assets:
|
||||
Property, plant and equipment
|
16.5 | |||
Goodwill
|
192.5 | |||
Other intangible assets
|
||||
- DERMAGRAFT product technology
|
710.0 | |||
- other intangible assets
|
1.5 | |||
Other non-current assets
|
0.1 | |||
Total assets
|
1,037.3 | |||
LIABILITIES
|
||||
Current liabilities:
|
||||
Accounts payable and other current liabilities
|
49.3 | |||
|
||||
Non-current liabilities:
|
||||
Long term debt, less current portion
|
9.1 | |||
Deferred tax liabilities
|
238.7 | |||
Other non-current liabilities
|
1.0 | |||
Total liabilities
|
298.1 | |||
Fair value of identifiable assets acquired and liabilities assumed
|
739.2 | |||
|
||||
Consideration
|
||||
Cash consideration payable
|
739.2 |
|
6 months to
|
6 months to
|
||||||
|
June 30,
|
June 30,
|
||||||
|
2011
|
2010
|
||||||
|
$’M | $’M | ||||||
Revenues
|
2,125.3 | 1,730.1 | ||||||
|
||||||||
Net income attributable to Shire plc
|
401.6 | 313.6 | ||||||
|
||||||||
Per share amounts:
|
||||||||
Net income per ordinary share attributable to Shire plc – basic
|
72.9c | 57.5c | ||||||
|
||||||||
Net income per ordinary share attributable to Shire plc – diluted
|
70.3c | 56.1c |
(i)
|
an adjustment to net income of $49.9 million and $9.8 million for the six months to June 30, 2011 and 2010 respectively, to eliminate the income statement effect of changes in the fair value of ABH’s preferred stock warrants (which were extinguished on acquisition of ABH);
|
(ii)
|
an adjustment to increase amortization expense by approximately $20.0 million for both the six months to June 30, 2011 and 2010, to reflect amortization of intangible assets, principally for DERMAGRAFT product technology, over their estimated useful lives;
|
(iii)
|
an adjustment to decrease net income by $6.9 million for the six months to June 30, 2010 to reflect acquisition and integration costs incurred by Shire, and increase net income by $23.9 million for the six months to June 30, 2011 to eliminate the acquisition and integration costs incurred by ABH and Shire;
|
(iv)
|
an adjustment of $1.4 million and $1.5 million in the six months to June 30, 2011 and June 30, 2010 respectively to reflect interest income foregone on the Company’s cash resources used to fund the acquisition of ABH and interest expense incurred as result of the partial funding of the acquisition of ABH through the Company’s revolving credit facility; and
|
(v)
|
adjustments to reflect the tax effects of the above adjustments, where applicable.
|
|
Opening
|
|
|
Closing
|
||||||||||||
|
liability
|
Amount
|
|
liability at
|
||||||||||||
|
at January 1,
|
charged to re-
|
|
June 30,
|
||||||||||||
|
2011
|
organization
|
Paid/Utilized
|
2011
|
||||||||||||
|
$'M
|
$'M
|
$'M
|
$'M
|
||||||||||||
|
|
|
|
|
||||||||||||
Involuntary termination benefits
|
10.1 | 5.9 | (3.7 | ) | 12.3 | |||||||||||
Other reorganization costs
|
2.3 | 7.1 | (9.1 | ) | 0.3 | |||||||||||
|
12.4 | 13.0 | (12.8 | ) | 12.6 |
|
2011
|
2010
|
||||||
|
$’M | $’M | ||||||
As at January 1,
|
23.4 | 20.8 | ||||||
Provision charged to operations
|
114.8 | 85.2 | ||||||
Provision utilization
|
(109.4 | ) | (83.2 | ) | ||||
As at June 30,
|
28.8 | 22.8 |
|
June 30,
|
December 31,
|
||||||
|
2011
|
2010
|
||||||
|
$’M | $’M | ||||||
Finished goods
|
98.6 | 91.9 | ||||||
Work-in-progress
|
162.4 | 113.9 | ||||||
Raw materials
|
75.3 | 54.2 | ||||||
|
336.3 | 260.0 |
|
June 30,
|
December 31,
|
||||||
|
2011
|
2010
|
||||||
|
$’M | $’M | ||||||
Prepaid expenses
|
41.9 | 45.1 | ||||||
Income tax receivable
|
71.3 | 42.4 | ||||||
Value added taxes receivable
|
20.9 | 21.5 | ||||||
Other current assets
|
64.5 | 59.4 | ||||||
|
198.6 | 168.4 |
|
June 30,
|
December 31,
|
||||||
|
2011
|
2010
|
||||||
|
$’M | $’M | ||||||
Goodwill arising on businesses acquired
|
612.9 | 402.5 |
|
2011
|
2010
|
|
$’M
|
$’M
|
|
____________
|
____________
|
As at January 1,
|
402.5
|
384.7
|
Acquisitions
|
192.5
|
-
|
Foreign currency translation
|
17.9
|
(29.0)
|
|
____________
|
____________
|
As at June 30,
|
612.9
|
355.7
|
|
____________
|
____________
|
|
June 30,
|
December 31,
|
||||||
|
2011
|
2010
|
||||||
|
$’M | $’M | ||||||
Amortized intangible assets
|
||||||||
Intellectual property rights acquired for currently marketed products
|
2,562.2 | 2,516.4 | ||||||
Acquired product technology
|
710.0 | - | ||||||
Other intangible assets
|
24.2 | 22.0 | ||||||
|
3,296.4 | 2,538.4 | ||||||
Unamortized intangible assets
|
||||||||
Intellectual property rights acquired for In-process R&D (“IPR&D”)
|
150.6 | 139.7 | ||||||
|
3,447.0 | 2,678.1 | ||||||
|
||||||||
Less: Accumulated amortization
|
(767.6 | ) | (699.2 | ) | ||||
|
2,679.4 | 1,978.9 |
|
Other intangible assets
|
|||||||
|
2011
|
2010
|
||||||
|
$’M | $’M | ||||||
As at January 1,
|
1,978.9 | 1,790.7 | ||||||
Acquisitions
|
711.5 | 2.7 | ||||||
Amortization charged
|
(73.6 | ) | (69.3 | ) | ||||
Foreign currency translation
|
62.6 | (71.0 | ) | |||||
As at June 30,
|
2,679.4 | 1,653.1 |
|
June 30,
|
December 31,
|
||||||
|
2011
|
2010
|
||||||
|
$’M | $’M | ||||||
Trade accounts payable and accrued purchases
|
218.2 | 234.7 | ||||||
Accrued rebates – Medicaid
|
399.3 | 379.6 | ||||||
Accrued rebates – Managed care
|
210.0 | 170.3 | ||||||
Sales return reserve
|
75.4 | 69.8 | ||||||
Accrued bonuses
|
65.2 | 91.6 | ||||||
Accrued employee compensation and benefits payable
|
66.5 | 48.1 | ||||||
R&D accruals
|
57.5 | 60.7 | ||||||
Marketing accruals
|
25.0 | 26.5 | ||||||
Deferred revenue
|
4.9 | 13.7 | ||||||
Other accrued expenses
|
195.5 | 144.3 | ||||||
|
1,317.5 | 1,239.3 |
|
June 30,
|
December 31,
|
||||||
|
2011
|
2010
|
||||||
|
$’M | $’M | ||||||
Income taxes payable
|
4.7 | 16.2 | ||||||
Value added taxes
|
13.0 | 9.9 | ||||||
Short-term debt
|
30.0 | - | ||||||
Other current liabilities
|
27.8 | 23.5 | ||||||
|
75.5 | 49.6 |
|
June 30,
|
December 31,
|
||||||
|
2011
|
2010
|
||||||
|
$’M | $’M | ||||||
Income taxes payable
|
111.4 | 130.0 | ||||||
Deferred revenue
|
14.2 | 14.1 | ||||||
Deferred rent
|
11.8 | 12.8 | ||||||
Insurance provisions
|
15.5 | 13.5 | ||||||
Other non-current liabilities
|
20.7 | 20.4 | ||||||
|
173.6 | 190.8 |
|
Operating
|
|||
|
leases
|
|||
|
$’M | |||
2011
|
18.2 | |||
2012
|
31.6 | |||
2013
|
27.6 | |||
2014
|
24.7 | |||
2015
|
19.7 | |||
2016
|
17.1 | |||
Thereafter
|
41.1 | |||
|
180.0 |
|
Fair value
|
Fair value
|
|||||||
|
|
June 30,
|
December 31,
|
||||||
|
|
2011
|
2010
|
||||||
|
|
$’M | $’M | ||||||
Assets
|
Prepaid expenses and other current assets
|
1.1 | 3.7 | ||||||
Liabilities
|
Other current liabilities
|
4.1 | 2.7 |
|
Location of net (loss)/gain
recognized in income
|
Amount of net (loss)/gain
recognized in income
|
|||||||
Six months to
|
June 30,
|
June 30,
|
|||||||
|
|
2011
|
2010
|
||||||
|
|
$’M | $’M | ||||||
Foreign exchange contracts
|
Other income, net
|
(2.6 | ) | 38.5 |
Carrying
|
Fair value
|
|||||||||||||||||||
value
|
|
|
|
|
||||||||||||||||
|
Total
|
Level 1
|
Level 2
|
Level 3
|
||||||||||||||||
At June 30, 2011
|
$'M
|
$'M
|
$'M
|
$'M
|
$'M
|
|||||||||||||||
Financial assets:
|
|
|
|
|
|
|||||||||||||||
Available-for-sale securities(1)
|
107.5 | 107.5 | 107.5 | - | - | |||||||||||||||
Contingent consideration receivable (2)
|
53.1 | 53.1 | - | - | 53.1 | |||||||||||||||
Foreign exchange contracts
|
1.1 | 1.1 | - | 1.1 | - | |||||||||||||||
Financial liabilities:
|
||||||||||||||||||||
Foreign exchange contracts
|
4.1 | 4.1 | - | 4.1 | - | |||||||||||||||
|
||||||||||||||||||||
Total
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||||||
At December 31, 2010
|
$'M
|
$'M
|
$'M
|
$'M
|
$'M
|
|||||||||||||||
Financial assets:
|
||||||||||||||||||||
Available-for-sale securities(1)
|
83.9 | 83.9 | 83.9 | - | - | |||||||||||||||
Contingent consideration receivable (2)
|
61.0 | 61.0 | - | - | 61.0 | |||||||||||||||
Foreign exchange contracts
|
3.7 | 3.7 | - | 3.7 | - | |||||||||||||||
Financial liabilities:
|
||||||||||||||||||||
Foreign exchange contracts
|
2.7 | 2.7 | - | 2.7 | - |
(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 discounted cash flow method). This discounted cash flow approach uses significant unobservable inputs, such as future sales of the divested product, relevant contractual royalty rates, an appropriate discount rate and assumed weightings applied to scenarios used in deriving a probability weighted fair value.
|
|
·
|
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
|
||||
2011
|
||||
$'M
|
||||
|
||||
Balance at January 1,
|
61.0 | |||
Loss recognized in the income statement due to change in fair value during the period
|
(3.5 | ) | ||
Reclassification of amounts due from Noven to Other receivables within Other current assets
|
(9.2 | ) | ||
Foreign exchange translation recorded to other comprehensive income
|
4.8 | |||
Balance at June 30,
|
53.1 |
|
June 30, 2011
|
December 31, 2010
|
||||||||||||||
|
Carrying
|
|
Carrying
|
|
||||||||||||
|
amount
|
Fair value
|
amount
|
Fair value
|
||||||||||||
|
$’M | $’M | $’M | $’M | ||||||||||||
|
||||||||||||||||
Financial liabilities:
|
||||||||||||||||
Convertible bonds
|
1,100.0 | 1,283.9 | 1,100.0 | 1,139.8 | ||||||||||||
Building financing obligation
|
8.4 | 9.4 | 8.4 | 8.2 |
|
·
|
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
|
3 months to
|
6 months to
|
6 months to
|
|||||||||||||
June 30,
|
June 30,
|
June 30,
|
June 30,
|
|||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
$’M | $’M | $’M | $’M | |||||||||||||
Amounts attributable to Shire plc shareholders
|
||||||||||||||||
Numerator for basic earnings per share
|
205.5 | 160.5 | 416.8 | 326.2 | ||||||||||||
Interest on convertible bonds, net of tax
|
8.4 | 8.4 | 16.8 | 16.8 | ||||||||||||
Numerator for diluted earnings per share
|
213.9 | 168.9 | 433.6 | 343.0 | ||||||||||||
Weighted average number of shares:
|
||||||||||||||||
|
Millions
|
Millions
|
Millions
|
Millions
|
||||||||||||
Basic(1)
|
552.3 | 546.6 | 551.1 | 545.7 | ||||||||||||
Effect of dilutive shares:
|
||||||||||||||||
Share based awards to employees(2)
|
9.3 | 10.2 | 10.3 | 10.2 | ||||||||||||
Convertible bonds 2.75% due 2014(3)
|
33.5 | 33.2 | 33.4 | 33.2 | ||||||||||||
Diluted
|
595.1 | 590.0 | 594.8 | 589.1 |
June 30,
|
June 30,
|
June 30,
|
June 30,
|
|||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
No. of shares
|
No. of shares
|
No. of shares
|
No. of shares
|
|||||||||||||
Millions
|
Millions
|
Millions
|
Millions
|
|||||||||||||
Share awards(1)
|
2.9 | 8.1 | 3.8 | 8.1 |
SP
|
HGT
|
All Other
|
Total
|
|||||||||||||
3 months to June 30, 2011
|
$’M | $’M | $’M | $’M | ||||||||||||
Product sales
|
676.7 | 316.6 | - | 993.3 | ||||||||||||
Royalties
|
51.8 | - | 11.6 | 63.4 | ||||||||||||
Other revenues
|
4.7 | 0.2 | 1.3 | 6.2 | ||||||||||||
Total revenues
|
733.2 | 316.8 | 12.9 | 1,062.9 | ||||||||||||
Cost of product sales(1)
|
94.1 | 49.6 | - | 143.7 | ||||||||||||
Research and development(1)
|
105.1 | 71.8 | - | 176.9 | ||||||||||||
Selling, general and administrative(1)
|
294.7 | 91.9 | 53.7 | 440.3 | ||||||||||||
Loss on sale of product rights
|
2.2 | - | - | 2.2 | ||||||||||||
Reorganization costs
|
2.7 | - | 4.8 | 7.5 | ||||||||||||
Integration and acquisition costs
|
9.0 | - | - | 9.0 | ||||||||||||
Total operating expenses
|
507.8 | 213.3 | 58.5 | 779.6 | ||||||||||||
Operating income/(loss)
|
225.4 | 103.5 | (45.6 | ) | 283.3 | |||||||||||
Total assets
|
3,555.3 | 1,875.9 | 734.4 | 6,165.6 | ||||||||||||
Long-lived assets(2)
|
174.9 | 691.1 | 42.9 | 908.9 | ||||||||||||
Capital expenditure on long-lived assets(2)
|
18.2 | 27.4 | 5.3 | 50.9 |
(1)
|
Depreciation from manufacturing plants ($10.5 million) and amortization of favorable manufacturing contracts ($0.4 million) is included in Cost of product sales; depreciation of research and development assets ($6.1 million) is included in Research and development; and all other depreciation and amortization ($51.8 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
|
All Other
|
Total
|
|||||||||||||
3 months to June 30, 2010
|
$’M | $’M | $’M | $’M | ||||||||||||
Product sales
|
551.3 | 213.0 | - | 764.3 | ||||||||||||
Royalties
|
44.2 | - | 38.5 | 82.7 | ||||||||||||
Other revenues
|
0.5 | 0.6 | 1.3 | 2.4 | ||||||||||||
Total revenues
|
596.0 | 213.6 | 39.8 | 849.4 | ||||||||||||
Cost of product sales(1)
|
84.6 | 34.5 | - | 119.1 | ||||||||||||
Research and development(1)
|
84.8 | 62.2 | - | 147.0 | ||||||||||||
Selling, general and administrative(1)
|
236.6 | 61.9 | 55.9 | 354.4 | ||||||||||||
Gain on sale of product rights
|
(4.1 | ) | - | - | (4.1 | ) | ||||||||||
Reorganization costs
|
3.3 | - | 5.3 | 8.6 | ||||||||||||
Total operating expenses
|
405.2 | 158.6 | 61.2 | 625.0 | ||||||||||||
Operating income/(loss)
|
190.8 | 55.0 | (21.4 | ) | 224.4 | |||||||||||
Total assets
|
2,081.5 | 1,574.3 | 1,213.1 | 4,868.9 | ||||||||||||
Long-lived assets(2)
|
169.5 | 587.4 | 48.8 | 805.7 | ||||||||||||
Capital expenditure on long-lived assets(2)
|
2.7 | 161.9 | 2.1 | 166.7 |
(1)
|
Depreciation from manufacturing plants ($9.8 million) and amortization of favorable manufacturing contracts ($0.4 million) is included in Cost of product sales; depreciation of research and development assets ($3.5 million) is included in Research and development; and all other depreciation and amortization ($50.4 million) is included in Selling, general and administrative.
|
(2)
|
Long-lived assets comprise all non-current assets (excluding goodwill and other intangible assets, deferred tax assets, investments, income tax receivable and financial instruments).
|
SP
|
HGT
|
All Other
|
Total
|
|||||||||||||
6 months to June 30, 2011
|
$’M | $’M | $’M | $’M | ||||||||||||
Product sales
|
1,292.8 | 589.8 | - | 1,882.6 | ||||||||||||
Royalties
|
89.3 | - | 47.7 | 137.0 | ||||||||||||
Other revenues
|
12.3 | 0.5 | 2.7 | 15.5 | ||||||||||||
Total revenues
|
1,394.4 | 590.3 | 50.4 | 2,035.1 | ||||||||||||
Cost of product sales(1)
|
176.0 | 92.2 | - | 268.2 | ||||||||||||
Research and development(1)
|
207.8 | 147.0 | - | 354.8 | ||||||||||||
Selling, general and administrative(1)
|
561.3 | 172.0 | 109.9 | 843.2 | ||||||||||||
Loss on sale of product rights
|
3.5 | - | - | 3.5 | ||||||||||||
Reorganization costs
|
5.0 | - | 8.0 | 13.0 | ||||||||||||
Integration and acquisition costs
|
2.6 | - | - | 2.6 | ||||||||||||
Total operating expenses
|
956.2 | 411.2 | 117.9 | 1,485.3 | ||||||||||||
Operating income/(loss)
|
438.2 | 179.1 | (67.5 | ) | 549.8 | |||||||||||
Total assets
|
3,555.3 | 1,875.9 | 734.4 | 6,165.6 | ||||||||||||
Long-lived assets(2)
|
174.9 | 691.1 | 42.9 | 908.9 | ||||||||||||
Capital expenditure on long-lived assets(2)
|
23.1 | 63.8 | 7.9 | 94.8 |
(1)
|
Depreciation from manufacturing plants ($18.2 million) and amortization of favorable manufacturing contracts ($0.9 million) is included in Cost of product sales; depreciation of research and development assets ($10.8 million) is included in Research and development; and all other depreciation, amortization and impairment charges ($102.4 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
|
All Other
|
Total
|
|||||||||||||
6 months to June 30, 2010
|
$’M | $’M | $’M | $’M | ||||||||||||
Product sales
|
1,092.6 | 389.8 | - | 1,482.4 | ||||||||||||
Royalties
|
102.8 | - | 75.2 | 178.0 | ||||||||||||
Other revenues
|
1.2 | 1.3 | 2.6 | 5.1 | ||||||||||||
Total revenues
|
1,196.6 | 391.1 | 77.8 | 1,665.5 | ||||||||||||
Cost of product sales(1)
|
165.0 | 56.0 | - | 221.0 | ||||||||||||
Research and development(1)
|
158.7 | 119.3 | - | 278.0 | ||||||||||||
Selling, general and administrative(1)
|
486.1 | 124.7 | 103.5 | 714.3 | ||||||||||||
Gain on sale of product rights
|
(4.1 | ) | - | - | (4.1 | ) | ||||||||||
Reorganization costs
|
6.7 | - | 6.9 | 13.6 | ||||||||||||
Integration and acquisition costs
|
0.6 | - | - | 0.6 | ||||||||||||
Total operating expenses
|
813.0 | 300.0 | 110.4 | 1,223.4 | ||||||||||||
Operating income/(loss)
|
383.6 | 91.1 | (32.6 | ) | 442.1 | |||||||||||
Total assets
|
2,081.5 | 1,574.3 | 1,213.1 | 4,868.9 | ||||||||||||
Long-lived assets(2)
|
169.5 | 587.4 | 48.8 | 805.7 | ||||||||||||
Capital expenditure on long-lived assets(2)
|
5.0 | 187.4 | 4.0 | 196.4 |
(1)
|
Depreciation from manufacturing plants ($18.4 million) and amortization of favorable manufacturing contracts ($0.9 million) is included in Cost of product sales; depreciation of research and development assets ($7.2 million) is included in Research and development; and all other depreciation and amortization ($101.3 million) is included in Selling, general and administrative.
|
(2)
|
Long-lived assets comprise all non-current assets (excluding goodwill and other intangible assets, deferred tax assets, investments, income tax receivable and financial instruments).
|
·
|
On June 23, 2011 Shire announced that the Pulmonary-Allergy Drugs Advisory Committee to the US Food and Drug Administration (“FDA”) recommended, by a vote of twelve to one, that the efficacy and safety data for FIRAZYR provides substantial evidence to support approval of FIRAZYR for the treatment of acute attacks of HAE in patients 18 years and older. In addition, by a vote of eleven to one, with one abstention, the Committee recommended self-administration of the drug by patients. Shire has been assigned an action date of August 25, 2011 under the Prescription Drug User Fee Act.
|
·
|
On June 24, 2011 Shire announced that the European Medicines Agency has approved the purification of REPLAGAL drug substance at its new manufacturing facility in Lexington, MA. REPLAGAL is the first product that will be made available to patients from the new facility. With this approval, Shire now has two approved facilities for the production of HGT products – Alewife, which is located in Cambridge, MA, and the new Lexington facility. This provides increased manufacturing flexibility for REPLAGAL.
|
·
|
Shire’s continuing priority is to ensure long-term, uninterrupted treatment for patients with Type I Gaucher disease with VPRIV at the approved dose and frequency prescribed by their physician. Shire continues to meet all requested demand for VPRIV globally and continues to supply the product to new patients - either naïve to therapy or those switching from different therapies. Shire can continue to meet all anticipated demand for VPRIV globally. We are working to obtain approval of the new manufacturing facility in Lexington for VPRIV which will provide substantial additional manufacturing capacity. Process validation runs are currently ongoing.
|
·
|
On April 4, 2011, following approval by the FDA on February 28, 2011, Shire launched once-daily INTUNIV extended-release tablets as adjunctive therapy to stimulants for the treatment of ADHD in children and adolescents aged 6 to 17 as part of a total treatment program.
|
·
|
On June 7, 2011 following approval by Health Canada on February 10, 2011, Shire announced the launch of MEZAVANT for the new expanded indication to include maintenance of clinical and endoscopic remission (mucosal healing) in patients with ulcerative colitis. MEZAVANT is the first and only once-daily treatment indicated in Canada for this expanded indication, which was approved following MEZAVANT's demonstrated efficacy and long-term safety profile during maintenance clinical trials of up to 12 months.
|
·
|
On July 14, 2011 the FDA approved LIALDA for the maintenance of remission in patients with ulcerative colitis. This approval is based on results from a six-month study demonstrating the safety and effectiveness of LIALDA in maintaining endoscopic remission in adult patients. This approval follows the previous indication of LIALDA approved by the FDA in 2007 for the induction of remission in patients with active, mild to moderate ulcerative colitis.
|
·
|
On March 21, 2011, prior to acquisition by Shire, ABH filed a Class IV Medical Device Application to Health Canada to seek approval for DERMAGRAFT for the treatment of DFU.
|
·
|
A pivotal Phase 3 clinical trial to assess the efficacy and safety of DERMAGRAFT in treating VLU is ongoing.
|
·
|
An improved lead candidate has been selected for development and a Phase 1 program has been initiated to determine safety and tolerability of this compound. The ongoing Phase 1 program will be supportive of potentially three different CNS-related indications: ADHD, hyperactivity in Autism Spectrum Disorder and Paediatric Anxiety.
|
·
|
On June 28, 2011 Shire announced that it had completed the acquisition of ABH for a cash purchase price of $739 million. A strong strategic fit for Shire, this acquisition combines ABH’s experience and commercial capability in regenerative medicine with Shire’s strengths and expertise in human cell biological manufacturing. It also creates a new strategic platform based on tissue regeneration using cell-based therapies and adds DERMAGRAFT, a leading US marketed product for DFU, to Shire’s portfolio. There are also further growth prospects for DERMAGRAFT through a potential expanded indication for VLU.
|
·
|
In May and June 2011, Shire was notified that six separate Abbreviated New Drug Applications (“ANDAs”) were submitted under the Hatch-Waxman Act seeking permission to market generic versions of all approved strengths of VYVANSE. The notices were from Sandoz; Amneal; Watson Laboratories, Inc.; Roxane; Mylan; and Actavis. Within the requisite 45 day period, Shire filed lawsuits for infringement of certain of Shire’s VYVANSE patents against all the ANDA filers. The filing of the lawsuits triggered a stay of approval of all six ANDAs for up to 30 months.
|
·
|
Product sales were up 30% to $993 million (2010: $764 million) as strong growth continued through the second quarter, assisted in part by favorable foreign exchange. On a Non-GAAP CER(1) basis, product sales were up 26%.
|
·
|
Operating income was up 26% to $283 million (2010: $224 million), due to higher total revenues in the quarter, partially offset by higher operating expenses, as the Company continues to invest in targeted R&D programs and to incur higher SG&A expenditure to support the continued growth and planned product launches.
|
·
|
Diluted earnings per ADS increased by 26% to 108c (2010: 86c), principally due to higher operating income.
|
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 2011 product sales and revenues restated using 2010 average foreign exchange rates to 2010 actual product sales and revenues. Average exchange rates for the three and six months to June 30, 2011 were $1.63:£1.00 and $1.44:€1.00 (2010: $1.49:£1.00 and $1.27:€1.00) and $1.62:£1.00 and $1.40:€1.00 (2010: $1.53:£1.00 and $1.33:€1.00) respectively.
|
|
3 months to
|
3 months to
|
|
|||||||||
|
June 30,
|
June 30,
|
|
|||||||||
|
2011
|
2010
|
change
|
|||||||||
|
$'M
|
$'M
|
%
|
|||||||||
Product sales
|
993.3 | 764.3 | +30 | |||||||||
Royalties
|
63.4 | 82.7 | -23 | |||||||||
Other revenues
|
6.2 | 2.4 | +158 | |||||||||
Total
|
1,062.9 | 849.4 | +25 |
|
3 months to
|
3 months to
|
|
|
||||||||||||||||||||
|
June 30,
|
June 30,
|
Product sales
|
Non-GAAP
|
US prescription
|
Exit market
|
||||||||||||||||||
|
2011
|
2010
|
growth
|
CER growth
|
growth1
|
share1
|
||||||||||||||||||
|
$'M
|
$'M
|
%
|
%
|
%
|
%
|
||||||||||||||||||
SP
|
|
|
|
|
||||||||||||||||||||
ADHD
|
|
|
|
|
||||||||||||||||||||
VYVANSE
|
185.9 | 148.0 | +26 | +25 | +21 | 15 | ||||||||||||||||||
ADDERALL XR
|
146.9 | 80.4 | +83 | +82 | +16 | 8 | ||||||||||||||||||
INTUNIV
|
59.6 | 51.2 | +16 | +16 | +88 | 4 | ||||||||||||||||||
EQUASYM
|
5.9 | 8.2 | -28 | -36 | n/a | n/a | 3 | |||||||||||||||||
DAYTRANA
|
- | 16.3 | n/a | n/a | n/a | n/a | ||||||||||||||||||
|
||||||||||||||||||||||||
Gastrointestinal ("GI")
|
||||||||||||||||||||||||
LIALDA / MEZAVANT
|
99.2 | 69.6 | +43 | +41 | +8 | 20 | ||||||||||||||||||
PENTASA
|
65.8 | 60.6 | +9 | +9 | -3 | 15 | ||||||||||||||||||
RESOLOR
|
1.6 | - | n/a | n/a | n/a | 3 | n/a | 3 | ||||||||||||||||
|
||||||||||||||||||||||||
Regenerative Medicine
|
||||||||||||||||||||||||
DERMAGRAFT
|
2.0 | - | n/a | n/a | n/a | 2 | n/a | 2 | ||||||||||||||||
|
||||||||||||||||||||||||
General Products
|
||||||||||||||||||||||||
FOSRENOL
|
45.3 | 45.1 | - | -5 | -13 | 6 | ||||||||||||||||||
XAGRID
|
23.2 | 21.6 | +7 | -4 | n/a | n/a | 2 | |||||||||||||||||
CARBATROL
|
16.7 | 23.0 | -27 | -27 | -17 | 10 | ||||||||||||||||||
Other product sales
|
24.6 | 27.3 | -10 | -17 | n/a | n/a | ||||||||||||||||||
|
676.7 | 551.3 | +23 | |||||||||||||||||||||
HGT
|
||||||||||||||||||||||||
ELAPRASE
|
127.8 | 99.8 | +28 | +20 | n/a | 2 | n/a | 2 | ||||||||||||||||
REPLAGAL
|
119.9 | 81.9 | +46 | +32 | n/a | 3 | n/a | 3 | ||||||||||||||||
VPRIV
|
63.3 | 28.7 | +121 | +110 | n/a | 2 | n/a | 2 | ||||||||||||||||
FIRAZYR
|
5.6 | 2.6 | +115 | +89 | n/a | 3 | n/a | 3 | ||||||||||||||||
|
316.6 | 213.0 | +49 | |||||||||||||||||||||
Total product sales
|
993.3 | 764.3 | +30 |
(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 June 30, 2011.
|
(2)
|
IMS NPA Data not available.
|
(3)
|
Not sold in the US in the second quarter of 2011.
|
|
3 months to
|
3 months to
|
|
|||||||||
|
June 30,
|
June 30,
|
|
|||||||||
|
2011
|
2010
|
Change
|
|||||||||
|
$'M
|
$'M
|
%
|
|||||||||
ADDERALL XR
|
26.9 | 27.5 | -2 | |||||||||
FOSRENOL
|
12.4 | 6.0 | +107 | |||||||||
3TC and ZEFFIX
|
11.3 | 38.1 | -70 | |||||||||
Others
|
12.8 | 11.1 | +15 | |||||||||
Total
|
63.4 | 82.7 | -23 |
|
6 months to
|
6 months to
|
|
|||||||||
|
June 30,
|
June 30,
|
|
|||||||||
|
2011
|
2010
|
change
|
|||||||||
|
$'M
|
$'M
|
%
|
|||||||||
Product sales
|
1,882.6 | 1,482.4 | +27 | |||||||||
Royalties
|
137.0 | 178.0 | -23 | |||||||||
Other revenues
|
15.5 | 5.1 | +204 | |||||||||
Total
|
2,035.1 | 1,665.5 | +22 |
|
6 months to
|
6 months to
|
|
|
||||||||||||||||||||
|
June 30,
|
June 30,
|
Product sales
|
Non-GAAP CER
|
US prescription
|
Exit market
|
||||||||||||||||||
|
2011
|
2010
|
growth
|
growth
|
growth1
|
share1
|
||||||||||||||||||
|
$'M
|
$'M
|
%
|
%
|
%
|
%
|
||||||||||||||||||
Specialty Pharmaceuticals
|
|
|
|
|
||||||||||||||||||||
ADHD
|
|
|
|
|
||||||||||||||||||||
VYVANSE
|
388.2 | 302.4 | +28 | +28 | +22 | 15 | ||||||||||||||||||
ADDERALL XR
|
258.1 | 172.2 | +50 | +49 | +14 | 8 | ||||||||||||||||||
INTUNIV
|
101.5 | 85.7 | +18 | +18 | +114 | 4 | ||||||||||||||||||
EQUASYM
|
10.5 | 10.6 | -1 | -7 | n/a | n/a | 3 | |||||||||||||||||
DAYTRANA
|
- | 34.7 | n/a | n/a | n/a | n/a | ||||||||||||||||||
|
||||||||||||||||||||||||
GI
|
||||||||||||||||||||||||
LIALDA / MEZAVANT
|
186.3 | 133.2 | +40 | +39 | +10 | 20 | ||||||||||||||||||
PENTASA
|
130.3 | 118.8 | +10 | +10 | -2 | 15 | ||||||||||||||||||
RESOLOR
|
2.5 | - | n/a | n/a | n/a | n/a | 3 | |||||||||||||||||
|
||||||||||||||||||||||||
Regenerative Medicine
|
||||||||||||||||||||||||
DERMAGRAFT
|
2.0 | - | n/a | n/a | n/a | 2 | n/a | 2 | ||||||||||||||||
|
||||||||||||||||||||||||
General Products
|
||||||||||||||||||||||||
FOSRENOL
|
86.5 | 92.1 | -6 | -9 | -13 | 6 | ||||||||||||||||||
XAGRID
|
45.9 | 45.0 | +2 | -4 | n/a | n/a | 2 | |||||||||||||||||
CARBATROL
|
33.3 | 43.1 | -23 | -23 | -13 | 10 | ||||||||||||||||||
Other product sales
|
47.7 | 54.8 | -13 | -18 | n/a | n/a | ||||||||||||||||||
|
1,292.8 | 1,092.6 | +18 | |||||||||||||||||||||
Human Genetic Therapies
|
||||||||||||||||||||||||
ELAPRASE
|
231.3 | 200.6 | +15 | +11 | n/a | 2 | n/a | 2 | ||||||||||||||||
REPLAGAL
|
225.3 | 149.9 | +50 | +42 | n/a | 3 | n/a | 3 | ||||||||||||||||
VPRIV
|
122.3 | 34.5 | +254 | +246 | n/a | 2 | n/a | 2 | ||||||||||||||||
FIRAZYR
|
10.9 | 4.8 | +127 | +111 | n/a | 3 | n/a | 3 | ||||||||||||||||
|
589.8 | 389.8 | +51 | |||||||||||||||||||||
Total product sales
|
1,882.6 | 1,482.4 | +27 |
(1)
|
Data provided by IMS NPA. Exit market share represents the average monthly US market share in the month ended June 30, 2011.
|
(2)
|
IMS NPA Data not available.
|
(3)
|
Not sold in the US in the six months to June 30, 2011.
|
|
6 months to
|
6 months to
|
|
|||||||||
|
June 30,
|
June 30,
|
|
|||||||||
|
2011
|
2010
|
Change
|
|||||||||
|
$'M
|
$'M
|
%
|
|||||||||
3TC and ZEFFIX
|
46.8 | 74.7 | -37 | |||||||||
ADDERALL XR
|
43.7 | 68.3 | -36 | |||||||||
FOSRENOL
|
20.5 | 11.1 | +85 | |||||||||
Other
|
26.0 | 23.9 | +9 | |||||||||
Total
|
137.0 | 178.0 | -23 |
|
June 30,
|
December 31,
|
||||||
|
2011
|
2010
|
||||||
|
$’M | $’M | ||||||
Cash and cash equivalents (1)
|
144.6 | 550.6 | ||||||
Convertible debt
|
1,100.0 | 1,100.0 | ||||||
RCF
|
30.0 | - | ||||||
Building financing obligation
|
8.4 | 8.4 | ||||||
Total debt
|
1,138.4 | 1,108.4 | ||||||
Net debt
|
(993.8 | ) | (557.8 | ) |
(1)
|
Substantially all of the Company’s cash and cash equivalents are held by foreign subsidiaries (i.e. those subsidiaries incorporated outside of Jersey, Channel Islands, the jurisdiction of incorporation of Shire plc, Shire’s holding company). The amount of cash and cash equivalents held by foreign subsidiaries has not had, and is not expected to have, a material impact on the Company’s liquidity and capital resources.
|
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.
|
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. (4)
|
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. (5)
|
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. (6)
|
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.(7)
|
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. (8)
|
4.03
|
Form of Ordinary Share Certificate of Shire Limited. (9)
|
4.04
|
Form of American Depositary Receipt Certificate of Shire Limited. (10)
|
4.05
|
Trust Deed for the New Shire Income Access Trust, dated August 29, 2008. (11)
|
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. (12)
|
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. (13)
|
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). (14)
|
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. (15)
|
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. (16)
|
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. (17)
|
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. (18)
|
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. (19)
|
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. (20)
|
10.10*
|
Settlement Agreement, dated August 14, 2006 by and between Shire Laboratories Inc. and Barr. (21)
|
10.11*
|
Product Development and License Agreement, dated August 14, 2006 by and between Shire LLC and Duramed Pharmaceuticals, Inc. (22)
|
10.12*
|
Product Acquisition and License Agreement, dated August 14, 2006 by and among Shire LLC, Shire plc and Duramed Pharmaceuticals, Inc. (23)
|
10.13
|
Service Agreement between Shire plc and Mr Angus Russell, dated March 10, 2004. (24)
|
10.14
|
Novation Agreement dated November 21, 2005 relating to the Employment Agreement of Angus Russell dated March 10, 2004. (25)
|
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. (26)
|
10.16
|
Form of Amended and Restated Employment Agreement between Shire plc and Mr Matthew Emmens, dated March 12, 2004. (27)
|
10.17
|
Amendment Agreement dated November 21, 2005 relating to the Amended and Restated Employment Agreement of Matthew Emmens dated March 12, 2004. (28)
|
10.18
|
Ratification and Guaranty dated November 21, 2005 relating to the Amended and Restated Employment Agreement of Matthew Emmens dated March 12, 2004. (29)
|
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. (30)
|
10.20
|
Ratification and Guaranty dated May 20, 2008 relating to the Amended and Restated Employment Agreement of Matthew Emmens dated March 12, 2004. (31)
|
10.21
|
Form of Indemnity Agreement for Directors of Shire Limited. (32)
|
10.22
|
Service Agreement between Shire Limited and Mr Angus Russell, dated July 2, 2008. (33)
|
10.23
|
Service Agreement between Shire Limited and Mr Graham Hetherington, dated July 2, 2008. (34)
|
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. (35)
|
10.25
|
Amended Agreement dated February 24, 2009 relating to the Product Development and License Agreement dated August 14, 2006. (36)
|
10.26
|
Amendment of the Service Agreement of A.C Russell dated January 15, 2010. (37)
|
10.27
|
Amendment to the Shire Portfolio Share Plan as approved by the Annual General meeting held on April 27, 2010. (38)
|
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.
|
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.
|
101.INS
|
|
XBRL Instance Document
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
101.DEF
|
|
XBRL Taxonomy Definition Linkbase Document
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
*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 2.1 to Shire’s Form 8-K filed on July 1, 2011.
|
(5)
|
Incorporated by reference to Exhibit 99.02 to Shire’s Form 8-K filed on October 1, 2008.
|
(6)
|
Incorporated by reference to Exhibit 99.02 to Shire’s Form 8-K filed on April 29, 2011.
|
(7)
|
Incorporated by reference to Exhibit 4.01 to Shire’s Form 8-K filed on May 23, 2008.
|
(8)
|
Incorporated by reference to Exhibit 4.02 to Shire’s Form 8-K filed on May 23, 2008.
|
(9)
|
Incorporated by reference to Exhibit 4.03 to Shire’s Form 8-K filed on May 23, 2008.
|
(10)
|
Incorporated by reference to Exhibit 4.04 to Shire’s Form 8-K filed on May 23, 2008.
|
(11)
|
Incorporated by reference to Exhibit 4.05 to Shire’s Form 10-K filed on February 27, 2009.
|
(12)
|
Incorporated by reference to Exhibit 99.1 to Shire’s Form 8-K filed on February 23, 2007.
|
(13)
|
Incorporated by reference to Exhibit 10.2 to Shire’s Form 10-Q filed on May 1, 2007.
|
(14)
|
Incorporated by reference to Exhibit 10.01 to Shire’s Form 8-K filed on May 23, 2008.
|
(15)
|
Incorporated by reference to Exhibit 10.1 to Shire’s Form 10-Q filed on August 2, 2007.
|
(16)
|
Incorporated by reference to Exhibit 10.2 to Shire’s Form 10-Q filed on August 2, 2007.
|
(17)
|
Incorporated by reference to Exhibit 10.3 to Shire’s Form 10-Q filed on August 2, 2007.
|
(18)
|
Incorporated by reference to Exhibit 10.02 to Shire’s Form 8-K filed on May 23, 2008.
|
(19)
|
Incorporated by reference to Exhibit 10.03 to Shire’s Form 8-K filed on May 23, 2008.
|
(20)
|
Incorporated by reference to Exhibit 10.09 to Shire’s Form 10-K/A filed on May 30, 2008.
|
(21)
|
Incorporated by reference to Exhibit 10.1 to Shire’s Form 10-Q filed on November 7, 2006.
|
(22)
|
Incorporated by reference to Exhibit 10.2 to Shire’s Form 10-Q filed on November 7, 2006.
|
(23)
|
Incorporated by reference to Exhibit 10.3 to Shire’s Form 10-Q filed on November 7, 2006.
|
(24)
|
Incorporated by reference to Exhibit 10.11 to Shire’s Form 10-K filed on March 12, 2004.
|
(25)
|
Incorporated by reference to Exhibit 10.03 to Shire’s Form 8-K filed on November 25, 2005.
|
(26)
|
Incorporated by reference to Exhibit 10.06 to Shire’s Form 8-K filed on May 23, 2008.
|
(27)
|
Incorporated by reference to Exhibit 10.13 to Shire’s Form 10-K filed on March 12, 2004.
|
(28)
|
Incorporated by reference to Exhibit 10.01 to Shire’s Form 8-K filed on November 25, 2005.
|
(29)
|
Incorporated by reference to Exhibit 10.02 to Shire’s Form 8-K filed on November 25, 2005.
|
(30)
|
Incorporated by reference to Exhibit 10.04 to Shire’s Form 8-K filed on May 23, 2008.
|
(31)
|
Incorporated by reference to Exhibit 10.05 to Shire’s Form 8-K filed on May 23, 2008.
|
(32)
|
Incorporated by reference to Exhibit 10.07 to Shire’s Form 8-K filed on May 23, 2008.
|
(33)
|
Incorporated by reference to Exhibit 10.22 to Shire’s Form 10-Q filed on November 10, 2008.
|
(34)
|
Incorporated by reference to Exhibit 10.23 to Shire’s Form 10-Q filed on November 10, 2008.
|
(35)
|
Incorporated by reference to Exhibit 10.24 to Shire’s Form 10-Q filed on November 10, 2008.
|
(36)
|
Incorporated by reference to Exhibit 10.25 to Shire’s Form 10-Q filed on May 7, 2009.
|
(37)
|
Incorporated by reference to Exhibit 10.26 to Shire’s Form 10-K filed on February 26, 2010.
|
(38)
|
Incorporated by reference to Exhibit 10.27 to Shire's Form 10-Q filed on May 6, 2010.
|
/s/ Angus Russell
|
||
Date: August 8, 2011
|
Angus Russell
Chief Executive Officer
|
|
/s/ Graham Hetherington
|
||
Date: August 8, 2011
|
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
|
|
Prepaid Expenses and Other Current Assets (Details) (USD $)
In Millions |
Jun. 30, 2011
|
Dec. 31, 2010
|
---|---|---|
Prepaid Expenses and Other Current Assets Disclosure [Abstract] | ||
Prepaid Expenses | $ 41.9 | $ 45.1 |
Income Tax Receivable | 71.3 | 42.4 |
Value Added Taxes Receivable | 20.9 | 21.5 |
Other Assets, Current | 64.5 | 59.4 |
Prepaid Expense and Other Assets, Current | $ 198.6 | $ 168.4 |
Consolidated Balance Sheets (Parenthetical)
In Millions, except Per Share data |
Jun. 30, 2011
GBP (£)
|
Dec. 31, 2010
GBP (£)
|
---|---|---|
Consolidated Balance Sheets | ||
Common Stock, Par Value | £ 0.05 | £ 0.05 |
Common Stock, Shares Authorized | 1,000.0 | 1,000.0 |
Common stock, Shares Issued | 562.3 | 562.2 |
Common Stock, Shares, Outstanding | 562.3 | 562.2 |
Treasury Stock, Shares | 11.5 | 14.0 |
Consolidated Statements of Income (USD $)
In Millions, except Per Share data |
3 Months Ended | 6 Months Ended | ||||||
---|---|---|---|---|---|---|---|---|
Jun. 30, 2011
|
Jun. 30, 2010
|
Jun. 30, 2011
|
Jun. 30, 2010
|
|||||
Revenues: | ||||||||
Product sales | $ 993.3 | $ 764.3 | $ 1,882.6 | $ 1,482.4 | ||||
Royalties | 63.4 | 82.7 | 137.0 | 178.0 | ||||
Other revenues | 6.2 | 2.4 | 15.5 | 5.1 | ||||
Total revenues | 1,062.9 | 849.4 | 2,035.1 | 1,665.5 | ||||
Costs and Expenses: | ||||||||
Cost of product sales | 143.7 | [1] | 119.1 | [1] | 268.2 | 221.0 | ||
Research and development | 176.9 | 147.0 | 354.8 | 278.0 | ||||
Selling, general and administrative | 440.3 | [1] | 354.4 | [1] | 843.2 | 714.3 | ||
Loss/(gain) on sale of product rights | 2.2 | (4.1) | 3.5 | (4.1) | ||||
Reorganization costs | 7.5 | 8.6 | 13.0 | 13.6 | ||||
Integration and acquisition costs | 9.0 | 0 | 2.6 | 0.6 | ||||
Total operating expenses | 779.6 | 625.0 | 1,485.3 | 1,223.4 | ||||
Operating income | 283.3 | 224.4 | 549.8 | 442.1 | ||||
Interest income | 0.6 | 0.5 | 1.2 | 0.8 | ||||
Interest expense | (9.9) | (8.3) | (19.1) | (17.3) | ||||
Other (expense)/income, net | 0 | (2.6) | 0.3 | 8.2 | ||||
Total other expense, net | (9.3) | (10.4) | (17.6) | (8.3) | ||||
Income before income taxes and equity in earnings of equity method investees | 274.0 | 214.0 | 532.2 | 433.8 | ||||
Income taxes | (69.7) | (54.5) | (117.8) | (108.1) | ||||
Equity in earnings of equity method investees, net of taxes | 1.2 | 1.0 | 2.4 | 0.5 | ||||
Net income | 205.5 | 160.5 | 416.8 | 326.2 | ||||
Net income attributable to Shire plc | 205.5 | 160.5 | 416.8 | 326.2 | ||||
Earning per ordinary share - basic | ||||||||
Earnings per ordinary share - basic | $ 0.372 | $ 0.294 | $ 0.757 | $ 0.598 | ||||
Earnings per ordinary share - diluted | ||||||||
Earnings per ordinary share - diluted | $ 0.359 | $ 0.286 | $ 0.729 | $ 0.582 | ||||
Weighted average number of shares (millions): | ||||||||
Basic | 552.3 | 546.6 | 551.1 | 545.7 | ||||
Diluted | 595.1 | 590.0 | 594.8 | 589.1 | ||||
Amounts attributable to Shire plc | ||||||||
Net income attributable to Shire plc | $ 205.5 | $ 160.5 | $ 416.8 | $ 326.2 | ||||
|
Commitments and Contingencies
|
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2011
|
|||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies Disclosure | 13. Commitments and contingencies
(a) Leases
Future minimum lease payments under operating leases at June 30, 2011 are presented below:
The Company leases land, facilities, motor vehicles and certain equipment under operating leases expiring through 2021. Lease and rental expense amounted to $17.7 million and $16.6 million for the six months to June 30, 2011 and 2010 respectively, which is predominately included in selling, general and administrative (“SG&A”) expenses in the Consolidated Statements of Income.
(b) Letters of credit and guarantees
At June 30, 2011 the Company had irrevocable standby letters of credit and guarantees with various banks totaling $30.4 million, providing security for the Company's performance of various obligations. These obligations are primarily in respect of the recoverability of insurance claims, lease obligations and supply commitments. The Company has restricted cash of $9.2 million, as required by these letters of credit.
(c) Collaborative arrangements
Details of significant updates in collaborative arrangements in the six months to June 30, 2011 are included below:
In-licensing arrangements
JUVISTA On June 19, 2007 Shire signed an agreement with Renovo Limited (“Renovo”) to develop and commercialize JUVISTA. On February 11, 2011, Renovo announced its Phase 3 trial for JUVISTA in scar revision surgery did not meet its primary or secondary endpoints. On March 2, 2011, Shire terminated its agreement with Renovo.
Out-licensing arrangements
Shire has entered into various collaborative arrangements under which the Company has out-licensed certain product or intellectual property rights for consideration such as up-front payments, development milestones, sales milestones and/or royalty payments. In certain of these arrangements Shire and the licensee are both actively involved in the development and commercialization of the licensed product and have exposure to risks and rewards dependent on its commercial success. In the six months to June 30, 2011 Shire received milestone payments totaling $6.8 million (2010: $nil). In the six months to June 30, 2011 Shire recognized milestone income of $8.6 million (2010: $4.3 million) within other revenues and $27.6 million (2010: $22.8 million) within product sales for shipment of product to the relevant licensee.
(d) Commitments
(i) Clinical testing
At June 30, 2011 the Company had committed to pay approximately $273.8 million (December 31, 2010: $156.2 million) to contract vendors for administering and executing clinical trials. The timing of these payments is dependent upon actual services performed by the organizations as determined by patient enrollment levels and related activities.
(ii) Contract manufacturing
At June 30, 2011 the Company had committed to pay approximately $117.2 million (December 31, 2010: $108.6 million) in respect of contract manufacturing. The Company expects to pay $67.2 million of these commitments in 2011.
(iii) Other purchasing commitments
At June 30, 2011 the Company had committed to pay approximately $150.6 million (December 31, 2010: $104.1 million) for future purchases of goods and services, predominantly relating to active pharmaceutical ingredients sourcing. The Company expects to pay $141.8 million of these commitments in 2011.
(iv) Investment commitments
At June 30, 2011 the Company had outstanding commitments to subscribe for interests in companies and partnerships for amounts totaling $8.3 million (December 31, 2010: $5.7 million) which may all be payable in 2011, depending on the timing of capital calls.
(v) Capital commitments
At June 30, 2011 the Company had committed to spend $76.0 million (December 31, 2010: $76.0 million) on capital projects. This includes commitments for the expansion and modification of its offices and manufacturing facilities at the HGT campus in Lexington, Massachusetts.
(e) Legal and other proceedings
General
The Company recognizes loss contingency provisions for probable losses when management is able to reasonably estimate the loss. Where the estimated loss lies within a range the Company records a loss contingency provision based on its best estimate of the probable loss. Where no particular amount within that range is a better estimate than any other amount, the minimum amount is recorded. These estimates are often developed substantially before the ultimate loss is known, so estimates are refined each accounting period, as additional information becomes known. In instances where the Company is unable to develop a reasonable estimate of loss, no litigation loss is recorded at that time. As information becomes known a loss provision is set up when a reasonable estimate can be made. The estimates are reviewed quarterly and the estimates are changed when expectations are revised. Any outcome upon settlement that deviates from the Company's estimate may result in an additional expense or release in a future accounting period. At June 30, 2011 provisions for litigation losses, insurance claims and other disputes totaled $43.4 million (December 31, 2010: $33.8 million).
Specific
VYVANSE In May and June 2011, Shire was notified that six separate Abbreviated New Drug Applications (“ANDAs”) were submitted under the Hatch-Waxman Act seeking permission to market generic versions of all approved strengths of VYVANSE. The notices were from Sandoz, Inc. (“Sandoz”); Amneal Pharmaceuticals LLC (“Amneal”); Watson Laboratories, Inc.; Roxane Laboratories, Inc. (“Roxane”); Mylan Pharmaceuticals, Inc.; and Actavis Elizabeth LLC and Actavis Inc. (collectively, “Actavis”). Within the requisite 45 day period, Shire filed lawsuits for infringement of certain of Shire's VYVANSE patents in the US District Court for the District of New Jersey against each of Sandoz, Roxane, Amneal and Actavis; in the US District Court for the Central District of California against Watson Laboratories, Inc.; and in the US District Court for the Eastern District of New York against Mylan Pharmaceuticals, Inc. and Mylan Inc. (collectively “Mylan”). The filing of the lawsuits triggered a stay of approval of all six ANDAs for up to 30 months. INTUNIV In March and April 2010, Shire was notified that three separate ANDAs were submitted under the Hatch-Waxman Act seeking permission to market generic versions of all approved strengths of INTUNIV. The notices were from Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd (collectively, “Teva”); Actavis; and Anchen Pharmaceuticals, Inc. and Anchen, Inc. (collectively, "Anchen"). Within the requisite 45 day period, Shire filed lawsuits in the US District Court for the District of Delaware against each of Teva, Actavis and Anchen for infringement of certain of Shire's INTUNIV patents. The filing of the lawsuits triggered a stay of approval of these ANDAs for up to 30 months. These lawsuits have been consolidated. The previously scheduled Markman hearing was cancelled by the Court and has not been rescheduled. No trial date has been set. In October 2010, Shire was notified that two separate ANDAs were submitted under the Hatch-Waxman Act seeking permission to market generic versions of the 4mg strength of INTUNIV. The notices were from Watson Pharmaceuticals, Inc. and from Impax Laboratories, Inc. (“Impax”). Shire was subsequently advised that Impax amended its ANDA to include the 1mg, 2mg and 3mg strengths of INTUNIV. Within the requisite 45 day period, Shire filed a lawsuit in the US District Court for the Northern District of California against each of Watson Pharmaceuticals, Inc., Watson Laboratories, Inc.-Florida, Watson Pharma, Inc., ANDA, Inc. (collectively “Watson”) and Impax for infringement of certain of Shire's INTUNIV patents. The filing of the lawsuit triggered a stay of approval of these ANDAs for up to 30 months. A Markman hearing has been scheduled for May 2, 2012. No trial date has been set. In February 2011, Shire was notified that Mylan Pharmaceuticals, Inc had submitted an ANDA under the Hatch-Waxman Act seeking permission to market a generic version of the 4mg strength of INTUNIV. Within the requisite 45 day period, Shire filed a lawsuit in the US District Court for the Southern District of New York against Mylan for infringement of certain of Shire's INTUNIV patents. In April 2011, Shire filed a lawsuit against Mylan in the US District Court for the District of West Virginia for infringement of certain of Shire's INTUNIV patents and dismissed the lawsuit in the Southern District of New York. The filing of the lawsuit in West Virginia did not trigger a stay of approval of this ANDA. A Markman hearing has been scheduled for June 7, 2012. A trial is scheduled to start on September 16, 2013. In March 2011, Shire was notified that Sandoz had submitted an ANDA under the Hatch-Waxman Act seeking permission to market a generic version of the 4mg strength of INTUNIV. Within the requisite 45 day period, Shire filed a lawsuit in the US District Court for the District of Colorado against Sandoz for infringement of certain of Shire's INTUNIV patents. The filing of the lawsuit triggered a stay of approval of this ANDA for up to 30 months. No trial date has been set.
REPLAGAL Mt. Sinai School of Medicine of New York University (“Mt. Sinai”) initiated lawsuits against Shire in Sweden on April 14, 2010 and in Germany on April 20, 2010 alleging that Shire's enzyme replacement therapy (“ERT”) for Fabry disease, REPLAGAL, infringes Mt. Sinai's European Patent No. 1 942 189, granted April 14, 2010. Mt. Sinai sought injunctions against the use of REPLAGAL in these jurisdictions until expiration of the patent. Mt. Sinai has been granted Supplementary Protection Certificates (“SPC”) in respect of the patent in certain EU countries (including Sweden and Germany) which, where granted, extends the patent until August 2016. Where no SPC has been granted, the patent expires November 2013. Shire filed an opposition against Mt. Sinai's patent before the European Patent Office (“EPO”) on July 23, 2010 and commenced invalidity proceedings in the UK on December 8, 2010. Mt. Sinai has counterclaimed alleging infringement in the UK proceedings. A hearing date has not been set for the EPO opposition or Swedish law suit. The UK hearing date is scheduled for May 2012.
On January 18, 2011 the German Court found that REPLAGAL infringes Mt. Sinai's patent, and granted Mt Sinai's request for an injunction. Shire has appealed this decision, but no hearing date has been set. As a result of the supply shortage for the only other ERT for Fabry Disease, Mt. Sinai had undertaken not to enforce the injunction in Germany prior to September 30, 2011 and on June 30, 2011, as a result of the on-going supply shortage of the other ERT, Mt. Sinai has extended its undertaking until December 31, 2011.
FOSRENOL
In February 2009 Shire was notified that three separate ANDAs were submitted under the Hatch-Waxman Act seeking permission to market generic versions of all approved strengths of FOSRENOL. The notices were received from Barr Laboratories, Inc. (“Barr”); Mylan, Inc., Mylan Pharmaceuticals, Inc. and Matrix Laboratories, Inc. (collectively, “Mylan-Matrix”); and Natco Pharma Limited (“Natco”). Within the requisite 45 day period, Shire filed lawsuits in the US District Court for the Southern District of New York against each of Barr, Mylan-Matrix and Natco for infringement of certain of Shire's FOSRENOL patents. A Markman hearing was held on June 17, 2010. In April 2011, Shire and Barr reached a settlement which provides Barr with a license to market its own generic version of FOSRENOL in the US but only after October 1, 2021, or earlier under certain circumstances. No payments to Barr are involved with the settlement. As a result of the settlement, the lawsuit against Barr was subsequently dismissed. The lawsuit against Mylan-Matrix has been dismissed, and consequently, Mylan-Matrix may enter the market upon FDA approval of its version of generic FOSRENOL. No trial date has been set with respect to Natco and a stay of approval of up to 30 months remains in effect.
In December 2010, Shire was notified that an ANDA was submitted under the Hatch-Waxman Act seeking permission to market generic versions of all approved strengths of FOSRENOL. The notice was from Alkem Laboratories Ltd. (“Alkem”). Within the requisite 45 day period, Shire filed lawsuits in both the US District Court for the Southern District of New York and the US District Court for the Northern District of Illinois against Alkem for infringement of certain of Shire's FOSRENOL patents. The filing of the lawsuits triggered a stay of approval of this ANDA for up to 30 months. No trial date has been set.
LIALDA
In May 2010 Shire was notified that an ANDA was submitted under the Hatch-Waxman Act seeking permission to market a generic version of LIALDA. The notice was received from Zydus Pharmaceuticals USA, Inc. (“Zydus”). Within the requisite 45 day period, Shire filed a lawsuit in the US District Court for the District of Delaware against Zydus and Cadila Healthcare Limited, doing business as Zydus Cadila. The filing of the lawsuit triggered a stay of approval of the ANDA for up to 30 months. A Markman hearing is scheduled for April 26, 2012. A trial is scheduled for October 8, 2012. ADDERALL XR On November 1, 2010 Impax filed suit against Shire in the US District Court for the Southern District of New York claiming that Shire is in breach of its supply contract for the authorized generic version of ADDERALL XR. Shire's ability to supply this product is limited by quota restrictions that the US Drug Enforcement Administration places on amphetamine, which is the product's active ingredient. Impax is seeking specific performance, equitable relief and damages. Shire has filed a counterclaim against Impax seeking damages and a declaratory judgment that Shire has satisfied its obligations under the supply contract. A trial is scheduled for January 9, 2012. In February 2011, Shire was notified that an ANDA was submitted under the Hatch-Waxman Act seeking permission to market a generic version of all approved strengths of ADDERALL XR. The notice was received from Watson Laboratories, Inc. (“Watson Laboratories”). This new ANDA is not covered under the existing settlement agreements entered into in November 2007 between Shire and Watson Pharmaceuticals, Inc (the “Settlement Agreements”). The Settlement Agreements cover a different ANDA and do not provide any license for Watson Laboratories to sell the products covered in Watson Laboratories' new ANDA. Within the requisite 45 day period, Shire filed a lawsuit in the U.S. District Court for the Southern District of New York against Watson Pharmaceuticals, Inc., Watson Laboratories, Inc.-Florida, Watson Pharm, Inc., Andrx Corporation, and Andrx Pharmaceuticals, L.L.C. for infringement of certain of Shire's ADDERALL XR patents and also for breach of contract in connection with the Settlement Agreements. The filing of the lawsuit triggered a stay of approval of this ANDA for up to 30 months. No trial date has been set.
Subpoena related to ADDERALL XR, DAYTRANA and VYVANSE
On September 23, 2009 the Company received a civil subpoena from the US Department of Health and Human Services Office of Inspector General in coordination with the US Attorney for the Eastern District of Pennsylvania seeking production of documents related to the sales and marketing of ADDERALL XR, DAYTRANA and VYVANSE. The investigation covers whether Shire engaged in off-label promotion and other conduct that may implicate the civil False Claims Act. Shire is cooperating fully with this investigation. At this time, Shire is unable to predict the outcome or duration of this investigation.
|
Document and Entity Information (USD $)
In Millions, except Share data |
6 Months Ended | |
---|---|---|
Jun. 30, 2011
|
Jul. 29, 2011
|
|
Document And Entity Information Abstract | ||
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2011 | |
Document Fiscal Year Focus | 2011 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false | |
Entity Registrant Name | Shire plc | |
Entity Central Index Key | 0000936402 | |
Entity Current Reporting Status | Yes | |
Entity Voluntary Filers | No | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Well Known Seasoned Issuer | Yes | |
Entity Common Stock Shares Outstanding | 562,367,582 | |
Entity Public Float | $ 17,197.0 |
Accounts Receivable, Net (Details) (USD $)
In Millions |
6 Months Ended | ||
---|---|---|---|
Jun. 30, 2011
|
Jun. 30, 2010
|
Dec. 31, 2010
|
|
Account Receivable Disclosure [Abstract] | |||
Accounts Receivable | $ 797.2 | $ 692.5 | |
Provision for Discounts and Doubtful Accounts | 28.8 | 22.8 | |
Royalty Income Receivable | 63.4 | 75.8 | |
Provision for Discounts and Doubtful Accounts [Roll Forward] | |||
Provision for Discounts and Doubtful Accounts, Beginning Balance | 23.4 | 20.8 | |
Provision for Discounts and Doubtful Accounts, Period Expense | 114.8 | 85.2 | |
Provision for Discounts and Doubtful Accounts, Utilization | (109.4) | (83.2) | |
Provision for Discounts and Doubtful Accounts, Ending Balance | $ 28.8 | $ 22.8 |
Earnings Per Share
|
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2011
|
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Earnings Per Share [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share | 16. Earnings per share
The following table reconciles net income and the weighted average ordinary shares outstanding for basic and diluted earnings per share for the periods presented:
(1) Excludes shares purchased by the ESOT and presented by the Company as treasury stock. (2) Calculated using the treasury stock method. (3) Calculated using the 'if-converted' method.
The share equivalents not included in the calculation of the diluted weighted average number of shares are shown below:
(1) Certain stock options have been excluded from the calculation of diluted EPS because (a) their exercise prices exceeded Shire plc's average share price during the calculation period or (b) satisfaction of the required performance/market conditions cannot be measured until the conclusion of the performance period. .
|
Reorganization Costs (Details) (USD $)
In Millions |
3 Months Ended | 6 Months Ended | 27 Months Ended | 6 Months Ended | 16 Months Ended | 6 Months Ended | |||||
---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2011
|
Jun. 30, 2010
|
Jun. 30, 2011
|
Jun. 30, 2010
|
Jun. 30, 2011
Specialty Pharmaceuticals
Owings Mills
|
Jun. 30, 2011
Specialty Pharmaceuticals
Owings Mills
|
Jun. 30, 2011
International Commercial Hub
|
Jun. 30, 2011
International Commercial Hub
|
Jun. 30, 2011
One-time Termination Benefits
|
Jun. 30, 2011
Contract Termination
|
Jun. 30, 2011
Other Reorganization
|
|
Restructuring And Related Cost [Line Items] | |||||||||||
Reorganization Cost | $ 7.5 | $ 8.6 | $ 13.0 | $ 13.6 | $ 5.0 | $ 8.0 | |||||
Reorganization Cost, Cost Incurred to Date | 30.7 | 29.3 | |||||||||
Accelerated Depreciation, Property, Plant and Equipment | 4.4 | ||||||||||
Restructuring Reserve [Roll Forward] | |||||||||||
Restructuring Reserve, Beginning Balance | 12.4 | 10.1 | 0 | 2.3 | |||||||
Restructuring Reserve, Period Expense | 13.0 | 5.9 | 0 | 7.1 | |||||||
Restructuring Reserve, Paid and Utilized | (12.8) | (3.7) | 0 | (9.1) | |||||||
Restructuring Reserve, Ending Balance | $ 12.6 | $ 12.6 | $ 12.3 | $ 0 | $ 0.3 |
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Business Combinations
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Jun. 30, 2011
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Business Combination Disclosure | 2. Business combinations
Acquisition of Advanced BioHealing, Inc (“ABH”)
On May 17, 2011 the Company announced that it had entered into an Agreement and Plan of Merger, (the “Agreement”) to acquire 100% of the outstanding shares and other equity instruments of ABH. On June 28, 2011, in accordance with the terms of the Agreement, Shire completed its acquisition of ABH. The preliminary fair value of cash consideration payable by the Company is $739.2 million, subject to certain customary post closing adjustments. The purchase price was funded by a combination of Shire's existing cash resources and a $30.0 million draw down of Shire's revolving credit facility.
The acquisition of ABH adds the DERMAGRAFT product, a regenerative bio-engineered skin substitute, to Shire's portfolio. DERMAGRAFT is marketed in the US for the treatment of diabetic foot ulcers (“DFU”) greater than six weeks in duration, and brings future growth prospects through a potential expanded indication for venous leg ulcers (“VLU”). The acquisition combines ABH's expertise and commercial capability in regenerative medicine with the Company's strengths and expertise in human cell biological manufacturing.
The acquisition of ABH has been accounted for as a purchase business combination. The assets acquired and the liabilities assumed from ABH have been recorded at their preliminary fair values at the date of acquisition, being June 28, 2011. The Company's consolidated financial statements and results of operations include the results of ABH from June 28, 2011. In the three and six months to June 30, 2011 the Company included revenues of $2.0 million (2010: $nil) and post tax losses of $0.6 million (2010: $nil) for ABH within its Unaudited Consolidated Statements of Income.
The Company's preliminary allocation of the purchase price to the assets acquired and liabilities assumed is outlined below:
The purchase price allocation is preliminary pending final determination of the cash consideration payable (which may be adjusted based on ABH's closing adjusted working capital) and the fair values of certain assets acquired and liabilities assumed. The final determination of these fair values will be completed as soon as possible but no later than one year from the acquisition date. Other intangible assets include $710.0 million relating to DERMAGRAFT product technology, representing DFU and the potential expanded indication for VLU in the US, the product brand name and related relationships. The fair value of this asset has been estimated using an income approach, using the excess earnings method. The estimated useful life of the technology is 18 years, and amortization expense will be recorded on a straight line basis. Goodwill arising of $192.5 million, which is not deductible for tax purposes, has been assigned to the Specialty Pharmaceuticals (“SP”) operating segment. Goodwill includes the values of tax synergies, assembled workforce and future potential indications for the DERMAGRAFT product which do not meet the criteria for recognition as separate intangible assets.
In the three and six months to June 30, 2011 the Company incurred acquisition-related costs of $6.9 million (2010: $nil), which have been charged to Integration and acquisition costs in the Company's income statement. Supplemental disclosure of pro forma information
The following unaudited pro forma financial information presents the combined results of the operations of Shire and ABH as if the acquisition of ABH had occurred at January 1, 2010. The unaudited pro forma financial information is not necessarily indicative of what the consolidated results of operations actually would have been had the acquisition been completed at the date indicated. In addition, the unaudited pro forma financial information does not purport to project the future results of operations of the combined Company.
The unaudited pro forma financial information above reflects the following pro forma adjustments:
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Segmental Reporting
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Segment Reporting, Disclosure of Entity's Reportable Segments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segmental Reporting | 17. Segmental reporting
Shire's internal financial reporting is in line with its business unit and management reporting structure and includes two segments: SP and HGT. The SP and HGT 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 two operating 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 ($10.5 million) and amortization of favorable manufacturing contracts ($0.4 million) is included in Cost of product sales; depreciation of research and development assets ($6.1 million) is included in Research and development; and all other depreciation and amortization ($51.8 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 ($9.8 million) and amortization of favorable manufacturing contracts ($0.4 million) is included in Cost of product sales; depreciation of research and development assets ($3.5 million) is included in Research and development; and all other depreciation and amortization ($50.4 million) is included in Selling, general and administrative. (2) Long-lived assets comprise all non-current assets (excluding goodwill and other intangible assets, deferred tax assets, investments, income tax receivable and financial instruments). |
(1) Depreciation from manufacturing plants ($18.2 million) and amortization of favorable manufacturing contracts ($0.9 million) is included in Cost of product sales; depreciation of research and development assets ($10.8 million) is included in Research and development; and all other depreciation, amortization and impairment charges ($102.4 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).
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(1) Depreciation from manufacturing plants ($18.4 million) and amortization of favorable manufacturing contracts ($0.9 million) is included in Cost of product sales; depreciation of research and development assets ($7.2 million) is included in Research and development; and all other depreciation and amortization ($101.3 million) is included in Selling, general and administrative. (2) Long-lived assets comprise all non-current assets (excluding goodwill and other intangible assets, deferred tax assets, investments, income tax receivable and financial instruments).
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Segmental Reporting (Tables)
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Segment Reporting, Disclosure of Entity's Reportable Segments [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Segment Reporting Information, by Segment |
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Other Noncurrent Liabilities (Tables)
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Other Liabilites, Noncurrent [Abstract] | |||||||||||||||||||||||||||||||||||||
Schedule of Other Noncurrent Liabilities |
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Fair Value Measurement
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Fair Value Disclosure | 15. Fair value measurement
Assets and liabilities that are measured at fair value on a recurring basis
At June 30, 2011 and December 31, 2010 the following financial assets and liabilities are measured at fair value on a recurring basis using quoted prices in active markets for identical assets (Level 1); significant other observable inputs (Level 2); and significant unobservable inputs (Level 3).
(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.
Certain estimates and judgments were required to develop the fair value amounts. The fair value amounts shown above are not necessarily indicative of the amounts that the Company would realize upon disposition, nor do they indicate the Company's intent or ability to dispose of the financial instrument.
The following methods and assumptions were used to estimate the fair value of each material class of financial instrument:
Assets Measured at Fair Value on a Recurring Basis Using Significant Unobservable Inputs (Level 3)
The change in the fair value of the Company's contingent consideration receivable, which is measured at fair value on a recurring basis using significant unobservable inputs (Level 3), is as follows
Financial assets and liabilities that are not measured at fair value on a recurring basis
The carrying amounts and estimated fair values as at June 30, 2011 and December 31, 2010 of the Company's financial assets and liabilities which are not measured at fair value on a recurring basis are as follows:
Certain estimates and judgments were required to develop the fair value amounts. The fair value amounts shown above are not necessarily indicative of the amounts that the Company would realize upon disposition, nor do they indicate the Company's intent or ability to dispose of the financial instrument.
The following methods and assumptions were used to estimate the fair value of each material class of financial instrument:
The carrying amounts of cash and cash equivalents, restricted cash, accounts receivable, accounts payable and accrued expenses and drawings under the RCF approximate to fair value because of the short-term maturity of these amounts. |
Goodwill
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Goodwill [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
Goodwill Disclosure | 7. Goodwill
During the six months to June 30, 2011 the Company completed its acquisition of ABH for cash consideration payable of $739.2 million, which resulted in goodwill of $192.5 million (see Note 2). The goodwill has been assigned to the SP operating segment.
At June 30, 2011 goodwill of $444.5 million (December 31, 2010: $245.9 million) is held in the SP segment and $168.4 million (December 31, 2010: $156.6 million) in the HGT segment.
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Consolidated Statements of Comprehensive Income (USD $)
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Consolidated Statements of Comprehensive Income | |||||
Net income | $ 205.5 | $ 160.5 | $ 416.8 | $ 326.2 | |
Other comprehensive income: | |||||
Foreign currency translation adjustments | 29.6 | (47.1) | 100.2 | (82.2) | |
Unrealized holding gain/(loss) on available-for-sale securities (net of taxes of $1.1 million, $1.6 million, $3.4 million and $2.6 million) | 5.9 | (15.9) | 16.0 | (22.6) | |
Other than temporary impairment of available-for-sale securities | 0 | 1.5 | 2.4 | 1.5 | |
Comprehensive income | 241.0 | 99.0 | 535.4 | 222.9 | |
Components of accumulated other comprehensive income | |||||
Foreign currency translation adjustments | 185.6 | 185.6 | 85.4 | ||
Unrealized holding gain on available-for-sale securities, net of taxes | 18.7 | 18.7 | 0.3 | ||
Accumulated other comprehensive income | $ 204.3 | $ 204.3 | $ 85.7 |
Other Intangible Assets, Net (Tables)
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Schedule of Intangible Assets by Major Class, (Excluding Goodwill) |
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Intangible Assets (Excluding Goodwill) Roll Forward |
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Accounts Receivable, Net
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Receivables [Abstract] | ||||||||||||||||||||||||||||
Accounts Receivable, Net | 4. Accounts receivable, net
Accounts receivable at June 30, 2011 of $797.2 million (December 31, 2010: $692.5 million), are stated net of a provision for discounts and doubtful accounts of $28.8 million (December 31, 2010: $23.4 million).
Provision for discounts and doubtful accounts:
At June 30, 2011 accounts receivable included $63.4 million (December 31, 2010: $75.8 million) related to royalty income.
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Accounts Payable and Accrued Expenses
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Accounts Payable and Accrued Expenses | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Accounts Payable and Accrued Expenses Disclosure | 9. Accounts payable and accrued expenses
There are potentially different interpretations as to how shipments of authorized generic ADDERALL XR to Teva and Impax should be included in the Medicaid rebate calculation. Since authorized generic launch in 2009 the Company has recorded its accrual for Medicaid rebates based on its best estimate of the rebate payable, consistent with the Company's interpretation of the Medicaid rebate legislation. Shire believes that its interpretation of the Medicaid rebate legislation is reasonable and correct. Additionally, from October 1, 2010 forward, provisions of the 2010 Affordable Care Act provide further clarity, in a manner consistent with the Company's interpretation, as to how shipments of authorized generics from that date should be included in the Medicaid rebate calculation.
However, the Centers for Medicare and Medicaid Services (“CMS”) could disagree with Shire's interpretation of the Medicaid rebate legislation for shipments of authorized generics prior to October 1, 2010. CMS could require Shire to apply an alternative interpretation of the Medicaid rebate legislation and request that Shire pays up to $210 million above the recorded liability. However, Shire believes it has a strong legal basis supporting its interpretation of the Medicaid rebate legislation, and that there would be a strong basis firstly to limit any additional payment to a level approximating the full, un-rebated cost to the States of ADDERALL XR (equivalent to approximately $132 million above the recorded liability), and secondly to initiate litigation to recover any amount paid in excess of the recorded liability. The result of any such litigation cannot be predicted. |
Inventories
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Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||
Inventories Disclosure | 5. Inventories
Inventories are stated at the lower of cost or market value and comprise:
At June 30, 2011 inventories included $14.0 million (December 31, 2010: $4.1 million) of costs capitalized prior to regulatory approval of the related product or relevant manufacturing process. At June 30, 2011 pre-approval inventory relates solely to VPRIV manufactured at the Company's new manufacturing facility at Lexington Technology Park (“LTP”), which has not yet received regulatory approval.
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Inventories (Tables)
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Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||
Schedule of Inventory |
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Reorganization Costs
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Restructuring and Related Activities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reorganization Cost Disclosure | 3. Reorganization costs
Establishment of an International Commercial Hub in Switzerland
In March 2010 the Company initiated plans to relocate certain research and development (“R&D”) and commercial operations to Switzerland to support its Human Genetic Therapies (“HGT”) and SP businesses outside the US. In the six months to June 30, 2011, the Company incurred reorganization costs totaling $8.0 million relating to employee involuntary termination benefits and other re-organization costs. The transition to the international commercial hub in Switzerland will be effected over the remainder of 2011. The total reorganization costs incurred since March 2010 are $29.3 million.
Owings Mills
In March 2009 the Company initiated plans to phase out operations and close its SP manufacturing facility at Owings Mills, Maryland. Between 2009 and 2011, all products manufactured by Shire at this site will transition to DSM Pharmaceuticals, Inc., and operations and employee numbers at the site will wind down over this period. In the six months to June 30, 2011 the Company incurred reorganization costs of $5.0 million which relate to employee involuntary termination benefits and other costs. The total reorganization costs incurred since March 2009 are $30.7 million.
As a result of the decision to transfer manufacturing from the Owings Mills site the Company revised the useful life of property, plant and equipment in the facility and in the six months to June 30, 2011 incurred accelerated depreciation of $4.4 million, which has been charged to Cost of product sales. The reorganization costs and accelerated depreciation have been recorded within the SP operating segment.
The liability for reorganization costs arising on the establishment of the international commercial hub in Switzerland and transfer of manufacturing from Owings Mills at June 30, 2011 is as follows:
At June 30, 2011 the closing liability for reorganization costs was recorded within accounts payable and accrued expenses. |
Goodwill (Roll Forward) (Details) (USD $)
In Millions |
6 Months Ended | |
---|---|---|
Jun. 30, 2011
|
Jun. 30, 2010
|
|
Goodwill [Roll Forward] | ||
Goodwill, Beginning Balance | $ 402.5 | $ 384.7 |
Goodwill, Acquired During Period | 192.5 | 0 |
Goodwill, Translation and Purchase Accounting Adjustments | 17.9 | (29.0) |
Goodwill, Ending Balance | $ 612.9 | $ 355.7 |
Consolidated Statements of Comprehensive Income (Parenthetical) (USD $)
In Millions |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2011
|
Jun. 30, 2010
|
Jun. 30, 2011
|
Jun. 30, 2010
|
|
Consolidated Statements of Comprehensive Income | ||||
Unrealized Holding Gain (Loss) on Securities Arising During Period, Tax | $ 1.1 | $ 1.6 | $ 3.4 | $ 2.6 |
Other than Temporary Impairment of Available-for-Sale Securities Included in Net Income, Tax | $ 0 | $ 0 | $ 0 | $ 0 |
Derivative Instruments (Tables)
|
6 Months Ended | ||||||||||||||||||||||||||||||||
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Jun. 30, 2011
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Derivative Instruments and Hedging Activities Disclosure [Abstract] | |||||||||||||||||||||||||||||||||
Schedule of Foreign Exchange Contracts, Statement of Financial Position |
|
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Schedule of Foreign Exchange Contracts, Gain (Loss) in Other Income (Expense) |
|
Accounts Receivable, Net (Tables)
|
6 Months Ended | |||||||||||||||||||||||||||
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Jun. 30, 2011
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Receivables [Abstract] | ||||||||||||||||||||||||||||
Schedule of Provision for Doubtful Accounts |
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Other Liabilities, Noncurrent (Details) (USD $)
In Millions |
Jun. 30, 2011
|
Dec. 31, 2010
|
---|---|---|
Other Liabilities, Noncurrent Disclosure [Abstract] | ||
Income Taxes Payable | $ 111.4 | $ 130.0 |
Deferred Revenue | 14.2 | 14.1 |
Deferred Rent | 11.8 | 12.8 |
Insurance Provisions | 15.5 | 13.5 |
Other Noncurrent Liabilities | 20.7 | 20.4 |
Other Liabilities, Noncurrent, Total | $ 173.6 | $ 190.8 |
Derivative Instuments (Details) (USD $)
In Millions, except Share data, unless otherwise specified |
6 Months Ended | 12 Months Ended | |
---|---|---|---|
Jun. 30, 2011
year
day
|
Jun. 30, 2010
|
Dec. 31, 2010
|
|
Interest Rate Risk | |||
Cash and Short-Term Deposits, Average Interest Rate | 1.00% | ||
Convertible Bonds, Fixed Interest Rate | 2.75% | ||
Convertible Bond, Principal Amount | $ 1,100.0 | ||
Long-term Investments | |||
Available-for-Sale Securities | 107.5 | ||
Equity Method Investments | 9.3 | ||
Cost Method Investments | 8.9 | ||
Long-term Investments, Total | 125.7 | 101.6 | |
Credit Risk | |||
Entity-Wide Revenue, Major Customer, USA, Percent | 44.00% | ||
Foreign Exchange Risk | |||
Swap and Foreign Exchange Contract, Number Outstanding | 22 | ||
Swap and Forward Contract, Days-to-Maturity, Maximum | 90 | ||
Foreign Currency Contract, Asset, Fair Value Disclosure | 1.1 | 3.7 | |
Foreign Currency Contracts, Liability, Fair Value Disclosure | 4.1 | 2.7 | |
Foreign Exchange Contract, Gain (Loss), Net | $ (2.6) | $ 38.5 |
Goodwill (Details) (USD $)
In Millions |
Jun. 30, 2011
|
Dec. 31, 2010
|
Jun. 30, 2010
|
Dec. 31, 2009
|
Jun. 30, 2011
Specialty Pharmaceuticals
|
Dec. 31, 2010
Specialty Pharmaceuticals
|
Jun. 30, 2011
Human Genetic Therapies
|
Dec. 31, 2010
Human Genetic Therapies
|
Jun. 28, 2011
ABH Member
|
---|---|---|---|---|---|---|---|---|---|
Goodwill [Line Items] | |||||||||
Cost of Acquired Entity, Cash Paid | $ 739.2 | ||||||||
Purchase Price Allocation, Goodwill | 444.5 | 245.9 | 168.4 | 156.6 | 192.5 | ||||
Goodwill | $ 612.9 | $ 402.5 | $ 355.7 | $ 384.7 |
Segment Reporting (Details) (USD $)
In Millions |
3 Months Ended | 6 Months Ended | |||||||
---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2011
|
Jun. 30, 2010
|
Jun. 30, 2011
|
Jun. 30, 2010
|
Dec. 31, 2010
|
|||||
Reconciliation from Segment Totals to Consolidated [Line Items] | |||||||||
Product Sales | $ 993.3 | $ 764.3 | $ 1,882.6 | $ 1,482.4 | |||||
Royalties | 63.4 | 82.7 | 137.0 | 178.0 | |||||
Other Revenues | 6.2 | 2.4 | 15.5 | 5.1 | |||||
Revenues | 1,062.9 | 849.4 | 2,035.1 | 1,665.5 | |||||
Cost of Product Sales | 143.7 | [1] | 119.1 | [1] | 268.2 | 221.0 | |||
Research and Development | 176.9 | 147.0 | 354.8 | 278.0 | |||||
Selling, General and Administrative | 440.3 | [1] | 354.4 | [1] | 843.2 | 714.3 | |||
Loss/(gain) on sale of product rights | 2.2 | (4.1) | 3.5 | (4.1) | |||||
Reorganization Cost | 7.5 | 8.6 | 13.0 | 13.6 | |||||
Integration and Acquisition Cost | 9.0 | 0 | 2.6 | 0.6 | |||||
Total operating expenses | 779.6 | 625.0 | 1,485.3 | 1,223.4 | |||||
Operating Income (Loss) | 283.3 | 224.4 | 549.8 | 442.1 | |||||
Assets | 6,165.6 | 4,868.9 | 6,165.6 | 4,868.9 | 5,387.6 | ||||
Long-Lived Assets | 908.9 | 805.7 | 908.9 | 805.7 | |||||
Capital Expenditure on Long-Lived Assets | 50.9 | 166.7 | 94.8 | 196.4 | |||||
Depreciation and Amortization, by Report Line | |||||||||
Cost of Product Sales, Depreciation, Manufacturing Plant | 10.5 | 9.8 | 18.2 | 18.4 | |||||
Cost of Product Sales, Amortization, Favorable Manufacturing Contract | 0.4 | 0.4 | 0.9 | 0.9 | |||||
Research and Development Expense, Depreciation of Research and Development Asset | 6.1 | 3.5 | 10.8 | 7.2 | |||||
Selling, General and Administrative Expense, Depreciation and Amortization | 51.8 | 50.4 | 102.4 | 101.3 | |||||
Specialty Pharmaceuticals
|
|||||||||
Reconciliation from Segment Totals to Consolidated [Line Items] | |||||||||
Product Sales | 676.7 | 551.3 | 1,292.8 | 1,092.6 | |||||
Royalties | 51.8 | 44.2 | 89.3 | 102.8 | |||||
Other Revenues | 4.7 | 0.5 | 12.3 | 1.2 | |||||
Revenues | 733.2 | 596.0 | 1,394.4 | 1,196.6 | |||||
Cost of Product Sales | 94.1 | 84.6 | 176.0 | 165.0 | |||||
Research and Development | 105.1 | 84.8 | 207.8 | 158.7 | |||||
Selling, General and Administrative | 294.7 | 236.6 | 561.3 | 486.1 | |||||
Loss/(gain) on sale of product rights | 2.2 | (4.1) | 3.5 | (4.1) | |||||
Reorganization Cost | 2.7 | 3.3 | 5.0 | 6.7 | |||||
Integration and Acquisition Cost | 9.0 | 0 | 2.6 | 0.6 | |||||
Total operating expenses | 507.8 | 405.2 | 956.2 | 813.0 | |||||
Operating Income (Loss) | 225.4 | 190.8 | 438.2 | 383.6 | |||||
Assets | 3,555.3 | 2,081.5 | 3,555.3 | 2,081.5 | |||||
Long-Lived Assets | 174.9 | 169.5 | 174.9 | 169.5 | |||||
Capital Expenditure on Long-Lived Assets | 18.2 | 2.7 | 23.1 | 5.0 | |||||
Human Genetic Therapies
|
|||||||||
Reconciliation from Segment Totals to Consolidated [Line Items] | |||||||||
Product Sales | 316.6 | 213.0 | 589.8 | 389.8 | |||||
Royalties | 0 | 0 | 0 | 0 | |||||
Other Revenues | 0.2 | 0.6 | 0.5 | 1.3 | |||||
Revenues | 316.8 | 213.6 | 590.3 | 391.1 | |||||
Cost of Product Sales | 49.6 | 34.5 | 92.2 | 56.0 | |||||
Research and Development | 71.8 | 62.2 | 147.0 | 119.3 | |||||
Selling, General and Administrative | 91.9 | 61.9 | 172.0 | 124.7 | |||||
Loss/(gain) on sale of product rights | 0 | 0 | 0 | 0 | |||||
Reorganization Cost | 0 | 0 | 0 | 0 | |||||
Integration and Acquisition Cost | 0 | 0 | 0 | 0 | |||||
Total operating expenses | 213.3 | 158.6 | 411.2 | 300.0 | |||||
Operating Income (Loss) | 103.5 | 55.0 | 179.1 | 91.1 | |||||
Assets | 1,875.9 | 1,574.3 | 1,875.9 | 1,574.3 | |||||
Long-Lived Assets | 691.1 | 587.4 | 691.1 | 587.4 | |||||
Capital Expenditure on Long-Lived Assets | 27.4 | 161.9 | 63.8 | 187.4 | |||||
All Other Segment
|
|||||||||
Reconciliation from Segment Totals to Consolidated [Line Items] | |||||||||
Product Sales | 0 | 0 | 0 | ||||||
Royalties | 11.6 | 38.5 | 47.7 | 75.2 | |||||
Other Revenues | 1.3 | 1.3 | 2.7 | 2.6 | |||||
Revenues | 12.9 | 39.8 | 50.4 | 77.8 | |||||
Cost of Product Sales | 0 | 0 | 0 | 0 | |||||
Research and Development | 0 | 0 | 0 | 0 | |||||
Selling, General and Administrative | 53.7 | 55.9 | 109.9 | 103.5 | |||||
Loss/(gain) on sale of product rights | 0 | 0 | 0 | 0 | |||||
Reorganization Cost | 4.8 | 5.3 | 8.0 | 6.9 | |||||
Integration and Acquisition Cost | 0 | 0 | 0 | 0 | |||||
Total operating expenses | 58.5 | 61.2 | 117.9 | 110.4 | |||||
Operating Income (Loss) | (45.6) | (21.4) | (67.5) | (32.6) | |||||
Assets | 734.4 | 1,213.1 | 734.4 | 1,213.1 | |||||
Long-Lived Assets | 42.9 | 48.8 | 42.9 | 48.8 | |||||
Capital Expenditure on Long-Lived Assets | $ 5.3 | $ 2.1 | $ 7.9 | $ 4.0 | |||||
|
Consolidated Statements of Cash Flows (USD $)
In Millions |
6 Months Ended | |
---|---|---|
Jun. 30, 2011
|
Jun. 30, 2010
|
|
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net income | $ 416.8 | $ 326.2 |
Adjustments to reconcile net income to net cash provided by operating activities: | ||
Depreciation and amortization | 132.3 | 129.1 |
Share based compensation | 34.9 | 26.7 |
Gain on sale of non-current investments | 0 | (11.1) |
Other | (5.7) | 11.0 |
Movement in deferred taxes | 17.7 | 58.8 |
Equity in earnings of equity method investees | (2.4) | (0.5) |
Loss/(gain) on sale of product rights | 3.5 | (4.1) |
Changes in operating assets and liabilities: | ||
Increase in accounts receivable | (56.2) | (43.9) |
Increase in sales deduction accrual | 66.1 | 154.3 |
Increase in inventory | (30.6) | (50.1) |
Increase in prepayments and other assets | (13.8) | (83.3) |
Decrease in accounts payable and other liabilities | (77.1) | (43.2) |
Net cash provided by operating activities | 485.5 | 469.9 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Movements in restricted cash | 4.8 | 6.0 |
Purchases of subsidiary undertakings, net of cash acquired | (719.7) | 0 |
Purchases of non-current investments | (4.5) | 0 |
Purchases of property, plant and equipment ("PP&E") | (95.0) | (208.1) |
Purchases of intangible assets | 0 | (2.7) |
Proceeds from disposal of non-current investments, PP&E and product rights | 6.9 | 2.1 |
Returns of equity investments and proceeds from short term investments | 1.6 | 0 |
Net cash used in investing activities | (805.9) | (202.7) |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from drawings of revolving credit facility | 30.0 | 0 |
Repayment of debt acquired with ABH | (13.1) | 0 |
Payment under building finance obligation | (0.4) | (1.3) |
Extinguishment of building finance obligation | 0 | (43.1) |
Tax benefit of stock based compensation | 18.8 | 4.4 |
Proceeds from exercise of options | 0.8 | 1.8 |
Payment of dividend | (60.5) | (49.8) |
Payments to acquire shares by ESOT | (63.9) | (1.7) |
Net cash used in financing activities | (88.3) | (89.7) |
Net (decrease)/increase in cash and cash equivalents | (406.0) | 183.6 |
Effect of foreign exchange rate changes on cash and cash equivalents | 2.7 | 6.1 |
Cash and cash equivalents at beginning of period | 550.6 | 498.9 |
Cash and cash equivalents at end of period | 144.6 | 682.5 |
Supplemental information associated with continuing operations: | ||
Interest paid | (16.2) | (13.0) |
Income taxes paid | (147.7) | (205.0) |
Non cash investing and financing activities: | ||
Equity in Vertex Pharmaceuticals, Inc. ("Vertex") received as part consideration for disposal of non-current investment | $ 0 | $ 9.1 |
Earnings Per Share (Tables)
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6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2011
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Calculation of Numerator and Denominator in Earnings Per Share |
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Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share |
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Summary of Significant Accounting Policies (Policies)
|
6 Months Ended |
---|---|
Jun. 30, 2011
|
|
Policy Text Block [Abstract] | |
Basis of Preparation | (a) Basis of preparation
These interim financial statements of Shire plc and its subsidiaries (collectively “Shire” or the “Company”) and other financial information included in this Form 10-Q, are unaudited. They have been prepared in accordance with generally accepted accounting principles in the United States of America (“US GAAP”) and US Securities and Exchange Commission (“SEC”) regulations for interim reporting. The balance sheet as of December 31, 2010 was derived from audited financial statements but does not include all disclosures required by US GAAP. These interim financial statements should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company's Annual Report on Form 10-K for the year to December 31, 2010. Certain information and footnote disclosures normally included in financial statements prepared in accordance with US GAAP have been condensed or omitted from these interim financial statements. However, these interim financial statements include all adjustments, which are, in the opinion of management, necessary to fairly state the results of the interim period and the Company believes that the disclosures are adequate to make the information presented not misleading. Interim results are not necessarily indicative of results to be expected for the full year. |
Use of Estimates in Consolidated Financial Statements | (b) Use of estimates in interim financial statements
The preparation of interim financial statements, in conformity with US GAAP and SEC regulations, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the consolidated financial statements and reported amounts of revenues and expenses during the reporting period. Estimates and assumptions are primarily made in relation to the valuation of intangible assets, the valuation of equity investments, sales deductions, income taxes (including provisions for uncertain tax positions and the realization of deferred tax assets), provisions for litigation and legal proceedings, and contingent consideration receivable from product divestments. If actual results differ from the Company's estimates, or to the extent these estimates are adjusted in future periods, the Company's results of operations could either benefit from, or be adversely affected by, any such change in estimate. |
New Accounting Pronouncements | (c) New accounting pronouncements
Adopted during the period
Revenue Recognition in Multiple Deliverable Revenue Arrangements
On January 1, 2011 the Company adopted new guidance issued by the Financial Accounting Standard Board (“FASB”) on revenue recognition in multiple deliverable revenue arrangements. This amends the existing guidance on allocating consideration received between the elements in a multiple-deliverable arrangement and establishes a selling price hierarchy for determining the selling price of a deliverable. The selling price used for each deliverable will be based on vendor specific objective evidence (“VSOE”) if available, third party evidence if VSOE is not available, or estimated selling price if neither VSOE nor third party evidence is available. It replaces the term “fair value” in the revenue allocation with “selling price” to clarify that the allocation of revenue is based on entity specific assumptions rather than the assumptions of a market place participant. The guidance eliminates the residual method of allocation and requires that arrangement consideration be allocated using the relative selling price method. The guidance also significantly expands the disclosures related to a vendor's multiple-deliverable revenue arrangements. The guidance has been adopted prospectively from January 1, 2011 for new arrangements, or existing arrangements which have been materially modified subsequent to the date of adoption. The adoption of the guidance did not impact the Company's consolidated financial position, results of operations or cash flows.
Effect of Denominating the Exercise Price of a Share-Based Payment Award in the Currency of the Market in Which the Underlying Equity Security Trades
On January 1, 2011 the Company adopted new guidance issued by the FASB on the effect of denominating the exercise price of a share-based payment award in the currency of the market in which the underlying equity security trades. This guidance clarifies that an employee share-based payment award with an exercise price denominated in the currency of a market in which a substantial portion of the entity's equity securities trades should not be considered to contain a condition that is not a market, performance, or service condition. Therefore, an entity would not classify such an award as a liability if it otherwise qualifies as equity. The Company has historically accounted for share based payment awards in a manner consistent with the guidance, and therefore the adoption of this guidance did not impact the Company's consolidated financial position, results of operations or cash flows.
Milestone Method of Revenue Recognition
On January 1, 2011 the Company adopted new guidance issued by the FASB on defining a milestone and determining when it may be appropriate to apply the milestone method of revenue recognition for research or development transactions. This guidance clarifies that: (i) consideration that is contingent on achievement of a milestone in its entirety may be recognized as revenue in the period in which the milestone is achieved only if the milestone is judged to meet certain criteria to be considered substantive; (ii) milestones should be considered substantive in their entirety and may not be bifurcated; (iii) an arrangement may contain both substantive and non substantive milestones; and (iv) each milestone should be evaluated individually to determine if it is substantive. The adoption of the guidance did not impact the Company's consolidated financial position, results of operations or cash flows. Fees Paid to Federal Government by Pharmaceutical Manufacturers
On January 1, 2011 the Company adopted new guidance issued by the FASB on the accounting for the annual fee paid by pharmaceutical manufacturers to the US Treasury in accordance with the Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act for each calendar year beginning on or after January 1, 2011. The annual fee in 2011 is $2.5 billion. A portion of the fee will be allocated to individual entities on the basis of the amount of their branded prescription drug sales to certain US Government programs for the preceding year as a percentage of the industry's branded prescription drug sales for the same period to these same programs. This guidance specifies that the liability for the fee should be estimated and recorded in full upon the first qualifying sale with a corresponding deferred cost that is amortized to expense using a straight-line method of allocation unless another method better allocates the fee over the calendar year that it is payable. The adoption of the guidance did not have a material impact on the Company's consolidated financial position, results of operations or cash flows. Disclosure of Supplementary Pro Forma Information for Business Combinations
On January 1, 2011 the Company adopted new guidance issued by the FASB which clarifies the acquisition date that should be used for reporting pro forma financial information disclosures in a business combination when comparative financial statements are presented. The guidance specifies that the entity should disclose revenue and earnings of the combined entity as though the business combination that occurred during the current year had occurred as of the beginning of the comparable prior annual reporting period. The guidance also improves the usefulness of the pro forma revenue and earnings disclosures by requiring a description of the nature and amount of material, nonrecurring pro forma adjustments that are directly attributable to the business combination. The guidance is effective prospectively for business combinations for which the acquisition date is on or after January 1, 2011. The Company has historically presented proforma business combination disclosures in accordance with the guidance, and therefore the adoption of guidance did not impact the Company's disclosure on business combinations.
To be adopted in future periods Amendments to Achieve Common Fair Value Measurement and Disclosure Requirements in US GAAP and International Financial Reporting standards (“IFRS”)
In May 2011 the FASB issued guidance on fair value measurement and disclosure, which both amends existing requirements and improves the comparability of fair value measurement and disclosure between US GAAP and IFRS. Some of the amendments clarify the application of existing fair value measurement requirements and other amendments change a particular principle or requirement for measuring fair value or for disclosing information about fair value measurements. The guidance will be effective prospectively for interim and annual periods beginning after December 15, 2011. Early adoption is not permitted. The Company is currently evaluating the impact of adopting this guidance.
Presentation of Comprehensive Income
In June 2011 the FASB issued guidance on the presentation of comprehensive income which revises the manner in which entities present comprehensive income in their financial statements. The guidance requires entities to report components of comprehensive income in either: (i) a single, continuous statement of comprehensive income; or (ii) two separate but consecutive statements. The guidance does not change those items which must be reported in other comprehensive income, and does not change the definition of net income or the calculation of earnings per share. The guidance will be effective retrospectively for interim and annual periods beginning after December 15, 2011. Early adoption is not permitted. The Company is currently evaluating the impact of adopting this guidance. |
Fair Value Measurement (Contingent consideration) (Details) (USD $)
In Millions |
6 Months Ended |
---|---|
Jun. 30, 2011
|
|
Fair Value Assets Measured On Recurring Basis Unobservable Input Reconciliation Line Items | |
Fair Value Measurement With Unobservable Inputs Reconciliation Recurring Basis Asset Value Beginning Balance | $ 61.0 |
Loss recognized in the income statement due to change in fair value during the period | (3.5) |
Reclassification of amounts due from Noven to Other current assets | (9.2) |
Foreign exchange translation recorded to other comprehensive income | 4.8 |
Fair Value Measurement With Unobservable Inputs Reconciliation Recurring Basis Asset Value Ending Balance | $ 53.1 |
Prepaid Expenses and Other Current Assets (Tables)
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Jun. 30, 2011
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Prepaid Expense and Other Assets, Current [Abstract] | ||||||||||||||||||||||||||||||||||
Prepaid Expense and Other Assets, Current |
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Fair Value Measurement (Tables)
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Jun. 30, 2011
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Fair Value, Assets And Liabilities Measured on Recurring Basis |
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Schedule of Financial Assets and Liabilities Not Measured at Fair Value on Recurring Basis |
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Schedule Of Fair Value Assets Measured On Recurring Basis Using Significant Unobservable Inputs (level 3) |
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Reorganization Cost (Tables)
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6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2011
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Restructuring and Related Activities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Restructuring and Related Costs |
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Other Intangible Assets, Net
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Jun. 30, 2011
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Other Intangible Assets, Net | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Intangible Assets Disclosure | 8. Other intangible assets, net
At June 30, 2011 the net book value of intangible assets allocated to the SP segment was $ 2,184.5 million (December 31, 2010: $1,482.9 million) and in the HGT segment was $494.9 million (December 31, 2010: $496.0 million).
The change in the net book value of other intangible assets for the six months to June 30, 2011 and 2010 is shown in the table below:
In the six months to June 30, 2011 the Company acquired intangible assets totaling $711.5 million, principally relating to DERMAGRAFT product technology acquired with ABH (see Note 2 for further details). The weighted average amortization period of acquired amortizable intangible assets is 18 years.
Management estimates that the annual amortization charge in respect of intangible assets held at June 30, 2011 will be approximately $183 million for each of the five years to June 30, 2016. Estimated amortization expense can be affected by various factors including future acquisitions, disposals of product rights, regulatory approval and subsequent amortization of the acquired IPR&D projects, foreign exchange movements and the technological advancement and regulatory approval of competitor products. |
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