SHIRE PLC
|
||||
By:
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/s/ A C Russell
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|||
Name: |
Angus Russell
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|||
Title: |
Chief Executive Officer
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EXHIBIT INDEX
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Number
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Description
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99.01
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Press Release dated July 28, 2011
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Exhibit 99.01
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Press Release
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![]() |
www.shire.com
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Financial Highlights
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Q2 2011(1)
|
|
Product sales
|
$993 million
|
+30%
|
Total revenues
|
$1,063 million
|
+25%
|
|
||
Non GAAP operating income
|
$342 million
|
+26%
|
US GAAP operating income
|
$283 million
|
+26%
|
|
||
Non GAAP diluted earnings per ADS
|
$1.33
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+29%
|
US GAAP diluted earnings per ADS
|
$1.08
|
+26%
|
|
||
Non GAAP cash generation
|
$440 million
|
+7%
|
Non GAAP free cash flow
|
$235 million
|
-1%
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US GAAP net cash provided by operating activities
|
$284 million
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0%
|
|
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Q2 2011
|
|
Q2 2010
|
||||||||
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US GAAP
|
Adjustments
|
Non GAAP
|
US GAAP
|
Adjustments
|
Non GAAP
|
||||||
|
|
$M
|
|
$M
|
|
$M
|
|
$M
|
|
$M
|
|
$M
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Total revenues
|
|
1,063
|
|
-
|
|
1,063
|
|
849
|
|
-
|
|
849
|
Operating income
|
|
283
|
|
59
|
|
342
|
|
224
|
|
46
|
|
270
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Diluted earnings per ADS
|
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$1.08
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|
$0.25
|
|
$1.33
|
|
$0.86
|
|
$0.17
|
|
$1.03
|
·
|
Product sales were up 30% to $993 million (Q2 2010: $764 million) as strong growth continued through the second quarter, assisted in part by favorable foreign exchange. On a constant exchange rate (“CER”) basis, which is a Non GAAP measure, product sales were up 26%.
|
·
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Non GAAP operating income was up 26% to $342 million (Q2 2010: $270 million). As expected Non GAAP operating expenses increased as we continue to invest in our targeted research and development (“R&D”) programs and incur higher selling, general and administrative (“SG&A”) expenditure to support our continued growth and planned product launches. On a US GAAP basis, operating income was up 26% to $283 million (Q2 2010: $224 million).
|
·
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Non GAAP diluted earnings per American Depositary Share (“ADS”) were up 29% to $1.33 (Q2 2010: $1.03), due to the higher Non GAAP operating income and a lower quarterly Non GAAP effective tax rate of 23% (Q2 2010: 25%). On a US GAAP basis, diluted earnings per ADS were up 26% to $1.08 (Q2 2010: $0.86).
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·
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Cash generation, a Non GAAP measure, was up 7% to $440 million (Q2 2010: $411 million). Higher cash receipts from gross product sales were partially offset by significantly higher sales deduction payments in Q2 2011, due to higher rebate levels in 2011 and timing delays for rebate payments in 2010 following US Healthcare Reform, together with higher payments on operating expenditure.
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·
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Non GAAP net debt at June 30, 2011 was $972 million (December 31, 2010: $531 million), an increase of $441 million, as the net cash provided by operating activities in H1 2011 and existing cash resources were used to fund the acquisition of Advanced BioHealing Inc. (“ABH”), other capital expenditure, the dividend payment and the purchase of shares by the Employee Share Ownership Trust (“ESOT”).
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![]() |
2 |
·
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EQUASYM® for the treatment of ADHD in certain European countries;
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·
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RESOLOR® in certain European countries, for the symptomatic treatment of chronic constipation in women for whom laxatives fail to provide adequate relief;
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·
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DERMAGRAFT® for the treatment of Diabetic Foot Ulcers (“DFU”) in Canada;
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·
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VPRIV for the treatment of Type 1 Gaucher disease in certain European and Latin American countries; and
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·
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FIRAZYR® for the symptomatic treatment of acute attacks of hereditary angioedema (“HAE”) in the US and certain European and Latin American countries.
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![]() |
3 |
·
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On June 23, 2011 Shire announced that the Pulmonary-Allergy Drugs Advisory Committee to the U.S. 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.
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·
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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 Human Genetic Therapies (“HGT”) products – Alewife, which is located in Cambridge, MA, and the new Lexington facility. This provides increased manufacturing flexibility for REPLAGAL.
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·
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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.
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·
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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.
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·
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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.
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·
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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.
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·
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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.
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![]() |
4 |
·
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A pivotal Phase 3 clinical trial to assess the efficacy and safety of DERMAGRAFT in treating VLU is ongoing.
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·
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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.
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·
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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, the ABH business becomes part of Shire’s Specialty Pharmaceuticals (“SP”) business. 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.
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·
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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.; Amneal Pharmaceuticals LLC; Watson Laboratories, Inc.; Roxane Laboratories, Inc.; Mylan Pharmaceuticals, Inc.; and Actavis Elizabeth LLC and Actavis Inc. 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.
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![]() |
5 |
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Page
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Overview of Second Quarter 2011 Financial Results
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7
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Financial Information
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11
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Non GAAP Reconciliations
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20
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Safe Harbor Statement
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24
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Explanation of Non GAAP Measures
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25
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Trademarks
|
26
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Investor Relations
|
Eric Rojas (erojas@shire.com)
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+1 781 482 0999
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Sarah Elton-Farr (seltonfarr@shire.com)
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+44 1256 894 157
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|
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Media
|
Jessica Mann (jmann@shire.com)
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+44 1256 894 280
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|
Jessica Cotrone (jcotrone@shire.com)
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+1 781 482 9538
|
UK dial in:
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0800 077 8492 or 0844 335 0351
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US dial in:
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1 866 8048688 or 1 718 3541175
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International dial in:
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+44 208 974 7900
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Password/Conf ID:
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818608
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Live Webcast:
|
http://www.shire.com/shireplc/en/investors
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![]() |
6 |
|
|
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Year on year growth
|
US Exit Market Share(1)
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||||||
Product
|
|
Sales $M
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|
|
Sales
|
|
|
CER
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|
US Rx(1)
|
|
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|
|
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|||||
VYVANSE
|
|
185.9
|
|
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+26%
|
1
|
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+25%
|
|
+21%
|
15%
|
ADDERALL XR
|
|
146.9
|
|
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+83%
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1
|
|
+82%
|
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+16%
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8%
|
ELAPRASE®
|
|
127.8
|
|
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+28%
|
1
|
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+20%
|
|
n/a(2)
|
n/a(2)
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REPLAGAL
|
|
119.9
|
|
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+46%
|
1
|
|
+32%
|
|
n/a(3)
|
n/a(3)
|
LIALDA / MEZAVANT
|
|
99.2
|
|
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+43%
|
1
|
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+41%
|
|
+8%
|
20%
|
PENTASA®
|
|
65.8
|
|
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+9%
|
|
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+9%
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-3%
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15%
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VPRIV
|
|
63.3
|
|
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+121%
|
1
|
|
+110%
|
|
n/a(2)
|
n/a(2)
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INTUNIV
|
|
59.6
|
|
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+16%
|
1
|
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+16%
|
|
+88%
|
4%
|
FOSRENOL®
|
|
45.3
|
|
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+0%
|
1
|
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-5%
|
|
-13%
|
6%
|
FIRAZYR
|
|
5.6
|
|
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+115%
|
1
|
|
+89%
|
|
n/a(3)
|
n/a(3)
|
DERMAGRAFT
|
|
2.0
|
|
|
n/a
|
1
|
|
n/a
|
|
n/a
|
n/a
|
RESOLOR
|
|
1.6
|
|
|
n/a
|
1
|
|
n/a
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|
n/a(3)
|
n/a(3)
|
OTHER
|
|
70.4
|
|
|
-27%
|
1
|
|
-32%
|
|
n/a
|
n/a
|
Total product sales
|
|
993.3
|
|
|
+30%
|
1
|
|
+26%
|
|
||
(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.
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(2)
|
IMS NPA Data not available.
|
(3)
|
Not sold in the US in Q2 2011.
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![]() |
7 |
2.
|
Royalties
|
|
|
|
|
Year on year growth
|
|||||
Product
|
|
Royalties to Shire $M
|
|
|
Royalties
|
|
|
CER
|
|
|
|
|
|
|
|
|
|
||
ADDERALL XR
|
1.00
|
26.9
|
|
|
-2%
|
|
|
-2%
|
|
FOSRENOL
|
1.00
|
12.4
|
|
|
107%
|
|
|
107%
|
|
3TC® and Zeffix®
|
1.00
|
11.3
|
|
|
-70%
|
|
|
-70%
|
|
Other
|
1.00
|
12.8
|
|
|
15%
|
|
|
5%
|
|
Total
|
1.00
|
63.4
|
|
|
-23%
|
|
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-25%
|
|
|
|
|
|
|
|
|
|
![]() |
8 |
3.
|
Financial details
|
Q2 2011
$M |
% of product sales
|
Q2 2010
$M |
% of product sales
|
||||
Cost of product sales (US GAAP)
|
143.7
|
|
14%
|
119.1
|
16%
|
||
Transfer of manufacturing from Owings Mills
|
(2.8)
|
|
|
(7.4)
|
|
||
Depreciation
|
(8.3)
|
|
|
(3.8)
|
|
||
Cost of product sales (Non GAAP)
|
132.6
|
|
13%
|
107.9
|
14%
|
||
|
|
|
|
|
|
Q2 2011
$M |
% of product sales
|
Q2 2010
$M |
% of product sales
|
||||
R&D (US GAAP)
|
176.9
|
|
18%
|
|
147.0
|
|
19%
|
Depreciation
|
(6.1)
|
|
|
|
(3.5)
|
|
|
R&D (Non GAAP)
|
170.8
|
|
17%
|
|
143.5
|
|
19%
|
|
|
|
|
|
|
|
|
Q2 2011
$M |
% of product sales
|
Q2 2010
$M |
% of product sales
|
||||
SG&A (US GAAP)
|
440.3
|
|
44%
|
|
354.4
|
|
46%
|
Intangible asset amortization
|
(36.7)
|
|
|
|
(33.8)
|
|
|
Depreciation
|
(15.1)
|
|
|
|
(16.6)
|
|
|
SG&A (Non GAAP)
|
388.5
|
|
39%
|
|
304.0
|
|
40%
|
|
|
|
|
|
|
|
|
![]() |
9 |
![]() |
10 |
|
Page
|
|
|
Unaudited US GAAP Consolidated Balance Sheets
|
12
|
|
|
Unaudited US GAAP Consolidated Statements of Income
|
13
|
|
|
Unaudited US GAAP Consolidated Statements of Cash Flows
|
15
|
|
|
Selected Notes to the Unaudited US GAAP Financial Statements
|
|
(1) Earnings per share
|
17
|
(2) Analysis of revenues
|
18
|
|
|
Non GAAP reconciliation
|
20
|
![]() |
11 |
|
June 30,
|
December 31,
|
||||||
|
2011
|
2010
|
||||||
|
$M | $M | ||||||
ASSETS
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
144.6 | 550.6 | ||||||
Restricted cash
|
21.9 | 26.8 | ||||||
Accounts receivable, net
|
797.2 | 692.5 | ||||||
Inventories
|
336.3 | 260.0 | ||||||
Deferred tax asset
|
166.9 | 182.0 | ||||||
Prepaid expenses and other current assets
|
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
|
612.9 | 402.5 | ||||||
Other intangible assets, net
|
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
|
1,317.5 | 1,239.3 | ||||||
Convertible bonds
|
1,100.0 | - | ||||||
Deferred tax liability
|
4.4 | 4.4 | ||||||
Other current liabilities
|
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
|
173.6 | 190.8 | ||||||
|
||||||||
Total liabilities
|
3,250.0 | 2,936.2 | ||||||
|
||||||||
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)
|
(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 |
![]() |
12 |
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 | |||||||||||||
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
|
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 |
![]() |
13 |
|
3 months to
|
3 months to
|
6 months to
|
6 months to
|
||||||||||||
|
June 30,
|
June 30,
|
June 30,
|
June 30,
|
||||||||||||
|
2011
|
2010
|
2011
|
2010
|
||||||||||||
Earnings per ordinary share – basic
|
37.2 | c | 29.4 | c | 75.7 | c | 59.8 | c | ||||||||
|
||||||||||||||||
Earnings per ADS – basic
|
111.6 | c | 88.2 | c | 227.1 | c | 179.4 | c | ||||||||
|
||||||||||||||||
Earnings per ordinary share – diluted
|
35.9 | c | 28.6 | c | 72.9 | c | 58.2 | c | ||||||||
|
||||||||||||||||
Earnings per ADS – diluted
|
107.7 | c | 85.8 | c | 218.7 | c | 174.6 | c | ||||||||
|
||||||||||||||||
Weighted average number of shares:
|
||||||||||||||||
|
Millions
|
Millions
|
Millions
|
Millions
|
||||||||||||
|
||||||||||||||||
Basic
|
552.3 | 546.6 | 551.1 | 545.7 | ||||||||||||
Diluted
|
595.1 | 590.0 | 594.8 | 589.1 |
![]() |
14 |
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 | |||||||||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||||||||||
Net income
|
205.5 | 160.5 | 416.8 | 326.2 | ||||||||||||
Adjustments to reconcile net income to net cash provided by operating activities:
|
||||||||||||||||
Depreciation and amortization
|
68.8 | 64.9 | 132.3 | 129.1 | ||||||||||||
Share based compensation
|
19.2 | 12.6 | 34.9 | 26.7 | ||||||||||||
Gain on sale of non-current investments
|
- | - | - | (11.1 | ) | |||||||||||
Loss/(gain) on sale of product rights
|
2.2 | (4.1 | ) | 3.5 | (4.1 | ) | ||||||||||
Other
|
1.1 | 5.7 | (5.7 | ) | 11.0 | |||||||||||
Movement in deferred taxes
|
(24.5 | ) | 6.5 | 17.7 | 58.8 | |||||||||||
Equity in earnings of equity method investees
|
(1.2 | ) | (1.0 | ) | (2.4 | ) | (0.5 | ) | ||||||||
Changes in operating assets and liabilities:
|
||||||||||||||||
Decrease/(increase) in accounts receivable
|
18.6 | (33.1 | ) | (56.2 | ) | (43.9 | ) | |||||||||
Increase in sales deduction accrual
|
34.9 | 89.3 | 66.1 | 154.3 | ||||||||||||
Increase in inventory
|
(17.9 | ) | (25.8 | ) | (30.6 | ) | (50.1 | ) | ||||||||
Increase in prepayments and other assets
|
(18.8 | ) | (64.5 | ) | (13.8 | ) | (83.3 | ) | ||||||||
(Decrease)/increase in accounts payable and other liabilities
|
(4.3 | ) | 72.8 | (77.1 | ) | (43.2 | ) | |||||||||
Net cash provided by operating activities(A)
|
283.6 | 283.8 | 485.5 | 469.9 |
![]() |
15 |
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 | |||||||||||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||||||||||
Movements in restricted cash
|
8.9 | (0.3 | ) | 4.8 | 6.0 | |||||||||||
Purchases of subsidiary undertakings, net of cash acquired
|
(719.7 | ) | - | (719.7 | ) | - | ||||||||||
Purchases of non-current investments
|
(2.0 | ) | - | (4.5 | ) | - | ||||||||||
Purchases of property, plant and equipment ("PP&E")
|
(48.5 | ) | (164.6 | ) | (95.0 | ) | (208.1 | ) | ||||||||
Purchases of intangible assets
|
- | (2.7 | ) | - | (2.7 | ) | ||||||||||
Proceeds from disposal of non-current investments, PP&E and product rights
|
6.8 | - | 6.9 | 2.1 | ||||||||||||
Returns of equity investments and proceeds from short term investments
|
0.5 | - | 1.6 | - | ||||||||||||
Net cash used in investing activities(B)
|
(754.0 | ) | (167.6 | ) | (805.9 | ) | (202.7 | ) | ||||||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||||||||||
Proceeds from drawing of revolving credit facility
|
30.0 | - | 30.0 | - | ||||||||||||
Repayment of debt acquired with ABH
|
(13.1 | ) | - | (13.1 | ) | - | ||||||||||
Payment under building finance obligation
|
(0.2 | ) | (0.7 | ) | (0.4 | ) | (1.3 | ) | ||||||||
Extinguishment of building finance obligation
|
- | (43.1 | ) | - | (43.1 | ) | ||||||||||
Tax benefit of stock based compensation
|
9.8 | (0.4 | ) | 18.8 | 4.4 | |||||||||||
Proceeds from exercise of options
|
0.6 | 0.4 | 0.8 | 1.8 | ||||||||||||
Payment of dividend
|
(60.5 | ) | (49.8 | ) | (60.5 | ) | (49.8 | ) | ||||||||
Payments to acquire shares by ESOT
|
(63.9 | ) | (1.7 | ) | (63.9 | ) | (1.7 | ) | ||||||||
Net cash used in financing activities(C)
|
(97.3 | ) | (95.3 | ) | (88.3 | ) | (89.7 | ) | ||||||||
Effect of foreign exchange rate changes on cash and cash equivalents (D)
|
0.3 | 4.1 | 2.7 | 6.1 | ||||||||||||
Net (decrease)/increase in cash and cash equivalents(A) +(B) +(C) +(D)
|
(567.4 | ) | 25.0 | (406.0 | ) | 183.6 | ||||||||||
Cash and cash equivalents at beginning of period
|
712.0 | 657.5 | 550.6 | 498.9 | ||||||||||||
Cash and cash equivalents at end of period
|
144.6 | 682.5 | 144.6 | 682.5 |
![]() |
16 |
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 | |||||||||||||
Numerator for basic EPS
|
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 EPS
|
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:
|
||||||||||||||||
Stock options(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 |
3 months to
|
3 months to
|
6 months to
|
6 months to
|
|||||||||||||
June 30,
|
June 30,
|
June 30,
|
June 30,
|
|||||||||||||
2011
|
2010
|
2011
|
2010
|
|||||||||||||
Millions
|
Millions
|
Millions
|
Millions
|
|||||||||||||
Share awards(1)
|
2.9 | 8.1 | 3.8 | 8.1 |
![]() |
17 |
3 months to June 30,
|
2011
|
2010
|
2011
|
2011
|
||||||||||||
|
|
%
|
% of total
|
|||||||||||||
$M | $M |
change
|
revenue
|
|||||||||||||
Net product sales:
|
|
|
||||||||||||||
SP
|
|
|
||||||||||||||
ADHD
|
|
|
||||||||||||||
VYVANSE
|
185.9 | 148.0 | 26 | % | 17 | % | ||||||||||
ADDERALL XR
|
146.9 | 80.4 | 83 | % | 14 | % | ||||||||||
INTUNIV
|
59.6 | 51.2 | 16 | % | 6 | % | ||||||||||
EQUASYM
|
5.9 | 8.2 | -28 | % |
<1
|
% | ||||||||||
DAYTRANA
|
- | 16.3 | n/a | n/a | ||||||||||||
398.3 | 304.1 | 31 | % | 37 | % | |||||||||||
GI
|
||||||||||||||||
LIALDA/MEZAVANT
|
99.2 | 69.6 | 43 | % | 9 | % | ||||||||||
PENTASA
|
65.8 | 60.6 | 9 | % | 6 | % | ||||||||||
RESOLOR
|
1.6 | - | n/a |
<1
|
% | |||||||||||
166.6 | 130.2 | 28 | % | 16 | % | |||||||||||
Regenerative Medicine
|
||||||||||||||||
DERMAGRAFT
|
2.0 | - | n/a |
<1
|
% | |||||||||||
2.0 | - | n/a |
<1
|
% | ||||||||||||
General products
|
||||||||||||||||
FOSRENOL
|
45.3 | 45.1 | - | 4 | % | |||||||||||
XAGRID®
|
23.2 | 21.6 | 7 | % | 2 | % | ||||||||||
CARBATROL®
|
16.7 | 23.0 | -27 | % | 2 | % | ||||||||||
85.2 | 89.7 | -5 | % | 8 | % | |||||||||||
Other product sales
|
24.6 | 27.3 | -10 | % | 2 | % | ||||||||||
Total SP product sales
|
676.7 | 551.3 | 23 | % | 64 | % | ||||||||||
HGT
|
||||||||||||||||
ELAPRASE
|
127.8 | 99.8 | 28 | % | 12 | % | ||||||||||
REPLAGAL
|
119.9 | 81.9 | 46 | % | 11 | % | ||||||||||
VPRIV
|
63.3 | 28.7 | 121 | % | 6 | % | ||||||||||
FIRAZYR
|
5.6 | 2.6 | 115 | % |
<1
|
% | ||||||||||
Total HGT product sales
|
316.6 | 213.0 | 49 | % | 29 | % | ||||||||||
Total product sales
|
993.3 | 764.3 | 30 | % | 93 | % | ||||||||||
Royalties:
|
||||||||||||||||
ADDERALL XR
|
26.9 | 27.5 | -2 | % | 3 | % | ||||||||||
FOSRENOL
|
12.4 | 6.0 | 107 | % | 1 | % | ||||||||||
3TC and ZEFFIX
|
11.3 | 38.1 | -70 | % | 1 | % | ||||||||||
Other
|
12.8 | 11.1 | 15 | % | 1 | % | ||||||||||
Total royalties
|
63.4 | 82.7 | -23 | % | 6 | % | ||||||||||
Other revenues
|
6.2 | 2.4 | 158 | % | 1 | % | ||||||||||
Total Revenues
|
1,062.9 | 849.4 | 25 | % | 100 | % |
![]() |
18 |
6 months to June 30,
|
2011
|
2010
|
2011
|
2011
|
||||||||||||
|
|
%
|
% of total
|
|||||||||||||
$M | $M |
change
|
revenue
|
|||||||||||||
Net product sales:
|
|
|
||||||||||||||
SP
|
|
|
||||||||||||||
ADHD
|
|
|
||||||||||||||
VYVANSE
|
388.2 | 302.4 | 28 | % | 19 | % | ||||||||||
ADDERALL XR
|
258.1 | 172.2 | 50 | % | 13 | % | ||||||||||
INTUNIV
|
101.5 | 85.7 | 18 | % | 5 | % | ||||||||||
EQUASYM
|
10.5 | 10.6 | -1 | % |
<1
|
% | ||||||||||
DAYTRANA
|
- | 34.7 | n/a | n/a | ||||||||||||
758.3 | 605.6 | 25 | % | 37 | % | |||||||||||
GI
|
||||||||||||||||
LIALDA/MEZAVANT
|
186.3 | 133.2 | 40 | % | 9 | % | ||||||||||
PENTASA
|
130.3 | 118.8 | 10 | % | 6 | % | ||||||||||
RESOLOR
|
2.5 | - | n/a |
<1
|
% | |||||||||||
319.1 | 252.0 | 27 | % | 16 | % | |||||||||||
Regenerative Medicine
|
||||||||||||||||
DERMAGRAFT
|
2.0 | - | n/a |
<1
|
% | |||||||||||
2.0 | - | n/a |
<1
|
% | ||||||||||||
General products
|
||||||||||||||||
FOSRENOL
|
86.5 | 92.1 | -6 | % | 4 | % | ||||||||||
XAGRID
|
45.9 | 45.0 | 2 | % | 2 | % | ||||||||||
CARBATROL
|
33.3 | 43.1 | -23 | % | 2 | % | ||||||||||
165.7 | 180.2 | -8 | % | 8 | % | |||||||||||
Other product sales
|
47.7 | 54.8 | -13 | % | 2 | % | ||||||||||
Total SP product sales
|
1,292.8 | 1,092.6 | 18 | % | 64 | % | ||||||||||
HGT
|
||||||||||||||||
ELAPRASE
|
231.3 | 200.6 | 15 | % | 11 | % | ||||||||||
REPLAGAL
|
225.3 | 149.9 | 50 | % | 11 | % | ||||||||||
VPRIV
|
122.3 | 34.5 | 254 | % | 6 | % | ||||||||||
FIRAZYR
|
10.9 | 4.8 | 127 | % |
<1
|
% | ||||||||||
Total HGT product sales
|
589.8 | 389.8 | 51 | % | 29 | % | ||||||||||
Total product sales
|
1,882.6 | 1,482.4 | 27 | % | 93 | % | ||||||||||
Royalties:
|
||||||||||||||||
3TC and ZEFFIX
|
46.8 | 74.7 | -37 | % | 2 | % | ||||||||||
ADDERALL XR
|
43.7 | 68.3 | -36 | % | 2 | % | ||||||||||
FOSRENOL
|
20.5 | 11.1 | 85 | % | 1 | % | ||||||||||
Other
|
26.0 | 23.9 | 9 | % | 1 | % | ||||||||||
Total royalties
|
137.0 | 178.0 | -23 | % | 6 | % | ||||||||||
Other revenues
|
15.5 | 5.1 | 204 | % | 1 | % | ||||||||||
Total Revenues
|
2,035.1 | 1,665.5 | 22 | % | 100 | % |
![]() |
19 |
US GAAP
|
Adjustments
|
Non GAAP
|
||||||||||||||||||||||
3 months to,
|
June 30,
2011
|
Amortization
& asset
impairments
|
Acquisitions
& integration
activities
|
Divestments,
reorganizations
& discontinued
operations
|
Reclassify
depreciation
|
June 30,
2011
|
||||||||||||||||||
|
(a)
|
(b)
|
(c)
|
(d)
|
|
|||||||||||||||||||
$M | $M | $M | $M | $M | $M | |||||||||||||||||||
Total revenues
|
1,062.9 | - | - | - | - | 1,062.9 | ||||||||||||||||||
Costs and expenses:
|
||||||||||||||||||||||||
Cost of product sales
|
143.7 | - | - | (2.8 | ) | (8.3 | ) | 132.6 | ||||||||||||||||
Research and development
|
176.9 | - | - | - | (6.1 | ) | 170.8 | |||||||||||||||||
Selling, general and administrative
|
440.3 | (36.7 | ) | - | - | (15.1 | ) | 388.5 | ||||||||||||||||
Loss on sale of product rights
|
2.2 | - | - | (2.2 | ) | - | - | |||||||||||||||||
Reorganization costs
|
7.5 | - | - | (7.5 | ) | - | - | |||||||||||||||||
Integration and acquisition costs
|
9.0 | - | (9.0 | ) | - | - | - | |||||||||||||||||
Depreciation
|
- | - | - | - | 29.5 | 29.5 | ||||||||||||||||||
Total operating expenses
|
779.6 | (36.7 | ) | (9.0 | ) | (12.5 | ) | - | 721.4 | |||||||||||||||
Operating income
|
283.3 | 36.7 | 9.0 | 12.5 | - | 341.5 | ||||||||||||||||||
Interest income
|
0.6 | - | - | - | - | 0.6 | ||||||||||||||||||
Interest expense
|
(9.9 | ) | - | - | - | - | (9.9 | ) | ||||||||||||||||
Total other expense, net
|
(9.3 | ) | - | - | - | - | (9.3 | ) | ||||||||||||||||
Income before income taxes and equity in earnings of equity method investees
|
274.0 | 36.7 | 9.0 | 12.5 | - | 332.2 | ||||||||||||||||||
Income taxes
|
(69.7 | ) | (3.9 | ) | (1.1 | ) | (2.4 | ) | (77.1 | ) | ||||||||||||||
Equity in earnings of equity method investees, net of tax
|
1.2 | - | - | - | - | 1.2 | ||||||||||||||||||
Net income
|
205.5 | 32.8 | 7.9 | 10.1 | - | 256.3 | ||||||||||||||||||
Impact of convertible debt, net of tax
|
8.4 | - | - | - | - | 8.4 | ||||||||||||||||||
Numerator for diluted EPS
|
213.9 | 32.8 | 7.9 | 10.1 | - | 264.7 | ||||||||||||||||||
Weighted average number of shares (millions) – diluted
|
595.1 | - | - | - | - | 595.1 | ||||||||||||||||||
Diluted earnings per ADS
|
107.7 | c | 16.5 | c | 4.1 | c | 5.1 | c | 133.4 | c |
(a)
|
Amortization and asset impairments: Amortization of intangible assets relating to intellectual property rights acquired ($36.7 million), and tax effect of adjustments;
|
(b)
|
Acquisition and integration activities: Costs associated with the acquisition and integration of ABH ($6.9 million) and integration of Movetis ($2.1 million), and tax effect of adjustments;
|
(c)
|
Divestments, reorganizations and discontinued operations: Accelerated depreciation ($2.2 million) and dual running costs ($0.6 million) on the transfer of manufacturing from Owings Mills to a third party, re-measurement of DAYTRANA contingent consideration to fair value ($2.2 million), reorganization costs ($7.5 million) on the transfer of manufacturing from Owings Mills to a third party and establishment of an international commercial hub in Switzerland, and tax effect of adjustments; and
|
(d)
|
Depreciation: Depreciation of $29.5 million included in Cost of product sales, R&D costs and SG&A costs for US GAAP separately disclosed for the presentation of Non GAAP earnings.
|
![]() |
20 |
US GAAP
|
Adjustments
|
Non GAAP
|
||||||||||||||||||
3 months to,
|
June 30,
2010
|
Amortization & asset impairments
|
Divestments, reorganizations & discontinued operations
|
Reclassify depreciation
|
June 30,
2010
|
|||||||||||||||
|
(a)
|
(b)
|
(c)
|
|
||||||||||||||||
$M | $M | $M | $M | $M | ||||||||||||||||
Total revenues
|
849.4 | - | - | - | 849.4 | |||||||||||||||
Costs and expenses:
|
||||||||||||||||||||
Cost of product sales
|
119.1 | - | (7.4 | ) | (3.8 | ) | 107.9 | |||||||||||||
Research and development
|
147.0 | - | - | (3.5 | ) | 143.5 | ||||||||||||||
Selling, general and administrative
|
354.4 | (33.8 | ) | - | (16.6 | ) | 304.0 | |||||||||||||
Gain on sale of product rights
|
(4.1 | ) | - | 4.1 | - | - | ||||||||||||||
Reorganization costs
|
8.6 | - | (8.6 | ) | - | - | ||||||||||||||
Depreciation
|
- | - | - | 23.9 | 23.9 | |||||||||||||||
Total operating expenses
|
625.0 | (33.8 | ) | (11.9 | ) | - | 579.3 | |||||||||||||
Operating income
|
224.4 | 33.8 | 11.9 | - | 270.1 | |||||||||||||||
Interest income
|
0.5 | - | - | - | 0.5 | |||||||||||||||
Interest expense
|
(8.3 | ) | - | - | - | (8.3 | ) | |||||||||||||
Other expense, net
|
(2.6 | ) | - | - | - | (2.6 | ) | |||||||||||||
Total other expense, net
|
(10.4 | ) | - | - | - | (10.4 | ) | |||||||||||||
Income before income taxes and equity in earnings of equity method investees
|
214.0 | 33.8 | 11.9 | - | 259.7 | |||||||||||||||
Income taxes
|
(54.5 | ) | (9.6 | ) | (1.9 | ) | - | (66.0 | ) | |||||||||||
Equity in earnings of equity method investees, net of tax
|
1.0 | - | - | - | 1.0 | |||||||||||||||
Net income
|
160.5 | 24.2 | 10.0 | - | 194.7 | |||||||||||||||
Impact of convertible debt, net of tax
|
8.4 | - | - | - | 8.4 | |||||||||||||||
Numerator for diluted EPS
|
168.9 | 24.2 | 10.0 | - | 203.1 | |||||||||||||||
Weighted average number of shares (millions) – diluted
|
590.0 | - | - | - | 590.0 | |||||||||||||||
Diluted earnings per ADS
|
85.8 | c | 12.3 | c | 5.1 | c | - | 103.2 | c |
(a)
|
Amortization and asset impairments: Amortization of intangible assets relating to intellectual property rights acquired ($33.8 million), and tax effect of adjustment;
|
(b)
|
Divestments, reorganizations and discontinued operations: Accelerated depreciation ($6.0 million), dual running costs ($1.4 million) on the transfer of manufacturing from Owings Mills, gain on sale of products rights relating to the disposal of non core products to Laboratorios Almirall S.A. ($4.1 million) and reorganization costs ($8.6 million) on the transfer of manufacturing from Owings Mills and establishment of an international commercial hub in Switzerland, and tax effect of adjustments; and
|
(c)
|
Depreciation: Depreciation of $23.9 million included in Cost of product sales, R&D costs and SG&A costs for US GAAP separately disclosed for the presentation of Non GAAP earnings.
|
![]() |
21 |
US GAAP
|
Adjustments
|
Non GAAP
|
||||||||||||||||||||||
6 months to,
|
June 30,
2011
|
Amortization
& asset
impairments
|
Acquisitions
& integration
activities
|
Divestments,
reorganizations
& discontinued
operations
|
Reclassify
depreciation
|
June 30,
2011
|
||||||||||||||||||
|
(a)
|
(b)
|
(c)
|
(d)
|
|
|||||||||||||||||||
$M | $M | $M | $M | $M | $M | |||||||||||||||||||
Total revenues
|
2,035.1 | - | - | - | - | 2,035.1 | ||||||||||||||||||
Costs and expenses:
|
||||||||||||||||||||||||
Cost of product sales
|
268.2 | - | - | (5.6 | ) | (13.8 | ) | 248.8 | ||||||||||||||||
Research and development
|
354.8 | - | - | - | (10.8 | ) | 344.0 | |||||||||||||||||
Selling, general and administrative
|
843.2 | (72.7 | ) | - | - | (29.7 | ) | 740.8 | ||||||||||||||||
Loss on sale of product rights
|
3.5 | - | - | (3.5 | ) | - | - | |||||||||||||||||
Reorganization costs
|
13.0 | - | - | (13.0 | ) | - | - | |||||||||||||||||
Integration & acquisition costs
|
2.6 | - | (2.6 | ) | - | - | - | |||||||||||||||||
Depreciation
|
- | - | - | - | 54.3 | 54.3 | ||||||||||||||||||
Total operating expenses
|
1,485.3 | (72.7 | ) | (2.6 | ) | (22.1 | ) | - | 1,387.9 | |||||||||||||||
Operating income
|
549.8 | 72.7 | 2.6 | 22.1 | - | 647.2 | ||||||||||||||||||
Interest income
|
1.2 | - | - | - | - | 1.2 | ||||||||||||||||||
Interest expense
|
(19.1 | ) | - | - | - | - | (19.1 | ) | ||||||||||||||||
Other income, net
|
0.3 | 2.4 | - | - | - | 2.7 | ||||||||||||||||||
Total other expense, net
|
(17.6 | ) | 2.4 | - | - | - | (15.2 | ) | ||||||||||||||||
Income before income taxes and equity in earnings of equity method investees
|
532.2 | 75.1 | 2.6 | 22.1 | - | 632.0 | ||||||||||||||||||
Income taxes
|
(117.8 | ) | (15.8 | ) | (4.9 | ) | (4.4 | ) | (142.9 | ) | ||||||||||||||
Equity in earnings of equity method investees, net of tax
|
2.4 | - | - | - | - | 2.4 | ||||||||||||||||||
Net income
|
416.8 | 59.3 | (2.3 | ) | 17.7 | - | 491.5 | |||||||||||||||||
Impact of convertible debt, net of tax
|
16.8 | - | - | - | - | 16.8 | ||||||||||||||||||
Numerator for diluted EPS
|
433.6 | 59.3 | (2.3 | ) | 17.7 | - | 508.3 | |||||||||||||||||
Weighted average number of shares (millions) – diluted
|
594.8 | - | - | - | - | 594.8 | ||||||||||||||||||
Diluted earnings per ADS
|
218.7 | c | 29.9 | c | (1.1c | ) | 8.9 | c | - | 256.4 | c |
(a)
|
Amortization and asset impairments: Amortization of intangible assets relating to intellectual property rights acquired ($72.7 million), impairment of available for sale securities ($2.4 million), and tax effect of adjustments;
|
(b)
|
Acquisitions and integration activities: Costs associated with acquisition and integration of ABH ($6.9 million) and integration of Movetis ($3.9 million), adjustment to contingent consideration payable for EQUASYM ($8.2 million), and tax effect of adjustments;
|
(c)
|
Divestments, reorganizations and discontinued operations: Accelerated depreciation ($4.4 million) and dual running costs ($1.2 million) on the transfer of manufacturing from Owings Mills to a third party, re-measurement of DAYTRANA contingent consideration to fair value ($3.5 million), reorganization costs ($13.0 million) on the transfer of manufacturing from Owings Mills to a third party and the establishment of an international commercial hub in Switzerland, and tax effect of adjustments; and
|
(d)
|
Depreciation: Depreciation of $54.3 million included in Cost of product sales, R&D costs and SG&A costs for US GAAP separately disclosed for the presentation of Non GAAP earnings.
|
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22 |
US GAAP
|
Adjustments
|
Non GAAP
|
||||||||||||||||||||||
6 months to,
|
June 30,
2010
|
Amortization
& asset
impairments
|
Acquisitions
& integration
activities
|
Divestments,
reorganizations
& discontinued
operations
|
Reclassify depreciation
|
June 30,
2010
|
||||||||||||||||||
|
(a)
|
(b)
|
(c)
|
(d)
|
|
|||||||||||||||||||
$M | $M | $M | $M | $M | $M | |||||||||||||||||||
Total revenues
|
1,665.5 | - | - | - | - | 1,665.5 | ||||||||||||||||||
Costs and expenses:
|
||||||||||||||||||||||||
Cost of product sales
|
221.0 | - | - | (14.7 | ) | (6.3 | ) | 200.0 | ||||||||||||||||
Research and development
|
278.0 | - | - | - | (7.2 | ) | 270.8 | |||||||||||||||||
Selling, general and administrative
|
714.3 | (68.4 | ) | - | - | (32.9 | ) | 613.0 | ||||||||||||||||
Gain on sale of product rights
|
(4.1 | ) | - | - | 4.1 | - | - | |||||||||||||||||
Reorganization costs
|
13.6 | - | - | (13.6 | ) | - | - | |||||||||||||||||
Integration and acquisition costs
|
0.6 | - | (0.6 | ) | - | - | - | |||||||||||||||||
Depreciation
|
- | - | - | - | 46.4 | 46.4 | ||||||||||||||||||
Total operating expenses
|
1,223.4 | (68.4 | ) | (0.6 | ) | (24.2 | ) | - | 1,130.2 | |||||||||||||||
Operating income
|
442.1 | 68.4 | 0.6 | 24.2 | - | 535.3 | ||||||||||||||||||
Interest income
|
0.8 | - | - | - | - | 0.8 | ||||||||||||||||||
Interest expense
|
(17.3 | ) | - | - | - | - | (17.3 | ) | ||||||||||||||||
Other income/(expense), net
|
8.2 | - | - | (11.1 | ) | - | (2.9 | ) | ||||||||||||||||
Total other expense, net
|
(8.3 | ) | - | - | (11.1 | ) | - | (19.4 | ) | |||||||||||||||
Income before income taxes and equity in earnings of equity method investees
|
433.8 | 68.4 | 0.6 | 13.1 | - | 515.9 | ||||||||||||||||||
Income taxes
|
(108.1 | ) | (19.3 | ) | (0.1 | ) | (5.0 | ) | - | (132.5 | ) | |||||||||||||
Equity in earnings of equity method investees, net of tax
|
0.5 | - | - | - | - | 0.5 | ||||||||||||||||||
Net income
|
326.2 | 49.1 | 0.5 | 8.1 | - | 383.9 | ||||||||||||||||||
Impact of convertible debt, net of tax
|
16.8 | - | - | - | - | 16.8 | ||||||||||||||||||
Numerator for diluted EPS
|
343.0 | 49.1 | 0.5 | 8.1 | - | 400.7 | ||||||||||||||||||
Weighted average number of shares (millions) – diluted
|
589.1 | - | - | - | - | 589.1 | ||||||||||||||||||
Diluted earnings per ADS
|
174.6 | c | 25.0 | c | 0.3 | c | 4.1 | c | - | 204.0 | c |
(a)
|
Amortization and asset impairments: Amortization of intangible assets relating to intellectual property rights acquired ($68.4 million), and tax effect of adjustment;
|
(b)
|
Acquisitions and integration activities: Costs associated with the acquisition of EQUASYM ($0.6 million), and tax effect of adjustments;
|
(c)
|
Divestments, reorganizations and discontinued operations: Accelerated depreciation ($12.1 million) and dual running costs ($2.6 million) on the transfer of manufacturing from Owings Mills, gain on sale of product rights relating to the disposal of non core products to Laboratorios Almirall S.A. ($4.1 million), reorganization costs ($13.6m) on the transfer of manufacturing from Owings Mills and the establishment of an international commercial hub in Switzerland, gain on disposal of the investment in Virochem ($11.1 million), and tax effect of adjustments; and
|
(d)
|
Depreciation: Depreciation of $46.4 million included in Cost of product sales, R&D costs and SG&A costs for US GAAP separately disclosed for the presentation of Non GAAP earnings.
|
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23 |
|
3 months to June 30,
|
6 months to June 30,
|
||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
||||||||||||
|
$M | $M | $M | $M | ||||||||||||
Net cash provided by operating activities
|
283.6 | 283.8 | 485.5 | 469.9 | ||||||||||||
Tax and interest payments, net
|
156.4 | 127.6 | 162.8 | 217.7 | ||||||||||||
Non GAAP cash generation
|
440.0 | 411.4 | 648.3 | 687.6 |
|
3 months to June 30,
|
6 months to June 30,
|
||||||||||||||
|
2011
|
2010
|
2011
|
2010
|
||||||||||||
|
$M | $M | $M | $M | ||||||||||||
Net cash provided by operating activities
|
283.6 | 283.8 | 485.5 | 469.9 | ||||||||||||
Capital expenditure(1)
|
(48.5 | ) | (45.3 | ) | (95.0 | ) | (88.9 | ) | ||||||||
Non GAAP free cash flow
|
235.1 | 238.5 | 390.5 | 381.0 |
|
June 30,
|
December 31,
|
||||||
|
2011
|
2010
|
||||||
|
$M | $M | ||||||
Cash and cash equivalents
|
144.6 | 550.6 | ||||||
Restricted cash
|
21.9 | 26.8 | ||||||
|
||||||||
Convertible bonds
|
(1,100.0 | ) | (1,100.0 | ) | ||||
Revolving credit facility
|
(30.0 | ) | - | |||||
Building finance obligation
|
(8.4 | ) | (8.4 | ) | ||||
Non GAAP net debt
|
(971.9 | ) | (531.0 | ) |
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24 |
This press release contains financial measures not prepared in accordance with US GAAP. These measures are referred to as “Non GAAP” measures and include: Non GAAP operating income; Non GAAP net income; Non GAAP diluted earnings per ADS; effective tax rate on Non GAAP income before income taxes and earnings of equity method investees (“Effective tax rate on Non GAAP income”); Non GAAP cost of product sales; Non GAAP research and development; Non GAAP selling, general and administrative; Non GAAP other income; Non GAAP cash generation; Non GAAP free cashflow and Non GAAP net debt. These Non GAAP measures exclude the effect of certain cash and non-cash items, that Shire's management believes are not related to the core performance of Shire’s business.
|
·
|
Intangible asset amortization and impairment charges; and
|
·
|
Other than temporary impairment of investments.
|
·
|
Upfront payments and milestones in respect of in-licensed and acquired products;
|
·
|
Costs associated with acquisitions, including transaction costs, fair value adjustments on contingent consideration and acquired inventory;
|
·
|
Costs associated with the integration of companies; and
|
·
|
Noncontrolling interest in consolidated variable interest entities.
|
·
|
Gains and losses on the sale of non-core assets;
|
·
|
Costs associated with restructuring and re-organization activities;
|
·
|
Termination costs; and
|
·
|
Income / (losses) from discontinued operations.
|
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25 |
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26 |