UK Headquarters
Hampshire International Business Park
Chineham Basingstoke
Hampshire RG24 8EP
United Kingdom
Tel +44 (0)1256 894000
Fax +44 (0)1256 894708
www.shire.com

Press Release
Shire delivers strong quarter: driven by $243m of new
product sales (+164% YOY growth). Revenue guidance
upgraded.
Basingstoke, UK and Philadelphia, US – July 31, 2008 – Shire Limited (LSE: SHP, NASDAQ: SHPGY) the
global specialty biopharmaceutical company announces results for the three months to June 30, 2008.
Q2 2008 Financial Highlights•

Product sales up 40% to $706m•

Product sales excluding ADDERALL XR® up 64% to $409m•

New product sales(1) $243m, 34% of product sales (2007: 18%)•

Total revenues up 35% to $776m•

US GAAP earnings per ADS: loss $0.44 (2007: loss $9.93)•

Non GAAP earnings per ADS up 70% to $0.95 (2007: $0.56)•

Revenue guidance upgraded - 2008 revenue growth now expected to be at least 20% (previous
guidance: mid to high teens)(1) New product sales comprise DAYTRANA, ELAPRASE, FOSRENOL, LIALDA / MEZAVANT and VYVANSE

Angus Russell, Chief Executive Officer, commented:“Shire continues to deliver strong growth and broaden its business in specialty biopharmaceuticals. Our
product sales for the quarter were up 40% on Q2 2007 with sales of new products now comprising 34% of
total product sales. At $409m, product sales excluding ADDERALL XR were up 64% reflecting the
success of our strategy to build a pipeline and portfolio for Shire’s future growth.
We are pleased with the performance of ELAPRASE, FOSRENOL, LIALDA, REPLAGAL andVYVANSE and are looking forward to the continued growth of VYVANSE in the US supplemented by the
recent launch of the adult indication, the additional dosage strengths and the back-to-school season.
We have decided to commence a phased discontinuation of DYNEPO. Resources supporting this productwill be re-directed to faster growing, profitable core global products.
The proposed acquisition of Jerini AG in Germany, which we expect to complete in Q3, is an excellent
match for our business and we expect to benefit from both its near term revenues and long term growth.
®
The recent EU approval of Jerini's orphan drug FIRAZYR reinforces our confidence in this product.
In addition to FIRAZYR, we have acquired seven new products since the start of 2007 which supports
delivery of our long term strategy. Shire is in line to deliver another set of excellent results for 2008 and is
upgrading its full year guidance for total revenue growth from the mid to high teens to at least 20%.”

Shire Limited Incorporated and registered in Jersey No. 99854
Registered Office: 22 Grenville Street, St Helier, Jersey JE4 8PX1

Q2 2008 Unaudited Results
Q2 2007

Q2 2008(1)

US GAAP

Adjustments

Non GAAP(1)

$M

$M

$M

$M

$M

775.6

-

775.6

574.9

-

574.9

Operating(loss)/income(67.3)

313.8

246.5

(1,775.1)

1,915.8

140.7

Net (loss)/income(79.0)

267.1

188.1

(1,811.3)

1,916.6

105.3

Ordinary share(14.6c)

46.2c

31.6c

(331.0c)349.6c18.6c

ADS(43.8c)138.6c94.8c(993.0c)

1,048.8c

55.8c

US GAAP

Adjustments$M
Revenues

Non GAAP

Diluted (loss)/earnings
per:Note: Average exchange rates for Q2 2008 and Q2 2007 were $1.97: £1.00 and $1.98: £1.00, respectively.
(1)

Non GAAP operating income, Non GAAP net income, Non GAAP diluted earnings per ordinary share and Non GAAP diluted
earnings per ADS exclude intangible asset amortization charges and other items as described on page 7. For an explanation of
why Shire's management believes that these Non GAAP financial measures are useful to investors, see page 7. For areconciliation of these Non GAAP financial measures to the most directly comparable financial measures prepared inaccordance with US GAAP, see pages 25-28.

2008 Financial Outlook
Apart from the updates below, we reiterate the guidance given as part of the first quarter 2008 results,
including confirmation that we expect VYVANSE sales to be at the lower end of a range of $350 to $400
million. In combination, the updates constitute upgraded guidance following a strong performance in thefirst half of 2008. This guidance excludes revenues and costs associated with the proposed acquisition ofJerini AG (“Jerini”):•

Revenue growth to be at least 20% (previous guidance: mid to high teens);•

Capital expenditure to be in the range $300 to $330 million (previous guidance: $320 to $350 million);•

Depreciation to be approximately $75 million (previous guidance: approximately $90 million); and•R&D spend is being increased to approximately $500 million (previous guidance: $465 to $490
million). This increase reflects Shire’s strong pipeline with the completion during Q2 of the acquisitionTMof METAZYM (arylsulfatase-A), and the acceleration of various core projects including the Phase 3
trials for velaglucerase alfa.

The following items are excluded from net (loss)/income in calculating Non GAAP earnings, all of which
are excluded from our financial outlook:•

Intangible asset amortization charges;•

Gains and losses on the sale of non-core assets;•

Upfront payments and milestones in respect of in-licensed and acquired products, including thepayment to Zymenex A/S (“Zymenex”) for METAZYM of $135 million;•

Intangible asset impairment charges, inventory write-downs and exit costs of $150 million associatedwith DYNEPO, which Shire has decided to stop commercializing;•

Costs associated with the introduction of a new holding company, expected to be approximately $15
million; and•Taxes associated with these items.

In addition depreciation, which is included in cost of product sales, R&D costs and selling, general andadministrative costs in our GAAP results, has been separately disclosed for the presentation of non GAAP
earnings (see pages 25 to 28).

2

Recent Developments
Proposed acquisition of Jerini
On July 3, 2008 Shire announced that it was launching a voluntary public takeover offer for all shares inJerini for an equity purchase price of €328 million. Shire has also invested approximately €21 million in
return for the subscription of newly issued Jerini shares, equating to approximately 9% of the increased
share capital. Jerini's Supervisory and Management Boards unanimously support the transaction and will
recommend acceptance of the offer to its shareholders. Subject to completion of certain sale andpurchase agreements, Shire has rights to approximately 76% of Jerini’s share capital before the receipt ofany takeover offer acceptances. Once the offer document is posted, it is anticipated that the offer will be
open for acceptance by the remaining shareholders until the end of Q3 2008 and is contingent upon thefulfilment of certain customary terms and conditions, including approval by relevant merger control
authorities.
®
The proposed acquisition will add Jerini’s hereditary angioedema (“HAE”) product, FIRAZYR (icatibant),(expected to be launched in the EU in H2 2008) to Shire’s Human Genetic Therapies (“HGT”) portfolio.

On July 15, 2008 Shire announced that the European Commission had granted Jerini marketing
authorization for FIRAZYR in the treatment of acute attacks of HAE which allows Jerini to market
FIRAZYR in the European Union’s 27 member states, making it the first product to be approved in all EU
countries for the treatment of HAE.
On July 17, 2008 the German Federal Cartel Office issued confirmation of merger clearance.
For further details see Shire’s press releases of July 3 and July 15, 2008.
DYNEPOThe Company has today announced that it has decided to stop the commercialization of DYNEPO.
Changes in the external environment including the launch of several bio-similars at lower prices have
proved challenging for DYNEPO, a gene-activated erythropoietin indicated for use in treating anemia
associated with kidney disease, making it an uneconomic product for Shire. Product sales will wind downover the second half of 2008 as all patients are transferred off DYNEPO by the end of the year.
Shire has recorded charges of $150.3 million in the quarter ended June 30, 2008 to cover intangible asset
impairment, inventory write-down and other exit costs. The cash effect of these exit costs is approximately$20 million.

Product Highlights
New Product Launches - subject to obtaining relevant regulatory/governmental approvals, productlaunches planned over the next two years include:®

•

MEZAVANT (mesalazine) in certain EU countries during 2008;•

INTUNIVTM (guanfacine) for use in children and adolescents in the US in 2009;•

FOSRENOL® (lanthanum carbonate) in the pre-dialysis Chronic Kidney Disease (“CKD”) market in the
US in 2009;•

TM
DAYTRANA (methylphenidate transdermal system) for use in children in the EU in 2009 andadolescents in the US in 2010; and•Velaglucerase alfa for the treatment of Gaucher disease in the US and the EU in 2010.
TM

VYVANSE(lisdexamfetamine dimesylate) – Attention Deficit and Hyperactivity Disorder (“ADHD”)•

On April 23, 2008 Shire announced that the Food and Drug Administration (“FDA”) had approved theadult indication for VYVANSE, making it the first and only once-daily prodrug stimulant approved totreat adults with ADHD. Shire launched VYVANSE for adult ADHD in June 2008.

•

On May 8, 2008 Shire announced the results of a Phase 3 pivotal study in which VYVANSE
demonstrated significant improvements in ADHD symptoms in adults and met all safety and efficacy
endpoints.

•

By June 30, 2008 Shire had agreements with nine of its top eleven managed care organizations for
VYVANSE.

3

•On July 2, 2008 Shire shipped to wholesalers stocks of three additional dosage strengths (20mg,
40mg and 60mg) for VYVANSE representing product sales of approximately $24 million. These
product sales will be recognized into revenue in Q3 2008.
®

LIALDA /MEZAVANT – Ulcerative Colitis•

On April 1, 2008 the product was launched in Ireland as MEZAVANT XL and, following approval in
Luxembourg on June 26, 2008, is now approved in 15 countries. Further launches are planned incertain other EU countries during 2008, subject to the successful conclusion of pricing andreimbursement negotiations.

•

During April 2008, TAP Pharmaceutical Products Inc. (“TAP”) commenced co-promotion of LIALDA in
the US in accordance with the co-promotion agreement entered into on March 26, 2008. Thisagreement adds more than 500 additional sales representatives from TAP which will increase thereach and frequency of sales calls covering an additional 22,000 doctors.

FOSRENOL – Hyperphosphatemia•

Following the launch of the product in Slovenia and Switzerland during the second quarter of 2008
and in Malta and Malaysia in July 2008, FOSRENOL is now available in 29 countries.

ELAPRASE® – Hunter syndrome•

During the three months to June 30, 2008 ELAPRASE was approved for commercial sale in Brazil.
ELAPRASE is now approved in 40 countries worldwide.

Pipeline Highlights
INTUNIVTM - ADHD•On May 8, 2008 Shire announced pivotal trial results for INTUNIV which is in registration in the US.
The data demonstrated that INTUNIV has significant efficacy in reducing ADHD symptoms for patientstaking the medication when compared to patients taking a placebo at all measured time points up to
24 hours after dosing.

®
JUVISTA - Improvement of scar appearance•

Nine Phase 2 efficacy trials for JUVISTA have now been reported of which seven demonstrated
statistically significant efficacy. Further Phase 2 clinical trials in other surgery types are ongoing andare expected to report during 2008 and 2009. Renovo Limited (“Renovo”) is also intending to initiate a
Phase 3 trial in the second half of 2008 in support of Renovo’s filing of a European regulatory dossierand has recently announced that the European Medicines Agency (“EMEA”) has given clearance tocommence Phase 3 trials. Shire is considering the EMEA advice to Renovo and Renovo’s EU Phase
3 plans and will give guidance on the US development plan in due course.

Velaglucerase alfa - Gaucher disease•

Shire has completed enrolment in a worldwide Phase 3 clinical program for velaglucerase alfa, an
enzyme replacement therapy being developed for the treatment of Gaucher disease. This
comprehensive development program includes the evaluation of velaglucerase alfa in naïve patientsand patients previously treated with imiglucerase across three clinical studies. It is anticipated that thisdevelopment program will support global filings in the second half of 2009.

METAZYM (HGT-1111) - Metachromatic Leukodystrophy (“MLD”)•

METAZYM is being investigated for the treatment of MLD and has completed a Phase 1b clinical trial
in twelve patients in Europe and an extension to this study is ongoing. The product has been grantedorphan drug designation in the US and in the EU. The current plan is to initiate a Phase 2/3 clinical
trial by the end of 2008. This product will now be referred to as HGT-1111.
TM

PLICERA•(HGT-3410) - Gaucher disease

In March 2008 Amicus Therapeutics Inc. (“Amicus”) announced positive data from its Phase 2 clinical
trial for PLICERA. Results from this Phase 2 trial support the previously reported interim findings that
PLICERA was generally safe and well tolerated at all doses and increased target enzyme activity
levels in a majority of patients. Shire has rights to PLICERA in markets outside the US.

4

HGT-3510 - Pompe disease•

In June 2008 Amicus initiated Phase 2 clinical trials of HGT-3510, an orally administered, small
molecule pharmacological chaperone being jointly developed for the treatment of Pompe disease by
Shire and Amicus. Shire has rights to HGT-3510 in markets outside the US.

HGT-1410 - Sanfilippo syndrome (Mucopolysaccharidosis IIIA)•On May 22, 2008 orphan drug designation was granted by the FDA for HGT-1410, an enzyme
replacement therapy being developed for the treatment of Sanfilippo syndrome, a lysosomal storage
disorder. Pre-clinical development for this product is continuing.

Business Highlights
A new listed holding company for the Shire group•

On May 23, 2008 Shire Limited, a public company with its primary listing on the London Stock
Exchange (secondary listing on NASDAQ), incorporated in Jersey and tax resident in the Republic of
Ireland, became the holding company of the Shire group, pursuant to a scheme of arrangement under
Sections 895 to 899 of the United Kingdom Companies Act 2006 (the “Scheme”). The Scheme wasapproved by the High Court of England and Wales and the shareholders of Shire plc, the former
holding company of the Shire group. The introduction of a new holding company tax resident in
Ireland, is designed to help protect Shire’s tax position.

•

Immediately prior to the Scheme becoming effective, Shire Limited was substituted for Shire plc as
principal obligor under Shire’s $1.1 billion 2.75 per cent convertible bond due 2014 originally issued by
Shire plc (and the terms and conditions of such bonds were accordingly amended).

•Shire incurred costs associated with the introduction of the new holding company of $12.2 million in
the six months to June 30, 2008.

Completion of acquisition of METAZYM•

On June 4, 2008 Shire completed the acquisition of the global rights to the clinical candidate
arylsulfatase-A, currently known as METAZYM, from Zymenex for $135 million in cash (see Pipeline
Highlights above). This acquisition is expected to bring forward Shire’s entry into the MLD market.

Sale of non-core assets•

Following the transfer of the relevant marketing consents Shire recognised previously deferred gains
of $9.1 million arising from product divestments in 2007, including $8.6 million from the sale of noncore products to Laboratorios Almirall S.A (“Almirall”) in 2007.

HGT analyst day•

Shire is planning an analyst day for November 18, 2008 in Lexington, Massachusetts - specific details
will be issued nearer the date.

Share purchases•

In the three months to June 30, 2008 1.4 million American Depositary Shares (“ADSs”) were acquiredby the Employee Share Ownership Trust (“ESOT”) for a cash consideration of $71.0 million (2007:$55.5 million) at an average ADS price of $50.12.

Board changes•

On June 18, 2008 Shire’s former Chief Financial Officer, Angus Russell, became Chief Executive
Officer and Shire’s former Chief Executive Officer Matthew Emmens became Chairman and NonExecutive Director. Shire’s former Chairman, Dr James Cavanaugh, retired from the Shire Board andDavid Kappler became Deputy Chairman.

•

On July 1, 2008 Graham Hetherington joined Shire as Chief Financial Officer and Executive Board
Director. Graham Hetherington has a broad range of experience in senior financial roles having mostrecently held positions as Chief Financial Officer of Bacardi (2007) and Allied Domecq plc (19992005).

•

On April 24, 2008 Shire announced that Michael Rosenblatt M.D. joined the Shire Board as a NonExecutive Director.

•

On July 29, 2008 Robin Buchanan, due to his other commitments, stepped down from the Shire Boardon the completion of his term of office.

5

Dividend
In respect of the six months ended June 30, 2008, the Board resolved to pay an interim dividend of 2.147
US cents per ordinary share (2007: 2.147 US cents per share).
Dividend payments will be made in Pounds Sterling to Ordinary shareholders and in US Dollars to holdersof American Depository Shares (“ADSs”). A dividend of 1.085 pence per ordinary share (2007: 1.048
pence) and 6.441 US cents per ADS (2007: 6.441 US cents) will be paid on October 9, 2008 to persons
whose names appear on the register of members of the Company at the close of business on September
12, 2008.
As previously disclosed Shire intends to put in place Income Access Share arrangements enabling
shareholders to choose whether they receive their dividends from a company resident for tax purposes in
the Republic of Ireland or from a company resident for tax purposes in the United Kingdom. The
arrangements will be in place for the interim dividend. In accordance with the Shire ADS Deposit
Agreement, the ADS Depositary will make an election on behalf of all holders of ADSs to receive UK
sourced dividends. Details of the Income Access Share arrangements can be found in the Scheme
Circular issued on April 16, 2008, which is available on the Company’s website www.shire.com.

For further information please contact:
Investor Relations

Media

Cléa Rosenfeld (Rest of the World)+44 1256 894 160

Eric Rojas (North America)+1 484 595 8252

Jessica Mann (Rest of the World)+44 1256 894 280

Matthew Cabrey (North America)+1 484 595 8248

Dial in details for the live conference call for investors 14:30 BST/09:30 EDT on July 31, 2008:
UK and International dial in: +44 (0)2030234496
US dial in: 1 8669665335
Password/Conf ID: Shire
Webcast: http://www.shire.com/shire/InvestorRelations/showevent.jsp?event=73&tn=2&m1=33

6

Notes to editors
SHIRE LIMITED
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on
meeting the needs of the specialist physician. Shire focuses its business on attention deficit andhyperactivity disorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases as well
as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire’s inlicensing, merger and acquisition efforts are focused on products in specialist markets with strong
intellectual property protection and global rights. Shire believes that a carefully selected and balanced
portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong
results.
For further information on Shire, please visit the Company’s website: www.shire.com

THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT
OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forwardlooking statements involve a number of risks and uncertainties and are subject to change at any time. In
the event such risks or uncertainties materialize, the Company’s results could be materially affected. The
risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty ofpharmaceutical research, product development, manufacturing and commercialization including, but notlimited to, the establishment in the market of VYVANSE™ (lisdexamfetamine dimesylate) (Attention Deficitand Hyperactivity Disorder (“ADHD”)); the impact of competitive products, including, but not limited to, theimpact of those on the Company’s ADHD franchise; patents, including but not limited to, legal challenges
relating to the Company’s ADHD franchise; government regulation and approval, including but not limited
to the expected product approval date of INTUNIV™ (guanfacine extended release) (ADHD); theCompany’s ability to secure new products for commercialization and/or development; the Company’s
proposed offer for Jerini AG, including but not limited to, the Company’s ability to successfully complete
the offer and integrate Jerini AG, as well as realize the anticipated benefits of the acquisition; and otherrisks and uncertainties detailed from time to time in the Company’s filings with the Securities andExchange Commission, including the Company’s Annual Report on Form 10-K for the year ended
December 31, 2007.
Non GAAP Measures
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 ordinary share, Non GAAP diluted earnings per ADS andeffective tax rate on Non GAAP income. These non GAAP measures exclude the effect of certain cash
and non-cash items, both recurring and non-recurring, that Shire's management believes are not related tothe core performance of Shire’s business.
These non GAAP financial measures are used by Shire’s management to make operating decisions
because they facilitate internal comparisons of the Company’s performance to historical results and tocompetitors’ results. These measures are also considered by Shire’s Remuneration Committee inassessing the performance and compensation of employees, including its executive directors.
The non GAAP measures are presented in this press release as the Company's management believe thatthey will provide investors with a means of evaluating, and an understanding of how Shire’s management
evaluates, the Company’s performance and results on a comparable basis that is not otherwise apparent
on a US GAAP basis, since many one-time, infrequent or non-cash items that the Company’s
management believe are not indicative of the core performance of the business may not be excluded
when preparing financial measures under US GAAP.
These non GAAP measures should not be considered in isolation from, as substitutes for, or superior tofinancial measures prepared in accordance with US GAAP.

7

The following are trademarks either owned or licensed by Shire Limited or companies within the
Shire group which are the subject of trademark registrations in certain territories, or which are
owned by third parties as indicated and referred to in this press release:

Shire Product®
ADDERALL XR
AMIGAL™
®
CALCICHEW range
CARBATROL®
COMBIVIR
DAYTRANA™
®
DYNEPO®
ELAPRASE®
EPIVIR®
EPZICOM /KIVEXA (EPZICOM)®
FIRAZYR®
FOSRENOLINTUNIV™
®
JUVISTA®
LIALDAMETAZYM™
MEZAVANT®
®
PENTASAPLICERA™
®
RAZADYNE®
RAZADYNE ER®
REMINYLREMINYLREMINYL XL™
REMINYL XL®
REPLAGALVYVANSE™
XAGRID™
ZEFFIX
3TC

Active ingredient(mixed salts of a single-entity amphetamine)(migalastat hydrochloride) (trademark of Amicus Therapeutics (“Amicus”))(calcium carbonate with or without Vitamin D3)(carbamazepine - extended-release capsules)(lamivudine) (trademark of GlaxoSmithKline (“GSK”))(methylphenidate transdermal system)(epoetin delta) (trademark of Sanofi-Aventis)(idursulfase)(lamivudine) (trademark of GSK)
(lamivudine) (trademark of GSK)
(icatibant) (trademark of Jerini)(lanthanum carbonate)(guanfacine – extended release)(human TGFβ3) (trademark of Renovo)(mesalamine)(arylsulfatase-A)(mesalazine)(mesalamine) (trademark of Ferring)(isofagomine tartrate) (trademark of Amicus)(galantamine) (trademark of Johnson & Johnson (“J&J”))(galantamine) (trademark of J&J)
(galantamine hydrobromide) (UK and Republic of Ireland)(galantamine) (trademark of J&J, excluding UK and Republic of Ireland)(galantamine hydrobromide) (UK and Republic of Ireland)(galantamine) (trademark of J&J, excluding UK and Republic of Ireland)(agalsidase alfa)(lisdexamfetamine dimesylate)(anagrelide hydrochloride)(lamivudine) (trademark of GSK)
(lamivudine) (trademark of GSK)

8

OVERVIEW OF US GAAP FINANCIAL RESULTS
1.

Introduction

Summary of Q2 2008
Revenues from operations for the three months to June 30, 2008 increased by 35% to $775.6 million(2007: $574.9 million).
The operating loss for the three months to June 30, 2008 was $67.3 million (2007 loss: $1,775.1 million).
The loss in the second quarter of 2008 was due to the $135.0 million write-off of in-process research anddevelopment in respect of the acquisition of METAZYM, and the intangible asset impairment charge,
inventory write-down and exit costs ($150.3 million) in respect of DYNEPO, which Shire has decided tostop commercialising. The operating loss in the second quarter of 2007 was due to the $1,896.0 million
write-off of in-process research and development acquired as part of the $2.6 billion acquisition of New
River Pharmaceuticals Inc. (“New River”).
Cash inflow from operating activities for the three months to June 30, 2008 decreased by 1% to $180.4
million (2007: $183.0 million), as a result of the payment of $135.0 million in respect of the acquisition of
METAZYM offset by strong cash generation from underlying operations.
Cash, cash equivalents and restricted cash at June 30, 2008 totaled $835.5 million (December 31, 2007:$802.0 million). The increase of $33.5 million was less than the cash inflow from operating activities
primarily due to the purchase of property, plant and equipment, payments to acquire shares by the ESOTand the dividend payment.

2.

Product sales

For the three months to June 30, 2008 product sales increased by 40% to $705.7 million (2007: $504.2
million) and represented 91% of total revenues (2007: 88%).
Product Highlights
Product
Specialty Pharmaceuticals
ADDERALL XR
VYVANSEDAYTRANALIALDA / MEZAVANTPENTASAFOSRENOLXAGRID

Sales
$M

Sales
Growth (2)US Rx
Growth (1) (2)US Average
Quarterly Market
Share(1)

296.4
65.2
22.6
32.0
44.8
42.4
20.6

16%
n/a
14%
n/a
11%
73%
20%

-6%
n/a
-11%
n/a
-2%
-4%
n/a

23.1%
7.4%
1.8%
10.8%
16.8%
8.2%
n/a

Human Genetic Therapies
ELAPRASE
REPLAGAL

80.8
44.7

89%
40%

n/a
n/a

n/a
n/a

(1)

Product specific prescription data is provided by IMS Health (“IMS”), a leading global provider of business intelligence for the pharmaceutical andhealthcare industries. All other US market share data stated in the text below is also provided by IMS.

(2)

Compared to Q2 2007.

Specialty Pharmaceuticals
US ADHD market share
Shire’s average quarterly market share of the US ADHD market rose to 32.3% in the three months to June30, 2008 (2007: 28.6%), driven by the introduction of VYVANSE in July 2007. The overall US ADHD
market grew by 7% in the same period. Shire has the leading portfolio of products in the US ADHD
market.

ADDERALL XR – ADHD
As a result of the launch of VYVANSE in July 2007, ADDERALL XR’s average quarterly market share of
the US ADHD market for Q2 2008 fell to 23.1% (2007: 26.3%), a decrease of 12% compared to Q2 07.
US prescriptions for ADDERALL XR for the period to June 30, 2008 decreased by 6% compared to thesame period in 2007 due to the 12% decrease in average market share offset by 7% growth in the US
ADHD market.

9Sales of ADDERALL XR for the three months to June 30, 2008 were $296.4 million, an increase of 16%
compared to the same period in 2007 (2007: $255.1 million). Product sales grew despite the decline in
US prescriptions primarily due to price increases in October 2007 and April 2008.
Litigation proceedings concerning Shire’s ADDERALL XR patents are ongoing. Further information on
this litigation can be found in our filings with the US Securities and Exchange Commission (“SEC”),
including our Annual Report on Form 10-K for the year to December 31, 2007.

VYVANSE – ADHDVYVANSE was launched in the US market in July 2007. Product sales for the three months to June 30,
2008 were $65.2 million (2007: $nil) representing a 20% increase compared to sales of $54.4 million in Q1
2008.
Product sales growth was driven by a 15% increase in prescription demand compared to Q1 2008
together with a price increase in May 2008. For the three months to June 30, 2008 VYVANSE’s averagequarterly market share was 7.4% (Q1 08: 6.1%) of the US ADHD market.
By July 18, 2008 VYVANSE had achieved a US ADHD average weekly market share of 8.2% based on
weekly prescription volumes.

DAYTRANA – ADHD
Product sales for the three months to June 30, 2008 were $22.6 million (2007: $19.9 million).
Prescriptions declined by 11% from the same period last year due to a reduction in DAYTRANA’s averagequarterly market share of the US ADHD market to 1.8% (2007: 2.2%).
Despite the decrease in prescriptions compared to 2007, sales of DAYTRANA grew 14% due to higher
market growth, lower sales deductions and a price increase in January 2008.
On June 9, 2008 Shire announced a voluntary recall of a limited portion of DAYTRANA patches because
certain patches did not meet their release liner removal specifications which may have resulted in somepatients and caregivers having difficulties removing the liners. The voluntary recall was not due to safetyissues. Shire and Noven Pharmaceuticals Inc. (the manufacturer of DAYTRANA) continue to pursue
enhancements to the product and to work closely with the FDA to implement changes that may improvethe usability of DAYTRANA. No interruption in the production of DAYTRANA is anticipated.

US oral mesalamine market share
Shire’s average quarterly market share of the US oral mesalamine market rose to 27.6% in the threemonths to June 30, 2008 (2007: 19.9%), driven by the introduction of LIALDA in March 2007. The overall
US oral mesalamine market grew by 1% in the same period.

LIALDA/MEZAVANT – Ulcerative colitis
Shire launched LIALDA in the US oral mesalamine market in March 2007, and during the three months toJune 30, 2008 LIALDA had reached an average quarterly market share of 10.8%. LIALDA’s product sales
in the US for the three months to June 30, 2008 were $30.9 million (2007: $5.0 million). This compares tosales of $26.7 million and an average quarterly market share of 9.1% in Q1 2008.
Sales of MEZAVANT outside the US for the three months ended June 30, 2008 were $1.1 million (2007:$nil). The product was launched as MEZAVANT XL in the UK in November 2007 and as MEZAVANT in
Canada and Germany in January and February 2008 respectively. Shire launched MEZAVANT XL in
Ireland in April 2008 and further launches are planned in certain other EU countries during 2008, subject
to the successful conclusion of pricing and reimbursement negotiations.

PENTASA – Ulcerative colitis
Sales of PENTASA for the three months to June 30, 2008 were $44.8 million, an increase of 11%
compared to the same period in 2007 (2007: $40.2 million). Sales grew despite a decrease inprescriptions due to the impact of price increases in August 2007 and April 2008.
US prescriptions for the three months to June 30, 2008 were down 2% compared to the same period in2007 primarily due to a 3% decrease in PENTASA’s US average quarterly market share from 17.3% in2007 to 16.8% in 2008, offset by a 1% increase in the US oral mesalamine market.
10

FOSRENOL – Hyperphosphatemia
FOSRENOL has been launched in 29 countries and global sales totaled $42.4 million for the three months
to June 30, 2008 (2007: $24.5 million). Sales of FOSRENOL outside the US for the three months ended
June 30, 2008 were $19.3 million (2007: $9.0 million).
US sales of FOSRENOL for the three months to June 30, 2008 were up 49% to $23.1 million compared tothe same period in 2007 (2007: $15.5 million).
FOSRENOL’s average quarterly prescription share of the US phosphate binder retail market decreased to
8.2% for the three months to June 30, 2008 (2007: 8.5%). Contributing to product sales increase wereprice increases in October 2007 and February 2008. As a consequence of focusing on specialist
physicians, clinics and dialysis centers, FOSRENOL’s dollar share of the non-retail market has increased
to 17.2% in June 2008 compared to 12.3% in June 2007.
Effective April 16, 2008 Shire and Abbott Laboratories Inc. mutually agreed to terminate their CoPromotion Agreement for FOSRENOL in the United States. Shire will continue to promote FOSRENOL
on its own in the United States and throughout Europe.

XAGRID – Thrombocythemia
Sales for the three months to June 30, 2008 were $20.6 million, an increase of 20% compared to thesame period in 2007 (2007: $17.1 million). Expressed in transaction currencies (XAGRID is primarily soldin Euros and Pounds Sterling), sales increased by 10% due to growth in many of Shire’s existing markets,with exchange rate movements against the US dollar accounting for the remaining 10% increase.

Human Genetic Therapies
ELAPRASE – Hunter syndrome
Sales for the three months to June 30, 2008 were $80.8 million, an increase of 89% compared to thesame period in 2007 (2007: $42.7 million). The sales growth was primarily driven by increased unit sales
in North America, EU, Latin America, and Asia Pacific. The product is now approved for marketing andcommercial distribution in 40 countries. Exchange rate movements against the US dollar contributed 12%
to the growth compared to the prior year.

REPLAGAL – Fabry disease
Sales for the three months to June 30, 2008 were $44.7 million, an increase of 40% compared to thesame period in 2007 (2007: $31.9 million). The sales growth was primarily driven by increased unit sales
in the EU and Latin America. The product is now approved for marketing and commercial distribution in
42 countries. Exchange rate movements against the US dollar contributed 11% to the growth comparedto the prior year.

11

3.

Royalties

Royalty revenue increased by 1% to $64.8 million for the three months to June 30, 2008 (2007: $64.0
million). The following table provides an analysis of Shire’s royalty income:Royalty Highlights

Product
3TC

Royalties
to Shire$M
35.6

Royalty(1)
Growth%-9%

ZEFFIX

10.8

4%

Other

18.4

26%

Total

64.8

1%

(1)

Compared with Q2 2007.

3TC – HIV infection and AIDS
Shire receives royalties from GSK on worldwide 3TC sales. Royalties from sales of 3TC for the threemonths to June 30, 2008 were $35.6 million, (2007: $39.0 million). Excluding favorable foreign exchange
movements of 7%, there has been a decline of 16% compared to the same period in 2007. While thenucleoside analogue market for HIV has continued to grow, competitive pressures from new products andentrants to the market have increased, leading to a decline in 3TC sales.

ZEFFIX – Chronic hepatitis B infection
Shire receives royalties from GSK on worldwide ZEFFIX sales. Royalties from sales of ZEFFIX for thethree months to June 30, 2008 were $10.8 million, an increase of 4% (2007: $10.4 million). The impact offoreign exchange movements has contributed 13% to the reported growth; excluding favorable foreignexchange movements there has been a decrease of 9% compared to the same period in 2007.

OTHER
Other royalties are primarily in respect of REMINYL and REMINYL XL (known as RAZADYNE andRAZADYNE ER in the US), a product marketed worldwide (excluding the UK and the Republic of Ireland)
by Janssen Pharmaceutical N.V. (“Janssen”), an affiliate of Johnson & Johnson. Shire has exclusive
marketing rights in the UK and the Republic of Ireland.
Sales of the REMINYL/RAZADYNE range, for the symptomatic treatment of mild to moderately severe
dementia of the Alzheimer’s type, continue to grow.
Litigation proceedings relating to 3TC, COMBIVIR, EPIVIR, EPZICOM, RAZADYNE, RAZADYNE ER,
REMINYL, REMINYL XL and ZEFFIX are ongoing. Further information on these litigations can be foundin our filings with the SEC, including our Annual Report on Form 10-K for the year to December 31, 2007.

12

4.

Financial details

Cost of product sales

Cost of product sales (US GAAP)
Write-down of inventory and exit
costs of DYNEPO
Depreciation
Cost of product sales (Non GAAP)

2008$m_________
142.9(53.4)(3.0)_________
86.5_________% of productsales_________
20%

12%

2007
$m
_________
74.0
(2.9)
_________
71.1_________% of productsales_________
15%

14%

The cost of product sales increased to $142.9 million for the three months to June 30, 2008 (20% of
product sales), up from $74.0 million in the corresponding period in 2007 (2007: 15% of product sales).
For the three months to June 30, 2008 cost of product sales included charges of $53.4 million (8% of
product sales) (2007: $nil) relating to the write-down of inventory and other exit costs for DYNEPO, which
the Company has decided to stop commercialising, and $3.0 million of depreciation (2007: $2.9 million).
Excluding these charges, cost of product sales decreased as a percentage of product sales to 12% (2007:
14% of product sales).
Research and development (“R&D”)

R&D (US GAAP)
Payments in respect of in-licensed
products
R&D commitments in respect of
DYNEPO
Depreciation
R&D (Non GAAP)

2008$m_________
145.3% of productsales_________
21%

2007
$m
_________
103.1

-

(5.9)

(6.5)
(3.1)
_________
135.7_________(3.1)_________
94.1_________

19%% of productsales_________
20%

19%

R&D expenditure increased to $145.3 million for the three months to June 30, 2008 (21% of productsales), up from $103.1 million in the corresponding period in 2007 (20% of product sales).
Excluding costs relating to the exiting of post-approval marketing commitments for DYNEPO, which theCompany has decided to stop commercialising, and depreciation (see reconciliation table above), R&D
expenditure increased by $41.6 million over the same period in 2007, remaining consistent as apercentage of product sales at 19% (2007: 19% of product sales). Contributing to the increased R&D
expenditure in the second quarter of 2008 over 2007 were costs associated with projects in-licensed andacquired since the second half of 2007 including PLICERA, SPD550, AMIGAL, JUVISTA and METAZYM
together with Phase 3(b) and Phase 4 studies to support new product launches.
Selling, general and administrative (“SG&A”)

SG&A (US GAAP)
Costs associated with theintroduction of a new holding
company
Amortization
Impairment of intangible assets
Depreciation
SG&A (Non GAAP)

2008$m_________
428.8

(6.6)
(31.0)(90.4)(11.2)_________
289.6_________% of productsales_________
61%

41%

2007
$m
_________
280.6(17.6)(9.9)_________
253.1_________% of productsales_________
56%

50%

13

SG&A expenses increased to $428.8 million for the three months to June 30, 2008 from $280.6 million in
the corresponding period in 2007. Excluding an intangible asset impairment charge of $90.4 million in
respect of DYNEPO, amortization of intangible assets (increased due to VYVANSE, launched July 2007),
costs associated with the introduction of the new holding company and depreciation costs (seereconciliation table above), SG&A expenditure increased by $36.5 million to $289.6 million.
Excluding these items, SG&A decreased as a percentage of product sales to 41% (2007: 50%) reflecting
the sales impact in the three months to June 30, 2008 of the successful launches of VYVANSE,
LIALDA/MEZAVANT and ELAPRASE.
Other increases in SG&A expenses mainly relate to the increase in advertising, promotional andmarketing spend to support VYVANSE and LIALDA/MEZAVANT.
Gain on sale of product rights
For the three months to June 30, 2008 Shire recognized gains of $9.1 million (2007: $5.0 million) arisingfrom product divestments in 2007, including $8.6 million from the sale of non-core products to Almirall.
These gains were deferred at December 31, 2007 pending the transfer of the relevant consents.
In process R&D charge
During the three months to June 30, 2008 the Company recorded an in-process R&D charge of $135.0
million in respect of the acquisition of the global rights to the clinical candidate arylsulfatase-A currently
known as METAZYM (HGT-1111), from Zymenex.
During the three months to June 30, 2007 Shire expensed the portion of the New River purchase priceallocated to in-process R&D totaling $1,896.0 million. This amount represented the value of thoseacquired development projects which, at the acquisition date, had not been approved by the FDA or otherregulatory authorities, including the adult indication of VYVANSE.
Interest income
For the three months to June 30, 2008 Shire received interest income of $6.5 million (2007: $14.9 million).
Interest income primarily relates to interest received on cash and cash equivalents. Interest income forthe three months to June 30, 2008 is lower than the same period in 2007 due to lower average cash andcash equivalent balances and lower average US Dollar interest rates.
Interest expense
For the three months to June 30, 2008 the Company incurred interest expense of $16.8 million (2007:$28.0 million). In the three months to June 30, 2007 interest expense included a $7.9 million write-off ofdeferred financing charges on repayment of term loans used to fund the acquisition of New River following
the issue of the $1.1 billion convertible bonds in May 2007.
In both three month periods to June 30, 2008 and 2007 interest expense includes a provision for interest,
which may be awarded by the Court in respect of amounts due to those ex-Transkaryotic Therapies, Inc.
(“TKT”) shareholders who have requested appraisal of the acquisition consideration payable for their TKT
shares. A trial date of December 10, 2008 has been set. Further information on this litigation can befound in our filings with the SEC, including our Annual Report on Form 10-K for the year to December 31,
2007.
Taxation
The effective rate of tax for the three months to June 30, 2008 was -0.3% (2007: -1%). Excluding the tax
effect of items excluded from non GAAP income as outlined on pages 25-26, the effective rate of tax on
non GAAP income is 20% (2007: 24%). The effective rate of tax on non GAAP income in the three months
to June 30, 2008 was 4% lower than the corresponding period in 2007 principally due to a permanent tax
benefit arising on the debtor substitution of the Company’s convertible bond on the Scheme of
Arrangement in May 2008.
Equity in earnings of equity method investees
Net losses of equity method investees of $1.9 million were recorded for the three months to June 30, 2008(2007: earnings $0.7 million). This comprised earnings of $1.5 million from the 50% share of the anti-viralcommercialization partnership with GSK in Canada (2007: $3.1 million) offset by losses of $3.4 million
being the Company’s share of losses in the GeneChem, AgeChem and EGS Funds (2007: loss $2.4
million).

14

FINANCIAL INFORMATIONTABLE OF CONTENTS

Page
Unaudited US GAAP Consolidated Balance Sheets

16

Unaudited US GAAP Consolidated Statements of Operations

18

Unaudited US GAAP Consolidated Statements of Cash Flows

20

Selected Notes to the Unaudited US GAAP Financial Statements

22(1) Earnings per share

22(2) Analysis of revenues

23

Non GAAP reconciliation

25

15

Unaudited US GAAP results for the three months to June 30, 2008
Consolidated Balance Sheets
June 30,
2008$M_________

December 31,
2007$M_________

801.2
34.3
463.5
151.6
4.7
135.0
100.3
_________

762.5
39.5
441.5
174.1
10.6
143.3
125.3
_________

1,690.6

1,696.8

66.7
434.2
221.8
1,620.5
142.2
26.8_________

110.2
368.6
219.4
1,764.5
143.7
26.9_________ASSETS
Current assets:
Cash and cash equivalents
Restricted cash
Accounts receivable, net
Inventories, net
Assets held for sale
Deferred tax asset
Prepaid expenses and other current assets
Total current assets
Non current assets:
Investments
Property, plant and equipment, net
Goodwill
Other intangible assets, net
Deferred tax asset
Other non-current assets
Total assets

4,202.8

4,330.1__________________

677.2
10.6
490.5
40.3
_________

674.2
11.3
480.2
96.5
_________

1,218.6

1,262.2

1,100.0
31.9
338.1
388.0
_________

1,100.0
32.9
332.4
375.6
_________

1,858.0

1,840.9__________________

LIABILITIES AND SHAREHOLDERS’ EQUITYCurrent liabilities:
Accounts payable and accrued expenses
Deferred tax liability
Liability to dissenting shareholders
Other current liabilities
Total current liabilities
Non-current liabilities:
Convertible bonds
Other long term debt
Deferred tax liability
Other non-current liabilities
Total non-current liabilities

Total liabilities

3,076.6_________

3,103.1_________

16

Unaudited US GAAP results for the three months to June 30, 2008
Consolidated Balance Sheets (continued)

Shareholders’ equity:
Common stock of 5p par value; 1,000 million shares authorized; and559.9 million shares issued and outstanding (2007: 750 million
shares authorized; and 553.2 million shares issued andoutstanding)
Exchangeable shares: nil shares issued and outstanding (2007: 0.7
million)Treasury stock (19.6 million shares (2007: 10.3 million shares))
Additional paid-in capital
Accumulated other comprehensive income
Accumulated deficit
Total shareholders’ equity
Total liabilities and shareholders’ equity

June 30,
2008$M_________

December31, 2007$M_________

55.5

55.2

(380.5)2,563.9
14.2(1,126.9)_________

33.6(280.8)2,503.4
55.7(1,140.1)_________

1,126.2_________

1,227.0_________

4,202.8

4,330.1__________________

17

Unaudited US GAAP results for the three and six months to June 30, 2008
Consolidated Statements of Operations
3 months toJune 30,
2008$M________

3 months toJune 30,
(1)
2007
$M
________

6 months
to June 30,
2008$M________

6 months toJune 30,
(1)
2007
$M
________

Revenues:
Product sales
Royalties
Other revenues

705.7
64.8
5.1
________

504.2
64.0
6.7
_______

1,337.4
129.9
10.5________

965.7
123.5
13.9
________

Total revenues

775.6________

574.9_______

1,477.8________

1,103.1________

Costs and expenses:(1) (2) (3)Cost of product sales(1) (3)
Research and development(1) (2)
Selling, general and administrative
Integration costs
Gain on sale of product rights
In-process R&D charge

142.9
145.3
428.8
(9.1)
135.0
________

74.0
103.1
280.6
1.3
(5.0)
1,896.0_______

233.2
267.3
763.3
(16.7)
135.0________

141.3
184.2
519.2
1.3
(5.0)
1,896.0________

Total operating expenses________

842.9_______________

1,382.1________

Operating (loss)/income(67.3)(1,775.1)

95.7(1,633.9)

Interest income
Interest expense
Other income/(expenses), net

6.5(16.8)
0.7________

14.9(28.0)
1.8_______

19.2(34.1)
13.4________

34.7(35.8)
2.3________

Total other (expenses)/income, net(9.6)________(11.3)_______(1.5)________

1.2________

2,350.0

2,737.0(Loss)/income before income taxes andequity in (losses)/earnings of equity method
investees
Income taxes
Equity in (losses)/earnings of equity method
investees(76.9)(0.2)(1,786.4)(25.6)

94.2(44.3)(1,632.7)(67.1)(1.9)________

0.7_______(0.3)________

1.2________Net (loss)/income(79.0)________(1,811.3)_______

49.6________(1,698.6)________(1)

For the three months to June 30, 2007 $4.7 million of depreciation was reclassified from Selling, general and administrative(SG&A) costs to Cost of product sales ($1.9 million) and Research and Development costs ($2.8 million). For the six months toJune 30, 2007 $8.7 million of depreciation was reclassified from SG&A costs to Cost of product sales ($3.9 million) and Researchand development ($4.8 million).

(2 )Cost of product sales includes amortization of intangible assets relating to favorable manufacturing contracts of $0.4 million for thethree months to June 30, 2008 (2007: $nil) and $0.9 million for the six months to June 30, 2008 (2007: $nil). Selling, general andadministrative costs includes amortization and impairment charges of intangible assets relating to intellectual property rights
acquired of $121.4 million for the three months to June 30, 2008 (2007: $17.6 million) and $152.3 million for the six months toJune 30, 2008 (2007: $32.9 million).

(3)

Costs, predominantly relating to manufacturing set-up costs for new products, of $1.8 million and $3.6 million for the three months
and six months to June 30, 2007, have been reclassified from Research and development to Cost of product sales.

18Unaudited US GAAP results for the three months and six months to June 30, 2008
Consolidated Statements of Operations (continued)
3 months
3 months
to June 30, to June 30,
2008
2007
$M
$M
________________

6 months
6 months
to June 30, to June 30,
2008
2007
$M
$M
________________(Loss)/earnings per ordinary share - basic(14.6c)________(331.0c)________

9.1c________(317.5c)________(Loss)/earnings per ordinary share – diluted(14.6c)(331.0c)

8.2c(317.5c)________________________________________(43.8c)(993.0c)________________

24.6c(952.5c)________

542.5
542.5
________

547.3
547.3
________

543.7
579.6
________

535.0
535.0
________(Loss)/earnings per ADS - diluted

Weighted average number of shares:
Basic
Diluted19

Unaudited US GAAP results for the three months and six months to June 30, 2008
Consolidated Statements of Cash Flows
3 months
6 months
3 months
6 months
to June 30, to June 30, to June 30, to June 30,
2008
2008
2007
2007
$M
$M
$M
$M
________________________________
CASH FLOWS FROM OPERATINGACTIVITIES:Net (loss)/income
Adjustments to reconcile net (loss)/income to
net cash provided by operating activities:
Depreciation and amortization
Amortization of deferred financing charges
Interest on building financing obligation
Share based compensation
In-process R&D charge on New Riveracquisition
Impairment of intangible assets
Gain on sale of long-term assets
Gain on sale of product rights
Movement in deferred taxes
Equity in losses/(earnings) of equity method
investees
Changes in operating assets and liabilities, netof acquisitions:
Decrease/(increase) in accounts receivable
Increase/(decrease) in sales deduction
accrualDecrease/(increase) in inventory
Decrease in prepayments and other current
assets(Increase)/decrease in other assets
Increase/(decrease) in accounts and notes
payable and other liabilities
Increase in deferred revenue
Net cash provided by operating activities(A)(79.0)(1,811.3)

49.6(1,698.6)

48.9
1.2
0.7
19.4

33.5
9.2
11.8

96.3
2.5
1.9
35.7

63.7
9.2
22.4

90.4
(0.4)
(9.1)
(16.4)

1,896.0
(5.0)
0.1

90.4
(9.8)
(16.7)
17.4

1,896.0
(4.9)
13.8

1.9

(0.7)

0.3

(1.2)

22.0

(25.2)(28.4)(103.0)27.6
19.5(10.8)(26.6)

35.5
10.4

18.9
(40.0)

3.8
(2.7)

25.1
9.8

24.3
(2.4)

11.3
0.7

50.7
1.9
________

25.1
52.0________(66.4)
5.5________

7.6
88.5________

180.4________

183.0________

246.1________

284.4________

20

Unaudited US GAAP results for the three months and six months to June 30, 2008
Consolidated Statements of Cash Flows

CASH FLOWS FROM INVESTING
ACTIVITIES:
Movements in short-term investments
Movements in restricted cash
Purchases of subsidiary undertakings, net ofcash acquired
Expenses related to the New River acquisition
Purchases of long-term investments
Purchases of property, plant and equipment
Purchases of intangible assets
Proceeds from disposal of long-term assets
Proceeds/deposits received for sale of productrightsProceeds from disposal of property, plant andequipment
Returns from equity investments
Net cash used in investing activities(B)3 months
to June 30,
2008$M________

3 months
to June 30,
2007$M________

0.2

55.8
(9.2)

5.2

55.8
(9.6)

-

(2,458.6)-(2,458.6)(0.1)(61.6)-(57.3)(3.7)(15.7)
(3.6)
-

(1.1)
(89.4)
10.3(60.4)(5.8)(33.6)(31.8)
-

-

9.8

5.0

16.8

0.8
0.4
________

1.0________

0.9
0.4________

2.2________(60.3)________(2,481.5)________(68.7)________(2,525.0)________-

1,300.0(1,300.0)-

1,300.0(1,300.0)-

1,100.0(279.4)-

1,100.0(279.4)

-

141.8

-

141.8

(0.2)
0.7

(29.8)
1.7

(0.4)
1.0

(32.7)
24.1

6 months to
6 months
June 30, to June 30,
2008
2007
$M
$M
________________

CASH FLOWS FROM FINANCING
ACTIVITIES:
Proceeds from drawings under bank facility
Repayment of drawings under bank facility
Proceeds from issue of 2.75% convertible
bonds due 2014
Redemption of New River convertible notes
Proceeds from exercise of New Riverpurchased call option
Payment of debt arrangement and issuance
costs
Payment under building financing obligation
Proceeds from exercise of options(Costs)/proceeds from issue of common stock,net
Proceeds from exercise of warrants
Payment of dividend
Payments to acquire shares by employee shareownership trust (“ESOT”)(2.9)(36.4)(1.0)(29.4)(2.9)(36.4)

877.3
7.0(29.4)(71.0)________(55.5)________(104.1)________(99.9)________Net cash (used in)/provided by financing(C)
activities(109.8)________

848.4________(142.8)________

1,708.8________

0.3

2.4

4.1

3.4

________________________________

10.6(1,447.7)

38.7(528.4)790.6________________________________

801.2

598.5
________________

801.2

598.5
________

Effect of foreign exchange rate changes on(D)cash and cash equivalents
Net increase/(decrease) in cash and cash(A) +(B) +(C) +(D)equivalents
Cash and cash equivalents at beginning of
periodCash and cash equivalents at end of period________

2,046.2

762.5

1,126.921

Unaudited US GAAP results for the three and six months to June 30, 2008
Selected Notes to the US GAAP Financial Statements(1) Earnings per share
3 months
to June 30,
2008$M________

3 months
to June 30,
2007$M________

6 months toJune 30,
2008$M________

6 months toJune 30,
2007$M________Net (loss)/income(79.0)________(1,811.3)________

49.6________(1,698.6)________

Numerator for basic EPS(1)Impact of convertible bonds, net of tax(79.0)________-(1,811.3)________

49.6
(2.2)
________(1,698.6)________

Numerator for diluted EPS(79.0)________(1,811.3)________

47.4________(1,698.6)________

Weighted average number of shares:

No. ofsharesMillions

No. ofsharesMillions

No. ofsharesMillions

No. ofsharesMillions

542.5

547.3

543.7

535.0

Convertible bonds 2.75% due 2014________-________

3.2
32.7________________

Diluted542.5________

547.3________

579.6________

535.0________

Basic (2)Effect of dilutive shares:
Stock options(3)
(4)

(1)

Includes the after tax interest charge in respect of the convertible bonds ($9.3 million), and the tax benefit recognized on
substitution of the convertible bonds from Shire plc to Shire Limited on the Scheme of Arrangement ($11.5 million).
(2)
Excludes shares purchased by the ESOT and presented by the Company as treasury stock.
(3)
Calculated using the treasury stock method.
(4)
Calculated using the ”if-converted” method.

The share equivalents not included in the above calculation of the diluted weighted average number ofshares are shown below:

Stock options out of the money
Stock options in the money
Warrants
Convertible bonds 2.75% due 2014

3 months
to June 30,
2008
No. ofshares(2)Millions__________

3 months toJune 30,
2007
No. ofshares(2)Millions_________

6 months toJune 30,
2008
No. ofshares(1)Millions___________

6 months toJune 30,
2007
No. ofshares(2)Millions__________

17.9
1.3
32.7

1.1
6.4
0.4
21.2

17.4
-

1.4
7.1
0.6
10.7

____________________________________(1)

For the six months ended June 30, 2008, certain stock options have been excluded from the calculation of diluted
EPS because their exercise prices exceeded Shire Limited’s average share price during the calculation period.

(2)

For the three months ended June 30, 2008 and the three and six months ended June 30, 2007 no share options,warrants or ordinary shares underlying the convertible bonds have been included in the calculation of the diluted
weighted average number of shares, because the Company made a net loss during the calculation period and theinclusion of these items would be anti-dilutive.

22

Unaudited US GAAP results for the three months to June 30, 2008
Selected Notes to the US GAAP Financial Statements (continued)(2) Analysis of revenues
three months to June 30,

2008

2007

2008

$M

$M

change

2008
% of
total
revenue

296.4
65.2
22.6

255.1
19.9

16%
14%

38%
8%
3%

384.2

275.0

40%

49%

44.8
32.0

40.2
5.0

11%
-

6%
4%

76.8

45.2

70%

10%

42.4
7.0
13.9
16.2
8.7
20.6

24.5
1.9
13.5
17.9
7.6
17.1

73%
3%
-9%
14%
20%

6%
1%
2%
2%
1%
3%

108.8

82.5

32%

15%

Other product sales

10.4

26.9

-61%

1%

Total Specialty product sales

580.2

429.6

35%

75%

Human Genetic Therapies ("HGT")ELAPRASE
REPLAGAL
Total HGT product sales

80.8
44.7
125.5

42.7
31.9
74.6

89%
40%
68%

10%
6%
16%

Total product sales

705.7

504.2

40%

91%

Royalty income:3TC
ZEFFIX
Other

35.6
10.8
18.4

39.0
10.4
14.6

-9%
4%
26%

5%
1%
2%

Total

64.8

64.0

1%

8%

Other income

5.1

6.7

-24%

1%

Total Revenue

775.6

574.9

35%

100%

%
Net product sales:
Specialty Pharmaceuticals ("Specialty")
ADHD
ADDERALL XR
VYVANSEDAYTRANAGI
PENTASALIALDA / MEZAVANT

General products
FOSRENOL*DYNEPO*CALCICHEWCARBATROLREMINYL/REMINYL XLXAGRID* Reclassified to General products following Shire’s decision to stop the commercialization of DYNEPO.

23

Unaudited US GAAP results for the six months to June 30, 2008
Selected Notes to the US GAAP Financial Statements (continued)(2) Analysis of revenues
six months to June 30,

2008

2007

2008

$M

$M

change

2008
% of
total
revenue

557.9
119.6
42.9

504.2
31.8

11%
35%

38%
8%
3%

720.4

536.0

34%

49%

89.0
59.2

84.0
5.0

6%
-

6%
4%

148.2

89.0

67%

10%

78.6
13.7
27.5
34.1
17.0
39.3

47.3
1.9
25.6
33.4
14.6
31.6

66%
7%
2%
16%
24%

5%
1%
2%
2%
1%
3%

210.2

154.4

36%

14%

19.1

52.6

-64%

1%

1,097.9

832.0

32%

74%

152.3
87.2
239.5

69.3
64.4
133.7

120%
35%
79%

10%
6%
16%

Total product sales

1,337.4

965.7

38%

90%

Royalty income:3TC
ZEFFIX
Other

72.9
21.2
35.8

74.5
19.4
29.6

-2%
9%
21%

5%
1%
3%

Total

129.9

123.5

5%

9%

Other income

10.5

13.9

-24%

1%

Total Revenue

1,477.8

1,103.1

34%

100%

%
Net product sales:
Specialty Pharmaceuticals ("Specialty")
ADHD
ADDERALL XR
VYVANSEDAYTRANAGI
PENTASALIALDA / MEZAVANT

General products
FOSRENOL*DYNEPO*CALCICHEWCARBATROLREMINYL/REMINYL XLXAGRID

Other product sales
Total Specialty product sales
Human Genetic Therapies ("HGT")ELAPRASE
REPLAGAL
Total HGT product sales* Reclassified to General products following Shire’s decision stop the commercialization of DYNEPO.

24

Unaudited results for the three months to June 30, 2008
Non GAAP reconciliation
US GAAP

Adjustments

Reclassify
depreciation

3 months toJune 30,
2008

$M

$M

$M

$M

775.6

-

-

775.6

Cost of product sales

142.9(53.4)(a)(3.0)

Research and development

145.3

(6.5)

(b)

(3.1)

Selling, general and administrative

428.8(128.0)(c)(11.2)

(9.1)

9.1

(d)

-

(135.0)(e)-

Total revenues

3 months toJune 30,
2008

Non GAAP

Costs and expenses:

Gain on sale of product rights
In-process R&D charge
Depreciation

135.0

(g)
(g)
(g)

86.5
135.7
289.6
-

(g)

-

-

17.3

Total operating expenses

842.9(313.8)-529.1

Operating (loss)/income(67.3)

313.8

-

246.5

Interest income

6.5

6.5

(16.8)--

Interest expense-(16.8)

Other income, net

0.7

-

-

0.7

Total other (expenses)/income, net

(9.6)

-

-

(9.6)

(Loss)/income before income taxes andequity in losses of equity method investees(76.9)

313.8

Income taxes(0.2)(46.7)(1.9)(79.0)

267.1

-

(5.8)

(79.0)

261.3

Diluted earnings per ordinary share

542.5(14.6c)

34.0
46.2c

Diluted earnings per ADS(43.8c)138.6cEquity in losses of equity method investees,
net of tax
Net (loss)/income
Impact of convertible debt, net of tax
Numerator for diluted EPS from ongoing
operations
Weighted average number of shares(millions) - diluted

(f)

-

(1)

(1)

17.3

236.9
(46.9)

-

(1.9)
188.1

-

(5.8)

-

182.3

576.5
31.6c
94.8c

(1)

After the above adjustments, the Company made non GAAP net income during the calculation period. As a result, (i) the after tax
impact of the convertible bond has been deducted from the numerator and (ii) in-the-money share options and convertible bonds are
now included in the calculation of the diluted weighted average number of shares as they have a dilutive effect.

The following adjustments and reclassifications are included above:
a)
b)
c)
d)
e)
f)
g)

Write down of inventory and other exit costs in respect of DYNEPO ($53.4 million);R&D commitment in respect of DYNEPO ($6.5 million);
Amortization of intangible assets relating to intellectual property rights acquired ($31.0 million), impairment charge in respectof DYNEPO intangible asset ($90.4 million) and costs associated with the introduction of the new holding company ($6.6
million);Gains on the disposal of non-core product rights ($9.1 million);
In-process R&D in respect of METAZYM acquired from Zymenex ($135.0 million);
Tax effect of adjustments outlined in (a) to (e); andDepreciation of $17.3 million included in cost of product sales, R&D costs and SG&A costs for US GAAP now separately
disclosed for the presentation of non GAAP earnings.

25Unaudited results for the three months to June 30, 2007
Non GAAP reconciliation$M

Non GAAP(1)3 months toJune 30,
2007
$M

-

574.9

US GAAP
3 months toJune 30,
2007$M

Adjustments$M

Total revenues

574.9

-

Costs and expenses:
Cost of product sales
Research and development
Selling, general and administrative
Integration costs

74.0
103.1
280.6
1.3

(5.9)
(17.6)(1.3)

Gain on sale of product rights

(5.0)

5.0

(d)

-

(1,896.0)(e)-In-process R&D charge
Depreciation

1,896.0

Reclassify
depreciation

(a)
(b)
( c)

(2.9)
(3.1)
(9.9)
-

(h)

71.1
94.1
253.1
-

(h)
(h)

(h)

-

-

15.9

Total operating expenses

2,350.0(1,915.8)

-

434.2

Operating (loss)/income(1,775.1)

1,915.8-

140.7Interest income

14.9

-

Interest expense(28.0)

7.9

Other income, net

1.8

Total other (expenses)/income, net(Loss)/income before income taxes andequity in earnings of equity method
investees
Income taxes
Equity in earnings of equity method
investees, net of tax
Net (loss)/income
Impact of convertible debt, net of tax
Numerator for diluted EPS fromongoing operations
Weighted average number of shares(millions) - diluted
Diluted (loss)/earnings per ordinary share
Diluted (loss)/earnings per ADS

15.9

-

14.9

-

(20.1)--

1.8(11.3)

7.9

-

(3.4)

(1,786.4)

1,923.7(f)(25.6)

(7.1)

0.7

-

(1,811.3)

1,916.6-

1.7(1,811.3)

1,918.3

547.3(331.0c)(993.0c)

28.0
349.6c1,048.8c

137.3
(g)

-

(32.7)

-

(2)

0.7

-

105.3

-

1.7

-

107.0

(2)

575.3
18.6c
55.8c

(1)

Non GAAP earnings for 2007 have been recalculated to include the impact of the share based compensation charge which had
previously been excluded. The impact, net of tax, is a decrease in non GAAP net income of $8.9 million.

(2)

After the above adjustments, the Company made non GAAP net income during the calculation period. As a result (i) the after
tax impact of the convertible bond has been added to the numerator and (ii) in-the-money share options, warrants andconvertible bonds are now included in the calculation of the diluted weighted average number of shares as they have a dilutive
effect.

The following adjustments and reclassifications are included above:
a)
b)
c)
d)
e)
f)
g)
h)

Upfront and milestone payments in respect of in-licensing technology from Noven ($5.9 million);
Amortisation of intangible assets relating to intellectual property rights acquired ($17.6 million);
Integration costs in respect of the acquisition of New River ($1.3 million);
Gain on disposal of non-core product rights ($5.0 million);
Write-off of in-process research and development acquired as part of the acquisition of New River ($1,896.0 million);
Write-off of deferred financing costs on repayment of term loans drawn down to partly fund the New River acquisition;
Tax effect of adjustments outlined in (a) to (f); andDepreciation of $15.9 million included in cost of product sales, R&D costs and SG&A costs for US GAAP now separately
disclosed for the presentation of non GAAP earnings.

26

Unaudited results for the six months to June 30, 2008
Non GAAP reconciliation
US GAAP

Non GAAP

6 months toJune 30,
2008

Adjustments$M$M

Reclassify
depreciation$M

1,477.8--

Cost of product sales

233.2(53.4)(a)(5.6)

Research and development

267.3

(6.5)

(b)

(6.0)
(22.0)

Total revenues

6 months toJune 30,
2008$M
1,477.8

Costs and expenses:

Selling, general and administrative

763.3(164.5)(c)Gain on sale of product rights(16.7)

16.7

(d)

-

(e)

33.6

(h)
(h)
(h)

174.2
254.8
576.8
-

In-process R&D charge
Depreciation

135.0
-

(135.0)-Total operating expenses

1,382.1(342.7)-

1,039.4

95.7

342.7

-

438.4

Interest income

19.2

-

-

19.2

Interest expense(34.1)--(34.1)

Other income, net

13.4

(9.4)

-

4.0

Total other (expenses)/ income, net

(1.5)

(9.4)

-

(10.9)

Income before income taxes and equity inlosses of equity method investees

94.2

333.3

Income taxes(44.3)(55.1)

Equity in losses of equity method investees,
net of tax

(0.3)

-

Net income

49.6

278.2

-

327.8

Impact of convertible debt, net of tax

(2.2)

-

-

(2.2)

Numerator for diluted EPS from ongoing
operations

47.4

278.2

-

325.6

Diluted earnings per ordinary share

579.6
8.2c

48.0c

579.6
56.2c

Diluted earnings per ADS

24.6c

144.0c168.6cOperating income

Weighted average number of shares(millions) - diluted

(f)

(g)

-

(h)

33.6

427.5
(99.4)-(0.3)

The following adjustments and reclassifications are included above:
a)
b)
c)
d)
e)
f)
g)
h)

Write down of inventory and exit costs in respect of DYNEPO ($53.4 million);R&D commitment in respect of DYNEPO ($6.5 million);
Amortization of intangible assets relating to intellectual property rights acquired ($61.9 million), impairment charge in respectof DYNEPO intangible asset ($90.4 million) and costs associated with the new holding company ($12.2 million);
Gains on the disposal of non-core product rights ($16.7 million);
In-process R&D in respect of METAZYM acquired from Zymenex ($135.0 million);
Gain on the disposal of a minority equity investment ($9.4 million);
Tax effect of adjustments outlined in (a) to (f); andDepreciation of $33.6 million included in cost of product sales, R&D costs and SG&A costs for US GAAP now separately
disclosed for the presentation of non GAAP earnings.

27

Unaudited results for the six months to June 30, 2007
Non GAAP reconciliation
US GAAP
6 months toJune 30,
2007$M

Adjustments$M

Reclassify
depreciation$M

Non GAAP(1)6 months toJune 30,
2007$M

1,103.1--

1,103.1

Costs and expenses:
Cost of product sales
Research and development
Selling, general and administrative
Integration costs

141.3
184.2
519.2
1.3

(5.9)
(32.9)
(1.3)

(5.9)
(5.5)
(19.4)-

Gain on sale of product rights

(5.0)

5.0

(d)

-

(1,896.0)(e)-Total revenues

In-process R&D charge

1,896.0

Depreciation

(a)
(b)
(c)

(h)

135.4
172.8
466.9
-

(h)
(h)

(h)

-

-

30.8

Total operating expenses

2,737.0(1,931.1)

-

805.9

Operating (loss)/income(1,633.9)

1,931.1

-

297.2

34.7

-

-

34.7

Interest income

(f)

30.8

Interest expense(35.8)

7.9-(27.9)

Other income, net

2.3

-

-

2.3

Total other income, net

1.2

7.9

-

9.1

(1,632.7)

1,939.0-

306.3(67.1)(11.2)-(78.3)

1.2

-

-

1.2

(1,698.6)

1,927.8

-

229.2

-

1.7

-

1.7

(1,698.6)

1,929.5

-

230.9

535.0
(317.5c)(952.5c)18.4
359.2c
1,077.6c(Loss)/income before income taxes and equity
in earnings of equity method investees
Income taxes
Equity in earnings of equity method investees,
net of tax
Net (loss)/income
Impact of convertible debt, net of tax
Numerator for diluted EPS from ongoing
operations
Weighted average number of shares (millions) diluted
Diluted (loss)/earnings per ordinary share
Diluted (loss)/earnings per ADS

(g)

(2)

(2)

553.4
41.7c
125.1c(1)

Non GAAP earnings for 2007 have been recalculated to include the impact of the share based compensation charge which had
previously been excluded. The impact, net of tax, is a decrease in non GAAP net income of $16.6 million.
(2)

After the above adjustments the Company made non GAAP net income during the calculation period. As a result (i) the after tax
impact of the convertible bond has been added to the numerator and (ii) in-the-money share options, warrants and convertible bonds
are now included in the calculation of the diluted weighted average number of shares as they have a dilutive effect.
The following adjustments and reclassifications are included above:
a)
b)
c)
d)
e)
f)
g)
h)

Upfront and milestone payments in respect of in-licensing technology from Noven ($5.9 million);
Amortisation of intangible assets relating to intellectual property rights acquired ($32.9 million);
Integration costs in respect of the acquisition of New River ($1.3 million);
Gain on the disposal of non-core product rights ($5.0 million);
Write-off of in-process research and development acquired as part of the acquisition of New River ($1,896.0 million);
Write-off of deferred financing costs on repayment of term loans drawn down to partly fund the New River acquisition;
Tax effect of adjustments outlined in (a) to (f); andDepreciation of $30.8 million included in cost of product sales, R&D costs and SG&A costs for US GAAP now separately
disclosed for the presentation of non GAAP earnings.

28