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Second Quarter results to June 30, 2006 Shire plc

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Page 1: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

Second Quarter resultsto June 30, 2006Shire plc

Page 2: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

2

THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

"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 forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to; risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization; the impact of competitive products, including, but not limited to the impact of those on Shire's Attention Deficit and Hyperactivity Disorder (ADHD) franchise; patents, including but not limited to, legal challenges relating to Shire's ADHD franchise; government regulation and approval, including but not limited to the expected product approval dates of SPD503 (ADHD), SPD465 (ADHD), MESAVANCE (SPD476) (ulcerative colitis) and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire's ability to benefit from the acquisition of Transkaryotic Therapies Inc.; Shire's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire's and its predecessor registrant Shire Pharmaceuticals Group plc's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2005.

The following are trademarks of Shire plc or its subsidiaries, which are the subject of trademark registrations in certain countries.

ADDERALL XR® (mixed salts of a single-entity amphetamine prroduct), AGRYLIN® (anagrelide hydrochloride), CALCICHEW® (range (calcium carbonate with or without vitamin D3 )), CARBATROL® (carbamazepine), EQUETROTM (carbamazepine), FOSRENOL® (lanthanum carbonate), XAGRID® (anagrelide hydrochloride), REPLAGALTM (agalsidase alfa), MESAVANCE™ (mesalamine)

The following are trademarks of third parties. 3TC® (trademark of GlaxoSmithKline (GSK)), PENTASA® (trademark of Ferring AS) ), DYNEPO® (trademark of Aventis Pharma Holdings GmbH), ZEFFIX® (GSK), REMINYL/RAZADYNE ® (trademark of Johnson & Johnson, excluding UK and Republic of Ireland), DAYTRANA™ (methylphenidate transdermal) (trademark of Noven Pharmaceuticals Inc. (Noven))

Page 3: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

3

Agenda

Introduction and summary of Q2 Matthew Emmens

Q2 Financial Review Angus Russell

Conclusion Matthew Emmens

Questions & Answers All

Page 4: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

Matthew Emmens Chief Executive OfficerIntroduction and summary of Q2

Page 5: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

5

Financial Highlights

36.1c

EPS (diluted):

+12%

H1 Growth

+23%

Q1 Growth

+3%424.6439.1Total Revenues

65.9c- ADS

Q2 Growth

65.9c

Q2 05(1)

$m Q2 06

$m

43.9cNon GAAP EPS (diluted)(2) - ADS

(1) Adjusted to reflect retrospective adoption of SFAS 123R

(2) This is a non GAAP financial measure. It excludes items that management believe are not indicative of the ongoing business in 2006 & 2005.

Good results in line with expectations

Q2 revenues up 3%

Revenue growth in H1 of 12%

Dividend of 5.8038 cents per ADS

Re-affirming guidance

Page 6: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

6

Q2 Execution

Demonstrating our ability to execute

DAYTRANA launched

SPD465 filed

ELAPRASE US approval

FOSRENOL– continued roll-out internationally

Page 7: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

7

ADHD Progress

ADDERALL XR US market share leader : 26%

Citizen Petition – still under review by the FDA

No generic copies of ADDERALL XR drugs approved to date

Patent litigation and settlement discussions progressing with Barr

DAYTRANA

Launched in the US market

Very positive reaction from patients and physicians

NRP104 - US PDUFA October 6 2006

SPD465 – filed with the FDA on July 21 – PDUFA May 21 2007

SPD503 – filing scheduled for Q3 2006

*source IMS

Page 8: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

8

ADHD Portfolio Positioning

√√√√Stimulant / methylphenidate

First transdermal patchDAYTRANA

Non-stimulant / guanfacineSPD503

Stimulant / amphetamine

Long acting – 16 hoursSPD465

Pro drug / *amphetamine

Low abuse potentialNRP104

√√√√√√Stimulant / amphetamine

First in Class / 8-10 hoursADDERALL XR

EuropeUSAdultPediatricDifferentiating

features

Products

√√ = approved= approved = in development = in development -- not yet filednot yet filed

= filed not yet approved= filed not yet approved = future development planned= future development planned

*with potential to treat within the non-stimulant market

Page 9: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

9

Renal and GI

FOSRENOL (Hyperphosphatemia)

Product performing well in launched markets

US market share increase – 11.9% week ending 14 July 2006*

Major European countries to launch in Q4 2006

DYNEPO (anemia in cancer)

Results study inconclusive; Shire to review

MESAVANCE (Ulcerative Colitis)

US PDUFA October 21 2006

Expected responses from European and Canadian authorities Q1 2007

*source IMS

Page 10: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

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HGT ELAPRASE (Hunter Syndrome)

US approval received

Potential for up to 500 patients in the US

European response expected before year-end

Pre-approval access received for France, Italy, Spain and Sweden

GA-GCB (Gaucher Disease)

Phase 3 enrolment commenced

Page 11: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

11

R&D Pipeline and new product launches

The above launch and filing dates are indicative and subject to the regulatory/government approvals process.

H1 06 H2 06 H1 07

MESAVANCEEU / Canada

Launch

ELAPRASEUS Launch

SPD465FDA filed

FOSRENOLContinue the roll-out in Europe

MESAVANCEFiled in Canada

and EU

SPD503FDA filing

DAYTRANALaunched in US

MESAVANCEUS Launch

NRP104US Launch

ELAPRASEEU Launch

DYNEPOEU Launch

GA-GCBEnrolment Phase 3

Page 12: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

Angus Russell Chief Financial OfficerQ2 Financial Review

Page 13: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

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Total Revenues

____

+12%

0%

- 59%

+16%

H1 Growth

+5%

-33%

-4%

-74%

62.6

10.4

60.4

2.7

Royalties

Other Revenue

____

+23%

+28%

Q1 Growth

____

+3%

____

424.6

____

439.1Total Revenues

+7%

Q2 Growth

351.6

Q2 05$m

Q2 06$m

376.0Product Sales

Page 14: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

14

* Source: IMS Data** Pre-acquisition sales

Major Product Sales

+23%-38%9.96.2FOSRENOL

n/a+25%**22.628.3REPLAGAL

-10%-25%21.816.2CARBATROL

-4%+11%31.034.5PENTASA

-88%-88%17.22.0North America

n/a+14%12.414.1ROW

n/a+16%10.111.7CALCICHEW

220.7

Q2 06$m

205.4

Q2 05$m

+7%

Sales Growth

AGRYLIN/XAGRID

+8%ADDERALL XR

US Rx Growth *

Page 15: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

15

* Foreign exchange movements have contributed +1% to reported growth** Foreign exchange movements have contributed +2% to reported growth*** Includes REMINYL/RAZADYNE and the impact of RAZADYNE ER US launch stocking during Q2 05

Royalties

60.4

13.7

8.4

38.3

Q2 06$m

62.6

14.4

7.7

40.5

Q2 05$m

-4%

-5%

+9%**

-5%*

Growth

Other ***

Total

ZEFFIX

3TC

Page 16: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

16

Net Income/EPS

Non GAAP EPS (diluted)(2)

65.9c

69.1c

43.9c

46.8c

- ADS

Non GAAP EPS (diluted)(2)

- ADS (excluding FAS123R)

65.9c36.1c- ADS

EPS (diluted):

$m

109.9

-

109.9

Q2 05(1)Q2 06

$m

61.3

13.2

74.5

Net income

- GAAP

- Adjustments

- Non GAAP(2)

(1) Adjusted to reflect retrospective adoption of SFAS 123R

(2) This is a non GAAP financial measure. It excludes items that management believe are not indicative of the ongoing business in 2006 & 2005.

Page 17: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

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EPS Reconciliation

69.1c116.246.8c81.9Net income for non GAAP diluted EPS (ADS) (Ex FAS 123R)

3.2c6.32.9c7.4FAS 123R effect (net of tax)

--(3.1c)(5.1)Taxes on above adjustments

--0.9c1.6Integration costs

--10.0c16.7Cost of product sales fair value adjustment

65.9c109.936.1c61.3Net income for diluted EPS (ADS)

43.9c

Q2 06cents/ADS

109.9

Q2 05 (1)

$m

65.9c74.5Net income for non GAAP diluted EPS (ADS)

Q2 05 (1)

cents/ADSQ2 06

$m

(1) Adjusted to reflect retrospective adoption of SFAS 123RThis slide contains non GAAP financial measures. Management believes that the presentation of these non GAAP financial measures provide useful information to investors regarding Shire’s performance as the excluded items are not indicative of the ongoing business in 2006 & 2005.

Page 18: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

18

Financial Ratios

23%

52%

17%

88%

12%

Q2 06

32%Operating margin

45%

16%

88%

12%

Q2 05(1)

R&D : Revenues

SG&A (excl. D&A) : Product sales

Gross margin

COGS : Product sales

(on a non-GAAP basis)

(1) Adjusted to reflect retrospective adoption of SFAS 123RThis slide contains non GAAP financial measures. Management believes that the presentation of these non GAAP financial measuresprovide useful information to investors regarding Shire’s performance as the excluded items are not indicative of the ongoing business in 2006 & 2005.

Page 19: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

19

Cash generation

Cash Flow – Q2 2006

Cash surplus for Q2 : +41

+ 133

Tax / interest

Equity financing

- 32

Millions of USD

Net long-term asset purchases

+ 8

947*Total Liquidity at 30.06.06

500Add Revolving facility

447“Free Cash”

(30)Restricted cash

(439)Provision for amounts due for appraisal rights

916Net Cash at 30.06.06

41Cash Surplus

875Net Cash at 31.3.06

- 50 Daytrana

* Excludes $300m revolving facility

- 18

Page 20: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

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Outlook - 2006

Shire’s business continues to perform strongly - 2006 revenue growth expected to be in the low double digit range.low double digit range.

Earnings for 2006 impacted by costs associated with the continued development and launch of 5 new products in 2006 and H1 2007 in addition to the roll-out of FOSRENOL across Europe and new higher strengths of FOSRENOL in the US.

These launches will require additional A&P spend and in some cases additional sales reps. In addition, Shire is seeking to maximize the level of ADDERALL XR market share. Consequently, SG&A costs are expected to rise during the year to between $770 – 800 million;

The level of quarterly SG&A spend is expected to increase over Q2 2006 as we reflect a full quarter’s cost for the new US sales forces for GI (to launch MESAVANCE) and HGT (to launch ELAPRASE);

The planned regulatory filings, phase 3(b)/4 studies to support new product launches, the transfer of 2 HGT projects into pre-clinical development and the commencement of phase 3 trials on GA-GCB, are expected to result in R&D spend in the range of $310 – 330 million;

The level of quarterly R&D spend is expected to increase over Q2 2006 as we commence new phase 3(b)/4 studies to support new product launches (including DAYTRANA, FOSRENOL and MESAVANCE);

D&A - approximately 50% higher than 2005 charge reflecting the acquisition of TKT and the amortization of anticipated capitalized BD milestone payments;

Estimated tax rate - approximately 28%.

The following statements are based on the assumption that there will be no generic launch of ADDERALL XR during 2006 and that prescription growth in the US ADHD market will be 5%.

Page 21: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

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Outlook - 2006The financial outlook for the full year stated above excludes the accounting impact of the following items:

The milestone payment of $50m paid to New River in February 2006 following the FDA’sacceptance of the filing of NRP104. This has increased R&D expense in Q1 2006;

A US GAAP adjustment of approximately $50m (recorded within cost of goods sold) to reflect the difference between the accounting fair value and book value of acquired REPLAGAL inventory of which $40.3m was charged in H1 2006 ;

HGT integration costs estimated at $7m in 2006 of which $3.9m was incurred in H1 2006;

The adoption from January 1, 2006 of US GAAP accountancy standard SFAS 123R for share based compensation; $45m expected for 2006 of which $16.7m charged in H1 2006 (H1 2005: $13.0m charge adopted retrospectively)

Note: Any launch of a generic version of ADDERALL XR during 2006 would have a material impact on the Company’s performance and would be expected to put the Company’s expected revenue growth at significant risk.

Page 22: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

Matthew Emmens Chief Executive OfficerConcluding remarks

Page 23: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

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Concluding Remarks

Good results - in line with expectations

Guidance re-affirmed – 2006 revenue growth expected to be in the low double digit range

Demonstrating our ability to execute

DAYTRANA - launched

SPD465 - filed

ELAPRASE - approved

FOSRENOL – continued roll-out internationally

Launches and filing before mid-2007 - on track

NRP104

MESAVANCE

DYNEPO

SPD503

Planned launches before mid - 2007

Filing planned for Q3 2006

Page 24: Second Quarter results to June 30, 2006 - Shireinvestors.shire.com/.../archive/q2-2006-presentation-280706.pdf · (2) This is a non GAAP financial measure. It excludes items that

Questions and answers

All