First Quarter Results to March 31, 2007 Shire plc April 25, 2007 - PowerPoint PPT Presentation

First Quarter Results to March 31, 2007 Shire plc April 25, 2007

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 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 (guanfacine extended release) (ADHD) and SPD465 (extended release triple-bead mixed amphetamine salts) (ADHD); Shire’s ability to secure new products for commercialization and/or development; Shire’s ability to benefit from its acquisition of New River Pharmaceuticals Inc.; and other risks and uncertainties detailed from time to time in Shire plc’s filings with the Securities and Exchange Commission, particularly Shire plc’s Annual Report on Form 10-K for the year ended December 31, 2006. 2

Agenda � Introduction and Q1 Highlights Matthew Emmens � Q1 Financial Review Angus Russell � Product Launches Matthew Emmens � Conclusion Matthew Emmens � Questions & Answers All 3

Matthew Emmens CEO Introduction and Q1 Highlights

Q1 2007 Financial Highlights � Product sales up 33% to $462 million � Total revenues up 29% to $528 million � EPS – ADS (diluted) � GAAP up 78% 64 cents � Non GAAP * up 39% 75 cents * This is a non GAAP financial measure which excludes intangible asset amortization charges, the accounting impact of share-based compensation and the effect of certain cash and non-cash items, both recurring and non-recurring, that Shire's management believes are not related to the core performance of Shire’s business. 5

A series of transactions and approvals has created a solid foundation for the future and transformed Shire… � TKT acquisition diversified our portfolio and moved Shire into high-value, niche, biologic products with long exclusivity � Early stage TKT/HGT pipeline should drive significant growth in 2013 and beyond � Barr settlement created more certainty for our ADHD franchise � Recent product approvals and lifecycle extensions fuel strong growth going forward � Acquisition of New River underpins our ADHD franchise long-term � The ownership of the patented CARRIERWAVE platform technology may lead to other pharmaceutical applications 6

Q1 2007 Highlights - Executing on Strategy � New River Acquisition Completed – April 19 � ADHD � VYVANSE – FDA paediatric approval on February 23 � ADDERALL XR – Marketing license application for adult indication granted by Health Canada � DAYTRANA – Strong launch continues � GI � LIALDA – Launched on March 19 � Very positive reaction from patients and physicians � Latest market share – 1.2% of TRx and 3.2% of NRx 7

Q1 2007 Highlights - Executing on Strategy � Renal � FOSRENOL – launched in 6 more countries in 2007 including the UK � 19 countries in total � Authorization to launch received in Italy � DYNEPO – Launched in Germany in March � Human Genetic Therapies � ELAPRASE – US and European launches in progress � 291 patients globally on therapy by March 31 � REPLAGAL – Launched in Japan on February 15 � GA-GCB – Phase 3 clinical program has begun with first patients dosed in February 8

2007 Newsflow � VYVANSE – launch planned for June – sNDA for adult indication to be filed with FDA in Q2 � SPD503 – paediatric non-stimulant – PDUFA June 24 � SPD465 – long-acting stimulant for adults – PDUFA May 21 � DAYTRANA – EU filing in H2 9

Shire has one of the strongest late-stage pipelines in the Specialty Pharma sector 2008 2009 2010 2011 2012 2013-2015 2007 2008 2009 2010 2011 2012 2013-2015 2007 � Sanfilippo � VYVANSE New � SPD503 � MLD � GA-GCB � DYNEPO Product � CEPO � SPD465 * � LIALDA / Launch MEZAVANT � SPD493 Label � FOSRENOL � ELAPRASE Expansion - CKD CNS � FOSRENOL Expanding EU � DAYTRANA � Seasonique � VYVANSE Geographic EU EU � ELAPRASE Reach EU � Seven potential new product launches over a 30 month period from 2006-2008 * Launch timing subject to review 10

Angus Russell CFO Q1 Financial Review

Total Revenues Q1 07 Q1 06 Growth $m $m % Product Sales 461.5 346.0 33% Q1 07 Q1 06 Growth $m $m % Product Sales 87% 400.2 338.2 18% (excl. new launches) DAYTRANA 11.9 - 61.0 Royalties 59.5 ELAPRASE 26.6 - 13% FOSRENOL EU 6.5 0.6 FOSRENOL US 16.3 7.2 Other Revenue 7.2 4.0 461.5 346.0 Product Sales 100% 33% Total Revenues 528.2 411.0 29% Total Revenue 466.9 403.2 16% (excl. new launches) 12

Major Product Sales Q1 07 Q1 06 Sales US RX* $m $m Growth Growth ADDERALL XR 249.1 206.1 21% 5% PENTASA 43.8 28.1 56% 6% REPLAGAL 32.5 25.8 26% n/a ELAPRASE 26.6 - n/a n/a FOSRENOL 22.8 7.8 192% 15% CARBATROL 15.5 14.1 10% -6% XAGRID** 14.5 12.1 20% n/a DAYTRANA 11.9 - n/a n/a * Source: IMS Data ** worldwide sales excluding US and Canada 13

Royalties Q1 07 Q1 06 Growth $m $m (%) 3TC 35.5 39.5 -10% * ZEFFIX 9.1 7.7 18% ** Other *** 14.9 13.8 9% Total 59.5 61.0 -2% *Foreign exchange movements have contributed +4% to reported growth **Foreign exchange movements have contributed +11% to reported growth ***Includes REMINYL/RAZADYNE 14

Net Income/EPS Q1 07 Q1 06 Growth Net income ($m) (%) - GAAP 112.7 61.1 84% - Adjustments 18.9 30.4 - Non GAAP (1) 131.6 91.5 44% EPS - ADS (diluted) - GAAP 63.9c 36.0c 78% - Non GAAP (1) 74.7c 53.7c 39% (1) These are non GAAP financial measures. They exclude intangible asset amortization charges, the accounting impact of share-based compensation and the effect of certain cash and non-cash items, both recurring and non-recurring, that Shire's management believes are not related to the core performance of Shire’s business. 15

EPS Reconciliation Q1 07 Q1 07 Q1 06 Q1 06 $m cents/ADS $m cents/ADS Net income for diluted EPS (ADS) 112.7 63.9c 61.1 36.0c Cost of product sales fair value adjustment - - 23.6 13.8c New River milestone payment - - 50.0 29.4c Integration costs - - 2.3 1.5c Amortization 15.3 8.7c 13.7 7.8c SFAS 123R effect 10.6 6.0c 9.0 5.4c Taxes on above adjustments (7.0) (3.9c) (27.6) (16.2c) Gain on disposition of discontinued operations - - (40.6) (24.0c) Net income for non GAAP EPS (ADS) (Ex SFAS 131.6 74.7c 91.5 53.7c 123R and amortization) 16

Financial Ratios Q1 07 Q1 06 FY 06 (on a non-GAAP basis) COGS : Product sales 14% 11% 13% Gross margin 86% 89% 87% R&D : Revenues 15% 18% 17% SG&A (excl. D&A) : Product sales 45% 51% 52% EBITDA margin 34% 30% 28% This slide contains non GAAP financial measures. They exclude intangible asset amortization charges, the accounting impact of share-based compensation and the effect of certain cash and non-cash items, both recurring and non-recurring, that Shire's management believes are not related to the core performance of Shire’s business. 17

Cash flow – YTD 2007 Millions of USD Cash generation + 100 Net tax/interest + 1 - 28 Product milestones Asset sales + 8 Fixed asset purchases - 20 Share issue + 878 Net Cash at 31.12.06 1,157 - 6 New River acquisition/funding costs Cash Surplus Q1 2007 919 paid Net Cash at 31.3.07 2,076 - 44 Provision for amounts due (459) Treasury stock purchases for appraisal rights Option/Warrant Restricted cash (30) + 29 1,587 “Free Cash” exercises New facilities 2,300 3,887 Liquidity at 31.03.07 Less New River Payments (2,600) (approx) Cash surplus for YTD 2007 : +919 Revised liquidity 1,287 18

Q1 2007 Actual v 2007 Guidance (including NRP) Q1 07 Original Updated Actual FY Guidance FY Guidance Revenue growth 29% Around 20% Low 20% range Revenue growth (excl. launches) 16% R&D - GAAP ($m) 80.8 Less SFAS 123R (2.3) R&D - Non GAAP ($m) 78.5 $360m to $380m $340m to $360m SG&A - GAAP ($m) 213.8 Less SFAS 123R (7.5) SG&A - Non GAAP ($m) 206.3 $930m to $960m Unchanged D&A - GAAP ($m) 28.9 Less amortization (15.3) Up 20% approx $70m Up 80% approx $100m Depn - Non GAAP ($m) 13.6 Up 20% approx. $50m Unchanged Tax rate 27% 26% Unchanged New River Integration costs - n/a $10m (to be non GAAPed) 19

Matthew Emmens CEO Product Launches

VYVANSE � Next generation of ADHD treatment � VYVANSE - innovative and future flagship product for ADHD � Impressive efficacy, extended duration, less potential for abuse � Strong IP until 2024 � FDA approval received on February 23, 2007 � Awaiting final DEA scheduling � Launch in June is optimal � sNDA for adult indication expected to be filed in Q2 2007 22