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

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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

• r 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.

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Agenda

Introduction and Q1 Highlights

Matthew Emmens

Q1 Financial Review

Angus Russell

Product Launches

Matthew Emmens

Conclusion

Matthew Emmens

Questions & Answers

All

Matthew Emmens CEO Introduction and Q1 Highlights

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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.

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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

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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

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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

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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

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2010 2010 2007 2007 2009 2009 2008 2008 2011 2011 2012 2012 2013-2015 2013-2015 Expanding Geographic Reach Label Expansion New Product Launch

Shire has one of the strongest late-stage pipelines in the Specialty Pharma sector

Seven potential new product launches over a 30 month period from 2006-2008

* Launch timing subject to review

VYVANSE DYNEPO LIALDA /

MEZAVANT

SPD503 SPD465* GA-GCB Sanfilippo MLD CEPO SPD493 FOSRENOL

• CKD

ELAPRASE

CNS

FOSRENOL

EU

ELAPRASE

EU

DAYTRANA

EU

Seasonique VYVANSE

EU

Angus Russell CFO Q1 Financial Review

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Total Revenues

Q1 07 Q1 06 Growth $m $m % Product Sales 87% 400.2 338.2 18%

(excl. new launches)

DAYTRANA 11.9

• ELAPRASE

26.6

• FOSRENOL EU

13% 6.5 0.6 FOSRENOL US 16.3 7.2 Product Sales 100% 461.5 346.0 33%

Q1 07 Q1 06 Growth $m $m %

Product Sales 461.5 346.0 33% Royalties 59.5 61.0 Other Revenue 7.2 4.0 Total Revenues 528.2 411.0 29%

Total Revenue 466.9 403.2 16%

(excl. new launches)

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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

Major Product Sales

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*Foreign exchange movements have contributed +4% to reported growth **Foreign exchange movements have contributed +11% to reported growth ***Includes REMINYL/RAZADYNE

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%

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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.

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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 123R and amortization)

131.6 74.7c 91.5 53.7c

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Financial Ratios

(on a non-GAAP basis)

Q1 07 Q1 06 FY 06 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.

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Cash generation

Cash flow – YTD 2007

Cash surplus for YTD 2007 : +919

+ 100 Net tax/interest Share issue Option/Warrant exercises + 8

Millions of USD

Product milestones + 1 + 29 Asset sales + 878

• 28

Treasury stock purchases New River acquisition/funding costs paid Fixed asset purchases

• 20
• 6
• 44

Net Cash at 31.12.06

1,157

Cash Surplus Q1 2007

919

Net Cash at 31.3.07

2,076

Provision for amounts due for appraisal rights

(459)

Restricted cash

(30)

“Free Cash”

1,587

New facilities

2,300

Liquidity at 31.03.07

3,887

Less New River Payments (approx)

(2,600)

Revised liquidity

1,287

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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)

Matthew Emmens CEO Product Launches

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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

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Most Parents Report that their Child’s ADHD Medication Wears Off before 6 PM

Harris Interactive Omnibus Survey

389 parents surveyed about their child who is currently taking a once- daily ADHD medication in the morning Conducted October 2006

Results

53% report that their child’s ADHD medication stops working before 6PM 63% report their child’s once-daily stimulant medication works 11 hours

• r less

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VYVANSE provides efficacy throughout the day

• 10.3
• 8.9
• 7.7
• 48.2*
• 51.8*
• 51.5*
• 60
• 50
• 40
• 30
• 20
• 10

VYVANSE Placebo

The CPRS was used to assess the duration of therapeutic response in 285 patients by separately analyzing the assessments performed per protocol in the morning (~10 AM), afternoon (~2 PM), and evening (~6 PM). *P<.0001 vs placebo. Adapted from Biederman, et al, Clinical Therapeutics, March 2007

% Change

~10 AM ~2 PM

~6 PM

Median daily dosing time was between 7:30 AM and 8 AM.

Change in Score at Endpoint From Baseline on Conners’ Parent Rating Scale (CPRS) Across the Day

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Consistency/Reliability are the most important Attributes of an ADHD medication

Quantitative Research w/750 High Rxers of ADHD

medications:

Physicians need for the therapy they prescribe to work the first

• time. They do not like to prescribe again and when they do, they

have to explain why their first choice did not work. Physicians want to have their first prescription work with every patient, the same way, every time and for the long term.

Brain Surgery quantitative study, January 2006

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VYVANSE appears to have less variability in drug delivery than ADDERALL XR

Concentration ( Concentration (ng/mL ng/mL) ) Time (h) to Maximum Concentration ( Time (h) to Maximum Concentration (Tmax Tmax) )

VYVANSE 70 mg (n=8) (d-amphetamine) ADDERALL XR 30 mg (n=9) (total amphetamine)

Steady-state pharmacokinetics in pediatric patients (ages 6 to 12) in a randomized, 3-way crossover, double-blind study that included VYVANSE, ADDERALL XR, and placebo. Data on file, LDX005. Shire US Inc.

50 100 150 200 250 300 1 2 3 4 5 6 7 8 9 10 11 12

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74% of Patients Taking VYVANSE Were Much/Very Much Improved (CGI-I)

10 20 30 40 50 60 70 80

Much improved Very much improved

• 32% of patients taking VYVANSE responded as “very much improved”

% of Subjects % of Subjects Much/Very Much Improved Much/Very Much Improved

*P<.0001. CGI-I=Clinical Global Impressions-Improvement (ITT Analysis) Data on file, LDX 003. Shire US Inc.

18% 72%* 74%*

VYVANSE Placebo ADDERALL XR

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VYVANSE Market Research

Over 1,600 high prescribing physicians have participated in 11 market research projects since January 2006

In the most recent study that included 200 physicians, 3/4ths said they were

likely/very likely to prescribe VYVANSE and less than 8% said that they are not likely to prescribe it.

Based on another study with 200 physicians, 93% said they would prescribe

VYVANSE.

Over 400 consumers have participated in 5 research projects since October 2006

In one study of 160 caregivers, over 100 had a positive impression of

VYVANSE’s product profile relative to the ADHD medication their child is currently taking.

The attraction to VYVANSE is driven by its effectiveness until 6 PM In another study of 100 caregivers, 92% stated they liked the medication; 88%

stated that they are likely or very likely to ask their physicians about VYVANSE.

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LIALDA – Impressive Efficacy from a Novel QD Formulation

As the only once daily oral 5-ASA proven to control symptoms

and induce remission, LIALDA helps patients overcome the disruption of UC

LIALDA induces remission as measured by stringent clinical and

endoscopic endpoints

LIALDA utilizes MMXTM (Multi-matrix) technology to delay initial

release of mesalamine to the terminal ileum and ensure that mesalamine is released throughout the colon with just one daily dose.

LIALDA simplifies the route to remission with just two to four

tablets taken once a day

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Profile of LIALDA Attractive to GEs and Patients

GEs rate LIALDA more favorably for UC than Colazal, Asacol or

Remicade

98% of GEs reported they intended to prescribe LIALDA for at least one

patient

GEs intend to prescribe LIALDA for new starts, patients in flare and

patients in remission

55% of patients report they prefer the profile of LIALDA to that of their

current medication

66% of patients who knew about LIALDA reported that they would ask

their doctor to prescribe it

MCO Pharmacy Directors were more concerned about budget impact

from biologics (Remicade, Humira) than the impact from 5-ASA

Survey of 120 GEs, 25 MCO Pharmacy Directors and 160 UC patients

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Launch Progress

Field promotion by 120 reps targeting 8,925 GI physicians began

March 19

Shire call activity increased 37% from pre-launch to launch Shire stocked 26,000 pharmacies with LIALDA prior to launch Shire has trained a sufficient amount of speakers on the LIALDA

data and are available to conduct speaker programs

Branded Direct to Patient campaign planned to commence in May Latest prescription data: NRx 3.2% and TRx 1.2% share of the

branded oral mesalamine market.

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Global FOSRENOL Launch Trajectories

0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20% 1 2 3 4 5 6 7 8 9 10 11 12 13 14

Estimated Share of ESRD Patients

Sweden Actual Germany Actual US Actual France Actual

Concluding Remarks

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Concluding Remarks

Excellent results – the business continues to perform strongly

Successful launches in 2006 and Q1 2007 with upgraded guidance for full year

Continuing to demonstrate our ability to execute

ADDERALL XR – leading US market share DAYTRANA - strong launch continues ELAPRASE – rapid launch in US and EU LIALDA – approved and launched in Q1 2007, quick uptake FOSRENOL - strong start in Europe, US position improving DYNEPO – launched in Q1 2007, good reception

VYVANSE to launch in the US by mid-2007 Early stage pipeline advancing toward clinical development Shire will continue to evolve in order to maintain its long-term growth

Questions and Answers All

APPENDIX

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Appendix 1-2006 Non GAAP net income - revised basis

Q1 Q2 Q3 Q4 FY $m $m $m $m $m Net income for diluted EPS (ADS) 61.1 61.3 87.2 68.6 278.2 New River milestone payments 50.0 -

• -

50.0 Cost of product sales fair value adjustment 23.6 16.7 6.7 - 47.0 Upfront license payments (Duramed and Warren)

• 30.5 -

30.5 Integration costs 2.3 1.6 - 1.7 5.6 Gain on sale of product rights

• (63.0) -

(63.0) Taxes on above adjustments (21.3) (5.1) 7.1 (0.5) (18.8) Gain on disposition of discontinued operations (40.6) -

• -

(40.6) 75.1 74.5 68.5 69.8 288.9 FAS 123R effect 9.0 7.6 9.1 17.1 42.9 Intangible asset amortization 13.7 13.3 14.6 15.7 57.4 Taxes on above adjustments (6.3) (5.9) (6.6) (8.8) (26.9) 91.5 89.5 85.6 93.8 362.3

(1) 2006 Non GAAP basis (2) Revised Non GAAP using 2007 basis

2006 Net income for non GAAP diluted EPS (ADS) (2) Net income for non GAAP diluted EPS (ADS) (1)

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Appendix 2-2006 Non GAAP diluted EPS - revised basis

Q1 Q2 Q3 Q4 FY cents/ADS cents/ADS cents/ADS cents/ADS cents/ADS(3) Diluted EPS (ADS) 36.0c 36.1c 51.3c 40.2c 163.8c New River milestone payments 29.4c

• 29.4c

Cost of product sales fair value adjustment 13.8c 9.9c 3.9c

• 27.9c

Upfront license payments (Duramed and Warren)

• 18.0c
• 18.0c

Integration costs 1.5c 0.9c

• 0.9c

3.3c Gain on sale of product rights

• (37.2c)
• (37.2c)

Taxes on above adjustments (12.6c) (3.0c) 4.2c (0.3c) (11.1c) Gain on disposition of discontinued operations (24.0c)

• (24.0c)

44.1c 43.9c 40.2c 40.8c 170.1c FAS 123R effect 5.4c 4.4c 5.2c 10.0c 24.9c Intangible asset amortization 7.8c 7.8c 8.7c 9.3c 33.6c Taxes on above adjustments (3.6c) (3.3c) (3.9c) (5.1c) (15.6c) 53.7c 52.8c 50.2c 55.0c 213.0c

(1) 2006 Non GAAP basis (2) Revised Non GAAP using 2007 basis (3) Full year numbers do not equate to the sum of the quarters due to the change in denominator each quarter.

2006 Non GAAP EPS (ADS) (1) Non GAAP EPS (ADS) (2)