Full Year 2007 Results
Shire plcFebruary 21, 2008
2
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 including, but not limited to, the successful development of JUVISTA® (Human TGFβ3) and velaglucerase alfa (GA-GCB); manufacturing and commercialization including, but not limited to, the launch and establishment in the market of VYVANSE™(lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder (“ADHD”)); the impact of competitive products including, but not limited to, the impact of those on Shire’s 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 date of INTUNIV™ (guanfacine extended release) (ADHD); Shire’s ability to secure new products for commercialization and/or development; 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.
3
Agenda
Introduction and Product Highlights Matthew Emmens
2007 Financial Review Angus Russell2008 Guidance
Pipeline Review Michael Cola/Sylvie Gregoire
VYVANSE Update Michael Cola
Concluding Remarks Matthew Emmens
Questions & Answers All
Matthew Emmens CEO
Introduction and Product Highlights
5
Introduction Excellent performance in all areas of the business
Strong product sales reflecting good results and successful product launches across all areas of our business
Executing our strategy
6 launches in past two years: FOSRENOL, ELAPRASE, DAYTRANA, LIALDA, VYVANSE, DYNEPO
Strong track record of approvals or “approvables” in past four years
Robust intellectual property for key growth driving products
Rich pipeline with a focus on orphan drugs and specialist products treating symptomatic disorders
16+ potential launches from 2008-2015 (9 from new products)
Global expansion into new markets (South America, Russia, Mexico, Australia, Japan)
2008 revenue growth expected to be in the mid to high teens and positive revenue growth through 2010
6
2007 Financial Highlights
Product sales up 41% to $2.17 billion
New Products sales:
23% of total sales for 2007 versus 6% in 2006
32% of total sales for Q4 2007 versus 12% in Q4 2006
Total revenues up 36% to $2.436 billion
Non GAAP Earnings per ADS up 38% to $2.95
Dividend up 20%
7
Product HighlightsADHD franchise exceeds 31% US market share
VYVANSE
Promotion began 3rd week July 2007– 6% market share*
Adult indication PDUFA date – April 28, 2008
DAYTRANA
Enhanced process and improved ease of use
Regulatory submission was filed for product approval in the EU
GI franchise 26% share of US oral mesalamine market
LIALDA / MEZAVANT
Latest US weekly market share – 9.8% of NRx and 8.9% of TRx *
Launched in the UK during Q4 2007 and in Canada January 2008
Further launches in EU planned in 2008
PENTASA
Latest US weekly market share – 17.1% of TRx*
*SOURCE: IMS NGPS weekly data – as at February 18, 2008
8
Product HighlightsHuman Genetic Therapies
ELAPRASE
Best in class Lysosomal Storage Disease launch
Now approved in 37 countries
Additional geographical expansion planned
REPLAGAL
REPLAGAL sales continue to show significant growth with new patients starting therapy in European markets as well as through geographic expansion into Canada, Latin America and Japan
Approved in 41 countries
Renal FOSRENOL
European launch saw rapid take up of FOSRENOL with patient shares 10 months post launch at 12% in Germany and 19% in France
Successful Shire initiated FDA Advisory Committee has provided a clear regulatory pathway for approval of FOSRENOL for pre-dialysis CKD patients
Now available in 24 countries
DYNEPO
Launched in several EU countries in 2007
9
Business Development HighlightsNew River Pharmaceuticals
Global rights, full ownership and control of VYVANSE’s development program
Acquired five pipeline compounds in new technologies and new markets
Worldwide rights (ex-EU member states) from Renovo plc:
JUVISTA, a novel biological treatment for the prevention and reduction of scarring
Ex-US rights from Amicus Therapeutics Inc:
AMIGAL ™, Fabry disease (Phase 2)
PLICERA ™, Gaucher disease (Phase 2)
AT2220, Pompe disease (Phase 1)
Exclusive rights (ex US and Japan) from Alba Therapeutics Corp:
SPD550 in Phase 2 development for the treatment of Celiac disease
Angus RussellCFO
2007 Financial Review
11
2007 2006 Growth
$m $m
Product Sales 2,170.2 1,535.8 41%
Royalties 247.2 242.9
Other Revenues 18.9 17.8
Total Revenues 2,436.3 1,796.5 36%
2007 2006 Growth
$m $m
Product Sales 661.3 427.6 55%
Royalties 61.8 61.1
Other Revenues 1.4 8.3
Total Revenues 724.5 497.0 46%
FY
Q4
Total Revenues
Sales from New Launches (% total product sales)
1319
23
32
05
101520253035
Q1 Q2 Q3 Q4
2007%
2007 Q4 07$m $m
Established Products 1,680.8 17% 451.7 21%
ELAPRASE 181.8 57.4LIALDA 50.5 29.2FOSRENOL US 62.1 14.2FOSRENOL EU 40.1 12.0VYVANSE 76.5 65.9DAYTRANA 64.2 23.0DYNEPO 14.2 7.9
New Product Sales 489.4 * 209.6
Total Product Sales 2,170.2 41% 661.3 55%* 23% of FY product sales
Growth Growth
12
Major Product Sales2007 2006 Sales US RX*
$m $m Growth Growth
ADDERALL XR 1,030.9 863.6 19% 16% 3%
VYVANSE 76.5 - n/a n/a
DAYTRANA 64.2 25.1 156% -10% 166%
PENTASA 176.4 137.8 28% 25% 3%
LIALDA 50.5 - n/a n/a
FOSRENOL 102.2 44.8 128% 123% 5%
CARBATROL 72.3 68.3 6% 11% -5%
XAGRID 66.8 53.3 25% n/a
ELAPRASE 181.8 23.6 670% n/a
REPLAGAL 143.9 117.7 22% n/a*Source: IMS data
13
ADHD Mkt Avg FY Mkt ADHD Mkt Avg Q4 MktTRx ('000)* Share $M TRx ('000)* Share $M
Sales Demand 37,333 1.8% (1) $68.4 9,818 4.7% (2) $47.2
Stocking $50.3 $40.5
Underlying Gross Sales (3) $118.7 100% (3) $87.7 100%
Sales Coupons ($25.0) (21%) ($12.4) (14%) 36% 25%
Wholesaler discounts and rebates ($17.2) (15%) ($9.4) (11%)
Net Sales $76.5 64% $65.9 75%
* Per IMS data
Notes1 FY - Revenue per TRx = $3.41 (price per unit) x 29.6 units per TRx2 Qtr - Revenue per TRx = $3.41 (price per unit) x 30.2 units per TRx3 Includes the recognition of original launch stocks of $57.4m (FY) of w hich $36.9m w as recognised in Q4
2007 Q4 2007
VYVANSE – Gross to Net Sales
Sales deductions will trend towards a
long term rate of ~ 28% as rebates increase partially offset by coupons reducing over time
14
ADHD Mkt Avg FY Mkt ADHD Mkt Avg Q4 MktTRx ('000)* Share $M TRx ('000)* Share $M
Sales Demand 37,333 2.1% (1) $93.0 9,818 2.1% (2) $25.3
Stocking $6.3 $2.8
Underlying Gross Sales $99.3 100% $28.1 100%
Sales Coupons ($13.2) (13%) ($1.4) (5%)
Returns (3) ($5.9) (6%) 35% ($0.6) (2%) 18%
Wholesaler discounts and rebates ($16.0) (16%) ($3.1) (11%)
Net Sales $64.2 65% $23.0 82%
* Per IMS data
Notes1 FY - Revenue per TRx = $3.98 (price per unit) x 29.4 units per TRx2 Q4 - Revenue per TRx = $3.98 (price per unit) x 30.7 units per TRx3 Includes Voluntary Market w ithdraw al (4%)
2007 Q4 2007
Daytrana – Gross to Net Sales
Low in Q4 due to expiry of 2007
coupon program.
Sales deductions will trend towards long term rate of
~25%.
Coupons expected to moderate to 10% in 2008
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Royalties
2007 2006 Growth$m $m (%)
3TC 145.3 150.9 -4% *
ZEFFIX 41.0 34.8 18% **
Other *** 60.9 57.2 6%
Total 247.2 242.9 2%
*Includes favourable foreign exchange movements of 4% **Includes favourable foreign exchange movements of 8% ***Includes REMINYL/RAZADYNE
16
Key Financial Ratios (% of net product sales)(on a non-GAAP basis)
COGS 14% 14% 13% 13%
Gross margin 86% 86% 87% 87%
R&D 18% 19% 19% 20%
SG&A 45% 46% 52% 54%
Operating EBITDA (1) 24% 21% 16% 14%
Operating EBITDA (% total revenue) (2) 31% 29% 28% 25%
(1) Excluding royalties(2) Including royalties
This slide contains non GAAP financial measures. They exclude intangible asset amortization in respect of acquired intellectual property and the effect of certain cash and non-cash items, both recurring and non-recurring, that Shire's management believes are not related to the core performance of Shire’s business.
2007 2006
Inc FAS123R
Excl FAS123R
Inc FAS123R
Excl FAS123R
17
Net Income/EPS – Actual
Net income ($m)
- GAAP (1,451.8) (1,451.8) 278.2 278.2
- Adjustments 2,003.1 1,983.1 84.2 52.7
- Non GAAP(1) 551.3 531.3 362.4 330.9 52% 61%
EPS - ADS (diluted)
- GAAP (806.1c) (806.1c) 163.8c 163.8c
- Non GAAP(1) 294.6c 284.1c 213.0c 195.0c 38% 46%
Growth %
Inc FAS123R
Excl FAS123R
2007 2006
Inc FAS123R
Excl FAS123R
Inc FAS123R
Excl FAS123R
(1) These are non GAAP financial measures. They exclude intangible asset amortization charges 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.
18
Cash generation
Cash flow – Dec YTD 2007
Cash outflow for 2007 : -355
+645
Net tax/interest
Share issue
Convertible
+237
Millions of USD
-217
-7
Asset sales
+877
Other Financing (inc Treasury stock, dividend etc.)
New River acquisition
Fixed asset purchases-124
-2,601
+1,100
-265 In-licensing payments & milestones
(2) Shire has a revolving credit facility of $1.2bn which was undrawn at 31 December 2007
(1) Shire’s balance of cash and cash equivalents at 31 December 2007 includes $40m of restricted cash and is available to finance payments due to TKT dissenting shareholders (provision at 31 December 2007 of $480m)
Cash at 31/12/06 1,157
Cash outflow in 2007 (355)
Cash at 31/12/07 (1) 802
Convertible debt (1,100)
Net debt at 31/12/07 (2) (298)
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2007 Actual v Guidance
Non GAAP (Exc FAS 123R) Actual Guidance
Revenue growth 36% > 30%
R&D - GAAP ($m) 566.6
Less Renovo (75.0) Amicus (50.0) Alba (25.0) Noven (5.9) FAS 123R (17.0)
R&D - Non GAAP ($m) 393.7 $365m to $375mas % of Net Product Sales 18%
SG&A - GAAP ($m) 1,041.7 Less Net legal settlement (17.0)
FAS 123R (52.7)
SG&A - Non GAAP ($m) 972.0 $955m to $975m
as % of Net Product Sales 45%
17% - 18%
46% - 47%
20
2007 Actual v Guidance (continued)Actual Guidance
Amortisation ($m) 95.0 versus 2006: + 66% + 70%
Depreciation ($m) 59.3versus 2006: + 37% + 30%
Depreciation & Amortisation 154.3
Tax charge - US GAAP 55.5 Less non GAAP adjustments* 87.8
Non GAAP Charge 143.3
Non GAAP Income before tax 692.8
Effective Tax rate 21% Low 20%'s
* see Appendix (EPS Reconciliation slide)
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Inc FAS123R Exc FAS123R
Revenue growth Mid to high teens
Vyvanse Product Sales $350 - $400m**
R&D $465 - $490m $450 - $475m
SG&A $1,125 - $1,165m $1,080 - $1,120m
Capex $320- $350m
Depreciation Growth ~50%
Non GAAP Tax Rate ~ 23%
Fully diluted share capital 590m
Interest - after tax add back $13m
* Non GAAP net income for 2008 will include FAS123R and will exclude : amortisation(1) , balance of gains on the sale of non-core products ($29m) and upfront payments & milestones in respect of in-licensed products.(1) Amortisation forecast: 25% growth vs 2007.** Assumes the adult indication is launched by mid year 2008.
2008 Non GAAP Guidance*
Michael Cola, President, Specialty Pharmaceuticals
Sylvie Gregoire, President, HGT
Pipeline Review
23
R&D investment will drive growth
Focus on products for the specialist market and rare genetic diseases where there is low competitive intensity.
New indications and geographic expansion will maximize the return on our currently marketed products
Acquire products with relatively low technical risk of development in areas where we have expertise
Target the acquisition of companies in new areas that form the cornerstone of a new Business
24
Shire R&D portfolio is well-balanced with both short and long term opportunities for growth
Development Phase
ADHDHGT
Intuniv
VYVANSE – Adult-US
Registration
Daytrana - EU
Phase III
Lialda –Diverticulitis
Fosrenol CKD
VYVANSE - EU
Women’sHealth
DaytranaAdolescent
Velaglucerase
Phase II
Women’s Health
Juvista (SPD 538)
Larazotideacetate
(SPD 550)
Amigal
Plicera
AT2220
Phase I
Elaprase IT
Research-Preclinical
Sanfilippo ERT
MLD ERT
GI Renal Other
25
Shire has one of the strongest mid to late-stage pipelines in its sector
20102007 20092008 2011-2015
DAYTRANA ADOLESCENT
VELAGLUCER-ASE ALFA
PLICERA
AMIGAL
AT2220
ELAPRASE IT
SANFILIPPO ERT
MLD ERT
VYVANSE EU
JUVISTA
LIALDA DIVERTICULITIS
SPD 550
WOMEN’S HEALTH PORTFOLIO
VYVANSE
DYNEPO
LIALDA / MEZAVANT
FOSRENOLEU
ELAPRASE EU
DAYTRANA EU
INTUNIV**
VYVANSE ADULT
FOSRENOL -CKD
*16+ potential launches from 2008-2015 - 9 from new products
*Subject to regulatory approvals**Approvable letter received
26
0
100
200
300
400
500
2005 2006 2007 2008
Spec PharmaHGT
R&D investment
18%18%19%21%Shire Total
13%13%14%19%Spec Pharma
42%45%74%86%HGT
2008200720062005
R&
D In
vest
men
t ($M
)
R&D investment as a percentage of sales
27
Balanced R&D investment
Ph3b/4 & Lifecycle Programs
(44%)
Ph3 Programs(22%)
Research – Ph2Programs
(19%)
Post-Approval Commitments
(15%)
2008 $450 – 475M*
*Excludes SFAS No. 123(R)
Specialty Pharma Portfolio
29
Program PhII PhIII Registration
VYVANSE Adult ADHD - USDaytranaADHD - EU
JuvistaPrevention & treatment of scarringSPD 550Celiac disease
Lialda DiverticulitisVYVANSEADHD - EU
IntunivNon-stimulant for treatment of ADHD
Specialty Pharma programs focus on lifecycle opportunities and new product development
DaytranaAdolescent ADHD - US
FosrenolCKD (pre-dialysis)
Marketed Product Life cycle opportunities
New populations, indications and
geographic expansion
New Product Development:Existing & New Therapeutic Areas
HGT Portfolio
31
CommercialPh II/IIIPh I/IIPreclinical IND Tox
POC
HGT product pipeline focusing on new platforms and technology
ReplagalFabry DiseaseElapraseHunter Syndrome
VelagluceraseGaucher Disease
Elaprase ITHunter – CNSSanfilippoSanfilippo ERT
MLDMetachromaticLeukodystropy ERT
AmigalFabry DiseasePliceraGaucher DiseaseAT2220Pompe Disease
Marketed Product Support
Grow ERT Franchise
New Platform: Pharmacological
Chaperones
New Technology: CNS Diseases
Research Expand pipeline through internal Research capability
32
R&D news flow
2H-091H-08 1H-092H-08
VYVANSE adult ADHD launch (US)
JUVISTA Ph2 data
ELAPRASE Geographic Expansion
AT2220 Ph2 Initiation
FOSRENOL CKD launch (US)
VELAGLUCERASE Ph3 enrollment complete
ELAPRASE IT Ph1 Initiation
SANFILIPPO and MLD tox programs
DAYTRANA EU launch
SPD550 Ph2 data
AMIGAL Ph3 Initiation
PLICERA Ph2 data
INTUNIV launch
DAYTRANA adolescent sNDAfiling
VELAGLUCERASE filing
33
Duration of Patent and Regulatory Exclusivity
^ Currently difficult generic approval pathway for locally acting drugs*Orphan Drug** Regulatory Exclusivity in EU until 2017Revisions as of March 5, 2008
19
2000 2005 2010 2015 2020 2025
20232012
20122012DYNEPO
2013**2019ELAPRASE*
20182009FOSRENOL
20202010LIALDA^
VYVANSE
Patent Term Regulatory Exclusivity
20202011REPLAGAL*
34
Projected Patent^ and Regulatory Exclusivities*For Current Pipeline Products
2019
2021
2019
2018
2018
2010 2015 2020
AMIGAL 2
VELAGLUCERASE 1
ELAPRASE IT 1
PLICERA 2
AT-2220 2
1. Biologic Product2. Orphan Designation Obtained or Being Sought- 7 yr exclusivity in US; 10 year exclusivity in EU^ Last to expire of currently published patent applications, regardless of jurisdiction; applications not yet granted.* Exclusivity for new, approved biologics in EU is 10 years; currently no generic approval pathway in US. Exclusivities for new chemical entities
(non-biologics) are: US 5 yrs; EU 10 yrs.Revisions as of March 5, 2008
JUVISTA 1
INTUNIV
SPD-550 2019
2021
2019
35
SummaryBalanced R&D investment of approximately 18% of product sales in2008
Strong news flow over the next 24 months
Initiation of one Ph1 program
Initiation of one Ph2 program
Ph 2 data from three new products
Initiation of one Ph3 program
Completion of two Ph3 programs and subsequent regulatory submissions
One new product launch
Four launches of market expansion programs of existing products
Michael ColaPresident, Specialty Pharmaceuticals
VYVANSE – Launch Update
37
Introduction
Launch Progress
Adult Indication
Managed Care Update
38
Key attributes of VYVANSE support differentiation as a NCE
The first Pro-drug Stimulant
Consistent time to maximum concentration of d-amphetamine from patient to patient
Significant efficacy throughout the day, even at 6:00 PM
Adverse event profile that is mild to moderate in severity and incidence decreases over time
Significantly lower abuse related liking effect than an equivalent oral dose of d-amphetamine
5
39
VYVANSE Launch Performance
Over 900,000 prescriptions since launch
Over 50% (23,000) of high volume physicians prescribing
Double industry norms for promotional campaign recall and recognition
* Projection based on daily prescription volume
+6.3%*
0%
1%
2%
3%
4%
5%
6%
7%
6/22
6/29 7/6 7/13
7/20
7/27 8/38/10
8/17
8/24
8/31 9/7 9/14
9/21
9/28
10/5
10/12
10/19
10/26 11
/211
/911/1
611
/2311
/30 12/7
12/14
12/21
12/28 1/41/1
11/1
81/2
5 2/1 2/82/15
TRx
Sha
re
Labor Day
ThanksgivingChristmas/New Year’s
MLK
40
VYVANSE launch has been tracking in line with other blockbuster CNS drug launches
Source: IMS NPA
0
100,000
200,000
300,000
400,000
500,000
600,000
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
Launch Month
TRx
Paxil Risperdal Zyprexa Seroquel Lunesta Strattera Vyvanse
41
Highest volume ADHD prescribers are adopting VYVANSE, and trickle down is occurring with lower level prescribers
Source: IMS
Vyvanse TRx Market Share Uptake Comparison
3.4%4.1%
4.8% 5.2% 5.6%3.6%
4.7%5.7%
6.6%7.2% 7.7%
4.5%5.8%
6.9%7.8%
8.6% 9.1%
0.1% 1.2%2.6%
0.1%
1.6%0.1%2.0%
0%1%2%3%4%5%6%7%8%9%
10%
Jun-07 Jul-07 Aug-07 Sep-07 Oct-07 Nov-07 Dec-07 Jan-08Month
TRx M
arke
t Sha
re
All Top 43,000 Top 14,000
42
Coupons are declining as a % of TRx as New Starts convert to fully paid TRxs
Coupons are now less than 15% of total prescriptions
% of Weekly TRx that are Coupons
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
7/20/0
77/2
7/07
8/3/07
8/10/0
78/1
7/07
8/24/0
78/3
1/07
9/7/07
9/14/0
79/2
1/07
9/28/0
710
/5/07
10/12
/0710
/19/07
10/26
/0711
/2/07
11/9/
0711
/16/07
11/23
/0711
/30/07
12/7/
0712
/14/07
12/21
/0712
/28/07
1/4/08
1/11/0
81/1
8/08
1/25/0
82/1
/082/8
/08
43
Level of Interference
3.6
5.7
6.8
5.8
5.9
3.2
3.3
3.5
1 3 5 7 9
Social Interactions
Homework
Family Interactions
School Activities
Adderall XRWith VYVANSE (avg. 6 weeks)
n=1960*p<0.01 vs. Before VYVANSE
Q: Before/since taking VYVANSE, how much did/do your child’s symptoms interfere with school activities?Q: Before/since taking VYVANSE, how much did/do the symptoms interfere with family interactions?Q: Before/since taking VYVANSE, how much did/do the symptoms interfere with homework?Q: Before/since taking VYVANSE, how much did/do the symptoms interfere with social interactions?
Patient reported experience with VYVANSE exceeds what they previously reported on AXR
*
*
*
*
Source: VYVANSE New Start Patient Experience program which includes survey data from over 10,000 parents of children prescribed VYVANSE, of whom 39% previously took ADDERALL XR. Parents were surveyed at their child’s initiation of VYVANSE and after 6 weeks of therapy. Data collected were from July 2007 – January 2008
44
At 4 months, VYVANSE is already seen by physicians as the top choice for patients who need additional efficacy
Source: CTS Posttest, November 2007, n=189
Q: Please write in your first choice ADHD medication for treated patients who need additional efficacy?”
0%
5%
10%
15%
20%
25%
30%
% o
f Phy
sici
ans
Vyvanse Adderall XR Strattera Concerta Adderall Focalin XR Daytrana
First Choice for Additional Efficacy
45
VYVANSE is also the first choice for patients that need a longer duration of effect
Source: CTS Posttest, November 2007, n=194
Q: Please write in your first choice ADHD medication for treated patients that need a longer duration of effect?”
0%
5%
10%
15%
20%
25%
30%
35%
40%
% o
f Phy
sici
ans
Vyvanse Concerta Adderall XR Daytrana Strattera Focalin XR
First Choice for Longer Duration of Effect
VYVANSE Adult Indication
47
The VYVANSE adult claim represents a significant opportunity for growth in 2008
VYVANSE Adult Indication:
Filed on June 29, 2007
PDUFA date is April 28, 2008
Commercial launch planned for Q2 2008
Strong effort to both physicians and consumers
Duration important for adult day
Lower abuse related liking effect compared to equivalent oral dose of d-amphetamine
New opportunity to grow the adult market
Efforts by all companies to expand adult market have been minimal since promotion of AXR was discontinued
No major consumer efforts in several years
* There has been no adult promotion to date
48
0
5,000
10,000
15,000
20,000
25,000
30,000
35,000
40,000
2003 2004 2005 2006 2007
6-12 13-17 18+
Current ADHD Market Growth is Primarily Driven by Adults
Source: Age Data - Verispan’s Vector One National; Annual Growth – IMS NPA
Tota
l Pre
scrip
tions
(000
)
Percent Market Growth by Age Segment
+20.4%+25.2%
+17.3%
+15.4%
+10.9%
+14.9%
+10.5%
+5.0%
-0.7%
+9.1%
-3.0%
-5.8%
+14.4%
+3.1%
+2.3%
+16.8% +6.1% +3.2% +5.7%Annual Growth: +17.3%
5-Year CAGR:
18+: 16.4%
13-17: 4.8%
6-12: 1.4%
49
Adults represent the largest and fastest growing segment of the ADHD market
% of total ADHD prescriptions by age category
Source: Verispan’s Vector One: MAT 12/07
36%41%
23%
Adult18+
Child0 – 12 yrs
Adolescent13 – 17 yrs
200736.3MM TRx
28%
46%
25%
200223.4MM TRx
Adult18+
Child0 – 12 yrs
Adolescent13 – 17 yrs
28%
23%
36%41%46%
25%
50
The adult ADHD market remains substantially underdeveloped
Popu
latio
n*N
= 29
6.6
MM
Patient Group by Age
% Prevalence** Drug Treated***
81%4.0MM
24%2.4MM
Total Patients
4.9MM
* US Census**Prevalence data calculated from data presented from Kessler, 2006 and CDC/NHIS *** Drug Treated=Number diagnosed * drug treatment rate
9.9MM
School Age (4-17)(24.3%)72 MM
Adults(75.6%)224 MM
6.9%
4.4%
Untreated
0.9MM
7.5MM
51
39%
43%
46%
20%
30%
40%
50%
Shar
e of
Pre
fere
nce
Vyvanse
Child Adolescent Adult
Pre-launch market research has shown that physicians stated preference for VYVANSE in adults is even greater than in children
SYMPTOMATIC PATIENTS
Source: FutureScope market research, April 2007, n= 500 physicians
Child<Adol/Adult (p<0.05)
52
15%
17%
19%
21%
23%
25%
27%
Jan-04
Mar-04
May-04
Jul-0
4Sep
-04Nov-04Jan
-05Mar-
05May
-05Jul-0
5Sep-05Nov-05Jan
-06Mar-
06May
-06Jul-0
6Sep-06Nov-06
% S
hare
of A
dult
Tota
l Pre
scrip
tions
VYVANSE share in adults will increase with label change/promotion of the indication as did AXR
Source: Verispan Vector One
ADDERALL XR®
Adult Approval
53
Shire already holds the market lead by a wide margin among brands in Adult ADHD
0%
5%
10%
15%
20%
25%
30%
Adderall XR Concerta Strattera Focalin XR
Monthly Market Share
Source: Verispan’s Vector One: National
54
VYVANSE differentiation will increase with release of new clinical data in 2008
Other
2Q08Flexibility3 new dosage strengths
Mid 08Efficacy, Duration311 Classroom Analog
Mid 08Tolerability310 Dose Optimization
TimingParameters of Differentiation
Studies
Managed Care Update
56
VYVANSE Managed Care Coverage in 9 months exceeds 12 month goal!
ADDERALL XR has outstanding managed care formulary coverage
Our goal was to have VYVANSE achieve parity formulary status to AXR within 18 months of launch; 75% to this goal within 12 months
In total, VYVANSE will have ~80% parity formulary status to ADDERALL XR contracted lives by April 1
We have executed agreements with the top 6 managed care organizations
Lives Covered at Tier 2 (MM)
0
20
40
60
80
100
120
140
160
180
200
3Q07 4Q07 1Q08 April 1, 2008
Plan
Rep
orte
d Li
ves
57
DACON holding steady at 1.0, validating and reinforcing Duration message
DACON of ADDERALL XR started out immediately at launch at 1.2 has remained there for many years
DACON of VYVANSE was close to 1.0 at launch and has held steady at 1.0 after 6 months, validating the long duration of effect
Managed Care was skeptical at launch but now is impressed as DACON has held steady and they see this replicated in their own plan level data
0.6
0.8
1
1.2
1.4
1 2 3 4 5 6 7 8 9 10 11 12
Month Post-Launch
DACO
N
Adderall XR Vyvanse
58
Medicaid Coverage is good and has steadily improved since launch
July 31, 2007: 17% Open AccessSept 31, 2007: 38% Open AccessDec 31, 2007: 58% Open AccessAnticipated Apr 08: >75% Open Access
RI
MA
CA
FL
NC
NJ34
VA
MS
MD
AL
SC
IN
LA
AZ
WA
WI
KY
OK
MN
CO
AR
PA
NYOR
KS
IA
NVNE
ME
SD
MTND
AK
WY
VT
ID
UTWV
HI
NMGA
IL
MI
MO
NH
TX
OH DE
CT
TN
DC
*Open Access based on % of ADHD Rxs in Medicaid; Note: AZ has varying access by plan
Source: IMS November 2007 ADHD TRx’s
February 15, 2007: 68% Open Access*
59
VYVANSE – Positioned for the long term
Outstanding IP protection to 2023 US / 2024 EU
Further investment
Phase IV research to strengthen product profile
Development of the adult market
Penetration into nascent Global markets
Opportunities beyond ADHD
Matthew Emmens CEO
Concluding remarks
61
Concluding Remarks
Excellent 2007 results
Successful ongoing launches
Accelerating new product sales representing 23% of total sales for full year
2007 and 32% of total sales for Q4 2007
Successful positioning of VYVANSE for continued growth
Good progress in strengthening our pipeline by in-licensing rights to 5 biological and small molecule products
16+ potential launches 2008 - 2015
9 of which are new products
2008 revenue growth expected to be in the mid to high teens range and positive revenue growth through 2010
Questions and Answers
All
APPENDIX
64
EPS Reconciliation2007 2007 2006 2006
$m cents/ADS $m cents/ADS
Net income for diluted EPS (ADS) (1,451.8) (806.1c) 278.2 163.8cCost of product sales fair value adjustment - - 47.0 27.9c
In-licensing and milestone payments 155.9 82.2c 80.5 47.4c
Gain on disposal of product rights (127.8) (66.9c) (63.0) (37.2c)
Legal settlement provision 17.0 9.0c - -
Integration New River/TKT 9.2 4.8c 5.6 3.3c
Intangible asset amortization 95.0 50.1c 57.4 33.6c
FAS 123R - Catch up charge 29.2 15.4c - -
Gain on disposition of discontinued ops - - (40.6) (24.0c)
New River in-process R&D charge 1,866.4 1,028.1c - -
Taxes on above adjustments * (61.8) (32.5c) (34.2) (19.8c)
Non GAAP net income / EPS (ADS) (Inc FAS123R) 531.3 284.1c 330.9 195.0c
FAS 123R 46.0 24.2c 43.0 24.9c
Taxes on FAS 123R * (26.0) (13.7c) (11.5) (6.9c)
Non GAAP net income / EPS (ADS) (Exc FAS123R) 551.3 294.6c 362.4 213.0c
* Total Tax on 2007 Non GAAP Adjustments - $87.8m
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