matthew emmens, ceo shire...
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Deutsche Bank32nd Annual Healthcare ConferenceMay 2, 2007
Matthew Emmens, CEOShire plc
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, 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 (guanfacineextended 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.
3
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
4
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
5
2007 Highlights - Executing on Strategy
Renal
FOSRENOL – launched in 7 more countries in 2007 including the UK
20 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
6
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
7
2010201020072007 2009200920082008 2011-20152011-2015
ExpandingGeographic
Reach
LabelExpansion
NewProductLaunch
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
FOSRENOLEU
ELAPRASE EU
DAYTRANA EU Seasonique VYVANSE
EU
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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VYVANSE provides efficacy throughout the day
-10.3 -8.9 -7.7
-48.2*-51.8*-51.5*
-60
-50
-40
-30
-20
-10
0
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
% C
hang
e~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 onConners’ Parent Rating Scale (CPRS) Across the Day
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VYVANSE appears to have lessvariability in drug delivery than ADDERALL XR
Con
cent
ratio
n (
Con
cent
ratio
n ( n
g/m
Lng
/mL ))
Time (h) to Maximum Concentration (Time (h) to Maximum Concentration (TmaxTmax))
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.
0
50
100
150
200
250
300
0 1 2 3 4 5 6 7 8 9 10 11 12
13
74% of Patients Taking VYVANSE Were Much/Very Much Improved (CGI-I)
0
10
20
30
40
50
60
70
80Much improved Very much improved
32% of patients taking VYVANSE responded as “very much improved” where as only 16% of patients taking ADDERALL XR responded as “very much improved”
% o
f Sub
ject
s%
of S
ubje
cts
Muc
h/Ve
ry M
uch
Impr
oved
Muc
h/Ve
ry M
uch
Impr
oved
*P<.0001.CGI-I=Clinical Global Impressions-Improvement (ITT Analysis)Data on file, LDX 003. Shire US Inc.
18%
72%* 74%*
VYVANSEPlacebo 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.
16
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
17
Launch Progress
Sales Representatives began detailing Lialda on 3/19/2007
Source: IMS NGPS
0
100
200
300
400
500
600
700
800
900
1000
0.0%
0.5%
1.0%
1.5%
2.0%
2.5%
3.0%
3.5%
4.0%
Actual TRx NRx Share TRx Share
Actual TRx 47 69 190 380 565 683 881
NRx Share 0.2% 0.4% 1.0% 1.9% 2.7% 3.2% 4.0%
TRx Share 0.1% 0.1% 0.3% 0.7% 0.9% 1.2% 1.5%
3/9 3/16 3/23 3/30 4/6 4/13 4/20
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
22
Q1 2007 Financial Highlights
Product sales up 33% to $462 million
Total revenues up 29% to $528 million
EPS – ADS (diluted)
GAAP up 78% 64 cents
Non GAAP* up 39% 75 cents
* This is a non GAAP financial measure which excludes amortization charges, the accounting impact of share-based compensation and the effect of certain cash and non-cash items, both recurring and non-recurring, that Shire's management believes are not related to the core performance of Shire’s business.
23
Q1 2007 Actual v 2007 Guidance(including NRP)
Q1 07 Original Updated Actual FY Guidance FY Guidance
Revenue growth 29% Around 20% Low 20% rangeRevenue growth (excl. launches) 16%
R&D - GAAP ($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)
24
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 or less
25
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 firsttime. They do not like to prescribe again and when they do, theyhave to explain why their first choice did not work.
Physicians want to have their first prescription work with everypatient, the same way, every time and for the long term.
Brain Surgery quantitative study, January 2006
26
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
27
Study 302: Lialda Induced Remission; Asacol Did Not
In Study 302, Lialda 4.8 g and 2.4 g were compared to placebo with a stringent clinical and endoscopic remission primary endpoint (consistent with those used in the Remicade UC trials)
A separate arm using the US formulation of Asacol (2.4 g) was also compared to placebo using the same stringent endpoint
Asacol failed to reach significance vs. placebo on the primary endpoint of remission
Asacol’s failure to induce remission in more patients than placebo is consistent with its labeled indication of “treatment of mildly to moderately active UC”.
This study was not a head to head study; Lialda and Asacol were not compared against each other
28
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 4.0% and TRx 1.5% share of the branded oral mesalamine market.
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