Merrill Lynch conference. Matthew Emmens, CEO Shire plc September 20, 2007

Transcription

1 Merrill Lynch conference Matthew Emmens, CEO Shire plc September 20, 2007

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 date of INTUNIV (guanfacine) extended release (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.; the successful development of JUVISTA (human TGFβ3) 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,

3 Introduction Continue to execute on strategy effectively Excellent half year results Revenue growth accelerating with new product launches - (up 30% for H on previous year) Upgrading revenue growth guidance to at least 25% (previous guidance low 20% range) VYVANSE Launch rapid uptake Good progress in strengthening our R&D pipeline 3

4 Q2 Financial Highlights Product sales up 34% to $504 million Total revenues up 31% to $575 million Net cash provided by operating activities up 33% to $183 million 4

5 Total Revenues Q2 07 Q2 06 Growth $m $m % Product Sales % Royalties Other Revenue Total Revenues % Q2 07 Q2 06 Growth $m $m % Product Sales 81% % (excl. new launches) ELAPRASE DAYTRANA FOSRENOL US 19%* FOSRENOL EU LIALDA DYNEPO Product Sales 100% % * New launches contributed 13% to product sales in Q

6 Financial Ratios (on a non-gaap basis) Q2 07 Q2 06 HY 07 COGS : Product sales 14% 12% 14% Gross margin 86% 88% 86% R&D : Revenues 16% 16% 16% SG&A (excl. D&A) : Product sales 49% 51% 47% EBITDA margin 29% 30% 31% This slide contains non GAAP financial measures. They exclude intangible asset amortization charges, the accounting impact of sharebased 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. 6

7 Q Highlights New River acquisition JUVISTA license agreement with Renovo $1.1 billion convertible bond ADHD VYVANSE Launched July 2 2.8% market share* snda for adult indication filed during the quarter INTUNIV (SPD503) Approvable letter received SPD465 Approvable letter received GI LIALDA Launched in Q1 Latest weekly market share 8.7% of NRx and 6% of TRx * Very positive reaction from patients and physicians SOURCE: IMS NGPS as at September 7,

8 Portfolio Highlights Human Genetic Therapies ELAPRASE Now available in 33 countries REPLAGAL Approved in 41 countries; REPLAGAL sales continue to show significant growth with new patients starting therapy through in European markets as well as through geographic expansion into Canada, Latin America and Japan; GA-GCB Renal Phase 3 clinical program consisting of 3 trials is currently enrolling patients FOSRENOL Now available in 21 countries Launched in Italy, Canada, and Slovak Republic DYNEPO Launched in Germany, UK, Ireland and Italy 8

9 LIALDA Good launch uptake Monthly Rx Actual T Rx NRx Share TRx Share Rx (000 s) % 8.0% 7.0% 6.0% 5.0% 4.0% 3.0% 2.0% 1.0% 0 March April May June July Aug 0.0% Actual TRx NRx Share 0.8% 3.7% 5.9% 6.6% 6.9% 8.1% TRx Share 0.3% 1.4% 2.7% 3.6% 4.4% 5.4% Source: IMS NGPS 9

10 JUVISTA - (human recombinant TGFβ3) Phase 2 Clinical Trial 0050 Highlights Trial meets its primary endpoint and is highly statistically significant (p<0.0001) Demonstrates clinical efficacy of Lonza manufactured, microbially derived, drug substance, proposed to be used in Phase 3 trials and commercial supply Supports 200ng/100l/linear cm of wound margin as an appropriate dose for Phase 3 studies and establishes a broad response range (50-500ng) Fifth statistically significant Phase 2 efficacy trial reported for JUVISTA 10

11 VYVANSE Launch update

12 VYVANSE is positioned as a new class of ADHD medication not just a replacement to AXR 12

13 Key attributes to support VYVANSE as an NCE in a new class 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 13

14 Weekly TRxs are separating from weekly coupon redemptions demonstrating that patients are refilling Weekly Coupon Redemptions Weekly RX Data Jul 13-Jul 20-Jul 27-Jul 03-Aug 10-Aug 17-Aug 24-Aug 31-Aug Every redeemed coupon is accompanied by an Rx Only one coupon (30 capsules) can be redeemed per patient SOURCE: IMS Daily Rx & PSKW 14

15 VYVANSE is taking market share from all products in the ADHD category, not just ADDERALL XR 3.0% 2.0% Rx Share Change by ADHD Product Since VYVANSE Launch +2.90% 1.0% 0.0% 6/22 6/29 7/6 7/13 7/20 7/27 8/3 8/10 8/17 8/24 8/31-1.0% -1.00% -2.0% Adderall XR Vyvanse Concerta Strattera Generic MPH Generic AMPH SOURCE: IMS NGPS - Universe 15

16 VYVANSE patients are coming from AXR and other brands 5,335 patients started on VYVANSE have enrolled and completed baseline surveys 87% had used a prescription for ADHD prior to VYVANSE 34% 11% 13% 42% AXR Concerta Focalin XR Other Source: VYVANSE New Start Patient Experience program 16

17 With use of VYVANSE, ADHD interfered significantly less with life s activities among children previously using ADDERALL XR Level of Interference School Activities Family Interactions Before VYVANSE With VYVANSE (average 33 days) Homework Social Interactions n=125 n=125 No interference No Interference Very severe interference Very severe interference 12 17

18 Wk 47 Wk 49 Wk 51 Back to School is not a one-two week event; It runs through October ADHD Market (IMS NGPS) Weekly TRx Volume 2007 actual through 9/7/2007 (week 36) "Back to School" season Labor Day Holiday Vyvanse launch in July Wk 1 Wk 3 Wk 5 Wk 7 Wk 9 Wk 11 Wk 13 Wk 15 Wk 17 Wk 19 Wk 21 Wk 23 Wk 25 Wk 27 Wk 29 Wk 31 Wk 33 Wk 35 Wk 37 Wk 39 Wk 41 Wk 43 Wk 45 ADHD ADHD TRxs in 000's

19 Month 22 Month 23 Month 24 Successor Molecules (Lexapro, Nexium) follow a different pattern than line extensions such as AXR Successor Molecule Launch % Conversion of Original Brand & Generics (based on TRx volume) 80% 70% 60% Adderall XR 50% 40% 30% 20% 10% 0% % Conversion = New Product TRx/ (New Product TRx + Original Brand TRx + Generic of Original TRx) 19 % Conversion Vyvanse Month 1 Month 2 Month 3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month 11 Month 12 Month 13 Month 14 Month 15 Month 16 Month 17 Month 18 Month 19 Month 20 Month 21 LEXAPRO NEXIUM VYVANSE ADDERALL XR Nexium Lexapro

20 Managed Care update Coverage is progressing as planned: 6-9 month post-launch review period on adding new products to formulary is common All targeted plans have received clinical information on VYVANSE Negotiations with numerous plans are progressing Parity with AXR formulary status expected by 18 months 20

21 Managed Care Tier Status has only modest impact on share in ADHD Tier 2 Tier 3 Adderall XR 28.1% 25.3% Concerta 22.8% 19.9% Strattera 10.0% 9.2% Source: IMS PlanTrak June

22 Summary VYVANSE rapid launch uptake Tracking in line with the industry s best successor molecule launches Patients starting on coupons are refilling Rxs Back to school is not a one-two week event, but lasts at least two full months Physicians and Patients are providing very positive feedback on their clinical experience with VYVANSE Coverage is progressing as planned VYVANSE has tremendous growth potential beyond 2009 Very strong IP Europe Potential for other indications 22

23 Strong market exclusivity for growth drivers VYVANSE LIALDA^ FOSRENOL ELAPRASE* 2013 EU DYNEPO Patent Life Regulatory Exclusivity ^ Currently no generic approval pathway for locally acting drugs *Orphan Drug 23

24 Shire has one of the strongest late-stage pipelines in the Specialty Pharma sector Product Launches VYVANSE DYNEPO INTUNIV* LIALDA / SPD465* MEZAVANT FOSRENOL EU DAYTRANA EU ELAPRASE EU Seasonique GA-GCB VYVANSE EU FOSRENOL -CKD ELAPRASE CNS SANFILIPPO MLD CEPO SPD493 JUVISTA Eight potential launches over a 30 month period from * Approvable letter received 24

25 Business Development Strategy What s Next? Specialty biopharmaceutical company Seek drugs with strong competitive position and intellectual property Address the needs of the specialist physician Treatment of symptomatic disorders Concentrate resources on lower-risk projects with relatively fast development timelines Small and efficient sales forces In-license/acquire products with potential peak sales of $300 - $500 million 25

26 Concluding Remarks 2007 guidance upgraded as revenue growth accelerates revenue growth to be at least 25% for 2007 (previous guidance low 20% range) Excellent H1 07 results Successful ongoing launches Continuing to demonstrate our ability to execute VYVANSE rapid launch uptake 2.8% market share* ELAPRASE rapid uptake in US and EU LIALDA 8.7% NRx, 6% TRx* FOSRENOL strong start in Europe DYNEPO launched in Q1 2007, good reception Good progress in strengthening our R&D pipeline SOURCE: IMS NGPS as at September 7,

27 Questions and Answers All