Cowen Healthcare Conference Shire plc

Transcription

1 Cowen Healthcare Conference Shire plc Michael Cola President, Specialty Pharmaceuticals

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 GA-GCB (velaglucerase alfa); 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,

3 Agenda Introduction & Product Highlights VYVANSE Update Pipeline Review Concluding Remarks Q & A 3

4 Introduction Excellent performance in all areas of the business in 2007 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 (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

5 LIALDA s launch continues with 9.2% national monthly TRx share in February 2008 NRx Volume TRx Volume TRx Share 25, % 20, % Rx Volume 15,000 10, % 4.0% 5, % 0 March April May June July Aug Sept Oct Nov Dec Jan Feb 0.0% NRx Volume 722 3,143 5,340 5,896 6,268 7,689 7,594 8,744 8,571 8,513 9,375 9,112 TRx Volume 725 3,427 7,020 9,258 11,583 14,452 15,429 18,575 19,201 20,595 22,685 22,361 TRx Share 0.3% 1.4% 2.7% 3.6% 4.4% 5.4% 6.3% 6.9% 7.5% 8.0% 8.6% 9.2% TRx Share in representative targeted geography ~12% versus ~6% in uncalled on geography (Source: IMS XPonent 2/22/08) Source: IMS Monthly NPA February

6 Lialda demonstrates strong launch performance, while Pentasa continues to hold share Cumulatively Monthly TRx share change by product since Lialda launch Asacol Pentasa Total Balsalazide Lialda 10.0% 9.2% 8.0% 6.0% % Share Change 4.0% 2.0% 0.0% -2.0% -4.0% Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan- 08 Feb -6.0% -8.0% Total Balsalazide includes Branded Colazal and Generic Balsalazide Disodium -6.8% Source: IMS Monthly NPA February

7 Best in Class Launch First & only enzyme replacement therapy for the treatment of Hunter syndrome Now approved in 39 countries Recent approval in Mexico marks first ELAPRASE approval in Latin America Additional geographic expansion planned in Latin America, Russia & Asia Pacific Elaprase Global Sales ($M) $60 $50 $40 $30 $20 $10 $0 Q Q Q Q Q Q Quarter 7

8 VYVANSE Launch Update

9 Introduction Launch Progress Adult Indication Managed Care Update 9

10 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 10

11 Vyvanse Launch Performance 7% 6% 5% Spring Break 6.7%* TRx Share 4% 3% 2% 1% 0% 6/22 6/297/6 7/13 7/20 7/278/3 Labor Day Over 1,000,000 prescriptions since launch 8/10 8/17 8/24 8/319/7 9/14 9/21 9/28 10/5 10/12 10/19 10/26 11/2 11/9 11/16 11/23 11/30 12/7 12/14 12/21 12/28 1/4 1/11 1/18 Topped 50,000 prescriptions for the first time in most recent 2 weeks 60% (25,000) of high volume physicians prescribing MLK Thanksgiving Christmas/New Year s Double industry norms for promotional campaign recall and recognition 1/252/12/8 2/15 2/22 2/293/7 3/14 * Projection based on daily prescription volume 11

12 VYVANSE launch has been tracking in line with other blockbuster CNS drug launches Paxil Risperdal Zyprexa Seroquel Lunesta Strattera Vyvanse 600, , ,000 TRx 300, , , Source: IMS NPA Launch Month 12

13 Highest volume ADHD prescribers are adopting VYVANSE, and trickle down is occurring with lower level prescribers Vyvanse TRx Market Share Uptake Comparison TRx Market Share 12% 10% 8% 6% 4% 2% 0% 0.1% 0.1% 2.0% 1.6% 1.2% 4.5% 3.6% 2.6% 5.8% 3.4% 4.7% 7.0% 4.1% 5.8% 7.9% 4.8% 6.7% 8.6% 5.2% 7.2% 9.1% 5.6% 7.7% 10.2% Jun-07 Jul-07 Aug-07 Sep-07 Oct-07 Nov-07 Dec-07 Jan-08 Feb-08 Month All Top 43,000 Top 14, % 8.6% Source: IMS 13

14 VYVANSE Adult Indication

15 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 Q 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 15

16 Current ADHD Market Growth is Primarily Driven by Adults Total Prescriptions (000) 40,000 Percent Market Growth by Age Segment 35,000 30,000 25, % +17.3% +9.1% +14.4% 20, % 15, % +14.9% +5.0% -3.0% +3.1% 10,000 5, % +10.5% -0.7% -5.8% +2.3% Annual Growth: +17.3% +16.8% +6.1% +3.2% +5.7% Year CAGR: 18+: 16.4% 13-17: 4.8% 6-12: 1.4% Source: Age Data - Verispan s Vector One National; Annual Growth IMS NPA 16

17 Adults represent the largest and fastest growing segment of the ADHD market % of total ADHD prescriptions by age category MM TRx MM TRx 28% 28% Adult 18+ Child 0 12 yrs 46% 46% 41% 41% Adult 18+ Child 0 12 yrs 36% 36% Adolescent yrs 25% 25% Source: Verispan s Vector One: MAT 12/07 Adolescent yrs 23% 23% 17

18 The adult ADHD market remains substantially underdeveloped Patient Group by Age % Prevalence** Total Patients Drug Treated*** Untreated School Age (4-17) (24.3%) 72 MM 6.9% 4.9MM 81% 4.0MM 0.9MM Population* N= MM Adults (75.6%) 224 MM 4.4% 9.9MM 24% 2.4MM 7.5MM * US Census **Prevalence data calculated from data presented from Kessler, 2006 and CDC/NHIS *** Drug Treated=Number diagnosed * drug treatment rate 18

19 VYVANSE share in adults will increase with label change/promotion of the indication as did AXR 27% 25% 23% 21% 19% 17% 15% 19 Jan-04 Mar-04 May-04 Jul-04 Sep-04 Nov-04 Jan-05 Mar-05 May-05 Jul-05 Sep-05 Nov-05 Jan-06 Mar-06 May-06 Jul-06 % Share of Adult Total Prescriptions Sep-06 Nov-06 Source: Verispan Vector One ADDERALL XR Adult Approval

20 Shire already holds the market lead by a wide margin among brands in Adult ADHD Monthly Market Share 30.0% 25.0% 20.0% 15.0% 10.0% 5.0% 0.0% Feb-07 Mar-07 Apr-07 May-07 Jun-07 Jul-07 Aug-07 Sep-07 Oct-07 Nov-07 Dec-07 Adderall XR Concerta Strattera Focalin XR Source: Verispan s Vector One: National 20

21 VYVANSE differentiation will increase with release of new clinical data in 2008 Studies 310 Dose Optimization Parameters of Differentiation Tolerability Timing Mid Classroom Analog Efficacy, Duration Mid 08 Other 3 new dosage strengths Flexibility 2Q08 21

22 Managed Care Update

23 VYVANSE Managed Care Coverage in 9 months exceeds 12 month goal! Lives Covered at Tier 2 (MM) 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 Plan Reported Lives Q07 4Q07 1Q08 April 1,

24 DACON holding steady at 1.0, validating and reinforcing Duration message 1.4 DACON Month Post-Launch Adderall XR Vyvanse 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 24

25 Medicaid Coverage is good and has steadily improved since launch Anticipated April 2008: 75% Open Access* AK CA OR WA NV ID AZ UT MT WY NM CO ND SD NE KS OK MN IA MO AR WI IL MS IN MI AL TN KY OH GA WV SC PA VA NC NY MD VT NH NJ 34 DE DC ME CT MA RI HI TX LA FL July 31, 2007: Sept 31, 2007: Dec 31, 2007: 17% Open Access 38% Open Access 58% Open Access *Open Access based on % of ADHD Rxs in Medicaid; Note: AZ has varying access by plan 25 Source: IMS December 2007 ADHD TRx s

26 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 26

27 Pipeline Review

28 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 28

29 Shire R&D portfolio is well-balanced with both short and long term opportunities for growth Amigal Velaglucerase Plicera Fosrenol CKD AT2220 Lialda Diverticulitis Larazotide acetate (SPD 550) Daytrana Adolescent Daytrana - EU MLD ERT Juvista (SPD 538) VYVANSE - EU VYVANSE Adult- US Sanfilippo ERT Elaprase IT Women s Health Women s Health Intuniv Research- Preclinical Phase I Phase II Phase III Registration Development Phase HGT ADHD GI Renal Other 29

30 R&D investment 500 R&D Investment ($M) Spec Pharma HGT R&D investment as a percentage of sales HGT 86% 74% 45% 42% Spec Pharma 19% 14% 13% 13% Shire Total 21% 19% 18% 18% 30

31 Shire has one of the strongest mid to late-stage pipelines in its sector *16+ potential launches from from new products VYVANSE DYNEPO LIALDA / MEZAVANT VYVANSE ADULT FOSRENOL - CKD DAYTRANA EU INTUNIV** DAYTRANA ADOLESCENT VELAGLUCER- ASE ALFA PLICERA AMIGAL AT2220 ELAPRASE IT FOSRENOL EU SANFILIPPO ERT MLD ERT ELAPRASE EU VYVANSE EU JUVISTA LIALDA DIVERTICULITIS SPD 550 WOMEN S HEALTH PORTFOLIO *Subject to regulatory approvals **Approvable letter received 31

32 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 Q 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 of which are new products 2008 revenue growth expected to be in the mid to high teens range and positive revenue growth through

33 QUESTIONS AND ANSWERS

34 APPENDIX

35 2008 Non GAAP Guidance* Inc FAS123R Exc FAS123R Revenue growth Vyvanse Product Sales Mid to high teens $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 ** Assumes the adult indication is launched by mid year

36 Duration of Patent and Regulatory Exclusivity VYVANSE LIALDA^ FOSRENOL ELAPRASE* 2013** 2019 DYNEPO REPLAGAL* Patent Term ^ Currently difficult generic approval pathway for locally acting drugs *Orphan Drug ** Regulatory Exclusivity in EU until 2017 Revisions as of March 5, 2008 Regulatory Exclusivity 19 36

37 Projected Patent^ and Regulatory Exclusivities* For Current Pipeline Products JUVISTA 1 INTUNIV SPD AT PLICERA ELAPRASE IT VELAGLUCERASE AMIGAL Biologic Product 2. 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,