Cowen Healthcare Conference

Transcription

1 Cowen Healthcare Conference Shire plc March 8, 2011 Sylvie Grégoire President, Human Genetic Therapies Our purpose We enable people with life-altering conditions to lead better lives

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 adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of Shire s Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure new products for commercialization and/or development; government regulation of Shire s products; Shire s ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on Shire s products; Shire s ability to register, maintain and enforce patents and other intellectual property rights relating to its products; Shire s ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in Shire s filings with the Securities and Exchange Commission. 2

3 Agenda Business Model Financial Performance Recent Highlights Growth Drivers Insight into Orphan Diseases ADHD Business Update Q&A 3

4 Shire s Business Model Has Been the Key to Our Financial Growth Business Model Financial Impact Specialty biopharmaceutical company with expanding global reach Treatment of symptomatic diseases Operating leverage through efficient commercial infrastructure Growth through licensing and acquisition Focus on projects with relatively low risk and strong IP protection Growth CAGR Total revenues 235% 16% EBITDA 198% 15% Note: data covers timeframe of 1/1/2003 through 12/31/2010 4

5 Strong top-line and EPS growth in $3.1 billion Total revenues $3.5 billion 2009 $2.7 billion 15% Total revenues $3.0 billion Product Sales Royalties and Other Revenues Total revenues 15% to $3.5 billion Product sales 16% to $3.1 billion Non GAAP Earnings per ADS 21% to $4.23 Financial results support our aspirational target of mid-teens growth 5

6 Recent Highlights Self-administration label for the treatment of acute HAE attacks approved by the European Commission Complete response filed with the FDA Positive efficacy and safety US Phase 3 results included Approved by FDA as adjunctive therapy to stimulants for the treatment of ADHD in children and adolescents 6

7 Drivers for Future Growth Launching new products and new indications Advancing the pipeline Investing in biologic manufacturing and global operations 7

8 Drivers for Future Growth Launching new products and new indications Brazil; Adolescent launch (US & Canada); Adult launch in Canada File MAA in Europe Continue development of new uses US launch* Maintenance indication* Progress EU Phase 3 Continue European launches *Pending regulatory approval 8

9 Drivers for Future Growth SPD Platelet reduction Guanfacine Carrier Wave Movetis programs HGT IT programs Hunter CNS, Sanfilippo A, MLD HGT DMD Advancing the pipeline Investing in biologic manufacturing and global operations Complete REPLAGAL and VPRIV submissions for new plant approval Continue build-out of EU hub in Switzerland 9

10 Insight Into Orphan Diseases Our purpose We enable people with life-altering conditions to lead better lives

11 Past year completes series of transformational events for Shire s rare disease business HGT has transformed into a global business with leading marketed products and a focused pipeline 2010 Rev $909M VPRIV US/EU Launch Fabry Ex-US market Hunter US/ EMEA/LatAm markets HGT Profitability Market Expansion Jerini Acquisition, HAE EU market Lexington Campus, Atlas facility Metazym acquisition Amicus deal VPRIV acceleration and early access LTP-300 Roller Bottle Facility completed Santaris (LNA) collaboration REPLAGAL market leader in Fabry Acceleron deal

12 Shire HGT Business Model Supports Strong Growth PATIENT-CENTRIC BUSINESS MODEL PORTFOLIO STRENGTH FUTURE GROWTH Rare diseases with unmet need High impact Rx / high margin products Global development/ commercialization 4 Marketed products 4 potential new product launches by 2017 Multiple platform technologies (incl. Santaris LNA) #1 or #2 in our markets Pipeline growth via internal Research and Business Development to drive sales growth Strong RoW growth with minimal infrastructure 12

13 Adding to the Portfolio through Internal Research Engine: Three Technology Horizons - Core, Emerging, Future Build The Future Build New Capability Extend Core Capabilities Lysosomal Storage Diseases Enzyme Replacement Therapy Optimized Protein Production Hunter Syndrome Fabry Disease Gaucher Disease CNS Lysosomal Storage Diseases Enzyme Replacement Therapy Intrathecal Delivery Optimized protein production CNS Platform Hunter CNS Sanfilippo A Metachromatic Leukodystrophy Orphan Diseases Novel Disease Space Novel Therapeutic Modalities Novel Delivery Technologies Patient-Centric Focus Internal R&D External Collaborations 13

14 Augmenting the HGT Portfolio through R&D and Business Development >500 Genetic Disorders Disease Criteria Product Criteria New Programs for R&D or BD Prioritization Criteria Unmet Patient Need Prevalence Commercial Fit Scientific Validity Unmet Patient Need Competition Proof of Concept Development Feasibility IP/Exclusivity 14

15 HGT Rare Diseases Range 2,000 to 50,000 Patients Globally Concentrated in Centers of Excellence 60,000 Disease Prevalence 50,000 Global Disease Prevalence 40,000 30,000 20,000 10,000 - DMD HAE Gaucher Fabry Hunter MLD Sanfilippo 15

16 HGT Portfolio Maintains Strategic Focus on Rare Diseases Product Replagal Fabry disease Elaprase Hunter syndrome Firazyr HAE VPRIV Gaucher disease HGT 4510 (ACE 031) DMD HGT 2310 Hunter CNS HGT 1410 Sanfilippo ERT HGT 1110 MLD ERT IT Animal POC Preclinical IND Tox Phase I/II Phase II/III Commercial Launch Growth Drivers Retention and additional switch (ex-us) Revenue growth from ROW US approval, Self-Administration, Global launches Retention and additional switches, continued global launches Ph II/III Proof of Concept in DMD Differentiation within the sector Novel technology: ERT's delivered into CNS Research Expand pipeline through internal research capability IV ERT AE Peptide SC Protein IT Platform Research 16 16

17 ADHD Business Update and VYVANSE New Uses Our purpose We enable people with life-altering conditions to lead better lives

18 Global ADHD Portfolio US ADHD market TRx volume grew 12.2% in 2010 For the majority of children, adolescent and adult ADHD patients based on efficacy and duration of symptom control Vyvanse Equasym Shire ADHD EU Only School Day Control Intuniv Children and adolescent patients that: Can t or won t take a stimulant Sub-optimal responders to their current stimulant treatment 18

19 VYVANSE Priorities NEW adolescent indication for VYVANSE Increase recognition of the importance of inattentive symptoms with HCPs in adolescent & young adult patients Establish VYVANSE as a preferred treatment option within our target audience for adolescents and adults with ADHD 19

20 INTUNIV Near Term Drivers of Growth Continued acceptance and uptake of monotherapy indication New indication for adjunctive therapy to stimulants Fastest growing segment of non-stimulant market Significant off-label use of unapproved products (clonidine, atypical antidepressants, SSRI) as adjunctive therapy Direct To Mom (DTM) Television March Launch monotherapy Q3 - adjunctive therapy 20

21 Dopamine dysregulation implicated in many neuropsychiatric disorders Schizophrenia Major Depression (5) Dopamine-dependent symptoms Mood Excessive Daytime Sleepiness Cognition Wakefulness Reward-Impulsivity VYVANSE should only be used to treat ADHD ADHD Bipolar Disorder Binge Eating Disorder Kessler RC et al. Am J Psychiatry 2006;163: ; Atlfas et al. BMC Psychiatry 2002;2:9; Hudson et al. Biol Psychiatry 2007;61: ; Ross et al. Schiz. Res 2006;88:90-95; Wingo et al. J Clin Psychiatry, 2007, 68:11: ; Walters et. al. J Clin Sleep Med, 2008, 4:6: ; Dunlop & Nemeroff Arch Gen Psych (2007); 64:

22 Solid foundation for future growth Sustaining growth in a challenging macroeconomic environment Continuing to build our global presence Meeting the needs of patients and families with innovative, truly valued products 22

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24 Questions and Answers Our purpose We enable people with life-altering conditions to lead better lives

25 APPENDIX Our purpose We enable people with life-altering conditions to lead better lives

26 Replenishing our pipeline Preclinical and earlier Phase 1 Phase 2 Phase 3 Registration Carrier Wave for Pain Guanfacine Carrier Wave ADHD VYVANSE MDD VYVANSE (EU) ADHD LIALDA (US) Maintenance of Remission HGT 1110 MLD SPD 535 Platelet Reducing VYVANSE EDS INTUNIV (EU) ADHD FIRAZYR (US) HAE HGT 1410 Sanfilippo A VYVANSE Negative symptoms and cognitive impairment in schizophrenia LIALDA Diverticular Disease Undisclosed Programs HGT 2310 Hunter CNS VYVANSE Other Non-ADHD uses RESOLOR (EU) Chronic Constipation (Males) SPD 557 (M0003) GERD XAGRID (Japan) Essential Thrombocythaemia SPD 556 (M0002) Ascites HGT 4510 DMD ERT DMD Angioedema Early Research ADHD/CNS GI Hematology Pain 26

27 2010 Full Year performance summary 2010 $m 2009 $m Growth Like for Like Growth (1) Product sales 3,128 2, % +17% Royalties and other revenues % +9% Total revenues 3,471 3, % +16% EBITDA (2) 1, % +21% EPS - ADS (2) $4.23 $ % Cash generation (2) 1, % (1) Like for Like Growth' excludes movements in exchange rates by applying 2009 exchange rates to 2010 results. (2) These are Non GAAP financial measures. See appendix for a list of items excluded from the US GAAP equivalent used to calculate these measures. 27

28 2010 Portfolio strength and diversity Core product sales (1) Financial Year Fourth Quarter 2010 $m 2009 $m Growth Like for Like Growth (2) 2010 $m Growth Like for Like Growth (2) VYVANSE % +26% % +25% ELAPRASE % +16% % +17% REPLAGAL % +87% % +88% LIALDA / MEZAVANT % +24% % +27% PENTASA % +10% 60 +3% +3% FOSRENOL % <1% 45-5% -2% INTUNIV n/a (3) n/a (3) 43 n/a (3) n/a (3) VPRIV n/a (3) n/a (3) 59 n/a (3) n/a (3) FIRAZYR % +91% 3 +48% +59% OTHER % -4% 73-29% -27% CORE PRODUCT SALES 2,767 2, % +35% % +33% (1) Core product sales represent Shire s product sales excluding ADDERALL XR. (2) 'Like for Like Growth' excludes movements in exchange rates by applying 2009 exchange rates to 2010 results. (3) INTUNIV was launched in the US in Q (2009 sales $5.4m). In 2009 VPRIV generated sales from early access programs (2009 sales $2.5m). 28

29 2010 Core product sales up $700m REPLAGAL VPRIV +$140m ELAPRASE +$51m Other +$4m Royalties (excluding AXR) & other revenues -$3m VYVANSE LIALDA +$57m +$157m $3,471m Total revenues $3,008m Total revenues AXR (1) INTUNIV +$129m -$233m +$161m 2009 Core products (2) growth % (1) Product sales and royalties (2) Core product sales represent Shire s product sales excluding ADDERALL XR. 29

30 Operating leverage emerging key financial ratios Year on Year: Product sales Core product sales % +34% % +25% R&D (1) SG&A (1) +14% +13% +10% -3% Ratios: % of product sales Gross margin (1) R&D (1) SG&A (1) (1) (2) EBITDA 86.5% 19% 41% 26% 86.5% 19% 42% 25% (1) These are Non GAAP financial measures. See appendix for a list of items excluded from the US GAAP equivalents used to calculate these measures. (2) Excluding royalties and other revenues 30

31 Dynamics beyond 2010 DRIVERS KEY ELEMENTS SUSTAINED PRODUCT SALES GROWTH INVESTING IN FUTURE GROWTH ABSORBING THE IMPACT OF RECENT TRANSACTIONS DELIVERING FINANCIAL PERFORMANCE Young growing portfolio Significant diversification of sources of growth Progressing the pipeline Optimising the global reach of our products Infrastructure to sustain future growth Movetis acquisition DAYTRANA divestment Expanded operating margins Earnings growth Strong cash generation 31

32 Shire 2011 outlook Direction versus FY 2010 Full year 2011 dynamics Product sales Royalties Growth continuing at 2010 rate Generic erosion (Total royalties & other revenue -10%) Product gross margins R&D and SG&A Tax rate Reported EPS-ADS 10-13% growth 22-24% tax rate cemented by Swiss operations Good Earnings growth 32

33 2010 Royalties 2010 $m Financial Year 2009 $m Growth Fourth Quarter 2010 $m Growth 3TC and ZEFFIX % 39-11% ADDERALL XR % 14-73% REMINYL % 8-43% Other % 13 n/a Total Royalties % 74-36% 33

34 Non GAAP net debt December, $m December, $m Cash and cash equivalents Restricted cash Convertible bonds Building finance obligation (1,100) (8) (1,100) (47) Net debt (531) (615) 34

35 Non GAAP measures This presentation contains financial measures not prepared in accordance with US GAAP. These Non GAAP financial measures are used by Shire s management to make operating decisions because they facilitate internal comparisons of the Company s performance to historical results and to competitors results. They should not be considered in isolation from, as substitutes for, or superior to financial measures prepared in accordance with US GAAP. The following items are excluded from these non-gaap financial measures: Amortization and asset impairments: Intangible asset amortization and impairment charges; and Other than temporary impairment of investments. Acquisitions and integration activities: Upfront payments and milestones in respect of in-licensed and acquired products; Costs associated with acquisitions, including transaction costs, fair value adjustments on contingent consideration and acquired inventory; Costs associated with the integration of companies; and Non-controlling interest in consolidated variable interest entities. Divestments, re-organizations and discontinued operations: Gains and losses on the sale of non-core assets; Costs associated with restructuring and re-organization activities; Termination costs; and Income / (losses) from discontinued operations. 35