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
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. To be as brave as the people we help 2
Agenda • Business Model | Financial Performance • Recent Highlights | Growth Drivers • Insight into Orphan Diseases • ADHD Business Update • Q&A To be as brave as the people we help 3
Shire’s Business Model Has Been the Key to Our Financial Growth Business Model Financial Impact 2003-2010 • Specialty biopharmaceutical company with expanding global reach • Treatment of symptomatic Growth CAGR Growth CAGR diseases Total 235% 16% • Operating leverage through revenues efficient commercial EBITDA 198% 15% infrastructure • Growth through licensing and acquisition • Focus on projects with relatively low risk and strong IP protection Note: data covers timeframe of 1/1/2003 through 12/31/2010 To be as brave as the people we help 4
Strong top-line and EPS growth in 2010 $3.1 billion 2010 Total revenues $3.5 billion 15% $2.7 billion 2009 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 To be as brave as the people we help 5
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 To be as brave as the people we help 6
Drivers for Future Growth Launching new products and new indications Advancing the pipeline Investing in biologic manufacturing and global operations To be as brave as the people we help 7
Drivers for Future Growth Launching new products and new indications Launching new products and new indications • Brazil; Adolescent launch • Brazil; Adolescent launch (US & Canada); Adult launch in (US & Canada); Adult launch in • US launch* • US launch* Canada Canada • File MAA in Europe • File MAA in Europe • Continue development of new uses • Continue development of new uses • Maintenance indication* • Maintenance indication* • Progress EU Phase 3 • Progress EU Phase 3 • Continue European launches • Continue European launches *Pending regulatory approval To be as brave as the people we help 8
Drivers for Future Growth Advancing the pipeline Investing in biologic Advancing the pipeline Investing in biologic manufacturing and global manufacturing and global operations operations • SPD 535 - Platelet reduction • SPD 535 - Platelet reduction Complete REPLAGAL • Guanfacine Carrier Wave • Guanfacine Carrier Wave and VPRIV submissions for new plant approval • Movetis programs • Movetis programs • HGT IT programs – Hunter CNS, • HGT IT programs – Hunter CNS, Sanfilippo A, MLD Sanfilippo A, MLD Continue build-out of • HGT 4510 - DMD EU hub in Switzerland • HGT 4510 - DMD To be as brave as the people we help 9
Insight Into Orphan Diseases Our purpose We enable people with life-altering conditions to lead better lives
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 VPRIV acceleration and REPLAGAL market early access leader in Fabry Jerini Acquisition, HAE EU market HGT Profitability LTP-300 Roller Bottle Lexington Campus, Facility completed Atlas facility Santaris (LNA) Acceleron deal Metazym acquisition collaboration Market Expansion Hunter US/ EMEA/LatAm markets Fabry Ex-US market Amicus deal 2005 2006 2007 2008 2009 2010 To be as brave as the people we help 11 11
Shire HGT Business Model Supports Strong Growth PATIENT-CENTRIC PORTFOLIO FUTURE BUSINESS STRENGTH GROWTH MODEL • Rare diseases with • 4 Marketed products • #1 or #2 in our markets unmet need • 4 potential new • Pipeline growth via • High impact Rx / product launches by internal Research and high margin products 2017 Business Development to drive sales growth • Global development/ • Multiple platform commercialization technologies • Strong RoW growth with (incl. Santaris LNA) minimal infrastructure To be as brave as the people we help 12
Adding to the Portfolio through Internal Research Engine: Three Technology Horizons - Core, Emerging, Future Build The Future Build New Capability Orphan Diseases • Novel Disease Space • Novel Therapeutic Modalities Extend • Novel Delivery Technologies Core Capabilities CNS Lysosomal Storage • Patient-Centric Focus Diseases • Enzyme Replacement Therapy • Intrathecal Delivery • Optimized protein production Internal R&D Lysosomal Storage Diseases External Collaborations • Enzyme Replacement Therapy CNS Platform • Optimized Protein Production • Hunter CNS • Hunter Syndrome • Sanfilippo A • Fabry Disease • Metachromatic Leukodystrophy • Gaucher Disease To be as brave as the people we help 13
Augmenting the HGT Portfolio through R&D and Business Development Prioritization Criteria >500 Genetic Disorders • Unmet Patient Need • Prevalence Disease Criteria • Commercial Fit • Scientific Validity • Unmet Patient Need Product Criteria • Competition • Proof of Concept • Development Feasibility • IP/Exclusivity New Programs for R&D or BD To be as brave as the people we help 14
HGT Rare Diseases Range 2,000 to 50,000 Patients Globally Concentrated in Centers of Excellence Disease Prevalence 60,000 50,000 Global Disease Prevalence 40,000 30,000 20,000 10,000 - DMD HAE Gaucher Fabry Hunter MLD Sanfilippo To be as brave as the people we help 15
HGT Portfolio Maintains Strategic Focus on Rare Diseases Preclinical Product Animal POC IND Tox Phase I/II Phase II/III Commercial Launch Growth Drivers Replagal Retention and additional switch 2001 (ex-US) Fabry disease Elaprase 2006 Revenue growth from ROW Hunter syndrome Firazyr US approval, Self-Administration, 2008 Global launches HAE VPRIV Retention and additional switches, 2010 continued global launches Gaucher disease HGT 4510 (ACE 031) Ph II/III Proof of Concept in DMD DMD HGT 2310 Hunter CNS Differentiation within the sector HGT 1410 Novel technology: ERT's delivered Sanfilippo ERT into CNS HGT 1110 MLD ERT IT Expand pipeline through internal Research research capability IV ERT AE Peptide SC Protein IT Platform Research To be as brave as the people we help To be as brave as the people we help To be as brave as the people we help 16 16 16 16
ADHD Business Update and VYVANSE New Uses Our purpose We enable people with life-altering conditions to lead better lives
Global ADHD Portfolio US ADHD market TRx volume grew 12.2% in 2010 EU Only Equasym For the majority of children, “School Day Control” adolescent and adult ADHD patients based on efficacy and duration of symptom control Shire ADHD Vyvanse Intuniv Children and adolescent patients that: •Can’t or won’t take a stimulant •Sub-optimal responders to their current stimulant treatment To be as brave as the people we help 18
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 To be as brave as the people we help 19
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