BIO CEO and Investor Conference February 10, 2009 Sylvie...
Transcript of BIO CEO and Investor Conference February 10, 2009 Sylvie...
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BIO CEO and Investor ConferenceFebruary 10, 2009
Sylvie Grégoire President, Shire HGT
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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, the Company’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 the Company’s Specialty Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate new products for commercialization and/or development; government regulation of the Company’s products; the Company’s ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company’s products; the Company’s ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company’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 the Company’s filings with the Securities and Exchange Commission.
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Product Information
Today’s presentation include information about certain products that are not approved for marketing in the United States. This information is for investor purposes only, and should not be relied upon by health care professionals. It is intended to be informative with respect to Shire HGT’s pipeline, and is not in any way intended to be promotional in nature.
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Shire Purpose Statement
We enable people with life-altering conditions to
lead better lives.
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Shire HGT Business Model SupportsStrong Growth
Rare diseases with unmet need
High impact Rx / high margin products
Global development / commercialization
3 Marketed products
Pipeline gaps filled
8 potential launches by 2015
#1 or #2 in our markets
Growth via internal Research and BD
Strong RoW growth with minimal infrastructure
BUSINESSMODEL
PORTFOLIOSTRENGTH
FUTUREGROWTH
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Orphan Disease Landscape ProvidesSignificant Opportunities for Development
Infectious Diseases
9%
Neuro logical Disorders
11%Other
11%
Cancer and related
47%
Transplantation2%Cardiovascular
Diseases2%
Blood Disorders
1%
Respiratory Disorders
4%
Auto immune Disorders
5%
Genetic Disorders
8%
~ 7,000 orphan diseases
Individually rare but collectively affect 1 in 10
25 million Americans
25-30 million EU
50% Pediatric
85% Serious or life-threatening
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Long Term Ratios Reflect R&D Investment with Minimal Commercial Infrastructure
Spec Pharma HGT Total Spec Pharma HGT TotalTotal sales % 85% 15% 100% 70% 30% 100%
Gross Margin 85% 89% 86% 86% 87% 86%
R&D (14%) (47%) (19%) (14%) (25%) (17%)
S&M (37%) (19%) (35%) (31%) (16%) (26%)
G&A - - (11%) - - (9%)
EBITDA Margin 34% 23% 21% 41% 46% 34%
2007 TARGET
Note: All expense ratios are a percentage of product sales
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HGT’s Global Revenue Diversification Meets Corporate Milestone in 2008
2015 Total: $1,706
U.S.A Revenue, 17%
EU5 + Canada Revenue, 42%
RoW Revenue, 41%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
50%
2008 Total: $505
U.S.A Revenue, 15%
EU5 + Canada Revenue, 60%
RoW Revenue, 25%
0%
10%
20%
30%
40%
50%
60%
70%
USA Revenue20%
RoW Revenue40%
EU5 + CanadaRevenue 40%
USA Revenue15%
EU5 + CanadaRevenue 60%
RoW Revenue25%
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CommercialPh II/IIIPh I/IIPreclinical IND Tox
POC
HGT Pipeline in October 2007
REPLAGAL®Fabry Disease
ELAPRASE®Hunter Syndrome
VelagluceraseGaucher Disease
HGT 2310 Idursulfase-IT/Hunter CNSHGT 1410 Sanfilippo ERT
HGT 1110MLD ERT
Marketed Product Support
Grow ERT Franchise
New Technology: CNS Diseases
Research
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CommercialPh II/IIIPh I/IIPreclinical IND Tox
POC
HGT Pipeline Gaps Filled Through Recent BD and Research Success
REPLAGAL®Fabry Disease
ELAPRASE®Hunter Syndrome
VelagluceraseGaucher Disease
HGT 2310 Idursulfase-IT/Hunter CNSHGT 1410 Sanfilippo ERT
HGT 1111MLD ERT
HGT 3310 (AMIGAL™)Fabry Disease
HGT 3410 (PLICERA™)Gaucher Disease
HGT 3510 (AT2220)Pompe Disease
Marketed Product Support
Grow ERT Franchise
New Platform: Pharmacological
Chaperones
New Technology: CNS Diseases
Research
Expand pipeline through Internal Research Capability
New in past 12 mo
HGT 2610Krabbe/GLD ERT
FIRAZYR®*HAE
Expansion to New Products and Targets
* Shire owns a 98% interest in Jerini AG; FIRAZYR® is a registered trademark of Jerini AG
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Prioritization CriteriaRare Diseases
• Competition• Proof of Concept• Development Feasibility• IP/Exclusivity
• Prevalence• Unmet Need• Commercial Fit
Selecting Products for In-Licensing/Acquisition
Disease Criteria
Product Criteria
Business Development Opportunities
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Shire HGT- Key Strengths
Fully integrated business, exclusively focused on rare diseases
Global reach – development, regulatory, commercial
Demonstrated success in bringing rare disease products to market
Simultaneous global filings; early market access
Setting new standards for MPS launches with ELAPRASE®
Combine entrepreneurial culture with sufficient resources to achieve success
Why we are a good partner
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Replagal
67
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Fabry Market Continues to Demonstrate Strong Growth
Source: EvaluatePharma
$0
$100
$200
$300
$400
$500
$600
$700
2001 2002 2003 2004 2005 2006 2007
$M
2001-2007 CAGR 99%
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Elaprase
72
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Manage New Patient Accruals
Early TX and CNS Patients
Maintain Compliance
Geographic expansion
Customer Service Model
Focus on early treatment
Published case studies
HOS working groups
Hunter-CNS program
Persistency programs
Publish Long Term Clinical Data
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Goal: To establish FIRAZYR as a new global standard of care for HAE patients
Safety Convenience
Treats attacks quickly
Treats all kinds of attacks
Not a “blood derived”product
Not immunogenic
Pre-filled “Ready toUse” Syringe
Subcutaneous dosing
Room temp storage
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HGT Revenue Growth Reflects Launch of 8 New Products*
20112008 20102009 2012 - 2015
*Subject to regulatory approvals
REPLAGAL
ELAPRASE
FIRAZYR
velaglucerase
MLD/1111
AMIGAL
Pompe/3510
PLICERA
Hunter CNS
Sanfilippo/1410
REPLAGAL
ELAPRASE
FIRAZYR
velaglucerase
MLD/1111
REPLAGAL
ELAPRASE
FIRAZYR
velaglucerase
REPLAGAL
ELAPRASE
FIRAZYR
REPLAGAL
ELAPRASE
FIRAZYR
Krabbe/2610
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Shire HGT Positioned for Strong Growth
LYSOSOMALSTORAGEDISEASES
LYSOSOMALSTORAGEDISEASES
LYSOSOMALSTORAGEDISEASES
RAREGENETIC
DISEASES
RAREGENETIC
DISEASES
ORPHANDISEASESShir
e HGT’s F
uture Gr
owth
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To be as brave as the people we help.
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Questions
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HGT Key Criteria for Long Term Revenue Growth
REPLAGAL® - approved in 44 countriesELAPRASE® - approved in 43 countriesFIRAZYR® - approved in 30 countries
HGT Pipeline:velaglucerase alfaHGT-1111 (MLD)AMIGAL (ex-US)PLICERA (ex-US)HGT- 3510 (Pompe, ex-US)HGT-1410 (Sanfilippo-A)HGT- 2310 (Hunter-CNS)HGT-2610 (Krabbe)
Strong IP/Orphan
Speed of Registration
Premium Pricing
High Levels of Reimbursement
Unmet Niche Markets
Symptomatic Disease
Global infrastructure
HGT Global Products