Shire Pharmaceuticals Group plc THE SAFE HARBOR STATEMENT UNDER THE - - PowerPoint PPT Presentation
Shire Pharmaceuticals Group plc THE SAFE HARBOR STATEMENT UNDER THE - - PowerPoint PPT Presentation
Full Year and Fourth Quarter Results ended 31 December 2002 Shire Pharmaceuticals Group plc THE SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995 Statements included herein that are not historical facts, are
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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, 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 and commercialization, patents, government regulation and approval, including but not limited to the expected product approval date of lanthanum carbonate (FOSRENOL), the impact of competitive products, including but not limited to the impact of same on Shire’s ADHD franchise, and other risks and uncertainties detailed from time to time in our filings, including the Annual Report filed on Form 10-K by Shire with the Securities and Exchange Commission. Trademark Information:
Unless otherwise indicated, certain product names set out in this document are trademarks of the Shire Group, many of which are the subject of trademark registrations in certain territories. These names include, but are not limited to, Adderall, Adderall XR, Agrylin, Colazide, Carbatrol, DextroStat, Fluviral S/F, Fosrenol, Pacis, Pentasa, ProAmatine, Solaraze, Troxatyl, EnSoTrol, Microtrol, OptiScreen, ProScreen, Solutrol, and Xagrid. 3TC, Epivir, Combivir, Trizivir, and Zeffix are trademarks of GlaxoSmithKline. Reminyl and Concerta are trademarks of Johnson & Johnson. Aricept is a trademark of Pfizer / Eisai. Exelon is a trademark of Novartis. NeisVac-C is a trademark of Baxter International. Adept is a trademark of ML Laboratories. MethyPatch is a trademark of Noven Pharmaceuticals.
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Agenda
Full Year 2002 Achievements Rolf Stahel Fourth Quarter and Full Year 2002 Financial Review Angus Russell R&D Overview Wilson Totten 2003 Outlook and Summary Rolf Stahel Questions & Answers All
Rolf Rolf Stahel Stahel – – Chief Executive Chief Executive Full Year 2002 Achievements Full Year 2002 Achievements
Shire Pharmaceuticals Group plc Shire Pharmaceuticals Group plc
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Full Year 2002 Achievements
Context: First Adderall generic launched mid-February 2002 Total of three generics in market by end 2002 Outcome: Culmination of five years of planning Good earnings growth Strong revenue growth
Driven by both US and international businesses Strong royalty flow
Outstanding Adderall to Adderall XR switch Continued progression of pipeline of 22 projects
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Financial Highlights – FY 2002
Millions of USD, except per share amounts
Most Recent 2002 Growth Guidance 2002 Growth
FY 02*
Revenues 1,037.3 Operating income 327.0 Income before tax 329.1 Net income 250.6 EPS (diluted): Ordinary shares 49.0c ADS 147.1c
FY 02* FY 02*
Revenues Revenues 1,037.3 1,037.3 Operating income Operating income 327.0 327.0 Income before tax Income before tax 329.1 329.1 Net income Net income 250.6 250.6 EPS (diluted): EPS (diluted): Ordinary shares Ordinary shares 49.0c 49.0c ADS ADS 147.1c 147.1c
Mid to high teens growth 22% Mid to high single digit growth 11%**
* Results for all periods are restated for the OTC divestment, accounted for as a discontinued operation ** Growth calculation is based on a 2002 EPS number, which excludes the gain on the disposal of the OTC business (impact of 1.2c per ADS). The 2001 EPS number adds back the impact of the merger charges and stock compensation costs (impact of 108.6c per ADS in total)
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Analysis of Revenues – FY 2002
Millions of USD
+ 29 111.9 144.7 International + 22 587.5 714.7 United States
n/a 3.0
- Other**
+ 22 853.0 1,037.3 Total Revenues
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5.5 3.1 Licensing* + 20 145.1 174.8 Royalties + 23 699.4 859.4 Product Sales Growth (%) FY 01 FY 02
* 2001 figures include one-time milestones paid to Shire Laboratories ** 2001 figures include revenues from contract manufacturing. The facility has since been divested.
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Product Sales – FY 2002
Millions of USD + 23 36.8 45.3 Carbatrol + 22 350.3 427.7 Adderall Brand
- 65
317.7 109.8 Adderall + 874 32.6 317.9 Adderall XR Growth (%) FY 01 FY 02 CNS Franchise
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Product Sales – FY 2002
Millions of USD + 34 38.0 50.9 ProAmatine + 15 75.5 87.2 Pentasa + 39 85.5 119.2 Agrylin Growth (%) FY 01 FY 02 Other Franchises
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Royalty Income – FY 2002
Millions of USD
- + 23
+ 8 Underlying Growth (%)* + 160 21.1 Other** Reported Growth (%) FY 02 Royalties + 20 174.8 Total + 25 21.2 Zeffix + 10 132.5 3TC
* Underlying sales growth expressed in constant exchange rates ** Includes Reminyl
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2002 ADHD Franchise Conversion
Retention of Business – Invoices based on volume, not market share TRx Volume (000s)* Average Market Share (MS)*
1000 2000 3000 4000 5000 6000 7000 Adderall Adderall XR Adderall Franchise 2001 2002
+ 0.6%
0% 5% 10% 15% 20% 25% 30% 35% Adderall Adderall XR Adderall Franchise 2001 2002
- 4 MS points
* Source: IMS Monthly Data
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2002 ADHD Franchise Conversion
Impact on Financial Results Actual Sales (Millions of USD)
50 100 150 200 250 300 350 400 450 Adderall Adderall XR Adderall Franchise 2001 2002
+ 22%
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Growing with the Market
US ADHD Market – Recent Trends*
100000 200000 300000 400000 500000 600000 700000 20/12/2002 27/12/2002 03/01/2003 10/01/2003 17/01/2003 24/01/2003 31/01/2003 07/02/2003 14/02/2003
Week TRX Prescription Volume (000s) Total ADHD Market
20000 40000 60000 80000 100000 120000 140000
TRx Prescription Volume (000s) Adderall XR and atomoxetine
ADHD Market Adderall XR atomoxetine * Source: IMS Weekly Data
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Intellectual Property Rights
Legal suit launched against Barr Laboratories regarding ANDA filed against Adderall XR Shire intends to vigorously defend its intellectual property rights
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MethyPatch Acquisition
Leverages Shire ADHD expertise and sales efforts Broadens and diversifies ADHD portfolio beyond Adderall XR Provides Shire access to:
53% of ADHD market* which currently uses methylphenidate The first once-daily ADHD product to use a transdermal delivery system
* Source: IMS Monthly Data (January 2003)
Angus Russell – Group Finance Director Fourth Quarter and Full Year 2002 Financial Review
Shire Pharmaceuticals Group plc
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Accounting Presentation
Non GAAP measures
SEC guidance published Jan 2003
OTC divestment
Discontinued operation Results for all periods restated
Equity method investees
Separate caption in income statement Previously in other income
Investment write-downs
Presented in other expense 2001: $55.7m reclassified from
- ther charges to other expense
NO IMPACT ON PREVIOUSLY REPORTED NET INCOME
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Financial Highlights*
Millions of USD, except per share amounts
+ 22% + 16% Revenue Growth 147.1c 41.5c
- ADS
49.0c 329.1 327.0 1,037.3 FY 02 Q4 02 EPS (diluted): 13.8c
- Ordinary shares
93.6 Income before tax 100.6 Operating income 302.5 Revenues
* Results and growth rates for all periods are restated for the OTC divestment, accounted for as a discontinued operation.
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Components of reported EPS in 2001
Diluted EPS per ADS 104.5 cents 4.1 cents Shire BioChem merger costs Stock option compensation 23.0 cents EPS for 2001 as reported
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Product Sales – Q4 2002
Millions of USD + 8
- 4
- 81
+ 213 Growth (%)
- 9.4
10.2 Carbatrol
- 2
124.1 119.4 Adderall Brand
- 79
91.5 17.2 Adderall + 638 32.6** 102.2 Adderall XR US Rx Growth (%)* Q4 01 Q4 02 CNS Franchise
* Source: IMS Data ** Includes $11.0m of launch stock
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Product Sales – Q4 2002
Millions of USD + 47 + 20 + 65 Growth (%) + 12 11.0 16.1 ProAmatine
- 1
22.0 26.5 Pentasa + 15 22.8 37.6 Agrylin US Rx Growth (%)* Q4 01 Q4 02 Other Franchises
* Source: IMS Data
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Royalty Income – Q4 2002
Millions of USD
- + 29
+ 10 Underlying Growth (%)* + 141 6.6 Other** Reported Growth (%) Q4 02 Royalties + 45 51.2 Total + 49 5.9 Zeffix + 35 38.7 3TC
* Underlying sales growth expressed in constant exchange rates, and excluding Emory settlement both in 2001 and 2002 ** Includes Reminyl
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Financial Ratios
32 38 18 84 16 FY 02 31 33 17 Operating margin 33 17 81 19 Q4 02 38 19 84 16 Q4 01 FY 01 20 R&D : Revenues 37 S,G&A (excl. D&A) : Product sales 84 Gross margin 16 COGS : Product sales
Includes $121.3m in BioChem merger charges and $6.8m in stock option compensation charges
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Cash Flow – FY 2002
Millions of USD Net cash surplus for FY 2002 : $371 Cash generation + $437 Tax / interest
- $78
Products / equity investments
- $26
- $22
Fixed assets Acquisitions and disposals + $54 Financing + $6
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Balance Sheet
Millions of USD
1,214 806 1,573 31.12.02 963 554 1,485 30.09.02 842 Gross cash* 435 Net cash 1,263 Net assets 31.12.01
* Cash, cash equivalents, and marketable securities
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Potential Uses of Cash
M&A Opportunities (to be discussed later in presentation)
Remains primary use of cash
Planned Share Repurchase Program
Shareholder approval granted at AGM (June 2002) to repurchase up to 10% of the Company’s issued share capital
Wilson Totten – Group R&D Director R&D Overview
Shire Pharmaceuticals Group plc
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R&D Strategy: 2003
Support revenue growth through key new product launches CNS – ADHD: franchise development and extension GI: new franchise / pipeline established Oncology: exploit existing value and evaluate earlier initiatives Anti-infectives: developing value
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Fosrenol
Candidate product for hyperphosphataemia under regulatory review in EU and US EU Status:
Additional data analysis required
Based on existing studies and additional external expert report
Likely that review period will extend into H2 2003
US Status:
Discussions have covered conduct of manufacturing site inspections as well as further detailed analysis of clinical and pre- clinical data sets FDA action letter expected shortly
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Fosrenol
Update of lanthanum patient exposure 154 26 >24 m 518 466 >12 m 258 236 >18 m 46 911 1762 February 2003
- 846
1707 March 2002 ~36 m >6 m Total safety population
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Additional Approvals / Regulatory Action – 2003 Current Expectations Adderall XR – Adult Indication Adderall XR – Canada MethyPatch – US Xagrid – EU
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CNS
Project Indication Status MethyPatch ADHD Registration SPD417 Bipolar Disorder Phase III SPD503 ADHD Phase III SPD473 ADHD Phase I SPD465 ADHD Phase I SPD451 Parkinson’s Disease Preclinical SPD483 ADHD Preclinical
ADHD franchise development and extension
MethyPatch in registration (US) Adderall XR adult sNDA in registration (US) Adderall XR in registration (Canada) SPD503 Phase III started SPD473 Phase II initiation H2 2003 2 new Adderall franchise initiatives disclosed
SPD465 and SPD483
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Gastrointestinal
New franchise / pipeline established
Project Indication Status SPD476 Ulcerative Colitis Phase II SPD480 Ulcerative Colitis Phase II Pentasa 500mg Ulcerative Colitis Phase II Colazide 500mg Ulcerative Colitis Phase II
Pentasa and Colazide support in market SPD476 Phase III initiation H2 2003 SPD480 in Phase II
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Oncology
Exploit existing value and evaluate earlier initiatives
Project Indication Status Xagrid – EU Thrombocythaemia Registration Troxatyl Leukaemia Phase II Troxatyl Pancreatic cancer Phase II
Agrylin and Solaraze support in market Troxatyl: moving to Phase III for AML and pancreatic cancer 2 lead optimization projects ongoing
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Anti-infectives
Developing value
Project Indication Status SPD754 HIV / AIDS Phase II SPD707 Influenza vaccine Phase II (SPD756) HIV / AIDS Phase I SPD703
- S. pneumonia vaccine
Phase I SPD704
- N. meningitidis vaccine
Phase I SPD705
- P. aeruginosa vaccine
Phase I SPD701 Influenza vaccine Phase I
SPD754 to complete Phase II during 2003 SPD756 likely to be discontinued, pending final review Phase I results in 2003 for SPD703 and SPD705 CD nomination expected for Hepatitis C Virus 2 HIV lead optimisation projects started
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Key R&D Project Progressions*
SPD476 (UC)
H2 2003
2005
TROXATYL (pancreatic)
2006
H2 2003
Phase 3 Phase 2 Phase 1 Pre-clinical
H1 2003
TROXATYL (AML)
2006
SPD473 (ADHD)
H2 2003
2006
CARBATROL (bipolar)
2004
XAGRID (EU) FOSRENOL ADDERALL XR (adult) SPD705 (P. Aeru)
Apr 2002
TBD
SPD754 (HIV / AIDS)
2005
H2 2002 H1 2003
SPD503 (ADHD)
2005
SPD421 (epilepsy) SPD480 (UC)
2006
SPD703 (S. Pneu)
Sep 2002
2006
ADDERALL XR (Canada) METHYPATCH (ADHD) Filing
* Anticipated as of February 27, 2003
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R&D Pipeline*
Therapeutic Area PC/Phase I Phase II and beyond Total CNS 4 3 7 Anti-infectives 5 2 7 Oncology 3 3 GI 4 4 Other 1 1 22 13 9 Total
* As of February 27, 2003
Updates
Discontinuations: SPD421, SPD452, SPD453 Additions: MethyPatch, SPD465, SPD483
Rolf Stahel – Chief Executive 2003 Outlook and Summary
Shire Pharmaceuticals Group plc
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M&A Strategy
Ideal targets:
CNS Could provide opportunity to build out franchise GI Could bridge from current products to new R&D projects Renal Could provide opportunity to build out franchise* Biologics Could provide funding for Biologics R&D, bridge to new R&D projects
* Dependant on Fosrenol regulatory approval
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FY 2003 Financial Outlook
Full year 2003 Guidance Revenue growth Low to mid teens Operating margin circa 30%* EPS growth (per ADS) High single to low double digit*
* Inclusive of modest dilution from MethyPatch acquisition
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Summary
Significant achievements during 2002
Good earnings growth Strong revenue growth Outstanding Adderall to Adderall XR switch
Confident outlook
Solid financial position Active M&A strategy Strategic in-licensing of MethyPatch project in registration Vigorous defence of intellectual property rights Emerging late stage R&D pipeline