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Full Year 2009 Results Shire plc February 19, 2010 Angus Russell - PowerPoint PPT Presentation

Full Year 2009 Results Shire plc February 19, 2010 Angus Russell Michael Cola Chief Executive Officer President, Specialty Pharmaceuticals Graham Hetherington Sylvie Grgoire Chief Financial Officer President, Human Genetic Therapies


  1. Full Year 2009 Results Shire plc February 19, 2010 Angus Russell Michael Cola Chief Executive Officer President, Specialty Pharmaceuticals Graham Hetherington Sylvie Grégoire Chief Financial Officer President, Human Genetic Therapies Our purpose We enable people with life-altering conditions to lead better lives 1

  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 and integrate 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

  3. Agenda • Opening remarks Angus Russell • Financial review Graham Hetherington • Specialty Pharma update Michael Cola • HGT update Sylvie Grégoire • Concluding remarks Angus Russell • Q & A All To be as brave as the people we help 3

  4. Opening remarks Angus Russell CEO Our purpose We enable people with life-altering conditions to lead better lives 4

  5. Excellent results in a transformational year • Core product sales (1) up 25% to $2.1 billion • Up 28% on Like for Like (2) basis • Q4 2009 core product sales (1) up 36% versus Q4 2008 • FY 2009 Non GAAP diluted earnings per ADS: $3.49 • Q4 2009 Non GAAP diluted earnings per ADS: $1.11 • Leveraging our existing infrastructure • Decrease in full year SG&A expense versus 2008 • Cash generation of $921 million during 2009 (1) Core products represent Shire’s products excluding ADDERALL XR (2) 'Like for Like Growth' excludes movements in exchange rates by applying 2008 exchange rates to 2009 results. To be as brave as the people we help 5

  6. Shire’s business model has been the key to our success Financial impact past 7 years Business Model (2003 – 2009) • Specialty biopharmaceutical company % Growth CAGR • Treatment of symptomatic Revenues 190% 16% diseases EBITDA 169% 15% • Small sales forces • Focus on lower risk projects with relatively fast development timelines and strong IP protection Note: data covers timeframe of 1/1/2003 through 12/31/2009 To be as brave as the people we help 6

  7. Strategy is delivering VPRIV (velaglucerase alfa) and REPLAGAL currently Focused on the needs addressing unmet needs of patients INTUNIV – first and only selective a2A agonist indicated Launching new for the treatment of ADHD* products Presence in 28 countries and growing Acquisitions and Acquisition of EQUASYM facilitates immediate access to geographic expansion EU ADHD market Progress in development programs, antithrombotic, Pipeline opportunities CarrierWave technology, HGT research, and new for long term growth technology (Santaris) Sustaining our Aspiration to grow sales in the mid-teens range year-on- financial performance year on average over the course of 2009 through 2015 To be as brave as the people we help To be as brave as the people we help 7 7 *The active ingredient in INTUNIV, is thought to selectively stimulate a2A adrenoreceptors in the prefrontal cortex. See Intuniv Wayne, PA: Shire US Inc; 08/2009 and Wang M, Ramos BP, Paspalas CD, et al. α 2A-Adrenoceptors strengthen working memory networks by inhibiting cAMP-HCN channel signaling in prefrontal cortex. Cell . 2007;129:397-410

  8. Financial Review Graham Hetherington CFO Our purpose We enable people with life-altering conditions to lead better lives 8

  9. Strong 2009 earnings Reported EPS-ADS*: $3.49 Adjusted EPS-ADS*: $3.17 (Excludes impact of ADDERALL XR change in best estimate) Ahead of Expectations + Strong Q4 Product sales - Higher R&D + XR Royalties - Higher SG&A + XR Product sales $2.83 2009 Guidance framework (updated Oct 2009) $3.23 EPS-ADS Range * EPS-ADS represents Non GAAP diluted earnings per ADS To be as brave as the people we help 9

  10. 2009 Performance summary Financial Year Fourth Quarter 2009 2008 Reported Like for Like 2009 Reported Like for Like Growth (3) Growth (3) $m $m Growth $m Growth 3,008 3,022 - +2% 893 +17% +14% Total Revenues EBITDA (1) 982 1,035 -5% -5% 336 +26% +24% Adjusted EPS - ADS (1) (2) $3.17 n/a n/a $0.79 n/a Reported EPS - ADS (1) $3.49 $3.86 -10% $1.11 +9% (1) These are Non GAAP financial measures. See appendix for a list of items excluded from the US GAAP equivalent used to calculate these measures. (2) Adjusted EPS – ADS on a diluted basis excludes the 32c effect of the change in best estimate of Medicaid rebate liability for ADDERALL XR. (3) 'Like for Like Growth' excludes movements in exchange rates by applying 2008 exchange rates to 2009 results. To be as brave as the people we help 10

  11. 2009 Revenue summary Financial Year Fourth Quarter 2009 2008 Reported Like for Like 2009 Reported Like for Like Growth (3) Growth (3) $m $m Growth $m Growth Core Product Sales (1) 2,067 1,653 +25% +28% 585 +36% +32% 627 1,101 -43% -43% 192 -30% -30% ADDERALL XR Sales Total Product Sales 2,694 2,754 -2% - 777 +10% +8% Royalty and Other 314 268 +17% +20% 116 +89% +87% Revenue Total Revenues 3,008 3,022 - +2% 893 +17% +14% (1) Core product sales represent Shire’s product sales excluding ADDERALL XR. (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. (3) 'Like for Like Growth' excludes movements in exchange rates by applying 2008 exchange rates to 2009 results. To be as brave as the people we help 11

  12. 2009 Total revenues in-line with 2008 +$37m +$18m Other +$29m +$48m Other REPLAGAL +$96m ELAPRASE FOSRENOL LIALDA +$186m XR Prod Sales VYVANSE $3.0bn +$68m $3.0bn XR Royalties -$474m Core Products Reported Growth FY +25% Q4 +36% 2008 2009 ACTUAL ACTUAL To be as brave as the people we help 12

  13. 2009 Portfolio Strength and Diversity – Core Product Sales Financial Year Fourth Quarter 2009 2008 Reported Like for Like 2009 Reported Like for Like Growth (2) Growth (2) $m $m Growth $m Growth 505 319 +58% +58% 145 +41% +40% VYVANSE 353 305 +16% +20% 94 +26% +19% ELAPRASE 236 140 +68% +69% 67 +63% +62% LIALDA / MEZAVANT 215 186 +16% +16% 58 +23% +23% PENTASA 194 176 +10% +16% 61 +37% +26% REPLAGAL 184 155 +19% +23% 47 +40% +33% FOSRENOL 6 - n/a n/a 2 n/a n/a FIRAZYR 5 - n/a n/a 5 n/a n/a INTUNIV 3 - n/a n/a 3 n/a n/a VPRIV 366 372 -2% +5% 103 +21% +16% OTHER CORE PRODUCT SALES (1) 2,067 1,653 +25% +28% 585 +36% +32% (1) Core product sales represent Shire’s product sales excluding ADDERALL XR. (2) 'Like for Like Growth' excludes movements in exchange rates by applying 2008 exchange rates to 2009 results. To be as brave as the people we help 13

  14. Core product sales growth FY 2009 FY 2007 $2.1bn $1.1bn 700 600 500 400 $m 300 CAGR = 35% 200 100 0 Q1 0 7 Q2 0 7 Q3 0 7 Q4 0 7 Q1 0 8 Q2 0 8 Q3 0 8 Q4 0 8 Q1 0 9 Q2 0 9 Q3 0 9 Q4 0 9 Core product sales represent Shire’s product sales excluding ADDERALL XR. To be as brave as the people we help 14

  15. Operating leverage emerging – Key financial ratios Year on Year Movements: FY 2009 FY 2008 -2% +27% Total Product Sales +25% +45% Core Product Sales (ex XR) +10% +27% R&D (1) -3% +13% SG&A (1) Ratios: % of Total Product Sales R&D (1) 19% 17% SG&A (1) 42% 42% % of Core Product Sales R&D (1) 25% 29% SG&A (1) 55% 71% (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. To be as brave as the people we help 15

  16. 2009 Cashflow Millions of USD Cash generation +921 - 262 Capital expenditure - 253 Tax and interest payments - 120 EQUASYM, licenses & Jerini payments - 54 Payment of dividend Cash and cash equivalents at December 31, 2008 247 +27 Other financing Cash inflow to December 31, 2009 285 +19 Cash and cash equivalents as at December 31, 2009 (1) Proceeds from Virochem sale 532 Convertible Debt (1,100) Proceeds from sale of Jerini +7 Peptides business Finance lease obligation (47) Net debt at December 31, 2009 (2) (615) +285 Net cash Inflow (1) Shire’s balance of cash and cash equivalents at December 31, 2009 includes $33m of restricted cash. (2) Shire has a revolving credit facility of $1.2bn which was undrawn at December 31, 2009. To be as brave as the people we help 16

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