Full Year and Fourth Quarter Results ended 31 December Shire Pharmaceuticals Group plc

Transcription

1 Full Year and Fourth Quarter Results ended 31 December 2003 Shire Pharmaceuticals Group plc

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 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, the implementation of the planned reorganisation 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. 2

3 Agenda Full Year 2003 Strategy update Matthew Emmens Fourth Quarter and Full Year 2003 Financial Review Angus Russell R&D Review Wilson Totten Conclusion Matthew Emmens Questions & Answers All 3

4 Matthew Emmens Chief Executive Officer Full Year 2003 Strategy update

5 Highlights Another excellent year for Shire Continued success of Adderall XR Pipeline progress 6 products in Registration 2 projects in Phase III 2 in Phase II* Potential for 11** launches in the period Fosrenol EU initiated labelling discussions with Reference Member State US approvable letter responses delivered to the FDA NDA for Bipotrol filed; the first US carbamazepine treatment for bipolar disorder *excluding SPD754 and Troxatyl **excluding SPD754 and Troxatyl but including SPD465 in Phase I 5

6 Strategy Search, Develop and Market not invent M&A / in-licensing focused on US market Seek to acquire products with broader IP platforms Implementation early stage therapeutic research exit completed Q exit vaccines around mid 2004 new management and infrastructure organisation to deliver strategy 6

7 New organisation to deliver strategy Rationale: Reduce complexity Eliminate inefficiency Create a new world class center in US Build effective organisation Platform for managing future growth Implementation: Reduce US number of sites New management processes Relocate and hire talent One US office in world Pharmaceutical heartland approx $55 million restructuring cost to create an efficient, streamlined with long term infrastructure savings as business grows 7

8 New organisation to deliver strategy Therapeutic area focus Commercial and R&D alignment Structure and sites in N America (14 to 4) Global team building and communication Platform for growth 8

9 Financial Highlights FY 2003 Millions of USD, except per share amounts Revenues 1,237.1 Operating income Income before tax Net income Most Recent 2003 Financial Guidance Mid to high teens growth 2003 actual results +19% EPS (diluted): Ordinary shares 54.2c ADS 162.6c High single to low double digit growth +11% 9

10 Major Product Sales FY 2003 Millions of USD FY 2003 FY 2002 Growth (%) US Rx Growth (%)* Adderall XR Agrylin Pentasa Carbatrol ProAmatine * Source: IMS Data 10

11 Royalty Income FY 2003 Millions of USD FY 03 Royalties FY 02 Royalties FY 01 Royalties Growth (%) FY 03/FY 02 3TC * Zeffix ** Other *** Total * Foreign exchange movements have contributed 4% to reported growth ** Foreign exchange movements have contributed 6% to reported growth *** Includes Reminyl 11

12 Angus Russell Chief Financial Officer Financial Review

13 Financial Highlights Millions of USD, except per share amounts Q4 03 % YTD 03 % Revenues , Operating income Income before taxes Net Income EPS (diluted): - Ordinary shares -ADS 16.3c 48.9c 54.2c c 13

14 Major Product Sales Q Millions of USD Q4 03 Q4 02 Growth (%) US Rx Growth (%)* Adderall XR Agrylin Pentasa Carbatrol ProAmatine * Source: IMS Data 14

15 Royalty Income Q Millions of USD Q4 03 Royalties Q4 02 Royalties Reported Growth (%) 3TC * Zeffix ** Other *** Total * Foreign exchange movements have contributed 1% to reported growth ** Foreign exchange movements have contributed -3% to reported growth *** Includes Reminyl 15

16 Financial Ratios FY 03 FY 02 Q4 03 Q4 02 COGS : Product sales Gross margin R&D : Revenues S,G&A (excl. D&A) : Product sales Operating margin

17 Cash Flow FY 2003 Millions of USD Cash generation + $480 - $100 Tax / interest - $52 Products / equity investments - $51 - $47 Fixed assets Financing Net cash surplus for FY 2003 : $230 million 17

18 Balance Sheet Millions of USD Net assets 1,923 1,783 1,573 Net cash 1, Gross cash* 1,414 1,275 1,214 * Cash, cash equivalents, and marketable securities 18

19 Potential Uses of Cash Introduction of dividend policy First interim payment in 2004: 1 pence per share for the six months ending June 2004 In-licensing and M&A Opportunities Remains primary use of cash 19

20 Outlook Revenue growth for 2004: high single digit range* Earnings for 2004 Subject to: Internal re-organisation restructuring costs (approx 23 cents per ADS) Outcome of planned exit of the vaccines business Beyond 2004 EPS growth on average in mid teens range Aim to maintain consistent margins * Despite loss of exclusivity on PROAMATINE in Q and AGRYLIN in the US in Q

21 Dr Wilson Totten Chief Scientific Officer

22 R&D Content R&D portfolio summary Registration Update: Featuring Bipotrol, first US carbamazepine bipolar treatment Emerging Data: Featuring SPD503; a novel non-stimulant for the treatment of ADHD Summary / Pipeline flow 22

23 Progress with R&D Portfolio Pipeline Progression Agrylin paed exclusivity Pentasa 500mg Bipotrol NDA Adderall XR Adderall XR paed exclusivity Fosrenol US Fosrenol EU SPD476 filed filed filed Adult responses filed studies completed responses filed labelling discussions In Phase III Out-licensed Agrylin Japan Fosrenol - Japan Out-licensing In discussion SPD754 (HIV) SPD756 (HIV) Troxatyl SPD760 (HCV) Vaccines exit All development projects 23

24 BIPOTROL: Patient Need Characteristic range of manic and/or depressive symptoms Licensed treatments include: Lithium, Chlorpromazine, Valproate, Olanzapine, Lamotrigine, Risperidone, Quetiapine, Olanzapine/fluoxetine Extensive off-label use of anti-convulsants and atypical anti-psychotics as monotherapy and/or combination use Individuals respond to some drugs but not others and / or have troublesome side effects Anti-epileptics are foundation therapies yet no carbamazepine products licensed in US for bipolar disorder 24

25 BIPOTROL: Market Potential Estimated disease prevalence of 3% to 6.5%* Diagnosis rate is accelerating because of increased recognition CBZ classified as a 1st line mood stabilizer by APA guidelines Bipotrol key features: First carbamazepine indicated for bipolar disease in US Unique formulation with smooth coverage Specific dose titration Favourable side effect profile New product introductions may prove complementary to Bipotrol *Angst. J Affect Disord. 1998;50:

26 BIPOTROL Study week, DB, PC, Parallel-Group Safety and Efficacy Study of bipolar I disorder (n=239) Young Mania Rating Scale Total Score (ITT Population; Endpoint = LOCF at Day 21) Mean Total Score p value: compared to placebo following ANCOVA with baseline score as covariate Placebo Treatment Group Bipotrol BASELINE (BS) ENDPOINT (EP) Change (EP - BS) 26

27 BIPOTROL Study week, DB, PC, Parallel-Group, Safety and Efficacy Study of bipolar I disorder (n=239) % Patients Improved as Assessed by CGI-Improvement During DB Treatmentt (ITT Population; Endpoint = LOCF at Day 21) % Im proved Placebo 79.8 *** Bipotrol 63.5 *** 65.0 *** ** * p < 0.05 ** p < 0.01 *** p <0.001 compared to placebo 0.0 DB Day 7 DB Day 14 DB Day 21 Endpoint DB Treatment Week 27

28 BIPOTROL: Current status New data (study 304) reinforces efficacy seen in previous work Favourable side effect profile (weight gain / cosmetic) NDA filed February

29 SPD503: Profile Guanfacine originally used off-label in refractory ADHD patients or in those with contraindications to stimulants Non-scheduled, non-stimulant compound Established safety profile for active ingredient in adults On approval, will be the first guanfacine product licensed for ADHD Novel, patent protected, once-daily formulation of guanfacine Shire holds license to use-patent in ADHD Paediatric phase III started February

30 SPD503: Study week, DB, PC, Parallel-Group Safety and Efficacy Study (n=345) Mean Total Score ADHD Rating Scale: Mean Total Score at Endpoint and Change in LS Mean from Baseline (ITT Population) ** p<0.001; *** p< (adjusted Dunnett test compared to plecabo following ANCOVA with baseline score as covariate ** Placebo 2 mg 3 mg 4 mg Treatment Group ** *** BASELINE ENDPOINT Change in LS Mean 30

31 SPD503: Status Study 301 demonstrated highly statistically significant differences from placebo for all dose groups using ADHD-RS, Conners Parent and Teacher Rating Scales, Parent Global Assessment and CGI Safety profile consistent with established profile for guanfacine (somnolence, sedations, fatigue) with potential for improvement of incidence, particularly dry mouth Target filing date 2005 Patent protection through

32 Key Projects Flow P1 P2 P3 Reg FOSRENOL XAGRID (EU) ADDERALL XR (adult) METHYPATCH (ADHD) BIPOTROL (Bipolar) Feb 2004 Pentasa 500mg (UC) Mar 2004 SPD503 (ADHD) 2005 SPD476 (UC) Sep SPD480 (UC) H SPD473 (ADHD) 2006 SPD465 (ADHD) H

33 Matthew Emmens Chief Executive Officer Concluding remarks

34 Conclusion Another excellent year for Shire Strategy implementation well underway Restructured and refocused Global team building and efficient communication Platform for future growth Gearing up late stage pipeline Exciting data for Bipotrol and SPD503 Fosrenol progress 11 potential launches by 2007 Active in-licensing / M&A Dividend policy Confident outlook for 2004 and beyond 34