Deutsche Bank Mid-Cap Life Sciences, Services and Devices...

24
Deutsche Bank Mid-Cap Life Sciences, Services and Devices Conference 27 June 2003 Shire Pharmaceuticals Group plc

Transcript of Deutsche Bank Mid-Cap Life Sciences, Services and Devices...

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Deutsche Bank Mid-Cap Life Sciences, Services and Devices Conference

27 June 2003

Shire Pharmaceuticals Group plc

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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 materialise, 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 manufacturing and commercialisation, the impact of competitive products, including, but not limited to, the impact on Shire’s Attention Deficit Hyperactivity Disorder (ADHD) franchise, patents, including but not limited to, legal challenges relating to Shire’s ADHD franchise, government regulation and approval, including but not limited to the expected product approval date of lanthanum carbonate (FOSRENOL®) and METHYPATCH®, 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.

Trade mark Information:The following are trade marks of Shire or companies within the Shire Group, which are the subject of trade mark registrations in certain territories.ADDERALL XR® (mixed amphetamine salts), ADDERALL® (mixed amphetamine salts), AGRYLIN® (anagrelide hydrochloride), AMATINE® (midodrine hydrochloride), CALCICHEW® (calcium carbonate), CARBATROL® (carbamazepine), COLAZIDE® (balsalazide), DEXTROSTAT® (dextroamphetamine salt), EMUTROL™, ENSOTROL®, FARESTON™ (toremifene), FLUVIRAL® S/F (split-virion influenza vaccine), FOSRENOL® (lanthanum carbonate), METHYPATCH® (methylphenidate), MICROTROL®, MICROTROL DR™, MICROTROL PR™, MICROTROL XR™, OPTISCREEN®, PROAMATINE® (midodrine hydrochloride), PROSCREEN™, RAPITROL™, SOLARAZE® (diclofenacsodium 3%), SOLUTROL™, TROXATYL® (troxacitabine), XAGRID® (anagrelide hydrochloride).The following are trade marks of third parties: 3TC (lamivudine) (trade mark of GlaxoSmithKline (GSK)), ADEPT (4% icodextrin solution) (trade mark of ML Laboratories plc), AZT (trade mark of GSK), BIO-HEP B (trade mark of Berna Biotech AG), COMBIVIR (trade mark of GSK), EPIVIR (trade mark of GSK), HEPAVAX GENE (trade mark of Berna Biotech AG), NEISVAC-C (trade mark of Baxter International Inc.), PENTASA (trade mark of Ferring), REMINYL (galantamine hydrobromide) (trade mark of Johnson & Johnson), TRIZIVIR (trade mark of GSK), ZEFFIX (lamivudine) (trade mark of GSK) , Concerta (trade mark of Johnson & Johnson), Metadate CD (trade mark of Celltech), Ritalin LA (trade mark of Novartis),Strattera (trade mark of Eli Lilly), Focalin (trade mark of Novartis), ASACOL (trade mark of Procter & Gamble).

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Key products Highlights

Resilience against atomoxetineMarket growth opportunities

Treated vs. untreatedPediatric vs. adult

Recommencement of promotional efforts underwayCarbamazepine usage in epilepsy has slowed towards more heavily promoted products

Sales force promotion scheduled to resume H2 200375% usage in Crohn’s disease allows good fit with SPD476 inflammatory bowel disease project

Pediatric extension potentially extends market exclusivity to September 2004Strong support from sales outside US

Continued expansion of market shareFaces orphan drug expiry in September 2003

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Adderall Adderall XR Strattera OthersConcerta

3%

30%

30%

2%

35%

FY 2002

3%12%

14%

57%

14%

Q1 2003

Our Changing Competitive Environment

Share of Voice*Share of Voice*

* Sales Calls (IPS)

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ADHD - Physician Call Frequency

SOURCE: *IMS Exponent Feb 03

6.85%27,000–20,001

6.64%20,000–15,001

8.94%15,000–10,001

2.21%10,000–9,001

2.49%9,000–8,001

2.64%8,000–7,001

3.02%7,000–6,001

3.39%6,000–5,001

3.86%5,000–4,001

4.58%4,000–3,001

5.68%3,000–2,001

7.61%2,000–1,001

14.57%1,000–1

Percent ofADHD Rx’s*

PhysicianRank

5.3

10.8

15.8

19.1

20.4

20.4

21.8

21.9

23.3

23.5

24.5

27.1

31.1

AnnualizedCalls/Physician

20.73%

23.92%

26.81%

27.87%

27.52%

28.54%

29.33%

29.18%

29.32%

29.20%

29.95%

30.84%

29.79%

Adderall XR February

Market Share

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Adderall XRNumber 1 Market Share with HVP’s

*High Volume Prescribers, IMS Exponent

16.36%All Other

1.25%Focalin

6.19%Strattera

1.90%Ritalin LA

3.04%Metadate CD

27.32%Concerta

16.01%Adderall /Adderall Generic

27.84%Adderall XR

February 2003Market Share

for HVP’s*Product

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Adderall XR vs. ConcertaMonthly Market Share (comparable months post-launch)

14.16%

21.23%22.34%

15.66%

20.21%

16.61%17.41%

18.58%

12.57%

10.22%

7.60%

3.48%

20.90%20.00%

14.57%16.01%

17.26% 18.46%

11.51%13.02%

9.71%

1.30%

4.54%

7.36%

0%2%4%

6%8%

10%12%14%

16%

18%20%22%24%

1 2 3 4 5 6 7 8 9 10 11 12

Adderall XR Concerta

SOURCE: IMS NPA.Month 12 for Adderall XR is Oct 02Month 12 for Concerta is July 01

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11.27

%

13.37

%

8.78% 9.0

7% 9.47% 9.8

5% 10.00

%

9.92% 10

.08%

10.29

%

16.15

%

15.23

%15

.80%

4.57%

12.00

% 12.87

%

0.02% 0.2

5%1.7

6%

3.85%

8.51%

7.81%

6.31%

8.29%

5.14%

9.62%

10.59

%10

.94%

13.70

%15

.06%

14.80

%

14.40

%

13.28

%

8.48%

11.67

%11

.89%

12.39

%

6.31%

0.11%

0.01%

0.00%

0.64%

2.76%

1.52%

5.53%

4.54%

3.88%

6.78% 7.1

9% 7.89% 8.5

0%

10.72

%

0%

2%

4%

6%

8%

10%

12%

14%

16%

wk

01

wk

02

wk

03

wk

04

wk

05

wk

06

wk

07

wk

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wk

09

wk

10

wk

11

wk

12

wk

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wk

14

wk

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wk

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wk

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wk

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wk

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wk

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wk

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wk

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wk

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wk

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wk

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wk

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Adderall XR Strattera

SOURCE: IMS NPAWeek 1 for Adderall XR is 10/26/01; Week 26 is 4/19/02Week 1 for Strattera is 12/20/02; Week 26 is 6/13/03

Adderall XR vs. Strattera LaunchWeekly Market Share Trend (comparable 26 weeks post-launch)

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Weekly Market Share Trend

22.5%

23.7%

12.4%

28.0%

24.7%

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

27/1

2/20

02

03/0

1/20

03

10/0

1/20

03

17/0

1/20

03

24/0

1/20

03

31/0

1/20

03

07/0

2/20

03

14/0

2/20

03

21/0

2/20

03

28/0

2/20

03

07/0

3/20

03

14/0

3/20

03

21/0

3/20

03

28/0

3/20

03

04/0

4/20

03

11/0

4/20

03

18/0

4/20

03

25/0

4/20

03

02/0

5/20

03

09/0

5/20

03

16/0

5/20

03

23/0

5/20

03

30/0

5/20

03

06/0

6/20

03

13/0

6/20

03

ADDERALL XR STRATTERA CONCERTA

((--3.3)3.3)

((--1.2)1.2)

ADHD TRx Market GrowthYTD March 2003: 14%MAT March 2003: 15%

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+ 12+ 6923.439.7Agrylin

- 2+ 6917.529.7Pentasa

+ 14+ 459.613.8ProAmatine

- 19

+ 24

- 59

+ 86

Growth (%)

- 111.69.4Carbatrol

- 7108.1134.1Adderall Brand

- 7746.218.9Adderall

+ 11661.9115.2Adderall XR

US Rx Growth (%)*

Q1 02Q1 03

Millions of USD

Product Sales – Q1 2003

* Source: IMS Data

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* Underlying sales growth expressed in constant exchange rates** Includes Reminyl

--

--

+ 10

+ 11

Underlying Growth (%)*

+ 987.3Other**

Reported Growth (%)

Q1 03 Royalties

+ 2147.8Total

+ 216.4Zeffix

+ 1134.13TC

Millions of USD

Royalty Income – Q1 2003

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30

42

21

87

13

Q1 02(%)

29

43

18

85

15

Q1 03(%)

32

38

18

84

16

FY 02(%)

33Operating margin

33

17

81

19

Q4 02(%)

R&D : Revenues

S,G&A (excl. D&A) : Product sales

Gross margin

COGS : Product sales

Financial Ratios

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* Cash, cash equivalents, and marketable securities

1,290

896

1,647

31.03.03

1,214

806

1,573

31.12.02

944Gross cash*

537Net cash

1,315Net assets

31.03.02

Balance Sheet

Millions of USD

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FY 2003 Financial Outlook

* Previously low to mid teens** Unchanged

High single to low double digit**EPS growth (per ADS)

Circa 30%**Operating margin

Mid to high teens*Revenue growth

GuidanceFull year 2003

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22139Total

440GI

330Oncology

725Anti-infectives

734CNS

TotalPhase II and beyondPC/Phase ITherapeutic Area

110Other

* As of May 1, 2003

R&D Pipeline*

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SPD476 Positioning

Pentasa releases mesalamine in small intestine and colon(75% Rx for Crohn’s in US)

Enemas used for disease in descending colon / rectum (“left sided disease”)

SPD 476 releases throughout colon and terminal ileum

Balsalazide cleaved in colon to release active mesalamine

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SPD476 Characteristics

Tablet treatment for inflammatory bowel disease currently in Phase II

High 5-ASA loading per tablet (1.2 g)

High drug levels in the ascending, transverse and left colon detected 24hrs post dosing

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SPD476 Phase II (Pilot Efficacy)

Conducted in Italy by our partner, Giuliani

Study Objectives:Patients with mild-moderate left-sided ulcerative colitisSPD476 1.2g tablets dosed t.i.d vs. Asacol 4g rectal suspension Primary endpoint: Clinical remissionSecondary endpoints: Endoscopic and histologic improvement

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Randomised patients79

SPD47640

Clinical Remission24 (60%)

Clinical Improvement7 (17.5%)

Withdrawn8 (20%)

Endoscopic Remission18 (45%)

SPD476 Phase II (Results)

Enema39

Withdrawn12 (30.8%)

Clinical Remission19 (48.7%)

Clinical Improvement4 (10.3%)

Endoscopic Remission14 (35.9%)

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SPD476 Phase II (Conclusions)

SPD476 3.6g / day seems at least as effective as AsacolEnema 4g / day in inducing clinical and endoscopic remission at 8 weeks in patients with left-sided ulcerative colitis

Poor compliance with enemas in long term

SPD476 provides novel high dose formulation of 5-ASA which may ease compliance (vs enemas and lower strength oral agents) during long-term maintenance therapy

Shire plans to progress SPD476 to Phase III trials in H2 2003

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Registration Update

MethyPatch – USNoven to meet with FDA in order fully to understand concerns and discuss the next stepsShire in turn to discuss way forward with Noven

Fosrenol US and EU submission of additional data from existing and ongoing studies over next few months

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US Pediatric Studies Update

AgrylinAgreement to undertake clinical program evaluating AGRYLIN in pediatric patientsExecution of program as agreed and submission of data to FDA would extend marketing exclusivity from March 2004 to September 2004

Adderall XRAgreement to undertake clinical program evaluating ADDERALL XR in adolescent patientsExecution of program as agreed and submission of data to FDA would extend marketing exclusivity from October 2004 to April 2005

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Strong business performance in Q1 2003Revenue growth of 28%Net income growth of 11%Resilience of Adderall XR versus atomoxetine

Well positioned for future growthSolid financial positionStrong R&D pipelineActive M&A program

Summary

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Shire Pharmaceuticals Group plc