Second Quarter and Interim results
ended 30 June 2001
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Shire Pharmaceuticals Group plc
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1
Rolf Stahel
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Chief Executive
Shire Pharmaceuticals Group plc
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2
Comment on the "Safe Harbor" Statement under the Private Securities
Litigation Reform Act of 1995
The statements made during today's presentation, or in response to questions
during the Question & Answer period, that are not historical facts, are
forward-looking statements that involve risks and uncertainties, including but
not limited to, risks associated with the inherent uncertainty of pharmaceutical
research, product development and commercialisation, the impact of competitive
products, patents, and other risks and uncertainties, including those detailed
from time to time in periodic reports, including the Annual Report filed on Form
10K by Shire with the Securities and Exchange Commission.
3
Q2 Financial Highlights
(before APB 25 and exceptional merger charges)
|X| Revenues $ 211m +32%
|X| Operating income $ 65m +56%
|X| Income before tax $ 71m +72%
|X| EPS (diluted)
o Ordinary shares 10.6 cents)
) +66%
o ADS 31.7 cents)
4
Key Royalty Income
Q2 01 Q2 00 Royalty
$m $m Growth %
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3TC*(1) 31.1 29.4 +6
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Zeffix* 4.4 2.9 +49
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Other 3.0 1.3 +128
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* Trade Mark
(1) 3TC Franchise: Epivir/Combivir/Trizivir trademarks of GlaxoSmithKline
5
Adderall**
|X| Revenues: Q2 01 up 56% at US$69m
|X| Market Share: 32.7% Rx US ADHD* market(1)
|X| Adderall XR(2)
o Novel, once a day formulation of Adderall**
o Phase III data presented at the APA(3) on 9 May 2001
o NDA submitted early - 3 October 2000
o Anticipated launch in Q4 2001(4)
(1) IMS data - June 2001
(2) Trade mark under registraton
(3) American Psychiatry Association
(4) Subject to regulatory approval
* ADHD: Attention Deficit Hyperactivity Disorder
** Trademark
6
Agrylin*
|X| Revenues: Q2 01 up 39% at US$26m
|X| Market Share: 21.3% Rx US market(1)
|X| Unique Selling Points:
o Only US approved treatment for Essential Thrombocythaemia
o Orphan drug status granted in US, EU, and Japan
o Selectively reduces platelets
o Offers a new therapy for avoiding potential risks of "pan-marrow"
treatments
o Extensive safety database >4000 patients with myeloproliferative
disorders (MPD's)
(1) IMS data - June 2001
* Trade Mark
7
3TC** Franchise
Epivir/Combivir/Trizivir(1)
|X| Royalties: Q2 01 up 6% at US$31m
|X| Unique Selling Points:
o Minimal side effects
o Ease of compliance (simple dosing, no food/water restrictions)
o Benefits of the M184V mutation
(1) 3TC, Epivir, Combivir and Trizivir are trademarks fo GlaxoSmithKline
(2) IMS data - June 2001
** Trade Mark
8
Reminyl**
|X| Market Share: 7.1% NRx US AD* market(1) at week nine.
|X| Unique Selling Points:
o Dual mode of action widely acknowledged(2,3)
o First AD* treatment to demonstrate effectiveness in treating patients
with vascular dementia and mixed dementia(4,5)
o Studies planned in Lewy body dementia and mild cognitive impairment(6)
(1) IMS data - to June 2001
(2) Europe - included in labelling
(3) US - included on promotional materials approved by DDMAC (FDA)
(4) XVII World Congress of Neurology, June 2001
(5) Reminyl is not yet approved for these indications
(6) Conducted by Janssen Research Foundation
* AD: Alzheimer's
** Trade Mark
9
Reminyl UK IMS data
Line graph depicting the following data:
First Year of Launch
Market share of new prescriptions
No. of Prescriptions (projected)
Month 1 2 3 4 5 6 7 8 9 10 11 12
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Reminyl 104 0 238 490 671 561 1305
Aricept 314 693 1149 1777 1810 2431 2530 2694 2929 3173 2204 3428
Exelon 33 162 105 160 233 244 229 214 483 541 496 350
* IMS Data
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Zeffix(1)
|X| Royalties: Q2 01 up 49% at US$4.4m
|X| Unique Selling Points:
o Only approved oral treatment for hepatitis B
o Efficacy and durability of response
o Endorsement by key opinion leaders in Asia Pacific(2)
(1) Zeffix is a trademark of GlaxoSmithKline
(2) Asia Pacific Consensus Group on the Prevention and Management of Chronic
Hepatitis B and C
11
Post merger structure
Diagram representing Biologics (US/Canada), Search (US/Canada/UK), Shire Labs
Drug Delivery (US), and Lead Optimisation (Canada) allowing Shire Development
(UK/US/Canada) to bring products to market to be sold by all sales and marketing
forces in UK/Eire, Canada, US, Spain, Germany, Italy, and France.
12
Merger Integration
New Appointments Previous Employer
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President, Shire Biologics
Randall Chase BioChem Pharma*
Senior VP Shire Pharmaceutical Development
Gervais Dionne BioChem Pharma*
Global Head of Legal Affairs
Tatjana May AstraZeneca
Global Head of Human Resources
Chrisian Proulx BioChem Pharma*
Commercial Director (Strategic Marketing)
Mark Webster Abbott Laboratories
Vice President - Global IP
Shona McDiarmid BioChem Pharma*
*Canada
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Angus Russell
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Group Finance Director
Shire Pharmaceuticals Group plc
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14
1H 01 Financial Highlights
(before APB 25 and exceptional merger charges)
|X| Revenues $401m +29%
|X| Operating income $121m +46%
|X| Income before tax $128m +50%
|X| EPS (diluted)
o Ordinary shares 19.2 cents )
) +45%
o ADS 57.7 cents )
15
Key Product Sales
Q2 01 vs. Q2 00
Q2 01 Q2 00 Sales Scrip**
$m $m Growth % Growth %
Adderall* 69.4 44.4 +56 +14
Agrylin* 25.8 18.5 +39 +26
Pentasa* 19.1 13.2 +45 +5
ProAmatine* 10.5 5.9 +79 +28
Carbatrol* 9.9 5.3 +87 +28
* Trade Mark
** IMS Data
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Key Product Sales
1H 01 vs. 1H 00
1H 01 1H 00 Sales Scrip
$m $m Growth % Growth %
Adderall* 139.6 98.9 +41 +17
Agrylin* 42.9 29.5 +45 +33
Pentasa* 33.5 23.5 +42 +8
Carbatrol* 19.5 10.9 +79 +35
ProAmatine* 18.1 9.4 +92 +30
* Trade Mark
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Key Product Royalties
1H 01 vs. 1H 00
1H 01 1H00 Royalty
$m $m Growth %
3TC* 58.6 56.4 +4
Zeffix* 8.1 5.3 +54
Other 3.9 1.9 +104
* Trade Mark
18
Financial Ratios
(before APB 25 and exceptional merger charges)
1H 01 Q2 01 Q2 00 FY 00
% % % %
COGS: Product sales 17 16 19 19
Gross margin 83 84 81 81
R&D: Revenues 20 20 25 23
S,G&A (excl D&A): 30 31 29 26
Revenues
Operating margin 30 31 26 30
19
Exceptional merger charges
|X| Asset impairments $ 85.4m
|X| Merger transaction costs $ 83.5m
|X| Disposal of assets $ 8.1m
|X| Total $ 177.0m
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Cash Flow
Q2 2001
Cash generation _______________________________ +$24m
- -$12m______________________ Tax/interest
- -$9m ____________________ Product acquisitions
-$2m ____ Fixed assets
Financing _____________________________ +$18m
Net cash surplus $19m
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Balance Sheet
30.06.01 30.06.00 31.12.00
$m $m $m
Net Assets 1,091 1,076 1,175
Net Cash 295 200 250
Gearing nil nil nil
22
Wilson Totten
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Group R&D Director
Shire Pharmaceuticals Group plc
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23
Development pipeline
Therapeutic PC/Phase 1 Phase II and beyond Total
Area
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CNS 6 4 10
Antivirals 2 0 2
Oncology 1 3 4
Biologics 4 0 4
Metabolic/GI 0 4 4
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Total 13 11 24
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13 early stage projects, 11 late stage
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Reminyl*
|X| UK NICE recommends Alzheimer's disease treatments to be made available for
UK patients
|X| Reminyl* first to show efficacy in dementia with vascular components(1)
o 6 month data presented at AAN(2) May 2001
o 12 month data presented at WCN(3) in June 2001
|X| Study ongoing in patients with vascular dementia(4)
|X| Studies planned in Lewy body dementia and mild cognitive impairment
(1) Not yet approved by regulatory agencies
(2) American Association of Neurology
(3) World Congress of Neurology
(4) Trials ongoing by J&J
*Trademark
25
Adderall XR(1) (SLI 381)
|X|
|X| Positive Phase III data presented at APA(2) May 2001
o All doses of Adderall XR showed significant improvement in CGIS-T(3)
and CGIS-P(4) assessments in all treatment weeks compared to placebo
o The extended release nature of the Adderall XR(1) formulation was
shown by continued, significant improvement in afternoon assessments
by teachers and early afternoon and late afternoon assessments by
parents
o
o Trade Mark under registration
(2) American Psychiatric Association
(3) Conners Global index Scale-Teacher (CGIS-T)
(4) Conners Global index Scale-Parent (CGIS-P)
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Frakefamide
|X| AstraZeneca offer to return rights to Shire
|X| Results from Phase II study contradict previous positive results
|X| If development continues
o Likely to be slower and...
o Risk of failure higher than previously anticipated
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Epilepsy
|X| SPD 418, extended release formulation of established anti-epileptic drug,
discontinued
o Unsatisfactory Phase I results
|X| Shire remains committed to epilepsy
o Two follow on projects initiated
|X| Potentially powerful global epilepsy strategy
28
Agrylin*
|X| Orphan drug designation granted for EU
o Already granted for US and Japan
o
|X| EU filing planned early 2002
o Following discussions with regulatory authorities
* Trademark
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Foznol
|X|
|X|
|X| First EU filing 13 March 2001
|X|
|X| US filing to FDA planned for end 2001
30
Rolf Stahel
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Chief Executive
Shire Pharmaceuticals Group plc
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31
Q2 01 Summary
|X| Revenue growth 32%
|X| EPS growth 66%
|X| Reminyl* launched in the US by Janssen Pharmaceutica and Ortho McNeil; 7.1%
market share at week nine
|X| Rapid integration of BioChem Pharma Inc. merger
*Trademark
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Forthcoming news flow and
events
|X| FDA approval and launch of Adderall XR(R) (expected Q4 01)
|X| Foznol US filing (expected Q4 01)
|X| Foznol first European approval (expected Q2 02)
|X| Agrylin* European filing (expected Q1 02)
|X| Second Look US approval (expected Q4 01)
*Trademark
33
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Shire Pharmaceuticals Group plc
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Reminyl US IMS data
Line graph depicting the following data:
First Year of Launch
Market share of new prescriptions
No. of Prescriptions (projected)
Week of launch 1 2 3 5 6 7 8 9
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Reminyl 488 777 954 1527 1808 2005 2194 1940
Aricept 1002 2592 3382 4857 5306 7144 8198 8713
Exelon 323 693 1328 2448 3043 2865 3679 4194
* IMS Data
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US Alzheimer's Market Share
Line graph depicting the following data:
% of Prescriptions (projected)
06/04/01 13/04/01 20/04/01 27/04/01 04/05/01 11/05/01 18/05/01 25/05/01 01/06/01 08/06/01 15/06/01 22/06/01
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Reminyl 0.0 0.0 0.0 0.1 0.2 0.6 1.1 1.3 1.5 2.1 2.7 3.0
Aricept 78.7 78.8 78.8 77.9 78.3 77.7 77.0 76.8 77.0 76.5 76.0 76.0
Exelon 21.0 20.9 20.8 21.7 21.2 21.3 21.6 21.6 21.2 21.1 21.0 20.7
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