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Strategic Overview of the
Biotechnology Industry
May 23, 2017
© 2003 Wyeth.
Cavan Redmond
Executive Vice President
General Manager
Wyeth BioPharma Business Unit
Funding the Future
“As the industry regains its strength, there is more money for
frontier research in biotechnology”
Companies are also
raising more money…
Billions of Dollars
40
…industry revenues
are growing…
IPOs,
Follow-Ons,
Venture Capital,
and other
sources
32
100
Total Revenues
1.5
80
0
60
-1.5
16
40
-3
8
20
-4.5
24
0
'98
'99
'00
'01
'02
'03
0
'98
'01
'03
'05 Est. '08 Est.
Data: Biotechnology Industry Organization, Ernst & Young, Bloomberg Financial Markets
Source: Business Week – May 24, 2004
3
…and profits are
finally in view
-6
Total Net Income
'98
'01
'03
'05 Est. '08 Est.
Profile of the Biotechnology Industry
1,400†
~360
155
10
Biotechnology
Companies
4
Generating
Revenue
Products Approval
by FDA
Products With
Sales >$1Bn
Profile of the Biotechnology Industry
1,400†
Total # of Biotech Companies
2000
1999
1998
1997
1996
1995
1994
1993
~360
0
200
400
600
Public
800
1000
1200
1400
Private and Public
155
10
Biotechnology
Companies
5
Generating
Revenue
Products Approval
by FDA
Products With
Sales >$1Bn
Profile of the Biotechnology Industry
1,400†
2000 Revenue: $24.9 Billion
2003 Revenue: $41.3 Billion
12
53
40
$0-0.5 million
$0.5-5 million
$5-50 million
$50-500 million
$500+ million
100
156
~360
155
10
Biotechnology
Companies
6
Generating
Revenue
Products Approval
by FDA
Products With
Sales >$1Bn
Biotech Products – The Future is Now
Total Market
Biotech
Fixed Combinations
Generics
0
5
10
15
20
% Growth Constant Dollars
*Generics Market based on 8 key markets
Source: IMS Health: MIDAS, MAT Dec 2003
7
25
30
Only A Few Have A Portfolio of Biotech
Products
14
12
10
0
Source: IMS Health December 2003 National Sales Perspectives. Wyeth total
includes European BMP.
8
Roche
2
Berlix
4
SP
6
Medimmune
8
Biogen
Idec
Number of U.S. Marketed
Products
Number of Total Launched
BioPharma Products
Globalization of Biotech is Critical
North America accounted for
63% of sales in 2003
40
Sales (US$ Bn)
35
30
25
20
15
10
5
0
1999
2000
North America
Africa, Asia & Australia
Source:IMS Health: MIDAS, MAT Dec 2003
9
2001
2002
Europe
Latin America
2003
Biotechnology Industry – Creating
Accessible Innovation
Global Revenue
Global R&D Expenditures
$41.3 Bn
$22.0 Bn
$30.3
$16.3
U.S.
Europe
$229.5 Bn
$8.3
$30.1 Bn
$5.0
Asia
$1.4
Source:IMS Health: MIDAS, MAT Dec 2003
PhRMA: R&D Expenditure 2001
Source:Ernst & Young: Beyond Borders
The Global Technology Report 2003
11
$0.2
Investing Today for Tomorrow's Healthcare
System
Pharmaceutical Market
Global
$467.9 Bn
U.S. Pharmaceutical Market
$229.5 Bn
Source:IMS Health: MIDAS, MAT Dec 2003
PhRMA: R&D Expenditure 2001
12
U.S. R&D Expenditures
$30.1 Bn
13
14
Declining Drug Approvals is
Biotechnology’s Opportunity
New SMD, rDNA and mAb Therapeutics Approved in the U.S. (1/1/90 – 10/1/03)
Number of Products
50
SMDs
rDNA/mAb
40
30
20
10
0
’90 ’91 ’92 ’93 ’94 ’95 ’96 ’97 ’98 ’99 ’00 ’01 ’02 ’03
Note: SMD = small molecule drug
rDNA = recombinant protein
mAb = monoclonal antibody
Source: Tufts Center for the Study of Drug Development Outlook 2004
15
The Global Innovation Gap
Number of Top 50 NCEs by Country of Origin
50
40
30
20
10
0
1985-1989
U.S.
Japan
Switzerland
1995-1999
EU - 15 Total
Source: Gambardella, Alfonso, et al. ‘Global Competitiveness in Pharmaceuticals/A European Perspective.’ November, 2000.
16
The Cross-Over Effect
 Pharma
17
 Biotechnology
 Integrated Infrastructure
 Discovery Innovation
 Global Reach
 Technical Expertise
 Financial Resources
 Risk Profile
 Partnership Drive
 Partnership Driven
R&D Budget Allocation
Clinical
Evaluation:
Phase IV
Screening
Dosage
and Testing Formulation
11.0%
15.6% 4.9% 8.0%
Synthesis and
Extraction
Toxicology
Source:PhRMA Annual Survey
18
32.0%
Clinical Evaluation:
Phases I, II and III
12.9%
Regulatory
Process
9.1% 4.5%
Process
Others
Development 2.0%
Development Risks
Standard Probabilities of Success
Phase 0 Phase I Phase II Phase III Phase IV
Small
Molecules
12%
20%
30%
65%
95%
Replacement
Proteins
20%
35%
40%
65%
95%
Therapeutic
Proteins
12%
20%
30%
65%
95%
Therapeutic
Vaccines
12%
20%
30%
65%
95%
Prophylactic
Vaccines
22%
39%
54%
68%
96%
Source: Tufts Center for the Study of Drug Development
20
Wyeth’s Alzheimer’s Program Utilizes
All Three Platforms
Proteins
Peptide-CRM
Conjugate
(ACC-001)
Humanized Antibody
(AAB-001)
Alliance with Elan
22
Small
Molecules
Vaccines
Alzheimer’s Disease
5HT 1A Antagonist
(SRA-333)
Gamma Secretase
Beta Secretase (BACE)
23
Breaking The Manufacturing Bottleneck
 Transformation
 Multiple Sites
 Technology Transfer
 Global Work Force
 Regulatory Interactions
24
25
Discovery
R&D Strength
Clinical
BioPharma Strength
Low
26
Commercialization Strength
High