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Biotech 2008: A Global Transformation. G. Steven Burrill Chief Executive Officer Burrill & Company. Wisconsin Life Sciences Transformation: World Perspectives & Wisconsin’s Advantage Madison, WI, February 21, 2008. Last Updated: November 4, 2014. Exclusive focus on Life Sciences - PowerPoint PPT Presentation
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1
G. Steven BurrillChief Executive OfficerBurrill & Company
Biotech 2008: A Global Transformation
Last Updated: April 20, 2023
Wisconsin Life Sciences Transformation: World Perspectives & Wisconsin’s Advantage Madison, WI, February 21, 2008
2
Burrill & Company
Exclusive focus on Life Sciences
Human Healthcare (Rx and Dx)
Nutraceuticals/Wellness
Agbio
Industrial
Biofuels/ Bioenergy
Enabling Technologies
3
Burrill & Company – exclusively focused on life sciences
Private Equity / Venture Capital Group
Investing across the entire spectrum of the life sciences/biotechnology ≈ $950 million under management
Merchant Banking (Burrill LLC)
Strategic Partnering including licensing, research and other collaborations
Strategic Advisory Services including new company formation
Merger & Acquisitions across life sciences
Spin-outs ranging from products, to research divisions to disease area franchises
Media
Publications (biotech book, newsletters, special purpose publications [stem cells, personalized medicine, aging etc.], The Journal of Life Sciences, web-based intelligence reports)
Conferences
Headcount: 60+ professionals and staff
4
Burrill & Company U.S. & International Locations
San Francisco (HQ)New YorkIndianapolisPortland
United States
Shanghai
China
Tokyo
Japan
Mumbai
India
London
United Kingdom
Kuala Lumpur
Malaysia
Dubai
UAE
5
Burrill Life Sciences Capital Fund III (2006) $283
Burrill Life Sciences Capital Fund II (2003)(1) $211
Burrill Life Sciences Capital Fund I(1)
Burrill Biotechnology Capital Fund (1999)(1) $140
Burrill Agbio I + Annex & Agbio II Capital Funds (1998(1)/2001)(1)$ 82
Burrill Nutraceuticals Capital Fund (2000)(1) $ 61 $283
Malaysian Life Sciences Capital Fund (a JV Fund) $150
Burrill AgBio II Annex* (a side-car fund to the MLSCF) $ 20
Total Funds Under Management at 12/31/07 $947
(1) Fully invested, including reserves/commitments for subsequent financings in existing portfolio companies
Burrill Funds Under Management -($ millions)
6
Strategic Investors in Burrill & Company Funds
7
Burrill Merchant Banking Services (Burrill LLC)
Transactions Across Life Sciences for Public and Private Clients Sell-side Buy-Side Divestitures Reverse mergers
M&A Transactions
Potential Scope of Potential Scope of
Burrill LLCBurrill LLC
Client RelationshipClient Relationship
Representing Biotech and Big Pharma Out-licensing, profit shares,
options, and regional deals, etc. Preclinical through marketed products
Strategic Partnering
Create a New Company or Merge into an Established Entity Newco financings for pharma
and biotech
Spin-Outs
Private Placements PIPE financing Late-stage venture financing M&A financing
Financing
8
For inquires, contact Britt Fenton-Olsen at (415) 591-5475 or [email protected]
Burrill Created/Hosted Industry Events
9
To order most recent book or complete sets, visit: www.burrillandco.com
G. Steven Burrill’s Annual Book
Our 22nd annual book will be out February 2008
10
Burrill Biointelligence Group Reports
The Burrill & Company’s Special Reports:
The Burrill Personalized Medicine Biointelligence Report
The Burrill Stem Cell Biointelligence Report
The Burrill Aging Biointelligence Report
The Burrill China Biointelligence Report
The Burrill India Biointelligence Report
The Burrill Media’s quarterly/monthly bio-intelligence report:
The Burrill Canadian biotech News Monthly
M&A/Partnering Stem Cells Personalized Medicine
11
Mr. William Patrick
Editor in Chief
A six-times per year publication.
For information, see our website
The Journal of Life Sciences
www.burrillandco.com and www.tjols.com
12
The Journal of Life Sciences on the web Weekly Brief and Weekly Brief, California Edition
To request the free weekly e-mail editions: [email protected]
13
Themes in ’88 book
…Into The Marketplace
Science being converted to business
Products coming to market place
Are product liability, regulatory reform, patent court behavior insurmountable barriers?
Partner or vertically integrate?
Acquisitions by pharma desirable?
How will the industry evolve?
14
Biotech is Transforming the Globe
…and being transformed by it
15
Webster: trans·for·ma·tion Pronunciation: "tran(t)s-f&r-'mA-sh&n”, -Function: noun
1. The act or process of transforming somebody or something
Webster: trans.form
1a: To change in composition or structure
Transformation
16
Chemistry Biochemistry
A Global Transformation…
To…To………FromFrom
On Size fits all drugs Personalized medicine
Aging (just happens) Aging is optional / controllable
Therapeutics/diagnostics/devices “Theranostics”
Treating sickness Preventing Sickness
Food for survival Food for health
17
A Global Transformation…
To…To………FromFrom
Fossil fuels Alternative fuels (biomass conversion)
Unavailable local capital Global arbitrage
Fully integrated business model (FIPCO) Virtually Integrated business model (VIPCO)
Local companies Global companies
US centric biotech industry Global industry
Changing the healthcare environment Transforming the world
18
Circa 1953 – Watson and Crick
Circa 1973 – Inception of biotech
ALZA (`68) Cetus (`71) Amgen (`80),
Genentech (`76 ) Biogen (`78),
Centocor (`79) Hybritech (`78)
Circa 1993 - Meaningful biotech revenue
Circa 2008 – Transforming the world
Life Sciences – Biotech: A Short History …
19
Understand the pieces
Hardware of Life (20th Century) genes/proteins
Software of Life (21st Century) – systems/network
“Biomarkers ‘r us” (Note: “genes ‘r us” biz model failed)
Cost per bit of biological info rapidly decreasing (Moore’s law)
The consequences are staggering …
Era of Unprecedented Advances in Medical Research
20
Moore’s law – Cost Per Base
21
Challenges/Opportunities in Improvement of Care
And we see its implications:
Evidence based medicine
Advances in health information (Web MD)
Personalized, predictive, preventative medicine - (3 P’s)
Electronic Health Records (EHR)
BUT …
Delivery system so flawed can’t bring healthcare “advances” to market place
Government increasingly the payor (Medicare/other government healthcare systems)
22
Climate change
Energy needs/alternative fuels
Poverty
Security/terrorism
Philosophical - ideological conflict (religious conflict)
Also Era of Macro Issues
23
FDA
NIH
CDC
DOD/DARPA/SARPA
USDA
DOE – Energy Alternatives
……yet we are the envy of the world
24
Total US Spend for Biotech/Pharma Research
NIH $29B Pharma $43B Biotech $30+B
TOTAL $100+B
25
Current Healthcare System in “Silos”
Insurers
Employers (Providing $)
Providers/ Managed Care
Doctors/Nurses/Hospitals
Suppliers
Pharma Companies
Diagnostic Companies
Medical Device Companies
Medical Innovators
26
Integration Is Essential BUT Where Is It Happening?
Kaiser Permanente (California)
Intermountain Health (Utah)
Analogy (Clayton Christiansen/ Harvard)
Color TVs invented by RCA but no sales since nobody would broadcast in color
RCA then bought NBC, then integration happened
…Therefore integration within the healthcare system is essential if benefits of new technologies are to be realized
27
HHS Secretary Michael Leavitt
“Combining gene based medical care with health information technology could transform healthcare…”
“Personalized healthcare will combine basic scientific breakthrough of the human genome with computer-age ability to exchange and memorize data”
28
Not only integration, but a greater need for international collaboration
Pandemic diseases
Regulatory harmonization Approvals
Patents
Drug/ Food Safety
Diseases know no borders
It’s a global economy
29
Entering a Period of Co-opetition (Cooperation/ Competition)
Strategic Partnering
Co-development
Co-branding
Co-promotion
Co-marketing
Country to country
Public/private
Big/small
Within industry/outside industry (IT/biotech)
30
Life Science Investment Thesis “To create and capture value across the spectrum of the life-sciences industries”
K
Biopharmaceuticals
Seeds
Food ingredients
Bio FuelsBiomaterials
Bio Processing
Tools
Agriculture
Addressing major m
arket needs
Therapeutics Traits
Diagnostics
Wellness Enhancers
Medical devices
Services
Human Health Care
“Sustain & Nourish the world”
Buildin
g sust
ainab
le b
usines
ses
FEED THE WORLD
FUEL THE WORLD
HEAL THE WORLD
31
So let’s look at where we are and what happened during the last year...
32
Key Industry Stats – Biotech 2008
USA Europe
Asia/Pacific Canada Total
Sales / Rev. $89B $12B $3.5B $1.5B $106B
AnnualR&D $23B $4B $0.4B $0.8B $28B
Number ofCompanies 1,450 1,600 740 450 4300
Number ofEmployees 131,00
010,000 13,000 7000 151,000
Number ofPublic Co.’s 370 160 140 75 745
Market Cap $455B $30B $50B $12B $547B
33
Pharma vs. Biotech Industry Market Cap ($B)
Company 12/31/07 12/31/06 12/31/05 12/31/04 12/31/03 12/31/02 12/31/01 12/31/00
Pfizer 155 187 172 199 280 192 251 290
Johnson & Johnson 191 180 186 184 154 112 181 146
Merck 127 82 69 69 103 165 133 216
Eli Lilly 60 62 65 65 77 50 88 105
Bristol-Myers Squibb 53 50 46 47 58 65 112 145
Pfizer/Merck 282 269 241 268 383 357 384 506
Total US Biotech 455 496 491 399 342 213 366 425
Industry 1.6x 1.8x 2.0x 1.5x 0.9x 0.6x 1.0x 0.8x
34
Top ten Biotech Companies by Market Cap
Position
Biotech 1986
Biotech 1991
Biotech 1996
Biotech 2001
Biotech 2006
Biotech 2007
1 Genentech Amgen Amgen Amgen Genentech Genentech
2 Cetus Genentech Genentech Genentech Amgen Amgen
3ALZA ALZA Chiron Elan
Gilead Sciences
Gilead Sciences
4 AppliedBiosystems Centocor ALZA Shire Celgene Genzyme
5 Centocor Chiron Biogen ALZA Biogen Idec
Celgene
6 Amgen Genzyme Genzyme Biogen Genzyme BiogenIdec
7Nova Cetus
GeneticsInstitute Chiron
Serono (ADR) Shire ADR
8Chiron Synergen Centocor Immunex Shire
(ADR) Elan
9 GeneticsInstitute
GeneticsInstitute IDEXX MedImmun
e
QuestDiagnostic
es Amylin
10Biogen
DiagnosticProducts Immunex Millennium MedImmun
e
Millennium Pharmaceutical
s
35
Historical Biotech Market Cap 1997–2006
$109
$149
$312
$441
$382
$224
$341
$400
$490 $489$455
$0
$100
$200
$300
$400
$500
1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007
36
….And these small Life Science companies are becoming increasingly important as a source of value creation and innovation in the healthcare sector
Source: Capital IQ, Windhover, Burrill Analysis
Top Five US Pharma* vs. Total Biotech Market Cap Market Value of
selected Big Pharma
acquisitions of public Biotechs
(2005-2007)
37
So, what really happened during the last year ?
Stem cells politically hot and the science is delivering
Technology/platform companies rebounded
BioFuels are BOOMING…
Industrial biotech is finally happening
Ag/animal health show progress
acreage is up
but “organics” and “natural’ are hot
38
Increased interest in “wellness” not just sickness
Personalized medicine makes real progress
Regulatory concerns:
IVD/MIA “approvals”
FDA Critical Path
Theranostics
Biogenerics/biosimiliars/follow-on biologics
Big pharma buys into the biotech pipeline
So, what really happened during the last year ?
39
So, what really happened during the last year ?
… My projections for 2008 will followat the end
Reimbursement dynamics continue to dominate, especially in the US
India/China make real progress (Malaysia, Korea, others do too)
Industry raises $45b in capital in US alone
The last year has been a good year, not a great one
40
Transformation:Sickness to Wellness
41
Healthcare Industry Dilemma…
Rising Healthcare Costs
Loss of Patent Protection for Blockbuster Drugs
Need for Innovation; build vs. buy
Reimbursement/Payment system changes – Medicare Part D
Compulsory Licensing
42
Healthcare Costs Have Been Rising -For a Long Time
43
Prescription Drug Costs as Percentage of Healthcare
44
Estimate of Overall US Healthcare Spending on Prescription Drugs (by general public)
45
Worldwide Global Pharmaceutical Sales –
46
…by the way, the Global Nutraceuticals Industry is $228 Billion in 2006
0
10,000
20,000
30,000
40,000
50,000
60,000
70,000
80,000
90,000
US
A
Eur
ope
Japa
n
Can
ada
Chi
na
Res
t of A
sia
Lat A
mer
Aus
t/NZ
EE
/Rus
sia
Mid
Eas
t
Afr
ica
Source: Nutrition Business Journal May/June 2007
Supplements
Natural Foods
Functional Foods
Personal Care
(millions)
47
Today’s Medicine Challenge: One Size Doesn’t Fit All
48
Pharmacogenomics Shapes the Healthcare Business in 2000+
49
140 Years of Drug Discovery Technology
penicillinssulphonamidesaspirin
psychotropics
NSAIDS
H2-antagonistsbeta blockers
lipid lowerersACE-inhibitors
Biotech drugs
chronicdegenerativedisease associatedwith ageing,inflammation,cancer
drugs againsttargets identifiedfrom disease genes
1900 20301950 1960 1970 1980 1990 2000 2010 2020 2040
New
Th
erap
euti
c C
ycle
s
1st generation 2nd generation 3rd generation
natural productsand derivatives
serendipity
receptors
enzyme
genetic engineering
cell pharmacology/molecular biology
genomics/ proteomics
So
urc
e:
CM
S,
Le
hm
an
Bro
the
rs r
ese
arc
h
50
Confluence of Technology, Tools, and Knowledge
51
A Systems Biology Approach – Follow the Pathways
52
The Molecular Basis of
Biological Processes
Alterations in Disease
New Targets for Dx, Rx, Vx
The Molecular Heterogeneity of
Disease
Disease Subtypes
Right Rx forDisease
Individual Genetic Variation
Pharmaco-genetics
New Targets for Dx, Rx, Vx
DiseasePredisposition
PDxPRx
Analyzing the Molecular Profiles (Biosignatures) of Body Functions in Health and Disease
53
Selected Targeted Treatments
Personalized cancer vaccines
Favrille – FavId for non-Hodgkin's lymphoma
Genitope – MyVax for non-Hodgkin's lymphoma
Gleevec (Novartis) - pH+ CML kinase inhibitor
Iressa (AstraZeneca) – EGFR tyrosine kinase inhibitor
Tarceva (Genentech/OSI) – HER1/EGFR inhibitor
Erbitux (ImClone/BMS) – HER1/EGFR inhibitor
Avastin (Genentech) – VEGF/VEGFR inhibitor
Herceptin (Genentech) – HER2 inhibitor
BilDil (NitroMed) - heart failure in African American patients
Other “Semi Targeted” Treatments (approved or late stage trials)
Nexavar (Bayer/Onyx) – multikinase inhibitor
Tykerb (GSK) - ErbB-2/EGFR inhibitor
Enzastaurin (Lilly) - PKC-Beta, AKT/P13 inhibitor
54
Innovation Gap Getting Wider
55
Safer, More Effective Drugs
Target Identification
Target Validation
LeadDevelopment
Preclinical Clinical Market
Faster path todisease targetsusing genetic data
Speed trials by testing onpatients selected for likelyhigh response and safety
Knowledge of biological pathwaysand gene variants help eliminatepoor candidates
Target optimal populationby combining drug withmolecular diagnostic testing
56
Big “New” Markets
Obesity/diabetes/metabolic disease
Alzheimer's/memory
Anti-aging
Anti infectives (antibiotic resistance)
Wellness (preventative/predictive cure)
57
Projected Alzheimer’s Disease Prevalence, 2000 to 2100
58
Aging . . . Is it a Disease?
By 2030, 20% of US population will be over 65 years of age…
About 1.4 million Americans are in their 90s, and another 64,000 are 100 years old or older
Baby boomers represent 30% of the total US population
Per person, seniors consume about five times the drugs of their working-age counterparts
59
Medicines in Development for Older Americans*
* Some medicines are listed in more than one category
DISEASE
Alzheimer's Diseasse/Dementia
27
Bladder/Kidney 9
Depression 19
Diabetes 48
Epilepsy 7
Eye Disorders 23
GI Disorders 23
Lung/Respiratory 52
Musculoskeletal 6
Osteoarthritis 11
PRODUCTS INDEVELOPMENT
DISEASE
Osteoporosis 20
Pain 41
Parkinson's Disease 17
Prostate 6
Rhumatoid Arthritis 38
Sepsis 3
Sexual Dysfunction 15
Skin Conditions 14
Sleep Disorders 11
Other 17
PRODUCTS INDEVELOPMENT
60
Chronic Disease
125 million Americans have one or more chronic conditions (e.g. congestive heart failure, diabetes)
Chronic diseases account for 75% of all health care expenditures
Current costs for chronic diseases is approaching $1 trillion
These expenditures are not delivering what is possible
61
Stratifying Into Risk Categories Diabetes Type 2: What’s Becoming Possible?
62
Products in WW Development 2007 III and Registration
0
100
200
300
400
500
600
Phase III RegistrationSource: BioCentury Publications
571 Total
248 Total
388 Risk-Adjusted to Approval
208 Risk-Adjusted to Approval
63
Products in Phase III by Disease / Target Area
Source: BioCentury
64
0
5
10
15
20
25
30
35
40
45
19821983198419851986 19871988198919901991 1992199319941995 19961997199819992000 20012002200320042005
New Indications
Biotech Drugs
2006
Number of Products Approved — 1982–2006
2007
65
Biotechnology Drugs in Clinical Development
66
MDx is at the Center of the New Dx World
67
Diagnostic Innovation Makes Impact on Cancer Therapy
68
In Vitro Diagnostics, By Application
69
Looking Forward, Patent Exposure is Set to Increase Significantly
70
Biogeneric Status of Biotech Drugs
71
Adverse Event Reports 1990-2006
0
50100
150
200250
300
350
400450
500
Source: CDER OSE report 10/5/07 AERS database (includes all US marketed drug and biologic products)
(thousands)
72
Pulled from the MarketDateApproved
Drug Name
Use Risks
Date
Withdrawn
2002
2001
Zelnorm
Bextra
IBS - C
Pain reliever
Heart attack
Heart attack/stroke; fatal skin reactions
2007
2005
1999 Vioxx Pain reliever Heart attack/stroke 2004
1997 Baycol Cholesterol Severe damage to muscle, that is sometimes fatal
2001
1999 Raplon Anesthesia An inability to breathe normally 2001
1993 Propulsid Heartburn Fatal heart rhythm abnormalities 2000
1997 Rezulin Type 2 diabetes Severe liver toxicity 2000
1988 Hismanal Antihistamine Fatal heart rhythm abnormalities 1999
1997 Raxar Antibiotic Fatal heart rhythm abnormalities 1999
1997 Posicor High blood pressure
Dangerous interactions with other drugs
1998
1997 Duract Pain reliever Severe liver damage 1998
1985 Seldane Antihistamine Fatal heart rhythm abnormalities 1998
1973 Pondimin Obesity Heart valve abnormalities 1997
1996 Redux Obesity Heart valve abnormalities 1997
Blockbuster drugs pulled from the
Blockbuster drugs pulled from the
market gave investors concern
market gave investors concern
73
On the Regulatory/Patent/Policy Front… Patent reform (PTO proposals to restrict claims examined in a
single application and limit continuation applications) FDA resources – PDUFA IV authorization
follow-on biologics (biogenerics) drug safety theranostics food safety (pet food)
Biofuels – renewable and alternative energy sources through use of biotechnology
Medicare Prescription Drug Price Negotiation Act – Non-interference (proposal to require Medicare interference)
Sarbanes Oxley compliance – reducing the burden on small companies
SBIR eligibility Agbio/ GMO’s Stem cell research – federal funding
74
The Cost of Developing a New Drug has Greatly Increased
75
CMS Becomes Dominant Customer (40% of Market in 2008)
2002 Rx Payment Sources ($B)
Out of Pocket, $48.6
Other Public, $5.0
Medicaid, $28.6Medicare, $2.6
Private Insurance, $77.6
2008 Projected ($B)
Out of Pocket, $60.0
Other Public, $10.0
Medicaid, $30.0
Medicare, $65.0
Private Insurance, $95.0
2002 Rx Payment Sources ($B) 2008 Projected ($B)
Total = $260Total = $162.4
2002 data: Health Affairs Volume 23, Number 1; January 2004.2008 data: Tag & Associates estimate
Source:
76
Medicare Heads Towards Bankruptcy
77
Major Government Initiatives in Biotechnology
EU/Eastern Europe/Scandinavia China India Japan Malaysia Singapore UAE/Dubai and Kuwait Israel Various Latin American Countries (esp.
Chile/Brazil) Australia/New Zealand
78
Healthcare Costs are Growing Much Faster Than Productivity (Revenue Per Employee)
$100,000
$120,000
$140,000
$160,000
$180,000
$200,000
$220,000
1998 1999 2000 2001 2002
$3,500
$4,000
$4,500
$5,000
$5,500
$6,000
Revenue per employee
Healthcare costs per employee
Source: Hewitt Health Value Initiative; United States Census; Bureau of Labor Statistics (2002 Productivity estimated based on first 3 Quarters)
CAGR=3%
CAGR=10%
GM Cannot CompeteHealthcare costs per car are $1700
more then Toyota
79
…so, healthcare cost increases are on everyone’s agenda
Politicians/Congress/White House
Payors/Reimbursors/Insurers
Physicians/Providers
Patients/Consumers
…and patients are empowered, have economic costs,
and really want to stay well!
80
PHARMA/PHARMAPHARMA/PHARMA PHARMA/BIOTECHPHARMA/BIOTECH BIOTECH/BIOTECHBIOTECH/BIOTECH
Significant Mergers & Acquisitions 2007
Schering-Plough/Organon
$ 14.4 billion
Hologic/Cytyc
$ 5.9 billion
Mylan/Merck Generics
$ 6.6 billion
Siemens/Dade Behring
$ 7.1 billion
AstraZeneca/MedImmune
$ 15.6 billion
Eisai/MGI Pharma
$ 3.5 billion
GSK/Reliant
$ 2.7 billion
Shire/New River
$ 2.5 billion
Celgene/Pharmion
$ 2.7 billion
Qiagen NV/Digene
$ 1.5 billion
Amgen/Illypsa
$ 420 million
Genzyme/Bioenvision
$ 308 million
81
M&A 2007 - Total
Industry M&A Activity:Total Deal Number & Average Deal Value
0
50
100
150
200
250
2004 2005 2006 2007
Nu
mb
er o
f D
eals
$0
$200
$400
$600
$800
$1,000
Do
llar
is i
n M
illi
on
s
Number of Deals Average Deal Value
82
M&A
Industry M&A Activity: Total Number of Deals by Total Deal Value
78
19
33
69
61
57
19
43
13
7 7
1
58
17
49
20
128
5
59
16
50
15 13 13
2
0
10
20
30
40
50
60
70
80
90
<50M 50M-99M 100M-499M 500M-999M 1B-2.5B 2.5B-10B 10B+
Num
ber
of D
eals
2004 2005 2006 2007
83
Partnering – Big Pharma
BIG PHARMA ALLIANCES IN 2007
0
5
10
15
20
25
30
Num
ber
of A
llian
ces
Series1 24 21 20 18 18 17 15 15 13 13 11 11 10 9 8 6
Novartis
J&J GSK Merck Roche Pfizer AZBayer Scheri
ngEli Lilly Wyeth SP
Sanofi Aventis
Abbott Takeda BMS BI
84
Partnering - Upfronts
$0
$10
$20
$30
$40
$50
$60
$70
Dollars in Millions
Average Total Upfront Payments By Stage of Development At Deal Closing
2003 2004 2005 2006 2007
85
Wellness: Its Time Has Come
Rising healthcare costs are impacting individuals
Rising incidence of chronic disease
Recognition of the importance of genetic variation
Scientific knowledge base for:
Personalization
Cost effective technologies
Financial markets beginning to recognize opportunity
86
The Demands for Agriculture Stay the Same
0
1
2
3
4
5
6
7
8
1950 1975 2000 2020
WorldPopulation
Arable Land(billion ha.)
Farmland perperson(ha)
Source: 1999-United Nations
More food on less land with half the water.
87
Market Overview – Agriculture
88
Global Area of Biotech Crops 1996 to 2005 By Crop
89
2005 Was The Tipping Point For Industrial Biotechnology
Perfect Storm • Energy security
• Global Warming
• Economics
• Political Will
• Market pull
• Ready technology
89
Biofuels Sustainability 2008
90
Exciting Time Since
VC investments increased dramatically Oil companies invested in technology and
infrastructure Supportive legislation Frenzy to access technology Frothy Pre-money Valuations No success stories
91
What Has Happened Since?
Ethanol plant construction exploded (All corn based) Now have 113 in operation, 77 under construction Production at 6 billion gallons, potential for 12B
Price of feed grains $2 historically, topped $5.00 20% of corn crop today, 50% in two years ! 13% of soybeans going to biodiesel
The focus has been on biofuels - Ethanol
92
Implications
Unprecedented energizing of rural America
Price of corn Feed costs: poultry, beef, and swine Sales of pickup trucks, farm equipment and
new kitchens Land values Food costs: Meat, HFCS
93
Energy Bill & Farm Bill
The Energy Independence and Security Act of 2007 By 2022
o Renewable Fuel (20% reduction in GHG) 36 B gallons
o Advanced biofuels (other than corn starch with 50% life cycle reduction in GHG 21 B gallons
o Cellulosic Biofuel (>60% reduction in GHG) 16 B gallons
2008 Farm Bill – Energy Title (In Conference) Tax incentives Funding for development and demonstration
Key Future Drivers!
94
2007 Great Year But with Storm Clouds Forming
Perfect Storm
• Energy security• Global Warming• Economics• Political Will• Market pull• Ready technology
Second Perfect Storm
• Social
• Economic
• Environmental
95
Storm Clouds
Commodity prices drive up food prices
Acreage Swap between Corn and Soybeans
The linkage: Corn – Soybeans – Palm Oil
Exaggerated by imminent US lead recession
Economic discontinuities caused by speed of adoption
96
Social, Economic and Environmental Issues will Dominate 2008
US recession How long how deep? Fewer IPOs, Fewer Acquisitions
What will big oil do ? Access to project financing
Funding of small technology companies
$5M, $20M, $100 M Will we get the project financing needed given the
economic and political uncertainty
IPOs early in year critical – several good ones ready to file, some even have revenues!
Uncertainty a big risk
97
Opportunities
From an investor stand point – “Ethanol is dead”
Cellulosic sourcing of sugars will be hot Increasing interest in alternative fuels
Butanols Alkanes
Lots of opportunities outside biofuels Bioplastics / Biomaterials APIs Specialty chemicals
98
Some Learnings From Agbio
Be proactive, get ahead of the issues Engage all parties, respect their issues (they may
be right) Do not be defensive Find common ground Energy security, sustainability, reduced
environmental foot print It is not about the science it is about the political,
social, economic and environmental issues
99
Capital Raised 1980-2007
100
0
10
20
30
40
50
60
1983 1986 1991 1995 2000 2003
Droughts
Rallies
Biotech’s F=Five cycles Length of Rallies/Droughts in Months
101
Small, Mid-Cap vs. NASDAQ, DOW
-22.50%
-20.00%
-17.50%
-15.00%
-12.50%
-10.00%
-7.50%
-5.00%
-2.50%
0.00%
2.50%
5.00%
7.50%
10.00%
12.50%
15.00%
17.50%
20.00%
22.50%
Dec/06 Jan/07 Feb/07 Mar/07 Apr/07 May/07 Jun/07 Jul/07 Aug/07 Sep/07 Oct/07 Nov/07 Dec/07
Mid Cap
Small Cap
Dow Jones
NASDAQ
102
Billion-Dollar Club
103
IPOs – Not What They Used To Be
104
IPOs – Not What They Used to Be
Number
of IPOs
Positive sinceIPO
Negative
sinceIPO
Acquired
Amount Raised*
($ Million)
Average % changeSince IPO**
2003
7 1 4 2 $438 (3.34%)
2004
29 6 17 6 1,628 (12.64%)
2005
17 5 10 2 819 4.55%
2006
19 6 13 0 920 8.26%
2007
28 11 18 0 2,041 2.00%
Total
100 29 62 10 5,846 (0.24%) * Includes over-allotments ** As of 12/31/07Source: Burrill & Company
105
2007 Life Science Financing Overview
Initial Public Offerings: 27 offerings with proceeds of at least $20.0m $2b total proceeds raised $70m average deal size $162.3m median pre-money valuation The share price of issuing companies increased
2% on average 5 days post pricing The share price since time of offering has
increased 2% on average
106
Finance and Capital Markets
The global financial markets have created additional opportunities for companies to look
outside their borders for financing
Europeans on NASDAQ/NYSE Chinese on NYSE Americans on AIM/Euronext/SWX Other markets are available
Mothers (Tokyo) DFX (Dubai) Hong Kong
107
Transformation:
FIPCO’s to VIPCO’s
108
FIPCO (Fully Integrated Pharma Co.)
ResearchTechnology
Manufacturing
Clinical &Regulatory
Sales &Distribution
CSO
CMO
CROs
Partnerships
Academia, Scientific, Institutions
R&D
Preclinical Support
Clinical Development
Manufacturing
Sales & Distribution
Preclinical CRO
VIPCO (Virtually Integrated Pharma Co.)
Changing Business Models
109
So What Does Big Pharma Do Better Than Anyone Else?
Discovery?
Development?
Manufacturing?
Distribution?
Disease Management?
What is the Answer?
110
Difficult financing at early stages Successive venture rounds at increasing value is
challenging…public equity values have compressed the whole equation
Time and cost of development has been increasing and risk/return has been decreasing
Therefore, a new model must emerge
Financing Biotech Companies the Old Way Doesn’t Work
111
VC & Angels are hesitant to invest Business models are changing More financing of projects
Selective platforms are coming back
Higher bar for regulatory approval
Reimbursement compression
Capital efficiency required
BUT…
Rate of start-ups are increasing (go figure…)
How Does All This Impact Entrepreneurial Start-ups in 2008
112
So the predictions for 2008…
113
The Predictions for Biotech in 2008
Sales of products will continue to increase, but reimbursement becomes more challenging
Despite stricter regulatory oversight, more products to the marketplace
Regulators Raising the bar for innovation, theranostics Pharmacovigilence is the name of the game Drug safety will continue to be a major issue
Congress aiming to add power to Medicare to negotiate what it pays for drugs
Congress may reduce the capital gains differential (bad for the capital raising side of the industry)
114
Biofuels boom
Ag/Animal Health continue to progress
Biotech’s globality increases with US dominance continuing to decrease
US research engine faces challenging times
Non-health care aspects of biotech also becoming less dominant as industrial, biofuels, ag increase in importance
Clusters are redefined away from geography to virtual clusters (diseases, markets, unique industry segments)
Business models continue to evolve
The Predictions for Biotech in 2008 (continued)
115
The Predictions for Biotech in 2008 (continued)
Both big Pharma and big Biotech will be competing for companies with advanced product pipelines
We will see US biotechs accessing capital overseas…international companies accessing capital in non-local markets
“Capital Markets” worse than 2007, but
30 IPO’s in 2008 (mostly 2H ‘08)
2008 $50 billion will be raised by the US biotechs
MKT Cap will reach $500B
Of the 60 IPO’s completed by 2006, most all trading above offer price by end of 2008
116
It’s going to be a tough, competitive year with
biotech companies transforming the world
… and being transformed by it!
117
G. Steven BurrillChief Executive OfficerBurrill & Company
Biotech 2008: A Global Transformation
Wisconsin Life Sciences Transformation: World Perspectives & Wisconsin’s Advantage Madison, WI, February 21, 2008
Last Updated: April 20, 2023