Biotechnology 2009: The Current State of the Industry

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5 Δεκ 2012 (πριν από 4 χρόνια και 8 μήνες)

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Biotechnology 2009


The Current State of the Industry and its Implications

June 19
th
, 2009

MBC Finance Committee Presentation

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Capital Market Influences

Biotechnology 2009

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NBI

BTK

DJIA

Nasdaq

Capital Market Influences

Select Market Indices (Jan 2007 to present)

(14.0%)

(15.2%)

(25.8%)

(30.9%)

Note: Indices values as of June 1, 2009

Source: Yahoo! Finance; CANACCORD Adams

10
-
month lag: NASDAQ vs. BTK/NBI

(46.9%)

NBI <$100 MM

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Number of issues


% life science
issues


4.7%


23.5%


14.9%


9.7%


8.8%

All Industries

Life Science

Capital Market Influences

Annual IPO Activity: 1999


Present

295

293

74

72

80

14

69

11

7

7

234

44


18.8%

Source: IPOMonitor, Hoover’s IPO Central, Johnston Blakely & Co

100

200

300

400

1999

2000

2001

2002

2003

2004

196


12.2%

2005

24

195

27


13.8%

2006

210


16.6%

2007

31

31

2008

3


9.7%

8

2009


0.0%

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Capital Market Influences

Biopharma IPO Activity

0.0%

20.0%

40.0%

60.0%

80.0%

100.0%

2000

2004

53

25

Preclinical

Phase I

Phase II

Phase III

NDA filed

37.7%

92.0%

Preclinical

Phase II

Phase III

NDA filed

Percent of total IPOs

Source: SEC filings

Note:

Includes biopharmaceutical and related issues only.


Lead compound in clinical development


% of total life
science IPOs


76.8%


56.8%

100.0%

2007

Phase I

Phase II

Phase III

Approved
Product


48.4%

15

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0
20
40
60
80
100
2000
2001
2002
2003
2004
2005
2006
2007
2008
Number of issues

IPO Performance

Life Science IPOs (2000 to 2008)

Total Life Science IPOs

Issues currently above IPO PPS

69

11

7

7

44

24

27

31

3


% life science
issues above
IPO PPS


54.5%


28.6%


28.6%


31.8%


29.2%


18.5%


16.1%


33.3%


17.4%

Note: Stock transactions involving mergers of equals or reverse mergers calculated using current share prices.

Source: Johnston Blakely & Co

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0
30
60
90
120
150
Biopharma
Medical
device
Diagnostic
Discovery
Other
Life Science IPO Performance

Sector Performance (2000 to 2008)

Number of issues

27

18

6

2

130

64

17

9

3

Total IPOs

IPOs currently above IPO PPS

Note: Stock transactions involving mergers of equals or reverse mergers calculated using current share prices.

Source: Johnston Blakely & Co


% life science
issues above
IPO PPS


28.1%


35.3%


22.2%


33.3%


20.8%

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0%
20%
40%
60%
80%
100%
IPO Value
Current Value
Life Science IPO Performance

Aggregate Performance (2000 to 2009)

Percent of Aggregate Value


$2,000

(23.9%)

Note:

Represents value of one common share in 223 life science IPOs from 2000 through 2008. Stock transactions involving merger
s of equals or reverse
mergers calculated using current share prices. Current share price as of February 23, 2009.

Source:

Johnston Blakely & Co


Cumulative value
of one share/IPO


$2,630

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$0
$250
$500
$750
$1,000
$1,250
Q1 2008
Q2 2008
Q3 2008
Q4 2008
Q1 2009
$1,076

$515

$1,001

$217

dollars in millions

Public Equity Financings

Biotechnology (2008


Q1 2009)

Note: Represents dollars raised through IPO, follow
-
on and PIPE financings.

Source: Burrill & Co., CANACCORD Adams

$821

Vertex
Pharmaceuticals

All other issues

(15 offerings)

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$0
$500
$1,000
$1,500
$2,000
$2,500
$3,000
Q1 07
Q2 07
Q3 07
Q4 07
Q1 08
Q2 08
Q3 08
Q4 08
Q1 09
dollars in millions


241


# of announced
financings


220


185


207


133

$2.6 B

Source:

NVCA

Life Science Venture Financings

Quarterly Funding Activity (2007 to present)

$2.2 B

$1.9 B

$2.4 B

$2.3 B

$1.9 B

$2.2 B

$1.6 B

$1.0 B


198


175


223


266

(61.8%)

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0%
20%
40%
60%
80%
100%
Private Companies
Small/Micro Cap
Mid/Large Cap
percent of total

377

37

Capital Market Influences

Financial Resources

> 12 mos cash

< 12 mos cash

< 6 mos cash

~800

Source: Nature Biotechnology, BIO


Number of
Companies

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Capital Market Influences

Summary Conclusions


Unprecedented financial challenges confronting the industry may be
protracted with no near
-
term resolution.



The key premise that the only financing uncertainty was clearing
price is now likely a thing of the past.



Capital allocated for high beta investments likely to be significantly
reduced.



Complete lack of capital for many companies may result in a
fundamental shift in how industry conducts business.


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Pharmaceutical Industry
Dynamics

Biotechnology 2009

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Pharmaceutical Sector Performance

Large Pharma Company Index
(1990


1998)


Note:

Index calculated as aggregate of company share prices. Share prices adjusted to reflect dividends and splits


Includes companies with securities trading on the NYSE. Data for AZ and NVS not available for period.

Source:

Yahoo! Finance; Johnston Blakely & Co. research

Company Index


Abbott


Bristol
-
Myers Squibb


Eli Lilly


Glaxo SmithKline


Johnson & Johnson


Merck


Pfizer


Schering Plough


Wyeth

0%
100%
200%
300%
400%
500%
600%
percent of initial index value

Aggregate Index Price
Dec 31, 1990

Aggregate Index Price
Dec 31, 1998

67.97

432.06

+ 535.7%

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0%
20%
40%
60%
80%
100%
(14.4%)

Pharmaceutical Sector Performance

Large Pharma Company Index
(1998


present)


percent of initial index value

Note:

Index calculated as aggregate of company share prices. Share prices adjusted to reflect dividends and splits


Includes companies with securities trading on the NYSE.

Source:

Yahoo! Finance; Johnston Blakely & Co. research

Company Index


Abbott


Astra Zeneca


Bristol
-
Myers Squibb


Eli Lilly


Glaxo SmithKline


Johnson & Johnson


Merck


Novartis


Pfizer


Schering Plough


Wyeth

Aggregate Index Price
Dec 31, 1998

Aggregate Index Price
Sept 30, 2008

510.48

436.99

Aggregate Index Price
June 15, 2009

(25.0%)

382.86

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0%
100%
200%
300%
400%
Dec 31, 1998

Sept 30, 2008

BTK Index


(25.0%)

510.48

436.99

185.13

784.16

+ 255.8%

percent of initial index value

Large Pharma Index

Biopharma Index

Note:

Index calculated as aggregate of company share prices. Share prices adjusted to reflect dividends and splits


Includes companies with securities trading on the NYSE.

Source:

Yahoo! Finance; Johnston Blakely & Co. research

Comparative Sector Performance

Large Pharma vs. Biopharma

382.86

Jun 15, 2009

Aggregate Index Price

658.73

Dec 31, 1998

Sept 30, 2008

Jun 15, 2009

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Recognition of declining productivity and impending patent expirations.


Reallocation of resources towards more downstream activities.

-
strategic disaggregation of the pharmaceutical value chain


Leverage discovery activities through interactions with the biotech
sector.


Emergence of new discovery technologies combine with promise of
new genomics frontier.

R&D Productivity

Historical Trends

In the 90’s. the pharmaceutical industry moved aggressively to
formalize relationships with the biotech sector.

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0.0%
20.0%
40.0%
60.0%
80.0%
100.0%
1989
1999
2000
2001
2002
2003
2004
2005
2006
2007
Pre/non clinical %:

51.0%

44.0%

39.0%

32.0%

25.9%

25.7%

27.2%

Percent of total R&D expenditures

Pharma R&D Expenditures

1989
-

2007 (by function)


Pre/non
clinical


Ph I


III
clinicals


Post
-
approval
studies


Regulatory/
other

Source: PhRMA,

Note: Pre/non
-
clinical category includes process development, QC and formulation related expenditures.

32.5%

31.9%

27.3%

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$0.0
$10.0
$20.0
$30.0
$40.0
$50.0
1999
2000
2001
2002
2003
2004
2005
2006
2007
Pre/non clinical:

$12.0b

$11.8b

$10.7b

$10.1b

$10.5b

$11.7b

$11.2b

$11.5b

Note: Pre/non
-
clinical category includes process development, QC and formulation related expenditures. Figures in 2006 dollars.

Source: PhRMA

$27.2b

$30.2b

$33.6b

$39.1b

$40.8b

$43.0b

$34.4b

$36.1b

Total R&D expenditures ($B)

CAGR

7.0%

0.8%

Pharma R&D Expenditures

Growth Rate 1999
-

2007

Pre/non clinical R&D

Clinical/regulatory R&D

$46.7b

$12.8b

Pharmaceutical Innovation

Relative New Therapeutic Contributions (1997


2006)

0.0%
20.0%
40.0%
60.0%
80.0%
100.0%
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
Percent of annual new drug approval

21

39

49

40

43

38

33

31

41

45

Bio/Specialty Pharma:

Large Pharma:

66.7%

33.3%

74.4%

25.6%

40.8%

59.2%

42.5%

57.5%

51.2%

48.8%

57.9%

42.1%

39.4%

60.6%

48.4%

51.6%

70.7%

29.3%

84.4%

15.6%

Source: PhRMA, BIO

Large Pharma

Bio/specialty pharma

20

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Pharmaceutical Innovation

Strategic Implications

Big pharma’s R&D strategy of “buy vs. make” appears misguided.


Data suggests that sustainable competitive advantage and value creation
resides in product innovation.



-

discovery & early
-
stage development a defining core competence



-

economics rewards the originator of innovation


Ability to create defensible barriers based on downstream competencies
likely transient.



-


information technology has eliminated information asymmetries



-

fundamental shift in economics


Disaggregation of value chain in the pharma industry likely of limited
strategic value.




outsource discovery/develop/mfg; focus on regulatory/sales & mktg



-

contrasts with experience in other industries



-

alternate strategies to focus resources likely more productive (disease focus)

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Significant uncertainty remains regarding the value pharmaceutical
companies will ultimately derive from product
-
driven acquisitions.


Product portfolios of targets often quite limited.



-

acquired drug candidates often still face regulatory & market risk.


Duplication of downstream competencies.



-

acquiror capabilities likely deeper



-

incremental value to acquiror limited


Cultural integration issues often present daunting barrier.



-

much of the value resides in human capital


May provide short
-
term top
-
line benefit.



-

accelerate revenue growth

Pharmaceutical M&A Activity

Large Biotech Acquisitions: Implications

For biopharma companies with approved products, it remains a
seller’s market.

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Pharmaceutical M&A Activity

Acquisition Profile (2005


2008)

0.0%
20.0%
40.0%
60.0%
80.0%
100.0%
No. of Big Pharma Acquisitions
Source: Johnston Blakely & Co research

Note: includes acquisition by U.S. big pharma co’s only

43 transactions

Percent of total transaction volume


Product
-
oriented acquisitions

-
late
-
stage clinicals

-
marketed products


Technology
-
oriented acquisitions

-
early clinical development

-
preclinical stage

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Pharmaceutical M&A Activity

“Embedded Option” Acquisitions


Deal structures implicitly or explicitly capturing inherent
option value


-

options deals proliferating


-

Novartis investment in Proteon Therapeutics’ $38 mm Series B providing

Novartis exclusive option to acquire company.



Condition of capital markets driving this strategy.



Venture investors often required to accept it.

Current trends suggest that the pharma industry will increase its
focus on lower cost bets


but pursue many more of them.

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Pharmaceutical Industry Dynamics

Summary Conclusions


Interest in early
-
stage technology
-
oriented companies primarily resides
with large pharma.


-
significant shift in public market interest towards much more mature
companies



Over the past few years, private company M&A exits have yielded higher
returns than IPOs.


-
emerging as a critical influence behind new company formation



Large pharma offering significant premiums for select smaller biopharma
companies.


-
Memory Pharma acquisition by Roche (307% premium)

-
Genelabs acquisition by GSK (465% premium)



Consolidation pressures likely to drive significant uptick in merger activity
within the sector.

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Strategic Implications

Biotechnology 2009

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Biotechnology 2009

Strategic Implications


Financial Resources

Significant

Limited

Technology Position

Significant

Limited





Depth of financial resources is rapidly emerging as the defining
strategic variable today.

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Financial Resources

Significant

Limited

Technology Position

Significant

Limited


Net acquiror


Selective acquisitions


Strengthen current
franchise


Net acquiror


Reposition franchise


Continued sustainability


Merger to enable resource
consolidation


Proactive strategy to sell



Salvage value


Current environment requires implementation of actions to avoid
slipping into lower right quadrant.

Biotechnology 2009

Strategic Implications


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Financial Resources

Significant

Limited

Technology Position

Significant

Limited


Net acquiror


Selective acquisitions


Strengthen current
franchise


Net acquiror


Reposition franchise


Continued sustainability


Merger to enable resource
consolidation


Proactive strategy to sell



Salvage value


Majority of Companies

Majority of companies have a very limited time window…

Meta Stable/Short half life

Biotechnology 2009

Strategic Implications


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2009 All Rights Reserved

Johnston Blakely
& Company
Johnston Blakely
& Company
Johnston Blakely
& Company
Johnston Blakely
& Company
Johnston Blakely
& Company, LLC
Johnston Blakely
& Company
Johnston Blakely
& Company
Johnston Blakely
& Company
Johnston Blakely
& Company
Johnston Blakely
& Company, LLC
Johnston Blakely
& Company
Johnston Blakely
& Company
Johnston Blakely
& Company
Johnston Blakely
& Company
Johnston Blakely
& Company, LLC
Johnston Blakely
& Company
Johnston Blakely
& Company
Johnston Blakely
& Company
Johnston Blakely
& Company
Johnston Blakely
& Company, LLC
Biotechnology 2009


The Current State of the Industry and its Implications

Benjamin Conway

978
-
526
-
4014

ben@johnstonblakely.com

MBC Finance Committee Presentation