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EY Beyond Borders 2015
EY Beyond Borders 2015
EY Beyond Borders 2015
Beyond borders
Reaching new heights
Section heading
To our clients
and friends
These are very good times for the biotechnology industry. For the
second straight year, biotech companies have delivered strong, and
sometimes unprecedented, results on almost every metric we track
revenues, profitability, financings, new drug approvals and more.
Across the biotechnology industry, these achievements have been
accompanied by optimism that the sector has entered a renewed age
of innovation, buoyed by both high-profile product breakthroughs and
scientific advancements.
Investors have not simply recognized these efforts. They have rewarded them. Market
valuations for biotechs reached new heights in both the US and Europe in 2014, and
the window for initial public offerings remained open for eight consecutive quarters, a
new record. As a result of the booming stock market, historic amounts of innovation
capital are available to the smaller players in the industry, which remain the wellspring
of future breakthroughs.
In this, our 29th annual Beyond borders report, Reaching new heights, we celebrate the
biotechnology industrys recent achievements. In doing so, we take stock of not just
where we have been, but the implications for the future.
We firmly believe the biotechnology industry cannot afford to become complacent.
In particular, the industry must continue to work with patients, payers, providers and
governments around the globe to devise not just new products for unmet medical
needs, but beyond the pill solutions that improve care delivery and health outcomes.
Moreover, the industry has a vital role to play in helping devise new payment and
financing schemes that enable access to the breakthrough innovations of the future.
At EY, we arent becoming complacent either. Long-time
readers will notice a change in the format of this years
report. Recognizing that time is a precious commodity,
we are moving away from issuing large, annual reports
to the more frequent publication of insights via a new
digital platform. Thus, we are unbundling in-depth
perspective pieces from our industry trend data to
enable readers to access our content when it is most
needed: in real time. You can join the conversation and
keep up to date with our latest perspectives at our new
digital home, Vital Signs (ey.com/VitalSigns), and our
Twitter feed (@EY_LifeSciences).
As biotechnology companies strive to solve harder
problems, EYs global organization stands ready to
help you reach even higher heights.
2
Glen T. Giovannetti
Global Life
Sciences Leader
Section heading
Contents
4
10
12
14
Financial performance
15
20
United States
28
Europe
31
Australia
32
Canada
33
Financing
34
39
United States
47
Europe
54
Deals
55
63
United States
65
Europe
68
Appendix
69
Acknowledgments
70
72
Contacts
Beyond borders Biotechnology Industry Report 2015
This was a year for the record books. On almost every measure we track revenues, profitability, capital
raised and more the industry reached new heights in 2014, spurred by a confluence of positive trends.
Sustained sales of high-profile products continued to boost investor sentiment. Examples include Biogens
Tecfidera and Gilead Sciences hepatitis C medicines, Sovaldi and Harvoni, which quickly became two of the
most successful product launches in the industrys history.
Financial performance
The news-making product successes
of 2014 had an outsized impact on the
industrys financial results. In particular,
the rapid ramp-up of Gilead Sciences
hepatitis C products significantly boosted
the revenues and net income of the sector.
Financial performance was also affected
by the large number of initial public
offerings (IPOs), which increased revenues
and R&D while lowering net income.
Across the four established biotech
clusters that we track the US, Europe,
Australia and Canada revenues
grew 24% in 2014. Adjusting for the
Gilead effect, revenue growth would
have been 12%, still ahead of the 10%
delivered in 2013.
Total
US
Europe
Australia
Canada
$93,050
$23,992
$5,794
$260
R&D expense
$35,387
$28,831
$5,576
$681
$299
$14,852
$10,618
$3,255
$1,066
($87)
$1,063,415
$853,862
$162,149
$42,177
$5,227
183,610
110,090
58,770
13,370
1,380
714
403
196
52
63
Revenues
Market capitalization
Number of employees
Number of public companies
60
50
Number of approvals
40
30
20
10
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
US product approvals are based only on approvals by FDAs Center for Drug Evaluation and Research (CDER).
Source: EY and FDA.
2009
2010
2011
2012
2013
2014
25
Number of companies
20
15
10
2007
2008
2009
2010
2011
2012
2013
2014
Financing
The biotech bull market drove an
extraordinary surge in IPOs and follow-on
financings. Capital raised via US and
European IPOs rose a remarkable 93% to
US$6.8 billion in 2014. This annual total
was the second-highest in the industrys
history, second only to the US$7.8 billion
raised during the genomics bubble of 2000.
While the IPO class of 2014 may have
netted less capital, the companies that
listed during the most recent window
were more mature than those that
debuted in 2000. Eighty-one percent of
the members of the 2013-14 class had
lead candidates in Phase II or later, and
the majority retained the rights to their
products. Meanwhile, capital raised in
follow-on offerings increased by 49% to
US$13.8 billion, setting a new record.
Deals
This was a standout year for M&A and
alliances involving biotech companies,
as several trends made this a sellers
market. Booming stock market valuations
gave biotech companies more financing
options and, therefore, more power at the
negotiating table. This bargaining power
was further boosted by the fact that big
pharma companies have been eager
to acquire commercial-stage biotech
companies to address revenue shortfalls
that have arisen due to pricing pressures,
slower growth in emerging markets and
R&D challenges. In addition, big pharma
companies face more competition for the
best assets from specialty pharma firms
and big biotechs.
M&A activity reached a 10-year high
in both deal number and value (after
normalizing the numbers to exclude
megadeals, which we define as
transactions valued at US$5 billion or
more). There were 68 biotechnology M&A
deals with a total value of US$49 billion,
a 46% increase over 2013. Adjusting for
megadeals, pharma companies spent
more on biotech acquisitions than at any
time in the previous seven years.
In a sign of the
increased bargaining
power of biotech
companies, acquirers
paid significantly
higher deal premiums.
Reasons to celebrate
The biotechnology industrys strong
performance in 2014 across so many
different metrics is a reason to celebrate.
Inevitably, there will be declines in some of
the measures we track as we cycle out of
the current boom period. Having reached
new heights, however, it is worth taking a
moment to reflect on just how much the
industry has matured. Indeed, the view
from the top is pretty good.
External perspective
Katrine Bosley
Everyone has some idea of what biopharma CEOs do, based on what you can see as a team member within a
company or as someone watching the industry from outside. In general, though, I find that these views usually
see only part of the picture.
I didnt fully appreciate this until I first
stepped into the CEO role. For every
visible part of that role, theres a lot that
happens behind the scenes. It takes a
while to figure out where to focus your
time as a CEO, and there are areas that
require much more time and energy
than I had anticipated. Three of these
areas are the board of directors, external
engagement and capital strategy.
I found that biotech CEOs can lean on
three different groups for advice and
perspective: their senior management
team, their board of directors and their
fellow CEOs. With my internal team,
we discuss everything from the vision,
strategy and values to organizational
development, day-to-day management
and operational issues that are central to
building a biotech.
I tap my CEO posse for advice and
real-time, been-there-done-that
perspectives. In many cases, these CEOs
are shepherding companies that are two
to three years ahead of mine in terms of
their evolution. That means I get both
critical outsider views from this group and
10
Board matters
The board, in my mind, is first and
foremost a resource. Like my peers, my
board also provides an invaluable external
perspective because the other directors
have diverse experiences, and they have a
bit of distance from the day-to-day details
of the company. Intuitively, I expected
my board would help me make important
industry connections and supply me with
hands-on knowledge on all the companys
strategic issues. What I didnt fully grasp
initially was what an important role they
would play in pressure-testing my point of
view and how vital that would be to finding
the right balance between charging ahead
toward a goal and changing course.
I spend about 20% of my time preparing for
or meeting with my board members, both
formally and informally. That sounds like
a lot of time. Still, given the complexity of
building a biotech company, theres never
enough time to address each and every
External engagement
I also spend a lot of time focused
externally, whether its a media interview
or at conferences or interacting with
current or potential investors or recruiting.
There are many different stakeholders
youre always communicating with
and listening to: patients, scientists,
physicians, regulators, employees,
investors They all pay attention, and all
are crucial to building a company.
While the actual time spent in external
encounters may be short, the preparation
time beforehand is considerable. CEOs
need to plan out and practice how they
want to communicate on a broad range
of issues, from strategic to financial to
scientific. To tell the story effectively,
Capital strategy
Of course, I spend a lot of time on
fundraising. As the CEO of a biotech
start-up, Im always planning two or three
financing steps ahead, identifying how
to tap diverse pools of capital for my
companys needs.
I find it helpful to think in a multi-year
time frame to plan and to set goals. A
big piece of that planning relates to the
financial strategy. Even if the CEO thinks
two or three steps ahead, the reality
he or she responds to will be different
from the plan. By thinking through
multiple scenarios over several years,
the CEO has a better grasp of how much
capital will be required to reach the next
value-creating milestone.
Often a CEO has to decide whether its
better to raise more money now or later.
In flush times, raising money is tempting
11
External perspective
Jrn Aldag
CEO, uniQure
Last year, approximately 12 European companies listed on the NASDAQ, while 19 biotechs listed on European
exchanges. That near parity suggests European companies now have broader access to the capital markets and
are not limited to listing on their in-country exchanges.
This is welcome news. But it also means
European biotechs have an important
strategic decision to make: should they
pursue a US listing or are there more
advantages to listing on an exchange
closer to home?
As both a board member and a CEO, I
have faced this choice. Regardless of
which option a European biotech company
chooses, it must thoroughly prepare for
the event. In the past, some European
biotechs have underestimated their IPO
readiness and the scrutiny that comes
with being a public company.
I believe it is possible for a European
biotech to list in Europe and assemble
a strong and loyal investor base that
provides the liquidity necessary for future
growth. Let me give you an example.
I am a board member of Molecular
Partners, a Zurich-based biotech that
listed on the Swiss SIX exchange in
December 2014. We were fortunate to
have good-quality, long-term investors
who want to be associated with Molecular
Partners and dig deep into its story. Our
listing was facilitated by what I call a local
12
Forging ties
To build awareness for uniQure, I spent
seven weeks telling, and refining, our
story to US investors as part of the preIPO road show. In the process, we were
able to take advantage of how interwoven
the biotech and financial industries are in
the US as compared to Europe.
In the US, successful IPOs follow a
well-established path. As ideas emerge
from academia, companies are founded
13
Section heading
Financial
performance
Financial
performance
14
Financial performance
2014
2013
% change
24%
123.1
99.0
R&D expense
35.4
29.4
20%
Net income
14.9
4.5
231%
Market capitalization
1,063.4
794.8
34%
Number of employees
183,610
168,010
9%
714
619
15%
Number of companies
Public companies
Numbers may appear inconsistent because of rounding.
Source: EY, Capital IQ and company financial statement data.
15
Financial performance
Europe
Canada
2014
2013
2014
2013
2014
2013
27%
26%
34%
32%
22%
24%
35 years of cash
12%
15%
11%
8%
8%
7%
23 years of cash
17%
12%
13%
10%
7%
5%
12 years of cash
22%
24%
16%
15%
25%
5%
21%
23%
25%
36%
38%
59%
Chart shows percentage of biotech companies with each level of cash. Numbers may appear inconsistent because of rounding.
Source: EY, Capital IQ and company financial statement data.
16
Financial performance
Revenues generated by US and European biotechnology commercial leaders fuel investor sentiment
US commercial leaders
EU commercial leaders
140
30
120
Revenues (US$b)
100
20
80
15
60
10
40
5
20
25
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
17
Financial performance
A maturing industry
Company
Gilead Sciences
Market cap at
end of 2014
Market cap at
end of 2009
US$ change
CAGR
(200914)
$142,207
$38,940
$103,267
30%
Biogen
$80,163
$15,472
$64,691
39%
Amgen
$121,167
$57,257
$63,910
16%
Celgene
$89,343
$25,591
$63,752
28%
Regeneron Pharmaceuticals
$41,471
$1,946
$39,525
84%
Alexion Pharmaceuticals
$36,689
$4,324
$32,365
53%
Illumina
$26,210
$3,838
$22,373
47%
Vertex Pharmaceuticals
$28,574
$8,244
$20,330
28%
BioMarin Pharmaceutical
$13,331
$1,895
$11,436
48%
Incyte Corporation
$12,351
$1,080
$11,271
63%
CAGR: compound annual growth rate. Numbers may appear inconsistent due to rounding.
Source: EY and Capital IQ.
Company
Shire
Jazz Pharmaceuticals
Alkermes
Market cap at
end of 2014
Market cap at
end of 2009
US$ change
CAGR
(200914)
$41,681
$10,581
$31,099
32%
$9,904
$244
$9,660
110%
$8,563
$892
$7,672
57%
Novozymes
$13,014
$6,448
$6,565
15%
Actelion
$12,915
$6,367
$6,549
15%
BTG
$4,720
$721
$3,999
46%
Eurofins Scientific
$3,876
$777
$3,099
38%
Genmab
$3,336
$709
$2,627
36%
Meda
$5,255
$2,726
$2,529
14%
$2,704
$196
$2,508
69%
CAGR: compound annual growth rate. Numbers may appear inconsistent due to rounding.
Source: EY and Capital IQ.
18
Financial performance
19
Financial performance
Financial performance
United States
2014
2013
% change
Revenues
93.1
72.1
R&D expense
28.8
23.6
22%
Net income
10.6
2.7
293%
Market capitalization
Number of employees
853.9
636.5
34%
110,090
99,850
10%
Financing
37.8
20.0
89%
Number of IPOs
63
41
54%
7.3
5.7
28%
17%
Number of companies
403
345
Private companies
Public companies
2,116
2,010
5%
2,519
2,355
7%
20
Financial performance
Lead
product status
Therapeutic
area
Alnylam Pharmaceuticals
$7,462
Phase III
Multiple
Puma Biotechnology
$5,706
Phase III
Cancer
Juno Therapeutics*
$4,722
Phase I/II
Cancer
Agios Pharmaceuticals*
$4,104
Phase II
Cancer
Receptos*
$3,793
Phase III
Multiple
Intercept Pharmaceuticals
$3,332
Phase III
Hepatic
Acadia Pharmaceuticals
$3,168
Phase III
Multiple
bluebird bio*
$2,876
Phase III
Genetic
Kite Pharma*
$2,413
Phase II
Cancer
Clovis Oncology
$1,904
Phase III
Cancer
FibroGen*
$1,582
Phase III
Multiple
Neurocine Biosciences
$1,698
Registration
Multiple
Ophthotech*
$1,510
Phase III
Ophthalmic
Chimerix*
$1,468
Phase III
Infection
Auspex Pharmaceuticals*
$1,448
Phase III
Neurology
Ultragenyx Pharmaceutical*
$1,400
Phase III
Multiple
Radius Health*
$1,281
Phase III
Musculoskeletal
Acceleron Pharma*
$1,257
Phase II/III
Cancer
Achillion Pharmaceuticals
$1,228
Phase II
Infection
Karyopharm Therapeutics*
$1,224
Phase II
Cancer
TetraPhase Pharmaceuticals*
$1,217
Phase III
Infection
Avalanche Biotechnologies*
$1,213
Phase II
Ophthalmic
Merrimack Pharmaceuticals
$1,196
Phase III
Cancer
NewLink Genetics
$1,111
Phase III
Cancer
OvaScience
$1,052
Development
Womens Health
Sangamo BioSciences
$1,040
Phase II
Multiple
21
Financial performance
22
Financial performance
2011
2012
2013
2014
Alexion
Alexion
Alexion
Alexion
Alexion
Amgen
Amgen
Amgen
Amgen
Amgen
Amylin
Amylin
Acquired by BMS
Biogen
Biogen
Biogen
Biogen
Biogen
Biomarin Pharmaceutical
Biomarin Pharmaceutical
Biomarin Pharmaceutical
Bio-Rad Laboratories
Bio-Rad Laboratories
Bio-Rad Laboratories
Bio-Rad Laboratories
Celgene
Celgene
Celgene
Celgene
Celgene
Cephalon
Acquired by Teva
Cubist
Cubist*
Organic growth
Bio-Rad Laboratories
Cubist
Cubist
Cubist
Gen-Probe
Gen-Probe
Acquired by Hologic
Genzyme
Acquired by Sanofi
Gilead Sciences
Gilead Sciences
Gilead Sciences
Gilead Sciences
Gilead Sciences
IDEXX Laboratories
IDEXX Laboratories
IDEXX Laboratories
IDEXX Laboratories
IDEXX Laboratories
Illumina
Illumina
Illumina
Illumina
Illumina
Organic growth
Life Technologies
Life Technologies
Life Technologies
Life Technologies
Organic growth
Organic growth
Myriad Genetics
Organic growth
Organic growth
Organic growth
Salix Pharmaceuticals
Talecris Biotherapeutics
Acquired by Grifols
United Therapeutics
United Therapeutics
Organic growth
Incyte Corporation
Acquired by Thermo Fisher
Scientific
Medivation
Myriad Genetics
Pharmacyclics
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Salix Pharmaceuticals
Salix Pharmaceuticals
Salix Pharmaceuticals
United Therapeutics
United Therapeutics
United Therapeutics
Vertex Pharmaceuticals
Vertex Pharmaceuticals
Organic growth
Vertex Pharmaceuticals
Vertex Pharmaceuticals
Organic growth
ViroPharma
Decline in sales
23
Financial performance
2014
2013
US$ change
% change
Commercial leaders
Revenues
19.4
31%
81.3
61.8
R&D expense
17.2
14.6
2.6
18%
23.4
12.9
10.6
82%
Market capitalization
644.5
473.3
171.2
36%
Number of employees
71,540
65,785
5,755
9%
Revenues
11.8
10.3
1.5
14%
R&D expense
11.6
9.0
2.6
29%
Other companies
(12.8)
(10.1)
(2.7)
-26%
Market capitalization
209.4
163.3
46.1
28%
38,568
34,094
4,474
13%
Number of employees
24
Investors saw
opportunities in US
biotech companies
regardless of their size.
Financial performance
Total assets
Cash and
equivalents
plus
short-term
investments
80
19%
210,781
24%
32,610
95%
6,883
34%
9,477
4,335%
53,582
41%
20,238
100%
New England
75
29%
209,554
42%
16,517
27%
6,487
24%
75
-112%
36,129
27%
13,711
34%
San Diego
44
13%
60,027
31%
2,870
-53%
1,677
11%
(918)
107%
9,057
-40%
6,040
42%
34
17%
53,320
56%
3,706
31%
1,863
52%
(913)
780%
7,322
45%
2,659
42%
New Jersey
25
9%
100,907
27%
8,971
20%
2,973
10%
1,353
25%
21,534
31%
9,745
38%
Mid-Atlantic
20
5%
16,026
19%
2,277
32%
808
9%
(8)
-91%
4,885
12%
2,111
14%
Southeast
19
6%
6,909
30%
335
26%
239
15%
(404)
17%
2,064
13%
644
29%
19
19%
134,530
45%
20,335
7%
4,965
6%
4,438
-3%
70,514
5%
28,170
41%
Pacific Northwest
16
33%
12,683
78%
537
-19%
858
62%
(852)
23%
2,061
53%
1,287
49%
Pennsylvania/Delaware Valley
12
20%
15,322
13%
899
-25%
575
15%
(520)
38%
2,448
-25%
1,059
-6%
North Carolina
13
18%
11,775
47%
1,247
31%
489
47%
(804)
397%
5,135
45%
1,377
-17%
12
0%
3,928
49%
67
-40%
193
-2%
(306)
-28%
773
-3%
631
26%
Texas
9
29%
3,352
38%
254
-2%
237
36%
(299)
177%
1,257
71%
833
137%
Colorado
7
17%
2,809
-7%
62
-11%
226
51%
(311)
69%
1,043
24%
685
45%
Utah
4
0%
2,793
39%
778
27%
85
38%
151
24%
867
1%
228
-46%
Other
14
0%
9,145
16%
1,585
38%
273
34%
458
64%
3,425
42%
1,438
59%
Total
403
17%
853,862
34%
93,050
29%
28,831
22%
10,618
293%
222,095
17%
90,857
46%
Region
Number
of public
companies
Midwest
Market
capitalization
Revenue
R&D
Net income
(loss)
Market capitalization as of 31 December 2014. Percent changes refer to change over December 2013. Numbers may appear inconsistent because of rounding.
New England: Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont; Mid-Atlantic: Maryland, Virginia, District of Columbia; Mid-West: Illinois,
Michigan, Ohio, Wisconsin; Southeast: Alabama, Florida, Georgia, Kentucky, Louisiana, Tennessee, South Carolina; Pacific Northwest: Oregon, Washington
Source: EY, Capital IQ and company financial statement data.
25
Financial performance
In both the US and Europe, biotech stocks outperformed the broader indices,
led by mid-sized biotechs in the US and large firms in Europe.
US market capitalization relative to leading indices
EY US biotech industry
+200%
Pharma industry US
2013
Russell 3000
NASDAQ Composite
2014
EY US medtech industry
2015
+150%
+100%
+50%
0%
-50%
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar
Chart includes companies that were active on 31 March 2015.
Source: EY and Capital IQ.
Large-cap (>US$10b)
Mid-cap (US$2bUS$10b)
2013
Small-cap (US$200mUS$2b)
2014
Micro-cap (<US$200m)
2015
+350%
+300%
+250%
+200%
+150%
+100%
+50%
0%
-50%
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar
Chart includes companies that were active on 31 March 2015.
Source: EY and Capital IQ.
26
Financial performance
CAC-40
DAX
FTSE 100
Pharma industry EU
2013
EY EU medtech industry
2014
2015
+100%
+50%
0%
-50%
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar
Chart includes companies that were active on 31 March 2015.
Source: EY and Capital IQ.
Large-cap (>US$10b)
Mid-cap (US$2bUS$10b)
2013
Small-cap (US$200mUS$2b)
2014
Micro-cap (<US$200m)
2015
+150%
+100%
+50%
0%
-50%
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar
Chart includes companies that were active on 31 March 2015.
Source: EY and Capital IQ.
27
Financial performance
Financial performance
Europe
2014
2013
% change
23,992
20,915
15%
5,576
4,910
14%
3,255
1,087
199%
Market capitalization
162,149
114,699
41%
Number of employees
58,770
54,440
8%
7,182
4,384
64%
31
288%
2,068
1,569
32%
Financing
Capital raised by public companies
Number of IPOs
Capital raised by private companies
Number of companies
196
164
20%
Private companies
1,940
1,987
-2%
2,136
2,151
-1%
Public companies
28
Financial performance
A brightening climate
29
Financial performance
2011
2012
2013
2014
Actelion
Actelion
Actelion
Actelion
Elan Corporation
Elan Corporation
Elan Corporation
Acquired by Perrigo
Eurofins Scientific
Eurofins Scientific
Ipsen
Ipsen
Actelion
Alkermes
Alkermes
Eurofins Scientific
Eurofins Scientific
Ipsen
Ipsen
Ipsen
Jazz Pharmaceuticals
Jazz Pharmaceuticals
Jazz Pharmaceuticals
Meda
Meda
Meda
Meda
Meda
Novozymes
Novozymes
Novozymes
Novozymes
Novozymes
QIAGEN
QIAGEN
QIAGEN
QIAGEN
QIAGEN
Shire
Shire
Shire
Shire
Shire
30
2014
2013
US$ change
% change
Commercial leaders
19,397
17,046
2,351
R&D expense
3,059
2,802
256
9%
5,016
2,278
2,738
120%
Revenues
14%
Market capitalization
111,265
77,918
33,348
43%
Number of employees
44,757
42,147
2,610
6%
Revenues
4,605
3,888
717
18%
R&D expense
2,529
2,128
401
19%
(1,750)
(1,171)
(579)
-49%
Market capitalization
50,931
36,850
14,081
38%
Number of employees
14,027
12,316
1,711
14%
Other companies
Financial performance
Financial performance
Australia
2014
2013
% change
9%
5,794
5,318
681
650
5%
1,066
957
11%
Market capitalization
42,177
38,068
11%
Number of employees
13,370
12,380
8%
52
51
2%
R&D expense
Net income
Number of companies
Public companies
Numbers may appear inconsistent because of rounding.
Source: EY, Capital IQ and company financial statement data.
31
Financial performance
Financial performance
Canada
2014
2013
% change
Revenues
260
623
R&D expense
299
310
-4%
(87)
(227)
62%
Market capitalization
5,227
5,601
-7%
Number of employees
1,380
1,340
3%
Number of companies
Public companies
63
59
7%
Private companies
172
181
-5%
235
240
-2%
32
Section
Financing
heading
Financing
33
Financing
2000
IPOs
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
7,838
548
593
484
2,068
1,692
2,091
2,262
119
840
1,325
863
880
3,526
6,802
13,415
2,233
1,763
4,904
6,857
6,604
9,286
8,889
4,098
9,226
5,955
5,869
7,616
9,310
13,838
Debt
1,529
1,907
4,472
7,296
6,349
6,030
9,662
10,575
5,776
5,614
12,079
20,587
14,040
12,831
26,049
Venture
4,121
3,694
3,504
4,073
5,277
5,495
6,044
7,930
5,987
5,809
5,805
5,678
5,518
5,948
7,630
26,903
8,382
10,332
16,757
20,551
19,821
27,083
29,657
15,980
21,491
25,163
32,998
28,055
31,614
54,319
Follow-on
and other
Total
Numbers may appear inconsistent because of rounding. Convertible debt instruments included in debt.
Source: EY, BioCentury, Canadian Biotech News, Capital IQ and VentureSource.
34
Financing
Commercial leaders
60
50
40
30
20
10
00
01
02
03
04
05
06
07
08
09
10
11
12
13
14
35
Financing
2.0
200
1.6
160
1.2
120
0.8
80
0.4
40
0.0
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
Number of deals
Capital raised
36
Financing
A rising tide
US and European venture investment in early stage private companies holds steady
Seed and first rounds
100%
80%
60%
40%
20%
0%
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
37
Financing
Below range
80%
60%
40%
20%
0%
2010
2011
2012
2013
2014
38
Within range
100%
Percentage of IPOs
Financing
Financing
United States
IPOs
Venture
50
40
30
20
10
00
01
02
03
04
05
06
07
08
09
10
11
12
13
14
US biotechnology recorded a
colossal year in 2014, setting a new
all-time record in total capital raised
(US$45.1 billion) as well as funds raised
through IPOs (US$4.9 billion) and debt
(US$23.3 billion). The amounts raised
in the two other financing categories
represented the second-highest totals
in the industrys history: venture capital
generated US$5.6 billion (second to
the US$6.1 billion raised in 2007) and
follow-on financing raised US$10.7 billion
(behind the almost US$13 billion raised
in 2000).
The sectors strong overall performance
was underpinned by successful launches
of well-differentiated products that could
39
Financing
Q2
Q3
Q4
Total
IPOs
$1,739
(23)
$1,055
(17)
$958
(13)
$1,193
(10)
$4,946
(63)
$4,651
(83)
$2,047
(47)
$1,081
(27)
$2,943
(49)
$10,722
(206)
Debt
$6,711
(31)
$9,734
(44)
$2,031
(40)
$5,325
(26)
$23,801
(141)
Venture
$1,333
(95)
$1,882
(115)
$1,059
(103)
$1,325
(70)
$5,600
(383)
$14,434
(232)
$14,719
(223)
$5,130
(183)
$10,786
(155)
$45,069
(793)
Total
Figures in parentheses are number of financings. Numbers may appear inconsistent because of rounding.
Source: EY, BioCentury, Capital IQ and VentureSource.
50
40
Capital raised (US$b)
30
20
10
00
01
02
03
04
05
06
07
08
09
10
40
11
12
13
14
Financing
Midwest
New England
New Jersey
Pacific Northwest
San Diego
0
0
200
400
600
800
1,000
1,200
1,400
1,600
1,800
41
Financing
US biopharmaceutical venture capital rebounds to its highest levels since the financial crisis
Total amount raised
18
15
12
4
9
3
6
1
0
2000
2001
2002
2003
2004
2005
2006
42
2007
2008
2009
2010
2011
2012
2013
2014
Financing
Month
Company
Region
Therapeutic focus
Intarcia Therapeutics
New England
Phase III
Metabolic/endocrinology
200
March
Juno Therapeutics
Pacific Northwest
Phase I
Oncology
134
August
Invitae
Multiple
120
October
Adaptive Biotechnologies
Pacific Northwest
Multiple
105
April
Paratek Pharmaceuticals
New England
Phase III
Infection
93
June
Naurex
Midwest
Phase II
Neurology
80
May
Spark Therapeutics
Pennsylvania/Delaware Valley
Phase III
Multiple
73
May
Human Longevity
San Diego
Multiple
70
March
Melinta Therapeutics
New England
Phase III
Infection
70
February
C3 Jian
Phase II
Dental
61
March
Viamet Pharmaceuticals
North Carolina
Phase II
Infection
60
October
Precision Therapeutics
Midwest
Multiple
60
November
Kolltan Pharmaceuticals
New England
Phase I
Oncology
60
March
ProNAi Therapeutics
Midwest
Phase II
Oncology
60
April
Juno Therapeutics*
Pacific Northwest
Phase I
Oncology
56
April
* In April 2014, Juno Therapeutics added US$56 million to its 2013 Series A round.
Source: EY, BioCentury, Capital IQ and VentureSource.
43
Financing
Number of deals
70
60
50
40
30
Number of deals
20
1
10
0
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
44
Financing
2.0
25
1.6
20
1.2
15
0.8
10
0.4
0.0
Q1
Q2
Q3
Q4
Q1
Q2
2012
Q3
Q4
Q1
2013
Q2
Q3
Q4
Number of deals
Number of deals
Capital raised
2014
Q4
2014
60%
54%
Q3
46%
38%
Q2
63%
73%
Q1
27%
50%
Q4
2013
50%
85%
Q3
15%
58%
Q2
42%
33%
Q1
0%
10%
20%
67%
30%
40%
50%
60%
70%
80%
90%
100%
45
Financing
IPO pricing
range
Post-IPO
performance (as of
31 December 2014)
Company
Region
Lead product
clinical stage
Therapeutic focus
Juno Therapeutics
Pacific Northwest
Phase II
Oncology
305
Above
118%
FibroGen
Phase III
Multiple
168
Within
52%
Acucela
Pacific Northwest
Phase III
Ophthalmic
163
Within
-67%
Bellicum Pharmaceuticals
Texas
Phase II
Oncology
161
Above
21%
Kite Pharma
Phase II
Oncology
147
Above
239%
Versartis
Phase II
Metabolic/endocrinology
145
Within
7%
Ultragenyx Pharmaceutical
Phase II
Multiple
139
Above
109%
Dermira
Phase II
Dermatology
125
Within
13%
ZS Pharma
Texas
Phase III
Multiple
123
Above
131%
Avalanche Biotechnologies
Phase II
Ophthalmic
117
Within
218%
Akebia Therapeutics
Midwest
Phase II
Hematology/renal
115
Within
-32%
Otonomy
San Diego
Phase III
115
Within
108%
Revance Therapeutics
Phase III
Aesthetics
110
Within
6%
Zafgen
New England
Phase II
Metabolic/endocrinology
110
Within
93%
Tokai Pharmaceuticals
New England
Phase II
Oncology
105
Within
-2%
Dicerna Pharmaceuticals
New England
Phase I
Oncology
103
Above
10%
Sage Therapeutics
New England
Phase II
Neurology
103
Within
103%
Auspex Pharmaceuticals
San Diego
Phase III
Neurology
97
Within
337%
Concert Pharmaceuticals
New England
Phase II
Multiple
93
Within
-5%
Coherus Biosciences
Phase III
Multiple
92
Within
21%
46
Financing
Financing
Europe
IPOs
Venture
10
00
01
02
03
04
05
06
07
08
09
10
11
12
13
14
47
Financing
Commercial leaders
10
00
01
02
03
04
05
07
08
09
10
11
12
13
14
Q1
Q2
Q3
Q4
Total
$719
(9)
$214
(6)
$519
(10)
$405
(6)
$1,856
(31)
$1,349
(46)
$728
(23)
$170
(17)
$869
(27)
$3,116
(113)
Debt
$1,331
(6)
$80
(6)
$755
(14)
$82
(9)
$2,248
(35)
$314
(40)
$633
(56)
$487
(41)
$596
(46)
$2,030
(183)
$3,713
(101)
$1,654
(91)
$1,931
(82)
$1,952
(88)
$9,250
(362)
IPOs
Venture
Total
Figures in parentheses are number of financings. Numbers may appear inconsistent because of rounding.
Source: EY, BioCentury, Capital IQ and VentureSource.
48
06
Financing
Denmark
France
Germany
Israel
Netherlands
Switzerland
UK
2.5
2.0
1.5
1.0
0.5
0.0
0
100
200
300
400
500
600
700
2.5
12
8
1.5
6
1.0
2
0.5
0.0
10
2.0
0
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
49
Financing
Country
Status
Adaptimmune
UK
Oncology
Phase I
Amount
(US$m)
104
Month
September
Adapt Pharma
Ireland
Substance abuse
95
May
Biocartis
Switzerland
Non-disease-specific
Molecular diagnostics
86
September
Cell Medica
UK
Infection
Phase III
82
November
Glycotope
Germany
Womens health
Phase III
73
March
NovImmune
Switzerland
Autoimmune
Phase II
66
February
Ascendis Pharma
Denmark
Metabolic/endocrinology
Phase II
60
December
Cardiorentis
Switzerland
Cardiovascular
Phase III
60
September
Nucana BioMed
UK
Oncology
Preclinical
57
April
ProQR Therapeutics
Netherlands
Respiratory
56
April
Enigma Diagnostics
UK
Respiratory
Molecular diagnostics
50
October
Wilson Therapeutics
Sweden
Metabolic/endocrinology
Phase II
40
April
Kymab
UK
Autoimmune
Preclinical
40
May
Nordic Nanovector
Norway
Oncology
Phase I
40
June
Anokion
Switzerland
Autoimmune
Preclinical
36
May
50
Financing
3.5
35
3.0
30
2.5
25
2.0
20
1.5
15
1.0
10
0.5
0.0
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
Number of deals
Capital raised
51
Financing
Country
Lead product
clinical stage
Therapeutic focus
Gross
raised
(US$m)
IPO pricing
range
Post-IPO
performance (as of
31 December 2014)
Circassia Pharmaceuticals
UK
Phase III
Autoimmune
333
Within
-15%
Forward Pharma
Denmark
Phase II
Autoimmune
235
Within
-1%
Molecular Partners
Switzerland
Phase II
Multiple
116
Below
3%
ProQR Therapeutics
Netherlands
Preclinical
Respiratory
112
Within
67%
uniQure
Netherlands
Marketed
Multiple
92
Above
-13%
MediWound
Israel
Marketed
Dermatology
80
Within
-52%
UK
NA
66
NA
Auris Medical
Switzerland
Phase III
61
Below
-35%
Egalet
Denmark
Phase III
Neurology
58
Within
-53%
-34%
6%
Innocoll
Ireland
Marketed
Multiple
58
Below
Affimed Therapeutics
Germany
Phase II
Oncology
56
Below
-11%
arGEN-X
Netherlands
Phase I
Multiple
55
Within
-18%
Fermentalg
France
NA
Industrial
54
Within
-36%
Genticel
France
Phase I
Infection
53
Within
-35%
MacroCure
Israel
Phase III
Dermatology
53
Below
-27%
GalMed Pharmaceuticals
Israel
Phase II
Metabolic/endocrinology
44
Within
-57%
VBL Therapeutics
Israel
Phase II
Multiple
40
Below
-1%
Abzena
UK
NA
37
NA
-5%
Israel
Phase III
Genetic
35
Within
-42%
Genomic Vision
France
NA
Molecular diagnostics
34
Within
-31%
52
Financing
Parameters
360
Share price relative to offer price
Number of
companies
320
280
240
200
160
US
biotech
Europe
biotech
62
12
Highest
386%
67%
75 percentile
100%
-9%
11%
-31%
25 percentile
-10%
-45%
Lowest
-75%
-57%
Median
120
80
40
0
-40
-80
US companies (62)
Share price relative to offer price was calculated as of 31 December 2014. Median data are shown in yellow bars.
Source: EY, Capital IQ and finance.yahoo.com.
53
Deals
Financing | Financing the future
Deals
54
Deals
Changing dynamics
Pharma returns to
M&A dealmaking
A look at the numbers shows pharma
buyers were primarily responsible for the
years heightened deal activity. As we have
written in the last several issues of Beyond
borders, the pharma subsector continues
to face a number of headwinds, including
pricing pressures, R&D productivity
challenges and a slowdown in high-growth
emerging markets. These challenges have
resulted in the groups subpar revenue
relative to the industry overall. In 2014,
the need to accelerate growth helped
explain pharmas renewed emphasis on
dealmaking, despite the fact that target
valuations have reached record highs.
Indeed, M&A activity between pharmas and
either US or European biotechs reached a
level in 2014 not seen since 2009, when
Roche bought out the remaining shares
of Genentech that it didnt already own.
Excluding megadeals, pharmas spent more
in 2014 to acquire biotechs than they
had annually in the previous nine years.
Deal numbers also rebounded: pharmas
acquired 27 biotechs in 2014, the highest
deal volume since 2008.
55
Deals
70
70
60
60
50
50
40
40
30
30
20
20
10
10
2007
2008
2009
2010
2011
2012
2013
2014
Number of deals
Pharma-biotech
Chart excludes transactions where deal terms were not publicly disclosed.
Source: EY, BioCentury, Capital IQ and VentureSource.
Biotech buyers?
Biotech buyers, meantime, signed 41
transactions in 2014, making them a
presence at the deal table. However, in
terms of the number of deals, that is the
second-lowest volume of biotech-biotech
transactions since 2007. (The lowest was in
2013, when there were 33 deals.)
Biotech-biotech deal values also retreated,
with the total dollars spent in 2014
dipping 51% year over year to one of the
lowest levels in the past decade. Smaller
biotechs, as opposed to the commercial
leaders, accounted for most of the years
56
Deals
Specialty pharma
Big biotech
100%
80%
60%
40%
20%
0%
2007
2008
2009
2010
2011
2012
2013
2014
Data analyzed through 14 December 2014. Total firepower refers to the combined firepower of big pharma,
specialty pharma and big biotech.
Source: EY and Capital IQ.
57
Deals
50
200
40
160
30
120
20
80
10
40
2007
2008
2009
2010
2011
2012
2013
2014
Chart shows potential value, including up-front and milestone payments, for
alliances where deal terms are publicly disclosed.
Source: EY, Medtrack and company news.
Biotech-biotech
Up-fronts/biobucks
14%
12%
10%
8%
3
6%
2
4%
2%
2007
2008
2009
58
Number of deals
Number of deals
Biotech-biotech
2010
2011
2012
2013
2014
0%
Pharma-biotech
Capturing more
value up front
Deals
Notable biotech
transactions
40%
30%
20%
10%
0%
2009
2010
2011
2012
2013
2014
Chart excludes transactions where bid premium was not publicly disclosed.
Chart includes biotech deals only.
Source: EY, Medtrack and company news.
59
Deals
Country
Acquired company
Country
Total potential
value (US$m)
CVRs/milestones
(US$m)
US
Cubist Pharmaceuticals
US
9,500
Roche
Switzerland
InterMune
US
8,300
US
Idenix Pharmaceuticals
US
3,850
Otsuka Pharmaceutical
Japan
Avanir Pharmaceuticals
US
3,500
Meda
Sweden
Rottapharm
Italy
3,093
Forest Laboratories
US
Aptalis Pharma
Canada
2,900
Endo International
Ireland
Auxilium Pharmaceuticals
US
2,600
US
Alios BioPharma
US
1,750
Roche/Genentech
US
Seragon Pharmaceuticals
US
1,725
1,000
Baxter International
US
Chatham Therapeutics
US
1,410
1,340
Mallinckrodt
US
Cadence Pharmaceuticals
US
1,400
AMAG Pharmaceuticals
US
Lumara Health
US
1,025
350
Baxter International
US
AesRx
US
843
828
BioMarin Pharmaceutical
US
Prosensa
Netherlands
840
160
Teva Pharmaceuticals
Israel
Labrys Biologics
US
825
625
Bristol-Myers Squibb
US
iPierian
US
725
550
Total potential value includes up-front, milestone and other payments from publicly available sources.
Source: EY, Capital IQ, Medtrack and company news.
60
Deals
Company
Country
Partner
Country
Celgene
US
Nogra Pharma
Ireland
710
Sanofi/Genzyme
US
Alnylam Pharmaceuticals
US
700
Pfizer
US
OPKO Health
US
295
AbbVie
US
Infinity Pharmaceuticals
US
275
Celgene
US
Forma Therapeutics
US
225
Novartis
Switzerland
Ophthotech
US
200
Servier
France
Intarcia Therapeutics
US
171
Sanofi
France
MannKind
US
150
Roche/Genentech
US
NewLink Genetics
US
150
Alexion Pharmaceuticals
US
ModeRNA Therapeutics
US
125
US
MacroGenics
US
125
Daiichi Sankyo
Japan
Charleston Laboratories
US
100
Baxter International
US
Merrimack Pharmaceuticals
US
100
Celgene
US
Sutro Biopharma
US
95
Pfizer
US
Cellectis
France
80
61
Deals
Up-front
payments (US$m)
Company
Country
Partner
Country
Japan
Edison Pharmaceuticals
US
4,295
Pfizer
US
Cellectis
France
2,855
80
Celgene
US
Nogra Pharma
Ireland
2,575
710
US
Ablynx
Belgium
2,297
27
60
Takeda Pharmaceutical
Japan
MacroGenics
US
1,600
ND
Viking Therapeutics
US
Ligand Pharmaceuticals
US
1,538
ND
Bristol-Myers Squibb
US
CytomX Therapeutics
US
1,242
50
Astellas Pharma
Japan
Proteostasis Therapeutics
US
1,200
ND
Celgene
US
Sutro Biopharma
US
1,185
95
Roche
US
NewLink Genetics
US
1,150
150
Servier
France
Intarcia Therapeutics
US
1,051
171
Novartis
Switzerland
Ophthotech
US
1,030
200
Baxter International
US
Merrimack Pharmaceuticals
US
970
100
US
Geron
US
935
35
Sanofi
France
MannKind
US
925
150
Total potential value includes up-front, milestone and other payments from publicly available sources.
ND refers to deals where up-front amounts were not publicly disclosed.
Source: EY, Medtrack and company news.
Realizing value
In 2013, the story was one of promise.
A warming financing climate and
greater competition for deals created
a more positive dealmaking climate;
for smaller biotechs and their backers,
there was renewed hope that as a class,
biotechs would recognize more value
for their efforts.
In 2014, that promise became reality.
The same market forces at work in
62
Deals
Pharma-biotech
United States
Biotech-biotech
75
50
60
40
45
30
30
20
15
Number of deals
Deals
US M&As, 200714
10
2007
2008
2009
2010
2011
2012
2013
2014
Chart excludes transactions where deal terms were not publicly disclosed.
Source: EY, Capital IQ, Medtrack and company news.
63
Deals
In 2014, biotech
companies realized
more value from
their licensing
efforts than in
recent memory.
40
160
35
140
30
120
25
100
20
80
15
60
10
40
20
2007
2008
2009
2010
2011
2012
2013
2014
Biotech-biotech
Up-fronts/biobucks
4.0
12%
3.0
9%
2.0
6%
1.0
3%
0.0
2007
2008
2009
64
Number of deals
Number of deals
Biotech-biotech
2010
2011
2012
2013
2014
0%
Pharma-biotech
Deals
Europe
Biotech-biotech
Number of deals
25
30
20
24
15
18
10
12
Number of deals
Deals
2007
2008
2009
2010
2011
2012
2013
2014
Chart excludes transactions where deal terms were not publicly disclosed.
Source: EY, Capital IQ, Medtrack and company news.
65
Deals
Pharma-biotech
Biotech-biotech
Number of deals
18
75
15
60
12
45
9
30
6
15
Number of deals
2007
2008
2009
2010
2011
2012
2013
2014
66
Pharma-biotech
Biotech-biotech
Up-fronts/biobucks
1.5
15%
1.2
12%
0.9
9%
0.6
6%
0.3
3%
0.0
2007
2008
2009
2010
2011
2012
2013
2014
0%
Deals
The biotechnology
industrys strong
performance in
2014 across so
many different
metrics is a reason
to celebrate.
Indeed, the view
from the top is
pretty good.
67
Appendix
Appendix
68
Appendix
Acknowledgments
Project leadership
Data analysis
Design
PR and marketing
Editing assistance
Russell Colton brought his incomparable
skills as a copy editor and proofreader to
this publication. His patience, hard work
and attention to detail were unparalleled.
Russ was assisted by Sue Brown.
69
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