Positive Performance Continues For Biotechs, But Ex-Majors Underperform

BioForum
Edition 42
Quarter 2 FY13
February 2013
Positive performance
continues for Biotechs,
but ex-majors
underperform
www.pwc.com.au/bioforum
Highlights
H
i
g
h
l
i
g
h
t
s
2
Key developments during the quarter
Sirtex Medical was added to the S&P/ASX200 following
the removal of Integra Mining Limited. As of 31 December
2012, Sirtex had a market capitalisation of $732 million.
Mesoblast announced it would go ahead with a
1,700-patient phase III trial of Revascor, its heart failure
treatment, in 2013.
The Federal Government called for submissions on
Australian pharmaceutical patents and released its
discussion paper in November. A panel will review the
degree to which the current patents system suffciently
supports innovation while maintaining competition in
the industry.
CSL shares reached a record $54 after it forecast a
20 percent increase in net proft in 2013, largely due to the
performance of plasma protein subsidiary CSL Behring.
Q2FY13 - Key statistics
- Life Sciences index up 9.4% (Q1FY13 up 13.5%)
- Life Sciences (ex majors) index down 8.2%
(Q1FY13 up 6.7%)
- ASX All Ordinaries index up 5.9% (Q1FY13 up 6.6%)
- NASDAQ Biotech down 3.7% (Q1FY13 up 9.9%)
PwC | BioForum: February 2013
Introduction
pwc.com.au/privateclients
Manoj Santiago
PwC Private Clients
3
In the second quarter...
The Australian Life Sciences Index continued on a
positive path ending the December quarter with a 9.4
per cent gain. This was helped by the performance of
Cochlear and CSL which recorded increases of 17.8 per
cent and 17.2 per cent respectively.
The Index continued to outperform the All Ordinaries
Index, which grew 5.9 per cent, its highest level since
June 2011. Quarterly results for the Australian Life
Science Index were down on Q1 FY13 when the index
rose by 13.5 per cent.
For the frst time since Q1 FY12, the NASDAQ Biotech
Index fell. At one point during the quarter it was
down close to 8%, only to rebound after US elections
given the benefts to the Life Sciences industry
contained in President Obamas healthcare plan The
NASDAQ Composite fell 3.1 per cent, impacted by the
uncertainty of the US elections and fscal policy
Sector performance in detail
It was a lacklustre start to the quarter for the Life
Sciences Index ex majors which posted a loss of 8.2 per
cent, off the back of an 11.2 per cent fall last quarter.
The result was led by the weaker performance of non-
major Med Device companies including Unilife (-27 per
cent) and Reva Medical (- 22 per cent).
Over the past 12 months the ex-majors trails the Life
Science Index by 42.6 percent and the All Ordinaries
Index by 14 per cent.
The weak performance of ex-majors was largely caused
by Medical Devices companies, with this index down
10.8%. The Pharma/Biotech index ex CSL was down
6.9% in comparison.
IPOs and secondary raisings
There were no Australian IPOs in the second quarter
but domestic secondary fnancing is up with 34 raisings
totalling $136m. This was led by Mayne Pharma
raising $84m to fund acquisitions. In the US, there
were four IPOs this quarter, three in the Biotech sector
and one in Medical Devices, collectively totalling $232
million. There were also 74 raisings totalling $16.1bn,
a fgure massively infated by four raisings by Abbott
Laboratories subsidiary, AbbVie totalling $AU14.1bn.
Commentary
Small and midsized Life Sciences companies continue to
underperform despite a promising pipeline of products
which is a worrying sign, said Manoj Santiago, PwC Life
Sciences partner. Two quarters do not make a trend,
but as we move into the remainder of the year well see
whether this identifes itself as a persistent gap and, if so,
what the underlying causes are.
Whether or not this manifests as a long term trend, its
clear there is currently scepticism in the marketplace,
particularly focused on company boards. To alleviate
this, Life Sciences companies need to be managing
shareholder and market expectations better and
communicating realistic goals, said Mr Santiago.
Within the Life Sciences industry, we are beginning
to see an alignment of executive remuneration and
shareholder earnings which is an indicator of how
well boards can meet promises and how this is
matched to remuneration, said Mr Santiago. There
can be a temptation for companies to offer sizeable
remuneration to increase the profle of their board, but
this can only be effective to a certain extent in such an
unforgiving market.
I
n
t
r
o
d
u
c
t
i
o
n
Each quarter Bioforum reports on the
Australian and US pharmaceutical,
biotechnology and medical devices markets
and the broader life sciences industry. As well
as reviewing market performance, BioForum
covers initial and secondary capital raisings,
clinical milestones, partnerships and mergers
and acquisitions.
PwC MoneyTree Report
The report is a quarterly study of venture capital investment activity in the
United States. As a collaboration between PwC and the National Venture
Capital Association based on data from Thomson Reuters, it is the only
industry-endorsed research of its kind.
4
Key Developments
US venture capital
US venture capitalists invested $26.5 billion in 3,698 deals in 2012. This was 10 percent less than 2011 in dollar
terms and 6 percent less in deal volume, according to the latest MoneyTree report prepared by PwC and the US
National Venture Capital Association.
Biotechnology investment dollars declined 15 percent to US$4.1 billion, with volume fat at 466 deals, but the
sector was still the second largest for the year in terms of dollars and deals.
In the fourth quarter of 2012, US$1.3 billion was invested in 135 biotechnology companies. This was an
increase of 3 percent in dollars and 13 percent in the number of deals from the third quarter, when US$1.2
billion went into 119 rounds.
Investment in medical devices fell 13 percent in dollar terms and 15 percent in deals in 2012, fnishing the
year with US$2.4 billion going into 313 deals. Still, in the fourth quarter, medical devices investment was up
32 percent in dollar terms and 9 percent in deals from Q3 2012, with US$581 million going into 74 deals.
The life sciences sector (biotech and medical devices combined) accounted for 25 percent of all venture capital
dollars invested in 2012, compared to 26 percent in 2011. Much of the decline occurred in frst-time fnancings,
where both biotechnology and medical devices recorded the lowest number of deals since 1995.
0
2,000
4,000
6,000
8,000
10,000
$
U
S
D
m
Medical Devices and Equipment Biotech
4,970
3,972 3,945
4,886
4,148
3,601
2,602
2,309
2,814
2,439
2008 2009 2010 2011 2012
Biotech Medical Devices and Equipment
531
459
498
468 466
398
343
346
368
313
200
0
400
600
800
1,000
2008 2009 2010 2011 2012
N
u
m
b
e
r

o
f

d
e
a
l
s
29,921
20,381
23,315
29,463
26,525
5,000
10,000
15,000
20,000
25,000
30,000
35,000
2008 2009 2010 2011 2012
Total US VC funding
0
$
U
S
D
m
Total US VC deals
4,163
3,140
3,622
3,937
3,698
1,000
0
2,000
3,000
4,000
5,000
2008 2009 2010 2011 2012
N
u
m
b
e
r

o
f

d
e
a
l
s
Yearly Life Sciences VC Funding Dollars
Yearly Life Sciences VC Funding Volume
Yearly Total VC Funding Dollars
Yearly Total VC Funding Volume
06
Quarterly
key fndings
08
Market
performance
18
Announcements
23
Appendix
27
Methodology
29
Contacts
C
o
n
t
e
n
t
s
5
Contents
6
01
Quarterly
key fndings
Q
u
a
r
t
e
r
l
y

k
e
y

f
n
d
i
n
g
s
7
Quarterly key fndings
Market performance Q2 FY13 Page
Life sciences industry total MCap A$44,604m 9
Life sciences industry growth 9.4%
Pharma/biotech sector total MCap A$32,006m 11
Pharma/biotech sector growth 11.4%
Medical device sector total MCap A$12,598m 11
Medical device sector growth 4.6%
Individual company performance
Top individual performer Uscom Limited 16
Change in market cap over the past four quarters 199%
Bottom individual performer Bioxyne Ltd 17
Change in market cap over the past four quarters -93%
Financing
Australian IPO count 0 12
Total raised A$m
US IPO count 4 12
Total raised A$232m
Australian secondary fnancing count 34 14
Total raised A$136m
US secondary fnancing count 74 14
Total raised A$16,105m
Announcements Q4 FY13 Page
Australia
Partnerships 10 19
Mergers & acquisitions
10
20
Clinical trials
13
21
Regulatory
8
22
Other
7
22
8
02
Market
performance
ASX All Ordinaries (Index) NASDAQ Composite (Index) NASDAQ Biotech (Index) Life Sciences
(market cap A$m)
Life Sciences ex majors
(market cap A$m)
% Change (Jun-Sep) % Change (Sep-Dec)
-10.0%
-5.0%
0.0%
5.0%
10.0%
15.0%
6.6%
5.9%
6.2%
-3.1%
9.9%
-3.7%
13.5%
9.4%
6.7%
-8.2%
-60%
-40%
-20%
0%
20%
40%
60%
80%
ASX All Ordinaries NASDAQ Composite NASDAQ Biotech Life Sciences Life Sciences ex majors
31-Dec-10 31-Mar-11 30-Jun-11 30-Sep-11 31-Dec-11 31-Mar-12 30-Jun-12 30-Sep-12 31-Dec-12
Figure 1: Weekly performance over the quarter of the Australian life sciences compared to major indices
ASX All Ordinaries Life Sciences Life Sciences ex majors NASDAQ Biotech NASDAQ Composite
-10%
-5%
0%
5%
10%
15%
30-Sep 05-Oct 12-Oct 19-Oct 26-Oct 02-Nov 09-Nov 16-Nov 23-Nov 30-Nov 07-Dec 14-Dec 21-Dec 28-Dec 31-Dec
Graph 1: Quarterly movements of the Australian life sciences sector compared to major indices
M
a
r
k
e
t

p
e
r
f
o
r
m
a
n
c
e
9
Performance overview
Figure 2: Two-year comparison of the Australian life sciences sector by market capitalisation compared to major indices
Table 1: Quarterly movements of the Australian life sciences sector compared to major indices
Value
30-Jun-12 30-Sep-12 31-Dec-12
% Change
(Jun-Sep)
% Change
(Sep-Dec)
ASX All Ordinaries (Index) 4,135 4,406 4,665 6.6% 5.9%
NASDAQ Composite (Index) 2,935 3,116 3,020 6.2% -3.1%
NASDAQ Biotech (Index) 1,352 1,486 1,431 9.9% -3.7%
Life Sciences (market cap A$m) 35,934 40,786 44,604 13.5% 9.4%
Life Sciences ex majors (market cap A$m) 7,730 8,249 7,573 6.7% -8.2%
ASX All Ordinaries (Index) NASDAQ Composite (Index) NASDAQ Biotech (Index) Life Sciences (market cap A$m) Life Sciences ex majors
(market cap A$m)
-10.0%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
% Change (Sep11-Sep12) % Change (Dec11-Dec12)
8.3%
13.5%
29.0%
15.9%
53.3%
31.9%
33.6%
42.0%
6.7%
-0.6%
10
-15%
-10%
-5%
0%
5%
10%
15%
Lif e Sciences Lif e Sciences ex majors Pharma/Biotech Pharma/Biotech ex CSL Med Device Med Device ex COH, RMD
30-Sep-12 07-Oct-12 14-Oct-12 21-Oct-12 28-Oct-12 04-Nov-12 11-Nov-12 18-Nov-12 25-Nov-12 02-Dec-12 09-Dec-12 16-Dec-12 23-Dec-12 30-Dec-12
Figure 3: Quarterly performance of the Australian life sciences sector and subsectors
Graph 2: Yearly performance of the Australian life sciences sector by market capitalisation compared to major indices
M
a
r
k
e
t

p
e
r
f
o
r
m
a
n
c
e
Table 2: Yearly performance of the Australian life sciences sector by market capitalisation compared to major indices
% Change (Sep11-Sep12) % Change (Dec11-Dec12)
30-Sep-11 30-Sep-12 % Change 31-Dec-11 31-Dec-12 % Change
ASX All Ordinaries (Index) 4,070 4,406 8.3% 4,111 4,665 13.5%
NASDAQ Composite (Index) 2,415 3,116 29.0% 2,605 3,020 15.9%
NASDAQ Biotech (Index) 970 1,486 53.3% 1,085 1,431 31.9%
Life Sciences (market cap A$m) 30,526 40,786 33.6% 31,420 44,604 42.0%
Life Sciences ex majors (market cap A$m) 7,730 8,249 6.7% 7,622 7,573 -0.6%
Table 3: Quarterly summary of the Australian life sciences indices performance
MCap
(A$m)
% of total
value
Companies
with share
price gains
Proportion
of subsector
up
Companies
with share
price losses
Proportion
of subsector
down
Companies
with share
price fat
Proportion
of subsector
fat
Total
number of
companies
Pharma/Biotech 32,006 72% 20 36% 30 55% 5 9% 55
Pharma/Biotech ex CSL 5,123 68% 19 35% 30 56% 5 9% 54
Med Device 12,598 28% 15 41% 19 51% 3 8% 37
Med Device ex COH,
RMD
2,450 32% 13 37% 19 54% 3 9% 35
Life Sciences 44,604 100% 35 38% 49 53% 8 9% 92
Life Sciences ex majors 7,573 100% 32 36% 49 55% 8 9% 89
M
a
r
k
e
t

p
e
r
f
o
r
m
a
n
c
e
11
Life Sciences Life Sciences ex majors Pharma/Biotech Pharma/Biotech ex CSL Med Device Med Device ex COH, RMD
-40%
-20%
0%
20%
40%
60%
31-Dec-10 31-Mar-11 30-Jun-11 30-Sep-11 31-Dec-11 31-Mar-12 30-Jun-12 30-Sep-12 31-Dec-12
Figure 4: Two-year comparison of the Australian life sciences indices performance by market capitalisation
Graph 3: Quarterly performance of the Australian life sciences sector and subsectors by market capitalisation
% Change (Jun-Sep) % Change (Sep-Dec)
Pharma/Biotech Pharma/Biotech ex CSL Med Device Med Device ex COH, RMD Life Sciences Life Sciences ex majors
-15.0%
-10.0%
-5.0%
0.0%
5.0%
10.0%
15.0%
20.0%
14.4%
8.7%
11.5%
3.0%
13.5%
6.7%
11.3%
-6.9%
4.6%
-10.8%
9.4%
-8.2%
Table 4: Quarterly performance of the Australian life sciences sectors by market capitalisation $A$m
Market capitalisation (A$m)
30-Jun-12 30-Sep-12 31-Dec-12
% Change
(Jun-Sep)
% Change
(Sep-Dec)
Pharma/Biotech 25,136 28,744 32,006 14.4% 11.3%
Pharma/Biotech ex CSL 5,062 5,501 5,123 8.7% -6.9%
Med Device 10,799 12,041 12,598 11.5% 4.6%
Med Device ex COH, RMD 2,668 2,747 2,450 3.0% -10.8%
Life Sciences 35,934 40,786 44,604 13.5% 9.4%
Life Sciences ex majors 7,730 8,249 7,573 6.7% -8.2%
12
40
0
10
20
30
40
50
Q2FY12 Q3FY12 Q4FY12 Q1FY13 Q2FY13
C
a
p
i
t
a
l

R
a
i
s
e
d

(
A
$
m
)
*
Medical Devices Biotech
0
50
100
150
200
250
300
350
400
C
a
p
i
t
a
l

R
a
i
s
e
d

(
A
$
m
)
*
158
284
95
187
12
49
95
229
4
Figure 5: Quarterly comparison of IPOs in Australia
Figure 6: Quarterly comparison of IPOs in the US
M
a
r
k
e
t

p
e
r
f
o
r
m
a
n
c
e
Quarterly fnancing
IPO fnancing
Note: * Amount shown is total market cap addition to the LS Index
from IPOs on frst day of trading
Note: * Amount shown is total market cap addition to the LS Index
from IPOs on frst day of trading
Table 5: Number of quarterly Australian IPO listings
Biotech Med Devices ASX
Q2FY13 - - 17
Q1FY13 - - 9
Q4FY12 - 1 13
Q3FY12 - - 12
Q2FY12 - - 20
Table 7: Total of quarterly US IPO listings
Biotech Med Devices
Q2FY13 3 1
Q1FY13 1 1
Q4FY12 3 1
Q3FY12 3 -
Q2FY12 6 2
Table 6: Listing of quarterly Australian IPO listings
Company Listing date
Capital
raised
(A$)
Valuation
on listing Sector
None
Total -
Table 8: Listing of quarterly US IPO listing
Company Listing date
Capital
raised
(A$m) Sector
Regulus Therapeutics Inc 04/10/2012 44 Biotech
KYTHERA
Biopharmaceuticals Inc
10/10/2012 68 Biotech
Puma Biotechnology Inc 18/10/2012 117 Biotech
Atossa Genetics Inc 07/11/2012 4 Med
Devices
Total 232
M
a
r
k
e
t

p
e
r
f
o
r
m
a
n
c
e
13
0
100
200
300
400
500
600
C
a
p
i
t
a
l

R
a
i
s
e
d

(
A
$
m
)
FY09 FY10 FY11 FY12 FY13
7
24
145
360
360
0
500
1,000
1,500
2,000
2,500
C
a
p
i
t
a
l

R
a
i
s
e
d

(
A
$
m
)
6
1,662
251
368
458
675
107
277
99
Figure 7: Annual comparisons of IPOs in Australia
Figure 8: Annual comparison of IPOs in the US Table 10: Number of IPO listings in the US
Biotech Med Devices
FY13 4 2
FY12 13 4
FY11 6 8
FY10 7 2
FY09 - 1
Yearly fnancing
Table 9: Number of IPO listings in Australia
Biotech Med Devices ASX
FY13 - - 17
FY12 - 2 75
FY11 1 1 127
FY10 1 - 53
FY09 1 - 24
Quarterly fnancing
Secondary fnance market
14
0
50
100
150
200
250
C
a
p
i
t
a
l

R
a
i
s
e
d

(
A
$
m
)
194
9
9
9
9
28
28
5
111
25
0
6,000
4,000
2,000
8,000
10,000
12,000
14,000
16,000
18,000
C
a
p
i
t
a
l

R
a
i
s
e
d

(
A
$
m
)
1,105
71
2,114
207
1,841
384
1,847
1,318
15,756
349
Figure 9: Quarterly comparison of secondary fnancing
in Australia
Figure 10: Quarterly comparison of secondary fnancing
in the US
Table 11: Number of secondary deals (AU)
Biotech
Avg.
amount
raised
($m)
Med
Devices
Avg.
amount
raised
($m)
Q2FY13 22 5.1 12 2.1
Q1FY13 24 1.2 8 0.6
Q4FY12 21 0.4 12 2.3
Q3FY12 16 0.6 9 1.0
Q2FY12 38 5.1 12 0.7
Table 12: Number of secondary deals (US)
Biotech Med Devices
Q2FY13 56 18
Q1FY13 49 26
Q4FY12 50 19
Q3FY12 33 9
Q2FY12 30 8
M
a
r
k
e
t

p
e
r
f
o
r
m
a
n
c
e
Yearly fnancing
M
a
r
k
e
t

p
e
r
f
o
r
m
a
n
c
e
15
0
500
1,000
1,500
2,000
2,500
C
a
p
i
t
a
l

R
a
i
s
e
d

(
A
$
m
)
2,081
71
246
271
383
95
294
55
139
29
C
a
p
i
t
a
l

R
a
i
s
e
d

(
A
$
m
)
0
5,000
10,000
15,000
20,000
25,000
3,330
719
5,974
2,400
1,493
5,578
5,429
776
17,603
1,667
Figure 11: Annual comparison of secondary fnancing
in Australia
Figure 12: Annual comparison of secondary fnancing in the US
Table 13: Number of Australian secondary raisings
Biotech Med Devices
FY13 46 20
FY12 99 39
FY11 154 43
FY10 107 39
FY09 87 41
Table 14: Number of US secondary raisings
Biotech Med Devices
FY13 105 44
FY12 138 42
FY11 70 121
FY10 122 57
FY09 48 24
M
a
r
k
e
t

p
e
r
f
o
r
m
a
n
c
e
16
Performers over past four quarters
Top 10
01
Uscom Ltd
Return: 199%
Closing price: $0.20
MCap: A$12.63m
Uscom completed a $1.2m capital raising and recorded sales of $800k in FY12.
The company cut cash burn and posted a loss after tax of $1.8m, down 32%
from FY11.
02
Sirtex Medical Ltd
Return: 193%
MCap: A$732.24m
Sirtex reported its annual proft before tax was up 54% to $2.1m. The
September quarter was Sirtexs 33rd consecutive quarter of growth. Dose sales
of SIR-Spheres microspheres, the companys liver cancer treatment, were up
23% from FY11. Proft rose 54% to $22.1m and dividends 42% to $5.56m year
on year.
03
Medical Developments
International Ltd
Return: 188%
MCap: A$94.72m
The company signed a licensing agreement with Nippon Zoki Pharmaceutical,
which comprised an initial payment of $100k, and another agreement with
CSIRO worth $750k. It also won a fve year tender with several Canadian
hospitals. MDIs proft was up 55% to $2.7m and it paid two separate
$0.03 dividends.
04
Cryosite Ltd
Return: 162%
MCap: A$17.72m
Cryosite forecast a proft after tax of $1.022m compared to $330k the prior
year due to organic growth, cost savings and productivity growth. It paid its
frst dividend of 0.5c a share and agreed with Regeneus to develop a protocol
for the cryopreservation of human stem cells.
05
Clover Corporation Ltd
Return: 93%
MCap: A$95.81m
Proft for the 12 months ended 31 July 2012 was $4.4m after tax. Normalised
sales revenue rose 20% to $38.4m and Clover paid a fully franked dividend of
1.5c a share.
06
ITL Ltd
Return: 86%
MCap: A$19.66m
The company completed a restructure involving the sale of its Malaysian
distributor for $1.1m. It announced a net proft of $1.3m, completed a debt
restructure and reduced its inventory holdings by $4m. Management bought
back 29% of issued capital for $6.55m.
07
CSL Ltd
Return: 68%
MCap: A$26,882.95m
CSL informed the market that NPAT for fscal 2013 was expected to be 20%
higher than previous forecasts due to an improved sales mix, supply chain
effciencies and higher than expected royalty income from Gardasil sales.
The company announced a $900m on market share buyback, which boosted
EPS by 4%.
08
Novogen Ltd
Return: 65%
MCap: A$17.13m
Novogen announced it had acquired 100% of Triaxial Pharmaceuticals. Proft
for FY12 rose 120% to $1.3m.
09
ResMed Inc
Return: 60%
MCap: A$5,637.17m
ResMed posted a record September quarter result, with revenues up 8%
to $340m compared to September 2011, while June quarter revenue was
up 9% to $372m.
10
Suda Ltd
Return: 52%
MCap: A$20.21m
The company had a strong September quarter, with its share price rising 169%,
and recruited patients for a phase III trial of its ArTiMist technology. The price
rise was largely unexplained, prompting an ASX query.
0% 50% 100% 150% 250% 200%
UCM
SRX
MVP
CTE
CLV
ITD
CSL
NRT
RMD
SUD
10
Medical Australia Ltd
Return: -56%
MCap: A$3.63m
A loss of $670k after tax was recorded for FY12. This was an increase of $330k on
the prior year.
09
Bone Medical Ltd
Return: -60%
MCap: A$.95m
The company posted a loss of $1.58m and revenues decreased 92%. It continued to
raise cash through convertible notes during the year.
08
Medivac Ltd
Return: -68%
MCap: A$3.89m
Signifcant delays in receiving regulatory approval put pressure on cash resources and
required redundancies and cost cutting. Losses for FY12 totalled $3.49m after tax, up
from a loss of $2.32m in FY11.
07
BioProspect Ltd
Return: -75%
MCap: A$2.28m
BioProspect posted a loss of $3.3m for FY12, with sales of Regen products down
$245k to $49k, and impairment costs of $300k.
06
Actinogen Ltd
Return: -80%
MCap: A$.89m
Actinogen posted a loss of $1.53m after tax in FY12, compared to $740k in FY11,
which included a $667k goodwill impairment.
05
Immuron Ltd
Return: -80%
MCap: A$4.14m
The company issued $2.4m in shares, posted a loss of $2.3m and budgeted for
negative cash fow for FY13.
04
HealthLinx Ltd
Return: -83%
MCap: A$1.39m
A heads of agreement with Mane DX involving the sale of HealthLinxs ovarian cancer
assets expired in December. HealthLinx posted a net loss for the year of $2.3m.
CEO Nick Gatsios resigned in November.
03
ImpediMed Ltd
Return: -85%
MCap: A$14.51m
ImpediMed posted a loss of $12.3m, an improvement on the prior fnancial year, but
revenue fell $990k. US sales of the companys L-Dex U400 fuid status assessment
devices were slower than expected.
02
Agenix Ltd
Return: -92%
MCap: A$.91m
The company recorded a loss of $1.36m for FY12. A series of equity raisings were
held throughout the year. In December, Agenix said a payment relating to a fxed
subscription agreement would not be paid.
01
Bioxyne Ltd
Return: -93%
MCap: A$2.16m
The companys phase IIb COPD trial had disappointing results, revealing no
statistically signifcant clinical beneft across the entire cohort of patients. However,
clinical benefts were observed for patients under 65 years.
M
a
r
k
e
t

p
e
r
f
o
r
m
a
n
c
e
17
Performers over past four quarters
Bottom 10
-100% -90% -80% -70% -50% -60% -40% -30% -20% -10% 0%
MLA
BNE
MDV
BPO
ACW
IMC
HTX
IPD
AGX
BXN
Announcements
18
03
A
n
n
o
u
n
c
e
m
e
n
t
s
19
Australia partnerships
Company Pharma/biotech
partner
Application Value (A$m) Comments
Biotech Total 7
BioDiem Ltd (BDM) Griffth University Broad spectrum
antimicrobial
compound
Not disclosed BioDiem entered into an agreement with
Griffth University to expand the range of
variants of its antimicrobial compound BDM-I.
Invion Ltd (IVX) Numoda Corporation Chronic
infammation
Not disclosed Invion entered into a strategic alliance with
Numoda Corporation for its upcoming
clinical trials.
Medical
Developments
International Ltd
(MVP)
Major international
pharmaceuticals
company
Asthma Not disclosed The company signed an MOU for a two year
right to supply its Compact Space Chamber
plus asthma device.
Phosphagenics Ltd
(POH)
Agila Specialties
Private Ltd
Injectable antibiotic
formulation
Undisclosed upfront
payment and
royalties
Phosphagenics licensed its drug
delivery platform to Agila, which will
take responsibility for developing and
commercialising the product.
Progen
Pharmaceuticals Ltd
(PGl)
Medigen Biotech
Corporation
Hepatocellular
carcinoma
Not disclosed Progen signed a binding term sheet with
Medigen Biotech, a listed Taiwanese company,
to develop new therapeutics for liver diseases
and cancers.
QRxPharma Ltd
(QRX)
Paladin Labs Inc MoxDuo painkiller US$0.5m upfront,
US$25m in milestone
payments and
double-digit royalties
QRxPharma agreed to give Paladin Labs
commercialisation rights to MoxDuo, its
formulation of oxycontin and morhone.
Sirtex Medical Ltd
(SRX)
Singapore General
Hospital
Carbon Cage
nanoparticles
Not disclosed Sirtex signed a master research collaboration
agreement with Singapore General Hospital
to explore the potential of Carbon Cage
Nanoparticle technology as a new generation
cancer therapy.
Medical devices Total 3
Atcor Medical
Holdings Ltd (ACG)
Major international
pharmaceuticals
company
Early detection of
cardiovascular risk
US$3.2m AtCor has signed a supply contract for its
SphygmoCor systems and clinical trial support
systems, to be placed at sites throughout
Europe and America.
Cogstate Ltd (CGS) Major international
pharmaceuticals
company
Cognitive testing
technology
US$3.7m Cogstate was awarded a contract to
utilise its cognitive testing technology in
a phase III clinical program for treatment
of schizophrenia.
Tyrian Diagnostics
Ltd (TDX)
Agenix Ltd (AGX) Medical diagnostics $0.5m in AGX shares Tyrian has licensed its GiagnostIQ device
to Agenix and also its IP for detection of
active TB.
20
A
n
n
o
u
n
c
e
m
e
n
t
s
Mergers, acquisitions and divestments
Dominant company Other company Type of deal Value (A$m) Comments
Biotech Total 8
Acuvax Ltd (ACU) Biolife Science Ltd 20m ACU shares
post-consolidation
and potential 20m in
performance shares
Acuvax purchased 100% of the issued capital
of Biolife Science, including rights to a novel
immunotherapy for HER-2 specifc cancers,
including gastric and breast cancer.
Avexa Ltd (AVX) Coal Holdings USA
LLC
Investment US$4m investment
and US$6m loan
Avexa announced it would invest in a US coal
company with the aim of generating cash fow
to fund its drug trials.
Benitec Ltd (BLT) Tacere Therapeutics Acquisition US$1.5m plus
potential future cash
royalties
The company completed the acquisition of
Tacere, which is conducting a phase I/II ready
program in hepatitis C that uses Benitecs gene
silencing technology ddRNAi.
Cordlife Ltd (CBB) Shandong Blood
Bank
Divestment US$8.65 Cordlife entered into a conditional SPA to sell
its 4.05% shareholding in Shandong Cord
Blood Bank, purchased in March 2012 for
US$8.16m.
Nabi
Pharmaceuticals
Biota Holdings Ltd
(BTA)
Merger US$27m Nabi acquired all ordinary shares in Biota to
create a new company Biota Pharmaceuticals
(NASDAQ:BOTA). Biota has delisted from
the ASX.
Mayne Pharma
Group Ltd (MYX)
N/A Asset purchase $14m Mayne announced it would purchase Kapanol
from GlaxoSmithKline, a modifed release oral
opioid used to treat pain.
Mayne Pharma
Group Ltd (MYX)
Metrics Inc Acquisition US$105m plus up
to $15m in earn out
payments
Mayne purchased Metrics, a US based provider
of contract development services to the
pharmaceutical industry. The acquisition was
funded by US$44.5m in debt and an A$65m
equity raising.
Novogen Ltd (NRT) Triaxial
Pharmaceuticals
Acquisition $1.885m Novogen completed acquisition of 100% of
Triaxial, a company applying its technologies
to benzopryan compounds to create a new
family of drugs.
SomnoMed Ltd
(SOM)
MAS Nordic Acquisition $430,000 SomnoMed announced the acquisition of MAS
Nordic, a distributor for SomnoMeds business
in Scandinavia.
SomnoMed Ltd
(SOM)
Ortosom Acquisition 464,395 SOM
shares and 35% of
SomnoMed France
SomnoMed acquired Orthosom in France to form
a new operation, SomnoMed-Orthosom. The
head of Orthosom will run the new operation.
A
n
n
o
u
n
c
e
m
e
n
t
s
21
Clinical trials
Company Drug Application Comments
Pre-clinical Total 2
Allied Healthcare Group Ltd
(AHZ)
CardioCel Heart valve
reconstruction
Allied reported successful results from a pre-clinical study of
the use of CardioCel to repair heart valves.
Bionomics Ltd (BNO) BNC375 Alzheimers disease Pre-clinical modelling identifed a new compound with
prospects as an Alzheimers treatment.
Phase I Total 2
Living Cell Technologies Ltd
(LCT)
Diabecell Type I Diabetes Living Cell said an interim analysis of its phase I/IIa trial in
Diabecell showed signifcant benefts of the treatment.
Neuren Pharmaceuticals Ltd
(NEU)
NNZ-2566 Rett Syndrome The company announced that a phase I study of an oral
formulation of NNZ-2566 was successful.
Phase II Total 1
Clinuvel Pharmaceuticals Ltd
(CUV)
Scenesse Vitiligo Clinuvel announced successful results from its phase
IIa pilot study, showing Scenesse signifcantly improves
repigmentation in vitiligo patients compared to NB-UVB.
Phase III Total 3
Bioniche Life Sciences (BNC) Urocidin Bladder cancer The company discontinued its phase III trial for Urocidin due
to low recruitment and issues with the trial design.
Healthlinx Ltd (HTX) OvPlex Ovarian cancer The primary endpoint in Healthlinxs second clinical study to
validate the diagnostic performance of OvPlex was achieved.
Starpharma Holdings Ltd (SPL) VivaGel Bacterial vaginosis Two phase III studies of ViviGel showed statistically
signifcant cure and resolution of patient reported symptoms,
but the primary endpoint of clinical cure after 2-3 weeks was
not met.
Other Total 5
Allied Healthcare Group Ltd
(AHZ)
HPV Vaccine HPV infection An initial study of a novel HPV vaccine was successful.
The vaccine is in development by Allieds investment
company Coridon.
Avexa Ltd (AVX) AVX13616 Anti-bacterial
compound
The companys research partner announced positive results
from trials against a broad range of bacteria.
Benitec Ltd (BLT) Oculopharyngeal
muscular
dystrophy
program
Gene silencing Early data from a joint study between Benitec and the Royal
Holloway at the University of London demonstrated the
silencer was highly effcient.
Gi Dynamics Inc (GID) EndoBarrier Weight Loss GI Dynamics said a study evaluating the long term benefts
of EndoBarrier showed that the treatment provides sustained
weight loss benefts in patients when re-implanted for an
additional year.
Sirtex Medical Ltd (SRX) SIR-Spheres
Microspheres
Metastatic colorectal
cancer
A newly published study showed patients experienced a
statistically signifcant survival beneft from treatment with
SIR spheres microspheres compared to the best available
alternate treatments.
22
A
n
n
o
u
n
c
e
m
e
n
t
s
Regulatory
Company Product Application Comments
Biotech Total 6
BioDiem Ltd (BDM) BDM-I Antimicrobial
compound
The Japanese Patent Offce granted the company a patent for
BDM-I.
Benitec Ltd (BLT) RNAi agents Genetic encoding The Chinese Patent Offce granted a patent to Benitec for
Multiple promoter expression cassettes for simultaneous
delivery of RNAi agents
Bone Medical Ltd (BNE) Axcess IV Osteoporosis Bone Medicals oral peptide technology was granted a patent
in China.
NuSep Ltd (NSP) In-vitro diagnostics
medical devices
NuSep was accredited by the TGA for the manufacture of its
IVF devices.
Novogen Ltd (NRT) ME-344 Composition of ME-
344 and its uses in
treating cancer
The European Patent Offce granted Novogens subsidiary
Marshall Edwards a patent on the composition and uses of
ME-344 until 2025.
Starpharma Holdings Ltd
(SPL)
Docetaxel Cancer An animal trial showed Starpharmas dendrimer-enhanced
version of docetaxel had superior anti-cancer effects across a
range of cancers when compared to Taxotere.
Atcor Medical Holdings Ltd
(ACG)
SphygmoCor Aortic blood pressure
measurement
The FDA granted the company clearance to market the
SphygmoCor XCL system in the US.
Heartware International Inc
(HIN)
Ventricular Assist
System
Heart transplantation The company announced that the FDA has approved
its Ventricular Assist System and it will commence
commercialisation immediately.
Other news
Company Product Application Comments
Biotech Total 6
Alchemia Ltd (ACL) N/A N/A Alchemia announced it has been unable to secure suffcient
investment for its subsidiary Audeo Oncology and the
proposed demerger will not proceed in the short term.
NuSep Ltd (NSP) N/A N/A NuSep will spin off its therapeutic plasma business, Prime
Biologics, which is valued at $46m. The new company is
expected to list on the ASX in May 2013 and will remain 10%
owned by NuSep.
Genetic Technologies Ltd
(GTG)
N/A N/A Dr Mel Bridges and director Huw Jones were voted off the
board, prompting the resignation of CEO Dr Paul MacLeman,
director Greg Brown and head of legal and corporate
Dr David Spurling.
Genetic Technologies Ltd
(GTG)
N/A N/A The company has fled multiple patent infringement suits in
association with Sheridan Ross in respect of its non-coding
DNA technologies.
CSL Ltd (CSL) N/A N/A CSL rebranded CSL Biotherapies to CSL Behring, in line
with global operations, and created a new title bioCSL
for the companys vaccine, pharmaceuticals and in-vitro
diagnostics operations.
Mesoblast Ltd (MSB) Mesenchymal
Precursor Cell
Technology
Regenerative
medicine
Mesoblast has reached an agreement with the FDA on the
manufacturing process it will use to supply MPC cells for its
upcoming phase III clinical trials.
Sunshine Heart Inc (SHC) C-Pulse Heart assist system Sunshine Heart was awarded the 2012 North American
Heart Failure Treatment New Product Innovation award for
its Heart Assist System.
Appendix
04
23
Closing MCap (A$m) Quarterly return Annual return
Medical device
AMT Advanced Surgical Design & Manufacture Limited 3.79 -22% -45%
AHZ Allied Healthcare Group Ltd 18.70 -9% -48%
ADO Anteo Diagnostics Limited 48.51 7% -15%
ACG Atcor Medical Holdings Limited 10.55 17% -15%
BRC Brain Resource Company Limited (The) 22.47 -2% 7%
CLV Clover Corporation Limited 95.81 8% 93%
COH Cochlear Limited 4510.81 18% 28%
CGS Cogstate Ltd 25.07 -13% 38%
CMP Compumedics Limited 11.99 6% -18%
CYC Cyclopharm Limited 9.88 -17% -15%
ELX Ellex Medical Lasers Limited 16.13 12% 46%
GBI Genera Biosystems Limited 9.97 -20% -17%
GID GI Dynamics Inc 157.48 -23% -41%
HIN Heartware International, Inc 1115.74 -14% 17%
IPD Impedimed Limited 14.51 -53% -85%
ISN Isonea Limited 15.29 16% -46%
ITD ITL Limited 19.66 2% 86%
LBT Labtech Systems Limited 5.66 14% 50%
MLA Medical Australia Limited 3.63 -33% -56%
MGZ Medigard Limited 1.46 45% 0%
MDV Medivac Limited 3.89 0% -68%
MDG Medtech Global Limited 3.51 -22% -30%
NAN Nanosonics Limited 126.67 -1% -19%
NDL Neurodiscovery Limited 2.42 -4% -22%
OBJ OBJ Limited 21.97 36% 6%
OIL Optiscan Imaging Limited 14.12 -2% -30%
OSP Osprey Medical Inc 41.69 27% 1%
RMD Resmed Inc 5637.17 2% 60%
RVA Reva Medical 164.56 -22% -15%
SFP Safety Medical Products Limited 3.17 0% 14%
SOM Somnomed Limited 35.14 -1% -10%
SUD Suda Limited 20.21 -3% 62%
SHC Sunshine Heart, Inc. 61.24 -18% -8%
TDX Tyrian Diagnostics Limited 1.02 0% -50%
UNS Unilife Corporation 172.35 -27% -32%
UBI Universal Biosensors, Inc. 157.88 6% 22%
UCM Uscom Limited 12.63 21% 199%
24
C
o
m
p
a
n
i
e
s

i
n

t
h
e

P
w
C

L
i
f
e

S
c
i
e
n
c
e
s

I
n
d
e
x
Companies in the
PwC Life Sciences Index
Pharma and Biotech
ACR Acrux Limited 474.52 -11% -1%
ACW Actinogen Limited 0.89 -71% -80%
ACU Acuvax Limited 2.46 0% 0%
AGX Agenix Limited 0.91 -69% -92%
ACL Alchemia Limited 108.11 -26% 28%
ALT Analytica Limited 12.32 5% 16%
ANP Antisense Therapeutics Limited 15.82 -42% -52%
AVX Avexa Limited 16.11 -5% -39%
AVH Avita Medical Ltd 38.99 -11% -4%
BLT Benitec Limited 14.69 -13% -7%
BDM Biodiem Limited 5.97 -32% -50%
BNC Bioniche Life Sciences 33.21 -20% -51%
BNO Bionomics Limited 131.30 -4% -39%
BPO Bioprospect Limited 2.28 -50% -75%
BIT Biotron Limited 30.82 50% 8%
BXN Bioxyne Ltd 2.16 -53% -93%
BNE Bone Medical Limited 0.95 -33% -60%
CZD Calzada Limited 16.29 2% -16%
CDY Cellmid Limited 8.18 0% -6%
CIR Circadian Technologies Limited 17.02 -3% -26%
CUV Clinuvel Pharmaceuticals Limited 63.53 17% 18%
CBB Cordlife Limited 7.77 -10% -34%
CTE Cryosite Limited 17.72 31% 162%
CSL CSL Limited 26882.95 17% 68%
GTG Genetic Technologies Limited 33.72 -35% -35%
HTX Healthlinx Limited 1.39 0% -83%
HCT Holista Colltech Limited 9.46 30% -37%
IMC Immuron Limited 4.14 -41% -80%
IMU Imugene Limited 3.78 -35% -8%
IDT Institute Of Drug Technology Australia Limited 9.50 -2% -44%
IVX Invion Limited 21.92 0% -10%
LCT Living Cell Technologies Limited 17.85 -2% 9%
MYX Mayne Pharma Group Limited 163.66 4% -23%
MVP Medical Developments International Limited 94.72 34% 188%
MSB Mesoblast Limited 1521.80 -21% -23%
NLS Narhex Life Sciences Limited 3.01 40% -36%
NEU Neuren Pharmaceuticals Limited 41.40 30% 30%
NRT Novogen Limited 17.13 129% 65%
NSP Nusep Limited 9.63 32% 7%
PAB Patrys Limited 19.28 0% 12%
C
o
m
p
a
n
i
e
s

i
n

t
h
e

P
w
C

L
i
f
e

S
c
i
e
n
c
e
s

I
n
d
e
x
25
26
C
o
m
p
a
n
i
e
s

i
n

t
h
e

P
w
C

L
i
f
e

S
c
i
e
n
c
e
s

I
n
d
e
x
Pharma and Biotech (continued)
PXS Pharmaxis Ltd 382.59 7% 19%
POH Phosphagenics Limited 147.93 16% -31%
PYC Phylogica Limited 11.15 -17% -38%
PBT Prana Biotechnology Limited 71.54 -7% 35%
PRR Prima Biomed Ltd 117.27 -44% -31%
PBP Probiotec Limited 23.53 22% 5%
PGL Progen Pharmaceuticals Limited. 7.41 15% 50%
PVA Psivida Corp. 30.29 -19% 4%
QRX Qrxpharma Limited 130.16 32% -40%
SIE Scigen Limited 22.09 -11% -41%
SRX Sirtex Medical Limited 732.24 38% 193%
SPL Starpharma Holdings Limited 368.73 -13% 14%
TEO Telesso Technologies Limited 0.60 -50% -47%
TIS Tissue Therapies Limited 53.48 -22% -19%
VLA Viralytics Limited 29.21 26% 0%
Notes:
BTA Biota Holdings removed from ASX and from Life Sciences index following merger with Nabi Pharmaceuticals to form Biota
Pharmaceuticals (NASDAQ: BOTA)
CXD Company voluntarily delisted from the ASX in December 2012
SLA Company removed from index subsequent to suspension from trading
SUD Eastland Medical Systems changed name to Suda Limited, including an ASX code change from EMS to SUD
05
Methodology
27
28
M
e
t
h
o
d
o
l
o
g
y
Sources
BioForum draws on historical data from the
following sources:
Bloomberg
Connect 4
The Australian Stock Exchange
Company websites
PwC Global Pharma and Life Science
Quarterly Newsbriefs
Market performance
The Australian life sciences sectors market
performance is tracked through two indices:
1. PwC Life Sciences Index
2. PwC Life Sciences Index ex majors (CSL, ResMed
and Cochlear)
Analysis is provided without the large-capitalisation stocks
(majors) so the performance of smaller-capitalisation
stocks can be observed.
The PwC Life Sciences Index is based on the performance
of life sciences companies listed on the Australian
Securities Exchange (ASX). It comprises two subsectors:
1. Pharmaceutical / Biotechnology
2. Medical devices
These sectors have been classifed according to the
Global Industry Classifcation Standard. The index
includes life sciences companies primarily involved
in research, development, commercialisation and
manufacturing of pharmaceutical and biotechnology
products and medical devices. It excludes healthcare,
medical software and distribution companies.
Companies included in the PwC Life Sciences Index are
listed at the end of each issue of BioForum.
The PwC Life Sciences Index is based on the combined
market capitalisation of the listed companies and
calculates the change of their value over the quarter
and change over the previous year. These changes are
compared to the changes in the market performance of
the following indices:
ASX All Ordinaries
NASDAQ Composite
NASDAQ Biotech
Different formulae are used to calculate the value
of these indices and track their performance. These
formulae use a combination of company market prices
and a weighted average of market capitalisation.
Because of these different methods of calculating
value, the absolute value of the indices cannot be
directly compared. Only their changes over time can be
sensibly compared.
The index is designed as a measure of the health and
performance of the industry, not as a measure of
returns to investors.
Top and bottom performers
Annual data on these companies is sourced from
Bloomberg each quarter. Company announcements are
sourced from company websites.
IPO and secondary fnance markets
IPO and secondary fnancing data is sourced from the
Connect 4 databases health-care industry category. We
include data from companies on the PwC Life Sciences
Index only. Data on options, rights and bonus issues is
excluded. The US IPO and secondary fnancing data is
sourced from Thompson Reuters.
Announcements
These are from companies listed on the PwC
Life Sciences Index only. They are sourced from
Connect 4 using the health-care industry category.
We include announcements on partnerships, mergers
and acquisitions and divestments, clinical results,
regulatory activity and other information.
Announcements on the following are excluded:
trading halts
capital raisings
proposed (versus actual) mergers,
acquisitions and partnerships
progress reports on clinical trials
(results only are included)
market registration approval
Methodology
06
29
Contacts
PwC Australia Life Sciences
and Innovation Practice contacts
30
Australian Industry Leaders
Life Sciences
PwC Australia Life Sciences
Craig Lawn
P: +612 8266 0147
E: craig.s.lawn@au.pwc.com
Michelle Chiang
P: +612 8266 7575
E: michelle.w.chiang@au.pwc.com
Manoj Santiago
P: +612 8266 4494
E: manoj.santiago@au.pwc.com
Assurance
Manoj Santiago
P: +612 8266 4494
E: manoj.santiago@au.pwc.com
Michelle Chiang
P: +612 8266 7575
E: michelle.w.chiang@au.pwc.com
Tax and Legal
Craig Lawn
P: +612 8266 0147
E: craig.s.lawn@au.pwc.com
Sandra Mason
P: +612 8266 0470
E: sandra.mason@au.pwc.com
Stephanie Fabian
P: +612 4925 1278
E: stephanie.fabian@au.pwc.com
National Pharmaceuticals Leader
John Cannings
P: +612 8266 6410
E: john.cannings@au.pwc.com
Written and edited by:
PwC (pwc.com.au), a global professional services
organisation serving the life sciences sector and other
industries with the help of editor and proofreader
Karen Hunt.
Quantitative research, analysis
and writing:
Max Oke, Consultant
PwC Life Sciences Practice
contributors:
Craig Lawn, Partner, National Life Sciences
Industry Leader
Manoj Santiago, Partner, Sydney Life Sciences
Industry Leader
Michelle Chiang, Partner, Sydney Life Sciences
Industry Leader
A
c
k
n
o
w
l
e
d
g
e
m
e
n
t
s
Acknowledgements
31
This document is provided by PwC as general guidance only and does not constitute the provision of accounting, legal advice, tax services, investment
advice, or professional consulting of any kind. The information is provided as is with no assurance or guarantee of completeness, accuracy or timeliness
of the information and without warranty of any kind, express or implied, including but not limited to warranties of performance, merchantability and ftness
for a particular purpose. In no event will PwC or its professionals be liable in any way to you or to anyone else for any decision made or action taken in
reliance on the information or for any direct, indirect, consequential, special or other damages related to you or your use of information, even if advised
of the possibility of such damages. Before making any decision or taking any action, you should consult a professional adviser who has been provided
with all the pertinent facts relevant to your particular situation.
2013 PricewaterhouseCoopers. All rights reserved. In this document, PwC refers to PricewaterhouseCoopers a partnership formed in Australia,
which is a member frm of PricewaterhouseCoopers International Limited, each member frm of which is a separate legal entity.
PricewaterhouseCoopers
201 Sussex Street
Sydney NSW 2000
+61 2 8266 0000
WL274257
www.pwc.com.au/bioforum

Positive Performance Continues For Biotechs, But Ex-Majors Underperform

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Positive Performance Continues For Biotechs, But Ex-Majors Underperform

Uploaded by

Copyright:

Available Formats

BioForum

You might also like