BioForum Edition 46 Quarter 2 FY14 January 2014
Cautious optimism: The Life Sciences boom andlessons from the past
www.pwc.com.au/bioforum
Highlights
Highlights
2
Key developments• The two public offerings of dorsaVi and Innate
Immunotherapeutics led to the busiest quarter for IPO activity in the sector since Q3FY11. This was in addition to the backdoor listing of Cynata Therapeutics and the IPO of LifeHealthcare Group, a medical devices distributor (not part of the PwC Life Sciences Index).
• The government has confirmed it will exclude businesses with incomes of greater than $20b from claiming research and development tax concessions.
• The progression of legislation for quarterly payments of research and development tax offset benefits remains stalled in the Australian parliament. If passed, quarterly payments were slated to commence 1 January 2014.
• CSL was named Australia's most respected "chemical/life sciences" company in a survey by the Australian Financial Review.
Q2FY14 Key statistics
0.1% Life Sciences Index(up 7% in Q1FY14)
8.3% Nasdaq Biotech(up 20.7% in Q1FY14)
1.7% Life Sciences Index ex Majors(up 15.7% in Q1FY14)
10.7% Nasdaq Composite(up 10.8% in Q1FY14)
2.6% ASX All Ordinaries(up 9.3% in Q1FY14)
PwC | BioForum: January 2014
the sector. Carefully pricing floats, managing investor expectations and continuing to educate the market on risks will dictate whether the current IPO market strength becomes the norm.
Government support for the sector has certainly changed since the last boom, most notably the new R&D tax incentive. As we mentioned last edition, these are steps in the right direction, but we don’t think they’re enough to truly extract the maximum value for the Australian economy that’s presented by the sector’s performance.
We see this as a key challenge for the Australian life sciences sector: capturing and creating more value within Australia. Achieving this requires attracting and maintaining talent, fostering partnerships to get the most out of previous success stories and building a supportive environment that allows the sector to compete beyond development and well into manufacture, commercialisation and distribution.
There has been plenty of talk that the life sciences sector has the potential to replace some of Australia’s changing or dwindling industries. This can only happen through a coordinated effort, led by the industry but supported by regulators and governments. Can the sector develop a unified position on its response to the various challenges that exist, and if they do, will governments respond?
The success of 2013 for the life sciences sector isn’t fully captured in the impressive performance of the PwC Life Sciences Index. The sector is increasingly part of the mainstream market, and the mainstream economy. By applying the knowledge gained from the last time that life sciences companies had this momentum, 2013 might be seen as the start of a trend, rather than just a good year.
Introduction
pwc.com.au/privateclients
Manoj Santiago PwC Private Clients
3
Cautious optimism: The Life Sciences boom and lessons from the past
Despite a relatively flat December quarter for the PwC Life Sciences Index, it was the end of a very successful calendar year for the Life Sciences sector. A resurgent IPO market and increased media coverage leave the sector primed for a strong 2014. The current success of the Life Sciences sector gives rise to the question; in the 10 years since the last Australian Biotech boom, what has the sector learnt and how can it capture more value to truly capitalise on its success?
The PwC Life Sciences Index was down 0.1 per cent for the December quarter, outperformed by the All Ordinaries which returned 2.6 per cent. Whilst a slightly disappointing final quarter, the Index finished 2013 up 17.4 per cent compared to 14.8 per cent for the All Ordinaries. The standout story remains the Life Sciences Index ex majors, which finished the year up 29.2 per cent, almost double the annual return of the broader market.
It was a bumper quarter for the whole IPO market, but two floats and a backdoor listing for the life sciences sector is particularly encouraging. With a strong pipeline of companies looking to list in 2014, the Life Sciences IPO market looks set to flourish.
Some commentators are calling this a ‘renaissance’ for the Australian Life Sciences sector. If that is the case, what will make this resurgence different from previous periods of growth?
Communication with investors and other stakeholders is something that’s been difficult in the past – not surprising in such a varied, technology sector. However, thanks to measures such as AusBiotech’s revised Code of Best Practice for Reporting by Life Sciences Companies, companies now have a better idea of what the market expects from them.
History proves that it doesn’t take much for capital markets to lose faith in life sciences companies. The few life sciences companies which have listed in the past five years have not performed in accordance with initial expectations. While similar outcomes are experienced in other sectors, these companies receive disproportionate attention given the unique nature of
Introduction
4
Some commentators are calling this a ‘renaissance’ for the Australian Life Sciences sector. If that’s the case, what are some of the lessons we’ve learnt from the last time Biotech boomed and what can companies do to capitalise on the sector’s strength?
PwC | BioForum: January 2014
06 Quarterly key findings
08 Market performance
18 Announcements
26 Appendix
30 Methodology
32 Contacts
Contents5
Contents
6
01Quarterly key findings
PwC | BioForum: January 2014
Quarterly key findings
7
Quarterly key findings
Market performance Q2FY14 Page
Life sciences industry total MCap A$51,119m 11
Life sciences industry growth -0.1%
Pharma/biotech sector total MCap A$39,457m 11
Pharma/biotech sector growth 4.0%
Medical device sector total MCap A$11,663m 11
Medical device sector growth -12.4%
Individual company performance
Top individual performer Admedus Limited 16
Change in market cap over the past four quarters 638%
Bottom individual performer Pharmaxis Limited 17
Change in market cap over the past four quarters -92%
Financing
Australian IPO count 2 12
Total listed A$83m
US IPO count 10 12
Total raised A$777m
Australian secondary financing count 46 14
Total raised A$189m
US secondary financing count 57 14
Total raised A$2,919m
Announcements Q2FY14 Page
Australia
Partnerships 17 19
Mergers & acquisitions 07 20
Clinical trials 24 21
Regulatory 23 23
Other 07 25
8
02Market performance
PwC | BioForum: January 2014
Figure 1: Weekly performance over the quarter of the PwC Life Sciences Index compared to major indices
ASX All OrdinariesLife Sciences Life Sciences ex majors NASDAQ BiotechNASDAQ Composite
-6%
-4%
-2%
0%
04%
02%
06%
08%
10%
12%
30-Sep 04-Oct 11-Oct 18-Oct 25-Oct 01-Nov 08-Nov 15-Nov 22-Nov 29-Nov 06-Dec 13-Dec 27-Dec20-Dec 31-Dec
ASX All Ordinaries (Index) NASDAQ Composite(Index)
PwC Life Sciences Index (Index)
9.3%
2.6%
10.8% 10.7%
20.7%
8.3%7.0%
-0.1%
15.7%
1.7%
PwC Life Sciences Index exmajors (Index)
-5.0%
0.0%
5.0%
10.0%
15.0%
20.0%
25.0%
NASDAQ Biotech (Index)
% Change (Jun-Sep) % Change (Sep-Dec)
Graph 1: Quarterly movements of PwC Life Sciences Index compared to major indices
Market perform
ance9
Performance overview
Table 1: Quarterly movements of the PwC Life Sciences Index compared to major indices
Value
30-Jun-13 30-Sep-13 31-Dec-13% Change (Jun-Sep)
% Change (Sep-Dec)
PwC Life Sciences Index (Index) 47,932 51,310 51,268 7.0% -0.1%
PwC Life Sciences Index ex majors (Index) 7,232 8,367 8,507 15.7% 1.7%
ASX All Ordinaries (Index) 4,775 5,218 5,353 9.3% 2.6%
NASDAQ Composite (Index) 3,403 3,771 4,177 10.8% 10.7%
NASDAQ Biotech (Index) 1,813 2,189 2,370 20.7% 8.3%
Table 2: Yearly performance of the PwC Life Sciences Index compared to major indices
% Change (Sep12-Sep13) % Change (Dec12-Dec13)
30-Sep-12 30-Sep-13 % Change 31-Dec-12 31-Dec-13 % Change
Life Sciences (Index) 39,692 51,310 29.3% 43,672 51,268 17.4%
Life Sciences ex majors (Index) 7,154 8,367 17.0% 6,586 8,507 29.2%
ASX All Ordinaries (Index) 4,406 5,218 18.4% 4,665 5,353 14.8%
NASDAQ Composite (Index) 3,116 3,771 21.0% 3,020 4,177 38.3%
NASDAQ Biotech (Index) 1,486 2,189 47.3% 1,431 2,370 65.6%
10
Lif e Sciences Lif e Sciences ex majors Pharma/Biotech Pharma/Biotech ex CSL Med Device Med Device ex COH, RMD
-20%
-15%
-10%
-5%
0%
5%
10%
15%
20%
30-Sep-13 07-Oct-13 14-Oct-13 21-Oct-13 28-Oct-13 04-Nov-13 11-Nov-13 18-Nov-13 25-Nov-13 02-Dec-13 09-Dec-13 16-Dec-13 23-Dec-13 30-Dec-13
Figure 3: Quarterly performance of the PwC Life Sciences Index and its subsectors
0.0%
10.0%
20.0%
30.0%
50.0%
40.0%
70.0%
60.0%
% Change (Sep12-Sep13) % Change (Dec12-Dec13)
ASX All Ordinaries (Index)
18.4%14.8%
NASDAQ Composite (Index)
21.0%
38.3%
NASDAQ Biotech (Index)
47.3%
65.6%
Life Sciences (Index)
29.3%
17.4%
(Index)Life Sciences ex majors
17.0%
29.2%
Graph 2: Yearly performance of the PwC Life Sciences Index compared to major indices
Market perform
ance
Table 3: Quarterly performance of the PwC Life Sciences Index and its subsectors
Market capitalisation (A$m)
30-Jun-13 30-Sep-13 31-Dec-13% Change (Jun-Sep)
% Change (Sep-Dec)
Life Sciences 47,932 51,310 51,268 7.0% -0.1%
Life Sciences ex majors 7,232 8,367 8,507 15.7% 1.7%
Pharma/Biotech 35,741 38,513 40,057 7.8% 4.0%
Pharma/Biotech ex CSL 5,685 6,601 6,608 16.1% 0.1%
Med Device 12,191 12,797 11,211 5.0% -12.4%
Med Device ex COH, RMD 1,547 1,766 1,899 14.1% 7.5%
-60%
-40%
-20%
0%
20%
40%
60%
80%
100%
120%
140%
31-Dec-11 31-Mar-12 30 -Jul-12 30-Sep-12 31-Dec-12 31-March-13 30-June-13 30-Sep-13 31-Dec-13
ASX All OrdinariesLife Sciences Life Sciences ex majors NASDAQ BiotechNASDAQ Composite
Figure 2: Two-year comparison of the PwC Life Sciences Index compared to major indices
PwC | BioForum: January 2014
Market perform
ance11
Life Sciences Life Sciences ex majors Pharma/Biotech Pharma/Biotech ex CSL Med Device Med Device ex COH, RMD
-20%
0%
20%
40%
60%
80%
200%
180%
120%
160%
140%
100%
31-Dec-11 31-Mar-12 30-Jun-12 30-Sep-12 31-Dec-12 31-Mar-13 30-Jul-13 30-Sep-13 31-Dec-13
Figure 4: Two-year performance of the PwC Life Sciences Index and its subsectors
Graph 3: Quarterly performace of the PwC Life Sciences Index and its subsectors
-15.0%
-10.0%
-5.0%
0.0%
5.0%
10.0%
20.0%
15.0%
% Change (Jun-Sep) % Change (Sep-Dec)
Life Sciences Life Sciences exmajors
Pharma/Biotech Pharma/Biotech exCSL
Med Device Med Device exCOH, RMD
7.8%
4.0%
16.1%
0.1%
5.0%
-12.4%
14.1%
7.5%7.0%
-0.1%
15.7%
1.7%
Table 4: Quarterly summary of the PwC Life Sciences Index and its subsectors
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 flat
Proportion of subsector
flat
Total number of companies
Life Sciences 51,268 100% 43 49% 36 41% 8 9% 87
Life Sciences ex majors 8,507 100% 42 50% 34 40% 8 10% 84
Pharma/Biotech 40,057 78% 28 53% 20 38% 5 9% 53
Pharma/Biotech ex CSL 6,608 78% 27 52% 20 38% 5 10% 52
Med Device 11,211 22% 15 44% 16 47% 3 9% 34
Med Device ex COH, RMD 1,899 22% 15 47% 14 44% 3 9% 32
12
0
20
40
60
80
100
Capi
tal R
aise
d (A
$m)*
Medical Devices Biotech
Q2FY13 Q3FY13 Q4FY13 Q1FY14 Q2FY14
46
83
Medical Devices Biotech
0
500
1,000
1,500
2,000
2,500
3,000
Cap
ital
Rai
sed
(A$m
)
Q2FY13 Q3FY13 Q4FY13 Q1FY14 Q2FY14
757
229
4
2,361
55
1,544
57
569
208
Figure 5: Quarterly comparison of IPOs in Australia
Figure 6: Quarterly comparison of IPOs in the US
Market perform
ance
Quarterly financing
IPO financing
Note: * Amount shown is total market cap addition to the LS Index from IPOs on first day of trading
Note: * Amount shown is total amount raised
Table 5: Number of quarterly Australian IPO listings
Biotech Med Devices ASX
Q2FY14 2 - 32
Q1FY14 1 - 8
Q4FY13 - - 11
Q3FY13 - - 12
Q2FY13 - - 17
Table 7: Number of quarterly US IPO listings
Biotech Med Devices
Q2FY14 8 2
Q1FY14 11 -
Q4FY13 9 1
Q3FY13 6 2
Q2FY13 3 1
Table 6: Listing of quarterly Australian IPO listings
Company Listing date
Capital raised
(A$)Valuation on listing Sector
DorsaVi Ltd 11/12/2013 18 49 Biotech
Innate Immunotherapeutics Ltd
23/12/2013 10 34 Biotech
Total 83.00
Table 8: Listing of quarterly US IPO listings
Company Listing date
Capital raised
(A$m) Sector
LDR Holding Corp 08/10/2013 79 Med Devices
Tandem Diabetes Care Inc 13/11/2013 129 Med Devices
MacroGenics Inc 09/10/2013 84 Biotech
Aerie Pharmaceuticals Inc 24/10/2013 71 Biotech
Karyopharm Therapeutics Inc 05/11/2013 117 Biotech
Relypsa Inc 14/11/2013 81 Biotech
Xencor Inc 02/12/2013 78 Biotech
Kindred Biosciences Inc 11/12/2013 58 Biotech
Tetralogic 11/12/2013 56 Biotech
Adamis Pharmaceuticals Corp 12/12/2013 25 Biotech
Total 777
PwC | BioForum: January 2014
Market perform
ance13
Medical Devices Biotech
0
100
200
300
400
500
600
Capi
tal R
aise
d (A
$m)
FY10 FY12 FY13 FY14FY11
7
145
360
352
129
Medical Devices Biotech
0
500
1,000
1,500
2,000
2,500
3,000
3,500
4,000
4,500
5,000
FY10 FY11 FY12 FY13 FY14
Capi
tal R
aise
d (A
$m)
1,662
251
368
458586
107
4,181
211
1,326
208
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
FY14 19 2
FY13 19 5
FY12 12 4
FY11 6 8
FY10 7 2
Yearly financing
Table 9: Number of IPO listings in Australia
Biotech Med Devices ASX
FY14 3 - 40
FY13 - - 49
FY12 - 2 75
FY11 1 1 127
FY10 1 - 53
Quarterly financing
Secondary finance market
14
Medical Devices Biotech
0
50
100
150
200
250
Capi
tal R
aise
d (A
$m)
Q2FY13 Q3FY13 Q4FY13 Q1FY14 Q2FY14
111
25
200
5
68
3
35
78130
59
Medical Devices Biotech
0
2,000
4,000
6,000
8,000
10,000
12,000
14,000
16,000
18,000
Capi
tal R
aise
d (A
$m)
15,54115,541
349
1,323
473
2,016
3224,084
2,524
Q2FY13 Q3FY13 Q4FY13 Q1FY14 Q2FY14
2,529
389
Figure 9: Quarterly comparison of secondary financing in Australia
Figure 10: Quarterly comparison of secondary financing in the US
Table 11: Number of secondary deals in Australia
Biotech
Avg. amount
raised ($m)
Med Devices
Avg. amount
raised ($m)
Q2FY14 33 3.9 13 4.5
Q1FY14 22 1.6 10 7.8
Q4FY13 32 2.1 4 0.8
Q3FY13 22 9.1 5 1.0
Q2FY13 22 5.1 12 2.1
Table 12: Number of secondary deals in the US
Biotech Med Devices
Q2FY14 43 14
Q1FY14 48 19
Q4FY13 38 22
Q3FY13 33 24
Q2FY13 52 18 M
arket performance
PwC | BioForum: January 2014
Yearly financing
Market perform
ance15
Medical Devices Biotech
0
100
200
300
400
600
500
FY10 FY11 FY12 FY13 FY14
Capi
tal R
aise
d (A
$m)
246
271
9555
407
37
165
136
Medical Devices Biotech
0
5,000
10,000
15,000
20,000
30,000
25,000
FY10 FY11 FY12 FY13 FY14
Capi
tal R
aise
d (A
$m)
5,974
2,400
1,279
5,5785,250
781
22,003
4,067
2,016
322
Figure 11: Annual comparison of secondary financing in Australia
Figure 12: Annual comparison of secondary financing in the US
Table 13: Number of Australian secondary raisings
Biotech Med Devices
FY14 55 23
FY13 100 29
FY12 99 39
FY11 154 43
FY10 107 39
Table 14: Number of US secondary raisings
Biotech Med Devices
FY14 48 19
FY13 152 85
FY12 125 43
FY11 66 121
FY10 122 57
Market perform
ance
16
Performers over past four quarters
Top 10
01 Admedus Ltd Return: 638% Closing price: $0.16 MCap: A$188.33m
Coridon, in which Admedus owns a 47% stake, was approved to begin a phase I trial for its herpes simplex virus vaccine. The company began selling its cardiovascular patch CardioCel in Europe in November, increased revenue 15% to $7.4m and cut its operating loss to $2.4m, down from $10m the prior year. High-profile investors including Fortescue CEO Andrew Forrest have bought up large holdings, driving up Admedus’s share price.
02 Oncosil Medical Ltd Return: 420% Closing price: $0.13 MCap: A$45.03m
Oncosil acquired UK-based cancer company Enigma Therapeutics in February and appointed Dr Neil Frazer as CEO in early July. Multiple capital raisings were heavily oversubscribed.
03 Isonea Ltd Return: 379% Closing price: $0.34 MCap: A$90.68m
After a $13.5m capital raising in late June, Isonea launched its flagship Airsonea wheeze monitoring device in Australia in September and later in the US. A poll of 100 medical professionals showed 80 recommended Isonea’s iPhone-based wheeze monitoring system for asthma sufferers.
04 Prana Biotechnology Ltd
Return: 267% Closing price: $0.77 MCap: A$318.61m
Prana Biotechnology is to report the results of two phase II trials for its Alzheimer’s and Huntington’s disease drug PBT2. The company distanced itself from claims that a patient in the Alzheimer’s trial had significant improvement in symptoms as the trial has not been finished and is a double blind trial.
05 Psivida Corp Return: 249% Closing price: $4.54 MCap: A$96.45m
The US FDA denied the company regulatory approval for its macular oedema treatment, Iluvien, for a third time, leading to a share price collapse in October. However, the FDA later advised that further clinical trials may not be necessary, lifting PVA to a two-month high.
06 Neuren Pharmaceuticals Ltd
Return: 229% Closing price: $0.12 MCap: A$171.71m
The FDA awarded a fast-track designation for Neuren’s Rett Syndrome treatment after Neuren began a phase II clinical trial for the treatment in April 2013.
07 Medical Australia Ltd Return: 206% Closing price: $0.25 MCap: A$23.98m
Medical Australia agreed to acquire animal healthcare company Medivet for $11m, and it completed a $4m capital raising in December.
08 Impedimed Ltd Return: 206% Closing price: $0.25 MCap: A$44.42m
An American Medical Association panel recommended accepting a new ‘category one’ code for Impedimed’s device, which will mean it receives better reimbursement coverage from US health insurers.
09 Bioprospect Ltd Return: 200% Closing price: $0.00 MCap: A$8.69m
Bioprospect acquired an option to purchase an 80% stake in Invatec Health, which has developed a method for the diagnosis of mental health disorders.
10 Anteo Diagnostics Ltd Return: 154% Closing price: $0.16 MCap: A$122.15m
Anteo Diagnostics completed a $5.5m capital raising in December. The company was granted a patent for its Mix&Go product in Japan and it signed a deal with BBI Solutions to investigate the manufacturing and performance benefits of Mix&Go technology on BBI particles used in lateral flow applications.
0% 200%100% 300% 400% 500% 600% 700%
AHZ OSL
ISN PBT
PVA NEU
MLA IPD
BPO ADO
PwC | BioForum: January 2014
Market perform
ance17
Performers over past four quarters
Bottom 10
10 Avexa Ltd Return: -37% Closing price: $0.01 MCap: A$11.11m
The company reported a loss of $3m and raised $1.03m from a share purchase plan in November.
09 Optiscan Imaging Ltd Return: -39% Closing price: $0.054 MCap: A$8.87m
Optiscan reported a $0.6m loss in 2013, down from $2.5m in 2012. It raised $1m via a convertible note issue.
08 Circadian Technologies Ltd
Return: -41% Closing price: $0.21 MCap: A$9.97m
Robert Klupacs stepped down as CEO of Circadian Technologies in December. Revenue for 2013 was down 22.3% and comprehensive losses increased to $5.97m, compared to $4.9m in 2012.
07 Biotron Ltd Return: -44% Closing price: $0.08 MCap: A$17.35m
Biotron’s loss for the year was up 62% to $3.85m. It published positive preliminary headline results from a phase IIa HIV reservoir trial in March and received ethics approval for a three-month dosing study for BIT225 in hepatitis C patients in November.
06 Clinuvel Pharmaceuticals Ltd
Return: -48% Closing price: $0.95 MCap: A$35.16m
Clinuvel reported delays in receiving European regulatory approval for its drug to treat a rare and painful skin disorder caused by intolerance to light. It reported a $6.95m loss, down from $9.67m the previous year.
05 Universal Biosensors Inc
Return: -50% Closing price: $0.460 MCap: A$78.72m
The company’s product LifeScan was subject to a worldwide recall in March. Annual revenue fell 43%, leading to a loss of $3m after tax, which was up $2m on the prior year.
04Advanced Surgical Design & Manufacture Ltd
Return: -52% Closing price: $0.05 MCap: A$2.19m
ASDM made a loss after tax of $0.57m, up from $0.17m the prior year. It raised $0.8m through a rights issue, secured a debt financing facility and cut its total debt to $2.6m in FY13 from $1.9m in FY12.
03 Prima Biomed Ltd Return: -65% Closing price: $0.039 MCap: A$49.15m
Prima’s share price slumped after an early stage study found its ovarian cancer treatment produced no observed difference in the control group, although the study was not sufficiently powered to detect statistical significance.
02 Safety Medical Products Ltd
Return: -75% Closing price: $0.00 MCap: A$.99m
FY13 losses totalled $0.94m, more than double the prior year. The company purchased a gold company in May and it has sold all non-Australian patents relating to its SecureTouch syringe.
01 Pharmaxis Ltd Return: -92% Closing price: $0.105 MCap: A$32.45m
A committee advised the FDA against recommending the company’s drug Bronchitol for use in cystic fibrosis patients in the US. The FDA also added Aridol to its import alert list, effectively stopping imports of the product until removal.
-100% -90% -80% -70% -60% -50% -40% -30% -20% -10% 0%
AVX
OIL
CIR
BIT
CUV
UBI
AMT
PRR
SFP
PXS
Announcements
18
03
PwC | BioForum: January 2014
Announcem
ents19
Australia – partnershipsCompany Partner Application Value (A$m) Comments
Anteo Diagnostics Ltd (ADO)
BBI Solutions Mix&Go Undisclosed Anteo and BBI will together investigate the manufacturing and performance benefits of Anteo’s Mix&Go technology on BBI particles used in lateral flow applications in a paid project, building on previous work and progressing agreed phases.
Atcor Medical Holdings Ltd (ACG)
Major international pharmaceutical company
SphygmoCor systems US$0.6m AtCor signed a contract to supply SphygmoCor systems and clinical trial support services to a major international pharmaceutical company.
Circadian Technologies Ltd (CIR)
DSM Pharmaceutical Products
Age-related macular degeneration
Undisclosed Circadian's subsidiary Opthea signed an agreement with DSM Pharmaceutical Products for process development and manufacture of Opthea's lead molecule, a soluble form of human VEGFR-3 in development for the treatment of age-related macular degeneration.
Clover Corporation Ltd (CLV)
Major international infant formula company
Driphorm powders Undisclosed Clover Corporation signed a further five-year global deal with a multinational infant formula company to supply Hi-DHA tuna oil and microencapsulated Driphorm powders.
Holista Colltech Ltd (HCT)
Veripan Lowered glycaemic index
Undisclosed Holista Colltech signed an agreement with Switzerland-based Veripan for the latter to sell its patented Neosolite GI, which can lower the glycaemic index in baked products.
Impedimed Ltd (IPD)
Institut Curie L-Dex lymphoedema treatment and detection
Undisclosed Impedimed signed a service agreement with the Institut Curie for France's first prospective, multi-centre clinical trial using L-Dex.
Invion Ltd (IVX) Accolade Pharma INV104 Inhaled Zafirlukast
Undisclosed Invion signed a licensing deal with Accolade Pharma LLC allowing it to develop inhaled formulations of Zafirlukast for the treatment of asthma and other respiratory conditions.
Isonea Ltd (ISN) uHealth AirSonea wheeze monitoring device
Undisclosed Isonea will collaborate with the Sydney-based digital health organisation uHealth to develop sales and distribution opportunities for its AirSonea wheeze rate monitoring device.
Mesoblast Ltd (MSB)
Ziopharm Oncology Cancer therapeutics N/A Mesoblast and Ziopharm announced a partnership to develop a new class of cancer therapeutics.
Novogen Ltd (NRT) Cornell University Brain cancer N/A Novogen signed a sponsored research agreement with Cornell University for the purpose of seeking a treatment capable of delivering long-term remission for the main form of primary brain cancer, glioblastoma multiforme.
Novogen Ltd (NRT) Yale University Ovarian cancer N/A Novogen and Yale University established a joint venture to develop chemotherapy strategies to fight ovarian cancer.
Probiotec Ltd (PBP) CSIRO Weight management N/A The company has entered into a 20 year agreement with the CSIRO to research health issues relating to weight management.
Qrxpharma Ltd (QRX)
ABIC Marketing Pain relief N/A Qrxpharma executed a licensing agreement with ABIC Marketing, the Israeli domestic subsidiary of Teva Pharmaceutical Industries, allowing immediate release of MoxDuo in Israel.
Qrxpharma Ltd (QRX)
Aspen Pharmaceuticals Pain relief $250k milestone payment and double-digit royalties
The company signed a licensing agreement with Aspen Pharmacare Holdings allowing immediate release of MoxDuo in South Africa.
Unilife Corporation (UNS)
Global pharmaceutical company
Drug delivery system Undisclosed Unilife signed a deal with a global pharmaceutical company seeking to use the Unilife Ocu-ject ocular drug delivery system to deliver a target injectable therapy into the eye.
Unilife Corporation (UNS)
Novartis Drug delivery system Undisclosed Unilife agreed to supply injectable drug delivery systems for use with one of Novartis’s targeted early-stage pipeline drugs. Unilife has granted Novartis an option for exclusivity.
Uscom Ltd (UCM) Uscom devices Cardiovascular devices $6.6m over five years Uscom has agreed to allow Naqu Area Pioneer Pharma Co Ltd Shanghai, a wholly owned subsidiary of China Pioneer Pharma Holdings Ltd, to distribute Uscom devices in China.
20
Announcem
ents
Mergers, acquisitions and divestmentsCompany Other company Type of deal Value (A$m) Comments
Admedus Ltd (AHZ) Genzyme Australasia Acquisition Undisclosed Admedus purchased a manufacturing site from Genzyme Australasia to scale up production of CardioCel to meet demand for this breakthrough treatment for the repair and reconstruction of congenital heart defects.
Agenix Ltd (AGX) A Chinese pharmaceutical company
Divestment US$2m Agenix entered into a binding deal with a Chinese pharmaceutical company to divest its AGX-1009 project, a tenofovir pro-drug for hepatitis B, which has successfully completed pre-clinical trials.
Bioxyne Ltd (BXN) Mariposa Health Ltd Divestment $2.1m in cash, debt and equity, plus 2.5-6.5% royalties on gross revenue
Bioxyne entered into a non-binding agreement to sell its HI-164 oral vaccine project together with all of its intellectual properties to Mariposa Health Ltd.
Ellex Medical Lasers Ltd (ELX)
A North American glaucoma consumable device business
Acquisition $3m Ellex Medical Lasers signed a binding agreement to acquire a glaucoma consumable device business.
Genetic Technologies Ltd (GTG)
Simavita Holdings Acquisition $13.9m Genetic Technologies subsidiary Gtech International Resources acquired Simavita Holdings, with the merged company changing name to Simavita Ltd.
Imugene Ltd (IMU) Biolife Science Qld Acquisition $2.5m Imugene acquired 100% of Biolife Science Qld, a company with the rights to a novel cancer immunotherapy platform.
Mesoblast Ltd (MSB) Osiris Therapeutics Acquisition US$20m Mesoblast acquired the culture expanded mesenchymal stem cell business of Osiris Therapeutics.
Probiotec Ltd (PBP) Valeant International Bermuda
Divestment $10m cash Probiotec will sell its Lofenoxal and Vermox products, including all intellectual property and business assets associated with these brands in Australia, and with New Zealand for the Vermox product.
PwC | BioForum: January 2014
Announcem
ents21
Clinical trialsCompany Drug Application Comments
Phase I
Living Cell Technologies Ltd (LCT)
Diabecell Type I diabetes Living Cell Technologies said a phase I/Iia trial of Diabecell in patients with type I diabetes showed overall unaware hypoglycaemic events were reduced by 57%, the average daily insulin dose was reduced in 7/8 patients and HbA1C fell 1.5-2% in the group receiving the bigger dose.
Patrys Ltd (PAB) PAT-SM6 Myeloma A phase I/Iia trial in multiple myeloma treated with Patrys's PAT-SM6 showed 36% of patients experienced stable disease post treatment, with no patients reporting serious adverse effects.
Phase II
Antisense Therapeutics Ltd (ANP)
ATL1103 Acromegaly An interim analysis of Antisense's phase II clinical trial of ATL1103 in patients with the growth disorder acromegaly showed positive results.
Biotron Ltd (BIT) BIT225 HIV/HCV Biotron's BIT225 enhances anti-viral activity in HIV/HCV genotype 3 co-infected patients according to preliminary data from a phase II study.
Biotron Ltd (BIT) BIT225 HCV An independent study published in the peer-reviewed journal Antiviral Research demonstrated that Biotron’s p7 inhibitor, BIT225, is active against HCV genotypes 1, 2, 4, 5 and 6 using an in vitro cell culture assay.
Mesoblast Ltd (MSB) Mesenchymal precursor cells
Heart failure A team of researchers found that patients with end-stage heart failure who receive a surgically implanted left ventricular assist device heart pump to maintain circulation may obtain specific benefit to their native heart from a single dose of Mesoblast’s proprietary mesenchymal precursor cells injected directly into their heart during surgery.
Phase III
Clinuvel Pharmaceuticals Ltd (CUV)
Scenesse Erythropoietic protoporphyria (light intolerance disorder)
Clinuvel said 87 patients diagnosed with the rare light intolerance disorder erythropoietic protoporphyria completed its phase III US study with results showing that Scenesse improved their ability to expose their skin to light and improved their quality of life.
Mesoblast Ltd (MSB) Mesenchymal precursor cells
Type II diabetes Mesoblast said line results from the phase 2 trial of its proprietary mesenchymal precursor cells in subjects with type 2 diabetes support the safety and tolerability of a single intravenous infusion of MPCs in type 2 diabetes and there was an improvement in glycaemic control as evidenced by reduction in haemoglobin A1c.
Pre-clinical and other
Avita Medical Ltd (AVH) ReCell spray-on skin
Skin regeneration Positive interim results for a study on ReCell for the restoration of pigment in hypopigmented burn scars were presented in Germany. The presentation highlighted excellent repigmentation outcomes from the randomised controlled pilot study of 20 participants.
Benitec Biopharma Ltd (BLT)
Tribetarna Lung cancer Pre-clinical experiments showed that Tribetarna treatment produces significantly increased survival in non-small cell lung cancer in vivo.
Calzada Ltd (CZD) NovoSorb Surgical wounds Calzada's fully owned subsidiary PolyNovo Biomaterials announced positive results from the clinical trial of the NovoSorb biodegradable temporising matrix dermal scaffold for the treatment of full thickness surgical wounds, finding NovoSorb was safe and well tolerated in all patients and showed superior cosmetic and functional outcomes compared to skin grafting alone.
Cellmid Ltd (CDY) Anti-midkine antibody
Biomarker Cellmid completed a two-year study involving 574 individuals, confirming statistically significant healthy midkine levels and providing some insights into a group of outliers who showed elevated midkine levels.
Cellmid Ltd (CDY) Anti-midkine antibody
Cancer research Cellmid completed several cancer xenograft efficacy and mechanism of action studies using its lead anti-midkine antibody, showing reduced tumour growth and spread and anti-angiogenic mechanism of action.
Cogstate Ltd (CGS) Cognigram Cognitive decline Cogstate reported that Merck published results from two new studies that add to the body of evidence that supports Cognigram as a sensitive assessment to detect and monitor cognitive decline over time, namely in healthy individuals and adults with mild cognitive impairment who carry a biological marker in the brain, Aß amyloid.
Ellex Medical Lasers Ltd (ELX)
Retinal rejuvenation therapy
Macular degeneration
Ellex Lasers said results of a pilot study of its proprietary retinal rejuvenation therapy in the treatment of early age-related macular degeneration show a 44% reduction in accumulation of drusen deposits and that 64% of patients at the greatest risk of AMD progression improved sufficiently to be removed from this category.
22
Announcem
ents
Clinical trialsCompany Drug Application Comments
Gi Dynamics Inc (GID) EndoBarrier Type II diabetes A new meta-analysis outlined a robust efficacy and safety profile of GI Dynamics' EndoBarrier therapy, an endoscopically-delivered device therapy approved for the treatment of type 2 diabetes and obesity.
Mesoblast Ltd (MSB) Mesenchymal precursor cells
Stroke recovery Mesoblast announced positive pre-clinical trial results which demonstrated that its proprietary mesenchymal precursor cells could improve functional recovery following a stroke.
Mesoblast Ltd (MSB) Mesenchymal stem cells
Bone marrow transplant recipients
Mesoblast said a peer-reviewed article in the November 2013 issue of the scientific journal Biology of Blood and Marrow Transplantation has shown that use of its proprietary culture-expanded mesenchymal stem cell product, Prochymal, resulted in a significant survival benefit among responding paediatric bone marrow transplant recipients with refractory acute graft versus host disease.
Nanosonics Ltd (NAN) Trophon EPR Ultrasound disinfection
A Nanosonics supported study showed that 79.5% of ultrasound probe handles used in intra-cavity procedures showed signs of contamination despite undergoing the conventional disinfection process with glutaraldehyde, compared to no signs of contamination with the use of Nanosonics' Trophon EPR product.
Novogen Ltd (NRT) Trilexium Ovarian cancer Novogen's US subsidiary, CanTx, has found that lead drug candidate Trilexium is highly effective at destroying ovarian cancer spheroid architecture in a research project at Yale University.
Novogen Ltd (NRT) N/A Degenerative diseases
A pilot program aimed at development of drugs to treat a wide range of genetic and non-genetic degenerative diseases including muscular dystrophy, motor neurone disease, Huntington’s Disease, cystic fibrosis and Alzheimer’s returned positive findings, with a pilot drug proving to be highly cytotoxic against the initial screen: stem cells from a neuromuscular dystrophy disease.
Prana Biotechnology Ltd (PBT)
PBT2 Memory loss Prana announced the publication of an article in the peer reviewed Aging Cell showing the effects of PBT2 on neurogenesis and in reversing the memory and learning losses associated with aging in normal (ie non transgenic) old mice.
Starpharma Holdings Ltd (SPL)
Taxotere Chemotherapy Starpharma announced positive results for its dendrimer formulation of the major chemotherapeutic docetaxel, Taxotere, ahead of clinical trials later this year. In the pre-clinical study, animals treated with Starpharma’s dendrimer-docetaxel formulation exhibited a lack of neutropenia.
Starpharma Holdings Ltd (SPL)
Dendrimer-enhanced oxaliplatin
Colon and colorectal cancer
Starpharma issued positive results for its dendrimer-enhanced oxaliplatin, specifically that its dendrimer version of oxaliplatin results in a significant reduction in the serious neurotoxicity commonly seen with oxaliplatin.
RegulatoryCompany Product Application Comments
Acrux Ltd (ACR) Axiron Testosterone replacement therapy
Axiron is now being distributed by Eli Lilly in Brazil for therapy in men for conditions associated with a deficiency or absence of endogenous testosterone. The product is being sold under the trademark Axeron.
Acrux Ltd (ACR) Axiron Testosterone replacement therapy
Axiron is now approved in Germany for testosterone replacement therapy for male hypogonadism when testosterone deficiency has been confirmed by clinical features and biochemical tests.
Admedus Ltd (AHZ) CardioCel Cardiovascular scaffold
Admedus made its first sale of CardioCel into Europe after receiving the CE mark in August.
Admedus Ltd (AHZ) CardioCel Cardiovascular scaffold
Eight surgeons were approved to use CardioCel to repair and treat heart defects in adult patients under the authorised prescriber scheme, bringing the total number of authorised surgeons to 14.
Agenix Ltd (AGX) ThromboView Antibody imaging agent
The company was granted a Chinese patent for humanised antibodies derived from DD-3B6/22, specific for the D-Dimer fragment of Fibrin, which is the basis of the company’s lead diagnostic product, ThromboView.
Analytica Ltd (ALT) PeriCoach Incontinence Analytica has registered its PeriCoach system with the Australian Therapeutic Goods Administration.
Bioniche Life Sciences Inc (BNC)
Purified hyaluronate sodium product
Horse medicine Bioniche's purified hyaluronate sodium product for horses has been approved by the US Food and Drug Administration for sale in the US.
Cellmid Ltd (CDY) N/A N/A The Japanese Patent Office granted Cellmid’s patent application JP 2007-544236, for treatment or prevention of diseases associated with a functional disorder of regulatory T cells.
Cellmid Ltd (CDY) N/A N/A The European Patent Office granted an important antibody patent for recognising C-domin of midkine.
Cochlear Ltd (COH) Nucleus hybrid implant
Hearing implant Cochlear said an advisory committee to the US Food and Drug Administration voted favourably on the Cochlear Nucleus Hybrid L24 Cochlear Implant System.
Cyclopharm Ltd (CYC) TechnegasPlus generator
Tomography imaging
Cyclopharm has received approval from the Japanese Ministry of Health to market the latest model of the TechnegasPlus Generator for clinical use.
Gi Dynamics Inc (GID) EndoBarrier Type II diabetes The German Institute of Medical Documentation and Information has designated preliminary OPS codes to EndoBarrier. The codes allow government authorities to track costs and align reimbursement codes for EndoBarrier therapy.
Immuron Ltd (IMC) Travelan Traveller's diarrhoea
Immuron's Canadian partner for Travelan, Paladin Labs, has received a Health Canada licence authorising the sale of Travelan in Canada.
Immuron Ltd (IMC) Travelan Traveller's diarrhoea
The US Patents and Trademarks Office has allowed Immuron patent claims directed to methods of treating enteric diseases caused by gram-negative bacteria with the use of Immuron’s hyperimmune colostrum platform technology.
Medical Developments International Ltd (MVP)
Space Chamber Plus
Respiratory devices
Medical Developments has received 510(k) approval from the FDA to sell its range of Space Chamber Plus Medical Devices in the US.
Neuren Pharmaceuticals Ltd (NEU)
NNZ-2566 Fragile X syndrome
Neuren said the US Food and Drug Administration has granted orphan drug designation to NNZ-2566 for treatment of Fragile X Syndrome. Orphan drug designation is a special status that the FDA may grant to a drug to treat a rare disease or condition.
Announcem
ents23
PwC | BioForum: January 2014
24
Announcem
ents
RegulatoryCompany Product Application Comments
Oncosil Medical Ltd (OSL)
N/A Cancer The US Patent and Trademark Office has allowed patent application 13/314,239, relating to devices and methods for cancer therapy.
Patrys Ltd (PAB) PAT-SM6 Cancer The Australian Patent Office has granted a key patent in the PAT-SM6 family; application number 2007355108 for novel glycosylated peptide target in neoplastic cells. This is the second patent to be granted in Australia.
Patrys Ltd (PAB) PAT-SM6 Cancer Patrys received orphan drug status from the USA Food and Drug Administration for PAT-SM6, its lead anti-cancer product.
Pharmaxis Ltd (PXS) Bronchitol Cystic fibrosis The Scottish Medicines Consortium has accepted Bronchitol for use by the National Health Service in Scotland. Bronchitol is licensed for the treatment of adult cystic fibrosis (CF) patients aged 18 years and above as an add-on therapy to best standard of care.
Phylogica Ltd (PYC) N/A Peptide libraries Phylogica has been granted a US patent for its synthetic phylomer libraries. This core patent (designated USSN 11/672,419) covers generic methods of designing synthetic phylomer peptide libraries based on the identification of parts of natural proteins, which are predicted to form structures independently when isolated from the parent protein from which they are derived.
Psivida Corp (PVA) Psivida said its licensee Alimera Sciences has received a letter from the US Food and Drug Administration stating that due to concerns regarding the risk and safety profiles of Iluvien, its new drug application could not be approved in its present form.
Qrxpharma Ltd (QRX) MoxDuo Pain relief QRX resubmitted its new drug application for MoxDuo.
PwC | BioForum: January 2014
Other news
Announcem
ents25
Company Product Application Comments
Avita Medical Ltd (AVH) N/A N/A Managing director and CEO Dr William Dolphin has agreed to step down as CEO and from the board and his interim replacement until 30 June 2014 will be chief operating and financial officer Timothy Rooney.
Bioniche Life Sciences Inc (BNC)
N/A N/A Bioniche said it intends to delist from the ASX in the first half of 2014 given the very low level of trading on the Australian Securities Exchange, subject to ASX approval.
Bioniche Life Sciences Inc (BNC)
N/A N/A Bioniche has hired Dr Michael Berendt as its new CEO to replaces Graeme McRae.
Bioxyne Ltd (BXN) N/A N/A Bioxyne advised that Dr Phillip Comans has stepped down as chief executive officer.
Circadian Technologies Ltd (CIR)
N/A N/A Circadian advised that Robert Klupacs will step down from as chief executive and managing director.
Holista Colltech Ltd (HCT) 80Less Sugar replacement The company has developed a low calorie sugar called 80Less that is as sweet as sugar but has only 20% of the calories. The product only required 1/5 as much as cane sugar and is hence, on a per gram basis cheaper than standard sugar.
Isonea Ltd (ISN) N/A N/A Isonea said Michael Thomas would step down from his role as the company’s chief executive officer.
26
Appendix
04
PwC | BioForum: January 2014
Closing MCap (A$m) Quarterly return Annual return
Medical device
AHZ Admedus Limited 188.33 74% 638%
AMT Advanced Surgical Design & Manufacture Limited 2.19 -9% -52%
ADO Anteo Diagnostics Limited 122.15 162% 154%
ACG Atcor Medical Holdings Limited 25.96 -11% 143%
BRC Brain Resource Company Limited (The) 25.43 -24% 2%
CLV Clover Corporation Limited 87.55 -1% -11%
COH Cochlear Limited 3,382.59 -3% -26%
CGS Cogstate Limited 35.55 -23% 9%
CMP Compumedics Limited 14.19 6% 16%
CYC Cyclopharm Limited 14.36 25% 47%
ELX Ellex Medical Lasers Limited 34.67 16% 89%
GBI Genera Biosystems Limited 12.41 32% 21%
GID GI Dynamics Inc 323.45 -9% 36%
IPD Impedimed Limited 44.42 36% 206%
ISN Isonea Limited 90.68 -55% 379%
ITD ITL Limited 24.38 -3% 41%
LBT LBT Innovations Limited 7.78 3% 37%
MLA Medical Australia Limited 23.98 4% 206%
MGZ Medigard Limited 2.55 12% 75%
MDG Medtech Global Limited 6.02 71% 71%
NAN Nanosonics Limited 218.39 2% 73%
OBJ OBJ Limited 45.86 106% 74%
OSL Oncosil Medical Limited 45.03 0% 420%
OIL Optiscan Imaging Limited 8.87 -13% -39%
OSP Osprey Medical Inc 81.87 -6% 62%
RMD Resmed Inc 5,983.36 -6% 35%
RVA Reva Medical 146.39 -20% -9%
SFP Safety Medical Products Limited 0.99 0% -75%
SOM Somnomed Limited 49.20 -6% 35%
SUD Suda Limited 69.85 189% 129%
TDX Tyrian Diagnostics Limited 1.02 0% 0%
UNS Unilife Corporation 453.78 41% 133%
UBI Universal Biosensors, Inc. 78.72 -37% -50%
UCM Uscom Limited 10.60 -22% -30%
Companies in the PwC Life Sciences Index
Companies in the Pw
C Life Sciences Index27
Closing MCap (A$m) Quarterly return Annual return
Pharma and Biotech
ACR Acrux Limited 411.31 -22% -10%
ACW Actinogen Limited 4.43 57% 120%
AGX Agenix Limited 2.18 -5% -19%
ACL Alchemia Limited 188.16 -7% 48%
ALT Analytica Limited 17.92 50% 23%
ANP Antisense Therapeutics Limited 22.34 7% 36%
AVX Avexa Limited 11.11 -20% -37%
AVH Avita Medical Limited 42.29 13% 13%
BLT Benitec Biopharma Limited 48.52 55% 64%
BNC Bioniche Life Sciences Inc 45.00 -8% 9%
BNO Bionomics Limited 309.25 -8% 111%
BPO Bioprospect Limited 8.70 50% 200%
BIT Biotron Limited 17.35 -11% -44%
BXN Bioxyne Limited 1.63 67% -29%
BNE Bone Medical Limited 1.08 100% 0%
CZD Calzada Limited 31.29 -2% 68%
CDY Cellmid Limited 19.31 7% 93%
CIR Circadian Technologies Limited 9.97 -27% -41%
CUV Clinuvel Pharmaceuticals Limited 35.16 -40% -48%
CTE Cryosite Limited 22.02 -29% 21%
CSL CSL Limited 33,448.75 8% 28%
CYP Cynata Therapeutics Limited 13.62 0% -18%
DVL Dorsarvi Limited 50.62 0% 5%
GTG Genetic Technologies Limited 34.36 -30% -23%
HCT Holista Colltech Limited 14.13 45% 37%
IDT IDT Australia Limited 27.96 4% 70%
IMC Immuron Limited 10.54 125% 29%
IMU Imugene Limited 8.02 89% 55%
IIL Innate Immunotherapeutics Limited 34.50 0% -
IVX Invion Limited 38.87 29% 47%
LCT Living Cell Technologies Limited 27.85 -9% 56%
MYX Mayne Pharma Group Limited 411.33 15% 147%
MVP Medical Developments International Limited 66.96 -12% -31%
MSB Mesoblast Limited 1,879.59 3% 10%
NEU Neuren Pharmaceuticals Limited 171.71 21% 229%
NRT Novogen Limited 31.49 21% 21%
NSP Nusep Limited 11.22 48% -1%
PAB Patrys Limited 30.24 79% 37%
PXS Pharmaxis Limited 32.45 -19% -92%
POH Phosphagenics Limited 117.35 37% -21%
28
Companies in the Pw
C Life Sciences Index
PwC | BioForum: January 2014
Closing MCap (A$m) Quarterly return Annual return
PBT
PYC Phylogica Limited 14.30 -6% -32%
PBT Prana Biotechnology Limited 318.61 73% 267%
PRR Prima Biomed Limited 49.15 0% -65%
PBP Probiotec Limited 22.23 27% 0%
PGL Progen Pharmaceuticals Limited. 12.16 4% -8%
PVA Psivida Corp. 96.45 5% 249%
QRX Qrxpharma Limited 118.15 -4% -17%
RGS Regeneus Limited 79.98 74% 70%
SIE Scigen Limited 30.38 10% 38%
SRX Sirtex Medical Limited 655.35 -14% -11%
SPL Starpharma Holdings Limited 250.46 -16% -33%
TIS Tissue Therapies Limited 72.17 0% -2%
VLA Viralytics Limited 26.62 -19% -9%
Notes:
AHZ Company changed name from Alied Healthcare Group to Admedus
LFC Company divested Cordlife assets and entered funeral industry
BDM Biodiem delisted from the ASX in November 2013
IIL Innate Immunotherapeutics added to index following IPO
DVL Dorvsarvi added to index following IPO
CYP Cynata Therapeutics added to index following backdoor listing into EcoQuest
29Com
panies in the PwC Life Sciences Index
30
05Methodology
PwC | BioForum: January 2014
SourcesBioForum draws on historical data from the following sources:• Capital IQ• Connect 4• The Australian Stock Exchange• Company websites• PwC Global Pharma and Life Science Quarterly
Newsbriefs
Market performanceThe Australian life sciences sector’s market performance is tracked through two indices:1. PwC Life Sciences Index2. 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/Biotechnology2. Medical devicesThese sectors have been classified according to the Global Industry Classification 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. Only the changes in market capitalisation of companies are reflected in the index to ensure that companies entering or leaving the index do not bias the results. Due to methodology changes it is not appropriate to compare current values of the PwC Life Sciences index with values calculated in previous Bioforum reports.
These changes are compared to the changes in the market performance of the following indices:• ASX All Ordinaries• NASDAQ Composite• NASDAQ BiotechDifferent 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 Life Sciences 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 performersAnnual data on these companies is sourced from Bloomberg each quarter. Company announcements are sourced from company websites.
IPO and secondary finance marketsIPO and secondary financing data is sourced from the Connect 4 database’s 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 financing data is sourced from Thompson Reuters.
AnnouncementsThese 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
31M
ethodology
32
06Contacts
PwC | BioForum: January 2014
33
Tax and Legal
Sandra Mason P: +612 8266 0470 E: [email protected]
Stephanie Fabian P: +612 4925 1278 E: [email protected]
National Pharmaceuticals Leader
John Cannings P: +612 8266 6410 E: [email protected]
PwC Australia Life Sciences and Innovation Practice contacts
Australian Industry Leaders – Life Sciences
PwC Australia Life Sciences
Michelle Chiang P: +612 8266 7575 E: [email protected]
Manoj Santiago P: +612 8266 4494 E: [email protected]
Assurance
Manoj Santiago P: +612 8266 4494 E: [email protected]
Michelle Chiang P: +612 8266 7575 E: [email protected]
34
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.
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
Acknowledgements
Acknow
ledgements
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 fitness 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.
© 2014 PricewaterhouseCoopers. All rights reserved. In this document, ‘PwC’ refers to PricewaterhouseCoopers a partnership formed in Australia, which is a member firm of PricewaterhouseCoopers International Limited, each member firm of which is a separate legal entity.
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