www.pwc.com.

au/bioforum

Medical devices Impeccable timing?

BioForum
Edition 45
Quarter 1 FY14 October 2013

Highlights
Q4FY13 key statistics

Highlights

7.0%
(up 2.4% Q4FY13)

Life Sciences Index Nasdaq Biotech

(up 8.6% Q4FY13)

20.7% 9.3%

10.8%
(up 5.1% Q4FY13)

Nasdaq Composite

15.4%
(up 0.4% Q4FY13)

Life Sciences Index ASX All Ordinaries (down 4.1% Q4FY13) ex Majors

Key developments
The new Coalition Government announced its ministry, naming the Honourable Ian Macfarlane MP as Minister for Industry. The Government says it is open to the idea of a patent box tax incentive, which comprises lower company tax rates on income attributable to patented IP to encourage commercialisation activities in Australia. A national survey by Auspoll found that the scientific literacy of Australian adults has fallen over the past three years. The survey asked respondents a series of questions on basic scientific facts. Flinders University Associate Professor Michael Sorich expressed concern about the trend towards personalised medicine, particularly in cancer treatment. He said this was putting pressure of the Australian Government to subsidise moretreatments.

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Introduction

Introduction
In the first quarter...
The Ex- major Medical Devices sector has emerged as the stand-out performer in this edition of Bioforum, suggesting renewed investor confidence in this previously volatile sector. And perhaps the timing for this sector could not be better. With the new government focused on advancing Australian exports beyond the resources sector, will the Medical Devices sector (Med Device) emerge as a key industry to drive economic growth? Over the past year, the Med Device sector recorded a substantial 67 per cent growth, up 14.1 per cent for the quarter. Leading this charge was Isonea, which has returned a staggering 1129 per cent during the year off the back of the Australian launch of AirSonea, its smartphone based wheeze monitoring device. So, whats driving this success? One school of thought is that it is a market correction driven by a greater sense of optimism in the prospects of Australian Med Device firms; however, we think theres more to it. PwCs 2011 Medical Technology Innovation Scorecard outlined the five pillars of innovation that make a successful Med Device industry. These included powerful financial incentives, leading resources for innovation, a supportive regulatory system, demanding and price-insensitive patients, and a supportive investment community. We believe these foundations are increasingly strong in the Australian economy and the Med Device industry is ripe to grow and prosper. In another optimistic sign for the Life Sciences sector, this quarter saw the first Australian IPO since Q4FY12. Regeneus, a regenerative medicine company, raised $10.5m for a total valuation of $46m. The Med Device sector backed up its impressive market performance with total secondary raisings of $78m, the highest result since Q2Fy10, led by large raisings from Isonea and GI Dynamics. The broader sector performed strongly in the September quarter, with the PwC Life Sciences index up 7 per cent and the Ex-majors index up 15.4 percent. Despite this, there were some lacklustre results from some mid-sized Pharmaceutical firms due to disappointing clinical trials and regulatory hurdles, headed by QRx Pharma (-26 per cent), Phosphagenics (-35 per cent) and Prima Biomed (-43 per cent). These falls serve as a reminder to investors to beware of clinical and regulatory risks and that investing in this sector is a long run game. This quarter saw AusBiotech increase their discussions about a patent box tax incentive. Under this scheme, to incentivise firms to keep their commercialisation activities within Australia, income attributable to patented IP will be subject to lower tax rates. Commercialisation and R&D are critically important and we welcome these discussions for ongoing tax reform. However, to be successful, R&D needs to be supported by some degree of manufacturing. More incentives to grow and sustain Australian manufacturing would benefit the entire industry, allowing for greater ingenuity in both the design and prototype phase of commercialisation.

Manoj Santiago PwC Private Clients pwc.com.au/privateclients

PwC | BioForum: October 2013

PwCs 2011 Medical Technology Innovation Scorecard outlined the five pillars of innovation that make a successful Med Device industry. These included powerful financial incentives, leading resources for innovation, a supportive regulatory system, demanding and price-insensitive patients, and a supportive investment community. We believe these foundations are increasingly strong in the Australian economy and the Med Device industry is ripe to grow and prosper.

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Contents

Contents

06 24
Appendix

Quarterly key findings

08 28

Market performance

18

Announcements

Methodology

30
Contacts

PwC | BioForum: October 2013

01
Quarterly key findings

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Quarterly key findings

Quarterly key findings

Market performance
Life sciences industry total MCap Life sciences industry growth Pharma/biotech sector total MCap Pharma/biotech sector growth Medical device sector total MCap Medical device sector growth

Q1FY14
A$51,304m 7.0% A$38,507m 7.7% A$12,797m 5.0%

Page
11

12

12

Individual company performance

Top individual performer Change in market cap over the past four quarters Bottom individual performer Change in market cap over the past four quarters Isonea Limited 1129% Pharmaxis Limited -89% 17 16

Financing
Australian IPO count Total raised US IPO count Total raised Australian secondary financing count Total raised US secondary financing count Total raised 1 A$46m 11 A$757m 32 A$113m 67 A$2,337m 15 15 13 13

Announcements Australia
Partnerships Mergers & acquisitions Clinical trials Regulatory Other

Q1FY14
14 6 12 18 9

Page
19 20 21 22 23

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02
Market performance

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Market performance

Performance overview
Figure 1: Weekly performance over the quarter of the Australian life sciences compared to major indices
25% 20% 15% 10% 5% 0% 30-Jun

05-Jul

12-Jul

19-Jul

26-Jul

02-Aug

09-Aug

16-Aug NASDAQ Biotech

23-Aug

30-Aug Life Sciences

06-Sep

13-Sep

20-Sep

30-Sep

ASX All Ordinaries

NASDAQ Composite

Life Sciences ex majors

Table 1: Quarterly movements of the Australian life sciences sector compared to major indices
Value 31-Mar-13 ASX All Ordinaries (Index) NASDAQ Composite (Index) NASDAQ Biotech (Index) Life Sciences (market cap A$m) Life Sciences ex majors (market cap A$m) 4,980 3,239 1,669 46,804 7,207 30-Jun-13 4,775 3,403 1,813 47,932 7,232 30-Sep-13 5,218 3,771 2,189 51,304 8,345 % Change (Mar-Jun) -4.1% 5.1% 8.6% 2.4% 0.4% % Change (Jun-Sep) 9.3% 10.8% 20.7% 7.0% 15.4%

Graph 1: Quarterly movements of the Australian life sciences sector compared to major indices
25.0% 20.0% 15.4% 15.0% 10.0% 5.0% 0.0% -5.0% -10.0% -4.1% 9.3% 5.1% 2.4% 10.8% 8.6% 20.7%

7.0% 0.4%

ASX All Ordinaries (Index)

NASDAQ Composite (Index)

NASDAQ Biotech (Index) % Change (Jun-Sep)

Life Sciences (market cap A$m)

Life Sciences ex majors (market cap A$m)

% Change (Mar-Jun)

Figure 2: Two-year comparison of the Australian life sciences sector by market capitalisation compared to major indices
140% 120% 100% 80% 60% 40% 20% 0% -20% -40% -60% 30-Sep-11 31-Dec-11 31-Mar-12 30-Jun-12 NASDAQ Composite 30-Sep-12 31-Dec-12 31-Mar-13 Life Sciences 30-Jun-13 Life Sciences ex majors 30-Sep-13

ASX All Ordinaries

NASDAQ Biotech

PwC | BioForum: October 2013

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Market performance
Table 2: Yearly performance of the Australian life sciences sector by market capitalisation compared to major indices
% Change (Jun12-Jun13) 30-Jun-12 ASX All Ordinaries (Index) NASDAQ Composite (Index) NASDAQ Biotech (Index) Life Sciences (market cap A$m) Life Sciences ex majors (market cap A$m) 4,135 2,935 1,352 34,842 6,638 30-Jun-13 4,775 3,403 1,813 47,932 7,232 % Change 15.5% 16.0% 34.1% 37.6% 9.0% % Change (Sep12-Sep13) 30-Sep-12 4,406 3,116 1,486 39,692 7,154 30-Sep-13 5,218 3,771 2,189 51,304 8,345 % Change 18.4% 21.0% 47.3% 29.3% 16.6%

Graph 2: Yearly performance of the Australian life sciences sector by market capitalisation compared to major indices
50.0% 40.0% 30.0% 20.0% 10.0% 0.0% ASX All Ordinaries (Index) NASDAQ Composite (Index) NASDAQ Biotech (Index) Life Sciences (market cap A$m) Life Sciences ex majors (market cap A$m) 15.5% 18.4% 21.0% 16.0% 9.0% 16.6% 47.3% 37.6% 29.3%

34.1%

% Change (Jun12-Jun13)

% Change (Sep12-Sep13)

Figure 3: Quarterly performance of the Australian life sciences sector and subsectors
20% 15% 10% 5% 0% -5% -10% 30-Jun-13

07-Jul-13

14-Jul-13 Lif e Sciences

21-Jul-13

28-Jul-13

04-Aug-13

11-Aug-13

18-Aug-13

25-Aug-13

01-Sep-13

08-Sep-13

15-Sep-13

22-Sep-13

29-Sep-13

Lif e Sciences ex majors

Pharma/Biotech

Pharma/Biotech ex CSL

Med Device

Med Device ex COH, RMD

Table 3: Quarterly summary of the Australian life sciences indices performance

MCap (A$m) Pharma/Biotech Pharma/Biotech ex CSL Med Device Med Device ex COH, RMD Life Sciences Life Sciences ex majors 38,507 6,579 12,797 1,766 51,304 8,345

Companies Proportion Companies Proportion Companies Proportion Total % of total with share of subsector with share of subsector with share of subsector number of value price gains up price losses down price flat flat companies 75% 79% 25% 21% 100% 100% 34 33 25 24 59 57 67% 66% 74% 75% 69% 70% 14 14 7 6 21 20 27% 28% 21% 19% 25% 24% 3 3 2 2 5 5 6% 6% 6% 6% 6% 6% 51 50 34 32 85 82

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Market performance
Figure 4: Two-year comparison of the Australian life sciences indices performance by market capitalisation
180% 150% 120% 90% 60% 30% 0% -30% 30-Sep-11 30-Dec-11 Life Sciences 30-Mar-12 Life Sciences ex majors 30-Jun-12 30-Sep-12 30-Dec-12 Pharma/Biotech ex CSL 30-Mar-13 Med Device 30-Jun-13 30-Sep-13 Pharma/Biotech Med Device ex COH, RMD

Table 4: Quarterly performance of the Australian life sciences sectors by market capitalisation $A$m
Market capitalisation (A$m) 31-Mar-13 Pharma/Biotech Pharma/Biotech ex CSL Med Device Med Device ex COH, RMD Life Sciences Life Sciences ex majors 35,611 6,152 11,193 1,055 46,804 7,207 30-Jun-13 35,741 5,685 12,191 1,547 47,932 7,232 30-Sep-13 38,507 6,579 12,797 1,766 51,304 8,345 % Change (Mar-Jun) 0.4% -7.6% 8.9% 46.6% 2.4% 0.4% % Change (Jun-Sep) 7.7% 15.7% 5.0% 14.1% 7.0% 15.4%

Graph 3: Quarterly performance of the Australian life sciences sector and subsectors by market capitalisation
50.0% 40.0% 30.0% 20.0% 10.0% 0.4% 0.0% -10.0% Pharma/Biotech 7.7% 46.6%

15.7% 8.9% 5.0%

14.1% 7.0% 2.4% 0.4%

15.4%

-7.6% Pharma/Biotech ex CSL Med Device Med Device ex COH,RMD % Change (Jun-Sep) Life Sciences Life Sciences ex majors

% Change (Mar-Jun)

PwC | BioForum: October 2013

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Market performance

IPO financing
Quarterly financing

Figure 5: Quarterly comparison of IPOs in Australia

50

Table 5: Number of quarterly Australian IPO listings

Biotech Q1FY14 Q4FY13
46

Med Devices -

ASX 8 11 12 17 9

1 -

40
Capital Raised (A$m)*

Q3FY13 Q2FY13 Q1FY13

30

20

Table 6: Listing of quarterly Australian IPO listings

10

Company
0 Q1FY13 Q2FY13 Q3FY13 Q4FY13 Biotech Q1FY14 Medical Devices

Listing date 9/19/2013

Capital raised (A$) 10.5m

Valuation on listing 46m

Sector Biotech

Regeneus Ltd Total

Note: * Amount shown is total market cap addition to the LS Index from IPOs on first day of trading

Figure 6: Quarterly comparison of IPOs in the US

3,000 2,500 Capital Raised (A$m) 2,000 57 1,500 2,361 1,000 1,544 500 95 4 229 Q2FY13 Q3FY13 Q4FY13 Biotech Q1FY14 Medical Devices 757 55

Table 7: Total of quarterly US IPO listings

Biotech Q1FY14 Q4FY13 Q3FY13 Q2FY13 Q1FY13 11 9 6 3 1 Med Devices 1 2 1 1

Table 8: Listing of quarterly US IPO listing

Capital raised (A$m) 116 27 50 72 85 13 72 48 67 27 180 757

49 Q1FY13

Company Agios Pharmaceuticals Inc Heat Biologics Inc Cellular Dynamics Intl Inc Conatus Pharmaceuticals Inc Onconova Therapeutics Inc Tonix Pharm Hldg Corp Sophiris Bio Inc Regado Biosciences Inc Five Prime Therapeutics Inc Evoke Pharma Inc Ophthotech Corp Total

Listing date 23/07/2013 23/07/2013 24/07/2013 24/07/2013 24/07/2013 09/08/2013 16/08/2013 22/08/2013 18/09/2013 24/09/2013 24/09/2013

Sector Biotech Biotech Biotech Biotech Biotech Biotech Biotech Biotech Biotech Biotech Biotech

Note: * Amount shown is total amount raised

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Market performance

Yearly financing

Figure 7: Annual comparisons of IPOs in Australia

600 500 Capital Raised (A$m) 400 300 200 100 0 7 360

Table 9: Number of IPO listings in Australia

Biotech FY14 FY13 FY12 FY11 FY10 1 1 1 Med Devices 2 1 ASX 8 49 75 127 53

352 145 46

FY10

FY11

FY12

FY13
Biotech

FY14

Medical Devices

Figure 8: Annual comparison of IPOs in the US

5,000 4,500 4,000
Capital Raised (A$m)

Table 10: Number of IPO listings in the US

Biotech FY14 11 19 12 6 7 Med Devices 5 4 8 2

211

FY13 FY12 FY11

3,500 3,000 2,500 2,000 1,500 1,000 500 0 FY10

251 107 586 757 4,181

FY10

1,662

458 368

FY11

FY12

FY13
Biotech

FY14

Medical Devices

PwC | BioForum: October 2013

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Market performance

Secondary finance market

Quarterly financing
Figure 9: Quarterly comparison of secondary financing inAustralia
250 6 200 Capital Raised (A$m)

Table 11: Number of secondary deals (AU)

Avg. amount raised ($m) 1.6 2.1 8.0 5.1 1.2 Avg. amount raised ($m) 7.8 0.8 0.9 2.1 0.6

Biotech Q1FY14 Q4FY13 22 32 25 22 24

Med Devices 10 4 7 12 8

150 25 100 201 3 50 5 28 0 Q1FY13 Q2FY13 Q3FY13 Q4FY13 Biotech Q1FY14 Medical Devices 111 68 35 78

Q3FY13 Q2FY13 Q1FY13

Figure 10: Quarterly comparison of secondary financing in the US

18,000 16,000 14,000 Capital Raised (A$m) 12,000 10,000 8,000 6,000 4,000 2,000 0 721 1,055 473 1,323 4,084 322 2,016 15,541 15,541 2,524 349

Table 12: Number of secondary deals (US)

Biotech Q1FY14 Q4FY13 Q3FY13 Q2FY13 Q1FY13 48 38 33 52 29 Med Devices 19 22 24 18 21

Q1FY13

Q2FY13

Q3FY13

Q4FY13
Biotech

Q1FY14

Medical Devices

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Market performance

Yearly financing
Figure 11: Annual comparison of secondary financing inAustralia
600 500 400 300 200 100 0 FY10 FY11 FY12 FY13 Biotech Medical Devices 246 95 271 55 39

Table 13: Number of Australian secondary raisings

Biotech FY14 FY13 FY12 FY11 FY10 22 103 99 154 107 Med Devices 10 31 39 43 39

Capital Raised (A$m)

383 294

408

78 35 FY14

Figure 12: Annual comparison of secondary financing in the US

30,000

Table 14: Number of US secondary raisings

Biotech FY14 48 152 125 66 122 Med Devices 19 85 43 121 57

25,000 20,000 15,000 10,000 2,400 5,000 5,974 0 FY10 5,578 1,279 FY11 FY12 781 5,250

4,067

FY13 FY12 FY11

Capital Raised (A$m)

22,003

FY10

322 2,016 FY13 Biotech FY14

Medical Devices

PwC | BioForum: October 2013

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Market performance

Top 10
Performers over past four quarters
ISN OSL AHZ NEU ACG PVA NRT MGZ CTE BNO 0% 200% 400% 600% 800% 1000% 1200%

01 02 03 04 05 06 07 08 09 10

Isonea Ltd

Return: 1129% Closing price $0.75 MCap A$200.89m Return: 400% Closing price $0.13 MCap A$39.28m Return: 287% Closing price $0.09 MCap A$94.96m Return: 252% Closing price $0.10 MCap A$125.09m Return: 217% Closing price $0.19 MCap A$28.08m Return: 157% Closing price $4.11 MCap A$112.53m Return: 129% Closing price $0.17 MCap A$25.24m Return: 127% Closing price $0.03 MCap A$2.28m Return: 124% Closing price $0.65 MCap A$30.32m Return: 120% Closing price $0.82 MCap A$323.24m

Isonea completed a $13.5m capital raising in late June ahead of the September launch of its AirSonea device in Australia and the US. A poll of 100medical professionals showed 80% recommended the iPhone-based wheeze monitoring system for asthma sufferers.

Oncosil Medical Ltd

Oncosil acquired Enigma Therapeutics, a UK-based cancer company, in February. Dr Neil Frazer was appointed CEO in early July and multiple capital raisings were heavily oversubscribed. Coridon, in which Allied Healthcare owns a 47% stake, was approved to begin a phase I trial of its herpes simplex virus vaccine. European approval of its cardiovascular patch CardioCel appears more likely in the first quarter of FY14. The company increased revenue 15% to $7.4m and cut its operating loss to $2.4m, down from $10m in the prior year. The US Food and Drug Administration awarded a fast track designation for Neurens Rett Syndrome treatment and Neuren began a phase II clinical trial inApril 2013. AtCor Medicals SphygmoCor Xcel system for measuring central aortic blood pressure received an excellent rating from the European Artery Society. Results from a randomised clinical study demonstrated the benefits of using central blood pressure measurement to manage the health of patients with high blood pressure. The date is approaching when pSividas Iluvien implant could be approved under the US Prescription Drug User Fee Act, triggering a $25m milestone payment. The potential approval could allow the company to file an NDA for the diabetic macula oedema treatment earlier than expected. There has been speculation about pSivida becoming a takeover target. A major oncology study showed Novogens CS-6 was highly active against ovarian cancer stem cells, which are considered some of the hardest cancer cellsto kill.

Allied Healthcare Group Ltd

Neuren Pharmaceuticals Ltd

Atcor Medical HoldingsLtd

Psivida Corp.

Novogen Ltd

Medigard Ltd

Medigard entered into an exclusive agreement with Shanghai Sol-Millennium Medical Products, which will manufacture and distribute Medigards blood collection device and blood flash needle.

Cryosite Ltd

Cryosites revenue rose 9% and its profit was up 22% compared to the prior financial year. The company paid two one-cent dividends during the year.

Bionomics Ltd

Bionomics acquired Eclipse Therapeutics in September 2012 and raised $15.6m through a rights issue. Preliminary data from a phase I trial of its ovarian cancer drug BNC105 was positive and enrolment for a phase II trial in metastatic renal cancer was completed.

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Market performance

Bottom 10
Performers over past four quarters
PXS BXN PRR ACW SFP AGX BNE IMC AMT IMU
-100% -90% -80% -70% -60% -50% -40% -30% -20% -10% 0%

10 09 08 07 06 05 04 03 02 01

Imugene Ltd

Return: -47% Closing price: $0.01 MCap: A$3.03m Return: -48% Closing price: $0.07 MCap: A$2.41m Return: -66% Closing price: $0.00 MCap: A$4.14m Return: -67% Closing price: $0.00 MCap: A$1.08m Return: -74% Closing price: $0.02 MCap: A$2.07m

Imugene offered a share purchase plan at a 10% discount in April and posted a loss of$1.26m after tax for the half year ended December 2012. It is moving from its animal vaccine portfolio to a pharmaceutical business with an emphasis on drug delivery technologies.

Advanced Surgical Design & ManufactureLtd

ASDM made a loss after tax of $570k, up from $170k the prior year. A rights issue during the year raised $800k. A debtors financing facility was secured and the company cut its total debt to $2.6m in FY13 from $1.9m in FY12.

Immuron Ltd

Immuron posted a $3.5m loss for the financial year after revenue fell $1.1m. CEOJoeBaini resigned in February. A rights issue in February raised $1.86m.

Bone Medical Ltd

Funding arrangements with La Jolla Cove investors have become strained, with La Jolla delaying payments, and the company engaged DH Flinders to source new capital. Revenue effectively fell to zero with a net loss of $1.85m leaving Bone Medical in a negative working capital position and lacking funding to continue R&D. Agenix was advised that no further payments from a working capital facility would be made from December 2012. This required directors, senior management and some shareholders to provide unsecured funding. Agenix secured funding with Baycrest Capital of up to $3m over three years and reported a $3.26m loss for FY13 due to significant impairment of R&D intangibles.

Agenix Ltd

Safety Medical ProductsLtd

Return: -75% FY13 losses totalled $940k, more than double the prior year, after the company Closing price: $0.002 purchased a gold company in May. It disposed of all non-Australia patents relating toits SecureTouch syringe. MCap: A$.89m Return: -79% Closing price: $0.01 MCap: A$.62m
Actinogen posted a loss of $160k, significantly less than the FY12 result of $1.6m. Itannounced it would close its Nedlands laboratory in a cost-saving exercise and made two scientist positions redundant.

Actinogen Ltd

Prima Biomed Ltd

Return: -80% Primas share price slumped after an early stage study showed no observed difference Closing price: $0.039 between patients taking its ovarian cancer treatment and the control group, although the study was not sufficiently powered to detect statistical significance. MCap: A$49.15m Return: -87% Closing price: $0.00 MCap: A$.98m Return: -89% Closing price: $0.13 MCap: A$43.20m
The companys phase IIb COPD trial had disappointing results, revealing no statistically significant clinical benefit across the entire cohort of patients. However, benefits were observed for patients under 65 years. A proposed transaction with Vitality Devices was terminated after a due diligence process. The ASX queried Bioxynes cash position in August. Pharmaxis received a negative recommendation from a US committee advising the FDA on the use of Bronchitol in cystic fibrosis patients. The FDA also added Aridol toits Import Alert list, effectively stopping imports of the product until removal.

Bioxyne Ltd

Pharmaxis Ltd

PwC | BioForum: October 2013

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03
Announcements

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Announcements

Australia partnerships
Company Biotechnology Benitec Biopharma Ltd (BLT)
UNSW Lung cancer N/A

Partner

Application

Value (A$m)

Comments Total 6
Benitec announced that it has executed a licensing agreement with the University of New South Wales (UNSW) related to the companys Tribetarna program, a therapy for lung cancer. Benitec has licensed its ddRNAI gene silencing technology to Regen for the development of cancer vaccines. Bionomics signed an option and license agreement with Merck to discover and develop novel small molecule candidates for the treatment of chronic pain, including neuropathic pain. Natural Garden agreed to distribute 30,000 units of Cellmids FGF-5 inhibitor hair growth lotions. Cellmid signed a collaboration agreement with Abcodia, a UK biomarker validation company, to test midkine in its collection of longitudinal serum samples using Cellmids MK-ELISA. Fujikura will exercise its option to license Cellmids midkine diagnostic technology by paying the milestone fee under a previous arrangement.

Benitec Biopharma Ltd (BLT) Bionomics Ltd (BNO)

Regen BioPharma

Cancer vaccines

Undisclosed

Merck

Chronic pain

Undisclosed

Cellmid Ltd (CDY) Cellmid Ltd (CDY)

Natural Garden Abcodia

Distribution of hair growth lotions Midkine testing

Undisclosed N/A

Cellmid Ltd (CDY)

Fujikura Kasei

Midkine diagnostic technology

$440k

Medical Devices Nanosonics Ltd (NAN) Tyrian Diagnostics Ltd (TDX) Unilife Corporation (UNS) Pharma Mayne Pharma Group Ltd (MYX)
HedgePath Pharmaceuticals Cancer Equity stake in HedgePath of 30-45% Undisclosed GE Disinfection system Undisclosed

Total 3
GE Healthcare announced a sales and marketing investment to accelerate the roll-out of Trophon EPR, a system for disinfecting ultrasound systems. Tyrian and Bayer CropScience agreed to terminated their license agreement on 1 September 2014. Unilife signed a long-term supply contract with Sanofi for 150m Unifill syringes a year, after a four-year ramp-up period.

Bayer Crop Science Sanofi

N/A Syringe technology

N/A Up to $15m in milestone payments and royalties

Total 5
Mayne signed a supply and license agreement with HedgePath to develop, register and commercialise Maynes drug Suba-Intraconazole for treatment of a variety of cancers. Mayne signed two marketing and distribution agreements for Subacap, an improved formulation of Itraconazole used to treat fungal infections, in four key European pharmaceuticalmarkets. Phylogica expanded its collaboration with Janssen Biotech to discover, develop and commercialise new peptide drug conjugates derived from Phylogicas phylomer drug discovery platform. $1.25m in milestones and double digit royalties Undisclosed QRx and Aspen Pharma signed a deal for the immediate release of Moxduo in Australia, New Zealand and Oceania. Starpharma and Gowan announced a new partnership using Starpharmas Priostar dendrimer technology in crop protection formulations.

Mayne Pharma Group Ltd (MYX)

ISDIN and Glenmark

Fungal infections

Phylogica Ltd (PYC)

Janssen Biotech

Peptide drug conjugates

QRxpharma Ltd (QRX) Starpharma Holdings Ltd (SPL)

Aspen Pharma

Moxduo pain relief

Gowan Company

Pripostar dendrimer technology

PwC | BioForum: October 2013

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Announcements

Mergers, acquisitions and divestments

Dominant company Biotechnology Genetic Technologies Ltd (GTG) Medical Devices Advanced Surgical Design & Manufacture Ltd (AMT)
ITL Ltd (ITD) Medical Australia Ltd (MLA) Suda Ltd (SUD) Orthofix Australia Divestment Undisclosed Simavita Holdings Acquisition Undisclosed

Other company

Type of deal

Value (A$m)

Comments Total 1
Genetic Technologys subsidiary Gtech merged with Sydney-based company Simavita, which develops solutions for incontinence.

Total 4
ASDM entered into a 12-month transitional distribution services agreement with Orthofix, which has acquired ASDMs spinal business. ITL acquired long-term leasehold land and a medical device facility in Malaysia. Medical Australia announced it would acquire MediVet for $11m through a share issue. MediVet is a leading animal health company. Suda acquired NovaDel Pharma, including its NovaMist technology.

N/A MediVet

Asset purchase Acquisition

$1.5m $11m

NovaDel Pharma

Acquisition

Undisclosed

Pharma
Mayne Pharma Group Ltd (MYX) Libertas Pharma Acquisition Undisclosed

Total 1
Mayne Pharma acquired US-based Libertas Pharma, a generic pharmaceutical company.

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Announcements

Clinical trials
Company Phase I Biotron Ltd (BIT) Drug
BIT225 HCV and HIV

Application

Comments Total 2
The study of Biotrons BIT225 formulation demonstrated that the capsule administered drug is better absorbed and has a relative bioavailability more than 1.6 times greater than the previous powder formulation. The trial of QT Penthrox met the primary endpoint and all secondary endpoints.

Medical Developments International Ltd (MVP) Phase II

Allied Healthcare Group Ltd (AHZ) Patrys Ltd (PAB)

QT/QTc Penthrox

Pain relief

CardioCel PAT-SM6 Tissue repair Cancer treatment

Total 3
Five-year data from the trial in CardioCel patients showed no signs of calcification at site of repair. Additional data released from a phase I/Iia trial showed that PATSM6 is active in patients with end-stage disease who are resistant to other marketed therapies. Viralytics achieved the primary endpoint in its phase II trial of Cavatak in late stage melanoma patients.

Viralytics Ltd (VLA)

Cavatak

Melanoma

Phase III Suda Ltd (SUD)

ArTiMist Malaria

Total 2
The phase III trial of ArTiMist, Sudas malaria treatment, showed it was superior to intravenous quinine and a rapid and effective treatment for young children. Interim results of the phase II trial were positive, with solid progress towards meeting the primary endpoint.

Viralytics Ltd (VLA)

Cavatak

Melanoma

Pre-clinical and other Cogstate Ltd (CGS)

Lurasidone Cognitive function test

Total 5
A peer-reviewed paper showed that Lurasidone, an atypical antipsychotic drug, improved cognitive function of schizophrenia patients, as measured by the Cogstate tests, significantly more than the control group. Pre-clinical trial data for cell therapy Ntcell in a non-human primate model of Parkinsons disease demonstrated recovery from movement abnormalities, improvements in neurological defects, and an increase in neural connections and the number of dopamine-producing neurons in the affected area of the brain. Neuren announced positive results from a validated animal model using its drug molecule NNZ-2591 for Fragile X Syndrome. Osprey received FDA approval to undertake a clinical trial of its Avert System to study a marketing claim expansion to include reduction of contrast-induced nephropathy for patients undergoing angiogram or stenting procedures. A pre-clinical study showed improved tumour-inhibiting efficacy and reduced overall toxicity using a dendrimer enhanced version of the blockbuster cancer drug, Oxaliplatin.

Living Cell Technologies Ltd (LCT)

Ntcell

Parkinsons disease

Neuren Pharmaceuticals Ltd (NEU) Osprey Medical (OSP)

NNZ-2591 Avert System

Fragile X Syndrome Contrast-induced nephropathy

Starpharma Holdings Ltd (SPL)

Oxaliplatin

Cancer

PwC | BioForum: October 2013

22
Announcements

Regulatory
Company Biotechnology Analytica Ltd (ALT) Bioniche Life Sciences Inc (BNC) Bone Medical Ltd (BNE) Circadian Technologies Ltd (CIR)
N/A Folltropin Axcess II VEGF-D Burette technology Animal health Musculoskeletal diseases Lymphangioleiomyomatosis (Lung disease)

Product

Application

Comments Total 6
A Chinese patent was granted for Analyticas core AutoStart system intellectual property. Regulatory authorities in seven European countries have agreed to register Bioniches top-selling animal health product Folltropin. Bone Medical received a notice of allowance for its Axcess II patent application in Canada. The US FDA designated Circadians VEGF-D assay kit as a humanitarian use device for the detection of circulating VEGF-D intended to monitor patients who have been diagnosed with lymphangioleiomyomatosis for disease progression and response to therapeutic intervention. The European Patent Office said it would grant Imugenes patent application protecting its Linguet drug delivery technology. The Japan Patent Office granted a key foundation patent application protecting Imugenes Linguet drug delivery technology.

Imugene Ltd (IMU) Imugene Ltd (IMU) Medical Devices Allied Healthcare Group Ltd (AHZ) Atcor Medical Holdings Ltd (ACG)
Atcor Medical Holdings Ltd (ACG) Atcor Medical Holdings Ltd (ACG) Isonea Ltd (ISN)

Linguet Linguet

Drug delivery technology Drug delivery technology

CardioCel SphygmoCor Cardiac defects Measurement of central aortic blood pressure Measurement of central aortic blood pressure Aortic blood pressure measurement Wheeze monitoring Wheeze monitoring Ultrasounds

Total 7
CardioCel received a CE Mark in Europe. AtCors SphygmoCor Xcel system was approved for sale in Mexico. AtCors SphygmoCor Xcel system was approved for sale in the Republic of Korea. Atcor announced that its European patent application, Method and apparatus for determination of central aortic pressure, has been successful. AirSonea received a CE Mark in Europe. The Therapeautic Goods Administration approved the companys AirSonea technology for sale in Australia. Trophon EPR was approved for use in South Korea following receipt of a product licence from the Korean Food and DrugAdministration.

SphygmoCor SphygmoCor

AirSonea AirSonea Trophon EPR

Isonea Ltd (ISN) Nanosonics Ltd (NAN)

Pharma Neuren Pharmaceuticals Ltd (NEU) Patrys Ltd (PAB)

N/A PAT-SM6 Neuropeptide formulations Anti-cancer

Total 5
The US Patent Office issued a notice of allowance for two Neuren patents. Patryss anti-cancer drug PAT-SM6 has been granted orphan drug designation by the European Medicines Agency for multiple myeloma. Pharmaxis received approval for simplified access to Bronchitol for cystic fibrosis treatment under the Pharmaceutical BenefitsScheme. The French National Health Authority approved Iluvien for the treatment of chronic diabetic macular oedema considered insufficiently responsive to available therapies. Patients will be reimbursed 100% of the cost of Iluvien under a French program for treatment of severe diseases. The FDA issued a complete response letter regarding the companys new drug application for Moxduo requiring it to resubmit its application. QRx plans to complete its refiling in Q4 2013. The delay has been caused by timing issues in data included in the original submission.

Pharmaxis Ltd (PXS)

Bronchitol

Cystic fibrosis

pSivida Corp (PVA)

Iluvien

Eye disease

QRxpharma Ltd (QRX)

Moxduo

Pain relief

23
Announcements

Other news
Company Biotechnology Bioniche Life Sciences (BNC) Imugene Ltd (IMU) Medical Devices Isonea Ltd (ISN) Nanosonics Ltd (NAN) Pharma Calzada Ltd (CZD) Pharmaxis Ltd (PXS)
N/A N/A

Product

Application

Comments Total 2
Bioniche founder and CEO Graeme McRae will step down from his position once a replacement is found, but will remain in the role of chairman. Imugene discontinued development of its fast-melt ibuprofen tablets due to unsuccessful testing.

Ibuprofen

Pain relief

AirSonea N/A Wheeze monitoring device N/A

Total 2
Isonea launched its flagship product AirSonea in Australia. Former Cochlear executive Michael Kavanagh was appointed as the CEO of Nanosonics.

N/A N/A

Total 5
Calzada refuted allegations in major newspapers that it had been involved in a secret drug trial at the Essendon FootballClub. Pharmaxis announced pricing of Bronchitol in France was delayed due to issues in agreeing a reimbursed price withauthorities. Dr Esra Ogru stepped down as CEO after she was suspended when the board discovered irregular invoicing and accounting transactions at Phosphagenics. Phylogica appointed Dr Richard Hopkins as CEO. Progen appointed Heng Hsin Tang as acting managingdirector.

Bronchitol

Cystic fibrosis

Phosphagenics Ltd (POH)

N/A

N/A

Phylogica Ltd (PYC) Progen Pharmaceuticals Ltd (PGL)

N/A N/A

N/A N/A

PwC | BioForum: October 2013

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04
Appendix

25
Companies in the PwC Life Sciences Index

Companies in the PwC Life Sciences Index

Closing MCap (A$m) Medical device AMT AHZ ADO ACG BRC CLV COH CGS CMP CYC ELX GBI GID IPD ISN ITD LBT MLA MGZ MDG NAN OBJ OSL OIL OSP RMD RVA SFP SOM SUD TDX UNS UBI UCM Advanced Surgical Design & Manufacture Limited Allied Healthcare Group Limited Anteo Diagnostics Limited Atcor Medical Holdings Limited Brain Resource Company Limited (The) Clover Corporation Limited Cochlear Limited Cogstate Limited Compumedics Limited Cyclopharm Limited Ellex Medical Lasers Limited Genera Biosystems Limited Gi Dynamics Inc Impedimed Limited Isonea Limited Itl Limited Lbt Innovations Limited Medical Australia Limited Medigard Limited Medtech Global Limited Nanosonics Limited Obj Limited Oncosil Medical Limited Optiscan Imaging Limited Osprey Medical Inc Resmed Inc Reva Medical Safety Medical Products Limited Somnomed Limited Suda Limited Tyrian Diagnostics Limited Unilife Corporation Universal Biosensors, Inc. Uscom Limited 2.406 94.960 46.991 28.077 33.566 85.894 3,500.290 35.912 12.350 11.490 26.322 9.275 371.422 32.621 200.893 25.038 7.552 10.894 2.275 3.509 222.085 22.922 39.284 9.434 75.168 7,486.246 187.863 0.893 52.064 20.058 1.022 321.265 132.779 12.302 -33.3% 81.6% 1.7% 171.4% 22.2% -9.6% -2.0% 30.6% 47.3% 14.3% 55.0% 9.5% 37.8% 100.0% 106.9% 7.1% -22.1% 30.6% -16.7% 66.7% 35.5% 60.0% 202.3% -11.4% 46.9% 13.0% 7.1% -50.0% 28.6% 8.0% 0.0% 0.0% 8.2% 5.9% -48% 287% 3% 217% 32% -3% -10% 24% 16% -2% 82% -23% 15% 6% 1129% 50% 48% 96% 127% -22% 67% 14% 400% -31% 118% 47% -12% -75% 43% -23% 0% 20% -16% 9% Quarterly return Annual return

PwC | BioForum: October 2013

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Companies in the PwC Life Sciences Index

Closing MCap (A$m) Pharma and Biotech ACR ACW AGX ACL ALT ANP AVX AVH BLT BDM BNC BNO BPO BIT BXN BNE CZD CDY CIR CUV CTE CSL GTG HCT IDT IMC IMU IVX CBB LCT MYX MVP MSB NEU NRT NSP PAB PXS POH PYC Acrux Limited Actinogen Limited Agenix Limited Alchemia Limited Analytica Limited Antisense Therapeutics Limited Avexa Limited Avita Medical Limited Benitec Biopharma Limited Biodiem Limited Bioniche Life Sciences Inc Bionomics Limited Bioprospect Limited Biotron Limited Bioxyne Limited Bone Medical Limited Calzada Limited Cellmid Limited Circadian Technologies Limited Clinuvel Pharmaceuticals Limited Cryosite Limited Csl Limited Genetic Technologies Limited Holista Colltech Limited Idt Australia Limited Immuron Limited Imugene Limited Invion Limited Life Corporation Limited Living Cell Technologies Limited Mayne Pharma Group Limited Medical Developments International Limited Mesoblast Limited Neuren Pharmaceuticals Limited Novogen Limited Nusep Limited Patrys Limited Pharmaxis Limited Phosphagenics Limited Phylogica Limited 551.187 0.625 2.068 191.360 10.080 21.614 13.563 39.037 32.745 4.974 37.712 323.236 5.746 22.601 0.978 1.077 31.674 18.864 13.617 60.765 30.316 31,928.804 40.337 9.072 20.291 4.142 3.025 30.076 12.433 31.416 354.980 79.241 1,818.421 125.085 25.236 8.246 16.085 43.197 86.740 9.338

Quarterly return

Annual return

-5.98% -65.00% -17.39% 90.63% -10.00% 40.00% 7.14% -7.69% 5.71% 6.06% -10.00% 141.18% 100.00% 3.66% 0.00% 0.00% 15.71% 12.50% 19.15% -12.15% 51.16% 3.93% -16.84% 16.67% 80.00% 0.00% 125.00% 103.13% 40.00% 109.76% 50.00% 3.94% 7.55% 39.71% -15.38% -4.00% 26.09% -7.14% -35.38% 5.88%

3.12% -79.41% -73.87% 17.31% -14.29% -26.32% -25.00% -11.11% -7.50% -43.55% -32.50% 119.96% 0.00% -5.56% -86.67% -66.67% 76.09% 80.00% -22.22% 1.27% 124.14% 39.13% -28.18% 25.00% 60.00% -66.39% -47.06% 14.04% 40.00% 68.63% 124.11% 5.60% -15.18% 251.85% 129.17% -15.79% -23.68% -88.79% -32.80% -40.00%

27
Companies in the PwC Life Sciences Index

Closing MCap (A$m) PBT PBT PRR PBP PGL PVA QRX RGS SIE SRX SPL TIS VLA Prana Biotechnology Limited Prima Biomed Limited Probiotec Limited Progen Pharmaceuticals Limited. Psivida Corp. Qrxpharma Limited Regeneus Limited Scigen Limited Sirtex Medical Limited Starpharma Holdings Limited Tissue Therapies Limited Viralytics Limited 199.629 49.148 17.467 13.268 112.526 117.276 28.822 27.614 770.930 289.644 68.560 34.035

Quarterly return

Annual return

81.63% -42.65% 17.86% 6.67% 2.75% -25.71% N/A 100.00% 13.61% 26.38% 165.22% 53.06%

97.78% -80.00% -4.35% 2.13% 156.88% 14.71% N/A -11.11% 43.26% -31.33% -22.78% 41.51%

Notes: ACU TEO HIN RGS CBB Company removed from index as trading has been suspended indefinitely pending proposed acquisition of Biolife Science Ltd Company removed from index as trading has been suspended indefinitely pending proposed acquisition of Mimetica Pty Ltd Company delisted from ASX Company added to index after IPO Company changed name from Cordlife Limited to Life Corporation Limited

PwC | BioForum: October 2013

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05
Methodology

29
Methodology

Methodology
Sources
BioForum draws on historical data from the followingsources: Capital IQ Connect 4 The Australian Stock Exchange Company websites PwC Global Pharma and Life Science Quarterly Newsbriefs 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 Life Sciences index is designed as a measure of the health and performance of the industry, not as a measure of returns to investors.

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 twosubsectors: 1. Pharmaceutical/Biotechnology 2. Medical devices These 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.

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 finance markets

IPO and secondary financing 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 financing 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 areincluded) market registration approval

PwC | BioForum: October 2013

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06
Contacts

31

PwC Australia Life Sciences and Innovation Practice contacts

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

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

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

National Pharmaceuticals Leader

John Cannings P: +612 8266 6410 E: john.cannings@au.pwc.com

PwC | BioForum: October 2013

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Acknowledgements

Acknowledgements
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 IndustryLeader Manoj Santiago, Partner, Sydney Life Sciences Industry Leader Michelle Chiang, Partner, Sydney Life Sciences Industry Leader

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