Bioforum Edition 42

8/12/2019 Bioforum Edition 42

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BioForum Edition 42Quarter 2 FY13February 2013

Positive performancecontinues for Biotechs,

but ex-majorsunderperform

www.pwc.com.au/bioforum


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HighlightsHi gh l i gh t s

2

Key developments during the quarter Sirtex Medical was added to the S&P/ASX200 following

the removal of Integra Mining Limited. As of 31 December 2012, Sirtex had a market capitalisation of $732 million.

Mesoblast announced it would go ahead with a1,700-patient phase III trial of Revascor, its heart failuretreatment, in 2013.

The Federal Government called for submissions on Australian pharmaceutical patents and released itsdiscussion paper in November. A panel will review thedegree to which the current patents system suf ciently supports innovation while maintaining competition inthe industry.

CSL shares reached a record $54 after it forecast a

20 percent increase in net pro t in 2013, largely due to the performance of plasma protein subsidiary CSL Behring.

Q2FY13 - Key statistics

- Life Sciences index up 9.4% (Q1FY13 up 13.5%)

- Life Sciences (ex majors) index down 8.2%(Q1FY13 up 6.7%)

- ASX All Ordinaries index up 5.9% (Q1FY13 up 6.6%)

- NASDAQ Biotech down 3.7% (Q1FY13 up 9.9%)


3/32PwC | BioForum: February 2013

Introduction

pwc.com.au/privateclients

Manoj SantiagoPwC Private Clients

3

In the second quarter...

The Australian Life Sciences Index continued on apositive path ending the December quarter with a 9.4per cent gain. This was helped by the performance ofCochlear and CSL which recorded increases of 17.8 percent and 17.2 per cent respectively.

The Index continued to outperform the All OrdinariesIndex, which grew 5.9 per cent, its highest level sinceJune 2011. Quarterly results for the Australian LifeScience Index were down on Q1 FY13 when the indexrose by 13.5 per cent.

For the rst time since Q1 FY12, the NASDAQ BiotechIndex fell. At one point during the quarter it wasdown close to 8%, only to rebound after US electionsgiven the bene ts to the Life Sciences industrycontained in President Obamas healthcare plan TheNASDAQ Composite fell 3.1 per cent, impacted by theuncertainty of the US elections and scal policy

Sector performance in detail

It was a lacklustre start to the quarter for the LifeSciences Index ex majors which posted a loss of 8.2 percent, off the back of an 11.2 per cent fall last quarter.The result was led by the weaker performance of non-major Med Device companies including Unilife (-27 percent) and Reva Medical (- 22 per cent).

Over the past 12 months the ex-majors trails the LifeScience Index by 42.6 percent and the All OrdinariesIndex by 14 per cent.

The weak performance of ex-majors was largely causedby Medical Devices companies, with this index down10.8%. The Pharma/Biotech index ex CSL was down6.9% in comparison.

IPOs and secondary raisings

There were no Australian IPOs in the second quarterbut domestic secondary nancing is up with 34 raisingstotalling $136m. This was led by Mayne Pharmaraising $84m to fund acquisitions. In the US, there were four IPOs this quarter, three in the Biotech sectorand one in Medical Devices, collectively totalling $232million. There were also 74 raisings totalling $16.1bn,a gure massively in ated by four raisings by AbbottLaboratories subsidiary, AbbVie totalling $AU14.1bn.

Commentary

Small and midsized Life Sciences companies continue tounderperform despite a promising pipeline of products which is a worrying sign, said Manoj Santiago, PwC LifeSciences partner. Two quarters do not make a trend,but as we move into the remainder of the year well see whether this identi es itself as a persistent gap and, if so, what the underlying causes are.

Whether or not this manifests as a long term trend, itsclear there is currently scepticism in the marketplace,particularly focused on company boards. To alleviate

this, Life Sciences companies need to be managingshareholder and market expectations better andcommunicating realistic goals, said Mr Santiago.

Within the Life Sciences industry, we are beginningto see an alignment of executive remuneration andshareholder earnings which is an indicator of how well boards can meet promises and how this ismatched to remuneration, said Mr Santiago. Therecan be a temptation for companies to offer sizeableremuneration to increase the pro le of their board, butthis can only be effective to a certain extent in such anunforgiving market.

I n t r o d u c t i o n

Each quarter Bioforum reports on the Australian and US pharmaceutical,biotechnology and medical devices marketsand the broader life sciences industry. As wellas reviewing market performance, BioForumcovers initial and secondary capital raisings,clinical milestones, partnerships and mergersand acquisitions.


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PwC MoneyTree ReportThe report is a quarterly study of venture capital investment activity in theUnited States. As a collaboration between PwC and the National VentureCapital Association based on data from Thomson Reuters, it is the onlyindustry-endorsed research of its kind.

4 Key Developments

US venture capitalUS venture capitalists invested $26.5 billion in 3,698 deals in 2012. This was 10 percent less than 2011 in dollarterms and 6 percent less in deal volume, according to the latest MoneyTree report prepared by PwC and the US National Venture Capital Association.

Biotechnology investment dollars declined 15 percent to US$4.1 billion, with volume at at 466 deals, but thesector was still the second largest for the year in terms of dollars and deals.

In the fourth quarter of 2012, US$1.3 billion was invested in 135 biotechnology companies. This was anincrease of 3 percent in dollars and 13 percent in the number of deals from the third quarter, when US$1.2billion went into 119 rounds.

Investment in medical devices fell 13 percent in dollar terms and 15 percent in deals in 2012, nishing the year with US$2.4 billion going into 313 deals. Still, in the fourth quarter, medical devices investment was up32 percent in dollar terms and 9 percent in deals from Q3 2012, with US$581 million going into 74 deals.

The life sciences sector (biotech and medical devices combined) accounted for 25 percent of all venture capitaldollars invested in 2012, compared to 26 percent in 2011. Much of the decline occurred in rst-time nancings, where both biotechnology and medical devices recorded the lowest number of deals since 1995.

0

2,000

4,000

6,000

8,000

10,000

$ U S D m

Medical Devices and Equipment Biotech

4,9703,972 3,945

4,8864,148

3,601

2,6022,309

2,814

2,439

2008 2009 2010 2011 2012

BiotechMedical Devices and Equipment

531459 498 468 466

398

343346 368

313

200

0

400

600

800

1,000

2008 2009 2010 2011 2012

N u m b e r o f d e a l s

29,921

20,381

23,315

29,463

26,525

5,000

10,000

15,000

20,000

25,000

30,000

35,000

2008 2009 2010 2011 2012

Total US VC funding

0

$ U S D m

Total US VC deals

4,163

3,1403,622

3,937 3,698

1,000

0

2,000

3,000

4,000

5,000

2008 2009 2010 2011 2012

N u m b e r o f d e a l s

Yearly Life Sciences VC Funding Dollars

Yearly Life Sciences VC Funding Volume

Yearly Total VC Funding Dollars

Yearly Total VC Funding Volume



06 Quarterlykey ndings

08 Marketperformance

18 Announcements

23 Appendix

27 Methodology

29 Contacts

C o n t e n t s

5

Contents
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6

01Quarterlykey fndings



Q u ar t e r l y k e y f n d i n g s

7

Quarterly key fndings

Market performance Q2 FY13 Page

Life sciences industry total MCap A$44,604m 9

Life sciences industry growth 9.4%

Pharma/biotech sector total MCap A$32,006m 11

Pharma/biotech sector growth 11.4%

Medical device sector total MCap A$12,598m 11

Medical device sector growth 4.6%Individual company performance

Top individual performer Uscom Limited 16

Change in market cap over the past four quarters 199%

Bottom individual performer Bioxyne Ltd 17

Change in market cap over the past four quarters -93%

Financing

Australian IPO count 0 12

Total raised A$m

US IPO count 4 12

Total raised A$232m

Australian secondary nancing count 34 14

Total raised A$136m

US secondary nancing count 74 14

Total raised A$16,105m

Announcements Q4 FY13 Page

Australia

Partnerships 10 19

Mergers & acquisitions 10 20

Clinical trials 13 21

Regulatory 8 22

Other 7 22


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ASX All Ordinaries (Index) NASDAQ Composite (Index) NASDAQ Biotech (Index) Life Sciences(market cap A$m)

Life Sciences ex majors(market cap A$m)

% Change (Jun-Sep) % Change (Sep-Dec)

-10.0%

-5.0%

0.0%

5.0%

10.0%

15.0%

6.6% 5.9% 6.2%

-3.1%

9.9%

-3.7%

13.5%

9.4%

6.7%

-8.2%

-60%

-40%-20%

0%

20%

40%

60%

80%

ASX All Ordinaries NASDAQ Composite NASDAQ Biotech Life Sciences Life Sciences ex majors

31-Dec-10 31-Mar-11 30-Jun-11 30-Sep-11 31-Dec-11 31-Mar-12 30-Jun-12 30-Sep-12 31-Dec-12

Figure 1: Weekly performance over the quarter of the Australian life sciences compared to major indices

ASX All Ordinaries Life Sciences Life Sciences ex majorsNASDAQ BiotechNASDAQ Composite

-10%

-5%

0%

5%

10%

15%

30-Sep 05-Oct 12-Oct 19-Oct 26-Oct 02-Nov 09-Nov 16-Nov 23-Nov 30-Nov 07-Dec 14-Dec 21-Dec 28-Dec 31-Dec

Graph 1: Quarterly movements of the Australian life sciences sector compared to major indices

M ar k e t p e r f or m a n c e

9

Performance overview

Figure 2: Two-year comparison of the Australian life sciences sector by market capitalisation compared to major indices

Table 1: Quarterly movements of the Australian life sciences sector compared to major indices

Value

30-Jun-12 30-Sep-12 31-Dec-12% Change(Jun-Sep)

% Change(Sep-Dec)

ASX All Ordinaries (Index) 4,135 4,406 4,665 6.6% 5.9%

NASDAQ Composite (Index) 2,935 3,116 3,020 6.2% -3.1%

NASDAQ Biotech (Index) 1,352 1,486 1,431 9.9% -3.7%

Life Sciences (market cap A$m) 35,934 40,786 44,604 13.5% 9.4%

Life Sciences ex majors (market cap A$m) 7,730 8,249 7,573 6.7% -8.2%


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11

Life Sciences Life Sciences ex majors Pharma/Biotech Pharma/Biotech ex CSL Med Device Med Device ex COH, RMD

-40%

-20%

0%

20%

40%

60%

31-Dec-10 31-Mar-11 30-Jun-11 30-Sep-11 31-Dec-11 31-Mar-12 30-Jun-12 30-Sep-12 31-Dec-12

Figure 4: Two-year comparison of the Australian life sciences indices performance by market capitalisation

Graph 3: Quarterly performance of the Australian life sciences sector and subsectors by market capitalisation

% Change (Jun-Sep) % Change (Sep-Dec)

Pharma/Biotech Pharma/Biotech ex CSL Med Device Med Device ex COH, RMD Life Sciences Life Sciences ex majors-15.0%

-10.0%

-5.0%

0.0%

5.0%

10.0%

15.0%

20.0%

14.4%

8.7%

11.5%

3.0%

13.5%

6.7%

11.3%

-6.9%

4.6%

-10.8%

9.4%

-8.2%

Table 4: Quarterly performance of the Australian life sciences sectors by market capitalisation $A$m

Market capitalisation (A$m)

30-Jun-12 30-Sep-12 31-Dec-12% Change(Jun-Sep)

% Change(Sep-Dec)

Pharma/Biotech 25,136 28,744 32,006 14.4% 11.3%

Pharma/Biotech ex CSL 5,062 5,501 5,123 8.7% -6.9%

Med Device 10,799 12,041 12,598 11.5% 4.6%

Med Device ex COH, RMD 2,668 2,747 2,450 3.0% -10.8%

Life Sciences 35,934 40,786 44,604 13.5% 9.4%

Life Sciences ex majors 7,730 8,249 7,573 6.7% -8.2%


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12

40

0

10

20

30

40

50

Q2FY12 Q3FY12 Q4FY12 Q1FY13 Q2FY13

C a p i t a l R a i s e d

( A $ m ) *

Medical Devices Biotech

0

50

100

150

200

250

300

350

400

Q2FY12 Q3FY12 Q4FY12 Q1FY13 Q2FY13

C a p i t a l R a i s e d ( A

$ m ) *

Med ical Dev ices Biotech

158

284

95

187

12

49

95

229

4

Figure 5: Quarterly comparison of IPOs in Australia

Figure 6: Quarterly comparison of IPOs in the US

Mar k e t pe r f or manc e

Quarterly fnancing

IPO fnancing

Note: * Amount shown is total market cap addition to the LS Indexfrom IPOs on rst day of trading

Note: * Amount shown is total market cap addition to the LS Indexfrom IPOs on rst day of trading

Table 5: Number of quarterly Australian IPO listings

Biotech Med Devices ASX

Q2FY13 - - 17

Q1FY13 - - 9

Q4FY12 - 1 13

Q3FY12 - - 12

Q2FY12 - - 20

Table 7: Total of quarterly US IPO listings

Biotech Med Devices

Q2FY13 3 1

Q1FY13 1 1

Q4FY12 3 1

Q3FY12 3 -

Q2FY12 6 2

Table 6: Listing of quarterly Australian IPO listings

Company Listing date

Capitalraised

(A$) Valuationon listing Sector

None

Total -

Table 8: Listing of quarterly US IPO listing

Company Listing date

Capitalraised

(A$m) Sector

Regulus Therapeutics Inc 04/10/2012 44 Biotech

KYTHERABiopharmaceuticals Inc

10/10/2012 68 Biotech

Puma Biotechnology Inc 18/10/2012 117 Biotech

Atossa Genetics Inc 07/11/2012 4 MedDevices

Total 232




13

Medical Dev ices B io tech

0

100

200

300

400

500

600


$ m )

FY09 FY10 FY11 FY12 FY13

724

145

360

360

Medical Dev ices B io tech

0

500

1,000

1,500

2,000

2,500


$ m )


6

1,662

251

368

458675

107

277

99

Figure 7: Annual comparisons of IPOs in Australia

Figure 8: Annual comparison of IPOs in the US Table 10: Number of IPO listings in the US

Biotech Med Devices

FY13 4 2

FY12 13 4

FY11 6 8

FY10 7 2

FY09 - 1

Yearly fnancing

Table 9: Number of IPO listings in Australia

Biotech Med Devices ASX

FY13 - - 17

FY12 - 2 75

FY11 1 1 127

FY10 1 - 53

FY09 1 - 24


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Yearly fnancing


15


0

500

1,000

1,500

2,000

2,500


$ m )


2,081

71

246

271

383

95

294

55

13929



$ m )

0

5,000

10,000

15,000

20,000

25,000


3,330

7195,974

2,400

1,493

5,5785,429

776

17,603

1,667

Figure 11: Annual comparison of secondary nancingin Australia

Figure 12: Annual comparison of secondary nancing in the US

Table 13: Number of Australian secondary raisings

Biotech Med Devices

FY13 46 20

FY12 99 39

FY11 154 43

FY10 107 39

FY09 87 41

Table 14: Number of US secondary raisings

Biotech Med Devices

FY13 105 44

FY12 138 42

FY11 70 121

FY10 122 57

FY09 48 24


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Mar k e t pe r f or manc e

16

Performers over past four quarters

Top 10

01 Uscom LtdReturn: 199%Closing price: $0.20MCap: A$12.63m

Uscom completed a $1.2m capital raising and recorded sales of $800k in FY12.The company cut cash burn and posted a loss after tax of $1.8m, down 32%from FY11.

02 Sirtex Medical LtdReturn: 193%Closing price: $13.13MCap: A$732.24m

Sirtex reported its annual pro t before tax was up 54% to $2.1m. TheSeptember quarter was Sirtexs 33rd consecutive quarter of growth. Dose salesof SIR-Spheres microspheres, the companys liver cancer treatment, were up23% from FY11. Pro t rose 54% to $22.1m and dividends 42% to $5.56m yearon year.

03 Medical Developments International LtdReturn: 188%Closing price: $1.67MCap: A$94.72m

The company signed a licensing agreement with Nippon Zoki Pharmaceutical, which comprised an initial payment of $100k, and another agreement withCSIRO worth $750k. It also won a ve year tender with several Canadianhospitals. MDIs pro t was up 55% to $2.7m and it paid two separate$0.03 dividends.

04 Cryosite LtdReturn: 162%Closing price: $0.38MCap: A$17.72m

Cryosite forecast a pro t after tax of $1.022m compared to $330k the prior year due to organic growth, cost savings and productivity growth. It paid itsrst dividend of 0.5c a share and agreed with Regeneus to develop a protocolfor the cryopreservation of human stem cells.

05 Clover Corporation LtdReturn: 93%Closing price: $0.58MCap: A$95.81m

Pro t for the 12 months ended 31 July 2012 was $4.4m after tax. Normalisedsales revenue rose 20% to $38.4m and Clover paid a fully franked dividend of1.5c a share.

06 ITL LtdReturn: 86%Closing price: $0.21MCap: A$19.66m

The company completed a restructure involving the sale of its Malaysiandistributor for $1.1m. It announced a net pro t of $1.3m, completed a debtrestructure and reduced its inventory holdings by $4m. Management boughtback 29% of issued capital for $6.55m.

07 CSL LtdReturn: 68%Closing price: $53.90MCap: A$26,882.95m

CSL informed the market that NPAT for scal 2013 was expected to be 20%higher than previous forecasts due to an improved sales mix, supply chainef ciencies and higher than expected royalty income from Gardasil sales.The company announced a $900m on market share buyback, which boostedEPS by 4%.

08 Novogen LtdReturn: 65%Closing price: $0.17MCap: A$17.13m

Novogen announced it had acquired 100% of Triaxial Pharmaceuticals. Pro tfor FY12 rose 120% to $1.3m.

09 ResMed IncReturn: 60%Closing price: $3.94MCap: A$5,637.17m

ResMed posted a record September quarter result, with revenues up 8%to $340m compared to September 2011, while June quarter revenue wasup 9% to $372m.

10 Suda LtdReturn: 52%

Closing price: $0.03MCap: A$20.21m

The company had a strong September quarter, with its share price rising 169%,and recruited patients for a phase III trial of its ArTiMist technology. The pricerise was largely unexplained, prompting an ASX quer y.

0% 50% 100% 150% 250%200%

UCM

SRX

MVP

CTE

CLV

ITD

CSL

NRT

RMD

SUD



10 Medical Australia LtdReturn: -56%Closing price: $0.008MCap: A$3.63m

A loss of $670k after tax was recorded for FY12. This was an increase of $330k onthe prior year.

09 Bone Medical LtdReturn: -60%Closing price: $0.002MCap: A$.95m

The company posted a loss of $1.58m and revenues decreased 92%. It continued toraise cash through convertible notes during the year.

08 Medivac LtdReturn: -68%Closing price: $0.006MCap: A$3.89m

Signi cant delays in receiving regulatory approval put pressure on cash resources andrequired redundancies and cost cutting. Losses for FY12 totalled $3.49m after tax, upfrom a loss of $2.32m in FY11.

07 BioProspect LtdReturn: -75%Closing price: $0.001MCap: A$2.28m

BioProspect posted a loss of $3.3m for FY12, with sales of Regen products down$245k to $49k, and impairment costs of $300k.

06 Actinogen LtdReturn: -80%Closing price: $0.010MCap: A$.89m

Actinogen posted a loss of $1.53m after tax in FY12, compared to $740k in FY11, which included a $667k goodwill impairment.

05 Immuron LtdReturn: -80%Closing price: $0.010MCap: A$4.14m

The company issued $2.4m in shares, posted a loss of $2.3m and budgeted fornegative cash ow for FY13.

04 HealthLinx Ltd Return: -83%Closing price: $0.002MCap: A$1.39m

A heads of agreement with Mane DX involving the sale of HealthLinxs ovarian cancerassets expired in December. HealthLinx posted a net loss for the year of $2.3m.CEO Nick Gatsios resigned in November.

03 ImpediMed LtdReturn: -85%Closing price: $0.080MCap: A$14.51m

ImpediMed posted a loss of $12.3m, an improvement on the prior nancial year, butrevenue fell $990k. US sales of the companys L-Dex U400 uid status assessmentdevices were slower than expected.

02 Agenix LtdReturn: -92%Closing price: $0.023MCap: A$.91m

The company recorded a loss of $1.36m for FY12. A series of equity raisings wereheld throughout the year. In December, Agenix said a payment relating to a xedsubscription agreement would not be paid.

01 Bioxyne LtdReturn: -93%

Closing price: $0.014MCap: A$2.16m

The companys phase IIb COPD trial had disappointing results, revealing no

statistically signi cant clinical bene t across the entire cohort of patients. However,clinical bene ts were observed for patients under 65 years.


17

Performers over past four quarters

Bottom 10

-100% -90% -80% -70% -50%-60% -40% -30% -20% -10% 0%

MLA

BNE

MDV

BPO

ACW

IMC

HTX

IPD

AGX

BXN


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Announcements

18

03


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A n n o u n c e m e n t s

21

Clinical trialsCompany Drug Application Comments

Pre-clinical Total 2

Allied Healthcare Group Ltd(AHZ)

CardioCel Heart valvereconstruction

Allied reported successful results from a pre-clinical study ofthe use of CardioCel to repair heart valves.

Bionomics Ltd (BNO) BNC375 Alzheimers disease Pre-clinical modelling identi ed a new compound withprospects as an Alzheimers treatment.

Phase I Total 2

Living Cell Technologies Ltd(LCT)

Diabecell Type I Diabetes Living Cell said an interim analysis of its phase I/IIa trial inDiabecell showed signi cant bene ts of the treatment.

Neuren Pharmaceuticals Ltd(NEU)

NNZ-2566 Rett Syndrome The company announced that a phase I study of an oralformulation of NNZ-2566 was successful.

Phase II Total 1

Clinuvel Pharmaceuticals Ltd(CUV)

Scenesse Vitiligo Clinuvel announced successful results from its phaseIIa pilot study, showing Scenesse signi cantly improvesrepigmentation in vitiligo patients compared to NB-UVB.

Phase III Total 3

Bioniche Life Sciences (BNC) Urocidin Bladder cancer The company discontinued its phase III tr ial for Urocidin dueto low recruitment and issues with the trial design.

Healthlinx Ltd (HTX) OvPlex Ovarian cancer The primary endpoint in Healthlinxs second clinical study to validate the diagnostic performance of OvPlex was achieved.

Starpharma Holdings Ltd (SPL) VivaGel Bacterial vaginosis Two phase III studies of ViviGel showed statisticallysigni cant cure and resolution of patient reported symptoms,but the primary endpoint of clinical cure after 2-3 weeks wasnot met.

Other Total 5

Allied Healthcare Group Ltd(AHZ)

HPV Vaccine HPV infection An initial study of a novel HPV vaccine was successful.The vaccine is in development by Allieds investmentcompany Coridon.

Avexa Ltd (AVX) AVX13616 Anti-bacterialcompound

The companys research partner announced positive resultsfrom trials against a broad range of bacteria.

Benitec Ltd (BLT) Oculopharyngealmusculardystrophyprogram

Gene silencing Early data from a joint study between Benitec and the RoyalHolloway at the University of London demonstrated thesilencer was highly ef cient.

Gi Dynamics Inc (GID) EndoBarrier Weight Loss GI Dynamics said a study evaluating the long term bene tsof EndoBarrier showed that the treatment provides sustained weight loss bene ts in patients when re-implanted for anadditional year.

Sirtex Medical Ltd (SRX) SIR-SpheresMicrospheres Metastatic colorectalcancer A newly published study showed patients experienced astatistically signi cant survival bene t from treatment withSIR spheres microspheres compared to the best availablealternate treatments.


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22

A nnounc e me nt s

Regulatory Company Product Application Comments

Biotech Total 6

BioDiem Ltd (BDM) BDM-I Antimicrobialcompound

The Japanese Patent Of ce granted the company a patent forBDM-I.

Benitec Ltd (BLT) RNAi agents Genetic encoding The Chinese Patent Of ce granted a patent to Benitec forMultiple promoter expression cassettes for simultaneousdelivery of RNAi agents

Bone Medical Ltd (BNE) Axcess IV Osteoporosis Bone Medicals oral peptide technology was granted a patentin China.

NuSep Ltd (NSP) In-vitro diagnosticsmedical devices

NuSep was accredited by the TGA for the manufacture of itsIVF devices.

Novogen Ltd (NRT) ME-344 Composition of ME-

344 and its uses intreating cancer

The European Patent Of ce granted Novogens subsidiary

Marshall Edwards a patent on the composition and uses ofME-344 until 2025.

Starpharma Holdings Ltd(SPL)

Docetaxel Cancer An animal trial showed Starpharmas dendrimer-enhanced version of docetaxel had superior anti-cancer effects across arange of cancers when compared to Taxotere.

Medical devices Total 2

Atcor Medical Holdings Ltd(ACG)

SphygmoCor Aortic blood pressuremeasurement

The FDA granted the company clearance to market theSphygmoCor XCL system in the US.

Heartware International Inc(HIN)

Ventricular AssistSystem

Heart transplantation The company announced that the FDA has approvedits Ventricular Assist System and it will commencecommercialisation immediately.

Other newsCompany Product Application Comments

Biotech Total 6

Alchemia Ltd (ACL) N/A N/A Alchemia announced it has been unable to secure suf cientinvestment for its subsidiary Audeo Oncology and theproposed demerger will not proceed in the short term.

NuSep Ltd (NSP) N/A N/A NuSep will spin off its therapeutic plasma business, PrimeBiologics, which is valued at $46m. The new company isexpected to list on the ASX in May 2013 and will remain 10%owned by NuSep.

Genetic Technologies Ltd(GTG)

N/A N/A Dr Mel Bridges and director Huw Jones were voted off theboard, prompting the resignation of CEO Dr Paul MacLeman,director Greg Brown and head of legal and corporateDr David Spurling.

Genetic Technologies Ltd(GTG)

N/A N/A The company has led multiple patent infringement suits inassociation with Sheridan Ross in respect of its non-codingDNA technologies.

CSL Ltd (CSL) N/A N/A CSL rebranded CSL Biotherapies to CSL Behring, in line with global operations, and created a new title bioCSLfor the companys vaccine, pharmaceuticals and in-vitrodiagnostics operations.

Mesoblast Ltd (MSB) MesenchymalPrecursor CellTechnology

Regenerativemedicine

Mesoblast has reached an agreement with the FDA on themanufacturing process it will use to supply MPC cells for itsupcoming phase III clinical trials.

Medical devices Total 1

Sunshine Heart Inc (SHC) C-Pulse Heart assist system Sunshine Heart was awarded the 2012 North AmericanHeart Failure Treatment New Product Innovation award forits Heart Assist System.


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Closing MCap (A$m) Quarterly return Annual return

Medical device

AMT Advanced Surgical Design & Manufacture Limited 3.79 -22% -45%

AHZ Allied Healthcare Group Ltd 18.70 -9% -48%

ADO Anteo Diagnostics Limited 48.51 7% -15%

ACG Atcor Medical Holdings Limited 10.55 17% -15%

BRC Brain Resource Company Limited (The) 22.47 -2% 7%

CLV Clover Corporation Limited 95.81 8% 93%

COH Cochlear Limited 4510.81 18% 28%

CGS Cogstate Ltd 25.07 -13% 38%

CMP Compumedics Limited 11.99 6% -18%

CYC Cyclopharm Limited 9.88 -17% -15%

ELX Ellex Medical Lasers Limited 16.13 12% 46%

GBI Genera Biosystems Limited 9.97 -20% -17%

GID GI Dynamics Inc 157.48 -23% -41%

HIN Heartware International, Inc 1115.74 -14% 17%

IPD Impedimed Limited 14.51 -53% -85%

ISN Isonea Limited 15.29 16% -46%

ITD ITL Limited 19.66 2% 86%

LBT Labtech Systems Limited 5.66 14% 50%

MLA Medical Australia Limited 3.63 -33% -56%

MGZ Medigard Limited 1.46 45% 0%

MDV Medivac Limited 3.89 0% -68%

MDG Medtech Global Limited 3.51 -22% -30%

NAN Nanosonics Limited 126.67 -1% -19%

NDL Neurodiscovery Limited 2.42 -4% -22%

OBJ OBJ Limited 21.97 36% 6%

OIL Optiscan Imaging Limited 14.12 -2% -30%

OSP Osprey Medical Inc 41.69 27% 1%

RMD Resmed Inc 5637.17 2% 60%

RVA Reva Medical 164.56 -22% -15%

SFP Safety Medical Products Limited 3.17 0% 14%

SOM Somnomed Limited 35.14 -1% -10%SUD Suda Limited 20.21 -3% 62%

SHC Sunshine Heart, Inc. 61.24 -18% -8%

TDX Tyrian Diagnostics Limited 1.02 0% -50%

UNS Unilife Corporation 172.35 -27% -32%

UBI Universal Biosensors, Inc. 157.88 6% 22%

UCM Uscom Limited 12.63 21% 199%

24

C om pani e s i nt h e P wC L i f e S c i e nc e s I nd e x

Companies in the PwC Life Sciences Index




Pharma and Biotech

ACR Acrux Limited 474.52 -11% -1%

ACW Actinogen Limited 0.89 -71% -80%

ACU Acuvax Limited 2.46 0% 0%

AGX Agenix Limited 0.91 -69% -92%

ACL Alchemia Limited 108.11 -26% 28%

ALT Analytica Limited 12.32 5% 16%

ANP Antisense Therapeutics Limited 15.82 -42% -52%

AVX Avexa Limited 16.11 -5% -39%

AVH Avita Medical Ltd 38.99 -11% -4%

BLT Benitec Limited 14.69 -13% -7%

BDM Biodiem Limited 5.97 -32% -50%

BNC Bioniche Life Sciences 33.21 -20% -51%

BNO Bionomics Limited 131.30 -4% -39%

BPO Bioprospect Limited 2.28 -50% -75%

BIT Biotron Limited 30.82 50% 8%

BXN Bioxyne Ltd 2.16 -53% -93%

BNE Bone Medical Limited 0.95 -33% -60%

CZD Calzada Limited 16.29 2% -16%

CDY Cellmid Limited 8.18 0% -6%

CIR Circadian Technologies Limited 17.02 -3% -26%

CUV Clinuvel Pharmaceuticals Limited 63.53 17% 18%

CBB Cordlife Limited 7.77 -10% -34%

CTE Cryosite Limited 17.72 31% 162%

CSL CSL Limited 26882.95 17% 68%

GTG Genetic Technologies Limited 33.72 -35% -35%

HTX Healthlinx Limited 1.39 0% -83%

HCT Holista Colltech Limited 9.46 30% -37%

IMC Immuron Limited 4.14 -41% -80%

IMU Imugene Limited 3.78 -35% -8%

IDT Institute Of Drug Technology Australia Limited 9.50 -2% -44%

IVX Invion Limited 21.92 0% -10%

LCT Living Cell Technologies Limited 17.85 -2% 9%

MYX Mayne Pharma Group Limited 163.66 4% -23%

MVP Medical Developments International Limited 94.72 34% 188%

MSB Mesoblast Limited 1521.80 -21% -23%

NLS Narhex Life Sciences Limited 3.01 40% -36%

NEU Neuren Pharmaceuticals Limited 41.40 30% 30%

NRT Novogen Limited 17.13 129% 65%

NSP Nusep Limited 9.63 32% 7%

PAB Patrys Limited 19.28 0% 12%

C o m p a n i e s i n t h e P w C L i f e S c i e n c e s I n d e x

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26

C om pani e s i nt h e P wC L i f e S c i e nc e s I nd e x


Pharma and Biotech (continued)

PXS Pharmaxis Ltd 382.59 7% 19%

POH Phosphagenics Limited 147.93 16% -31%

PYC Phylogica Limited 11.15 -17% -38%

PBT Prana Biotechnology Limited 71.54 -7% 35%

PRR Prima Biomed Ltd 117.27 -44% -31%

PBP Probiotec Limited 23.53 22% 5%

PGL Progen Pharmaceuticals Limited. 7.41 15% 50%

PVA Psivida Corp. 30.29 -19% 4%

QRX Qrxpharma Limited 130.16 32% -40%

SIE Scigen Limited 22.09 -11% -41%

SRX Sirtex Medical Limited 732.24 38% 193%

SPL Starpharma Holdings Limited 368.73 -13% 14%

TEO Telesso Technologies Limited 0.60 -50% -47%

TIS Tissue Therapies Limited 53.48 -22% -19%

VLA Viralytics Limited 29.21 26% 0%

Notes:BTA Biota Holdings removed from ASX and from Life Sciences index following merger with Nabi Pharmaceuticals to form Biota

Pharmaceuticals (NASDAQ: BOTA)

CXD Company voluntarily delisted from the ASX in December 2012

SLA Company removed from index subsequent to suspension from trading

SUD Eastland Medical Systems changed name to Suda Limited, including an ASX code change from EMS to SUD


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Me t h od ol o g y SourcesBioForum draws on historical data from the

following sources: Bloomberg Connect 4 The Australian Stock Exchange Company websites PwC Global Pharma and Life Science

Quarterly Newsbriefs

Market performanceThe Australian life sciences sectors marketperformance 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-capitalisationstocks can be observed.The PwC Life Sciences Index is based on the performanceof life sciences companies listed on the AustralianSecurities Exchange (ASX). It comprises two subsectors:1. Pharmaceutical / Biotechnology

2. Medical devicesThese sectors have been classi ed according to theGlobal Industry Classi cation Standard. The indexincludes life sciences companies primarily involvedin research, development, commercialisation andmanufacturing of pharmaceutical and biotechnologyproducts and medical devices. It excludes healthcare,medical software and distribution companies.Companies included in the PwC Life Sciences Index arelisted at the end of each issue of BioForum .The PwC Life Sciences Index is based on the combinedmarket capitalisation of the listed companies andcalculates the change of their value over the quarterand change over the previous year. These changes arecompared to the changes in the market performance ofthe following indices: ASX All Ordinaries NASDAQ Composite NASDAQ Biotech

Different formulae are used to calculate the valueof these indices and track their performance. Theseformulae use a combination of company market pricesand a weighted average of market capitalisation.Because of these different methods of calculating value, the absolute value of the indices cannot bedirectly compared. Only their changes over time can besensibly compared.The index is designed as a measure of the health andperformance of the industry, not as a measure ofreturns to investors.

Top and bottom performers

Annual data on these companies is sourced fromBloomberg each quarter. Company announcements aresourced from company websites.

IPO and secondary fnance marketsIPO and secondary nancing data is sourced from theConnect 4 databases health-care industry category. Weinclude data from companies on the PwC Life SciencesIndex only. Data on options, rights and bonus issues isexcluded. The US IPO and secondary nancing data issourced from Thompson Reuters.

Announcements

These are from companies listed on the PwCLife Sciences Index only. They are sourced fromConnect 4 using the health-care industry category.We include announcements on partnerships, mergersand acquisitions and divestments, clinical results,regulatory activity and other information. Announcements on the following are excluded: trading halts capital raisings proposed (versus actual) mergers,

acquisitions and partnerships progress reports on clinical trials

(results only are included) market registration approval

Methodology



06

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Contacts


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PwC Australia Life Sciencesand Innovation Practice contacts

30

Australian Industry Leaders Life Sciences

PwC Australia Life SciencesCraig LawnP: +612 8266 0147E: [email protected]

Michelle ChiangP: +612 8266 7575E: [email protected]

Manoj SantiagoP: +612 8266 4494E: [email protected]

Assurance

Manoj SantiagoP: +612 8266 4494E: [email protected]

Michelle ChiangP: +612 8266 7575E: [email protected]

Tax and Legal

Craig LawnP: +612 8266 0147E: [email protected]

Sandra MasonP: +612 8266 0470E: [email protected]

Stephanie FabianP: +612 4925 1278E: [email protected]

National Pharmaceuticals Leader

John CanningsP: +612 8266 6410E: [email protected]



Written and edited by:PwC (pwc.com.au), a global professional servicesorganisation serving the life sciences sector and otherindustries with the help of editor and proofreaderKaren Hunt.

Quantitative research, analysisand writing:Max Oke, Consultant

PwC Life Sciences Practicecontributors:Craig Lawn, Partner, National Life SciencesIndustry Leader

Manoj Santiago, Partner, Sydney Life SciencesIndustry Leader

Michelle Chiang, Partner, Sydney Life SciencesIndustry Leader

A c k n ow l e d g e m e n t s

Acknowledgements

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